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Operator
Operator
Good day and thank you for standing by. Welcome to the Q4 2025 Novo Nordisk earnings conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there'll be a question-and-answer session. (Operator Instructions) Please be advised that today's conference is being recorded.
您好,感謝您的耐心等待。歡迎參加諾和諾德2025年第四季財報電話會議。目前,所有參與者均處於只聽模式。演講結束後,將進行問答環節。(操作人員指示)請注意,今天的會議正在錄音。
I would now like to turn the conference over to your first speaker today, Michael Novod, Head of Investment Relations.
現在我謹將會議交給今天的第一位發言人,投資關係主管麥可‧諾沃德。
Michael Novod - Head of Investor Relation
Michael Novod - Head of Investor Relation
Thank you very much, and welcome to this Novo Nordisk Earnings call for the full year of 2025. My name is Michael Novod. I'm the Head of Investor Relations at Novo Nordisk. With me today, I have CEO of Novo Nordisk, Maziar Doustdar; EVP, Product and Portfolio Strategy, Ludovic Helfgott; EVP, U.S. Operations, David Moore; EVP, Research and Development and Chief Scientific Officer; Martin Holst Lange; and Chief Financial Officer, Karsten Knudsen.
非常感謝,歡迎參加諾和諾德2025年全年業績電話會議。我的名字是麥可諾沃德。我是諾和諾德公司的投資人關係主管。今天陪同我出席的有:諾和諾德執行長 Maziar Doustdar;產品與組合策略執行副總裁 Ludovic Helfgott;美國營運執行副總裁 David Moore;研發執行副總裁兼首席科學官 Martin Holst Lange;以及財務長 Karsten Knudsen。
All speakers will be available for the Q&A session. Today's call is being webcast live, and a recording will be made available on our website. The call is scheduled to last 1 hour.
所有發言者都將參加問答環節。今天的電話會議將進行網路直播,錄影將在我們的網站上提供。通話預計持續1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. Next slide, please. We need to advise you that this call will contain forward-looking statements. These are subject to risks and uncertainties that could cause actual results to differ materially from expectations. For further information on the risk factors, please see the company announcement for the full year 2025 and the slides prepared for this presentation.
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採用固定匯率。請看下一張投影片。我們需要告知您,本次電話會議將包含前瞻性陳述。這些都存在風險和不確定性,可能導致實際結果與預期結果有重大差異。有關風險因素的更多信息,請參閱公司 2025 年全年公告和為本次演示準備的幻燈片。
With that, over to you, Mike, for an update on our strategic aspirations.
接下來,請麥克介紹我們的策略目標。
Unidentified Company Representative
Unidentified Company Representative
Thank you, Michael. Next slide, please. In 2025, Novo Nordisk delivered 10% sales growth and operating profit growth of 6%. We sharpened our strategic focus in 2025, doubling down in our core therapeutical areas of obesity and diabetes. This year, marks the conclusion of the 2025 strategic aspirations that were established back in 2019.
謝謝你,麥可。請看下一張投影片。2025年,諾和諾德實現了10%的銷售額成長和6%的營業利潤成長。2025 年,我們進一步明確了策略重點,加倍投入肥胖症和糖尿病等核心治療領域。今年標誌著2019年制定的2025年策略願景的完成。
Since then, we have more than doubled our sales and operating profit and our Obesity care sales have increased from DKK6 billion in 2019 to DKK82 billion in 2025. Rare disease is now positioned for sustained growth with the late-stage pipeline assets (inaudible), now called the Cinemex and Italo Piaba. Furthermore, over DKK 300 billion has been returned to our shareholders since 2019. Most importantly, we have increased our reach by an additional 16 million people with our obesity and diabetes treatments.
自那時以來,我們的銷售額和營業利潤翻了一番多,肥胖症護理銷售額從 2019 年的 60 億丹麥克朗增加到 2025 年的 820 億丹麥克朗。罕見疾病領域目前憑藉後期研發管線資產(聽不清楚),即現在的 Cinemex 和 Italo Piaba,正處於持續成長的階段。此外,自 2019 年以來,我們已向股東返還了超過 3,000 億丹麥克朗。最重要的是,我們的肥胖症和糖尿病治療方案已惠及額外 1,600 萬人。
This quarter, we saw several exciting readouts, including the next-generation treatment for type two diabetes with the Phase II readout of zenagamatide and Phase III readout for CagriSema.
本季度,我們看到了幾個令人興奮的結果,包括下一代二型糖尿病治療藥物 zenagamatide 的 II 期結果和 CagriSema 的 III 期結果。
Novo Nordisk also continued to build upon its pipeline across therapy areas. Martin will discuss this in more detail later in the call. By late 2025, we received FDA approval for the Wegovy pill, the first oral GLP-1 for obesity and submitted CagriSema in the U.S.
諾和諾德也持續拓展在各治療領域的研發管線。馬丁將在稍後的通話中更詳細地討論這個問題。到 2025 年底,我們獲得了 FDA 對 Wegovy 藥丸的批准,這是第一個用於治療肥胖症的口服 GLP-1 藥物,並在美國提交了 CagriSema 申請。
Dave will speak more to the Wegovy pill later, but we are encouraged by the early uptake of the pill and what we see these milestones would mean for people living with obesity. We are treating nearly 46 million people with our innovative medicines, reflecting Novo Nordisk commitment to innovation and the ongoing efforts to expand access to our therapies worldwide.
Dave 稍後會更詳細地談談 Wegovy 藥丸,但我們對這種藥丸的早期普及感到鼓舞,也看到了這些里程碑對肥胖症患者的意義。我們正在用我們的創新藥物治療近 4600 萬患者,這體現了諾和諾德對創新的承諾以及為在全球範圍內擴大我們療法的可及性而不斷做出的努力。
Finally, Karsten will come back to it, but we have released our 2026 guidance. which reflects a year of pricing headwinds. We do not take this lightly, and we will do all we can to pursue the volume opportunities in obesity and diabetes. Next slide, please.
最後,卡斯滕還會再談到這個問題,但我們已經發布了2026年的業績指引,其中反映了2026年價格方面面臨的不利因素。我們對此高度重視,並將盡一切努力抓住肥胖症和糖尿病領域的銷售機會。請看下一張投影片。
Yesterday, we also announced changes to the executive management team. Dave Moore has decided to leave Novo Nordisk for personal reasons after more than 8 years with the company. Dave began his Novo journey in 2017 and returned to Novo in 2022 after time outside of the company to lead our global business development area before returning to the U.S. as the Executive Vice President of the U.S. operations in January of 2025. Dave has moved the needle throughout his time at Novo from driving the blockbuster launch of Ozempic through leading the acquisition of 3 Kaplan manufacturing sites to overseeing the launch of the Vigobipill in the U.S.
昨天,我們也宣布了高階主管團隊的變動。在諾和諾德公司工作超過 8 年後,戴夫·摩爾因個人因素決定離開該公司。Dave 於 2017 年加入 Novo,並在離開公司一段時間後於 2022 年重返 Novo,領導我們的全球業務發展領域,之後於 2025 年 1 月回到美國,擔任美國業務執行副總裁。Dave 在 Novo 工作期間取得了顯著成就,從推動 Ozempic 的重磅上市,到領導收購 Kaplan 的 3 個生產基地,再到監督 Vigobipill 在美國的上市。
In addition, (inaudible) has decided to leave Novo Nordisk to pursue new opportunities. Ludo joined Novo Nordisk back in 2019 to lead what was back then called biopharm business and eventually became our rare disease therapy area. Ludovic's patient-first leadership is reflected in Novo Nordisk's strong presence in rare blood and endocrine disorders today. Ludovic was able to translate this passion across all of our therapy areas over the last 10 months as the Head of Product and portfolio strategy.
此外,(聽不清楚)已決定離開諾和諾德公司尋求新的發展機會。Ludo 於 2019 年加入諾和諾德,領導當時被稱為生物製藥業務的部門,該部門最終發展成為我們的罕見疾病治療領域。盧多維克以患者為中心的領導理念體現在諾和諾德如今在罕見血液和內分泌疾病領域的強大影響力上。在過去 10 個月擔任產品和產品組合策略負責人期間,Ludovic 將這種熱情傳遞到了我們所有的治療領域。
On behalf of Novo Nordisk and myself, I would like to thank Dave and Ludovic for their bold and steady leadership. After a thoughtful selection process over the last few months, I'm very pleased to announce the addition of Jamie Miller and Hong Chow to Novo Nordisk and the executive management team.
我謹代表諾和諾德公司和我本人,感謝戴夫和盧多維克展現出的果敢而穩健的領導能力。經過幾個月的深思熟慮的遴選過程,我非常高興地宣布 Jamie Miller 和 Hong Chow 加入諾和諾德及其執行管理團隊。
Next slide, please. Starting February 5, Jamie Miller joins Novo Nordisk as an Executive Vice President of U.S. Operations. Jamie brings more than 30 years of extensive leadership experience in the pharmaceutical industry with proven track record in launching major therapies and shaping commercial strategy.
請看下一張投影片。自 2 月 5 日起,Jamie Miller 加入諾和諾德公司,擔任美國營運執行副總裁。Jamie 在製藥業擁有超過 30 年的豐富領導經驗,在推出重大療法和製定商業策略方面擁有良好的業績記錄。
He joins us from UnitedHealth Group, where he served as the CEO of Optum Specialty Holdings and brings deep expertise in U.S. market access and product life cycle management. Beginning February 15, Hong Chow will join Novo Nordisk as an Executive Vice President of Product and Portfolio Strategy.
他先前在聯合健康集團擔任Optum Specialty Holdings的首席執行官,擁有豐富的美國市場准入和產品生命週期管理經驗。自2月15日起,洪週將加入諾和諾德公司,擔任產品與產品組合策略執行副總裁。
Hong brings deep global leadership experience to Novo Nordisk serving as the Executive Vice President and Head of China and International at Merck Healthcare and leading their global cardiovascular metabolism and endocrine portfolio. Her leadership in advancing innovation, health equity and large-scale product strategies at companies such as Merck, Roche and Bayer demonstrates her outstanding capability to drive our vision forward.
洪先生擁有豐富的全球領導經驗,曾任默克醫療保健公司執行副總裁兼中國及國際業務負責人,領導其全球心血管代謝和內分泌產品組合。她在默克、羅氏和拜耳等公司推動創新、健康公平和大規模產品策略的領導力,證明了她有能力推動我們的願景向前發展。
We look forward to welcoming Jamie and Hung to over notice this month, and both Dave and Ludo will help to ensure successful transition to their successors throughout the end of this quarter. I will now hand over to Ludo for an update on our commercial execution in 2025.
我們期待本月 Jamie 和 Hung 的到來,Dave 和 Ludo 也將在本季末協助確保順利過渡到他們的繼任者。現在我將把發言權交給 Ludo,讓他為我們 2025 年的商業執行做個報告。
Ludovic Helfgott - Executive Vice President - Rare Disease
Ludovic Helfgott - Executive Vice President - Rare Disease
Thank you, Mike, and please turn to next slide. The global GLP-1 market grew over 30% in 2025. Novo Nordisk's total sales increased by 10% as U.S. operations grew 8% and international operations grew 14%. Sales growth was positively impacted by one-offs in the U.S.
謝謝你,麥克,請翻到下一張投影片。2025年全球GLP-1市場成長超過30%。諾和諾德的總銷售額成長了 10%,其中美國業務成長了 8%,國際業務成長了 14%。美國的一些一次性交易對銷售成長產生了積極影響。
Our GLP-1 sales in diabetes increased by 6%, driven by U.S. operations, plus 5%, and international operations growing 7%. Insulin sales decreased by 1%. U.S. operations increased by 2%, positively impacted by positive channel and payer mix and partially countered by a decline in volume.
我們的 GLP-1 在糖尿病領域的銷售額成長了 6%,其中美國業務成長了 5%,國際業務成長了 7%。胰島素銷量下降了1%。美國業務成長了 2%,這得益於通路和支付方組合的積極變化,但部分被銷量下降所抵消。
International operations decreased by 2%, impacted by market share losses. Obesity care sales increased 31% in 2025, driven by both operating units. U.S. operations grew 15%, and IO grew 73%. In both geographies, growth was driven by Wegovy.
受市佔率損失的影響,國際業務下降了2%。2025 年肥胖症護理銷售額成長 31%,這主要得益於兩個營運部門的共同努力。美國業務成長了 15%,IO 業務成長了 73%。在這兩個地區,成長均由 Wegovy 推動。
RAS disease sales increased by 9%. This was driven by sales increase in the U.S. operations of 7% and in international operations of 10%. In both operating units, the sales increase was primarily driven by the (inaudible) disorder products, mainly due to Sogroya launch uptake.
RAS疾病銷售額成長了9%。這主要得益於美國業務銷售額成長 7% 和國際業務銷售額成長 10%。在兩個營運部門中,銷售額的成長主要由(聽不清楚)疾病治療產品推動,這主要是由於 Sogroya 的上市推廣。
Next slide, please. Sales in international operations were driven by GLP-1 products in obesity and diabetes care. The GLP-1 volume growth in international operations was 44% in 2025. And Novo Nordisk remains the overall Gildan market leader with a 62% volume market share. GLP-1 diabetes sales increased by 7%, driven by the sales growth of Ozempic.
請看下一張投影片。國際業務的銷售額主要由用於肥胖症和糖尿病治療的 GLP-1 產品推動。2025 年,GLP-1 在國際業務中的銷量成長了 44%。諾和諾德仍然是吉爾丹市場的整體領導者,市佔率為 62%。受 Ozempic 銷售成長的推動,GLP-1 糖尿病藥物銷售額成長了 7%。
In Region China, GLP-1 diabetes sales decreased by 5%, which was negatively impacted by wholesaler inventory movements. Total Obesity care sales grew up to DKK31 billion in 2025. Wegovy was launched in 35 new countries in 2025, more than tripling the number of launches back in 2024. Sales of Wegovy reached DKK28 billion in '25, growing 134%.
在中國地區,GLP-1 糖尿病藥物的銷售額下降了 5%,這受到了批發商庫存變動的負面影響。到 2025 年,肥胖症護理產品的總銷售額將成長至 310 億丹麥克朗。Wegovy 於 2025 年在 35 個新國家推出,比 2024 年的推出數量增加了三倍以上。Wegovy 2025 年的銷售額達到 280 億丹麥克朗,成長了 134%。
We continue to see GLP-1 market growth in international operations a large unmet need remains and penetration rates are low. Looking into '26, we plan to further expand the obesity and diabetes markets in IO through new online channels and partnerships and by bringing new products to patients with the ongoing rollout of semaglutide 7.2 milligrams for weight loss and Ozempic 2-milligram for diabetes in certain markets.
我們看到 GLP-1 市場在國際業務中持續成長,但仍有大量未滿足的需求,滲透率較低。展望 2026 年,我們計劃透過新的線上管道和合作關係,以及透過在某些市場持續推出用於減肥的 7.2 毫克司美格魯肽和用於治療糖尿病的 2 毫克 Ozempic,進一步擴大 IO 的肥胖症和糖尿病市場。
And with that, I would like to thank my colleagues and the entire Novo Nordisk organization for a tremendous seven years. It has been a privilege to work on impactful medicines that have already and hopefully soon will make it to the hands of patients.
在此,我要感謝我的同事和整個諾和諾德公司,感謝他們七年來給予我的鼎力支持。能夠參與研發這些影響深遠的藥物,並且有機會讓它們惠及患者,我深感榮幸。
And now I would hand it over for Dave for an update on U.S. operations.
現在我將把麥克風交給戴夫,讓他報告美國方面的行動情況。
David Moore - Executive Vice President, US Operations
David Moore - Executive Vice President, US Operations
Thank you, Ludo. Next slide, please. Sales of GLP-1 diabetes care products in the U.S. increased by 5% in 2025. The sales increase was driven by continued uptake of Ozempic, partially countered by Victoza and and Rybelsus.
謝謝你,盧多。請看下一張投影片。2025年,美國GLP-1糖尿病照護產品的銷售額成長了5%。銷售額的成長主要得益於 Ozempic 的持續暢銷,但 Victoza 和 Rybelsus 的銷量在一定程度上抵消了這一增長。
Ozempic sales in the U.S. were positively impacted by gross to net sales adjustments and GLP-1 diabetes market growth, partially countered by market share losses and lower realized prices. Weekly Ozempic prescriptions are currently around 610,000. The GLP-1 diabetes market grew just over 10% in the fourth quarter of 2025 compared to the fourth quarter of 2024. In the U.S., we continue to meet people with type 2 diabetes where they are, including through our self-pay offering for Ozempic that is currently now around 8,000 prescriptions per week.
Ozempic 在美國的銷售額受到毛利淨銷售額調整和 GLP-1 糖尿病市場成長的正面影響,但部分被市佔率損失和較低的實際售價所抵消。目前每週 Ozempic 的處方量約為 61 萬張。與 2024 年第四季相比,2025 年第四季 GLP-1 糖尿病市場成長了 10% 以上。在美國,我們繼續在人們需要的地方為 2 型糖尿病患者提供服務,包括透過我們為 Ozempic 提供的自費服務,目前每週的處方量約為 8,000 張。
We also received FDA approval for the updated formulation of the Ozempic pill, formerly known as Rybelsus, and that happened last week. Next slide, please. As Mike noted earlier, 2025 ended with an exciting milestone for Novo Nordisk and importantly, people living with obesity in the U.S. The Wegovy pill was approved by FDA on December '22. And thanks to outstanding efforts across our entire organization, we were able to bring the first and best-in-class oral GLP-1 for weight management to the U.S.
上週,我們還獲得了 FDA 對 Ozempic 藥丸(以前稱為 Rybelsus)更新配方的批准。請看下一張投影片。正如麥克之前提到的,2025 年以諾和諾德公司以及美國肥胖症患者一個激動人心的里程碑而告終。 Wegovy 減肥藥於 2022 年 12 月獲得 FDA 批准。感謝我們整個組織的出色努力,我們得以將首個也是同類最佳的口服 GLP-1 體重管理藥物引入美國。
market on January 5. The Wegovy pill is the only GLP-1 peptide formulated into a pill, delivering the weight loss efficacy of injectable Wegovy in a once-daily oral tablet. When looking separately at the Phase III trial data in obesity for the Wegovy pill, and for orphoglippron, the Wegovy pill shows around 35% greater reported weight loss. We have seen encouraging early uptake of the Wegovy pill. Our compile data shows that total prescriptions are around 50,000 for the week ending January 23, with around 45,000 of these prescriptions coming through self-pay.
1月5日上市。Wegovy 藥片是唯一製成藥片的 GLP-1 勝肽,它以每日一次的口服片劑形式,提供與注射 Wegovy 相同的減肥效果。分別查看 Wegovy 藥丸和 orphoglippron 在肥胖症方面的 III 期試驗數據,Wegovy 藥丸報告的體重減輕幅度比 orphoglippron 高出約 35%。我們已經看到 Wegovy 藥丸的早期使用情況令人鼓舞。我們彙整的數據顯示,截至 1 月 23 日當週,總處方數約為 50,000 張,其中約 45,000 張處方為自費處方。
The uptake is over twice that of any prior antiobesity drug launches in the United States. Though it is still early in the launch, most prescriptions appear to be for patients new to these medications, suggesting the market is expanding. The Wegovy pill is offered at over 70,000 retail pharmacies and through NovoCare Pharmacy and numerous telehealth partners.
該藥物的吸收率是美國以往任何抗肥胖藥物上市吸收率的兩倍以上。雖然目前還處於上市初期,但大多數處方似乎都是開給首次服用這些藥物的患者,這表明市場正在擴大。Wegovy 藥丸在超過 70,000 家零售藥局、NovoCare 藥局以及眾多遠距醫療合作夥伴處均有販售。
Commercial access for the Wegovy pill is progressing with coverage currently via CVS, Prime, Optum and Anthem, amounting to just below half the covered lives we have for injectable Wegovy. We continue working to develop reimbursed access and broaden reach through more partnerships in order to provide people with obesity an oral therapeutic option with a competitive label of Wegovy and best-in-class weight loss.
Wegovy 藥丸的商業化進程正在推進,目前 CVS、Prime、Optum 和 Anthem 等保險公司已開始承保,覆蓋人數略低於注射用 Wegovy 的一半。我們將繼續努力發展健保報銷管道,並透過更多合作擴大覆蓋範圍,以便為肥胖症患者提供一種具有競爭力的口服治療選擇——Wegovy,並帶來一流的減肥效果。
Next slide, please. Wegovy sales increased by 16% in U.S. operations in 2025. The Wegovy sales growth was driven by increased volumes, partially countered by lower realized prices. In the holiday week ending January 23, Wegovy had around 230,000 weekly prescriptions.
請看下一張投影片。Wegovy 2025 年在美國的銷售額成長了 16%。Wegovy 的銷售成長主要得益於銷售量增加,但部分被售價下降所抵銷。在截至 1 月 23 日的假期週內,Wegovy 的每週處方量約為 23 萬份。
The recent decline in injectable Wegovy prescriptions at the start of 2026 and is largely attributed to benefit changes at the turn of the year, including several states that are dropping Medicaid coverage of anti-obesity medicines.
2026 年初,注射用 Wegovy 處方量出現近期下降,這主要歸因於年初福利政策的變化,包括一些州取消了醫療補助計劃對肥胖症藥物的覆蓋。
The combined injectable and pill Wegovy brand is currently now more than 75,000 weekly NBRx and that makes it the leading anti-obesity medication franchise measured by NBRx in the U.S. In the last year, the branded anti-obesity market has more than doubled in size. U.S. operations has prioritized making our anti-obesity medications available to more people through multiple avenues to meet the outstanding unmet need.
注射和口服劑型的 Wegovy 品牌目前每週的處方量超過 75,000 份,使其成為美國處方量領先的抗肥胖藥物品牌。去年,品牌抗肥胖藥物市場規模成長了一倍以上。美國業務部門已將抗肥胖藥物的供應放在首位,透過多種途徑讓更多人能夠獲得這些藥物,以滿足尚未滿足的巨大需求。
Novo Nordisk launched NonoCare Pharmacy in March 2025. And together with retail and telehealth, total self-pay now makes up around 30% and of total injectable Wegovy prescriptions. In under one year, our increased efforts in the self-pay channel have resulted in close to 120,000 current weekly TRx across Wegovy and Ozempic brands, and we continue to add more patients daily.
諾和諾德於 2025 年 3 月推出了 NonoCare Pharmacy。加上零售和遠距醫療,目前自費就佔 Wegovy 注射處方總量的 30% 左右。不到一年時間,我們在自費管道加大投入,Wegovy 和 Ozempic 品牌目前的每週處方量已接近 12 萬份,而且我們每天都在增加患者數量。
Novo Nordisk will continue to invest in the expansion of the direct-to-patient initiatives like the recently announced collaboration with Amazon Pharmacy. In November, we announced that Novo Nordisk entered an agreement with the U.S. administration, including coverage for obesity medicines in U.S. Medicare Part D via the CMMI pilot program.
諾和諾德將繼續投資擴大直接面向患者的舉措,例如最近宣布與亞馬遜藥房的合作。11 月,我們宣布諾和諾德與美國政府達成協議,透過 CMMI 試點項目,將肥胖症藥物納入美國醫療保險 D 部分。
We are encouraged that more patients will have affordable access to our medicines, and we anticipate that coverage will begin around the middle of the year. In addition to access, we remain focused on bringing innovation to the market. Novo Nordisk submitted the high-dose semaglutide 7.2 milligram to FDA in November.
我們感到欣慰的是,將有更多患者能夠負擔得起我們的藥品,我們預計醫保覆蓋範圍將於年中左右開始。除了提供市場准入機會,我們也將繼續致力於將創新帶入市場。諾和諾德公司於 11 月向 FDA 提交了高劑量 7.2 毫克司美格魯肽的申請。
It's under the CNPV pilot program and we anticipate a decision during the first quarter of 2026. Furthermore, CagriSema has been submitted to the FDA in December, and we expect a decision towards the turn of the year. As my time at Novo Nordisk comes to an end, I'm excited about its future and proud of the positive impact I've witnessed on patients worldwide, and I look forward to seeing Novo Nordisk continue with this mission.
該項目屬於 CNPV 試點計劃,我們預計將在 2026 年第一季做出決定。此外,CagriSema 已於 12 月提交給 FDA,我們預計將在年底前得到決定。我在諾和諾德的工作即將結束,我對它的未來感到興奮,並為我親眼見證它對全球患者產生的積極影響感到自豪,我期待看到諾和諾德繼續履行這一使命。
And now I'll turn it over to Martin for an update on R&D.
現在我將把麥克風交給馬丁,讓他報告研發的最新進展。
Martin Lange - Executive Vice President, Chief Scientific Officer, Research & Development
Martin Lange - Executive Vice President, Chief Scientific Officer, Research & Development
Thank you, Dave. Please turn to the next slide. This week, we announced the top line readout from REIMAGINE 2, a Phase III trial for CagriSema in type 2 diabetes. The trial included around 2,700 people with type 2 diabetes inadequately controlled with metformin with or without an SGLT2 inhibitor. People were randomly assigned to receive either CagriSema 2.4 milligram or 1 milligram, semaglutide 2.4 milligram or 1 milligram or [cagrilintide] 2.4 milligram or placebo.
謝謝你,戴夫。請翻到下一張投影片。本週,我們公佈了 REIMAGINE 2 的主要結果,這是一項針對 2 型糖尿病患者的 CagriSema III 期試驗。該試驗納入了約 2700 名第 2 型糖尿病患者,這些患者使用二甲雙胍(無論是否聯合 SGLT2 抑制劑)治療後血糖控制不佳。人們被隨機分配接受 CagriSema 2.4 毫克或 1 毫克、索馬魯肽 2.4 毫克或 1 毫克、[cagrilintide] 2.4 毫克或安慰劑。
The study assessed superiority of CagriSema versus semaglutide on A1c as the primary end point with change in body weight as one of the secondary endpoints. Approximately 40% of all participants were using an SGLT2 inhibitor before initiating the trial. Please go to the next slide. In reimagine to -- sorry, CagriSema 2.4 milligram demonstrated superior A1c reduction and weight loss versus semaglutide 2.4 milligram. Assuming all people adhere to treatment and from a mean A1c baseline of 8.2%, CagriSema 2.4 milligram achieved a superior A1C reduction of 1.91 percentage points.
該研究評估了 CagriSema 與索瑪魯肽在 A1c 方面的優效性,這是主要終點,體重變化是次要終點之一。約 40% 的參與者在開始試驗前正在使用 SGLT2 抑制劑。請進入下一張投影片。重新想像—抱歉,CagriSema 2.4 毫克在降低 A1c 和減輕體重方面優於 semaglutide 2.4 毫克。假設所有患者都堅持治療,且平均 A1c 基線為 8.2%,CagriSema 2.4 毫克可使 A1c 降低 1.91 個百分點。
This is compared to 1.6 percentage points with semaglutide 2.4 milligram. In addition, CagriSema 2.4 milligram achieved a superior weight loss reduction of 14.2%. More than 40% of the participant treated with CagriSema .4 milligram achieved over 15% weight loss and around one in four achieved over 20% weight loss. In the trial, CagriSema appeared to have a safe and well-tolerated profile. The most common adverse events for gastrointestinal with the vast majority being mild to moderate and decreasing over time.
相較之下,使用 2.4 毫克司美格魯肽的療效為 1.6 個百分點。此外,CagriSema 2.4 毫克實現了 14.2% 的卓越減重效果。在接受 CagriSema 0.4 毫克治療的參與者中,超過 40% 的人體重減輕了 15% 以上,約四分之一的人體重減輕了 20% 以上。在試驗中,CagriSema 表現出良好的安全性和耐受性。最常見的胃腸道不良反應,絕大多數為輕度至中度,並且隨著時間的推移而減輕。
This data is in line with the recent top line readout of REIMAGINE-3 with CagriSema as an add-on to basal insulin. In that study, people treated with CagriSema 2.4 milligram achieved an A1c reduction of 2.3 percentage points and a weight loss of 2% at 40 weeks, all superior to placebo.
此數據與近期 REIMAGINE-3 試驗的主要結果一致,該試驗將 CagriSema 作為基礎胰島素的附加療法。在該研究中,接受 CagriSema 2.4 毫克治療的患者在 40 週時 A1c 降低了 2.3 個百分點,體重減輕了 2%,所有這些指標都優於安慰劑。
Results from the pivotal REIMAGINE-1 trial anticipated in the first quarter of 2026. In addition, we await the long-term safety and efficacy cardiovascular outcome trust redefined free. Following these results, Novo Nordisk will approach authorities to discuss the regulatory pathway for CagriSema in type 2 diabetes.
關鍵性 REIMAGINE-1 試驗結果預計將於 2026 年第一季公佈。此外,我們期待長期安全性和有效性心血管結果信託重新定義自由。根據這些結果,諾和諾德將與相關部門討論 CagriSema 在第 2 型糖尿病的監管途徑。
In summary, CagriSema has demonstrated superior results in both glycemic control and weight reduction. These results represent a highly effective treatment option for individuals with type 2 diabetes seeking seeking waste management solutions in addition to glycemic control.
總之,CagriSema 在血糖控制和體重減輕方面均表現出優異的效果。這些結果表明,對於尋求除血糖控制外還能提供廢棄物管理解決方案的 2 型糖尿病患者來說,這是一種非常有效的治療選擇。
Next slide, please. In November, we announced positive headline results from the first evaluation of [cagrilintide] formerly called [HbA1c] in peril type 2 diabetes. The trial investigated the efficacy, safety and pharmacokinetics of once-weekly subcutaneous and once daily all (inaudible) compared to placebo.
請看下一張投影片。11 月,我們公佈了 [cagrilintide](以前稱為 [HbA1c])在 2 型糖尿病危重症患者中的首次評估的積極主要結果。該試驗研究了每週一次皮下注射和每日一次注射(聽不清楚)與安慰劑相比的療效、安全性和藥物動力學。
The trial included around 450 people with type 2 diabetes inadequately controlled on metformin with or without an SGLT2 inhibitor as standard of care. About 40% of participants were using an SGLT2 inhibitor at baseline. The trial was a combined multi-ascending dose study, investigating six subcutaneous doses ranging from 0.4 milligrams to 40 milligrams and free or doses reaching from 6 milligram, 25 milligrams to 50 milligram.
該試驗納入了約 450 名第 2 型糖尿病患者,這些患者使用二甲雙胍(無論是否有 SGLT2 抑制劑)作為標準治療,但病情控制不佳。約 40% 的參與者在基線時正在使用 SGLT2 抑制劑。該試驗是一項綜合多劑量遞增研究,研究了 6 種皮下注射劑量(範圍從 0.4 毫克到 40 毫克)和遊離劑量(範圍從 6 毫克、25 毫克到 50 毫克)。
From a mean baseline HbA1c of 7.8%, once weekly (inaudible) lowered A1c by up to 1.8 percentage points at week 36 in a dose-dependent manner, assuming all people adhere to treatment. The proportion of people achieving A1c below 7% was up to 89.1%.
假設所有患者都堅持治療,那麼在平均基線 HbA1c 為 7.8% 的情況下,每週一次(聽不清楚)治療,在第 36 週時,A1c 可降低至多 1.8 個百分點,且呈劑量依賴性。糖化血紅素A1c低於7%的人比例高達89.1%。
Furthermore, people treated with oral (inaudible) achieved dose-dependent reductions of A1c of up to 1.5 percentage points by week 36 from a baseline of 8%. Almost 78% of people achieved an A1c level below 7%. The estimated improvement in A1C were all statistically significant versus placebo confirming the primary input on the trials.
此外,接受口服(聽不清楚)治療的族群,到第 36 週時,A1c 值從 8% 的基線降低了 1.5 個百分點,且呈現劑量依賴性。近 78% 的人糖化血紅蛋白 A1c 水平低於 7%。與安慰劑相比,A1C 的估計改善均具有統計意義,證實了試驗的主要結果。
Both subcutaneous and oral (inaudible) appear to have a safe and well-tolerated profile consistent with other incretin and amylin based therapies. The data further support the potential of (inaudible) as a next-generation treatment for type 2 diabetes, and we look forward to bringing it into an extensive Phase III program called AMBITION, in type 2 diabetes and other indications in the second half of 2026.
皮下注射和口服(聽不清楚)似乎都具有安全且耐受性良好的特性,與其他基於腸促胰素和胰淀素的療法一致。數據進一步支持了(聽不清楚)作為下一代 2 型糖尿病療法的潛力,我們期待在 2026 年下半年將其引入名為 AMBITION 的大規模 III 期項目,用於治療 2 型糖尿病和其他適應症。
In addition, the Phase III obesity program called AMC will start in the first quarter of 2026. As a reminder, the Phase Ib/IIa clinical trial with (inaudible) people with obesity or overweight demonstrated a 22% weight loss with the 20-milligram dose after 36 weeks of treatment.
此外,名為 AMC 的第三階段肥胖症計畫將於 2026 年第一季啟動。提醒一下,針對肥胖或超重人群的 Ib/IIa 期臨床試驗表明,20 毫克劑量治療 36 週後,體重減輕了 22%。
The AMBITION and the MACE programs will both investigate the subcutaneous maintenance dose up to 40 milligrams. Next slide, please. We have an exciting year ahead across therapy areas here at Novo Nordisk, Beginning with diabetes.
AMBITION 和 MACE 計畫都將研究皮下維持劑量,最高可達 40 毫克。請看下一張投影片。在諾和諾德,我們即將迎來令人興奮的一年,各個治療領域都將迎來新的發展,首先是糖尿病治療。
You just heard about the advantages that we made with our late-stage internal assets, CagriSema and (inaudible) . We've also achieved progress through external innovation that we have done throughout the last 3Y years. We expect Phase II data from our in-licensed UPT 251 asset, a GLP-1 GIP glucagon tri-agonist, in a Chinese type 2 diabetes population in the first half of this year with plans to initiate our own Phase II study in type 2 diabetes in the second half of this year. Within the diabetes associated comorbidities, the first readout of (inaudible) from the SU Phase III trial is anticipated in the second half of this year.
您剛剛聽到了我們利用後期內部資產 CagriSema 所取得的優勢。(聽不清楚)過去三年,我們透過外部創新也取得了進展。我們預計今年上半年獲得我們引進的 UPT 251(一種 GLP-1 GIP 胰高血糖素三激動劑)在中國 2 型糖尿病人群中的 II 期數據,併計劃於今年下半年啟動我們自己的 2 型糖尿病 II 期研究。在糖尿病相關合併症方面,SU III 期試驗的首次讀數預計將於今年下半年公佈。
The trial is assessing 3-point MACE relative risk reduction on top of standard of care (inaudible) the potential to be in first-in-class treatment targeting systemic inflammation in people living with atherosclerotic cardiovascular disease and chronic kidney disease. In obesity, we expect results from the redefined for file in the first quarter of this year. assessing weight loss efficacy compared to sebacate.
該試驗正在評估在標準治療基礎上降低 3 點 MACE 相對風險(聽不清楚),並有望成為針對患有動脈粥狀硬化性心血管疾病和慢性腎臟病患者的全身性發炎的首創治療方法。在肥胖症方面,我們預計今年第一季度將獲得重新定義的文件結果,以評估其與司巴吉特相比的減肥效果。
The study's primary endpoint is percent change in body weight assessed for noninferiority. We are assessing further CagriSema weight loss potential in the ongoing REDEFINE-11 trial with the results expected early in 2027.
研究的主要終點是評估體重變化百分比,以檢驗其非劣效性。我們正在進行 REDEFINE-11 試驗,以進一步評估 CagriSema 的減肥潛力,預計將於 2027 年初公佈結果。
And new Phase III trial with CagriSema high dose is also planned to initiate later share. For our triple agonist, we expect Phase II data from our in-licensed UPT 251 asset in a Chinese obese and overweight population in the first half of this year. And we have already initiated our own Phase Ib2 study in Obesity. We would also like to highlight the first human dose trial with our internal triagonist, a GLP-1, GIP Amelia targeted agonist that was completed in the third quarter of 2025. Single doses up to 1.5 milligram and multiple weekly subcutaneous doses up to 1.4 milligram were tested.
此外,一項使用高劑量 CagriSema 的新的 III 期試驗也計劃稍後啟動。對於我們的三重激動劑,我們預計將於今年上半年獲得從中國引進的 UPT 251 資產在中國肥胖和超重人群中進行的 II 期臨床試驗數據。我們已經啟動了我們自己的肥胖症 Ib2 期研究。我們也要重點介紹我們內部三種激動劑(一種 GLP-1、GIP Amelia 標靶激動劑)的首次人體劑量試驗,該試驗已於 2025 年第三季完成。測試了單次劑量高達 1.5 毫克和每週多次皮下注射劑量高達 1.4 毫克。
The primary endpoint was treatment emergent adverse events. The safety profile of the trial agonist was consistent with intent-based tapes. The percentage change in body weight from baseline rates from minus 3.6% and to 5.3% for the triagonist versus 0.5% for placebo at four weeks.
主要終點是治療期間出現的不良事件。試驗激動劑的安全性與基於意圖的錄影帶一致。四周時,三激動劑組的體重較基線變化百分比為 -3.6% 至 5.3%,而安慰劑組為 0.5%。
The four-week data confirm our belief in the potential for high weight loss efficacy with the triagonist. We recently initiated a Phase Ib/II trial in obesity with expected readout during the first half of 2027.
四週的數據證實了我們對三重激動劑具有很高的減肥功效的看法。我們最近啟動了一項針對肥胖症的 Ib/II 期試驗,預計將於 2027 年上半年公佈結果。
In addition, we have several ongoing submissions in obesity in the U.S. and globally. We anticipate the EU's decision on oral semaglutide 25-milligram and injectable semaglutide 7.2 milligram during the second half of this year. We also anticipate fourth comment decisions regarding semaglutide 7.2 milligram and later in the year, CagriSema in the U.S. 2026 is an exciting year in rare disease as well.
此外,我們在美國和全球範圍內還有幾項關於肥胖症的研究正在進行中。我們預計歐盟將在今年下半年對口服索馬魯肽 25 毫克和注射用索馬魯肽 7.2 毫克做出決定。我們也預計今年稍後將公佈有關司美格魯肽 7.2 毫克和 CagriSema 在美國的第四次意見徵詢決定。 2026 年對於罕見疾病領域來說也是令人興奮的一年。
The Phase III HIBISCUS readout for etavopivat in sickle cell disease is expected in the second quarter of this year. Etavopivat has a novel mechanism of action with the potential to improve both hemoglobin health and vaso-occlusive crisis event rates in people living with sickle cell disease.
預計今年第二季將公佈 etavopivat 治療鐮狀細胞疾病的 III 期 HIBISCUS 試驗結果。依他伐匹伐具有新穎的作用機制,有可能改善鐮狀細胞疾病患者的血紅素健康狀況和血管阻塞危象發生率。
Finally, we are awaiting regulatory decisions for Decenimig previously known as Mymet. Decenimig is a once-monthly, once every two weeks or once-weekly prophylaxis treatment to prevent or reduce the frequency of bleeding episodes in people with hemophilia A with or without inhibitors. Regulatory decisions in the U.S. and the EU is expected in the second half of 2026.
最後,我們正在等待監管機構對 Decenimig(原名 Mymet)做出決定。Decenimig 是一種每月一次、每兩週一次或每週一次的預防性治療,用於預防或減少患有 A 型血友病(伴或不伴抑製劑)患者的出血發作頻率。美國和歐盟的監管決定預計將在 2026 年下半年做出。
With that, over to you, Karsten.
那麼,接下來就交給你了,卡斯騰。
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 2025, our sales grew by 10% at constant exchange rates, driven by both operating units. In the U.S., sales growth was positively impacted by gross to net sales adjustments. The gross margin decreased to 81% compared to 84.7% in 2024.
謝謝你,馬丁。請翻到下一張投影片。2025年,在兩個營運部門的推動下,我們的銷售額以固定匯率計算成長了10%。在美國,毛銷售額與淨銷售額的調整對銷售成長產生了正面影響。毛利率從 2024 年的 84.7% 下降至 81%。
The decrease in gross margin is impacted by amortization and depreciation related to the acquisition of the three (inaudible) manufacturing sites as well as one-off restructuring costs related to the company-wide transformation we announced in the third quarter.
毛利率下降受到與收購三個(聽不清楚)製造基地相關的攤銷和折舊以及與我們在第三季度宣布的公司範圍內的轉型相關的一次性重組成本的影響。
Operating profit decreased by 1% in Danish krone and increased by 6% at constant exchange rates, reflecting higher sales and distribution costs tied to the global promotional activities and launches as well as increased early and early research and development stage investments. The main impact on operating profit was, however, the company-wide restructuring cost of around DKK8 billion. Excluding this, operating profit would have increased by 6% in Danish krone and 13% at constant exchange rates. Please go to the next slide.
以丹麥克朗計算,營業利潤下降了 1%,以固定匯率計算則增加了 6%,這反映出與全球促銷活動和產品發布相關的銷售和分銷成本增加,以及早期研發階段投資增加。然而,對營業利潤的主要影響是公司整體重組成本,約 80 億丹麥克朗。排除此因素,營業利潤以丹麥克朗計算將成長 6%,以固定匯率計算將成長 13%。請進入下一張投影片。
In 2025, from a net profit of DKK102 billion, we generated close to DKK120 billion in cash from operating activities. Our deployment of capital for our allocation principles investing in the business with around DKK60 billion going towards manufacturing capacity expansion through capital expenditure and around DKK30 billion to expand the R&D pipeline through business development activities.
2025 年,我們實現淨利 1,020 億丹麥克朗,並透過經營活動產生近 1,200 億丹麥克朗的現金。我們根據分配原則部署資本,投資於業務,其中約 600 億丹麥克朗用於透過資本支出擴大生產能力,約 300 億丹麥克朗用於透過業務發展活動擴大研發管道。
We also returned around DKK52 billion to shareholders in the form of dividends. At the Annual General Meeting in March 2026, the Board of Directors will propose a final dividend of [7.95] for an expected total 2025 dividend of DKK11.70, including the interim dividend paid out in August '25. This is a 2.6% increase compared to last year, making it the 30 consecutive year with increasing dividend per share.
我們也以股利的形式向股東返還了約 520 億丹麥克朗。在 2026 年 3 月的年度股東大會上,董事會將提議派發每股 [7.95] 的末期股息,預計 2025 年股息總額為每股 11.70 丹麥克朗,其中包括 2025 年 8 月派發的期中股息。與去年相比成長了2.6%,這是連續第30年提高每股股息。
Novo Nordisk will continue to deliver returns to shareholders in 2026 with total cash returns anticipated to be over DKK60 billion. In addition, the Board of Directors has approved a new share repurchase program of up to DKK15 billion to be executed during the next 12 months.
諾和諾德將在 2026 年繼續為股東帶來回報,預計現金回報總額將超過 600 億丹麥克朗。此外,董事會已批准一項新的股票回購計劃,金額高達 150 億丹麥克朗,將在未來 12 個月內執行。
Please turn to the next slide. In 2026, sales and operating profit will be positively impacted by a reversal of sales rebate provisions of USD4.2 billion related to the 340B drug pricing program in the U.S. In order to enhance transparency and comparability of underlying operating performance, Novo Nordisk will present outlook and expectations on adjusted sales and adjusted operating profit growth basis at constant exchange rates going forward.
請翻到下一張投影片。2026年,由於美國340B藥品定價計畫相關的42億美元銷售回扣條款的逆轉,銷售額和營業利潤將受到正面影響。為了提高基礎經營績效的透明度和可比性,諾和諾德將以固定匯率公佈未來調整後的銷售額和調整後的營業利潤成長展望和預期。
This is introduced to exclude certain exceptional and nonrecurring effects, primarily of noncash in nature, including the provision reversal. Adjusted operating profit will likewise exclude the impact of the 340B provision reversal as well as other exceptional and nonrecurring effects related to effects such as major impairment losses and major legal matters.
引入此條款是為了排除某些特殊且非經常性的影響,主要是非現金性質的影響,包括撥備衝回。調整後的營業利潤同樣將不包括 340B 撥備衝回的影響,以及與重大減損損失和重大法律事項等相關的其他特殊和非經常性影響。
For 2026, adjusted sales growth is expected to be minus 5% to minus 13% at constant exchange rates. Given the current exchange rate versus growth reported in Danish krone, growth reported in Danish krone is expected to be 3 percentage points lower than at constant exchange rates. The outlook reflects expectations for sales growth within international operations and expectations for sales decline within U.S. operations.
預計 2026 年經調整後的銷售額成長率(以固定匯率計算)將為 -5% 至 -13%。鑑於目前的匯率與以丹麥克朗計價的成長相比,以丹麥克朗計價的成長預計將比以固定匯率計算的成長低 3 個百分點。該展望反映了對國際業務銷售成長的預期以及對美國業務銷售下降的預期。
The global (inadubile) expansion is assumed to continue in 2026, enabling Novo Nordisk to increase patient breads and expand volumes. However, this is countered by lower realized prices, including impacts from the most favored nations agreements in the U.S. and loss of exclusivity for the semaglutide molecule in certain markets in international operations.
全球(不可否認的)擴張預計將在 2026 年繼續,使諾和諾德能夠增加患者數量並擴大規模。然而,由於美國最惠國待遇協議的影響,以及在某些國際市場中索馬魯肽分子失去獨家經營權,導致實際價格下降,抵消了上述影響。
Lastly, positive impacts related to U.S. gross to net sales adjustments during 2025 are not anticipated to reoccur. In International Operations, the outlook is based on current growth trends, including continued volume penetration from GLP-1 treatments and market expansion, mainly within obesity as well as intensifying competition and negative impacts from the patent expiry of semaglutide in certain markets.
最後,預計 2025 年美國毛銷售額與淨銷售額調整相關的正面影響不會再次發生。在國際業務方面,前景基於當前的成長趨勢,包括 GLP-1 治療的持續銷售滲透和市場擴張(主要在肥胖領域),以及競爭加劇和某些市場中索瑪魯肽專利到期帶來的負面影響。
In U.S. operations, the outlook is based on current prescription trends for the injectable GLP-1 portfolio, intensifying competition as well as negative impact from reduced antiobesity medication coverage in Medicaid. Furthermore, lower realized prices linked to investments in market access are amplified by the MFM agreement with the U.S. administration.
在美國的業務方面,前景是基於注射 GLP-1 產品組合目前的處方趨勢,競爭加劇,以及醫療補助計劃中抗肥胖藥物覆蓋範圍減少的負面影響。此外,與市場准入投資相關的較低實際價格,因 MFM 與美國政府達成的協議而進一步擴大。
Uptake related to the launch of the Wegovy pill is reflected based on a range of assumptions related to market penetration potential negative impact on the growth of the injectable and [NTB] medication category as well as channel mix.
Wegovy 藥丸上市後的市場接受度反映了一系列假設,這些假設與市場滲透潛力、對注射劑和 [NTB] 藥物類別成長的負面影響以及管道組合有關。
Adjusted operating profit growth is expected to be minus 5% to minus 13% at constant exchange rates. Given the current exchange rates versus the Danish krone, reported operating profit growth in Danish krone is expected to be around 5 percentage points lower than at constant exchange rates. The expectation for adjusted operating profit growth primarily reflects the sales growth outlook, combined with targeted investments in current and future growth opportunities within our R&D and commercial.
以固定匯率計算,調整後的營業利益成長率預計為-5%至-13%。鑑於目前的丹麥克朗匯率,以丹麥克朗計價的營業利益成長率預計將比以固定匯率計算低約 5 個百分點。調整後的營業利潤成長預期主要反映了銷售成長前景,以及我們在研發和商業領域對當前和未來成長機會的有針對性投資。
Other key modeling considerations for 2026 are shown on the slide. Of note, as of 2026, Novo Nordisk defines free cash flow as net cash generated from operating activities less purchase of property, plant and equipment and is expected to be DKK35 million to DKK45 billion.
幻燈片上顯示了 2026 年的其他關鍵建模考慮因素。值得注意的是,截至 2026 年,諾和諾德將自由現金流定義為經營活動產生的淨現金減去購買物業、廠房和設備的費用,預計為 3,500 萬丹麥克朗至 450 億丹麥克朗。
Capital expenditure is expected to be around DKK55 billion in 2026. In the coming years, the capital expenditure investments are expected to decline following expansion project finalizations. That covers the outlook for 2026.
預計2026年資本支出約550億丹麥克朗。未來幾年,隨著擴建項目的最終完成,資本支出投資預計將會下降。以上涵蓋了 2026 年的展望。
Now back to you, Mike.
現在把鏡頭交還給你,麥克。
Unidentified Company Representative
Unidentified Company Representative
Thank you, Karsten. Please turn to the next slide. Our 2025 strategic aspirations have run their course, and while we acknowledge 2025 presented significant challenges affecting our performance and share price, those adversaries have also made us more resilient.
謝謝你,卡斯滕。請翻到下一張投影片。我們的 2025 年策略目標已經實現,雖然我們承認 2025 年為我們的業績和股價帶來了重大挑戰,但這些挑戰也使我們更具韌性。
We have plenty of work left to do in order to meet the vast unmet needs for people living with diabetes, obesity and their related comorbidities as well as those with rare diseases, which we aim to treat in the future.
為了滿足糖尿病、肥胖症及其相關合併症患者以及未來計劃治療的罕見疾病患者的巨大未滿足需求,我們還有很多工作要做。
We expect to introduce new strategic aspirations as part of Capital Market Day, which will be held on September 21 in London. Until then, we will, of course, continue to report and track progress across key dimensions of the business.
我們預計在9月21日於倫敦舉行的資本市場日上推出新的策略目標。在此之前,我們當然會繼續報告並追蹤業務各個關鍵領域的進展。
With that, I will turn it back to you, Michael.
那麼,我就把機會交還給你了,麥可。
Michael Novod - Head of Investor Relation
Michael Novod - Head of Investor Relation
Thank you, Mike. Next slide, please. With that, we're now ready for the Q&A. We kindly ask all participants to limit her or himself to one or maximum two questions, including sub questions. Operator, we're now ready to take the first question.
謝謝你,麥克。請看下一張投影片。接下來,我們準備好進入問答環節。我們懇請所有參與者將提問數量限制在一到兩個問題之內,包括子問題。接線員,我們現在可以回答第一個問題了。
Operator
Operator
(Operator Instructions)
(操作說明)
James Quigley, Goldman Sachs.
James Quigley,高盛集團。
James Quigley - Analyst
James Quigley - Analyst
Got two, please. So firstly, just trying to try and get your guidance. You're suggesting low single-digit growth in international operations. And again, that one suggest minus 20 or so in the U.S. So could you give us a sense of how this breaks down between volumes and price high level, please.
請給我兩個。首先,我只是想尋求您的指導。你的意思是國際業務成長率將只有個位數。此外,有數據顯示美國市場可能出現-20左右的降幅。請問您能否簡單分析一下成交量和價格高點之間的具體情況?
Particularly, given that your key competitors suggested to mid-teens pricing on a global basis this morning. And the second question, on the Medicare, how are you thinking about the potential speed here?
尤其考慮到你的主要競爭對手今天早上在全球範圍內提出了十幾英鎊的定價方案。第二個問題是關於醫療保險,您認為它的潛在速度如何?
Again, your competitor suggested (inaudible) going to be pretty fast starting from July 1. The guidance and the slower uptake here. So what are the basis of your assumptions around the speed of unlock?
你的競爭對手再次表示(聽不清楚)從 7 月 1 日起速度會非常快。這裡的指導意見和較慢的接受速度。那麼,你對解鎖速度的假設依據是什麼?
Michael Novod - Head of Investor Relation
Michael Novod - Head of Investor Relation
Thank you, James. two questions, both for Karsten.
謝謝你,詹姆斯。我有兩個問題,都是問卡斯滕的。
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Thank you, James, and thank you for listening in and posing your question. As to the guidance first, with the international operations delivering 8% growth in the fourth quarter of last year and around 10% in the second half that's the run rate we are entering in 2026, then adjust for LOE in specific markets on sema, then you get to mid-single-digit growth for international. And consequently, based on our guidance, then the residual leaves the U.S. growth to be in the teens in terms of sales decline. So that's the key factors.
謝謝你,詹姆斯,也謝謝你的收聽和提問。關於業績指引,首先,國際業務在去年第四季實現了 8% 的成長,下半年成長了約 10%,這就是我們 2026 年的預期成長率,然後根據特定市場的支出調整,國際業務的成長將達到個位數中段。因此,根據我們的預測,剩餘部分將導緻美國銷售額下降兩位數。所以,這些都是關鍵因素。
I would say the U.S. decline is driven by price declines, and it's driven by both investments in market access being a key driver built off the cash channel in the U.S. at a different price point, so channel mix and then the MFN impact where we, a few quarters ago or one quarter ago, announced that it will have a low single-digit impact on group sales, so meaning roughly double on U.S. So the key notion is, of course, with these price reductions, to what extent are we then able to convert that into expanding volume reach and volumes in the marketplace. It's early days.
我認為美國市場的下滑是由價格下降所驅動的,而價格下降又是由兩方面因素共同作用的結果:一是加大對市場准入的投資,這是關鍵驅動因素,尤其是在美國現金渠道的基礎上,價格定位有所不同;二是渠道組合的變化,以及最惠國待遇的影響。幾個季度前或一個季度前,我們宣布最惠國待遇將對集團銷售額產生個位數百分比的影響,這意味著美國市場的銷售額將大約翻一番。因此,關鍵問題在於,在這些價格下調的基礎上,我們能在多大程度上將這些降價轉化為更大的市佔率和銷售成長。現在下結論還為時過早。
We have built assumptions in. Clearly, we've looked at the first four weeks of the Wegovy pill launch, where we are very encouraged, as Dave showed just before. And the same on the Wegovy injectable, we're actually looking at to the tune of 30% of the Wegovy injectable scripts now being cash-driven. So also building that. So we are seeing a volume response to the lower prices.
我們已經內建了一些假設。顯然,我們已經觀察了 Wegovy 藥丸上市的前四周,正如 Dave 剛才所展示的那樣,我們對此感到非常鼓舞。Wegovy注射劑的情況也是一樣,我們現在看到,Wegovy注射劑處方中約有30%是由現金支付的。所以也在建設中。因此,我們看到銷量對價格下跌做出了相應的反應。
Exactly how the year pans out, it remains to be seen because we have a number of variables at play. But net-net, it is price declines that drive U.S. down. On Medicare and impact from Medicare Part D and the MFN deal, we do expect that we'll have benefits starting around mid this year, having Wegovy reimbursed in Medicare party and hence, being available for seniors under reimbursed setting. We have included that in our guidance.
今年究竟會如何發展,還有待觀察,因為有許多變數在運作。但總的來說,是價格下跌導緻美國經濟下滑。關於醫療保險以及醫療保險D部分和最惠國待遇協議的影響,我們預計從今年年中左右開始,我們將受益於Wegovy在醫療保險中獲得報銷,因此,老年人可以在報銷環境下使用Wegovy。我們已將此內容納入指導方針中。
But at this point, given the lag times of educating physicians and physicians and admin staff understanding how it works and for patient to access that benefit, it will be a gradual ramp with limited benefit this year and a bigger benefit into 2027.
但就目前而言,考慮到教育醫生、醫生和行政人員了解其運作方式以及患者獲得該福利所需的時間,這將是一個逐步推進的過程,今年的益處有限,而到 2027 年將帶來更大的益處。
Operator
Operator
Sachin Jain, Bank of America.
Sachin Jain,美國銀行。
Sachin Jain - Analyst
Sachin Jain - Analyst
I've got two more on guidance, if I may, Karsten, and apologies. So maybe framing James's question slightly differently. I asked that pushes and Paul's question at the third quarter, and not an misspeaking, but I think you're roughly phrased as underlying growth, less three sets of headwinds are roughly low single digit at. So I'm just trying to understand between 3Q and the guidance today what shifted you from that sort of low single digit to now minus 5% to 13%. So the mid- to high single-digit delta versus consensus, how much that is volume and price?
卡斯滕,如果可以的話,我還有兩點要補充說明,並向你們道歉。所以或許應該稍微換個方式表達詹姆斯的問題。我問了關於推動因素以及保羅在第三季度提出的問題,我並沒有說錯,但我認為你大致的表述是,基本增長減去三組不利因素後,增長幅度大致為個位數低位。所以我想了解的是,從第三季到今天的業績指引,是什麼讓你們的預期從個位數低點轉變為現在的 -5% 到 13%。那麼,與普遍預期相比,個位數中高段位的差異,這體現在成交量和價格上嗎?
And within price, what's the new components, it seems to be cash channel. And then second, more specifically, a question I had frequently overnight is what needs to happen for you to achieve the bottom end of your guidance, multiple investors trying to work out how conservative that is, particularly around your oral assumptions being driven by injectable switch?
至於價格方面,新的組成是什麼?似乎是現金管道。其次,更具體地說,我經常在夜間被問到的一個問題是,為了實現您指導的下限,需要發生什麼?許多投資者都在試圖弄清楚這個指導意見有多保守,特別是關於您的口服假設是由注射劑轉換驅動的方面?
Michael Novod - Head of Investor Relation
Michael Novod - Head of Investor Relation
Thanks, Sachin. Also two questions for Karsten on guidance and also on the sort of push and pull between high and low.
謝謝你,薩欽。另外還有兩個問題想問卡斯滕,關於指導方針以及高低點之間的拉鋸戰。
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Yes. Thanks for these questions, Sachin. And as you recall, I didn't guide for 2026 at our Q3 call. So that's the starting point. And as we also noted in our current release, we based our guidance based on the latest trends we see in the market.
是的。謝謝你的提問,薩欽。如你所知,我在第三季財報電話會議上沒有給予 2026 年的業績指引。這就是起點。正如我們在最新發布的報告中所指出的,我們的指導意見是基於我們在市場上看到的最新趨勢而製定的。
So the guidance we put out now is based on, of course, the run rate we left 2025 with. So Q4 performance, as I alluded to before. And then whatever triggering events and expectations and assumptions around the future we are building in. So those are really the key points that we build in. What have we known more -- what do we know more today compared to Q3.
因此,我們現在發布的指導意見當然是基於我們對 2025 年的預測運行率。正如我之前提到的,這是第四季的業績。然後,還有我們所建構的未來中可能產生的各種觸發事件、預期和假設。所以這些就是我們著重強調的關鍵點。與第三季相比,我們今天知道了更多什麼?
We have some more nuances on the run rate in international operations. You see the 8% growth in the fourth quarter. And, of course, some more market intel on more specific and detailed pricing and reimbursement choices in some of the markets there. And then in the U.S., what we know there beyond the Q4 closeout is really about, I would say, the Wegovy pill uptake in the first month, as Dave alluded to, which we're very happy with. And then the Wegovy injectable cash business and the response to the lowering of the initiation prices to (inaudible).
關於國際業務的運作率,我們還有一些更細緻的說明。你可以看到第四季度增長了 8%。當然,還需要一些關於某些市場更具體、更詳細的定價和報銷選擇的市場情報。然後在美國,除了第四季度末的業績之外,我們所了解的情況實際上與戴夫提到的 Wegovy 藥丸在第一個月的服用量有關,我們對此非常滿意。然後是Wegovy的可注入現金業務以及對降低初始價格的反應。(聽不清楚)
so that's really kind of the key fundamental changes since three months ago. Thanks, Michael, for reminding me on that one. It's important to remember, and we've been experiencing this for some years now. The obesity market is just significantly more dynamic than most other markets where it's much more stable prescription trends through to normal GPs. So the macro variable that can both be positive and negative is the dynamics in the obesity market.
所以,這算是三個月以來最關鍵的根本改變。謝謝邁克爾提醒我這件事。這一點很重要,而且我們已經經歷這種情況好幾年了。肥胖症市場比其他大多數市場更具活力,其他市場的處方趨勢則穩定得多,一般全科醫生的處方量也相對較少。因此,既可能產生正面影響也可能產生負面影響的宏觀變數是肥胖症市場的動態。
It's -- we are not concerned about the expansion of the markets. We saw it more than double in 2025. So we're very confident in continued expansion of the market space. But the variables I'm alluding to is really, of course, as always, competitive dynamics -- as always, gross to net dynamics that are being forecasted with a lag. And then also the sourcing dynamics and channel dynamics impacting pricing and volume of the Wegovy pill and how that is impacting both Wegovy injectable, but also how a competitive launch plays into all of this.
我們並不擔心市場擴張。我們預計到 2025 年,這個數字將翻倍以上。因此,我們對市場空間的持續擴張非常有信心。但我所指的變量,當然,一如既往,是競爭動態——一如既往,是毛利潤與淨利潤的動態變化,而這種變化的預測存在滯後性。此外,還有採購動態和通路動態如何影響 Wegovy 藥丸的價格和銷量,以及這如何影響 Wegovy 注射劑,以及競爭性上市如何影響這一切。
So I'd say it's classic variables, but it's in a very dynamic market segment.
所以我認為這些都是經典的變量,但它處於一個非常動態的市場領域。
Operator
Operator
Richard Vosser, JPMorgan.
理查沃瑟,摩根大通。
Richard Vosser - Analyst
Richard Vosser - Analyst
Just one follow-up, thinking about formulary access for Wegovy. You highlighted the access for oral Wegovy in a pill. But are you seeing and how you're thinking about that access in the commercial channel this year? It seems like maybe employers would be incentivized to maybe reduce access given the availability of products in the cash channel, at lower prices. So just thoughts on that and how that might affect the mix and volumes in that channel?
還有一個後續問題,關於 Wegovy 的處方集准入問題。您重點介紹了口服藥片形式的 Wegovy 的可及性。但您是否關注並考慮今年在商業管道中獲得這種機會?鑑於現金管道可以以更低的價格買到產品,雇主似乎可能會有動機減少員工的購買管道。那麼,您對此有何看法?這可能會如何影響該頻道的混音和音量?
And maybe a second question, just compounder volume. Obviously, a very strong oral launch, and you're saying new patients, but any evidence that those lower prices are timing the compounder volume? And any idea that you're taking share using the oral from compounders.
或許還有第二個問題,關於複利交易量。顯然,口服藥物的上市非常成功,而且您也提到了新患者,但是有沒有證據表明較低的價格會影響複方製劑的銷售呢?任何你認為你正在服用複方製劑口服藥物的想法。
Michael Novod - Head of Investor Relation
Michael Novod - Head of Investor Relation
Thanks, Richard. So two questions for Dave. One on the formulary access and also the other one on compounder.
謝謝你,理查。我有兩個問題想問戴夫。一個是關於處方集訪問的,另一個是關於配藥師的。
David Moore - Executive Vice President, US Operations
David Moore - Executive Vice President, US Operations
Yes. Thanks very much, Richard. On the injectable side, we see relatively stable access. And of course, we have discussions every year to maintain that level of access. And as you've heard us talk about before, we're very interested in reducing that friction and making the experience easier for patients.
是的。非常感謝,理查德。在註射劑方面,我們看到了相對穩定的給藥途徑。當然,我們每年都會進行討論,以維持這種程度的准入。正如您之前聽我們談到的那樣,我們非常希望減少這種摩擦,並讓患者的就醫體驗更加輕鬆。
We did have some states that have decided to not cover AOMs, for example, California is a big one. But I will say that with the lower prices that are available today, we will continue to reengage with those states with the hopes that we can increase access in Medicaid as well.
有些州已經決定不承保 AOM,例如,加州就是一個很大的例子。但我想說的是,鑑於目前較低的價格,我們將繼續與這些州重新接洽,希望也能增加醫療補助計畫的覆蓋範圍。
On the pill side, what you heard me mention is we've actually seen some positive progress in just the first month. We started out the month of January, having CVS covering it right out of the gate. And then we quickly were able to add Prime, Optum and Anthem, and we will continue to build that over the course of the year, expecting there will be both plans as well as employers that will be interested in covering the pill.
關於避孕藥方面,正如我剛才提到的,我們實際上在第一個月就看到了一些積極的進展。一月份伊始,我們就和 CVS 合作,他們一開始就承擔了所有費用。然後我們迅速增加了 Prime、Optum 和 Anthem,我們將繼續在今年擴大合作範圍,預計會有更多保險計劃和雇主對涵蓋避孕藥感興趣。
On your second question about compounding, we haven't seen a change yet. It's early days. The compounding market, what we're seeing right now is, what we would consider relatively stable. I can tell you as of this week, we have over 170,000 people that are on the Wegovy pill, and most of that is self-pay. And we get daily feeds because of the way that we went to market.
關於你提出的第二個問題,即複利效應,我們目前還沒有看到任何變化。現在下結論還為時過早。就目前我們看到的複合市場而言,我們認為它相對穩定。我可以告訴大家,截至本週,已有超過 17 萬人正在服用 Wegovy 避孕藥,其中大部分是自費患者。由於我們進入市場的方式,我們每天都能獲得飼料。
And so we certainly expect that there could be some switching that's coming from compounding, but it's a little bit early to tell and we don't get any of that longitudinal data, but we'll certainly be researching that as more data comes in.
因此,我們當然預期複利效應可能會帶來一些轉變,但現在下結論還為時過早,我們也沒有獲得任何縱向數據,但隨著更多數據的出現,我們肯定會對此進行研究。
Operator
Operator
Peter Verdult, BNP Paribas.
Peter Verdult,法國巴黎銀行。
Peter Yu - Equity Analyst
Peter Yu - Equity Analyst
Two questions. Just firstly on Martin, I realize you're not going to change the messaging on REDEFINE-4 at this culture. But can you at least remind us on trial design, was flexible dosing allowed as we saw in REDEFINE-1 or is it more fixed in nature for (inaudible) in REDEFINE-4. Basically, any major trial differences we need to be aware of when we compare REDEFINE-4 to REDEFINE-1. And then Karsten, Mike, forgive me going back to guidance, but I'm not going to ask you to go line by line every assumption.
兩個問題。首先,關於 Martin,我知道在這種文化下,你不可能改變 REDEFINE-4 的訊息傳遞方式。但您至少可以提醒我們一下試驗設計方面的狀況嗎? REDEFINE-4 是否像 REDEFINE-1 一樣允許彈性給藥,還是像(聽不清楚)那樣更固定?基本上,在比較 REDEFINE-4 和 REDEFINE-1 時,我們需要注意任何主要的試驗差異。卡斯滕,麥克,請原諒我再次強調指導原則,但我不會要求你們逐行解釋每一個假設。
But just the spirit of the guidance you provided, I mean, is this reflecting sort of genuine concerns on cannibalization and competition? Or are you simply starting the year as conservatively as you can to finally prevent this persistent earnings downgrade story from continuing through 2026.
但就您提供的指導精神而言,我的意思是,這是否反映了對蠶食和競爭的真正擔憂?或者,你只是想以盡可能保守的方式開啟新的一年,以最終阻止這種持續的盈利預期下調的局面延續到 2026 年。
Michael Novod - Head of Investor Relation
Michael Novod - Head of Investor Relation
Thank you, Pete. So two questions. First, to Martin on REDEFINE-4. And then second to Mike, on high-level guidance dynamics.
謝謝你,皮特。所以,我有兩個問題。首先,致 REDEFINE-4 的 Martin。其次是麥克,關於高層指導動態。
Martin Lange - Executive Vice President, Chief Scientific Officer, Research & Development
Martin Lange - Executive Vice President, Chief Scientific Officer, Research & Development
Absolutely. So REDEFINE-1, you're absolutely right. We basically have no new news, so we're not going to change the story. REDEFINE-4 is comparing CagriSema and (inaudible) in obese population on weight launch, testing for noninferiority first, followed by superiority testing. The dosing was similar to REDEFINE-1.
絕對地。所以 REDEFINE-1,你說得完全正確。我們基本上沒有什麼新消息,所以我們不會改變報導內容。REDEFINE-4 正在比較 CagriSema 和(聽不清楚)在肥胖者中減肥的效果,首先進行非劣效性測試,然後進行優效性測試。劑量與 REDEFINE-1 相似。
As you recall, we took some learnings from REDEFINE-1, including that we needed to do longer studies. I think we maintain what we've always said for REDEFINE-4, but we also are looking forward to REDEFINE-11 where we'll see the full weight loss potential of CagriSema.
您可能還記得,我們從 REDEFINE-1 中吸取了一些經驗教訓,包括我們需要進行更長時間的研究。我認為我們仍然堅持我們對 REDEFINE-4 的說法,但我們也期待著 REDEFINE-11,屆時我們將看到 CagriSema 的全部減肥潛力。
Unidentified Company Representative
Unidentified Company Representative
Very good. So Peter, I think I'll start by saying we have all acknowledged how volatile and dynamic the obesity market is with a lot of and lots of moving parts. The way we guide is we discuss and talk, of course, to our operating units. We take a look at the macro trends. And we put the latest information we have in place.
非常好。彼得,我想先說一句,我們都認識到肥胖市場是多麼動盪和動態,涉及很多很多方面。我們指導的方式當然是透過與營運部門討論和溝通。我們來看看宏觀趨勢。我們已將掌握的最新資訊落實到位。
We start by looking at the last year's finish and the run rate to that, especially Q4, but even more so granularly looking at the 3 months within the data that we have available. So that's kind of a starting point. Then we basically go ahead and try to see the new data we have available cost and alluded to it. We have 4 weeks of pill data. It's incredibly encouraging, and we consider that.
我們首先查看去年的最終成績和與該成績的對比情況,特別是第四季度,但更細緻地查看我們現有數據中的三個月數據。所以這算是一個起點。然後我們基本上會繼續嘗試查看我們擁有的新數據,看看成本是多少,並且已經提到過這一點。我們有4週的藥丸數據。這非常令人鼓舞,我們會認真考慮這一點。
And it's in the guidance, basically, of course, not fully knowing what's going to happen in the next 11 months, but we make some good assumptions around that. Then there are things that we have actually previously discussed with all of you. Think about the LOE and international operations. That hasn't really changed. It was there before.
當然,指導意見中也提到了這一點。我們當然無法完全預測未來 11 個月會發生什麼,但我們對此做出了一些合理的假設。還有一些事情,我們之前其實已經跟大家討論過了。考慮一下LOE和國際營運。這一點其實並沒有改變。它之前就在那裡。
It is now. We have not seen the impact of that yet. It will come into place starting from Q2. and so will solve the other things on the upside that will come in, in Q2. We just touched upon it Medicare.
現在是了。我們尚未看到其影響。它將從第二季開始實施,並解決第二季出現的其他利多因素。我們剛才簡單提到了醫療保險。
Medicare is a group of people that we would love to provide GLP-1 products to. But we haven't started yet, and it's going to basically get going in the second part of the year. So we make again assumptions around that. We put the midpoint and our own targets. And then we give it the plus or minus the 4 points on each side.
我們非常希望向聯邦醫療保險(Medicare)人群提供 GLP-1 產品。但我們還沒開始,基本上要到下半年才會啟動。所以,我們再次圍繞這一點做出假設。我們設定了中間點和自己的目標。然後我們給它加上或減去兩邊各 4 分。
And that's how we've done it in the past. That's how we've done it this year.
我們過去也是這樣做的。今年我們就是這麼做的。
Operator
Operator
Mike Nedelcovych, TD Cowen.
邁克·內德爾科維奇,TD Cowen。
Michael Nedelcovych - Analyst
Michael Nedelcovych - Analyst
I have two questions. My first is on Wegovy pill supply. Given the strong launch of Wegovy pill, is there any risk of supply outages in 2026? For example, if adoption persists at this current high level, could Novo service that demand through the end of the year with its current capacity. And then my second question is on CagriSema and REDEFINE-4.
我有兩個問題。我的第一份是Wegovy藥丸供應。鑑於 Wegovy 藥丸的強勁上市,2026 年是否有供應中斷的風險?例如,如果目前的市場需求持續保持高位,Novo 能否憑藉其目前的產能滿足到年底的需求?我的第二個問題是關於 CagriSema 和 REDEFINE-4 的。
Martin, I have to admit your response to the earlier question struck me as somewhat ominous. Why do you think we will have to wait for REDEFINE-11 readout to see the full weight loss potential of CagriSema? Why could it not be revealed by REDEFINE-4 given the changes that were made to the trial?
馬丁,我必須承認,你對先前問題的回答讓我覺得有點不祥之兆。為什麼您認為我們需要等待 REDEFINE-11 研究結果才能看到 CagriSema 的全部減肥潛力?鑑於試驗中所做的改變,為什麼 REDEFINE-4 無法揭示這一點?
Michael Novod - Head of Investor Relation
Michael Novod - Head of Investor Relation
Thank you very much. Two questions. First, to Mike on the Wegovy pill supply and the second one to Martin on both REDEFINE-4 and REDEFINE-11.
非常感謝。兩個問題。首先,感謝 Mike 提供 Wegovy 藥丸,其次,感謝 Martin 提供 REDEFINE-4 和 REDEFINE-11。
Unidentified Company Representative
Unidentified Company Representative
Thanks very much, Mike. Over the last period, a number of occasions, I have spoken to how confident we are with regards to the Wegovy pill supply. We basically have said that we launched the pill in U.S. at a time where we will be confident enough to know we will not run into supply situation anymore. We have seen an incredible uptick, I would say, in the first month.
非常感謝,麥克。在過去的一段時間裡,我曾多次談到我們對 Wegovy 藥丸供應的信心。我們基本上已經說過,我們選擇在美國推出這種藥丸,是因為我們有足夠的信心知道不會再有供應問題。我想說,第一個月我們就看到了驚人的成長。
And today, I will reaffirm to you that we feel incredibly confident that we will be able to supply the U.S. market.
今天,我再次向大家重申,我們非常有信心能夠滿足美國市場的需求。
Martin Lange - Executive Vice President, Chief Scientific Officer, Research & Development
Martin Lange - Executive Vice President, Chief Scientific Officer, Research & Development
Yes. On REDEFINE-4, we always have to think about -- when we do amendments to ongoing clients, we cannot fully guide what will happen. We can extend the study. But we also had to acknowledge that the learnings that we took from REDEFINE-1 was in pad, we needed to do longer treatment duration. But it was actually also paradoxically in part to drive even more flexible dosing securing that we actually get more patients to the higher target producing longer time, that we cannot change and REDEFINE-4.
是的。在 REDEFINE-4 中,我們始終需要考慮——當我們對正在進行的客戶進行修改時,我們無法完全控制將會發生什麼。我們可以擴大研究範圍。但我們也必須承認,我們從 REDEFINE-1 中學到的經驗還不夠充分,我們需要進行更長時間的治療。但實際上,矛盾的是,部分原因也是為了推動更靈活的給藥方案,確保我們能夠讓更多患者達到更高的目標,從而延長治療時間,而我們不能改變 REDEFINE-4。
We have optimized that in REDEFINE-11. So the trial duration, we have tried to optimize in REDEFINE-4. But in REDEFINE-11, we have taken all the learnings on titration what we call flexible titration. I'm not sure I still like the word, but what we call flexible titration and put that to use in REDEFINE-11. And we can already now see that, that does really make a difference to the patients and how they act in the trial.
我們在 REDEFINE-11 中對此進行了最佳化。因此,我們在 REDEFINE-4 中嘗試優化試驗持續時間。但在 REDEFINE-11 中,我們吸收了所有關於滴定的經驗,我們稱之為靈活滴定。我不確定我是否還喜歡這個詞,但我們稱之為靈活滴定,並在 REDEFINE-11 中加以運用。我們現在已經可以看到,這確實會對患者以及他們在試驗中的行為產生影響。
So I still have a lot of optimism on REDEFINE-4, but I think the full weight loss potential we'll only learn when we do the full trial duration and the flexible dosing that really will drive patients to use CagriSema in the optimized way.
所以我對 REDEFINE-4 仍然抱有很大的樂觀態度,但我認為只有在完成整個試驗期和靈活的劑量方案後,我們才能了解其全部的減肥潛力,這才能真正促使患者以最佳方式使用 CagriSema。
Operator
Operator
Harry Sephton, UBS.
瑞銀集團的哈里·塞普頓。
Harry Sephton - Analyst
Harry Sephton - Analyst
I have two on the Wegovy pill, please. Just wanted to start with what your expectations are for the sustainability of the Wegovy pill demand. If you wouldn't mind, is there any evidence from Novo's (inaudible) experience that points to any variation in the stay time on therapy versus the injectable? And how do you think about also the demand for the pill through the competitor or (inaudible) And then my second question is on the economics of the Wegovy pill.
我需要兩粒Wegovy避孕藥。首先我想了解您對 Wegovy 藥丸需求的可持續性有何預期。如果您不介意的話,Novo(聽不清楚)的經驗是否有任何證據表明,治療持續時間與注射治療的持續時間有任何差異?那麼,您如何看待競爭對手或(聽不清楚)對這種藥丸的需求呢?我的第二個問題是關於 Wegovy 藥丸的經濟效益。
So given the much lower price point and the much higher API demand, how does the gross margin contribution of the Wegovy pill compared to the injectable?
鑑於 Wegovy 片劑的價格遠低於注射劑,而 API 需求卻遠高於注射劑,那麼 Wegovy 片劑的毛利率貢獻與注射劑相比如何?
Michael Novod - Head of Investor Relation
Michael Novod - Head of Investor Relation
Two questions. The first on the Wegovy pill demand and dosing to Mike. And then the second one around economics to Karsten.
兩個問題。第一個關於 Wegovy 藥丸需求和劑量的問題,是給 Mike 的。然後第二個問題是關於經濟學的,問的是卡斯滕。
Unidentified Company Representative
Unidentified Company Representative
When you think about the sustainability of growth and demand, then 2 things comes to my mind. One, of course, competitive and competitive pressure as well as how much you push yourself into doing something despite the competitors. Let me start with the first one. We have gone all in. This has been the best launch partially also because we have really put in all the activities and the promotions that we could think of, not least, of course, what it was alluded to earlier on, the partnership with all of our eHealth players being available in 70,000 retail pharmacies today has been partially due to that -- has been partially the reason behind that incredible uptake.
當你思考成長和需求的可持續性時,我會想到兩件事。當然,首先是競爭和競爭壓力,以及你克服競爭壓力,努力做某件事的程度。讓我先從第一個說起。我們已經全力以赴了。這次發表會之所以如此成功,部分原因在於我們投入了所有能想到的活動和推廣,當然,正如之前提到的,我們與所有電子健康合作夥伴的合作,使得我們的產品如今已在 7 萬家零售藥店上線,這在一定程度上促成瞭如此驚人的銷量。
But then, of course, the question comes, what happens after competition arrives? Can you uphold this? Is it sustainable? I would say that the last 2 years has taught us something very specific with the obesity market. It has taught us that the criteria for a patient picking up anti-obesity medication is the magnitude of weight loss.
當然,接下來就會出現一個問題:競爭到來之後會發生什麼事?你能做到這一點嗎?它可持續嗎?我認為,過去兩年讓我們對肥胖症市場有了一些非常具體的認知。它告訴我們,患者是否需要服用抗肥胖藥物的標準是體重減輕的幅度。
And when you take a look at this, then you realized based on our latest trial, we have shown that when you take the drug, then Wegovy pill gives you 16.6% weight loss in addition to all the CV benefits and the great stuff that it has, with 16.6% weight loss. We've also read the data from our competing product, and we have seen that they are at 12.4%. If you round those things up, then you get to 17% and 12%. If you ask pretty much any patients and certainly ask me, which one would you rather take, losing 17% weight loss or 12%, I know my answer, and we have seen the answer from 170,000 employees coming on very quickly, recognizing that this is not just a pill. It's a peptide.
當你仔細觀察後,你會發現,根據我們最新的試驗,我們已經證明,服用 Wegovy 藥丸後,除了所有心血管益處和其他優點外,還能減輕 16.6% 的體重。我們也查閱了競爭產品的相關數據,發現他們的佔比為 12.4%。如果將這些數字向上取整,那麼就是 17% 和 12%。如果你問幾乎所有患者,當然也包括我,你會選擇減重 17% 還是 12%,我知道我的答案,而且我們已經從 17 萬名員工那裡很快看到了答案,他們認識到這不僅僅是一顆藥丸。它是一種勝肽。
It's a large protein inside a pill that gives you that incredible efficacy. And that has been giving us a lot of optimism, and we will continue, of course, pushing this through and promoting it. Don't be surprised if you've seen the big game on Sunday, you see us visible. And we will basically make sure that we'll do our utmost to make this still a success. Thanks Mike and Carsten.
藥片含有一種大型蛋白質,正是這種蛋白質賦予了它驚人的療效。這給了我們很大的樂觀,我們當然會繼續推進和推廣這項工作。如果你看了周日的比賽,不要感到驚訝,你會看到我們的身影。我們將盡一切努力確保此事成功。謝謝Mike和Carsten。
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Thanks, Eric, for the manufacturing economics question. On gross margin, the short version is that the gross margin on the Wegovy pill is below that of the Wegovy injectable, but it's important to know that it's lower on gross margin level, but it's still an attractive gross margin. So we are all in pushing the pill. And of course, the overarching intention is to expand the markets and not cannibalize from our own products.
謝謝艾瑞克提出的製造業經濟學問題。就毛利率而言,簡而言之,Wegovy 片劑的毛利率低於 Wegovy 注射劑,但重要的是要知道,雖然它的毛利率較低,但仍然是一個有吸引力的毛利率。所以我們都在努力推廣避孕藥。當然,我們的整體目標是拓展市場,而不是蠶食自己的產品。
Operator
Operator
Thibault Boutherin, Morgan Stanley.
Thibault Boutherin,摩根士丹利。
Thibault Boutherin - Analyst
Thibault Boutherin - Analyst
First question, just on Ozempic and the timing of implementation of the MFN price. When does the MFN negotiated price kick in for Medicare and Medicaid this year, and is there any associated volume uplift given it's already covered? Or should you expect market share loss to sort of erase the benefit.
第一個問題,僅關於 Ozempic 和最惠國待遇價格的實施時間。今年聯邦醫療保險和醫療補助計劃何時開始實行最惠國待遇協商價格?鑑於該價格已被納入健保範圍,是否會有相關的銷售成長?或者,您應該預期市場佔有率的損失會抵銷這些收益?
And then just the second question, I guess, for Martin on the profile of Wegovy pill, just in order to understand the adherence, you help us with what happened to a patient if they missed a pill for a day or a couple of days how does that impact efficacy in terms of weight loss. And then similarly, on tolerability, if a patient is at the highest dose for some reason missed a few days of pill, can they go back and resume on 25-milligram, and what -- how do side effects look like?
那麼,第二個問題,我想問的是馬丁關於 Wegovy 藥丸的概況,為了了解依從性,請您幫助我們了解如果患者漏服一天或幾天藥丸會發生什麼情況,這會對減肥效果產生什麼影響。同樣地,關於耐受性,如果患者由於某種原因漏服了幾天的藥,而他正在服用最高劑量,他是否可以恢復服用 25 毫克,以及副作用是什麼樣的?
Michael Novod - Head of Investor Relation
Michael Novod - Head of Investor Relation
Okay. Two questions. First on Ozempic and MFN for you, Dave. And then the second question for you, Martin.
好的。兩個問題。Dave,這是Ozempic和MFN上的第一則訊息。那麼,馬丁,第二個問題要問你。
David Moore - Executive Vice President, US Operations
David Moore - Executive Vice President, US Operations
Yes. Thank you, Thibault . With respect to Ozempic, as you know, we have Medicare coverage right now in the diabetes. And so with respect to MFN as well as MSP. That's more of a 2027 event.
是的。謝謝你,蒂博。關於 Ozempic,如您所知,目前糖尿病患者可以獲得醫療保險的報銷。因此,對於最惠國待遇和最低支援價格而言也是如此。那更像是2027年才會發生的事。
Of course, we did make Ozempic available in self-pay. And as I mentioned, we're seeing about scripts a week now in self-pay for those patients that don't have coverage. But the MFN and MFP is more of a 2027 event.
當然,我們也提供了自費購買 Ozempic 的服務。正如我之前提到的,現在每周大約有幾張處方是為那些沒有醫療保險的患者自費開的。但最惠國待遇和多用途糧食政策更像是 2027 年才會發生的事情。
Martin Lange - Executive Vice President, Chief Scientific Officer, Research & Development
Martin Lange - Executive Vice President, Chief Scientific Officer, Research & Development
Absolutely on the Wegovy pill. We do know that, in general, when patients are on chronic treatment, sometimes they skip a dose, it is important to remind ourselves that semaglutide is semaglutide and the half-life of semaglutide once in steady state is very long, basically, as you know, also in the subcutaneous state, allowing for once weekly doses.
絕對在服用Wegovy藥丸。我們知道,一般來說,當患者接受長期治療時,有時會漏服一次劑量。重要的是要記住,索馬魯肽是索馬魯肽,一旦達到穩態,索馬魯肽的半衰期就非常長,基本上,正如您所知,皮下注射也是如此,因此可以每週給藥一次。
That basically means that when you are on a stable dose on the Wegovy pill and then skip a dose, it doesn't have a huge impact on your blood exposure in that period of time. And you can also then reinitiate at the 25-milligram dose without experiencing any untoward effects. So from that perspective, semaglutide is a semaglutide and we are benefiting from the long half-life of semaglutide also in the oral delivery.
這基本上意味著,當你服用 Wegovy 藥片的劑量穩定時,如果漏服一次,不會對你這段時間內的血液暴露量產生巨大影響。而且,您可以重新開始服用 25 毫克劑量,而不會出現任何不良反應。所以從這個角度來看,索馬魯肽就是索馬魯肽,我們也受益於索馬魯肽的長半衰期,口服給藥也是。
Other orals would have with shorter half-life a much different profile because that will both impact the potential efficacy, but also the potential tolerability if you skip 1 or 2 doses. Operator, we'll do two more questions.
其他口服藥物由於半衰期較短,其特性將大不相同,因為這不僅會影響潛在的療效,還會影響漏服 1 或 2 次劑量時的潛在耐受性。操作員,我們再問兩個問題。
Operator
Operator
Carsten Lombard Madsen, Danske Bank.
卡斯滕·隆巴德·馬德森,丹麥銀行。
Carsten Lønborg Madsen - Analyst
Carsten Lønborg Madsen - Analyst
Thank very much. In terms of CapEx, we again this year, guide for a relatively high CapEx level in terms of billion has been spent. Can you confirm that the API build-out is on track because it feels like there's entire programs taking longer and is being much more expensive than what we expected some years ago. And secondly, on the high doses Wegovy approval, which we're hopeful to see soon. Also, will you be launching immediately.
非常感謝。就資本支出而言,我們今年再次預期資本支出水準將相對較高,已支出數十億美元。能否確認 API 的建置是否按計畫進行?因為感覺有些項目耗時更長,成本也比我們幾年前預期的要高得多。其次,關於高劑量 Wegovy 的批准,我們希望很快就能看到。另外,你們會立即發布嗎?
Can you confirm that? And then which type of (inaudible) will you be launching?
能確認一下嗎?那麼,你們會推出哪種類型的(聽不清楚)呢?
Michael Novod - Head of Investor Relation
Michael Novod - Head of Investor Relation
Thank you, Carsten. And first, on CapEx to Karsten and then the second question on 7.2 to Mike.
謝謝你,卡斯滕。首先,關於資本支出的問題,請 Karsten 回答;然後,關於 7.2 的第二個問題,請 Mike 回答。
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Yes. Thank you for that question, Carsten. And as I said earlier on the we are moving downwards in terms of CapEx. This is the first step down, and then we expect to see a steeper slope in the coming years. And it really links to finalization of projects approved in prior years.
是的。謝謝你的提問,卡斯滕。正如我之前所說,我們在資本支出方面正在下調。這是下降的第一步,我們預計未來幾年下降幅度會更大。這與前幾年批准的項目的最終完成密切相關。
As it is with projects, some are ahead, some are behind, but in the broad scheme, we are on track. Specifically for API, we do expect to have some of the new major API facilities online already this year and more to come in the coming years.
專案總是如此,有些專案進展順利,有些專案進展緩慢,但總體而言,我們正按計劃進行。具體到 API 方面,我們預計今年將有一些新的、主要的 API 設施上線,未來幾年將有更多設施上線。
Unidentified Company Representative
Unidentified Company Representative
And Karsten, with regards to the 7.2 Wegovy high dose, Then, as you know, we have filed in December last year under the CNTV voucher program. And we have announced that we should expect the approval, hopefully, in this quarter. As soon as we get the approval, we are ready to launch.
卡斯滕,關於 7.2 Wegovy 高劑量,正如您所知,我們去年 12 月已根據 CNTV 代金券計劃提交了申請。我們已經宣布,預計在本季度獲得批准。一旦獲得批准,我們即可啟動。
So we will not sit on that regulatory approval. And we will go all in again because I think this is really, really important that the world a little bit understands that medicine is dosed differently and depending on how you dose things, you get a different effect of it.
所以,我們不會坐等監管部門的批准。我們將再次全力以赴,因為我認為讓世界稍微了解一下藥物的劑量不同,並且根據劑量的不同,會產生不同的效果,這一點真的非常重要。
And right now, semaglutide at 2.4 milligram is giving us 15%, 16% weight loss to separate that 15-milligram dosing gives you 20%, 21%. We have shown in a step up that when you increase the dose o to sema 7.2 million you get very close on par with trecepatide, and I think it's actually very important that the world gets to know this and then they can judge that on top of -- on par weight loss, you have also CV benefit, kidney benefits and liver benefits and then people can pick and choose which option they want. So it's very important that we go all in with that and we're planning to do so. And we will actually I think there was a question, and we will launch it in the same type of devices that we currently have available to start with.
目前,2.4 毫克的索馬魯肽可使體重減輕 15%、16%,而 15 毫克的劑量可使體重減輕 20%、21%。我們已經證明,當劑量增加到 720 萬時,塞瑪肽的效果非常接近曲塞帕肽。我認為讓全世界知道這一點非常重要,這樣人們就可以判斷,除了減肥效果相當之外,它還有心血管、腎臟和肝臟方面的益處,然後人們可以根據自己的需求選擇合適的方案。所以,全力以赴地去做這件事非常重要,我們也正計劃這樣做。實際上,我認為之前有人問過這個問題,我們會先在目前已有的同類型設備上推出這款產品。
Operator
Operator
Simon Baker, Rothschild & Co.
西蒙貝克,羅斯柴爾德公司
Simon Baker - Analyst
Simon Baker - Analyst
Two quick questions, if I may. The first one is just going back to the guidance question that's been repeatedly asked conceptually, would it be fair to say that because you have high visibility on pricing impact and low visibility on volume uplift, that is one of the key things that is reflected in your guidance? And the sort of second part that's related to that.
可以請教兩個問題嗎?第一個問題回到之前反覆提出的指導性問題,從概念上講,是否可以這樣說,因為您對價格影響有很高的可見性,而對銷量提升的可見性很低,所以這是您的指導性中反映的關鍵因素之一?以及與此相關的第二部分。
I just wonder if you could update us on your assumptions for generic competition in IO, specifically Canada. The reason I ask is we understand that all of the semaglutide generics have had notices of deficiency slapped on them by Health Canada and the expectation is they will not resolve until the midyear.
我想請您介紹一下您對印度洋地區(特別是加拿大)通用產品競爭的假設。我這樣問是因為我們了解到,加拿大衛生部已經對所有司美格魯肽仿製藥發出了缺陷通知,預計這些問題要到年中才能解決。
So generic semaglutide in Canada is at 2H rather than a 1H phenomenon. I'd be interested to get your thoughts on that and the extent, if any, to which that's reflected in the guidance.
因此,加拿大的通用索馬魯肽屬於 2H 現象,而非 1H 現象。我很想聽聽您對此的看法,以及相關指導在多大程度上(如果有的話)體現了這一點。
Michael Novod - Head of Investor Relation
Michael Novod - Head of Investor Relation
Two questions, more or less boiled down to one on the guidance dynamics again, Karsten.
卡斯滕,兩個問題,或多或少都歸結為一個關於導引動力學的問題。
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
So Simon, thanks for these questions. Whether how we detail build it, I'll say, for mature reimbursed brands, I think they are very mature, established trend lines for volume trends measured as (inaudible) and we have a good feeling for the prices have been contracted, et cetera. So for our mature reimbursed brands, that's -- I'd say that's reasonably straightforward.
西蒙,謝謝你的提問。至於我們如何詳細建立它,我想說,對於成熟的報銷品牌,我認為它們非常成熟,銷售趨勢線已經確立(聽不清楚),我們對價格已經簽訂合約等情況也有很好的了解。所以對於我們成熟的報銷品牌來說,這——我認為這相當簡單明了。
Where we see the uncertainty is how can I put it in the self-pay type channel because the price elasticity in the self-pay channel is something that we're still exploring. And as Dave was covering before, then we've seen a fantastic uptake of the Wegovy pill here in the first 4 weeks.
我們看到的不確定性在於如何將其納入自費管道,因為自費管道的價格彈性是我們仍在探索的問題。正如戴夫之前報導的那樣,在最初的 4 周里,我們看到 Wegovy 藥丸的使用率非常高。
But we also know that obesity self-pay is a super dynamic segment. So exactly how that works across the year, to what extent there are seasonalities, et cetera, stay time, sourcing, cannibalization, competition. Clearly, there are uncertainties there. And we put our best assumptions in, and it can go both ways. We can both have an upside and a downside.
但我們也知道,肥胖症自費治療是一個變化非常迅速的領域。那麼,全年究竟是如何運作的,季節性因素在多大程度上存在,以及停留時間、貨源、蠶食、競爭等因素。顯然,這裡面存在不確定性。我們只能做出最好的假設,但結果可能截然相反。我們兩者都有優勢也有劣勢。
And that's why we work with range. For Canada, specifically in our guidance, as we said in prior quarters that sema LOE in international markets will impact group sales by low single digits. Canada is the biggest contributor. And of course, we put in assumptions around timing of of generic launches, approvals and launches. We don't have detailed insights into the status of those price and remediation of these notices of deficiencies.
這就是我們採用範圍制的原因。對於加拿大,具體而言,正如我們在前幾個季度中所說,國際市場的 sema LOE 將對集團銷售額產生個位數低點的影響。加拿大是最大的貢獻國。當然,我們也對仿製藥的上市、核准和發售時間做出了假設。我們對這些價格和缺陷通知的補救措施的現狀沒有詳細的了解。
But obviously, the time is a key variable in terms of impact. I think the direction of travel is the same. But there could be both an upside and a downside to our guidance depending on the pace of approval of generics in Canada. So it remains to be seen.
但很顯然,時間是影響效果的關鍵變數。我認為行進方向是一樣的。但根據加拿大仿製藥審批的速度,我們的預測可能會有上升空間,也可能有下降空間。所以,這還有待觀察。
Unidentified Company Representative
Unidentified Company Representative
Great. Thank you, Karsten. Thank you, Simon. This also concludes the Q&A session. Thank you for participating, and please feel free to contact Investor Relations regarding any follow-up questions you might have.
偉大的。謝謝你,卡斯滕。謝謝你,西蒙。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。
Before we close the call, I would like to hand over to you, Mike, again for the final remarks.
在結束通話之前,我想再次把麥克風交給你,麥克,請你做最後的總結發言。
Michael Novod - Head of Investor Relation
Michael Novod - Head of Investor Relation
Thank you very much, Michael. I want to start by thanking Ludovic and Dave for all you have done for Novo Nordisk over the many, many years. I also once again to welcome Jamie and Hung and stress that I'm looking very much forward to working with both of you. 2026 will be basically a year where we will face some headwinds, especially on the back of the price declines. And we have shown that in our guidance today.
非常感謝你,麥可。首先,我要感謝 Ludovic 和 Dave 多年來為諾和諾德所做的一切。我再次歡迎Jamie和Hung的加入,並強調我非常期待與你們二位共事。 2026年我們將面臨一些挑戰,尤其是在價格下跌的背景下。我們在今天的指導方針中已經證明了這一點。
But I also like to say that price reduction in some ways is our investment for the future and for capturing more patients. Perhaps no other company better than Novo Nordisk is geared in improving health at scale within the field of diabetes and obesity, and we're ready to do that.
但我還想說,降價在某種程度上是我們對未來的投資,也是為了吸引更多患者。在糖尿病和肥胖症領域,或許沒有一家公司比諾和諾德更致力於大規模改善人們的健康,而我們也已經做好了準備。
And I believe much stronger than with affordable prices, we can get to those higher volumes faster. We are looking very much forward, of course, as we go forward to share more information with you, not least about the continuous uptake of the phenomenal Wegovy pill, success that we have seen, but maybe also much more exciting readouts and regulatory milestones throughout the year across all of our therapy areas. With that, I'd like to thank all of you guys for joining us today.
而且我相信,比起價格實惠,我們可以更快達到更高的銷售量。當然,我們非常期待與大家分享更多信息,特別是關於威戈維(Wegovy)這種神奇藥丸的持續推廣和我們所取得的成功,以及今年在我們所有治療領域可能取得的更多激動人心的成果和監管里程碑。最後,我要感謝各位今天蒞臨現場。
Thank you.
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了。