諾和諾德報告稱,2025 年前三個月銷售額和利潤均實現強勁增長,這得益於其對目標和可持續性的關注、患者獲得治療機會的擴大以及研發方面的進步。該公司仍然是 GLP-1 治療領域的全球領導者,致力於為慢性病患者提供服務。
美國GLP-1糖尿病照護產品的銷售額,尤其是Ozempic,成長了10%,而Wegovy的銷售額成長了39%。諾和諾德正在等待 FDA 審查,以確定在 2025 年下半年將 NASH 列為 Wegovy 的主要適應症。該公司旨在透過增加美國的處方趨勢和擴大其在國際上的 GLP-1 特許經營權來推動成長。
執行長 Lars Jorgensen 討論了 Ozempic 和 Wegovy 在市場上的成功,以及複方藥局對 Wegovy 市場份額的影響。諾和諾德專注於商業執行、研發進步和擴大生產能力,以治療更多疾病患者。
他們對支持患者的措施充滿信心,並期待他們的治療方法能惠及全球更多的患者。
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 Q1 2025 Novo Nordisk A/S earnings conference call. (Operator Instructions) Please be advised that today's conference is being recorded.
您好,感謝您的支持。歡迎參加 2025 年第一季 Novo Nordisk A/S 財報電話會議。(操作員指示)請注意,今天的會議正在錄音。
I would now like to hand the conference over to your first speaker today, Jacob Rode, Head of Investor Relations.
現在,我想將會議交給今天的第一位發言者,投資者關係主管 Jacob Rode。
Jacob Rode - Head of Investor Relations
Jacob Rode - Head of Investor Relations
Thank you and welcome to this Novo Nordisk Earnings call for the first three months of 2025. My name is Jacob Rode, and I'm the Head of Investor Relations at Novo Nordisk. And with me today, I have CEO of Novo Nordisk, Lars Jorgensen, Executive Vice President, US Operations; Dave Moore, Executive Vice President, International Operations, Mike Doustdar, Executive Vice President and Head of Development, Martin Houslanger; and finally, Chief Financial Officer, Karsten Knudsen. All speakers will be available for the Q&A session.
感謝並歡迎參加諾和諾德 2025 年前三個月收益電話會議。我叫 Jacob Rode,是諾和諾德公司的投資人關係主管。今天和我一起出席的還有諾和諾德公司執行長、美國營運執行副總裁 Lars Jorgensen;國際營運執行副總裁 Dave Moore、執行副總裁兼開發主管 Mike Doustdar、Martin Houslanger;最後是財務長 Karsten Knudsen。所有發言者都將參加問答環節。
Today's announcement and the slides for this call are available on our website, novonordisk.com. Please note that the call is being webcasted live, and a recording will be made available on our website as well. The call is scheduled to last one hour.
今天的公告和本次電話會議的幻燈片可在我們的網站 novonordisk.com 上找到。請注意,此次電話會議正在進行網路直播,錄音也將發佈在我們的網站上。此次通話預計將持續一個小時。
Next slide, please. The presentation is structured as outlined on slide 2. Please note that all sales and operating profit growth statements will be at constant exchange rates unless otherwise specified.
請看下一張投影片。簡報的結構如投影片 2 所示。請注意,除非另有說明,所有銷售額和營業利潤成長報表均以固定匯率計算。
Please turn to the next slide. We need to advise you that this call will contain forward-looking statements. These are subject to risks and uncertainties that could cause actual results to differ materially from expectations. For further information on the risk factors, please see the company announcement for the first three months of 2025, as well as the slides prepared for this presentation.
請翻到下一張投影片。我們需要提醒您,本次電話會議將包含前瞻性陳述。這些都受風險和不確定性的影響,可能導致實際結果與預期有重大差異。有關風險因素的更多信息,請參閱 2025 年前三個月的公司公告以及為本次演示準備的幻燈片。
With that, over to you, Lars, for an update on our strategic aspirations.
接下來,拉爾斯 (Lars) 將向您介紹我們的策略願景。
Lars Fruergaard Joergensen - President, Chief Executive Officer
Lars Fruergaard Joergensen - President, Chief Executive Officer
Thank you, Jacob. Next slide, please. In the first three months of 2025, we delivered 18% sales growth and 20% operating profit growth. 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. Starting with our focus on purpose and sustainability. We are now serving nearly 46 million patients with our diabetes and obesity treatments. This is an increase of almost 4 million patients compared to the first three months of 2024.
謝謝你,雅各。請看下一張投影片。2025年前三個月,我們的銷售額成長了18%,營業利潤成長了20%。在將發言權交給我的同事之前,我想先介紹一下我們策略願景的績效亮點。從我們對目標和永續性的關注開始。我們目前為近 4,600 萬名患者提供糖尿病和肥胖症治療服務。與 2024 年前三個月相比,患者人數增加了近 400 萬人。
Our total carbon emissions rose by 37% compared to the first three months of 2024. This was mainly driven by the acquisition of new production sites and capital expenditure activities related to expansion of manufacturing sites. These are also efforts to meet the high demand for our innovative treatments. To uphold our commitment to being a sustainable employer, we expanded the number of women in senior leadership positions to 42% compared to around 41% last year.
與 2024 年頭三個月相比,我們的碳排放量總量增加了 37%。這主要是由於收購新的生產基地和與擴建製造基地有關的資本支出活動所致。這也是為了滿足我們對創新治療的高需求而做出的努力。為了履行我們成為永續雇主的承諾,我們將高階領導職位中的女性人數從去年的 41% 左右增加到 42%。
In R&D, we completed the second and final pivotal trial we REDEFINE 2 with our next-generation obesity treatment, CagriSema. We remain on track for submission in the first quarter of 2026. Recently, our application for Wegovy 2.4 milligram for the treatment of metabolic dysfunction-associated steatohepatitis or MASH in short was accepted by the US FDA and granted priority review. In addition, the new drug application for weight management for oral semaglutide 25-milligram or as a person will call it Wegovy in a pill has been submitted to the US FDA. If approved, this will be the first oral GLP-1 treatment for obesity in the US.
在研發方面,我們利用下一代肥胖症治療藥物 CagriSema 完成了第二次也是最後一次關鍵試驗 REDEFINE 2。我們仍有望在 2026 年第一季提交。近日,我們用於治療代謝功能障礙相關脂肪性肝炎(簡稱MASH)的Wegovy 2.4毫克的申請被美國FDA受理,並被授予優先審查資格。此外,用於體重管理的口服 25 毫克司美格魯肽(或人們稱之為 Wegovy 片劑)新藥申請已提交給美國 FDA。如果獲得批准,這將是美國第一個用於治療肥胖症的口服 GLP-1 藥物。
Lastly, we are in licensed two early-stage assets that show promise in addressing obesity and other cytomembolic diseases. Martin will come back to this and our overall R&D milestones later. The quarterly sales growth is driven by both operating units. Dave and Mike will go through the details later. In terms of financial details, we delivered sales growth of 18% in the first three months of 2025. However, we have reduced our full year outlook due to lower-than-planned branded GLP-1 penetration impacted by the rapid expansion of compounding in the US Novo Nordisk is actively focused on preventing unlawful compounding as well as the efforts to expand patient access on our GLP-1 treatments. Karsten will come back to this later.
最後,我們獲得了兩項早期資產的許可,這些資產在治療肥胖症和其他細胞膜栓塞疾病方面顯示出良好的前景。馬丁稍後會再談到這一點以及我們的整體研發里程碑。季度銷售額的成長是由兩個營運部門共同推動的。Dave 和 Mike 稍後會討論詳細資訊。從財務細節來看,我們在 2025 年前三個月實現了 18% 的銷售額成長。然而,由於美國複合藥物的快速擴張影響了品牌 GLP-1 的滲透率低於計劃,我們下調了全年預期。諾和諾德積極致力於防止非法複合,並努力擴大患者獲得 GLP-1 治療的機會。卡斯滕稍後會再談這個問題。
We will continue to drive attractive growth and expand patient access in -- to our innovative treatments. In the US, this includes recent initiatives with Nova Care pharmacy, telehealth collaborations and the CVS formulary decision. In International Operations, there remains a large unmet need for patients, and we're excited to continue focused commercial efforts in existing and future markets in 2025. Furthermore, we realized the significance of our global footprint, including those activities based in the US Novo Nordisk has a strong presence in the US with over 10,000 full-time employees across the value chain. This includes research and development and substantial manufacturing footprint.
我們將繼續推動有吸引力的成長並擴大患者獲得我們創新治療的機會。在美國,這包括最近與 Nova Care 藥局合作的舉措、遠距醫療合作以及 CVS 處方集決定。在國際營運方面,患者仍存在大量未滿足的需求,我們很高興在 2025 年繼續專注於現有和未來市場的商業努力。此外,我們意識到全球足跡的重要性,包括在美國的活動,諾和諾德在美國擁有強大的影響力,在整個價值鏈上擁有超過 10,000 名全職員工。這包括研究和開發以及大量的製造足跡。
We have invested over USD24 billion in the US over the past 10 years, including ongoing expansions and improvements to our manufacturing site in Bloomington, Indiana and Casa, North Carolina. The existing US tariffs does not materially change our financial outlook for 2025. That being said, we are closely following potential tariffs on pharmaceutical products in the US. Before we move on to the particulars of the first quarter performance, I would like to update you on changes to executive management.
過去 10 年,我們在美國投資超過 240 億美元,包括持續擴建和改善位於印第安納州布魯明頓和北卡羅來納州卡薩的製造基地。現有的美國關稅不會實質地改變我們對 2025 年的財務前景。話雖如此,我們正在密切關注美國對藥品徵收的潛在關稅。在我們了解第一季業績的具體情況之前,我想先向您介紹一下高階主管的變動。
Please turn to the next slide. After nearly 30 years with Novo Nordisk, Camilla Sylvest decided to step down. Camilla played a pivotal role in establishing our GLP-1 and obesity franchises and be ahead of the development of our long-term social and environmental goals. I would like to thank Camilla for her meaningful contributions to Novo Nordisk and wish her all the best for the future.
請翻到下一張投影片。在諾和諾德公司工作近30年後,卡米拉·西爾維斯特決定辭職。卡蜜拉在建立我們的 GLP-1 和肥胖症特許經營權以及引領我們實現長期社會和環境目標方面發揮了關鍵作用。我感謝卡米拉對諾和諾德做出的有意義的貢獻,並祝福她未來一切順利。
This development has triggered several organizational changes effective 3rd of April, aimed at enhancing the speed of decision-making and strengthening the execution focus within our operating units. Ludovic Helfgott, formerly Executive Vice President, Rare Disease, now heads our product and portfolio strategy. This is a newly established area designed to forge a closer connection between commercial strategy, medical affairs and business development across all our therapy areas. Till Ludovic Helfgott becomes the newest member of Executive Management as Executive Vice President of Quality, IT and Environmental Affairs. The restructure will also enable a more to focus exclusively on the US operations as well as Henrik Wulff and CMC and [product supply].
這項發展引發了自 4 月 3 日起生效的幾項組織變革,旨在提高決策速度並加強我們營運部門的執行重點。前罕見疾病執行副總裁 Ludovic Helfgott 現負責我們的產品和投資組合策略。這是一個新設立的領域,旨在在我們所有治療領域的商業策略、醫療事務和業務發展之間建立更緊密的聯繫。Till Ludovic Helfgott 成為執行管理階層的最新成員,擔任品質、IT 和環境事務執行副總裁。此次重組也將使公司能夠更加專注於美國業務以及 Henrik Wulff 和 CMC 以及【產品供應】
I'd now like to give an update on our commercial execution in the first three months of 2025. Please turn to the next slide. As of January, North America Operations and International Operations were reorganized and financial reporting has been divided into US operations and International Operations. More details on the regions can be found in a company announcement. In the first three months of 2025, our sales increased by 18%. The sales growth was driven by both operating units with US operations growing 17% and International Operations growing 19%. Our GLP-1 sales in diabetes increased by 11%, driven by US operations growing 10% and International Operations growing at 13%.
現在,我想介紹一下我們 2025 年頭三個月的商業執行情況。請翻到下一張投影片。自一月份起,北美營運和國際營運進行了重組,財務報告分為美國營運和國際營運。有關各地區的更多詳細資訊請參閱公司公告。2025年前三個月,我們的銷售額成長了18%。銷售額的成長由兩個營運部門共同推動,其中美國業務成長了 17%,國際業務成長了 19%。我們的糖尿病 GLP-1 銷售額成長了 11%,其中美國業務成長了 10%,國際業務成長了 13%。
Interest sales increased by 3%, driven by US operations growing 13%. The sales increase was driven by phasing rebates as well as channel and payer mix, partly countered by a decline in volume. In terms of [sales], sales increased 1%. ObesiCare sales increased 65% and driven by US operations growing 40%, partly impacted by compounded GLP-1 and international ration growing 137%. In both geographies, growth was driven by Wegovy, partly offset by declining Saxenda sales as the obesity care market is growing towards once-weekly treatments. Rare disease sales increased by 3%, driven by a 5% sales increase in International Operations. Rare Disease sales in US operations grew 1% compared to last year.
受美國業務成長 13% 的推動,利息銷售額成長了 3%。銷售額的成長是由分階段返利以及通路和付款人組合推動的,但銷量的下降部分抵消了這一增長。就[銷售]而言,銷售額成長了1%。ObesiCare 的銷售額成長了 65%,其中美國業務成長了 40%,部分原因是複合 GLP-1 和國際配給量成長了 137%。在這兩個地區,成長均由 Wegovy 推動,但由於肥胖症護理市場正向每週一次的治療方向發展,Saxenda 銷售額的下降部分抵消了這一增長。罕見疾病銷售額成長 3%,得益於國際業務銷售額成長 5%。美國罕見疾病業務的銷售額與去年相比成長了 1%。
Please turn to the next slide. Today, Novo Nordisk remains the global GLP-1 volume market leader, serving nearly two-thirds of all patients on GLP-1 treatments across diabetes and obesity. Our ongoing scaling efforts have supported close to tripling of GLP-1 patients reached over the past three years. We are dedicated to serving patients who need our medicines and increasing our capacity to meet their needs, by integrating the three acquired fully finished sites and expanding our existing capacities, we are ready to reach more patients with serious chronic diseases.
請翻到下一張投影片。如今,諾和諾德仍然是全球 GLP-1 銷售市場的領導者,為近三分之二的糖尿病和肥胖症 GLP-1 治療患者提供服務。我們持續不斷的擴大努力使得過去三年內 GLP-1 患者數量增加了近兩倍。我們致力於為需要我們藥品的患者提供服務,並提高我們滿足他們需求的能力,透過整合收購的三個完全成品基地並擴大我們現有的產能,我們準備接觸更多患有嚴重慢性疾病的患者。
With that, I would hand over to Dave.
說完這些,我就把任務交給戴夫了。
David Moore - Executive Vice President, US Operations
David Moore - Executive Vice President, US Operations
Thank you, Lars. Please turn to the next slide. Sales of GLP-1 diabetes care products in the US increased by 10% in the first three months of 2025. The sales increase was mainly driven by the continued uptake of Ozempic. Following the US approval of the FLOW data earlier this year, Ozempic is now the only GLP-1 receptor agonist proven to reduce the risk of chronic kidney disease and people living with type 2 diabetes and chronic kidney disease.
謝謝你,拉爾斯。請翻到下一張投影片。2025年前三個月,美國GLP-1糖尿病照護產品的銷售額成長了10%。銷售額的成長主要得益於 Ozempic 的持續成長。繼今年稍早美國批准 FLOW 數據後,Ozempic 現已成為唯一被證實可降低慢性腎臟病風險以及 2 型糖尿病和慢性腎臟病患者風險的 GLP-1 受體激動劑。
Novo Nordisk remains the market leader in the US with more than 50% market share measured by total monthly prescriptions. Please turn to the next slide. Wegovy sales increased by 39% in US operations in the first three months of 2025. The Wegovy sales growth was driven by increased volumes which were negatively impacted by wholesaler inventory movements. This was partially countered by lower realized prices. Wegovy was around 200,000 weekly prescriptions, the total US branded anti-obesity market more than doubled with a growth rate of over 160% in the last year. The volume of compounded GLP-1s in the US is estimated to have impacted the uptake of Wegovy prescriptions and the growth of the branded obesity market during the first quarter of 2025.
諾和諾德仍然是美國市場的領導者,以每月處方總量計算,其市佔率超過 50%。請翻到下一張投影片。2025 年前三個月,Wegovy 在美國業務的銷售額成長了 39%。Wegovy 的銷售成長是由銷售增加所推動的,而批發商庫存變動則對其產生了負面影響。這在一定程度上被較低的實際價格所抵消。Wegovy 每週開出的處方約為 20 萬張,去年美國品牌減肥藥市場總量增加了一倍多,成長率超過 160%。據估計,美國複合 GLP-1 的數量將影響 2025 年第一季 Wegovy 處方的吸收和品牌肥胖市場的成長。
In February, the FDA removed semaglutide from the drug shortage list. As a result, it is now illegal under US compounding laws to make or sell compounded semaglutide drugs, except with rare exceptions. Novo Nordisk is working to prevent unlawful and unsafe compounding of semaglutide in the US while making sure patients have access to safe, legitimate semaglutide produced by Novo Nordisk. Following the resolution of the semaglutide shortage, we have a number of initiatives to support patients with obesity seeking treatment with Wegovy.
今年2月,FDA將司美格魯肽從藥品短缺名單中移除。因此,根據美國複合法律,除少數例外情況外,製造或銷售複合司美格魯肽藥物現在都是非法的。諾和諾德正在努力防止美國境內非法和不安全地配製司美格魯肽,同時確保患者能夠獲得諾和諾德生產的安全、合法的司美格魯肽。在解決司美格魯肽短缺問題後,我們採取了多項措施來支持尋求 Wegovy 治療的肥胖症患者。
In March, we introduced self-pay. Direct-to-patient delivery of all doses of Wegovy at a reduced cost of USD499 per month through our Novocare pharmacy. Access to Wegovy for cash-paying patients was further expanded in April with the announcement of collaborations with three telehealth organizations. And last week, it was announced that CBS chose Wegovy to be the only GLP-1 medicine covered for obesity on its national template formulary as of July 1, 2025.
三月份,我們推出了自付費用。透過我們的 Novocare 藥局直接向患者遞送所有劑量的 Wegovy,每月費用為 499 美元。今年 4 月,隨著與三家遠距醫療組織宣布合作,Wegovy 為現金付費患者提供的服務範圍進一步擴大。上週,哥倫比亞廣播公司 (CBS) 宣布,自 2025 年 7 月 1 日起,Wegovy 將作為其國家模板處方集中唯一涵蓋肥胖症的 GLP-1 藥物。
While Novo Nordisk is committed to providing patients with choices and did not pursue an exclusive formulary placement, we do believe the formulary decision by CVS speaks to the benefits of Wegovy. These include established cardiovascular benefits noted on the Wegovy label and we await the FDA priority review of the promising data from the ESSENCE trial for potential inclusion of NASH as a primary indication in the label in the second half of 2025. We will continue to identify additional ways to expand access to Wegovy.
雖然諾和諾德致力於為患者提供選擇,並且不追求獨家處方,但我們確實相信 CVS 的處方決定體現了 Wegovy 的優勢。這些包括 Wegovy 標籤上註明的已確定的心血管益處,我們等待 FDA 對 ESSENCE 試驗的有希望的數據進行優先審查,以便在 2025 年下半年將 NASH 作為標籤的主要適應症納入其中。我們將繼續尋找其他方法來擴大對 Wegovy 的訪問。
Now, I'd like to turn it over to Mike for an update on International Operations.
現在,我想讓麥克介紹國際業務的最新情況。
Maziar Doustdar - Executive Vice President - International Operations
Maziar Doustdar - Executive Vice President - International Operations
Thank you, Dave. If we can go to the next slide, please. Sales in international operations grew by 19% in the first three months of 2025, driven by GLP-1 products. GLP-1 diabetes cells increased 13% and driven by all regions. GLP-1 diabetes cells growth was negatively impacted by periodic supply constraints. Obesity care sales grew by 137% to DKK6.5 billion, Sales of Wegovy reached more than DKK5.5 billion, growing at 392%, driven by sales across all regions.
謝謝你,戴夫。請翻到下一張投影片。在 GLP-1 產品的推動下,2025 年頭三個月國際業務銷售額成長了 19%。GLP-1 糖尿病細胞成長了 13%,並且受到所有地區的推動。GLP-1 糖尿病細胞生長受到週期性供應限制的負面影響。肥胖護理銷售額成長 137%,達到 65 億丹麥克朗,Wegovy 銷售額達到 55 億丹麥克朗以上,成長 392%,這得益於所有地區的銷售成長。
Next slide, please. Novo Nordisk remains the market leader in international operations with a total diabetes and obesity GLP-1 volume market share of over 72%. Diabetes remains a significant global health challenge, affecting more than 550 million individuals in IO. Rybelsus is now available in over 40 markets and continues to gain market share in international operations. Meanwhile, Ozempic remains the leading GLP-1 diabetes product within IO, having launched in around 80 markets. With improved supply, we are now fully focused on our promotional activities to further expand the number of patients reached.
請看下一張投影片。諾和諾德在國際業務中仍保持市場領先地位,糖尿病和肥胖症 GLP-1 總銷量市場份額超過 72%。糖尿病仍是全球面臨的重大健康挑戰,影響印度洋地區超過 5.5 億人。Rybelsus 目前已覆蓋 40 多個市場,並在國際業務中繼續獲得市場份額。同時,Ozempic 仍然是 IO 領域領先的 GLP-1 糖尿病產品,已在約 80 個市場推出。隨著供應的改善,我們現在全力專注於促銷活動,以進一步擴大覆蓋患者的數量。
Also, within obesity, we see a substantial unmet need with more than 800 million people living with obesity in IO and only a few million of these people being treated. We have launched Wegovy in around 25 countries, including three in just the last month. reflecting a greater supply availability and staying true to our commitment in reaching more and more patients. We look very much forward to rolling out Wegovy in many more markets as the year goes through.
此外,在肥胖問題方面,我們發現有大量未滿足的需求,印度有超過 8 億肥胖患者,但其中只有數百萬人得到了治療。我們已在約 25 個國家推出了 Wegovy,其中僅在上個月就在 3 個國家推出了 Wegovy。反映出更大的供應可用性並忠於我們幫助越來越多患者的承諾。我們非常期待在未來的一年中在更多市場推出 Wegovy。
Next slide, please. Our rare disease sales increased by 3%. This was driven by sales increase in international operations of 5% and US operations sales growth of 1%. The Sales of rare endocrine disorder products increased by 14%, driven by Norditropin and improvement in manufacturing output as well as Sogroya launch uptake in international operations. This is countered by a decrease of 5% in US operations, mainly driven by Norditropin. Rare blood disorder sales decreased by 1%, driven by lower sales of NovoSeven.
請看下一張投影片。我們的罕見疾病銷售額成長了3%。這是由於國際業務銷售額成長 5% 以及美國業務銷售額成長 1% 所致。罕見內分泌失調產品的銷售額成長了 14%,這得益於 Norditropin 和製造產量的提高以及 Sogroya 在國際業務中的推出。與此形成鮮明對比的是,美國業務下降了 5%,主要原因是 Norditropin 的銷售量下降。罕見血液疾病銷售額下降了 1%,原因是 NovoSeven 銷售額下降。
Now, over to you, Martin, for an update on R&D.
現在,馬丁,請你來介紹研發的最新情況。
Martin Lange - Executive Vice President - Development
Martin Lange - Executive Vice President - Development
Thank you, Mike. Please turn to the next slide. In March, Novo Nordisk released the headline results from REDEFINE 2 the second and final PIVOTAL trial with CagriSema. The trial included people living with obesity overweight along with type 2 diabetes. REDEFINE 2 was a 68-week efficacy and safety trial with 1,206 people enrolled. People were randomly assigned to receive either CagriSema, a fixed-dose combination of (inaudible) 2.4 milligram and semaglutide 2.4 milligram or placebo. The mean baseline body weight was 102.2 kilograms.
謝謝你,麥克。請翻到下一張投影片。3 月,諾和諾德公佈了與 CagriSema 合作進行的第二次也是最後一次 PIVOTAL 試驗 REDEFINE 2 的主要結果。試驗對象為患有肥胖症、過重和第 2 型糖尿病的人。REDEFINE 2 是一項為期 68 週的療效和安全性試驗,共有 1,206 人參與。人們被隨機分配接受 CagriSema(一種 2.4 毫克(聽不清楚)和 2.4 毫克司美格魯肽的固定劑量組合)或安慰劑。平均基線體重為102.2公斤。
The REDEFINE 2 trial incorporated a flexible trial protocol similar to REDEFINE 1. After six weeks of treatment, assuming all people adhere to treatment, CagriSema resulted in a significant weight loss of 15.7% compared to 3.1% in the placebo. In the trial, CagriSema appeared to have a safe and well-tolerated profound. The most common adverse events were gastrointestinal with the vast majority being mild to moderate and decreasing over time in line with the GLP-1 receptor agonist class. We've now completed the second and last PIVOTAL CagriSema Phase 3 trial for weight management. We look forward to sharing more data from REDEFINE 1 and 2 at the American Diabetes Association in June.
REDEFINE 2 試驗採用了與 REDEFINE 1 類似的靈活試驗方案。經過六週的治療,假設所有人都堅持治療,CagriSema 可使體重顯著減輕 15.7%,而安慰劑組則減輕了 3.1%。在試驗中,CagriSema 似乎具有安全性和良好的耐受性。最常見的不良事件是胃腸道不良事件,絕大多數為輕度至中度,並且隨著時間的推移而減少,與 GLP-1 受體激動劑類一致。我們現在已經完成了第二次也是最後一次 PIVOTAL CagriSema 體重管理第三階段試驗。我們期待在 6 月的美國糖尿病協會會議上分享更多來自 REDEFINE 1 和 2 的數據。
We are on track with scaling of the CagriSema supply chain, and we still expect to file for the first regulatory approval in the first quarter of 2026. Next slide, please. Building on the learnings from REDEFINE 1 and 2 trials, we have extended the duration of redefined for which is now anticipated to read out in the first quarter of 2026.
我們正在按計劃擴大 CagriSema 供應鏈,我們仍預計將在 2026 年第一季申請第一個監管部門的批准。請看下一張投影片。基於 REDEFINE 1 和 2 試驗的經驗,我們延長了重新定義的持續時間,預計將在 2026 年第一季讀出。
Turning to REDEFINE 11. We expect the trial to be initiated during the second quarter 2025. The purpose of REDEFINE 11 is to investigate the potential for further weight loss by prolonging the duration of the trial to 80 weeks and focusing on dose re-escalation throughout the study.
轉向REDEFINE 11。我們預計試驗將於 2025 年第二季啟動。REDEFINE 11 的目的是透過將試驗時間延長至 80 週並專注於整個研究過程中的劑量重新升級來研究進一步減肥的可能性。
Next slide, please. In February, we submitted the oral semaglutide 25-milligram to the US FDA as the potential first oral GLP-1 treatment for obesity. Oral semaglutide 25-milligram demonstrates an overall efficacy and safety profile similar to once-weekly injectable semaglutide 2.4 milligram. For context, I would like to revisit the OASIS 4 results. OASIS 4 was a 64-week efficacy and safety trial comparing once daily oral semaglutide 25-milligram to placebo in 307 adults with obesity or overweight with one on comorbidities.
請看下一張投影片。今年 2 月,我們向美國 FDA 提交了 25 毫克口服司美格魯肽的申請,作為首個潛在的口服 GLP-1 肥胖症治療藥物。口服 25 毫克索馬魯肽的整體療效和安全性與每週注射一次的 2.4 毫克索馬魯肽相似。為了了解背景,我想重新審視 OASIS 4 的結果。OASIS 4 是一項為期 64 週的療效和安全性試驗,對 307 名患有肥胖症或超重且伴有合併症的成年人進行了每日一次口服 25 毫克司美格魯肽與安慰劑的比較。
In the trial, adults with obesity or overweight who received oral semaglutide 25 milligrams, experienced an average weight loss of 16.6%, from a baseline body weight of 105.9 kilograms, when assuming full adherence to the treatment regimen. Around one-third of participants achieved a weight loss greater of 20% or more. Secondary endpoint from OASIS 4 demonstrated improvements in cardiometabolic risk factors such as (inaudible) conference, blood pressure and inflammation in patients treated with oral 25 milligrams versus placebo.
在試驗中,患有肥胖症或超重的成年人口服 25 毫克司美格魯肽後,在完全遵守治療方案的情況下,體重從基線體重 105.9 公斤平均減輕了 16.6%。約三分之一的參與者體重減輕了 20% 或更多。OASIS 4 的次要終點表明,與接受安慰劑治療的患者相比,接受口服 25 毫克治療的患者心臟代謝風險因素(如(聽不清)會議、血壓和發炎)有所改善。
In addition, oral semaglutide 25-milligram appear to have a safe and well-tolerated profile on par with a semaglutide 2.4 milligram. The full publication of OASIS 4 is expected later this year. Altogether, oral and injectable semaglutide has been studied in robust clinical development programs with more than 43,000 semaglutide exposed patients and exposure from post-marketing use of over 33 million patient years. If approved, oral semaglutide 25-milligram is expected to be the first oral GLP-1 receptor agonist for weight loss. The manufacturing of the active pharmaceutical ingredient, bulk tablet manufacturing and packaging of oral semaglutide 25-milligram are all carried out in the United States and all manufacturing steps are up and running.
此外,口服 25 毫克索馬魯肽似乎具有與 2.4 毫克索馬魯肽相當的安全性和耐受性。OASIS 4 的完整版本預計將於今年稍後發布。總而言之,口服和注射用司美格魯肽已在強大的臨床開發項目中進行了研究,涉及超過 43,000 名使用司美格魯肽的患者,上市後使用史已有超過 3300 萬患者年。如果獲得批准,口服司美格魯肽25毫克有望成為第一個用於減肥的口服GLP-1受體激動劑。口服司美格魯肽25毫克的活性藥物成分製造、大片劑製造及包裝均在美國進行,所有製造步驟均已正常運作。
We anticipate the US FDA review will be completed around the turn of this year. Next slide, please. Turning to the upcoming R&D milestones. We look forward to a year with exciting trial readouts. Before speaking to the remainder of 2025, I would like to highlight some of the milestones from the last few months. In addition to the completion of Redefine and the submission of oral 25 milligrams semaglutide for obesity in the US, Novo Nordisk continues to pursue the expanded treatment optionality for people living with obesity.
我們預計美國 FDA 的審查將在今年年底左右完成。請看下一張投影片。轉向即將到來的研發里程碑。我們期待新的一年有令人興奮的試驗結果。在談論 2025 年剩餘時間之前,我想強調過去幾個月的一些里程碑。除了完成 Redefine 和在美國提交用於治療肥胖症的口服 25 毫克索馬魯肽之外,諾和諾德還繼續尋求擴大肥胖患者的治療選擇。
Although not shown in the slide, I would like to mention our newest agreement to in-license two early-stage assets for the treatment of obesity and other cardiometabolic diseases. These include a first-in-class oral non-incretin preclinical candidate in obesity and associated metabolic disorders. And GLP-1, GIP glucagon triple receptor agonist. The latter TBG asset is the second triagonist in our pipeline. And we expect the Phase 1 results from our internal try agonist in the second half of 2025. Within Rare Disease, the main phases of 2 Phase 3 trials, REAL 8 and REAL 9 were successfully completed with (inaudible) for nonreplacement indications and submitted for regulatory approval in the EU.
雖然幻燈片中沒有顯示,但我想提一下我們最新的協議,即授權兩種用於治療肥胖症和其他心臟代謝疾病的早期資產。其中包括用於治療肥胖症和相關代謝紊亂的首創口服非腸促胰島素臨床前候選藥物。及GLP-1、GIP胰高血糖素三重受體激動劑。後者的 TBG 資產是我們管道中的第二個三角資產。我們預計內部嘗試激動劑的第一階段結果將於 2025 年下半年公佈。在罕見疾病領域,2 個 3 期試驗的主要階段 REAL 8 和 REAL 9 已成功完成(聽不清楚)非替代適應症,並提交給歐盟監管部門批准。
Within cardiovascular and emerging therapeutic areas, we are excited to have submitted the ESSENCE Part 1 trial with once weekly semaglutide 2.4 milligram for regulatory approval in both EU and US for the treatment of mesh and moderate to advanced liver fibrosis, namely F2 and F3.
在心血管和新興治療領域,我們很高興已提交 ESSENCE 第 1 部分試驗,每週使用 2.4 毫克司美格魯肽,以獲得歐盟和美國監管部門的批准,用於治療網狀組織和中度至晚期肝纖維化,即 F2 和 F3。
As a reminder, is achieved both primary endpoints. By week 72, 37% of people treated with semaglutide 2.4 milligram achieved improved liver fibrosis with no worsening of the hepatitis while 63% achieved a resolution of CO2 hepatitis with no worsening of liver fibrosis. To put this into perspective, the ESSENCE Phase 3 trials, trial results are the best Phase 3 results within MESH to date. In US alone, around 13 million people live with mesh and currently have limited treatment options available. We're excited that the US FDA has accepted the supplemental new drug application and granted priority review for Wegovy to treat mesh in adults with moderate to advanced brochures with the decision anticipated in second half of this year.
提醒一下,兩個主要終點均已實現。到第 72 週,接受 2.4 毫克司美格魯肽治療的患者中,37% 的肝纖維化得到改善,且肝炎沒有惡化,而 63% 的患者的二氧化碳性肝炎得到緩解,且肝纖維化沒有惡化。從這個角度來看,ESSENCE 第 3 階段試驗的結果是迄今為止 MESH 中最好的第 3 階段結果。光是在美國,就有約 1,300 萬人患有網狀物,目前可用的治療選擇有限。我們很高興美國 FDA 接受了補充新藥申請,並對 Wegovy 用於治療中度至晚期成人網狀物給予優先審查,預計將於今年下半年做出決定。
Moving to upcoming milestones in 2025. I would like to start with a few data readouts in type 2 diabetes in the second half. Specifically, we expect the first Phase 3 results from CagriSema from reimaging free, investigating CagriSema as an add-on to basal insulin in people with type 2 diabetes. Moreover, we expect results from the subcutaneous and oral (inaudible) Phase 2 trial.
邁向 2025 年即將到來的里程碑。我想從下半年 2 型糖尿病的一些數據讀數開始。具體來說,我們預計 CagriSema 的第一階段 3 期結果將來自對免費重新成像的研究,該研究調查了 CagriSema 作為 2 型糖尿病患者基礎胰島素的補充。此外,我們期待皮下和口服(聽不清楚)第 2 階段試驗的結果。
Our upcoming readouts and clinical programs in obesity demonstrate the breadth of our pipeline in both modalities and mechanisms of actions to meet the need of patients. In addition to the initiation of REDEFINE 11 with CagriSema in the first half of 2025 that I mentioned earlier, we also expect the Phase 2 readout from the once-weekly GIP, GLP-1 co-agonist in the second quarter of 2025.
我們即將發布的肥胖症相關讀數和臨床項目展示了我們在治療方式和作用機制方面的廣泛性,可以滿足患者的需求。除了我之前提到的與 CagriSema 合作在 2025 年上半年啟動 REDEFINE 11 之外,我們還預計在 2025 年第二季度對每週一次的 GIP、GLP-1 聯合激動劑進行第 2 階段讀數。
We're also very excited to initiate the Phase 3 program for cegilentide in monotherapy in late 2025. Within Rare Disease, we expect US submission for (inaudible) in nonreplacement indications in the second quarter of 2025, as well as regulatory submissions for MyMate in the US and EU in the second half of 2025. Lastly, we look forward to the readout of the EVOKE and EVOKE+ trials in patients with early Alzheimer's disease.
我們也非常高興能夠在 2025 年底啟動西吉蘭肽單藥治療的 3 期臨床試驗。在罕見疾病領域,我們預計美國將在 2025 年第二季提交非替代適應症的(聽不清楚)申請,並於 2025 年下半年向美國和歐盟提交 MyMate 的監管申請。最後,我們預期早期阿茲海默症患者的 EVOKE 和 EVOKE+ 試驗結果。
With that, over to you, Karsten.
現在,輪到你了,卡斯滕。
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Thank you, Martin. Please turn to the next slide. In the first three months of 2025, our sales grew by 19% in Danish kroner and 18% at constant exchange rates, driven by both operating units. The gross margin decreased by 83.5% -- decreased to 83.5% compared to 84.8% in the first three months of 2024. The decrease mainly reflects amortizations and depreciations related to Catalent as well as costs related to ongoing capacity expansions, partially countered by positive product mix, driven by increased sales of GLP-1-based treatments. Sales and distribution costs increased by 12% in Danish kroner and by 10% at constant exchange rates.
謝謝你,馬丁。請翻到下一張投影片。2025 年頭三個月,在兩個營運部門的推動下,我們的銷售額以丹麥克朗計算成長了 19%,以固定匯率計算成長了 18%。毛利率下降了83.5%——與2024年前三個月的84.8%相比下降至83.5%。下降主要反映了與 Catalent 相關的攤銷和折舊以及與持續產能擴張相關的成本,但受 GLP-1 治療藥物銷售成長推動的積極產品組合部分抵消了這一影響。銷售和分銷成本以丹麥克朗計算增加了 12%,以固定匯率計算增加了 10%。
In US operations, the cost increase is mainly driven by promotional activities related to Wegovy and Ozempic. In international operations, the increase is mainly related to Wegovy launch and promotional activities. Research and development costs increased by 20% in Danish kroner and 19% at constant exchange rates. The increase in cost is mainly driven by obesity care and reflecting increased late-stage clinical trial activity as well as increased early research activities. Administration costs increased by 5%, both in Danish kroner and at constant exchange rates. Operating profit as a consequence, increased by 22% measured in Danish kroner and by 20% at constant exchange rates. EBITDA increased by 23% in Danish kroner and by 21% at constant exchange rates.
在美國業務中,成本增加主要由與 Wegovy 和 Ozempic 相關的促銷活動所推動。在國際業務方面,成長主要與Wegovy的推出和促銷活動有關。研發成本以丹麥克朗計算增加了 20%,以固定匯率計算增加了 19%。成本的增加主要是由於肥胖症護理,並反映了後期臨床試驗活動的增加以及早期研究活動的增加。管理成本以丹麥克朗和固定匯率計算均增加了 5%。因此,營業利潤以丹麥克朗計算成長了 22%,以固定匯率計算成長了 20%。EBITDA 以丹麥克朗計算成長了 23%,以固定匯率計算成長了 21%。
Net financial items showed a net loss of DKK1.8 billion compared with a net gain of DKK72 million last year. This primarily reflects losses on hedge currencies and financing costs related to the funding of the Catalent transaction. The effective tax rate was 21.6% in the first three months of 2025, compared to 20.4% in 2024. Net profit increased by 14%, and diluted earnings per share increased by 15% to DKK6.53. Free cash flow in the first three months of 2025 was DKK9.5 billion compared to DKK5 billion in the first three months of 2024.
淨財務項目顯示淨虧損 18 億丹麥克朗,去年淨利 7,200 萬丹麥克朗。這主要反映了對沖貨幣的損失以及與 Catalent 交易融資相關的融資成本。2025 年頭三個月的有效稅率為 21.6%,而 2024 年為 20.4%。淨利成長14%,每股攤薄收益成長15%至6.53丹麥克朗。 2025 年頭三個月的自由現金流為 95 億丹麥克朗,而 2024 年頭三個月的自由現金流為 50 億丹麥克朗。
Free cash flow is reflecting higher net cash generated from operating activities, partially countered by increased capital expenditure. Capital expenditure for property, plant and equipment was DKK13.4 billion compared to DKK8.4 billion in 2024. This was primarily driven by investments in additional capacity for API and fill finish capacity for both current and future injectable and oral products. We have returned DKK36.7 billion to shareholders, mainly as dividends in the first three months, 2025.
自由現金流反映出經營活動產生的淨現金增加,但部分被資本支出的增加所抵銷。物業、廠房和設備的資本支出為 134 億丹麥克朗,而 2024 年為 84 億丹麥克朗。這主要是由於對目前和未來注射劑和口服產品的 API 額外產能和填充能力的投資所致。我們已向股東返還了 367 億丹麥克朗,主要以 2025 年前三個月的股息形式回饋。
Following the step-up in CapEx investments in 2025, Novo Nordisk is not conducting a share buyback program an authorization to the Board of Directors to buy back shares was, however, in line with previous years adopted at the Annual General Meeting on 27th of March 2025. Should the initiation of a share buyback program later between relevance.
隨著 2025 年資本支出投資的增加,諾和諾德不再實施股票回購計劃,但授權董事會回購股票與 2025 年 3 月 27 日年度股東大會上通過的往年一致。是否應啟動股票回購計畫與稍後的相關性。
For 2025, the range for sales growth is now expected to be 13% to 21% at constant exchange rates. Given the current exchange rate versus Danish kroner, sales growth reported in Danish kroner is expected to be 3 percentage points lower than constant exchange rate growth. The new range reflects lower than planned penetration of branded GLP-1 treatments in the US impacted by compounded GLP-1s.
到 2025 年,預計銷售額成長率將達到 13% 至 21%(以固定匯率計算)。鑑於目前兌丹麥克朗的匯率,以丹麥克朗報告的銷售額成長預計將比固定匯率成長低 3 個百分點。新系列產品反映出,受複合 GLP-1 的影響,美國品牌 GLP-1 治療藥物的滲透率低於計劃。
The outlook reflects expectations for sales growth in US operations and international operations, mainly driven by volume growth of GLP-1-based treatment for obesity and diabetes. Following the US FDA removal of semaglutide injectables from the drug shortage list, the sales outlook assumes a reduction in patients on compounded GLP-1 treatments during the second half of 2025. The updated guidance reflects several efforts already underway, as mentioned by Lars, Mike and Dave.
該前景反映了對美國業務和國際業務銷售成長的預期,主要受基於 GLP-1 的肥胖症和糖尿病治療的銷售成長所推動。繼美國 FDA 將司美格魯肽注射劑從藥品短缺名單中移除後,銷售前景預計 2025 年下半年接受複方 GLP-1 治療的患者數量將減少。正如 Lars、Mike 和 Dave 所提到的,更新後的指南反映了已經在進行的幾項努力。
Operating profit growth is now expected to be 16% to 24% at constant exchange rates. Given the current exchange rates versus Danish kroner, growth reported in Danish kroner is expected to be around 5 percentage points lower than at constant exchange rates. The updated expectation for operating profit growth primarily reflects the lower sales growth outlook, partially countered by reduced spending.
以固定匯率計算,預計營業利潤成長率為 16% 至 24%。鑑於目前兌丹麥克朗的匯率,以丹麥克朗計算的成長率預計將比固定匯率低約 5 個百分點。更新後的營業利潤成長預期主要反映了較低的銷售成長前景,部分抵銷了支出的減少。
Novo Nordisk expects net financial items to show a gain of around DKK0.9 billion. This is mainly driven by expected gains on hedged currencies, primarily the US dollar, partially offset by interest expenses related to funding of the debt financed Catalent transaction. The effective tax rate for 2025 is still expected to be between 21% and 23%. The Capital expenditure is still expected to be around [DKK65 in] '25, reflecting expansion of the global supply chain.
諾和諾德預計淨財務項目將獲利約 9 億丹麥克朗。這主要受到對沖貨幣(主要是美元)的預期收益的推動,但部分被與債務融資 Catalent 交易相關的利息支出所抵消。預計2025年有效稅率仍將在21%至23%之間。預計資本支出仍將在 25 年達到 [65 丹麥克朗] 左右,反映出全球供應鏈的擴張。
In the coming years, the capital expenditure to sales ratio is still expected to be low double digits. Free cash flow is now expected to be DKK56 billion to DKK66 billion, reflecting the lower-than-expected sales growth mainly driven by lower volume growth of GLP-1 treatments in the US. All of the 2025 expectations are based on assumptions that the global and regional macroeconomic and political environment will not change significantly business conditions for Novo Nordisk during 2025 including changes in tariffs and duties. The announced tariffs currently in effect do not materially change our financial outlook for 2025. However, a potential expansion or increase of tariffs may have a negative impact on Novo Nordisk and our industry.
未來幾年,資本支出與銷售額之比預計仍將維持在低兩位數。目前預計自由現金流為 560 億丹麥克朗至 660 億丹麥克朗,反映銷售額成長低於預期,主因是美國 GLP-1 治療藥物銷售成長放緩。所有 2025 年的預期均基於以下假設:2025 年全球和區域宏觀經濟和政治環境不會顯著改變諾和諾德的經營狀況,包括關稅和關稅的變化。目前生效的已宣布關稅不會實質地改變我們對 2025 年的財務前景。然而,潛在的關稅擴大或增加可能會對諾和諾德和我們的行業產生負面影響。
That covers the outlook for 2025. Now, back to you, Lars.
這涵蓋了 2025 年的展望。現在,回到你身邊,拉爾斯。
Lars Fruergaard Joergensen - President, Chief Executive Officer
Lars Fruergaard Joergensen - President, Chief Executive Officer
Thank you, Karsten. Please turn to the final slide. The performance in the first three months of 2025 with 18% sales growth reflects that nearly 46 million people are now benefiting from our treatments. Further, we progressed our R&D pipeline, including completing the final pivotal trial for next-generation obesity treatment (inaudible). We have reduced our full year outlook due to lower-than-planned GLP-1 penetration, which is impacted by the rapid expansion of compounding in the US. I'm confident in our recent initiatives in the US to support patients to see the benefits of our (inaudible) treatments.
謝謝你,卡斯滕。請翻到最後一張投影片。2025 年頭三個月的銷售額成長了 18%,這表明目前已有近 4,600 萬人受益於我們的治療。此外,我們也推動了研發流程,包括完成下一代肥胖症治療的最後關鍵試驗(聽不清楚)。由於受到美國複合藥物快速擴張的影響,GLP-1 滲透率低於計劃,我們下調了全年預期。我對我們最近在美國採取的舉措充滿信心,這些舉措旨在幫助患者看到我們(聽不清楚)治療的益處。
Furthermore, the obesity opportunity remains large in international (inaudible) and look forward to reaching more patients with the additional rollout of Wegovy globally. At Novo Nordisk, we will continue to focus on commercial execution the progression of our R&D pipeline and expansion of our production capacity in the pursuit of treating more people living with (inaudible) diseases.
此外,國際上肥胖症治療機會仍然很大(聽不清楚),並期待隨著 Wegovy 在全球範圍內的進一步推廣,能夠惠及更多患者。在諾和諾德,我們將繼續專注於商業執行、研發管道的進展和生產能力的擴大,以期治療更多患有(聽不清楚)疾病的人。
With that, I would like to hand over the word to Jacob.
說完這些,我想把發言權交給雅各。
Jacob Rode - Head of Investor Relations
Jacob Rode - Head of Investor Relations
Thank you, Lars. And next slide, please. And with that, we are ready to take the Q&A. With that, operator, we are now ready to take the first question.
謝謝你,拉爾斯。請看下一張投影片。現在,我們準備開始問答環節。接線員,現在我們可以開始回答第一個問題了。
Operator
Operator
(Operator Instructions) Richard Vosser, JPMorgan.
(操作員指示)摩根大通的理查德·沃瑟。
Richard Vosser - Analyst
Richard Vosser - Analyst
Two, please. First one on the compounders in the US You've obviously done a partnership with HIMSS, but HIMMS themselves are suggesting that they will continue to personally compound and have a significant contribution to their business from personal compounding. That seems to be at odds with the partnership and an odds with your commentary of trying to reduce compounding and it being only allowed in rare circumstances. So could you just talk about how you expect that to go and how you expect to deal with that in the second half?
請給我兩份。首先是關於美國配藥商的問題,您顯然已經與 HIMSS 建立了合作關係,但 HIMMS 本身表示,他們將繼續進行個人配藥,並透過個人配藥為他們的業務做出重大貢獻。這似乎與合作關係相矛盾,也與您試圖減少複利且僅在極少數情況下才允許的評論相矛盾。那麼,您能否談談您對事情進展的預期以及您預計如何在下半年應對這一問題?
And then a second question, if I can, please. Just on the competitive effects from Mounjaro you're seeing on IO and how easy do you expect to be able to grow Ozempic once the supply constraints in IO are removed, how ready is the sales force? How confident are you on strong growth in IO?
如果可以的話,請問第二個問題。就您所看到的 Mounjaro 對 IO 產生的競爭影響而言,您認為一旦 IO 的供應限制消除,Ozempic 的增長會有多容易,銷售人員準備得如何?您對 IO 的強勁成長有多大信心?
Jacob Rode - Head of Investor Relations
Jacob Rode - Head of Investor Relations
Thanks a lot, Richard. Two questions for Dave and Mike, respectively. Let's start with the first question on compounding and next steps and hand it over to you, Dave.
非常感謝,理查德。分別向戴夫和麥克提出兩個問題。讓我們從複合和後續步驟的第一個問題開始,然後交給你,戴夫。
David Moore - Executive Vice President, US Operations
David Moore - Executive Vice President, US Operations
Thank you and thanks for the question, Richard. To be clear, we do not support a lawful compounding. We are against the illegal importation and the continuation of compounding in the United States. As you mentioned, we did announce collaborations with telehealth providers. The reason for this is increasingly people living with obesity are seeking health care through telehealth companies, that we need to be where patients are and to have an offering for the real Wegovy. These collaborations allow a link to Novocare Pharmacy, where the real Wegovy can be available through these telehealth companies.
謝謝,也謝謝你的提問,理查。需要明確的是,我們不支援合法複合。我們反對非法進口和繼續在美國複合。正如您所提到的,我們確實宣布與遠距醫療提供者合作。原因是越來越多的肥胖患者正在透過遠距醫療公司尋求醫療保健,我們需要在患者所在的地方提供服務,為真正的 Wegovy 提供服務。這些合作允許與 Novocare Pharmacy 建立聯繫,真正的 Wegovy 可以透過這些遠距醫療公司獲得。
As we've mentioned, on May 22, we fully expect the FDA to enforce the law. And at that time, we will continue to fight against unlawful compounding, for example, mass personalization. Thank you. Over to you, Mike.
正如我們所提到的,5 月 22 日,我們完全期待 FDA 能夠執行該法律。屆時,我們將繼續打擊非法複合,例如大規模個人化治療。謝謝。交給你了,麥克。
Maziar Doustdar - Executive Vice President - International Operations
Maziar Doustdar - Executive Vice President - International Operations
Thanks very much, Dave. Richard, I think to answer your question, I'll split it in between Ozempic and Wegovy. So we have Ozempic since 2019 in launch and now in 80 markets across IO. So a very decent footprint, I would say, in many, many countries. We have been launching Wegovy a bit due to the supply constraints, not at the speed we wanted to, also partially because we were servicing and maintaining, of course, the patients that were on Ozempic.
非常感謝,戴夫。理查德,我想回答你的問題,我會把它分成 Ozempic 和 Wegovy。因此,我們自 2019 年推出 Ozempic 以來,現已覆蓋印度 80 個市場。因此,我想說,這在很多國家都留下了非常顯著的足跡。由於供應限制,我們推出 Wegovy 的時間有點晚,沒有達到我們想要的速度,部分原因當然也是因為我們正在為使用 Ozempic 的患者提供服務和維護。
But now starting from this year, as the supply constraints are lifted. We have seen an acceleration like you would not have seen before. Just in the last couple of months, six new launches and more to come as we go forward. In terms of share number of prescriptions and volumes, if I just give you a couple of data points. We have currently 64% volume market share on injectable GLP-1, so on the back of Ozempic and Wegovy. And that 67% market share is rather stable. So it's not going down. And we, of course, hope to be able to continue fueling that with these so-called new launches as well as, of course, getting back to promoting Ozempic much more assertively than we have been during the constraint period.
但從今年開始,隨著供應限制的解除。我們看到了前所未有的加速。光是在過去的幾個月裡,我們就推出了六款新產品,未來還會推出更多產品。就處方數量和劑量份額而言,我只能給你幾個數據點。目前,我們在註射 GLP-1 市場的佔有率為 64%,這得益於 Ozempic 和 Wegovy。67%的市佔率相當穩定。所以它不會下降。當然,我們希望能夠透過這些所謂的新產品發布繼續推動這一進程,當然,也希望能夠比限制期間更加積極地推廣 Ozempic。
Jacob Rode - Head of Investor Relations
Jacob Rode - Head of Investor Relations
Thank you, Mike, and thank you, Dave. And also thank you to Richard. With that, we are ready for the next set of questions, please.
謝謝你,麥克,謝謝你,戴夫。同時也感謝理查德。這樣,我們就可以回答下一組問題了。
Operator
Operator
James Quigley, Goldman Sachs.
高盛的詹姆斯·奎格利。
James Quigley - Analyst
James Quigley - Analyst
So one on the guidance and one follow-up on the compounding pharmacy. So on the guidance, if we sort of assume a similar second quarter as in the first quarter, then the scenarios for progression in the second half are quite wide with around 8% growth bottom end and 22%, 23% growth at the upper end. So could you reconcile the potential outcomes? What are the most important variables there? And what are the key assumptions for both end of those variables?
因此,一個是關於指導,一個是關於複合藥房的後續。因此,根據指導,如果我們假設第二季度與第一季類似,那麼下半年的成長情境相當廣泛,最低成長約為 8%,最高成長約為 22% 或 23%。那麼你能調和潛在的結果嗎?其中最重要的變數是什麼?這些變數兩端的關鍵假設是什麼?
And secondly, on compounding. You mentioned there's having a significant impact, but have you got any more details of what the drag is on Wegovy market share? And have you done any surveys or how -- of what you think how many patients might drop off versus switch to branded and the branded switch to the Wegovy versus switching to appetite because you mentioned you have factored that into the guidance, just wondering how much that is baked into the guidance?
其次,關於複合。您提到這會產生重大影響,但您能否提供更多關於這對 Wegovy 市場份額造成拖累的詳細資訊?您是否做過任何調查,或者您認為有多少患者可能會放棄使用品牌藥物,而改用品牌藥物,以及有多少患者會改用 Wegovy,而不是改用食慾藥物,因為您提到您已經將這些因素納入了指導中,只是想知道這在多大程度上被納入了指導中?
Jacob Rode - Head of Investor Relations
Jacob Rode - Head of Investor Relations
Thanks a lot, James. And on the first one on guidance, we'll go to you, Karsten.
非常感謝,詹姆斯。關於指導的第一個問題,我們來談談你,卡斯滕 (Karsten)。
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Yes. Thank you, James, for that question. Yes, I think for the dynamics we see in our business, then -- we delivered 18% growth in the first quarter. And of course, our aim is to continue to drive attractive growth. And that entails increasing script trends in the US and continuing to drive our GLP-1 franchise in IO. So specifically, to the guidance ranges, this means in terms of the main drivers that a lot of patients on compounded products will go to branded products in the second half of this year, and we will be able to enable that through the cash channel and Novocare and the (inaudible) health collaborations.
是的。謝謝詹姆斯提出這個問題。是的,我認為就我們業務中看到的動態而言——我們在第一季實現了 18% 的成長。當然,我們的目標是繼續推動有吸引力的成長。這意味著要增加美國的劇本趨勢並繼續推動我們在印度洋的 GLP-1 特許經營。因此,具體來說,就指導範圍而言,就主要驅動因素而言,這意味著許多使用複合產品的患者將在今年下半年轉向品牌產品,我們將能夠透過現金管道和 Novocare 以及(聽不清楚)健康合作實現這一目標。
We also do have a label update with the MAS we spoke to before, classic commercial tactics and then, of course, the CVS collaboration. So the acceleration to deliver our guidance is mainly in the second half of the year when we talk about US while in international operations, we will see a continued step up over the coming quarters in terms of sales growth. So that takes us to kind of the basic fundamental of our guidance range.
我們也與之前談過的 MAS 進行了標籤更新,採用了經典的商業策略,當然還有與 CVS 的合作。因此,當我們談論美國時,實現我們指導的加速主要在下半年,而在國際業務中,我們將在未來幾季看到銷售成長的持續提升。因此,這便為我們提供了指導範圍的基本基礎。
And I would say on compounding specifically, given that the data quality on a number of patients on compounding is not very high. then it's based on market research, where we're looking at 1 million or more patients on compounded GLP-1 today. And then we've made estimates based on how many patients will either be able to benefit from the personalized exception or will drop off treatment. And as a consequence, the rest will go to a branded product.
我想特別說一下複合,因為許多患者的複合數據品質不是很高。然後它基於市場研究,我們目前研究的是使用複合 GLP-1 的 100 萬或更多患者。然後,我們根據有多少患者能夠從個人化例外中受益或放棄治療做出了估算。因此,剩餘的資金將用於品牌產品。
So a number of assumptions and -- but we have a lot of tactics in place to be able to to capture patients that will no longer be able to have a bulk compounded product with effect from the second half of this year given some patients will also have inventories in place personally and therefore, the second half comments. Thank you, James.
因此,有許多假設和——但是我們已經採取了很多策略來吸引那些從今年下半年開始將不再能夠獲得大宗複合產品的患者,因為一些患者也會有個人庫存,因此,下半年的評論。謝謝你,詹姆斯。
Jacob Rode - Head of Investor Relations
Jacob Rode - Head of Investor Relations
And I think that also covered part of question two. Anything to -- from you to add, Dave, on what we see currently in terms of magnitude of compounding potentially split on branded GLP-1 treatment as well?
我認為這也涵蓋了第二個問題的一部分。戴夫,您還有什麼要補充的嗎?就我們目前所看到的品牌 GLP-1 治療的複合幅度潛在分裂而言?
David Moore - Executive Vice President, US Operations
David Moore - Executive Vice President, US Operations
Yes. Thank you, Jacob. I will share that that the market research that Karsten mentioned also gives us an idea that certainly, semaglutide is overweight. We estimate 70% of compounding is of semaglutide. But I'd like you to focus on three things, three actions that we're taking to ensure that we're effective in this transition as compounding starts to wind down.
是的。謝謝你,雅各。我想分享的是,卡斯滕提到的市場研究也讓我們知道,司美格魯肽確實超重了。我們估計 70% 的複合藥物是司美格魯肽。但我希望你們專注於三件事,我們正在採取的三項行動,以確保在復合開始減弱時我們能夠有效地進行這一轉變。
Number one, we expand the cash offering. The [$499] via Novocare pharmacy was purposeful and planned at the time when compounding would start to diminish as well as the collaborations with telehealth companies. And soon, that cash offering will be available in all 9,000 CVS stores.
第一,我們擴大現金供應。透過 Novocare 藥局支付 [499 美元] 是有目的的,並且計劃在複方藥物開始減少以及與遠距醫療公司合作的時候進行。很快,所有 9,000 家 CVS 商店都將提供現金捐贈服務。
Number two, we continue to expand better coverage for Wegovy. This helps for some of those patients that may be on compounding that have insurance and would have access to Wegovy for a low co-pay.
第二,我們持續擴大Wegovy的覆蓋範圍。這對一些可能接受複合治療且擁有保險的患者有幫助,他們可以以較低的共付額使用 Wegovy。
And number three, as Karsten mentioned, we have targeted commercial efforts aimed at patients and health care practitioners so that we can focus on sema safety of real Wegovy versus compounding as well as the availability and the affordability.
第三,正如卡斯滕所提到的,我們已將商業努力瞄準患者和醫療保健從業者,以便我們能夠專注於真實 Wegovy 與複合藥物的安全性以及可用性和可負擔性。
Jacob Rode - Head of Investor Relations
Jacob Rode - Head of Investor Relations
Thanks a lot, Dave. And also, thanks to you, James. With that, we are ready for the next set of questions, please.
非常感謝,戴夫。另外,還要感謝你,詹姆斯。這樣,我們就可以回答下一組問題了。
Operator
Operator
Peter Verdult, BNP Paribas.
法國巴黎銀行的 Peter Verdult。
Peter Verdult - Analyst
Peter Verdult - Analyst
Pete here from BNP Paribas. Lars and Karsten, two quick ones. I suppose I'm still struggling just to understand where the disconnect has been with respect to your messaging given that February CMD in London about commercial execution being management's top priority and the prescription trends we've seen since then, especially when you have as you said, 40 million commercial lives where most patients apparently only have to pay $25 a month, to get access to Wegovy and you've been smashing it with DTC and reps. So is it really only about the compounders? Or do we have to consider your nearest branded competitor doing a better job?
我是法國巴黎銀行的皮特。拉爾斯和卡斯滕,兩個很快的人。我想我仍然很難理解您的訊息傳遞方面的脫節,因為 2 月在倫敦舉行的 CMD 會議上,管理層將商業執行作為首要任務,而我們從那時起就看到了處方趨勢,特別是當您說有 4000 萬個商業生命,其中大多數患者顯然只需每月支付 25 美元即可獲得 Wegovy 的使用權,而您一直在通過 DTC 和銷售代表。那麼這真的只與複合劑有關嗎?或者我們必須考慮您最近的品牌競爭對手做得更好嗎?
And then more quickly and secondly, just your thoughts on the recent (inaudible) diabetes data, especially given scalability doesn't seem to be an issue there.
然後更快地,其次,只是您對最近(聽不清楚)糖尿病數據的看法,特別是考慮到可擴展性似乎不是問題。
Jacob Rode - Head of Investor Relations
Jacob Rode - Head of Investor Relations
Thanks a lot, Pete. I think both of those go to you, Lars, but let's start with the first one on commercial execution as a priority.
非常感謝,皮特。拉爾斯,我想這兩個問題都該由你來解決,但我們首先要優先解決商業執行問題。
Lars Fruergaard Joergensen - President, Chief Executive Officer
Lars Fruergaard Joergensen - President, Chief Executive Officer
Yes. Thanks, Pete. You are right. This has been our focus for some time. But I think it's important to say that when you assess that based on script trends, it is really difficult as there is a significant share of the business turning into being compounded, and we estimate that that's a similar amount of business as what we have in the US on GLP-1. So I think Dave outlined our tactics, and we feel honestly very confident that we -- this is the right moment for us to make a serious change in the market. and that's baked into our guidance for the second half of the year.
是的。謝謝,皮特。你是對的。這一直是我們關注的重點。但我認為重要的是,當你根據腳本趨勢進行評估時,這確實很困難,因為有很大一部分業務變成了複合業務,我們估計這與我們在美國的 GLP-1 業務量相似。所以我認為戴夫概述了我們的策略,我們真的非常有信心——這是我們對市場進行重大改變的最佳時機。這已納入我們對今年下半年的期待。
I think also the point that CVS actually choose our brands without us paying for exclusivity is a sign that there is a very, very strong perception around Wegovy in the market. The added benefits we have on top of the real-world experienced weight loss is great, and that is just getting even better, assuming we get the mass indication as well. So what you get in one product here is just very, very attractive.
我認為 CVS 實際上選擇我們的品牌而不需要我們支付獨家經營權費用,這表明市場對 Wegovy 的認知度非常高。除了現實世界中減肥所經歷的額外好處之外,我們還獲得了很大的好處,而且如果我們也獲得了體重指示,那麼好處會變得更好。因此,您在這裡獲得的產品非常非常有吸引力。
In terms of (inaudible) I think there's been a lot of interest in how the oral category sales will develop. It's clear for us all along that we have the head start here. We have not pushed it as hard as we do now until we have ramped up manufacturing. We have seen significant scaling and efficiency step-up in our API facility in the US. And when we submit the data to FDA, you can assume that we have what it takes to do a full launch in the US. And then [mind], as was also alluded previously, this is a molecule with tremendous safety data. So more than 30 million patient lives.
就(聽不清楚)而言,我認為人們對口服類產品的銷售將如何發展很感興趣。我們一直都很清楚,我們在這裡處於領先地位。在提高生產能力之前,我們從未像現在這樣努力。我們已經看到美國 API 設施的規模和效率顯著提高。當我們將數據提交給 FDA 時,您可以認為我們有能力在美國全面推出該產品。然後 [請注意],正如之前提到的,這是一種具有大量安全資料的分子。超過 3000 萬患者的生命。
And I think we shouldn't be (inaudible) at that point as physicians and patients make choice on a trusted product and of course, efficacy is similar to what we have with Wegovy. So really Wegovy in a pill. I think it's a very attractive offering and assuming positive outcome with the agency we're ready to give this a big push. And also on this point, show a very strong commercial execution. So thank you, Pete, for that.
我認為我們不應該(聽不清楚),因為醫生和病人會選擇值得信賴的產品,當然,其功效與 Wegovy 相似。所以其實 Wegovy 就是一顆藥丸。我認為這是一個非常有吸引力的提議,並且假設與該機構取得積極成果,我們準備大力推動這一舉措。並且在這一點上,展現出非常強的商業執行力。所以謝謝你,皮特。
Jacob Rode - Head of Investor Relations
Jacob Rode - Head of Investor Relations
Thanks a lot, Lars. And thanks a lot, Pete as well. And with that, we are ready to the next set of questions, please.
非常感謝,拉爾斯。也非常感謝 Pete。現在,我們準備好回答下一組問題了。
Operator
Operator
Martin Parkhoi, SEB.
馬丁·帕克霍伊(Martin Parkhoi),SEB。
Martin Parkhoi - Analyst
Martin Parkhoi - Analyst
Martin Parkhoi, SEB. Just two questions, just last coming back to CBS again. Because one of the buzzwords that you have used for many years now is optionality. And I can understand that CVS is going for over when for the Wegovy, but do you think it's a win for patients in US to lose optionality and exclude another obesity product?
馬丁·帕克霍伊(Martin Parkhoi),SEB。只有兩個問題,最後再次回到 CBS。因為您多年來一直使用的流行詞之一就是可選性。我可以理解 CVS 正在為 Wegovy 付出代價,但您認為對於美國患者來說,失去選擇權並排除另一種減肥產品是一種勝利嗎?
Then secondly, also back to the all sema 25-milligram. I just understand that you said that you -- you have -- you can run with full steam when you launch. But what kind of opportunity do you see how big a part of the market would actually like to have the Wegovyin a pill instead of Wegovy as we know it today?
其次,也回到所有 sema 25 毫克。我只是明白你說過,當你發射時,你可以全力以赴。但是,您認為有什麼樣的機會?有多少市場實際上希望使用 Wegovyin 藥丸而不是我們今天所知的 Wegovy?
Jacob Rode - Head of Investor Relations
Jacob Rode - Head of Investor Relations
Great. Thanks a lot for those to, Martin. And I think again, both will go to you, Lars. So firstly, on the CVS one.
偉大的。非常感謝馬丁。我再次認為,兩者都將屬於你,拉爾斯。首先,關於 CVS。
Lars Fruergaard Joergensen - President, Chief Executive Officer
Lars Fruergaard Joergensen - President, Chief Executive Officer
Yes. So thank you, Martin, for the questions. You are right that we support optionality and open access to products. We believe it's in the best interest of patients and physicians that they can make the choice for the patient and the different patients have different needs, so we support that. So this is a situation where it's not a decision made by us. We have not made a, say, a bit on an exclusive contract, but it's a choice that CVS has made. We appreciate the partnership we have with CVS over many years.
是的。所以,馬丁,謝謝你提出這些問題。您說得對,我們支持產品的可選性和開放取用。我們相信,為患者做出選擇符合患者和醫生的最大利益,而且不同的患者有不同的需求,所以我們支持這一點。所以這種情況不是我們所做的決定。我們還沒有簽訂獨家合同,但這是 CVS 做出的選擇。我們感謝多年來與 CVS 的合作。
And as Dave also alluded to, is a partnership that now also includes our cash program in the 9,000 CVS outlets. So it's their choice. So it's not really something we have a say in. But of course, we do appreciate the perception about the product and what it can. And I think it talks to the real-world experience of Wegovy and of course, also for payer, what is the tangible value of reducing the risk of cardiovascular disease and hopefully also near term, say, the best mass profile you can think about. And getting all of that in one product is very, very attractive from a payer perspective.
正如戴夫所提到的,這種合作關係現在還包括我們在 9,000 家 CVS 門市的現金計劃。所以這是他們的選擇。所以這其實不是我們有權發言的事情。但當然,我們確實很欣賞大家對產品及其功能的評價。我認為這與 Wegovy 的實際體驗有關,當然,對於付款人來說,降低心血管疾病風險的實際價值是什麼,並且希望在短期內也能達到您能想到的最佳品質概況。從付款人的角度來看,將所有這些功能整合到一個產品中是非常有吸引力的。
In terms of the oral opportunity, I think it's important to true note that this is about competition within a category of those who prefer and all, we believe a majority of patients would still benefit the best from being on injectable therapy that's where you get typically efficacy. And also, we have learned over the past few years that weekly injection is actually very, very convenient. Having to deal with your disease once a week, in a very simple device solution is very convenient for patients. And I think physicians are nowadays very comfortable in prescribing injectable.
就口服藥物的機會而言,我認為必須真正注意到,這是關於那些喜歡藥物的人之間的競爭,我們相信大多數患者仍然會從注射療法中受益,而注射療法通常具有療效。而且,我們在過去幾年中了解到,每週注射其實非常非常方便。每週只需處理一次疾病,透過非常簡單的設備解決方案,患者會感到十分方便。我認為現在的醫生非常樂意開注射劑。
Having said that, there are patients who prefer and all, and we are pleased that we can compete very well in this segment, we believe will be way smaller than the Injectable segment. And being first to the market with a known molecule, known efficacy known safety and also a very -- some try to say that it's not as convenient. In our view, it is very convenient. You wake up in the morning, you take the tablet with some water and you're ready for your day. So we believe we can play very well in a smaller segment compared to the overall injectable category and will be first assuming a positive regulatory outcome.
話雖如此,還是有患者更喜歡這種藥物,我們很高興能夠在這一領域有很好的競爭力,我們相信這一領域將比注射劑領域小得多。作為第一個將已知分子、已知功效、已知安全性以及非常——有些人試圖說它不那麼方便——推向市場。我們認為這非常方便。早上醒來,用水送服藥片,就可以開始新的一天了。因此,我們相信,與整體注射劑類別相比,我們可以在較小的細分市場中發揮良好的作用,並且首先假設積極的監管結果。
Jacob Rode - Head of Investor Relations
Jacob Rode - Head of Investor Relations
Thank you, Lars, and thank you, Martin. And then we're next question, please.
謝謝你,拉爾斯,謝謝你,馬丁。那我們來問下一個問題。
Operator
Operator
Michael Nedelcovych, TD Cowen.
邁克爾·內德爾科維奇,TD·考恩。
Michael Nedelcovych - Analyst
Michael Nedelcovych - Analyst
I have two. My first relates to potential political risk. The current administration in the US has, at times, singled out GLP-1s when it raises the issue of apparent price disparities between the US and other countries Novo is presumably deep into negotiations with CMS about the IRA price discount for semaglutide starting in 2027. Do you sense any risk that the administration plans to take this as an opportunity to make an example of GLP-1s and demand a particularly severe price cut? That's my first question.
我有兩個。我的第一個想法與潛在的政治風險有關。當美國現任政府提出美國與其他國家之間明顯的價格差異問題時,有時會單獨提到 GLP-1。 Novo 可能正在與 CMS 就從 2027 年開始的司美格魯肽 IRA 價格折扣進行深入談判。您是否感覺到政府計劃藉此機會以 GLP-1 為例並要求大幅降價?這是我的第一個問題。
And then my second question relates to the pipeline and specifically in (inaudible) I believe Novo has been in discussion with the FDA about Phase 3 planning for an obesity trial, but the R&D milestone slide does not include a trial start in 2025. Can you tell us whether a Phase 3 trial for (inaudible) could yet start this year? And when a Phase 3 obesity trial does start has a decision been made as to whether the oral or subcutaneous formulation would be advanced first?
然後我的第二個問題與管道有關,具體來說(聽不清楚)我相信 Novo 一直在與 FDA 討論肥胖試驗的 3 期計劃,但研發里程碑幻燈片並不包括 2025 年開始的試驗。您能否告訴我們(聽不清楚)的第三階段試驗是否可以在今年開始?當第三階段肥胖試驗開始時,是否已經決定先採用口服製劑或皮下製劑?
Jacob Rode - Head of Investor Relations
Jacob Rode - Head of Investor Relations
Thanks a lot for those too, Mike. Again, I think for the first one, we'll go to you, Lars, on GLP-1 price negotiations.
我也非常感謝你,麥克。再次,我認為首先,我們會和你,拉爾斯,討論 GLP-1 價格談判。
Lars Fruergaard Joergensen - President, Chief Executive Officer
Lars Fruergaard Joergensen - President, Chief Executive Officer
Thank you, Michael. So when you look at it, if you take -- Wegovy first, we have very limited Wegovy exposure in Medicare so far. And if you take some of the others, say, overall governmental-funded channels like VA and Medicaid, those are channels with somewhat lower price point. And I think more comparable to what we see in the geographies. If you look at Ozempic, obviously, there's a bigger share of business in Medicare. And that's then what's being discussed under the IRA. And I cannot go into specifics around it because it's still relatively early days. But I think there is an established, say, mechanism in dealing with that.
謝謝你,麥可。因此,當您查看它時,如果您首先考慮 Wegovy,那麼到目前為止,我們在醫療保險中使用 Wegovy 的機會非常有限。如果你考慮其他一些管道,例如 VA 和 Medicaid 等整體政府資助管道,這些管道的價格會稍微低一些。我認為這與我們在地理上看到的更有可比性。如果你看一下 Ozempic,顯然它在醫療保險領域的業務份額更大。這就是愛爾蘭共和軍正在討論的內容。我無法透露具體細節,因為現在還處於早期階段。但我認為,已經有一個既定的機制來處理這個問題。
So I would actually say from an overall political risk point of view, I have to think we're in a good spot because our book of business pricing exposure is either lower or is already in ongoing price negotiations compared to perhaps other products that sit in parts of Medicare with higher price point or has not yet been opened up for negotiation. So I see relative limited, say, additional risk compared to what we're already facing. Having said that, it is still early days in an ongoing process.
因此,我實際上想說,從整體政治風險的角度來看,我認為我們處於一個良好的位置,因為與醫療保險中價格較高或尚未開放談判的其他產品相比,我們的業務定價風險要么較低,要么已經處於持續的價格談判中。因此,與我們已經面臨的風險相比,我認為額外的風險相對有限。話雖如此,但這一進程仍處於早期階段。
Jacob Rode - Head of Investor Relations
Jacob Rode - Head of Investor Relations
Thanks for that, Lars. And for the second one on (inaudible), we will hand it over to you, Martin.
謝謝你,拉爾斯。關於第二個問題(聽不清楚),我們將把它交給你,馬丁。
Martin Lange - Executive Vice President - Development
Martin Lange - Executive Vice President - Development
Yes. Thank you very much for the question. So not a lot of new to add from last quarter. As you know, the process is to submit an end of Phase 2 package specifically to the FDA, but also through other regulatory authorities. We are in that process and respect an outcome within the next couple of months, then we will know -- and this is what we plan for this is what we expect if we can progress into Phase 3. And that Phase 3 program will be initiated with current timelines in Q1 of next year. And the focus for the Phase 3 program will be both oral and injectable.
是的。非常感謝您的提問。因此與上一季相比,沒有太多新內容可以添加。如您所知,該流程是專門向 FDA 提交第二階段結束方案,同時也透過其他監管機構提交。我們正處於這個過程中,並期待在未來幾個月內得到結果,然後我們就會知道——這就是我們的計劃,也是我們期望的,如果我們能夠進入第三階段。第三階段計劃將於明年第一季按照當前時間表啟動。第三階段計劃的重點將是口服和注射。
Jacob Rode - Head of Investor Relations
Jacob Rode - Head of Investor Relations
Thank you, Martin, and thank you, Mike, and then we are ready to take the next set of questions, please.
謝謝馬丁,謝謝麥克,然後我們準備回答下一組問題。
Operator
Operator
Sachin Jain, Bank of America.
美國銀行的薩欽‧賈恩 (Sachin Jain)。
Sachin Jain - Analyst
Sachin Jain - Analyst
I'm just going to try and push Karsten and Dave to topics, if I may, there's any more color you're willing to give. So firstly, on the compounded smart of patient funnel, Karsten, if you could just give us any color as to what you're seeing for the inventory in the system. We've heard estimates as anywhere between 3 and 12 months. And then any color on what percentage you expect to shift to branded given that there on compound because they can't afford it or it's not covered.
我只是想嘗試推動 Karsten 和 Dave 討論主題,如果可以的話,您還可以提供更多資訊。首先,關於患者漏斗的複合智能,Karsten,您能否向我們介紹您在系統中看到的庫存情況。我們聽到的估計是3到12個月之間。然後,您預計有多少比例的人會轉向品牌,因為他們買不起或沒有覆蓋到化合物。
And then I'm going to be provocative on the branded capture. Some of what we hear is as these patients come off compounded Sema, cash patients may prefer Lilly given a cheaper syringe vial strategy and (inaudible) perception and efficacy safety is beginning to edge with Wegovy. So I know that's provocative, but I wonder you could just touch on that.
然後我將對品牌捕獲採取挑釁態度。我們聽到的一些消息是,隨著這些患者停止服用複方 Sema,現金患者可能更喜歡 Lilly,因為它有更便宜的注射器瓶策略,並且(聽不清楚)感知和功效安全性開始與 Wegovy 接軌。我知道這很具有挑釁性,但我想知道您是否可以談談這一點。
And then finally, a lot of what we've discussed has been the obesity market, but I wonder if you could touch on Ozempic. I'd assume limited compounding impact, markets slowing down, you're losing share from Mounjaro. So it's not exactly clear to me what changes that second half.
最後,我們討論的很多內容都是關於肥胖市場,但我想知道您是否可以談談 Ozempic。我認為複合影響有限,市場放緩,你正在失去蒙扎羅的市場份額。所以我不太清楚後半部會發生什麼變化。
Jacob Rode - Head of Investor Relations
Jacob Rode - Head of Investor Relations
Thank you, Sachin, for those two questions. On the first one compound, we'll hand it to Karsten, and then we'll hand over to David, anything to add before Dave goes on to the second question on Ozempic. But firstly, over to you, Karsten.
謝謝 Sachin 提出這兩個問題。關於第一個化合物,我們會將其交給 Karsten,然後我們會將其交給 David,在 Dave 繼續回答有關 Ozempic 的第二個問題之前,我們還有什麼要補充的嗎?但首先,交給你了,卡斯滕。
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Thanks, Sachin. And I wish I could give you like ratio sharp data points based on high-quality market data. But this is a fairly young segment in terms of data and market research. So you're correct that that within TeleHealth, the setup is more towards a subscription basis on three, six, nine, even 12 months. where patients get the incentive through a lower subscription rate if they sign up for a longer period of time.
謝謝,薩欽。我希望能夠根據高品質的市場數據為您提供類似比率的清晰數據點。但從數據和市場研究的角度來看,這是一個相當年輕的領域。所以您說得對,在 TeleHealth 中,設定更傾向於按三月、六月、九月甚至十二個月進行訂閱。如果患者註冊的時間較長,則可以享受較低的訂閱費率作為獎勵。
So yes, most likely, there will be some patients sitting within inventory on May 22, we don't have really good data on that, but that's also why we're cautioning in our outlook section of our company announcement that the market should expect a step up mainly in the second half of this year from compounding and of course, the CVS contract.
所以是的,很有可能,5 月 22 日會有一些患者坐在庫存中,我們對此沒有很好的數據,但這也是為什麼我們在公司公告的展望部分中警告說,市場應該預期今年下半年主要由於復合和 CVS 合約而出現上漲。
As to brand and drop off to different solutions, price sensitivity, et cetera. I'll hand that over to Dave on the in-market understanding of that one. Over to you, Dave.
至於品牌和不同解決方案的放棄、價格敏感度等等。我將把對此市場的理解交給戴夫。交給你了,戴夫。
David Moore - Executive Vice President, US Operations
David Moore - Executive Vice President, US Operations
Thank you, Karsten. We believe the strong label Wegovy as well as the brand awareness of Wegovy. And the fact that the sema compounded is overweight. We think that there is certainly a focus with health care practitioners to maintain that continuity of care. And what we've heard is the availability branded would Wegovy through these new channels, meeting the patients where they are is a very important step in terms of that transition and the funneling of patients. As Karsten mentioned, of the total number of compounded patients today, some will drop off. But certainly, as you mentioned in our guidance, we do expect to capture and see a real interest in patients coming over to the real Wegovy.
謝謝你,卡斯滕。我們相信Wegovy這個強大的品牌以及Wegovy的品牌知名度。而事實上訊號複合已經超重。我們認為,醫療保健從業者肯定會專注於保持照護的連續性。我們聽說,透過這些新管道,Wegovy 品牌的可用性,以及與患者見面,對於這種轉變和患者的匯集而言,是一個非常重要的一步。正如卡斯滕所提到的,在今天的複合患者總數中,有些人會減少。但當然,正如您在我們的指南中提到的那樣,我們確實希望吸引並看到患者對真正的 Wegovy 產生真正的興趣。
And then I'll shift over to Ozempic, Sachin. As we're seeing this year so far, the growth of the GLP-1 class, it does continue. It's lower than what we've seen in years past at 15%, but that still leaves plenty of opportunities still runway for future growth. And this continues to be a game around NBRx and our commercial leverage. So here are the things that we're focused on in the US with Ozempic.
然後我將轉到 Ozempic,Sachin。正如我們今年迄今所看到的,GLP-1 類藥物的成長確實在持續。這一比例低於過去幾年的 15%,但仍為未來的成長留下了大量機會。這仍然是一場圍繞 NBRx 和我們的商業槓桿的遊戲。以下是我們在美國推廣 Ozempic 時重點關注的事項。
First of all, our overarching commercial focus is leveraging the Ozempic label, the broadest of any GLP-1 label in the market and continues to be the most widely known GLP-1 as well. Our commercial efforts during this year include the launch of a new campaign called the Ozempic era campaign we are in the Ozempic era, and our patients are experiencing that and the understanding of the broad label is something that now both patients as well as physicians understand. And then lastly, we continue to focus on decreasing the outflow, meaning maintaining longer stay time and having patients have the full effect in getting to the 2-milligram dose.
首先,我們整體的商業重點是利用 Ozempic 標籤,這是市場上所有 GLP-1 標籤中最廣泛的,並且仍然是最廣為人知的 GLP-1。我們今年的商業努力包括發起一項名為「Ozempic 時代」的新活動,我們正處於 Ozempic 時代,我們的患者正在經歷這一時代,現在患者和醫生都對廣泛標籤有了更深的理解。最後,我們繼續致力於減少流出量,這意味著保持更長的停留時間並讓患者充分接受 2 毫克劑量。
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
And just building on Dave's comment before we hand it back to Jacob then for Ozempic. Also, our market research indicates a certain level of compounding, not a lot, but but potentially in the mid-single digits of GLP-1 diabetes treatment in the US after May 22, there might also be an uplift there to go for and benefit for with the tactics Dave just covered. Over to you, Jacob.
在我們將其交還給 Jacob 並討論 Ozempic 之前,我們先根據 Dave 的評論進行討論。此外,我們的市場研究表明,5 月 22 日之後,美國 GLP-1 糖尿病治療的複合增長率可能達到一定水平,雖然不是很多,但可能會達到中等個位數,採用 Dave 剛才介紹的策略,也可能會有一個提升,並從中受益。交給你了,雅各。
Jacob Rode - Head of Investor Relations
Jacob Rode - Head of Investor Relations
Thank you, Karsten. And with that, I think we are ready for the final set of questions, please.
謝謝你,卡斯滕。好了,我想我們已經準備好回答最後一組問題了。
Operator
Operator
Jo Walton, UBS.
瑞銀的喬沃爾頓。
Jo Walton - Analyst
Jo Walton - Analyst
You've talked a lot about pricing and your strong commercial focus. Could you give us an idea of what you think a typical price point would be for a compounded semaglutide? And how far a drift that is of the $500 that you're charging? The reason that I ask is I assume that this is a price-sensitive market. And yet the starter dose from your competitor is only $350. And I wonder whether people just can't move step-up from whatever they're paying today, up to that $500 and the $350 is a very compelling starting point for the compounder.
您談了很多關於定價和強大的商業重點的問題。您能否告訴我們,您認為複合司美格魯肽的典型價格是多少?這與您所收取的 500 美元相差多少?我之所以問這個問題,是因為我認為這是一個對價格敏感的市場。然而,您的競爭對手的起始劑量僅為 350 美元。我想知道人們是否無法將他們今天支付的費用提高到 500 美元,而 350 美元對於複合利率來說是一個非常有吸引力的起點。
Could I also just ask if you could tell us what the average stay time is now that you've got less of a supply constraint, whether you're seeing that obesity stay time get longer or whether you're still having to reacquire patients every few months. And if nobody minds, I'd also just like to take this opportunity to let people know that after 40 years as an analyst, this is my last purely pharma sulfide call.
我能否再問一下,您能否告訴我們,現在供應限制已經減少,平均住院時間是多少,您是否看到肥胖患者的住院時間變得更長,或者您是否仍然需要每隔幾個月重新接收患者。如果沒有人介意的話,我還想藉此機會讓人們知道,在擔任分析師 40 年後,這是我最後一次純粹從事製藥硫化物方面的工作。
Novo was one of the first companies outside of the UK that I covered back before the merger of Novo and to Nordisk. So I really am that old. But it will soon be time for me to move on. I have a couple of projects I need to complete before I leave the UBS team fully in Matthew's very capable hands. But I want to say it's been an enormous privilege to watch the development of many life cycles of drugs and to work with so many people in Novo and other companies, clients and competitors, many of whom I'm very proud to count friends.
Novo 是 Novo 與 Nordisk 合併之前我報道的第一批英國以外的公司之一。原來我真的有那麼老了。但我很快就要繼續前進了。在我將瑞銀團隊完全交給馬修(Matthew)之前,我還有幾個項目要完成。但我想說,能夠見證多種藥物生命週期的發展,並與 Novo 和其他公司的眾多人、客戶和競爭對手一起工作,我感到非常榮幸,我很自豪地將他們中的許多人視為朋友。
Jacob Rode - Head of Investor Relations
Jacob Rode - Head of Investor Relations
Thanks a lot, Jo. And first and foremost, from Team Novo -- congratulations on a very impressive career. On your two questions, let's move to Dave first of all, on GLP-1 pricing for the real Wegovy as well as for compounded ones and then on (inaudible).
非常感謝,喬。首先,代表 Team Novo 祝賀您取得如此輝煌的職業生涯。關於你的兩個問題,我們首先請 Dave 談談 GLP-1 對實際 Wegovy 和複合劑量的定價,然後(聽不清楚)。
David Moore - Executive Vice President, US Operations
David Moore - Executive Vice President, US Operations
Yes. Thank you for the question. And also congratulations to you. There is a range of prices that we hear in the marketplace. And it really does depend on whether or not that is a bundled price with a telehealth company. In terms of offering their telehealth services as well as medicine. As you pointed out, it is less over the compounded GLP-1 than what we're seeing in terms of the cash prices, no question.
是的。謝謝你的提問。也祝賀你。我們在市場上聽到的價格範圍是多種多樣的。這確實取決於這是否是與遠距醫療公司捆綁的價格。在提供遠距醫療服務和醫療方面。正如您所指出的,毫無疑問,複合 GLP-1 的價格低於我們所看到的現金價格。
When we think about the funnel and when we talked about the guidance and expectations, as Karsten mentioned, certainly, we do expect some patients not to transition, meaning they may be on a compounded GLP-1 and they may not transition over to a branded medication. One of the things that's important for us, though, is to ensure that we are educating around the availability of Wegovy through commercial insurance.
當我們考慮漏斗並談論指導和期望時,正如 Karsten 提到的那樣,我們確實預計一些患者不會轉變,這意味著他們可能正在使用複合 GLP-1,並且可能不會轉向品牌藥物。不過,對我們來說,重要的一件事是確保我們透過商業保險來普及 Wegovy 的可用性。
We have over 55 million Americans that have coverage for Wegovy, where they would receive the medicine for a low branded copay. And what we've learned is many patients on compounded GLP-1 do have insurance. So educating them, doing insurance verification as part of our commercial efforts is also important. And then to answer your question on State time, the current 12-month average stay time is around 7.4 months. That continues to increase as the brand grows and more and more patients continue with their therapy over time. Thank you.
我們有超過 5500 萬美國人擁有 Wegovy 的保險,他們可以以較低的品牌自付費用獲得藥物。我們了解到,許多服用複合 GLP-1 的患者確實有保險。因此,對他們進行教育、進行保險驗證作為我們商業努力的一部分也很重要。然後回答您關於國家時間的問題,目前 12 個月的平均停留時間約為 7.4 個月。隨著品牌的發展和越來越多的患者繼續接受治療,這一數字還在不斷增長。謝謝。
Jacob Rode - Head of Investor Relations
Jacob Rode - Head of Investor Relations
Thank you, Dave, and thank you, Jo. And with that, we are done with the Q&A, please, and I'll hand it over to Lars for a set of final remarks.
謝謝你,戴夫,謝謝你,喬。我們的問答環節到此結束,我將把時間交給拉爾斯進行最後的演講。
Lars Fruergaard Joergensen - President, Chief Executive Officer
Lars Fruergaard Joergensen - President, Chief Executive Officer
Yes. Thank you Jacob. We delivered 18% growth in the first quarter, driven by our innovative treatments. And we had to lower our guidance for the year because of how big compounding has been of semaglutide. I hope you feel we have a clear plan for how to counter that, close that down and really use our commercial taxes outlined today to gain a fair share of those patients. We remain very confident in the market opportunity the number of people with obesity willing and interested in seeking care.
是的。謝謝你,雅各。在創新療法的推動下,我們在第一季實現了 18% 的成長。由於司美格魯肽的複合效應太強,我們不得不降低今年的指導價。我希望您覺得我們有一個明確的計劃,如何應對這種情況,關閉這種情況,並真正使用我們今天概述的商業稅來獲得這些患者的公平份額。我們仍然對市場機會充滿信心,因為有許多肥胖患者願意並有興趣尋求治療。
And as we scale capacity and progress with our R&D pipeline, not least oral sema 25-milligram and I would also say, upcoming data for CagriSema, we feel really excited about our opportunity in this space. So I'll close with that and also thank Jo and wish you best of luck for the future. And thank you all for participating in this call. Thank you. Bye-bye.
隨著我們擴大產能並推進研發管線,尤其是口服 25 毫克 sema,還有即將發布的 CagriSema 數據,我們對這一領域的機會感到非常興奮。最後,我要感謝喬,並祝福你未來一切順利。感謝大家參加本次電話會議。謝謝。再見。
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。