諾和諾德的管理層會議強調了該公司在糖尿病和肥胖症市場的成功,並更新了 Ozempic、Rybelsus 和 Wegovy 等主要品牌的最新情況。該公司公佈了強勁的財務業績,並上調了今年的前景。他們討論了 Mim8 的積極數據和管道進展,包括胰島素 icodec 批准。
討論還涉及小分子的安全性、有效性和可擴展性,以及三期試驗計劃和可能擴展到中國市場的計劃。該公司的成長潛力和 2025 年的策略願景令投資者感到鼓舞。
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
James Quigley - Analyst
James Quigley - Analyst
Good morning, everybody. I'm James Quigley. European pharma manager here at Goldman Sachs, and it's a pleasure to welcome you here to the Novo second quarter management meeting.
大家早安。我是詹姆斯·奎格利。高盛歐洲製藥經理,很高興歡迎您參加 Novo 第二季管理會議。
So today we're joined by Lars Jørgensen, CEO; Karsten Knudsen, CFO; Camilla Sylvest, Head of Commercial; and also, Martin Lange, Head of Development. So with that all explained, I'll hand straight over to you guys to kick off.
今天,執行長 Lars Jårgensen 也加入了我們的行列。卡斯滕‧克努森,財務長;卡蜜拉‧西爾維斯特 (Camilla Sylvest),商務主管;還有開發主管 Martin Lange。解釋完所有內容後,我將直接將任務交給你們開始。
Lars Fruergaard Joergensen - President, Chief Executive Officer
Lars Fruergaard Joergensen - President, Chief Executive Officer
Good. Thank you. Thank you, James, and thank you, Goldman Sachs, for hosting us today. We're excited to be here. You have probably seen some of our slides. We'll go through them quickly just to set the stage and then get to the Q&A.
好的。謝謝。謝謝詹姆斯,也謝謝高盛今天接待我們。我們很高興來到這裡。您可能已經看過我們的一些幻燈片。我們將快速瀏覽它們,只是為了做好準備,然後進行問答。
So the first slide is the forward-looking statements. You know we'll be talking about the future. It could turn out to be different than what we preach here, so be aware of that, and there are more notes in our website, et cetera.
所以第一張投影片是前瞻性陳述。你知道我們會談論未來。它可能與我們在這裡宣講的不同,因此請注意這一點,並且我們的網站等中有更多註釋。
So you know our strategic aspirations. We feel we're making good progress serving more patients, strong commercial execution. We're really glad about how we're strengthening our market position in diabetes, how we're growing in obesity. We have a few challenges in rare diseases, but we are encouraged by future growth, not least because of the great data we have received on Mim8 over the past quarter. Excited about that.
所以你知道我們的戰略願望。我們覺得我們在服務更多患者方面取得了良好進展,商業執行力也很強。我們非常高興我們如何加強我們在糖尿病領域的市場地位,以及我們如何在肥胖領域取得進展。我們在罕見疾病方面面臨一些挑戰,但我們對未來的成長感到鼓舞,尤其是因為我們在過去一個季度收到了有關 Mim8 的大量數據。對此感到興奮。
And you can see all of the financial execution, commercial execution, turns into that we have upgraded our outlook for the year. So you should see that as a sign of confidence in the momentum we have in the business and also having a supply of products to fuel that continued growth.
你可以看到所有的財務執行、商業執行都顯示我們升級了今年的前景。因此,您應該將其視為對我們的業務勢頭充滿信心的標誌,並且也有足夠的產品供應來推動持續成長。
With that, I'll leave the work to Camilla for some comments on the commercial area.
說到這裡,我將把有關商業領域的一些評論的工作留給卡米拉。
Camilla Sylvest - Executive Vice President - Commercial Strategy and Corporate Affairs
Camilla Sylvest - Executive Vice President - Commercial Strategy and Corporate Affairs
Thank you, Lars. And here you see our sales growth of 25%, how it's distributed on regions and therapy areas, 36% growth in North America, 11% growth in international operations, growth driven by all regions. And when it comes to therapy areas, really our key brands, Ozempic, Rybelsus, Wegovy, that is driving our growth.
謝謝你,拉爾斯。在這裡您可以看到我們的銷售額成長了 25%,以及其在地區和治療領域的分佈情況,北美成長了 36%,國際業務成長了 11%,成長是由所有地區推動的。當談到治療領域時,我們的主要品牌 Ozempic、Rybelsus、Wegovy 正在推動我們的成長。
You see a strong growth in GLP-1 diabetes where we also continue to exceed our leadership in diabetes care, now with a market share in total diabetes above 34%. And if we zoom in on obesity, we have 37% growth. If we take a look at the US on the next slide, you can see that we are continuing to expand the number of starter doses into the market and also on total scripts. We now have, since the beginning of the year, a doubling of the total scripts.
您將看到 GLP-1 糖尿病的強勁增長,我們也繼續超越我們在糖尿病護理領域的領導地位,目前在糖尿病總體中的市場份額超過 34%。如果我們放大肥胖問題,我們會看到 37% 的成長。如果我們在下一張投影片上看美國,您可以看到我們正在繼續擴大市場的起始劑量數量以及總劑量。自今年年初以來,我們現在的腳本總數增加了一倍。
So we are progressing very nicely in terms of our ability to provide Wegovy to patients in the US but also in the rest of the world where we now have launched in 14 countries. And are continuing to launch in more and more countries as we speak.
因此,我們在向美國患者以及世界其他地區的患者提供 Wegovy 方面取得了非常好的進展,目前我們已在 14 個國家推出了 Wegovy。就在我們發言時,我們正在繼續在越來越多的國家/地區推出。
And with that, over to Dr. Lange to give us an update on R&D.
接下來,請蘭格博士為我們介紹研發的最新情況。
Martin Holst Lange - EVP, Head of Development
Martin Holst Lange - EVP, Head of Development
Thank you very much, Camilla. If I could have the next slide. As Lars already alluded to, we are very happy with the results that we saw from FRONTIER 2 Mim8 pivotal trial. It was a complex trial investigating the broad range of hemophilia A, with and without inhibitors, across the spectrum of hemophilia A in terms of severity. We had both males and females in the study. And we were investigating patients coming from either prophylaxis or on-demand treatment.
非常感謝你,卡米拉。如果我能有下一張投影片就好了。正如 Lars 已經提到的,我們對 FRONTIER 2 Mim8 關鍵試驗的結果感到非常滿意。這是一項複雜的試驗,調查了廣泛的甲型血友病(無論是否有抑制劑)以及整個血友病 A 譜系的嚴重程度。我們的研究中有男性和女性。我們正在調查來自預防或按需治療的患者。
We're also investigating both once weekly and once monthly. So quite a complex study with a lot of permutations when it comes to the primary endpoint.
我們也每周和每月一次進行調查。這是一項相當複雜的研究,在主要終點方面有許多排列。
At the end of the day, what you should take away is for the primary endpoint, regardless of looking at once weekly or once monthly, comparing to prophylaxis treatment or previous on-demand treatment. We see the mean annual bleed rate reduction of somewhere between 60% and 90%-plus, which is obviously exceedingly gratifying, even for patients coming from previous on-demand treatment -- sorry, prophylaxis treatment.
歸根結底,您應該了解的是主要終點,無論是每週一次還是每月一次,與預防性治療或之前的按需治療進行比較。我們看到平均年出血率降低了 60% 到 90% 以上,這顯然是非常令人滿意的,即使對於接受過以前按需治療(抱歉,是預防性治療)的患者也是如此。
If we look at the median annual bleed rate, it was zero across the board, indicating that regardless of which analysis we did, more than 50% of patients had zero bleeds. And if we look at the actual numbers, again, it's between 60%-plus and 90%-plus of patients that have zero bleeds.
如果我們看一下年出血率中位數,它全部為零,這表明無論我們進行哪種分析,都有超過 50% 的患者零出血。如果我們再次查看實際數字,就會發現 60% 以上到 90% 以上的患者實現了零出血。
So very, very strong efficacy data. Similarly, we saw a strong safety profile with no thromboembolic events. And somewhere between 5% and 12%, again, depending on the analysis, percent of patients reporting injection site reactions. So a very attractive number. Really, really happy with these data, and obviously moving towards a submission during the first half of 2025.
非常非常強大的功效數據。同樣,我們看到了很強的安全性,沒有發生血栓栓塞事件。根據分析,報告注射部位反應的患者百分比在 5% 到 12% 之間。這是一個非常有吸引力的數字。對這些數據真的非常滿意,並且顯然正朝著 2025 年上半年提交的方向邁進。
If I could have the next slide. We see broad pipeline progress. Of course, really, really happy with the almost global access -- sorry, approval for insulin icodec. I have to mention a complete response letter in the US, focusing on manufacturing and also, obviously, type 1 diabetes. We expect to be able to resubmit the icodec file in the US during the course of the first half of 2025.
如果我能有下一張投影片就好了。我們看到了廣泛的管道進展。當然,我對幾乎全球範圍內的使用感到非常非常高興——抱歉,胰島素 icodec 獲得批准。我必須提到美國的一封完整回信,重點放在製造業,顯然還有第 1 型糖尿病。我們預計能夠在 2025 年上半年在美國重新提交 icodec 文件。
Broadly speaking, we see a lot of progress in our pipeline. I want to call out, obviously, the data that we'll see from monlunabant in this half of the year, first on obesity and secondly on diabetic kidney disease, two Phase 2 studies that we'll read out in Q3 and Q4 respectively. Looking very much forward to seeing our first CagriSema data, the redefined one file that we'll read out in December of this year.
從廣義上講,我們看到我們的管道取得了許多進展。顯然,我想指出今年下半年我們將從monlunabant 看到的數據,首先是關於肥胖的數據,其次是關於糖尿病腎病的數據,這兩項2 期研究我們將分別在第三季度和第四季度宣讀。非常期待看到我們的第一個 CagriSema 數據,這是我們將在今年 12 月讀出的重新定義的文件。
I've already talked to Mim8, but maybe also mentioning that we have resubmitted concizumab in the US for both hemophilia with inhibitors, but also without inhibitors. And finally, we've initiated the ARTEMIS study, which is a study in acute myocardial infarction with ziltivekimab.
我已經與 Mim8 談過,但也許還提到我們在美國重新提交了 concizumab,用於治療帶有抑制劑和不帶有抑制劑的血友病。最後,我們啟動了 ARTEMIS 研究,這是一項使用 ziltivekimab 治療急性心肌梗塞的研究。
I think with that, over to you, Karsten.
我想,就交給你了,卡斯滕。
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Yeah. Thank you, Martin. So when we look at the results in the first six months, then we delivered a fantastic 25% sales growth. This is really industry-leading sales growth and a continuation of the sales growth we saw in the first quarter. The 25% has a benefit from rebate adjustments related to the US and also benefits from a reasonably easy comparator from last year linked to phasing of rebates last year. And I'll come back to why that's important.
是的。謝謝你,馬丁。因此,當我們查看前六個月的業績時,我們的銷售額實現了 25% 的驚人成長。這確實是業界領先的銷售成長,也是我們第一季銷售成長的延續。這 25% 的人受益於與美國相關的回扣調整,並且還受益於去年與去年分階段回扣相關的相當簡單的比較器。我會回到為什麼這很重要。
Our commercial investments are at a low level in that respect, 6%, adjust for something -- legal provisions last year, around 10%. So really indicating we have the commercial infrastructure in place, perhaps with -- unless we talk about obesity, where we're really investing in obesity market development activities across the board.
我們的商業投資在這方面處於較低水平,6%,根據去年的法律規定進行調整,約為 10%。因此,這確實表明我們已經擁有適當的商業基礎設施,除非我們談論肥胖問題,否則我們實際上正在全面投資於肥胖市場開發活動。
R&D really stepping up, 78% is overstating the true R&D step-up P&L wise due to the fact that we had an impairment on ocedurenone and also other assets in the second quarter. So adjusting for that, the R&D is still stepping up more than 30%, which is linked to our intent to really build a competitive pipeline for the company's future growth for the coming decades.
研發確實在加強,78% 的人誇大了真正的研發提升,因為我們在第二季度對 ocedurenone 和其他資產進行了減損。因此,對此進行調整後,研發仍將成長超過30%,這與我們為公司未來幾十年的未來成長真正建立有競爭力的管道的意圖有關。
Net-net, that yields an operating profit growth of 19% for the first six months. As I said, we have impairment impacts in the quarter. So if you look at it from an EBITDA point of view, then we have an EBITDA growth for the first six months of 32%.
淨利潤,前六個月營業利潤成長 19%。正如我所說,我們在本季受到了減損影響。因此,如果你從 EBITDA 的角度來看,那麼我們前六個月的 EBITDA 成長率為 32%。
Next slide, please. So Lars spoke, too, that we are upgrading our full-year sales outlook and that's why I said first half is benefiting from gross to net adjustments and an easy comparator. On the contrary, the second half has a tough comparator because it was phasing from last year.
請下一張投影片。因此,拉斯也表示,我們正在升級全年銷售前景,這就是為什麼我說上半年受益於毛淨調整和簡單的比較器。相反,下半年有一個艱難的比較,因為它與去年有所不同。
So the 25% implied in the second half of this year to get to a midpoint of our guidance range actually requires underlying growth closer to a 30% mark if you take the comparator into account. So really talking to an acceleration of underlying growth in the second half, driven by our GLP-1 franchise and, of course, enabled by scaling of supply chain.
因此,如果考慮到比較因素,今年下半年要達到我們指導範圍中點的 25%,實際上需要接近 30% 的基礎成長。因此,真正談論的是下半年潛在成長的加速,這是由我們的 GLP-1 特許經營權推動的,當然,也是透過供應鏈規模的擴大來實現的。
Operating profit, it's important to note that since we issued guidance at Q1, we had the impairment of ocedurenone, which had a 6% negative impact. And then the sales of -- we do this quarter has a 4 percentage point positive impact on our operating profit growth. So we really have a significant flow-through, 2% up on sales growth, 4% on OP. So a really solid gearing in terms of financial performance. And then, of course, I was about to say that translates into a step-up in our forecasted free cash flow for the year.
營業利潤,值得注意的是,自從我們在第一季度發布指導以來,我們對奧塞酮進行了減值,產生了 6% 的負面影響。然後,我們本季的銷售額對我們的營業利潤成長產生了 4 個百分點的正面影響。所以我們確實有顯著的流量,銷售成長 2%,營運成本成長 4%。因此,就財務表現而言,這是一個非常堅實的槓桿。當然,我想說的是,這意味著我們今年預測的自由現金流增加。
That takes us back to you, Lars.
這讓我們回到你身上,拉斯。
Lars Fruergaard Joergensen - President, Chief Executive Officer
Lars Fruergaard Joergensen - President, Chief Executive Officer
Yeah. So just in summary, we are executing well on progressing towards our strategic aspiration for 2025. We're very encouraged by the growth momentum we have. We have scaled our supply chain to be able to continue that trajectory in the second half of the year, as Karsten just alluded to. And we have really exciting, say, pipeline readout also coming in the second half of the year. So a strong start to the year and even more to come.
是的。總而言之,我們在實現 2025 年策略目標方面表現良好。正如卡斯滕剛才提到的那樣,我們已經擴大了供應鏈規模,以便能夠在下半年繼續保持這一軌跡。比方說,我們將在今年下半年發布令人興奮的管道數據。這是今年的一個好開端,而且未來還會有更多的開端。
With that, I think we should close on the slides and get to the Q&A. So please take your seat.
至此,我認為我們應該結束投影片並進行問答。所以請入座。
Jacob Martin Wiborg Rode - Head of IR
Jacob Martin Wiborg Rode - Head of IR
Thank you, Lars, for the presentation. That leaves a little bit more than half an hour for the Q&A. (Event Instructions) We have some mics going around and I think we'll start with James as per tradition, our host.
謝謝拉爾斯的介紹。剩下半個多小時的時間用於問答。 (活動說明)我們有一些麥克風,我想我們將按照傳統從我們的主持人詹姆斯開始。
James Quigley - Analyst
James Quigley - Analyst
Lovely, thank you. James Quigley from Goldman Sachs. Just starting on Wegovy net pricing. So again, I think there's a bit of confusion here on the development following the call, perhaps on the comments on channel mix, rebate adjustments, competition, et cetera. So could you take us through how you expect the Wegovy net prices to develop? And what are the key impacts from the rebate adjustments that we saw in the quarter?
可愛的,謝謝。高盛的詹姆斯·奎格利。剛開始使用 Wegovy 淨定價。再說一遍,我認為電話會議後的發展存在一些混亂,也許是對通路組合、回扣調整、競爭等的評論。那麼您能否向我們介紹一下您預計 Wegovy 淨價格將如何發展?我們在本季看到的回扣調整有何主要影響?
Lars Fruergaard Joergensen - President, Chief Executive Officer
Lars Fruergaard Joergensen - President, Chief Executive Officer
Yeah. So if I start. So we'll not get into guiding specifically on net price development for individual products. But I will just say that we don't see any, say, change in the marketplace. What happened in the second quarter was that we had a one-time, one-off true-up for rebates given last year.
是的。所以如果我開始的話。因此,我們不會專門指導個別產品的淨價格開發。但我只想說,我們沒有看到市場有任何變化。第二季發生的事情是,我們對去年給予的回扣進行了一次性、一次性的調整。
And of course, if you look at the book of business and, say, the sizable rebate adjustments or rebate accruals we make, when we end up knowing understanding the real flow of products and true that up, that can lead to, say, changes in the quarter. But these are -- when you look at the total book of business and say the yearly flow of business, we're down to a very small adjustment for that business.
當然,如果你看一下業務手冊,例如我們所做的大規模回扣調整或應計回扣,當我們最終了解產品的真實流程並證實這一點時,這可能會導致,比如說,變化在本季度。但這些是——當你查看總業務並說出年度業務流量時,我們對該業務進行了非常小的調整。
So I think it's difficult to judge the business based on one quarter when you have these. So we have to look at it in totality. And with the guidance upgrade we have given, that's the value. So you can take that as a sign that I think we have strong value development in our business, and that's what leads to the upgrade procedure.
所以我認為當你有這些時,很難根據一個季度來判斷業務。所以我們必須全面地看待它。透過我們給予的指導升級,這就是價值。因此,您可以將此視為我認為我們的業務具有強大的價值發展的標誌,這就是導致升級程序的原因。
Jacob Martin Wiborg Rode - Head of IR
Jacob Martin Wiborg Rode - Head of IR
Thank you, Lars. We'll move over here to Jo.
謝謝你,拉爾斯。我們要搬到喬這裡去。
Jo Walton - Analyst
Jo Walton - Analyst
Thank you. A question for Martin, please. In the past, you've said that you don't think that there are any scalable small molecules, and that the market will largely remain in the injectable space. Since those comments, we've seen a couple of small molecule GLP-type drugs. I wonder if you could update us on your view as to how the market is going to split between injectables and orals.
謝謝。請問馬丁一個問題。過去,您曾說過,您認為不存在任何可擴展的小分子,並且市場將主要保留在註射領域。自從這些評論以來,我們已經看到了幾種小分子 GLP 類藥物。我想知道您是否可以向我們介紹一下您對注射劑和口服劑市場將如何劃分的最新看法。
And also, if I can just ask how you're going to choose between your next injectables, should we expect all of them to come to the market? Or should we expect you to just develop one of them as your best?
另外,如果我可以問一下您將如何在下一個注射劑之間進行選擇,我們是否應該期望所有這些注射劑都會進入市場?或者我們應該期望您將其中一項發展為您最好的?
Martin Holst Lange - EVP, Head of Development
Martin Holst Lange - EVP, Head of Development
So first of all, on the small molecule side, actually, I said that I think monlunabant, from a scalability perspective, seems to be an attractive offering. Obviously, right now, we're working on demonstrating safety and efficacy of monlunabant. But from a scalability perspective, that seems to be by conventional wisdom to small molecule, that can be easily scaled.
首先,在小分子方面,實際上,我說我認為從可擴展性的角度來看,蒙魯那班似乎是一個有吸引力的產品。顯然,目前我們正在努力證明蒙魯那班的安全性和有效性。但從可擴展性的角度來看,這似乎是小分子的傳統智慧,可以輕鬆擴展。
When we look at what else is out there -- and of course, we're looking we're looking through the same lens, the certification, is it safe, and can it be scaled. And most of what we see out there is, from a chemistry perspective, slightly complex than conventional small molecules. And that basically means that they are more difficult and more expensive to scale. Of course, if you do the investment, you can do it.
當我們查看其他內容時,當然,我們正在透過相同的鏡頭查看認證,它是否安全,是否可以擴展。從化學角度來看,我們看到的大部分物質都比傳統的小分子稍微複雜一些。這基本上意味著它們的擴展更加困難且成本更高。當然,如果你做投資的話,也是可以的。
And then the question comes to what number of patients, the way we think about this and the way they scale, as you've seen our investments in the subcutaneous space, you would have to identify substantially to be able to scale those small molecules to an impactful degree. I think Karsten and Lars can talk more to that.
然後問題是有多少患者,我們對此的思考方式以及它們的擴展方式,正如您所看到的我們在皮下空間的投資一樣,您必須充分確定才能將這些小分子擴展到有影響力的程度。我認為卡斯滕和拉爾斯可以就此進行更多討論。
But from a pure chemistry perspective, they are not trivial. Of course, they can be produced, but they will not be sort of conventional small molecules that you can just produce to, let's say, double, triple million patients -- digit million patients.
但從純化學的角度來看,它們並不是微不足道的。當然,它們是可以生產的,但它們不會是那種傳統的小分子,你可以為兩百萬、三百萬患者——數百萬名患者生產。
Specifically for our own pipeline, we see obesity as a complex disease. And for us, obviously, to have the leading molecules in the incretin space, but also working on new modalities based on amylin biology, based on CB1 biology, that allows us to cater to different patient needs.
特別是對於我們自己的產品線,我們將肥胖視為一種複雜的疾病。顯然,對我們來說,我們不僅擁有腸促胰島素領域的領先分子,而且還致力於基於胰島澱粉樣蛋白生物學、CB1生物學的新模式,這使我們能夠滿足不同患者的需求。
And the way that we look at this, and this is maybe more familiar that you speak to that, if we see clinical medical differentiation between our molecules, we expect them to be able to coexist to cater to different patient needs. And that's the way that we build our pipeline, both in the oral and in the subcutaneous space.
我們看待這個問題的方式,這可能比你說的更熟悉,如果我們看到我們的分子之間的臨床醫學差異,我們期望它們能夠共存,以滿足不同患者的需求。這就是我們在口腔和皮下空間建立管道的方式。
Jacob Martin Wiborg Rode - Head of IR
Jacob Martin Wiborg Rode - Head of IR
We move over there to Pete.
我們搬到皮特那裡去。
Peter Verdult - Analyst
Peter Verdult - Analyst
Thanks. Pete Verdult. Can we move to actually insulin just for a second and give Wegovy a rest a bit. Just can you help us understand why there was such a positive rebate adjustment given what we've seen in terms of the interesting price cap and changes there? And when you think about IRA next year, is it really going to matter our insulin prices really already at rock bottom? Or is there going to be another downdraft when IRA hits on some of your insulin portfolio? Thank you.
謝謝。皮特·維爾杜特.我們可以暫時使用胰島素並讓 Wegovy 休息一下嗎?鑑於我們所看到的有趣的價格上限和變化,您能否幫助我們理解為什麼會有如此積極的回扣調整?當你考慮明年的 IRA 時,我們已經處於谷底的胰島素價格真的很重要嗎?或者,當 IRA 影響您的某些胰島素投資組合時,是否會出現另一場下跌?謝謝。
Jacob Martin Wiborg Rode - Head of IR
Jacob Martin Wiborg Rode - Head of IR
Thanks, Pete. Karsten will give better go on insulin technicalities and underlying movements.
謝謝,皮特。卡斯滕將更好地介紹胰島素的技術細節和基本動作。
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Yeah. So for insulins backlogs coming from before, when we estimate the gross net in the US, we sell to wholesalers and charge list price, and then it takes like three, four months before we receive rebates and then the rebates can go to different channels at different rates. So that's the estimates going into it. And that's also what happens for insulins.
是的。因此,對於先前積壓的胰島素,當我們估算美國的總淨額時,我們將其出售給批發商並收取標價,然後大約需要三四個月的時間才能收到回扣,然後回扣可以流向不同的管道不同的費率。這就是其中的估計。這也是胰島素的情況。
We had a bigger adjustment in the first quarter, but also an adjustment in the second quarter based on these estimates.I don't think it benefits anyone in here to go into the gory details about what channels and what rates and what channel mix. But it is true that the insulin growth in the US was very significant in the second quarter, and it was all driven by price adjustments or rebate adjustments in the second quarter of this year.
我們在第一季進行了更大的調整,但在第二季也根據這些估計進行了調整。但確實,美國第二季的胰島素成長非常顯著,而這一切都是由今年第二季的價格調整或回扣調整所推動的。
Underlying, when we look at it, insulin in the US is a declining market in terms of market growth. And our market share is also declining, linked, amongst other items, to the Lilly product discontinuation.
從根本上來說,從市場成長的角度來看,美國的胰島素市場是一個不斷下滑的市場。我們的市佔率也在下降,這與禮來公司產品停產等因素有關。
Jacob Martin Wiborg Rode - Head of IR
Jacob Martin Wiborg Rode - Head of IR
Thank you, Karsten. We'll move to Emily.
謝謝你,卡斯滕。我們將搬到艾米麗那裡。
Emily Field - Analyst
Emily Field - Analyst
Hi. Thanks. I'm Emily Field from Barclays. It seems that there's been growing concern also coming from the FDA regarding the safety of these compounded formulations of GLP-1. And I was just wondering, with your lowest dose remaining on the drug shortage list and no doses of truzapetide, at least from what we see on the FDA website, does that mean that compounders can still make your drug and not theirs? How much does the growth of compounding concern you, both from a patient safety perspective and then also taking what share could be Novo Nordisk?
你好。謝謝。我是巴克萊銀行的艾蜜莉·菲爾德。 FDA 似乎也越來越擔心這些 GLP-1 複合製劑的安全性。我只是想知道,至少從我們在FDA 網站上看到的情況來看,你們的最低劑量仍在藥物短缺清單上,並且沒有劑量的特魯扎肽,這是否意味著複合商仍然可以生產您的藥物,而不是他們的藥物?從病人安全的角度以及諾和諾德可能佔據的份額來看,複利的成長對您有多大影響?
Jacob Martin Wiborg Rode - Head of IR
Jacob Martin Wiborg Rode - Head of IR
Thank you, Emily. I'll get that to you, Lars, on the --
謝謝你,艾米麗。拉爾斯,我會在—
Lars Fruergaard Joergensen - President, Chief Executive Officer
Lars Fruergaard Joergensen - President, Chief Executive Officer
So just to outline, there's only one [sema] and that's produced by Novo Nordisk. So I don't know what compound is -- well, the compound, but I don't know where they get API from and what the quality of that is. And we've also seen that, I think, some of the safety reporting has -- there's been a high representation from compounded drugs. So we take patient safety very seriously and so does the US FDA.
簡單來說,只有一個 [sema],由諾和諾德 (Novo Nordisk) 製作。所以我不知道化合物是什麼——嗯,化合物,但我不知道他們從哪裡獲得 API 以及其品質如何。我認為,我們也看到,一些安全報告中複合藥物的比例很高。因此,我們非常重視病患安全,美國 FDA 也是如此。
Specifically on your point, we have, in dialogue with this day, removed the drug shortage notification on the other doses. We have all along said that we want to dynamically start patients in a way where they can have a good journey on the titration doses.
具體來說,針對您的觀點,我們在今天的對話中刪除了其他劑量的藥物短缺通知。我們一直說,我們希望以一種能讓患者在劑量滴定過程中順利進行的方式動態啟動。
We actually scale capacity significantly. So we couldn't principally have decided also to remove the shortage notification on the starter dose if we wanted to. But we just think that we've been out consistently saying to physicians and also FDA that we want to have a responsible approach to starting patients. So you can trust and when you start treatment with Wegovy from Novo Nordisk, we take care of you in the sense that you can titrate up to the doses.
我們實際上大幅擴展了容量。因此,如果我們願意的話,我們原則上不能決定取消起始劑量的短缺通知。但我們只是認為,我們一直在向醫生和 FDA 表示,我們希望採取負責任的方法來啟動病人。因此,您可以相信,當您開始使用諾和諾德的 Wegovy 治療時,我們會照顧您,因為您可以調整劑量。
So that led us to keep the notification on the starter dose, but we could in print have taken it away also because we still manage the doses. So when we look at look at it, we have significant step-up in capacity. We allocate that to different doses, and that leads to a significantly higher number of total scripts in the US market, and that's what fuels the growth and that's what turns into this upgraded outlook.
因此,這導致我們保留了有關起始劑量的通知,但我們也可以在印刷中將其刪除,因為我們仍然管理劑量。因此,當我們審視它時,我們的產能有了顯著提升。我們將其分配給不同的劑量,這導緻美國市場的總腳本數量顯著增加,這就是推動成長的原因,也是前景升級的原因。
Then how we look at individual doses and also, say, classified that from a drug shortage notification, those are minor tactics. And we could have taken all the way we wanted to, but we just think for consistency because we have said that for some time that we stick to that. Whether that leads into a massive compounding, I don't know, because we could just remove it and then there was no compounding. So I don't think compounding is a way forward generally to serve patients.
然後我們如何看待個人劑量,以及如何根據藥物短缺通知進行分類,這些都是次要策略。我們本可以採取我們想要的所有方式,但我們只是考慮一致性,因為我們已經說過一段時間以來我們一直堅持這一點。我不知道這是否會導致大規模複利,因為我們可以將其刪除,然後就不會有複利了。因此,我不認為複利通常是為病人服務的一種前進方式。
Jacob Martin Wiborg Rode - Head of IR
Jacob Martin Wiborg Rode - Head of IR
Thank you, Lars. Then we'll move to Sachin.
謝謝你,拉爾斯。然後我們將前往薩欽。
Sachin Jain - Analyst
Sachin Jain - Analyst
Sachin Jain, Bank of America. Can I just take one clarification at the last point and then I ask my CB1 question. I think there was a confusion on the lower dose yesterday because it was answered two different ways as to whether the [0.25] was going to grow or not grow. I just interpreted from your answer just there, the 0.25 can grow, but you're just not within the boundary of however FDA defines shortage. So I just want to clarify that before I ask my CB1.
薩欽‧賈恩 (Sachin Jain),美國銀行。我可以在最後一點澄清一下,然後問我的 CB1 問題嗎?我認為昨天對較低劑量存在混淆,因為對於 [0.25] 是否會增長有兩種不同的答案。我剛剛從你的回答中解釋說,0.25 可以增長,但你只是不在 FDA 定義的短缺範圍內。所以我想在問我的 CB1 之前先澄清一下這一點。
Lars Fruergaard Joergensen - President, Chief Executive Officer
Lars Fruergaard Joergensen - President, Chief Executive Officer
Yes, it can grow. So I'm just thinking hypothetically, we could allocate all our capacity to produce this starter dose and we would have new scripts [ex-code], but we want to make sure that patients can start and titrate to higher doses because that's good for the patient, but it's also good for our business because we get -- we grow the business by that. So don't put too much emphasis into underlying individual doses because it's totality of the business and how we allocate our capacity to produce that, that matters. I hope that's clear.
是的,它可以生長。所以我只是假設,我們可以分配我們所有的能力來生產這個起始劑量,我們會有新的腳本[前代碼],但我們希望確保患者可以開始並滴定到更高的劑量,因為這對病人,但這對我們的業務也有好處,因為我們透過它來發展業務。因此,不要過度強調潛在的個人劑量,因為這是業務的整體以及我們如何分配我們的生產能力,這很重要。我希望這是清楚的。
Sachin Jain - Analyst
Sachin Jain - Analyst
Thanks very much. CB1, there's a lot of focus predominantly on the CNS safety. So I wonder if you could just frame for us how you're thinking about on two metrics. The GLP-1 adverse event rates in the high single digits, I think if that's correct, for Wegovy. So what delta relative to that would give you comfort or not comfort?
非常感謝。 CB1,人們主要關注中樞神經系統的安全性。所以我想知道您是否可以向我們介紹您對兩個指標的看法。我認為,對於 Wegovy 來說,GLP-1 不良事件發生率高達個位數,如果這是正確的。那麼相對於此的增量是多少會帶給你舒適或不舒適呢?
And then on suicidal ideation, I compare it was about 5%. So in 600 patients across the two studies, we're literally talking about one, two, three events. So if you see any, is that a problem? And how many patients would you need to see low suicidal ideation before you get really comfortable on the site profile? Thank you.
然後關於自殺意念,我比較了一下,大概是 5%。因此,在兩項研究的 600 名患者中,我們實際上討論的是一個、兩個、三個事件。那麼如果你看到任何,這是一個問題嗎?在您對網站資料感到真正滿意之前,您需要看到多少患者自殺意念較低?謝謝。
Martin Holst Lange - EVP, Head of Development
Martin Holst Lange - EVP, Head of Development
So the way we think about this is that -- and it's a little bit going back to Jo's question, we aim to scale monlunabant to a great number of patients, and that basically means that we need to the level that we can exclude concerns about an excess of neuropsychiatric side effects.
所以我們思考這個問題的方式是——這有點回到喬的問題,我們的目標是將蒙魯那班擴展到大量患者,這基本上意味著我們需要達到可以排除擔憂的水平過多的神經精神副作用。
So to your own point, in any clinical study, there will be patients who report neuropsychiatric events. And just to give you an example, in this SELECT trial, we had 10 events of suicidal ideation on placebo and we have 10 events of suicidal ideation on semaglutide. So no excess.
因此,就您自己的觀點而言,在任何臨床研究中,都會有患者報告神經精神事件。舉個例子,在這個 SELECT 試驗中,安慰劑組有 10 例自殺意念事件,索馬魯肽組有 10 例自殺意念事件。所以沒有多餘的。
We intend to take the same approach for monlunabant. And at the end of the day, for the two ongoing and Phase 2 studies, reasonably large more than 600 patients, additional Phase 2 study continuously derisking the asset. And then obviously, our bigger development program to generate with actually a dedicated focus on this specific issue enough data to say we don't see an excess risk as compared to anything else out there. That's sort of our approach, but that is also the bar. I think that's our bar, but that would also be the path from regulators.
我們打算對蒙魯那班採取同樣的方法。最終,對於兩項正在進行的 2 期研究(涉及超過 600 名患者)來說,額外的 2 期研究不斷降低資產風險。顯然,我們更大的開發計劃實際上專注於這個特定問題,並產生足夠的數據來表明,與其他任何事情相比,我們沒有看到過度的風險。這是我們的方法,但也是標準。我認為這是我們的標準,但這也是監管機構的路徑。
Jacob Martin Wiborg Rode - Head of IR
Jacob Martin Wiborg Rode - Head of IR
Thank you, Martin. Thank you, Sachin. We'll move to the table at the back, and Mark Purcell first.
謝謝你,馬丁。謝謝你,薩欽。我們將移至後面的桌子,馬克·珀塞爾先行。
Mark Purcell - Analyst
Mark Purcell - Analyst
Mark Purcell from Morgan Stanley. A question on obesity time lines. A lot of your competitors are trying to accelerate their programs, doing relatively small Phase 2 studies and taking it to the FDA and looking to go into Phase 3 or Phase 2, and parallel Phase 3 studies together.
摩根士丹利的馬克·珀塞爾。關於肥胖時間線的問題。許多競爭對手都在試圖加速他們的項目,進行相對較小的第二階段研究,並將其提交給 FDA,並尋求進入第三階段或第二階段,以及並行的第三階段研究。
So in terms of amycretin, can you help us understand the probability you can go from a couple of Phase 1 studies, one Phase 2 ongoing in diabetes to a full Phase 3 program, both for the oral and the injectable side? And then following up on what Sachin was just asking, I mean, I don't think you'll learn a lot from an additional 600-patient Phase 2b study with IMV202.
那麼,就香蜜素而言,您能否幫助我們了解從幾項1 期研究(一項針對糖尿病正在進行的2 期研究)轉向完整的3 期計劃(無論是口服還是注射方面)的可能性?然後跟進 Sachin 剛才問的問題,我的意思是,我認為您不會從 IMV202 的額外 600 名患者 2b 期研究中學到很多東西。
So if you see a 15% weight loss in the AD study with no excess of grade 1, grade 2 CNS events, what would stop you for moving into Phase 3 straightaway?
因此,如果您在 AD 研究中看到體重減輕了 15%,且沒有超過 1 級、2 級 CNS 事件,那麼什麼會阻止您直接進入第 3 階段?
Martin Holst Lange - EVP, Head of Development
Martin Holst Lange - EVP, Head of Development
So maybe I'll take the last question first. I disagree a little bit in the sense that if you look at the historical data where we have seen neuropsychiatric side effects with other compounds, in one specific example, 30% of patients reported neuropsychiatric events in the development program, 30%.
所以也許我會先回答最後一個問題。我有點不同意,如果你看歷史數據,我們發現其他化合物會產生神經精神副作用,在一個具體例子中,30% 的患者在開發計劃中報告了神經精神事件,30%。
And most of these reported events quite soon after treatment initiation. And that basically means that with a sample size of 600, two additional studies that also amount to almost 600 patients, you have a reasonable volume and we have a reasonable exposure duration to say with any likelihood before you make, or I convinced Karsten to make Phase 3 investments, we have excluded the safety events.
大多數這些事件在治療開始後不久就報告了。這基本上意味著,樣本量為600 人,另外兩項研究也涉及近600 名患者,你有一個合理的數量,我們有一個合理的暴露持續時間,可以在你做之前說任何可能性,或者我說服卡斯滕做第三階段投資,我們已經排除了安全事件。
Again, there are no guarantees until we have the Phase 3 data. But given the historical data, I think the sample size and the duration of exposure will take us a long way. So if we see those three studies, Phase 2 studies come together, with no excess safety concerns and, let's say, 15% weight loss, absolutely happy. And then I will try to convince Karsten to invest in Phase 3.
同樣,在我們獲得第三階段數據之前,我們無法做出任何保證。但考慮到歷史數據,我認為樣本量和暴露的持續時間將讓我們走很長的路。因此,如果我們看到這三項研究,第二階段研究結合在一起,沒有過多的安全問題,而且,比方說,體重減輕了 15%,絕對令人高興。然後我會嘗試說服 Karsten 投資第三階段。
On -- could you remind me of the other question?
關於——你能提醒我另一個問題嗎?
Mark Purcell - Analyst
Mark Purcell - Analyst
(inaudible - microphone inaccessible)
(聽不清楚 - 麥克風無法存取)
Martin Holst Lange - EVP, Head of Development
Martin Holst Lange - EVP, Head of Development
Yes. So at the end of the day, you have to have a reasonable assumption and exposure to secure that safety is reasonable to go into Phase 3. That is why we -- the combination of the Phase 1 studies that we have done in obesity and the Phase 2 study that we are currently initiating will be able for us to potentially make a decision during the course of 2025 to say maybe we can go directly into Phase 3.
是的。因此,歸根結底,您必須有一個合理的假設和暴露,以確保進入第三階段的安全性是合理的。二階段研究將使我們能夠在2025 年期間做出決定,也許我們可以直接進入第三階段。
If we do that in the Phase 1 studies, we had to see clear differentiation on efficacy on safety and on pharmacokinetics. So we can pick the right dose. Then it's down to our risk willingness to say, do we want to go into Phase 3? Have we picked the right dose? Do we believe the efficacy? Do we believe the safety. But we also had to convince the authorities that we have sufficient safety to take that leap of faith.
如果我們在第一階段研究中這樣做,我們必須看到安全性和藥物動力學功效上的明顯差異。所以我們可以選擇適合的劑量。然後取決於我們的風險意願,我們是否想進入第三階段?我們選擇了正確的劑量嗎?我們相信它的功效嗎?我們相信安全嗎?但我們也必須讓當局相信我們有足夠的安全來實現這一信念的飛躍。
We've, in our history, done that twice, one Sogroya and one CagriSema. And I feel confident that we've sort of gotten that process right. It's not easy, it's not trivial, and certain things have to be in place.
在我們的歷史上,我們已經這樣做過兩次,一次是 Sogroya,一次是 CagriSema。我相信我們已經正確地完成了這個過程。這並不容易,也不是微不足道的,某些事情必須到位。
Jacob Martin Wiborg Rode - Head of IR
Jacob Martin Wiborg Rode - Head of IR
Thank you, Martin. We'll stay at the same table with Richard Vosser. And a reminder on one question per person, please.
謝謝你,馬丁。我們將與理查德·沃瑟 (Richard Vosser) 坐在同一張桌子上。請提醒每人一個問題。
Richard Vosser - Analyst
Richard Vosser - Analyst
Thanks, Jacob. Just one question, which would be just -- you mentioned it in your behest to remove the starter dose cap and you're managing that. So is that a removal in '25? Or is that a removal in '26? How should we think about the step-up into '25 and beyond in terms of the overall doses? But when does that start to dose? When are you comfortable enough on supply?
謝謝,雅各。只有一個問題,那就是——您在要求取消起始劑量上限時提到了這一點,並且您正在管理這一點。那麼這是25年的移除嗎?還是26年就刪除了?我們應該如何考慮在總劑量方面進入 25 年及以後的階段?但什麼時候開始服用呢?什麼時候對供應感到滿意?
Lars Fruergaard Joergensen - President, Chief Executive Officer
Lars Fruergaard Joergensen - President, Chief Executive Officer
So if you look at what has happened in the first six months, we have grown total scripts from 100,000 to 200,000. That's a significant number of doses. So the debate about what is starter dose, what is titration dose is a bit irrelevant in a way. Because with the guidance that we have and the comparator Karsten spoke about, if you start doing the math in terms of how many doses are going to the market in the second half, that's significantly more doses.
因此,如果您看看前六個月發生的情況,我們的腳本總數已從 100,000 個增加到 200,000 個。這是一個很大的劑量。因此,關於什麼是起始劑量、什麼是滴定劑量的爭論在某種程度上是無關緊要的。因為根據我們的指導和卡斯滕談到的比較器,如果你開始計算下半年將有多少劑量進入市場,那就是明顯更多的劑量。
So I mentioned before, if there was a priority on starter doses, we could just produce the starter doses and we would be flooding the market, and the new scripts would be skyrocketing. But that's not a sustainable patient journey.
所以我之前提到過,如果起始劑量有優先權,我們可以只生產起始劑量,就會充斥市場,新的劇本就會飆升。但這不是一趟可持續的患者旅程。
So we want to do what creates a good mix, titration or not. And that's what fuels the growth and also creates best efficacy of the product. So the whole discussion about starter doses, new scripts is becoming less relevant.
因此,無論是否進行滴定,我們都希望能夠創造出良好的混合效果。這就是推動成長並創造產品最佳功效的原因。因此,關於起始劑量、新方案的整個討論變得不再那麼重要。
It's a total number of scripts across all doses that matters. When you launch a product, it's new script and starter doses later on is actually, say, the total book of business. So it's, in a way, it's not, say, a '24, '25 decision because we manage this dynamically to create the best possible growth and patient experience.
重要的是所有劑量的腳本總數。當你推出一個產品時,它的新腳本和後來的起始劑量實際上就是整本業務手冊。因此,在某種程度上,這不是 24、25 年的決定,因為我們動態地管理這一點,以創造最佳的成長和患者體驗。
Jacob Martin Wiborg Rode - Head of IR
Jacob Martin Wiborg Rode - Head of IR
Thank you, Lars. Then we'll move to Simon, same table.
謝謝你,拉爾斯。然後我們將轉移到西蒙,同桌。
Simon Baker - Analyst
Simon Baker - Analyst
Thank you. Simon Baker from Redburn Atlantic. First, a quick clarification on Sachin's question on the CB1 development program. Are there any specific exclusion criteria from the studies related to the suicide ideation risk? And then the question I was going to ask, going back to what ask yesterday, on the monthly dose form. You're not there yet.
謝謝。雷德本大西洋公司的西蒙貝克。首先,快速澄清 Sachin 關於 CB1 開發計畫的問題。與自殺意念風險相關的研究是否有任何具體的排除標準?然後是我要問的問題,回到昨天問的關於每月劑量表的問題。你還沒到那兒。
I was just trying to get an idea of how far away you are, what the challenges are? Because others are in this space as well, is this a question purely of formulation? Is it about the specific pharmacokinetics of the molecules you're trying? So how -- I don't think you're down on a date, and I'm sure you won't give me one. But how far away is a monthly for injectable formulation as a viable product? Thank you.
我只是想了解您距離我們有多遠,面臨的挑戰是什麼?因為其他人也在這個領域,所以這只是一個純粹的表達問題嗎?與您正在嘗試的分子的特定藥物動力學有關嗎?那麼如何——我不認為你在約會上感到沮喪,而且我確信你不會給我一個。但注射製劑距離成為可行產品還有多遠呢?謝謝。
Martin Holst Lange - EVP, Head of Development
Martin Holst Lange - EVP, Head of Development
So specifically for CB1, we -- for us, it's a journey depending on data. So if we get through the first two studies, which are excluding certain patients without any new psychiatric side effects in excess, then we will discuss what in an exclusion criteria will we have for the next Phase 2 study. We'll open it up a little bit more if we do that, and that also comes out in a good way than we can maybe having no or very few exclusion criteria in Phase 3.
因此,特別是對於 CB1,我們來說,這是一個取決於數據的旅程。因此,如果我們完成前兩項研究,排除某些沒有任何新的精神副作用的患者,那麼我們將討論下一個 2 期研究的排除標準。如果我們這樣做的話,我們會更加開放一點,而且這也比我們在第三階段沒有或很少的排除標準更好。
It has to depend a little bit on the data. And if at the end of the day, we had to have an exclusion in our label, I think that is also acceptable. But right now, obviously, our full aspiration would be that they should be forward, but it has to depend on the data.
它必須有點依賴數據。如果最終我們必須在標籤中排除,我認為這也是可以接受的。但現在,顯然,我們的全部願望是他們應該前進,但這必須取決於數據。
On the once monthly, there are many technologies that you can apply for sort of extended delivery. Our approach is always first to focus on efficacy and safety. And if we can make that more convenient, then we'll do that. We have tested on once-monthly asset in clinic. It was honestly not a viable clinical profile. So we're sort of going back to the bench. In research, we are still pursuing, as far as I can see, at least three different ways of protecting administration.
每月一次,您可以應用許多技術來延長交貨時間。我們的方法始終首先關注功效和安全性。如果我們能讓這件事變得更方便,我們就會這麼做。我們在臨床上對每月一次的資產進行了測試。老實說,這不是一個可行的臨床概況。所以我們要回到替補席了。在研究中,據我所知,我們仍在尋求至少三種不同的保護管理的方式。
It's not our biggest priority. It is a priority because we still see efficacy safety driving any decision in this space. But obviously, it would be good for us to have that offering as well. So therefore, we are looking at it. But I think for anyone, maybe apart from one player, if you're a new clinic, you are still at least six years away from bringing it to patients.
這不是我們的首要任務。這是一個優先事項,因為我們仍然認為功效安全驅動著這個領域的任何決策。但顯然,擁有這種產品對我們來說也是有好處的。因此,我們正在研究它。但我認為,對於任何人來說,也許除了一名球員之外,如果你是一家新診所,距離將其帶給患者至少還需要六年的時間。
Jacob Martin Wiborg Rode - Head of IR
Jacob Martin Wiborg Rode - Head of IR
Thank you, martin. We'll move over here.
謝謝你,馬丁。我們就搬到這裡來吧。
Unidentified Participant 1
Unidentified Participant 1
I just wanted to briefly touch on the Catalent transaction. It's been going on for some time. How do you, today, feel about the likelihood reaching a beneficially -- mutually beneficial agreement with, first, Eli Lilly, and then with all the other potential complainants or with the other parties?
我只是想簡單談談康泰倫特交易。這種情況已經持續了一段時間了。今天,您對首先與禮來公司、然後與所有其他潛在投訴人或其他各方達成互惠互利協議的可能性有何看法?
Jacob Martin Wiborg Rode - Head of IR
Jacob Martin Wiborg Rode - Head of IR
Karsten on Catalent transaction?
卡斯滕參與 Catalent 交易?
Martin Holst Lange - EVP, Head of Development
Martin Holst Lange - EVP, Head of Development
Yes. So we're still confident that the transaction will close by the end of the year. We had a lot of advice before entering into the transaction in the first place in the beginning of this year. Then we've had a lot of interactions with regulators in the US and outside US. And we believe that we have a solid case to get to a close of the transaction towards the end of the year. So we look very much forward to that.
是的。因此,我們仍然有信心該交易將在今年年底前完成。在今年年初開始交易之前,我們得到了許多建議。然後我們與美國和美國以外的監管機構進行了許多互動。我們相信,我們有充分的理由在年底前完成交易。所以我們對此非常期待。
Jacob Martin Wiborg Rode - Head of IR
Jacob Martin Wiborg Rode - Head of IR
Thank you, Karsten. We move to [Alexander].
謝謝你,卡斯滕。我們搬到[亞歷山大]。
Unidentified Participant 2
Unidentified Participant 2
I had a question on China. You have approval for Wegovy in China. You have a very short patent window there two years ago, I think. Can you just comment on whether you still retain a lot of optimism around the China opportunity? The noise being made by the generics is getting louder all the time, there are plenty of people who are going to have a pop at this market. Do you have any indication about how quickly you've gone off with Wegovy in China?
我有一個關於中國的問題。您已獲得在中國使用 Wegovy 的批准。我認為兩年前你的專利窗口非常短。您能否簡單評論一下您是否仍對中國機會保持樂觀態度?仿製藥發出的噪音越來越大,有很多人會在這個市場上流行。您是否有任何跡象表明您與 Wegovy 在中國的合作有多快?
Jacob Martin Wiborg Rode - Head of IR
Jacob Martin Wiborg Rode - Head of IR
I'll give that to you, Camilla, China on med need and Wegovy.
我會把它交給你,卡米拉,中國醫療需求和 Wegovy。
Camilla Sylvest - Executive Vice President - Commercial Strategy and Corporate Affairs
Camilla Sylvest - Executive Vice President - Commercial Strategy and Corporate Affairs
Yes. Thanks a lot. So in China, there are more than 200 million people living with obesity, and we see great opportunity to make a difference in terms of Wegovy China. What is important, of course, is that we have a very strong presence in China in terms of our regional presence, in terms of our ability to launch new products. And we have worked in China also with local competition before -- in competition with locals before.
是的。多謝。因此,在中國,有超過 2 億人患有肥胖症,我們看到了 Wegovy 中國帶來改變的巨大機會。當然,重要的是我們在中國的區域影響力和推出新產品的能力都非常強大。我們之前也曾在中國與當地競爭對手合作過——之前與當地人競爭。
We at the moment do not see anyone sort of being represented in the short term on Wegovy. So we feel as long as we continue to bring innovation to China, we will continue to be a step ahead. Our understanding from dialogues with Chinese authorities is also that they very much value the innovation that we actually bring to China.
目前我們還沒有看到任何人在短期內出現在 Wegovy 上。所以我們覺得只要我們繼續為中國帶來創新,我們就會繼續領先一步。我們從與中國當局的對話中了解到,他們非常重視我們實際上為中國帶來的創新。
Then of course, over time, there will be most likely, as we've seen before, a system in China that would allow local generics to produce and to compete. But so far, this has been constructed in a way where there's always an incentive to bring innovation to China.
當然,隨著時間的推移,正如我們之前所看到的,中國很可能會建立一個允許本土仿製藥生產和競爭的體系。但到目前為止,它的建造方式始終有動力將創新引入中國。
And as we are a very innovation-based company, we are quite happy to see now that all of our new products, Wegovy, Rybelsus and so on, have -- including also a weekly or once weekly insulin, has now has approval in China much faster than in the past. So this actually allow us to keep -- to compete even faster in the Chinese market than just five years back.
由於我們是一家非常注重創新的公司,我們很高興看到我們所有的新產品,Wegovy、Rybelsus 等,包括每週一次或每週一次的胰島素,現在已在中國獲得批准比過去快得多。因此,這實際上使我們能夠比五年前更快地在中國市場競爭。
Jacob Martin Wiborg Rode - Head of IR
Jacob Martin Wiborg Rode - Head of IR
Thank you, Camilla. We'll move to Rajesh.
謝謝你,卡米拉。我們將搬到拉傑什。
Rajesh Kumar - Analyst
Rajesh Kumar - Analyst
Hi, good afternoon. Can I just clarify your CB1 comments earlier in terms of -- this is not my question, by the way. I want to ask about rebates. On CB1, are you going to do a trial control with semaglutide or trivepatide rather than placebo and compare neuropsychiatric there? Or is it just going to be a placebo control and then you'll see other --
嗨,下午好。我能否澄清一下您之前對 CB1 的評論——順便說一句,這不是我的問題。我想問一下關於回扣的事。在 CB1 上,您是否打算用索馬魯肽或曲維帕肽(而不是安慰劑)進行試驗對照並比較那裡的神經精神?或者它只是一個安慰劑對照,然後你會看到其他——
Martin Holst Lange - EVP, Head of Development
Martin Holst Lange - EVP, Head of Development
Without going into details, there will be an active comparator, there will also be a placebo comparator, there will potentially also be combinations happen in that study.
無需詳細說明,將會有一個主動比較器,也會有一個安慰劑比較器,在該研究中也可能會發生組合。
Rajesh Kumar - Analyst
Rajesh Kumar - Analyst
Understood. Very clear. On rebate, you mentioned that you get data back from the wholesaler two, three months. So if my very preliminary understanding of how the accrual accounting and the IT systems were there, you probably are guessing at the moment, the level of rebate you have booked in for Wegovy this quarter, right?
明白了。非常清楚。關於回扣,您提到您會在兩三個月內從批發商處獲取數據。因此,如果我對權責發生製會計和 IT 系統的了解非常初步,您現在可能會猜測您本季度為 Wegovy 預訂的回扣水平,對吧?
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Correct. And just to be precise, we don't get the data from the wholesalers. We get data from the insurance companies. So we charge wholesales at list price, then the rebate claims comes from the PBMs who get the claims, of course, through pharmacies, and that's where we get them.
正確的。準確地說,我們沒有從批發商那裡獲得數據。我們向保險公司取得數據。因此,我們按標價向批發商收取費用,然後折扣索賠來自獲得索賠的 PBM,當然是透過藥房,這就是我們獲得索賠的地方。
Rajesh Kumar - Analyst
Rajesh Kumar - Analyst
I would imagine that given the projection you've made for your full year, you have assumed that there would be a step-up in volumes, therefore, a step-up in rebates in the second half. And therefore, you've reflected that in the prices you've assumed for the quarter.
我想,考慮到您對全年的預測,您已經假設銷售量將會增加,因此下半年的回扣也會增加。因此,您已將這一點反映在您為該季度假設的價格中。
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
No. So the prices for the quarter, that's an estimate based on the volumes we sold. Then we make an estimate linked to what channels and under what formularies. And hence, conditions and rebates have they been sold to.
不。然後我們根據哪些管道和哪些處方集進行估計。因此,他們被賣給了條件和回扣。
Jacob Martin Wiborg Rode - Head of IR
Jacob Martin Wiborg Rode - Head of IR
Thank you, Karsten. Thank you, Lars. We'll move over here. Before that, just a reminder in terms of one question.
謝謝你,卡斯滕。謝謝你,拉爾斯。我們就搬到這裡來吧。在此之前,先提醒一個問題。
Ben Jackson - Analyst
Ben Jackson - Analyst
Hi, team. Ben Jackson from Jefferies. I was wondering if you have (technical difficulty) or data on what are the conditions on what the discontinuing around six months, maybe longer. Are they then rechallenging on a GLP-1? And are you seeing switches between GLP-1s there? And do you expect over the longer term that people aren't going to take this as a one and done, and are willing to go back on after discontinuing?
大家好。來自傑富瑞集團的班傑克森。我想知道您是否有(技術難度)或有關停止大約六個月(也許更長)的條件的數據。然後他們會重新挑戰 GLP-1 嗎?您是否看到 GLP-1 之間的切換?從長遠來看,您是否預期人們不會認為這已經是一件已經完成的事情,並且願意在停止後繼續使用?
Jacob Martin Wiborg Rode - Head of IR
Jacob Martin Wiborg Rode - Head of IR
Camilla, will you give that a go?
卡蜜拉,你願意嘗試嗎?
Camilla Sylvest - Executive Vice President - Commercial Strategy and Corporate Affairs
Camilla Sylvest - Executive Vice President - Commercial Strategy and Corporate Affairs
Yes. So thanks a lot. So keep in mind that six months is an average stay time, and it's based on experience in the US where we've seen some interruptions to supply in the past. So we continue to be very encouraged about the development of that stay time.
是的。非常感謝。因此請記住,六個月是平均停留時間,這是基於美國的經驗,我們過去曾看到一些供應中斷。因此,我們對停留時間的發展持續感到非常鼓舞。
And when we look at you say other countries where we haven't had that interruption of supply, we've seen that, for example in Denmark, where people started on treatment beginning of 2023, a big part -- a very big part, plus 90% were on the treatment also at the end of the year. So we are continuously encouraged about stay time.
當我們看到你說的其他沒有出現供應中斷的國家時,我們看到,例如在丹麥,人們從 2023 年初開始接受治療,很大一部分——非常大的一部分, 90% 的人也在年底接受了治療。因此,我們不斷鼓勵停留時間。
When we look at different groups of people, we see stay time is significantly longer for people that have been on Saxenda before. Maybe they are more prone to usage of GLP-1. And we also see that stay time is significantly longer with people that are living in, so to say, more affluent areas, so more on the East Coast and in the South of the US.
當我們觀察不同人群時,我們發現以前來過 Saxenda 的人的停留時間明顯更長。也許他們更傾向於使用 GLP-1。我們還發現,居住在較富裕地區的人們的停留時間明顯更長,尤其是居住在美國東海岸和南部的人。
And so also in terms of age, we see stay time being longer for people older than 30 to 40 years compared to younger and so on. So keep in mind, six months is really impacted by all these things. Having said that, close to or more than 80% of the Wegovy scripts are to patients that are naive to therapy, meaning they have not been on therapy before. So of course, there are some switches between GLP-1s, but I think this is close to -- if we look at competition, they are sourcing probably around 10% to 11% from Wegovy and so on.
因此,就年齡而言,我們發現 30 至 40 歲以上的人比年輕人等人的停留時間更長。因此請記住,六個月確實受到所有這些因素的影響。話雖如此,接近或超過 80% 的 Wegovy 腳本是針對未接受過治療的患者的,這意味著他們之前從未接受過治療。當然,GLP-1 之間存在一些轉換,但我認為這接近——如果我們看看競爭,他們可能從 Wegovy 等採購大約 10% 到 11% 的產品。
So there will always be sort of changes of that. But the majority of all patients starting on obesity treatment are new to treatment, just based on the fact that obesity really hasn't been treated to a large extent before. So we are still in the early days of a very low percentage of the total population being treated.
所以總是會有一些變化。但大多數開始接受肥胖治療的患者都是新手,因為肥胖之前確實沒有得到很大程度的治療。因此,我們仍處於接受治療的總人口比例非常低的早期階段。
Jacob Martin Wiborg Rode - Head of IR
Jacob Martin Wiborg Rode - Head of IR
Yes. Same table.
是的。同一張桌子。
Ben Jackson - Analyst
Ben Jackson - Analyst
Yeah. Thank you. Another question, if I may, on Catalent. I wanted to ask if you have a sense of how quickly you can ramp up on the fill, finish lines, because my understanding is that most of them are under a contract that might take a while to expire.
是的。謝謝。如果可以的話,還有一個關於卡塔倫特的問題。我想問你是否知道你能多快完成填充和終點線,因為我的理解是,他們中的大多數人都簽訂了可能需要一段時間才能到期的合約。
Jacob Martin Wiborg Rode - Head of IR
Jacob Martin Wiborg Rode - Head of IR
Karsten, I'll give it to you.
卡斯滕,我把它給你。
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Karsten Munk Knudsen - Chief Financial Officer, Executive Vice President
Yes, we do have a good sense of that because that's the core of the entire acquisition case to access additional capacity. So do bear in mind that we are already working with the Catalent as a CMO. So there are line working for Novo Nordisk already with Catalent.
是的,我們確實對此有很好的認識,因為這是獲得額外產能的整個收購案例的核心。因此請記住,我們已經作為 CMO 與 Catalent 合作。因此,諾和諾德 (Novo Nordisk) 已經與康泰倫特 (Catalent) 合作開展生產線。
So what we're getting is additional capacity on the different lines at the different sites. And of course, we honor the contracts that are in place with existing customers, so they have to run off.
因此,我們得到的是不同站點不同線路上的額外容量。當然,我們尊重與現有客戶簽訂的合同,因此他們必須離開。
And then, let's say, the deal closes by end of this year, then we'll have to do technology transfer to the new lines also during 2025. So you could say, additional capacity beyond what we have already contracted as a CMO will gradually start from 2016 and onwards.
然後,假設交易在今年年底完成,那麼我們也必須在 2025 年期間將技術轉移到新生產線。 所以你可以說,除了我們作為 CMO 已經簽訂的合約之外的額外產能將逐漸增加從2016年開始。
Jacob Martin Wiborg Rode - Head of IR
Jacob Martin Wiborg Rode - Head of IR
Thank you, Karsten. And we'll go to Emily -- sorry, over here, the same table.
謝謝你,卡斯滕。我們要去艾蜜莉——抱歉,在這兒,同一張桌子。
Kuti Katalia - Analyst
Kuti Katalia - Analyst
Hi. [Kuti Katalia] from Berenberg. Just a question on Wegovy access. So we've heard that certain employers have reversed their initial decisions to provide access to obesity medications just because of the escalating demand and associated costs. Is this a trend that you have seen? And related to that, could you just provide us an update as to your current formulary access, and specifically the proportion of covered lives that have employer opt-in?
你好。 [庫蒂·卡塔利亞]來自貝倫貝格。只是一個關於 Wegovy 訪問的問題。因此,我們聽說某些雇主只是因為需求不斷增加和相關成本而改變了最初提供肥胖藥物的決定。這是您看到的趨勢嗎?與此相關,您能否向我們提供有關您當前的處方訪問權限的最新信息,特別是雇主選擇加入的承保生活的比例?
Jacob Martin Wiborg Rode - Head of IR
Jacob Martin Wiborg Rode - Head of IR
In terms of the employee opt-in, Camilla, will you give that a go?
關於員工選擇加入,卡米拉,你會嘗試嗎?
Camilla Sylvest - Executive Vice President - Commercial Strategy and Corporate Affairs
Camilla Sylvest - Executive Vice President - Commercial Strategy and Corporate Affairs
Yeah. So yeah, first of all, we have more than 50 million patients being covered in the US, so very strong access. And around 80% of them, 80% pay up to only $25 per script in terms of self-pay. When it comes to opt-ins, there will always be opt-ins and opt-outs, but we continue to have a net opt-in, so to say, of employers. So it just means that we'll continue to broaden our access.
是的。所以,是的,首先,我們在美國有超過 5000 萬名患者受到覆蓋,因此獲得的機會非常大。其中約 80% 的人,80% 的人自費最多只支付每個腳本 25 美元。當談到選擇加入時,總會有選擇加入和選擇退出的情況,但我們仍然有雇主的淨選擇加入。所以這只是意味著我們將繼續擴大我們的訪問範圍。
Jacob Martin Wiborg Rode - Head of IR
Jacob Martin Wiborg Rode - Head of IR
Thank you, Camilla. And then the last question will go to Emily before we round off.
謝謝你,卡米拉。最後一個問題將在我們結束之前問艾米麗。
Emily Field - Analyst
Emily Field - Analyst
Hi. Emily Field from Barclays. A somewhat similar question, but going back to the question of stay time, how much do you think that insurance coverage in the US deflates -- or dampened stay time just with people switching jobs, aging into Medicare and so they might not have coverage to that degree? I mean do you see that as also a big dampening effect in addition to the supply constraints?
你好。巴克萊銀行的艾米麗·菲爾德。一個有點類似的問題,但回到停留時間的問題,您認為美國的保險覆蓋範圍會減少多少,或者只是隨著人們換工作、進入醫療保險而減少停留時間,因此他們可能沒有保險那個學位?我的意思是,您是否認為除了供應限制之外,這還有很大的抑製作用?
Camilla Sylvest - Executive Vice President - Commercial Strategy and Corporate Affairs
Camilla Sylvest - Executive Vice President - Commercial Strategy and Corporate Affairs
Yes. So I think there will always be people that may opt from one team to another where they are not covered or so, and that, of course, happens. But given that 50 million lives are covered, I think we don't need to be preoccupied with the potential in terms of coverage.
是的。因此,我認為總是會有人從一個團隊選擇另一個團隊,而他們沒有被覆蓋,當然,這種情況會發生。但鑑於涵蓋了 5000 萬人的生命,我認為我們不需要全神貫注於覆蓋方面的潛力。
Also keeping in mind, on stay time, it's really in the first sort of 60 days that we really see the drop-offs, probably part of getting used to GLP-1. But then once people continue to stay on, then they stay on longer. So keep in mind that it's -- six months is truly an average, and you have to think about the variation in this.
另外請記住,就停留時間而言,我們確實是在前 60 天中才真正看到了下降,這可能是習慣 GLP-1 的一部分。但一旦人們繼續堅持下去,他們就會堅持更久。因此請記住,六個月確實是平均時間,您必須考慮其中的變化。
And so of course, that's also why there are significantly higher stay time for people who have been on GLP-1 before most likely, because they have been -- they are either used to being initiated on GLP-1 knowing more what to expect. And therefore, the average daytime is much longer.
當然,這也是為什麼之前使用過 GLP-1 的人的停留時間明顯更長,因為他們要么習慣於開始使用 GLP-1,以了解更多的期望。因此,平均白天時間要長得多。
So think about it much more like that. But we have -- we think we're treating 1 million patients now, but 50 million being covered, this is not what is holding anyone back. So to the points from before, we're truly scaling production to be able to supply more doses into -- starter doses, so the people can start and continue on the treatment. That's really what we are working on right now.
所以更應該這樣思考。但我們認為我們現在正在治療 100 萬患者,但覆蓋了 5000 萬患者,這並不是阻礙任何人的原因。因此,就先前的觀點而言,我們確實正在擴大生產規模,以便能夠提供更多劑量的起始劑量,以便人們可以開始並繼續治療。這確實是我們現在正在努力的事情。
Jacob Martin Wiborg Rode - Head of IR
Jacob Martin Wiborg Rode - Head of IR
Thank you, Camilla. And before handing over to you, Lars, for final remarks. Thanks, everybody, in the room for coming and for everyone online for dialing in. In case of any follow-ups, please reach out to Investor Relations. Lars, final thoughts.
謝謝你,卡米拉。拉斯,在交給你做最後的發言之前。感謝房間裡各位的到來以及在線撥入的各位。拉斯,最後的想法。
Lars Fruergaard Joergensen - President, Chief Executive Officer
Lars Fruergaard Joergensen - President, Chief Executive Officer
So thank you. So I hope it comes across that we're very pleased about where we are as a company, both in terms of our traction with, say, sema and other products, not least in the US market. We upgrade because we have more supply coming and we're upgrading value. So you don't need to worry about the price per script, so to say.
所以謝謝你。因此,我希望人們對我們作為一家公司的現狀感到非常滿意,無論是在我們對 sema 和其他產品的吸引力方面,尤其是在美國市場。我們升級是因為我們有更多的供應並且我們正在提升價值。因此,您無需擔心每個腳本的價格。
A lot of questions, I appreciate that, on pipeline because we have a really exciting second half of the year, not only in a growth point of view, but also in terms of inflection points for pipeline. And I think Martin has some good points there.
我很欣賞關於管道的許多問題,因為我們今年下半年非常令人興奮,不僅從成長的角度來看,而且從管道的拐點來看。我認為馬丁有一些很好的觀點。
So thank you very much for your interest. We look forward to share more details on all these aspects as they evolve over time. Thank you.
非常感謝您的關注。隨著時間的推移,我們期待分享所有這些方面的更多細節。謝謝。