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
Richard Vosser - Senior Analyst
Richard Vosser - Senior Analyst
All right. Welcome, everyone, to Novo's Q1 roadshow. I'm Richard Vosser at JPMorgan. It's a great pleasure to have the Novo management team here in this roadshow. Munk Karsten, the CFO; Camilla Sylvest, Head of...
好的。歡迎大家參加 Novo 的第一季度路演。我是摩根大通的 Richard Vosser。很高興 Novo 管理團隊能參加這次路演。首席財務官 Munk Karsten;卡米拉西爾維斯特,...的負責人
Camilla Sylvest - Executive VP, Head of Commercial Strategy & Corporate Affairs and Member of the Management Board
Camilla Sylvest - Executive VP, Head of Commercial Strategy & Corporate Affairs and Member of the Management Board
Strategy.
戰略。
Richard Vosser - Senior Analyst
Richard Vosser - Senior Analyst
Exactly, and Martin Lange is Head of Development. So I'll hand over to Karsten for a few introductory remarks in the presentation. Thanks, Karsten.
沒錯,Martin Lange 是開發主管。因此,我將請 Karsten 在演示文稿中做一些介紹性發言。謝謝,卡斯滕。
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Great. Thank you, Richard, and thank you to JPMorgan for hosting this, launch presentation, and thanks to all of you participating in person. It's always good to interact in person.
偉大的。謝謝你,Richard,感謝摩根大通主持本次發布會,感謝大家親自參與。親自互動總是好的。
And I'd like to remind you that this launch session is being recorded. So just for general use. So we have a great team here in London, and we released our results last week. So you could say it's not as stressed as we had anticipated, but the reason why we released our numbers as I'm sure you're aware. But basically, we have to follow the Danish regulations for listed companies in Denmark. And when you have identified material information, then you have to go really without any undue notice and report as fast as possible.
我想提醒您,此次發布會議正在錄製中。所以只供一般用途。所以我們在倫敦有一個很棒的團隊,我們上週發布了我們的結果。所以你可以說它不像我們預期的那麼緊張,但我相信你知道我們公佈數據的原因。但基本上,我們必須遵守丹麥對丹麥上市公司的規定。當您確定了重要信息時,您必須在沒有任何不當通知的情況下真正去,並儘快報告。
So that entails a lot of hard work from everybody in the organization and the Board meeting, et cetera. So it's not something we take lightly. But the benefit for you is that then you had the weekend also to prepare for this launch session.
因此,這需要組織中的每個人以及董事會會議等方面的大量辛勤工作。所以這不是我們掉以輕心的事情。但對您來說,好處是您有周末時間來為這次發布會議做準備。
So the session for today is, I'd say, reasonably snappy on the presentation, and then we have a good time for Q&A and perhaps also a bit of time afterwards in the breakout if you didn't manage to ask your question at the launch session.
所以今天的會議,我想說,在演示文稿上相當活潑,然後我們有一個很好的問答時間,如果你沒有設法在會議上提出你的問題,也許還有一些時間在分組討論中啟動會話。
So I have to remind you about forward-looking statements. And we just saw this again that predicting about the future can be hard, and real events might fall out differently. So that's how the world operates.
因此,我必須提醒您有關前瞻性陳述。我們剛剛再次看到,預測未來可能很困難,而真實事件可能會以不同的方式出現。所以這就是世界的運作方式。
And in terms of our strategic aspirations as a company, we launched a concept back in '19, and we updated a couple of them at our latest Capital Markets Day. So this is how we report to the market on an ongoing basis.
就我們作為一家公司的戰略抱負而言,我們早在 19 年就推出了一個概念,並在最近的資本市場日更新了其中的幾個。這就是我們持續向市場報告的方式。
And just to cover some of the key components, in terms of our purpose and sustainability, our ESG performance, we continue to drive performance both on CO2, which is, of course, not getting easier this year because people have started to travel, and product distribution is moving a lot more towards air distribution linked to the kind of our supply chain situation. So still down compared to '19, but not as much down as last year.
為了涵蓋一些關鍵組成部分,就我們的目標和可持續性、我們的 ESG 績效而言,我們繼續推動二氧化碳方面的績效,當然,由於人們開始旅行,今年這並沒有變得更容易,以及產品分銷正朝著與我們的供應鏈情況相關的空氣分銷方向發展。所以與 19 年相比仍然下降,但沒有去年下降那麼多。
And on our social responsibility piece, I think it's a great achievement by Martin and the development team that now we have a positive scientific opinion around our thermal insulin solution that basically enables our human insulin to be stored at below 30 degrees for a month, which is really a key feature in developing markets. So really something that can make a difference.
在我們的社會責任文章中,我認為 Martin 和開發團隊的一項偉大成就是,現在我們對我們的熱胰島素解決方案有了積極的科學意見,基本上使我們的人胰島素能夠在 30 度以下的溫度下儲存一個月,這確實是發展中市場的一個關鍵特徵。所以真的可以有所作為。
The reason for the European registration is that then we can reference that in all these countries where it would be more relevant where perhaps less access to electricity and so on. And then finally, diversity and inclusion, also a key priority for the company to continue to progress on that.
歐洲註冊的原因是,我們可以參考在所有這些國家,在這些國家可能更容易獲得電力等等。最後,多樣性和包容性也是公司繼續在這方面取得進展的關鍵優先事項。
On our pipeline, which Martin will come back to later, after last year where it's more of an investment year and trial execution year, now we're starting to see some really good trial readouts. You saw some at the Capital Markets Day between Mim8 concizumab. And now you've seen ONWARDS 2, the first Phase III results, favorable Phase III results with the once-weekly insulin. So we're really happy about that as you'll hear later on and of course, the high-dose Ozempic in the U.S. marketplace.
在我們的管道上,馬丁稍後會回來,在去年更多的是投資年和試驗執行年之後,現在我們開始看到一些非常好的試驗讀數。您在 Mim8 concizumab 之間的資本市場日看到了一些。現在您已經看到了 ONWARDS 2,第一個 III 期結果,以及每週一次胰島素的良好 III 期結果。因此,我們對此感到非常高興,您稍後會聽到,當然還有美國市場上的高劑量 Ozempic。
Commercial, we keep performing against our aspirations or even ahead of those aspirations. Some of you will remember our initial obesity aspiration about doubling obesity. That's actually exactly what we did in the first quarter compared to the first quarter last year. So really fantastic traction on our obesity franchise these days.
商業上,我們一直在違背我們的願望甚至超越這些願望。你們中的一些人會記得我們最初關於肥胖加倍的肥胖願望。與去年第一季度相比,這實際上正是我們在第一季度所做的。這些天來,我們的肥胖專營權真是太棒了。
And then all of it turning into a great sales growth of 18%. Actually, the strongest sales growth in relative terms in 2 decades of Novo Nordisk and the biggest absolute sales growth quarter-over-quarter ever in the history of Novo Nordisk. So really amazing performance in terms of commercial execution and turning it into financial results also at 18% operating profit growth. I'll come back to that in more detail.
然後這一切都變成了 18% 的巨大銷售增長。實際上,這是諾和諾德 20 年來相對而言最強勁的銷售增長,也是諾和諾德歷史上最大的季度環比絕對銷售額增長。因此,在商業執行方面的表現非常驚人,並將其轉化為財務業績,營業利潤也增長了 18%。我將更詳細地討論這一點。
And then in terms of capital allocation, we had a very strong cash conversion in the first quarter and also allocation to shareholders at DKK 20 billion, a lot of value allocated to shareholders in terms of both dividends and share buybacks.
然後在資本分配方面,我們在第一季度進行了非常強勁的現金轉換,並向股東分配了 200 億丹麥克朗,在股息和股票回購方面為股東分配了很多價值。
So with that, I'll hand it over to Camilla to cover our status on commercial execution.
因此,我將把它交給 Camilla 來介紹我們在商業執行方面的狀態。
Camilla Sylvest - Executive VP, Head of Commercial Strategy & Corporate Affairs and Member of the Management Board
Camilla Sylvest - Executive VP, Head of Commercial Strategy & Corporate Affairs and Member of the Management Board
Yes. Thanks a lot, Karsten. Good morning, good afternoon, everyone, I should say, here in London. Our sales growth, 18% sales growth driven by a combination of a strong growth in International Operations of 13% and North America Operations growing 24%. We also see nice growth in each of the regions here, EMEA, China and Rest of World, so all units contributing to growth.
是的。非常感謝,卡斯滕。早上好,下午好,大家,我應該說,在倫敦。我們的銷售額增長 18%,這是由國際業務 13% 的強勁增長和北美業務增長 24% 共同推動的。我們還看到歐洲、中東和非洲、中國和世界其他地區的每個地區都有不錯的增長,因此所有單位都為增長做出了貢獻。
When we look at therapy area distribution, you see the 18% is clearly driven by a growth in GLP-1, where we see continued growth in North America of 38% in our GLP-1 franchise, up 60% in International Operations. We see an insulin growth rate of minus 4% driven by minus 15% in the U.S., but a slight increase of 1% in International Operations.
當我們查看治療區域分佈時,您會看到 18% 的增長顯然是由 GLP-1 的增長推動的,我們看到 GLP-1 特許經營在北美持續增長 38%,國際業務增長 60%。我們看到在美國的負 15% 推動了負 4% 的胰島素增長率,但在國際業務中略有增長 1%。
And then as Karsten was alluding to, 107% growth in our obesity franchise driven by 146% increase in North America Operations and 63 in IO. And then we have a continued single-digit growth in our rare disease franchise.
然後正如 Karsten 所暗示的那樣,我們的肥胖專營權增長了 107%,這是由北美業務增長 146% 和 IO 增長 63% 推動的。然後,我們的罕見病專營權繼續保持個位數增長。
And if we then zoom in on 2 of the biggest growth areas, if we start with GLP-1, especially our Ozempic franchise, you see here the 4 weeks rolling estimates of how prescriptions have really picked up in the beginning of this year on an NBRx level. On the right-hand side, you see the TRx level and a very steady performance, increasing the Ozempic share of the total GLP-1 segment.
如果我們然後放大兩個最大的增長領域,如果我們從 GLP-1 開始,特別是我們的 Ozempic 特許經營權,你會在這裡看到 4 週滾動估計處方在今年年初如何真正回升NBRx 水平。在右側,您可以看到 TRx 水平和非常穩定的性能,增加了 GLP-1 總片段中 Ozempic 的份額。
The short-term increase is driven by additional focus from our side on DTC, but of course, also on more doctors prescribing Ozempic. We see better pickup now in lower-tier segments also. And of course, there might potentially also be a halo effect to the semaglutide molecule in general.
短期增長是由於我們對 DTC 的額外關注,但當然,也有更多醫生開 Ozempic。我們現在也看到低端細分市場的回升更好。當然,一般來說,semaglutide 分子也可能存在光環效應。
When we then look at Wegovy here, you see the uptake on the total scripts, so TRx. And of course, we have not been promoting Wegovy the last quarter in the -- last quarter in the U.S. Despite that, we now still see a continued uptake, but we have also 80% coverage now in the commercial segment. We are currently not promoting 3 lowest doses. We don't want patients to be initiated if they cannot continue on the treatment. But we have now seen that our contract manufacturer is initiating the commercial production. So we expect to be back in the market with supply in the second half of this year and making our product available again. So that's the plan for Wegovy in the U.S. and how we expect this to continue.
然後,當我們在這裡查看 Wegovy 時,您會看到總腳本的吸收,即 TRx。當然,我們並沒有在美國上個季度的最後一個季度推廣 Wegovy。儘管如此,我們現在仍然看到繼續採用,但我們現在在商業領域也有 80% 的覆蓋率。我們目前不推廣 3 種最低劑量。如果患者不能繼續治療,我們不希望他們開始治療。但是我們現在已經看到我們的合同製造商正在開始商業生產。因此,我們希望在今年下半年重新進入市場,並再次提供我們的產品。這就是美國 Wegovy 的計劃,以及我們期望這種情況如何繼續下去。
And with that, I'll just hand it over to Martin to talk a little bit more about R&D.
有了這個,我將把它交給 Martin 來談談更多關於研發的事情。
Martin Holst Lange - Executive VP, Head of Development & Member of the Management Board
Martin Holst Lange - Executive VP, Head of Development & Member of the Management Board
Yes. Thanks very much, Camilla. (inaudible) This is going to be an exciting year in the R&D space. We'll have a lot of interesting readouts, obviously, starting with the icodec, but certainly also potentially with SELECT later on in the year if we get to do an interim analysis. But also we see very nice progress across all our programs.
是的。非常感謝,卡米拉。 (聽不清)這將是研發領域激動人心的一年。很明顯,從 icodec 開始,我們將有很多有趣的讀數,但如果我們進行中期分析,肯定還有可能在今年晚些時候使用 SELECT。但我們也看到我們所有項目的進展都非常好。
We have, as you know, Phase III programs ongoing in all of our therapy areas, which is an interesting place to be especially when we see those reading out in the years to come.
如您所知,我們的所有治療領域都在進行 III 期計劃,這是一個有趣的地方,尤其是當我們看到未來幾年的那些閱讀時。
I just want to call out 2 things in the diabetes space. First of all, obviously, as you know, we've got the 2.0 milligrams semaglutide approved in the U.S. for the treatment of type 2 diabetes. That is very, very exciting. Also because you've seen the data, you've seen the results based on the publication.
我只想在糖尿病領域指出兩件事。首先,顯然,如您所知,我們已獲得美國批准用於治療 2 型糖尿病的 2.0 毫克索馬魯肽。這是非常非常令人興奮的。也因為您已經看到了數據,所以您已經看到了基於出版物的結果。
Now we have it into the label very nicely describing the benefits of 2.0 milligram versus 1.0 milligram, namely more glycemic control, more weight loss, but no difference in the safety tolerability profile between the 2 doses of semaglutide and also a very nice description of the cardiovascular benefits of semaglutide, not sort of distinguishing between 1 and 2 milligram. So a broad label calling out good efficacy, good cardiovascular safety and good safety and tolerability. And Doug and his team are launching as we speak.
現在我們在標籤上很好地描述了 2.0 毫克與 1.0 毫克的益處,即更多的血糖控制,更多的體重減輕,但 2 劑 semaglutide 之間的安全耐受性沒有差異,並且很好地描述了semaglutide 的心血管益處,而不是區分 1 和 2 毫克。所以一個廣泛的標籤呼籲良好的療效、良好的心血管安全性以及良好的安全性和耐受性。 Doug 和他的團隊在我們發言時正在啟動。
We talked about the ONWARDS 2 program. This is truly, truly exciting. From our perspective, I think you've seen the program, the ONWARDS program is 6 trials. It spans type 1, it spans type 2 diabetes. It's a global program. It even has one study, ONWARDS 5 that caters to payers, potential payer discussions. It's a real-world evidence study with the potential of demonstrating A1c superiority, exactly what payers are looking for. That would be a first insulin treatment having real-world evidence available at the time of launch to cater to that discussion. And obviously, we are a bit excited about that.
我們談到了 ONWARDS 2 計劃。這真的,真的很令人興奮。從我們的角度來看,我想你已經看過這個程序了,ONWARDS 程序是 6 次試驗。它跨越 1 型,跨越 2 型糖尿病。這是一個全球計劃。它甚至有一項研究 ONWARDS 5 迎合付款人、潛在付款人的討論。這是一項真實世界的證據研究,有可能證明 A1c 的優勢,這正是付款人正在尋找的。這將是第一個在推出時有真實世界證據的胰島素治療,以迎合該討論。顯然,我們對此有點興奮。
ONWARDS 2 was the first study to read out. We're still waiting for the next 5 studies to read out. And it was, in some aspects, the most difficult and therefore, also the most interesting study that we had to look at because the comparison was insulin Tresiba or insulin degludec.
ONWARDS 2 是第一個讀出的研究。我們仍在等待接下來的 5 項研究結果出來。在某些方面,這是我們必須研究的最困難的研究,因此也是最有趣的研究,因為比較的是胰島素 Tresiba 或胰島素 degludec。
And degludec, as you know, really efficacious drug, but also probably the most hyper safe insulin, basal insulin that we have out there. So going up against Tresiba in our first readout was obviously interesting. Patients were your garden variety type 2 diabetes patients, A1c at baseline between 7 and 10. All patients being treated with basal insulin at time of randomization, any basal insulin.
如您所知,德谷胰島素是一種非常有效的藥物,但也可能是我們現有的最安全的胰島素,即基礎胰島素。因此,在我們的第一次讀數中與 Tresiba 對抗顯然很有趣。患者是您的花園品種 2 型糖尿病患者,基線時 A1c 在 7 到 10 之間。所有患者在隨機分組時接受基礎胰島素治療,任何基礎胰島素。
Approximately 30% of patients came from Tresiba. The rest came from various others, other basal insulins, primarily insulin [launching]. Patients were randomized to either into the icodec or insulin degludec. Really, really interesting.
大約 30% 的患者來自 Tresiba。其餘的來自其他各種,其他基礎胰島素,主要是胰島素[發射]。患者被隨機分配到 icodec 或胰島素 degludec。真的,真的很有趣。
And obviously, you've seen the headline results, which were truly exciting. This is a treat-to-target study. That's the regulatory requirement from the FDA perspective. That means that for 100 years, what we've seen when it comes to insulin development is noninferiority on primary endpoint.
顯然,您已經看到了令人興奮的標題結果。這是一項針對目標的治療研究。從 FDA 的角度來看,這是監管要求。這意味著 100 年來,我們在胰島素開發方面看到的是主要終點的非劣效性。
You guys have commented and asked about that in recent years. Why don't you see superiority if you think this is a better insulin? Basically because we had to do this treated time. And probably also to an extent because there was maybe not that much to differentiate on other than the risk of hypoglycemia. Now we have a once-weekly insulin with a super, super flat and stable profile.
近年來,你們對此發表了評論和詢問。如果您認為這是一種更好的胰島素,為什麼看不到優勢?基本上是因為我們不得不做這個治療時間。並且可能在一定程度上也是因為除了低血糖風險之外可能沒有太多可以區分的地方。現在我們有一個每週一次的胰島素,具有超級、超級平坦和穩定的特性。
I just remind you, insulin icodec has a peak to trough over a week of 14% difference. So really, really stable to be compared with 80%, 8-0 percent in for (inaudible) and Levemir and 40% for Tresiba. So really, really a flat and stable profile.
我只是提醒你,胰島素 icodec 的峰值和谷值在一周內有 14% 的差異。與 80%、8-0%(聽不清)和 Levemir 和 40% 的 Tresiba 相比,非常非常穩定。所以真的,真的是一個平坦而穩定的輪廓。
And that actually pans out even in a treat-to-time setting into superiority on A1c. That's the first -- in 100 years, we've never seen that in this kind of story. And that is in and of itself quite encouraging, obviously, making us quite optimistic of what comes next in the next 5 studies.
即使在按時治療的情況下,這實際上也能在 A1c 上取得優勢。這是第一次——100 年來,我們從未在這種故事中看到過這種情況。顯然,這本身就非常令人鼓舞,這讓我們對接下來的 5 項研究的結果相當樂觀。
But what is really also important is no difference in hypoglycemia. I've heard some of you talk about as a numerical difference in hypoglycemia, which is obviously true. You've seen the numbers here was 0.25 and 0.73. Just to remind you again that in previous studies with basal insulin, hypo rates have been in the vicinity of 1.4 to 4 events per patient per year.
但真正同樣重要的是低血糖沒有區別。我聽說你們中的一些人談論低血糖的數值差異,這顯然是正確的。您已經看到這裡的數字是 0.25 和 0.73。再次提醒您,在之前的基礎胰島素研究中,低血糖發生率約為每位患者每年 1.4 至 4 次。
Here, we are talking about less than 1 in both treatment arms. Basically means that the patients on insulin icodec has to wait 1.5 years before he or she gets a non-severe event of hypoglycemia. And when we talk about not severe, we saw no severe events of hypoglycemia on insulin icodec. We actually did see severe hypoglycemia with Tresiba in this trial, and therefore, again, speaking to the safety of this company.
在這裡,我們談論的是兩個治療組中的少於 1 個。基本上意味著使用 icodec 胰島素的患者必須等待 1.5 年才能發生非嚴重低血糖事件。當我們談論不嚴重時,我們沒有看到使用 icodec 胰島素的嚴重低血糖事件。實際上,在這項試驗中,我們確實看到 Tresiba 出現了嚴重的低血糖症,因此,再次談到這家公司的安全性。
Another front is actually a significant improvement in quality of life, significant not only from a statistical perspective but also from a clinical perspective, again speaking to the benefits of this molecule. So Camilla asked me, will we get the trial of efficacy, safety and convenience? I think the answer is yes.
另一個方面實際上是生活質量的顯著改善,不僅從統計角度來看,而且從臨床角度來看也很重要,再次說明了這種分子的好處。於是卡米拉問我,我們會得到療效、安全性和便利性的試用嗎?我認為答案是肯定的。
There's even another upside with insulin icodec, and that's on the environment, going from 7 to 1 injection per week. It obviously also have an impact on how much plastic, how much glass do we have put into landfills. I think in 2022, that's not a trivial thing to have as an added benefit. So not in the bag yet, still waiting for the last 5 trials, but a very, very strong start for icodec.
愛可可胰島素甚至還有另一個好處,那就是環境,每週注射 7 次到 1 次。它顯然也會影響我們在垃圾填埋場中投入了多少塑料、多少玻璃。我認為在 2022 年,作為額外的好處,這並不是一件微不足道的事情。所以還沒到包裡,還在等待最後的 5 次試驗,但對於 icodec 來說,這是一個非常非常強勁的開端。
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Thank you, Martin. I'm here as Head of Development, really happy with the insulin icodec. So we'll get back much more on that in the quarters to come with the 5 additional trials.
謝謝你,馬丁。我在這裡擔任開發主管,對胰島素 icodec 非常滿意。因此,我們將在接下來的 5 次額外試驗中得到更多關於這一點的信息。
So looking at financials, you've all been through this as part of our release. But just recapping, 18% sales growth at constant exchange rates. Take it into reported 24% sales growth, given the tailwind from especially the U.S. dollar. So really significant sales growth on a big base.
因此,查看財務數據,作為我們發布的一部分,你們都經歷過。但只是回顧一下,按固定匯率計算,銷售額增長了 18%。考慮到特別是美元的順風,將其計算為報告的 24% 的銷售增長。因此,在一個大的基礎上,銷售增長非常顯著。
Gross margin adjusted for currency is reasonably flat. And -- but of course, one thing worth noting is when you look at our employee count as we also have in our company release of -- which is up 9% over the last year. The biggest single driver of that is actually an increase in manufacturing. So as we've talked about, scaling manufacturing. Part of that is also scaling employees to all the classic of 7 shifts -- or 3 shifts, 7 days a week.
經貨幣調整後的毛利率相當平穩。而且 - 當然,值得注意的一件事是,當您查看我們公司發布的員工人數時,該人數比去年增長了 9%。最大的單一驅動因素實際上是製造業的增長。正如我們所討論的,擴大製造規模。其中一部分是將員工擴展到所有經典的 7 班制——或 3 班制,每週 7 天。
In terms of sales and distribution cost, 18%, it's a classic. It's investments in GLP-1 diabetes as well as obesity market development, no news there. And then R&D, up 29% being, of course, impacted by our Dicerna acquisition and the run rate of Dicerna, which is actually also what you see in terms of the step-up in other operating income compared to the first quarter last year. So net-net, Dicerna in the first quarter has a negative impact on our P&L to the tune of 2%. So adjust for that, as potentially some companies would do, then actually our operating profit growth would have been 20%, excluding Dicerna.
就銷售和分銷成本而言,18%,堪稱經典。它投資於 GLP-1 糖尿病以及肥胖市場的發展,沒有消息。然後是研發,增長 29%,當然,受到我們對 Dicerna 的收購和 Dicerna 的運行率的影響,這實際上也是你看到的其他營業收入與去年第一季度相比的增長。因此,淨淨值,Dicerna 在第一季度對我們的損益產生了 2% 的負面影響。因此,正如某些公司可能會做的那樣,對此進行調整,那麼實際上我們的營業利潤增長將達到 20%,不包括 Dicerna。
Apart from that, our R&D costs are really being driven by our focus to expand our pipeline and diversify and a lot of investments going into both research and development and from a therapeutic point of view, investing significantly in what we call other serious chronic diseases so our cardiovascular franchise as well as SNACs and trials in that area, Alzheimer's.
除此之外,我們的研發成本實際上是由我們專注於擴大我們的管道和多樣化以及大量投資進入研發和從治療的角度來看,大量投資於我們所說的其他嚴重慢性疾病,所以我們的心血管專營權以及 SNAC 和該領域的試驗,阿爾茨海默氏症。
All in all, 18% operating profit, 28% reported in reported terms, then we have the hedging going the other way. That's how it is when you hedge the U.S. dollar for 12 months. So very good hedging efficacy here in the beginning of the year and a net profit growth of 13%.
總而言之,18% 的營業利潤,28% 以報告的形式報告,然後我們將套期保值轉向另一種方式。對沖美元 12 個月就是這樣。所以年初的對沖效果很好,淨利潤增長了13%。
That start compared with the NBRx trajectory you saw with Camilla, led us to step up our outlook and raise our outlook significantly, I would say, from before 6 to 10 and now 10 to 14. And you see how it drills down throughout all our financial ratios. So pretty much no surprises there from top line all the way through to cash generation and increased share buyback to now DKK 24 billion.
與您在 Camilla 中看到的 NBRx 軌跡相比,這一開始使我們提高了我們的前景並顯著提高了我們的前景,我想說,從之前的 6 到 10,現在從 10 到 14。你會看到它是如何在我們所有的財務比率。因此,從收入一直到現金產生以及將股票回購增加到現在的 240 億丹麥克朗,幾乎沒有什麼意外。
So that covers kind of the warm-up commentary, and now we move into Q&A. And I think we're a small audience. (Operator Instructions) So I'll just sit down, and then I'll give it to Richard to have the opening question as our host.
這涵蓋了熱身評論,現在我們進入問答環節。我認為我們是一小群觀眾。 (操作員說明)所以我就坐下來,然後我將把它交給理查德作為我們的主持人提出開場問題。
Richard Vosser - Senior Analyst
Richard Vosser - Senior Analyst
So maybe two then. Firstly, on -- Camilla, you mentioned commercial access 80%. I think before the opt-in was sort of 40%. Can you give us update on the opt-in level from commercial employed?
所以也許兩個。首先,關於-- Camilla,您提到了80% 的商業訪問。我認為在選擇加入之前是 40%。您能否向我們提供有關商業僱員選擇加入級別的最新信息?
And then secondly, on Ozempic 2 milligrams, you've highlighted, I think Doug highlighted on the conference call that it will be priced in line with other doses for diabetes. So how do you manage that given the brand is very close in dosing to Wegovy. Does that have any impact on Wegovy in terms of cannibalization or -- yes.
其次,關於 Ozempic 2 毫克,你已經強調了,我認為 Doug 在電話會議上強調,它的定價將與其他治療糖尿病的劑量一致。那麼,鑑於該品牌與 Wegovy 的劑量非常接近,您如何管理這一點。就蠶食而言,這對 Wegovy 有什麼影響嗎?或者——是的。
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Thanks, Richard. So there's 2 for you, Camilla, one on opt-ins and the other one for pricing of 2.0
謝謝,理查德。所以有 2 個給你,Camilla,一個選擇加入,另一個定價 2.0
Camilla Sylvest - Executive VP, Head of Commercial Strategy & Corporate Affairs and Member of the Management Board
Camilla Sylvest - Executive VP, Head of Commercial Strategy & Corporate Affairs and Member of the Management Board
Yes. So Richard, we are approximately in a situation where we have 80% coverage gross, and then we have about half of the employers that opt in. So that means a 40% net coverage, so slightly more than what you recall from before. It continues to improve, but it's a long list of employers that we're, of course, working with, but it does consistently improve.
是的。所以理查德,我們大約處於這樣一種情況,即我們有 80% 的總覆蓋率,然後我們有大約一半的雇主選擇加入。這意味著 40% 的淨覆蓋率,比你之前回憶的略多。它繼續改進,但它是我們當然正在與之合作的一長串雇主,但它確實在不斷改進。
And on delivery on messaging, it's very, very important for us, of course, to stay completely true to what is the label. And we promote Ozempic in diabetes care. And right now, we don't promote Wegovy in obesity care. We will hopefully get back to that.
當然,在傳遞消息時,對我們來說,完全忠於標籤是非常非常重要的。我們在糖尿病護理中推廣 Ozempic。現在,我們不會在肥胖護理中推廣 Wegovy。我們希望能回到這一點。
But for us, it's extremely important to stay completely in line with that for good reasons, for business ethics reasons. Nevertheless, we do see a pickup in the scripts of Ozempic, as I just talked to, also because we're expanding our prescriber base.
但對我們來說,出於充分的理由和商業道德的原因,完全遵守這一點非常重要。儘管如此,正如我剛剛談到的那樣,我們確實在 Ozempic 的腳本中看到了一個回升,這也是因為我們正在擴大我們的處方者基礎。
But of course, also because Ozempic is recognized for a triad of benefits, HbA1c lowering, strong weight loss but also the significant cardiovascular risk reduction. So all of that with the increasing awareness, of course, builds more and more momentum for Ozempic.
但是,當然,也因為 Ozempic 被認為具有三大好處,即降低 HbA1c、顯著減輕體重以及顯著降低心血管風險。因此,隨著意識的提高,所有這一切當然為 Ozempic 建立了越來越多的動力。
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Thanks, Camilla. And just a bonus into on the coverage in obesity, as you would have seen then now we have a contract with the Department of Defense also. So in addition of continuing to enroll more employers under commercial, then of course, we're also working with some of the public employers in terms of getting access to whether it's under certain Medicaid plans or Department of Defense. So think we have good progress all. So very happy with that.
謝謝,卡米拉。正如您當時所看到的那樣,只是對肥胖症的覆蓋範圍的獎勵,現在我們也與國防部簽訂了合同。因此,除了繼續招收更多的商業雇主之外,當然,我們還與一些公共雇主合作,以獲取是否在某些醫療補助計劃或國防部下的訪問權。所以認為我們都有很好的進展。對此非常滿意。
Then I think we'll move to Wimal.
然後我想我們會搬到 Wimal。
Wimal Kapadia - Research Analyst
Wimal Kapadia - Research Analyst
Great. Can I just come back to Richard's question actually? So Ozempic high dose is priced at the same level as Ozempic 1 milligram, but as on 0.4 milligrams less than Wegovy. If the net price of Wegovy is similar to Saxenda, that's a [51] -- a 30% premium on Ozempic net price.
偉大的。我真的可以回到理查德的問題嗎?所以 Ozempic 高劑量的價格與 Ozempic 1 毫克相同,但比 Wegovy 低 0.4 毫克。如果 Wegovy 的淨價與 Saxenda 相似,那就是 [51]——比 Ozempic 的淨價高出 30%。
So I'm just curious, how do the pay discussions go? Because on 0.4 milligrams, that incremental dollar price is quite a lot. So I'm just curious how you -- you have a different rebate for the 2 milligrams within the 1 milligram. So that's the first question just following up on Richard.
所以我只是好奇,薪酬討論如何進行?因為 0.4 毫克的增量美元價格是相當多的。所以我只是好奇你是怎麼回事——你對 1 毫克中的 2 毫克有不同的回扣。所以這是跟進理查德的第一個問題。
And then the second one, again, probably for Camilla, the GLP-1s are clearly doing really well. But if we think about the diabetes market long term, so the bookings of metformin and insulin, and they're relatively stable at about 40 metformin, 20% roughly is coming down slowly. So you have 40% of diabetes volume to play for. What is the peak penetration for GLP-1 in the U.S.?
然後是第二個,可能對卡米拉來說,GLP-1 顯然做得很好。但如果我們長期考慮糖尿病市場,那麼二甲雙胍和胰島素的預訂量相對穩定在 40 左右,大約 20% 正在緩慢下降。因此,您有 40% 的糖尿病患者可以參與。 GLP-1 在美國的最高滲透率是多少?
Is it 25? Is it 30? How much do we need to leave for the SGLT2s long term? And then I guess tied to that, what does that mean for the rest of the world? Can Europe and the rest of the world get to that U.S. level?
是25嗎?是30嗎?我們需要為 SGLT2 長期留出多少資金?然後我想與此相關,這對世界其他地方意味著什麼?歐洲和世界其他地區能達到美國的水平嗎?
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Thanks, Wimal. I counted 2.5 question on that one. So thanks for pushing the limits. I think we'll let it pass this time around then we'll get back at you at another time.
謝謝,維馬爾。我在那個問題上數了 2.5 個問題。所以感謝你突破極限。我想這次我們會讓它過去,然後我們會在另一個時間回复你。
So Ozempic 2.0 pricing, I'll give that a shot and then, Camilla, if you can talk to GLP-1 volume/patient penetration U.S./Rest of World. So yes, on Ozempic 2.0, it's diabetes pricing. That's what we see also from competition. And I think the way you should look at it is it's a flat pricing between 0.5, 1 and 2.
所以 Ozempic 2.0 定價,我會試一試,然後,卡米拉,如果你能談談 GLP-1 的數量/美國/世界其他地區的患者滲透率。所以是的,在 Ozempic 2.0 上,它是糖尿病定價。這也是我們從競爭中看到的。我認為你應該看待它的方式是它是 0.5、1 和 2 之間的固定定價。
So from a payer point of view, you buy the portfolio. And actually a lot of patients are still only at 0.5. So it's a flat price across, but the blended volume, so to say, per patient is let's see how it all plays out but will be perhaps less than 1 milligram depending on the time horizon.
因此,從付款人的角度來看,您購買了投資組合。而且實際上很多患者仍然只有0.5。所以這是一個統一的價格,但是混合量,也就是說,每位患者讓我們看看它是如何發揮作用的,但根據時間範圍可能會小於 1 毫克。
So you have that, and then you have a different price point in obesity. So that's one key point to consider.
所以你有那個,然後你有一個不同的肥胖價格點。所以這是要考慮的關鍵點之一。
And then the other key point is, of course, that having formularies in 2 different disease categories, so to say, then, of course, the formularies in terms of managing the formularies and the opt-ins or whatever step at it or whatever to get access to the medicines are different and hence, caters for differentiation from a payer point of view also in terms of how they manage their categories in terms of could even be co-insurance designs could be different between those categories.
然後另一個關鍵點是,當然,有兩個不同疾病類別的處方集,也就是說,當然,處方集管理處方集和選擇加入或任何步驟或任何獲得藥物的途徑是不同的,因此,從付款人的角度來看,他們在如何管理自己的類別方面也有差異,甚至可能是共同保險設計在這些類別之間可能會有所不同。
And we spoke about the opt-in also from -- on Richard's point of view. So the categories are being managed different by the payers also vis-a-vis their customers.
我們也從理查德的角度談到了選擇加入。因此,付款人也針對他們的客戶管理不同的類別。
So Camilla, on GLP-1 penetration?
那麼卡米拉,關於 GLP-1 的滲透?
Camilla Sylvest - Executive VP, Head of Commercial Strategy & Corporate Affairs and Member of the Management Board
Camilla Sylvest - Executive VP, Head of Commercial Strategy & Corporate Affairs and Member of the Management Board
Yes. So GLP-1 penetration, very depending on launches of new products and the efficacy that we see. So we now are in Europe and in the U.S. on a volume base sort of 8% to 12% of the market, but we do see that it is significantly picking up.
是的。所以 GLP-1 的滲透,很大程度上取決於新產品的推出和我們看到的功效。所以我們現在在歐洲和美國的市場份額為 8% 到 12%,但我們確實看到它正在顯著回升。
Of course, a lot of this is related to the continued benefits that we see, the cardiovascular risk protection, weight loss and HbA1c loss. And just to give you an example from China, where we've seen now reimbursement of Ozempic. Then we have seen the market size of GLP-1 out of the total growth of 1% to now being closer to 7% or 8%, and that in a very few -- a very short time frame.
當然,這在很大程度上與我們看到的持續益處、心血管風險保護、體重減輕和 HbA1c 降低有關。只是給你一個來自中國的例子,我們現在已經看到了 Ozempic 的報銷。然後我們看到 GLP-1 的市場規模從 1% 的總增長到現在接近 7% 或 8%,而且在極少數——非常短的時間內。
So basically, you should -- of course, if you look at the volume growth, you see that this segment is growing at approximately 30% in volume, roughly across most regions, Europe and U.S. And then you would see other segments of the market growing a lot less. So I think if you apply that dynamics, assuming that whenever there are new launches into the segment, then of course, it keeps fueling the market growth rather than cannibalizing itself.
所以基本上,你應該——當然,如果你看一下銷量增長,你會發現這部分的銷量增長了大約 30%,大致遍及歐洲和美國的大多數地區,然後你會看到市場的其他部分增長少了很多。所以我認為,如果你應用這種動態,假設每當有新產品進入該細分市場,那麼當然,它會不斷推動市場增長,而不是自我蠶食。
Then I guess you can try to understand how to do the math of what this could be. It's clear that the benefits of GLP-1 are very, very strong and when we just compare HbA1c and weight and also cardiovascular risk profile versus some of the other compounds in the market.
然後我想你可以試著理解如何計算這可能是什麼。很明顯,GLP-1 的益處非常非常強大,當我們將 HbA1c 和體重以及心血管風險狀況與市場上的其他一些化合物進行比較時。
So I think that's the best way to look at it to try to understand what could this become. But there is also in guidelines now an increased focus on treating with GLP-1s right after metformin. So that's another support to this class.
所以我認為這是看待它以試圖了解它會變成什麼的最佳方式。但現在指南中也越來越關注在二甲雙胍之後立即使用 GLP-1 進行治療。所以這是對這個類的另一個支持。
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Great. Thanks, Camilla. We'll move to Pete -- Pete Verdult.
偉大的。謝謝,卡米拉。我們將搬到Pete——Pete Verdult。
Peter Verdult - MD
Peter Verdult - MD
Pete Verdult, Citi. Two questions. I'm going to -- sorry to harp on about this and expand on the questions from Rich and Wimal. In a couple of years, you're going to have a quite formidable competitor turning up where that whole GLP-1 pricing offset between obesity and diabetes is going to be gone. And that's obviously -- how should you or will be thinking about how you navigate that? Because all the responses you've made so far are all fair, but that dynamic is going to change quite considerably in 2 years. So I'd like you to discuss that.
花旗銀行Pete Verdult。兩個問題。我將要-- 很抱歉就這一點喋喋不休,並擴展Rich 和Wimal 的問題。幾年後,您將有一個非常強大的競爭對手出現,而肥胖和糖尿病之間的整個 GLP-1 定價抵消將消失。這很明顯——你應該或將如何考慮如何導航?因為到目前為止你所做的所有回應都是公平的,但這種動態將在 2 年內發生相當大的變化。所以我想讓你討論一下。
And then secondly, I asked this morning at the breakfast meeting, I mean, most of the industry have talked about responsible price increases, no more than inflation, but obviously now inflation is 7%, 8%. Is Novo going to eat it? Or do you think you've got the ability to put out your list price increases to protect yourself from inflation?
其次,我今天早上在早餐會上問,我的意思是,大多數行業都在談論負責任的價格上漲,不超過通貨膨脹,但顯然現在通貨膨脹是7%,8%。諾沃會吃嗎?還是您認為您有能力通過提高定價來保護自己免受通貨膨脹的影響?
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Yes. So Camilla, if you cover the first one vis-a-vis -- I think we explained clearly where we are today. So what could be the scenario vis-a-vis Lilly and what approach could they be pursuing? And how would we think about the market dynamics on GLP-1 pricing. And then I'll cover inflation and how we try to mitigate that.
是的。所以卡米拉,如果你對第一個問題進行比較——我想我們已經清楚地解釋了我們今天所處的位置。那麼,禮來公司的情況可能是什麼,他們會採用什麼方法呢?以及我們如何看待 GLP-1 定價的市場動態。然後我將介紹通貨膨脹以及我們如何嘗試緩解通貨膨脹。
Camilla Sylvest - Executive VP, Head of Commercial Strategy & Corporate Affairs and Member of the Management Board
Camilla Sylvest - Executive VP, Head of Commercial Strategy & Corporate Affairs and Member of the Management Board
Yes. So what we see now increasingly is that obesity is being reimbursed for Saxenda outside of the U.S. in an increasing number of markets. And of course, when the investment happens, then prices are, of course, not the same as before reimbursement in out of pocket.
是的。因此,我們現在越來越多地看到,在越來越多的市場中,Saxenda 在美國以外的市場正在報銷肥胖症。當然,當投資發生時,價格當然與自付費用報銷之前不同。
And of course, in the same to Karsten's point from before about the different channels in the U.S. by the time that you would expand into other channels, it could be Medicare, for example, over time, if we get the (inaudible) resolutions in place, then, of course, it's likely that prices will converge towards each other.
當然,與 Karsten 之前關於美國不同渠道的觀點相同,當您擴展到其他渠道時,它可能是醫療保險,例如,隨著時間的推移,如果我們得到(聽不清)決議那麼,當然,價格很可能會趨於一致。
So I think that's the dynamic that we are working towards to make sure that more and more patients can get access to obesity treatment. You know the numbers that just very few percentages are being treated despite a huge unmet need. So I think that's what we are pursuing.
所以我認為這是我們正在努力確保越來越多的患者能夠獲得肥胖治療的動力。您知道儘管有巨大的需求未得到滿足,但只有極少數百分比得到處理的數字。所以我認為這就是我們所追求的。
And I think that's what I should comment on and actually not what Lilly is more likely to do. And you should check with them on that. But I do think that over time, prices are likely to converge, but of course, this is offset by the volumes. And there is a very, very big demand, as we have noticed, of course, also in the recent year.
我認為這是我應該評論的,實際上不是禮來更有可能做的事情。你應該和他們核實一下。但我確實認為,隨著時間的推移,價格可能會趨同,但當然,這會被數量所抵消。正如我們所注意到的,當然,近年來也是如此,而且需求非常非常大。
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Yes. Thanks, Camilla. And of course, let's see what Lilly does. That's completely on their prerogative. And I think they've been out counting different scenarios also in terms of how they could go to market. So we'll have to wait and see.
是的。謝謝,卡米拉。當然,讓我們看看 Lilly 做了什麼。這完全是他們的特權。而且我認為他們在如何進入市場方面也一直在計算不同的情況。所以我們將不得不拭目以待。
On inflation and how to mitigate inflation, so the classic premise of inflation, we all see it and the numbers whether it's 7% or 8% in the U.S., et cetera. So running a company, then the starting point for mitigating inflation is one, pass on the increased cost to our customers that you see that across many, many industries. Secondly, how do we fend off inflationary pressures from your suppliers?
關於通貨膨脹以及如何緩解通貨膨脹,這是通貨膨脹的經典前提,我們都看到了它以及美國的數字是 7% 還是 8% 等等。因此,經營一家公司,那麼緩解通貨膨脹的起點就是,將增加的成本轉嫁給我們的客戶,你在許多行業中都看到了這一點。其次,我們如何抵禦來自供應商的通脹壓力?
And if I take the last one first then in terms of suppliers then, of course, we are -- we get the pressures from our suppliers. We have a rather mature procurement setup. So in terms of being clear about the contractual settings we have in our contracts with our suppliers, some of these contracts just doesn't open for suppliers to increase prices, some that lag effect and some they can break the contracts or whatever.
如果我先考慮最後一個,那麼就供應商而言,當然,我們是——我們從供應商那裡得到壓力。我們有一個相當成熟的採購設置。因此,就我們在與供應商的合同中明確的合同設置而言,其中一些合同只是不允許供應商提高價格,有些是滯後效應,有些可能會違反合同或其他原因。
So I think we have a very mature setup there to minimize the immediate inflationary pressures. But clearly, this is something that will happen.
所以我認為我們在那裡有一個非常成熟的設置,可以最大限度地減少直接的通脹壓力。但很明顯,這是會發生的事情。
On the cost side, we mitigate that through efficiencies and resource allocation. And then we're in the fortunate setting that as a rapidly growing business, we also have some margin leverage to work with.
在成本方面,我們通過提高效率和資源分配來緩解這種情況。然後我們處於幸運的環境中,作為一個快速發展的企業,我們也有一些利潤槓桿可以使用。
So we actually do have a number of levers to alleviate fully or partially the inflationary pressures we face as a company. And then reminding you just -- and I don't think I have to remind you, but mathematically, of course, we are in a better setting than low-margin industry. So being a high-margin industry then, of course, just in relative terms, it hits us at 40-plus percent operating margin less than other players or other industries.
因此,我們實際上確實有許多槓桿來完全或部分緩解我們作為一家公司所面臨的通脹壓力。然後提醒你——我認為我不必提醒你,但從數學上講,當然,我們處於比低利潤行業更好的環境中。因此,作為一個高利潤行業,當然,就相對而言,它給我們帶來的營業利潤率比其他參與者或其他行業低 40% 以上。
On the sales side, I think it's fair to say that in a number of markets, it's hard to kind of reopen contracts, especially in some like European markets that we have negotiated a price point of our products. And hence, it will be a very cumbersome, lengthy process, if at all possible, to open up.
在銷售方面,我認為可以公平地說,在許多市場中,很難重新簽訂合同,尤其是在我們已經協商產品價格點的歐洲市場。因此,如果可能的話,開放將是一個非常繁瑣、漫長的過程。
In some emerging market countries or IO markets, especially in hyperinflationary markets, there are already existing mechanisms for basically changing our prices. That could be in markets like Argentina and Turkey.
在一些新興市場國家或IO市場,特別是在惡性通貨膨脹的市場,已經存在基本改變我們價格的機制。這可能是在阿根廷和土耳其等市場。
And so if you -- actually, if you go to the appendix of our company announcement, you can see how we adjust for hyperinflation in terms of our reporting in order not to overstate our constant exchange rate growth. So we are actually backing out some of the hyperinflationary price increases in these markets. So there, we do have mechanisms in place.
因此,如果您 - 實際上,如果您查看我們公司公告的附錄,您可以看到我們如何根據報告調整惡性通貨膨脹,以免誇大我們的持續匯率增長。因此,我們實際上是在支持這些市場中的一些惡性通脹價格上漲。因此,我們確實有適當的機制。
In the U.S. and we are negotiating contracts for next year as we speak, not concluded. That's one out of many elements going into these negotiations between formulary positioning, competitive pressures, et cetera. And of course, inflation is one of the [documents] there as are many other aspects. So I think that's as clear as I can be on that one.
在美國,我們正在就明年的合同進行談判,但尚未結束。這是進入處方定位、競爭壓力等之間談判的眾多因素之一。當然,通貨膨脹與許多其他方面一樣是其中的[文件]之一。所以我認為這一點已經很清楚了。
Unidentified Analyst
Unidentified Analyst
The volumes are very strong. So given the inflationary environment, does that slow down any pricing pressure that you might see? Can you start as an argument? You obviously got the volumes to your advantage.
音量非常強勁。因此,考慮到通脹環境,這是否會減緩您可能看到的任何定價壓力?你能從爭論開始嗎?顯然,您的數量對您有利。
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Yes. Yes. So you would say the best way to fend off price decreases if you're in a U.S. setting is that you are differentiated enough, and you have the highest possible market share because then, of course, the harder it gets for payers and PBMs to throw off formulary.
是的。是的。因此,如果您在美國環境中,您會說抵禦價格下跌的最佳方法是您有足夠的差異化,並且您擁有盡可能高的市場份額,因為當然,付款人和 PBM 越難擺脫處方。
So clearly, when we -- on one hand side, when we show strong demand for our products like the Ozempic trajectory on volume and share then, of course, the payers would be very cautious to remove from formulary because they will have a lot of their customers that will be unhappy if they cannot get the product that they wish for. So that's on one hand side.
很明顯,當我們 - 一方面,當我們對我們的產品(如 Ozempic 的銷量和份額軌跡)表現出強烈的需求時,當然,付款人會非常謹慎地從處方中刪除,因為他們會有很多如果他們不能得到他們想要的產品,他們的客戶會很不高興。所以這是一方面。
Of course, on the other hand side, when you're effectively a procurement organization and you see value bucket increasing rapidly then, of course, you have to consider how to deal with that cost increase. So that's kind of the balancing factors.
當然,另一方面,當您實際上是一個採購組織並且您看到價值桶迅速增加時,當然,您必須考慮如何應對成本增加。所以這是一種平衡因素。
And that's, of course, their PBM job. And as we've said all along, our strategy is to grow the volumes and to maintain choice for patients to ensure basically co-preferred formulary in the (inaudible) market in the U.S.
當然,這就是他們的 PBM 工作。正如我們一直所說的那樣,我們的策略是增加數量並保持患者的選擇,以確保在美國(聽不清)市場中基本上共同首選的處方集。
Unidentified Analyst
Unidentified Analyst
I should know that. I'm sure you said for the upgrade of the sales guidance for growth, is that all -- how much of that is volume and before volume, right, versus price?
我應該知道的。我敢肯定,您所說的升級銷售指南以促進增長,僅此而已 - 其中有多少是數量和數量之前,對吧,與價格相比?
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
I'd say for all material purposes, the upgrade in guidance is driven by increased Ozempic volumes. Mark?
我想說的是,出於所有實質性目的,指導的升級是由增加的 Ozempic 數量驅動的。標記?
Mark Douglas Purcell - Equity Analyst
Mark Douglas Purcell - Equity Analyst
Two R&D questions. Very busy today. First one, I think most KOLs believe that the SELECT trial is going to be successful and described as being a sort of typical file for the future of obesity medicines. So it's really important you get this right.
兩個研發問題。今天很忙。第一個,我認為大多數 KOL 認為 SELECT 試驗將會成功,並被描述為未來肥胖藥物的一種典型文件。因此,正確處理這一點非常重要。
So we're also focused on Q3 and this potential interim. We've had CVOT studies reading out early before, and it sort of damages that potential when it comes to discussing with payers and governments and guideline policymakers and things like that.
所以我們也關注第三季度和這個潛在的中期。我們之前很早就讀過 CVOT 研究,在與付款人和政府討論以及指導政策制定者等類似事情時,它有點損害了這種潛力。
So I'm thinking number needed to treat as opposed to percentages there, particularly when it comes to CV [DAF] and all course mortality. So I guess if we say roughly 26 months into the trial, 4.5% event rate at that point, 17% benefit. That's not a massive number they needed to treat if you stop early.
所以我認為需要處理的數字而不是百分比,特別是在 CV [DAF] 和所有課程死亡率方面。所以我想如果我們說大約 26 個月的試驗,那時的事件率為 4.5%,收益為 17%。如果您提早停止,這不是他們需要治療的大量數字。
Can you help us understand what the stopping criteria are that ensures that you do not lose the power of this potential study? I mean, a lot of KOLs, I think you should do a primary prevention study and just wait and see what happens. But it's really important you get this one right. That's the first question.
您能幫助我們了解什麼是停止標準,以確保您不會失去這項潛在研究的力量嗎?我的意思是,很多KOL,我認為你應該做一個初級預防研究,然後等著看會發生什麼。但你把這件事做對真的很重要。這是第一個問題。
And the second one is really quite simple. For icodec, in the real world, if we see severe hypos, which I think most people feel there will be some, how do you treat a severe hypo with icodec relative to, obviously, a normal insulin given that you're going to have, as you said, I mean, incident levels will be pretty stable to the tune of 14% over a week. So presumably, you have to stay in hospital, you have to stay under some medical care for longer. So I'm just interested in that point, too.
第二個真的很簡單。對於 icodec,在現實世界中,如果我們看到嚴重的低血糖,我認為大多數人會覺得會有一些,那麼您如何使用 icodec 治療嚴重的低血糖,相對於,顯然,考慮到您將擁有的正常胰島素,正如你所說,我的意思是,事件水平將在一周內穩定在 14% 左右。所以大概,你必須留在醫院,你必須在一些醫療護理下停留更長時間。所以我也只是對這一點感興趣。
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Thanks, Mark. That's true for you, Martin, SELECT staffing rules and the pros and cons of doing an interim vis-a-vis stakeholders. And secondly, on icodec, how do we treat severe hypos in the real-world setting?
謝謝,馬克。這對你來說是正確的,Martin,SELECT 人員配備規則以及對利益相關者進行臨時處理的利弊。其次,在 icodec 上,我們如何處理現實環境中的嚴重低電壓?
Martin Holst Lange - Executive VP, Head of Development & Member of the Management Board
Martin Holst Lange - Executive VP, Head of Development & Member of the Management Board
Yes. So actually, I like that. We call it a simple question. The answer is going to be a little bit nerdy and a little bit complex. I think it's a super good question. It's obviously something that we've been looking at.
是的。所以實際上,我喜歡這樣。我們稱之為簡單的問題。答案會有點書呆子而且有點複雜。我認為這是一個非常好的問題。這顯然是我們一直在關注的東西。
And in all practical purposes, when you do an RCT for 26 or 52 weeks or however long you do it, that's real world because you send the patient home. And they are basically stopped with that potential problem.
在所有實際目的中,當您進行 26 或 52 週或多長時間的 RCT 時,這就是現實世界,因為您將患者送回家。他們基本上停止了這個潛在的問題。
Issues, we haven't seen it. And we have exposed at this point in time 5,000 patients in the ONWARDS program. We've not seen this issue. We look obviously at prolonged hypoglycemia. We haven't seen it.
問題,我們還沒有看到。目前,我們已經在 ONWARDS 計劃中暴露了 5,000 名患者。我們還沒有看到這個問題。我們很明顯地看到了長時間的低血糖。我們還沒有看到。
We also look at what some called repeat hypoglycemia. So there would be several events of hypoglycemia within a day where the patient may be able to eat basically their way out of hypoglycemia. But then when the food is gone, they go back, we haven't seen it.
我們還研究了一些所謂的重複低血糖症。因此,一天之內會發生幾次低血糖事件,患者可能基本上可以通過進食來擺脫低血糖。但是當食物沒有了,他們又回去了,我們還沒有看到它。
There's -- I mean, the flat and stable profile in and of itself protects a little bit from that. But the other thing is, and that's the nerdy part, and I apologize to my colleagues for that one.
有 - 我的意思是,平坦而穩定的輪廓本身可以保護一點。但另一件事是,這是書呆子的部分,我為此向我的同事道歉。
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Not to the audience.
不給觀眾。
Martin Holst Lange - Executive VP, Head of Development & Member of the Management Board
Martin Holst Lange - Executive VP, Head of Development & Member of the Management Board
Not to the rest of you. You have to hear it. You have to learn it. Camilla already knows it. So she can also say it. But the way that icodecs protection works is that it binds to albumin. And that basically means that, that level of albumin, all others being equal, the albumin and the insulin receptor complete all icodec.
不給你們其他人。你必須聽到它。你必須學習它。卡米拉已經知道了。所以她也可以這麼說。但是 icodecs 保護的工作方式是它與白蛋白結合。這基本上意味著,該水平的白蛋白,在所有其他條件相同的情況下,白蛋白和胰島素受體完成了所有 icodec。
And as you also know, if the insulin receptor is being occupied by insulin, it's being internalized into the cell. So therefore, it cannot bind anymore. That basically means that if you have not sufficient insulin receptors, icodec will simply be stuck on the albumin. And that actually in and of itself create, at least in theory, a very nice buffer to prevent hypoglycemia.
你也知道,如果胰島素受體被胰島素佔據,它就會被內化到細胞中。因此,它不能再綁定了。這基本上意味著,如果你沒有足夠的胰島素受體,icodec 只會卡在白蛋白上。實際上,至少在理論上,這本身就創造了一種非常好的緩沖劑來防止低血糖症。
The other thing, I actually -- and I probably shouldn't, but I've taken a little bit comfort is that in the ONWARDS 2 program, since it was a switch study, we had to load the patients with icodec to secure that they got up to a sufficient plasma concentration. And that basically meant that they had to start the first treatment, the first week with 150% of expected insulin dose rather than 100%. And we had 8 patients who inadvertently stayed on 150% for longer than 1 week.
另一件事,我實際上 - 我可能不應該,但我有點安慰的是,在 ONWARDS 2 程序中,因為它是一個轉換研究,我們必須用 icodec 加載患者以確保它他們達到了足夠的血漿濃度。這基本上意味著他們必須開始第一次治療,第一周使用 150% 的預期胰島素劑量,而不是 100%。我們有 8 名患者無意中保持 150% 的時間超過 1 週。
And that basically means that they were, in fact, overdosed, and they did not experience to be hypoglycemic. I think even though that was obviously a mistake, and we need to really optimize in the marketplace and our communication around how to do that switch. It actually speaks to the safety and the robustness of the icodec molecule that, I mean, even in that space, you don't introduce hypoglycemia.
這基本上意味著他們實際上是過量服用的,而且他們沒有經歷過低血糖症。我認為即使這顯然是一個錯誤,我們也需要真正優化市場以及我們圍繞如何進行轉換的溝通。它實際上說明了 icodec 分子的安全性和穩健性,我的意思是,即使在那個空間裡,你也不會引入低血糖症。
So I mean, I should never say never. But what we've seen so far, it looks really, really good. And it looks really safe. That was a long question to a simple answer.
所以我的意思是,我永遠不應該說永遠。但是到目前為止我們所看到的,它看起來非常非常好。而且看起來真的很安全。這是一個很長的問題,而不是一個簡單的答案。
On the other one, I'm not really prepared to go into numbers and detail. But you all know that we emphasized the main part of the SELECT trial for 17% differential on efficacy on -- based on the primary endpoint. If we do an interim analysis, our instructions to the (inaudible), the independent body that looks at the data is that whatever sort of happens while closing down the trial has to be a sufficient differential to secure that the approximately 100% -- sorry, 100 events that will be accrued while we closed down the trial cannot change the dynamics and the conclusion of the trial.
另一方面,我並沒有真正準備好進入數字和細節。但是你們都知道,我們強調了 SELECT 試驗的主要部分,即基於主要終點的療效差異為 17%。如果我們進行中期分析,我們對(聽不清)查看數據的獨立機構的指示是,在關閉試驗期間發生的任何類型的事情都必須有足夠的差異,以確保大約 100%——抱歉, 在我們關閉試驗期間將累積的 100 個事件不能改變動態和試驗的結論。
And that basically also mean that if you do an interim, the differential that will be, will be in excess of 17%. And not in a triple amount. It will be sort of in excess of 17%. I don't want to give the number.
這基本上也意味著,如果你做一個臨時的,那麼差異將超過 17%。而且不是三倍。它將超過 17%。我不想給電話號碼。
But that also means that, that would be highly statistically significant. It will obviously be clinically relevant. And I think, Camilla, if we just see on the good side of 17%, she will be happy from a commercial perspective.
但這也意味著,這將具有高度的統計意義。這顯然與臨床相關。我認為,卡米拉,如果我們只看到 17% 的好的一面,從商業角度來看,她會很高興。
And that also means that for some of the secondary endpoints that are also of clinical relevance and probably also both regulatory and payer interest, they would with some likelihood also be statistically significant or at the very least be going in the right direction.
這也意味著,對於一些也具有臨床相關性並且可能同時具有監管和付款人利益的次要終點,它們在一定程度上也可能具有統計學意義,或者至少朝著正確的方向發展。
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Thank you, Martin. Let me move down the line to Keyur.
謝謝你,馬丁。讓我下線到 Keyur。
Keyur Parekh - Equity Analyst
Keyur Parekh - Equity Analyst
Quite lots of questions. I'll keep it to two and then come back possibly. But Camilla, given what we know of ONWARDS 2, and Martin noted your point is not yet in the bag. You have still got 5 studies to come. But what would be a good or a bad outcome relative to market shares of the basal insulin market for icodec in 3, 4, 5 years' time?
相當多的問題。我會保持在兩個,然後可能會回來。但是,鑑於我們對 ONWARDS 2 的了解,Camilla 和 Martin 指出您的觀點還沒有放在包裡。你還有 5 項研究要做。但是,相對於 icodec 基礎胰島素市場在 3、4、5 年後的市場份額而言,好的或壞的結果是什麼?
Secondly, you kind of gave us a long list of reasons why Ozempic has been really strong. And I think all of those make perfectly logical sense. But the one you did not mention was potential rules of Ozempic while that is Wegovy supply constrained.
其次,你給了我們一長串 Ozempic 如此強大的原因。我認為所有這些都非常合乎邏輯。但是你沒有提到的是 Ozempic 的潛在規則,而那是 Wegovy 供應受限。
So I'm wondering if that -- are you saying that's not what you are believing? And consequently, when Wegovy does come back to the market in the second half of the year, you're not expecting to see any sequential decline in Ozempic U.S. volume over the first quarter? Or should we be assuming that you will have some flow-through into Wegovy and therefore, there's a sequential decline on Ozempic?
所以我想知道這是否——你是說這不是你所相信的嗎?因此,當 Wegovy 確實在今年下半年重返市場時,您是否預計第一季度美國 Ozempic 的銷量不會出現任何連續下降?或者我們是否應該假設您將有一些流入 Wegovy,因此 Ozempic 會出現連續下降?
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Thanks, Keyur, for those two questions. I'm actually looking forward to hearing the answers on both. So what icodec market share will make us satisfied, Camilla, in the basal segment. And if you can predict Ozempic in direct levels for the next couple of years, I would also be really happy on that one.
謝謝,Keyur,這兩個問題。我真的很期待聽到這兩個問題的答案。那麼 icodec 的市場份額將讓我們滿意,Camilla,在基礎部分。如果你能在未來幾年直接預測 Ozempic 的水平,我也會對此感到非常高興。
Camilla Sylvest - Executive VP, Head of Commercial Strategy & Corporate Affairs and Member of the Management Board
Camilla Sylvest - Executive VP, Head of Commercial Strategy & Corporate Affairs and Member of the Management Board
Thanks a lot, Keyur. Just turned this into my budget meeting. I really appreciate your question. So I have a guy here next to me taking notes and follow-up forever on the answers.
非常感謝,凱爾。剛剛把它變成了我的預算會議。我真的很感激你的問題。所以我旁邊有一個人在做筆記並永遠跟進答案。
Market share on icodec. We talked about earlier, we have a 37% share in value and 33% in volume in the basal segment. And of course, this is significantly lower than what we've seen in other segments. The premix segment, for example, or even the fast-acting segment.
icodec的市場份額。我們之前談到過,我們在基礎領域擁有 37% 的價值份額和 33% 的數量份額。當然,這比我們在其他領域看到的要低得多。例如,預混部分,甚至是速效部分。
So having a superior offering on HbA1c, that gives you no more hypos but equivalent on hypos is a very, very low way. And you really have to wait for a long time to see any hypos based on what Martin explained and also a quality of life that is significantly better.
因此,在 HbA1c 上提供優質產品,即不再為您提供低劑量但同等劑量的低劑量是一種非常非常低的方法。而且你真的必須等待很長時間才能看到基於馬丁解釋的任何假設以及明顯更好的生活質量。
This is, of course, very, very important. And taking all of that together has a potential to, of course, transform the way we look at basal insulin. So I would hope that we can make a significant inroad into the basal segment.
當然,這非常非常重要。當然,將所有這些結合起來有可能改變我們看待基礎胰島素的方式。所以我希望我們能夠在基礎領域取得重大進展。
And probably we should just see the rest of the ONWARDS trials before we get closer to what could a good aspiration level be. And -- but I do think that we need to be able to make something really good out of this for the sake of the many people that are truly concerned about hypos but are also struggling with trying to understand how they should remember their doses on an everyday basis.
在我們接近理想的理想水平之前,也許我們應該看看剩下的 ONWARDS 試驗。而且 - 但我確實認為,為了許多真正關心低血壓但也在努力理解他們應該如何記住他們的劑量的人,我們需要能夠從中做出真正好的事情。日常基礎。
We know more than forget to take their daily insulin injections. So I also personally look forward to the more real life -- the results of the trial where we leave patients more alone for a year's time to see what that looks like. Because, of course, compliance with a once weekly is likely to be higher, everything else equal.
我們知道的不僅僅是忘記每天注射胰島素。所以我個人也期待更真實的生活——試驗的結果,我們讓患者更加孤獨一年的時間,看看會是什麼樣子。因為,當然,每週一次的依從性可能會更高,其他一切都相同。
So I know I don't give you the market share answer, but at least what potential.
所以我知道我不會給你市場份額的答案,但至少有什麼潛力。
Keyur Parekh - Equity Analyst
Keyur Parekh - Equity Analyst
Majority market share...
大部分市場份額...
Camilla Sylvest - Executive VP, Head of Commercial Strategy & Corporate Affairs and Member of the Management Board
Camilla Sylvest - Executive VP, Head of Commercial Strategy & Corporate Affairs and Member of the Management Board
Sorry?
對不起?
Keyur Parekh - Equity Analyst
Keyur Parekh - Equity Analyst
Majority market share.
大部分市場份額。
Camilla Sylvest - Executive VP, Head of Commercial Strategy & Corporate Affairs and Member of the Management Board
Camilla Sylvest - Executive VP, Head of Commercial Strategy & Corporate Affairs and Member of the Management Board
Majority market share, we can always discuss or we discuss the absolute or relative, but that we can come back to. So I think that's enough for now until we've seen the rest of the ONWARDS trials. I appreciate the support from the room.
大多數市場份額,我們總是可以討論或者我們討論絕對的或相對的,但我們可以回到。所以我認為現在就足夠了,直到我們看到其餘的 ONWARDS 試驗。我感謝房間的支持。
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
I'm taking notes.
我在做筆記。
Camilla Sylvest - Executive VP, Head of Commercial Strategy & Corporate Affairs and Member of the Management Board
Camilla Sylvest - Executive VP, Head of Commercial Strategy & Corporate Affairs and Member of the Management Board
Then on Ozempic, actually, I did -- we did discuss. We have seen more prescribers from lower-tier segments prescribing, and we also understand the relevance of GLP-1, the very strong Ozempic performance in terms of approximately 80% getting in good control we know from our clinical trials.
然後在 Ozempic 上,實際上,我確實 - 我們確實討論過。我們已經看到更多來自較低級別的處方者開處方,我們也了解 GLP-1 的相關性,即我們從臨床試驗中了解到的大約 80% 獲得良好控制的非常強的 Ozempic 表現。
So a really, really great number of benefits. And that, of course, drives our continuous performance with Ozempic.
所以非常非常多的好處。當然,這推動了我們與 Ozempic 的持續表現。
I also spoke a little bit to the halo effect. There's probably an increased understanding of what this molecule can do, semaglutide. And of course, we cannot rule out that some people have -- are living with diabetes thinking if I can -- that they heard about what can this product do in terms of weight loss and then they are interested in that.
我還談到了光環效應。人們可能對這種分子的作用有了更多的了解,semaglutide。當然,我們不能排除有些人——如果我可以的話,患有糖尿病——他們聽說過這種產品在減肥方面能做什麼,然後他們對此感興趣。
We don't have -- I don't have any evidence to suggest that it's all off-label use or that it is. But I think it's very, very important for us to promote Ozempic for diabetes care and Wegovy for obesity care.
我們沒有——我沒有任何證據表明這一切都是標籤外使用或確實如此。但我認為推廣 Ozempic 用於糖尿病護理和 Wegovy 用於肥胖護理對我們來說非常非常重要。
So I think I would leave it with that part. And then would we then later on see a decline in Ozempic? That's, of course, part of what one has to consider would there be -- whenever we are fully supported on Wegovy, would there be some people who have even living with diabetes that have easier access to Wegovy this way than Ozempic? That's still to be seen. But these scenarios, of course, we try to cater for in the guidance that we have given you.
所以我想我會把它留在那部分。然後我們稍後會看到 Ozempic 的下降嗎?當然,這是人們必須考慮的一部分——每當我們完全支持 Wegovy 時,是否會有一些患有糖尿病的人比 Ozempic 更容易通過這種方式訪問 Wegovy?這還有待觀察。但是,當然,我們會嘗試在我們為您提供的指導中滿足這些情況。
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Yes. And just adding to this one. Forecasting NBRx is pretty much really, really complicated. And it's even more complicated to forecast the conversion from NBRx to TRx just to make it even worse.
是的。只是添加到這個。預測 NBRx 非常非常複雜。預測從 NBRx 到 TRx 的轉換更加複雜,只會讓情況變得更糟。
But what we saw last year was kind of interesting. When you looked at NBRx -- and then mid last year, there was also -- you remember the step-up in NBRx linked to potential halo effects, et cetera. But we saw a step-up, and then we saw the curve continuing from the step-up.
但我們去年看到的有點有趣。當您查看 NBRx 時 - 然後在去年年中,您還記得 NBRx 的升級與潛在的光環效應等有關。但是我們看到了一個進步,然後我們看到了從這個進步開始的曲線。
So I'm not saying we'll see the same now, but it's -- you don't find these very simple direct correlations at least based on historical data.
所以我並不是說我們現在會看到同樣的情況,但它是——至少根據歷史數據,你找不到這些非常簡單的直接相關性。
I think it's Sachin, and then we move the other way.
我想是薩欽,然後我們換個方向。
Sachin Jain - MD & Research Analyst
Sachin Jain - MD & Research Analyst
I just like a follow-up on icodec hypos, Mark's question. So if I remember the time of Tresiba, there was a lot of debate around various hypo definitions. My question is fairly straightforward. In an answer to the question, you talked about no severe, no repeat, no prolonged, but you've clearly had an excess of clinically relevant that was less than 3 [minimal]. Just to understand why that is so you've got 3 metrics that you're (inaudible) on and then one you're not, so what's the driver there?
我只是喜歡 icodec hypos 的後續,Mark 的問題。因此,如果我記得 Tresiba 的時代,圍繞各種低定義存在很多爭論。我的問題很簡單。在對問題的回答中,您談到了沒有嚴重、沒有重複、沒有延長,但您顯然有過多的臨床相關性,小於 3 [最小]。只是為了理解為什麼會這樣,所以你有 3 個你(聽不清)的指標,然後一個你沒有,那麼驅動因素是什麼?
And the second question is if you could spend a little bit more time on ONWARDS 5 as to what conversations you've had with payers? And now that you know a lot more about the molecule in the first study, what are your expectations in a realized setting or what level of A1c and can you get hypo superiority? (inaudible) and one very good one on [Sema Cagri]. Having seen Tirzepatide, would you consider a Sema Cagri Tirzepatide head-to-head opportunities?
第二個問題是您是否可以在 ONWARDS 5 上多花一點時間來了解您與付款人進行了哪些對話?既然您對第一項研究中的分子有了更多的了解,那麼您在實際環境中的期望是什麼或 A1c 的水平是多少,您能否獲得低優勢? (聽不清)和一個非常好的 [Sema Cagri]。看過 Tirzepatide 之後,您會考慮與 Sema Cagri Tirzepatide 正面交鋒的機會嗎?
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Thanks, Sachin. Three questions. So you beat Wimal. So one, Martin, I think you call the hypo nerdiness kind of a second effect question. Then ONWARDS 5, how -- why did we design that based on the payer dialogue and then [Sema Cagri] versus Tirzepatide?
謝謝,薩欽。三個問題。所以你打敗了Wimal。所以一個,馬丁,我認為你把低能書呆子稱為第二效應問題。然後 ONWARDS 5,我們為什麼要根據付款人對話以及 [Sema Cagri] 與 Tirzepatide 進行設計?
Martin Holst Lange - Executive VP, Head of Development & Member of the Management Board
Martin Holst Lange - Executive VP, Head of Development & Member of the Management Board
Yes. So we'll start from the beginning. So on the hypoglycemia, again, I think it's important to call out when we see a numerical difference at a very low level, I don't want to belittle the difference, but it's sort of comparing 1 to 2 and then say you have a doubling in risk.
是的。所以我們將從頭開始。所以關於低血糖,我認為當我們看到非常低水平的數值差異時,重要的是要指出,我不想貶低這種差異,但它有點像比較 1 和 2,然後說你有一個風險翻倍。
This is also why there is no statistically significant difference. It's basically a function of really, really few events. And another way of looking at this is you may have seen the number of -- or the proportion of patients reaching an A1c below 7. If you do that proportion, I think it's around 40-something versus 20-something.
這也是為什麼在統計上沒有顯著差異的原因。它基本上是非常非常少的事件的函數。另一種看待這個問題的方式是,你可能已經看到了 A1c 低於 7 的患者的數量或比例。如果你按照這個比例計算,我認為大約是 40 多歲而不是 20 多歲。
And the interesting thing is if you then make analysis reaching A1c below 7 without hypoglycemia, it's the same numbers more or less, again speaking to the very low rate of hypoglycemia. So absolutely a difference, but at a level where it's difficult to say, is this clinically relevant? I don't think it is.
有趣的是,如果您在沒有低血糖的情況下進行分析,將 A1c 降至 7 以下,它或多或少是相同的數字,再次說明低血糖的發生率非常低。所以絕對是不同的,但很難說,這在臨床上是否相關?我不認為它是。
You'll also see when we don't compare to Tresiba, I mean, next study reading out will be ONWARDS 1 versus (inaudible). And we know that there is a different hypo risk associated with that comparison. I think you'll see some maybe slightly different results. And if we can repeat what we do so far, I think both not only we, but also our future customers will say this is the same molecule.
當我們不與 Tresiba 進行比較時,您還會看到,我的意思是,下一個研究讀數將是 ONWARDS 1 與(聽不清)。我們知道,這種比較存在不同的低風險。我想你會看到一些可能略有不同的結果。如果我們可以重複我們迄今為止所做的事情,我認為不僅我們,而且我們未來的客戶都會說這是同一個分子。
ONWARDS 5, we basically -- I think at the very least, I probably also can share the frustration that we -- from a regulatory perspective, we were forced to increase the target. And that means going for A1c parity.
ONWARDS 5,我們基本上 - 我認為至少,我可能也可以分享我們的挫敗感 - 從監管的角度來看,我們被迫增加目標。這意味著要爭取 A1c 平價。
From a payer perspective, they don't really care. We saw that with Tresiba. We came with what we think was very nice hypoglycemia data and payers said, "Well, we can't pay for that. We would like to see A1c difference."
從付款人的角度來看,他們並不在乎。我們在 Tresiba 身上看到了這一點。我們提供了我們認為非常好的低血糖數據,付款人說:“好吧,我們不能為此付費。我們希望看到 A1c 的差異。”
We wanted to change that outlook for icodec. So we had a dialogue with some U.S. payers, some European authorities, the Chinese authorities. We asked them, "What are you looking for?" And very clearly, you had to demonstrate A1c superiority.
我們想改變對 icodec 的看法。因此,我們與一些美國付款人、一些歐洲當局、中國當局進行了對話。我們問他們:“你在找什麼?”很明顯,你必須證明 A1c 的優勢。
We know now also based on ONWARDS 2 that is the potential also on ONWARDS 5. And they very clearly stated we want to see real-world data. The problem in doing treat-to-target is that in our [assets], we can get more than 50% of the patients to a certain target. And in real life, that doesn't hold true. And therefore, they wanted to see what happens with real life.
我們現在也知道基於 ONWARDS 2,這也是 ONWARDS 5 的潛力。他們非常明確地表示我們希望看到真實世界的數據。進行目標治療的問題在於,在我們的 [資產] 中,我們可以讓超過 50% 的患者達到某個目標。而在現實生活中,這並不成立。因此,他們想看看現實生活中會發生什麼。
We've never been able to do that. But with the advent of digital tool monitoring, collecting data on remote advising on insulin titration through an app and an algorithm, that basically allowed us to virtually get the patient the app on an iPhone, the insulin and monitoring device for glycemic control and then saying goodbye, we will see you in a year. Obviously, we do have some visits, but I think it's 4 visits in a year.
我們從來沒有能夠做到這一點。但隨著數字工具監測的出現,通過應用程序和算法收集遠程建議胰島素滴定的數據,這基本上使我們能夠虛擬地讓患者在 iPhone 上使用應用程序,用於血糖控制的胰島素和監測設備,然後說再見,我們一年後見。顯然,我們確實有一些訪問,但我認為這是一年中的 4 次訪問。
Sachin Jain - MD & Research Analyst
Sachin Jain - MD & Research Analyst
Okay. 4. (inaudible).
好的。 4.(聽不清)。
Martin Holst Lange - Executive VP, Head of Development & Member of the Management Board
Martin Holst Lange - Executive VP, Head of Development & Member of the Management Board
They haven't. Historically, we have been looking somewhere between 0.2 and 0.4 depending on who you're talking to. I think, again, in a 26-week study versus Tresiba to see statistically significant points or 2, that's a very nice place to start because it could give us the aspiration of going maybe beyond that in ONWARDS 1 and 5.
他們沒有。從歷史上看,我們一直在尋找 0.2 到 0.4 之間的某個值,具體取決於您與誰交談。我再次認為,在一項針對 Tresiba 的為期 26 週的研究中,為了看到具有統計學意義的點或 2,這是一個非常好的起點,因為它可以讓我們有可能超越 ONWARDS 1 和 5 的願望。
And the final question was Cagrisema head-to-head with Tirzepatide. Sitting next to Camilla, I feel very confident that if the data that we see so far with Cagrisema holds true all the way through Phase III, I don't think I would mind doing a head-to-head because as you've also heard me say before, I do think that Cagrisema will hold its own on efficacy.
最後一個問題是 Cagrisema 與 Tirzepatide 的正面交鋒。坐在卡米拉旁邊,我非常有信心,如果到目前為止我們在卡格里塞馬看到的數據在第三階段一直都是正確的,我認為我不介意進行正面交鋒,因為正如你一樣之前聽我說過,我確實認為 Cagrisema 在功效上會保持自己的地位。
We have very high aspirations for that. And on the safety and tolerability side, so far, we've seen something that is not additive but actually just the sum of what is semaglutide. And that means that Cagrisema holds the potential for being competitive on both efficacy and safety. Obviously, I would like to see the data before I commit. But if it holds true, then we are all in.
我們對此抱有很高的期望。在安全性和耐受性方面,到目前為止,我們已經看到了一些不是添加劑的東西,而實際上只是索馬魯肽的總和。這意味著 Cagrisema 在療效和安全性方面具有競爭力。顯然,我想在提交之前查看數據。但如果它成立,那麼我們都在。
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Great. Thank you, Martin. Thank you, Sachin. We've time for two more questions. So I'll say it's two persons and one start each. And Jo, you are the first one.
偉大的。謝謝你,馬丁。謝謝你,薩欽。我們還有兩個問題的時間。所以我會說這是兩個人,每個人一個開始。喬,你是第一個。
Jo Walton - MD
Jo Walton - MD
Okay. Can I ask a more thought experiment? If sales growth continues closer to the level that you've seen in 1Q then you expect it to go back to because all sorts of fantastic things happen and all (inaudible) the rest of it. At what level of sales growth do you think we should actually see margin leverage come through? Because at the moment, you have the luxury of stronger sales, and you've got lots of ideas. And you can easily reinvest, and everybody still is very happy with that.
好的。我可以問一個更多的思想實驗嗎?如果銷售增長繼續接近您在第一季度看到的水平,那麼您預計它會回到因為各種奇妙的事情發生以及所有(聽不清)其餘的事情。您認為我們應該在什麼水平的銷售增長下實際看到利潤率槓桿作用?因為目前,你擁有更強勁的銷售額,而且你有很多想法。而且您可以輕鬆地進行再投資,每個人仍然對此感到非常滿意。
There must be some point at which is diminishing return, you haven't got all the ideas that you need to spend that much money in R&D. And Camilla, all of the (inaudible).
一定有某個時候收益遞減,你還沒有得到在研發上花那麼多錢所需的所有想法。還有卡米拉,所有的(聽不清)。
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Might just have to interject here. Of course, we will have lots of ideas and R&D on how to spend money.
可能只需要在這裡插話。當然,我們會有很多關於如何花錢的想法和研發。
Jo Walton - MD
Jo Walton - MD
Well, the huge amount of money that you get if you continue to have sort of 15% top line growth for any extended period of time. So can you just help us think about that level and where we should think about leverage coming through versus that reinvestment?
好吧,如果您在任何延長的時間內繼續保持 15% 的收入增長,您將獲得巨額資金。那麼你能不能幫助我們考慮一下這個水平,以及我們應該在哪裡考慮槓桿作用與再投資?
And I am going to sneak in just a very quick second one. Just wondering whether you've highlighted in the past that stay time is significantly less on obesity than it is on diabetes. Have you seen any evidence of people not staying on Ozempic, which would speak to perhaps some of them being the [B2C]? Or are we seeing much longer straight lines in obesity?
我將很快潛入第二個。只是想知道你過去是否強調過肥胖症的停留時間明顯少於糖尿病。你有沒有看到人們沒有留在 Ozempic 上的任何證據,這表明他們中的一些人可能是 [B2C]?或者我們是否看到肥胖的直線更長?
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Thanks, Jo. Two relevant questions. As you know also from our strategic aspirations, then we have clearly communicated even though that it's not necessarily translating into all spreadsheets in London and other good cities that we are -- we're working with a stable margin outlook in the medium term for the company.
謝謝,喬。兩個相關的問題。正如您從我們的戰略抱負中所知道的那樣,儘管它不一定會轉化為倫敦和我們所在的其他好城市的所有電子表格,但我們已經清楚地傳達了信息——我們正在努力實現中期利潤率前景穩定公司。
So our clear base plan is also at higher growth rates is really to be investing mainly in R&D. Right now, you should also bear in mind that as we spoke about the inflationary pressures, we also have to have some work to do there. We believe we can do it, but that's also a reality.
因此,我們明確的基本計劃也是更高的增長率,實際上是主要投資於研發。現在,您還應該記住,當我們談到通脹壓力時,我們還必須在這方面做一些工作。我們相信我們可以做到,但這也是現實。
So clearly, I don't want to invest in R&D unless I believe it has an attractive return, but that will be the key premise. And I think we've shown our financial discipline over and over again. So you shouldn't be modeling with upside on operating margin than you should be working on also investing in the long term. And stay time, we don't have any data, Camilla?
很明顯,我不想投資研發,除非我認為它有有吸引力的回報,但這將是關鍵前提。而且我認為我們已經一次又一次地展示了我們的財務紀律。因此,您不應該在運營利潤率上進行建模,而應該進行長期投資。留下時間,我們沒有任何數據,卡米拉?
Camilla Sylvest - Executive VP, Head of Commercial Strategy & Corporate Affairs and Member of the Management Board
Camilla Sylvest - Executive VP, Head of Commercial Strategy & Corporate Affairs and Member of the Management Board
Yes. That's right. We don't have any evidence of any changes in the data.
是的。這是正確的。我們沒有任何證據表明數據有任何變化。
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Right. It's too early. So we have a year down the road. Pete, last set of questions?
正確的。太早了。所以我們還有一年的時間。皮特,最後一組問題?
Peter James Welford - Senior Equity Analyst & European Pharmaceuticals Analyst
Peter James Welford - Senior Equity Analyst & European Pharmaceuticals Analyst
Yes. Probably two very quick ones. So just coming back to the Wegovy, Ozempic debate for a minute just in terms of high dose. Can you just remind us, is it generally true that the higher dose GLP-1 to 2 mg is that more commonly needed for larger obese type 2 diabetic figures? Is there any correlation between dose of GLP-1 needed versus -- and equally, what proportion of obesity Wegovy patients on your initial data did have type 2 diabetes? If you have to set the size of that, if you can give us that.
是的。可能是兩個非常快的。因此,就高劑量而言,回到 Wegovy,Ozempic 辯論一分鐘。您能否提醒我們,對於較大的肥胖 2 型糖尿病患者來說,較高劑量的 GLP-1 至 2 毫克通常是否更常見?所需的 GLP-1 劑量與 - 同樣,在您的初始數據中,肥胖 Wegovy 患者中有多少比例確實患有 2 型糖尿病之間是否存在任何相關性?如果你必須設置它的大小,如果你可以給我們。
And then can I just ask a quick one just on the Wegovy production? You say you want to make sure you've got enough stocks before you open the gate, if you like, given what's happened. Can you give us some sort of idea what sort of TRx or what the patient -- we have no idea of the range of production from capital.
然後我可以問一個關於 Wegovy 製作的快速問題嗎?你說你想在你打開大門之前確保你有足夠的股票,如果你願意的話,考慮到發生的事情。你能告訴我們什麼類型的 TRx 或什麼病人嗎?我們不知道資本的生產範圍。
But what are you assuming in terms of that before you do? Can you give us any idea of what you're assuming in terms of the demand before you do then say this is enough inventory we're opening up to at least give us some sort of idea of the time frame we're thinking about?
但是,在您這樣做之前,您對此有何假設?你能告訴我們你在需求方面的假設,然後說這是我們開放的足夠庫存,至少可以讓我們對我們正在考慮的時間框架有所了解嗎?
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Yes. So if I just take the inventory build first. And the way we do it in terms of sizing inventories, Pete, is we work with a number of scenarios because it is clearly super volatile what we're looking into based on our historic experiences.
是的。所以,如果我只是先建立庫存。皮特,我們在調整庫存大小方面的做法是處理多種情況,因為根據我們的歷史經驗,我們正在研究的顯然是超級不穩定的。
So we based the sizing of inventories as a combination of different scenarios, and then we furthermore combine it with our launch tactics, which you should expect to be probably more gradual than a big bang out of the gate. So it's impossible to give you 1 point estimate without for sure be completely wrong.
因此,我們將庫存規模作為不同場景的組合,然後我們進一步將其與我們的發布策略相結合,你應該期望它可能比一開始就大爆炸更漸進。所以不可能給你1分的估計,而不一定是完全錯誤的。
But you have the historic trends, both on TRx (inaudible) uptake as well as NBRx. So it's also how many new starts should we expect and a little bit longer. But the big question is, of course, to what extent do physicians have patient inventory, so to say, patients waiting for the product.
但是你有歷史趨勢,包括 TRx(聽不清)吸收和 NBRx。所以這也是我們應該期待有多少新的開始,並且會更長一點。但最大的問題當然是,醫生在多大程度上擁有患者庫存,也就是說,患者在等待產品。
So that's a big uncertainty, and that's what we are careful how to manage. So in reality, it's not only a TRx matter, it's also a patient-stocking type assessment that we're making. And we just want to make sure that it turns into a more controlled approach this time around.
所以這是一個很大的不確定性,這就是我們要小心處理的問題。所以在現實中,這不僅僅是一個 TRx 問題,它也是我們正在進行的患者庫存類型評估。我們只是想確保這一次它變成一種更可控的方法。
Then, Martin, on same 2.4 patient profiles and in terms of need of the doses?
那麼,馬丁,在相同的 2.4 患者資料和劑量需求方面?
Martin Holst Lange - Executive VP, Head of Development & Member of the Management Board
Martin Holst Lange - Executive VP, Head of Development & Member of the Management Board
So the dose part, I think you've seen a differential in terms of the -- those requirements for glycemic control versus weight. So you read the plateau for glycemic control. For example, on semaglutide, when you reach those 2.0 milligram approximately that we just got approved, you can't get much out on glycemic control moving beyond 2.0 milligram.
所以劑量部分,我認為你已經看到了 - 血糖控制與體重的要求之間的差異。所以你讀了血糖控制的高原。例如,在使用 semaglutide 時,當您達到我們剛剛獲得批准的大約 2.0 毫克時,您無法在超過 2.0 毫克的血糖控制方面獲得太多收益。
On body weight loss, we haven't seen any plateau yet. And that also means that, I mean, first of all, you see a difference between 1.0 and 1.2 in terms of body weight loss, but you also see moving beyond 2.0, for example, to 2.4 milligram a further body weight loss. And this is a little bit of an opposition to maybe what also we saw last week, where there was actually a plateau looking at the Tirzepatide data that appears to have sort of reached something between the 10 and 15-milligram in terms of body weight [growing].
在減肥方面,我們還沒有看到任何平台期。這也意味著,我的意思是,首先,你會看到 1.0 和 1.2 在體重減輕方面的差異,但你也會看到超過 2.0,例如,進一步減輕體重至 2.4 毫克。這可能與我們上週看到的情況有點相反,實際上,Tirzepatide 數據存在一個平台期,體重似乎達到了 10 到 15 毫克之間[生長]。
We haven't seen that for semaglutide yet. So we actually haven't established a full (inaudible) for the weight loss part of semaglutide.
我們還沒有看到索馬魯肽出現這種情況。所以我們實際上還沒有為索馬魯肽的減肥部分建立一個完整的(聽不清)。
On the clinical side, all patients that we've investigated with semaglutide 2.4 milligram have been not diabetics. I think in the real world, I don't know if we have data yet on patients on Wegovy being how many also had diabetes. I haven't seen the data, but so far, I mean, the vast majority of what we have on Wegovy at 2.4 milligrams (inaudible) not diabetics.
在臨床方面,我們用 semaglutide 2.4 毫克研究過的所有患者都不是糖尿病患者。我認為在現實世界中,我不知道我們是否有關於 Wegovy 患者的數據,即有多少人還患有糖尿病。我還沒有看到數據,但到目前為止,我的意思是,我們在 Wegovy 上獲得的絕大多數數據是 2.4 毫克(聽不清),而不是糖尿病患者。
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Great. Thank you, Martin, and thanks for joining this Novo Nordisk Q1 launch meeting. And thanks to Richard and JPMorgan for hosting it.
偉大的。謝謝您,Martin,感謝您參加本次諾和諾德第一季度發布會議。感謝 Richard 和摩根大通的主辦。
I'd just like by closing out with a comment that we'll be at ADA, and we'll be hosting a sell-side event at ADA in the U.S. in early June. So I hope to see you all. We'll probably do both some type of a sell-side, nice sell-side dinner. And then we'll have an investor event with Martin and a couple of his colleagues from R&D. So we hope to see you there, hopefully, with more data also out of R&D, but...
我只想在結束時發表評論說我們將參加 ADA,我們將在 6 月初在美國的 ADA 舉辦賣方活動。所以我希望能見到大家。我們可能會做某種類型的賣方,不錯的賣方晚餐。然後,我們將與 Martin 和他的幾位研發同事舉行投資者活動。所以我們希望在那裡見到你,希望還有更多來自研發的數據,但是......
Martin Holst Lange - Executive VP, Head of Development & Member of the Management Board
Martin Holst Lange - Executive VP, Head of Development & Member of the Management Board
Who knows?
誰知道?
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
Karsten Munk Knudsen - Executive VP, CFO & Member of the Management Board
So thank you, and have a great rest of the day.
所以,謝謝你,祝你今天休息愉快。