諾和諾德 (NVO) 2023 Q2 法說會逐字稿

內容摘要

諾和諾德 (Novo Nordisk) 報告稱,在糖尿病和肥胖症治療需求不斷增長的推動下,2023 年上半年銷售額和營業利潤增長強勁。他們在北美和國際運營部門實現了銷售增長,其中 GLP-1 銷售額增長了 50%,肥胖症銷售額增長了 157%。

該公司還宣布了其肥胖藥物索馬魯肽的心血管結果試驗的積極結果。諾和諾德在可持續發展目標方面取得了進展,並強調了其他研發里程碑。儘管費用增加,但營業利潤和淨利潤雙雙增長。

該公司上調了全年預期,預計銷售額和利潤將持續增長。諾和諾德對未來持樂觀態度,正在為新產品的推出做準備。他們正在解決供應鏈問題並致力於美國的商業准入。

諾和諾德仍然致力於其增長戰略,並做出了支持未來增長的投資決策。

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 Q2 2023 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, Daniel Bohsen, Head of Investor Relations. Go ahead.

    美好的一天,感謝您的支持。歡迎參加諾和諾德公司 2023 年第二季度收益電話會議。 (操作員指示)請注意,今天的會議正在錄製中。現在我想將會議交給今天的發言人、投資者關係主管丹尼爾·博森 (Daniel Bohsen)。前進。

  • Daniel Bohsen - CVP & Head of IR

    Daniel Bohsen - CVP & Head of IR

  • Thank you. Welcome to this Novo Nordisk earnings call for the first 6 months of 2023 and the outlook for the year. My name is Daniel Bohsen, and I'm Head of Investor Relations at Novo Nordisk. With me today, I have CEO of Novo Norsk, Lars 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 Knudsen.

    謝謝。歡迎參加諾和諾德 2023 年前 6 個月的財報電話會議以及今年的展望。我叫丹尼爾·博森 (Daniel Bohsen),是諾和諾德 (Novo Nordisk) 投資者關係主管。今天和我在一起的還有諾和諾斯克 (Novo Norsk) 首席執行官拉爾斯·喬根森 (Lars Jorgensen);執行副總裁兼商業戰略和企業事務主管 Camilla Sylvest;執行副總裁兼北美運營主管 Doug Langa;執行副總裁兼開發主管 Martin Holst Lange;最後是首席財務官 Karsten 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 this call is being webcast live and a recording will be made available on our website as well. The call is scheduled to last approximately 1 hour. Please turn to the next slide.

    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 上獲取。請注意,本次電話會議正在進行網絡直播,錄音也將在我們的網站上提供。通話預計持續約 1 小時。請翻到下一張幻燈片。

  • 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. Please turn to the next slide. As always, 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.

    該演示文稿的結構如幻燈片 2 所示。請注意,除非另有說明,所有銷售和營業利潤增長報表均採用固定匯率。請翻到下一張幻燈片。與往常一樣,我們需要告知您,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存在重大差異。

  • For further information on the risk factors, please see the company announcement for the first 6 months of this year and the slides prepared for this presentation. With that, over to you, Lars, for an update on our strategic aspirations.

    有關風險因素的更多信息,請參閱公司今年前 6 個月的公告以及為本次演示準備的幻燈片。現在,拉斯,請您了解我們戰略願景的最新情況。

  • 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 the first 6 months of 2023, we delivered 30% sales and 32% operating profit growth, which has enabled us to raise our outlook for the full year. I would like to start this call by going through the performance highlights across our strategic aspirations before handing over the word to my colleagues.

    謝謝你,丹尼爾。請翻到下一張幻燈片。 2023 年前 6 個月,我們實現了 30% 的銷售額和 32% 的營業利潤增長,這使我們能夠提高全年的預期。在向我的同事們傳達信息之前,我想首先回顧一下我們戰略願景的績效亮點。

  • Within Purpose and Sustainability, we're going to make progress across all dimensions. Our carbon emissions decreased by 28% compared to pre-pandemic levels in 2019. In line with our aspiration of being a sustainable employer, we continue to expand the number of women in senior leadership positions. This is now 40% compared to 38% last year.

    在目標和可持續性方面,我們將在各個方面取得進展。與 2019 年大流行前的水平相比,我們的碳排放量減少了 28%。為了符合我們成為可持續雇主的願望,我們繼續增加擔任高級領導職位的女性人數。目前這一比例為 40%,而去年為 38%。

  • Within R&D, we are encouraged by the many Phase III readouts with semaglutide in obesity. We are very pleased with the results of the recently completed cardiovascular outcomes trial SELECT. SELECT is the largest trial ever undertaken by Novo Nordisk and the results established the semaglutide 2.4 milligram as the only antiobesity medication with proven cardiovascular benefits.

    在研發過程中,我們對索馬魯肽治療肥胖症的許多 III 期結果感到鼓舞。我們對最近完成的心血管結果試驗 SELECT 的結果感到非常滿意。 SELECT 是諾和諾德有史以來最大規模的試驗,結果表明 2.4 毫克索馬魯肽是唯一經證實具有心血管益處的抗肥胖藥物。

  • We are committed to drive change in obesity and believe that the SELECT trial with semaglutide 2.4 milligram underlines the importance of recognizing obesity as a serious chronic disease. We believe the benefits of semaglutide on major adverse cardiovascular events in this population will not only be a big difference for patients, but also add value to society.

    我們致力於推動肥胖的改變,並相信 2.4 毫克索馬魯肽的 SELECT 試驗強調了認識到肥胖是一種嚴重慢性疾病的重要性。我們相信,索馬魯肽對該人群的主要不良心血管事件的益處不僅會對患者產生巨大影響,而且還會為社會增加價值。

  • Martin will come back to this and our overall R&D milestones later. The quarter sales growth reflects strong commercial execution across operating units. Both operating units contributed to sales growth, driven by increasing demand for GLP-1 based diabetes and obesity treatments. The performance in the first 6 months has enabled us to raise the outlook for the full year.

    馬丁稍後將回到這一點以及我們的整體研發里程碑。本季度銷售增長反映出各運營部門強勁的商業執行力。由於對基於 GLP-1 的糖尿病和肥胖症治療的需求不斷增長,這兩個運營部門都對銷售增長做出了貢獻。前 6 個月的表現使我們提高了全年的預期。

  • 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 performance for the first 6 months of 2023. With that, I'll give the word to Camilla for an update on execution.

    卡米拉和道格稍後將詳細介紹治療區域。 Karsten 將檢查財務狀況,但我對 2023 年前 6 個月的表現非常滿意。之後,我將向 Camilla 通報執行情況的最新情況。

  • 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 the first 6 months of 2023, our total sales increased by 30%. The sales increase was driven by both operating units with North America Operations growing 44% and International Operations growing 17%.

    謝謝拉爾斯,請翻到下一張幻燈片。 2023 年前 6 個月,我們的總銷售額增長了 30%。銷售額增長是由兩個運營部門推動的,北美運營部門增長了 44%,國際運營部門增長了 17%。

  • Our GLP-1 sales increased 50% driven by North America growing 44% and International Operations growing 62%. Insulin sales decreased by 7%, driven by a 2% decline in International Operations and by a 25% sales decline in North America Operations. The sales decline was driven by declining sales in the U.S., in Region China and EMEA.

    在北美增長 44% 和國際業務增長 62% 的推動下,我們的 GLP-1 銷售額增長了 50%。胰島素銷售額下降 7%,原因是國際業務銷售額下降 2%,北美業務銷售額下降 25%。銷售額下降的原因是美國、中國地區和歐洲、中東和非洲地區的銷售額下降。

  • Obesity sales grew 157% overall. In International Operations, sales grew 66%, driven by both Saxenda and Wegovy. In addition to Denmark and Norway, Wegovy has now also been launched in Germany. In North America Operations, Obesity Care sales grew 207%. Sales of Wegovy increased by 344% in the U.S., reflecting the performance since the commercial relaunch in January 2023.

    肥胖症銷售額總體增長 157%。在 Saxenda 和 Wegovy 的推動下,國際業務銷售額增長了 66%。除了丹麥和挪威外,Wegovy 現已在德國推出。在北美業務中,肥胖護理銷售額增長了 207%。 Wegovy 在美國的銷售額增長了 344%,反映了自 2023 年 1 月商業重新推出以來的表現。

  • Total Rare Disease sales decreased by 18%, driven by a 17% decrease in International Operations and by an 18% decrease in North America Operations. Rare Endocrine Disorders sales were impacted by a temporary reduction in manufacturing output. Please turn to the next slide.

    由於國際業務下降 17% 和北美業務下降 18%,罕見病總銷售額下降了 18%。罕見內分泌疾病的銷售受到製造業產出暫時減少的影響。請翻到下一張幻燈片。

  • With 24% sales growth in our Diabetes Care, we are growing faster than the total diabetes market, improving our global diabetes value market share over the last 12 months to 32.7% from 31%. This is in line with the aspiration of strengthening the Diabetes Care leadership, aiming at reaching a global value market share of more than 1/3 in 2025.

    我們的糖尿病護理業務銷售額增長了 24%,增長速度快於整個糖尿病市場,過去 12 個月我們的全球糖尿病價值市場份額從 31% 提高到 32.7%。這符合加強糖尿病護理領導地位的願望,旨在到 2025 年達到全球價值市場份額超過 1/3。

  • The increase primarily reflects GLP-1 market growth as well as share gains in both operating units. Please turn to the next slide. In International Operations, total Diabetes Care sales increased by 20% in the first 6 months of 2023. This was driven by GLP-1 sales growing 62%. Novo Nordisk is the market leader in International Operations with a GLP-1 value market share of 67%.

    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。請翻到下一張幻燈片。在國際業務中,2023 年前 6 個月糖尿病護理總銷售額增長了 20%。這是由 GLP-1 銷售額增長 62% 推動的。諾和諾德是國際運營領域的市場領導者,其 GLP-1 價值市場份額為 67%。

  • Ozempic continues its GLP-1 market leadership with around 45% market share. We're also pleased to see Rybelsus increasing its market share to just shy of 11%, driven by strong uptake across geographies. And with that, I would hand over the word to Doug.

    Ozempic 繼續保持 GLP-1 市場領先地位,市場份額約為 45%。我們還很高興看到 Rybelsus 在跨地區強勁增長的推動下,其市場份額增加至略低於 11%。說完,我就把這個詞交給了道格。

  • 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. The U.S. GLP-1 market volume grew more than 60% comparing Q2 of 2023 to Q2 of 2022. The volume growth acceleration is driven by a substantial increase in new patients initiating therapy with our portfolio of GLP-1 products, Ozempic and Rybelsus.

    謝謝你,卡米拉。請翻到下一張幻燈片。與2023 年第二季度相比,2022 年第二季度,美國GLP-1 市場銷量增長了60% 以上。銷量增長加速是由於開始接受我們的GLP-1 產品組合Ozempic 和Rybelsus 治療的新患者大幅增加所致。

  • Measured on total prescriptions, Novo Nordisk continues to be the market leader with a 55% market share. Please go to the next slide. Obesity Care sales increased by 157%, mainly driven by the U.S. due to a strong Wegovy uptake and continued demand for Saxenda. The global branded obesity market expansion continues with a global volume growth of around 76%.

    以總處方量衡量,諾和諾德繼續保持市場領先地位,佔據 55% 的市場份額。請轉到下一張幻燈片。肥胖護理銷售額增長了 157%,這主要是由美國市場對 Wegovy 的強勁吸收以及對 Saxenda 的持續需求推動的。全球品牌肥胖市場持續擴張,全球銷量增長約 76%。

  • In international operation, Obesity Care sales are driven by a strong Saxenda performance and the Wegovy launches in Denmark and Norway. We anticipate a continuation of the gradual rollout of Wegovy in International Operations, which now includes Wegovy launches in Denmark, Norway and Germany. In the U.S. alone, sales of Wegovy grew by 344% and we continue to see an overwhelming demand for Wegovy.

    在國際業務中,肥胖護理的銷售受到 Saxenda 的強勁業績以及在丹麥和挪威推出的 Wegovy 的推動。我們預計 Wegovy 將繼續在國際運營中逐步推出,目前包括在丹麥、挪威和德國推出 Wegovy。僅在美國,Wegovy 的銷售額就增長了 344%,我們繼續看到對 Wegovy 的巨大需求。

  • While supply capacity is gradually being expanded, the supply of the lower dose strengths will remain restricted to safeguard continuity of care. Next slide, please. Our Rare Disease sales decreased by 18%, and driven by Rare Blood Disorder sales decreasing 1% and Rare Endocrine Disorder sales declining 46%. Norditropin sales were impacted by a temporary reduction in manufacturing output. Now over to Martin for an update on R&D.

    雖然供應能力正在逐步擴大,但較低劑量的供應仍將受到限制,以保證護理的連續性。請下一張幻燈片。我們的罕見疾病銷售額下降了 18%,這是由罕見血液疾病銷售額下降 1% 和罕見內分泌疾病銷售額下降 46% 推動的。去甲腎上腺素的銷售受到製造業產量暫時減少的影響。現在請馬丁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. The obesity epidemic affects more than 750 million individuals and is associated with more than 200 possible health complications, including cardiovascular disease, which is the leading cause of death globally.

    謝謝你,道格。請翻到下一張幻燈片。肥胖流行影響了超過 7.5 億人,並與 200 多種可能的健康並發症有關,其中包括心血管疾病,心血管疾病是全球主要死亡原因。

  • Obesity, therefore, has a profound impact on individual patients and the outcomes, but also a substantial impact on society and health care spending. No pharmaceutical weight management intervention has to date demonstrated improvement in patient cardiovascular outcomes.

    因此,肥胖不僅對患者個體及其治療結果產生深遠影響,而且對社會和醫療保健支出也產生重大影響。迄今為止,還沒有任何藥物體重管理干預措施能夠改善患者的心血管結局。

  • Besides significant weight loss, semaglutide has shown benefits in a wide array of biomarkers associated with cardiovascular risk. This has been seen with STEP development program. This includes improvements in blood pressure, dyslipidemia, HbA1c and inflammatory markers.

    除了顯著減輕體重外,索馬魯肽還顯示出與心血管風險相關的多種生物標誌物的益處。 STEP 開發程序已經證明了這一點。這包括血壓、血脂異常、糖化血紅蛋白和炎症標誌物的改善。

  • These observations support observations from diabetes where semaglutide treatment has been demonstrated to be associated with a 26% reduction in risk of experiencing a major adverse cardiovascular event, or MACE. To investigate the potential impact of semaglutide in patients with obesity on reduction in risk of major adverse cardiovascular events, Novo Nordisk in 2018 initiated the SELECT trial.

    這些觀察結果支持了糖尿病的觀察結果,其中索馬魯肽治療已被證明與發生主要不良心血管事件 (MACE) 的風險降低 26% 相關。為了調查索馬魯肽對肥胖患者降低主要不良心血管事件風險的潛在影響,諾和諾德於 2018 年啟動了 SELECT 試驗。

  • Please turn to the next slide. SELECT was a large-scale outcomes trial and was conducted across 41 countries and more than 800 sites. 17,604 patients were enrolled and randomized in a 1:1 ratio to receive once-weekly semaglutide 2.4 milligram or placebo. The eligibility criteria were designed to include a broad population with overweight obesity and established atherosclerotic cardiovascular disease as defined by prior myocardial infraction, stroke or peripheral artery disease.

    請翻到下一張幻燈片。 SELECT 是一項大規模結果試驗,在 41 個國家和 800 多個地點進行。 17,604 名患者以 1:1 的比例入組並隨機接受每週一次 2.4 毫克索馬魯肽或安慰劑治療。資格標準旨在包括超重肥胖和患有動脈粥樣硬化性心血管疾病(根據既往心肌梗塞、中風或外周動脈疾病定義)的廣泛人群。

  • Patients with the prior history of diabetes were excluded. The primary objective was to demonstrate superiority of semaglutide 2.4 milligram versus placebo on top of standard of care for prevention of the primary endpoint. And this was consisting of major -- sorry, as defined by cardiovascular death, nonfatal myocardial infarction or nonfatal stroke. Key secondary objectives were to compare the effects of semaglutide 2.4 milligrams placebo with regards to mortality, cardiovascular risk factors, glucose metabolism, body weight and renal function.

    有糖尿病病史的患者被排除在外。主要目標是證明 2.4 毫克索馬魯肽相對於安慰劑在預防主要終點的護理標準之上的優越性。這包括重大——抱歉,按照心血管死亡、非致命性心肌梗塞或非致命性中風的定義。主要次要目標是比較 2.4 毫克索馬魯肽安慰劑對死亡率、心血管危險因素、葡萄糖代謝、體重和腎功能的影響。

  • I'm very excited to announce that SELECT achieved its primary endpoint and once-weekly semaglutide 2.4 milligram demonstrated a 20% reduction in major adverse cardiovascular events versus placebo. All components of the primary endpoint contributed to the overall cardiovascular risk reduction. The result from this SELECT trial establishes semaglutide 2.4 milligram as the only antiobesity medication with a proven cardiovascular benefit in a population with overweight or obesity and established cardiovascular disease without prior history of diabetes.

    我非常高興地宣布,SELECT 實現了其主要終點,每週一次的 2.4 毫克索馬魯肽與安慰劑相比,主要不良心血管事件減少了 20%。主要終點的所有組成部分都有助於總體心血管風險的降低。這項 SELECT 試驗的結果表明,索馬魯肽 2.4 毫克是唯一一種經證明對超重或肥胖以及既往無糖尿病病史且患有心血管疾病的人群具有心血管益處的抗肥胖藥物。

  • We believe that the cardiovascular risk reduction demonstrated with semaglutide 2.4 milligram in SELECT, hold immense value for patients and caregivers, the scientific community as well as society at large and that these results for semaglutide hold the potential have fundamentally changed how obesity is regarded and treated. In the trial, semaglutide 2.4 milligram to appear to have a safe and well-tolerated profile, in line with previous trials investigating semaglutide.

    我們相信,在SELECT 中使用2.4 毫克索馬魯肽可降低心血管風險,這對患者和護理人員、科學界以及整個社會具有巨大價值,並且索馬魯肽的這些結果有可能從根本上改變人們對肥胖的看法和治療方式。在試驗中,2.4 毫克索馬魯肽似乎具有安全性和良好的耐受性,與之前調查索馬魯肽的試驗一致。

  • We aim to share the full SELECT results at the American Heart Association Congress in 2023 and expect to file for regulatory approval of a label indication expansion for semaglutide 2.4 milligram later this year. Please go to the next slide. Building on the potential of broader cardiovascular benefits for semaglutide, Novo Nordisk initiated the STEP HFpEF trial to investigate the impact of semaglutide treatment on physiological function in patients with obesity and established heart failure.

    我們的目標是在 2023 年的美國心臟協會大會上分享完整的 SELECT 結果,並預計在今年晚些時候向監管機構提交 2.4 毫克索馬魯肽標籤適應症擴展的申請。請轉到下一張幻燈片。基於索馬魯肽具有更廣泛的心血管益處的潛力,諾和諾德啟動了 STEP HFpEF 試驗,以研究索馬魯肽治療對肥胖和心力衰竭患者生理功能的影響。

  • Heart failure with preserved ejection fraction or HFpEF affects half of the estimated 65 million patients with heart failure globally. Around 80% of HFpEF patients have overweight or obesity, which is believed to contribute significantly to the disease's pathophysiology. Individuals with obesity-related HFpEF with high risk of mortality and morbidity and experienced the greatest burden of debilitating symptoms and functional impairment. Improving these outcomes is a major goal of management and very full treatment options are available.

    全球估計有 6500 萬心力衰竭患者,其中一半患有射血分數保留的心力衰竭或 HFpEF。大約 80% 的 HFpEF 患者超重或肥胖,這被認為是該疾病的病理生理學的重要原因。患有肥胖相關 HFpEF 的個體具有高死亡率和發病風險,並且經歷了最大的衰弱症狀和功能障礙負擔。改善這些結果是治療的主要目標,並且有非常全面的治療選擇。

  • In the STEP HFpEF trial, 529 patients with obesity-related HFpEF and no prior history of diabetes were randomized in a one-to-one manner comparing semaglutide 2.4 milligram with placebo when both were added to standard of care. The primary endpoint was the average change from baseline in the Kansas City Cardiomyopathy Clinical Summary Score Questionnaire and body weight.

    在 STEP HFpEF 試驗中,529 名患有肥胖相關 HFpEF 且既往沒有糖尿病史的患者以一對一的方式隨機分組,比較索馬魯肽 2.4 毫克與安慰劑(兩種藥物均納入標準治療)。主要終點是堪薩斯城心肌病臨床總結評分問捲和體重相對於基線的平均變化。

  • Key secondary endpoints included the 6-minute walking test, a composite hierarchical endpoint, including hard outcomes and high-sensitivity C-reactive protein. In the trial, semaglutide showed a 16.6 points improvement versus 8.7 points in the placebo arm at week 52. The mean change was thus 7.8 points in favor of semaglutide, which is considered a clinically relevant and very strong result within chronic heart failure.

    關鍵的次要終點包括 6 分鐘步行測試,這是一個複合分層終點,包括硬結果和高敏 C 反應蛋白。在試驗中,第52 週時,索馬魯肽的改善為16.6 分,而安慰劑組為8.7 分。因此,索馬魯肽的平均變化為7.8 分,這被認為是慢性心力衰竭的臨床相關且非常有力的結果。

  • I would like to also touch completely -- sorry, I'd like to touch upon the headline results from OASIS 1. So please turn to the next slide, please. OASIS 1 was a Phase IIIb trial with once daily oral semaglutide 50 milligram. The trial design details are on the slide. Overall, patients who received oral semaglutide 50-milligram achieved a statistically significant weight loss of 17.4% after 68 weeks of treatment compared to 1.8% with placebo.

    我還想徹底談談——抱歉,我想談談 OASIS 1 的標題結果。所以請翻到下一張幻燈片。 OASIS 1 是一項 IIIb 期試驗,每天口服一次 50 毫克索馬魯肽。試驗設計細節在幻燈片上。總體而言,接受口服索馬魯肽 50 毫克的患者在治療 68 週後體重減輕了 17.4%,具有統計學意義,而安慰劑組的體重減輕了 1.8%。

  • The results are comparable with the weight loss demonstrated in step 1 with injectable semaglutide 2.4 milligram and will give patients and care givers an opportunity for individualized treatment. Please go to the next slide. In line with our business development strategy in obesity focused on either technology platforms or early- to mid-stage assets, we are pleased to announce the acquisition of Inversago Pharma. Inversago Pharma is focused on the development of a cannabinoid receptor 1 inverse agonist which is designed to help people live in with obesity, diabetes and complications associated with metabolic disorders.

    結果與步驟 1 中註射 2.4 毫克索馬魯肽所顯示的體重減輕相當,將為患者和護理人員提供個體化治療的機會。請轉到下一張幻燈片。根據我們專注於技術平台或早中期資產的肥胖業務發展戰略,我們很高興地宣布收購 Inversago Pharma。 Inversago Pharma 專注於開發大麻素受體 1 反向激動劑,旨在幫助患有肥胖、糖尿病和代謝紊亂相關並發症的人們。

  • The acquisition includes the lead asset, INV-202, an oral cannabinoid receptor-1 inverse agonist, designed to preferentially block cannabinoid receptors in peripheral tissues only. INV-202 demonstrated promising results in terms of weight loss in a Phase Ib trial and is currently in clinical development for diabetic kidney disease.

    此次收購包括主要資產 INV-202,這是一種口服大麻素受體 1 反向激動劑,旨在僅優先阻斷外周組織中的大麻素受體。 INV-202 在 Ib 期試驗中顯示出在減肥方面有希望的結果,目前正處於糖尿病腎病的臨床開發階段。

  • Next slide, please. Turning to R&D milestones. I would like to highlight some of the other exciting events, trial readouts and initiations across our therapy areas in 2023. Within diabetes, we anticipate the submission of oral semaglutide 25- and 50-milligram in U.S. and Europe during the second half of 2023 and further to initiate a Phase II trial with the GLP-1/GIP co-agonist in the fourth quarter.

    請下一張幻燈片。轉向研發里程碑。我想強調一下2023 年我們治療領域的其他一些令人興奮的事件、試驗結果和啟動情況。在糖尿病領域,我們預計2023 年下半年在美國和歐洲提交口服索馬魯肽25 毫克和50 毫克的申請,進一步於第四季度啟動 GLP-1/GIP 聯合激動劑的 II 期試驗。

  • Within obesity, we completed a Phase II Proof of Concept trial with PYY in May. During -- due to a modest treatment effect, we have decided to terminate the development of this PYY agonist. On a separate note, we are anticipating the results from the ongoing Phase I trial with oral amycretin during the fourth quarter.

    在肥胖方面,我們於 5 月份完成了 PYY 的第二階段概念驗證試驗。由於治療效果有限,我們決定終止這種 PYY 激動劑的開發。另外,我們預計第四季度正在進行的口服阿黴素 I 期試驗的結果。

  • In Rare Disease, Sogroya was approved in Japan and in Europe for the treatment of children with hormone deficiency. In Other Serious Chronic Diseases, we initiated HERMES, a Phase III heart failure cardiovascular outcomes trial, investigating Ziltivekimab in patients with heart failure with preserved ejection fraction. The current treatment options for these populations are very limited, and this makes one the greatest unmet needs in cardiology today. With that, over to you, Karsten.

    在罕見疾病領域,Sogroya 在日本和歐洲被批准用於治療激素缺乏症兒童。在其他嚴重慢性疾病中,我們啟動了 HERMES,這是一項 III 期心力衰竭心血管結果試驗,研究 Ziltivekimab 對射血分數保留的心力衰竭患者的療效。目前針對這些人群的治療選擇非常有限,這成為當今心髒病學中最大的未滿足需求之一。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 the first 6 months of 2023, our sales grew by 29% in Danish kroner and 30% at constant exchange rates, driven by both our operating units. The gross margin increased by 85.1% compared to 84.4% in 2022. The increase is driven by a positive product mix, reflecting increased sales of GLP-1-based treatments and a positive currency impact.

    謝謝你,馬丁。請翻到下一張幻燈片。 2023 年前 6 個月,在我們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 29%,以固定匯率計算增長了 30%。與 2022 年的 84.4% 相比,毛利率增長了 85.1%。這一增長是由積極的產品組合推動的,反映出基於 GLP-1 的治療藥物銷量的增加和積極的貨幣影響。

  • This is partially countered by costs related to the ongoing capacity expansions as well as lower realized prices, mainly in the U.S. and Region China. Sales and distribution costs increased by 27% in Danish kroner and by 28% at constant exchange rates. The increase is driven by both operating units.

    這在一定程度上被持續產能擴張相關的成本以及較低的實現價格(主要在美國和中國地區)所抵消。以丹麥克朗計算的銷售和分銷成本增加了 27%,以固定匯率計算則增加了 28%。這一增長是由兩個運營單位推動的。

  • In North America Operations, the cost increase is driven by the relaunch of Wegovy and promotional activities for Ozempic, while in international operations, the cost increase is driven by promotional activities for Rybelsus as well as Obesity Care market development activities.

    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。

  • The increase in sales and distribution costs are impacted by adjustments to legal provisions. Research and Development costs increased by 34% in both Danish kroner and at constant exchange rates. The increase is driven by higher late-stage clinical trial activity and increased early research activities compared to the first 6 months of 2022.

    銷售和分銷成本的增加受到法律規定調整的影響。以丹麥克朗和固定匯率計算的研發成本增加了 34%。與 2022 年前 6 個月相比,這一增長是由後期臨床試驗活動增加和早期研究活動增加推動的。

  • The acquisition of Forma Therapeutics in 2022 also impacted costs. Administration costs increased by 9% measured in Danish kroner and by 10% at constant exchange rates. Operating profit increased by 30% measured in Danish kroner and by 32% at constant exchange rates, reflecting the sales growth.

    2022 年收購 Forma Therapeutics 也影響了成本。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 10%。以丹麥克朗計算的營業利潤增長了 30%,按固定匯率計算則增長了 32%,反映了銷售額的增長。

  • Net financial items showed a net gain of DKK 96 million compared to a net loss of around DKK 2.8 billion. The effective tax rate was 19.9% in the first 6 months of 2023 compared to 20.7% in the first 6 months of 2022.

    淨財務項目顯示淨收益為 9600 萬丹麥克朗,而淨虧損約為 28 億丹麥克朗。 2023 年前 6 個月的有效稅率為 19.9%,而 2022 年前 6 個月的有效稅率為 20.7%。

  • Net profit increased by 43% and diluted earnings per share increased by 44% to DKK 17.41. Free cash flow was DKK 45.5 billion compared to DKK 42 billion in 2022, supporting the strategic aspiration to deliver attractive capital allocation to shareholders. The cash conversion is positively impacted by timing of payment of rebates in the U.S. This includes provisions related to the revised 340B distribution policy in the U.S. Note that income under the 340B Program has been partially recognized.

    淨利潤增長 43%,攤薄後每股收益增長 44%,達到 17.41 丹麥克朗。自由現金流為 455 億丹麥克朗,而 2022 年為 420 億丹麥克朗,支持了向股東提供有吸引力的資本配置的戰略願景。現金轉換受到美國回扣支付時間的積極影響。這包括與美國修訂後的 340B 分配政策相關的規定。請注意,340B 計劃下的收入已部分確認。

  • Capital expenditure for property, plant and equipment was DKK 10.6 billion compared to DKK 4 billion in 2022. This primarily reflects investments in additional capacity for active pharmaceutical ingredient production and fill-finish capacity for both current and future injectable and oral products. Please go to the next slide.

    物業、廠房和設備的資本支出為106 億丹麥克朗,而2022 年為40 億丹麥克朗。這主要反映了對現有和未來注射劑和口服產品的活性藥物成分生產和灌裝能力的額外產能的投資。請轉到下一張幻燈片。

  • A key priority for Novo Nordisk is to ensure attractive allocation of capital to shareholders. For 2022, the dividend per share increased 19.2% to DKK 12.40. For 2023, the Board of Directors has decided to pay out an interim dividend of DKK 6 per share, which will be paid out in August this year.

    諾和諾德的首要任務是確保向股東提供有吸引力的資本配置。 2022 年,每股股息增長 19.2%,達到 12.40 丹麥克朗。董事會決定派發2023年每股6丹麥克朗的中期股息,將於今年8月派發。

  • In line with our strategy, we have returned more than DKK 32 billion to shareholders in the first half during dividends and ongoing share repurchase program, which is up to DKK 30 billion for the full year. To secure liquidity for both the Novo Nordisk B shares and American Depository Receipts, the Board of Directors has decided to split the share in a 2:1 ratio in September 2023. Please go to the next slide.

    根據我們的戰略,上半年我們通過股息和持續的股票回購計劃向股東返還了超過 320 億丹麥克朗,全年返利高達 300 億丹麥克朗。為了確保諾和諾德 B 股和美國存託憑證的流動性,董事會決定於 2023 年 9 月按 2:1 的比例進行股份分割。請轉到下一張幻燈片。

  • Midway through 2023, we are continuing our sales growth momentum, which has enabled us to raise the outlook for the full year. We now expect the sales growth to be between 27% and 33% growth at constant exchange rates. This is based on a number of assumptions as described in the company announcement.

    到 2023 年中期,我們將繼續保持銷售增長勢頭,這使我們能夠提高全年的預期。我們目前預計,按固定匯率計算,銷售額增長將在 27% 至 33% 之間。這是基於公司公告中所述的多項假設。

  • The guidance reflects expectations for sales growth in both North America Operations and International Operations, mainly driven by volume growth of GLP-1 based treatments for Diabetes and Obesity Care, partially countered by declining sales in Rare Disease due to a temporary reduction in manufacturing output.

    該指引反映了對北美業務和國際業務銷售增長的預期,主要受到基於GLP-1 的糖尿病和肥胖護理治療藥物銷量增長的推動,但由於製造產量暫時減少而導致罕見疾病的銷售下降,部分抵消了這一增長。

  • The guidance reflects the level of volume growth of GLP-1-based diabetes treatment and the inherent uncertainty of the pace of the Obesity Care market expansion. Following the relaunch of Wegovy in the U.S. and the limited rollout in International Operations, the outlook also reflects expected continued periodic supply constraints and related drug shortage notifications across a number of products and geographies.

    該指南反映了基於 GLP-1 的糖尿病治療的銷量增長水平以及肥胖護理市場擴張步伐的固有不確定性。繼 Wegovy 在美國重新推出以及國際業務的有限推出之後,該前景還反映了預計持續的定期供應限制以及多個產品和地區的相關藥品短缺通知。

  • As mentioned by Doug, the supply of the lower Wegovy dose strengths in the U.S. will remain restricted to safeguard continuity of care, while supply capacity is gradually being expanded. We expect that operating profit growth will be between 31% and 37% at constant exchange rates. This primarily reflects the sales growth outlook and continued investments in current and future growth drivers within R&D and commercial.

    正如Doug所提到的,美國較低Wegovy劑量強度的供應將繼續受到限制,以保證護理的連續性,同時供應能力正在逐步擴大。我們預計按固定匯率計算營業利潤增長將在31%至37%之間。這主要反映了銷售增長前景以及對研發和商業領域當前和未來增長動力的持續投資。

  • For 2023, we expect net financial items to amount to a gain of around DKK 2.8 billion, mainly reflecting hedging gains associated with foreign exchange hedging contracts. Capital expenditure is still expected to be around DKK 25 billion, reflecting investments in additional capacity for active pharmaceutical ingredients and fill-finish capacity for both current and future injectable and oral products.

    2023年,我們預計金融項目淨收益約為28億丹麥克朗,主要反映與外匯對沖合約相關的對沖收益。資本支出預計仍約為 250 億丹麥克朗,反映了對活性藥物成分額外產能以及當前和未來注射劑和口服產品的灌裝產能的投資。

  • The free cash flow is now expected to be between DKK 64 billion and DKK 72 billion, reflecting the sales growth, a favorable impact from rebates in the U.S. and investments in capital expenditure. The updated cash flow expectation is reflecting business development activities. This covers the outlook for 2023. Now back to you, Lars, for final remarks.

    目前,自由現金流預計在 640 億丹麥克朗至 720 億丹麥克朗之間,反映了銷售增長、美國退稅和資本支出投資的有利影響。更新後的現金流量預期反映了業務發展活動。這涵蓋了 2023 年的展望。現在回到拉斯,請您發表最後的評論。

  • 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 are very satisfied with the sales growth in the first 6 months of 2023. The growth is driven by increasing demand for GLP-1 based diabetes and obesity treatments and we're serving more patients than ever before.

    謝謝你,卡斯滕。請翻到最後一張幻燈片。我們對 2023 年前 6 個月的銷售增長感到非常滿意。這一增長是由對基於 GLP-1 的糖尿病和肥胖治療的需求不斷增長推動的,而且我們為比以往更多的患者提供服務。

  • The performance in the first 6 months has enabled us to raise the outlook for the full year. Within R&D, we are very excited about the results from the SELECT trial. Obesity is a serious chronic disease associated with many comorbidities and the results from SELECT demonstrate the comorbidities associated with the condition can be significantly reduced by treating people with semaglutide 2.4 milligram. With that, I would like to hand over the word to Daniel.

    前 6 個月的表現使我們提高了全年的預期。在研發部門,我們對 SELECT 試驗的結果感到非常興奮。肥胖是一種嚴重的慢性疾病,與許多合併症相關,SELECT 的結果表明,通過使用 2.4 毫克索馬魯肽治療,可以顯著減少與肥胖相關的合併症。說到這裡,我想把話交給丹尼爾。

  • Daniel Bohsen - CVP & Head of IR

    Daniel Bohsen - CVP & Head of IR

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

    謝謝你,拉爾斯。請下一張幻燈片。我們現在準備好進行問答環節了。我懇請所有參與者將自己的問題限制在 1 個或最多 2 個。接線員,我們現在準備回答第一個問題。

  • Operator

    Operator

  • (Operator Instructions) And your first question comes from the line of Martin Parkhøi from SEB.

    (操作員說明)您的第一個問題來自 SEB 的 Martin Parkhái。

  • Martin Parkhøi - Head of Danish Equity Analysis

    Martin Parkhøi - Head of Danish Equity Analysis

  • Yes. Martin Parkhøi, SEB. First 1 question for Martin on the SELECT data actually related to CagriSema. Will it be possible to utilize fully or partly SELECT data in a potential labeling of CagriSema? And then second question is also on CagriSema, maybe to Karsten and Lars. Of course, you're building up the option, hopefully, every day. But respect to the PIN for the device for CagriSema, do you think you will be able to have a commercially acceptable amount of -- scale of production of the of PIN of CagriSema at the time of launch or the time of approval, I mean, of course?

    是的。馬丁·帕克哈伊,SEB。 Martin 的第一個問題是關於 SELECT 數據,實際上與 CagriSema 相關。是否可以在 CagriSema 的潛在標籤中完全或部分利用 SELECT 數據?第二個問題也是關於 CagriSema,可能是針對 Karsten 和 Lars。當然,你希望每天都在建立這個選項。但是,關於 CagriSema 設備的 PIN,您認為在推出或批准時,您是否能夠擁有商業上可接受的數量——CagriSema PIN 的生產規模,我的意思是,當然?

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

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

  • Thank you, Martin, for these questions. So Martin, if you start with CagriSema and SELECT.

    謝謝馬丁提出這些問題。馬丁,如果你從 CagriSema 和 SELECT 開始。

  • 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 very much, Martin. Obviously, it's something that we also discussed. I have to say that CagriSema is a couple of years down the road, so it's probably too early to speculate what we cannot do in terms of regulatory interactions. I think it's important to call out that for CagriSema, we're also doing redefined (inaudible). So CagriSema will have in and of itself cardiovascular data. But obviously, we are super excited for that outlook as well given the SELECT data.

    非常感謝你,馬丁。顯然,這也是我們討論過的事情。我不得不說,CagriSema 還需要幾年的時間,所以現在推測我們在監管互動方面不能做什麼可能還為時過早。我認為重要的是要指出,對於 CagriSema,我們也在重新定義(聽不清)。因此,CagriSema 本身就有心血管數據。但顯然,考慮到 SELECT 數據,我們對這一前景感到非常興奮。

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

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

  • And Martin, to your question around scaling of CagriSema. Then our starting point is that we see the dynamics in the obesity market now and the significant unmet needs, and that is also what is informing our supply chain strategies and scaling and preparation of CagriSema launch and also the elevated CapEx level that you're seeing in our guidance this year.

    馬丁,關於你關於 CagriSema 擴展的問題。那麼我們的出發點是,我們看到肥胖市場現在的動態以及未滿足的重大需求,這也是我們的供應鏈戰略、CagriSema 發布的規模和準備以及您所看到的資本支出水平升高的信息在我們今年的指導中。

  • Operator

    Operator

  • We will now go to our next question. And your next question comes of the line of Richard Parkes BNP Paribas.

    現在我們將討論下一個問題。你的下一個問題來自法國巴黎銀行的理查德·帕克斯 (Richard Parkes)。

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

    Richard J. Parkes - Head of Pharmaceutical and Biotechnology Team

  • Firstly, I wondered if you could talk about your thoughts over would go the commercial access in the U.S. going into 2024? There's been a few reports of payers restricting access or increasing co-pays due to the extent of current strong demand. So I'm just wondering how you're seeing it from a holistic perspective. And do you think you can leverage the SELECT results to impact that immediately? Or will you have to wait for a label update to influence your discussions with commercial payers? Then the second question, I just wondered if you could walk us through the timelines of how results of SELECT could influence potential legislative change in Medicare. Is that something that you can straightaway start to lobby for? Or do we again need to wait for label updates?

    首先,我想知道您是否可以談談您對 2024 年美國商業准入的想法?有一些報導稱,由於當前的強勁需求,付款人限制了訪問或增加了共同支付。所以我只是想知道你如何從整體角度看待它。您認為您可以利用 SELECT 結果立即產生影響嗎?或者您是否必須等待標籤更新才能影響您與商業付款人的討論?然後是第二個問題,我只是想知道您是否可以向我們介紹 SELECT 結果如何影響醫療保險潛在立法變革的時間表。您可以立即開始遊說嗎?或者我們是否需要再次等待標籤更新?

  • 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, Richard. Doug, I'll give the word to you, I believe, both are related to North America.

    謝謝你,理查德。道格,我告訴你,我相信,兩者都與北美有關。

  • 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 thank you, Richard. So for the first one, as it relates to access. It's the starting point is we're pleased with the level of access that we have today, and we continue to build on that. Remember, all major PBMs are covering it right now, and that means over 45 million people have access. And today, currently, 80% of them are paying less than $25. So I think that's important. As it relates to SELECT specifically, 1 important channel we still don't have access to is Medicare. Now will SELECT change that overnight? Maybe not. However, SELECT enhances the value proposition of semaglutide. And longer term, I think it will be difficult for anyone to restrict access to this phenomenal molecule and its life-saving properties. So we'll continue -- but we're pleased with the level of access today, and we continue to build on that.

    是的。謝謝你,理查德。對於第一個,因為它與訪問有關。我們的出發點是我們對今天擁有的訪問級別感到滿意,並且我們將繼續在此基礎上繼續發展。請記住,所有主要的 PBM 目前都在覆蓋它,這意味著超過 4500 萬人可以訪問。如今,80% 的人支付的費用低於 25 美元。所以我認為這很重要。由於它與 SELECT 特別相關,我們仍然無法訪問的一個重要渠道是 Medicare。現在 SELECT 會在一夜之間改變這一現狀嗎?也許不會。然而,SELECT 增強了索馬魯肽的價值主張。從長遠來看,我認為任何人都很難限制接觸這種非凡的分子及其救生特性。所以我們會繼續——但我們對今天的訪問水平感到滿意,我們將繼續在此基礎上繼續發展。

  • Operator

    Operator

  • We will now go to our next question. And your question comes from the line of Emily Field, Barclays.

    現在我們將討論下一個問題。你的問題來自巴克萊銀行艾米麗·菲爾德。

  • Emily Field - Head of European Pharmaceuticals Equity Research

    Emily Field - Head of European Pharmaceuticals Equity Research

  • I'll ask 2. The first is, there's been some attention to reports in the U.S. media about stay-time for Wegovy for a majority of patients potentially being less than a year. Do you have any updates on sort of your own data? Or what you're expecting for Wegovy stay-time? And then secondarily, could you just remind us of your targets for the supply ramp for Wegovy for the end of 2023 versus the end of 2022?

    我會問 2。首先,美國媒體報導了一些關於大多數患者在 Wegovy 的住院時間可能不到一年的報導。您對自己的數據有任何更新嗎?或者您對 Wegovy 的停留時間有何期望?其次,您能否提醒我們 2023 年底與 2022 年底 Wegovy 供應量增長的目標?

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

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

  • Doug, if you will take the first one on what we see on stay-time. And Karsten, you will take the Wegovy ramp-up this year.

    道格,您是否願意接受我們在停留時間所看到的第一個。 Karsten,今年你將參加 Wegovy 的升級。

  • 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

  • I'd start with, there's still too few data points to conclude on Wegovy stay-time. So we're really going to have to wait until 2024. I would say though we're are looking at some of the early snapshots data that we see from payers and databases. But again, it's really too early to conclude on stay-time.

    首先,關於 Wegovy 停留時間的數據點仍然太少。所以我們真的要等到 2024 年。我想說的是,儘管我們正在查看從付款人和數據庫中看到的一些早期快照數據。但同樣,現在就停留時間下結論還為時過早。

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

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

  • Thank you, Doug. Karsten?

    謝謝你,道格。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

  • Yes. Emily, in terms of Wegovy supply scaling, that is, of course, a top priority for us given the significant unmet need we see. As to the single-dose platform that we are applying in the U.S., the process and the progress you've seen -- or we have seen is that we started out this year with 1 CMO filling line. Then during the first half, we added an other line, and we are on track with adding a third CMO filling line and -- as we go into 2024. And then on top of that, we will be adding additional filling line capacity. So a significant step-up in Wegovy capacity over time. And in addition to that, it's important to note that we are also deploying our big platforms in terms of our cartridge -- in-house cartridge filling and FlexTouch platforms for our European launches of Wegovy. So there, we are also building optionality in terms of how to deploy Wegovy going forward. And then finally, in terms of scaling, I'd say, again, our CapEx program of DKK 25 billion is social scaling, both on the peptide API as well as fill-finish capacity.

    是的。 Emily,就 Wegovy 供應規模而言,鑑於我們看到大量未滿足的需求,這當然是我們的首要任務。至於我們在美國應用的單劑量平台,您所看到的流程和進展——或者我們看到的是,我們今年開始擁有 1 條 CMO 灌裝線。然後在上半年,我們添加了另一條生產線,並且我們正在按計劃添加第三條 CMO 灌裝線,並且 - 當我們進入 2024 年時。除此之外,我們將增加額外的灌裝線產能。隨著時間的推移,Wegovy 的能力將顯著增強。除此之外,值得注意的是,我們還在墨盒方面部署了我們的大平台——內部墨盒填充和 FlexTouch 平台,用於我們在歐洲推出的 Wegovy。因此,我們還在未來如何部署 Wegovy 方面建立了選擇性。最後,就規模化而言,我再次強調,我們 250 億丹麥克朗的資本支出計劃是社會規模化,無論是在肽 API 上還是在灌裝生產能力上。

  • Operator

    Operator

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

    您的下一個問題來自花旗集團的 Peter Verdult。

  • Peter Verdult - MD

    Peter Verdult - MD

  • Yes. Peter Verdult, Citi. Two questions for Martin on SELECT and the CB1 asset you acquired today. Martin, I realize you can't go into very much detail on SELECT, but are you at least able to characterize qualitatively the strength of the data with respect to any of the key secondary end points as well as reassure us that when we see that data at AHA on the primary end point, we're not going to be tripped up by any subgroup analysis showing regional efficacy differences or the (inaudible). And then secondly, on the CB1 inverse agonist. I mean, the (inaudible) the call remember the (inaudible). So can you just sketch out what's different here from both an efficacy and a safety perspective, I thought from memory on about 5 kilos of weight loss and (inaudible) big safety concern around suicide. So what's different here? When could Phase III start? And how does Novo want to position this asset relative to your existing obesity portfolio?

    是的。彼得·韋爾杜,花旗銀行。關於 SELECT 和您今天獲得的 CB1 資產,請向 Martin 提出兩個問題。馬丁,我知道您無法詳細介紹 SELECT,但是您至少能夠定性地描述數據相對於任何關鍵次要終點的強度,並讓我們放心,當我們看到這一點時根據美國心臟協會關於主要終點的數據,我們不會被任何顯示區域療效差異或(聽不清)的亞組分析所絆倒。其次,關於 CB1 反向激動劑。我的意思是,(聽不清)電話記得(聽不清)。那麼你能從功效和安全的角度概述一下這裡有什麼不同嗎?我憑記憶想到大約減輕了 5 公斤的體重,並且(聽不清)關於自殺的重大安全問題。那麼這裡有什麼不同呢?第三期什麼時候開始? Novo 希望如何相對於您現有的肥胖投資組合來定位該資產?

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

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

  • Yes. So Martin, on SELECT totality of data and then on safety on our new asset from Inversago.

    是的。 Martin 介紹了 SELECT 全部數據,然後介紹了 Inversago 的新資產的安全性。

  • 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 you're absolutely right for (inaudible), I can't go into too much detail. Obviously, we disclosed that for the primary endpoint, we saw that the individual mono components being myocardial infarction, stroke and cardiovascular death. All contributed to the estimate that we saw, suggesting at least in the primary endpoint, a level of consistency that gives us a lot of comfort potentially also for the secondary endpoints. But we will embark on those data until American Heart later this year. On Inversago, I think you're absolutely right. And obviously, we've also looked at historically data. I think it's important to recall that historically, the CB1 approach has been primarily directed towards the brain and effect on the brain. And that is a high likelihood attributable to the negative effects seen with historical approaches. With the INV-202 molecule, we're actually seeing a primarily peripheral activity. So designed to reach the brain with minimal activity, but maximum activity in the peripheral tissue. And what we have seen in the clinical space is actually an efficacy that is somewhat beyond what you just described for the historical compounds and a safety profile that appears at least in a smaller setting, to have been derisked in accordance with the design. So we are not saying that -- and we will say that for any drug development program, we had to derisk this further during our development. Next stage to investigate this in Phase II. And the focus is to look at this in monotherapy because we do have -- we do believe that the compound has a place in potential monotherapy, but also to look at it in combination with other modalities.

    所以你絕對正確(聽不清),我不能透露太多細節。顯然,我們披露了主要終點,我們看到單個單一成分是心肌梗塞、中風和心血管死亡。所有這些都對我們看到的估計做出了貢獻,表明至少在主要終點方面具有一定程度的一致性,這也可能給我們帶來了很多次要終點的安慰。但我們將在今年晚些時候開始研究這些數據,直到美國心臟協會。關於 Inversago,我認為你是完全正確的。顯然,我們也研究了歷史數據。我認為重要的是要記住,從歷史上看,CB1 方法主要針對大腦及其對大腦的影響。這很可能歸因於歷史方法的負面影響。對於 INV-202 分子,我們實際上看到了主要的外周活性。其設計目的是以最小的活動到達大腦,但在周圍組織中活動最大。我們在臨床空間中看到的實際上是一種功效,它在某種程度上超出了您剛剛描述的歷史化合物的功效,並且至少在較小的環境中出現的安全性概況,已根據設計消除了風險。所以我們並不是這麼說——我們會說,對於任何藥物開發計劃,我們都必須在開發過程中進一步消除這種風險。下一階段將在第二階段對此進行調查。重點是在單一療法中研究這一點,因為我們確實相信該化合物在潛在的單一療法中佔有一席之地,但也要結合其他方式來研究它。

  • Operator

    Operator

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

    您的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, Bank of America. Two questions on Wegovy supply, if I may. So Karsten, thanks for the updates on supply. It sounds like everything is on track. So trying to understand the driver of the vague language you've used. So just very simply, is there still uncertainty or issues with supply such as timing of the second Catalent facility, or speed of the second CDMO ramping? Or is this simply demand uncertainty post SELECT? And then secondly, just as we're all trying to model we gave you for the second half, what color can you give us on how you've dynamically managed supply? Should we be expecting a supply increase in the second half at any point? I guess what I'm trying to get a sense of is when you change the wording on the U.S. supply website, which isn't updated yet, what are you going to say, assuming you want to give some visibility relative to your prior September commentary?

    薩欽·賈恩 (Sachin Jain),美國銀行。如果可以的話,有兩個關於 Wegovy 供應的問題。卡斯滕,感謝您提供的最新供應情況。聽起來一切都步入正軌了。因此,嘗試了解您所使用的模糊語言的驅動因素。非常簡單,供應是否仍然存在不確定性或問題,例如第二個康泰倫特設施的時間安排,或第二個 CDMO 產能提升的速度?或者這只是 SELECT 後的需求不確定性?其次,正如我們都在努力為下半年提供的模型一樣,您能給我們什麼顏色來說明您如何動態管理供應?我們是否應該預期下半年供應會增加?我想我想要了解的是,當您更改美國供應網站上的措辭(該網站尚未更新)時,您會說什麼,假設您想提供相對於之前 9 月的一些可見性評論?

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

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

  • Thanks, Sachin. Again, it's important to note that this all starts with a very, very substantial demand driven by the unmet patient need in the U.S. and rest of world. And that's, of course, what we're scaling our supply chain to as a top priority, as I alluded to before. The language in the company announcement should absolutely not be understood as we are uncertain about our supply to the market. So our supply is rolling according to plans in terms of getting the new lines on track. And we have a supply plan, which has been shared with our commercial colleagues. And then, of course, there are some uncertainties about what dose strengths are being utilized in the specific markets. And the only responsible way to manage this as a company is, of course, the patients starting on Wegovy, they should be able to titrate up to the 2.4 milligram dose and thereby achieve the benefits that we showed in the STEP program of up to 17% weight loss. And the only way to -- the best way to do that is, of course, not to start more patients than we can secure continuity of care. And then furthermore, not to launch in more affiliate then we can support. So you should not see the language as uncertainty on the supply side, but more that we'll be navigating the market in a sustainable manner. And therefore, also the starter doses in the U.S. will be managed more dynamic in terms of how many we start given the fluctuations between the dose strengths.

    謝謝,薩欽。需要再次強調的是,這一切都始於美國和世界其他地區未滿足的患者需求所驅動的非常非常巨大的需求。當然,正如我之前提到的,這就是我們擴展供應鏈的首要任務。公司公告中的語言絕對不應該被理解,因為我們不確定我們對市場的供應。因此,我們的供應正在按計劃進行,以使新生產線步入正軌。我們有一個供應計劃,已與我們的商業同事共享。當然,特定市場中使用的劑量強度也存在一些不確定性。當然,作為一家公司管理這一問題的唯一負責任的方式是,從 Wegovy 開始的患者,他們應該能夠滴定至 2.4 毫克劑量,從而實現我們在 STEP 計劃中展示的高達 17 的益處% 體重減輕。當然,唯一的方法——最好的方法是,啟動的患者數量不要超過我們能夠確保連續護理的能力。此外,不要推出更多我們可以支持的附屬機構。因此,您不應將這種語言視為供應方面的不確定性,而更多地認為我們將以可持續的方式駕馭市場。因此,考慮到劑量強度之間的波動,美國的起始劑量也將在起始劑量方面進行更加動態的管理。

  • Operator

    Operator

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

    這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

  • Just coming on to SELECT and some of the safety concerns you've seen with regulators and the press around Wegovy, suicides, thyroid cancer, a couple of those. So what have you seen in SELECT around those issues? And what do you have in your own adverse event databases that could be used to address these concerns from our side? And then secondly, just thinking about the legal provisions that you alluded to, increasing SG&A. Are they due to your litigation against the counterfeit producers or anything else you could say on those?

    剛剛進入 SELECT 以及您在監管機構和媒體上看到的有關 Wegovy 的一些安全問題、自殺、甲狀腺癌等等。那麼您在 SELECT 中看到了哪些關於這些問題的信息?你們自己的不良事件數據庫中有哪些可以用來解決我們方面的這些問題?其次,想想你提到的法律規定,增加SG&A。這是由於您對假冒產品生產商提起的訴訟還是您可以對此說些什麼?

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

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

  • Martin, you take the SELECT. Karsten, you take legal provisions afterwards.

    馬丁,你選擇選擇。卡斯滕,你之後採取法律規定。

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

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

  • As you know, safety is very high at the top of our agenda, and we do that for all of our compounds. You also know that, broadly, GLP-1 has been on the market for 15 years in diabetes, 8 years in obesity. So we have a huge safety database across GLP-1 companies, but obviously also collected by the authorities. And in addition to that, we have data from our clinical clients. SELECT, obviously, due to its size, can almost stand alone in most safety assessments. And I think it's fair to say, again, I'm not allowed to go into any details. I think it's fair to say that SELECT is supporting our broad assessment of the attractive safety profile of semaglutide and the broader GLP-1 approach, including when looking at some of the issues that have been in the media in recent months. So we take a lot of comfort from being able to add the SELECT data to the data pool.

    如您所知,安全性是我們的首要任務,我們對所有化合物都這樣做。您還知道,總體而言,GLP-1 在治療糖尿病方面已上市 15 年,在治療肥胖症方面已上市 8 年。因此,我們擁有一個涵蓋 GLP-1 公司的龐大安全數據庫,但顯然也是由當局收集的。除此之外,我們還有來自臨床客戶的數據。顯然,由於 SELECT 的大小,它在大多數安全評估中幾乎可以獨立存在。我認為可以公平地說,我不被允許透露任何細節。我認為可以公平地說,SELECT 支持我們對索馬魯肽有吸引力的安全性和更廣泛的 GLP-1 方法的廣泛評估,包括在考慮最近幾個月媒體上出現的一些問題時。因此,能夠將 SELECT 數據添加到數據池中讓我們感到非常安心。

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

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

  • And on legal provisions. So it's standing operating procedure that every quarter, we assess our portfolio of ongoing litigations and look at our exposure there and then update our legal provisions. Sometimes some provisions go up, sometimes they go down. And -- but what we say here is that we have increased our provisions based on the current standing of our ongoing litigations, as described in the annual report in detail and the subsequent company announcements. We're not really able to comment on ongoing litigations and specifically on provisions related to that.

    以及法律規定。因此,按照常設操作程序,我們每個季度都會評估我們正在進行的訴訟組合併查看我們在那裡的風險,然後更新我們的法律規定。有時一些規定會上升,有時會下降。而且 - 但我們在這裡所說的是,我們根據正在進行的訴訟的現狀增加了準備金,如年度報告和隨後的公司公告中詳細描述的那樣。我們無法對正在進行的訴訟,特別是與此相關的條款發表評論。

  • Operator

    Operator

  • The next question. And your next question comes from the line of Michael Leuchten, UBS.

    下一個問題。您的下一個問題來自瑞銀集團的 Michael Leuchten。

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

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

  • Two questions, please. You obviously called out a meaningful rebate adjustment for Rybelsus in the quarter, but there's also some language in the press release around wholesale stocking. Just wondering how meaningful was that stocking effect in the second quarter, if at all? And then, I'm very sorry to go back to the supply question, but just following from Sachin. Will you or will you not be able to start supplying the lower doses from September? I think the question we all have is, will you be able to come back to patients at a lower dose in September or not?

    請教兩個問題。您顯然呼籲在本季度對 Rybelsus 進行有意義的回扣調整,但新聞稿中也有一些關於批發庫存的措辭。只是想知道第二季度的庫存效應有多大意義(如果有的話)?然後,我很抱歉回到供應問題,但只是遵循薩欽的說法。您是否能夠從 9 月份開始提供較低的劑量?我認為我們所有人都面臨的問題是,你們能否在 9 月份以較低的劑量回到患者身邊?

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

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

  • Yes. So Karsten, I think, both for you.

    是的。所以卡斯滕,我想,對你來說都是如此。

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

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

  • So in terms of wholesale stocking, this is in our first half commentary, and it's basically linked to the wholesale stocking we saw in the first quarter and communicated already in our first quarter release. So no material wholesale movements in the second quarter. As to the lower dose strengths of Wegovy in the U.S., again, it's important for us to reiterate that all dose strengths are available in the U.S. market of Wegovy, but we are limiting the lower dose strengths. So we only start the amount of patients that can titrate up, as also evidenced in the ongoing IQVIA script monitoring. So -- and after September, we expect that to continue to be the case. And then, of course, we'll dynamically be managing how many new patients we take on to the lower doses.

    因此,就批發庫存而言,這是我們上半年的評論,它基本上與我們在第一季度看到的批發庫存相關,並且已經在第一季度發布中進行了溝通。因此第二季度沒有材料批髮變動。至於 Wegovy 在美國的較低劑量強度,我們再次重申,所有劑量強度均可在 Wegovy 美國市場上獲得,但我們正在限制較低劑量強度。因此,我們只開始可滴定的患者數量,正如正在進行的 IQVIA 腳本監測所證明的那樣。因此,九月之後,我們預計這種情況將繼續存在。當然,我們將動態管理接受較低劑量的新患者數量。

  • Operator

    Operator

  • Your next question comes from the line of Peter Welford from Jefferies.

    您的下一個問題來自 Jefferies 的 Peter Welford。

  • Peter James Welford - Senior Equity Analyst & European Pharmaceuticals Analyst

    Peter James Welford - Senior Equity Analyst & European Pharmaceuticals Analyst

  • Two. One coming back to SELECT. I wonder, Martin, I'm not asking for any details, but I wonder if you can just tell us, will at the AHA presentation, is the focus going to be on the primary endpoint? Or wondering, how many of the sort of interesting secondary endpoints? I guess I'm looking at the slide where you highlight, for example, slowing Type 2 diabetes and some of the other (inaudible) get any insight into any of those sort of endpoints from SELECT at AHA? Or is it going to be -- is your strategy, I guess, more going to be a drift-wise sort of release of SELECT data as we go over time? And then secondly, just looking -- sort of going back to the prior question on Rybelsus, but looking more at the rebates. I wonder if you can just comment, if we look at the gross to net adjustment that we sort of see from prescriptions in 2Q for Ozempic and Rybelsus, it sounds as though for Ozempic 2Q is a real number. But for Rybelsus, could you just talk -- is there anything we should consider when we look at that number for any changes at all during the second quarter?

    二。一回到選擇。我想知道,馬丁,我不是要求提供任何細節,但我想知道您是否可以告訴我們,在 AHA 演講中,重點是否會集中在主要終點上?或者想知道有多少種有趣的次要終點?我想我正在看您強調的幻燈片,例如,減緩 2 型糖尿病和其他一些(聽不清)從 AHA 的 SELECT 中獲得對任何此類終點的深入了解?或者,我想,隨著時間的推移,您的策略是否會更多地以漂移方式發布 SELECT 數據?其次,只是看看——有點回到之前關於 Rybelsus 的問題,但更多地關注回扣。我想知道您是否可以評論一下,如果我們看看從 Ozempic 和 Rybelsus 的第二季度處方中看到的總淨調整,聽起來 Ozempic 2Q 是一個真實的數字。但對於 Rybelsus,您能否談談——當我們查看第二季度這個數字是否有任何變化時,我們應該考慮什麼?

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

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

  • Martin on SELECT what you can say about American Heart Association?

    馬丁在 SELECT 節目中您對美國心臟協會有何看法?

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

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

  • Obviously, our focus -- our primary focus for the presentation at American Heart is going to be on the primary endpoint and the confirmatory secondary endpoint. But to your point, we also have a great number of really interesting secondary endpoints that would be of relevance to a wide range of people. And our aim is obviously to share as much as we can during the congress and in the potential related publications.

    顯然,我們在美國心臟大會上的演講的主要焦點將是主要終點和驗證性次要終點。但就您而言,我們還有大量非常有趣的次要終點,這些終點與廣泛的人群相關。我們的目標顯然是在大會期間和潛在的相關出版物中盡可能多地分享。

  • Daniel Bohsen - CVP & Head of IR

    Daniel Bohsen - CVP & Head of IR

  • Thank you, Martin. Karsten, on the rebates from the U.S.?

    謝謝你,馬丁。卡斯滕,來自美國的回扣?

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

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

  • Yes. rebates in the U.S. and Rybelsus specifically. And it's correct, as you point out, there's some fluctuation in the gross net on Rybelsus. And I think the way you should think about it is that we had a slight positive rebate adjustment in the first quarter this year on Rybelsus and a slight negative rebate adjustment on Rybelsus in the U.S. in the second quarter. So that's why when you do quarter-over-quarter, kind of the sequencing doesn't look completely obvious. It's minor amounts. We're talking about a few hundred million DKK. So it's not something we normally calls out, but that's what's happening. The basic trends and the demand dynamics are still very strong as evidenced by more or less adopting of Rybelsus sales on a global scale.

    是的。特別是美國和 Rybelsus 的回扣。正如您所指出的,這是正確的,Rybelsus 的總淨值存在一些波動。我認為你應該考慮的是,今年第一季度我們對 Rybelsus 進行了輕微的正回扣調整,第二季度對美國的 Rybelsus 進行了輕微的負回扣調整。這就是為什麼當你按季度進行計算時,排序看起來並不完全明顯。這是少量的。我們談論的是幾億丹麥克朗。所以這不是我們通常所說的事情,但這就是正在發生的事情。基本趨勢和需求動態仍然非常強勁,全球範圍內或多或少採用 Rybelsus 銷售就證明了這一點。

  • Operator

    Operator

  • Your next question comes from the line of Simon Baker, Redburn.

    你的下一個問題來自西蒙·貝克(Simon Baker),雷德本(Redburn)。

  • Simon P. Baker - Head of Pharmaceutical Research

    Simon P. Baker - Head of Pharmaceutical Research

  • Two, if I may, please. Firstly, going back to Wegovy capacity, but not on fill and finish, on API. I just wondered if you could update us on where you are versus your current capacity on API? And then secondly, a question on Inversago and Ziltivekimab. Looking at the data that was presented at ADA. There was -- even after a week, there was a pretty broad range of responses in terms of weight loss. And the weight loss was greater than we saw in the Phase I study a week for [Calgary Summer]. So I just wonder if you could give us, firstly, an idea of any potential reasons for that spread of results? And secondly, -- is there any data, preclinical or clinical beyond 28 days, to see whether this is plateauing at a fairly modest level or whether it continues to go down as we see with your existing (inaudible)?

    兩個,如果可以的話,請。首先,回到 Wegovy 的產能,但不是 API 上的填充和完成。我只是想知道您能否向我們介紹一下您目前的 API 能力情況?其次,關於 Inversago 和 Ziltivekimab 的問題。查看 ADA 上提供的數據。即使在一周後,在減肥方面也出現了相當廣泛的反應。體重減輕幅度比我們在第一階段研究中看到的[卡爾加里夏季]每週的體重減輕幅度要大。所以我只是想知道您是否可以首先向我們介紹一下結果傳播的任何潛在原因?其次,是否有任何超過 28 天的臨床前或臨床數據來觀察這一情況是否穩定在相當適度的水平,或者是否像我們在您現有的情況下看到的那樣繼續下降(聽不清)?

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

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

  • Karsten, I don't know if you have some comments to the first question?

    Karsten,不知道你對第一個問題有什麼意見嗎?

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

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

  • Yes. So in terms of semaglutide API, Simon -- thank you for that. I think the starting point here is really look at our track record. So on Ozempic -- so Ozempic being the best-selling diabetes care product globally, growing more than 60% last year, growing pretty much at the same pace now in value, so even higher in volume. So that speaks to the scalability that we're doing on the API front. And you put on top of that Wegovy. So we are scaling our API setup significantly. And a key part actually of our DKK 25 billion CapEx program this year goes into peptide API, which, most likely, will be multiuse and hence, also cater for semaglutide manufacturing in the years to come.

    是的。就索馬魯肽 API 而言,Simon,謝謝您。我認為這裡的出發點是真正看看我們的業績記錄。 Ozempic 是全球最暢銷的糖尿病護理產品,去年增長了 60% 以上,現在價值增長速度幾乎相同,因此銷量甚至更高。這說明了我們在 API 方面所做的可擴展性。然後你把它放在 Wegovy 之上。因此,我們正在大幅擴展我們的 API 設置。實際上,我們今年 250 億丹麥克朗資本支出計劃的一個關鍵部分是肽 API,它很可能將具有多種用途,因此也可滿足未來幾年索馬魯肽的生產需求。

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

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

  • Martin, Inversago?

    馬丁、因弗薩戈?

  • 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 first of all, we've seen a broader set of data than what has been publicly available. We can't disclose that now, but obviously, it gives us a lot of comfort in not only the level but also the consistency of weight loss. Obviously, with the weight loss, there is some variation. We see that with most drugs. But it has not been anything that has concerned us. And similarly, obviously, on the safety side, we've seen more than what has been publicly disclosed. And I let -- and again -- and also with longer exposure time and it has given us sufficient comfort to do the acquisition.

    首先,我們看到的數據比公開的數據更廣泛。我們現在還不能透露這一點,但顯然,它不僅在減肥的水平上而且在減肥的一致性上都給我們帶來了很大的安慰。顯然,隨著體重的減輕,存在一些變化。我們在大多數藥物中都看到了這一點。但這並不是我們所關心的任何事情。同樣,顯然,在安全方面,我們看到的不僅僅是公開披露的內容。我讓——再一次——而且曝光時間更長,這讓我們有足夠的舒適感來進行收購。

  • Operator

    Operator

  • And your next question comes from the line of Florent Cespedes from Societe Generale.

    您的下一個問題來自法國興業銀行的 Florent Cespedes。

  • Florent Cespedes - Senior Equity Analyst

    Florent Cespedes - Senior Equity Analyst

  • Two, please. First, on China. Could you elaborate on the dynamic in this territory and if the back-to-growth is sustainable? And my second question, a follow-up on the product acquired today, the CB1. Could you confirm that you will initiate soon a Phase II program in monotherapy and in combo? And if -- it's highly likely that you will combine this product with Wegovy and CagriSema?

    請兩位。首先,關於中國。您能否詳細說明該領域的動態以及恢復增長是否可持續?我的第二個問題是今天購買的產品 CB1 的後續產品。您能否確認您將很快啟動單一療法和聯合療法的 II 期計劃?如果——您很可能將該產品與 Wegovy 和 CagriSema 結合起來?

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

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

  • Florent, if I got the question right, it was first on China and now back to growth in China? Karsten, will you provide some color to that?

    弗洛倫特,如果我沒問錯的話,首先是關於中國,現在又回到了中國的增長?卡斯滕,你能給它一些顏色嗎?

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

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

  • And this is really something we've been looking forward to because the volume-based procurement impact in China, which started in May of last year was, of course, a sizable impact on our Chinese business. And when you look at the growth rates for China here in the second quarter of more than 30%, that is really impressive. And this is really a story about the value of innovation. So we are being impacted by (inaudible) our older brands. But then on the contrary, then we see, most notably Ozempic growing significantly in China and also Xultophy and Ryzodeg pushing forward. So the Chinese opportunity remains intact as long as we continue to provide innovation into that market. And as you know, we also filed for Wegovy approval in China now. So we do see China as a significant long-term opportunity for the company.

    這確實是我們一直期待的事情,因為去年五月開始的中國批量採購對我們中國業務的影響當然是相當大的。當你看到中國第二季度超過 30% 的增長率時,這確實令人印象深刻。這確實是一個關於創新價值的故事。因此,我們正在受到(聽不清)舊品牌的影響。但相反,我們看到,最顯著的是 Ozempic 在中國的顯著增長,Xultophy 和 Ryzodeg 也在不斷推進。因此,只要我們繼續為該市場提供創新,中國的機會就不會受到影響。如您所知,我們現在也在中國申請了 Wegovy 批准。因此,我們確實認為中國對該公司來說是一個重要的長期機遇。

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

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

  • Martin?

    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. I can confirm indeed that we will initiate a Phase II trial investigating the INV-202 in patients with obesity in both mono and combination therapy. I can, at this point, not go into which combinations that we will investigate.

    是的。非常感謝。我確實可以確認,我們將啟動一項 II 期試驗,研究 INV-202 在單一療法和聯合療法中對肥胖患者的作用。在這一點上,我不能透露我們將研究哪些組合。

  • Operator

    Operator

  • And your next question comes from the line of Kerry Holford, Berenberg.

    你的下一個問題來自凱瑞·霍爾福德(Kerry Holford),貝倫貝格(Berenberg)。

  • Kerry Ann Holford - Analyst

    Kerry Ann Holford - Analyst

  • Yes, 2 questions, please. Firstly, on oral GLP-1. Aside from the Q2 performance, I wonder if you can just talk to why perhaps Rybelsus uptake in the diabetes market at least relative to Ozempic, has not been as substantial as you might have expected by now. And with that in mind, as you're approaching the launch of oral Wegovy, what you, within Novo, expect from the ramp of a new oral therapy into the obesity market? And then secondly, on GLP-1 formulation, your key competitor in the diabetes space has announced plans to launch its new (inaudible) in certain markets in a vial format. And I wonder if that's something you would consider for Wegovy in order to meet those supply demand.

    是的,請提 2 個問題。首先,關於口服GLP-1。除了第二季度的表現之外,我想知道您是否可以談談為什麼 Rybelsus 在糖尿病市場的採用率(至少相對於 Ozempic)尚未達到您目前預期的水平。考慮到這一點,當您即將推出口服 Wegovy 時,您對 Novo 內部的新口服療法進入肥胖市場有何期望?其次,關於 GLP-1 配方,您在糖​​尿病領域的主要競爭對手已宣布計劃以小瓶形式在某些市場推出其新產品(聽不清)。我想知道您是否會考慮讓 Wegovy 滿足這些供應需求。

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

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

  • Good. So first, Camilla, if you can talk about the way we look with the oral GLP-1 Rybelsus, the commercial dynamics.

    好的。首先,卡米拉,您能否談談我們對口服 GLP-1 Rybelsus 的看法,即商業動態。

  • 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

  • Yes. So in terms of dynamics for Rybelsus, we continue to gain share in the (inaudible) segment, (inaudible) oral antidiabetic segment. And of course, some patients prefer the oral therapy. Some patients prefer the injectable therapy, but it's clear that in its totality, we continue to, of course, grow our -- the use of GLP-1. If you were also asking into the oral opportunity in obesity, then we also expect that there will be people who will be favoring oral therapy in obesity as well. And of course, you have just heard about the recent data that we have presented on the 50 milligram. And we will continue to, of course, evaluate our launches of that based on portfolio [prioritization] and manufacturing capacity. But there is no doubt that there is a big unmet demand in obesity also for the oral compounds with an efficacy that is quite similar and 50 milligrams to the Wegovy 2.4.

    是的。因此,就 Rybelsus 的動態而言,我們繼續在(聽不清)細分市場、(聽不清)口服抗糖尿病細分市場中獲得份額。當然,有些患者更喜歡口服治療。有些患者更喜歡注射療法,但很明顯,總的來說,我們當然會繼續擴大 GLP-1 的使用。如果您還詢問口服治療肥胖症的機會,那麼我們也預計會有人讚成口服治療肥胖症。當然,您剛剛聽說過我們最近提供的 50 毫克數據。當然,我們將繼續根據產品組合[優先級]和製造能力來評估我們的推出。但毫無疑問,肥胖症患者對口服化合物的需求也有很大未得到滿足,其功效與 Wegovy 2.4 非常相似,劑量為 50 毫克。

  • Daniel Bohsen - CVP & Head of IR

    Daniel Bohsen - CVP & Head of IR

  • Thank you, Camilla. And Lars, supply chain strategy?

    謝謝你,卡米拉。拉爾斯(Lars),供應鏈戰略?

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

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

  • Yes. So I think we have a situation where we have 2 different device presentations for our GLP-1 portfolio. We have the single-shot device where we go in the U.S., and we leverage our FlexTouch platform outside of the U.S. So I think we have significant flexibility and also you can say, better scalability in that approach compared to relying on single-dose approach solely. So we don't have any current plans of going to vial, say, dosing or vial presentation for GLP-1 formulation.

    是的。因此,我認為我們的 GLP-1 產品組合有 2 種不同的設備演示。我們在美國擁有單劑量設備,並且我們在美國境外利用我們的FlexTouch 平台。因此,我認為我們具有顯著的靈活性,而且您也可以說,與依賴單劑量方法相比,該方法具有更好的可擴展性獨自。因此,我們目前沒有任何計劃將 GLP-1 製劑進行小瓶給藥或小瓶展示。

  • Operator

    Operator

  • We will now take the next question. And your next question comes from the line of Mike Nedelcovych from TD Cowen.

    我們現在回答下一個問題。您的下一個問題來自 TD Cowen 的 Mike Nedelcovych。

  • Michael Thomas Nedelcovych - Research Associate

    Michael Thomas Nedelcovych - Research Associate

  • I have 2 for Martin. The first is based on the impressive results we've seen with SELECT. Do you have any plans to conduct a cardiovascular outcomes trial in a primary prevention setting, perhaps with CagriSema? And if not, why not? And the second question is, Martin, you recently suggested you would consider running a trial, which tested alternative maintenance phase regimens after achieving target weight loss with either Wegovy or possibly CagriSema. Can you update us on your thinking around a potential trial in that vein? And might we see an initiation sometime in the near future?

    我有 2 個給馬丁。第一個基於我們在 SELECT 中看到的令人印象深刻的結果。您是否有計劃在一級預防環境中(或許與 CagriSema 合作)進行心血管結果試驗?如果沒有,為什麼不呢?第二個問題是,馬丁,您最近建議您考慮進行一項試驗,該試驗在使用 Wegovy 或可能的 CagriSema 實現目標減肥後測試替代維持階段方案。您能否向我們介紹您對這方面潛在試驗的最新想法?我們可能會在不久的將來看到啟動嗎?

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

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

  • Two great questions. So first on primary prevention. We are, of course, considering this. Given the SELECT results, I think we will be a little bit remiss not doing the consideration. You may know that we're also investigating primary prevention for semaglutide in the space of diabetes already. If there was a why not, and that's obviously part of our considerations. It is that the event rate in obesity is somewhat lower than we see it in diabetes, and that means that it would be -- have to be a very large trial, specifically looking at primary prevention where patients don't have an established cardiovascular disease. So we are taking all of this into account, and we'll keep you updated, but we've made no decisions at this point. And -- so in terms of the maintenance, this is part of our commitment in securing that an accrued weight loss can be maintained. I actually think -- and again, I can't disclose any data, but we have also been awaiting SELECT trial in this perspective because, obviously, we were very curious to investigate to what extent a weight loss was maintained over what -- for the sort of early patients would be a full 5-year period. So given that -- I can't disclose the data, I can't really give you our thinking, but just iterate our commitment through investigating how to best maintain an accrued weight loss following, obviously, semaglutide, but also CagriSema down the road.

    兩個很好的問題。首先是一級預防。當然,我們正在考慮這一點。鑑於 SELECT 結果,我認為我們不考慮的話會有點失職。您可能知道,我們也在研究索馬魯肽在糖尿病領域的一級預防。如果有一個原因,這顯然是我們考慮的一部分。肥胖的事件發生率比我們在糖尿病中看到的要低一些,這意味著這必須是一項非常大的試驗,特別是針對沒有明確患有心血管疾病的患者進行一級預防。因此,我們正在考慮所有這些因素,我們會隨時向您通報最新情況,但目前我們尚未做出任何決定。因此,就維持而言,這是我們確保維持累積減重的承諾的一部分。我實際上認為——再說一次,我不能透露任何數據,但從這個角度來看,我們也一直在等待SELECT 試驗,因為顯然,我們非常好奇,想調查在什麼情況下,體重減輕能維持到什麼程度——那種早期病人會持續整整5年的時間。因此,考慮到這一點,我無法透露數據,我無法真正向您提供我們的想法,但只是通過研究如何最好地維持在索馬魯肽和 CagriSema 後的累積體重減輕來重申我們的承諾。

  • Operator

    Operator

  • We will now go to the next question. One moment, please. And next question comes from the line of Harry Sephton from Credit Suisse.

    我們現在進入下一個問題。稍等一會兒。下一個問題來自瑞士信貸銀行的 Harry Sephton。

  • Harry Thomas d'Alton Sephton - Research Analyst

    Harry Thomas d'Alton Sephton - Research Analyst

  • Brilliant. My first one is on the Ozempic number in the U.S. in the second quarter. So prescription growth was about 96%, but you reported 44% sales growth. I was just hoping that you could confirm that there wasn't any one-off gross-to-net exceptionals in the second quarter. and that's just a reflection of your expected level of rebating with the growth in the product? And then my second question on tax. At this stage, can you indicate the expected impact to your effective tax rate from implementation of the global minimum tax rate?

    傑出的。我的第一個是關於美國第二季度的 Ozempic 數據。因此,處方藥增長約為 96%,但您報告的銷售額增長了 44%。我只是希望你能確認第二季度沒有出現任何一次性的毛淨值異常情況。這只是您隨著產品增長而預期的回扣水平的反映?然後是我關於稅收的第二個問題。現階段,您能否說明實施全球最低稅率對您的有效稅率的預期影響?

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

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

  • Yes, Karsten, I'll give both to you.

    是的,卡斯滕,我會把兩個都給你。

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

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

  • Yes. Thank you for those 2 questions. And for the first one, on Ozempic, no, there are no special major gross-to-net adjustment in the quarter. I think it's important to note that between what you see in IQVIA numbers and our net sales, you have inventory movements also that could impact the numbers. So no major movements and basically a reiteration around that when we look at Ozempic and gross to net in the U.S., we're still in the, I'd call it, 10% to 15% net price decline range. So no changes compared to prior quarters there. And always do be careful on looking at individual quarters when you do gross to net and reconciliations to TRx. As to impact from bps on our effective tax rate, it will be minor. So I think we're running around the 20% effective tax rate currently. And when we look forward, that's approximately the level we'll be looking at on effective tax rate going forward also bearing any major BD M&A transactions that would change our structure. But at this point, broadly neutral around 20%.

    是的。謝謝你提出這兩個問題。對於第一個,在 Ozempic 上,沒有,本季度沒有特別重大的總淨值調整。我認為值得注意的是,在 IQVIA 數據和我們的淨銷售額之間,庫存變動也可能會影響這些數據。因此,沒有重大變動,基本上重申了這一點,當我們觀察美國的 Ozempic 和毛淨價格時,我們仍然處於(我稱之為)10% 至 15% 的淨價格下降範圍。因此與前幾個季度相比沒有變化。當您進行毛淨值和 TRx 調節時,一定要小心查看各個季度。至於基點對我們的有效稅率的影響很小。所以我認為我們目前的有效稅率約為 20%。當我們展望未來時,這大約是我們未來將考慮的有效稅率水平,也包括任何將改變我們結構的重大 BD 併購交易。但目前來看,20% 左右大致中性。

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

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

  • We have time for 1 final set of questions, please.

    我們有時間回答最後一組問題。

  • Operator

    Operator

  • Your final question comes from the line of -- one moment, please. The final question is from the line of Michael Novod from Nordea.

    你的最後一個問題來自——請稍等一下。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 questions. One, to sort of the gradual rollout of the Wegovy in IO. So you commented to 2023, how confident are you, of course, also relating to supply about sort of a gradual, but also more accelerated rollout in '24 and '25 in IO of Wegovy and what we should we be able to expect in terms of larger markets? And then secondly, relating to Germany, can you detail a bit around the disease modification program in Germany that have triggered that you have launched, albeit in a controlled fashion in Germany for Wegovy?

    兩個問題。一是 Wegovy 在 IO 中的逐步推出。因此,您對 2023 年發表了評論,當然,您對 Wegovy IO 中 24 和 25 年逐步但更加速的供應以及我們應該能夠期待的內容有多大信心更大的市場?其次,關於德國,您能否詳細介紹一下德國啟動的疾病緩解計劃,儘管該計劃是在德國為 Wegovy 以受控方式啟動的?

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

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

  • Thank you, Michael. Camilla Bill, I'll give the word to you.

    謝謝你,邁克爾。卡米拉·比爾,我會轉告你的。

  • 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

  • Michael, as you know, we've now launched in the U.S. and in Denmark and Norway, where we see consistent trends on Wegovy and we will continue to roll out Wegovy in a manner that is, of course, responsible observing the uptake and the demand, in particular that we get. We have decided to launch in Germany as the third country in IO because there was a good opportunity to include Wegovy in the disease management program, and that basically means that we hopefully will be able to ensure that the people most in need of a weight loss product like Wegovy with the efficacy that it has, that they can get access to it. At the same time, of course, this is a slightly different approach that we have taken for given the high demand that there is. So we are continuing to roll it out both in Germany, but we'll also do that subsequently in other countries in a way where we could take, you can say, a responsible approach and the -- an approach that considers the high uptake on the demand so that we can ensure patient continuity, that is really the most important part of how we are trying to roll out Wegovy in more and more countries.

    Michael,如您所知,我們現在已在美國、丹麥和挪威推出,我們在這些國家看到了Wegovy 的一致趨勢,我們將繼續以負責任的方式推出Wegovy,當然,我們會負責任地觀察使用情況和使用情況需求,特別是我們得到的需求。我們決定在德國作為 IO 的第三個國家推出,因為這是一個將 Wegovy 納入疾病管理計劃的好機會,這基本上意味著我們希望能夠確保最需要減肥的人們像Wegovy 這樣的產品具有其功效,他們可以訪問它。當然,與此同時,鑑於需求量很大,我們採取的方法略有不同。因此,我們將繼續在德國推出它,但我們隨後也會在其他國家這樣做,我們可以採取一種負責任的方法,並且一種考慮到廣泛採用的方法需求,以便我們能夠確保患者的連續性,這確實是我們試圖在越來越多的國家推廣Wegovy 的最重要部分。

  • Daniel Bohsen - CVP & Head of IR

    Daniel Bohsen - CVP & Head of IR

  • Thank you, Camilla. So this concludes our Q&A session. Thank you for participating in the call, and feel free to reach out to Investor Relations with any follow-up questions. Before closing the call, I would like to give the word to you, Lars, for any final remarks.

    謝謝你,卡米拉。我們的問答環節到此結束。感謝您參加此次電話會議,如有任何後續問題,請隨時聯繫投資者關係部。在結束通話之前,拉斯,我想請您發表最後的意見。

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

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

  • Yes. Thank you, Daniel. So also a warm thanks from me for the interest here today. I hope it gives all of you that we are very pleased with the momentum we have in our business as represented in the growth for the first 6 months in our guidance for the year. and also the growth opportunity in the coming years. We're pursuing an innovation-based growth strategy, and it's clear that the data we have received from SELECT underpins a very attractive mid- to long-term growth profile for semaglutide and we're very pleased with that.

    是的。謝謝你,丹尼爾。我也衷心感謝您今天對這裡的關注。我希望這能讓大家知道,我們對我們的業務勢頭感到非常滿意,這一點在我們今年的指導中體現為前 6 個月的增長。以及未來幾年的增長機會。我們正在追求基於創新的增長戰略,很明顯,我們從 SELECT 收到的數據支撐了索馬魯肽非常有吸引力的中長期增長概況,我們對此感到非常滿意。

  • And I also like to underline, has been asked a couple of times, we are very confident in our scale and supply this aspiration, and we see capacities coming in line as we speak. And we have years back and are today making very important investment decisions to build what is needed to support this growth aspiration for the coming years. So with that, I'll close this call, and thank you again all for your interest. Thank you.

    我還想強調,已經被問過幾次了,我們對我們的規模非常有信心,並滿足這一願望,並且我們看到產能正在符合我們的要求。多年前和今天,我們正在做出非常重要的投資決策,以建立支持未來幾年增長願望所需的資源。因此,我將結束本次通話,並再次感謝大家的關注。謝謝。

  • Operator

    Operator

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

    謝謝。今天的電話會議到此結束。感謝您的參與。您現在可以斷開連接。