製藥公司諾和諾德 (Novo Nordisk) 報告稱,2023 年前 9 個月的銷售額增長了 33%,營業利潤增長了 37%。
該公司在永續發展目標方面取得了進展,並實現了其肥胖願望。
諾和諾德預計全年銷售將持續成長,並基於強勁的業績上調了預期。
該公司專注於解決慢性疾病,其藥物索馬魯肽在降低心血管風險方面取得了可喜的成果。
諾和諾德也正在探索索馬魯肽對其他疾病的潛在治療效果。
該公司還有多個其他研發里程碑正在進行中。
在電話會議上,公司高層討論了供應、定價和潛在的產品推出。
諾和諾德對其成長和擴大供應規模充滿信心,以支持其發展。
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 Q3 2023 Novo Nordisk AS Earnings Conference Call. At this time, all participants are in a listen-only mode aftersales as a question in the session on your telephone. You will then hear an automated message advising your hand is raised. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Daniel Bohsen, Head of Investor Relations. Please go ahead, sir.
美好的一天,感謝您的支持。歡迎參加諾和諾德 2023 年第三季財報電話會議。此時,所有參與者都處於只聽模式,在電話會議中提問。然後您將聽到一條自動訊息,建議您舉手。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第一位發言人,投資者關係主管丹尼爾·博森 (Daniel Bohsen)。請繼續,先生。
Daniel Bohsen - CVP & Head of IR
Daniel Bohsen - CVP & Head of IR
Welcome to this Novo Nordisk Earnings Call for the first 9 months of 2023. This call follows the early announcement of top line results and the updated outlook for 2023 shared in October. The release was advanced due to Danish securities regulations. My name is Daniel Bohsen, and I'm the Head of Investor Relations at Novo Nordisk. With me today, I have CEO of Novo Nordisk, 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. 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 the recording will be made available on our website as well. The call is catched 1 hour. Please turn to that. 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 material or further in the risk factors, please see the company announcement for the first 9 months of 2023 and the slides prepared for this presentation. With that, over to you, Lars, for an update on our aspirations.
歡迎參加諾和諾德 2023 年前 9 個月的收益電話會議。此次電話會議是在 10 月提前公佈頂線業績和更新的 2023 年展望之後舉行的。由於丹麥證券法規,該發布提前。我叫丹尼爾‧博森 (Daniel Bohsen),是諾和諾德 (Novo Nordisk) 投資者關係主管。今天與我在一起的有諾和諾德執行長 Lars Jorgensen、執行副總裁兼商業策略和企業事務主管 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 Doug Langa、馬丁·霍爾斯特·蘭格;最後是財務長 Karsten Knudsen。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,本次電話會議正在進行網路直播,錄音也將在我們的網站上提供。電話被接了1個小時。請轉向那個。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。請翻到下一張投影片。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。這些都受到風險和不確定性的影響,可能導致實際結果與實際結果有重大差異或進一步增加風險因素,請參閱 2023 年前 9 個月的公司公告以及為本次演示準備的幻燈片。拉斯,現在就請您來了解我們的願望的最新情況。
Lars Fruergaard Jorgensen - President, CEO & Member of Management Board
Lars Fruergaard Jorgensen - President, CEO & Member of Management Board
Thank you, Daniel. Next slide, please. In the first 9 months of 2023, we delivered 33% sales and 37% operating profit growth at constant exchange rates. I'd like to start this call by going through the performance highlights across our strategic aspirations before handing over the word to my colleagues. Within purpose and sustainability, we continue to make progress. Our carbon emissions decreased by 28% compared to prepandemic levels in 2019 and in line with our aspiration of being a state employer, we continue to expand the number of women in senior leadership positions. This is now 41% compared to 38% last year. In R&D, an important milestone is that we will stop the flow kidney outcomes trial early as semaglutide demonstrated a benefit in people with type 2 diabetes and chronic kidney disease. Further, within R&D, we have recently agreed to acquire osiduriron for the treatment of cardiovascular disease. This supports our expiration of establishing a presence in other serious chronic diseases with a high unmet medical need. Martin will come back to this and our overall R&D milestones later.
謝謝你,丹尼爾。請下一張投影片。 2023 年前 9 個月,以固定匯率計算,我們的銷售額成長了 33%,營業利潤成長了 37%。在向我的同事們傳達訊息之前,我想先回顧一下我們策略願景中的績效亮點,以此開始這次電話會議。在目標和永續性的範圍內,我們不斷取得進步。與 2019 年大流行前的水平相比,我們的碳排放量減少了 28%,為了符合我們成為國有雇主的願望,我們繼續增加擔任高階領導職位的女性人數。目前這一比例為 41%,而去年為 38%。在研發方面,一個重要的里程碑是,我們將儘早停止流腎結果試驗,因為索馬魯肽已證明對第 2 型糖尿病和慢性腎臟病患者有益。此外,在研發方面,我們最近同意收購奧西杜隆用於治療心血管疾病。這支持我們在其他嚴重的慢性疾病領域建立存在,這些疾病的醫療需求未被滿足。馬丁稍後將回到這一點以及我們的整體研發里程碑。
The sales growth reflects strong commercial execution with both operating units contributing to continued sales growth, driven by increasing demand for our GLP-1-based diabetes and obesity treatments. Camilla and Doug will go through the details in the therapy area later. Within commercial execution, we are pleased to have reached our obesity aspiration of DKK 25 billion and our expiration for diabetes by reaching a global value market share of 1/3. Naturally, the progress is not holding us back, and we continue to aim for treating more patients with our innovative treatments. Karsten will go through the financial details, but I'm very pleased with our overall performance for the first 9 months of 2023, which has enabled us to raise our outlook for the full year. With that, I'll give the word to Camilla for an update on commercial execution.
銷售成長反映了強大的商業執行力,在對我們基於 GLP-1 的糖尿病和肥胖治療的需求不斷增長的推動下,兩個營運部門都為持續的銷售成長做出了貢獻。卡米拉和道格稍後將詳細介紹治療領域的細節。在商業執行方面,我們很高興實現了 250 億丹麥克朗的肥胖目標,並透過達到 1/3 的全球價值市場份額來結束糖尿病。當然,進步並沒有阻礙我們,我們繼續致力於用我們的創新療法治療更多患者。 Karsten 將詳細介紹財務細節,但我對我們 2023 年前 9 個月的整體業績感到非常滿意,這使我們能夠提高全年的預期。這樣,我將轉告卡米拉,了解商業執行的最新情況。
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 9 months of 2023, our total sales increased by 33%. The sales growth was driven by both operating units with North American operations growing 49% and international operations growing 17%. Our GLP-1 sales increased 49% driven by North America, growing 43% and international operations growing 60%. Insulin sales decreased by 7%, driven by a 1% decline in international operations and a 24% sales decline in North America Operations. The sales decrease was driven by a decrease in sales in the U.S. and Region China. Obesity care sales grew 174% overall. In International Operations, sales grew 52%, driven by both Saxenda and VigoVI. In North America operations, Obesity care sales grew 244%. The Total rare disease sales decreased 18%, which was driven by a 22% decrease in international operations and by a 13% decrease in North America operations. Please turn to the next slide.
謝謝拉爾斯,請翻到下一張投影片。 2023 年頭 9 個月,我們的總銷售額成長了 33%。銷售成長由兩個營運部門推動,其中北美業務成長 49%,國際業務成長 17%。在北美成長 43% 和國際業務成長 60% 的推動下,我們的 GLP-1 銷售額成長了 49%。由於國際業務銷售額下降 1% 和北美業務銷售額下降 24%,胰島素銷售額下降 7%。銷售額下降的原因是美國和中國地區的銷售額下降。肥胖護理銷售額整體成長 174%。在 Saxenda 和 VigoVI 的推動下,國際營運部門的銷售額成長了 52%。在北美業務中,肥胖護理銷售額成長了 244%。罕見疾病總銷售額下降 18%,這是由於國際業務下降 22% 和北美業務下降 13% 所致。請翻到下一張投影片。
With 25% sales growth in our diabetes care, we are now growing faster than the total market, improving our global diabetes value market share to 33.3%. The increase reflects market share gains in both North America Operations and International Operations. In international operations, total diabetes care sales increased by 21% in the first 9 months of 2023. This was driven by GLP-1 sales growing 60%, driven by all geographical areas. Novo Nordisk is the market leader in international operated GLP-1 value market share of 69%. Sampi continues its GLP-1 market leadership with just shy of 46% market share. Rialto has 12% value market share driven by strong uptake across geographies. And with that, I will hand over to Doug.
我們的糖尿病照護銷售額成長了 25%,目前的成長速度快於整個市場,將我們的全球糖尿病價值市場份額提高到 33.3%。這一增長反映了北美業務和國際業務市場份額的成長。在國際業務中,2023 年前 9 個月,糖尿病護理總銷售額增長了 21%。這是由所有地理區域推動的 GLP-1 銷售額增長 60% 推動的。諾和諾德是國際營運的 GLP-1 價值市場的領導者,市佔率為 69%。 Sampi 繼續保持 GLP-1 市場領先地位,市佔率略低於 46%。由於跨地區的強勁採用,Rialto 擁有 12% 的價值市場份額。接下來,我會把工作交給道格。
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. The GLP-1 class expansion continues in the U.S. in the first 9 months of 2023. The U.S. GLP-1 market volume grew around 50% comparing Q3 of 2023 to Q3 of 2022. Measured on total prescriptions, Novo Nordisk continues to be the market leader with 53% market share. Please go to the next slide. Obesity care sales grew by 174% in the first 9 months of 2023. This was mainly driven by the U.S. The global branded anti-obesity market expansion continues with a global volume growth of 94%. In international operations, Obesity care sales are driven by strong Saxenda performance and the Wegovy launches in 5 international operation countries. While eager to launch Wegovy in more I/O countries, our focus remains to do this in a sustainable manner, for example, by capping volumes. In the U.S. alone, sales of Wegovy grew by 467%. Demand for Wegovy continues to exceed supply and to safeguard continuity of care for patients already on Wegovy, the supply of the lower Wegovy-dose strengths in the U.S. has been reduced since May of 2023. Please go to the next slide. Our rare disease sales decreased by 18%. The sales decrease was driven by a 13% decline in North America operations and a 22% sales decline in international operations. Sales of rare blood disorders increased by 2%, driven by the launch products in hemophilia A and B and partially countered by NovoSeven. Sales of rare endocrine disorder products decreased by 54%, reflecting a temporary reduction in manufacturing output. Now over to you, Martin, for an update on R&D.
謝謝你,卡米拉。請翻到下一張投影片。 2023 年前9 個月,美國GLP-1 類別的擴張仍在繼續。與2023 年第三季度相比,2022 年第三季度,美國GLP-1 市場銷量成長了約50%。以總處方量衡量,諾和諾德仍然是市場中的佼佼者佔據53%的市場份額,處於領先地位。請轉到下一張投影片。 2023 年前 9 個月,肥胖護理銷售額成長了 174%。這主要是由美國推動的。全球品牌抗肥胖市場持續擴張,全球銷量成長了 94%。在國際業務中,肥胖護理產品的銷售受到 Saxenda 強勁業績的推動,並且 Wegovy 在 5 個國際運營國家推出。雖然渴望在更多 I/O 國家推出 Wegovy,但我們的重點仍然是以可持續的方式實現這一目標,例如透過限制數量。光是在美國,Wegovy 的銷售額就成長了 467%。對 Wegovy 的需求持續超過供應,為了保障已經使用 Wegovy 的患者的護理連續性,自 2023 年 5 月以來,美國較低劑量的 Wegovy 的供應已減少。請轉至下一張投影片。我們的罕見疾病銷售額下降了 18%。銷售額下降的原因是北美業務銷售額下降 13%,國際業務銷售額下降 22%。罕見血液疾病的銷售額增加了 2%,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。罕見內分泌失調產品的銷售量下降了 54%,反映出製造業產出暫時減少。馬丁,現在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. Serious chronic noncommunicable diseases affect millions of people globally and have emerged in recent years as a major public health issue. Given our extensive scientific and clinical knowledge within metabolic diseases, we are well positioned to advance our understanding of semaglutide potential benefits and associated health complications. With the current body of evidence, it is clear that the beneficial effects of semaglutide goes even further than glycemic control and weight loss. Semaglutide has already now demonstrated convincing risk reductions in a number of cardiovascular outcome studies. This includes SUSTAIN 6 and PIONEER 6 in type 2 diabetes as well as TEPP-select in obesity. While we await data from the SELECT trial to be presented, we continue to build evidence for the semaglutide molecule in the cardiovascular space. In 2024, we expect several readouts. This includes type 2 diabetes cardiovascular outcome study sold will or semaglutide 14-milligram, and the functional outcomes trial, STRIDE, which focuses on the high-risk population with peripheral vascular disease.
謝謝你,道格。請翻到下一張投影片。嚴重的慢性非傳染性疾病影響著全球數百萬人,近年來已成為重大公共衛生議題。鑑於我們在代謝疾病方面廣泛的科學和臨床知識,我們有能力加深對索馬魯肽潛在益處和相關健康併發症的理解。根據目前的證據,很明顯,索馬魯肽的有益作用甚至比血糖控制和減肥更進一步。目前,索馬魯肽已在多項心血管結局研究中顯示出令人信服的降低風險的作用。這包括治療第 2 型糖尿病的 SUSTAIN 6 和 PIONEER 6 以及治療肥胖症的 TEPP-select。在我們等待 SELECT 試驗數據公佈的同時,我們繼續為索馬魯肽分子在心血管領域的作用建立證據。 2024 年,我們預計會有多個讀數。這包括第 2 型糖尿病心血管結局研究(出售 14 毫克 semaglutide),以及功能性結局試驗 STRIDE(重點關注患有外周血管疾病的高風險人群)。
As previously discussed, we also investigated the potential therapeutic effects of semaglutide on osteoarthritis and metabolic dysfunction associated with daltohepatisis, previously known as nonalcoholic steroid hepatitis. In addition to this, we recently announced early closure of the flow client due to efficacy. Next slide, please. This closure was based on a recommendation from the flow independent data monitoring committee following a preplanned interim analysis. As you know, FLOW is an outcomes trial conducted across 28 countries and more than 400 sites. 3,534 people were enrolled and randomized in a 1:1 ratio to receive either once weekly semaglutide 1.0 milligram or placebo. The eligibility criteria were designed to include patients with type 2 diabetes and high or very high risk for progression of chronic kidney disease. The primary objective of Flow is to demonstrate delay in progression of chronic kidney disease and to lower the risk of kidney and cardiovascular mortality through the composite primary endpoint. This is on top of standard of care, including the use of SGLT2s. The trial is powered to detect a 20% risk reduction on the primary endpoint.
如前所述,我們也研究了索馬魯肽對骨關節炎和與達爾托肝病(以前稱為非酒精類固醇肝炎)相關的代謝功能障礙的潛在治療作用。除此之外,我們最近也宣布由於功效原因提前關閉串流客戶端。請下一張投影片。此次關閉是基於流量獨立數據監測委員會在預先規劃的中期分析後提出的建議。如您所知,FLOW 是一項在 28 個國家和 400 多個地點進行的結果試驗。 3,534 名受試者以 1:1 的比例隨機入組,接受每週一次的索馬魯肽 1.0 毫克或安慰劑治療。資格標準旨在包括第 2 型糖尿病患者以及慢性腎臟病進展風險高或極高的患者。 Flow 的主要目標是證明慢性腎臟病進展的延遲,並透過複合主要終點降低腎臟和心血管死亡的風險。這是在標準護理之上的,包括使用 SGLT2。該試驗旨在檢測主要終點風險降低 20%。
Key secondary endpoints include annual rate of change in estimated glomerular filtration rate, major adverse cardiovascular events and all cost depth. Today, a few treatment options exist for chronic kidney disease in people living with type 2 diabetes. With a projected global increase in type 2 diabetes, there is a clear need for additional treatment options to help mitigate the residual risk in people or concomitant chronic kidney disease. The next step for me to close down the trial, start Flow is expected in the first half of 2024. The presentation of detailed data is expected to take place at a medical conference also during 2024. Next slide, please. In line with our strategic aspiration of establishing a presence in other serious chronic diseases, we are pleased to announce the acquisition of ocedurenone for the treatment of cardiovascular disease from KBP Biosciences. There remains a significant need in treatment of hypertension, which is a leading risk factor for cardiovascular events, heart failure, chronic kidney disease and death. Ocedurenone is a once-daily oral administered small molecule with a long half-life and a higher affinity for the mineralcorticoid receptor. Ocedurenone has an attractive efficacy and safety profile and is currently being examined in the Phase III trial, CLARINKD in patients with uncontrolled hypertension and advanced chronic adidisease. We expect to initiate additional cardiovascular as well as chronic kidney disease outcomes trials during the course of 2024.
關鍵的次要終點包括估計腎小球濾過率的年變化率、主要不良心血管事件和所有成本深度。如今,針對第 2 型糖尿病患者的慢性腎臟病有幾種治療選擇。隨著全球 2 型糖尿病的預期增加,顯然需要額外的治療方案來幫助減輕人們或伴隨的慢性腎臟病的殘餘風險。我結束試驗的下一步預計是在 2024 年上半年啟動 Flow。預計詳細數據的展示也將在 2024 年的醫學會議上進行。請下一張投影片。根據我們在其他嚴重慢性疾病領域建立業務的戰略意願,我們很高興地宣布從 KBP Biosciences 收購用於治療心血管疾病的 ocedurenone。高血壓的治療仍有巨大需求,高血壓是心血管事件、心臟衰竭、慢性腎臟病和死亡的主要危險因子。 Ocedurenone 是一種每日口服一次的小分子,半衰期長,對鹽皮質激素受體有較高的親和力。 Ocedurenone 具有吸引人的功效和安全性,目前正在 III 期試驗 CLARINKD 中對未受控制的高血壓和晚期慢性阿迪達斯病患者進行檢查。我們預計在 2024 年期間啟動更多心血管和慢性腎臟疾病結果試驗。
Next slide, please. Turning to other R&D milestones. I would like to highlight some of the other trial readouts and initiations across our therapy areas in 2023 and in the first half of 2024. Within diabetes in the third quarter of 2023, we initiated the first pivotal Phase III trial in the reimagined program for CagriSema in people with type 2 diabetes. In the fourth quarter, we have submitted oral semaglutide 25 and 50 milligrams in the EU. We are also anticipating the results from the ongoing pivotal Phase III trial for IcoSema combined free in the first half of 2024. IcoSema has the potential to be a first-in-class once-weekly fixed ratio combination of basal insulin and GLP-1 receptor agonist compared to type 2 diabetes in need of intensification. Within obesity, we are happy to announce that we in September initiated a 32-week Phase I trial with once weekly subcutaneous amicetin in people with all weight obesity. While we await select data going to be presented at the American Heart Association Congress, we have submitted the trial to the U.S. FDA and the European Medicines Agency. We are pleased that the FDA has granted priority review for the supplemental new drug application. This marks a significant milestone in our ongoing efforts to address unmet needs in patients with overweight and obesity and established cardiovascular disease.
請下一張投影片。轉向其他研發里程碑。我想強調一下2023 年和2024 年上半年我們治療領域的一些其他試驗結果和啟動情況。在2023 年第三季的糖尿病領域,我們在CagriSema 重新構想的計劃中啟動了第一個關鍵的III 期試驗2 型糖尿病患者。第四季度,我們在歐盟提交了口服索馬魯肽25毫克和50毫克。我們也預期 2024 年上半年正在進行的 IcoSema 免費組合關鍵 III 期試驗的結果。IcoSema 有潛力成為一流的每週一次固定比例的基礎胰島素和 GLP-1 受體組合與需要強化的2型糖尿病相比,激動劑。在肥胖方面,我們很高興地宣布,我們在 9 月啟動了一項為期 32 週的 I 期試驗,每週一次皮下注射阿米西汀,用於所有體重肥胖患者。在我們等待美國心臟協會大會上提交的選定數據的同時,我們已向美國 FDA 和歐洲藥品管理局提交了該試驗。我們很高興 FDA 授予了補充新藥申請的優先審查權。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需求的一個重要里程碑。
Finally, we also expect the chronic heart failure trial with preserved ejection fraction in obese patients and diabetes to read out in the last quarter of this year. In rare disease, nedosiran was approved by the U.S. FDA for treatment of primary hyperoxaluria type 1. This marks the first approved siRNA treatment for Novo Nordisk. In other serious chronic diseases, we initiated a Phase I trial with our angiopoietin like free protein inhibitor. This is a monoclonal antibody in development for cardiovascular disease, specifically for lowering of cholesterol and triglycerides. With that, over to you, Karsten.
最後,我們也預期肥胖和糖尿病患者射血分數保留的慢性心臟衰竭試驗將在今年最後一個季度公佈。在罕見疾病方面,nedosiran 被美國 FDA 批准用於治療 1 型原發性高草酸尿症。這標誌著諾和諾德首個核准的 siRNA 治療藥物。在其他嚴重的慢性疾病中,我們以血管生成素樣遊離蛋白抑制劑啟動了 I 期試驗。這是一種正在開發的用於心血管疾病的單株抗體,特別是用於降低膽固醇和三酸甘油酯。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 9 months of 2023, our sales grew by 29% in Danish kroner and 33% at constant exchange rates, driven by both our operating units. The gross margin increased to 84.5% compared to 84.3% in 2022. The increase in gross margin reflects a positive product mix, driven by increased sales of GLP-1-based treatments. This is partially countered by costs related to ongoing capacity expansions and negative currency impact and lower realized prices, mainly in the U.S. and Region China. Sales and distribution costs increased by 22% in Danish kroner and by 25% at constant exchange rates. The increase is driven by both operating units. In North America, the cost increase is driven by the relaunch of Wegovy and promotional activities for Ozempic. In international operations, the cost increase is driven by promotional activities for Rybelsus as well as obesity care market development activities. The increase in sales and distribution costs are impacted by adjustments to legal provisions.
謝謝你,馬丁。請翻到下一張投影片。 2023 年頭 9 個月,在我們兩個營運部門的推動下,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 33%。毛利率從 2022 年的 84.3% 增加至 84.5%。毛利率的成長反映了基於 GLP-1 的治療藥物銷量增加推動的積極的產品組合。這在一定程度上被持續產能擴張相關的成本、負面貨幣影響以及較低的實際價格所抵消,主要是在美國和中國地區。以丹麥克朗計算的銷售和分銷成本增加了 22%,以固定匯率計算則增加了 25%。這一增長是由兩個營運單位推動的。在北美,成本增加是由 Wegovy 的重新推出和 Ozempic 的促銷活動所推動的。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所推動的。銷售和分銷成本的增加受到法律規定調整的影響。
Research and development costs increased by 38% measured in Danish kroner and 39% at constant exchange rates. The increase reflects increased late-stage clinical trial activity and increased early research activities compared to the first 9 months of 2022. The excision of former therapeutics in '22 and in Misago Pharma also increased R&D spending. Administration costs increased by 9% measured in Danish kroner and 11% at constant exchange rates. Operating profit increased by 31% measured in Danish kroner and 37% at constant exchange rates, reflecting the sales growth. Net financials showed a net gain of DKK 1.2 billion compared to a net loss of DKK 5 billion last year. The effective tax rate was 19.9% in the first 9 months of 23 compared to 20.5% in the first 9 months of '22. Net profit increased by 47% and diluted earnings per share increased by 49% to SEK 13.71. Free cash flow was DKK 75.6 billion compared with DKK 62.6 billion in the first 9 months of 22. In line with the strategic aspiration of delivering attractive capital allocation to shareholders, a total of DKK 52 billion has been paid back to shareholders through share buybacks and dividends. The cash conversion is positively impacted by timing of payment of rebates in the U.S. Capital expenditure for property, plant and equipment was DKK 6.4 billion compared to DKK 7.2 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.
以丹麥克朗計算的研發成本增加了 38%,以固定匯率計算則增加了 39%。這一增長反映了與 2022 年前 9 個月相比,後期臨床試驗活動的增加和早期研究活動的增加。22 年和 Misago Pharma 取消以前的治療方法也增加了研發支出。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 31%,以固定匯率計算則成長了 37%,反映了銷售的成長。淨財務數據顯示淨收益為 12 億丹麥克朗,去年淨虧損為 50 億丹麥克朗。 23 年前 9 個月的有效稅率為 19.9%,而 22 年前 9 個月的有效稅率為 20.5%。淨利成長 47%,稀釋後每股收益成長 49%,達到 13.71 瑞典克朗。自由現金流為756 億丹麥克朗,而22 年前9 個月為626 億丹麥克朗。為了符合向股東提供有吸引力的資本配置的戰略願望,透過股票回購和重組等方式向股東返還了總計520 億丹麥克朗的資金。股利。現金轉換受到美國退稅支付時間的正面影響。財產、廠房和設備的資本支出為64 億丹麥克朗,而2022 年為72 億丹麥克朗。這主要反映了對活性藥物成分生產和灌裝/額外產能的投資。當前和未來的注射和口服產品的完成能力。
Please go to the next slide. Nine months into 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 32% and 38% at constant exchange rates. The increased sales outlook is primarily reflecting higher full year expectations to Ozempic volumes sold in the U.S. and gross to net adjustments for Ozempic and Wegovy in the U.S. The guidance reflects expectations for sales growth in both North America Operations and International Operations. The guidance is mainly driven by volume growth of GLP-1-based treatments for diabetes and obesity care. This is partially countered by declining sales in rare disease due to a temporary reduction in manufacturing output. The guidance reflects the level of volume growth of GLP-1 based treatments. The inherent uncertainty of the pace of Ozempic obesity care market expansion following the relaunch of govi the U.S. and a limited rollout in international operations are also included in the guidance range. Finally, the sales outlook reflects expected continued periodic supply constraints and related drug shortage notifications across a number of products and geographies. Novo Nordisk is investing in internal and external capacity to increase supply both short and long term.
請轉到下一張投影片。進入 2023 年已有九個月了,我們繼續保持銷售成長勢頭,這使我們能夠提高全年的預期。我們現在預計以固定匯率計算銷售額成長將在 32% 至 38% 之間。銷售前景的上調主要反映了對 Ozempic 在美國的全年銷售預期的提高以及 Ozempic 和 Wegovy 在美國的毛淨調整。該指引反映了對北美業務和國際業務銷售成長的預期。該指南主要是由基於 GLP-1 的糖尿病和肥胖症治療療法的銷售成長所推動的。由於製造業產出暫時減少,罕見疾病銷售下降,部分抵銷了此影響。該指南反映了基於 GLP-1 的治療藥物的銷售成長水準。在美國重新啟動 Govi 後,Ozempic 肥胖護理市場擴張步伐的固有不確定性以及國際業務的有限推廣也包含在指導範圍內。最後,銷售前景反映了許多產品和地區預期持續的定期供應限制和相關藥品短缺通知。諾和諾德正在投資內部和外部產能,以增加短期和長期供應。
While supply capacity for Wegovy is gradually being expanded, the lower dose strength in the U.S. will remain restricted to safeguard continuity of care. We now expect operating profit to grow between 40% and 46% 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. For 2023, we expect net financial items to amount to a gain of around DKK 1.6 billion, mainly reflecting gains associated with foreign exchange hedging contracts. Capital expenditure is still expected to be around DKK 25 billion, reflecting the upscaling of the supply chain and the innovation-based growth strategy pursued by Novo Nordisk. In the coming years, the capital expenditure to sales ratio is expected to be low double digits. The free cash flow is now expected to be between DKK 65 million and DKK 73 billion, reflecting the sales growth and favorable impact from rebates in the U.S. and investments in capital expenditure. The updated cash flow expectation is mainly reflecting increased net profit expectations, partially countered by business development activities. That covers the outlook for 2023. Now back to you, Lars, for final remarks.
雖然 Wegovy 的供應能力正在逐步擴大,但美國的較低劑量強度仍將受到限制,以保障護理的連續性。我們現在預計營業利潤以固定匯率計算將成長 40% 至 46%。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。 2023 年,我們預計金融項目淨收益將達到約 16 億丹麥克朗,主要反映與外匯對沖合約相關的收益。資本支出預計仍約為250億丹麥克朗,反映了諾和諾德供應鏈的升級和基於創新的成長策略。未來幾年,資本支出與銷售額的比率預計將處於較低的兩位數。目前,自由現金流預計在 6,500 萬丹麥克朗至 730 億丹麥克朗之間,反映了銷售成長以及美國回扣和資本支出投資的有利影響。更新後的現金流量預期主要反映了淨利預期的增加,部分受到業務發展活動的抵銷。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. Today's announcement discloses the full set of quarterly results and updated outlook for 2023, which was shared earlier in October. Overall, we are very satisfied with the sales growth in the first 9 months of 2023. The growth is driven by demand for our GLP-1-based theapeutic interventions for diabetes and obesity, which is now reaching more people than ever before. The performance in the first 9 months of the year has enabled us to raise the outlook for the full year. From an R&D perspective, we have reached a significant milestone with the submission of Select and look forward to sharing more data at American Heart Association. In addition, we're excited about the early closure of the FLOW trial and anticipate a read out in the first half of 2024. Finally, the ocedurenone will strengthen volume of cardiovascular disease and underlines the commitment to establish presence with other serious chronic diseases. With that, I'll hand over the final word to Daniel.
謝謝你,卡斯滕。請翻到最後一張投影片。今天的公告披露了 10 月初分享的全套季度業績和 2023 年更新展望。總體而言,我們對2023 年前9 個月的銷售成長感到非常滿意。這一增長是由對我們基於GLP-1 的糖尿病和肥胖症治療幹預措施的需求推動的,目前這種幹預措施惠及的人數比以往任何時候都多。今年前9個月的表現使我們提高了全年的預期。從研發的角度來看,我們透過提交 Select 達到了一個重要的里程碑,並期待在美國心臟協會分享更多數據。此外,我們對 FLOW 試驗的提前結束感到興奮,並預計在 2024 年上半年公佈結果。最後,奧塞酮將加強心血管疾病的治療量,並強調對其他嚴重慢性疾病的治療的承諾。至此,我將把最終決定權交給丹尼爾。
Daniel Bohsen - CVP & Head of IR
Daniel Bohsen - CVP & Head of IR
Thank you, Lars. Next slide, please. With that, we are now ready for the Q&A session, where I kindly ask all participants to limit her or himself to one or maximum 2 questions, including sub questions. Operator, we are now ready to take the first question.
謝謝你,拉爾斯。請下一張投影片。至此,我們現在準備好進行問答環節了,我懇請所有參與者將自己限制在 1 個或最多 2 個問題上,包括子問題。接線員,我們現在準備回答第一個問題。
Operator
Operator
Thank you. We will now go to the first question. And your first question comes from the line of Michael Nedelcovych from TD Cowen.
謝謝。我們現在來討論第一個問題。你的第一個問題來自 TD Cowen 的 Michael Nedelcovych。
Michael Thomas Nedelcovych - Research Associate
Michael Thomas Nedelcovych - Research Associate
I have one for Martin. Martin, if you'll allow me to set up something of a straw man, here's a potential set of expectations for the Phase III SELECT data when we see them at AHA. One, clinically meaningful benefit across each of the individual MACE components and regardless of BMI category; two, cardiovascular benefit that clearly emerges within 1 year on Wegovy therapy and does not diminish over time; and three, no noticeable imbalance in any very rare adverse events such as suicide or cancer. My question is, would you urge me to modify these expectations in any way?
我有一份給馬丁。馬丁,如果你允許我設定一些稻草人的東西,當我們在 AHA 看到第三階段 SELECT 資料時,這裡有一組潛在的期望。一、無論 BMI 類別為何,每個單獨的 MACE 組成部分都具有臨床意義的益處;二、Wegovy 治療一年內明顯顯現心血管益處,且不會隨著時間的推移而減弱;第三,自殺或癌症等非常罕見的不良事件並沒有明顯的不平衡。我的問題是,您會敦促我以任何方式修改這些期望嗎?
Daniel Bohsen - CVP & Head of IR
Daniel Bohsen - CVP & Head of IR
Martin a straw man for you?
馬丁對你來說是個稻草人嗎?
Martin Holst Lange - Executive VP of Development & Member of the Management Board
Martin Holst Lange - Executive VP of Development & Member of the Management Board
Thank you very much for that question. As you probably imagine, I cannot speculate to anything beyond what we've already disclosed. And that is the 20% risk reduction on the primary endpoint for MACE, which is obviously myocardial infraction stroke and cardiovascular death. We see attribution from all three, but we do not go into more detail. What I will commit to is obviously that we saw a very clear and positive safety profile from Select and with no outliers identified.
非常感謝你提出這個問題。正如您可能想的那樣,除了我們已經披露的內容之外,我無法推測任何內容。這就是 MACE 主要終點(顯然是心肌梗塞、中風和心血管死亡)的風險降低了 20%。我們看到了這三者的歸因,但我們沒有詳細說明。我要承諾的是,顯然我們從 Select 看到了非常清晰和積極的安全狀況,並且沒有發現任何異常值。
Daniel Bohsen - CVP & Head of IR
Daniel Bohsen - CVP & Head of IR
Thank you, Martin, and thanks, Mike, for the question. Next question please.
謝謝馬丁,也謝謝麥克提出的問題。請下一個問題。
Operator
Operator
Your next question comes from the line of Richard Parkes from BNP Paribas.
您的下一個問題來自法國巴黎銀行的理查德帕克斯。
Richard J. Parkes - Head of Pharmaceutical and Biotechnology Team
Richard J. Parkes - Head of Pharmaceutical and Biotechnology Team
I've got a couple. So firstly, when I look at Ozempic and Wegovy U.S. Simphony prescriptions, they're both trending flat to down over the last quarter, assuming due to supply constraints. But your guidance suggests an expected acceleration in top line growth in Q4. So I'm just wondering if you could help me to understand that. Are you expecting to see kind of further improved supply into the end of the year would be, I assume, kind of swing factor there? And then the second question is just your slide outlines the potential benefits of semaglutide beyond IcoSema control and weight loss and maybe we'll see some insight into that from the SELECT study. But your chart suggests there's potential for patients to benefit from the CV aspects that don't have diabetes or obesity. So I'm just wondering how you can capitalize on that given that your trials currently, I think, are just recruiting patients with either obesity and diabetes and comorbidities.
我有一對。首先,當我查看 Ozempic 和 Wegovy 美國 Simphony 處方時,假設由於供應限制,它們在上個季度都呈現持平甚至下降的趨勢。但您的指導表明第四季度營收成長預計將加速。所以我只是想知道你是否可以幫助我理解這一點。我認為,您是否預計年底供應會進一步改善,這是一種搖擺因素?第二個問題是您的幻燈片概述了索馬魯肽超越 IcoSema 控制和減肥的潛在益處,也許我們會從 SELECT 研究中看到一些對此的見解。但您的圖表表明,沒有糖尿病或肥胖症的患者有可能從心血管方面受益。所以我只是想知道你如何利用這一點,因為我認為你目前的試驗只是招募患有肥胖症、糖尿病和合併症的患者。
Daniel Bohsen - CVP & Head of IR
Daniel Bohsen - CVP & Head of IR
So I'll give the first to you, Karsten, supply going into our guidance.
因此,卡斯滕,我將首先向您提供我們的指導。
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Yes. So thank you for that question, Richard. And clearly, when we put out guidance, that's because we believe that's the most realistic forecast range that we're putting in. And we don't have too many months to roll on. So of course, we see the TRx trends and bake that into our forecast. What I would give of additional flavor on top of that is, of course, the growth rate is also a function of extra factory sales last year, and we did see a big having a lower base last year in the fourth quarter than what we would normalize into this year. And then, of course, there can be fluctuations in inventories, for instance, with wholesalers. And then finally, I would say this pickup in sales growth in the fourth quarter, this is not to be kind of read into anything, any difference on the supply situation. What we're selling in the fourth quarter has been produced months ago.
是的。謝謝你提出這個問題,理查德。顯然,當我們發布指導時,這是因為我們相信這是我們所輸入的最現實的預測範圍。而且我們沒有太多的時間可以繼續下去。當然,我們會看到 TRx 趨勢並將其納入我們的預測中。當然,除此之外,我想補充一點的是,成長率也是去年工廠額外銷售的函數,我們確實看到去年第四季的基數比我們預期的要低。今年正常化。當然,例如批發商的庫存可能會出現波動。最後,我想說第四季銷售成長的回升,這並不是解讀任何供應情況的差異。我們第四季銷售的產品是幾個月前生產的。
Daniel Bohsen - CVP & Head of IR
Daniel Bohsen - CVP & Head of IR
Thank you, Karsten. Martin, any comments on the benefits beyond weight loss for the same?
謝謝你,卡斯滕。馬丁,對於減肥以外的好處有什麼評論嗎?
Martin Holst Lange - Executive VP of Development & Member of the Management Board
Martin Holst Lange - Executive VP of Development & Member of the Management Board
So first of all, I think it's exactly right that our starting point is the cardiometabolic space starting out with obesity and diabetes. And these are the patients that we investigate. I think it's important to call out that the best majority of patients offering from ACVD, from heart failure, from chronic kidney disease, but also metabolic liver disease also have an element of metabolic arrangements and there's a clear association and overlap to both diabetes and obesity. So from our perspective, this actually creates some very nice synergies and are certainly not seen as exclusive. But our starting point is patients offering from diabetes and obesity.
首先,我認為我們的出發點是從肥胖和糖尿病開始的心臟代謝空間,這是完全正確的。這些就是我們調查的患者。我認為重要的是要指出,大多數患有 ACVD、心臟衰竭、慢性腎病以及代謝性肝病的患者也有代謝安排的因素,並且與糖尿病和肥胖有明顯的關聯和重疊。因此,從我們的角度來看,這實際上創造了一些非常好的協同效應,當然不會被視為排他性。但我們的出發點是患有糖尿病和肥胖症的患者。
Daniel Bohsen - CVP & Head of IR
Daniel Bohsen - CVP & Head of IR
Thank you, Martin. Thank you, Richard, for the questions, and we are ready for the next question.
謝謝你,馬丁。謝謝理查德提出的問題,我們準備好回答下一個問題。
Operator
Operator
Thank you. Your next question comes from the line of Seamus Fernandez from Guggenheim Securities.
謝謝。您的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 very quickly, as we think about the SELECT trial results in the wake, not just in the presentation, but the very rapid filing, there have been a lot of questions around this being actually a cardiovascular medication and perhaps gaining access to CMS in that regard. Can you just talk about the prospects of that actually becoming a reality? And then the second question is just on the oral incretin and the initiation of the subcutaneous incretin. Can you just help us understand, is this more of a supply chain related decision, an IRA-related decision, or a decision related to some challenges with the oral formulation of incretin?
因此,很快,當我們想到 SELECT 試驗結果後,不僅在演示中,而且在非常快速的歸檔中,圍繞這實際上是一種心血管藥物以及可能在 CMS 中獲得了很多問題那個方面。您能談談這實際上成為現實的前景嗎?第二個問題是關於口服腸促胰島素和皮下注射腸促胰島素的啟動。您能否幫助我們理解,這更多的是與供應鏈相關的決定、與 IRA 相關的決定,還是與口服腸促胰素製劑的一些挑戰相關的決定?
Daniel Bohsen - CVP & Head of IR
Daniel Bohsen - CVP & Head of IR
Thank you, Seamus. Doug, I'll give the first question to you.
謝謝你,西莫。道格,我將向你提出第一個問題。
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 Seamus. We do believe that there's an opportunity, a potential opportunity to use the medical exception process through the CB component, but let's wait to see.
是的。謝謝西莫。我們確實相信有一個機會,一個透過 CB 組件使用醫療例外流程的潛在機會,但讓我們拭目以待。
Daniel Bohsen - CVP & Head of IR
Daniel Bohsen - CVP & Head of IR
Thanks, Doug. Martin any thoughts on emicreating.
謝謝,道格。馬丁關於 emicreating 的任何想法。
Martin Holst Lange - Executive VP of Development & Member of the Management Board
Martin Holst Lange - Executive VP of Development & Member of the Management Board
Yes, on incretin in our decision to go also into subcutaneous is actually caused by another of the above of the 3 reasons that you mentioned. It's actually driven by the fact that we are learning that optionality is important for patients and prescribing physicians in both diabetes and obesity. And we've seen a clear potential for incretin to become both an oral, but certainly also a subcutaneous offering. And therefore, in Phase I, it is prudent for us to investigate both.
是的,我們決定將腸促胰素也注射到皮下注射實際上是由您提到的三個原因中的另一個原因引起的。這其實是因為我們了解到,在糖尿病和肥胖症方面,選擇對病人和開處方的醫生都很重要。我們已經看到腸促胰素具有成為口服製劑和皮下注射製劑的明顯潛力。因此,在第一階段,我們謹慎地對兩者進行調查。
Daniel Bohsen - CVP & Head of IR
Daniel Bohsen - CVP & Head of IR
Thanks, Martin, and thanks, Seamus. We are ready for the next question.
謝謝馬丁,謝謝西莫。我們準備好回答下一個問題了。
Operator
Operator
And your next question comes from the line of Peter Verdult from Citigroup Inc.
您的下一個問題來自花旗集團的 Peter Verdult。
Peter Verdult - MD
Peter Verdult - MD
Two questions, Karsten, your favorite topics. Supply and pricing. Just on supply, if we take the sort of run rate for GLP-1 volumes, your franchise in the U.S. and just extrapolate into '24, if nothing changes, I mean, there's going to be a big disconnect in terms of people's expectations for growth next year and I think it will be effectively flat. Now I know it's going to improve next year. But can I just push you on when we might see the handbrake being released. I mean, logical thinking might be that at the time of the Mounjaro launch, you'll want to be in a less capacity constrained position. So I know you can't go into too much detail, but just some incremental color on when we might see the hand break being removed would be helpful. And then on pricing, if we do our value per script calculation, there's a huge jump from Q2 to Q3, you've called out gross to net adjustments. We know that commercial mix has improved. But just making sure, is this a sort of high watermark a one-off in terms of value per prescription? In terms of baselining and thinking going forward, can we use the value per script in Q3 as a baseline? Or is it artificially high?
兩個問題,卡斯滕,你最喜歡的話題。供應和定價。就供應而言,如果我們採用 GLP-1 數量的運行率,即您在美國的特許經營權,然後推斷到 24 年,如果沒有任何變化,我的意思是,人們對明年的增長,我認為實際上會持平。現在我知道明年情況會有所改善。但是當我們看到手煞車被鬆開時,我可以推你一下嗎?我的意思是,邏輯思維可能是,在 Mounjaro 發佈時,您會希望處於容量限制較少的位置。所以我知道你不能透露太多細節,但是當我們看到手部斷裂被移除時,只要添加一些增量顏色就會有所幫助。然後在定價方面,如果我們計算每個腳本的價值,從第二季到第三季會有巨大的跳躍,您已經調出了毛淨調整。我們知道商業結構已經改善。但只是要確定一下,就每張處方的價值而言,這是否是一種一次性的高水位線?在基準和未來思考方面,我們可以使用第三季每個腳本的值作為基準嗎?還是人為地高?
Daniel Bohsen - CVP & Head of IR
Daniel Bohsen - CVP & Head of IR
Thanks, Pete. Karsten supply going into '24 and value per script.
謝謝,皮特。 Karsten 提供進入 24 年的服務以及每個腳本的價值。
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Pete, thank you for those my favorite subjects. So I would say, first of all, with the guidance that for the full year this year, that has a midpoint of 35% sales growth at constant exchange rates, at least in the Novo setting, it feels like we have released the hand break and moving at a very high pace in terms of growth rates, at least it's the highest in the history of the company. But that said, and extrapolations into 2024, I would say, first of all, we're clearly suing a growth strategy based on innovation. We have shown that we have the innovation platforms, especially in Ozempic and Wegovy to drive growth this year and clearly also next year. So not teaching you how to extrapolate, but if you extrapolate our implied Q4 sales growth based on our guidance, then you actually get to a sales growth number next year in the double digits, which is actually not that far away from where consensus is currently. So I do believe that we're scaling very fast. And then specifically on Wegovy and any handbags there. Then what I'd say as to 2024 is that in 2024, we will be delivering significant step-up in volumes through the U.S. market compared to 2023 as we did from '22 to '23.
皮特,謝謝你為我提供的那些我最喜歡的科目。所以我想說,首先,在今年全年的指導下,以固定匯率計算,銷售額增長中點為 35%,至少在 Novo 環境下,感覺我們已經釋放了手部休息而且增長率非常高,至少是公司史上最高的。但話雖如此,並推斷到 2024 年,我想說,首先,我們顯然正在起訴基於創新的成長策略。我們已經證明,我們擁有創新平台,尤其是在 Ozempic 和 Wegovy 方面,可以推動今年的成長,顯然明年也是如此。因此,不是教您如何推斷,但如果您根據我們的指導推斷我們隱含的第四季度銷售增長,那麼您實際上會得到明年兩位數的銷售增長數字,這實際上與目前的共識相差不遠。 。所以我確實相信我們的擴張速度非常快。然後特別是 Wegovy 和那裡的任何手袋。那麼對於 2024 年,我想說的是,與 2023 年相比,2024 年我們在美國市場的銷售量將顯著增加,就像我們從 22 年到 23 年所做的那樣。
And then to your pricing questions. As we've said on numerous occasions, the appropriate way of looking at net realized pricing in the U.S. is to look at the year-to-date numbers. So most contracts are contracted on an annual basis. And the trigger part is the lag effect between when a script is written, and then we received the rebate claims from the payers. And there's just a lag effect of several months, and that's on by in reality, Q3 is the first point where we see how the channel payer mix to is falling out for 2023. So I wouldn't use Q3 in isolation for anything forecasting-wise, I would recommend you to use year-to-date Q3 as a starting point.
然後是你的定價問題。正如我們在許多場合所說的,查看美國淨實現定價的適當方法是查看今年迄今為止的數據。因此,大多數合約都是按年簽訂的。觸發部分是從編寫腳本到我們收到付款人的回扣索賠之間的滯後效應。只有幾個月的滯後效應,實際上,第三季度是我們看到 2023 年通路支付者組合如何下降的第一個點。所以我不會單獨使用第三季來進行任何預測 -明智的,我建議您使用年初至今的第三季作為起點。
Daniel Bohsen - CVP & Head of IR
Daniel Bohsen - CVP & Head of IR
We're ready for the next question.
我們準備好回答下一個問題了。
Operator
Operator
Your next question comes from the line of Mark Purcell from Morgan Stanley.
您的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
The first one on GLP-1 on higher doses, at least starting higher dose trials for tirzepatide. You have 8 milligrams coming through at the end by the end of this year. Can you help me understand your expectations there and the importance of increasing your dose where the pivotal trial at 7.2 readout late next year? And then second, in terms of the Penn platform leverage, we estimate about 100 million GLP-1 pen unit is going to be sold by Novo in 2023 for GLP-1 is. The majority is the FlexTouch platform with a 3ML platform. So will you use those 2 platforms to launch with GOV in the U.S.? And if not, why not?
第一個是更高劑量的 GLP-1,至少開始了更高劑量的替澤帕肽試驗。到今年年底,您將消耗 8 毫克。您能否幫助我了解您的期望以及在明年底 7.2 讀數的關鍵試驗中增加劑量的重要性?其次,就 Penn 平台槓桿而言,我們估計 Novo 將在 2023 年以 GLP-1 的價格出售約 1 億支 GLP-1 筆單位。大多是FlexTouch平台和3ML平台。那麼您會使用這兩個平台在美國與 GOV 一起推出嗎?如果沒有,為什麼不呢?
Daniel Bohsen - CVP & Head of IR
Daniel Bohsen - CVP & Head of IR
Martin, the third question for you, GLP-1 higher dose considerations.
Martin,第三個問題給你,GLP-1更高劑量的考量。
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, absolutely. Thank you for that question. So you're absolutely right. We investigated 8 and 16 milligram in diabetes, but we're also investigating 7.2 milligrams in obesity. The purpose is obviously to assess whether we can achieve an even higher efficacy without compromising on safety. Our model suggests in particular in the new business space, that a high dose could potentially be associated with an even greater weight loss without having to compromise on safety and being diligent, we want to assess this.
是的,一點沒錯。謝謝你提出這個問題。所以你是完全正確的。我們研究了 8 毫克和 16 毫克對於糖尿病的影響,但我們也在研究 7.2 毫克對於肥胖的影響。目的顯然是評估我們是否可以在不影響安全性的情況下實現更高的功效。我們的模型表明,特別是在新的商業領域,高劑量可能與更大的減肥效果相關,而不必犧牲安全性和勤奮,我們希望對此進行評估。
Daniel Bohsen - CVP & Head of IR
Daniel Bohsen - CVP & Head of IR
Thank you, Martin. And if I understood your question correct, Mark, then the question was whether we leverage our FlexTop platform also to launch Wegovy in the U.S. in the FlexTouch device. But last, maybe to you, any strategic considerations on our device platforms.
謝謝你,馬丁。如果我理解你的問題正確的話,馬克,那麼問題是我們是否也利用我們的 FlexTop 平台在美國的 FlexTouch 設備上推出 Wegovy。但最後,也許對您來說,我們設備平台上的任何策略考量。
Lars Fruergaard Jorgensen - President, CEO & Member of Management Board
Lars Fruergaard Jorgensen - President, CEO & Member of Management Board
Yes, Mark, thanks for the question. I'll just say that we have a situation today where we have a number of device platforms outside the company on using outside vendor and technology. So that gives us flexibility. And it's actually part of fueling the growth today that we can flex this. So I'll not go into specific exploration about what we use of device per market, but we see that it's a strength that we can flex between different presentations. And we see today that is really the efficacy of the molecule that drives that. So that gives quite some flexibility in how we go to market country-by-country and strategic flexibility on our side.
是的,馬克,謝謝你的提問。我只想說,我們今天面臨的情況是,我們在公司外部擁有許多使用外部供應商和技術的設備平台。這給了我們靈活性。實際上,我們可以靈活運用這一點,這也是推動當今成長的一部分。因此,我不會具體探討我們在每個市場使用什麼設備,但我們看到這是我們可以在不同演示之間靈活運用的優勢。今天我們看到,這確實是驅動該分子的功效。因此,這為我們如何進入各國的市場以及我們這邊的戰略靈活性提供了相當大的靈活性。
Daniel Bohsen - CVP & Head of IR
Daniel Bohsen - CVP & Head of IR
Thank you, Lars. Next question, please.
謝謝你,拉爾斯。請下一個問題。
Operator
Operator
Your next question comes from the line of Emily Field from Barclays.
您的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'll have 2. One, just on the step 9 osteoarthritis study. I believe that this is not large enough to be added to the Wegovy label. So if this were to be a positive study, what would be your next steps plans? And then just on anti-obese medications and muscle loss. We've seen competitors more explicitly make efforts in R&D for compounds that could preserve lean mass over fat mass and overall weight loss. I was wondering if you could just give an update on where you stand on that within your R&D portfolio.
我將有 2 個。1 個,就在第 9 步骨關節炎研究。我認為這還不夠大,不足以添加到 Wegovy 標籤中。那麼,如果這是一項積極的研究,您的下一步計劃是什麼?然後就是抗肥胖藥物和肌肉流失。我們看到競爭對手更明確地致力於研發能夠維持瘦肉品質而不是脂肪品質和整體減肥的化合物。我想知道您是否可以介紹一下您在研發組合中的最新立場。
Daniel Bohsen - CVP & Head of IR
Daniel Bohsen - CVP & Head of IR
Thank you, Emily. Martin, 2 for you?
謝謝你,艾米麗。馬丁,2 給你嗎?
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 specifically on your arthritis trial, you are right. It's not the biggest trial. I think it's too early to speculate whether that will have an impact on the label. It's very, very clear that for us, it's also guiding for future clinical activities, specifically maybe for capacity or GLP-1 GIP combination. So it has actually 2 potentials both to serve for information, specifically for Wegovy, but also to guide us for future activities.
是的。因此,特別是在您的關節炎試驗中,您是對的。這還不是最大的考驗。我認為現在推測這是否會對品牌產生影響還為時過早。非常非常清楚的是,對我們來說,它也為未來的臨床活動提供指導,特別是容量或 GLP-1 GIP 組合。因此,它實際上有兩個潛力,既可以提供資訊(特別是為 Wegovy),也可以指導我們未來的活動。
Daniel Bohsen - CVP & Head of IR
Daniel Bohsen - CVP & Head of IR
And the second one, Martin, obesity and research and development focus on muscle loss.
第二個,馬丁,肥胖和研發重點是肌肉損失。
Martin Holst Lange - Executive VP of Development & Member of the Management Board
Martin Holst Lange - Executive VP of Development & Member of the Management Board
I think this is a relevant point. It's also a focus of ours with current treatments, specifically with Wegovy and Saxenda, we actually see a reasonable preservation of lean body mass, given the broader weight loss. But it has to be a focus area, and you will probably see also in our pipeline without going into details, maybe even by 2 assets that could lead to a preservation of lean mass.
我認為這是一個相關的觀點。這也是我們目前治療的重點,特別是 Wegovy 和 Saxenda,考慮到更廣泛的體重減輕,我們實際上看到了去脂體重的合理保留。但這必須是一個重點領域,您可能也會在我們的管道中看到,而無需詳細說明,甚至可能是兩種可以保持瘦體重的資產。
Daniel Bohsen - CVP & Head of IR
Daniel Bohsen - CVP & Head of IR
Thank you, Martin. Thank you, Emily. We are ready for the next question.
謝謝你,馬丁。謝謝你,艾米麗。我們準備好回答下一個問題了。
Operator
Operator
Your next question comes from the line of Simon Baker from Redburn.
您的下一個問題來自 Redburn 的 Simon Baker。
Simon P. Baker - Head of Pharmaceutical Research
Simon P. Baker - Head of Pharmaceutical Research
Two, if I may. Firstly, on China, growth looks pretty good over there. But I just wonder if you could give us an update on the impact of which used access to Chinese hospitals and how that is affecting things if indeed at all? And then secondly, on semaglutide, there was an interesting journal preprint on Monday looking at its use in alcohol use disorder, which looked very impressive. It'd be interesting to get your thoughts on the potential of that indication in your opinion.
如果可以的話,兩個。首先,就中國而言,那裡的成長看起來相當不錯。但我只是想知道您能否向我們介紹一下使用中國醫院的影響的最新情況,以及如果確實有的話,這會如何影響事情?其次,關於索馬魯肽,週一有一篇有趣的期刊預印本研究了它在酒精使用障礙中的用途,看起來非常令人印象深刻。就您認為的該指示的潛力提出您的想法會很有趣。
Daniel Bohsen - CVP & Head of IR
Daniel Bohsen - CVP & Head of IR
Thank you, Simon. So Camilla, the first one to you, do we see reduced access to Chinese hospitals?
謝謝你,西蒙。那麼卡米拉,第一個問你的,我們是否看到進入中國醫院的機會減少了?
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
So in general, we are working across the country, and we also have access to hospitals in general. What we do see in China is an effect of the VPP, of course, that's what we mainly insulin sales results. And that is also when you look at an overall IO business point of view, that is what is actually dragging down the overall IO insulin growth. But in China, Ozempic is going really well. We have a great momentum of Ozempic that we've had since the launch and since the inclusion on the reinvestment list and that can drive growth in China.
所以總的來說,我們在全國範圍內開展工作,而且我們也可以進入一般的醫院。我們在中國看到的是VPP的效果,當然,這就是我們主要的胰島素銷售結果。這也是當你從整體 IO 業務的角度來看時,這實際上是拖累整體 IO 胰島素增長的原因。但在中國,Ozempic 進展得非常順利。自從Ozempic推出以及被列入再投資名單以來,我們就擁有強勁的勢頭,這可以推動中國的成長。
Daniel Bohsen - CVP & Head of IR
Daniel Bohsen - CVP & Head of IR
No major issues with access. Martin, the second question.
訪問方面沒有重大問題。馬丁,第二個問題。
Martin Holst Lange - Executive VP of Development & Member of the Management Board
Martin Holst Lange - Executive VP of Development & Member of the Management Board
Yes. Thank you very much for the question. We have also seen these observational studies and being intrigued by the fact that GLP-1 may have a place in also treating alcohol abuse does actually live within the mode of action of GLP-1. From our perspective, when also considering the timing, the combination of 2 mode of actions that could potentially also help here, namely GLP-1 and amylin so specifically from our perspective CargriSema is probably the more attractive and efficacious approach. So if you see us going into that space, that would be with CagriSema and not with matte.
是的。非常感謝你的提問。我們也看到了這些觀察性研究,並且對 GLP-1 可能在治療酒精濫用方面也有一席之地這一事實感到好奇,它實際上存在於 GLP-1 的作用模式中。從我們的角度來看,在考慮時機時,兩種作用模式的組合也可能對此有所幫助,即GLP-1 和胰淀素,因此從我們的角度來看,CargriSema 可能是更具吸引力和更有效的方法。因此,如果你看到我們進入這個領域,那就是 CagriSema,而不是 Matte。
Daniel Bohsen - CVP & Head of IR
Daniel Bohsen - CVP & Head of IR
Thank you, Martin. We're 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
Your next question comes from the line of Naresh Chouhan from Intern Health.
您的下一個問題來自 Intern Health 的 Naresh Chouhan。
Naresh Chouhan - Founder
Naresh Chouhan - Founder
First one on would go the U.S. market access. We're hearing that a growing number of employers are having to opt out, having already opted in because the demand has been too high. Can you just help us get a sense of how big or small an issue this is? And obviously, next year, that's probably potentially like to increase when supply resumes and demand increases? And secondly, on supply. If I look back at when you seem to be relatively comfortable with the demand, we were around about 30,000 new pet starts a week in the U.S. is that a fair starting point for kind of the ability to supply and growth from there going into 2024?
第一個是進入美國市場。我們聽說越來越多的雇主不得不選擇退出,因為需求太高而已經選擇加入。您能幫助我們了解這個問題有多大或多小嗎?顯然,明年,當供應恢復和需求增加時,這一數字可能會增加?其次,在供應方面。如果我回顧一下,當你似乎對需求相對滿意時,我們在美國每周大約有 30,000 只新寵物開工,這對於從那裡到 2024 年的供應和增長能力來說是一個公平的起點嗎?
Daniel Bohsen - CVP & Head of IR
Daniel Bohsen - CVP & Head of IR
Thank you, Naresh. So Doug, any updates on U.S. market access for Wegovy?
謝謝你,納雷什。 Doug,關於 Wegovy 美國市場准入的最新情況嗎?
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. Thanks, Naresh. And overall, we're very pleased with the broad market access that we have for Wegovy. Most major PBMs and health plans are covering it, and that derives around 50 million people with obesity now being covered. And importantly, we're seeing about 80% of the patients that are paying less than $25 for Wegovy. Now to your question specifically around employers, we do see some opt outs, but we're seeing overall more opt-in and opt-out. So directionally, we're heading in the right direction. And our focus will be continuing on securing employer coverage as well as stronger access for ARMs overall.
是的。謝謝,納雷什。總的來說,我們對 Wegovy 擁有的廣泛市場准入感到非常滿意。大多數主要的 PBM 和健康計劃都涵蓋了這一點,這使得目前約有 5000 萬肥胖症患者得到了覆蓋。重要的是,我們看到大約 80% 的患者為 Wegovy 支付的費用低於 25 美元。現在,針對您特別針對雇主的問題,我們確實看到了一些選擇退出的情況,但我們總體上看到更多的選擇加入和選擇退出的情況。所以從方向上來說,我們正朝著正確的方向前進。我們的重點將繼續是確保雇主的覆蓋範圍以及為 ARM 提供更全面的准入機會。
Daniel Bohsen - CVP & Head of IR
Daniel Bohsen - CVP & Head of IR
Thank you, Doug. Karsten any additional comments on the go supply going into next year?
謝謝你,道格。 Karsten 對明年的 go 供應還有什麼其他評論嗎?
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Yes. So I think the way to look at the U.S. the good supply is a starting point of currently around 100,000 TRx per week according to IQVIA. And then we have the 5 different growth strengths. And of course, the magic is to get that split right into the link into manufacturing. And then we scale from there. And as we've said in prior quarters, then this is something we do dynamically. So don't look for hockey stick. It's a gradual process where, of course, we'll be starting at the lower doses and then increasing them as we move forward. There are different data sources in terms of new starts. So I'm not really sure what your data source is, but I think my data point is lower than yours in terms of number of new starts per week.
是的。因此,我認為看待美國良好供應的方式是根據 IQVIA 目前每週約 100,000 TRx 的起點。然後我們有 5 種不同的成長優勢。當然,神奇之處在於將這種拆分直接納入製造環節。然後我們從那裡開始擴展。正如我們在前幾個季度所說的那樣,這是我們動態做的事情。所以不要尋找曲棍球棒。這是一個漸進的過程,當然,我們將從較低劑量開始,然後隨著進展而增加劑量。新開工率有不同的資料來源。因此,我不太確定您的資料來源是什麼,但我認為就每週新啟動數量而言,我的資料點低於您的資料點。
Daniel Bohsen - CVP & Head of IR
Daniel Bohsen - CVP & Head of IR
Thank you Karsten. Thank you Naresh. We are ready for the next question please.
謝謝卡斯滕。謝謝納雷什。我們已經準備好回答下一個問題了。
Operator
Operator
Your next question comes from the line of Florent Cespedes from Societe Generale.
您的下一個問題來自法國興業銀行的 Florent Cespedes。
Florent Cespedes - Senior Equity Analyst
Florent Cespedes - Senior Equity Analyst
Two, please. First one on Wegovy in Europe. Have you started to talk to the payers in Europe as you have already submitted the data to the European authorities? And do you believe that you will need to show a statistically significant benefit on the cardiovascular base that will be presented at the AHA next week. And my second question is on Ozempic, following the flow results. How would you position the product on this population as we already have products available to treat these patients, notably the SGLT2. And it seems that in the trial of 15% of the patients are under SGLT2 treatment. So some color on this one would be helpful.
請兩位。歐洲第一個 Wegovy 網站。由於您已經向歐洲當局提交了數據,您是否開始與歐洲的付款人交談?您是否認為您需要在心血管基礎上展示統計上顯著的益處,該益處將於下週在美國心臟協會 (AHA) 上公佈。我的第二個問題是關於 Ozempic,遵循流程結果。由於我們已經有可用於治療這些患者的產品,特別是 SGLT2,您將如何將該產品定位於該族群。而且在試驗中似乎有15%的患者正在接受SGLT2治療。所以在這個上加一些顏色會很有幫助。
Daniel Bohsen - CVP & Head of IR
Daniel Bohsen - CVP & Head of IR
Thank you, Florent. Camilla, maybe the first one for you in terms of Wegovy outside the U.S.
謝謝你,弗洛倫特。卡蜜拉(Camilla),也許是您在美國以外地區使用 Wegovy 的第一個人。
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. I believe the question was whether we need statistical significance. I would just say, now we await the presentation at the conference. But in general, there is a great interest in Wegovy and, of course, also the benefits in Select. So we will get back to that, but we do see authorities interested in bringing up the discussion again with us already at this point for reimbursement of Wegovy. And just a reminder, we have reimbursement of Saxenda already in close to 15 countries all around the world. And of course, here, we are talking a step-up in treatment.
是的。我認為問題是我們是否需要統計顯著性。我只想說,現在我們等待會議上的演講。但總的來說,人們對 Wegovy 很感興趣,當然也對 Select 的好處感興趣。所以我們會回到這個主題,但我們確實看到當局有興趣在此時再次與我們討論 Wegovy 的報銷問題。提醒一下,我們已經在全球近 15 個國家提供 Saxenda 報銷服務。當然,我們在這裡談論的是治療的升級。
Daniel Bohsen - CVP & Head of IR
Daniel Bohsen - CVP & Head of IR
Thank you, Camilla. Martin, any medical perspectives on Flow and the population that we potentially could treat.
謝謝你,卡米拉。馬丁,關於 Flow 和我們可能治療的人群的任何醫學觀點。
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, absolutely. Maybe just also calling out on Select the study was designed to have a power specifically for the primary endpoint. So assuming statistically significant for the secondary endpoints is to be seen as an upside and not as something to be expected. I just want to call that out. But obviously, please tune in on what we can present on November 11 in Philadelphia. Specifically on Flow I think there's a tremendous unmet need in the diabetes space. It's also very, very clear that not all patients today who suffer from diabetes and chronic disease are on SGLT2 and on a GLP-1 and therefore, to have data to suggest that we can actually decrease and again, we haven't seen the data, but we can potentially decrease the kidney disease deterioration by a substantial number on top of standard of care, including SGLT2 is a really, really attractive offering. And it will allow more patients in need to get on a GLP-1.
是的,一點沒錯。也許只是在 Select 上呼籲這項研究的目的是專門針對主要終點。因此,假設次要終點具有統計顯著性,則應將其視為有利的一面,而不是預期的結果。我只是想大聲疾呼。但顯然,請關注我們 11 月 11 日在費城展示的內容。特別是在 Flow 方面,我認為糖尿病領域有巨大的未滿足需求。同樣非常非常清楚的是,並非當今所有患有糖尿病和慢性病的患者都在服用 SGLT2 和 GLP-1,因此,有數據表明我們實際上可以減少,但我們還沒有看到數據,但我們有可能在標準護理的基礎上大幅減少腎臟疾病的惡化,其中SGLT2 是一個非常非常有吸引力的產品。它將讓更多有需要的患者接受 GLP-1 治療。
Daniel Bohsen - CVP & Head of IR
Daniel Bohsen - CVP & Head of IR
Thank you, Martin. Thanks for the question, and we are ready for the next question.
謝謝你,馬丁。感謝您提出問題,我們準備好回答下一個問題。
Operator
Operator
Will now take the next question, and the question comes from the line of Richard Vosser from JPMorgan.
現在提出下一個問題,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
Question on the European rollout of Wegovy first. Obviously, we know in Denmark in May, there was a substantial demand for Wegovy in about 1% of the population. So I was wondering how that has developed since then, both in terms of volume and how you're seeing patients staying on the drug through Denmark given it's an out-of-pocket market. And then the second question is on your KP Bioscience product. Just wondering how that differentiates from other MR antagonists particularly ocedurenone from buyer, but there are also others in development from AstraZeneca, et cetera. Just your thoughts on how this is different.
首先是關於 Wegovy 在歐洲推出的問題。顯然,我們知道 5 月在丹麥,大約 1% 的人口對 Wegovy 有大量需求。所以我想知道從那時起情況如何發展,無論是在數量方面,還是在丹麥是一個自付費用市場的情況下,你如何看到患者在丹麥繼續服用該藥物。第二個問題是關於你們的 KP Bioscience 產品。只是想知道它與其他 MR 拮抗劑有何區別,特別是來自買方的 ocedurenone,但阿斯特捷利康等公司也有其他正在開發的拮抗劑。只是您對這有何不同的想法。
Daniel Bohsen - CVP & Head of IR
Daniel Bohsen - CVP & Head of IR
Thank you, Richard. Camila the first one to you, Wegovy roll out in Denmark.
謝謝你,理查。卡米拉(Camila)是您的第一個,Wegovy 在丹麥推出。
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 Denmark, we see a continued interest in Wegovy and Wegovy continues to perform very well. And it is more than 1% of the population at this point in time. In terms of how many states on the product, we also have, it's too early to give you exact daytime numbers, but we do have, I could say, anecdotal evidence that there is a very, very high number of the people that stay on the product from the beginning of the year when the product was launched.
是的。因此,在丹麥,我們看到人們對 Wegovy 的持續興趣,而 Wegovy 繼續表現出色。目前這一比例已超過總人口的 1%。至於產品上有多少個州,我們也有,現在給你確切的白天數字還為時過早,但我可以說,我們確實有軼事證據表明,有非常非常多的人繼續使用該產品從年初產品推出時起。
Daniel Bohsen - CVP & Head of IR
Daniel Bohsen - CVP & Head of IR
Thank you, Camilla. Martin, reflections on Ocedurenone.
謝謝你,卡米拉。馬丁,對 Ocedurenone 的思考。
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, absolutely. So what we've seen with Ocedurenone is a molecule with a very high affinity for the receptor and also a very high half-life. That actually means that we expect to see differentiation not only on efficacy but it also appears to have a potential upside on the safety side, specifically on hyperkalemia. So we do expect to see a differentiated drug in this space.
是的,一點沒錯。因此,我們所看到的 Ocedurenone 是一種對受體具有非常高親和力且半衰期非常長的分子。這實際上意味著我們不僅期望看到療效上的差異,而且在安全性方面似乎也有潛在的優勢,特別是在高血鉀症方面。因此,我們確實希望在這個領域看到一種差異化藥物。
Daniel Bohsen - CVP & Head of IR
Daniel Bohsen - CVP & Head of IR
Thank you, Martin. Thank you, Camilla. Thanks, Richard, for the question. We are ready for the next.
謝謝你,馬丁。謝謝你,卡米拉。謝謝理查提出這個問題。我們已經準備好迎接下一個。
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
Hopefully you can hear me. I've got 2 questions, firstly, if I could come back on the red gross margin. I appreciate the commentary year-to-date. But in the third quarter, it seemed to trend down quite a bit, which is getting somewhat unusual given the quite significant improvements we saw in the gross to net in your most profitable market for both Wegovy and Ozempic. So could you just talk a little bit about in the third quarter, what the incremental costs or whether perhaps any write-downs or something of inventory or something that could potentially depress the gross margin in what would normally be a more profitable quarter. And then secondly, just coming back to the comment that was made on Stay time thinking about it a different way, which is in the past, you've cited for Saxenda that around 25% or more of patients are on the drug for at least a year, and most of those are treated by obesity experts. I appreciate it's still early for Wegovy to necessarily good comments on the U.S. for state time. But can you sort of talk about whether you're seeing different trends than those of Saxenda, both in terms of the obesity experts versus those arms and also the number of patients perhaps of reaching a year at this point.
希望你能聽到我的聲音。我有兩個問題,首先,我是否可以恢復紅色毛利率。我很欣賞今年迄今為止的評論。但在第三季度,它似乎出現了相當大的下降趨勢,考慮到我們在 Wegovy 和 Ozempic 的最盈利市場的毛利和淨額方面都取得了相當顯著的改善,這有點不尋常。那麼,您能否談談第三季度的增量成本,或者是否有任何減記或庫存或可能會壓低通常利潤更高的季度毛利率的因素。其次,回到關於「停留時間」的評論,以不同的方式思考它,這是在過去,您在 Saxenda 中引用過,大約 25% 或更多的患者至少服用該藥物一年,其中大部分由肥胖專家治療。我很高興 Wegovy 在州政府時間裡對美國做出好的評論還為時過早。但您能否談談您是否看到了與 Saxenda 不同的趨勢,無論是在肥胖專家與這些手臂方面,還是在這一點上可能達到一年的患者數量方面。
Daniel Bohsen - CVP & Head of IR
Daniel Bohsen - CVP & Head of IR
Thank you, Peter. So first of all to Karsten, the gross margin and then later Doug on what we see on state time in the U.S. for Wegovy.
謝謝你,彼得。首先請卡斯滕介紹毛利率,然後請道格介紹我們在美國時間看到的 Wegovy 的情況。
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Yes, Peter, well supported gross margin Q3 and just a word of caution to begin with, looking at the gross margins at a quarterly basis is always tricky due to fluctuations over the year. But if I am to comment specifically on the quarter, then at constant exchange rates, the gross margin is flat compared to last year. So the decline compared to last year is FX driven. And then you could say, why is it not increasing compared to last year given the gross to net adjustment and the product mix. And there are basically 2 pieces to it. First of all, remember, the starting point, our gross margin is already higher at 84% or so. And then secondly, what is different compared to prior years is that the amount of CapEx we are running these days. And just from an accounting policy standard point of view, we are realizing more costs related to our capital expenditure projects into the P&L. So it doesn't all go to the balance sheet. Some of it also hits the P&L, and that is basically what is offsetting the benefit from product mix.
是的,彼得,第三季的毛利率得到了很好的支持,首先需要注意的是,由於一年中的波動,按季度查看毛利率總是很棘手。但如果我要具體評論本季,那麼以固定匯率計算,毛利率與去年持平。因此,與去年相比的下降是由外匯驅動的。然後你可能會說,考慮到毛淨調整和產品組合,為什麼與去年相比沒有增加。基本上有 2 個部分。首先,記住,起點,我們的毛利率已經很高了,大約是84%。其次,與前幾年相比,我們現在運行的資本支出量有所不同。僅從會計政策標準的角度來看,我們正在將更多與資本支出項目相關的成本計入損益表。所以它並不是全部進入資產負債表。其中一些也會影響損益表,這基本上就是抵消產品組合帶來的好處的原因。
Daniel Bohsen - CVP & Head of IR
Daniel Bohsen - CVP & Head of IR
Thank you, Karsten. And over to you, Doug, any insights on state time on Wegovy in the U.S. so far.
謝謝你,卡斯滕。 Doug,請您談談迄今為止對美國 Wegovy 州時間的任何見解。
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. Peter, thank you. Because generally, you're right. We expect to be able to say more about state time in 2024. Obviously, it's been difficult given the few time periods with unrestricted supply. But what I can say is based on early data from multiple sources, persistency on Wegovy, it looks better than Saxenda with fewer patients dropping off in the first 12 months, but we'll have more to say in 2024.
是的。彼得,謝謝你。因為一般來說,你是對的。我們預計能夠對 2024 年的國家時間進行更多說明。顯然,考慮到供應不受限制的時間段很少,這很困難。但我能說的是,基於多個來源的早期數據以及Wegovy 的持久性,它看起來比Saxenda 更好,前12 個月內脫落的患者較少,但我們將在2024 年有更多的話要說說。
Daniel Bohsen - CVP & Head of IR
Daniel Bohsen - CVP & Head of IR
Thank you, Doug. Thank you, Peter, and we are ready for the next question.
謝謝你,道格。謝謝你,彼得,我們準備好回答下一個問題。
Operator
Operator
Your next question comes from the line of Matthias Haggblom from Handelsbanken.
您的下一個問題來自德國商業銀行的 Matthias Haggblom。
Mattias Häggblom - Research Analyst
Mattias Häggblom - Research Analyst
R&D question. In the scenario that both high dose at 7.2 milligrams as well as CagriSema works in Phase III. Can you help us think about the regulatory pathway for a fixed dose combination with CagriSema the high-dose Sema and whether that would require a new Phase III or if a small bitching study would be enough.
研發問題。在 7.2 毫克高劑量和 CagriSema 都在 III 期工作的情況下。您能否幫助我們思考固定劑量組合與 CagriSema 和高劑量 Sema 的監管途徑,以及這是否需要新的 III 期試驗,或者小型研究是否就足夠了。
Daniel Bohsen - CVP & Head of IR
Daniel Bohsen - CVP & Head of IR
Thank you, Matthias. Martin?
謝謝你,馬蒂亞斯。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 absolutely. Thank you for that question, Matthias. That would most likely require a reasonably -- I think we can bridge some safety data, but we will still have to establish both safety and efficacy. So we actually see that as a potential opportunity, but we see that as a life cycle management activity.
是的,一點沒錯。謝謝你提出這個問題,馬蒂亞斯。這很可能需要合理的——我認為我們可以橋接一些安全數據,但我們仍然必須確定安全性和有效性。因此,我們實際上認為這是一個潛在的機會,但我們將其視為生命週期管理活動。
Daniel Bohsen - CVP & Head of IR
Daniel Bohsen - CVP & Head of IR
hank you, Martin. And we have time for 2 more set of questions. So we're ready for the next one.
謝謝你,馬丁。我們還有時間回答另外 2 組問題。所以我們已經準備好迎接下一場比賽了。
Operator
Operator
The next question comes from the line of Emmanuel Papadakis from DB.
下一個問題來自 DB 的 Emmanuel Papadakis。
Emmanuel Douglas Papadakis - Research Analyst
Emmanuel Douglas Papadakis - Research Analyst
Okay. Maybe a follow-on for Karsten on supply. Karsten you said you're going to significantly increase supply in 24% versus 23% as you did in '23 versus '22. Eyeball data, it looks like there was approximately a fivefold increase, 23% over '22. So you're telling us you're going to have another 5 fold increase in 2024. And if not, can you help us with the approximate quantum? And then a follow-on also on flow. Martin, you're helpful enough on Select to give us an indication that the contribution of components have been approximately equal, well balanced in Select? Is that also the case at Flow? Or how should we think about the contribution of the composite endpoint components? And what should we expect in terms of labeling?
好的。也許是卡斯滕供應的後續。 Karsten,您說過您將大幅增加供應量,從 23% 到 24%,就像您在 23 年和 22 年所做的那樣。眼球數據看起來大約增加了五倍,比 22 年增加了 23%。所以你告訴我們你將在 2024 年再增加 5 倍。如果沒有,你能幫我們提供大概的數量嗎?然後還有後續的流程。馬丁,您對 Select 的幫助很大,讓我們知道 Select 中組件的貢獻大致相等且平衡? Flow也是這樣嗎?或者我們應該如何考慮複合端點組件的貢獻?我們在標籤方面應該期待什麼?
Daniel Bohsen - CVP & Head of IR
Daniel Bohsen - CVP & Head of IR
Thank you, Emmanuel. First, Karsten, any additional supply?
謝謝你,伊曼紐。首先,卡斯滕,還有額外的供應嗎?
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Yes. And thanks for triangulating that way around Emmanuel. I'd love to give you a further flavor. But as you know, we are guiding for next year come our full year results late January. So that's where we'll be doing our financial guidance for '24 and giving too much granularity in scaling of Wegovy as we get too close to guiding for next year. So I'm sorry, but I'll have to provide that at a later point in time.
是的。感謝您圍繞伊曼紐爾進行三角測量。我很樂意給你更多的味道。但如您所知,我們正在為明年一月下旬的全年業績提供指導。因此,這就是我們將在 24 世紀制定財務指導方針的地方,並在我們非常接近明年的指導方針時,對 Wegovy 的擴展給出太多的粒度。所以很抱歉,但我必須稍後再提供。
Daniel Bohsen - CVP & Head of IR
Daniel Bohsen - CVP & Head of IR
Thank you, Karsten. Martin, can you share more on FLOW?
謝謝你,卡斯滕。 Martin,您能分享更多關於 FLOW 的資訊嗎?
Martin Holst Lange - Executive VP of Development & Member of the Management Board
Martin Holst Lange - Executive VP of Development & Member of the Management Board
I think it's a great question. And I maybe just want to clarify, I don't think we've seen equal contribution from the 3 mono components. We just say that they all contributed and obviously, again, we have to await November 11 until we see the full data set. Specifically for FLOW, I would really love to be able to answer you, but due to the nature of an interim analysis, we've not seen the data. So for better or worse, I know absolutely no more than you do at this point. So I can't speculate.
我認為這是一個很好的問題。我也許只是想澄清一下,我認為我們沒有看到 3 個單聲道組件的同等貢獻。我們只是說他們都做出了貢獻,顯然,我們必須再次等待 11 月 11 日才能看到完整的數據集。特別是對於 FLOW,我真的很想能夠回答您,但由於中期分析的性質,我們還沒有看到數據。因此,無論好壞,我現在所知道的絕對不比你多。所以我無法推測。
Daniel Bohsen - CVP & Head of IR
Daniel Bohsen - CVP & Head of IR
Thank you, Martin. Thank you, Emmanuel. Then we'll take the last set of questions.
謝謝你,馬丁。謝謝你,伊曼紐。然後我們將回答最後一組問題。
Operator
Operator
Your last question for today comes from the line of Michael Novod from Nordea.
今天的最後一個問題來自 Nordea 的 Michael Novod。
Michael Novod - Director of Healthcare, Healthcare Analyst & Sector Coordinator
Michael Novod - Director of Healthcare, Healthcare Analyst & Sector Coordinator
Just on the cost side, can you please go through some of the dynamics here in Q4 in order to sort of make the cost go up. As I see it, it needs to go up in an extreme pace for Q4. Are there any specific investments that you're able to take early or anything like that prior going into 2024, just to understand your EBIT guidance.
就成本而言,您能否回顧一下第四季度的一些動態,以便使成本上升。在我看來,第四季它需要以極快的速度成長。在進入 2024 年之前,您是否可以提前進行任何特定投資或類似投資,以便了解您的息稅前利潤指引。
Daniel Bohsen - CVP & Head of IR
Daniel Bohsen - CVP & Head of IR
That's over to you, Karsten.
這件事就交給你了,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
Yes, Michael, thanks for that question. When I look at our total operating cost growth in the fourth quarter, then it's actually not markedly different compared to year-to-date. So what you should be expecting is a continued, what I'll call high level of growth in R&D expenditure around the 40% mark and some 20% plus on S&D expenditure and the competitive gross margin also in the fourth quarter. So in reality, no big swings in the fourth quarter at constant exchange rates
是的,邁克爾,謝謝你的提問。當我查看第四季度的總營運成本成長時,實際上與年初至今並沒有明顯不同。因此,您應該期待的是,我稱之為研發支出持續高水準成長,約為 40%,特別發展支出約 20% 以上,第四季度的毛利率也具有競爭力。所以實際上,以固定匯率計算,第四季沒有太大的波動
Daniel Bohsen - CVP & Head of IR
Daniel Bohsen - CVP & Head of IR
Thank you, Karsten. Thanks for the question, Michael. And this concludes the Q&A session. Thank you for participating, and please feel free to contact Investor Relations in case you have any follow-up questions. Before we close the call, I would like to hand over to you, Lars, for any final remarks.
謝謝你,卡斯滕。謝謝你的提問,麥可。問答環節到此結束。感謝您的參與,如有任何後續問題,請隨時聯繫投資者關係部門。在我們結束通話之前,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. I also like to thank you all for participating today. I hope it's clear from our comments that we're very pleased with the strong momentum we have in our business also underlined with the base guidance for '23. And many questions on the coming years, not least the coming year. But we are really focused on pursuing innovation-based growth strategy, and I feel confident in our ability to scale supply to support that. We're really excited about FLOW, underlining the attractioness of semaglutide, and we are equally excited that we soon can disclose what Select has to show at the upcoming conference at AHA in a matter of a few days. So thank you all. We appreciate your time today. And with that, we'll close the call. Thank you.
是的。謝謝你,丹尼爾。我還要感謝大家今天的參與。我希望從我們的評論中可以清楚地看出,我們對我們業務的強勁勢頭感到非常滿意,這也強調了 23 年的基本指導。還有許多關於未來幾年的問題,尤其是未來的一年。但我們確實專注於追求基於創新的成長策略,我對我們擴大供應規模以支持這項策略的能力充滿信心。我們對 FLOW 感到非常興奮,強調了索馬魯肽的吸引力,我們同樣感到興奮的是,我們很快就能在幾天后即將舉行的 AHA 會議上披露 Select 必須展示的內容。謝謝大家。我們非常感謝您今天抽出時間。至此,我們就結束通話了。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。您現在可以斷開連線。