諾和諾德 (NVO) 2024 Q1 法說會逐字稿

Good afternoon, everyone. Welcome to the revamped Stirling Square Bank, and good afternoon to everyone in the room. And to those listening on the webcast, good morning, good afternoon, good evening. It's been a very busy week for earnings and in other events, but we are ending the week on a high with the Q1 ratio of Novo Nordisk.

大家下午好。歡迎來到改建後的史特靈廣場銀行，祝在座的各位下午好。對於那些收聽網路廣播的人，早上好，下午好，晚上好。對於收益和其他事件來說，這是非常繁忙的一周，但我們以諾和諾德第一季比率的高點結束了這一周。

The speakers don't really need introduction, but just out of courtesy, Karsten, Group's CFO; Camilla, Group Commercial Strategy Head; and last but not least, Martin, Head of R&D, joined by us and already of Investor Relations.

發言人並不需要介紹，只是出於禮貌，集團財務長卡斯滕 (Karsten)； Camilla，集團商業策略主管；最後但並非最不重要的一點是，研發主管馬丁（Martin）與我們一起加入，並且已經是投資者關係部門的負責人。

Now usually, I'd be saying without further ado, hand it straight over to Karsten to some slides and some Q&A. But I think it is worth just pausing and recognizing that it is Mr. Daniel Bohsen, his last function as the Head of Novo Investor Relations. And I think that needs to be sort of recognized by the audience in the room, not just yet, but when I say. But on that note, I have known Danny, I think, for over 15 years. He was in the (inaudible) analyst covering Novo Nordisk. And we were discussing instrument back in the days. And then I think with [Martin's flexing], he was sent off to Colombia to go sell some drugs. And then came back in 2020 to be a Head of Investor Relations. And I think we can all agree, being head of IR in 2020 to 2024 for Novo, not a bad place to be.

現在，我通常會說，事不宜遲，直接將其交給卡斯滕進行一些幻燈片和問答。但我認為值得停下來認識一下，這是 Daniel Bohsen 先生，他最後擔任 Novo 投資者關係主管。我認為這需要得到房間裡的觀眾的認可，不是現在，而是當我說的時候。但就這一點而言，我想我認識丹尼已經超過 15 年了。他是諾和諾德公司（Novo Nordisk）的（聽不清楚）分析師。那時我們正在討論樂器。然後我認為隨著[馬丁的表現]，他被派往哥倫比亞去出售一些毒品。然後在 2020 年回歸擔任投資者關係主管。我認為我們都同意，在 2020 年至 2024 年擔任 Novo 的 IR 主管，這並不是一個糟糕的職位。

So Danny, I mean this and hopefully, I'm speaking on behalf of everyone here and on the line, your professionalism, your patience dealing with people like ourselves, your responsiveness, helpfulness and just all around being a good bloke, really appreciate it. And we wish you well on your next venture with Novo Nordisk. But plenty of good times, and I have to say just to call out, I think [meeting] in 2016 was a particular highlight. So thank you for making that special.

所以丹尼，我的意思是這個，希望我代表這裡和線上的每個人發言，你的專業精神，你對待像我們這樣的人的耐心，你的反應能力，樂於助人以及作為一個好人的一切，真的很感激。我們祝福您與諾和諾德的下一次合作一切順利。但有很多美好的時光，我不得不說，我認為 2016 年的[會議]是一個特別的亮點。所以謝謝你讓這件事變得特別。

So before we say goodbye to Danny and wish him well, I do have a little gift for you. It's within my compliance policy of less than $25, but it's a -- it is to help you immerse yourself in the Taiwanese culture. So Danny, on behalf of everyone here, I do want to say thanks for everything, and good luck going forward. So thank you.

因此，在我們向丹尼道別並祝他一切順利之前，我有一份小禮物要送給你。它符合我的低於 25 美元的合規政策，但它是為了幫助您沉浸在台灣文化中。丹尼，我代表這裡的每個人，對所做的一切表示感謝，並祝你一切順利。所以謝謝。

And I will be asking Karsten about Taiwan and the change in performance over the next few quarters under new management. So thank you.

我將詢問卡斯滕有關台灣的情況以及未來幾季在新管理層領導下業績的變化。所以謝謝。

Great. Thank you, Pete, for those nice words to Daniel. We are all sad he's leaving, but we're also very much looking forward to following him in Taiwan. And we have a materiality assessment on what we report externally in terms of our segments business on. And every week, we'll be tracking in our weekly sales, if Taiwan sales is becoming big enough to include in the quarterly external announcement. So we're all rooting for you, Daniel, for Taiwan to make one of the coming quarters.

偉大的。皮特，謝謝你對丹尼爾說的好話。我們都很難過他的離開，但我們也非常期待跟著他去台灣。我們對我們的部門業務對外報告的內容進行了重要性評估。每週，我們都會追蹤每週的銷售額，如果台灣銷售額大到足以包含在季度外部公告中。所以我們都支持你，丹尼爾，台灣將成為未來幾季的一員。

And thank you to Pete and Citi for hosting in your beautiful new premises here, nicely revamped, so we appreciate that. And then we're bringing another strong quarter from team Novo in terms of performance. So continued growth, continued momentum from last year amongst the strongest growth stories in the industry, as you know, and we keep pushing that.

感謝皮特和花旗在這裡接待了你們美麗的新辦公大樓，並進行了很好的翻新，所以我們對此表示感謝。然後，我們將帶來 Novo 團隊在業績方面又一個強勁的季度表現。如您所知，去年的持續成長和持續勢頭是業內最強勁的成長故事，我們將繼續推動這一目標。

So as you know, the future is uncertain and it might play out differently. And hence, we have a nice deck with the forward-looking statements included. So no further details on that.

如您所知，未來是不確定的，結果可能會有所不同。因此，我們有一個很好的平台，其中包含前瞻性陳述。所以沒有更多細節。

Then every quarter, we bring a status on our strategy execution, and I'm not going to go through all the details. You'll hear a lot more about it in the coming hour. Just to say on the environmental side, we keep pushing forward. Now we started reporting on full Scope 1, 2 and 3, and you see that being up 32%. And there's one single key driver for our CO2 emissions being up that much. That is the fact that we're building a lot of new factories, which goes directly into our Scope 3 emissions. So we don't take it lightly, but now we are fully transparent around our environmental footprint.

然後每個季度，我們都會提供戰略執行的狀態，我不會詳細介紹所有細節。在接下來的一個小時內，您會聽到更多有關它的資訊。只是說在環境方面，我們不斷前進。現在我們開始報告完整的範圍 1、2 和 3，您會看到成長了 32%。我們的二氧化碳排放量大幅上升有一個關鍵驅動因素。事實上，我們正​​在建造許多新工廠，這些工廠直接影響我們的範圍 3 排放。因此，我們不會掉以輕心，但現在我們的環境足跡完全透明。

42 million people now on Novo products, up 4 million compared to a year ago, and then continued strong commercial execution that Camilla will come back to. I think actually, one of the biggest years ever in Novo history in terms of the magnitude and importance of an R&D readout. I'm getting an echo from the new audio. I'll keep talking. And then net-net, 24% sales growth. So really pushing on all fronts. You'll hear much more.

現在有 4,200 萬人使用 Novo 產品，比一年前增加了 400 萬人，然後卡米拉將繼續保持強勁的商業執行力。我認為實際上，就研發讀數的規模和重要性而言，這是 Novo 歷史上最重要的一年之一。我從新音訊中聽到了迴聲。我會繼續講下去。然後淨淨銷售額成長24%。所以真的在各方面都在努力。你會聽到更多。

So without further ado, over to Camilla on commercial execution.

言歸正傳，接下來就讓卡米拉來談談商業執行。

Thank you, Karsten. And just a recap on our sales growth numbers, this first quarter, we had 24% sales growth, 30% operating profit growth. As you can see from the slide here, 35% growth in North America and 11% growth in International Operations. The growth is really driven by GLP-1. We see a 32% growth in GLP-1 in diabetes, 42% growth in obesity. We are very pleased with the progression of, of course, our GLP-1 business both in diabetes and obesity.

謝謝你，卡斯滕。回顧我們的銷售成長數據，第一季度，我們的銷售成長了 24%，營業利潤成長了 30%。正如您從此處的幻燈片中看到的，北美業務成長了 35%，國際業務成長了 11%。這種增長實際上是由 GLP-1 推動的。我們發現糖尿病患者的 GLP-1 增加了 32%，肥胖患者的 GLP-1 增加了 42%。當然，我們對糖尿病和肥胖症領域 GLP-1 業務的進展感到非常高興。

On total diabetes, we continue to gain market share. We have also increased market share this last quarter and now at 33%. And if we now look at the obesity business here, you see a gradual increase of supply continue to expand our obesity business. We very much, of course, understand that at this point in time, the obesity business is a lot driven by the supply into the market. The underlying business is performing very well. There are no major changes to that compared to last year. So we continue to be happy to -- with the progression that we see here.

在整體糖尿病方面，我們繼續獲得市場份額。上個季度我們的市佔率也有所增加，目前已達到 33%。如果我們現在看看這裡的肥胖業務，您會發現供應逐漸增加，並繼續擴大我們的肥胖業務。當然，我們非常明白，目前肥胖業務在很大程度上是由市場供應所驅動的。基礎業務表現非常好。與去年相比，沒有重大變化。因此，我們仍然對我們在這裡看到的進展感到高興。

We have gradually increased our supply of the lower-dose strength since May last year, but again from January this year. And the fourth commercial access on the formularies means that we have approximately 50 million lives covered in the U.S. And we have now also launched Wegovy in 9 countries in International Operations plus Canada. So that means 10 countries now where we have made Wegovy available.

自去年五月以來，我們逐漸增加了低劑量強度的供應，但從今年一月開始又再次增加了供應。處方集的第四次商業准入意味著我們在美國覆蓋了大約 5000 萬人的生命。這意味著我們現在已經在 10 個國家/地區提供了 Wegovy。

We'll probably talk a little bit more about that later. So now I'll just hand over to Martin to say a few words about R&D.

我們稍後可能會詳細討論這一點。現在我將請 Martin 談談研發方面的情況。

Thank you very much, Camilla. As you all know, we conducted a small study called SELECT that read out last year, and we were very excited about the results. We are equally excited about the update to the U.S. label that we've received during this quarter. Obviously, we get the CV indication indicating that semaglutide is associated with a 20% risk reduction from MACE, major adverse cardiovascular events. That's myocardial infarction, stroke and it's cardiovascular death.

非常感謝你，卡米拉。眾所周知，我們進行了一項名為 SELECT 的小型研究，該研究於去年公佈，我們對結果感到非常興奮。我們對本季收到的美國標籤的更新同樣感到興奮。顯然，我們得到的 CV 指示顯示索馬魯肽與 MACE（主要不良心血管事件）風險降低 20% 相關。這就是心肌梗塞、中風和心血管死亡。

On top of that, this risk reduction is now reflected in the label. It is achieved regardless of baseline gender, age, race, ethnicity, body mass index and baseline renal functions. On top of that, we also saw -- were allowed to indicate the data despite the fact that it was outside of the testing hierarchy, where we see a 15% numerical reduction in cardiovascular death and a 19% significant reduction on all-cause mortality. And that is now reflected in the label, which obviously is something that we are very, very excited about.

最重要的是，這種風險降低現在已經反映在標籤上。無論基線性別、年齡、種族、民族、體重指數和基線腎功能如何，都能實現這一目標。最重要的是，我們也看到——儘管事實上它超出了測試層次，但我們仍被允許顯示這些數據，我們看到心血管死亡人數減少了15%，全因死亡率顯著減少了19 % 。現在這已經反映在標籤上，這顯然是我們非常非常興奮的事情。

In addition, the FDA has indicated that the mechanism of the CV benefit is not fully understood, indicating that, that benefit is associated with more than just the body weight loss. And this is something that we've talked to a couple of times. We see something in semaglutide that goes above and beyond body weight loss when it comes to the CV benefit, potentially also the renal benefits that we have observed with the molecule.

此外，FDA 表示，CV 益處的機制尚未完全了解，這表明該益處不僅與體重減輕有關。這是我們已經談過幾次的事情。我們發現索馬魯肽對心血管的益處超出了體重減輕的範圍，而且我們觀察到的該分子也可能對腎臟有益。

In line with our broader cardiovascular strategy, we are continuing to do acquisitions to bolster our pipeline. As you know, our focus when we talk about cardiovascular disease is not any cardiovascular disease. It's basically in the broader metabolic aspects of cardiovascular disease. Key focus is on [A, phase B] and inflammation and on heart failure with preserved ejection fraction.

根據我們更廣泛的心血管策略，我們正在繼續進行收購以加強我們的產品線。如您所知，當我們談論心血管疾病時，我們關注的焦點不是任何心血管疾病。它基本上涉及心血管疾病更廣泛的代謝方面。重點關注 [A，B 相] 和發炎以及射血分數保留的心臟衰竭。

We recently acquired a company called Cardior, having a lead asset, which was -- is an ASO, targeting microRNA 132, which is directly involved in heart failure pathophysiology. So this goes directly into our strategy of expanding our cardiovascular presence. We'll focus on heart failure, we'll focus on the [ACBD]. And we're very excited about progressing the cardio assets into further clinical development.

我們最近收購了一家名為 Cardior 的公司，該公司的主要資產是 ASO，針對 microRNA 132，它直接參與心臟衰竭病理生理學。因此，這直接影響到我們擴大心血管業務的策略。我們將重點放在心臟衰竭，我們將重點放在 [ACBD]。我們對於將有氧資產推進進一步的臨床開發感到非常興奮。

These were just 2 highlights. Obviously, it's quite exciting, as Karsten also alluded, to be in R&D in Novo Nordisk space. We do see progress across all of our study areas, obviously, with chief focus on diabetes, cardiovascular disease, obesity and rare blood disorders. But we do also see progress in our hepatology focus, specifically semaglutide for NASH, where we will see the readout of the ESSENCE Phase III trial later this year.

這些只是 2 個亮點。顯然，正如卡斯滕也提到的那樣，參與諾和諾德領域的研發是非常令人興奮的。顯然，我們確實在所有研究領域都取得了進展，主要關注糖尿病、心血管疾病、肥胖和罕見血液疾病。但我們也確實看到了肝病學重點方面的進展，特別是治療 NASH 的索馬魯肽，我們將在今年稍後看到 ESSENCE III 期試驗的結果。

We also see progress in our readout, obviously, exemplified by FLOW. And that basically means that we continue to press on all cylinders and see very successful readout, very successful initiations throughout the course of the year. This, I think, is almost going to be the quiet quarter because moving into the later stages of this year, we are looking towards 2 advisory committees with the U.S. FDA. One is on icodec. icodec has already received a positive CHMP opinion from the European authorities. It's approved in Canada and Switzerland. And it has an action date in U.S. in July. And the outcome for icodec in U.S. is focused specifically on type 1 diabetes. And the AdComm is also from a timing perspective place so that this is in due time for the action date. So it's going to be a good discussion.

顯然，我們也看到讀數方面取得了進展，以 FLOW 為例。這基本上意味著我們將繼續全力以赴，並在這一年中看到非常成功的讀數和非常成功的啟動。我認為，這幾乎將是一個安靜的季度，因為進入今年後期，我們正在尋求與美國 FDA 建立兩個諮詢委員會。一種是在 icodec 上。 icodec 已收到歐洲當局 CHMP 的積極意見。它在加拿大和瑞士獲得批准。它在美國的行動日期是七月。美國 icodec 的成果特別關注第 1 型糖尿病。 AdComm 也是從時間角度來看的，因此這對於行動日期來說是在適當的時間。所以這會是一次很好的討論。

We have been informed that the committee will not discuss the top 2 indications, which we've already discussed is clearly demonstrating a very nice benefit-risk, but also some very nice convenient benefits of icodec in this space.

我們被告知，委員會不會討論前2 個適應症，我們已經討論過這兩個適應症，這清楚地表明了icodec 在該領域的一個非常好的效益-風險，但也有一些非常好的方便的好處。

We have other Advisory Committee hearing is going to be about heart failure with preserved ejection fraction and semaglutide. And this is a huge upside. So as you know, we conducted the STEP HFpEF trials with the purpose of looking at 6-minute walking test and [cancer study] heart questionnaire. But in those 2 studies, we also saw 100 points, heart failure hospitalization and cardiovascular death. When we submitted the data, the FDA actually granted us both priority review, indicating that the data are actually exciting, clinically relevant, but also coming from 2 small studies. So we also got the Advisory Committee here in to discuss the impact of that. And again, a huge upside for semaglutide, specifically with Wegovy.

我們還有其他諮詢委員會聽證會將涉及射血分數保留的心臟衰竭和索馬魯肽。這是一個巨大的優勢。如您所知，我們進行了 STEP HFpEF 試驗，目的是觀察 6 分鐘步行測試和[癌症研究]心臟問卷。但在那兩項研究中，我們也看到了 100 分、心臟衰竭住院和心血管死亡。當我們提交數據時，FDA 實際上授予了我們兩項優先審查權，這表明這些數據實際上令人興奮，具有臨床相關性，而且也來自兩項小型研究。因此，我們也邀請了諮詢委員會來討論其影響。再次強調，索馬魯肽具有巨大的優勢，特別是與 Wegovy 一起使用。

I can feel Karsten is becoming impatient, so I have to start focusing. Maybe just calling out that in a couple of weeks, we'll see the long-awaited data in our rare blood disorder franchise for Mim8, which obviously also could potentially be something very, very exciting.

我能感覺到卡斯滕變得不耐煩，所以我必須開始集中註意力。也許只是指出，幾週後，我們將在 Mim8 的罕見血液疾病專營權中看到期待已久的數據，這顯然也可能是非常非常令人興奮的事情。

So with that, back to you, Karsten.

那麼，回到你身上，卡斯滕。

Thank you, Martin, for -- I mean I will walk through the slides, as always. Joking aside, amazing year from R&D in terms of readouts and actions. I cannot remember a year where we've had so much action and so many readouts and decision points. So really, really important to deliver on this.

謝謝馬丁，我的意思是我將一如既往地瀏覽幻燈片。開玩笑吧，在讀數和行動方面，研發工作是令人驚嘆的一年。我不記得哪一年我們採取瞭如此多的行動、如此多的讀數和決策點。實現這一點真的非常非常重要。

So results for the first 3 months, you've all seen it in our company announcement that -- coming back to 24% growth, continuing the momentum from last year, the same growth drivers being Ozempic and Wegovy and Rybelsus. Then in the quarter, we had a one-off in terms of an accounting estimate adjustment, which bumped up growth by 5%. So adjust for that, we are in the 19 range. Yes, last year's comparator was easier, but then there were some supply issues. So just to say, the run rate in the first quarter is around 20% apples-to-apples.

因此，前 3 個月的業績，你們都在我們公司的公告中看到了——增長回到了 24%，延續了去年的勢頭，同樣的增長動力是 Ozempic、Wegovy 和 Rybelsus。然後在本季度，我們進行了一次會計估計調整，使成長提高了 5%。因此，對此進行調整，我們處於 19 範圍內。是的，去年的比較器更容易，但隨後出現了一些供應問題。可以這麼說，第一季的運行率在 20% 左右。

Then in terms of our capital and resource allocation, as I called at the Capital Markets Day, of course, we continue to drive productivity for the broadly stable gross margin. Lower growth in commercial investments than sales growth simply due to the fact that we have the infrastructure in place and the demand nature for our products. But then on the other hand, linked to the slide you just saw, a lot of opportunity in R&D, so really pushing to expand and broaden our R&D pipeline, saving up R&D investments by 28%. All in all, operating profit up 30% and our earnings per share up 29% for the quarter.

然後，就我們的資本和資源配置而言，正如我在資本市場日所呼籲的那樣，我們當然會繼續提高生產力，以實現整體穩定的毛利率。商業投資的成長低於銷售成長，僅僅是因為我們擁有適當的基礎設施和對我們產品的需求性質。但另一方面，與您剛才看到的幻燈片相關，研發方面有很多機會，因此真正推動擴大和拓寬我們的研發管道，節省了 28% 的研發投資。總而言之，本季營業利潤成長 30%，每股收益成長 29%。

Outlook for the year. If you adjust for the accounting estimate adjustment in the first quarter, then our guidance is unchanged at constant exchange rates, but bumped by 1% linked to the one-off. So now our full year expectations are between 19% and 27% on top line growth and 22% and 30% on OP. And then given the strengthening dollar, then currencies are a little bit more favorable, which are then in turn offset by our heavy losses on the net financials.

全年展望。如果您對第一季的會計估計調整進行調整，那麼我們的指引在固定匯率下保持不變，但與一次性相關的則上漲了 1%。因此，現在我們對全年營收成長的預期為 19% 至 27%，營業收入成長為 22% 至 30%。然後，考慮到美元的走強，貨幣會變得更加有利，而這又會被我們淨財務狀況的嚴重損失所抵消。

All right. This covers the formal presentations. And then we have Daniel Bohsen facilitating his last Q&A. So we look forward to that. And of course, any specific questions on Taiwan, Daniel is more than open to cover them himself. Should we move to this? Yes?

好的。這涵蓋了正式演示。然後丹尼爾·博森 (Daniel Bohsen) 主持了他的最後一個問答。所以我們對此充滿期待。當然，對於任何有關台灣的具體問題，丹尼爾都非常樂意親自解答。我們應該轉向這個嗎？是的？

Luckily, I know Camilla has been the General Manager for Region China, so she will cover those questions today. But please state your name and institution. Let's go with one question per person, then we can take several rounds. And Emily had her hand up very fast.

幸運的是，我知道卡蜜拉一直是中國區總經理，所以她今天將回答這些問題。但請註明您的姓名和機構。我們每人提出一個問題，然後我們可以進行幾輪。艾米麗很快就舉起了手。

Emily Field from Barclays. I'm not going to ask directly about the competitor data overnight, but when could we expect to see the Phase I data from your once-monthly GLP-1/GIP? And how important do you think it is to have dosing convenience that goes beyond once-weekly?

巴克萊銀行的艾米麗·菲爾德。我不會在一夜之間直接詢問競爭對手的數據，但我們什麼時候可以看到你們每月一次的 GLP-1/GIP 的 I 期數據？您認為每週一次以外的給藥便利性有多重要？

Martin, I think this one is for you. A few words on that, our progress there.

馬丁，我想這個適合你。簡單說一下我們在這方面的進展。

The study for the once-monthly GLP-1/GIP is currently ongoing. We expect to see the readout around the turn of this year. In terms of the importance, I think the current dynamics, as I see it, and obviously, Camilla can also speak to that, there's a clear drive by efficacy over preference or anything else in this space. And obviously, our question where we have stuff in our pipeline is always -- is the differentiated efficacy. And then obviously, the convenience becomes a secondary factor. And we will continue to pursue that, but efficacy, as I see it, comes first.

每月一次的 GLP-1/GIP 的研究目前正在進行中。我們預計將在今年年初看到結果。就重要性而言，我認為當前的動態，正如我所看到的，顯然，卡米拉也可以說，在這個領域，功效比偏好或其他任何東西都有明顯的驅動力。顯然，我們的問題始終是──差異化功效。顯然，便利性成為次要因素。我們將繼續追求這個目標，但在我看來，效率是第一位的。

So let's go to Simon.

那我們就去找西蒙吧。

Simon Baker from Redburn. I too will refrain from asking you to comment on someone else's data that nobody has seen. But just in terms of how you see the market evolving over time, it seems highly unlikely that it will be the same in 2030 as it is today because of your own products that you have as well as others. It also seems unlikely that everything else outside Novo development will fail. Equally unlikely everything will work. So what's your assumption of how this market evolves both through your own portfolio evolution and the efforts of others?

來自雷德本的西蒙·貝克。我也不會要求你評論別人沒有看過的數據。但就您如何看待市場隨時間的演變而言，由於您擁有自己的產品以及其他產品，因此 2030 年市場不太可能與今天一樣。除 Novo 開發之外的其他一切似乎也不太可能失敗。同樣不太可能一切都會奏效。那麼，您對這個市場如何透過您自己的投資組合演變和其他人的努力而演變的假設是什麼？

Camilla, I think -- can you give some perspectives on the obesity market, how we think it will develop?

卡蜜拉，我想，您能否對肥胖市場提出一些看法，我們認為它將如何發展？

Simon, so of course, if we take a starting point in the number of people living with obesity, we know that there are more than 800 million. We know also today, we are helping treat less than 1 million in terms of full year equivalent patients, if we may call it like that. And that basically means that there's ample opportunity to grow in this space and to help many more patients.

西蒙，當然，如果我們以肥胖人數為起點，我們就會知道有超過 8 億人。我們今天也知道，如果我們可以這樣稱呼的話，我們正在幫助治療全年等效患者數量不到 100 萬人。這基本上意味著這個領域有充足的發展機會並幫助更多的患者。

It's likely that there will be different segments in the future where the high-efficacy segment is, of course, where we have our strong focus. From a science point of view, we have a strong label now with SELECT on Wegovy, where we're addressing not just weight loss but also beyond weight loss, cardiovascular risk profile. We know that, that is what people die from. 31% of everyone dies from cardiovascular issues.

未來可能會出現不同的細分市場，其中高效能細分市場當然是我們重點關注的領域。從科學的角度來看，我們現在在 Wegovy 上的 SELECT 上擁有了強大的標籤，我們不僅解決減肥問題，還解決減肥以外的心血管風險狀況。我們知道，這就是人們死亡的原因。 31% 的人死於心血管問題。

Now we have also, of course, our FLOW data. And so to complement Wegovy label with that is, of course, a life cycle management plan for us. In addition to that, we have been bringing on new compounds with also hopefully greater efficacy. But it's not to say that there will not also be a space for high-convenience products maybe with lower efficacy.

當然，現在我們還有 FLOW 數據。因此，為了補充 Wegovy 標籤，當然，我們還有一個生命週期管理計劃。除此之外，我們也一直在開發新的化合物，希望它們的功效也更大。但這並不是說高便利性但功效較低的產品就沒有空間了。

So having said that, today, there are 2 companies that are competing in this space. It's still early days. There's probably room for more just given the magnitude of the numbers. So I do expect that we've seen a lot of progress in the last few years on physicians that are willing to prescribe obesity products. Just a few years back, we all remember, it wasn't exactly like that. So there has been a lot of development. And hopefully, this means we can address more of these comorbidities related to obesity. And that, of course, clearly goes beyond just weight loss.

話雖如此，今天有兩家公司在這個領域競爭。現在還為時過早。考慮到數字的大小，可能還有更多的空間。因此，我確實希望在過去幾年中，我們在願意開設減肥產品的醫生方面取得了很大進展。我們都記得，就在幾年前，情況並非如此。所以有了很大的發展。希望這意味著我們可以解決更多與肥胖相關的合併症。當然，這顯然不僅僅是減肥。

Thanks, Camilla. So let's move over here, yes?

謝謝，卡米拉。那我們搬到這裡吧，好嗎？

Evan Seigerman from BMO Capital Markets. So I'm not going to ask about the FTC's second request because I know that's not you specifically. But I did want to ask about how much more capacity do you think you can get from the 3 facilities from Catalent? And what does that do to the supply of all of your products by 2026?

BMO 資本市場部的 Evan Seigerman。因此，我不會詢問聯邦貿易委員會的第二項要求，因為我知道那不是您特意提出的。但我確實想問一下，您認為 Catalent 的 3 個設施可以增加多少容量？到 2026 年，這對你們所有產品的供應有何影響？

Thank you, Evan. And Karsten?

謝謝你，埃文。卡斯滕呢？

Yes. So in terms of FTC, to cover that one first, it's completely normal that when you have a big transaction that there's a process with the FTC to assess any antitrust considerations. So there's nothing unusual there, and we have no changes in our expectations and in terms of deal certainty and confidence in that, just to cover that piece.

是的。因此，就聯邦貿易委員會而言，首先要討論這一點，當你進行一筆大交易時，聯邦貿易委員會有一個評估任何反壟斷考慮因素的流程，這是完全正常的。因此，這並沒有什麼不尋常的地方，我們的期望以及交易的確定性和信心方面沒有變化，只是為了涵蓋這一點。

As to scalability, we're not out explicitly guiding on the magnitude. But if you look at our current footprint on fill finish, this where we have around a handful or so of filling sites today, then adding 3 filling types of varying sizes, this is a meaningful step-up in capacity on our overall fill finish.

至於可擴展性，我們沒有明確指導其規模。但如果你看看我們目前在填充表面上的足跡，今天我們大約有幾個填充站點，然後添加 3 種不同尺寸的填充類型，這對我們整體填充表面的容量來說是一個有意義的提升。

And I would say on the single-dose syringes, we have very, very limited capacity in-house today. So that's mainly a CMO setup. And with this change, then we take a key platform for the company. We use it for currently Wegovy in U.S. as the main product, but then we take a very important production platform in-house under full control. So there's also a risk-control element to what we're doing here. So -- but a significant step-up. And the important part, the reason why we do it just to remind you, this is about speed and scale. So it is to step up capacity as fast as possible compared to other alternatives.

我想說的是，對於單劑量注射器，我們目前的內部產能非常非常有限。這主要是 CMO 設定。透過這項變化，我們為公司提供了一個關鍵平台。我們目前在美國的Wegovy使用它作為主要產品，但隨後我們在內部完全控制了一個非常重要的生產平台。因此，我們在這裡所做的事情還有一個風險控制因素。所以——但這是一個重大的進步。重要的是，我們這樣做只是為了提醒您，這與速度和規模有關。因此，與其他替代方案相比，要盡快提高產能。

Thank you, Karsten. Thanks for the question. Jo?

謝謝你，卡斯滕。謝謝你的提問。喬？

Jo Walton, UBS. It's along the same lines in terms of capacity. So I guess it's for Camilla, this one, though, perhaps. In the market today for obesity, people have moved from Saxenda to Wegovy. They've really moved up and not stayed at the lower efficacy. So let's just assume that CagriSema has good data. Should we be assuming that you would expect pretty much everyone to move from sema to CagriSema? Because that seems to be an even more difficult manufacturing problem given that cagrilintide you're making externally. And I just wonder whether governments, particularly when sema is cheaper if it's in IRA, will say that's good enough and that sema will be your baseload of product. And then in CagriSema would just be reserved for the more difficult patients. So it's more -- perhaps, it's more Simon's question about how the situation evolves and whether we should think of that transition that we've already seen moving to the next one or not.

喬沃爾頓，瑞銀集團。就容量而言，也是如此。所以我想這可能是給卡米拉的。在當今的肥胖市場上，人們已經從 Saxenda 轉向了 Wegovy。他們確實取得了進步，而不是停留在較低的效率。因此，我們假設 CagriSema 擁有良好的數據。我們是否應該假設您希望幾乎每個人都從 sema 遷移到 CagriSema？因為考慮到您在外部生產卡格里林肽，這似乎是一個更困難的製造問題。我只是想知道政府是否會說這已經足夠好了，並且 sema 將成為您產品的基本負載，特別是當 sema 在 IRA 中更便宜時。然後在 CagriSema 將只為更困難的患者保留。所以這更多是西蒙的問題，即情況如何演變，以及我們是否應該考慮我們已經看到的過渡到下一個過渡。

Thank you, Jo. Camilla?

謝謝你，喬。卡米拉？

So thanks, Jo. I think it is -- you are right, it's a completely different situation than what we have with Saxenda and Wegovy, not least just for the bare efficacy of what we have with Wegovy today, including the SELECT trial that Martin has just presented. And so because of the magnitude of the numbers and because of the number of people being treated, just the need and the demand out there, it's more likely to see an expansion of the market with new products coming in and a very strong base, of course, with Wegovy also into many years into the future.

所以謝謝，喬。我認為，你是對的，這與我們與 Saxenda 和 Wegovy 的情況完全不同，不僅僅是因為我們今天與 Wegovy 的效果，包括 Martin 剛剛介紹的 SELECT 試驗。因此，由於數字的巨大和接受治療的人數，以及那裡的需求和需求，更有可能看到市場隨著新產品的出現和非常強大的基礎而擴大。

So I would not see this whole additional of a strong pipeline as purely a cannibalization exercise. It wouldn't be the right thing to do because we have so many patients that need to be treated. And some need a higher focus on weight loss, other needs higher focus on comorbidities. So there is a position for also new innovations that are add-ons to the existing base that we are developing for many years into the future with Wegovy also.

因此，我不認為這整個額外的強大管道純粹是一種蠶食行為。這不是正確的做法，因為我們有太多患者需要治療。有些人需要更加關注減肥，其他人需要更加關注合併症。因此，新的創新也有一個位置，這些創新是我們與 Wegovy 一起在未來多年開發的現有基礎的附加內容。

Thank you, Camilla. Let's go to -- yes, James?

謝謝你，卡米拉。讓我們去——是的，詹姆斯？

It's [James Creedy] from Goldman Sachs. I've got a question for Martin on muscle sparing. So what are you hearing from doctors in terms of if there's like a desirable ratio in terms of fat loss versus muscle loss in terms of -- or is it more of a case of just losing the weight in general? And then as you think about SELECT versus STEP 1 and SUSTAIN 8, where it's 40% loss from lean body mass, have you seen any data from SELECT that suggests that flips over time or get a bit better?

我是高盛的[詹姆斯·克里迪]。我有一個關於肌肉保護的問題想問馬丁。那麼，您從醫生那裡聽到的關於脂肪減少與肌肉減少是否存在理想比例的說法是怎樣的——或者更多的是只是總體上減輕體重？然後，當您考慮 SELECT 與 STEP 1 和 SUSTAIN 8（其中去脂體重減少 40%）時，您是否看到 SELECT 中的任何數據表明隨著時間的推移，情況會發生變化或有所改善？

So what we hear from training physicians is that, that is currently not a consideration. I think it comes from a lot of these physicians have introduced weight loss with not drug interventions for a period of time. And if you look into sort of the broader literature, when you introduce a weight loss, the proportional weight loss coming from lean body mass is typically between -- somewhere between 25% and 45%. And the driver of that ratio between lean body mass loss and fat mass loss is typically the speed of weight loss.

所以我們從訓練醫生那裡聽到的是，目前這不是一個考慮因素。我認為這是因為許多醫生在一段時間內引入了非藥物幹預的減肥方法。如果你研究更廣泛的文獻，當你介紹減重時，來自去脂體重的體重減輕比例通常在 25% 到 45% 之間。瘦體重減輕與脂肪減少之間比率的驅動因素通常是體重減輕的速度。

So when you have a proportional weight loss from lean body mass around 35% to 40%, that's actually within that realm. And that basically means that, that is a normal and healthy weight loss. You could actually argue, and this is obviously also why we are super happy with data from SELECT, we can actually show even in cardiovascular risk, sick patients, so presumably slightly more frail patients, we show that we improved not only cardiovascular morbidity but actually also all-cause mortality. And that basically, again, just plays into this. This appears to be a healthy weight loss.

因此，當您的去脂體重按比例減輕 35% 至 40% 時，實際上就在這個範圍內。這基本上意味著，這是正常且健康的減肥。你實際上可以爭論，這顯然也是為什麼我們對SELECT 的數據非常滿意，我們實際上可以顯示，即使在心血管風險、患病患者、因此可能稍微虛弱的患者中，我們表明我們不僅改善了心血管發病率，而且實際上改善了還有全因死亡率。這基本上再次發揮了作用。這似乎是一種健康的減肥方式。

So based on current treatment, I don't see this as a broader problem. I think it has to be a focus area also with current treatments, in particular, in frail patients. And when we move into the potential for bigger weight loss, it has to continue to be a focus area. This is where we take some comfort from the animal biology because based on animal studies, both from us but also from others, and it appear to be associated with an even bigger improvement of the lean-to-fat mass ratio.

因此，根據目前的治療，我不認為這是一個更廣泛的問題。我認為這也必須成為目前治療的重點領域，特別是對於體弱的患者。當我們進入更大的減肥潛力時，它必須繼續成為一個重點領域。這是我們從動物生物學中得到一些安慰的地方，因為根據我們和其他人的動物研究，它似乎與瘦脂品質比的更大改善有關。

Then to body composition assessment in SELECT, so I don't have any data from there. But again, based on what we see, also based on the actual outcomes for patients, do they live longer, do they live healthier, we are quite comfortable with what we see right now.

然後在 SELECT 中進行身體組成評估，所以我沒有任何數據。但同樣，根據我們所看到的情況，也根據患者的實際結果，他們是否活得更長，他們活得更健康，我們對我們現在所看到的感到非常滿意。

Thank you, Martin. Thank you, James. Let's go to Sachin Jain on the first row.

謝謝你，馬丁。謝謝你，詹姆斯。讓我們去找第一排的 Sachin Jain。

Sachin Jain, Bank of America. Perhaps at Karsten on S&D phasing through the year alongside supplies. The question is first quarter S&D and the full year guide obviously implies an inflection in spend through the year. So any color on what is gating that inflection in spend? Is it linked to an inflection in supply? And is the supply inflection linked to whatever promotional activity you do around Ozempic, Wegovy, say, for example, SELECT or heart failure towards year-end?

薩欽‧賈恩 (Sachin Jain)，美國銀行。也許在卡斯滕，S&D 會在這一年與供應一起分階段進行。問題是第一季的 S&D 和全年指南顯然意味著全年支出的變化。那麼，對於控制支出變化的因素有什麼看法呢？它與供給的變化有關嗎？供應變化是否與您圍繞 Ozempic、Wegovy 所做的任何促銷活動（例如 SELECT 或心臟衰竭）有關？

Thank you, Sachin. Karsten, any comments on S&D phasing?

謝謝你，薩欽。 Karsten，對 S&D 分階段有何評論？

Yes. So S&D in the quarter was 20% of sales. Full year, we're looking at more around 22% or something like that in terms of the S&D ratio. So you are correct that our S&D phasing is slightly backloaded. And of course, that's linked to our commercial strategies, and our commercial strategies are linked to supply availabilities as well as R&D readouts.

是的。因此，本季的 S&D 佔銷售額的 20%。全年，我們預計 S&D 比率約為 22% 或類似水平。所以你是對的，我們的 S&D 階段稍微落後了。當然，這與我們的商業策略有關，而我們的商業策略與供應可用性以及研發讀數有關。

So for instance, now we have had SELECT, and now we'll start promoting even more based on the updated label from SELECT. That, of course, entails some promotional spending linked to that in the U.S., as a specific example. So you shouldn't link it directly -- as a direct causality that then, there's more out of manufacturing in a specific quarter. But of course, it's all tied together in a logic. So I think that's as precise as I can get.

例如，現在我們有了 SELECT，現在我們將開始根據 SELECT 更新的標籤進行更多促銷。當然，這需要一些與美國相關的促銷支出，舉個具體例子。所以你不應該直接將其聯繫起來——作為直接因果關係，那麼特定季度的製造業會更多。但當然，這一切都以邏輯連結在一起。所以我認為這是我所能得到的最精確的結果。

And on R&D, sorry, is there anything other than SELECT that you'd call out?

關於研發，抱歉，除了 SELECT 之外，還有什麼需要指出的嗎？

In terms of readouts?

在讀數方面？

Yes. You said commercial linked to R&D other than SELECT R&D. Apologies. You said commercial linked to R&D, so in SELECT, is there anything else that we should be thinking about this being linked to?

是的。你說商業與研發相關，而不是選擇研發。道歉。您說商業與研發相關，那麼在 SELECT 中，我們是否應該考慮與此相關的其他內容？

Well, you could say in terms of weekly launches, there will, of course, be some launch preparations taking place there. And then Martin's, in pipeline slide there, you saw that whatever we get in terms of feedback from the Advisory Committees also on HFpEF will impact our commercial strategies for the rest of the year.

嗯，你可以說，就每週的發布而言，當然會在那裡進行一些發布準備。然後馬丁在管道幻燈片中看到，無論我們從諮詢委員會獲得關於 HFpEF 的反饋，都將影響我們今年剩餘時間的商業策略。

Thank you, Sachin. Thank you, Karsten. So we can go to Richard.

謝謝你，薩欽。謝謝你，卡斯滕。這樣我們就可以去找理查德了。

Richard Parkes from BNP Paribas Exane. So a follow-on for a question I asked yesterday, but it's on the same theme related to potential segmentation of the market. Because obviously, the other companies are making it about if you can develop a scalable oral, then you can unlock a much broader opportunity in maybe that severely obese people with overweight and health issues.

法國巴黎銀行的理查‧帕克斯 (Richard Parkes)。這是我昨天問的一個問題的後續內容，但它的主題與市場潛在細分相關。因為顯然，其他公司正在努力，如果你能開發出一種可擴展的口服產品，那麼你就可以為患有超重和健康問題的嚴重肥胖者釋放更廣泛的機會。

So you've placed your bet on [rimonabant], which -- I suppose my question is what -- how confident are you that the drug isn't getting into the brain, and therefore, won't have psychiatric side effects? Because we see other companies that are developing BTK inhibitors arguing about who's got the best data of the drug's ability to penetrate the brain. So what underpins your confidence that the drug isn't getting into the brain, and therefore, unlikely to cause those side effects?

所以你把賭注押在了利莫那班上，我想我的問題是，你對這種藥物不會進入大腦、因此不會產生精神副作用有多大信心？因為我們看到其他正在開發 BTK 抑制劑的公司爭論誰擁有該藥物穿透大腦能力的最佳數據。那麼，是什麼讓您相信該藥物不會進入大腦，因此不太可能引起這些副作用？

Martin, this one's for you.

馬丁，這個是給你的。

Yes. Thank you. So we are quite confident that the brain penetration is substantially less than what has been the case for previous drugs in this class. We've never talked about ruling out some brain penetration. But if you look back at the historical cases, it was actually about exposure. And therefore, with a very low penetration that we expect to potentially see here based on the data, also clinical data that we have seen so far, we are not concerned.

是的。謝謝。因此，我們非常有信心，大腦滲透性大大低於此類藥物之前的情況。我們從未討論過排除某些大腦滲透的可能性。但如果你回顧歷史案例，其實就是曝光問題。因此，根據數據以及我們迄今為止所看到的臨床數據，我們預計可能會看到非常低的滲透率，因此我們並不擔心。

We take it seriously, and that's also why you'll actually see us -- normally, I'll talk about the speed to going into Phase III and further development. In this specific case, we actually specifically want to do a large-scale Phase II study with the purpose of ruling out any new psychiatric risks.

我們認真對待它，這也是為什麼你會真正看到我們——通常，我會談論進入第三階段和進一步開發的速度。在這個具體案例中，我們實際上特別想要進行大規模的第二期研究，目的是排除任何新的精神風險。

Thank you, Martin. We can go to Laura. There's a mic behind you.

謝謝你，馬丁。我們可以去找勞拉。你身後有一個麥克風。

Laura Hindley, Berenberg. Just going back to the once-monthly, what is the latest on applying your once-monthly technology to your other pipeline assets? So could you apply it to amycretin, CagriSema? And if not, what's the limiting factor? And does once-monthly tie into why you progressed the GLP-1/GIP combination, even though it's a once-weekly progression?

勞拉·欣德利，貝倫貝格。回到每月一次，將每月一次的技術應用於其他管道資產的最新情況是什麼？那你能把它應用到阿黴素、CagriSema 上嗎？如果不是，限制因素是什麼？即使是每週一次的進展，每月一次是否與您進行 GLP-1/GIP 組合的原因有關？

Thank you. Martin, that's also for you.

謝謝。馬丁，這也適合你。

So we have actually several different modalities for projected actions. And obviously, the ones that we have in the clinic right now is attracting some attention. That could potentially be applied elsewhere. But we currently have, as I said, several modalities being investigated in the preclinical space.

因此，我們實際上有幾種不同的預期行動方式。顯然，我們現在在診所擁有的那些正在引起一些關注。這可能會應用於其他地方。但正如我所說，我們目前正在臨床前領域研究幾種模式。

And what we, at the end of the day, will move forward also into later stages, development depends obviously on the efficacy but also the potential for scalability. So we are not committed to anything yet, and we have to see the current ongoing once-monthly with GLP-1/GIP. As an exposure, we started to investigate the technology.

最終，我們將進入後期階段，開發顯然取決於功效，但也取決於可擴展性的潛力。所以我們還沒有承諾任何事情，我們必須看看目前正在進行的每月一次的 GLP-1/GIP。作為曝光，我們開始研究這項技術。

Thank you. So we can go to Peter.

謝謝。這樣我們就可以去找彼得了。

Peter Welford for Jefferies. Can I come back to a topic that came up a while ago on Wegovy in terms of the different sort of formulations or types that could be available in the U.S. and sort of, in general, the U.S. strategy. Have you revised at all your current thinking in terms of sticking with the single-use pen in the U.S. market and not launching any other alternatives? And equally, any thoughts on a sort of direct distribution system that I think what your competitor obviously has done as well, where we just cut out the middleman to some extent to supply U.S. patients?

傑富瑞的彼得‧韋爾福德。我能否回到不久前在 Wegovy 上提出的一個主題，即美國可能提供的不同類型的表述或類型以及總體上的美國戰略。您是否已經改變了目前在美國市場堅持使用一次性筆而不推出任何其他替代品的想法？同樣，對於直接分銷系統有什麼想法，我認為您的競爭對手顯然也做了什麼，我們只是在某種程度上剔除了中間商來為美國患者提供服務？

Thank you, Peter. Camilla, portfolio considerations?

謝謝你，彼得。卡米拉，投資組合考量？

Yes. So we continue to, of course, evaluate how can we optimize our portfolio considerations also for the U.S. And right now, we are very focused on the single-dose device. But of course, over time, we are looking at also how can we make efficient dosing of GLP-1s in fixed, you can say, dosing regimen. How can we do that in a smarter way that requires less capacity? It's something that we constantly look at across our value chain. How can we optimize with the presentation format we have across the world? How can we release small products? And with that, also increase our scalability? So constantly, we will be evaluating those things.

是的。因此，我們當然會繼續評估如何優化我們在美國的投資組合考量。但當然，隨著時間的推移，我們也在研究如何在固定（可以說是給藥方案）中有效地給藥 GLP-1。我們如何以更聰明的方式、需要更少的容量來做到這一點？這是我們在整個價值鏈中不斷關注的事情。我們如何優化全球的演示格式？小產品如何發布？這樣，還可以提高我們的可擴充性嗎？因此，我們將不斷評估這些事情。

Good. Let's go up here to Rajesh.

好的。我們去拉傑什那裡吧。

Rajesh Kumar from HSBC. One for Martin. It would be unfair of me to ask you to comment on how others would design their clinical trials. But given the data pack we have seen so far in semaglutide, if you were designing next-generation trials for your next-generation products, would you be -- say, for example, with the like-for-like for SELECT [CAE CKD], would you be using placebo control or would you be using semaglutide? And what does that mean about how do you need to power the trial? What size of trial do you need?

來自匯豐銀行的拉傑什·庫馬爾。一件是給馬丁的。如果我要求你評論其他人如何設計他們的臨床試驗，那是不公平的。但考慮到我們迄今為止在索馬魯肽中看到的資料包，如果您正在為您的下一代產品設計下一代試驗，您會 - 例如，與 SELECT [CAE CKD ]，您會使用安慰劑對照還是會使用索馬魯肽？這對於您需要如何推動試驗意味著什麼？您需要多大規模的試驗？

Thank you. Martin, trial design consideration?

謝謝。馬丁，試驗設計考量？

So a really complex question and a lot of regulatory considerations also. I think you're actually seeing different approaches across industry right now. We are getting closer to, for example, in obesity in the cardiovascular space, if there is a gold standard, you can't compare to placebo. You have to compare to that gold standard, and that could potentially be semaglutide.

這是一個非常複雜的問題，而且還有很多監管考量。我認為您現在實際上看到了整個行業的不同方法。例如，我們越來越接近心血管領域的肥胖症，如果有黃金標準，就無法與安慰劑進行比較。你必須與黃金標準進行比較，這可能是索馬魯肽。

That basically means, from our perspective, if we, for example, look at CagriSema, if we want to claim the same benefit as semaglutide, we have to show parity with semaglutide or not a priority to semaglutide, if we did a head-to-head. That would require, I would say, a normal-sized outcomes trial if going for the same endpoint.

從我們的角度來看，這基本上意味著，例如，如果我們看看CagriSema，如果我們想要聲稱與索馬魯肽相同的益處，我們必須表現出與索馬魯肽相同的效果，或者不優先考慮索馬魯肽，如果我們進行了正面競爭-頭。我想說，如果要達到相同的終點，則需要進行正常規模的結果試驗。

If you had to show superiority over semaglutide, obviously, we are talking about a taller order. And there, we would have to be looking at obviously the sample size, but also what are the potential endpoints and what are other aspects of the trial design that would allow us to, within reason, demonstrate superiority on the relevant endpoints. You see others adding to the number of composites in the primary endpoint, and that's obviously a vehicle to increase the number of events that we're looking at and thereby influence the -- allowing it to go with a smaller sample size. So all of that has to play in.

如果你必須表現出優於索馬魯肽的優勢，顯然，我們正在談論一個更高的要求。在那裡，我們顯然必須考慮樣本量，但也要考慮潛在的終點是什麼，以及試驗設計的其他方面是什麼，這將使我們能夠在合理的範圍內證明相關終點的優越性。您會看到其他人增加了主要終點中的複合數量，這顯然是增加我們正在查看的事件數量的工具，從而影響 - 允許它使用較小的樣本量。所以所有這些都必須發揮作用。

If there is no gold standard, it makes still a lot of sense to compare to placebo. And if we look at other aspects of our product benefits, we would potentially also still be comparing to placebo. CagriSema, for example, is compared to placebo when it comes to cardiovascular outcomes. And that is basically because at the point in time where we initiated the trial, there was no gold standard.

如果沒有黃金標準，與安慰劑進行比較仍然很有意義。如果我們看看我們產品的其他方面的好處，我們可能仍然會與安慰劑進行比較。例如，在心血管結局方面，CagriSema 與安慰劑進行了比較。這基本上是因為在我們啟動試驗時，還沒有黃金標準。

Thank you, Martin. So let's go to Richard Vosser here in the front row. We have time for a few more questions.

謝謝你，馬丁。讓我們請前排的理查德·沃瑟 (Richard Vosser) 發言。我們還有時間再問幾個問題。

Richard Vosser from JPMorgan. Just a thought on the Part D redesign that we're going to see next year, how that could impact the net pricing for Ozempic and Rybelsus into '25?

摩根大通的理查‧沃瑟。只是想一下我們明年將看到的 D 部分重新設計，這將如何影響 Ozempic 和 Rybelsus 到 '25 的淨定價？

Thank you, Richard. Karsten, I think this one is for you.

謝謝你，理查。卡斯滕，我想這個適合你。

Thank you. So first of all, we are in negotiations -- business negotiation season. So we haven't formularies played out yet. So there's really a lot of uncertainty at this point in time. I would say, 2 pieces to it. There's the redesign and then there are the negotiations dynamics in Part D.

謝謝。首先，我們正處於談判──商務談判季節。所以我們還沒有製定處方。所以目前確實存在著很多不確定性。我想說，2塊。 D 部分包括重新設計和談判動態。

On the redesign, it's important to note that with the redesigned benefit design, then yes, there's a benefit because the donor toll is being eliminated, but then there's a different exposure in terms of catastrophic coverage as well as some other coverage. So net-net, while we initially thought it was directly positive, now we believe it's broadly neutral on the redesign.

在重新設計方面，值得注意的是，透過重新設計的福利設計，是的，有一個好處，因為捐助者的費用被消除了，但在災難性保險以及其他一些保險方面存在不同的風險。所以net-net，雖然我們最初認為它是直接積極的，但現在我們相信它在重新設計上基本上是中立的。

And then I'd say on the redesign impact to the plan sponsors, and hence, the insurance companies and how much -- how it impacts them and how much they can pass on to their customers and what that then in turn indirectly impacts us remain to be defined. But I would say that the competitive situation in the marketplace is unchanged between suppliers into the marketplace. So too early to comment on.

然後我想說的是重新設計對計劃發起人的影響，以及對保險公司的影響，以及它如何影響他們，他們可以將多少影響傳遞給他們的客戶，以及這反過來又間接影響我們仍然存在被定義為。但我想說的是，進入市場的供應商之間的市場競爭狀況並沒有改變。所以評論還為時過早。

Thank you, Karsten. Sachin, you had a question? And we take Emily afterwards and then end.

謝謝你，卡斯滕。薩欽，你有問題嗎？之後我們帶著艾米莉一起結束。

Sachin Jain, Bank of America. For Martin, sema, NASH, increasing flex towards year-end. Just wanted to clarify a comment you made on the call yesterday. I think your wording, and correct me if I was wrong, was if you repeated the Phase II, it would be a good outcome. Just wanted to clarify, the Phase II didn't hit that thing on fibrosis. So is just NASH resolution enough without fibrosis for filing commercial? And if that is incorrect, what's your confidence around hitting fibrosis? Is the effect size you saw in Phase II enough to get you across the hurdles in Phase III?

薩欽‧賈恩 (Sachin Jain)，美國銀行。對於 Martin、sema、NASH，在年底增加靈活性。只是想澄清你昨天在電話中發表的評論。我認為你的措辭是，如果你重複第二階段，那將是一個好的結果，如果我錯了，請糾正我。只是想澄清一下，第二階段並沒有解決纖維化問題。那麼，僅僅 NASH 解決方案就足以在沒有纖維化的情況下提交商業申請嗎？如果這是不正確的，那麼您對對抗纖維化有什麼信心？您在第二階段看到的效果量是否足以讓您跨越第三階段的障礙？

Thank you, Sachin. Martin?

謝謝你，薩欽。馬丁？

For regulatory approval, both improvement in steatosis and fibrosis is required, and the study is designed to look at that. Our dialogue with the FDA was that our Phase II trial was never sample-sized to look from a statistical perspective on fibrosis. So we saw a highly significant reduction in steatosis, which actually saw a great numerical reduction in fibrosis as well.

為了獲得監管部門的批准，需要改善脂肪變性和纖維化，而這項研究就是為了研究這一點。我們與 FDA 的對話是，我們的 II 期試驗從未進行過樣本量調整，無法從統計角度看待纖維化。因此，我們看到脂肪變性顯著減少，實際上纖維化也大幅減少。

And the statement from the FDA was if we saw a similar numerical reduction in a properly sample-sized study, obviously, that will become statistically significant. And from a regulatory perspective, that would also be acceptable. So instead of asking us to conduct 2 Phase III studies, they said that the Phase II study could serve as one of the 2 regulatory studies, and we now are doing ESSENCE as the other study.

FDA 的聲明是，如果我們在適當的樣本量研究中看到類似的數字減少，顯然，這將變得具有統計意義。從監管角度來看，這也是可以接受的。因此，他們沒有要求我們進行兩項 III 期研究，而是說 II 期研究可以作為 2 項監管研究之一，而我們現在正在做 ESSENCE 作為另一項研究。

Despite the 10% delta? If that's repeated in Phase III, is that going to account for that?

儘管有 10% 的增量？如果第三階段重複這種情況，這能解釋這一點嗎？

Slightly more than 10%. And yes, if that becomes statistically significant, then we are in a good place.

略高於10%。是的，如果這在統計上變得顯著，那麼我們就處於一個好的位置。

Thank you, Martin. Thanks, Sachin. Let's take the last questions from Emily, and then we will have time to talk with management afterwards also before they depart.

謝謝你，馬丁。謝謝，薩欽。讓我們回答艾米麗的最後一個問題，然後我們將有時間在管理層離開之前與他們交談。

Emily Field from Barclays. Going back to Wegovy pricing. I know this was asked yesterday but -- and there's an FT article today talking about Novo cuts Wegovy price. So maybe to ask it a little differently, how's the net price evolution for Wegovy in the U.S. than -- within your expectations? And you also mentioned pricing movements in certain channels. I know you'll have more Medicare going forward with SELECT, but could you just give some granularity on what you meant by that?

巴克萊銀行的艾米麗·菲爾德。回到 Wegovy 定價。我知道昨天有人問過這個問題，但今天英國《金融時報》有一篇文章談到 Novo 降低了 Wegovy 價格。因此，也許換個角度問，Wegovy 在美國的淨價格演變與您的預期相比如何？您也提到了某些管道的定價變更。我知道您將透過 SELECT 獲得更多的醫療保險，但您能否詳細說明您的意思？

So Karsten?

那麼卡斯滕？

It's probably me being cold. I better stand up for this. So this is completely as expected, right? So what we're looking at in the market is that this is a volume opportunity, and we are very happy with the market access we have in the U.S. So we have more than 50 million people with obesity covered in the U.S. today. So our market access is very good.

大概是我感冒了。我最好堅持這一點。所以這完全符合預期，對吧？因此，我們在市場上看到的是，這是一個數量機會，我們對在美國擁有的市場准入感到非常滿意。所以我們的市場准入非常好。

And of course, then we'll work with the payers to ensure that we have the appropriate market access that ensures this level of coverage or even more. And then, of course, the market is also defined through competition and competitive entry. So there are no surprises in pricing in the U.S. And just reminding you, this is a significant volume opportunity. So the 50 million people with obesity that we have covered for today, we are only serving a fraction of that, so less than 1 million now.

當然，然後我們將與付款人合作，確保我們擁有適當的市場准入，以確保這種水平的覆蓋範圍甚至更高。當然，市場也是透過競爭和競爭性進入來定義的。因此，美國的定價並不令人意外，只是提醒您，這是一個重要的銷售機會。因此，我們今天涵蓋的 5000 萬肥胖症患者，我們只為其中的一小部分提供服務，所以現在還不到 100 萬。

Thank you, Karsten. And that concludes the Q&A session. Before giving the word to Karsten for his final remarks, I just want to say thanks, Pete, for the kind words. And thanks to all of you that many of you have met many times over the last 4 years. And I've truly enjoyed the conversations, the challenging questions also in -- also the pushback. So thank you so much, and please remember to keep them on their toes also in the future.

謝謝你，卡斯滕。問答環節到此結束。在向卡斯滕做最後的發言之前，我只想感謝皮特的客氣話。感謝你們所有人，你們中的許多人在過去四年裡多次見過面。我真的很喜歡這些對話，還有挑戰性的問題——還有阻力。非常感謝您，也請記得讓他們今後也保持警覺。

Karsten, over to you. Any final words?

卡斯滕，交給你了。最後還有什麼話要說嗎？

Very briefly. Thank you, Citi, again. We feel we're on a roll. So amazing levels of sales growth continuing into this year, 24% for the quarter, turning into attractive profit growth, 30% for the quarter at the current exchange rates. Our innovation machine is really also on a roll in terms of readout and what you just have seen thus far between SELECT, FLOW, and hopefully, to be replicated into the near future on the coming readouts. So a very strong push on innovation for the rest of the year.

非常簡短。再次感謝花旗銀行。我們覺得一切順利。如此驚人的銷售成長水準一直持續到今年，該季度增長 24%，並轉化為有吸引力的利潤增長，按當前匯率計算，該季度增長 30%。我們的創新機器在讀出方面也確實進展順利，您迄今為止在 SELECT、FLOW 之間看到的內容也確實在不斷進步，希望在不久的將來能夠在即將到來的讀出中得到復制。因此，今年剩餘時間將大力推動創新。

So thank you for your attention. And we'll be around for another quarter, so looking forward to discuss in more detail. Thank you.

感謝您的關注。我們將再持續一個季度，因此期待更詳細的討論。謝謝。