Novo Nordisk 是一家製藥公司,正在停止開髮用於治療糖尿病的胰高血糖素激動劑。該公司的首席執行官馬丁伍德福德在電話會議上解釋說,該決定是基於這樣一個事實,即他們管道中的其他藥物似乎具有優越的療效和安全性。馬丁是諾和諾德的首席執行官。他正在接受關於一種新藥臨床試驗的採訪。第一個問題是關於決定使用比以前的試驗更高的劑量。馬丁說,這個決定是基於這樣的假設,即先前的試驗已經表明該藥物在較低劑量下是可以耐受的,並且增加劑量不會帶來更多副作用。第二個問題是關於藥物的耐受性,這在之前的試驗中一直是個問題。馬丁說,公司相信他們可以通過滴定劑量來提高當前試驗的耐受性,這意味著從較低的劑量開始,然後逐漸增加。諾和諾德是一家在市場上取得成功的製藥公司。他們將成功歸功於其巨大的市場份額以及對研發投資的承諾。他們目前正在開發一種新藥,希望能成功治療肥胖症和 2 型糖尿病。該公司還致力於改善他們的分銷渠道,以使他們的產品更容易獲得。最後,他們談到了這些藥物的競爭格局以及諾和諾德如何進行競爭。
諾和諾德是一家生產糖尿病藥物的製藥公司。在回答有關該公司計劃增加其 Wegovy 產品產量的問題時,這位首席執行官表示,他們已經開始為美國市場補充供應,他們預計到 2023 年底將有四個不同的地點生產該產品。他指出這將是產能上的一個階段性變化,並且公司已經制定了應急計劃,以防出現任何不可預見的問題。
首席執行官還討論了公司的新型糖尿病藥物 Ozempic 和 GLP-1。他們談論了藥物的功效以及它們之間協同作用的潛力。他們還討論了 Ozempic 的供應限制以及他們如何努力增加產量。最後,他們談到了這些藥物的競爭格局以及諾和諾德如何進行競爭。
總體而言,這些新藥物在治療糖尿病方面顯示出了希望,這些藥物的定價討論可能會基於它們在治療 2 型糖尿病患者中的有效性。
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
Keyur Parekh - Equity Analyst
Keyur Parekh - Equity Analyst
Good afternoon all, and thank you for joining us. My name is Keyur Parekh, and I cover Novo for Goldman Sachs. It's a pleasure to have the team in London. It's even a better pleasure to have them the day after they made a new lifetime high from a stock price perspective. Congratulations. With that, I'm going to pass it to you, Karsten, to make some opening comments, and then we'll go to Q&A from there.
大家下午好,感謝您加入我們。我的名字是 Keyur Parekh,我負責高盛的 Novo。很高興有團隊在倫敦。從股價的角度來看,在他們創下一生新高後的第二天擁有他們會更令人高興。恭喜。有了這個,我將把它傳遞給你,Karsten,讓你發表一些開場白,然後我們將從那裡開始問答。
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Great. Thank you, Keyur, and thank you to Goldman Sachs for hosting our quarterly London lunch meeting. And what an opening, right? So it's a tough act to follow. But clearly, with the dream team like this with my good colleagues, Ludovic Helfgott from Rare Disease, Martin Lange from Development and Camilla Sylvest from our Commercial Strategy area. Then I think we're set up for a great session today.
偉大的。謝謝 Keyur,也感謝高盛主辦我們每季度一次的倫敦午餐會。多麼開放,對吧?所以這是一個很難遵循的行為。但顯然,與我的好同事 Ludovic Helfgott、開發部的 Martin Lange 和商業戰略領域的 Camilla Sylvest 一起組成了這樣的夢之隊。那麼我認為我們今天的會議已經準備就緒。
We had kind of an unfortunate situation yesterday with our conference call that -- and some people would say, "Did you plan for that day?" And at least now, we have a sample size of one. Martin will say it's not enough, but that we cut the conference call, and then we get an all-time high on our share price. So I'm not sure if you can do any trending on that. But hopefully, there will be no trend, at least. And knocking on wood, with all kinds of technical support today, that this is being webcasted and out there just for us to be aware about that.
昨天我們的電話會議遇到了一個不幸的情況——有些人會說,“你為那天做了計劃嗎?”至少現在,我們的樣本量是 1。馬丁會說這還不夠,但我們取消了電話會議,然後我們的股價創下歷史新高。所以我不確定你是否可以對此做任何趨勢分析。但希望至少不會有趨勢。敲敲木頭,今天有各種技術支持,這正在網絡廣播,只是為了讓我們意識到這一點。
So for today's presentation, and we have brought not too many slides that we'll go through in the beginning. And then in case there should be questions, then we'll have time for that. And if not, then we'll run off. But I would be surprised if there wouldn't be a few questions on 483, so -- whatever the flavor of the day is.
因此,對於今天的演示,我們帶來的幻燈片不多,我們將在開始時進行演示。然後,如果有問題,我們將有時間解決。如果沒有,那我們就跑掉。但如果 483 上沒有幾個問題,我會感到驚訝,所以 - 無論今天的情況如何。
So jumping into our statements, then of course, as usual, our forward-looking statements, that there is a risk that the future doesn't pan out in line with our forward-looking statements. It could be better, it could be worse, but that is the risk that we all live under and enjoy.
因此,跳進我們的聲明,然後當然,像往常一樣,我們的前瞻性聲明,存在未來與我們的前瞻性聲明不一致的風險。它可能更好,也可能更糟,但這是我們所有人都生活在其中並樂在其中的風險。
And then just one slide on our strategic aspirations, which is basically how we portray the progress in terms of our corporate strategy execution. And without taking too much out of my colleagues' presentations, then briefly on each of the quadrants, purpose, sustainability. This is a core area for us. This is ESG in Novo Nordisk language. We continue to progress on our carbon emissions. So we're down 18% in carbon emissions compared to pre-COVID 2019. And actually, 18% is even not where we'd like to be. We're more ambitious than that. We have some pressures from distribution of our products. So that's why it could have been even better, but it's something that we're really driving performance management on.
然後是一張關於我們戰略願景的幻燈片,這基本上就是我們如何描述我們在公司戰略執行方面取得的進展。在不從我同事的演講中摘取太多內容的情況下,然後簡要介紹每個像限、目的和可持續性。這是我們的核心領域。這是諾和諾德語言中的 ESG。我們繼續在碳排放方面取得進展。因此,與 2019 年 COVID 之前相比,我們的碳排放量減少了 18%。實際上,18% 甚至不是我們想要的。我們比這更有野心。我們的產品分銷給我們帶來了一些壓力。所以這就是為什麼它可能會更好,但這是我們真正推動績效管理的事情。
In terms of adding value to society, then -- as of today, we are serving more patients than ever before in the history of the company. So of course, the core premise and the core objective of a company like Novo Nordisk is to discover and develop innovative medicine and make it available to patients on a global scale. And therefore, it's not only a pleasure based on the financials and the share price that Keyur alluded to, but even more importantly, we're serving more patients than ever, ever before.
那麼,就為社會增加價值而言——截至今天,我們服務的患者比公司歷史上以往任何時候都多。因此,當然,像諾和諾德這樣的公司的核心前提和核心目標是發現和開發創新藥物,並在全球範圍內為患者提供。因此,這不僅基於 Keyur 提到的財務狀況和股價,而且更重要的是,我們正在為比以往任何時候都多的患者提供服務。
And then we're progressing on our diversity and inclusion efforts and being a sustainable employer. Commercial exclusion, Camilla will go through, but 16% sales growth in an industry like the pharma industry, I don't know what the current run rate is, but at least, the last few years when we've been looking at the value at pharma, run rate for the global industry is to the tune of 4%, 5% or something like that. So having a clock speed at 16% is, of course, clearly competitive and in the top tier of the industry.
然後我們在多元化和包容性方面取得進展,並成為可持續發展的雇主。商業排除,卡米拉會經歷,但像製藥行業這樣的行業有 16% 的銷售增長,我不知道目前的運行率是多少,但至少,過去幾年我們一直在關注價值在製藥業,全球行業的運行率約為 4%、5% 或類似水平。因此,擁有 16% 的時鐘速度當然具有明顯的競爭力,並且處於行業的頂級水平。
And then pipeline, again, as I said before, this is why we're here as a company. This is to discover and develop innovative products for the benefit of patients. And it's just really a pleasure to see the progress we're making both in -- within diabetes care, progress within obesity and rare disease. So as you recall, we are pursuing a corporate strategy where we are expanding and diversifying our R&D pipeline. And I think this is clearly a picture, and Martin will come back to it, that we are stepping up investments in R&D to expand and diversify the pipeline.
然後是管道,正如我之前所說,這就是我們作為一家公司來到這裡的原因。這是為了發現和開發造福於患者的創新產品。很高興看到我們在糖尿病護理、肥胖症和罕見病方面取得的進展。因此,正如您所記得的那樣,我們正在推行一項公司戰略,即我們正在擴大和多樣化我們的研發渠道。我認為這顯然是一幅圖景,馬丁會回過頭來,我們正在加大對研發的投資,以擴大管道並使管道多樣化。
And then finally, on financials, 16% turns into 14% operating profit growth. I'll come back to the details. Continued efficiency drive and very competitive cash-to-earnings conversion and more than DKK 40 billion returned to shareholders. So -- and when you look at our balance sheet, then on an MAT basis, we're around 100% return on invested capital. So a fast-growing, high-margin company with a 100% return on invested capital, I think, these finance folks like myself, that's metrics we truly enjoy. So with that, I'll hand it over to you, Camilla, on Commercial.
最後,在財務方面,16% 變成了 14% 的營業利潤增長。我會回到細節。持續的效率驅動和極具競爭力的現金收益轉換以及超過 400 億丹麥克朗的股東回報。所以——當你查看我們的資產負債表時,在 MAT 的基礎上,我們的投資資本回報率約為 100%。因此,我認為,一家快速增長、高利潤的公司,投資資本回報率為 100%,像我這樣的財務人員,這是我們真正喜歡的指標。因此,我將把它交給你,卡米拉,關於商業。
Camilla Sylvest - Executive VP, Head of Commercial Strategy & Corporate Affairs and Member of the Management Board
Camilla Sylvest - Executive VP, Head of Commercial Strategy & Corporate Affairs and Member of the Management Board
Yes. Thanks a lot, Karsten, and let's just look at the 16% growth, how that's distributed among North America and international operations. You see 22% growth in North America. It's 62% of our share of growth. And then we have 11% growth in IO. That's driven mainly by growth in EMEA, double-digit. And also in the rest of the world, we have, as you can see, a minus 5% in China. That's related to the volume-based procurement, the VBP, that was implemented as of May this year.
是的。非常感謝,Karsten,讓我們看看 16% 的增長,這是如何在北美和國際業務中分配的。你看到北美有 22% 的增長。這是我們增長份額的 62%。然後我們的 IO 增長了 11%。這主要是由 EMEA 的兩位數增長推動的。在世界其他地區,如您所見,我們在中國的增長率為負 5%。這與今年 5 月開始實施的基於數量的採購 VBP 有關。
And when we look at how that is distributed across the therapy areas, you see that GLP-1 driving 44% growth, negative growth in insulin both in IO and in North America. And then obesity care growing 75%. Interestingly, 73% in IO without Wegovy, but only from Saxenda. And then in North America, combination of Saxenda and Wegovy, growing 77%. Rare disease, Ludovic will come back to in a minute, growing at 2%.
當我們查看其在治療領域的分佈情況時,您會看到 GLP-1 推動了 44% 的增長,IO 和北美的胰島素負增長。然後肥胖護理增長了 75%。有趣的是,IO 中有 73% 沒有 Wegovy,但僅來自 Saxenda。然後在北美,Saxenda 和 Wegovy 的組合增長了 77%。罕見疾病,Ludovic 將在一分鐘內恢復,以 2% 的速度增長。
And if we then look at GLP-1 class, especially in the U.S., you see a significant step-up in terms of the market growth. This is also what we've seen with previous launches into this segment, that the market growth keeps expanding, but now we are at a level where volume growth is above 40%. We can come back to how that is being driven also by guidelines. But what you see is, of course, that Ozempic is still the leading brand in the class. But of course, with the market growing so significantly, volume growth becomes much more significant for sales than actual market share development.
如果我們再看看 GLP-1 類,尤其是在美國,你會看到市場增長方面的顯著提升。這也是我們在之前推出該細分市場時看到的情況,即市場增長不斷擴大,但現在我們處於銷量增長超過 40% 的水平。我們可以回過頭來看看指南是如何推動它的。但是,您看到的當然是 Ozempic 仍然是同類產品中的領先品牌。但當然,隨著市場增長如此顯著,銷量增長對銷售額的影響遠大於實際市場份額的發展。
And then on obesity, here again, you see the 75% growth in the first 9 months. You see in the middle also a very strong volume growth of 63%. And I'm sure we'll come back to how our rollout plans are in the rest of the world and also that we are expecting to supply Wegovy, make all doses available towards the end of this year. That's still the plan exactly as we also discussed last time when we met.
然後在肥胖方面,您再次看到前 9 個月增長了 75%。您會在中間看到 63% 的非常強勁的銷量增長。我相信我們會回到我們在世界其他地區的推出計劃如何,以及我們期望供應 Wegovy,在今年年底前提供所有劑量。這仍然是我們上次見面時也討論過的計劃。
And with that, over to Ludovic for update on rare disease.
然後,讓 Ludovic 了解罕見病的最新情況。
Ludovic Helfgott - Executive VP, Head of Rare Disease & Member of Management Board
Ludovic Helfgott - Executive VP, Head of Rare Disease & Member of Management Board
Yes, exactly. Very quickly, just the rare disease franchise grew 2% in this year-to-date with a great growth on the rare blood disorder franchise, RBD, driven by hemophilia A, hemophilia B and NovoSeven, as you can see. Still a growth of 6% on NovoSeven, just to give an example, for a product that had been there for 26 years. It's still a growing franchise. And then the decrease on the endocrine disorder side, mostly driven by pricing essentially.
對,就是這樣。很快,今年迄今為止,只有罕見疾病特許經營權增長了 2%,罕見血液病特許經營權 RBD 的大幅增長,由血友病 A、血友病 B 和 NovoSeven 推動,如您所見。 NovoSeven 仍然增長了 6%,僅舉個例子,對於已經存在 26 年的產品。它仍然是一個不斷增長的特許經營權。然後是內分泌失調方面的減少,主要是定價驅動的。
Because from a volume perspective, the brand is clearly leader across the world, more than 60% of market share in the U.S., around 36% worldwide. So overall, this price declined mostly in the U.S., which explained the 3% slight decline in North America, one is in IO, It's a 4% sales growth. So we are on our sort of long-term trajectory with this 2% growth in year-to-date 2022.
因為從銷量的角度來看,該品牌顯然在全球處於領先地位,在美國的市場份額超過 60%,在全球約佔 36%。所以總的來說,這個價格主要在美國下降,這解釋了北美 3% 的小幅下降,一個是 IO,這是 4% 的銷售增長。因此,我們正處於我們的長期軌道上,2022 年迄今增長了 2%。
So we move to the rest of the pipeline.
所以我們轉向管道的其餘部分。
Martin Holst Lange - Executive VP, Head of Development & Member of the Management Board
Martin Holst Lange - Executive VP, Head of Development & Member of the Management Board
So you've heard it for Karsten, we are investing more than ever in R&D, and that is leading to a very nice progress of our pipeline in the early research days, but certainly also in a super nice progress in our clinical pipeline and in the development space. More than ever patients in clinical trials, more than ever active clinical trials in more than ever disease areas. And we're seeing nice progress across the board. So going from the 50,000 patients that we actually have in clinical trials as we speak, I want to talk about [92]. And that's basically because you heard of us talk about CagriSema in the obesity space.
所以你聽說過 Karsten,我們在研發方面的投資比以往任何時候都多,這導致我們的管道在早期研究日取得了非常好的進展,但肯定也使我們的臨床管道和在的發展空間。參與臨床試驗的患者比以往任何時候都多,臨床試驗比以往任何時候都活躍在比以往任何時候都多的疾病領域。我們看到全面的進展。因此,從我們目前在臨床試驗中實際擁有的 50,000 名患者出發,我想談談 [92]。這基本上是因為您聽說過我們在肥胖領域談論 CagriSema。
We think that we have an asset that will lead to a 25%-plus weight loss in the obesity space. That's exciting in and of itself. Hopefully, you also noticed that we initiated Phase III for CagriSema this week, which is going to be super, super exciting. We did not know what to expect from CagriSema in the space of type 2 diabetes and glycemia control. And therefore, we conducted a fairly small Phase II study, 90 patients being equally randomized to either CagriSema, semaglutide in monotherapy or cagrilintide in monotherapy.
我們認為我們擁有一項資產,可以使肥胖領域的體重減輕 25% 以上。這本身就令人興奮。希望您也注意到我們本周啟動了 CagriSema 的第三階段,這將是非常非常令人興奮的。我們不知道在 2 型糖尿病和血糖控制領域對 CagriSema 有什麼期望。因此,我們進行了一項相當小的 II 期研究,90 名患者被平均隨機分配到 CagriSema、單藥治療的 semaglutide 或單藥治療的 cagrilintide。
Super excited after 32 weeks of treatment to observe that we saw not only a numerically and substantially numerically better reduction in hemoglobin A1C for CagriSema as compared to semaglutide, and that was maybe not so surprising cagrilintide. But equally excited about seeing the weight loss. You know most of you that's seeing -- and accruing weight loss in type 2 diabetes is actually more difficult than what we see in non-diabetes, so both with semaglutide, but also whatever else is out there. You see somewhat less weight loss in type 2 diabetes than what you see in non-diabetes patients.
經過 32 週的治療後,我們非常興奮地觀察到,與 semaglutide 相比,我們不僅看到 CagriSema 的血紅蛋白 A1C 在數值上和數值上都有更好的降低,這也許並不令人驚訝。但同樣對看到體重減輕感到興奮。你知道你們中的大多數人都看到了——2 型糖尿病患者的體重減輕實際上比我們在非糖尿病患者身上看到的更難,所以既有 semaglutide,也有其他任何藥物。與非糖尿病患者相比,您看到 2 型糖尿病患者的體重減輕要少一些。
But combining cagrilintide and semaglutide, that leads to a 15% weight loss in 32 weeks. If we extrapolate that to our usual 68 weeks, it's a 20-plus percent weight loss. And that is better than anything we have seen in the type 2 diabetes space. I'm now looking at a different slide than I was promised. Maybe I should just look at my slide, but that is okay. Now you heard all of my stories about CagriSema. That is super exciting, and I could do it without looking at the slide. It is because -- it's actually some easy number to remember, because this gives me a great opportunity to also talk about what we've seen with in (inaudible) with ONWARDS 5. It's still 0.4 percentage point difference in A1C, a superior reduction as compared to whatever is out there.
但是結合使用卡格林肽和索馬魯肽,可以在 32 週內減輕 15% 的體重。如果我們將其外推到我們通常的 68 週,那就是體重減輕了 20% 以上。這比我們在 2 型糖尿病領域看到的任何東西都要好。我現在看的是一張不同於承諾的幻燈片。也許我應該看看我的幻燈片,但這沒關係。現在您已經聽到了我關於 CagriSema 的所有故事。這太令人興奮了,我不用看幻燈片也能做到。這是因為——它實際上是一些容易記住的數字,因為這給了我一個很好的機會來談論我們在 ONWARDS 5 中(聽不清)看到的東西。A1C 仍然有 0.4 個百分點的差異,這是一個很好的減少與外面的任何東西相比。
That is also super exciting. We have the vast majority of our patients of -- sorry, of our diabetes patients on insulin treatment still, more than 30 million across the board. And imagine that you can show a 0.4 percentage point different in this space. This is actually -- if I extrapolate UKPDS, I can start talking about reduction in cardiovascular mortality, reduction in all-cost mortality, 20% reduction in risk of amputations. That makes it meaningful for the individual patients, obviously, but actually also for payers. And I think when Camilla has to start to do pricing negotiations for icodec, that will make it super exciting. So obviously, the progress of icodec and a submission during the course of first half of next year is going to be super exciting.
這也是超級令人興奮的。我們的絕大多數患者——抱歉,我們的糖尿病患者仍在接受胰島素治療,總人數超過 3000 萬。想像一下,您可以在這個空間中顯示 0.4 個百分點的差異。這實際上是——如果我推斷 UKPDS,我可以開始談論心血管死亡率的降低、全成本死亡率的降低、截肢風險降低 20%。顯然,這對個別患者有意義,但實際上對付款人也有意義。而且我認為,當 Camilla 必須開始為 icodec 進行定價談判時,那將會非常令人興奮。很明顯,icodec 的進展和明年上半年的提交將非常令人興奮。
I do want to call out in the obesity space we also will see the readout of high-dose semaglutide in that space, 50 milligrams of semaglutide. We also have a 25 milligram story ongoing. In the rare disease space, Ludovic has already touched on that. But suffice it to say, super exciting to see the progress of (inaudible). So we initiated (inaudible) actually last week. And that basically means that we will -- and I hope you can agree with me that is an impressive record. We will spend approximately 4 years of clinical development. This is to be compared with the normal [AGS] in hemophilia that we spend in clinical development, specifically for (inaudible) we've progressed it very fast. We are now in Phase III and you should expect a readout from that trial during the course of '24.
我確實想在肥胖領域大聲疾呼,我們還將在該領域看到高劑量 semaglutide 的讀數,50 毫克 semaglutide。我們還有一個 25 毫克的故事正在進行中。在罕見病領域,Ludovic 已經談到了這一點。但我只想說,看到(聽不清)的進展超級令人興奮。所以我們實際上是上週發起的(聽不清)。這基本上意味著我們會——我希望你能同意我的看法,這是一個令人印象深刻的記錄。我們將花費大約 4 年的臨床開發時間。這將與我們在臨床開發中花費的血友病正常 [AGS] 進行比較,特別是(聽不清)我們已經取得了非常快的進展。我們現在處於 III 期,您應該期待在 24 年期間從該試驗中讀出結果。
And then back to you, Karsten.
然後回到你身邊,Karsten。
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Thank you, Martin.
謝謝你,馬丁。
Financial outlook. So you've seen our 9-month numbers, 16% sales growth really, amazing push on GLP-1 in diabetes as well as our BC franchise, as Camilla was alluding to. So that has enabled us to raise our outlook for the year from 12% to 16% to now 14% to 17% sales growth at same currencies. And then you layer in currency impacts another 10 percentage points, mostly from the strengthening U.S. dollar. So overall, when you look at the magnitude of growth for the company, then, of course, in absolute terms, this is the biggest absolute sales growth ever, ever in the history of the company at local exchange rates, and then you add in currencies. So the sheer size of step-up in growth is really remarkable in a historic setting.
財務前景。所以你已經看到了我們 9 個月的數字,真正的 16% 的銷售增長,驚人的推動糖尿病中的 GLP-1 以及我們的 BC 特許經營權,正如卡米拉所暗示的那樣。因此,這使我們能夠將今年的預期從 12% 提高到 16%,現在以相同貨幣計算的銷售增長率為 14% 到 17%。然後你將貨幣影響分層另外 10 個百分點,主要來自美元走強。所以總的來說,當你看公司的增長幅度時,當然,就絕對值而言,這是有史以來最大的絕對銷售增長,按當地匯率計算,這是公司歷史上有史以來最大的絕對銷售額增長,然後你再加上貨幣。因此,在歷史背景下,增長幅度之大確實令人矚目。
That, of course, goes through to our operating profit performance where we are raising our numbers correspondingly, then we lose the currency step-up in hedging. That's to be expected. I think when you do our net numbers on hedging, without going into details, then our hedging performance this year, our net currency performance this year is very, very attractive, even after hedging costs. And then finally, our cash flow, to be clear, how can you raise your outlook for the year in terms of sales and OP and then lower free cash flow? And there's a very simple explanation to that because -- the reason is that we lower our free cash flow guidance by DKK 3 billion, the range.
當然,這會影響到我們的營業利潤表現,我們相應地提高了我們的數字,然後我們失去了對沖貨幣的提升。這是可以預料的。我認為當你做我們的對沖淨值時,無需詳細說明,那麼我們今年的對沖表現,我們今年的淨貨幣表現非常非常有吸引力,即使在對沖成本之後也是如此。最後,我們的現金流,要清楚,你怎麼能提高你今年在銷售和 OP 方面的前景,然後降低自由現金流?對此有一個非常簡單的解釋,因為 - 原因是我們將自由現金流量指導下調了 30 億丹麥克朗,範圍。
But that is a function of the fact that we closed the (inaudible) transaction in the fourth quarter at around DKK 5 billion impact to our free cash flow and then underlying benefit of DKK 2 billion. So that's how we get to the net minus DKK 3 million on free cash flow. So excluding BD, a step-up in free cash flow generation, which we, of course, allocate to shareholders according to the classic principles around a 50% dividend payout ratio and then the remainder done through share buyback program, as we covered before. So no changes on capital allocation.
但這是因為我們在第四季度結束了(聽不清)交易,對我們的自由現金流產生了大約 50 億丹麥克朗的影響,然後是 20 億丹麥克朗的潛在收益。這就是我們如何獲得減去 300 萬丹麥克朗的自由現金流。因此,不包括 BD,這是自由現金流產生的一個升級,我們當然會根據大約 50% 的股息支付率的經典原則分配給股東,然後通過股票回購計劃完成剩餘部分,正如我們之前介紹的那樣。所以資本配置沒有變化。
So these are our aspirations for '25. You've seen them before. So I'm not going to reiterate that. I think we're ready to get into Q&A. And I think we have a long tradition of having the host shoot off the first couple of questions. And if we could just restrain, 2 questions each, and then we do the rounds as we move forward.
所以這些是我們對 25 年的期望。你以前見過他們。所以我不打算重申這一點。我想我們已經準備好進入問答環節了。我認為我們有讓主持人回答前幾個問題的悠久傳統。如果我們能克制一下,每個問題 2 個問題,然後我們在前進的過程中進行輪詢。
Keyur Parekh - Equity Analyst
Keyur Parekh - Equity Analyst
Keyur Parekh, Goldman Sachs. If I could start with 2, please. The first one is, in the unfortunate circumstance that Catalent was to receive a warning letter kind of for the Belgium facility between now and your relaunch date in kind of end of December, early January, how confident are you of maintaining kind of that date? And how is that going to be a function of supply from other parts of the manufacturing network? Or would you reconsider kind of pushing that date out? So that's kind of question #1.
Keyur Parekh,高盛。如果我可以從 2 開始,請。第一個是,在不幸的情況下,從現在到您在 12 月底、1 月初的重新啟動日期之間,Catalent 收到了比利時工廠的警告信,您對維持那個日期有多大信心?這將如何成為製造網絡其他部分供應的函數?或者你會重新考慮推遲那個日期嗎?所以這是第一個問題。
And then separately, Karsten, Lars and you bought kind of yesterday, mentioned a few times about confidence in maintaining current trajectory of growth and having supply kind of from a GLP-1 perspective to kind of continue doing that. How should we think about the timelines associated with that? Was that kind of a fourth quarter comment? Was that a 2023, 2024 outlook? So just kind of any context around that.
然後分別地,Karsten、Lars 和你昨天買了一些東西,提到過幾次關於保持當前增長軌蹟的信心,以及從 GLP-1 的角度來看供應某種程度上繼續這樣做。我們應該如何考慮與之相關的時間表?那是第四季度的評論嗎?那是 2023 年、2024 年的展望嗎?所以只是關於它的任何背景。
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Thank you, Keyur. On the first question, vis-à-vis Catalent, we do appreciate the sensitivity around the Catalent situation in the capital markets. And as a consequence, it's not a comment that we take lightly and put into our company announcements. So of course, the comment we put in is based on a careful assessment around the current level of inventories, the fact that Catalent is producing for inventory of commercial product as we speak, and then an assessment based on -- from our quality organization in terms of the quality situation at our CMO. So of course, there are no guarantees in this world, but we would not put this statement into our company announcement unless we're confident that we'll be able to resupply the U.S. market in December with Wegovy.
謝謝你,基爾。關於第一個問題,相對於康泰倫特,我們確實理解資本市場圍繞康泰倫特形勢的敏感性。因此,這不是我們掉以輕心並放入公司公告中的評論。因此,當然,我們提出的評論是基於對當前庫存水平的仔細評估,事實是 Catalent 正在為我們所說的商業產品庫存生產,然後是基於我們質量組織的評估我們 CMO 的質量狀況。所以當然,這個世界上沒有任何保證,但我們不會將此聲明放入我們的公司公告中,除非我們有信心我們能夠在 12 月用 Wegovy 重新供應美國市場。
Then to the second point in your question, around our forward-looking commentary. So we put a statement in our outlook section. We're basically saying that we're continuously expanding our supply capacity. And our assessment is that, at a potential -- that we have the supply capacity to supply according to the current growth trajectory of the company. And the reason why we put it in, just to be clear, was that in the beginning of that section we're talking about supply chain limitations, including for Ozempic. So this was just to avoid people becoming overly concerned that we are not able to supply at all or were kept at our current level of supply. So this is a comment intended as a forward looking statement that we are scaling and that we'll be able to cater for the current -- if that materializes based on demand, the current level of growth.
然後是你問題的第二點,圍繞我們的前瞻性評論。因此,我們在展望部分發表了聲明。我們基本上是在說我們在不斷擴大我們的供應能力。我們的評估是,根據公司當前的增長軌跡,我們有潛力提供供應能力。為了清楚起見,我們將其放入的原因是,在該部分的開頭,我們討論的是供應鏈限制,包括 Ozempic。所以這只是為了避免人們過度擔心我們根本無法供應或保持在目前的供應水平。因此,這是一個前瞻性聲明,我們正在擴大規模,我們將能夠滿足當前的需求——如果這能根據需求實現,即當前的增長水平。
Well, I think we have enough questions. I think, actually, just to make it simple for me, so it's not a speed contest, then we start here -- in front.
好吧,我想我們的問題已經夠多了。我想,實際上,只是為了讓我簡單一點,所以這不是速度競賽,然後我們從這裡開始——在前面。
Naresh Chouhan
Naresh Chouhan
Naresh Chouhan from Intron. Just a couple of questions on the Ozempic 2 mg launch. It looks like it got to almost 10% of total Ozempic scripts, and it looked like a phenomenal launch in 4 months. So 2 things. One, some of the drivers of that, is there a big bolus of patients who need to dose intensify? And therefore should we expect that growth to slow down when you can resupply? And the second thing is, is there any reason to think that this isn't 25%, 30% of total Ozempic scripts in the years to come as patients progress to -- from the 0.5 mg to the 1 mg to the 2 mg and it becomes a big part of the business? Because it's not something that I felt that you guys are focused on massively, but it could feel like it could be a very big opportunity.
來自 Intron 的 Naresh Chouhan。關於 Ozempic 2 mg 發布的幾個問題。它看起來幾乎佔 Ozempic 腳本總數的 10%,而且它看起來像是 4 個月內的一次非凡發布。所以兩件事。第一,其中的一些驅動因素,是否有大量需要劑量強化的患者?因此,當您可以重新補給時,我們是否應該期望增長放緩?第二件事是,有沒有理由認為隨著患者從 0.5 毫克到 1 毫克到 2 毫克和它成為業務的重要組成部分?因為這不是我覺得你們非常關注的事情,但感覺這可能是一個非常大的機會。
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
All right. Camilla, I think that's for you.
好的。卡米拉,我想這是給你的。
Camilla Sylvest - Executive VP, Head of Commercial Strategy & Corporate Affairs and Member of the Management Board
Camilla Sylvest - Executive VP, Head of Commercial Strategy & Corporate Affairs and Member of the Management Board
So you're absolutely right that we've seen a great uptake with 2.0 so far. And of course, this opportunity is in place to make sure the patient can continue on Ozempic treatment over time. We also know from our initial data that not everyone is progressing to the 1.0 from the get-go. So some people are at 0.5 and approximately half are progressing to 1.0. So you can imagine that over time, people will be able to stay on Ozempic, still intensifying the treatment and being very good control both with their blood sugar, their weight and, of course, also with the cardiovascular protection that Ozempic is giving them.
所以你是完全正確的,我們已經看到了 2.0 到目前為止的巨大吸收。當然,這個機會是為了確保患者能夠隨著時間的推移繼續接受 Ozempic 治療。我們還從我們的初始數據中了解到,並不是每個人都從一開始就向 1.0 邁進。所以有些人是 0.5,大約一半的人正在進步到 1.0。所以你可以想像,隨著時間的推移,人們將能夠繼續使用 Ozempic,繼續加強治療,並很好地控制血糖、體重,當然還有 Ozempic 給他們提供的心血管保護。
So you are right that over time the individual person is likely to upgrade. But of course, as we see more and more patients coming on to Ozempic with the growth of the market, then it's likely that there'll be a ratio of people on 2.0, but with many more coming in, if not so that this ratio is going to significantly differ from I would assume a 1/4 or a 25% of the total ballpark right. But that, of course, time will show. But it's really an (inaudible) on the same product. That's the whole purpose of it.
所以你是對的,隨著時間的推移,個人可能會升級。但是當然,隨著市場的增長,我們看到越來越多的患者來到 Ozempic,那麼很可能會有 2.0 的患者比例,但如果不是這樣的話,會有更多的患者進入 Ozempic與我假設的總球場權利的 1/4 或 25% 有很大不同。但是,當然,時間會證明這一點。但這實際上是同一產品的(聽不清)。這就是它的全部目的。
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Thanks, Camilla. And I think we'll go to Mark Purcell.
謝謝,卡米拉。我想我們會去找 Mark Purcell。
Mark Douglas Purcell - Equity Analyst
Mark Douglas Purcell - Equity Analyst
It's Mark Purcell from Morgan Stanley. So 2 questions. The first one is going back to oral sema and the SNAC technology. So we see it moving once week into clinical development. So could you help us understand where you are with the various generations of SNAC as you try to eliminate food and water interactions, you work on the post component and give us an idea of the advantages and disadvantages versus a capsule peptide where there's competitors entering the market as well as the oral small molecules where we see a lot more data over the next 6 months or so? That's the first question.
我是摩根士丹利的 Mark Purcell。所以2個問題。第一個是回到口腔 sema 和 SNAC 技術。所以我們看到它每週進入臨床開發一次。那麼,您能否幫助我們了解您對各代 SNAC 的看法,因為您試圖消除食物和水的相互作用,您在後期組件上工作,並讓我們了解與競爭者進入的膠囊肽相比的優缺點市場以及口服小分子,我們在接下來的 6 個月左右看到更多的數據?這是第一個問題。
And the second question is kind of going back to what (inaudible) was talking about as well, but the message around sema is becoming increasingly complex. You've got outcome trials such as FLOW and STRIDE focused on 1 milligram injectable. You've got, obviously, 2 milligrams going to 8 milligrams going to 16 milligrams. Then you have Rybelsus ad study, but then you're going to 50 milligrams. And then the obesity dose, I presume, is going to go up as well. So how do you take all this complexity and try to bridge cumulative evidence into the molecule to create a simple message, given that some of your competitors have far more simple messaging when it comes to doses, which they're using consistently for diabetes, for obesity, for sleep apnea, et cetera, et cetera?
第二個問題有點回到(聽不清)也在談論什麼,但圍繞 sema 的信息正變得越來越複雜。您已經進行了 FLOW 和 STRIDE 等針對 1 毫克注射劑的結果試驗。很明顯,從 2 毫克到 8 毫克再到 16 毫克。然後你有 Rybelsus 廣告研究,但你要 50 毫克。然後肥胖劑量,我想,也會上升。那麼你如何處理所有這些複雜性並嘗試將累積的證據橋接到分子中以創建一個簡單的信息,因為你的一些競爭對手在劑量方面有更簡單的信息,他們一直使用這種藥物治療糖尿病,因為肥胖,睡眠呼吸暫停等等,等等?
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Thanks, Mark. Martin, if you'll field the first one on oral sema and the SNAC technology and then branding too coming up.
謝謝,馬克。馬丁,如果你將第一個關於口語 sema 和 SNAC 技術,然後品牌也出現了。
Martin Holst Lange - Executive VP, Head of Development & Member of the Management Board
Martin Holst Lange - Executive VP, Head of Development & Member of the Management Board
Yes. So I think you're exactly right. We are focusing a lot on the SNAC technology because we want to and we need to increase the bioavailability, basically to reduce the amount needed for the efficacious and safe treatment. We are currently in clinical trials in fourth generation and have made some substantial upgrades to the bioavailability that we've seen, without going into too much details. It goes without saying that will give us a good leverage on the [FMC] part.
是的。所以我認為你是完全正確的。我們非常關注 SNAC 技術,因為我們希望並且需要提高生物利用度,基本上是為了減少有效和安全治療所需的量。我們目前正在進行第四代的臨床試驗,並且已經對我們所看到的生物利用度進行了一些實質性的升級,但沒有涉及太多細節。不用說,這將為我們提供 [FMC] 部分的良好影響力。
Our clear aim is actually also going a little bit to your question #2, the efficacy and the safety has to be on par with what we see in subcutaneous. And actually, what we have currently right now with Rybelsus is probably, from an efficacy perspective, somewhere between 0.5 and 1 milligram of subcutaneous Ozempic. Our aspiration is for 25 and 50 milligrams to be able to power with 2.0, 2.4 milligram of Ozempic and Wegovy.
我們的明確目標實際上也涉及到您的問題 #2,療效和安全性必須與我們在皮下觀察到的相當。實際上,從功效的角度來看,我們目前使用 Rybelsus 的可能是 0.5 至 1 毫克皮下臭氧。我們的願望是能夠用 2.0、2.4 毫克的 Ozempic 和 Wegovy 提供 25 和 50 毫克的能量。
Goes without saying -- if we substantially increase the bioavailability, there will be a little bit of a regulatory complexity in discussing the actual sort of doses because all of a sudden, what was 50 milligram could then in the next generation correspond to something lower. But I think that, for us, at that point in time, will be a luxury problem.
不言而喻——如果我們大幅提高生物利用度,那麼在討論實際劑量時就會有一點監管上的複雜性,因為突然間,下一代的 50 毫克可能對應於更低的劑量。但我認為,對我們來說,在那個時候,將是一個奢侈的問題。
When you talk about other formulations, I think what we've seen so far -- and we are carefully monitoring this SNAC technology is by far the most attractive in terms of securing bioavailability of peptide or protein. Comparing to the small molecules, I think you know my position on this. I think they will be reasonably good when it comes to efficacy. I think they will -- we still have to evaluate the safety. There's always some unknowns with small molecules. My understanding is actually from an FMC perspective, there's not really a big difference. Therefore, I think and Camilla can also talk to this, the small molecules that will have their place, but they will not be sort of super competitive from an efficacy safety or an [FFC] perspective. So we welcome them as vehicles who may be also broadening the field.
當你談論其他配方時,我認為我們到目前為止所看到的——我們正在仔細監測這種 SNAC 技術是迄今為止在確保肽或蛋白質的生物利用度方面最具吸引力的技術。與小分子相比,我想你知道我在這方面的立場。我認為它們在功效方面會相當不錯。我認為他們會——我們仍然需要評估安全性。小分子總是有一些未知數。我的理解實際上是從 FMC 的角度來看,並沒有太大的區別。因此,我認為和 Camilla 也可以談論這個,小分子將佔有一席之地,但從療效安全或 [FFC] 的角度來看,它們不會具有超級競爭力。因此,我們歡迎他們作為可能也在拓寬領域的工具。
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Thanks, Martin. Camilla?
謝謝,馬丁。卡米拉?
Camilla Sylvest - Executive VP, Head of Commercial Strategy & Corporate Affairs and Member of the Management Board
Camilla Sylvest - Executive VP, Head of Commercial Strategy & Corporate Affairs and Member of the Management Board
Yes. On the SNAC type molecule, it's clear that we are, of course, optimizing the impact that this molecule can have on different patient populations, And that also caters for the fact that some of these disease areas are very different. For example, diabetes very often driven by the physician in terms of specialist or primary care physicians. Then you have the obesity segment that is to a large extent also driven by demand from patients. It's easy to diagnose, then you have NASH that we are looking into that is very difficult to diagnose at the moment, requires a biopsy.
是的。在 SNAC 型分子上,很明顯,我們當然正在優化這種分子對不同患者群體的影響,這也迎合了這些疾病領域中的一些非常不同的事實。例如,就專科醫生或初級保健醫生而言,糖尿病通常是由醫生驅動的。然後你有肥胖部分,這在很大程度上也是由患者的需求驅動的。這很容易診斷,然後你有我們正在研究的 NASH,目前很難診斷,需要活組織檢查。
And then, of course, we are exploring it at Alzheimer's also, that is yet a completely different target group. The reason that I'm mentioning all of this is actually that it can sound complicated when you look at it across. But if you look at each of the disease areas and the target groups both in terms of patients and physicians. We are actually able with different brands as we have it also now to cater for a specific group, a specific key measures that relate to that particular target population. And we are also able, from a rebating structure point of view, to actually work with different segments. So there are some advantages of doing this.
然後,當然,我們也在阿爾茨海默氏症中探索它,那是一個完全不同的目標群體。我之所以提到所有這些,實際上是因為當你仔細觀察它時,它聽起來可能很複雜。但是,如果您從患者和醫生的角度來看每個疾病領域和目標群體。我們實際上能夠使用不同的品牌,因為我們現在也有不同的品牌來迎合特定的群體,這是與特定目標人群相關的特定關鍵措施。而且,從回扣結構的角度來看,我們也能夠實際與不同的細分市場合作。所以這樣做有一些好處。
Plus at the very end, we are able to confirm and detail and promote directly on label, which is, of course, very important for us to do so that we make sure that we stay very strongly in our business ethics with regards to what gets promoted to whom, especially the target groups of doctors, and this actually gives us a very flexible approach.
此外,在最後,我們能夠直接在標籤上確認、詳細說明和宣傳,這當然對我們來說非常重要,這樣我們就可以確保我們在獲得的東西方面非常遵守我們的商業道德提拔給誰,特別是醫生的目標群體,這其實給了我們一個非常靈活的做法。
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Thanks, Camilla. Then we'll move to Richard Vosser.
謝謝,卡米拉。然後我們將轉到 Richard Vosser。
Richard Vosser - Senior Analyst
Richard Vosser - Senior Analyst
Richard Vosser, JPMorgan. One question on icodec and ONWARDS 5 looked very, very strong, but the type 1 at hypo was not non -- wasn't non-inferior. What needs to happen for that? And does that have any commercial implications when you're talking to payers from a pricing standpoint? And then second question, just on CagriSema and GIP combinations maybe. CagriSema looks pretty good and on weight loss, but the HbA1c was not really at Mounjaro levels. It was better than Ozempic but not Mounjaro. What can you do to further enhance the HbA1c control?
理查德·沃瑟,摩根大通。一個關於 icodec 和 ONWARDS 5 的問題看起來非常非常強,但是 hypo 的類型 1 不是非 - 不是非劣等的。為此需要發生什麼?當您從定價的角度與付款人交談時,這是否具有任何商業意義?然後是第二個問題,可能只是關於 CagriSema 和 GIP 的組合。 CagriSema 看起來很不錯,並且正在減肥,但 HbA1c 並沒有真正達到 Mounjaro 水平。它比 Ozempic 好,但比 Mounjaro 好。您可以做些什麼來進一步增強 HbA1c 控制?
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Martin?
馬丁?
Martin Holst Lange - Executive VP, Head of Development & Member of the Management Board
Martin Holst Lange - Executive VP, Head of Development & Member of the Management Board
So we've -- if I can take the last question first. CagriSema is investigated in a 32-week study. And specifically on glucose control, part of the effect is seen by the weight loss. And that basically means that, if we extrapolate that weight loss over time into what we would say regulatory grade timelines, 68 weeks, actually up to 2 years, in type 2 diabetes, our extrapolations are indicating that CagriSema on glycemia control will, on a normal day be on par with tirzepatide and on a good day could actually also turn out to be superior. And if you combine sort of be the base case or even the upside with the weight loss that we've seen, this will be the most attractive offering that we would have in type 2 diabetes.
所以我們 - 如果我可以先回答最後一個問題。 CagriSema 在一項為期 32 週的研究中進行了調查。特別是在血糖控制方面,部分效果體現在體重減輕上。這基本上意味著,如果我們將隨著時間的推移體重減輕外推到我們所說的監管等級時間表,68 週,實際上長達 2 年,在 2 型糖尿病中,我們的外推表明 CagriSema 對血糖控制將在正常的一天與 tirzepatide 相當,在美好的一天實際上也可能變得更好。而且,如果您將基本情況甚至是我們已經看到的體重減輕結合起來,這將是我們在 2 型糖尿病中最有吸引力的產品。
Also because, as we've discussed previously, the safety profile of CagriSema appears to be very, very attractive. So from that perspective, you have to factor in the timing of treatment. And that's why we're fairly confident we'll be able to show superiority of the (inaudible) components, but potentially also of potential competitors.
還因為,正如我們之前所討論的,CagriSema 的安全性似乎非常非常有吸引力。所以從這個角度來看,你必須考慮治療的時機。這就是為什麼我們相當有信心能夠展示(聽不清)組件的優勢,但也可能展示潛在競爭對手的優勢。
On icodec, I think the type 1 diabetes is obviously something where we had to go into a dialogue on the risk of hypoglycemia. As we've also discussed, even though we did see more hypoglycemia with icodec than we did with other basal insulins, it was still at a fairly low level. And therefore, the risk-benefit discussions that we'll have with regulators, I think we are still in a reasonably good place. I don't want to speak to the commercial and the pricing negotiation. That's for Camilla. But overall, the type 1 population is sort of the minority in this space. And my sense is that pricing discussions will be based on phase -- sorry, type 2 diabetes patients, and this is where we see the superiority with -- on par with risk of hypoglycemia.
在 icodec 上,我認為 1 型糖尿病顯然是我們必須就低血糖風險進行對話的地方。正如我們還討論過的,儘管我們確實發現使用 icodec 的低血糖症比使用其他基礎胰島素時發生的低血糖多,但它仍然處於相當低的水平。因此,我們將與監管機構進行的風險收益討論,我認為我們仍然處於一個相當好的位置。我不想談商業和定價談判。那是給卡米拉的。但總的來說,第 1 類人群在這個領域中屬於少數。我的感覺是,定價討論將基於階段——抱歉,2 型糖尿病患者,這是我們看到優勢的地方——與低血糖風險相當。
Camilla Sylvest - Executive VP, Head of Commercial Strategy & Corporate Affairs and Member of the Management Board
Camilla Sylvest - Executive VP, Head of Commercial Strategy & Corporate Affairs and Member of the Management Board
Yes, exactly. You could work in commercial, Martin.
對,就是這樣。馬丁,你可以從事商業工作。
Martin Holst Lange - Executive VP, Head of Development & Member of the Management Board
Martin Holst Lange - Executive VP, Head of Development & Member of the Management Board
Okay. Thank you. That's always good to know.
好的。謝謝你。知道這一點總是好的。
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Thank you, Martin. Thank you, Richard. And we're on to Jo.
謝謝你,馬丁。謝謝你,理查德。我們要去喬了。
Jo Walton - MD
Jo Walton - MD
Jo Walton, Credit Suisse. I wonder, Camilla, if you could give us an update on the reimbursement sort of attitude of people and payers given that there's so much publicity about these drugs? Are payers thinking -- good God, if I don't put some restrictions, I'm going to have unaffected demand. And perhaps within that, you could say whether you're seeing any -- the longevity of people on -- will go for your -- sort of 5 months or so on Saxenda? Are people showing their enthusiasm for Wegovy by staying on it for much longer?
瑞士信貸的喬沃爾頓。我想知道,卡米拉,鑑於對這些藥物的宣傳如此之多,您是否可以向我們提供有關人們和付款人的報銷態度的最新信息?付款人是否在想——天哪,如果我不施加一些限制,我的需求將不會受到影響。也許在其中,你可以說你是否看到任何——人們的長壽——將適合你——大約 5 個月左右的 Saxenda?人們是否通過更長時間地使用 Wegovy 來表現出他們對 Wegovy 的熱情?
And my second question is just a broad one on U.S. pricing. So now that you should only raise your prices in line with CPI, and CPI is so high. Is there an opportunity in 2023 to have your list prices higher than you've materially -- you've had historically because CPI will be 8 or 9 perhaps, which is most unusual?
我的第二個問題只是關於美國定價的廣泛問題。所以現在你應該只根據CPI漲價,CPI這麼高。 2023 年是否有機會讓您的標價高於您的實際價格——您歷史上曾有過,因為 CPI 可能會達到 8 或 9,這是最不尋常的?
Camilla Sylvest - Executive VP, Head of Commercial Strategy & Corporate Affairs and Member of the Management Board
Camilla Sylvest - Executive VP, Head of Commercial Strategy & Corporate Affairs and Member of the Management Board
Thanks. So maybe I'll start with the first one, and then I think Karsten would like to speak to next year. Reimbursement attitude towards Ozempic is, of course, generally very strong in markets that traditionally reimburse. When it comes to weight loss products like Saxenda and Wegovy, then we have now 15 markets in international operations that have reimbursed Saxenda. Of course, it comes at a BMI normally around 30 or 35 with comorbidities. In the U.S., we have about 30 million lives covered. So a very good starting point in general to continue prescribing for more patients with reimbursement.
謝謝。所以也許我將從第一個開始,然後我想 Karsten 想在明年發言。當然,在傳統上報銷的市場中,對 Ozempic 的報銷態度通常非常強烈。談到像 Saxenda 和 Wegovy 這樣的減肥產品,我們現在有 15 個國際運營市場對 Saxenda 進行了報銷。當然,它的 BMI 通常在 30 或 35 左右,伴有合併症。在美國,我們覆蓋了大約 3000 萬人的生命。因此,總體而言,這是一個很好的起點,可以繼續為更多的報銷患者開處方。
The attitude, of course, with -- towards Wegovy and Ozempic, to make sure that it's not prescribed off-label is increasing. The awareness is increasing, we of course have the advantage that we have 2 different brands. So it's easier to understand and document. And we have been looking back at -- can we see a change in the Ozempic patients that have been prescribed to naive to treatment patients before and after the Wegovy launch. And so we took 1.5 years before the launch up until July last year '21 and then up until now, and there has been an increasing trend of prescribing GLP-1 products in type 2 diabetes earlier.
當然,對 Wegovy 和 Ozempic 的態度,以確保它不會在標籤外開處方,這種態度正在增加。意識在提高,我們當然有優勢,我們有兩個不同的品牌。所以它更容易理解和記錄。我們一直在回顧——我們能否看到 Ozempic 患者的變化,這些患者在 Wegovy 推出之前和之後被開給天真的治療患者。因此,我們在推出之前花了 1.5 年的時間,直到去年 21 年 7 月,然後直到現在,而且越來越早地在 2 型糖尿病中開出 GLP-1 產品的處方。
That trend continues. It has accelerated a bit after the launch of Wegovy, but not significantly. So I just want to say that the trend of prescribing GLP-1 products earlier to type 2 patients has increased a lot coming from guidelines from both ESD and ADA also. And of course, we also learn how well it works, especially with Ozempic, with the 3 benefits it has, including the cardiovascular risk profile. So that's just a great understanding of that.
這種趨勢仍在繼續。在 Wegovy 推出後,它有所加速,但並不顯著。所以我只想說,從 ESD 和 ADA 的指南來看,更早地為 2 型患者開 GLP-1 產品的趨勢已經增加了很多。當然,我們還了解到它的效果如何,尤其是與 Ozempic 一起使用時,它具有 3 大好處,包括降低心血管風險。所以這只是對此的一個很好的理解。
Then when it comes to stay time on Wegovy, we don't have new numbers to share with you, but we are following up on that. And as soon as we have more to share, we will share that. What we do know from Saxenda in the countries where that has now been reimbursed that the stay time, of course, is significantly extended. Plus, that we have seen in our data from Wegovy that people continue to lose weight beyond 60 weeks. So that also gives us an indication that stay time is likely to be much longer in Wegovy than it has been traditionally on Saxenda. And then to the price.
那麼關於在 Wegovy 上的停留時間,我們沒有新的數字可以與您分享,但我們正在跟進。一旦我們有更多要分享的內容,我們就會分享。我們從 Saxenda 那裡了解到,在那些現在已經報銷的國家,停留時間當然會大大延長。此外,我們從 Wegovy 的數據中看到,人們在 60 週後繼續減肥。因此,這也向我們表明,在 Wegovy 中的停留時間可能比傳統上在 Saxenda 中的停留時間長得多。然後到價格。
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
On the inflation turns in the U.S. and the most recent legislation, which where it takes a baseline back to 2021, as you know. And consequently, we will face a minor negative impact already here from the fourth quarter on products where we've taken price increases on and above the inflation since '21. As to our list price increases in '23, there's a multitude of factors that goes into our decision on list price increases.
如您所知,關於美國的通脹轉變和最近的立法,該立法將基線追溯到 2021 年。因此,從第四季度開始,我們將面臨對自 21 世紀以來我們已經將價格上漲至通貨膨脹率以上的產品的輕微負面影響。至於我們在 23 年的標價上漲,我們決定標價上漲的因素有很多。
First of all, the benefits of the products we're providing and the clinical data supporting that for patients, the competitive situation and of course, the overall pricing environment. So this is not the primary factor. But of course, we take all factors into account when we make that decision. So no further comments around that because there's also a certain level of competitive intel on that front. Then yes, Jeffrey?
首先,我們提供的產品的好處和支持患者的臨床數據、競爭形勢,當然還有整體定價環境。所以這不是首要因素。但當然,我們在做出決定時會考慮所有因素。所以沒有進一步的評論,因為在這方面也有一定程度的競爭情報。那麼是的,杰弗裡?
Unidentified Analyst
Unidentified Analyst
Can I just come back to Wegovy. But a different question, which is if the facility were to have to temporarily close for any reason, would that in any way impact your timeline? And have your thoughts on the amount of drug you need for the launch changed at all since the start of the year? Or are you still aiming for the same, if you like, volume of the different doses by the end of the year before you make that decision to launch?
我可以回到 Wegovy 嗎?但另一個問題是,如果該設施因任何原因不得不暫時關閉,這會以任何方式影響您的時間表嗎?自今年年初以來,您對發射所需藥物數量的想法是否發生了變化?或者,在您做出發布決定之前,您是否仍然希望在年底前實現相同(如果您願意)不同劑量的數量?
And then can I just ask with next year then when you bring on the other fill finish, should we think about the first half with the second CMO and then the second half with the second Catalent facility? Is this a sort of step function given we're talking about fill finish. We're not talking about sort of ramping up API, if you like. So essentially comes online? Or is this a gradual increase we should think and fill finish capacity coming during the course of 2023?
然後我可以問一下明年,當你進行另一個填充完成時,我們是否應該考慮與第二個 CMO 的上半年,然後是第二個 Catalent 設施的下半年?鑑於我們正在談論填充完成,這是一種階躍函數嗎?如果您願意,我們不是在談論某種程度的 API 升級。所以本質上是在線的?或者這是我們應該考慮並在 2023 年期間完成產能的逐步增加?
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
So as to resupply in the U.S. market towards the end of the year, as I said before, this is based on our combined knowledge and the fact that the CMO is producing as of today and the required inventory levels to launch that they're viable. Of course, there are hundred scenarios in the world that can impact any part of the business, but we would not put into our company announcement, the fact that we are resupplying the [market] on this. We believe that's a relevant scenario, speculating in all kinds of hypothetical items.
為了在年底前在美國市場重新供應,正如我之前所說,這是基於我們的綜合知識和 CMO 截至今天生產的事實以及啟動所需的庫存水平,它們是可行的.當然,世界上有數百種情況會影響業務的任何部分,但我們不會在公司公告中說明我們正在重新供應 [市場] 的事實。我們認為這是一個相關的場景,推測各種假設項目。
I don't think that adds any value, then we would have not put this wording in. As to next year and capacity, as you stated, the second CMO will go online in the first half, and online means that they will be supplying to a marketable product. And then the second site will get online in the second half of '23. And consequently, we will have 4 different sites supplying fill finish -- sorry, filling for Wegovy. So that will be step changes in filling capacity and, of course, additional backup capacity in that sense. Sachin.
我不認為這會增加任何價值,那麼我們就不會把這個詞寫進去。 至於明年和產能,正如你所說,第二個 CMO 將在上半年上線,而上線意味著他們將提供到適銷對路的產品。然後第二個站點將在 23 年下半年上線。因此,我們將有 4 個不同的站點提供填充飾面——抱歉,為 Wegovy 填充。因此,這將是填充容量的逐步變化,當然,從這個意義上講,還有額外的備用容量。薩欽。
Sachin Jain - MD & Research Analyst
Sachin Jain - MD & Research Analyst
Sachin Jain, Bank of America. I'm going to kick off with a comment you made on Ozempic yesterday with people trying to gauge off-label usage and how much of this switches. You made a comment around 40% of Ozempic being naive to diabetes treatment, I think. Was that NRx or TRx? Could you give a sense of what that number was pre Wegovy? And are you indicating this is a potential switch population to Wegovy? I just want to be super clear what the message was around that, if that's okay.
美國銀行的 Sachin Jain。我將從你昨天在 Ozempic 上發表的評論開始,人們試圖衡量標籤外的使用情況以及這些開關的數量。我認為,您曾評論過大約 40% 的 Ozempic 未接受過糖尿病治療。那是 NRx 還是 TRx?您能說說 Wegovy 之前的那個數字是多少嗎?您是否表示這是一個潛在的 Wegovy 轉換人群?如果可以的話,我只是想非常清楚地說明圍繞它傳達的信息是什麼。
And then the second question, apologies, going back to Wegovy supply. I just had a really simple question on process. So having had before it and you've been a receipt of it, is there any FDA inspection or process you're aware of that could drive a decision chain between now and launch? Or is it just status quo, i.e., this facilities operation until you hear otherwise? The background of the question is I'm trying to understand if there is a risk, the timeline of when that risk would emerge for you and for the market. And as part of the confidence, you don't know about an [SDN] inspection, therefore, you can bridge the gap to your second facility?
然後是第二個問題,抱歉,回到 Wegovy 供應。我只是有一個關於流程的非常簡單的問題。因此,在它之前並且您已經收到它,您是否知道任何 FDA 檢查或流程可以推動從現在到發布之間的決策鏈?還是只是現狀,即,在您聽到其他消息之前,此設施一直在運行?這個問題的背景是我試圖了解是否存在風險,以及風險何時會出現在您和市場上的時間表。作為信心的一部分,你不知道 [SDN] 檢查,因此,你可以彌合與你的第二個設施的差距嗎?
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Right. So if we start with the -- so my specific comment was related to a question at the conference call around Ozempic source of business. So source of business is basically new starts going on to Ozempic and that was my comment as to the 40% and then the evolution on that metric, Camilla?
正確的。因此,如果我們從 - 所以我的具體評論與電話會議上圍繞 Ozempic 業務來源的問題有關。所以業務來源基本上是 Ozempic 的新開始,這是我對 40% 的評論,然後是該指標的演變,卡米拉?
Camilla Sylvest - Executive VP, Head of Commercial Strategy & Corporate Affairs and Member of the Management Board
Camilla Sylvest - Executive VP, Head of Commercial Strategy & Corporate Affairs and Member of the Management Board
Yes. So we try to look at the 18 months ahead of Wegovy launch for Ozempic and see what -- how was the evolution in that and that basically moved with a delta that is very close to similar with the 12 months after the Wegovy launch. So it's just to say that we are now at, as Karsten said, close to 40%. It started 1.5 years around 17%. And in the middle around the Wegovy launch, just below 30% or more around 28%, 29%. So it's just to say, if you look at those deltas, this, of course, doesn't give us a full answer, but these are new to treatment patients on Ozempic.
是的。因此,我們嘗試查看 Ozempic 推出 Wegovy 之前的 18 個月,看看它的演變情況如何,並且基本上以與 Wegovy 推出後 12 個月非常接近的三角洲移動。因此,正如 Karsten 所說,我們現在接近 40%。它開始了 1.5 年,約為 17%。而在 Wegovy 推出前後的中間,略低於 30% 或更多,約為 28%、29%。所以這只是說,如果你看看那些三角洲,這當然不會給我們一個完整的答案,但這些對於接受 Ozempic 治療的患者來說是新的。
And so there is an increase in the trend, but not a significant increase in that trend. What we're trying to say before was that all along, Ozempic started with having a lot of GLP-1 source of business, and then it moved gradually to less and less of that. So it's natural that moves earlier and earlier in the treatment cascade because the guidelines is now also recommending that.
因此,趨勢有所增加,但趨勢並未顯著增加。我們之前想說的是,一直以來,Ozempic 都以擁有大量 GLP-1 業務來源開始,然後逐漸變得越來越少。因此,在治療級聯中越來越早地移動是很自然的,因為指南現在也建議這樣做。
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Good. And then a simple answer to a simple question on Catalent. So we would not say that we plan to resupply the U.S. market in December in case there was major uncertainty based on our perception of the ongoing regulatory or quality process. So I don't think it adds any value to get into more speculative around regulatory inspections and so on. This is based on our best assessment of the situation, and I don't think we can give more on that.
好的。然後是對 Catalent 上一個簡單問題的簡單回答。因此,我們不會說我們計劃在 12 月重新供應美國市場,以防根據我們對正在進行的監管或質量流程的看法存在重大不確定性。因此,我認為圍繞監管檢查等進行更多投機並沒有增加任何價值。這是基於我們對情況的最佳評估,我認為我們不能就此提供更多信息。
Sachin Jain - MD & Research Analyst
Sachin Jain - MD & Research Analyst
Can I take one follow-up, Camilla? So that increase in NRx starts of naive from mid-teens when you said 17% to 40%. If I answered that correctly, how much of that has translated into total TRx? So what percentage of TRx do you think is naive to therapy post Wegovy as an increase relative to (inaudible) that you would say this is a percentage of existing Wegovy business that we're not quite sure why it's there and may switch.
我可以跟進一次嗎,卡米拉?所以當你說 17% 到 40% 時,NRx 的增加從十幾歲開始就很天真了。如果我回答正確,其中有多少轉化為總 TRx?那麼,您認為 TRx 的多少百分比對於 Wegovy 後的治療來說是天真的,因為相對於(聽不清)你會說這是現有 Wegovy 業務的百分比,我們不太確定它為什麼存在並且可能會轉換。
Camilla Sylvest - Executive VP, Head of Commercial Strategy & Corporate Affairs and Member of the Management Board
Camilla Sylvest - Executive VP, Head of Commercial Strategy & Corporate Affairs and Member of the Management Board
So I wouldn't know exactly how that translates. It's quite difficult to get into that. But of course, if you look at the graphics that we showed before, you will see that the number of patients has increased significantly just due to the underlying market growth. Whenever there's a new launch into this segment, we have seen, and you've been following this for many years ever since, Victoza, Trulicity, Ozempic and now tirzepatide launch, keeps growing the underlying market. So of course, this translation from NBRx to TRx is a bit of a -- over time, it's difficult to compare directly. I think We won't speculate on that from here.
所以我不知道具體是怎麼翻譯的。進入那個是相當困難的。但是,當然,如果你看一下我們之前展示的圖表,你會發現僅僅由於潛在的市場增長,患者數量就顯著增加了。每當這個細分市場有新的上市時,我們已經看到,從那以後你已經關注了很多年, Victoza 、 Trulicity 、 Ozempic 和現在的 tirzepatide 推出,不斷擴大基礎市場。所以當然,從 NBRx 到 TRx 的這種轉換有點——隨著時間的推移,很難直接比較。我想我們不會從這裡推測。
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Thank you Camilla. Then it's Simon.
謝謝卡米拉。然後是西蒙。
Simon P. Baker - Head of Pharmaceutical Research
Simon P. Baker - Head of Pharmaceutical Research
Simon Baker from Redburn. Two questions, looking -- firstly, looking forward. We've obviously had quite a big development issue in Alzheimer's. So I just wanted to get your perspectives on the impact of lecanemab on Alzheimer's, more from the point of view of -- given the reaction to that data, has it changed what you feel you need to do with semaglutide in Alzheimer's? And related to that, is there any preclinical data on combination of anti-amyloid and GLP-1?
來自雷德本的西蒙·貝克。兩個問題,展望——首先,展望未來。顯然,我們在阿爾茨海默氏症方面遇到了相當大的發展問題。所以我只想了解你對 lecanemab 對阿爾茨海默氏症影響的看法,更多是從——鑑於對這些數據的反應來看,它是否改變了你認為你需要用 semaglutide 治療阿爾茨海默氏症?與此相關的是,是否有關於抗澱粉樣蛋白和 GLP-1 組合的臨床前數據?
And then sticking with the pipeline on CagriSema. We can't -- the data looks really impressive. We can't quite see from the slide because there are no confidence intervals. So is it additive? Or is it genuinely synergistic? And if the latter, what's the reason?
然後堅持使用 CagriSema 上的管道。我們不能——數據看起來非常令人印象深刻。我們無法從幻燈片中完全看到,因為沒有置信區間。那麼它是添加劑嗎?或者它是真正的協同作用?如果是後者,原因是什麼?
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Martin.
馬丁。
Martin Holst Lange - Executive VP, Head of Development & Member of the Management Board
Martin Holst Lange - Executive VP, Head of Development & Member of the Management Board
So specifically on Alzheimer's, I think the recent development has made us even more sort of enthusiastic of what we have on our hands. It's increasing the awareness of potential treatment in this space. Obviously, we have to see -- don't misunderstand me, a regulatory approval of what comes next. The data so far looks good. But they also have to be able to stand to regulatory scrutiny. I see this sort of, as we just discussed with obesity, I mean there's no real treatment out as we speak. So being more than one player, building and establishing the market is actually a plus.
因此,特別是在阿爾茨海默氏症方面,我認為最近的發展讓我們對我們手頭的東西更加熱情。它正在提高對該領域潛在治療的認識。顯然,我們必須看到——不要誤解我,監管機構對接下來的事情的批准。到目前為止的數據看起來不錯。但它們還必須能夠經受住監管審查。我看到了這種情況,正如我們剛剛討論的肥胖症,我的意思是我們所說的沒有真正的治療方法。因此,作為一個以上的參與者,建立和建立市場實際上是一個優勢。
We have a complementary mechanism of action to what is in other companies' pipeline. And that allows us to -- if we establish the efficacy part of this, and we would expect to have similar efficacy to what we've seen from other companies coming out, then with a drug that has a well-established safety profile will be a really, really attractive offering. So I think you see us more enthusiastic than ever. And we are obviously full speed ahead in terms of our development. Now you have to remind me of the other 2 questions.
我們有一個與其他公司管道中的補充行動機制。這使我們能夠——如果我們確定了其中的功效部分,並且我們希望具有與我們從其他公司看到的相似的功效,那麼具有良好安全性的藥物將是一個非常非常有吸引力的產品。所以我認為你看到我們比以往任何時候都更加熱情。就我們的發展而言,我們顯然正在全速前進。現在你必須提醒我其他兩個問題。
Simon P. Baker - Head of Pharmaceutical Research
Simon P. Baker - Head of Pharmaceutical Research
So the second part of that was, is there any preclinical data on the combination of anti-amyloid and GLP-1? And the second one was on CagriSema. Is it additive or is it generally synergistic? And the last...
所以第二部分是,是否有任何關於抗澱粉樣蛋白和 GLP-1 組合的臨床前數據?第二個是在 CagriSema 上。它是相加的還是通常是協同的?而最後...
Martin Holst Lange - Executive VP, Head of Development & Member of the Management Board
Martin Holst Lange - Executive VP, Head of Development & Member of the Management Board
I'll just give you 2 fluffy answer to that one. So yes, there are preclinical data, they're not published. We have them in-house, and we have them both on amyloid and on tau. And it seems as if GLP-1 treatment has impact on central inflammation, neuroplasticity, potentially amyloid and tau. And that obviously gives us some confidence in that, there is a reasonable mode of action in addition to what we've seen in the clinical space. And then on CagriSema, as a big, big caveat in trying to doing that kind of interpretation based on 90 patients, 30 in each treatment arm. And if we just take the numbers and also look at what we call the spaghetti plots of the individual patients, it could be a potential for synergy. But right now, we will settle with additivity because that, again, will show superiority versus anything else out there.
我只會給你 2 個蓬鬆的答案。所以是的,有臨床前數據,但沒有公佈。我們內部有它們,我們在澱粉樣蛋白和 tau 上都有它們。似乎 GLP-1 治療對中樞炎症、神經可塑性、潛在的澱粉樣蛋白和 tau 蛋白有影響。這顯然給了我們一些信心,除了我們在臨床領域看到的之外,還有一種合理的行動模式。然後在 CagriSema 上,作為一個很大的警告,試圖根據 90 名患者(每個治療組 30 名)進行這種解釋。如果我們只看數字並查看我們所謂的個體患者的意大利麵條圖,它可能是協同作用的潛力。但是現在,我們將解決可加性問題,因為這將再次顯示出優於其他任何東西的優勢。
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Thanks Martin. And now just need to -- yes, move over here.
謝謝馬丁。現在只需要——是的,搬到這裡。
Unidentified Analyst
Unidentified Analyst
Just a question on Ozempic supply constraints. Is the constraint [filing just in or] finish? Or is it API as well?
只是關於 Ozempic 供應限制的問題。約束[剛剛提交或]完成了嗎?還是它也是 API?
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Yes. So I'll take that one. So on Ozempic supply constraints, as we have seen in a number of markets and we have issued a drug shortage notification, which is something a pharma company has to issue when demand is greater than supply. It's not that we're not supplying it. It's just demand is greater than supply. And we're not going into any details about where our constraints are, but again, coming back to that we're scaling our manufacturing platforms, and we'll be able to cater for the growth trajectory we're currently on when we look forward.
是的。所以我會拿那個。因此,在 Ozempic 供應限制方面,正如我們在許多市場上看到的那樣,我們已經發布了藥品短缺通知,這是製藥公司在需求大於供應時必鬚髮布的通知。這並不是說我們不提供它。只是需求大於供應。我們不會詳細說明我們的限制在哪裡,但再次回到我們正在擴展我們的製造平台,我們將能夠滿足我們目前所處的增長軌跡向前。
Unidentified Analyst
Unidentified Analyst
This is the guidance then that those supply shortages would stop at some point in 2022? Or if you continue growing at...
那麼,這些供應短缺將在 2022 年某個時候停止的指導方針是什麼?或者,如果您繼續增長...
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
So the guidance is, as I said before, the current growth trajectory and then we're doing everything we can. Of course, on our side, it is frustrating that we're not able to meet patient demand and some patients will have to go without product. So -- so we're not holding back. And as you see right now on Ozempic, we are growing year-to-date, we're growing 70% in value, which means almost double up in volume. And so we're already scaling as we speak, and we'll continue to do that into next year. And then whether we meet full demand in all geographies, that's, of course, also a function about how the demand picture will look into next year, but significant scaling also next year. And yes, go here.
因此,正如我之前所說,指導是當前的增長軌跡,然後我們將竭盡所能。當然,在我們這邊,令人沮喪的是我們無法滿足患者的需求,一些患者將不得不放棄產品。所以 - 所以我們不會退縮。正如你現在在 Ozempic 上看到的那樣,我們今年迄今正在增長,我們的價值增長了 70%,這意味著數量幾乎翻了一番。因此,正如我們所說的那樣,我們已經在擴大規模,我們將在明年繼續這樣做。然後我們是否滿足所有地區的全部需求,當然,這也是關於明年需求情況的一個函數,但明年也會有顯著的擴展。是的,去這裡。
Unidentified Analyst
Unidentified Analyst
(inaudible) from Morgan Stanley. I just wanted to get your latest thoughts on glucagon agonist, particularly given your competitors here have shown increasingly encouraging data.
(聽不清)來自摩根士丹利。我只是想了解您對胰高血糖素激動劑的最新想法,特別是考慮到您的競爭對手已經顯示出越來越令人鼓舞的數據。
Martin Holst Lange - Executive VP, Head of Development & Member of the Management Board
Martin Holst Lange - Executive VP, Head of Development & Member of the Management Board
So we actually also had glucagon agonist in our pipeline. And you may have seen a publication that we should recently talking to potential safety issues, specifically, obviously, on our agonist, but potentially also in sort of a broader class. You think, I can't speculate to that, obviously. But I mean, that at least was our thinking that this could be a potential. And in that space, we were looking at reasonable efficacy.
所以我們實際上也有胰高血糖素激動劑在我們的管道中。你可能已經看到一份出版物,我們最近應該討論潛在的安全問題,特別是,顯然,關於我們的激動劑,但也可能在更廣泛的類別中。你認為,我不能推測,顯然。但我的意思是,至少我們認為這可能是一種潛力。在那個領域,我們正在研究合理的功效。
Yes, we saw good efficacy with our triagonist, but we did also see the safety issues. And then having both the GLP-1 and GLP, but more specifically, CagriSema in our pipeline, the risk to benefit was not really in support of continuing our (inaudible) approach. I really have to stress we did see efficacy. It looked good. It did not look as good as CagriSema does. And therefore, our confidence is based on the fact that CagriSema appears to have the superior efficacy profile and probably also the superior safety profile.
是的,我們看到了 triagonist 的良好療效,但我們也確實看到了安全問題。然後同時擁有 GLP-1 和 GLP,但更具體地說,我們的管道中有 CagriSema,受益的風險並不真正支持繼續我們的(聽不清)方法。我真的不得不強調我們確實看到了療效。看起來不錯。它看起來不像 CagriSema 那樣好。因此,我們的信心是基於這樣一個事實,即 CagriSema 似乎具有卓越的療效,也可能具有卓越的安全性。
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Thanks Martin. Then we have Michael Leuchten and then (inaudible) if you can get ready after Michael.
謝謝馬丁。然後我們有 Michael Leuchten,然後(聽不清)如果你能在 Michael 之後做好準備。
Michael Leuchten - Co-Head of Pharmaceuticals Research of Equity Research
Michael Leuchten - Co-Head of Pharmaceuticals Research of Equity Research
Two questions for Martin, please. Just on the ultra-high dose sema in the Phase II, that's a step change in dose that's quite different from what you tried before. Just wondering where that came from to go that aggressive on the dose range? And then on CagriSema, the tolerability in the Phase II, I think, at -- it was 60-something percent of tolerability and I think discontinuation is up to 20%. Lilly has managed to get that down in Phase III. Just wondering what you can do in Phase III to get a better tolerability.
請問 Martin 兩個問題。就 II 期的超高劑量 sema 而言,這是劑量的階躍變化,與您之前嘗試的完全不同。只是想知道在劑量範圍內如此激進的來源是哪裡?然後在 CagriSema 上,第二階段的耐受性,我認為,它是耐受性的 60%,我認為停藥率高達 20%。禮來(Lilly)公司已設法在第三階段將其降低。只是想知道您可以在 III 期做什麼來獲得更好的耐受性。
Martin Holst Lange - Executive VP, Head of Development & Member of the Management Board
Martin Holst Lange - Executive VP, Head of Development & Member of the Management Board
So super questions. First of all, (inaudible) tolerability shows a function of titration in this space. So that would go to both of your questions. Specifically on going to higher doses, we're actually following our normal step of more or less doubling the dose. We've shown that we can do that without introducing more tolerability issues. And based on what we know already now, we feel confident that these call them step increases will not introduce more tolerability issues than what we've seen. Obviously, we have to show that. That's why we do the clinical trials. But our assumption is that when we get to that level, tolerability has already been built, and you can actually do the next step without introducing more GI side effects.
超級問題。首先,(聽不清)耐受性顯示了這個空間中的滴定函數。所以這將解決你的兩個問題。特別是在增加劑量時,我們實際上是在遵循我們的正常步驟,即或多或少地加倍劑量。我們已經證明我們可以在不引入更多耐受性問題的情況下做到這一點。根據我們現在已經知道的情況,我們相信這些所謂的步驟增加不會引入比我們所看到的更多的耐受性問題。顯然,我們必須證明這一點。這就是我們進行臨床試驗的原因。但我們的假設是,當我們達到那個水平時,耐受性已經建立,您實際上可以在不引入更多 GI 副作用的情況下進行下一步。
The other part of it is actually -- and you see that from us and from our competitors, GI side effects reporting in terms of proportions and rates is more often than not a function of how often do you ask, how many visits do you have. And that's why you see higher rates in early development and lower rate as you progress because you have fewer site visits as you progress. We also become wiser on how to titrate.
它的另一部分實際上是——你從我們和我們的競爭對手那裡看到,在比例和比率方面的 GI 副作用報告往往取決於你問的頻率,你有多少次訪問.這就是為什麼您在早期開發中會看到更高的比率,而隨著您的進步,您會看到較低的比率,因為隨著您的進步,您的站點訪問量會減少。我們也對如何滴定變得更明智。
And specifically for CagriSema, it -- don't misunderstand me, I don't think we should look at the actual rates because they are a function on how did we -- how many visits do we have in the study, but more looking to the comparison to semaglutide and cagrilintide. And in that specific study, we actually saw a similar rate between semaglutide and CagriSema. And therefore, we are fairly confident that when we do titration right, we'll actually have a super attractive GI tolerability profile of CagriSema.
特別是對於 CagriSema,它——不要誤解我,我認為我們不應該看實際比率,因為它們是我們如何——我們在研究中有多少次訪問的函數,但更多的是看與 semaglutide 和 cagrilintide 的比較。在那個特定的研究中,我們實際上看到了 semaglutide 和 CagriSema 之間相似的比率。因此,我們相當有信心,當我們進行正確的滴定時,我們實際上將擁有 CagriSema 的超級有吸引力的 GI 耐受性概況。
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Thanks Martin. Then (inaudible) .
謝謝馬丁。然後(聽不清)。
Unidentified Analyst
Unidentified Analyst
(inaudible) from Bernstein. First, can I just ask on Wegovy price, please. I, know Karsten, you don't like to talk about net price. I'm going to ask anyway. Just first of all, is it fair to assume there was no co-pay volumes in the third quarter? And if the answer is yes, the net price looks at about $28 a day. Is that a fair estimate for the net price of Wegovy? And then maybe if you could just comment on the mix between cash and commercial volumes.
(聽不清)來自伯恩斯坦。首先,我可以問一下 Wegovy 的價格嗎?我知道 Karsten,你不喜歡談論淨價。無論如何我都要問。首先,假設第三季度沒有共付額是否公平?如果答案是肯定的,那麼每天的淨價約為 28 美元。這是對 Wegovy 淨價的合理估計嗎?然後也許你可以評論現金和商業量之間的組合。
And then my second question, one for Martin, is at obesity week this week, there's been a bit of discussion around the type of weight loss. So there's a competitor drug that has shown quite a nice fat loss, but actually, you saw an increase in lean mass. So I guess my question really is, and if look at step one, I should say, you saw a reduction in also lean mass. So I guess how much of this is considered by physicians today? And as we think about that increase in weight loss with CagriSema, does the quality and the type of weight loss really matter to outcomes?
然後我的第二個問題,一個給馬丁的,是本週的肥胖週,圍繞減肥的類型進行了一些討論。所以有一種競爭藥物已經顯示出相當不錯的脂肪減少,但實際上,你看到了瘦體重的增加。所以我想我的問題真的是,如果看第一步,我應該說,你看到瘦體重也減少了。所以我想今天的醫生考慮了多少?當我們考慮使用 CagriSema 增加減肥效果時,減肥的質量和類型真的對結果有影響嗎?
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Great. Thanks, [Simone]. So as to net price, I know you like to talk about that more than I do at these meetings. Then in -- when you look at the third quarter, then what I can say is -- as to our early experience program, what we call the bridge program, correct, there's nothing of that in third quarter numbers. But clearly, there would be co-pay support program. So buying down co-pay, that will also be in the third quarter. That's a normal U.S. tactic. So as to your reflection about the net pricing, you can say, it's clean from the bridge program, but it impacted by co-pay and classic rebate structures in the U.S. And as to the cash share, it's to the tune of 10%. And then Martin?
偉大的。謝謝,[西蒙]。至於淨價,我知道你比我在這些會議上更喜歡談論這個。然後——當你看第三季度時,我能說的是——關於我們的早期體驗計劃,我們稱之為橋樑計劃,正確的,第三季度的數字中沒有任何內容。但顯然,會有共付額支持計劃。所以購買共同支付,也將在第三季度。這是美國的正常策略。至於您對淨定價的反思,您可以說,它與過渡計劃無關,但它受到美國共同支付和經典回扣結構的影響。至於現金份額,它達到了 10%。然後馬丁?
Martin Holst Lange - Executive VP, Head of Development & Member of the Management Board
Martin Holst Lange - Executive VP, Head of Development & Member of the Management Board
Yes, I think you're exactly right. Healthy weight loss is -- I don't want to call it the next frontier, but it is certainly important. It's also important for me to call out that what we call lean body mass is a function of water and muscle mass. And the way that we assess it, unless we are careful, doesn't really allow you to distinguish. And that also means that when we discuss either increases in lean body mass or losses of the lean body mass, it's not always one-to-one. Fat mass is fat mass, no matter how you look at it. What we saw with semaglutide was actually a modest decrease in lean body mass and a substantially bigger decrease in fat mass. I think that is as good as it gets right now.
是的,我認為你完全正確。健康減肥是——我不想稱之為下一個前沿領域,但它確實很重要。對我來說同樣重要的是,我們所說的瘦體重是水和肌肉質量的函數。除非我們小心,否則我們評估它的方式並不能真正讓你區分。這也意味著當我們討論去脂體重的增加或去脂體重的減少時,並不總是一對一的。脂肪量就是脂肪量,不管你怎麼看。我們在 semaglutide 上看到的結果實際上是瘦體重適度下降,而脂肪量大幅下降。我認為這和現在一樣好。
But we also have a clear focus on obviously preserving as much lean body mass as we can, while obviously introducing a substantial fat mass loss. It's too early to say what we will see with CagriSema. Obviously, we will look into this. I think it's fair to say in our research effort, we are looking very much into this also. I think it's also important, going actually back to Michael's question in (inaudible) titrate how fast to introduce the weight loss. There is a risk if you do introduce a very fast and dramatic weight loss, you will lose almost 50-50 lean body mass and fat mass. So the tempered but consistent body weight loss could potentially be healthier than a very dramatic fast weight loss. All of these factors is something that we and I think others are looking very actively in.
但我們也明確關注盡可能多地保留瘦體重,同時明顯減少脂肪量。現在說我們將在 CagriSema 上看到什麼還為時過早。顯然,我們會對此進行調查。我認為可以公平地說,在我們的研究工作中,我們也對此進行了深入研究。我認為這也很重要,實際上回到邁克爾在(聽不清)滴定多快引入減肥的問題。如果您確實進行了非常快速和劇烈的體重減輕,則存在風險,您將失去近 50-50 的瘦體重和脂肪量。因此,緩和但持續的體重減輕可能比非常劇烈的快速減肥更健康。所有這些因素都是我們和我認為其他人正在非常積極地關注的事情。
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Thanks Martin. Then we have questions back here.
謝謝馬丁。然後我們有問題回到這裡。
Emily Field - Research Analyst
Emily Field - Research Analyst
Emily Field from Barclays. You've talked about in the past about the inflation cap component of the IRA as being a limited negative. I was just wondering if you could provide any more color or context on the expected impact of the U.S. business.
巴克萊銀行的艾米麗·菲爾德。你過去曾談到 IRA 的通脹上限部分是有限的負面影響。我只是想知道你是否可以提供更多關於美國業務預期影響的顏色或背景。
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Yes. So the function is, as I was covering before, it's basically for the products where we've taken list price increases on or above inflation compared to the base of 1st of Jan 2021. Those products, and then you can look at our list price history, you see it's mainly focused on our [GF1-based] products in diabetes. Those products will be exposed to an inflationary currency, so to say, already in the first quarter. Since we have not called it out more specifically, then it's not big enough to justify that. Normally, we're talking about anything beyond 3% on the U.S. business, we'd be calling out. And since we're not specifying -- it means that we're below that threshold.
是的。所以這個功能是,正如我之前提到的,它基本上是針對那些我們已經將標價與 2021 年 1 月 1 日的基數相比上漲或高於通貨膨脹的產品。這些產品,然後你可以查看我們的標價歷史,你看它主要集中在我們[基於 GF1] 的糖尿病產品上。這些產品將暴露在通貨膨脹的貨幣下,可以說,已經在第一季度了。由於我們沒有更具體地指出它,因此它還不足以證明這一點。通常,我們談論的是美國業務超過 3% 的任何事情,我們都會大聲疾呼。由於我們沒有具體說明——這意味著我們低於該閾值。
All right, then I need a time check. One final question. Is there anyone who hasn't asked a question, then we go all the way. Sorry -- this is good exercise -- all the way to the other end.
好吧,那我需要檢查一下時間。最後一個問題。有沒有人沒問過,那我們就一路走下去。抱歉——這是很好的練習——一直到另一端。
Richard J. Parkes - Head of Pharmaceutical and Biotechnology Team
Richard J. Parkes - Head of Pharmaceutical and Biotechnology Team
Yes, it's Richard Parkes from BNP Paribas Exane. I just wondered, could you update us on where you think we are now in terms of penetration of GLP-1 in diagnosed diabetics in the U.S.? And then secondly, on -- I know it's been talked about indirectly, but off-label use of Ozempic at the moment in obesity. How much real visibility have you got around how much of that is happening in the U.S.? And if that visibility is low, how do you factor that into your planning assumptions? Obviously, there's a lot less certainty around how long patients will stay on drug for an off-label prescription versus diabetes prescription for Ozempic?
是的,我是 BNP Paribas Exane 的 Richard Parkes。我只是想知道,您能否向我們介紹一下您認為我們現在在 GLP-1 在美國確診糖尿病患者中的滲透率方面的最新情況?其次,關於——我知道有人間接地討論過,但目前 Ozempic 在肥胖方面的標籤外使用。您對美國正在發生的事情有多少了解?如果可見性很低,您如何將其納入您的規劃假設?顯然,對於 Ozempic 的糖尿病處方和糖尿病處方,患者將在多長時間內服用藥物的不確定性要小得多?
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
I've got -- Camilla.
我有-- 卡米拉。
Camilla Sylvest - Executive VP, Head of Commercial Strategy & Corporate Affairs and Member of the Management Board
Camilla Sylvest - Executive VP, Head of Commercial Strategy & Corporate Affairs and Member of the Management Board
So today, around 10% or GLP-1 treatment is around 10% of U.S. volume. And of course, in diabetes. And when we talk about potential off-label use, I think we talked to it earlier, it's difficult to estimate exactly the size of that, but we have, of course, looked at the trend on the NBRx as we talked about earlier. So that's as close as we can get to giving you an estimate of that. There is no significant change in the trend that was already there before the launch of once-weekly GLP-1 in obesity. But there is an increase in the trend, but not a significant step-up, yes.
所以今天,大約 10% 或 GLP-1 治療約占美國數量的 10%。當然,還有糖尿病。當我們談論潛在的標籤外使用時,我想我們之前已經談過了,很難準確估計它的規模,但我們當然已經看到了我們之前談到的 NBRx 的趨勢。所以這就是我們可以給你的估計。在針對肥胖症推出每週一次的 GLP-1 之前已經存在的趨勢沒有顯著變化。但是趨勢有所增加,但沒有顯著增加,是的。
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
And then there's the modeling or the switching between Ozempic and Wegovy.
然後是建模或 Ozempic 和 Wegovy 之間的切換。
Camilla Sylvest - Executive VP, Head of Commercial Strategy & Corporate Affairs and Member of the Management Board
Camilla Sylvest - Executive VP, Head of Commercial Strategy & Corporate Affairs and Member of the Management Board
Yes. So when we look at international operations, and I know you're asking about the U.S., but when we look at international operations, you see an increase of 73% in Saxenda. And you also see a very steep increase in Ozempic sales. So you have those 2 products in parallel growing significantly. And of course, that's not in -- that's the best sort of one-to-one picture, we can imagine what would also happen we now start to supply Wegovy in the U.S. We are supplying Saxenda now that also -- so the obesity franchise grows also in the 70s in the U.S. as of now, while we also see a continued growth of Ozempic that Karsten mentioned also 70%.
是的。所以當我們看國際業務時,我知道你問的是美國,但當我們看國際業務時,你會看到 Saxenda 增長了 73%。您還可以看到 Ozempic 銷售額的急劇增長。所以這兩種產品同時顯著增長。當然,那不是——那是最好的一對一圖片,我們可以想像還會發生什麼,我們現在開始在美國供應 Wegovy。我們現在也供應 Saxenda——所以肥胖專營權截至目前,美國也在 70 年代增長,而我們也看到 Karsten 提到的 Ozempic 也持續增長 70%。
So those 2 franchises are able to actually coexist at very high growth rates because the underlying demand is very, very big, more than 700 million people living with obesity in the world and more than 500 million living with diabetes. And we are all together treating, including insulins, just around 35 million patients, right? So it's fair to say that there's still unexploited potential for better treatment for patients.
所以這兩個特許經營實際上能夠以非常高的增長率共存,因為潛在的需求非常非常大,世界上有超過 7 億人患有肥胖症,超過 5 億人患有糖尿病。我們一起治療大約 3500 萬患者,包括胰島素,對吧?因此,可以公平地說,在為患者提供更好的治療方面仍有未開發的潛力。
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Thanks, Camilla. I think that was the perfect way to end on a high note, lots of potential for treating patients with (inaudible) and many years to come. So thank you for attending the Novo Nordisk Q3 lunch meeting in London, and thanks to Keyur Parekh and Goldman Sachs for hosting this fantastic result of fantastic venue, and they are looking forward to see you all, if not before, then the 1st of February when we come with our full year results and 2023 guidance. Thank you.
謝謝,卡米拉。我認為這是以高調結束的完美方式,在未來很多年治療(聽不清)患者的潛力很大。因此,感謝您參加在倫敦舉行的諾和諾德 Q3 午餐會,感謝 Keyur Parekh 和高盛主辦了這個夢幻般的場地,他們期待著在 2 月 1 日與大家見面當我們得出全年業績和 2023 年指導意見時。謝謝你。
Martin Holst Lange - Executive VP, Head of Development & Member of the Management Board
Martin Holst Lange - Executive VP, Head of Development & Member of the Management Board
Thank you.
謝謝你。
Keyur Parekh - Equity Analyst
Keyur Parekh - Equity Analyst
Thank you.
謝謝你。