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Lars Fruergaard Jorgensen - President, CEO & Member of Management Board
Lars Fruergaard Jorgensen - President, CEO & Member of Management Board
I'm Lars Fruergaard Jørgensen. I'm the CEO of Novo Nordisk. And with me, I have Camilla Sylvest from Commercial; Martin from Medical; and Karsten, our CFO. So we'll do a quick introduction and just the theme by making a few presentations here. We will be talking about the future, which is inherently risky. So stay alert on the risk factors and our forward-looking statement here.
我是 Lars Fruergaard Jørgensen。我是諾和諾德的首席執行官。和我一起,我有來自 Commercial 的 Camilla Sylvest;來自醫學的馬丁;和我們的首席財務官卡斯滕。因此,我們將通過在這裡做一些演示來快速介紹一下主題。我們將談論未來,這本質上是有風險的。因此,請在此處對風險因素和我們的前瞻性聲明保持警惕。
On strategic aspirations, we have set these aiming at delivering strong contribution to society, the environment, but of course, also our shareholders. So we see that based on these aspirations, and we believe we're making good progress. We have exciting progress from an innovation point of view. Martin will talk a bit to that, as we really focused on raising the bar in diabetes and obesity and expand into some adjacent disease areas.
在戰略目標方面,我們的目標是為社會、環境以及我們的股東做出重大貢獻。因此,我們基於這些願望看到了這一點,我們相信我們正在取得良好進展。從創新的角度來看,我們取得了令人興奮的進展。 Martin 將就此談一談,因為我們真正專注於提高糖尿病和肥胖症的標準,並擴展到一些鄰近的疾病領域。
You can see our commercial execution is really strong, strong growth in the first half year here, a continuation of an accelerated growth trend we have seen over the past quarters, adding competitive strength in expanded market share in diabetes. And all that translates into very attractive growth numbers, and we have now, for the second quarter in a row, made significant upgrades in our earnings outlook for the year. And I think we also have quite attractive cash conversion and return to our shareholders.
您可以在這裡看到我們的商業執行非常強勁,上半年增長強勁,延續了我們在過去幾個季度看到的加速增長趨勢,在擴大糖尿病市場份額方面增加了競爭實力。所有這一切都轉化為非常有吸引力的增長數字,我們現在已經連續第二個季度對今年的盈利前景進行了重大升級。而且我認為我們也有相當有吸引力的現金轉換和回報給我們的股東。
So really strong start to the year, and we are quite confident on the competitive dynamics and commercial execution we see. And we think we have a really interesting and exciting pipeline that can further drive our position in diabetes and obesity and really this innovation bar and stay competitive for the long term.
今年的開局非常強勁,我們對我們看到的競爭動態和商業執行充滿信心。而且我們認為我們有一個非常有趣和令人興奮的管道,可以進一步推動我們在糖尿病和肥胖症方面的地位,真正實現這個創新標準並保持長期競爭力。
With that, I'll hand over to Camilla for a few commercial updates.
有了這個,我將把一些商業更新交給卡米拉。
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. Thank you, Lars. And as you know, 16% sales growth in the first half of this year, primarily driven by North America, 65% of the sales growth coming from North America, 35% coming from IO, you see 10% growth in IO. You also see each of the regions growing, except for China, where the negative growth is related to the volume-based procurement, VBP, impact that initiated as of May, as we have discussed several times.
是的。謝謝你,拉斯。如你所知,今年上半年銷售額增長 16%,主要由北美推動,65% 的銷售額增長來自北美,35% 來自 IO,你看到 IO 增長 10%。您還看到每個地區都在增長,除了中國,那裡的負增長與從 5 月開始的基於數量的採購 VBP 的影響有關,正如我們多次討論的那樣。
On the right-hand side, you see the growth per therapy area. You see strong growth driven by GLP-1, 45% growth, on GLP-1 driven both by North America and also by International Operations. Then you see a decline in the insulin growth primarily driven by price decreases in the U.S., but in IO, the negative growth is related to also Tier 2 China. And then you see obesity growth of 84%, 60% in IO, all driven by Saxenda, and then a 102% growth in North America, of course, driven by a combination of both Saxenda and Wegovy. And then we have flat growth in rare disease.
在右側,您可以看到每個治療區域的增長。您會看到 GLP-1 推動了強勁的增長,在北美和國際運營的推動下,GLP-1 增長了 45%。然後你會看到主要受美國價格下跌驅動的胰島素增長下降,但在 IO 中,負增長也與第 2 級中國有關。然後你會看到肥胖增長了 84%,IO 增長了 60%,這都是由 Saxenda 推動的,然後是北美 102% 的增長,當然,這是由 Saxenda 和 Wegovy 共同推動的。然後我們在罕見病方面的增長持平。
If we look at the GLP-1 class expansion, you here see a significant increase in the GLP-1 class growth, more than 35% growth. And you also see that Ozempic now has the market leadership in this segment as a brand. And you also see that Novo Nordisk continues to increase our total market share in GLP-1, now up to 56.4%. The market -- underlying market dynamics seen there very strong by a much stronger recognition of the opportunity to treat both HbA1c, weight and cardiovascular risk profile for people living with diabetes.
如果我們看一下 GLP-1 類擴展,你會看到 GLP-1 類增長顯著增加,增長超過 35%。您還可以看到,Ozempic 作為一個品牌現在在這一領域擁有市場領導地位。您還可以看到,諾和諾德繼續增加我們在 GLP-1 中的總市場份額,目前高達 56.4%。市場——潛在的市場動態非常強勁,因為人們對治療糖尿病患者的 HbA1c、體重和心血管風險狀況的機會有了更強烈的認識。
If we zoom in on obesity care, you see here market growing 84%. We also have an 84% market share in the obesity segment. Much more interesting is, of course, that there is a much stronger desire to treat people with obesity. And this is, of course, a combination of market development, effort, the recognition that obesity needs to be treated because of the risk that it inherently has on other serious chronic conditions.
如果我們放大肥胖護理,你會看到這裡的市場增長了 84%。我們在肥胖領域也佔有 84% 的市場份額。當然,更有趣的是,治療肥胖患者的願望要強烈得多。當然,這是市場開發、努力以及對肥胖需要治療的認識的結合,因為它固有地對其他嚴重的慢性疾病具有風險。
And in the U.S., we now have formulary access of more than 80% and net access somewhat lower than that. And then we are, as we have discussed, we are looking to make all doses of Wegovy available in the U.S. towards the end of the year. And the commercial production of -- at our CMO has been reinitiated in Q2, and we are progressing towards making all doses available at the end of the year.
在美國,我們現在擁有超過 80% 的處方集訪問權限,而網絡訪問權限則略低於此。然後,正如我們所討論的,我們希望在年底前在美國提供所有劑量的 Wegovy。我們的 CMO 的商業生產已在第二季度重新啟動,我們正朝著在年底提供所有劑量的方向前進。
And then finally, we have also outside the U.S., made Wegovy available initially now in France at a clinical experience program. And we're also looking forward to launching Wegovy in a few countries towards the end of the year. And of course, the majority of the launches in International Operations for Wegovy will be in 2023.
最後,我們還在美國以外的地方推出了 Wegovy,現在在法國的臨床體驗項目中提供了最初的服務。我們也期待在年底前在一些國家推出 Wegovy。當然,Wegovy 國際業務的大部分發布將在 2023 年進行。
And with that, I'd like to hand over to Martin to say a few words about SELECT.
有了這個,我想請 Martin 談談 SELECT。
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 very much. I'm going to start with SELECT. Most of you who have had some attention on that study over the last couple of days, I just want to take a step back and remind us what is SELECT. SELECT is a cardiovascular outcome for 17,500 patients being randomized to either semaglutide or placebo with the primary purpose of looking for cardiovascular outcome.
非常感謝。我將從 SELECT 開始。在過去幾天裡對這項研究有所關注的大多數人,我只想退後一步,提醒我們什麼是 SELECT。 SELECT 是 17,500 名患者的心血管結局,他們被隨機分配到 semaglutide 或安慰劑組,主要目的是尋找心血管結局。
As with most cardiovascular outcome products, SELECT is -- basically means that we have to accrue a certain number of events in order to do a statistical analysis at end of life. Also, as the most outcome (inaudible) there is an opportunity to then group and what we call an interim analysis with fewer events in the group. Given that we want to make absolutely certain that we get a good and robust, both from our own perspective, from our patient's, from our investigator's perspective and certainly also from a payer and regulatory perspective.
與大多數心血管結果產品一樣,SELECT 基本上意味著我們必須累積一定數量的事件才能在生命結束時進行統計分析。此外,作為最多的結果(聽不清),有機會進行分組,我們稱之為中期分析,小組中的事件較少。鑑於我們希望絕對確定我們獲得了良好和穩健的結果,無論是從我們自己的角度,從我們的患者的角度,從我們的研究者的角度來看,當然也從付款人和監管的角度來看。
We set the bar very high. I started on SELECT, this sample size, to be able to show 17% difference between SELECT and placebo. That basically means that we have a 99% power to show (inaudible).
我們把標准定得很高。我從 SELECT(這個樣本量)開始,以便能夠顯示 SELECT 和安慰劑之間 17% 的差異。這基本上意味著我們有 99% 的能力來展示(聽不清)。
It also means that we can show statistical difference, so patients with below 17%, but also obviously higher than [10%]. But if we wanted to start at the interim analysis, we needed something that is bigger than that because we have fewer events. That basically means our agreement with the Data Monitoring Committee was to only recommend to start SELECT if the point estimate that they observed on the primary endpoint was substantially above 17%. Some of you are asking what is substantially above 17%. That's a number we don't want to disclose. But we have to mention that, that is 17 percentage points, probably even beyond 20% in terms of what we can disclose.
這也意味著我們可以顯示統計差異,因此低於 17% 的患者,但也明顯高於 [10%]。但如果我們想從中期分析開始,我們需要比這更大的東西,因為我們有更少的事件。這基本上意味著我們與數據監測委員會的協議是僅在他們在主要終點觀察到的點估計值大大高於 17% 時才建議開始選擇。你們中的一些人在問什麼是大大高於 17%。這是一個我們不想透露的數字。但我們不得不提到的是,就我們可以披露的內容而言,這是 17 個百分點,甚至可能超過 20%。
That also means that when the (inaudible) or recommend us to continue to (inaudible), it leads to some minor, we are below that substantial number. That does not mean that the base is -- or sorry, SELECT is the same one. Actually, it means that we basically can go back to our base assumption. There's a potential 17% difference. It could be slightly more, it could be slightly less. But that's our best assumption, and we're going to continue to file until the end towards mid of next year.
這也意味著,當(聽不清)或建議我們繼續(聽不清)時,它會導致一些輕微的,我們低於那個可觀的數字。這並不意味著基礎是 - 或者抱歉,SELECT 是同一個。實際上,這意味著我們基本上可以回到我們的基本假設。有17%的潛在差異。可以多一點,也可以少一點。但這是我們最好的假設,我們將繼續提交申請,直到明年年中結束。
I've also been asked a couple of times, does the DMC look at other than the secondary -- sorry, the primary endpoint? As with any (inaudible) that prerogative to look at the totality of the data that goes for every (inaudible) that goes (inaudible). But we also have to consider, and I'm sorry to become a little technical here, again, this is a function of how many events [we have]. And if you look at the secondary point, we have approximately 1/3 of the events that we have on the primary.
我也被問過幾次,DMC 是否關注次要終點——抱歉,主要終點?與任何(聽不清)有特權查看每個(聽不清)(聽不清)的數據的整體一樣。但我們也必須考慮,我很抱歉在這裡變得有點技術性,再說一次,這是[我們有]多少事件的函數。如果您查看次要點,我們在主要點上擁有大約 1/3 的事件。
That also means that we don't have a lot of power to take statistical business in those (inaudible). And therefore, we specifically recommended and guide that the (inaudible) primarily focus on the primary. They had the prerogative to look at the totality of the data, but we asked them to primarily look at the primary.
這也意味著我們沒有足夠的權力在這些領域開展統計業務(聽不清)。因此,我們特別建議並指導(聽不清)主要關注初級。他們有權查看全部數據,但我們要求他們主要查看主要數據。
(inaudible) illustrates 17% was the very (inaudible) numbers with those 17% will be very (inaudible). And we have the statistical power to even detect statistical difference in the [dose]. You have seen smaller outcome trials than this, show statistical difference all the way down to 11%. And therefore, we are very, very confident that SELECT around this next year will come up as planned with variable data..
(聽不清)說明 17% 是非常(聽不清)的數字,而這 17% 將非常(聽不清)。而且我們有統計能力甚至可以檢測[劑量]的統計差異。你見過比這更小的結果試驗,顯示統計差異一直下降到 11%。因此,我們非常非常有信心,明年左右的 SELECT 將按計劃提供可變數據。
Turning to something completely different, but also super exciting. We, last week, reported on 2 additional (inaudible) that basically said we have now reported of 5 of 6 ONWARDS trials. ONWARDS is the development program for (inaudible). We're super excited about the results that we've seen so far. They are depicted in this slide. ONWARDS 1 and 2 and 3 are in phase (inaudible). We've already heard us talk about ONWARDS 1 and 2. Superiority in terms of glycemic control versus insulin icodec and insulin glargine, with no difference in risk of hypoglycemia in both lines.
轉向完全不同的東西,但也非常令人興奮。上週,我們報告了另外 2 項(聽不清),基本上說我們現在已經報告了 6 項 ONWARDS 試驗中的 5 項。 ONWARDS 是(聽不清)的開發計劃。我們對迄今為止所看到的結果感到非常興奮。這張幻燈片中描述了它們。 ONWARDS 1 和 2 和 3 同相(聽不見)。我們已經聽說過我們談論 ONWARDS 1 和 2。在血糖控制方面優於 icodec 和甘精胰島素,這兩條線的低血糖風險沒有差異。
ONWARDS 3, this is a similar trial in the sense that we're looking at base load treatment. The difference between ONWARDS 3 and ONWARDS 1 and 2 is that was double blind, double (inaudible). So really is very, very high on the scientific reason and showing the same superiority over insulin icodec as we've seen in the open label trial, is speaking to the robustness of the data that we've generated, but also to the really exciting profile that we've seen in insulin icodec.
ONWARDS 3,從某種意義上說,這是一個類似的試驗,我們正在研究基本負載處理。 ONWARDS 3 和 ONWARDS 1 和 2 之間的區別是雙盲,雙(聽不清)。所以真的是非常非常高的科學理由,並顯示出與我們在開放標籤試驗中看到的胰島素 icodec 相同的優勢,這說明了我們生成的數據的穩健性,但也說明了真正令人興奮的我們在胰島素 icodec 中看到的配置文件。
Second reason why ONWARDS 3 is exciting is it caters to approved global regulatory submission of insulin icodec because we have China and Chinese patients in the ONWARDS 3 program. And we have an agreement with the Chinese authorities that integrating China in the global program also allows us to see approved global regulatory submission and finalization of the program.
ONWARDS 3 令人興奮的第二個原因是它迎合了批准的全球監管提交的胰島素 icodec,因為我們在 ONWARDS 3 計劃中有中國和中國患者。我們與中國當局達成了一項協議,將中國納入全球計劃也使我們能夠看到批准的全球監管提交和計劃的最終確定。
ONWARDS 4 is important because this is basal-bolus in type 2 diabetes. Has approximately 40% of the volume split between base load and basal-bolus. So from a volume perspective and from a (inaudible) perspective, (inaudible). And we're super happy to see no difference in glycemic control, no difference in (inaudible).
ONWARDS 4 很重要,因為這是 2 型糖尿病的基礎推注。在基礎負荷和基礎推注之間有大約 40% 的體積分配。因此,從音量的角度和(聽不清)的角度來看,(聽不清)。我們非常高興地看到血糖控制沒有差異,(聽不清)沒有差異。
But then we can conclude that we had an (inaudible) in type 2 diabetes and a really, really strong candidate in basal-bolus in the good icodec control, good safety and a superior continue profile. And therefore, we are as excited as the -- about the prospects of insulin icodec.
但隨後我們可以得出結論,我們在 2 型糖尿病中具有(聽不清),並且在良好的 icodec 控制、良好的安全性和卓越的連續性方面,在基礎推注中確實非常強大的候選人。因此,我們對 icodec 胰島素的前景感到非常興奮。
Finally, just taking you through some of the highlights of what is going to come next in the next couple of quarters. Obviously, I think as with some of you, I am super curious and super excited about Phase II CagriSema trial reading out later this year. This is for type 2 diabetes. We can also point out this is (inaudible) for the combination of semaglutide and (inaudible) in terms of type 2 diabetes. We know that it has a very, very attractive profile in terms of weight loss. So we need to assess the potential in [controlling] type 2 diabetes. That's going to read out during the course of Q3.
最後,只是帶您了解接下來幾個季度將要發生的事情的一些亮點。顯然,我想和你們中的一些人一樣,我對今年晚些時候宣讀的第二階段 CagriSema 試驗感到非常好奇和興奮。這是針對2型糖尿病的。我們還可以指出,這是(聽不清)semaglutide 的組合和(聽不清)2 型糖尿病的組合。我們知道它在減肥方面非常非常有吸引力。因此,我們需要評估 [控制] 2 型糖尿病的潛力。這將在第三季度的過程中讀出。
And then obviously, we are excited about the initiation of our combination of semaglutide and it's just (inaudible). This is interesting from a clinical, from a medical and also from a commercial perspective, getting the best of two worlds with the GLP-1 and the (inaudible).
然後很明顯,我們對啟動索馬魯肽組合感到興奮,這只是(聽不清)。從臨床、醫學和商業角度來看,這很有趣,GLP-1 和(聽不清)兩全其美。
In the space of obesity, obviously, we are looking very much forward to seeing the result of (inaudible). That's basically, again (inaudible) and GLP-1 analogue. And really having the potential that we have seen in (inaudible) in terms of efficacy, in terms of safety, but the added convenience of an oral (inaudible).
顯然,在肥胖領域,我們非常期待看到(聽不清)的結果。基本上,再次(聽不清)和 GLP-1 類似物。並且確實具有我們在(聽不清)在功效方面看到的潛力,就安全性而言,但增加了口服的便利性(聽不清)。
In the rare disease space, I think you've heard us talk a lot about concizumab. You've heard probably a lot about Mim8. Looking very much forward to initiating Mim8 placebo then. But we're really excited about having started Phase II for NDec, which is our (inaudible) obviously with a tremendous (inaudible).
在罕見病領域,我想你已經聽到我們談論了很多關於 concizumab 的話題。您可能聽說過很多關於 Mim8 的信息。非常期待啟動 Mim8 安慰劑。但是我們真的很高興為 NDec 啟動了第二階段,這顯然是我們的(聽不清)具有巨大的(聽不清)。
And finally, I just want to point out our initiation of our ATTR asset in ATTR cardiomyopathy. That is an asset that we bought from Prothena last year. As with (inaudible) also with this very high unmet need. .
最後,我只想指出我們在 ATTR 心肌病領域的 ATTR 資產的啟動。這是我們去年從 Prothena 購買的資產。與(聽不清)一樣,還有這種非常高的未滿足需求。 .
So with that, over to you, Karsten.
有了這個,交給你,卡斯滕。
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Thank you, Martin. So on to the financials. You've seen the P&L. So I'm not going to go through it in details. You heard 16%, the constant exchange rate sales growth in the first 6 months, in Camilla's presentation. I can do it even better because when I add in currency, then we are accrued 25% reported. So a really, really amazing growth level for the company when you look at both the relative and absolute growth levels.
謝謝你,馬丁。再說財務。你已經看到了損益表。所以我不打算詳細介紹它。您在卡米拉的演講中聽到了 16%,即前 6 個月的固定匯率銷售額增長。我可以做得更好,因為當我添加貨幣時,我們會獲得 25% 的報告。因此,當您查看相對和絕對增長水平時,公司的增長水平非常非常驚人。
When you go through our P&L, you see the continued dynamics on our gross margin of benefit from product mix, driven by GLP-1 portfolio, continue to drive efficiencies. And then, of course, we have a negative impact from pricing but net-net and improving gross margin at constant exchange rates of some 60 basis points in the first 6 months.
當您查看我們的損益表時,您會看到在 GLP-1 產品組合的推動下,我們從產品組合中獲益的毛利率持續動態,繼續推動效率。然後,當然,我們會受到定價的負面影響,但在前 6 個月以大約 60 個基點的恆定匯率計算,淨淨值和毛利率的提高。
R&D, look at that growth rate. 26% up on R&D spending that link to basically the investments that Martin and Marcus, our research colleague, are pursuing in terms of expanding and diversifying our pipeline. Around half of the step-up in R&D comes from the acquisition of Dicerna Therapeutics that closed in the fourth quarter of last year. And we're already now starting to see some encouraging signs, not reporting in Martin's slides, but in our early pre-projects with Marcus starting to get additional volumes into our early pipeline. So really encouraging there and the continued investment in R&D going forward.
研發,看看那個增長率。研發支出增加了 26%,這與我們的研究同事 Martin 和 Marcus 在擴大和多樣化我們的管道方面所進行的投資有關。大約一半的研發增長來自於去年第四季度完成的對 Dicerna Therapeutics 的收購。我們現在已經開始看到一些令人鼓舞的跡象,不是在 Martin 的幻燈片中報告,而是在我們早期的前期項目中,Marcus 開始在我們的早期管道中增加額外的數量。因此,這真的令人鼓舞,並且繼續對研發進行投資。
Net-net, operating profit up 14%. Then, of course, you see hedging going the other way with net financials of a negative 2.8, which is basically [the opposite]. We account for our hedging in net financials, not in the lines. Taxes, nothing to say and net-net diluted earnings per share of 13% in the first 6 months, very attractive.
淨額,營業利潤增長14%。然後,當然,您會看到對沖走向相反的方向,淨財務值為負 2.8,這基本上 [相反]。我們在淨財務中考慮我們的對沖,而不是在行中。稅收,無話可說,前 6 個月的每股淨攤薄收益為 13%,非常有吸引力。
This all then plays into an upgrade of our full year outlook is driven by the momentum behind our Tier 1 franchise in diabetes, Rybelsus and Ozempic, as well as market growth in the obesity segment. So you see the step-up, as Camilla showed you, with Saxenda in International Operations and also some Wegovy sales in U.S. So really strong momentum in our obesity franchise, which in combination with type 1 diabetes, enables us to step up our guidance in terms of sales growth and operating profit growth.
這一切都對我們全年展望的升級起到了推動作用,這是由我們在糖尿病、 Rybelsus 和 Ozempic 的一級特許經營權背後的動力以及肥胖細分市場的增長推動的。因此,正如 Camilla 向您展示的那樣,隨著 Saxenda 在國際業務中的發展以及 Wegovy 在美國的一些銷售,您看到了進步。因此,我們的肥胖專營權勢頭非常強勁,與 1 型糖尿病相結合,使我們能夠在以下方面加強指導銷售增長和營業利潤增長方面。
And then again, currencies are favorable, especially the U.S. dollar strengthening this year that we're all aware about. So now we are seeing a 9 percentage point benefit on top line and 14 percentage points benefit on our operating profit from currencies, which again will partially be offset by hedging losses. But when you do the net math, we actually do have a favorable impact, net of currencies of -- to the tune of DKK 3 billion to DKK 4 billion this year. So very favorable.
再說一次,貨幣是有利的,尤其是我們都知道的今年美元走強。因此,現在我們看到了 9 個百分點的收入收益和 14 個百分點的貨幣營業利潤收益,這些收益將再次被對沖損失部分抵消。但是,當您進行淨計算時,我們實際上確實產生了有利的影響,扣除貨幣 - 今年達到 30 億丹麥克朗至 40 億丹麥克朗。所以非常優惠。
And this then translates into an upgraded cash flow generation of between DKK 57 billion and DKK 62 billion, which plays into our capital allocation strategy that we're sticking to in terms of returning our free cash flow in the form of dividends and share buybacks. So we're maintaining our share buyback program of DKK 24 billion for this year. And then the Board has decided to issue an interim dividend here in August of DKK 4.25 per share, which ties into our strategy of continuing with around 50% payout ratio of net profit in the form of dividends between interim and full year results.
然後,這將轉化為 570 億丹麥克朗至 620 億丹麥克朗之間的升級後現金流產生,這在我們堅持以股息和股票回購形式返還自由現金流方面發揮了資本配置策略的作用。因此,我們將維持今年 240 億丹麥克朗的股票回購計劃。然後,董事會決定在 8 月份在此發行每股 4.25 丹麥克朗的中期股息,這與我們在中期和全年業績之間以股息的形式繼續以約 50% 的淨利潤支付率的戰略相關。
So that was the brief run-up of our financials and off to you, Lars.
這就是我們財務狀況的簡要介紹,拉爾斯,請交給你。
Lars Fruergaard Jorgensen - President, CEO & Member of Management Board
Lars Fruergaard Jorgensen - President, CEO & Member of Management Board
Yes. So thank you to my colleagues and now we're ready for the Q&A session and welcome questions from both buy and sell side. And if you could please start by stating your name and affiliation, then we have some microphones working around.
是的。所以感謝我的同事們,現在我們已經準備好進行問答環節了,歡迎來自買賣雙方的提問。如果您可以先說明您的姓名和所屬機構,那麼我們有一些麥克風可以解決。
So should we start with our host, out of respect, I think.
所以我們應該從我們的主人開始,出於尊重,我想。
Wimal Kapadia - Research Analyst
Wimal Kapadia - Research Analyst
Wimal Kapadia from Bernstein. So can I just ask about SELECT, not the interim? So my question is really about how important SELECT is to uptake. So if I think about reimbursement and penetration in the near term, with and without SELECT, how does Novo actually think about it? Because we think it's really important. But given where we are in terms of penetration and how mature this market is, does it actually matter near term to how well Wegovy's actually going to do? That's the first question.
來自伯恩斯坦的 Wimal Kapadia。那麼我可以只問關於 SELECT 的問題,而不是臨時的嗎?所以我的問題實際上是關於 SELECT 的重要性。因此,如果我考慮短期內的報銷和滲透,無論有沒有 SELECT,諾和實際上是如何考慮的?因為我們認為這真的很重要。但考慮到我們在滲透率方面的位置以及這個市場的成熟程度,短期內這對 Wegovy 的實際表現真的很重要嗎?這是第一個問題。
And then my second question is on Rybelsus and pricing. So 2Q looks quite painful again on a net price basis, if I'm just doing the simple math of reported sales and volumes. And so the first half overall looks quite tough. So my question really is, are we now starting to see greater pressure for Rybelsus from payers as they compare to SGLT2 pricing? And so is it fair to assume moving forward that actually Rybelsus' pricing will decline to a greater extent than the injectable GLP-1?
然後我的第二個問題是關於 Rybelsus 和定價。因此,如果我只是對報告的銷售額和銷量進行簡單的數學計算,那麼從淨價格的角度來看,第二季度看起來還是很痛苦的。所以上半年整體看起來相當艱難。所以我的問題是,與 SGLT2 定價相比,我們現在是否開始看到付款人對 Rybelsus 的壓力更大?因此,假設 Rybelsus 的定價實際上會比可注射的 GLP-1 下降幅度更大,這是否公平?
Lars Fruergaard Jorgensen - President, CEO & Member of Management Board
Lars Fruergaard Jorgensen - President, CEO & Member of Management Board
Thank you. So Camilla, first, on SELECT, how important is it to have these days. And then perhaps Karsten on pricing.
謝謝你。所以卡米拉,首先,在 SELECT 上,擁有這些天是多麼重要。然後也許是 Karsten 的定價。
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 it's very clear that Wegovy has already stablished itself as a very important brand in the eyes of people living with obesity, but also with [decisions]. So in the short term, we believe that there's a very, very strong momentum in the obesity market. We even see the market development now, growing the market 84%. And it basically means that there is, both for the short term and the medium term, a clear, important impact from products that can reduce weight loss with -- to the tune of 17% to 18% that we see with Wegovy.
所以很明顯,Wegovy 已經確立了自己在肥胖人群眼中的一個非常重要的品牌,但也有 [decisions]。因此,在短期內,我們相信肥胖市場的勢頭非常非常強勁。我們甚至看到了現在的市場發展,市場增長了 84%。這基本上意味著,無論是在短期還是中期,可以減輕體重的產品都會產生明顯而重要的影響——我們在 Wegovy 上看到的影響為 17% 到 18%。
Having said that, of course, over time, a landmark study like SELECT would also describe how this actually transitions into reducing also other serious chronic issues that are related to obesity. And this, of course, then linked to cardiovascular outcomes. But of course, understanding that will be important. Just like 20 years ago, we saw how important it was to understand type 2 diabetes.
話雖如此,當然,隨著時間的推移,像 SELECT 這樣的具有里程碑意義的研究也將描述這實際上如何轉變為減少與肥胖相關的其他嚴重慢性問題。當然,這與心血管結果有關。但是,當然,理解這一點很重要。就像 20 年前一樣,我們看到了解 2 型糖尿病的重要性。
So when you ask about whether that has an impact on payers, of course, it's an additional cardiovascular endpoint we will be able to add, but it's also clear that even with Saxenda now, we see reimbursement in many, many more countries because the importance of treating obesity has been much better understood lately and recently. And this, of course, in itself is already very strong. And that's why we see such a strong sales growth even in International Operations.
因此,當您詢問這是否對付款人有影響時,當然,這是我們可以添加的額外心血管終點,但同樣清楚的是,即使現在有了 Saxenda,我們也看到了許多國家的報銷,因為它的重要性最近和最近人們對治療肥胖症的研究有了更好的了解。當然,這本身就已經非常強大了。這就是為什麼我們看到即使在國際業務方面也有如此強勁的銷售增長。
So short answer, yes, it's very important to get SELECT and we look forward to the readout next year as planned, but it's clear that the demand for Wegovy is there anyhow, and it's very strong.
如此簡短的回答,是的,獲得 SELECT 非常重要,我們期待明年按計劃進行讀數,但很明顯,對 Wegovy 的需求無論如何都存在,而且非常強勁。
Lars Fruergaard Jorgensen - President, CEO & Member of Management Board
Lars Fruergaard Jorgensen - President, CEO & Member of Management Board
Thank you, Camilla. Karsten, on pricing?
謝謝你,卡米拉。卡斯滕,關於定價?
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Yes. So first of all, never look at pricing for just one quarter, right, because there are so many compounding factors there between factories, IQVIA, Scripts inventory, you name it. So never look at it by quarter.
是的。所以首先,永遠不要只看一個季度的定價,對,因為工廠之間有很多複合因素,IQVIA,腳本庫存,你說的。所以永遠不要按季度看。
And we price Rybelsus according to the product benefits and which are very closely aligned to the overall benefits of the TF1 category. So I wouldn't tie it to SGLT2 pricing rolling forward or anything like that. This is a TF1-based product with TF1 benefits. And then I would say, depending on how you do your value modeling, then clearly, we have also a nice uptake ex U.S. on Rybelsus.
我們根據產品優勢對 Rybelsus 進行定價,並且與 TF1 類別的整體優勢非常接近。因此,我不會將其與 SGLT2 價格向前滾動或類似的東西聯繫起來。這是具有 TF1 優勢的基於 TF1 的產品。然後我會說,這取決於你如何進行價值建模,那麼很明顯,我們在美國前對 Rybelsus 也有很好的吸收。
So we see Japan moving very nicely, and we also see some European markets pulling up very nicely with Rybelsus. So we see good trajectory and the product doubling and actually being a very nice sales growth driver. But of course, it's a little bit overshadowed by the fantastic Ozempic performance.
所以我們看到日本的發展非常好,我們也看到一些歐洲市場在 Rybelsus 的帶動下非常好。因此,我們看到了良好的發展軌跡,產品翻了一番,實際上是一個非常好的銷售增長動力。但是,當然,這有點被 Ozempic 出色的表現所掩蓋。
Jo Walton - MD
Jo Walton - MD
Jo Walton from Credit Suisse. A couple of questions, please, and I'll be coming back to the first one again. But it seems more than 6 months ago when you were saying 6% to 8% constant currency growth, and now you've delivered 16% in the first half.
瑞士信貸的喬沃爾頓。請提出幾個問題,我將再次回到第一個問題。但似乎在 6 個多月前,當你說 6% 到 8% 的固定貨幣增長時,現在你已經在上半年實現了 16%。
Now at the beginning of the year, you said absolutely don't expect any leverage coming through, we'll reinvest everything. Now we've got a much higher top line. I'm just wondering how long you can stick with that line. Absolutely, we can understand more investment in R&D. You invest today, we see the benefit. Well, the shareholders see the benefit in the future.
現在在年初,你說絕對不要指望任何槓桿作用,我們會再投資一切。現在我們的收入要高得多。我只是想知道你能堅持多久。當然,我們可以理解更多的研發投入。您今天投資,我們看到了收益。好吧,股東們看到了未來的好處。
But in the review that Karsten gave, you didn't highlight just how much the marketing costs have gone up in the first half as well. So I wondered if you could just talk a little bit about the environment, whether this is proactive because Lilly is coming down the road with Mounjaro, and you just want to be sacked in every doctor's seat, so that Lilly can't even get in. Or whether this is massive DTC, which is something about the sustainability and how we should think about that enormous marketing expense going on?
但在 Karsten 給出的評論中,您並沒有強調上半年營銷成本也上漲了多少。所以我想知道你是否可以談談環境,這是否是積極主動的,因為禮來正在和蒙扎羅一起走在路上,你只想在每個醫生的座位上被解僱,這樣禮來甚至無法進入. 或者這是否是大規模的 DTC,這與可持續性有關,我們應該如何看待正在發生的巨額營銷費用?
And my second question would be to Camilla on the acceptability of reimbursement. We've all got multibillion dollar numbers out there for the obesity market. And when it's quite small, we can imagine that payers will pay for very obese people to get reimbursed.
我的第二個問題是向卡米拉詢問報銷的可接受性。我們都有數十億美元的肥胖市場數據。當它很小的時候,我們可以想像付款人會支付給非常肥胖的人以獲得報銷。
But what is it -- can you give us an update on how people are thinking about that reimbursement more broadly? Because you mentioned 80% reimbursement, but you said the net number was less. So perhaps, I don't know whether it's you can only take it for 2 years; or the minute you come down below a certain BMI, you have to stop; or how we should be thinking about that.
但它是什麼——你能告訴我們人們如何更廣泛地考慮報銷嗎?因為你提到了80%的報銷,但是你說淨數少了。所以也許,我不知道是不是你只能用2年;或者當你低於某個 BMI 時,你必須停下來;或者我們應該如何考慮。
And it ties in perhaps to SELECT. If you get SELECT, does that change people like ICER's view, so they come back and say, this is awesome, it's now cost effective at a much lower price and gets you -- is that what really triggers everyone to start reimbursing you?
它可能與 SELECT 相關。如果您獲得 SELECT,這是否會改變人們喜歡 ICER 的觀點,所以他們會回來說,這太棒了,現在它以更低的價格具有成本效益並讓您獲得 - 這真的會觸發每個人開始向您報銷嗎?
Lars Fruergaard Jorgensen - President, CEO & Member of Management Board
Lars Fruergaard Jorgensen - President, CEO & Member of Management Board
Yes. Thank you. Allow me to give some initial perspectives on the margin and the leverage, and Karsten can perhaps chip in. You know that there are always year-over-year different things. Like now, we dig in Dicerna. We have impact from volume-based procurement in China, et cetera. But from a strategic point of view, it's really the market shaping of obesity and launching Ozempic, Rybelsus, et cetera, and of course, also Wegovy, that's what's driving our investments. So the opportunity we have over the coming, say, cycle based on the [similar-based] products is a tremendous opportunity.
是的。謝謝你。請允許我對保證金和槓桿率給出一些初步的看法,卡斯滕也許可以參與進來。你知道,每年都有不同的事情。就像現在,我們在 Dicerna 進行挖掘。我們受到中國基於數量的採購等的影響。但從戰略的角度來看,這確實是肥胖的市場塑造和推出 Ozempic、Rybelsus 等,當然還有 Wegovy,這才是推動我們投資的動力。因此,我們在即將到來的(例如,基於[基於相似的]產品的周期)中擁有的機會是一個巨大的機會。
So it's not something where we say that now competition is coming, so we upped our game. It's really a deep build of both the obesity market, but also the awareness of what a product like Ozempic can deliver. And of course, when you have Rybelsus, you also need to have a bit more of a GP type approach.
所以這不是我們說現在競爭即將到來的事情,所以我們提高了比賽水平。這確實是肥胖市場的深度構建,也是對像 Ozempic 這樣的產品可以提供的產品的認識。當然,當你有 Rybelsus 時,你還需要更多的 GP 類型的方法。
And we can see, as you also look for yourself, we can see that when we do those investments, we actually get a return on it. So when you sit with really, really strong products, making sure they are off to a good track and get the right perception in the market is a very important investment to make upfront. And then you can say, longer term, we have also guided that we believe that we'll have some leverage after we have produced those perceptions. And we also have the intention to build further brands that we can invest in down the road. But it's now have to do those massive investments.
我們可以看到,當您也在尋找自己時,我們可以看到,當我們進行這些投資時,我們實際上獲得了回報。因此,當您使用非常非常強大的產品時,確保它們走上正軌並在市場上獲得正確的認知是一項非常重要的前期投資。然後你可以說,從長遠來看,我們也指導我們相信在我們產生這些看法之後我們會有一些影響力。我們還打算建立更多我們可以在未來投資的品牌。但它現在必須進行那些大規模的投資。
And then we look at our options down the road in R&D and commercial. And I think the only thing we can promise is we'll keep investing in the opportunities we have. And then the success of that will then generate the leverage over time.
然後我們看看我們在研發和商業方面的選擇。我認為我們唯一可以承諾的是,我們將繼續投資於我們擁有的機會。然後,隨著時間的推移,它的成功將產生影響力。
Camilla, on obesity reimbursement.
卡米拉,關於肥胖報銷。
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. Obesity reimbursement, very exciting. And I'll just give you a perspective for the U.S. and then for countries outside the U.S. .
是的。肥胖報銷,很精彩。我只會給你一個關於美國的觀點,然後是美國以外的國家。
So in U.S., we talk about 80% gross access in the Commercial segment and approximately 40% access, net access, in the Commercial segment, driven by employers' opt-in. So this is the technicalities of the U.S. market. But in summary, it basically means that 20 million people have access to obesity treatments. And when you compare that to how many are being treated today, there is, of course, already a good opportunity for people to get treatment at low copay (inaudible).
因此,在美國,我們談論的是商業領域 80% 的總訪問量和商業領域的大約 40% 的訪問量,即網絡訪問量,這是由雇主的選擇推動的。這就是美國市場的技術特點。但總而言之,這基本上意味著 2000 萬人可以獲得肥胖治療。當您將其與今天接受治療的人數進行比較時,當然,人們已經有很好的機會以低共付額接受治療(聽不清)。
Then outside the U.S., we've seen a very interesting development the last few years, where more and more countries are starting to reimburse Saxenda, our first-generation D2C product. And typically, in most countries are now just treating roughly, but in the 10 countries that have a sort of government reimbursement, we are more looking at people that have a BMI above 30 or all above 35. And in some cases, also with comorbidities. So of course, when Saxenda is already reimbursed at this level, it seems like there are good perspective also for a product like Wegovy with even higher weight loss to also get to that same stage.
然後在美國以外,過去幾年我們看到了一個非常有趣的發展,越來越多的國家開始報銷我們的第一代 D2C 產品 Saxenda。通常,在大多數國家,現在只是粗略地對待,但在有某種政府報銷的 10 個國家中,我們更多地關注 BMI 高於 30 或全部高於 35 的人。在某些情況下,還有合併症.所以當然,當 Saxenda 已經報銷到這個水平時,看起來像 Wegovy 這樣具有更高減肥效果的產品也有很好的前景也能達到同樣的階段。
And I wanted just to let you know that we also see significant higher uptake in those countries, government-funded where we, of course, have reimbursement. And the dialogue with the government about this is also, of course, where, as we talked about before, SELECT will pay in because when we can model what the long-term impact of this might be, knowing that obesity is related to many, many serious, other health conditions, then, of course, the health economics of this is very positive. And this is also what NICE has endorsed here in the U.K. already for Wegovy.
我只想讓你知道,我們也看到在那些由政府資助的國家/地區的吸收率顯著提高,我們當然可以報銷。當然,與政府就此進行的對話也是,正如我們之前談到的,SELECT 將付出代價,因為當我們可以模擬這可能產生的長期影響時,知道肥胖與許多因素有關,許多嚴重的、其他的健康狀況,當然,這對健康經濟學來說是非常積極的。這也是 NICE 在英國已經為 Wegovy 認可的內容。
Lars Fruergaard Jorgensen - President, CEO & Member of Management Board
Lars Fruergaard Jorgensen - President, CEO & Member of Management Board
So there is an interesting dynamic effect here. If you go a few years back and look at the obesity market and the discussion we had about what does it take to unlock it, that is different compared to today. So something has changed in the awareness of obesity as a disease.
所以這裡有一個有趣的動態效果。如果你回到幾年前,看看肥胖市場以及我們關於如何解鎖它的討論,那與今天相比是不同的。因此,人們對肥胖作為一種疾病的認識發生了一些變化。
And you can speculate whether it's the experiences of health care systems during a pandemic, you can speculate whether it's now that we feel that now there's a real solution to the problem. And often, you can find that problems are not being acknowledged until there is a solution.
你可以推測這是否是大流行期間醫療保健系統的經驗,你可以推測是不是現在我們覺得現在有一個真正解決問題的辦法。通常,您會發現在找到解決方案之前,問題並沒有得到承認。
So something is changing. And it also brings to the first question that the SELECT data are important, but it's not the only key to unlock the market. So a dynamic effect -- and also when you think ahead, say, the more consumer type nature of the obesity market that we're starting to see is also different compared to what we have seen on, say, classic pharmaceutical interventions.
所以有些事情正在改變。這也帶來了第一個問題,即 SELECT 數據很重要,但它並不是打開市場的唯一鑰匙。因此,這是一種動態效應——而且當你提前考慮時,我們開始看到的肥胖市場的更多消費者類型性質與我們在經典藥物干預等方面看到的情況也不同。
[Mark], you control the...
[馬克],你控制...
Simon Mather - Pharmaceutical Equity Analyst
Simon Mather - Pharmaceutical Equity Analyst
Simon Mather, BNP Exane. Going back to SELECT. Martin, just wondering, obviously, you talked about this high barrier above the delta above the 17%. For argument's sake, let's say it's 5% to 22%. Could you comment, if -- if the trial was stopped for futility, is that margin the same on the downside as it is on the upside? And so therefore, we could assume the number could be 12 to 21 that the Data Monitoring Board come back to you with, is my first question.
西蒙·馬瑟,法國巴黎銀行 Exane。回到選擇。馬丁,只是想知道,很明顯,你談到了高於 17% 的三角洲上方的這個高障礙。為了論證的緣故,假設它是 5% 到 22%。您能否發表評論,如果 - 如果試驗因徒勞而停止,那麼下行的保證金與上行的保證金是否相同?因此,我們可以假設數據監控委員會回复給您的數字可能是 12 到 21,這是我的第一個問題。
And second one is just again on Wegovy. Hearing talks of payers pushing for prior auths now increase -- increases prior auths. I'm just wondering if you could essentially comment whether or not that's true or not because they're seeing the huge demand for the product. And so they're obviously a bit worried that their budgets are going to be blown out of the water.
第二個又是在 Wegovy 上。現在越來越多地聽到有關付款人推動先前身份驗證的討論 - 增加了先前身份驗證。我只是想知道您是否可以從本質上評論這是否正確,因為他們看到了對該產品的巨大需求。所以他們顯然有點擔心他們的預算會被花光。
I'm just wondering also could you share potentially the average stay time that you're seeing given the drug to market for 12 months.
我只是想知道你能否分享一下你看到的藥物上市 12 個月的平均停留時間。
Lars Fruergaard Jorgensen - President, CEO & Member of Management Board
Lars Fruergaard Jorgensen - President, CEO & Member of Management Board
So Martin, I don't know to what degree you can put more clarity on SELECT.
所以馬丁,我不知道您可以在多大程度上對 SELECT 進行更明確的說明。
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 think a little bit. This is an important question. And first of all, we specifically, again, primarily directed to keep the focus on the primary endpoint and focus for efficacy and not futility. But should they show futility, they would have been looking at this can never be specifically significant. And there, we are not even close to 17%. We would have to go below 10% to reach that level. So from that perspective, we are very far in our assumptions away from the from futility for the 17%, yes.
我覺得有點。這是一個重要的問題。首先,我們再次明確指出,主要目標是將注意力集中在主要終點上,關注有效性而不是徒勞。但如果他們表現出徒勞,他們會一直認為這永遠不會特別重要。在那裡,我們甚至沒有接近 17%。我們必須低於 10% 才能達到這個水平。所以從這個角度來看,我們的假設與 17% 的徒勞無益相距甚遠,是的。
Lars Fruergaard Jorgensen - President, CEO & Member of Management Board
Lars Fruergaard Jorgensen - President, CEO & Member of Management Board
Camilla, on reimbursement again for Wegovy and prior...
卡米拉,再次為 Wegovy 和之前的報銷...
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. Prioritization, we are not having any new information on that. That is particularly, on the other hand, prevalent. On the other hand, we are seeing that -- we see more and more employers opt in. It's a long tail of a number of employers, of course. But of course, this becomes (inaudible) to more and more important for everyone to treat and to offer and to make that treatment available.
是的。優先級,我們沒有任何新的信息。另一方面,這尤其普遍。另一方面,我們看到——我們看到越來越多的雇主選擇加入。當然,這是許多雇主的長尾。但是,當然,對於每個人來說,治療、提供和提供治療變得越來越重要(聽不清)。
So of course, over time, it's likely that there will be -- as we've seen when we move into more and more channels, there will be negotiations of price levels and so on. But this is to say because we are adding (inaudible), also a product that hasn't been on the market for very long.
所以當然,隨著時間的推移,很可能會有 - 正如我們所看到的,當我們進入越來越多的渠道時,將會有價格水平的談判等等。但這就是說,因為我們正在添加(聽不清),這也是一款上市時間不長的產品。
Then on the stay time, you also asked about that. We see -- we haven't concluded on new stay time data for Wegovy yet since it's too early and given also that we haven't been fully in the market. But what we can say is that we, of course, expect the stay time on Wegovy to be longer, given that we have shown in clinical trials that people reduce weight up until 60 weeks. And even up towards 102 weeks, we see no increase in the weight again. So from that point of view, we expect that people would like to stay longer on the product than what we see on Saxenda today, where the average is more 5 to 6 months.
然後關於停留時間,你也問了。我們看到了——我們還沒有就 Wegovy 的新停留時間數據得出結論,因為現在還為時過早,而且我們還沒有完全進入市場。但是我們可以說的是,我們當然希望在 Wegovy 上的停留時間更長,因為我們在臨床試驗中表明人們在 60 週內可以減輕體重。即使到了 102 週,我們也沒有看到體重再次增加。因此,從這個角度來看,我們預計人們希望在產品上停留的時間比我們今天在 Saxenda 上看到的更久,後者的平均時間為 5 到 6 個月。
Lars Fruergaard Jorgensen - President, CEO & Member of Management Board
Lars Fruergaard Jorgensen - President, CEO & Member of Management Board
Karsten?
卡斯滕?
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Yes. Just a small additional comment. So as we put in our announcement, now we have more than 80% unrestricted access in commercial in the U.S. So we actually upgraded our commercial access in the U.S. compared to the last quarter.
是的。只是一個小的附加評論。因此,正如我們在公告中所說,現在我們在美國擁有超過 80% 的商業無限制訪問權限。因此,與上一季度相比,我們實際上升級了我們在美國的商業訪問權限。
And when we look at access at a patient level, then we are -- when you go across channels, we're around 20 million people with obesity who have insurance access in the U.S., and that's a number which is increasing as we speak.
當我們從患者層面考慮訪問時,我們是 - 當你跨渠道時,我們有大約 2000 萬肥胖症患者在美國有保險訪問權,而且這個數字在我們說話時正在增加。
Michael Leuchten - Co-Head of Pharmaceuticals Research of Equity Research
Michael Leuchten - Co-Head of Pharmaceuticals Research of Equity Research
It's Michael Leuchten from UBS. Just going back to Wegovy. In Q2, the value of the volume was relatively low. And I was wondering if you could comment to whether you need to respond to Lilly's fairly aggressive copay program that seems to be running for quite a while. And I think about this in terms of Wegovy but also in terms of Ozempic.
我是瑞銀的 Michael Leuchten。剛回到韋戈維。在第二季度,成交量的價值相對較低。我想知道您是否可以評論一下您是否需要回應禮來相當激進的共付額計劃,該計劃似乎已經運行了很長時間。我從 Wegovy 和 Ozempic 的角度來考慮這一點。
Lars Fruergaard Jorgensen - President, CEO & Member of Management Board
Lars Fruergaard Jorgensen - President, CEO & Member of Management Board
Yes. So I can answer that. No, I don't think we have to do that. I think we had a similar tactics when we launched Wegovy to build early experience as we build access. We have robust access, as Camilla just -- for Wegovy, but also for Ozempic. So it's in that state to state commercial model you have to compete long term. It's not in the initial, say, early access experience we feel we have to compete. So we are quite comfortable with that. And yes, we used similar tactics when we launched Wegovy.
是的。所以我可以回答這個問題。不,我認為我們不必這樣做。我認為當我們推出 Wegovy 以在我們建立訪問權限時建立早期經驗時,我們採用了類似的策略。我們擁有強大的訪問權限,就像 Camilla 一樣 - 對於 Wegovy,而且對於 Ozempic。所以在那種狀態下,你必須長期競爭商業模式。比如說,我們認為我們必須競爭的並不是最初的搶先體驗體驗。所以我們對此很滿意。是的,我們在推出 Wegovy 時使用了類似的策略。
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
And sorry, Lars. Just on a very technical specific comment, Michael, on Q2 for Wegovy. So technically, the reason why you get to the value prescript that you get to is also impacted by the current supply chain situation that we've been discussing on Wegovy and the availability of the different dose strengths. So the fact that some of the dose strengths are not available in the U.S. market leads to the fact that the wholesaler inventory levels are lower. And as a consequence, you get to a lower value prescript than you otherwise would have in a growing concern business.
對不起,拉斯。邁克爾在 Wegovy 的第二季度發表了非常技術性的評論。因此,從技術上講,您獲得價值規定的原因也受到我們在 Wegovy 上討論的當前供應鏈情況以及不同劑量強度的可用性的影響。因此,某些劑量強度在美國市場上不可用的事實導致批發商庫存水平較低的事實。因此,您獲得的價值規定比您在日益增長的關注業務中獲得的價值要低。
Keyur Parekh - Equity Analyst
Keyur Parekh - Equity Analyst
Keyur Parekh from Goldman Sachs. Two questions, please. First, coming out that we met last time in London, your view was that icodec should have majority share of the basal insulin market, and that was before you saw the entirety of the Phase III data. So now that you have the data kind of, and you've shared it with us, what's your updated view on what would be a good or a bad commercial outcome for insulin icodec, the part of the basal insulin market.
來自高盛的 Keyur Parekh。請教兩個問題。首先,我們上次在倫敦見面時,您的觀點是 icodec 應該在基礎胰島素市場佔有大部分份額,那是在您看到全部 III 期數據之前。因此,既然您已經擁有了某種數據,並且您已經與我們分享了它,那麼您對作為基礎胰島素市場的一部分的 icodec 胰島素的好或壞商業結果有何最新看法。
Separately, Lars, apologies for going back to this. This is the third time in about 12 months that you've come and given us updated time lines for Wegovy supply. I'm sure it's more frustrating for you than for all of us combined. But love your thoughts on at what point does it start becoming an issue from a patient or a doctor perspective, that people who have been waiting for this drug for 6, 12 months now are still being told, "You're going to have wait a bit longer." And what's kind of your learning from this as a company for it not to happen ever again?
另外,Lars,為回到這個問題而道歉。這是您在大約 12 個月內第三次來為我們提供更新的 Wegovy 供應時間表。我敢肯定,這對你來說比我們所有人的總和更令人沮喪。但是愛你的想法,從病人或醫生的角度來看,它在什麼時候開始成為一個問題,那些已經等待這種藥物 6、12 個月的人現在仍然被告知,“你將等待有點長。”作為一家公司,你從這件事中學到了什麼,才能讓它不再發生?
Lars Fruergaard Jorgensen - President, CEO & Member of Management Board
Lars Fruergaard Jorgensen - President, CEO & Member of Management Board
Camilla, first, on the icodec opportunity.
卡米拉,首先,關於編解碼器的機會。
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 I think when we met last time, we already had some readouts from the first 2 trials. And I think the last readouts we've had now from the next 3 trials are confirming what we saw when we discussed last time. So we believe icodec has a great opportunity to transform the basal insulin segment.
是的。所以我想當我們上次見面時,我們已經從前兩次試驗中得到了一些讀數。而且我認為我們現在從接下來的 3 次試驗中獲得的最後讀數證實了我們上次討論時所看到的內容。因此,我們相信 icodec 有一個很好的機會來改變基礎胰島素領域。
Imagine to what Martin said, we have a very, very strong HbA1c profile. We have a once-weekly treatment, should be a lot easier to treat. We have patient satisfaction in some of our trials that also shows that this is truly relevant to them. And then we have a very safe profile.
想像一下 Martin 所說的,我們的 HbA1c 曲線非常非常強。我們每週進行一次治療,應該更容易治療。我們在一些試驗中獲得了患者的滿意度,這也表明這與他們真正相關。然後我們有一個非常安全的配置文件。
And topping that, we also have a very strong environmental profile. Because of the once weekly, it also means that we reduce carbon emissions and plastics with 70% to 80%. So there is a lot of good things to like about icodec, and we so much look forward to bringing it to the market.
最重要的是,我們還擁有非常強大的環境形象。因為每週一次,也意味著我們減少了70%到80%的碳排放和塑料。因此,icodec 有很多值得喜歡的地方,我們非常期待將它推向市場。
And last time we talked, we also talked about our opportunity in the basal segment. We now have a market share around 37% in value, 33% in volume. And of course, there is room for us to expand on that. So that's what we are coming from. So I would only say that since last time, we have only sort of underlined that this is a great opportunity.
上次我們交談時,我們還談到了我們在基礎領域的機會。我們現在的市場份額約為 37% 的價值,33% 的數量。當然,我們還有擴展的空間。這就是我們的來源。所以我只想說,自上次以來,我們只是強調這是一個很好的機會。
Lars Fruergaard Jorgensen - President, CEO & Member of Management Board
Lars Fruergaard Jorgensen - President, CEO & Member of Management Board
And a fair challenge on Wegovy supply. You know the history and the flow wins almost. Thus, you can say from a strategic point of view, we decided to launch in a device and a filling format. We do not have in-house to go in with a contract manufacturer. It's not unusual to launch only on 1 site. So we have had a robust plan on adding segment search site, and that's -- we're progressing on that, and that will happen during '23.
以及對 Wegovy 供應的公平挑戰。你知道歷史和流量幾乎是贏家。因此,您可以從戰略角度說,我們決定以設備和填充格式推出。我們沒有內部與合同製造商合作。僅在 1 個站點上啟動並不罕見。所以我們有一個關於添加分段搜索網站的強大計劃,那就是 - 我們正在推進這方面的工作,這將在 23 年期間發生。
The launch volumes we had expected was adequately handled by that one site. And they would be ahead also if issues happen. Then it turned out the launch volumes were significantly larger than we had planned for. And a worst case event happened, and the factory had to shut down. So when things go wrong, it's often a combination of more than one thing happening. So a significantly higher demand, a quality issue.
我們預期的發射量由該站點充分處理。如果發生問題,他們也會領先。然後事實證明,發射量比我們計劃的要大得多。最壞的情況發生了,工廠不得不關閉。因此,當出現問題時,通常會發生不止一件事情。所以一個顯著更高的需求,一個質量問題。
And then you can say many learnings in how to avoid that from happening again. You can say you should have a broad set of, say, capabilities in how you choose devices and fulfill the market based on that. And you have that flexibility in your own setup. You have more options to favor optionality in how you fulfill markets to the degree possible is also good.
然後你可以說很多關於如何避免這種情況再次發生的教訓。你可以說你應該有一套廣泛的能力,比如說,你如何選擇設備並以此為基礎滿足市場。而且您在自己的設置中擁有這種靈活性。你有更多的選擇來支持你如何盡可能地滿足市場的選擇性也是好的。
But it's not unusual that you launch a new product out of one facility. But luckily -- and normally, you have more capacity than what we ended up having here (inaudible).
但從一個設施推出新產品並不罕見。但幸運的是——通常情況下,你的容量比我們最終在這裡的容量更大(聽不清)。
In terms of when it comes to problem for our patients and physicians, at the time where you run out, so to say, you have to communicate a lot to the physicians because they can no longer [start a] prescription. So we decided to take the starter doses out to make sure that to kind of handle that in one go. And those patients who then stayed on treatment, they could titrate up to the high dose, which we can provide.
說到我們的病人和醫生遇到問題的時候,在你用完的時候,可以這麼說,你必須和醫生溝通很多,因為他們不能再[開始]處方。因此,我們決定取出起始劑量,以確保一次性處理好。然後那些繼續接受治療的患者,他們可以滴定到我們可以提供的高劑量。
So say, right now, I think it's a relative stable situation from a subscriber patient point of view because those on treatment, they can stay on treatment and physicians do not need to worry too much about can we go, can we not because we have taken the [high] doses out.
所以說,現在,我認為從訂戶患者的角度來看,這是一個相對穩定的情況,因為那些正在接受治療的人,他們可以繼續治療,醫生不需要太擔心我們能不能去,不能因為我們有取出[高]劑量。
Then it's fair to say that we have moved the time line somewhat. When this happened in December, relatively quick, we had to make an assessment and guide what we do believed in. And we guided that there would be limited supply during the first half. And if you look at what our contract manufacturer has done, they have actually, quite competently, delivered on the plan. Now we have a situation where volumes coming out is a bit below that plan that was made back then. But baking in the different remediations we need to do and the oversight you put in to make sure that now it's robust, that is a fine art, [to fail].
那麼公平地說,我們已經稍微改變了時間線。當這種情況在 12 月發生時,相對較快,我們必須做出評估並指導我們所相信的。我們指導上半年供應有限。如果你看看我們的合同製造商做了什麼,他們實際上已經非常稱職地按計劃交付了。現在我們遇到的情況是,出貨量略低於當時制定的計劃。但是,我們需要做不同的補救措施,並進行監督以確保它現在很健壯,這是一門藝術,[失敗]。
So I'm actually online pleased with what they're doing. But it's really important for us that we do not go out in the market, again, until we believe we had the inventory needed not to create that issue with patients and physicians. And we are in this for the long term, so you can tell you the guidance was during second half and now we are towards the end of the year, that's a few months later.
所以我實際上對他們正在做的事情感到滿意。但對我們來說,再次進入市場非常重要,直到我們相信我們擁有不需要與患者和醫生產生問題的庫存。我們是長期的,所以你可以告訴你指導是在下半年,現在我們接近年底,那是幾個月後。
And for me, a few months of delay is the right thing to do if you can get back in a reliable manner and drive that business for the long term because we think the opportunity is intact. We are very confident in what Wegovy can do. And we're also confident in our ability to get the volumes up and have, say, redundancy, more sites, more contract manufacturers doing this part of the workforce.
對我來說,如果您能夠以可靠的方式恢復並長期推動該業務,那麼延遲幾個月是正確的做法,因為我們認為機會完好無損。我們對 Wegovy 能做的事情很有信心。而且我們也對我們提高產量的能力充滿信心,例如,冗餘、更多的站點、更多的合同製造商從事這部分勞動力。
So we'll come back really, really strong. But I respect the critical point that we didn't get this perfectly right, and we're not happy about that. But certain things happen, and when it happens at the same time, it can end up in this type of challenge.
所以我們會非常非常強大地回來。但我尊重我們沒有完全正確的關鍵點,我們對此並不滿意。但是某些事情會發生,當它同時發生時,它可能會以這種挑戰告終。
Keyur Parekh - Equity Analyst
Keyur Parekh - Equity Analyst
The word you described was to transform the basal insulin market. Is that transforming from a volume perspective or a value perspective as well?
你描述的詞是改變基礎胰島素市場。是從數量的角度還是從價值的角度進行轉變?
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. It's too early to comment on that, Keyur. So at least I would promise you from a volume perspective and data, we can talk about pricing, right? So I think that's premature for now. When we get (inaudible) through the launch, around the launch time, that, that is the right time to talk about this.
是的。 Keyur 對此發表評論還為時過早。所以至少我會從數量和數據的角度向你保證,我們可以談談定價,對吧?所以我認為現在還為時過早。當我們(聽不清)通過發佈時,在發佈時間前後,那是討論這個問題的合適時機。
Emily Field - Research Analyst
Emily Field - Research Analyst
Emily Field from Barclays. A question on the Treat and Reduce Obesity Act in the United States. What needs to happen for that to move forward? Do you need any more data? And could that be impacted if there was a change in legislative control at the midterm? Kind of just any incremental color there.
來自巴克萊的艾米麗菲爾德。關於美國治療和減少肥胖法案的問題。為了向前發展,需要發生什麼?您還需要更多數據嗎?如果在中期立法控制發生變化,這會受到影響嗎?那裡只是任何增量顏色。
And maybe a question for Martin. Pfizer looks like they might be advancing a once-daily oral GLP-1. So just any updated thoughts on the competitive landscape from potential novel competition.
也許是馬丁的問題。輝瑞看起來他們可能正在推進每日一次的口服 GLP-1。因此,只是對潛在新穎競爭的競爭格局的任何更新想法。
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
Camilla (inaudible) and then Martin.
卡米拉(聽不清)然後是馬丁。
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 what needs to happen in the U.S. is there needs to be a bipartisan vote for the Treat and Reduce Obesity Act to basically allow for obesity prescriptions in Medicare Part D. And of course, it's difficult for -- as with all political processes, to say exactly when will that happen. But there's a lot of just traction around this, as we've talked about a couple of times today. .
是的。因此,在美國需要發生的事情是,需要對《治療和減少肥胖法》進行兩黨投票,以基本上允許醫療保險 D 部分中的肥胖處方。當然,與所有政治進程一樣,很難確切地說什麼時候會發生。但是,正如我們今天多次談到的那樣,這方面有很多吸引力。 .
Also, in the U.S. about the importance of treating this. And just a -- and a comment to that. We also do know that there is a great underlying need also in this segment, of course. So that's why we continue to work on this. And this may be more a matter of when exactly it happens and if it happens, in my view.
此外,在美國,關於治療這個問題的重要性。只是一個 - 和對此的評論。當然,我們也知道這一領域也有很大的潛在需求。所以這就是我們繼續努力的原因。在我看來,這可能更多的是它何時發生以及是否發生的問題。
Lars Fruergaard Jorgensen - President, CEO & Member of Management Board
Lars Fruergaard Jorgensen - President, CEO & Member of Management Board
And while Martin works for Novo Nordisk, not Pfizer, a perspective.
雖然馬丁為諾和諾德工作,而不是輝瑞公司,但這是一個觀點。
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 obviously, Pfizer are not the only ones looking at new or versions of GLP-1. I think small molecules are interesting in the sense that the data we have seen so far is a reasonable efficacy. I think the safety assessment is still out with small molecules, that's always a little bit of an unknown until you've seen the data.
是的。很明顯,輝瑞並不是唯一關注新版或新版 GLP-1 的公司。我認為小分子很有趣,因為我們迄今為止看到的數據是一種合理的功效。我認為小分子的安全評估仍然存在,在你看到數據之前,這總是有點未知。
From a timing perspective, they are sort of way into the future. And that means from a true differential perspective, maybe they perceive that, that could be different. And based on our own efforts also and potentially improving not only by availability, but also our manufacturing, as far as we can see, we have also there a competitive profile with Rybelsus in next-generation.
從時間的角度來看,它們是通往未來的道路。這意味著從真正的差異化角度來看,也許他們認為,這可能會有所不同。並且基於我們自己的努力,並且可能不僅通過可用性,而且通過我們的製造來改進,據我們所見,我們在下一代 Rybelsus 也有競爭優勢。
Peter Verdult - MD
Peter Verdult - MD
Pete Verdult. Two questions for Martin, just on GLP/GIP and CMD. Can you just remind us how Novo is trying to differentiate in the GLP/GIP space and the preferential ratio and binding you have between GOP and GLP with your offering?
皮特·維爾多特。 Martin 有兩個問題,關於 GLP/GIP 和 CMD。您能否提醒我們 Novo 如何嘗試在 GLP/GIP 領域進行區分,以及您在 GOP 和 GLP 之間的優惠比例和綁定與您的產品?
And then just wondering as we go back to CMD. What was the thinking to stand up and mention this interim analysis at that point? I mean, I'm just wondering, did you do that because you were confident that it's going to hit the endpoint? But if not, I just want to understand why you decided to mention it because judging by the events of the last three days, it could have saved you a lot of hassle, a lot of share price pain if you just let the data speak for itself.
然後只是想知道當我們回到 CMD 時。當時站起來提到這個中期分析的想法是什麼?我的意思是,我只是想知道,你這樣做是因為你確信它會達到終點嗎?但如果不是,我只是想了解您為什麼決定提及它,因為從過去三天的事件來看,如果您只讓數據說話,它可能會為您省去很多麻煩,很多股價痛苦本身。
Lars Fruergaard Jorgensen - President, CEO & Member of Management Board
Lars Fruergaard Jorgensen - President, CEO & Member of Management Board
I guess I can start answering that because Martin has not been responsible for this all along. So sometime back, somebody in the company mentioned a potentially interim analysis. And that was maybe a mistake because it's a difficult topic to actually communicate on because we don't sit with the insights.
我想我可以開始回答這個問題了,因為馬丁一直沒有對此負責。所以前一段時間,公司裡有人提到了一個潛在的中期分析。這可能是一個錯誤,因為這是一個很難實際交流的話題,因為我們不接受這些見解。
So before the CMD, there was increasing talk about it. So we just felt we had to kind of level the playing field by telling what's the setup and what we believe about it. And I think also at the ADA Investor Meeting, there was also a quite clear message coming out according -- along with Martin just mentioned.
所以在 CMD 之前,關於它的討論越來越多。所以我們只是覺得我們必須通過講述設置是什麼以及我們對它的信念來平衡競爭環境。而且我認為在 ADA 投資者會議上,也有一個非常明確的信息——與剛剛提到的 Martin 一樣。
So there was a historical mentioning of it. And that meant that we had to kind of clarify at the CMD. Going forward, you should not expect us to talk to interim analysis (inaudible).
所以有歷史記載。這意味著我們必須在 CMD 上進行澄清。展望未來,您不應指望我們會討論中期分析(聽不清)。
Martin, GLP/GIP.
馬丁,GLP/GIP。
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
That was a good answer and guidance also. So on GLP-1/GIP, obviously, you've already seen that that's a good combination. From our perspective, when looking at a combination of mechanisms, what we are trying to assess is optimizing efficacy while minimizing potential safety (inaudible).
這也是一個很好的答案和指導。所以在 GLP-1/GIP 上,很明顯,你已經看到這是一個很好的組合。從我們的角度來看,在查看機制組合時,我們試圖評估的是優化功效,同時最大限度地減少潛在安全性(聽不清)。
As you all know, we both had a (inaudible) actually in our pipeline. We also obviously had the dual agonist, and we still have that in our pipeline. Always our assessment still depends on efficacy versus risk safety. And when looking at our pipeline, we do see efficacy with GLP-1/GIP. We do see efficacy with the [agonist].
眾所周知,我們都有一個(聽不清)實際上在我們的管道中。我們顯然也有雙重激動劑,而且我們的管道中仍然有它。我們的評估始終取決於有效性與風險安全性。在查看我們的管道時,我們確實看到了 GLP-1/GIP 的功效。我們確實看到了[激動劑]的功效。
But we also specifically with glucagon saw a potential safety issue. Having then, what we believe, is the potential purchase combination of (inaudible) in our pipeline, where we saw potential for far superior weight loss, as we just disclosed, it could potentially also work in type 2 diabetes without having to compromise on safety and tolerability, basically the same profile as we have with the (inaudible).
但我們也專門用胰高血糖素看到了一個潛在的安全問題。然後,我們認為,在我們的管道中(聽不清)的潛在購買組合,正如我們剛剛披露的那樣,我們看到了顯著減輕體重的潛力,它也可能在 2 型糖尿病中起作用,而不必在安全性上妥協和耐受性,基本上與我們對(聽不清)的配置文件相同。
No reason to progress on the file specifically because of the glucagon. We keep until we are absolutely certain that, that type of (inaudible) is going to make it. I mean, with any development programs, there are potential risk. And we've seen fewer and fewer risk ahead of us as we speak. They're still there. But to hedge all of our bets, we keep our own GLP-1/GIP in our pipeline. We believe that we still haven't seen the data on efficacy to be a good and safe compound.
沒有理由特別因為胰高血糖素而在文件上取得進展。我們一直保持到我們完全確定那種(聽不清)會成功。我的意思是,任何開發計劃都存在潛在風險。在我們發言時,我們已經看到越來越少的風險擺在我們面前。他們還在那裡。但為了對沖我們所有的賭注,我們將自己的 GLP-1/GIP 保留在我們的管道中。我們相信,我們還沒有看到關於療效的數據是一種好的和安全的化合物。
But again, based on what we've seen so far, CagriSema is probably the better combination because you get even more efficacy, and you get that without having to compromise on safety, tolerability. So I think I don't want to belittle that combination. I think it's good. I think it's strong. I think we also have something better in our pipeline.
但同樣,根據我們迄今為止所看到的情況,CagriSema 可能是更好的組合,因為您可以獲得更高的功效,而且您無需在安全性和耐受性上做出妥協。所以我想我不想貶低這種組合。我認為這很好。我認為它很強大。我認為我們的管道中也有更好的東西。
Lars Fruergaard Jorgensen - President, CEO & Member of Management Board
Lars Fruergaard Jorgensen - President, CEO & Member of Management Board
Because we're committed to raising the innovation height in both diabetes and obesity. And with the assets that's on the way market, you need to really be sharp on that step change in innovation heights. And we believe we have some good shots on that, that you know about. But we also believe that we have early stuff that's preclinical that is aimed at redefining what does good look like in a market where there's a lot of good choice today, but still a lot of patients with significant unmet medical need. So it's about understanding what does -- decades from now, what does innovation look like, and then have a state and a pipeline with different horizons doing that.
因為我們致力於提高糖尿病和肥胖症的創新高度。對於即將上市的資產,您需要真正敏銳地把握創新高度的階梯式變化。我們相信我們在這方面有一些好的鏡頭,你知道的。但我們也相信,我們有早期的臨床前研究,旨在重新定義當今市場上有很多好的選擇,但仍有很多患者的醫療需求未得到滿足。所以這是關於理解什麼——從現在起幾十年後,創新是什麼樣子,然後有一個不同視野的國家和一個管道來做這件事。
Richard Vosser - Senior Analyst
Richard Vosser - Senior Analyst
Richard Vosser from JPMorgan. Could I come back to the comment on the volumes not coming out of the manufacturing process, of being a bit below? Is that because there's lots of product wastage that the manufacturing process is not as efficient as you'd like?
摩根大通的理查德·沃瑟。我能否回到關於未從製造過程中出來的數量的評論,有點低於?那是因為有很多產品浪費導致製造過程沒有您想要的那麼高效嗎?
Is that because you can't get enough plastic or something from the suppliers? Or are there not enough filters for the manufacturer? Just some color on what's going on there so that we can have comfort that it could be fixed.
那是因為你不能從供應商那裡得到足夠的塑料或其他東西嗎?還是製造商沒有足夠的過濾器?只是對那裡發生的事情進行一些顏色,以便我們可以放心它可以修復。
And then secondly, just thinking about the oral peptides and future peptides like CagriSema. Is there a way you can file those as a BLA? Or do peptides always have to be NDAs in the U.S.?
其次,只考慮口服肽和未來的肽,如 CagriSema。有沒有辦法可以將它們歸檔為 BLA?還是肽在美國總是必須是 NDA?
Lars Fruergaard Jorgensen - President, CEO & Member of Management Board
Lars Fruergaard Jorgensen - President, CEO & Member of Management Board
Thank you, Richard. Two rather detailed questions, I would say. So if we look at -- I cannot go into all the details about exactly what's happening on the line. I hope you respect that. But if you look at our own manufacturing setups, we have different performance levels on different filling sites, and that contains a bit over time for different reasons.
謝謝你,理查德。我想說兩個相當詳細的問題。因此,如果我們看一下——我無法詳細了解在線上正在發生的事情的所有細節。我希望你尊重這一點。但是,如果您查看我們自己的製造設置,我們在不同的灌裝地點有不同的性能水平,並且由於不同的原因,隨著時間的推移會有所不同。
So what we're looking at here is not, say, a variance that's much different from what we would see in our own (inaudible). And of course, when you have taken a site down and done remediation, there's retraining and oversight that needs to be put in place. And that can sometimes mean that, say, release processes, so volume is lower in a period of time. We have also experienced that ourselves. So there's not a, say, a particular problem that's blocking it.
所以我們在這裡看到的並不是,比如說,與我們自己看到的(聽不清)有很大不同的差異。當然,當您關閉站點並進行修復時,需要進行再培訓和監督。這有時可能意味著,比如說,發布流程,所以一段時間內的數量會降低。我們自己也經歷過。因此,沒有一個特定的問題阻礙了它。
But of course, when you're running at a demand that's higher than supply, that becomes a problem. And we are aiming at already next year to have enough lines running, enough sites running that we can get ahead of the game. So we don't need to have a discussion with you if there's a line running a bit slower than normal because that's actually part of doing manufacturing. So it's a scaling game to make sure that you have, say, robustness against that.
但是,當然,當您的需求高於供應時,這就會成為一個問題。我們的目標是明年有足夠的線路運行,運行足夠的站點,我們可以領先於遊戲。因此,如果有一條生產線運行速度比正常慢一點,我們不需要與您討論,因為這實際上是製造的一部分。所以這是一個規模化的遊戲,以確保你有,比如說,對抗它的魯棒性。
And then, Martin, on all peptides and regulation approach.
然後,馬丁,關於所有肽和調節方法。
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
BLA versus NDA, I'm not at liberty to go into our regulatory strategy, as we speak. As you know, it's an evolving environment, and we will sort of follow the opportunity (inaudible).
BLA 與 NDA,正如我們所說,我無權進入我們的監管策略。如您所知,這是一個不斷發展的環境,我們將順勢而為(聽不清)。
Simon P. Baker - Head of Pharmaceutical Research
Simon P. Baker - Head of Pharmaceutical Research
Simon Baker from Redburn. I've got two very quick questions and then one for Martin. Just on SELECT. Given there's clearly a surprisingly high focus on the magnitude of the benefit, can you say whether any of the existing access that Wegovy has is conditional on the magnitude of the benefit in a positive SELECT study?
來自雷德本的西蒙·貝克。我有兩個非常簡短的問題,然後是一個給馬丁的問題。就在 SELECT 上。鑑於對收益幅度的關注顯然出人意料,您能否說 Wegovy 擁有的任何現有訪問權是否取決於積極 SELECT 研究中收益的幅度?
And then a quick question for Karsten on the financials. You gave some commentary in the statement on the net financials for the quarter. I don't think I saw it broken down into financial income and expenses. Just wondering if you could give some color on what was in the financial income line.
然後是一個關於財務狀況的快速問題。您在該季度的淨財務報表中發表了一些評論。我認為我沒有看到它分解為財務收入和支出。只是想知道您是否可以對財務收入線中的內容進行一些說明。
And then for Martin, on icodec. We saw across the ONWARDs study, say, for ONWARDS 6, that the level of hypos were broadly the same on both arms. Were the only differences in the distribution of hypos over time on any of those studies? Or are they occurring at roughly the same rates on both arms as difference between icodec and control? That's it.
然後是馬丁,在 icodec 上。我們在 ONWARDs 研究中看到,例如,對於 ONWARDS 6,雙臂的低血糖水平大致相同。在這些研究中,隨著時間的推移,假設分佈的唯一差異是什麼?或者它們在兩個手臂上的發生率是否與 icodec 和控制之間的差異大致相同?而已。
Lars Fruergaard Jorgensen - President, CEO & Member of Management Board
Lars Fruergaard Jorgensen - President, CEO & Member of Management Board
I don't think we can get into more details on the first question. But Karsten, on the financials.
我認為我們無法就第一個問題深入了解更多細節。但是卡斯滕,在財務方面。
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Yes, we can get into a lot of details on the financials. So -- but (inaudible) tells me, it has to be a short answer. So put very simply, we had to the tune of DKK 2 billion in benefit on EBIT from currency in the second quarter, and we had roughly DKK 1 billion, a little bit more than DKK 1 billion, in hedging losses in the second quarter. So actually very favorable on a net currency.
是的,我們可以深入了解財務方面的許多細節。所以——但是(聽不清)告訴我,它必須是一個簡短的答案。簡而言之,我們在第二季度從貨幣息稅前利潤中獲得了大約 20 億丹麥克朗的收益,而第二季度我們有大約 10 億丹麥克朗,略高於 10 億丹麥克朗來對沖損失。所以實際上對淨貨幣非常有利。
The spread between the DKK 1 billion are a little bit more the DKK 1.6 billion in net financials. That's interest costs and all kinds -- and some minor value adjustments to some equity positions we have. So a lot of, I would say, minor stuff.
10 億丹麥克朗之間的價差比 16 億丹麥克朗的淨金融資產多一點。那是利息成本和各種成本——以及我們擁有的一些股權頭寸的一些小的價值調整。所以很多,我會說,小東西。
Lars Fruergaard Jorgensen - President, CEO & Member of Management Board
Lars Fruergaard Jorgensen - President, CEO & Member of Management Board
And Martin?
馬丁呢?
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 the distribution of hypoglycemia is that we've seen, obviously, with very low numbers in ONWARDS once a day, it's difficult to assess. But in ONWARDS 4 and ONWARDS 6, we see unique distribution over time. And maybe also important to call out, we've not seen prolonged sense of hypoglycemia and we've conducted a specific and dedicated hypoglycemia study, where we saw no difference between insulin glargine and insulin icodec. So from a hypoglycemia perspective, specifically in type 2 diabetes, we are very confident.
是的。因此,我們已經看到低血糖症的分佈,顯然,每天一次的 ONWARDS 的數字非常低,很難評估。但在 ONWARDS 4 和 ONWARDS 6 中,隨著時間的推移,我們看到了獨特的分佈。也許也很重要的一點是,我們沒有看到過長時間的低血糖感,我們已經進行了一項專門的低血糖研究,我們發現甘精胰島素和艾科德胰島素之間沒有區別。所以從低血糖的角度來看,特別是2型糖尿病,我們非常有信心。
Lars Fruergaard Jorgensen - President, CEO & Member of Management Board
Lars Fruergaard Jorgensen - President, CEO & Member of Management Board
Final question.
最後一個問題。
Peter James Welford - Senior Equity Analyst & European Pharmaceuticals Analyst
Peter James Welford - Senior Equity Analyst & European Pharmaceuticals Analyst
Peter Welford, Jefferies. Two questions and then just a quick clarification. Just on turning back to the SELECT interim analysis. Sorry, we're going back there again. Just to understand, though, I think you said at the Capital Markets Day that the secondary endpoints would be considered. You've now said that 1/3 of events roughly happened in the secondary versus the primary.
彼得韋爾福德,傑富瑞。兩個問題,然後只是一個快速的澄清。剛剛回到 SELECT 中期分析。對不起,我們又要回到那裡了。不過,為了理解,我認為您在資本市場日說過將考慮次要終點。您現在已經說過 1/3 的事件大致發生在次要與主要之間。
So just to be super clear here. If we hadn't seen, should we say, 22%, above 20%, the interim would have then said the trial should be unblinded, irrespective of secondary. Just to be super clear on this. There was a limit at which point it will be unblinded, irrespective of the secondary analysis.
所以在這裡要超級清楚。如果我們沒有看到,我們應該說,22%,超過 20%,那麼臨時會說試驗應該是非盲的,不管次要的。只是要非常清楚這一點。無論二次分析如何,它都會被揭盲。
And then just coming back to reimbursement, just based on SELECT. In the U.S., could there be a scenario where SELECT could lead to a secondary prevention style reimbursement? And I guess leading on from that, is it possible to conduct a primary prevention trial in obesity? Or is that the sort of study that would need, I guess, like the U.K., for example, a sort of government access type trial, if you like? Is it even viable to conduct primary prevention in this sort of market?
然後只是基於SELECT返回報銷。在美國,是否存在 SELECT 可能導致二級預防式報銷的情況?我想從那開始,是否有可能對肥胖進行一級預防試驗?或者,如果你願意,我想,這是否需要像英國一樣的政府訪問類型試驗?在這樣的市場上進行一級預防是否可行?
And then sorry, just to clarify. CagriSema, you said, was really important, the type 2 diabetes trial. Does that mean we should get a press release from the time -- on the Phase II? Or typically, this normal Novo, we should wait for November probably for an update in 3Q?
然後對不起,只是為了澄清。你說,CagriSema 非常重要,2 型糖尿病試驗。這是否意味著我們應該在第二階段獲得新聞稿?或者通常情況下,這個普通的 Novo,我們應該等到 11 月才可能在 3Q 更新?
Lars Fruergaard Jorgensen - President, CEO & Member of Management Board
Lars Fruergaard Jorgensen - President, CEO & Member of Management Board
So Martin, I think there was a new variant of this SELECT question. I don't know if you want to repeat the answer.
所以馬丁,我認為這個 SELECT 問題有一個新的變體。不知道你要不要重複回答。
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
Well, it's a slightly different answer, but you're absolutely right. I mean, focusing on the primary endpoint, there was a set cutoff. And they -- again, it's a guidance, and they had the prerogative to look at the totality of the data. But we highlight they have been looking at the primary endpoint and follow that guidance of following that specific endpoint -- sorry, set-point.
嗯,這是一個略有不同的答案,但你是絕對正確的。我的意思是,專注於主要終點,有一個設定的截止點。他們 - 再次,這是一個指導,他們有權查看全部數據。但我們強調他們一直在關注主要終點,並遵循遵循該特定終點的指導——抱歉,設定點。
Just to clarify, when we talk about the decrease power on the secondary endpoint, the primary endpoint is a composite of myocardial infarction, stroke and cardiovascular death. It goes without saying, if you look at individual components of that endpoint, then you lose power and therefore, either the differential has to be very, very big or it has to have a lot of events. It also means that, that's why we add some specifics, is to focus on the primary endpoint because the likelihood of seeing anything on secondary endpoint is not [feasible].
澄清一下,當我們談論次要終點的降低能力時,主要終點是心肌梗死、中風和心血管死亡的複合終點。不用說,如果您查看該端點的各個組件,那麼您就會失去動力,因此,差異必須非常非常大,或者必須有很多事件。這也意味著,這就是我們添加一些細節的原因,即關注主要終點,因為在次要終點上看到任何東西的可能性是不[可行的]。
Specifically on CagriSema, don't think I said it was very important. I don't want to belittle it. I said it was very exciting. I think it's really, really interesting also because from a scientific perspective, I'm curious, but goes without saying if this turns out to be as strong in diabetes as it is in obesity, we have a really, really effective (inaudible).
特別是關於 CagriSema,不要以為我說這很重要。我不想貶低它。我說這很令人興奮。我認為這真的非常有趣,因為從科學的角度來看,我很好奇,但不用說,如果這對糖尿病和肥胖症一樣強,我們有一個非常非常有效的(聽不清)。
Lars Fruergaard Jorgensen - President, CEO & Member of Management Board
Lars Fruergaard Jorgensen - President, CEO & Member of Management Board
So to close, we are really pleased with our execution commercially. We are really pleased in how we are building our pipeline. I think icodec is an example of us aiming to raise innovation height to levels where people have said upfront that, that's not possible.
所以最後,我們對我們的商業執行感到非常滿意。我們對我們如何構建我們的管道感到非常高興。我認為 icodec 是我們旨在將創新高度提高到人們預先說過的水平的一個例子,這是不可能的。
We are also very pleased with the execution of Wegovy. Despite the challenges we've spoken about here, we think there's a tremendous opportunity in obesity market. I think we're really well positioned to grab that. And when we look at our opportunities for driving growth there, also short term, we are very encouraged about that.
我們也對 Wegovy 的執行感到非常滿意。儘管我們在這裡談到了挑戰,但我們認為肥胖市場存在巨大的機會。我認為我們非常有能力抓住這一點。當我們看到我們在那裡推動增長的機會時,也是短期的,我們對此感到非常鼓舞。
And all of that has led to both exciting clinical data and our operate for the second time this year. So we are on a roll, and I'd like to thank again Wimal and Bernstein for hosting us here today and to all of you for showing up with great questions. Thank you very much.
所有這些都帶來了令人興奮的臨床數據和我們今年的第二次運營。所以我們進展順利,我要再次感謝 Wimal 和 Bernstein 今天在這裡接待我們,並感謝大家提出了很好的問題。非常感謝。