諾和諾德報告稱,2024 年銷售額和營業利潤將成長 26%,重點關注糖尿病和肥胖症治療。他們強調了對永續發展和研發進步的承諾,特別是在 CagriSema 等肥胖症治療領域。
該公司的 GLP-1 和胰島素產品實現了成長,保持了糖尿病護理市場的領先地位,並透過收購實現了全球擴張。他們討論了未來的里程碑、財務表現和 2025 年的計劃,強調了他們強大的產品組合和以患者為中心的方法。
問答環節涵蓋了患者對治療的反應、市場定位和供應鏈挑戰等主題。諾和諾德對其業績和未來前景依然保持樂觀。
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.
您好,感謝您的支持。
Welcome to the full year 2024 Novo Nordisk earnings conference call.
歡迎參加諾和諾德 2024 年全年財報電話會議。
(Operator Instructions) Please be advised that today's conference is being recorded.
(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 Martin Rode, Head of Investor Relations.
現在,我想將會議交給今天的第一位發言者,投資者關係主管雅各布·馬丁·羅德 (Jacob Martin Rode)。
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thank you.
謝謝。
Welcome to this Novo Nordisk Earnings call for the full year of 2024.
歡迎參加諾和諾德 2024 年全年財報電話會議。
My name is Jacob Martin, and I'm the Head of Investor Relations at Novo Nordisk.
我叫雅各馬丁 (Jacob Martin),是諾和諾德公司的投資人關係主管。
With me today, I have CEO of Novo Nordisk.
今天和我一起的還有諾和諾德公司的執行長。
Lars Jorgensen, Executive Vice President and Head of Commercial Strategy and Corporate Affairs, Camilla Sylvest, Executive Vice President, US Operations and Head of Global Business Development, Dave Moore, Executive Vice President and Head of Development, Martin Hollinger; and finally, Chief Financial Officer, Karsten Knudsen.
執行副總裁兼商業策略與公司事務主管 Lars Jorgensen、美國營運執行副總裁兼全球業務發展主管 Camilla Sylvest、執行副總裁兼發展主管 Dave Moore、Martin Hollinger;最後是財務長 Karsten Knudsen。
All speakers will be available for the Q&A session.
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.
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,錄音也將在我們的網站上發布。
The call is scheduled to last one hour and 15 minutes.
此次通話預計將持續一小時十五分鐘。
Please turn to the next slide.
請翻到下一張投影片。
The presentation is structured as outlined on slide 2.
簡報的結構如投影片 2 所示。
Please note that all sales and operating profit growth statements will be at constant exchange rates unless otherwise specified.
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.
請翻到下一張投影片。
We need to advise you that this call will contain forward-looking statements.
我們需要提醒您,本次電話會議將包含前瞻性陳述。
These are subject to risks and uncertainties that could cause actual results to differ materially from expectations.
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。
For further information on risk factors, please see the company announcement for the full year of 2024 and the slides prepared for this presentation.
有關風險因素的更多信息,請參閱 2024 年全年公司公告和為本次演示準備的幻燈片。
With that, over to you, Lars, for an update on our strategic aspirations.
現在,拉爾斯 (Lars),請您來介紹一下我們的戰略抱負的最新情況。
Lars Fruergaard Joergensen - President, Chief Executive Officer
Lars Fruergaard Joergensen - President, Chief Executive Officer
Thank you, Jacob.
謝謝你,雅各。
Next slide, please.
請看下一張投影片。
In 2024, we delivered 26% sales growth and 26% operating profit growth.
2024年,我們的銷售額成長26%,營業利潤成長26%。
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.
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中的績效亮點。
Starting with our focus on purpose and sustainability.
從我們對目標和永續性的關注開始。
We are now serving more than 45 million patients with our diabetes and obesity treatments.
我們目前為超過 4500 萬名患者提供糖尿病和肥胖症治療服務。
This is an increase of almost 4 million patients compared to last year and reflects our continued capacity expansion efforts.
與去年相比,這增加了近 400 萬名患者,反映了我們持續的容量擴張努力。
Our total carbon emissions rose by 23%, compared to 2023.
與 2023 年相比,我們的碳排放量總量增加了 23%。
This was mainly driven by our increased production volumes and increased investments in capital expenditure to meet the high demand for our innovative treatments.
這主要是由於我們增加了產量並增加了資本支出投資以滿足對創新治療方法的高需求。
To uphold our commitment of being a sustainable employer, we expanded a number of women in senior leadership positions to 42% compared to around 41% last year.
為了履行我們作為永續雇主的承諾,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 have -- we had several exciting obesity readouts this quarter such as CagriSema, semaglutide 7.2 milligram and amycretin.
在研發方面,本季我們有幾個令人興奮的肥胖數據,例如 CagriSema、semaglutide 7.2 毫克和 amycretin。
These results reinforce our strategic aspiration of developing superior treatment solutions for people living with obesity.
這些結果強化了我們為肥胖患者開發卓越治療方案的策略性意願。
For CagriSema, we remain confident in its potent biology and look forward to further exploring its potential and to making it available to patients.
對於 CagriSema,我們對其強大的生物學能力充滿信心,並期待進一步探索其潛力並將其提供給患者。
Martin will come back to this and overall R&D milestones later.
馬丁稍後會回顧這一情況以及整體研發里程碑。
The quarterly sales growth reflects solid commercial execution across both operating units.
季度銷售額的成長反映了兩個營運部門穩健的商業執行。
Camilla and Dave will go through the details later.
卡米拉和戴夫稍後會討論詳細情況。
Karsten will go through the financial details, but I'm pleased with the sales growth of 26% in 2024 as well as attractive growth outlook for 2025.
Karsten 將介紹財務細節,但我對 2024 年 26% 的銷售成長以及 2025 年誘人的成長前景感到滿意。
Now, I would like to hand over the word to Camilla for an update on commercial execution in 2024.
現在,我想將 2024 年商業執行的最新進展交給卡米拉。
Camilla Sylvest - Executive Vice President - Commercial Strategy and Corporate Affairs
Camilla Sylvest - Executive Vice President - Commercial Strategy and Corporate Affairs
Thank you, Lars, and please turn to the next slide.
謝謝你,拉爾斯,請翻到下一張投影片。
In 2024, our total sales increased by 26%, and the sales growth was driven by both operating units with North American operations growing 30% and international operations growing 19%.
2024 年,我們的總銷售額成長了 26%,銷售成長由兩個營運部門共同推動,其中北美業務成長 30%,國際業務成長 19%。
In the US, sales growth was positively impacted by gross to net sales adjustments.
在美國,銷售成長受到毛銷售額與淨銷售額調整的正面影響。
Our GLP-1 sales in diabetes increased by 22%, driven by North America operations growing 23% and international operations growing 18%.
我們的糖尿病領域的 GLP-1 銷售額成長了 22%,其中北美業務成長了 23%,國際業務成長了 18%。
Insulin sales increased by 17%, driven by North America operations growing 52%, positively impacted by gross to net sales adjustments and international operations growing 6%.
胰島素銷售額成長了 17%,其中北美業務成長了 52%,受到毛銷售額對淨銷售額調整和國際業務成長 6% 的正面影響。
Obesity care sales increased 57%, driven by North America operations growing 45% and international operations growing 107%.
肥胖護理銷售額成長了 57%,其中北美業務成長了 45%,國際業務成長了 107%。
In both geographies, growth was driven by Wegovy, partly offset by declining Saxenda sales as the obesity care market is moving towards once-weekly treatment.
在這兩個地區,成長都由 Wegovy 推動,但隨著肥胖護理市場逐漸轉向每週一次的治療,Saxenda 銷售額的下滑部分抵消了這一增長。
Rare disease sales increased by 9%, driven by a 20% increase in North America operations.
罕見疾病銷售額成長了 9%,這得益於北美業務成長了 20%。
And rare disease sales in international operations remained unchanged compared to last year.
國際業務中罕見疾病的銷售額與去年相比保持不變。
Please turn to the next slide.
請翻到下一張投影片。
I would like to reiterate our commitment to continue reaching more patients with our innovative treatments.
我想重申我們致力於繼續透過創新治療方法來惠及更多患者的承諾。
Today, Novo Nordisk is the global GLP-1 volume market leader serving nearly two-thirds of all patients on GLP-1 treatments across diabetes and obesity.
如今,諾和諾德是全球 GLP-1 產量市場的領導者,為近三分之二的糖尿病和肥胖症 GLP-1 治療患者提供服務。
Our ongoing scaling efforts have supported an almost tripling of GLP-1 patient reached over the last three years.
我們持續的擴大努力使得 GLP-1 患者數量在過去三年內增加了近三倍。
In December 2024, we announced that the acquisition of the Catalent sites from Novo Holdings was completed.
2024 年 12 月,我們宣布完成從 Novo Holdings 收購 Catalent 工廠的交易。
This transaction supports our ongoing scaling efforts and will expand Novo Nordisk global fill and finish footprint from 11 to 14 sites.
這項交易支持了我們正在進行的擴大規模的努力,並將使諾和諾德的全球灌裝和精加工業務從 11 個地點擴展到 14 個地點。
We still expect the three sites to gradually increase market supply beyond our pre-existing CMO contracts to the market from '26 and allow us to reach significantly more patients in the years to come.
我們仍然預計,從26年開始,這三個工廠將逐步增加市場供應量,超越我們現有的CMO合同,並使我們能夠在未來幾年接觸到更多的患者。
Please turn to the next slide.
請翻到下一張投影片。
Within Diabetes Care, sales growth was 20%, driven by our GLP-1 portfolio and Insulin.
在糖尿病照護領域,銷售額成長了 20%,這得益於我們的 GLP-1 產品組合和胰島素。
We sustained our diabetes value market share leadership with an unchanged market share of 33.7%, compared to last year.
與去年相比,我們繼續保持糖尿病價值市場份額的領先地位,市場份額保持不變,為 33.7%。
This remains above our strategic aspiration of reaching one-third of the global diabetes value market in 2025.
這仍然高於我們在 2025 年佔據全球糖尿病價值市場三分之一的策略目標。
Please turn to the next slide.
請翻到下一張投影片。
In International Operations, diabetes care sales increased by 12% in 2024, which was mainly driven by GLP-1, diabetes care sales growing 18%.
在國際業務方面,2024年糖尿病照護銷售額將成長12%,主要受GLP-1的推動,糖尿病照護銷售額將成長18%。
Novo Nordisk remains the market leader in international operations with a GLP-1 diabetes value market share of almost 64%.
諾和諾德仍保持國際業務市場的領先地位,GLP-1 糖尿病價值市佔率接近 64%。
And with that, I would hand over the word to Dave.
說完這些,我就把麥克風交給了戴夫。
David Moore - Executive Vice President - Corporate Development
David Moore - Executive Vice President - Corporate Development
Thank you, Camilla.
謝謝你,卡米拉。
Please turn to the next slide.
請翻到下一張投影片。
Sales of GLP-1 diabetes care products in the US increased by 24%.
美國GLP-1糖尿病照護產品的銷售額成長了24%。
The sales increase was mainly driven by the continued uptake of Ozempic and the GLP-1 class growth.
銷售額的成長主要得益於 Ozempic 的持續成長和 GLP-1 類藥物的成長。
Novo Nordisk remains the market leader in the US with more than 52% market share measured by total monthly prescriptions.
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 52%。
Please turn to the next slide.
請翻到下一張投影片。
Wegovy sales increased by 86% globally, driven by a 59% growth in North America operations.
受北美業務 59% 成長的推動,Wegovy 全球銷售額成長了 86%。
And Wegovy sales in international operations have reached more than DKK11 billion.
其中Wegovy國際業務銷售額已超過110億丹麥克朗。
The global total branded obesity market more than doubled with a growth rate of 119%.
全球品牌肥胖市場總量成長了一倍多,成長率為 119%。
In the US, the Wegovy sales growth was driven by increased volumes partially countered by lower realized prices in the US.
在美國,Wegovy 銷售成長主要得益於銷售成長,但美國實際價格下降部分抵銷了這一成長。
The positive volume development was also reflected in the Wegovy prescription trends in the US, which currently is around 200,000 weekly prescriptions.
美國的 Wegovy 處方趨勢也反映了積極的數量發展,目前每週的處方量約為 200,000 張。
That's compared to around 100,000 weekly prescriptions in January 2024.
相較之下,2024 年 1 月每週的處方量約為 10 萬張。
We have reached broad formulary access for Wegovy in the US and continue to work on expanding it further.
我們已經在美國獲得了 Wegovy 的廣泛處方權,並繼續致力於進一步擴大其範圍。
Currently, Wegovy has coverage for around 55 million people living with obesity in the United States.
目前,Wegovy 已為美國約 5,500 萬肥胖患者提供保險。
In International Operations, Wegovy has now been launched in more than 15 countries, underlining our commitment to reaching more patients.
在國際營運方面,Wegovy 現已在 15 多個國家推出,彰顯了我們致力於惠及更多病患的承諾。
Next slide, please.
請看下一張投影片。
Our Rare Disease sales increased by 9%.
我們的罕見疾病銷售額成長了 9%。
This was driven by sales in North America operations of 20%, while sales in International Operations were unchanged.
這是由於北美業務的銷售額成長了 20%,而國際業務的銷售額則保持不變。
Sales of rare endocrine disorder products increased by 31%, driven by launches of Sogroya and increased Norditropin supply as well as a positive impact from gross to net sales adjustments in the US.
罕見內分泌疾病產品的銷售額成長了 31%,這得益於 Sogroya 的推出和 Norditropin 供應的增加,以及美國毛銷售額向淨銷售額調整的正面影響。
Rare blood disorder sales increased by 3%, driven by an increase in Hemophilia B sales.
罕見血液疾病銷售額成長了 3%,這得益於血友病 B 銷售額的成長。
Now, I will turn it over to Martin for an R&D update.
現在,我將把它交給馬丁來報告研發更新。
Martin Lange - Executive Vice President - Development
Martin Lange - Executive Vice President - Development
Thank you, Dave.
謝謝你,戴夫。
Please turn to the next slide.
請翻到下一張投影片。
In December, Novo Nordisk released the headline results from the first pivotal trial with CagriSema, redefined one and people living with obesity or overweight.
12 月,諾和諾德發布了與 CagriSema 合作進行的首次關鍵試驗的主要結果,重新定義了肥胖或超重人群。
Before getting into the results, I would like to quickly touch upon the trial design.
在討論結果之前,我想先快速談談試驗設計。
Based on the CagriSema weight loss data observed in Phase 1 and 2 trials, we incorporated a flexible protocol in REDEFINE 1.
根據第 1 階段和第 2 階段試驗中觀察到的 CagriSema 減重數據,我們在 REDEFINE 1 中加入了靈活的協議。
The protocol followed a 16-week titration schedule and permitted dose modifications based on tolerability or concerns about excessive weight loss throughout the trial.
該方案遵循 16 週的滴定計劃,並允許根據耐受性或對整個試驗期間體重過度減輕的擔憂調整劑量。
This was done to balance efficacy, tolerability and trial dropout.
這樣做是為了平衡功效、耐受性和試驗退出率。
REDEFINE 1 was a 68-week efficacy and safety trial with 3,417 people enrolled.
REDEFINE 1 是一項為期 68 週的療效和安全性試驗,共有 3,417 人參與。
People were randomly assigned to either receive CagriSema, a fixed dose combination of aquilintide 2.4 milligram and semaglutide 2.4 milligram or Cagrilintipe 2.4 milligram in monotherapy, semaglutide 2.4 milligram in monotherapy or placebo.
受試者被隨機分配接受 CagriSema(2.4 毫克阿奎林肽和 2.4 毫克索馬魯肽的固定劑量組合)或 Cagrilintipe 2.4 毫克單藥治療、索馬魯肽 2.4 毫克單藥治療或安慰劑治療。
In line with the regulatory guidelines, the purpose of the trial was to demonstrate superiority of CagriSema over placebo, cagilentide and semaglutide on body weight reduction.
根據監管指南,該試驗的目的是證明 CagriSema 在減輕體重方面優於安慰劑、卡吉倫肽和司美魯肽。
Next slide, please.
請看下一張投影片。
Previous trials in our modeling indicated that CagriSema could provide a potential weight loss of approximately 25%.
我們模型中的先前試驗表明,CagriSema 可帶來約 25% 的潛在減重效果。
While the 25% weight loss was not observed in Redefine 1, we are encouraged by the weight loss profile of CagriSema, which stands out as one of the most substantial weight reductions observed in a clinical Phase 3a trial.
雖然在 Redefine 1 中沒有觀察到 25% 的體重減輕,但 CagriSema 的減肥概況讓我們感到鼓舞,它是臨床 3a 期試驗中觀察到的最顯著的體重減輕之一。
From a mean baseline body weight of 106.9 kilograms CagriSema demonstrated a superior and clinically relevant loss of 22.7% of body weight after 68 weeks, compared to reductions of 11.8% with cagrilintide, 16.1% semaglutide, and 2.3% of placebo.
從平均基線體重 106.9 公斤開始,CagriSema 治療 68 週後顯示出卓越的臨床相關性減重效果,減重 22.7%,而卡格林肽減重 11.8%,索馬魯肽減重 16.1%,安慰劑減重 2.3%。
In the trial, CagriSema appeared to have a safe and well-tolerated profile.
在試驗中,CagriSema 似乎具有安全性和良好的耐受性。
The most common adverse events were gastrointestinal with the vast majority being mild to moderate and decreasing over time in line with GLP-1 receptor agonist class.
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,且隨著時間的推移而減少,與 GLP-1 受體激動劑類一致。
Generally, we observed a low level of gastrointestinal adverse events.
總體而言,我們觀察到較低的胃腸道不良事件。
People on CagriSema experienced 2.8 gastrointestinal events per patient per year compared to 1.2 on cagrilintide and 2.6% on semaglutide 2.4 milligram.
服用 CagriSema 的患者每位患者每年經歷 2.8 次胃腸道事件,而服用卡格林肽的患者每位患者每年經歷 1.2 次,服用 2.4 毫克索馬魯肽的患者每位患者每年經歷 2.6%。
Discontinuation rates due to gastrointestinal-related adverse events were also low with 3.6% in the CagriSema arm.
CagriSema 組因胃腸道相關不良事件導致的停藥率也很低,為 3.6%。
For both the capuilentide and the semaglutide arm, the gasolines discontinuation were 1.3%.
對於卡普崙肽和索馬魯肽組,汽油停藥率均為 1.3%。
Notably, the severity of gastrointestinal events for CagriSema was similar to the comparator.
值得注意的是,CagriSema 的胃腸道事件的嚴重程度與比較劑相似。
As a reference, in Step 1, semaglutide 2.4 milligram had a destination rate due to gastrointestinal-related adverse event of 4.5%.
作為參考,在步驟 1 中,司美魯肽 2.4 毫克因胃腸道相關不良事件導致的終點率為 4.5%。
Lastly, the overall discontinuation rate for CagriSema was 11.7%.
最後,CagriSema 的整體停藥率為 11.7%。
For comparison, semaglutide showed a discontemaglutide showed a discontinuation rate of 17% in Step 1.
相較之下,索馬魯肽在步驟 1 的停藥率為 17%。
In the REDEFINE 1 trial, the extended dose modification promited us to conduct a more in-depth analysis of people receiving the highest dose at 68 weeks, followed by an analysis of people on lower doses at six weeks.
在 REDEFINE 1 試驗中,延長劑量調整促使我們對 68 週時接受最高劑量的人進行更深入的分析,然後對 6 週時接受較低劑量的人進行分析。
In the following slide, I will guide you through a post hoc analysis based on these two subgroups and share some reflections and considerations regarding the data.
在下面的幻燈片中,我將指導您進行基於這兩個子組的事後分析,並分享一些有關數據的思考和考慮。
Next slide, please.
請看下一張投影片。
The first subgroup comprised 57% of the total population and consisted of people in the trial, we ended on the highest 2.4 milligram dose of CagriSema at 68 weeks.
第一個亞組佔總人口的 57%,由試驗人員組成,我們在 68 週時結束了最高劑量的 2.4 毫克 CagriSema。
The second group accounted for 29% of the population consisted of those who were at lower doses of CagriSema at 68 weeks.
第二組佔人口的 29%,由在 68 週時服用較低劑量 CagriSema 的人組成。
The remaining 14% of the population were on either treatment post or have been discontinued at 68 weeks.
其餘 14% 的人口正在接受治療或在 68 週時停止治療。
The First Shop Group achieved a 12.7% mean weight loss at 20 weeks and a full 22.2% mean weight loss at 68 weeks.
第一家商店組在第 20 週時平均減重 12.7%,在第 68 週時平均減重 22.2%。
The weight loss trajectory for the first shop group did not plateau at 68 weeks.
第一組購物者的減肥軌跡在 68 週時並沒有達到穩定狀態。
CagriSema showed a high tolerability with fewer gastrointestinal adverse events compared to semaglutide 2.4 milligram.
與 2.4 毫克索馬魯肽相比,CagriSema 耐受性更高,胃腸道不良事件更少。
This suggests that additional weight loss could be achieved with a trial of longer duration.
這表明,透過更長時間的試驗可以實現額外的減肥。
The second subgroup showed a potent treatment response by achieving 15.9% mean weight loss at 20 weeks and 25.1% at 68 weeks approaching a normal BMI at the end of treatment.
第二亞組顯示出強大的治療反應,在 20 週時平均體重減輕了 15.9%,在 68 週時減輕了 25.1%,在治療結束時接近正常 BMI。
The average treatment dose was 1.1 milligram at 68 weeks.
68週時平均治療劑量為1.1毫克。
Those reductions occurred from the mid trial to end of treatment and did not occur to gastrointestinal adverse events alone.
這些減少發生於從試驗中期到治療結束,並且不僅僅是發生在胃腸道不良事件上。
This group of people could potentially achieve higher weight loss with higher doses through increased focus on dose escalation -- dose re-escalation as well as longer treatment duration.
透過更重視劑量遞增-劑量重新遞增以及延長治療時間,這群人有可能以更高的劑量達到更高的減重效果。
Overall, CagriSema demonstrates a potent treatment response resulting in a superior weight loss efficacy compared to semaglutide.
整體而言,CagriSema 表現出強大的治療反應,與索馬魯肽相比具有更佳的減肥效果。
Furthermore, the REDEFINE 1 data indicate that a patient-centric and individualized treatment regimen which take the initial dose escalation -- dose re-escalation and trial duration into account could potentially enhance efficacy of CagriSema while maintaining a favorable safety profile.
此外,REDEFINE 1 數據表明,以患者為中心、個人化的治療方案,考慮到初始劑量遞增——劑量再遞增和試驗持續時間,可以潛在地提高 CagriSema 的療效,同時保持良好的安全性。
While it may appear counterintuitive that lower doses of CagriSema leads to more substantial weight loss.
較低劑量的 CagriSema 卻能導致更顯著的體重減輕,看起來可能有悖常理。
This patent is consistent with the observations from the step and step up trials with semaglutide.
該專利與索馬魯肽逐步試驗的觀察結果一致。
However, it appears to be more pronounced with the potent biology of CagriSema.
然而,CagriSema 強大的生物學特性似乎使其更加明顯。
In addition, we have previously observed very responses to anti-obesity medications across different populations.
此外,我們先前觀察到不同族群對抗肥胖藥物的反應非常不同。
Based on the insights from REDEFINE 1 and the reflection I've just shared with you on the data will further explore Cagrisema potential in a new Phase 3 trial, REDEFINE 11.
基於 REDEFINE 1 的見解和我剛剛與您分享的對數據的反思,將在新的 3 期試驗 REDEFINE 11 中進一步探索 Cagrisema 的潛力。
The trial will have a longer trial duration and focus on dose escalation and reescalation.
該試驗將持續更長的時間並重點關注劑量的增加和再增加。
Next slide, please.
請看下一張投影片。
Turning towards the next step for CagriSema.
轉向 CagriSema 的下一步。
We are currently anticipating the results of REDEFINE 2 in the first quarter of 2025.
我們目前預計 REDEFINE 2 的結果將於 2025 年第一季公佈。
The REDEFINE 11 trial will be initiated in the first half of 2025 and we now expect to submit CagriSema in the first quarter of 2026.
REDEFINE 11 試驗將於 2025 年上半年啟動,我們目前預計將在 2026 年第一季提交 CagriSema。
The adjusted time lines are not related to the redefined development program, but driven by supply chain reticentness when launching into a large and rapidly expanding market of obesity.
調整後的時間表與重新定義的開發計劃無關,而是由於進入龐大且快速擴張的肥胖市場時供應鏈的謹慎所致。
Next slide, please.
請看下一張投影片。
Earlier this year, Novo Nordisk announced the headline results from the Phase 3 trial step-up with semaglutide 7.2 milligram.
今年早些時候,諾和諾德公佈了 7.2 毫克索馬魯肽第三階段試驗的主要結果。
The 72-week efficacy and safety trial investigated subcutaneous semaglutide 7.2 milligram, compared to semaglutide 2.4 milligram and placebo. 1,407 people with obesity were enrolled in the trial with a BMI of 30 or higher without diabetes.
這項為期 72 週的療效和安全性試驗研究了皮下注射 7.2 毫克索馬魯肽與皮下注射 2.4 毫克索馬魯肽和安慰劑的療效對比。 1,407 名肥胖患者參加了該試驗,他們的 BMI 為 30 或更高,且沒有糖尿病。
The mean baseline body weight was 113 kilograms.
平均基線體重為113公斤。
When evaluating the effects of treatment when all people are here to treatment after 72 weeks, semaglutide 7.2 milligram achieved a superior weight loss of 20.7%, compared to a reduction of 17.5% of semaglutide 2.4 milligram and 2.4% with placebo.
當所有患者在接受治療72週後評估治療效果時,7.2毫克索馬魯肽取得了20.7%的優異減重效果,而2.4毫克索馬魯肽減重17.5%,安慰劑減重2.4%。
In the trial, semaglutide 7.2 milligrams appear to have a safe and well-tolerated profile.
在試驗中,7.2 毫克的索馬魯肽似乎具有安全性和良好的耐受性。
We have also completed the step-up trial in an obese population with type 2 diabetes and are now evaluating the next steps in light of our overall obesity portfolio.
我們也完成了針對患有第 2 型糖尿病的肥胖族群的升級試驗,目前正在根據我們的整體肥胖狀況評估下一步措施。
Next slide, please.
請看下一張投影片。
Recently, we announced the headline results from the Phase 1b/2a trial with once-weekly subcutaneous emacreten in 125 people with overweight obesity.
最近,我們公佈了 1b/2a 期試驗的主要結果,該試驗對 125 名超重肥胖患者進行了每週一次皮下注射依瑪克林。
The trial was a combined single ascending dose, multiple ascending dose and dose response trial investigating three different maintenance doses with a total treatment duration of up to 36 weeks.
本試驗為單次遞增劑量、多次遞增劑量和劑量反應綜合試驗,研究三種不同的維持劑量,總治療時間最長為 36 週。
The primary endpoint was a treatment was treatment-emergent adverse events.
主要終點是治療過程中出現的不良事件。
The most common adverse events were gastrointestinal, and the vast majority were mild to moderate in severity.
最常見的不良事件是胃腸道不良事件,絕大多數嚴重程度為輕度至中度。
Overall, the safety profile of amycretin was consistent with amycretin based therapies.
總體而言,阿米克林的安全性與以阿米克林為基礎的療法一致。
People in the dose response part of the trial had a baseline body weight of 92.7 kilograms.
參加試驗劑量反應部分的受試者的基線體重為 92.7 公斤。
People treated with amycretin achieved an estimated bodyweightloss of 0.7%, 16.2% and 22% at their respective doses.
接受阿米克林治療的患者在相應劑量下體重減輕估計為 0.7%、16.2% 和 22%。
This was achieved on 1.2 -- sorry, 1.25 milligrams, 5 milligrams, and 20 milligrams respectively.
這分別在 1.2(對不起,是 1.25 毫克)、5 毫克和 20 毫克上實現。
This compared to a body weight gain of between 1.9% to 2.3% for people treated with placebo.
相比之下,接受安慰劑治療的人體重增加 1.9% 至 2.3%。
The effect of treatment was evaluated if all people were adherent to treatment.
如果所有人都堅持治療,則對治療效果進行評估。
We are very encouraged by the results for subcutaneous amycretin for people living with overweight obesity.
我們對皮下注射阿米克林對超重肥胖患者的效果感到非常鼓舞。
And based on the results, we are now planning for further clinical development of amycretin in people with overweight obesity.
根據研究結果,我們目前正計劃對超重肥胖患者進一步進行阿米克林的臨床開發。
Next slide, please.
請看下一張投影片。
Overall, we have a competitive portfolio in obesity underlined by the recent readouts from CagriSema, semaglutide 7.3 milligrams and subcutaneous amycretin.
整體而言,我們在肥胖症領域擁有頗具競爭力的產品組合,CagriSema、7.3 毫克索馬魯肽和皮下阿米克林的最新數據突顯了這一點。
Our strategic ambitions remains to build a portfolio of superior treatment options in obesity and a focus on efficacy, safety and scalability, be it injectable at all.
我們的策略目標仍然是建立一系列優質的肥胖症治療方案,並專注於療效、安全性和可擴展性,無論是否可注射。
Our marketed portfolio started with Saxenda.
我們的行銷組合始於 Saxenda。
We then set the bar with the Wegovy's attractive clinical profile with double-digit weight loss and a proven cardiovascular risk reduction from the SELECT trial.
然後,我們根據 Wegovy 的臨床表現設定了標準,即 SELECT 試驗證明的兩位數減重效果和心血管風險降低效果。
In the short term, we expect to increase our competitiveness further with semaglutide 7.2 milligrams, as well as oral semaglutide 25 milligrams.
短期內,我們預期透過索馬魯肽7.2毫克以及口服索馬魯肽25毫克進一步增強我們的競爭力。
As illustrated on the right-hand side of the slide, the next-generation anti-obesity medications in our pipeline feature multiple different mode of actions that can address different segments in the obesity market.
如幻燈片右側所示,我們研發的下一代抗肥胖藥物具有多種不同的作用方式,可以針對肥胖市場的不同部分。
Selected highlights are the planned Phase 3 trial with cagilentide in more therapy, further development based on the promising amycretin Phase 1/2 data and the initiation of our triple agonist Phase 1 trial.
選定的亮點是計劃中的使用卡吉倫肽進行更多治療的 3 期試驗、基於有希望的阿米克林 1/2 期數據的進一步開發以及啟動我們的三重激動劑 1 期試驗。
We look forward to sharing data from all of these trials when they read out.
我們期待在讀完所有這些試驗後分享其數據。
Next slide, please.
請看下一張投影片。
Turning to the upcoming R&D milestones.
展望即將到來的研發里程碑。
We look forward to a year with many exciting trial readouts.
我們期待新的一年能出現許多令人興奮的試驗結果。
Before turning to 2025, I would like to highlight a few milestones from the last few months.
在邁向 2025 年之前,我想強調過去幾個月發生的幾個里程碑。
We continue our focus on investigating how our innovative treatment impact related comorbidities in diabetes and obesity.
我們將繼續致力於研究我們的創新治療如何影響與糖尿病和肥胖症相關的合併症。
Positively, Ozempic is now the only GLP-1 receptor agonist proven to reduce the risk of chronic kidney disease in people with type 2 diabetes and chronic kidney disease.
積極的一面是,Ozempic 目前是唯一被證明可以降低第 2 型糖尿病和慢性腎臟病患者患慢性腎臟病風險的 GLP-1 受體激動劑。
This is based on the data from the FLOW trial and positive opinion from the European regulatory authorities and a US FDA approval.
這是基於 FLOW 試驗的數據以及歐洲監管機構的積極意見和美國 FDA 的批准。
We have also submitted the label extension applications for oral to megasite 14-milligram on the Rybelsus brand to US and the European authorities based on the data from the
我們還根據 Rybelsus 品牌的數據,向美國和歐洲當局提交了口服至 14 毫克劑量的標籤擴展申請。
[sogagrafa].
[索加格拉法]。
Further, we have resubmitted the results from the STEP HFpEF trials with a magnetite 2.4 milligram in people with obesity to the US FDA.
此外,我們已向美國 FDA 重新提交了針對肥胖族群所進行的 2.4 毫克磁鐵礦的 STEP HFpEF 試驗結果。
The submission includes data from FLOW and so, further substantiating the benefits of semaglutide for patients with heart failure.
提交的內容包括來自 FLOW 的數據,因此進一步證實了司美魯肽對心臟衰竭患者的益處。
Excitingly, we have initiated a Phase 1 trial with a once-weekly subcutaneous triagonist in people with overweight obesity in the fourth quarter of 2024.
令人興奮的是,我們已經在 2024 年第四季度啟動了針對超重肥胖人群每週一次皮下注射三角激動劑的 1 期試驗。
Moving to the milestones in 2025.
邁向 2025 年的里程碑。
I would like to start with a few exciting data readouts in type 2 diabetes in the second half that supports our aspirations of raising the innovation bar.
我想先介紹一下下半年 2 型糖尿病領域的一些令人興奮的數據,這些數據支持了我們提高創新標準的願望。
Specifically, we expect the first Phase 3 results from CagriSema as well as Phase 2 results for both subcutaneous and amycretin and once weekly GIP/GLP-1 co-agonist.
具體來說,我們期待 CagriSema 的第一個 3 期結果以及皮下和阿米克雷汀以及每週一次的 GIP/GLP-1 聯合激動劑的 2 期結果。
Moving to obesity and the first half of '25.
轉向肥胖和25年上半年。
We are now expecting to submit or semaglutide 25-milligram for people with obesity to the US regulatory authorities in the first quarter.
我們目前預計將在第一季向美國監管機構提交用於肥胖症患者的25毫克索馬魯肽。
Furthermore, we also expect Phase 2 results from the once weekly GLP-1, GIP co-agonist.
此外,我們也期待每週一次的 GLP-1、GIP 合併激動劑的第 2 階段結果。
For CagriSema, specifically, we expect results from REDEFINE 2 and REDEFINE 4, during 2025 and to initiate the new REDEFINE 11 trial later during the first half of 2025.
具體來說,對於 CagriSema,我們預計 REDEFINE 2 和 REDEFINE 4 的結果將在 2025 年獲得,並將在 2025 年上半年啟動新的 REDEFINE 11 試驗。
Within Rare Disease, we expect regulatory submissions of Mim8 in the US and in the EU in the first half -- sorry, in the second half of 2025.
在罕見疾病領域,我們預計 Mim8 將於 2025 年上半年(抱歉,是 2025 年下半年)在美國和歐盟提交監管申請。
With then cardiovascular and emerging therapy areas, we look forward to read out the -- sorry, we look forward to the readout of the evoke and the evoke+ trials in patients with early Alzheimer's disease.
隨著心血管和新興治療領域的發展,我們期待著讀出 - 抱歉,我們期待著讀出針對早期阿茲海默症患者的 evoke 和 evoke+ 試驗的結果。
With that, over to you, Karsten.
現在,就交給你了,卡斯滕。
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Thank you, Martin.
謝謝你,馬丁。
Please turn to the next slide.
請翻到下一張投影片。
In 2024, our sales grew by 25% in Danish kroner and by 26% at constant exchange rates, driven by both operating units.
2024 年,在兩個營運部門的推動下,我們的銷售額以丹麥克朗計算成長了 25%,以固定匯率計算成長了 26%。
In the US, sales growth was positively impacted by gross to net sales adjustments.
在美國,銷售成長受到毛銷售額與淨銷售額調整的正面影響。
The gross margin increased to 84.7% compared to 84.6% in 2023.
毛利率由 2023 年的 84.6% 上升至 84.7%。
The increase is mainly driven by a positive price impact due to growth to net sales adjustments in the US and the positive product mix.
成長的主要原因是美國淨銷售額調整成長和積極的產品組合帶來的正面價格影響。
This is partially countered by costs related to ongoing capacity expansions.
這在一定程度上被持續產能擴張相關的成本所抵消。
Sales and distribution costs increased by 9% in Danish kroner and by 10% at constant exchange rates.
銷售和分銷成本以丹麥克朗計算增加了 9%,以固定匯率計算增加了 10%。
In North America operations, the cost increase is mainly driven by promotional activities related to Wegovy.
在北美業務中,成本的增加主要是由於Wegovy相關的促銷活動所致。
In International Operations, the increase is mainly related to obesity care market development activities, Wegovy launch activities as well as promotional activities for GLP-1 diabetes products.
在國際業務方面,成長主要與肥胖護理市場開發活動、Wegovy 發布活動以及 GLP-1 糖尿病產品的促銷活動有關。
Additionally, the increase in sales institution costs is negatively impacted by an adjustment to legal provisions in 2023.
此外,2023年法律條文的調整也將對銷售機構成本的增加產生負面影響。
Research and development costs increased by 48%, both measured in Danish kroner and at constant exchange rates.
研發成本增加了 48%,無論是以丹麥克朗或以固定匯率計算。
The increase in cost is mainly reflecting increased late-stage clinical trial activity, increased early research activities as well as impairment losses related to intangible assets.
成本的增加主要反映後期臨床試驗活動的增加、早期研究活動的增加以及與無形資產相關的減損損失。
Administration costs increased by 9% in both Danish kroner and at constant exchange rates.
以丹麥克朗和固定匯率計算,管理成本增加了 9%。
Operating profit increased by 25% measured in Danish kroner and by 26% at constant exchange rates.
以丹麥克朗計算,營業利潤成長了 25%,以固定匯率計算,營業利潤成長了 26%。
Operating profit is positively impacted by gross to net sales adjustments in the US and negatively impacted by impairment losses.
營業利潤受到美國毛銷售額與淨銷售額調整的正面影響,並受到減損損失的負面影響。
EBITDA increased by 32% in Danish Kroner and 33% at constant exchange rates.
EBITDA(以丹麥克朗計算)成長了 32%,以固定匯率計算則成長了 33%。
Net financial items showed a net loss of DKK1.1 billion compared to a net gain of DKK2.1 billion last year.
淨財務項目顯示淨虧損為 11 億丹麥克朗,去年的淨收益為 21 億丹麥克朗。
This primarily reflects losses on nonhedged currencies.
這主要反映了非對沖貨幣的損失。
The effective tax rate was 20.6% in 2024, compared to 20.1% in 2023.
2024 年有效稅率為 20.6%,而 2023 年為 20.1%。
Net profit increased by 21% and diluted earnings per share increased by 22% to
淨利成長21%,每股攤薄收益成長22%,至
[DKK22.63].
[22.63丹麥克朗]。
Net profit and diluted earnings per share are impacted by the impairments related to intangible assets.
淨利和每股攤薄收益受到無形資產相關減損的影響。
Cash flow from operating activities in 2024 was realized at DKK121 billion, an increase of DKK12 billion versus 2023.
2024年實現經營活動現金流為1,210億丹麥克朗,較2023年增加120億丹麥克朗。
As for allocation of DKK47 billion to CapEx for Supply Chain and around DKK82 billion related to Catalent site acquisition results in free cash flow of minus DKK14.7 billion.
至於分配給供應鏈資本支出的 470 億丹麥克朗和與 Catalent 站點收購相關的約 820 億丹麥克朗,導致自由現金流為負 147 億丹麥克朗。
This compares to DKK68.3 billion in 2023.
相較之下,2023 年這一數字為 683 億丹麥克朗。
Please go to the next slide.
請翻到下一張投影片。
In line with our strategic aspiration to deliver attractive capital allocation to shareholders, we have returned DKK64.3 billion to shareholders via dividends and share buyback during 2024.
根據我們向股東提供有吸引力的資本配置的戰略願望,我們在 2024 年透過股息和股票回購向股東返還了 643 億丹麥克朗。
At the Annual General Meeting on March 27, 2025, the Board of Directors will propose a final dividend of DKK7.90 for a total 2024 dividend of DKK11.40 including the interim dividend paid in August 2024.
在 2025 年 3 月 27 日舉行的年度股東大會上,董事會將提議派發 7.90 丹麥克朗的末期股息,包括 2024 年 8 月支付的中期股息在內,2024 年的總股息為 11.40 丹麥克朗。
This is a 21% increase compared to 2023, making it the 29th consecutive year with increasing dividend per share.
這比 2023 年增長了 21%,這是連續第 29 年增加每股股息。
In addition to the dividend, the DKK20 billion share buyback program for the past 12 months has been concluded.
除了股息外,過去 12 個月的 200 億丹麥克朗股票回購計畫已經完成。
Novo Nordisk capital allocation priorities prioritizes attractive investments into the company, including supply chain expansions and R&D as well as consistent dividend payout.
諾和諾德的資本配置重點是優先對公司進行有吸引力的投資,包括供應鏈擴張和研發以及持續的股息支付。
Consequently, following the further step-up in CapEx, Novo Nordisk is not initiating a new share buyback program at this point in time.
因此,隨著資本支出進一步增加,諾和諾德目前不會啟動新的股票回購計畫。
Please go to the next slide.
請翻到下一張投影片。
We continued the growth momentum in 2025 and expect the sales growth to be between 16% and 24% at constant exchange rates.
我們將在 2025 年延續成長勢頭,預計以固定匯率計算銷售額成長率將在 16% 至 24% 之間。
This is based on several assumptions as described in the company announcements.
這是基於公司公告中描述的幾個假設。
The guidance reflects expansion expectations for sales growth in both North America Operations and International Operations.
該預期反映了北美業務和國際業務銷售成長的擴張預期。
The sales growth is expected to be mainly driven by volume growth of GLP-1-based treatment for obesity and diabetes care, also reflecting our continued scaling of our supply chain.
預計銷售成長主要受益於基於 GLP-1 的肥胖症和糖尿病治療藥物的銷售成長,這也反映了我們供應鏈的持續擴大。
Our reported sales are expected to be 3 percentage points higher compared to constant exchange rates and operating profit is expected to be 5 percentage points higher compared to constant exchange rates.
我們報告的銷售額預計比固定匯率高出 3 個百分點,營業利潤預計將比固定匯率高出 5 個百分點。
We expect that the operating profit will grow between 19% and 27% at constant exchange rates.
我們預計,以固定匯率計算,營業利潤將成長19%至27%。
This primarily reflects the sales growth outlook and continued investments in current and future growth drivers within research, development and commercial.
這主要反映了銷售成長前景以及對研究、開發和商業領域當前和未來成長動力的持續投資。
And negative mid-single-digit operating profit growth impact related to the acquisition of the three Catalent and manufacturing sites is also included in the guidance.
此外,與收購 Catalent 三家工廠及製造基地相關的中個位數負營業利潤成長影響也包含在預期之中。
For 2025, we expect net financial items to amount to a loss of around DKK9 billion.
到 2025 年,我們預計淨金融計畫損失將達到約 90 億丹麥克朗。
This mainly reflects losses on currencies, primarily the US dollar and increased interest expenses related to funding of the Catalent site transaction as this acquistition was mainly debt financed.
這主要反映了貨幣損失(主要是美元)以及與 Catalent 站點交易融資相關的利息支出增加(因為此次收購主要透過債務融資)。
The effective tax rate for 2025 is expected to be in the range of 21% to 23% and.
預計2025年有效稅率在21%至23%之間。
The increase compared to 2024 is mainly driven by country and therapy sales mix.
與 2024 年相比的成長主要得益於國家和療法銷售組合。
CapEx is expected to be around DKK65 billion in 2025, reflecting expansion of the supply chain.
預計 2025 年資本支出將達到約 650 億丹麥克朗,反映出供應鏈的擴張。
In the coming years, CapEx to sales ratio is still expected to be in the low double digits.
未來幾年,資本支出與銷售額比例預計仍將維持在兩位數以下。
The free cash flow is expected to be DKK75 million to DKK85 billion, reflecting the sales growth, a favorable impact from rebates in the US countered by increased investments in manufacturing facilities.
預計自由現金流為 7,500 萬至 850 億丹麥克朗,反映出銷售額的成長、美國退稅帶來的有利影響以及製造設施投資的增加。
That covers the outlook for 2025.
這涵蓋了 2025 年的展望。
Now, back to you, Lars.
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.
謝謝你,卡斯滕。
Please turn to the final slide.
請翻到最後一張投影片。
We are pleased with the performance in 2024, where 26% sales growth reflects that more than 45 million people are now benefiting from our treatments.
我們對 2024 年的業績感到滿意,26% 的銷售額成長反映出目前有超過 4,500 萬人受益於我們的治療。
Further, we completed the acquisition of three Catalent sites.
此外,我們也完成了三家 Catalent 工廠的收購。
And during the year, we progressed our R&D pipeline, including obesity projects, such as CagriSema and amycretin.
今年,我們推進了研發管道,包括肥胖症項目,例如 CagriSema 和 amycretin。
With effective 2025 outlook, we will continue to focus on strong commercial execution and the progression of our early and late-stage R&D pipeline and on the expansion of our production capacity.
透過有效的 2025 年展望,我們將繼續專注於強大的商業執行力、早期和後期研發管道的進展以及生產能力的擴大。
With that, I would like to hand the word back to Jacob.
說完這些,我想把話語交還給雅各。
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thank you, Lars.
謝謝你,拉爾斯。
Next slide, please.
請看下一張投影片。
With that, we are now ready for the Q&A.
現在,我們就可以進行問答了。
We kindly ask all participants to limit her or himself to one or maximum two questions, including sub questions.
我們懇請所有參與者將自己的問題限制為一個或最多兩個,包括子問題。
Operator, we are now ready to take the first question, please.
接線員,我們現在可以回答第一個問題了。
Operator
Operator
(Operator Instructions) Richard Vosser, JPMorgan.
(操作員指示)摩根大通的理查德·沃瑟 (Richard Vosser)。
Richard Vosser - Analyst
Richard Vosser - Analyst
Two questions, please.
請問兩個問題。
Firstly, on Wegovy,could you give us some more details of what's holding back the US prescriptions in the last quarter of '24 and the early part of '25?
首先,在 Wegovy 上,您能否向我們詳細介紹 2024 年最後一個季度和 2025 年初美國處方藥增長受阻的原因?
What can you do about it?
你能做什麼呢?
And how should we anticipate the growth in prescriptions from here?
那我們該如何預測今後處方藥的成長呢?
And second question, just thanks for all the dosing data.
第二個問題,感謝提供所有的劑量數據。
But based on that, and what you've seen in REDEFINE 1 and the tolerability that you've shown, how do you think the profile of CagriSema will stack up versus [Z band] and REDEFINE 4?
但基於這一點,以及您在 REDEFINE 1 中看到的情況和您所展示的耐受性,您認為 CagriSema 的概況與 [Z 波段] 和 REDEFINE 4 相比如何?
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thank you, Richard, for those two questions.
謝謝理查提出這兩個問題。
On the first one, on Wegovy prescription trends, we'll turn to you, David.
第一個問題,關於 Wegovy 處方趨勢,我們將請您發言,大衛。
David Moore - Executive Vice President - Corporate Development
David Moore - Executive Vice President - Corporate Development
Thank you, Richard, for the question.
謝謝理查提出這個問題。
I think it's important to remember that the total market for anti-obesity medicines grew in the US last year by 160%.
我認為值得記住的是,去年美國減肥藥物的整體市場成長了 160%。
And so the story continues to be about market expansion for obesity.
因此,故事仍然圍繞著肥胖症市場的擴張。
And for our own brand, Wegovy, recall, we started last year with around 100,000 prescriptions and ended with over 200,000 prescriptions.
就我們自己的品牌 Wegovy 而言,回想一下,去年年初我們開出了大約 10 萬張處方,而去年年底則超過了 20 萬張處方。
And so the scaling efforts are recognized and that's being pulled through in the market.
因此,擴大規模的努力得到了認可,並在市場上得到了推廣。
In the beginning of the year, and this is normal, there are movements in benefit plans and patients changing in terms of their co-pays and co-insurance.
在年初,福利計劃會變動,病患的共付額和共同保險也會發生變化,這是正常的。
This is normal, but it does have an impact with total prescriptions in the beginning of the year. as well as coming through holidays as well as Martin Luther King holiday in the beginning of the year.
這是正常的,但確實會對年初的總處方量產生影響。以及年初的假期和馬丁路德金紀念日。
It's important to remember, we're treating 1.2 million patients with Wegovy today, and we have access of 55 million people living with obesity in the US.
重要的是要記住,我們今天用 Wegovy 治療了 120 萬名患者,並且我們已經接觸了美國 5500 萬名肥胖患者。
Driving new prescriptions is, of course, our focus.
當然,推動新處方是我們的重點。
And what we can say about that is we are shipping more of the starter doses as we speak.
我們可以告訴大家的是,我們正在運送更多的起始劑量。
Those started doses are making their way through the supply chain from the wholesaler to a retailer, which is also new for us to have this amount of new starter doses.
這些已開始使用的劑量正在透過供應鏈從批發商流向零售商,對我們來說,擁有如此數量的新起始劑量也是新鮮事。
And now it's our opportunity to pull through this market expansion and connect more people with Wegovy in the US.
現在我們有機會實現這一市場擴張,並讓更多的美國民眾透過Wegovy 獲得聯繫。
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thank you, Dave.
謝謝你,戴夫。
And then we turn to the second question, which goes to you Martin on current thoughts on CagriSema profile also looking ahead to REDEFINE 4.
然後我們轉到第二個問題,Martin,請問您目前對 CagriSema 簡介的看法以及對 REDEFINE 4 的展望。
Martin Lange - Executive Vice President - Development
Martin Lange - Executive Vice President - Development
Yes.
是的。
Thank you very much, Richard.
非常感謝,理查德。
So REDEFINE 4, as you rightly mentioned, this had trial CagriSema versus semaglutide.
因此,正如您正確提到的,REDEFINE 4 對 CagriSema 與 semaglutide 進行了試驗。
The first statistical testing will be non-inferiority and based on what we've seen with REDEFINE 1, there's a good assumption that will come out with non-inferiority established.
第一次統計測試將是非劣效性,根據我們在 REDEFINE 1 中看到的情況,有一個很好的假設,即非劣效性已經確立。
Second test for superiority.
第二次優越性測試。
And again, I think it's too early to speculate, but we will see the data when we will see them, but that is test number two.
我再說一次,我認為現在推測還為時過早,但我們會在看到數據時看到它們,但這是第二次測試。
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thank you, Martin, and thank you, Richard.
謝謝你,馬丁,謝謝你,理查。
Then we are ready for the next set of questions, please.
那我們可以開始下一組問題了。
Operator
Operator
Harry Sephton, UBS.
瑞銀(UBS)的 Harry Sephton。
Harry Sephton - Analyst
Harry Sephton - Analyst
It's Harry Sephton from UBS.
我是瑞銀的 Harry Sephton。
I'd like to start with the REDEFINE 1 results, And can we address this difference between the weight loss profile that doesn't show a typical dose response?
我想從 REDEFINE 1 的結果開始,我們能否解決沒有顯示典型劑量反應的減肥概況之間的差異?
You talked about the fact that fewer patients finished at the higher dose in the initial results as a potential explanation to the weaker weight loss versus your modeling, the data you've shown today somewhat contradicts this.
您談到,在初步結果中,接受較高劑量治療的患者較少,這可能是導致體重減輕效果不如您的模型所致,但您今天展示的數據與此有些矛盾。
So what have you seen to explain this discrepancy?
那麼您看到什麼來解釋這種差異呢?
Is it a speed of titration issue?
這是滴定速度的問題嗎?
Or are there other factors you can help explain this?
或者有其他因素可以幫助您解釋這一點嗎?
And what read across can you take from these data for the imminent REDEFINE 2 data?
您能從這些數據中得到什麼對於即將到來的 REDEFINE 2 數據的意義呢?
My second question is following the amycretin subcut data.
我的第二個問題是關於阿米克汀皮下注射數據。
How do you see the positioning of this product versus CagriSema in the future?
您如何看待該產品未來相對於CagriSema的定位?
Do we need incremental efficacy from here?
我們是否需要從現在開始提高效力?
Or does the benefit from amycretin more come from scalability and the flexibility of both the injectable and oral formulations?
或者阿米克林的優勢更多來自於注射劑型和口服劑型的可擴展性和靈活性?
And what is the timing for the initiation of your Phase 3 program for amycretin?
你們的阿米克汀第 3 階段研究計畫的啟動時間是什麼時候?
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thank you, Harry, for those two questions.
謝謝 Harry 提出這兩個問題。
On the first one, in terms of REDEFINE 1 data, we'll turn it to you, Martin.
第一個問題,就 REDEFINE 1 數據而言,我們將把它交給你,馬丁。
Martin Lange - Executive Vice President - Development
Martin Lange - Executive Vice President - Development
Yes.
是的。
Thank you very much, Harry.
非常感謝,哈利。
So first of all, I think it's important to call out, we don't really see discrepancies.
因此首先,我認為有必要指出,我們並沒有真正看到差異。
We see a picture emerging that we've seen to an extent in the step certainly in the step-up study programs, and we see that also now in REDEFINE 1.
我們看到了一幅正在浮現的圖景,我們在逐步研究計劃中已經在一定程度上看到了這一點,我們現在也在 REDEFINE 1 中看到了這一點。
We see a group of people who titrate with very strong safety and tolerability to the fullest dose.
我們看到一群人以非常強的安全性和耐受性滴定到最大劑量。
They have a very substantial weight loss.
他們的體重下降非常明顯。
And specifically, in REDEFINE 1, we see the potential for even further weight loss with longer treatment duration.
具體來說,在 REDEFINE 1 中,我們看到了隨著治療時間延長而進一步減輕體重的潛力。
Then we see some early responders who clearly lose weight faster than the other group.
然後我們發現一些早期反應者的減肥速度明顯比另一組更快。
They also appear to have the potential to lose more than the other group.
他們似乎也有可能比另一組遭受更多損失。
And what we can see from this is basically that on average, that group which is bigger than what we've normally seen in our trials, losers actually a mean of 25.2 percentage point at the end of trial, approaching a BMI that would indicate non obesity.
我們從中可以看出,基本上平均而言,該組人數比我們在試驗中通常看到的人數要多,在試驗結束時,失敗者的實際體重平均下降了 25.2 個百分點,接近表明非肥胖的 BMI。
That actually then plays into a dynamic because these patients have slightly more gastrointestinal side effects, they also -- some of them expressed concerns about the speed of weight loss.
這實際上就產生了一種動態,因為這些患者的胃腸道副作用稍微多一些,他們中的一些人也對減肥速度表示擔憂。
And therefore, they start to titrate a little bit down.
因此,它們開始稍微降低滴定度。
That, again, is a big potential because they can actually lose more weight.
這又是一個很大的潛力,因為他們實際上可以減掉更多的體重。
It's to your point, allowing them to do individual dose titration. -- titrate a little bit slower and then coming up to higher doses, balancing the speed of their weight loss and the gastrointestinal side effects.
正如您所說,允許他們進行個別劑量滴定。 ——滴定速度稍微慢一些,然後增加劑量,平衡減肥速度和胃腸道副作用。
Obviously, this population also seems to be benefiting from an even -- or could be benefiting from an even longer trial duration.
顯然,這些人群似乎也從更長的試用期中受益,或者可能受益。
And that basically means we see two distinct groups, one being what we call early or high responders.
這基本上意味著我們看到兩個不同的群體,一個是我們所說的早期或高反應者。
But both groups actually showing more weight loss potential.
但實際上,兩組都展現了更大的減肥潛力。
We can utilize that in the future programs for Cagrisema, specifically starting with REDEFINE 11.
我們可以在 Cagrisema 的未來程序中利用這一點,特別是從 REDEFINE 11 開始。
But we can certainly also use those data when we designed the amycretin program using the same biology.
但當我們利用相同的生物學原理設計 amycretin 程式時,我們當然也可以使用這些數據。
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thank you, Martin.
謝謝你,馬丁。
And for the second question on amycretin, CagriSema and having a portfolio, I'll turn it to you, Camilla.
第二個問題關於 amycretin、CagriSema 和投資組合,我將交給你,卡米拉。
Camilla Sylvest - Executive Vice President - Commercial Strategy and Corporate Affairs
Camilla Sylvest - Executive Vice President - Commercial Strategy and Corporate Affairs
Thank you very much.
非常感謝。
Yes, there's no doubt that with the size of the obesity market, it will be a key strength to have a broad portfolio of products like Martin shared with you in the slides just before.
是的,毫無疑問,鑑於肥胖市場的規模,擁有像馬丁剛才在幻燈片中與大家分享的廣泛的產品組合將成為關鍵優勢。
We believe we have a very strong portfolio that enables us to work with optionality, optionality in terms of different patient segments and different markets to address the big unmet need that there is.
我們相信,我們擁有非常強大的產品組合,這使我們能夠根據不同的患者群體和不同的市場選擇性地開展工作,以解決尚未滿足的巨大需求。
Remember, there is very few percentage points of the total population that is currently being treated.
請記住,目前正在接受治療的總人口只佔總人口的一小部分。
And I think historically, we've talked about sort of the people with obesity as one group.
我認為從歷史上看,我們將肥胖人群作為一個群體來討論。
But as we expand our portfolio, we will be able to target different needs of different segments as well as different geographies.
但隨著我們擴大產品組合,我們將能夠滿足不同細分市場和不同地區的不同需求。
So we have remain very confident, of course, in CagriSema and also in amycretin.
因此,我們當然對 CagriSema 和 amycretin 仍然非常有信心。
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thank you, Camilla.
謝謝你,卡米拉。
Thank you, Martin, and thank you, Harry, for those two questions.
謝謝馬丁和哈利提出的這兩個問題。
Then we are ready for the next set of questions, please.
那我們可以開始下一組問題了。
Operator
Operator
Michael Nedelcovych, TD Cowen.
邁克爾·內德爾科維奇(Michael Nedelcovych),TD Cowen。
Michael Nedelcovych - Analyst
Michael Nedelcovych - Analyst
I have 2.
我有 2 個。
My first is on supply.
我的第一個是供應。
Lilly has indicated that it can boost its increase in supply by 60% in the coming months.
禮來公司表示,未來幾個月其供應量可增加 60%。
You all have never quantified capacity, but do you feel that your efforts to boost production will be competitive with this number.
你們從來沒有量化過產能,但是你覺得你們提高產量的努力與這個數字相比是否具有競爭力。
This might be an oversimplification, but if we grant the prescription trends in the US are largely reflective of supply rather than demand than it would seem your competitor may be ramping capacity more swiftly.
這可能過於簡單化,但如果我們承認美國的處方趨勢很大程度上反映的是供應而不是需求,那麼看起來你的競爭對手可能會更快地提高產能。
Do you think that's a fair interpretation?
您認為這是合理的解釋嗎?
And then my second question is on oral semaglutide 25 milligrams, which you now plan to file for weight loss in the US It's notable that you are not pursuing the 50-milligram dose.
我的第二個問題是關於口服 25 毫克索馬魯肽的,您現在計劃在美國申請減肥藥申請,值得注意的是,您並沒有追求 50 毫克的劑量。
I assume this decision was related to supply considerations, but please correct me if I'm wrong.
我認為這個決定與供應考慮有關,但如果我錯了,請糾正我。
And how should we think about the eventual launch of this offering?
我們應該如何看待該產品的最終推出?
Just as an example, you've used the term capped as it relates to Wegovy's ex-US launches.
僅作為示例,您使用了“上限”一詞,因為它與 Wegovy 在美國以外的發布有關。
Should we also think of oral semaglutide weight loss launch as capped?
我們是否也應該認為口服索馬魯肽減肥藥的推出是有上限的?
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thank you, Mike, for those two questions, one on supply and then on launch considerations around oral sema.
謝謝 Mike 提出的這兩個問題,一個是關於供應,另一個是關於口服 Sema 的推出考慮。
First, our supply will turn to you, Karsten.
首先,我們的供應將轉向你,卡爾斯滕。
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Michael, thanks for this question.
邁克爾,謝謝你提問。
And let me start basically my answer on the slide we showed earlier on.
讓我根據我們之前展示的幻燈片開始回答這個問題。
So we scaled our patient reach with [Novogeal Bronze] by almost a Factor III over the last three years, and latest data point from IQVIA, and this is based on IQVIA latest data point, we are serving almost two-thirds of the global GLP-1 market and then competition sitting on the remaining one-third.
因此,我們在過去三年中透過 [Novogeal Bronze] 將我們的患者覆蓋範圍擴大了近 III 倍,根據 IQVIA 的最新數據點,這是基於 IQVIA 的最新數據點,我們服務於全球近三分之二的 GLP-1 市場,而競爭對手佔據剩下的三分之一。
Specifically for the last year, just to have hard data, we have expanded patient reach, again, based on IQVIA numbers, more in absolute numbers, more than any other competitor in this market.
具體來說,就去年而言,僅從硬數據來看,我們擴大了患者覆蓋範圍,同樣基於 IQVIA 的數據,絕對數字超過了該市場上的任何其他競爭對手。
So actually, we have grown faster in terms of serving more patients over the last 12 months based based on IQVIA -- then I'd say as a forward-looking statement in terms of our scaling into 2025.
因此實際上,基於 IQVIA 的數據,過去 12 個月我們在服務更多患者方面發展更快——然後我會說這是我們在 2025 年擴展方面的前瞻性聲明。
With the guidance we have and the size of the base we have, you can say, a sales growth in, say, a midpoint of 20%, then you apply rebate enhancement and [due] mix impacts and share of the total portfolio, then then you get to a scaling volume scaling of GLP-1 franchise in terms of patients served nicely in excess of 30% into this year.
根據我們的指導和基礎規模,可以說,銷售額增長率中位數為 20%,然後應用回扣增強和[應有的]組合影響以及總投資組合的份額,那麼 GLP-1 特許經營的數量就會擴大,就服務的患者而言,今年的增長率將超過 30%。
So I think we are very competitive in terms of scaling.
所以我認為我們在擴展方面非常有競爭力。
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thank you, Karsten.
謝謝你,卡斯滕。
And then on oral semaglutide 25 milligram, probably too early to talk about launch and positioning, but the high-level value proposition of
然後是口服索馬魯肽 25 毫克,現在談論上市和定位可能還為時過早,但
[oral semaglutide].
[口服司美魯肽]。
Camilla Sylvest - Executive Vice President - Commercial Strategy and Corporate Affairs
Camilla Sylvest - Executive Vice President - Commercial Strategy and Corporate Affairs
High-level value proposition back to what we talked about before.
高層次的價值主張回到我們之前所談論的。
It is likely that there will be an all segment in obesity as there has been actually also before, but due to tolerability issues, this has been quite small.
很可能會出現肥胖的全部細分市場,因為實際上以前也存在過,但由於耐受性問題,這個細分市場還很小。
Now, we have product that is moving in terms of clinical trials and efficacy with a 16% weight loss or semaglutide 25 milligram.
現在,我們的產品正在進行臨床試驗和療效研究,其效果為,25 毫克索馬魯肽可使體重減輕 16%。
And of course, that gives us an opportunity to launch this in selected markets.
當然,這給了我們一個在選定市場推出該產品的機會。
And with that, we will, of course, benefit from the benefits of semaglutide in general, and this gives us optionality to address an oral more specifically.
這樣一來,我們當然會從索馬魯肽的整體益處中受益,這也為我們提供了更具體地解決口服藥物的選擇。
So that's part of our plans and our order portfolio.
這是我們計劃和訂單組合的一部分。
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thank you, Camilla, and thank you, Mike, for those two questions.
謝謝卡米拉和麥克提出的這兩個問題。
Then we turn to the next set of questions, please.
那麼請我們討論下一組問題。
Operator
Operator
Sachin Jain, Bank of America.
美國銀行的 Sachin Jain。
Sachin Jain - Analyst
Sachin Jain - Analyst
Two questions, similar topics, if I may.
兩個問題,如果可以的話,都是類似的主題。
So back on CagriSema, Martin expert detailed explanation.
所以回到CagriSema,Martin專家進行了詳細的解釋。
Just wondering if Dave or Camilla could touch on how you're going to translate that into a commercial message.
只是想知道 Dave 或 Camilla 是否可以談談如何將其轉化為商業訊息。
So very simply, what doses should patients be on how titrate and at the doses they get to, what do you think the profile versus
因此,非常簡單,患者應該服用多少劑量,如何滴定,以及他們達到的劑量,你認為與
[Terzaris].
[特薩里斯]。
And how are you thinking about positioning this relative to Wegovy? -- just seems quite confusing to me.
您如何考慮將其與 Wegovy 進行定位? ——對我來說這似乎相當令人困惑。
And the second one is just for Karsten on the wide guidance range.
第二個只是為了卡爾斯滕的廣泛指導範圍。
You started with 8% this year at the beginning of last year, bottom to top end, what are the key areas of uncertainty or delta's view as you think about '25?
從去年年初到今年,您的成長率為 8%,從底部到頂部,當您考慮 25 年時,主要的不確定領域或 Delta 的觀點是什麼?
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thank you, Sachin, for those two questions.
謝謝 Sachin 提出這兩個問題。
Firstly, on CagriSema and the value of the individualized treatment on you Camilla.
首先,關於CagriSema和個人化治療對你的價值,卡米拉。
Camilla Sylvest - Executive Vice President - Commercial Strategy and Corporate Affairs
Camilla Sylvest - Executive Vice President - Commercial Strategy and Corporate Affairs
Yes.
是的。
So agree, of course, with the results we have seen, we are very confident in the product.
所以當然同意,根據我們看到的結果,我們對產品非常有信心。
We are very confident in our portfolio, and it's really the optionality that we are working with on how to target specific segments and specific geographies.
我們對我們的產品組合非常有信心,而且我們確實在努力選擇如何瞄準特定細分市場和特定地區。
I think it's a little bit premature for us to reveal our full commercial approach as to how we are utilizing the benefits of these different options that we have in our pipeline, but it is the sum of the pipeline that we just talked to that will really enable us to address more and more people living with obesity.
我認為現在透露我們的全部商業方法(即我們如何利用我們產品線中不同選項的優勢)還為時過早,但正是我們剛才談到的所有產品線的總和才真正使我們能夠解決越來越多肥胖患者的問題。
.
。
So that's how we are moving forward.
這就是我們前進的方式。
And why you will also see us addressing different types of products with different optionalities as we just discussed all now CagriSema, amycretin and of course, also higher dose Wegovy.
您還會看到我們針對具有不同可選性的不同類型產品,正如我們剛剛討論的 CagriSema、amycretin,當然還有更高劑量的 Wegovy。
This is all part of our opportunity to play in obesity.
這些都是我們在肥胖領域發揮作用的機會。
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thank you Camilla.
謝謝你,卡米拉。
Then on the second question, we turn to you Karsten.
那麼關於第二個問題,我們請 Karsten 回答。
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Yes, Sachin, thank you for that -- so our guidance range breadth is in line with what we had last year and is also reflective of the rapid growth rate that we're delivering as a company.
是的,Sachin,謝謝你——所以我們的指導範圍廣度與去年的水平一致,也反映了我們作為一家公司所實現的快速增長率。
The main swing factors which can all be both positive and negative, I would call out three main ones, one being supply as we've seen in prior years and more supply can make us reach more patients and and more markets.
主要的影響因素既可以是正面的,也可以是負面的,我認為主要有三大因素,一是供應,正如我們在前幾年看到的那樣,更多的供應可以讓我們接觸到更多的患者和更多的市場。
And of course, negative supply fluctuations would impact the other way.
當然,負面的供應波動也會產生另一種影響。
So that's number one.
這是第一點。
Number two is competition and magnitude of competition. of course, we do not have forward-looking visibility to we see what's in the market today.
第二是競爭和競爭的激烈程度。當然,我們沒有前瞻性的眼光來了解當今的市場狀況。
So it's based on our current read of the markets.
這是基於我們目前對市場的解讀。
And then the third factor is gross to net adjustments where we've seen some sizable gross to net adjustments in the US over the past few years, reflecting a 69% spread between gross and net sales in the US and that swing factor can also both be positive and negative.
第三個因素是毛利與淨利的調整,過去幾年來我們看到美國出現了相當大的毛利與淨利的調整,反映出美國毛銷售額與淨銷售額之間的差距為 69%,而且這個波動因素既可以是正數,也可以是負數。
So that would be the main three factors.
這就是主要的三個因素。
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thank you, Karsten.
謝謝你,卡斯滕。
Thank you to you as well, Sachin.
也謝謝你,Sachin。
Then we are ready for the next question, please.
那我們可以開始下一個問題了。
Operator
Operator
Richard Parkes, BNP Paribas.
法國巴黎銀行的理查帕克斯 (Richard Parkes)。
Richard Parkes - Analyst
Richard Parkes - Analyst
Firstly, on CagriSema, I've got sound still a little bit confused on the inverse dose response.
首先,關於 CagriSema,我對逆劑量反應仍然有點困惑。
I'm just wondering -- why has this not been seen in any of the trials today?
我只是想知道——為什麼在今天的任何試驗中都沒有出現這種情況?
I'm not just to conclude that not all patients need the 20% plus weight loss that can be achieved.
我並不是想得出結論說並非所有患者都需要達到 20% 以上的減重效果。
So I'm just wondering kind of why that's not been seen before?
所以我只是想知道為什麼以前沒有見過這種情況?
And then in terms of the prescription demand currently, I mean you flagged formulary changes, but your net access sounds like it hasn't changed.
然後就目前的處方需求而言,我的意思是您標記了處方集的變化,但您的網路存取聽起來好像沒有改變。
So has there been some kind of big formulary changes, but the net access overall is the same?
那麼,是否存在某種重大的處方變化,但整體的淨訪問量是一樣的?
I'm just wondering what impact compounding pharmacies are having on demand currently.
我只是想知道配藥藥局目前對需求有何影響。
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thank you very much for those two questions.
非常感謝您提出這兩個問題。
Firstly, on CagriSema, we'll turn to you Lars.
首先,在 CagriSema,我們來向你提問,Lars。
Lars Fruergaard Joergensen - President, Chief Executive Officer
Lars Fruergaard Joergensen - President, Chief Executive Officer
Yes.
是的。
So thank you, Richard.
所以謝謝你,理查德。
So just to give a perspective on how we see this.
只是為了提供一個我們對此看法的觀點。
So Martin alluded to that also in the past, have we seen a difference in how patients respond.
馬丁過去也提到過這一點,我們是否看到患者的反應有所不同。
That has been based on, say, lower potency products.
這是基於較低效力的產品。
So we saw a similar -- when we developed Wegovy, but with less say, spread, so to say.
因此,當我們開發 Wegovy 時,我們看到了類似的情況,但可以說,發言權較少,傳播範圍較廣。
And in our view, we have to relate to that when you develop highly potent biologies like what we see with CagriSema, these differences will be amplified.
我們認為,我們必須認識到,當你開發出像 CagriSema 那樣的高效生物製劑時,這些差異將會被放大。
So the fact that patients are different and respond in a different way means that we'll see increasingly as we move up and develop highly efficacy products, you will see this difference in response.
因此,由於患者之間存在差異且其反應也不同,因此隨著我們不斷進步和開發高效產品,您將越來越多地看到這種反應差異。
And in terms of use in the market also to the prior question, I think it's perhaps less confusing for physicians than we believe because they actually use to patients responding quite differently on treatment.
對於市場使用方面,對於先前的問題,我認為這對醫生來說可能沒有我們想像的那麼令人困惑,因為他們實際上習慣於對治療反應截然不同的患者。
And that goes for obesity, but it also goes for any, say, chronic disease that patients respond differently to medicines.
這不僅適用於肥胖症,也適用於任何慢性疾病,因為患者對藥物的反應不同。
So physicians are used to a more patient-centric treatment regime.
因此,醫生習慣更以病人為中心的治療方案。
And I think what really matters here is that we have a highly potent biology that kind of does the job.
我認為真正重要的是我們擁有一種能夠完成這項任務的高效生物學。
And the other thing it's up for -- for the rest of us to acknowledge that this is a new sign we get in large-scale clinical development, but it's really linked to the potency of the product.
另一件事是——我們其他人必須承認這是我們在大規模臨床開發中得到的新跡象,但它確實與產品的效力有關。
And I anticipate that we see similar signals as we develop equally potent biologies in the future.
我預計,當我們在未來開發同樣有效的生物製劑時,我們將會看到類似的訊號。
So I'm quite comfortable with the profile and also that it works for patients and that it will also work in the hands of physicians who are used to more indivilized treatment of patients.
因此,我對該方案非常滿意,並且它對患者有效,並且對於習慣於對患者進行個人化治療的醫生來說,它也同樣有效。
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thank you, Lars.
謝謝你,拉爾斯。
And then on -- for the next question, I'll turn to you, Dave, on access/formulary movements in the US.
然後——對於下一個問題,我將找你,戴夫,關於美國的獲取/處方集運動。
David Moore - Executive Vice President - Corporate Development
David Moore - Executive Vice President - Corporate Development
Yes.
是的。
Thank you for the question, Richard.
謝謝你的提問,理查德。
It's important that we reiterate that -- it's our belief that building a sustainable obesity market for the long term is through market access and having patients have a reasonable co-pay and access to the medicine.
我們必須重申這一點——我們相信,要長期建立可持續的肥胖症市場,就要透過市場准入以及讓患者有合理的共同支付能力並獲得藥品。
I'm happy to say for 2025 that we have maintained our broad access for Wegovy, covering 55 million people with obesity.
我很高興地說,到 2025 年,我們將繼續保持 Wegovy 的廣泛覆蓋,涵蓋 5,500 萬肥胖者。
There were no major changes with opt-ins and opt-outs.
選擇加入和選擇退出方面沒有重大變化。
It's important to note that these patients have Wegovy available at a low out-of-pocket cost, more than 80% of them paying less than $25 for a prescription.
值得注意的是,這些患者使用 Wegovy 的自付費用很低,其中 80% 以上的患者僅需支付不到 25 美元的處方費。
And this is also, in addition, we have now more than 20 states that also cover Wegovy through Medicaid.
此外,現在我們有超過 20 個州透過醫療補助計劃涵蓋 Wegovy。
You also had a question about compounding.
您也對複合有疑問。
Our latest market intelligence does tell us and show us that it is having an impact, and it is growing faster than we had anticipated.
我們最新的市場情報確實告訴並向我們展示它正在產生影響,並且其增長速度比我們預期的要快。
I want to remind everyone that we do not supply compounding, and we have significant actions in place to curtail this.
我想提醒大家,我們不提供複利,我們已經採取重大措施來遏止這種現象。
Our focus is on patient safety and educating patients and providers that this is not sema and also to work with the regulators to curtail compounding as well.
我們的重點是病人安全,並教育病人和提供者這不是安全問題,同時也與監管機構合作以減少複合治療。
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thank you, Dave, and thank you, Richard, for those two questions.
謝謝戴夫和理查德提出的這兩個問題。
Then we'll turn to the next question, please.
那我們來討論下一個問題。
Operator
Operator
Emily Field, Barclays.
巴克萊銀行的艾米麗·菲爾德 (Emily Field)。
Emily Field - Analyst
Emily Field - Analyst
Just to follow up on the compounding point, for a few months now, all the doses of semaglutide have been marked is available on the FDA drug shortage website, but the molecule is still marked as in shortage.
只是為了跟進配藥點,幾個月來,所有劑量的司馬魯肽都已標記為可在 FDA 藥品短缺網站上獲得,但該分子仍然標記為短缺。
When do you expect that to be removed?
您預計什麼時候會將其刪除?
And then would that lead to a similar kind of off-ramp from the FDA for the compounders that we saw FDA issued a directive in December for trazepatide?
那麼,這是否會導致 FDA 為複合藥物生產商提供類似的豁免,就像 FDA 在 12 月針對曲氮帕肽發布的指令一樣?
And then secondly, another question on REDEFINE 1.
其次,還有一個關於 REDEFINE 1 的問題。
The red curve for the patients that were on the lower dose at the end of treatment, is it fair to say that a significant number of those patients did go up to [2.4 milligram] and then titrated down whether for tolerability or that they were very, very fast responders to the weight loss.
紅色曲線代表治療結束時採用較低劑量的患者,可以公平地說,這些患者中有相當一部分的劑量確實增加到了 [2.4 毫克],然後逐漸減少,無論是為了耐受性,還是因為他們對減肥的反應非常非常快。
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thank you, Emily.
謝謝你,艾米麗。
And on the first one, a follow-up question on compounding, we'll turn to you, Dave.
關於第一個關於複利的後續問題,我們將請您回答,戴夫。
David Moore - Executive Vice President - Corporate Development
David Moore - Executive Vice President - Corporate Development
Yes.
是的。
As you mentioned, we are still listed on the drug shortage list.
正如你所提到的,我們仍然被列在藥品短缺名單上。
We are in active dialogue with FDA.
我們正在與 FDA 進行積極對話。
It is ongoing.
它仍在進行中。
Of course, as we increase the resilience in our supply that has an impact on our ability to get off the drug shortage list, and we are focused on doing that as fast as possible as we believe this will help our further actions to curtail compounding in the future.
當然,隨著我們提高供應的彈性,這對我們擺脫藥品短缺的能力有影響,我們致力於盡快做到這一點,因為我們相信這將有助於我們採取進一步行動,減少未來的複合成長。
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thank you, Dave.
謝謝你,戴夫。
And then on the early responder Kirk, we'll turn to you, Martin.
然後關於早期響應者柯克,我們將轉向你,馬丁。
Martin Lange - Executive Vice President - Development
Martin Lange - Executive Vice President - Development
Yes.
是的。
Absolutely.
絕對地。
I want to go back to Lars' point that obesity is a complex disease.
我想回到拉爾斯的觀點:肥胖是一種複雜的疾病。
And patients have individual response to treatment.
且患者對治療的反應各有不同。
So in the group where patients did not titrate to full dose at end of trial, the mean dose at week 20 was around 1.5 milligrams, indicating that very few actually opted to try to try to full 2.4 milligram dose.
因此,在試驗結束時患者未滴定至全劑量的組別中,第 20 週的平均劑量約為 1.5 毫克,這表明實際上很少有人選擇嘗試服用 2.4 毫克的完整劑量。
This is more to be seen as a group of fast and high response.
這更多地被視為一個快速且高反應的群體。
And therefore, with the weight loss that they accrued, which was then also faster than the other group, they started to to slow down to balance the speed of their weight loss, their gastrointestinal side effects, but also the fact that they were approaching a level below the definition of obesity.
因此,隨著他們的體重逐漸減輕,並且比另一組更快,他們開始放慢速度來平衡減肥速度、胃腸道副作用,以及他們接近肥胖定義的水平的事實。
And therefore, again, it speaks to the very powerful biology that we see, but also the need to individualize treatment.
因此,這再次說明了我們所看到的非常強大的生物學特性,但也說明了個人化治療的必要性。
And again, I'll just remind you, this is the trial at a population level where we've seen very few gastrointestinal side effects at the level of Wegovy.
我再次提醒您,這是一項在人群層面進行的試驗,我們在 Wegovy 層面上觀察到的胃腸道副作用非常少。
And therefore, that is not the key driver of how patients choose to titrate, right?
因此,這不是患者選擇滴定方法的關鍵驅動因素,對嗎?
I think Lars has a really good point.
我認為拉爾斯的觀點非常正確。
Patients know how to do this together with their physicians.
患者知道如何與醫生一起做到這一點。
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thanks a lot, Martin, and thank you, Emily, for the two set of questions.
非常感謝馬丁,也非常感謝艾蜜莉提出的兩個問題。
With that, we are ready for the next question, please.
現在我們可以開始回答下一個問題了。
Operator
Operator
Florent Cespedes, Bernstein.
弗洛朗·塞斯佩德斯、伯恩斯坦。
Florent Cespedes - Analyst
Florent Cespedes - Analyst
Two quick ones, please.
請快速問兩個問題。
First for Dave, could you give us your view on the situation in the US for semaglutide regarding IRA, Inflation Reduction Act, because now you're on the list.
首先,戴夫,您能否給我們介紹美國關於 IRA、通膨削減法案的索馬魯肽情況的看法,因為現在您在名單上。
So could you remind us how you will manage the situation for 2027?
那麼,您能否提醒我們您將如何應對 2027 年的情況?
And when should we have the final level of rebates, if you could remind us that the process would be great.
如果您能提醒我們,我們什麼時候應該獲得最終的回扣水平,那麼這個過程將會很棒。
Second question for Martin on Monludaban.
第二個問題問馬丁,關於 Monludaban。
Maybe could you give us some color on the Phase 2 if from the kidney trial, notably on the tolerance if there is any readout on the tolerance side that could maybe help you to design or adjust the rest of the clinical -- ongoing clinical trials.
也許您能給我們一些關於第二階段腎臟試驗的詳細信息,特別是耐受性方面的信息,如果有任何關於耐受性的讀數,也許可以幫助您設計或調整其餘的臨床試驗——正在進行的臨床試驗。
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thanks a lot, Florent.
非常感謝,弗洛朗。
On the first one, IRA, of course, I have to speak too much, but with that, over to you Dave.
關於第一個問題,IRA,當然我要說很多,但現在交給你了,戴夫。
David Moore - Executive Vice President - Corporate Development
David Moore - Executive Vice President - Corporate Development
Yes.
是的。
Thank you, Florent.
謝謝你,弗洛朗。
As expected, semaglutide containing products, Ozempic, Rybelsus, Sema, Wegovy.
如預期,含有司馬魯肽的產品有Ozempic、Rybelsus、Sema、Wegovy。
They are selected for the second round of CMS negotiations.
他們被選中參加第二輪 CMS 談判。
It's too early to speculate on the potential impact.
現在推測潛在影響還為時過早。
As we've stated in the past, we oppose government price setting like we have from the beginning.
正如我們過去所說的那樣,我們從一開始就反對政府定價。
The process, though, is as follows: the negotiations will end in the beginning of November.
不過,流程如下:談判將於 11 月初結束。
The maximum fair price will be published by the end of November, and it will be effective in the 1st of January 2027.
最高公平價格將於11月底公佈,並於2027年1月1日生效。
And just for background, the rough US channel mix across our portfolio is about 50% commercial, 30% Medicare, 10% Medicaid and 10% other.
僅作為背景介紹,我們投資組合中的美國通路結構大致為約 50% 商業、30% 醫療保險、10% 醫療補助和 10% 其他。
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thank you, Dave.
謝謝你,戴夫。
And on the next question on the monobrand in diabetic kidney disease, we'll turn to you, Martin.
下一個關於糖尿病腎病變單一品牌的問題,我們將請您回答,馬丁。
Martin Lange - Executive Vice President - Development
Martin Lange - Executive Vice President - Development
Thank you very much for that question.
非常感謝您提出這個問題。
So to remind us, one being we never did the acquisition of Boludabant to develop it purely for diabetic kidney disease.
因此需要提醒我們的是,我們收購 Boludabant 從來不是為了純粹為了治療糖尿病腎病變。
Our focus was on the weight loss potential.
我們的重點是減肥潛力。
Second, I'll just remind you that these are small studies.
其次,我只想提醒你,這些都是小型研究。
So obviously, we try to see them in the context of the full picture.
顯然,我們試圖從整體的角度來看它們。
So we are not discouraged by the fact that we did not see impact on the actual diabetic kidney disease.
因此,對於沒有看到對實際糖尿病腎病變的影響,我們並不感到沮喪。
That study did confirm a weight loss potential for molunobant.
這項研究確實證實了莫魯諾班的減重潛力。
And when we look at the safety and tolerability profile, it was comparable, albeit with slightly lower rates than in the dedicated obesity story.
當我們觀察安全性和耐受性情況時,我們發現它們是可以比較的,儘管其發生率比專門的肥胖故事中略低。
Basically indicating that we can still have an aspiration of exploring this further in Phase 2b with lower doses looking at weight loss potential, but obviously also -- and this has been the attempt from the getgo, also ruling out an ability -- a potential safety concern.
基本上表明我們仍然可以在第 2b 階段進一步探索這個問題,使用較低的劑量來觀察減肥潛力,但顯然也是——這是從一開始就進行的嘗試,也排除了一種能力——潛在的安全隱患。
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thank you, Martin.
謝謝你,馬丁。
Yes.
是的。
Thank you as well, Florent.
也謝謝你,弗洛朗。
And then we are ready for the next set of questions, please?
那我們可以開始回答下一組問題了嗎?
Operator
Operator
Evan Seigerman, BMO Capital Markets.
埃文·塞格曼 (Evan Seigerman),BMO 資本市場。
Evan Seigerman - Analyst
Evan Seigerman - Analyst
Kind of a big picture question.
這是一個宏觀問題。
There seems to be an obsession with absolute weight loss, whether a percent more or less can make a winner or a loser and specifically referring to CagriSema.
人們似乎對絕對減肥效果非常痴迷,不管多減百分之一是成功還是失敗,特別是 CagriSema。
Maybe walk me through how you view the ideal product profile of an asset?
也許您可以向我介紹一下您如何看待資產的理想產品配置?
Is it better weight loss, notating tolerability, longer acting, better delivery.
其減肥效果是否更好、耐受性是否良好、作用時間是否更長、給藥效果是否更好。
As you think about your portfolio what would you like to see in kind of your next-generation products?
當您考慮您的產品組合時,您希望看到什麼樣的下一代產品?
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thank you, Evan.
謝謝你,埃文。
I think on the high level, obesity question, we'll turn to you, Lars.
我認為,在高層次上,關於肥胖問題,我們將向你尋求幫助,拉爾斯。
Lars Fruergaard Joergensen - President, Chief Executive Officer
Lars Fruergaard Joergensen - President, Chief Executive Officer
Thank you, Evan, for bringing that up.
謝謝你,埃文,提出這個問題。
I think it's really be a good topic to discuss.
我認為這確實是一個值得討論的好話題。
And obviously, it's a quite broad topic.
顯然,這是一個相當廣泛的話題。
And I think it -- the discussion opens up with what we now see in terms of this case's biologies because you say that with former generation products like Wegovy, you could, in principle, say, load patients up and all would say tolerate the weight loss they see.
我認為,討論將從我們現在看到的該案例的生物學角度展開,因為您說,使用像 Wegovy 這樣的上一代產品,原則上可以說,讓患者承受負荷,所有人都會說可以忍受他們所看到的體重減輕。
And also, the GI tolerability, we know is very good.
而且我們知道它的胃腸道耐受性非常好。
But when you get into, say, the next-generation products, where you amplify the weight loss, you tease out the difference between different patients who we are still trying to look into the [omics] and figure out what defines the difference.
但當你進入下一代產品時,你會擴大減重範圍,你會發現不同患者之間的差異,我們仍在嘗試研究[組學]並找出定義差異的原因。
And we have a lot of data.
我們擁有大量數據。
So we can start actually finding ideas about who will respond in certain ways and from a speed of weight loss, et cetera.
因此,我們可以開始真正地尋找關於誰會以某種方式做出反應以及從減肥速度等方面做出反應的想法。
So that -- then we're into the topic of, say, quality of weight loss.
那麼——我們來討論一下減肥品質這個主題。
And I think in the early days of obesity, we have all been obsessed by the percentage over time.
我認為在肥胖症出現的早期,我們都一直沉迷於隨時間推移的百分比。
And I think that's a problematic ratio because if you have lived with obesity, a good part of your life and suddenly, you lose, say 25%, in some even more percent weight loss in a matter of, say, half year to a year, that's a very, very dramatic, say, change in your life and not necessarily what anyone would like.
我認為這個比例是有問題的,因為如果你一生中大部分時間都患有肥胖症,而突然間,在半年到一年的時間裡,你的體重下降了 25% 甚至更多的百分比,這對你的生活來說是一個非常非常巨大的變化,不一定是任何人所希望的。
So that's one.
這就是其中之一。
And then, of course, we have all the comorbidities.
當然,我們也患有各種合併症。
And increasingly, I think with the establishment of CV benefits, liver benefits, et cetera, it also becomes a matter of, say, the health outcome improvements you have.
而且我認為,隨著心血管福利、肝臟福利等的建立,這也越來越成為一種有關健康狀況改善的問題。
So in this, say, opportunity space, I think it's important to be able to address those opportunities with different type of agents, to cater for these differences.
因此,在這個機會空間中,我認為重要的是能夠透過不同類型的代理商來解決這些機會,以滿足這些差異。
Short term, as I mentioned before, I think patients together with the physician are quite comfortable in managing this journey.
短期內,正如我之前提到的,我認為患者和醫生一起處理這趟旅程會非常舒適。
And I think we are perhaps struggling a bit in doing the perfect segmentation of what this market will look like.
我認為,我們可能在對這個市場進行完美細分方面遇到了一些困難。
But I think we can look into all the data we have and find ways to also more targeted direct specific products to certain subsegments.
但我認為,我們可以研究我們擁有的所有數據,並找到更有針對性地將特定產品推向特定細分市場的方法。
So I think this is another example of the fact that we're in the early days of of understanding obesity, how patients are different.
所以我認為這是另一個例子,說明我們對肥胖症以及患者之間的差異的了解還處於早期階段。
And I think it's all opportunity for us with the breadth of the portfolio we have and all the data we have.
我認為,憑藉我們廣泛的產品組合和所有的數據,這對我們來說都是機會。
So yes, percentage of weight loss matters what quality of weight loss and benefit on comorbidities, et cetera, et cetera, also matters.
所以是的,減肥的百分比很重要,減肥的品質以及對合併症的好處等等也很重要。
And it's a net total equation that I think we have a really exciting opportunity for continuous leadership in the space.
這是一個淨總體方程,我認為我們有一個真正令人興奮的機會來繼續保持該領域的領導地位。
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thank you, Lars, and thank you, Evan, for the questions.
謝謝拉爾斯 (Lars) 和埃文 (Evan) 提出的問題。
Then we have time for two more sets of questions, and let's start with the first one, please.
然後我們還有時間再問兩組問題,我們從第一組問題開始。
Operator
Operator
Luisa Hector, Berenberg.
路易莎·赫克托(Luisa Hector),貝倫貝格。
Luisa Hector - Analyst
Luisa Hector - Analyst
For REDEFINE 1, could you just comment on what percentage of patients down-titrated?
對於 REDEFINE 1,您能否評論一下降劑量患者的百分比是多少?
And any color on the timing at which that happened.
以及發生該事件的時間的任何細節。
And perhaps on the highest dose, what the discontinuation rate was?
請問最高劑量下的停藥率是多少?
And then I wonder if I could ask you a question on amycretin and progression there.
然後我想知道我是否可以問您一個關於阿米克林及其進展的問題。
So when I pulled together your comments on CagriSema, the high potency, individual patient responses and then we layer in the proposed FDA guidelines that say Phase 2 data should be sufficient to capture maximal or new maximal weight reduction effects with the dosing regimen.
因此,當我匯總您對 CagriSema 的評論、高效力、個別患者反應,然後我們分層考慮 FDA 提出的指南時,該指南指出第 2 階段的數據應該足以透過給藥方案捕捉最大或新的最大減肥效果。
Do you feel that you have enough data to progress into Phase 3?
您是否認為您擁有足夠的數據來進入第 3 階段?
Or would perhaps another Phase 2 be advisable?
或者也許建議再進行第二階段?
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thank you for those two questions, Luisa.
謝謝你提出這兩個問題,路易莎。
I think both of them for you, Martin, start with the first one.
馬丁,我認為對你來說,這兩個都是從第一個開始的。
So on the data in REDEFINE 1.
因此關於REDEFINE 1中的數據。
Martin Lange - Executive Vice President - Development
Martin Lange - Executive Vice President - Development
Yes.
是的。
So first of all, we had these two very clear distinct groups.
首先,我們有這兩個非常不同的群體。
The larger group of 57% of the people titrating to 2.4 milligram.
其中,57% 的人劑量較大,滴定至 2.4 毫克。
Just to give you an example, they were at a mean dose of 2.2 milligram at 20 weeks.
舉個例子,他們在 20 週時的平均劑量為 2.2 毫克。
And they then continue to the full 2.4 milligram% and appear to stay on that.
然後他們繼續將劑量增加到 2.4 毫克%,並且似乎一直保持在這個水平。
There were a few patients doing ups and downs, but it would not be meaningful to try to tease them out.
有幾個病人上下起伏,但試圖挑出他們是沒有意義的。
Similarly, I just want to remind you, at week 20, the other group were at 1.5 milligram, and they down titrated a little bit as a group to add
同樣,我只是想提醒你,在第 20 週,另一組的劑量為 1.5 毫克,他們作為一個組稍微減少了劑量,以添加
[Endotrial 1.1].
[內視鏡 1.1]。
While the -- while basically securing a weight loss that was higher than what we've seen before, namely 25.2%.
同時,基本上確保了減重效果高於我們先前所見的水平,即 25.2%。
At the same time, this way of allowing patients to do -- I don't want to say personal titration, but close to actually allowed us to see the lowest overall dropout ever seen in a Phase 3 pivotal trial.
同時,這種允許患者進行治療的方式——我不想說是個人化滴定,但實際上接近讓我們看到第三階段關鍵試驗中最低的總體退出率。
But also very low and again, the lowest gastrointestinal dropouts seen in the pivotal trial.
但也非常低,並且再次是關鍵試驗中觀察到的最低的胃腸道退出率。
And just a reminder, CagriSema in REDEFINE 1, 3.6% dropout, semaglutide in Step 1 4.5% drop out due to gastrointestinal side effects.
需要提醒的是,CagriSema 在 REDEFINE 1 中,有 3.6% 的患者退出,而 semaglutide 在第 1 步中,由於胃腸道副作用,有 4.5% 的患者退出。
So we're actually quite encouraged by the data.
因此,這些數據實際上讓我們感到非常鼓舞。
And as Lars also alluded to, by employing this individual approach to patients moving forward, we can really leverage the full benefit of not only CagriSema, but also our pipeline products.
正如拉爾斯所提到的,透過對患者採用這種個人化的方法,我們不僅可以充分利用 CagriSema,還可以充分利用我們管道產品的優勢。
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
And then on the second question on amycretin, we'll turn to you, Martin, again, and on the next steps.
然後關於阿米克林的第二個問題,我們將再次請您,馬丁,討論下一步。
Martin Lange - Executive Vice President - Development
Martin Lange - Executive Vice President - Development
So as you know, we have generated the data on the oral version of amycretin.
如您所知,我們已經產生了有關口服阿米克林的數據。
They are very consistent with the data that we see with the subcutaneous version of amycretin in patients with obesity.
它們與我們在肥胖患者中使用皮下注射阿米克林所得到的數據非常一致。
We have an ongoing Phase 2 trial in patients with type 2 diabetes.
我們正在對第 2 型糖尿病患者進行第 2 期試驗。
Our current assessment is that we live up to the spirit of the FDA draft guidance.
我們目前的評估是,我們遵守了 FDA 指導草案的精神。
Obviously, as in any progression of clinical development, we had to discuss with the regulatory authorities, which we'll do in short order.
顯然,與任何臨床開發進展一樣,我們必須與監管機構進行討論,我們會盡快進行。
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thank you, Martin, and thanks to you as well, Luisa.
謝謝你,馬丁,也謝謝你,路易莎。
And then we are ready for a final set of questions, please.
然後我們準備好回答最後一組問題。
Operator
Operator
Michael Novod, Nordea.
北歐聯合銀行 (Nordea) 的邁克爾諾沃德 (Michael Novod)。
Michael Novod - Analyst
Michael Novod - Analyst
Michael Novod from Nordea.
來自 Nordea 的 Michael Novod。
Also two questions.
還有兩個問題。
So the first one with the data on hand with CagriSema and the flexibility and more sort of individualized treatment as well as sort of your plans for amycretin.
因此,第一個問題是,根據 CagriSema 現有的數據以及靈活性和更個人化的治療,以及您對阿米克汀的計劃。
Have you changed any sort of view on whether -- how to sort of weather the LOE on semaglutide in 2032, and the way of sort of replacing Wegovy with either of these drugs?
您是否改變了對如何度過 2032 年索馬魯肽的 LOE 以及如何用其中任何一種藥物取代 Wegovy 的看法?
And then secondly, can you tease out also on -- when you look at the very early data on CagriSema and also amycretin, anything more to add on whether amycretin looks different in terms of tolerability.
其次,當您查看 CagriSema 和 amycretin 的早期數據時,您能否進一步說明 amycretin 在耐受性方面是否有所不同。
I know it's very early data you have, but what sort of try to pin down on how this could look in later-stage trials, whether it's just as tolerable as CagriSema?
我知道您擁有的只是非常早期的數據,但是您如何嘗試確定這在後期試驗中會如何表現,是否與 CagriSema 一樣具有耐受性?
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Michael, thanks for those two questions.
邁克爾,謝謝你提出這兩個問題。
I think first, on the overall view on CagriSema and amycretin, will turn to you, Camilla.
我認為首先,關於對 CagriSema 和 amycretin 的總體看法,請您發言,卡米拉。
And afterwards, on amycretin tolerability, we'll turn to you Martin.
之後,關於阿米克林的耐受性,我們將請馬丁來討論。
But over to you, Camilla.
但交給你了,卡米拉。
Camilla Sylvest - Executive Vice President - Commercial Strategy and Corporate Affairs
Camilla Sylvest - Executive Vice President - Commercial Strategy and Corporate Affairs
Yes.
是的。
Thanks alot.
多謝。
So in terms of whether we have changed anything in our view towards loss of exclusivity, I would say we have not.
因此,關於我們對喪失獨家經營權的看法是否發生了改變,我的回答是沒有。
What we have learned now is, of course, that little bit more clarity on different segments.
當然,我們現在學到的是,對不同部分的了解更加清晰了。
We talked about individual life treatment.
我們討論了個人生活待遇。
We learn more about how each product works, but it only gives rise to us getting more information about how we are going to position this port portfolio of opportunities that we have.
我們更了解了每種產品的工作原理,但這只會讓我們獲得更多關於如何定位我們擁有的港口機會組合的資訊。
So the short answer is no, and we also continue to, of course, build on semaglutide franchise.
所以簡短的回答是否定的,當然,我們也會繼續發展司馬魯肽的特許經營權。
You just saw the new indications that we got.
您剛剛看到了我們得到的新跡象。
So full speed on that going forward, but also full speed on the new innovation, simply establishing this full portfolio.
因此,我們要全速前進,同時也要全速推進新的創新,建立完整的產品組合。
So no radical changes to that at all.
因此,根本不會發生根本性的改變。
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thank you, Camilla.
謝謝你,卡米拉。
And then on the amycretin data to you, Martin?
那麼馬丁,您可以向我諮詢阿米克林的數據嗎?
Martin Lange - Executive Vice President - Development
Martin Lange - Executive Vice President - Development
Thank you very much.
非常感謝。
It's early days.
現在還為時過早。
And obviously, what we can say at this point in time is we are working with two powerful biologies.
顯然,我們現在可以說的是,我們正在研究兩種強大的生物學。
They appear to have similar efficacy, but also safety and tolerability potential.
它們似乎具有相似的功效,也具有安全性和耐受性潛力。
And obviously, that also means that we have to think in the power of the combination biology into our amycretin development program to accrue the full potential, both in terms of weight loss, but also safety and tolerability and potentially also comorbidities, when we do develop amycretin and CagriSema moving forward.
顯然,這也意味著我們必須將組合生物學的力量融入我們的阿米克汀開發計劃中,以便在我們進一步開發阿米克汀和 CagriSema 時,充分發揮其潛力,不僅在減肥方面,而且在安全性和耐受性以及潛在的合併症方面。
Jacob Martin Rode - Head of Investor Relations
Jacob Martin Rode - Head of Investor Relations
Thank you, Martin, and also thank you to you, Michael.
謝謝你,馬丁,也謝謝你,麥可。
Now, that concludes the Q&A session.
問答環節到此結束。
Thank you for participating and feel free to contact Investor Relations regarding any follow-up questions that you may have.
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 fully close the call, I would like to hand over the word to you, Lars, for final remarks.
在我們結束通話之前,我想將發言權交給你,拉爾斯,請你做最後的發言。
Lars Fruergaard Joergensen - President, Chief Executive Officer
Lars Fruergaard Joergensen - President, Chief Executive Officer
Thank you, Jacob.
謝謝你,雅各。
I'm very pleased with the 2024 sales growth of 26%, driven by our GLP-1 portfolio in both operating units.
我對 2024 年 26% 的銷售成長感到非常滿意,這得益於我們兩個營運部門的 GLP-1 產品組合。
And within R&D, we see a strong momentum, as we just discussed in our pipeline, is underlined by the recent readouts in obesity, both for CagriSema and amycretin.
在研發領域,我們看到了強勁的勢頭,正如我們剛剛在管道中討論的那樣,最近肥胖症方面的數據突顯了這一點,無論是 CagriSema 還是 amycretin。
And of course, I'm also very pleased with the expected 2025 outlook.
當然,我對 2025 年的預期前景也非常滿意。
We continue to focus heavily on commercial execution and on the progression of our R&D pipeline and the expansion of our production capacity.
我們將繼續高度重視商業執行、研發管道的推進以及生產能力的擴大。
So the plan is very clear, and we know what it takes to execute on this.
所以這個計畫非常明確,我們也知道如何執行這個計畫。
So also thank you from me on management on your time today.
因此,我謹代表管理層感謝您今天抽出時間。
We appreciate the opportunity to discuss our business with you.
我們很高興有機會與您討論我們的業務。
Thank you very much.
非常感謝。
Bye-bye.
再見。
Operator
Operator
Thank you.
謝謝。
This concludes today's conference call.
今天的電話會議到此結束。
Thank you for participating.
感謝您的參與。
You may now disconnect.
您現在可以斷開連線。