Novo Nordisk Aktie

All right. Good evening, and welcome to the 2026 Novo Nordisk Investor Event in connection with the American Diabetes Association's Annual Meeting here in New Orleans. So my name is Michael Novod. I'm heading up the IR team at Novo. And I'm just going to run through a bit of practicalities -- currently not. I just want to throw a bit of a practicalities. So we're going to start with having a short presentation and then also followed by Q&A. And then the event is going to have a duration of 50 minutes before we're going to conclude. And with -- all right, I should also say that we do expect to make forward-looking statements, and they may differ from expectations. So read that just as a reminder. Today's speakers on the stage is our CEO, Mike Doustdar, he's going to give some brief introduction and is also Martin Horsager, our as Vice President, Head of Research and Development; and also Chief Scientific Officer; and then also for the Q&A will also be joined by CartoCusen, our CFO. So with that, Mike.

Thanks very much. So also, I may be have welcome to ADA and to this session. I'll start with the slide that you have seen a number of times. I will not spend too much time on it. But -- we are quite proud that when we walk through the halls of the ADA, actually, this congress is no longer just about diabetes, but obesity, I would say, 10 years ago, we were the only 1 echoing the voice of people suffering from obesity. And today, it is nice to see that so many other companies are with us in that journey. -- connected, of course, to these 2 conditions -- there are a lot of other comorbidities, MASH, CVD, chronic kidney disease. And in all of those, we are a proud owner of assets and build -- we would like to build upon that heritage as we go forward. We also have, of course, our rare disease franchise where I will not get too much into it today. Now this week, we also made an announcement about how we are doing with our pill, which has been 1 of the most talked upon assets of Novo Nordisk and the launches recently. I think at the last quarterly meeting, we talked upon -- we talked about how the field has become the best product launch of within the category of GLP-1 and perhaps within the whole category of launches in U.S. We are quite happy that we announced just a couple of days ago that we have now reached more than 3 million prescriptions. And I have to put that in perspective, we are now in week 22, I believe. It took us 10 weeks or it took us 12 weeks to get to 1 million prescriptions. And in the last subsequent 10 weeks, we have done 2 additional million prescriptions. That's in light of competition having arrived in the latter part. So if that is not acceleration, I don't know what is. I think it's been going very well. And we are also very happy to see that the pill is creating a halo effect on the whole franchises of Wegovy. On the back of the Gobi high dose, the GVHD, of course, the original Wegovy. The appeal is really causing us now have around 60% of the NBRx in the U.S. under the brand Wegovy compared to our competitors. So this is something we are very, very proud of. Then I also thought I shared this slide with you before I pass it to Martin to go in through the details. One of the most questions that I get on the pill is why are you doing so well, especially in the light of competition having arrived because I guess I am speaking on behalf of most of you, that very few had anticipated that. And the reason, I think, is a combination of, of course, the efficacy that you see here, 16.6% and versus 12.4%. That's some 34 percentage difference in efficacy of the pill versus what we are competing with, the tolerability happens to also be at least compared to our competitor better when you compare the number of people that dropped out of our child versus in their trial respective trial? The [ MAC ] and the label of Wegovy is helping a lot. This is a product that's not just reducing weight what is giving you the cardioprotection that Wegovy is synonymous with. So that is also another reason why the physicians are prescribing this medication. The safety profile of it on the back of 50 million patient lives is also something physicians speak to us about. And maybe last but not least, when you compare it to our competitor, is the least restrictive medication, which is the part that most people have ignored and/or did not speak to for maybe good or bad reasons. Yes, I think I'll be the first to say we have 1 restrictions compared to our competitor, and that's -- that you have to wait 30 minutes before you take food with the medication. You take a sip of water and then you wait 30 minutes has not been a problem for millions of patients that are on the pill right now. Meanwhile, against that single restrictions, we can see where the restrictions for my competing peers are. It is quite complicated and restrictive to take the other medication. And that's the fact of it and then that's what the physicians and the patients are trying to, of course, find a way around. And perhaps this combined with good sales and marketing is really the reasons why we feel very comfortable that we are on a good path. We have launched a product now in UAE 2 days ago actually, and early data, and it is really early data, gives me also very good hope that, that will be an equally good launch. And then more of that to come as we go forward with more launches, which we will announce going forward. Now it has been, I think, I'm subjective, but I think it has been a good ADA for us with some 40 different abstracts accepted 100% of the assets that we submitted has been accepted by ADA among which, of course, the products that you see -- we have had 36 presentations and 4 oral presentations covering more than 15 different clinical trials. And Martin will now speak to some of the highlights of those things.

Yes. Thank you very much, Mike. So -- good lord Yes.

Can we turn the volume down? So I'm going to focus, obviously, on you've seen top line data on [ Kagoshima ] type 2 diabetes. I'll remind you, we also did redefine 2, which was -- it is part of the beef program. But today, I'm going to focus on the REIMAGINE program that is the dedicated type 2 diabetes program, a secondary endpoint of weight loss. I'm going to focus on tenant in type 2 diabetes. And then I'm going to show you some details also on [ VBT 251. ] -- the highlights -- all right. So very briefly, Actually, I had to say the summer of [ Huliosenstok and Donana ] tough act to follow. And you probably attended most of you the session that was just finalized. You've seen the data. It is 3 studies basically comprising the spectrum of type diabetes from very early type 2 diabetes in REIMAGINE 1 through advanced tattoo diabetes in REIMAGINE 2 late-stage type 2 diabetes in reimagine free. So when we talk about the very early type 2 diabetes, the average duration of diabetes was actually less than 2 years in that population. The free start is have reasonably similar design. So comparing CagriSema 2.4 milligram to 1 milligram in all of them in all of them also a placebo arm and reimagine to also compare it to the mono component of semaglutide and [ agile ] In all 3 studies, less than 50% female. Obviously, you've seen a couple of times during this ADA. You also have heard us talk about it before. We do know that, that impacts the weight loss observed in the studies that we do because we see bigger weight loss with women that we do with men. We have a mean BMI in the 2 first studies of around 35 in and BMI in the last study of 31. Again, important when you interpret the data. And that basically is reflecting a mean body weight around 100 kilos in the first 2 sides and 90 kilograms in the last -- the weight loss you've seen and REIMAGINE 2 at the highest dose, 14.2 percentage point weight loss with an A1c lowering of 1.9%. And do want to mention, if I placebo control that, it's going to be 2 percentage points, which obviously, in this basin, you've seen other diabetes data being presented at this [ years ADA ] by similar control does actually still matter in type 2 diabetes. Obviously, we want the big way losses, but the first license to operate is good glycemic control. So approximately 2 percentage points lower A1c in this specific study, combined with a 4.2 percentage point weight loss. For consistency, we basically see around the same 14% weight loss in the Re-Imagine 1 and the reimagined free studies and around 2 percentage point lowering in A1C. Obviously, there's a range. It depends on the specific population -- but again, if your placebo-controlled somewhere between 1.6 and 1.8 lowering in A1C. So really, really robust and consistent data. there were a lot of discussions of the tolerability profile of CagriSema. We talked about it. You also saw it today, you see improved glycemic control, superior glycemic control vis-a-vis semaglutide in monotherapy, better weight loss savesmeglutide in monotherapy, but comparable adverse events rates as compared to semaglutide in monotherapy. So better basically get better weight loss, better glycemic control, but with the same safety and tolerability profile. -- and no new safety events occurring in the space of these studies. Just want to point out, we are not ready to do regulatory submission of type 2 diabetes for CagriSema because we are awaiting the cardiovascular outcomes data for basically both the type 2 diabetes, but also the obesity. We're doing that in 1 file called redefine 3 and that will read out next year. What will also happen next is obviously that we do initiate the higher dose of CagriSema. As you've seen, we've successfully established that we can increase the dose of semaglutide in monotherapy to 7.2 milligram without compromising on safety and tolerability as compared to lower doses of semaglutide. We intend to leverage that and initiating higher dose CagriSema studies later this year. .

Turning to [ Zenaganside, ] just reminding you that in obesity in the same time span of the study, approximately 6 months, we saw in obesity percentage point weight loss. Obviously, we expect to see something slightly lower in type 2 diabetes. And specifically, we saw almost 15% weight loss in type 2 diabetes. We do know that there is a little bit of a resistance to weight loss in patients with type 2 diabetes. So it is expected to see a slightly lower weight loss. But as you've also seen during this year's ADA a 15% weight loss in 6 months is quite impressive in type 2 diabetes. In particular, if we combine that with, again, I was about to say almost the usual approximately 1.6 lowering in A1C. Again, this is at 6 months, not in the longer studies. I know that at least 1 of you will ask him to the safety and tolerability profile. And I do want to spend a little bit of time if I can get the slide -- on the withdrawal rate of what we saw with CagriSema. You obviously see the nausea rates, the vomiting rates based on what we've seen during this week 3, it's not a surprising data in a Phase I/II trial. But there has been some concern expressed about the high withdrawal rates, 34% in the highest dose. This is simply because of trial technicalities because with this very powerful biology and an attempt to really push the dose escalation, we basically withdrew patients from the study if they did not want to dose escalate, which basically meant that people who felt that they had already lost more than 20% of their body weight, they did not need to go to the next dose. Not necessarily because they saw side effects but rather because they basically didn't want to lose more weight. They opted to not escalate the dose, which basically meant that they had to exit the trial. So there's a little bit of technicality in interpreting this data. When we look at the overall tolerability profile where we model what we can do in terms of dose titration in Phase III we assess that we will have a safety tolerability profile on [ part with ] CagriSema, which means that is expected to be on par with that of Wegovy. So a really, really strong efficacy profile, both on weight loss glycemic control, but also potentially a very strong safety profile and tolerability profile. We are conducting a quite broad development program, obviously, in obesity as a focus on weight loss. There is also a focus on immediate comorbidities as we see it in [ MAS ] which is sleep apnea and near osteoarthritis focused. So you've seen a combination trial or basket trial from some of our competitors, we've opted to do individualized trials -- so some trials focusing just on the wait loss. Some of the initial trials focusing on sleep at and neat arthritis. And then obviously -- and I think this is important we aim to show the same weight loss as we have shown with the subcutaneous treatment in an oral space will demonstrate that starting with MAS 9, which is our oral [ Senogamtide ] study. it's only 1 study, and that's basically because we aim to have it on the market at the same time as the injection. And we can bridge the safety data and some of the other data from the subcutaneous program to the old programs just like we've done with semaglutide. And that really calls for a very strong offering. Again, I can only quote the data that we have at 6 months. in obesity, 24% weight loss in Diabetes, 15% weight loss and a lowering of [ AT ] of 1.7%. So delivered in both subcutaneous but also an or profile. We'll have a cardiovascular study. It's not the usual free or 4 or 5 [ MEstudieIts ] actually a study focusing on heart failure. We do believe that there's too little focus on the impact of heart failure, both from an augmented lead perspective, but also in terms of what we've seen with semaglutide in that space. So therefore, we pursue that really very focused with [ Ameren. ] And this is an outcome study. It's not a functionality study. It's a true outcome study. And then obviously, we have the type 2 diabetes program as well. UPT 251, super exciting acquisition. You've seen the high-level data. Obviously, I have to call out that in this study testing free doses of actually 4 dose regimen of UPT 251 versus placebo. This is conducted in Chinese patients and in China only that does lead to an expected lower weight loss than what we would see from a global population. We've seen that in our stores, our competitors have as well. Rule of thumb is that you expect an Asian population to maybe lose 2/3 of the weight loss as compared to what you would expect to see in a global population. And therefore, when we do our modeling, just as we've seen for another triagonist during this week 8, we expect to see similar weight loss. So the 19% could translate to what we have seen from our competitors. Of course, we had to show that in Phase III, but really exciting weight loss potential. What is equally exciting is that in the face of that big big weight loss potential, we actually see a safety and tolerability profile that is very, very attractive. So -- sorry, this is the weight loss. I just tend to ramp without looking at the slides. So obviously, a 19% weight loss or 20% weight loss in the highest dose in this population and quite a number or proportion of the patients, 50% of patients reaching more than 20% weight loss in this all Asian population, we expect to see, as I said, substantially more weight loss in a global population comparable to that what we've seen from our competitors.

At the same time, you've seen the data today, those of you who went to the poster, a really, really attractive tolerability profile, very low withdrawal rates even at the highest dose, 0% withdrawal rate due to adverse events. A lot of you have said well, maybe there's also a bias in an old Asian population from that perspective. Just want to say, we've done a number of studies, our competitors have done a number of studies in Asia over the years. There are real also in those populations. So I think this is reflective of a good safety and tolerability profile. And when we look at the actual adverse went, it looks really, really attractive and very competitive. We are currently investigating UBT 251 now in a global population, which basically means that we intend to initiate Phase III in short order. We're not giving the time lines, but aiming to have regulatory submissions and launch around the turn of the stack. Briefly on R&D milestones. Obviously, you heard a lot about CagriSema. You heard a lot about UBT. You heard a lot about Senagemtin. I think for CagriSema, what is next is redefine -- that is the study where we're taking all of the learnings to really look at the weight loss potential of CagriSema. That study will read out in Q1 of next year, which is approximately a time of launch of CagriSema, expecting the U.S. regulatory approval later this year. we will see a continuous presence and initiation of Phase I study in both type 1 and type 2 diabetes that is not shown in this slide, but you will get more details and information on that if you attend Capital Markets Day. In U.S. for diabetes, we expect to see regulatory approval for 25-milligram of Ozempic or Ozempic later this year, which will obviously also be exciting. In rare disease, I just want to call that out. I know it's a diabetes conference, but we expect to see regulatory approval of [ Mint ] in U.S. And obviously, we intend to do the regulatory submission of its evoke were expecting a decision next year. then obviously just advertising a little bit for what is immediately ahead of us in Q3, we expect to see the readout of the [ SUSE ] trial. This is the first of the 3 cardiovascular outcomes trials that we do with ziltivekimab. The [ SHUS ] trial specifically is in patients with established cardiovascular disease, kidney disease and established inflammation. -- and the intent is basically to show improvement on Freepoint MAC with the intervention. It is well established that increased IC or increased inflammation is associated with increased risk of cardiovascular disease. We do know that more than 2 million patients live in U.S. with established cardiovascular disease and increased inflammation and therefore, future unmet need because there is no treatment available. This is driving high levels of mortality, high levels of stroke myocardial infarction and so on. And therefore, if an intervention can improve that the potential is tremendous. What we've seen from [ sitevecumab ] is up to 90% lowering in CRP as a proxy for inflammation in such a population. We've also seen a set and tolerability profile, which is important with NTI 6 treatment that is really attractive. So in Phase II, no increased risk of severe infections no meaningful neutropenia, no meaningful impact on liver or dyslipidemia. So really, really a potentially attractive safety and tolerability profile but also a potential for really impacting outcomes for patients through reduction in cardiovascular events, MACE, that is myocardio infraction, stroke or cardiovascular death. So really firing really also, I had to call out high risk. This would be a first -- and while we obviously await the data with high anticipation, it is a first-in-class, and that carries a risk that you have to take into consideration. But more to come I think with that, we're going to Q&A.

Thank you, Martin. Thank you, Mike. And as I said, we have around 25 minutes for Q&A, and Carsten is also joining us here on stage. Richard?

Richard Vosser, JPMorgan. Just we saw the Career data in diabetes and you went through it slightly. But how are you thinking about that opportunity in diabetes? To imagine 1 data looked quite similar to the readat published just yesterday. So how are you thinking about it? How are the doctors thinking about Amylin versus the use of glucagon in diabetes? .

So I really don't want to talk either good or bad about my competitors. I had to disagree with you that they look similar. So I think you're correct that ratatitide showed a 1.7 percentage point reduction in A1C, but the placebo arm showed 0.8 billion percent reduction. So when you placebo correct, which we have to do a scientist, the reduction is around 1.1, 1.2 percentage points, just 1.1%, 1%. Yes. All right. 1.1. Fair enough. .

And this is to be compared with what we've seen just with Kagem, which is around 1.6 to 1.8 placebo-controlled. So I actually don't agree. I think the weight loss was comparable. But on a simpler control, I think Hapisemma seems to stand out. And I would say the safety and tolerability profile with Cagrisema also appears to be more attractive. Obviously, indirect comparisons, you know my caveats around that. But I don't think I fully buy into the premise of this is comparable between the 2. I actually think in type 2 diabetes care stands up, both on efficacy and safety and tolerability. Great .

Thank you, Martin. Martin Baker from SEB. Just a question on the 2 triagonist. Can you talk a little bit how you position them up against each other also on an indication level, which 1 is -- are they going in Phase III in all indications? Or are there some differences you will look at? And then just into the UBT251io mentioned the 2/3 in China and maybe we should try not to put up the expectations so much for the global readout in Phase II. So that being 30%. But can you talk a little about your expectations for that? And also what kind of dose levels you have used? .

Yes, absolutely. So we're not going into too much detail when we talk about which indication we will pursue. I think your question is super relevant. So we'll not necessarily do what has been done for magnesite reteitide CagriSema for that matter. I think we'll look at really targeting these opportunities to where the biology warrants it. Maybe starting with higher baseline BMIs. As we've already seen, these biologies have really, really big weight loss potential. -- if you have a baseline BMI of 27 or 30 for that matter, you don't need a 25, 30 weight loss. And therefore, we'll probably for both of them be looking at maybe even going towards higher PMIs. When it comes to comorbidities, we'll obviously look at the boats. We know what JP1 does and has the potential to do -- the triangles containing glucagon or addressing the glucagon biology, it makes sense to go into for capital mesh we saw data today with another compound. I don't want to discuss their weight loss and their safety profile, but the data on the liver looked really, really interesting but you also saw a lot of discussions during this weekend on the amylin biology, for example, on both preservation potentially on other benefits and taking a differentiated approach. So we're not necessarily -- or we are not going to pursue the 2 assets for the same indications. We can really really think about what would be the right patient population to address with these biologies individually. Seamus? .

James Fernand Guggenheim. Just 2 quick questions. Martin, I'm just struggling a little bit with the math on the 34% of patients dropping out because they achieved 20% weight loss and then seeing only at the high dose of 14% weight loss as a relative driver from 36%. So just -- I'm trying to figure out what I'm missing there. .

I wasn't giving numbers. I was giving examples on some patients actually felt that they had lost enough weight. It was very clear that A lot of them, obviously, will do due to adverse events. We had not optimized the titration that we'll do in fish. But quite a high number also decided to leave for other reasons, including that they had reached a weight loss that was sufficient for them. don't try to match the number because I was not giving numbers. .

Perfect. And then just in terms of 2 factors, and maybe this is a little bit more of a question for Mike. But in terms of the supply opportunity and the scale at which you'll be able to launch CagriSema, I think folks are definitely interested given the dual chamber pen and some of the perceived complexity there. .

Yes. So it will be a global launch. I think at 1 point or the other, we had said that maybe we will launch the dual chamber for U.S. and dto a co-formulation for the rest of the world. That strategy has changed. We will basically without the co-formulations with the dual chamber be able to launch this globally. So that's what we're pursuing.

Steve?

BNP, 1 for Martin. Just given all the news all of the competing data sets we've seen and issues with fixed versus flexible dosing, placebo dropout patients taking primitive drugs. And just the number of trials we're seeing, just in terms of clinical trial execution for a Phase III programs, Liliano known to be good trial executed in the space. But are we being -- honestly for the wheel, but how much more challenging now as Head of R&D of Novo is it to conduct these trials with all those facts to consider

I would say, not necessarily more challenging, but you have to be more mindful of what you do. For us, these dynamics are not different than when we had the same dialogue in type 2 diabetes 10 years ago, 15 years ago, you saw improvements coming in. And you also saw a drop in other therapies in our cardiovascular outcome studies, we Five years ago, 3 years ago, had dialogue on dropping on SGLT2s and Pan potentially the CV benefit of semaglutide. If you design and the study is correct, then you will be able to take care of that. You've not seen -- I mean, we're doing studies all the time. You've not seen the impact of drop in in our studies, yet it's obviously something that we monitor. It's also something that we dialogue with the investigators and they, in that turn, dialogue with patients on show that we can handle it. Some of it you can potentially also cover from a statistical perspective. I think when it comes to flexible dosing, we have to acknowledge, we took our learnings with CagriSema. Flexible dosing has to be employed. You've also seen some data today where force titration were used and leading to massive dropouts. That's not what you can do specifically from a regulatory perspective. But you have to employ flexible dosing in the right way. So again, we took learnings from CagriSema. We've taken those learnings into the REDEFINE 11. I think you heard me talk about at the quarterly meeting, that we already see the impact of that. And we're taking all of those learnings further into macitenand we'll do that again when we go to the triagonist. So I think from a trial conduct perspective, if you do the right planning and you have the right approach, but there is an art to it, it's not more cumbersome, but you have to be mindful of what to do. .

James?

James Gordon from Barclays. A question on UBT. So I saw the phase -- the earlier Chinese sector, but there wasn't a lot of detail on the tolerability. So can you elaborate a little bit? Is it that you think this could be better on and/or tolerability or more like it's going to be quite similar to Rete? And like was there anything in terms of people having like skin sensitivity or cardiac issues? And then maybe just sticking with BCG, just so we saw the repeat in obesity, how are you thinking that might impact your injectable franchise next year? And how will the picture will be particularly like lower dose refer say, versus AGM, please?

So I think the last question is for Mike or Carsten, will take. All right. Your first question, sorry. Additional details on tolerability. .

Yes. Sorry. So the poster that was shown today was not ours. It was basically shown by the investigators that worked on the study together with United. -- and they decided just to look at the dropout rates. When we look at the data, we can only do modeling transferring the data from Phase II in Chinese [indiscernible] Phase I first in a caucasian population and then into Phase II there we see -- we never plan to see superior over, for example, retest, -- it's the same biology. But we see the potential for parity on weight loss plus/minus. And then we see a tolerability profile that at least in this study and the other data that we have looks maybe more attractive than what we've seen for another triagonist. I mean you saw the dropout data. Obviously, it's a small study, and we have to take that into account Nevertheless, if you look at the actual data, and I've been privileged to those data, it looks quite attractive. Not in the small studies, I mean same-size is not to really make those observations. .

Yes. And James, thanks for your question on the competitor 4-milligram I think the important notion is that if you look at our portfolio today, then with our injectable sema franchise, most recently launched sema high dose, 7.2 in the U.S. market. we have a highly competitive portfolio in terms of efficacy, proven brands, go-to-markets and acknowledgment around all the convinces of that brand. And on top of that, Then, as you know, we launched with the Vigo. So we heard some hints around convenience of compares to play. And there, I think that the Google pill has proven with the uptake Mark showed earlier. -- that if you want convenience, then a daily pill like the Google pill is hard to beat. So -- so we'll welcome competition and look to expand the market. And with our portfolio, we are ready for that combined with CagriSema, which will be approved at that point also. .

Maybe I can add to that also, James, that from what we hear from the patients thereafter the magnitude of the weight loss and tolerability and the speed of the weight loss. So from the data is from our competitor, yes, with 1 titration, you can get to 19% weight loss, but you need to wait 80 weeks to get there. That's very different than, of course, if the situation was after 4 months -- 4 weeks, you titrate and then you get to the 19%. So I think patients don't care so much about 1 or 2 or 3 those changes, but how fast do they get to that percentage weight loss. And then as Karsten touched upon, if you look at the products available right now in the market, ours or even our competitors in a fewer weeks, you get to that level weight loss basically at very similar, if not better tolerability. So that's how I look at it from a patient's angle.

James

Freedom Goldman Sachs. But Two menu-related questions. So firstly, on demicemotide, -- how are you thinking about the doses and the titration scheme for the Phase III. You mentioned that the Phase III will be a new titration scheme. So how how did your modeling give you confidence on that? And are there any other measures as well that you could take to help attenuate the safety profile, the tolerability profile in the Phase III -- and second, we've had a lot on menu biology at the meeting and as more data emerges in the class. How do you think about differentiation between the assets that we've seen data for. So does DAC versus Sara matter? Do you believe these are molecule-specific, co-specific anything on CagriSema versus any game versus Petri versus a loyal inside any views there would be great. Yes.

Absolutely. So on dosing, I mean, we have to go back to what we saw with CagriSema. There are a group of people who can titrate these biologies, GLP1 usable biologies every 4 week as we basically intended, and they had a REDEFINED 1 better, i.e., lower side effects profile as compared to Wegovy 57%. Then there's a group of people who actually got the bigger weight loss more than 25%. And but who also started to go down in those basically because they either lost way too fast or because there's a side of things. That group of people, you should not recommend to titrate every 4 weeks, you have to acknowledge that they are super responders, so they should titrate with lower frequency. And we basically, for convenience, decided every 8 weeks. So we now have employed that in REDEFINE 11. As we already discussed, we can see that work that improves how many patients actually get to the higher doses and stay on those doses with a good safety and tolerability profile. Again, I'm looking at blinded data, I can't see weight loss. -- but I can see how many patients go to the recommended dose. And we are doing that in redefined -- sorry, in the AMaZe program as well. What we are also doing is actually adding an extra dusted, acknowledging that the dose deposePhase I and II were maybe slightly too ambitious. And again, that makes us quite confident that we will see the weight loss potential that we've already discussed in type 2 diabetes also the claim control but with a tolerability profile comparable to that of CagriSema. And then on Emlen biology, I mean, jurist. You've heard me talk a lot about, in particular, when it comes to cardiovascular outcomes. I do not think actually, I think I know that GLP-1 is not just a GLP-type for example, stands hard on CV benefit as compared to other incretin-based therapies I have to assume it must be the same for eminent biology. We've seen 1 asset with a weight loss comparable to agile but will now dose response on the higher doses, whereas we can actually see that if we increase the dose of cagintide, we can get to higher weight losses. .

There's another competitor that have seen a very high weight loss, but where we are a little bit down on what the tolerability profile will look like because at some doses, they saw a really good tolerability profile at others, they looked at tolerability profiles that resembled GLP-1. And you don't want a 19% weight loss if you get the same tolerability profile as the GLP-1 because then it's just for patients another GLP-1. The promise has to be that you get to your desired weight loss with a better tolerability profile. And that is where we see cabrilentide right now stand a little bit out.

big?

Simon Bay from Roshan CoRedborne. Two, if I may, please. Just following up on a couple of earlier questions and starting with James. Are there any differences you'd call out between the receptor affinity across the 3 alumin receptors in calcitonin between grilling Tide and Zengamtite. You answered -- I was going to ask the question about does this actually matter? Do we know? And then just picking back on something that Pete was talking about, particularly in light of some of the data we saw this afternoon on server did. Going forward, is it -- is it practical or ethical to run placebo-controlled obesity studies going forward? Are you good to get your perspectives on that? .

Absolutely. So I I think the jury is still out if it matters the specificity for men versus casitonin. -- they are all slightly different. -- there's also a difference between grind and Seagen side, and that's where I've seen the most data close end. They appear to have the same weight loss potential, the same tolerability potential. Some are saying you want more calcitonin for bone preservation, maybe others are saying, you want more Amlin for better weight loss and better tolerability. I'm not sure we've seen those differences pan out. So what we are doing is basically to ensure that we have a portfolio of Amlin biology that caters to basically both. .

Really good question. I think as long as there's a regulatory requirements, we'll have to continue doing the placebo-controlled studies for better worse, we had to do active comparator for CagriSema with the individual ones we don't mind doing that. Our aim is to take differentiated products to the market. So we've already now shown that CagriSema a step-up Isaismagltypa relied more serves. .

-- all that in Beane. But you're losing market share with Ozempic, why would you not file for Tegsesity? -- given that you have capacity for global loans?

So you meanComandiabetes. -- basically because we need to have the reimagined data -- sorry, redefined free data before we can do the regulatory submission.

Michael? .

Mike Mandekic, TD Cowen. One of your competitors showed some compelling if early data for a once-monthly injectable at this conference. I'm curious if your approach to that effort has evolved at all? Do you think a once-monthly injectable could be a meaningful segment in the PC market? .

So I mean, obviously, we're pretty curious about once monthly. You also saw that we were interested in that specific asset. That being said, I'm not sure that the data were as compelling as we had hoped for, in particular, on the tolerability side, but also a little bit on the efficacy side. I think the efficacy side is a matter of dosing. And maybe they will see a bigger weight loss in Phase III, but they really had to think about their titration because the 1 month tolerability was not as attractive as I would have expected and to give patients something for a once-monthly setting the proposition has to be that it is a very attractive tolerability profile. So we are also pursuing less frequent dosing. Obviously, part of what we just discussed can be mitigated by even longer half as you see us taking once modestly asset into Phase I this year. And we can -- if everything goes right, have those assets potentially in the market around the turn of the decade, to be able to compete in that space in a meaningful way. But again, the tolerability profile has to be better than what we've seen .

Ben?

Ben Jefferies. One for you, Martin, on UBT, -- is this a scenario whereby you can get the SNAP technology involved again and go with the oral route. And perhaps when can we start to see that progressing? And then a really quick 1 for yourself, Mark, I think you made a couple of comments in an interview today talking about potential for aesthetics and longevity. Is that through using the best in Type 2 diabetes portfolio as well? Or is there more interest to diversify beyond these core areas as well?

Yes. So we're going to realize not any peptide lenses sales to the SA technology. That being said, we are obviously pursuing an oral version of UT5. I just want to advertise, we're also doing a tangent as we just discussed, an oral version of an Amlin. And then we have actually a small molecule, which is the CSL inhibitor let's start a Phase I a couple of months ago. .

And I was basically making a reference that the biology is that we are playing around with and have expertise in can do multiple different things, and we will not shy away from pursuing and following the science in those biologies. So that was the reference. .

All right. We have to cut here, but thanks a lot for joining this Novo Nordisk investor event at the ADA of 2026 in New Orleans. Thanks, Mike. Thanks, Martin, and thanks, Carsten. Thanks all for joining. And there's also be couple of minutes afterwards to discuss with management.

Thank you very, very much.

Thank you.

Good day, and thank you for standing by. Welcome to the Q1 2026 Novo Nordisk Earnings Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded.

I would now like to hand the conference over to your first speaker today, Michael Novod, Head of Investor Relations. Please go ahead.

Thank you very much, operator. Welcome to this Novo Nordisk earnings call for the first 3 months of 2026. My name is Michael Novod, I'm the Head of Investor Relations at Novo Nordisk. With me today, I have CEO of Novo Nordisk, Mike Doustdar; EVP, U.S. Operations, Jamey Millar; EVP, International Operations, Emil Kongshoej Larsen; EVP, Research and Development and Chief Scientific Officer, Martin Holst Lange; and Chief Financial Officer, Karsten Knudsen.

All speakers will be available for the Q&A session. Today's call is being webcasted live, and a recording will be made available at our website. The call is scheduled to last 1 hour. Next slide, please. The presentation is structured as outlined on Slide 2. Please note that all sales and operating profit growth statements will be at CER, unless otherwise specified.

Next slide, please. As usual, we need to advise you that this call will contain forward-looking statements. These are subject to risks and uncertainty that could cause actual results to differ materially from expectations. For further information on the risk factors, please see the company announcement for the first 3 months of 2026 and the slides prepared for this presentation.

With that, over to you, Mike, for an update on our strategic milestones in the first quarter of 2026.

Thank you, Michael. Next slide, please. In 2026, Novo Nordisk is focused on driving competitiveness, progressing our pipeline and making focused investments towards growth opportunities while delivering returns. Today, Novo Nordisk is serving more than 45 million people living with obesity and diabetes. Of those, more than 4 million people are using our obesity treatments, which means we are now treating over 50% more people living with obesity compared to just a year ago. We are excited to continue bringing new Wegovy options to patients that includes the Wegovy pill in the U.S. and Wegovy HD, also known as high-dose or 7.2 milligram, which is now approved in the U.S., U.K., European Union and Brazil. It is no secret that the Wegovy pill is off to a record-breaking start in the U.S. Since launching it some 16 weeks ago, we have seen over 1 million people using Wegovy pill.

As the global momentum behind the peptide-based therapies accelerates, Wegovy pill is defining a novel category as the only oral peptide for the treatment of obesity, setting a new benchmark for what patients and physicians can expect. All of this is something we are very proud of, and it highlights our strong innovation and launch capabilities. Within research and development, we continue to advance our pipeline across therapy areas. In the first quarter of 2026, we have had 6 regulatory approvals and more than 10 clinical trials initiations. Martin will dive deeper into all of these exciting accomplishments in a few minutes, along with our expected milestones for the rest of the year.

Novo Nordisk is making strategic investments in growth opportunities to drive our competitiveness and progress our pipeline. In the first quarter of 2026, we have invested about DKK 22 billion in research and development and commercial initiatives. On top of that, we returned nearly DKK 38 billion to our shareholders through dividends and share buybacks. Lastly, we have raised our 2026 guidance, which Karsten will get back to later on. Next slide, please.

In the first 3 months of 2026, adjusted sales decreased by 4%, driven by lower realized prices, partly offset by GLP-1 volume growth and market expansion. U.S. operations decreased 11%, partially offset by international operations, which grew 6%. Our GLP-1 sales in Diabetes decreased by 11%, mainly driven by U.S. operations. Obesity care sales increased 22%, driven by both operating units. International operations grew by 44% and U.S. operations grew by 9%.

With that, handing it to you, Jamey.

Thank you, Mike. Next slide, please. Early this year, Novo Nordisk launched the Wegovy pill in the United States. Wegovy pill delivers weight loss efficacy on par with that of injectable Wegovy in a once-daily easily administered oral tablet. In addition to the weight loss indication, Wegovy pill is the only oral GLP-1 product approved for the reduction of major adverse cardiovascular events, specifically a reduction in cardiovascular death, heart attack and stroke. Furthermore, it is supported by semaglutide's long-standing safety and tolerability profile with around 50 million patient years of real-world experience and does not have drug-to-drug interaction restrictions in its label. Since the launch, we have been focused on use, users and usage. The use of Wegovy pill continues unabated, far outpacing the uptake of any prior GLP-1 drug launch in the United States.

First quarter TRxs were 1.3 million in total. And since launch, we have generated more than 2 million TRxs. We estimate this translates into more than 1 million people treated since launch. For the week ending on April 17, total weekly prescriptions were 207,000. In terms of users, our source of business analysis supports that the Wegovy pill is bringing new health care providers and new patients to Wegovy. In terms of patients, we see close to 80% of Wegovy pill users are GLP-1 treatment-naive patients. We also see patients coming to Wegovy pill from competitor products with limited cannibalization from injectable Wegovy.

Lastly, in terms of usage, we are tracking titration, refills and stay time. While it is early in terms of usage evaluation, we are encouraged by what we see and early trends are consistent with our expectations. We continue to seek improved pull-through of reimbursed volume, leveraging strong standard formulary positions in the commercial segment. By the end of the first quarter, all 3 of the largest PBMs added Wegovy pill at parity with injection on their standard template formularies. This will have an impact on the balance between reimbursed and self-pay volume over time. As expected, the early volume is largely in the self-pay segment. Next slide, please.

Wegovy High-Dose was launched in the U.S. in April in a single-dose device, giving patients and health care providers the opportunity to experience greater weight loss with the Wegovy brand. Based on the step-up trial results, when patients adhered to treatment, the 7.2 milligram dose of semaglutide delivered 20.7% mean weight loss in people with obesity with approximately 1 in 3 people experiencing 25% or greater weight loss. Importantly, despite the higher dose, the rate of discontinuation in the trial due to adverse events is similar to that observed with the 2.4 milligram dose. Wegovy High-Dose has been launched nationwide across all channels with the 3 largest PBMs having added Wegovy High-Dose to their respective standard formularies as a line extension. It is still early days, but we are already seeing users titrate to the 7.2 milligram dose. Next slide, please.

Our recent commercial efforts, including the expansion of Wegovy offerings with the Wegovy pill and Wegovy HD and options for accessing our medicines have driven a notable shift in new-to-brand prescription dynamics in the branded anti-obesity medication space. The Wegovy franchise is now leading on NBRx market share with a share of around 65%.

With that, over to you, Emil.

Thank you, Jamey. Please turn to the next slide. In the first 3 months of 2026, obesity care sales in international operations grew by 44% to DKK 9.2 billion. This was driven by strong volume growth and market expansion, partly offset by lower prices, particularly in China following price reductions after the NRDL listing of a competitor product. Novo Nordisk continues to be volume market leader in international operations with around 55% weekly injectable GLP-1 volume market share. While our market share has been declining over recent quarters, we are starting to see our share growth stabilizing, which indicates that we are gradually seeing the benefit of our efforts to drive competitiveness in the market.

As examples, we are expanding our telehealth partnerships and in some of our largest markets, around 20% of Wegovy sales is coming from telehealth channels. We are also differentiating our GLP-1 portfolio with the U.K. approval of Wegovy 7.2 milligram in a single-dose device and the launches of Ozempic 2.0 milligram. In addition, Novo Nordisk is expecting to launch Wegovy in select markets in the second half of 2026, pending regulatory decision.

With that, over to you, Karsten.

Thank you, Emil. Please turn to the next slide. In the first 3 months of 2026, our reported sales increased by 32%, reaching DKK 96.8 billion. However, as part of our 2025 full year results, we did introduce adjusted metrics to exclude certain exceptional and nonrecurring effects, primarily of noncash nature, including the provision reversal of USD 4.2 billion related to the 340B drug pricing program in the U.S. That means our adjusted sales declined by 4%, driven by lower realized prices, partly offset by GLP-1 volume growth and market expansion across geographies. The adjusted gross margin decreased to 80.6% compared to 83.5% in 2025, reflecting lower realized prices, onetime costs as well as a negative currency impact. This was partially offset by positive product mix from increased GLP-1 sales.

Adjusted operating profit decreased by 6% at CER, reflecting the lower sales and gross profit, combined with continued investments in R&D and commercial activities, including ongoing launches. Through our disciplined cost base approach, we are on track to deliver the DKK 8 billion of savings from the company-wide transformation announced back in the third quarter of 2025, which are being reinvested into growth opportunities. At the end of the first quarter, the number of full-time employees was around 68,000, which is a decrease of almost 10,000 employees compared to 12 months ago. Please turn to the next slide.

Novo Nordisk is off to a good start. And for 2026, adjusted sales growth is now expected to be between minus 4% and minus 12% at CER. The improvement in outlook is mainly driven by increased expectations for GLP-1 product sales. In International Operations, the outlook is based on current growth trends, including continued volume penetration from GLP-1 treatments and market expansion, mainly within obesity and negative impacts from the compound patent expiry of semaglutide molecule in certain markets. In U.S. operations, the outlook is based on current prescription trends for the injectable GLP-1 portfolio, intensifying competition as well as negative impact from reduced obesity medication coverage in Medicaid.

Further lower realized prices linked to investments in market access amplified by the Most-Favored-Nations agreement with the U.S. administration is assumed. Uptake related to the Wegovy pill is reflected in the outlook based on a range of assumptions related here to, such as market penetration, potential negative impact on the growth of the injectable obesity medication category as well as channel mix. Adjusted operating profit growth is now expected to be minus 4% to minus 12% at CER, primarily reflecting the updated sales outlook. We continue our targeted investment in growth opportunities within R&D and commercial, partly funded by reinvestment of savings from the company-wide transformation in 2025 as well as further optimization initiatives and disciplined resource allocation. Our key modeling considerations for 2026 are shown on the slide. That was the outlook for 2026.

Now over to you, Martin.

Thank you, Karsten. Please turn to the next slide. The first quarter was eventful with numerous readouts and regulatory milestones. Within obesity, we recently obtained FDA approval for high-dose semaglutide at 7.2 milligram in the U.S. We have also initiated the 2 pivotal Phase III trials in the zenagamtide development program, AMAZE. In addition, we have initiated Phase III trials to investigate zenagamtide in people with obesity and sleep apnea, in people with obesity and knee osteoarthritis and to investigate how well zenagamtide helps people with obesity in maintaining their weight loss.

Within diabetes, we completed the pivotal Phase III trial, REIMAGINE 1 for CagriSema in people with type 2 diabetes in adequately controlled the diet and exercise. In the trial, CagriSema demonstrated a superior HbA1c reduction of up to 1.8 percentage points and a superior weight loss of up to 13.8%, respectively, at 40 weeks. The detailed results from the REIMAGINE 1, 2, and 3 trials will be presented at the American Diabetes Association Conference in 2026. Lastly, a weekly received FDA approval as the first and only once-weekly long-acting basal insulin for people living with type 2 diabetes. We expect to launch a weekly in the FlexTouch device in the U.S. in the second half of 2026. Please go to the next slide.

Recently, we announced the top line results from the Phase III HIBISCUS study, which evaluated the potential of Etavopivat in sickle cell disease in addition to standard of care. Sickle cell disease is an inherited condition in which red blood cells take on a sickle shape because of abnormal hemoglobin. This alteration leads to blocked blood vessels, poor circulation and episodes of severe pain known as vaso-occlusive crisis or VOCs. The following complications can impact any organ and are often accompanied by anemia and fatigue and may ultimately lead to organ damage and a shortened lifespan. Approximately 8 million individuals worldwide are affected by sickle cell disease. Treatment options remain limited and the unmet need is significant, underscoring urgent need for improved therapies that address both VOCs and hemoglobin response.

Etavopivat is a novel and once-daily orally available small molecule designed to improve red blood cell health via pyruvate kinase-R or PKR activation. Etavopivat was tested in the HIBISCUS trial, a randomized, double-blinded 52-week efficacy and safety trial investigating Etavopivat versus placebo in 385 people aged 12 years or older with sickle cell disease. The co-primary endpoint was annualized VOC rates, reduction and hemoglobin response on top of standard of care. Next slide, please.

Etavopivat successfully met both co-primary endpoints in HIBISCUS, making it the first of its class to meet both co-primary endpoints by substantially reducing VOC events and improving hemoglobin response in sickle cell disease. In the trial, Etavopivat demonstrated a superior reduction in the annualized rate of VOCs by 27% compared to placebo. In addition, time to first VOC event was delayed by around 4 months compared to placebo. In the co-primary endpoint measuring hemoglobin response, Etavopivat demonstrated a superior increase in the proportion of people achieving a hemoglobin response greater than 1 gram per deciliter at week 24 of 48.7% compared to 7.2% with placebo. As an exploratory analysis, Etavopivat also significantly reduced the risk of blood transfusion. In the trial, Etavopivat appeared to be well tolerated with top line safety profile in line with previous Etavopivat trials. Based on the results from the HIBISCUS trial, Novo Nordisk plans to submit the first regulatory approval of Etavopivat in the fourth quarter of 2026. Next slide, please.

Earlier this year, Novo Nordisk and United Laboratories announced the top line results for UBT251 in 2 Chinese Phase 2 trials, one in obesity and one in diabetes, respectively. UBT251 is a long-acting synthetic peptide triple agonist targeting the receptors for GLP-1, GIP and glucagon. In the obesity Phase II trial, the highest mean weight loss observed for people treated with UBT251 was 19.7% after 24 weeks of treatment. In the type 2 diabetes trial, the largest mean A1c reduction with UBT251 was 2.16 percentage points at 24 weeks and the highest mean weight loss observed was 9.8%. In both trials, the safety and tolerability profile of UBT251 appeared to be consistent with tri-agonist-based therapies. Within obesity, Novo Nordisk has initiated a global Phase Ib/IIa trial with results expected in 2027. For type 2 diabetes, Novo Nordisk expects to start a global Phase II trial with UBT251 in second quarter of 2026. Next slide, please.

After a busy quarter, we anticipate an exciting year ahead across all therapy areas. Starting within obesity, we still expect a decision in the U.S. for CagriSema at the end of '26 with a potential launch in '27 around the same time of the REDEFINE 11 top line results. In addition, we expect to initiate a Phase IIIb trial with CagriSema high dose in the second quarter of 2026. Overall, we remain excited about the profile of CagriSema and prospect of launching soon given the strong weight loss profile as well as the broader cardiometabolic effects observed. We also expect to initiate the AMAZE 9 trial investigating oral zenagamtide in people living with obesity in the third quarter and a Phase III trial with cagrilintide high dose in the fourth quarter of 2026.

In the U.S., we anticipate the decision regarding Wegovy FlexTouch that was resubmitted in Q1. In the EU, we expect a decision on Wegovy pill and the single-dose device for injectable Wegovy 7.2 milligram. Within obesity-related comorbidities, we expect Phase III results for efruxifermin in the SYNCHRONY real-world trial in people with metabolic dysfunction-associated steatohepatitis or MASH, with fibrosis stage 1 through 4. The primary endpoint of the trial is safety and tolerability of efruxifermin. Within diabetes, we have initiated the Phase II trial for our tri-agonist targeting GLP-1, GIP and amylin. We also expect to initiate the zenagamtide Phase III development program AMBITION in the fourth quarter of '26.

Within diabetes-associated comorbidities, the first readout of Ziltivekimab from the ZEUS Phase III trial is anticipated in the third quarter of this year. The trial is assessing 3-point MACE relative risk reduction on top of standard of care. Ziltivekimab has the potential to be first-in-class treatment, targeting systemic inflammation in people living with atherosclerotic cardiovascular disease and chronic kidney disease. 2026 is an exciting year in rare disease as well. Besides the HIBISCUS results I just mentioned, we are awaiting regulatory decisions in the U.S. and EU later this year for denecimig, previously known as Mim8 for people living with hemophilia A.

With that, over to you, Michael.

Thank you, Martin. Next slide, please. With that, we're now ready for the Q&A. [Operator Instructions] Operator, we're now ready to take the first question.

[Operator Instructions]

And your first question today comes from the line of Richard Vosser from JPMorgan.

Two questions, please, both on oral Wegovy. You've seen very strong uptake, but there seems to be a bit of a drop-off in the patients going between the 4 mg and the 9 mg doses in terms of titration. So just wanted your views on what might be behind that. Is that the jump in price? Is it tolerability? Or is it weight loss results? And how you're thinking that will impact the stay time of the product and the growth going forward? And one just on supply of oral Wegovy as well. You've referenced launches in a couple of international operations markets. How many markets do you think you can sustain? And generally, how is supply going?

Thank you, Richard. Two questions. One, starting with Jamey and then over to Karsten on supply.

Yes. Thank you for the question. Overall, titration is happening as expected and comparable to what we see with injectable Wegovy. So we're pleased with the progress there. Of course, it's early post launch in the evaluative kind of period of usage. But we also see movement toward the 9 and 25-milligram doses continued uptake on a week-over-week basis.

Great. Thanks, Jamey. And Richard, thanks for the question on supply. The way I'll put it is, while we do not have unlimited supply for the Wegovy pill due to the product design, then despite the fact that we are setting a new record in terms of product uptake in the U.S. market with the Wegovy tablet, we are still able to announce launches in the first markets ex U.S. already this year. So this speaks really to scaling of supply and the inventories we've put in place. And then we play it gradually from here in terms of the pace of international rollout.

Your next question comes from the line of Sachin Jain from Bank of America.

Two again, please. So firstly, I guess, Karsten, on SG&A. It's lowest absolute number for a number of quarters. It feels a little bit odd into a product launch. So should we think of this as a new commercial model with telehealth and this is a base? Or anything to think about the cadence of SG&A through the course of the year? The second one is a broad question around price, maybe for Michael or Jamey and [indiscernible] into your comments around no intention to lower prices and oral price in the sweet spot. I wonder if you could just dig into that a little bit further. Is there no intention to lower come into the 150 or 149 lower oral dose holding? And if oral price is the sweet spot, how do we think about price mix across the business shifting to this lower price bracket? And I guess that trends to higher dose oral pricing, reimbursed pricing and bleeds diabetes pricing.

Thanks, Sachin. First question to Karsten and then second goes to Mike.

Yes. Thanks, Sachin, for this question. So on SG&A in the quarter, first and foremost, it's important to note that we have a one-off, which is favorable in the fact that we are adjusting a legal provision, which has a benefit of, I would say, a notch more than $100 million that favorably impacts the quarter. So one should adjust for that. In terms of continued investment, then I promise you that we have gone pretty much all in, in terms of the Wegovy pill launch and resourcing of that. You've seen the Super Bowl ads, et cetera. And then with the model that we are deploying together with the telehealth partners, then that yields a different scalability in terms of promotional presence between paid versus earned media.

And that has yielded a very, very high share of [ voice ] share in the first quarter. Through the coming quarters, expect us to be disciplined around our spending. We have less employees in the company, which, of course, helps on SG&A. And -- but at the same time, we are truly investing in the growth drivers we have, be that Wegovy HD, the launch products coming up and the Wegovy tablets. So in terms of SG&A ratio, we are in the low 20s for the full year.

So Sachin, I think price is dynamic and element of volume uptake. If you take a look at where we are with our volume uptake, that's why we say we are at the sweet spot. We are seeing a situation where at the current prices, we have had 2 million scripts after 16 weeks, more than 200,000 scripts per week despite competitor having come now more than a week -- more than a month into the game and having more than 1 million patients on our product. So at this point, I would say we have priced this product perfectly correct. We also have said that, of course, it's dynamic because if you look at this in a longer spectrum, then we foresee a situation where volume uptick continues, of course, to continue. And then that would mean that prices have to come down if your ambition is to get to hundreds of millions of patients at one point or the other, at that point, of course, the prices will be very different. But for now, this is the right price.

Your next question comes from the line of Simon Baker, Rothschild & Co.

Two if I may, please, really following on from Sachin's questions. Firstly, on the oral Wegovy, I just wonder in light of the launch and the success of the launch, if you're getting a better handle on this price volume dynamic? And as part of that, what's been your feedback for patients choosing the pill? Is it convenience? Is it efficacy? Or is it cost because it's the cheapest option in the market at the moment? Just some idea on how this price elasticity is evolving. And then secondly, going back to cost, one for Karsten. Not only was SG&A even after the legal adjustment low in the quarter, R&D was as well. So I just wonder if you could give us an idea on the phasing of R&D through the rest of the year.

Great. First question for Jamey and then second question for Karsten.

Yes. I think on price elasticity, as Mike said, the volume uptake and receptivity in the market suggests that we found that sweet spot in terms of price leading to record volumes. In terms of oral attractiveness to consumers and patients, the key decision criteria still is magnitude of weight loss and the Wegovy pill demonstrated 17% weight loss. In addition, the attractiveness of the limited time offer pricing for the initial starting dose brings people to the product as well.

Thanks, Jamey, and thanks, Simon, for the question on R&D cost. As you heard from Martin's introductory comments, then we have a lot going in R&D, and it's a strategic priority for the company to expand our pipeline to drive growth not only for the medium term, but also for the long term. So the R&D ratio in the quarter, yes, is a notch on the low side compared to what we expect for the full year. So expect us to lean in on R&D investment in the coming quarters.

Your next question comes from the line of Peter Verdult from BNP Paribas.

Pete Verdult, BNP. Two questions, one for Martin and one maybe for Jamey as well. Martin, can I just push you for some more info on your next-gen GLP-1? Is it fair to assume that this will be differentiated on dosing frequency? Or do you still believe there is scope within the GLP-1 class to differentiate on efficacy or safety? And then maybe, Jamey, for you, just because you are new to the management team and you bring an outsider perspective inwards. Could you just give us a flavor of what you found when you arrived in your role at Novo and some of the -- a few of the biggest changes you've made since taking the role on?

Thanks, Pete. First question to Martin and then to Jamey.

Yes. I think you've -- thank you for the question, Pete. I think you've heard me talk about before, when we talk about differentiation, we look at efficacy, differentiation, tolerability, dosing frequency and maybe scalability. Let's assume that this one has one or more of these potential traits, but we'll not go further into detail, and you'll have to maybe attend CMD to learn more.

Great. Thanks, Martin. And Jamey, what have you learned?

It's a big question, but a short answer. Firstly, just a lot of opportunity. I think the first quarter milestones, whether it's approvals, clinical data readouts have produced a great environment to make a change in the trajectory of the business, specifically, obviously, Wegovy pill as we're discussing, but also Wegovy high dose, the 7.2 milligram strength really allows us to level the playing field from an efficacy standpoint. So a lot of opportunities and levers to leverage. I think the second thing just in a snapshot, and Mike talks about it often is the opportunity to integrate our thinking across market access, sales, marketing, medical, regulatory in a differentiated way.

Your next question comes from the line of Michael Leuchten from Jefferies.

Two questions as well, please. And linked, Ozempic had a pretty strong first quarter. Can you talk to the price erosion in the U.S. you saw in Q1? And how should that -- or would that look like once the Medicare bridge program kicks in? Would there be collateral damage for Ozempic in diabetes in the second half? And that links to the second question on guidance. So Karsten, you haven't changed the lower end of the range when Q1 came in quite robustly. What's the variables that doesn't allow you to lift that lower end double-digit decline in -- for the rest of the year?

Thanks a lot. Two questions for Karsten.

Yes. Thanks, Michael, for those very relevant questions. So first, in terms of Ozempic and Ozempic performance, then I'd say what we've seen here in the first quarter in the U.S. setting, which is what you're alluding to, is very much a continuation of what we saw towards the end of last year and what the same commentary in connection with full year. So both on volume trending and on pricing, the same, we're looking at these, call it, minus 10% to up to minus 15% price erosion. So really no change there. And that's what we're looking into for the full year. So I really don't want to get into the quarters, but same guidance this year as last year and even the year before on Ozempic U.S. price.

As to guidance and where we are now, the important point on guidance and our thinking behind guidance here at Q1 is that now we're 3 months down the road, and we've seen a number of items actually partially playing our way in terms of the oral script trends. We've got the Wegovy high-dose approval in U.S. We have decided to launch Wegovy tablet ex U.S. in a few select markets. And then we've gotten more info both on competition as well as LOE approvals in IO. So based on that, we're more confident in our outlook. And as a consequence, we parallel shifted both sales and OP ranges by 1 percentage point. So you should see that as increased confidence. And yes, I'm with you that the range is a not wide, but you should take it as a signal of confidence that we lifted the range by 1 percentage point.

Your next question comes from the line of Mike Nedelcovych from TD Cowen.

I have 2. My first is on Ziltivekimab. I'm wondering if you could tell us between ZEUS, HERMES, ARTEMIS and ATHENA, which trial you view as having the largest opportunity? And then my second question is on Wegovy IP in the U.S. I know that you guide to expiration of the semaglutide composition of matter patent as the loss of exclusivity date, but there's almost a decade difference between the drug substance patent and the latest dated patents for Wegovy pill and Wegovy injection. So my question is, does Novo plan to defend that IP?

Thank you, Mike. One question for Martin and one for Karsten.

Yes. Thank you for that. So from an indication and a potential perspective for Ziltivekimab, ZEUS, HERMES and ARTEMIS are the only ones that will lead to potential indications, respectively, in ASCVD, heart failure with preserved ejection fraction and post-myocardial infarction. From a medical perspective, obviously, we have a high level of confidence in the biology. There is a potential of improving outcomes in all of these 3 categories. We still had to flag the high risk. This is first-in-class, and we need to establish not only the efficacy in terms of improved outcomes, but also the safety and tolerability of an anti-IL-6. So we still see this as very, very high potential across those 3 indications, but also high risk until we've seen the first readout.

Thanks, Martin. And Karsten?

Yes. On IP, as you know, Michael, this industry works in the way that we take very significant risks in early investments in R&D with a fairly low probability of success early on. So those big risks and investments in return, we get patent protection for a certain period of time. And that's why when we then get into that period, it's very important for us to defend that patent protection. It's granted by patent authorities in the different geographies. So this is not something that we decide on our own. And when granted, of course, we intend to defend all our patents in court should they be challenged by generics.

Your next question comes from the line of James Gordon from Barclays.

James Gordon from Barclays. Two questions. First question just on long-term semaglutide in general obesity pricing. So I know you've invested tens of billions in CapEx to brew sema very efficiently at scale. But then in India, I think it's at least 8 generics approved and some very low prices, at least for the vial form just $14. So it does look like the generic companies chemically synthesize at very low cost. So your latest thinking about manufacturing efficiency, do you still think like long term with synthesis generics would struggle to match you on price with your different technique? Or do you think we are going to have an order of magnitude for once the patents go in the West, and that does make it tougher for next-generation obesity therapies?

And then the second question was just a follow-up on some of the comments about SG&A, just trying to square it because you did a 47% adjusted EBIT margin. It sounds like with the one-off on legal, it's still mid-40s, but the midpoint of the full year guide is more like 40%. So is it because of lots more R&D? Or is it also like you're allowing for doing a lot more sales and marketing for an ex U.S. oral Wegovy launch? Otherwise, it seems like if you would get to a higher margin.

Thank you, James. Two questions for Karsten, one on sema and manufacturing mode and pricing and then one on SG&A.

Yes. Thanks, James, for those 2 questions. So first of all, first and foremost, on sema manufacturing, based on our [ manu ] process and set up and we believe that we are hypercompetitive in terms of unit cost in producing sema and hypercompetitive in terms of scale also in terms of how much sema we are able to produce and the reach we can do in pretty much at a global scale. What that leads into in pricing in different health care systems and different channels remains to be seen. I think it's important to note that over time, more of this is going to be available in the [ care ] segment with different partners and different go-to-market models. So let's see where pricing pans out, how much pricing can brand recognition and brand loyalty carry compared to generics in this market and consequently, how much price differentiation and price upgrade can we go for next-generation products remains to be seen. I think India is not a good proxy for other markets, to be honest.

Then to your second question on margins, then I would say -- it's important to note that our point of departure is an already very competitive margin if you look at it compared to the rest of our peers in the industry. So being at, call it, 40% operating margin or 40% plus is already very high. So strategically, for us as a company, it's more important for us to invest in future growth more so than short-term margin optimization. So that's why it's important that, of course, we optimize the opportunity we have short and medium term with the assets in the market or coming to the market soon as well as investing in pipeline. So that's the key driver. So yes, we could drive for higher margin, but that's not our strategy and nor the intention. I would though say that we are very disciplined and rational, as I also said in the beginning, with our resources and having less -- almost 10,000 less FTEs today compared to a year ago. So we are really reallocating our resources towards our key growth opportunities. I think that covers the SG&A comments.

Your next question comes from the line of Evan Seigerman from BMO Capital Markets.

First question on the impact of generic semaglutide in Canada. How are you thinking about that as you have contemplated your guidance? Maybe some illustrative kind of concepts around that would be great. And secondarily, on a bigger -- taking a step back, you had some pretty striking data for sickle cell disease. Is rare disease -- I know it's a pillar of the company, but is this an area where you should be leaning in more to complement what you're doing in obesity and diabetes to kind of give investors that next leg of growth?

Thank you, Evan. One for Emil on Canada and then one for Mike on rare disease.

Yes. As you will know, most of you, we now have, of course, 2 approved generics in Canada, slight delay compared to what -- where they could have come in from a regulatory point of view, took some time to get the approvals. Now they're there. It has not made us change our overall guidance at the group level that we will see low double -- single digit, sorry, impact at group level. So we don't guide on country level in terms of impact. But I can tell you, we are very ready and the leading tactic in Canada, that is a savings card that has seen a very good uptake, both for Ozempic and Wegovy. So that gives us a lot of maneuverability as we see how this unfolds. And I think you all know the framework in Canada. After 3 generics, there's a mandated 65% price decline versus our list. So we know sort of the game there, and we are ready to play it, particularly with the savings card. And we have optionality on the second brand as well.

Yes. So Evan, our strategy is to really ensure that we drive growth short, medium and long term. And we will do that with the current products, and we plan also to do that with our pipeline of our products across all therapy areas. I'm incredibly proud and happy of what I have seen with Etavo that comes in a family of a lot of other best-in-class and great rare blood and hematology drugs. So that, of course, is no secret. But all in all, stay tuned. And of course, we'll share with you more and more about our overall strategy. But the main aim is to really make sure we have multiple legs to stand on so we can drive growth short, medium and long term for you guys.

Your next question comes from the line of James Quigley from Goldman Sachs.

I've got 2, please. So first of all, can you talk to what you're seeing in the early stages of the Foundayo launch? What's the latest feedback here from physicians and patients, particularly on how to manage relative food and water interactions, but also in terms of the awareness of the weight loss differential between the 2 products? And are there any patterns or trends in terms of the patients that you -- the patients that are going on each drug? That's number one. And number two, for the AMAZE program, you started 7 Phase III trials on ClinicalTrials.gov. Can you talk to the dosing protocol here in the obesity trials. The primary endpoint is running out to week 84, so taking into account one of the key learnings from the CagriSema program, but how flexible is the dosing in the protocol, particularly given the unpredictability we saw in CagriSema and also before seeing the results of REDEFINE 11?

Thanks, James. First question for Jamey regarding what we see post Foundayo launch and then the second question to Martin on what he can say about AMAZE.

Of course, it's early days, but I think what we see so far is an affirmation of the strength of the Wegovy pill profile. As mentioned before, the #1 decision criteria is efficacy, and we have unsurpassed efficacy with that 17% weight loss with Wegovy pill. We also introduced very quickly an indirect treatment comparison, which is a well-respected health economic population health approach to comparing indirectly studies based on population adjustment in the Phase III trials, and that showed better efficacy with Wegovy pill than the competitor as well as a lower likelihood of discontinuation due to adverse events and specifically GI events. So what we've heard in the market is consistent with the strength of our profile.

Thanks Jamey. Martin?

Thank you for the question. Obviously, very relevant. We did take a lot of learnings from the REDEFINE program, as you know. They were both around the patient population. The need and wish to lose a substantial amount of weight is obviously a key imperative, and we've implemented that starting with REDEFINE 11, but also in the AMAZE program. And then we have adapted the flexible dosing so that we prompt patients more we work or we allow investigators to work more with patients to get them to higher doses while maintaining the flexible nature of trials. We clearly learned also from REDEFINE that approximately 1/3 of patients do need flexible dosing to achieve the full weight loss potential, and we need to allow that as well while helping and guiding the patients.

We implemented that in REDEFINE 11. Without going into too much detail, we can already now see a substantial impact in REDEFINE 11. I haven't seen the weight loss data I had to say, but I'm looking at the titration data and the model seems to work. And we have employed more or less the same algorithm in the AMAZE program. So we are quite confident that we'll help patients really achieve the full weight loss potential of amycretin or zenagamtide.

Your next question comes from the line of Graham Parry from Citigroup.

So on Wegovy pill, could you quantify the total inventory impact on Wegovy pill sales in the quarter? You flagged in the release prelaunch inventory build. Has there been any further inventory increase through the quarter? And do you expect that to run off? Or should we expect further inventory increases in subsequent quarters? And then secondly, a question just on the CagriSema co-formulation, why the decision to terminate? Is that a technical or a commercial decision?

Thank you, Graham. Two questions first for Karsten regarding Wegovy pill inventory and then the second to Martin on the co-formulation.

Yes. Thanks for that question, Graham. So for the Wegovy tablet, we reported around DKK 2.3 billion sales in the first quarter to the tune of $150 million of those were related to what we would call pipeline filling and the pipeline filling covers both the initial inventory build with the wholesalers and in pharmacies, the customary launch orders, if you will. And the second piece is just also the customary inventory build in connection with the brand getting bigger and in this case, very, very fast. So that happens for all products. It's just a question of the pace of the inventory build. It's like we manage inventories in the company in terms of days on hand of inventories, the same way it works with pharmacies and wholesalers in the U.S.

So this is absolutely normal, what we are seeing. And in terms of going forward, then it's also absolutely normal that there will be a certain degree of inventory build in conjunction with the brand continuing to expand so that what you see in terms of when you see IQVIA scripts, then there will be additional sales, especially in the early phases of a product life cycle, which is linked to inventory build across the chain. That happens for all products, and we've seen it for decades.

Very clear. Martin?

Yes. And thank you for the question. As you know, we've always talked to that we are scaling the dual-chamber device of CagriSema to a full-scale launch. So we are very confident in that. We saw the co-formulation as a flexibility or upside -- the way we now think about it is that we have front-loaded and sped up the AMAZE program and the type 2 diabetes program as well as the oral program for zenagamtide. So with full scalability on the dual chamber device combined with anything zenagamtide coming in more or less the same time or even before as the co-formulation could, it really didn't make sense to progress. It was not a technical thing. You heard me talk about last quarter, we did see full bioavailability. So it actually worked. There was just no need from a production perspective to progress it.

Your next question comes from the line of Florent Cespedes from ODDO BHF.

Florent Cespedes from ODDO BHF. Two quick ones, please. First, a follow-up on the GLP-1 franchise in diabetes. I was wondering how could you reenergize the business in the coming years? It will be mainly driven by innovation? And you could maybe give us a little bit more color on the 2 different geographical areas, U.S. and ex U.S. And my second question is for Martin. regarding the tri-agonist, when should we have more visibility on the profile of the 2 products and whether you would -- you intend to decide to keep one or both going forward depending on the profile. So if you could have more color on this point would be great.

Thank you, Florent. Two questions. We'll split the first in 2. So one to Emil on how to drive Ozempic in IO and also to Jamey on driving Ozempic pill in U.S. and then over to you, Martin, afterwards.

Yes. Thanks for the question. We are very much focused on getting back in the game with Ozempic now that we have full supply as of 8, 9 months, and we are seeing already some emerging positive trends in terms of share growth, particularly in U.K. And what will further increase the momentum, we believe, is our 2.0 launch. We've had the first launches in 3 European markets, particularly in Germany. We're seeing very good traction, but also in the Netherlands. In the U.K., it always takes a bit longer with local payers, et cetera, but remain optimistic there as well. You might know that in IO, 2/3 of all patients have already gotten to our 1-milligram dose and many would benefit from uptitrating both in terms of weight and A1c.

If I can maybe add another combo angle here is also that we've actually, in China, launched [ Qyonzo ] which is our once-weekly combination of a GLP-1 and our weekly insulin. And -- or sorry, we will launch it come this summer. We just got the approval, and we have good expectations. We have seen very good traction so far in insulin in China. We own the 2 leading brands, Ryzodeg and Xultophy and also have good traction for our once-weekly insulin in China. So whether it's insulins or it's GLP-1, we still have a strong belief in diabetes across IO.

Thanks, Emil. And Jamey, on U.S. and Ozempic, maybe?

Yes. In the U.S., we'll continue to focus on the efficacy in terms of A1c reduction in type 2 diabetes, but also the holistic benefits in terms of cardiovascular benefits that semaglutide uniquely owns in that space. And then as mentioned, the Ozempic pill, we've just introduced this week, and we think that will bring new life into Ozempic facing pill on the iconic naming and awareness of Ozempic generally.

Thank you. And Martin?

Yes. Thank you very much. So it's important to call out the 2 tri-agonists are 2 different biologies, one combining GLP-1, GIP and Glucagon, the other GLP-1, GIP and amylin. I think based on what we see so far that they both have a substantial potential to introduce weight loss across the board with a good safety and tolerability profile. But they may also contain individual traits that will clearly differentiate them that could be an effect on liver, it could be an effect on bone effectively. And it could also be differentiated weight loss in different subpopulations. So if you take that approach, obviously, it's early days. We intend to progress both. So we understand the full efficacy framework for both biologies, but also the safety and tolerability. And we'll see more insights. We already have Phase II data of UBT251. You've seen the weight loss potential in both obesity and diabetes. It seems to be quite stellar. And obviously, with Phase II data coming in from our internal tri-agonist next year, we'll have better visibility on how to potentially differentiate.

Thank you, Martin. Thank you, Florent. and operator, we'll take the last question.

Your last question for today comes from the line of Carsten Lonborg Madsen from Danske Bank.

I was just interested in hearing your wording on the ex- U.S. oral Wegovy launch. When you launched in the U.S., you are quite clear that this would be a full broad-based sort of very aggressive U.S. launch of oral Wegovy. But what's your sort of commentary on the ex-U.S. launch, including maybe observations on pricing levels outside the U.S. for the Wegovy tablet?

Great. Thank you, Karsten. And that's a question for me. Yes, we are, of course, excited to have the opportunity to launch in selected key markets that lend themselves particularly well to the Wegovy pill in IO, and we see a lot of halo effects from the U.S. already also on our injectable franchise. So we are going to go all in when we get the chance to launch. There will not be any half measures in IO where we launch. But of course, the general play in IO this year, that's the high-dose launches of 7.2 milligram where we see good traction with the messaging already. And of course, when we then bring the device, we have a strong belief that, that will be part of turning around brand sentiment. So that's why we have 20 launches planned, and that's the main play. But of course, it's a nice decision where we get to launch the Wegovy pill.

Thanks, Karsten. And this concludes the Q&A session. Thank you for participating, and please feel free to contact Investor Relations regarding any follow-up questions you might have. Before we close the call, I would like to hand over to you, Mike, for the final remarks.

Thank you, Michael. Please go to the next slide. I'm very satisfied with our announcement today. 2026 is off to an exciting start, but we have much work left to do. So expect continued hard work from all of us in all fronts. This year, we are looking forward to, first and foremost, continuing to drive uptake with new products while providing access to many more patients worldwide. Secondly, progressing our pipeline across the therapy areas and development stages, building innovation from within and through business development. Third, continuing to make this the best organization for our employees and patients we seek our medicine through fast decisions and intentional resource allocation.

And fourthly, strengthening the foundation of Novo Nordisk by sustaining our purposeful direction and thoroughly building partnerships such as the collaborations with OpenAI to help ensure strong positioning not only for this year, but for many more years to come.

Thank you very much. Stay tuned.

Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.

Good afternoon, everybody. On behalf of the Board, a warm welcome to Novo Nordisk Annual General Meeting of 2026. I'm Lars Rebien Sorensen. I'm the Chair of the Board, and it's my pleasure to welcome you to this Annual General Meeting. For those of you who prefer Danish over English, real-time translation is available here at the Bella center. For those of you that participate online, you can choose the preferred language in the broadcast system. '25 was a profound year of transformation. For decades, Novo Nordisk has flourished in the diabetes market, building our expertise patient by patient and innovation by innovation.

Our entry into obesity, a therapeutic field that we pioneered and shaped threw us into an era of unprecedented growth that frankly even surprised us. The demand we met changed everything. People with obesity are actively seeking our medicines. Self-paying consumers are seeking faster access. And all of this growth shed the global spotlight on everything we do in the company. This extraordinary period has taught us some important lessons. We discovered that people living with obesity face completely different challenges than those living with diabetes. Instead of fear, they often feel shame and stigmatization.

Instead of conventional clinical support, they want discretion. These learnings require entirely different approaches than our traditional physician-focused model, forcing us to rethink the traditional approach to patient care and market access. We need to meet the patients where they are. The competitive landscape has evolved just as dramatically, where we once enjoyed a clear market leadership in obesity, virtually every major pharmaceutical company now recognizes that this is an attractive market.

This competition, while challenging, validates the therapeutic area that we pioneered and drives continued innovation for the patients. We are not intimidated by this new reality, reaping more than a century of working within the area of diabetes, and we have learned how to win even in crowded markets. In response to these market shifts, we have made decisive changes to remain leaders in obesity and diabetes care.

We have focused our strategy on these core therapeutic areas, not as a limitation, but as a recognition that serving the 2 billion people that by 2030 will be living with obesity, overweight and diabetes provides a massive opportunity for growth and impact of the company. Yet shaping the focus also reflects our DNA. Throughout history, we have always succeeded when concentrating our efforts where we make the greatest difference.

In 2025, also marked the important leadership transition. August 7, Mike Doustdar was appointed President and CEO, the only sixth Chief Executive Officer in our 103-year history. I have worked with Mike for most of his more than 30 years at Novo Nordisk. During my tenure as CEO, he joined the executive management team to lead international operations.

I know him as a strong, highly competent leader with a sharp commercial mindset and a very, very competitive edge. Since stepping into the role, he has moved quickly to execute on a number of strategic initiatives and our collaboration has been direct, constructive and aligned with the company's strategic priorities. The most challenging decision in 2025 was the reduction of our workforce, the largest reduction by number in our company's history.

After scaling up rapidly during the period of hyper growth, we recognized that staffing levels had become unsustainable as market dynamics have shifted requiring difficult but necessary actions to simplify the organization to improve the speed of decision-making and reallocate those resources freed up towards growth opportunities within diabetes and obesity. We approach this with a deep respect for those colleagues affected, conducted the process swiftly with dignity, consistent with the way of Novo Nordisk way.

During 2025, we also made changes to the composition of the Board. Following a period of dialogue between the Novo Nordisk Board and the Board of the Novo Nordisk Foundation, different visions of the pace and extent of Board renewal made the extraordinary general meeting necessary to provide clarity on governance. This change reflects our commitment to having the right competencies for the right -- for the reality that we are operating in. And I'm convinced that the reconfigured Board, including the candidates nominated at this meeting, should they be reelected, stands ready to support management in responding rapidly to the changing market conditions.

Equally important, the Board is committed to constructively engage with shareholders so that their perspectives can help us shape the road going forward. As our transformation continues, so does our long-standing commitment to sustainable business practices. The triple bottom line, balancing financial performance with social responsibility and environmental stewardship remains fundamental to our identity.

Long-term value creation requires attention to these broader impacts, and we continue to invest in sustainable practices while setting realistic, achievable targets that we can deliver upon. The year ahead will test our determination and capabilities. We face it with confidence knowing that our renewed focus, strengthened competencies and uncompromising commitment to people with serious chronic conditions positions us well for the challenges and the opportunities ahead. Thank you for your continued trust and support as we write the new next pivotal chapter for Novo Nordisk.

Let me now turn to the introduction of my fellow Board colleagues. Members of the Board of Directors are present at the general meeting sitting up here, all looking nice. In February, November or February, Novo Nordisk conducted an employee election. So I would also like to thank the 4 employee-elected Board members for their work, and I'll get back to the newly elected Board members who will join the Board from today.

Since the Extraordinary General Meeting in November, we have had a good collaboration within the Board, undertaking the task of challenging and supervising and supporting the company and its management with frequent dialogue to ensure alignment. I'd also like to thank the Board members who stepped in during this period for their commitment and willingness to serve. Following today's meeting, we look forward to welcoming even more competencies and perspectives to the Board.

Members of the executive management are also present -- at this general meeting, throughout this past year, we have seen a number of changes within the executive management, most recently with the exciting addition of Jamie Miller, Vice President of our U.S. Operations; and Hong Chow, Executive Vice President, Product and Portfolio Strategy. I am confident that the executive management possesses the right capabilities and competencies to be successful in executing the strategy, and I'm happy to report that the collaboration between the Board and the executive management is characterized by transparency and trust.

Also present in person are Deloitte, our auditors, Sumit Sudan and Lars Siggaard Hansen. And finally, I'd like to inform you that the Board of Directors this year has appointed Anders Orjan Jensen to act as Chair of the General Meeting. Anders is joined on stage, as you can see, by his colleague, Louise Korpela. Louise will be paying attention to the shareholders that are participating virtually.

And I'll now leave it to Anders to take us through the agenda. Thank you.

Thank you very much, Lars, and I'll commence with a few formalities and practical information. First of all, I can confirm that I have reviewed the convening notice and all the material presented ahead of the general meeting, and this information complies with all requirements under the Danish Companies Act and also the Articles of Association. And I can, therefore, conclude that the meeting today is lawfully convened.

Turning to the agenda of the meeting. It contains all the customary items for our Annual General Meeting at Novo Nordisk. And we also have 3 proposals from the Board of Directors, 2 of them relates to renewal of authorizations. And then we have a technical amendment relating to the name of the region where general meetings are held. All of the proposals can be adopted by a simple majority, except those that relate to changes to the articles that require a qualified majority of 2/3.

Also, a quorum needs to be present, meaning that 2/3 of all votes needs to be present in the room. And I can confirm that, that is satisfied and that, therefore, this meeting today can pass final resolutions regarding all items on the agenda. Before we kick off with the agenda, I can mention a few information about attendance here today. A total of 901 have requested admission cards for the meeting today. Of these 645 are shareholders. And just before the meeting here began, there are a little more than 300 present of those 235 shareholders, and I think a few more have joined since.

In addition to those participating here, a large number of shareholders have exercised their right to submit voting instructions ahead of the meeting. That can be done either by proxy or postal vote. In total, 57% of the share capital and 86% of the total number of votes are represented here today. Of all of these votes, 99.9% have actually been submitted in advance by voting instructions. And that also means that we already now can know that all the proposals on the agenda carry sufficient support to be approved in accordance with the Board's recommendations.

That, of course, should not preclude that we, of course, here today can have a good discussion. There can be questions and debate around all the items on the agenda. Now a few practical information regarding the format of the meeting and how to speak and vote. To allow as many shareholders as possible to participate, Novo Nordisk allows shareholders to both participate here but also online via an online application. It is also possible to follow the meeting via webcast.

Novo Nordisk has had this format for quite a few years, so many of you will know all the details. But for those that are new, I'll just give a brief introduction to how to vote and speak here at the meeting. For those that are present here, if you wish to speak, you can make your way up here and register with my colleague, Anna, who sits over here to the left. And please mention your name and which item you want to address, and then I'll give you the name when we get there.

If there is a formal vote, you need to vote using your mobile devices. At the entrance, you received this instruction letter, you can see behind me that has a QR code. If you scan that QR code with your phone, you'll get a link where you can submit your votes. You can see it here, you'll have the options will pop up on the screen. And once you have elected, there will be a green check mark confirming that your vote has been submitted.

For those participating online, you will also be able to submit comments or questions to submit questions, use the QR function on the page, type in your comment and press send. The message will then be received up here. It will be processed and Louise will read them out loud as they arrive, and we have the right agenda item. If there is a formal vote, that will also pop up on the screen, and you can simply click your election. And again, a green checkmark will confirm your vote has been received.

It is possible to change the vote also by pressing the button change vote. If you have any technical problems and then you can call a mobile number available here is +4545-46-0997. For those participating via webcast and just watching, it's not impossible there to submit questions or vote. To ensure we have a focused and efficient meeting, I kindly ask that everybody who takes the stand up here, keep their presentations fairly short and concise and in line with the items on the agenda.

Please also bear in mind that after this meeting, there's a shareholders' meeting where all members of management will actually be present and can answer even more questions. Final comment relates to the language of the meeting here today. It's conducted in English, but it is permitted to ask questions in Danish, but they will be answered in either English or Danish depending on who answers. Now that was a lot of formalities. Thank you for your patience, and let's turn now to the agenda.

As is customary here at Novo Nordisk, the first 3 items will be presented together. This year, the company's CEO, Mike Doustdar, will present the company's report and also the annual report for 2025. Then the Chair of the Board will take the stage to continue the report and also present the proposed allocation of profits. After these presentations, there will be an opportunity to ask questions and comments. So please welcome Mike Doustdar to the podium.

Thank you very much, Anders. Also a big welcome from my side to all of you to this AGM. As Lars said, 2025 was indeed a challenging and a transformational year for Novo Nordisk. It was a year where we had to make a number of very difficult decisions. None of those decisions were more difficult, I would say, for me and for my management team than the one leading to 9,000 individuals leaving the company globally. This was, as Lars mentioned, the highest number of layoffs we've had in the history of the company, I would even probably dare so in the history of Danish corporate history.

Many of those colleagues had been doing well for us. So we don't take decisions like this lightly. But I also say that it was a very important decision we needed to make. We had to make those decisions simply because we wanted to simplify the company, make it faster, but we also needed to take the investments and make sure that R&D is fueled this year. The savings that came out of less number of headcounts through this exercise is right now being poured into our R&D and accelerations of many things that will live for a very long future.

So I'm, in some ways, quite happy that we ended up doing that. Now I do want to use the stage and this moment to thank all of my colleagues who are with us and every day come to the office with their resilience, with their professionality and with their commitment. I also like to thank everyone who left the company for their many years of commitment. And once again, what we did was not an easy decision, but it was to the benefit of the longevity of Novo Nordisk we all love.

If you go to the next slide, please. This is a slide that you have seen over 5 years. We started showing it to you at this event since 2019. If you take a look at the right-hand side, then you see a lot has changed since 2019. Our sales and operating profit has doubled -- we have generated more than DKK 75 billion just from our obesity sales, and we have treated 16 million more patients than just 5 years ago.

This slide shows our annual strategic aspirations or what I would like to call our to-do list for any given year. And this is the version from last year. If you take a look, then you see last year, we delivered 10% sales growth in constant exchange rate. That was on the back of both operating unit, international operations as well as United States delivering growth numbers. We generated 6% growth on profit in constant exchange rate. We spent DKK 8 billion on the transformation I just spoke to. If you would adjust to that, the operating profit growth would have been 13%.

Our obesity continued to be the main growth driver, once again, growing at 31%. We have lost some market share within diabetes, but still have about 1/3 of the diabetes value market share. And 2025 was also a very decent year for growth of rare disease business that has historically been a bit struggling. On the R&D front, we also had some good movements of the pipeline. Semaglutide Phase II study was completed. CagriSema Phase III was completed. Wegovy pill at the end of the year, got an FDA approval. And we acquired a company called Akero and a MASH asset that came with that called efruxifermin, which will be very interesting for our future.

We also submitted a number of approvals that we will benefit from going into this year. Semaglutide 7.2 milligram was submitted for approval. Mim8 in rare disease was submitted and most famously, CagriSema, our next generation of GLP-1 product for obesity and diabetes also was sent for approval last year. Next slide, please. This slide shows the highlights of how we entered into 2026. By now, most of you guys have seen or known that we have launched the oral version of semaglutide, Wegovy pill in U.S., and it has been a crazy good launch, perhaps the best launch pharmaceuticals has ever seen, and we are very proud of that.

In many ways, this launch has set historical first for us. The first antidiabetic -- the anti-obesity pill that got approved to date. The first AOM that is a peptide and not a small molecule, which is quite important. You see on the slide, 16.6% efficacy. That's exactly the same as the injectable Wegovy. It's able to be so effective because it's a peptide in a pill and the only one so far that has been able to do that. It's the first product with such a strong uptake, as I explained.

You don't see the numbers of the prescriptions on the side. We're keeping that as a secret for the upcoming quarterly announcement. You'll get to see that soon. But you could see the projection of these curves, and you could see that 3x -- it was 3x better than what our competitor, Lilly, introduced tirzepatide and some 10x better than our own Wegovy injectable. So this has been a very good uptake. It's also the first time the pill became available not just through the traditional channels, but through all the eHealth providers, all of our partners and some 70,000 pharmacies around U.S. So it has been so far very good.

Next slide, please. As we do continue to launch good products like the Wegovy pill, we also need to expand access and move forward with our pipeline. We have advanced the pipeline as this slide shows quite a bit. We've had the first bullet point achieved actually, semaglutide 7.2 or what we call Wegovy High-Dose was approved by FDA in record time, 53 days. No other product has ever been approved so fast by FDA. So we are very proud of that.

As we go forward, we see that the next big approval will be our CagriSema approval, hopefully towards the end of this year, allowing us to launch that product beginning of next year. Zenagamtide in diabetes and obesity, initiated Phase III. UBT251, a very interesting triple agonist product in both diabetes and obesity have initiated Phase II. Ziltivekimab in CKD and ASCVD Phase III was initiated. And it's going to also be an exciting year for rare disease on the back of, hopefully, Mim8 regulatory approval and the Phase III results of etavopivat becoming available later on this year.

That -- you can go to the next slide, please. That marks the end of item #1 on the agenda. Now I will talk about item #2, which is the presentation and adoption of the statutory annual report for 2025. Our annual report was published on February 4, talking about the financial results of 2025 and obviously, the outlook for '26. If you go to the next slide. In 2025, sales grew, as I mentioned, by 10% in constant exchange rate and operating profit by 6 percentage points also in constant exchange rate.

The cost of goods sold increased by 24%, bringing the margin to 81%. This has been impacted by the acquisition of Catalent, the manufacturing sites as well as costs related to the transformation that I alluded to earlier on. Sales and distribution costs increased by 7% to a large extent, these are the expenditures we do behind our obesity franchises. R&D costs increased by 10%, and that's to progress the pipeline that I a little bit earlier spoke to. And that led to a financial net profit increase of 1 percentage points.

Next slide. Total assets increased by DKK 77 billion to DKK 542 billion during 2025. This increase was due to noncurrent assets due to, a, acquisition of Akero, as I touched upon; and b, our ongoing CapEx expenditures that we're doing, building the factories and so on and so forth. Hereby, we conclude the presentation of the income statement and the balance sheet. So we move on, next slide, please, to 2026.

The guidance for 2026 is that states here on the slide. First and foremost, before I get into it, I'd like to bring to your attention that we have tried to increase transparency. So we will present all of these numbers in adjusted sales and profit at constant exchange rate. This means that the numbers exclude exceptional nonrecurring events. They're primarily of noncash nature, including provision reversals. But that also means that adjusted profit will exclude the impact of 340B and provision reversal that we have done in U.S.

For 2026, as you can see, adjusted sales growth is minus 5% to minus 13% at constant exchange rates. Given the current exchange situation with Danish crowns, we expect that in DKK, the numbers will be some 3 percentage points lower when the year finishes. The same numbers are also expected on the operating profit side, minus 5% to minus 13% in constant exchange rate. The 2026 outlook reflects growth in international operations and degrowth decline in United States. We are assuming a growing GLP-1 market growth.

The GLP-1 market will continue to grow, and Novo Nordisk will continue to capture patients out of that growth. However, this is countered by pressure on our pricing. We've spoken to that earlier during the quarterly results. We see pressure on our prices in U.S. on the back of most favored nation dialogue and discussions with the U.S. administration, adjusting the prices downwards. Prices in the cash channels in U.S. have also furthermore gone down to provide broader access and affordability to patients.

And in the international operations, selected of our markets are going through loss of exclusivity of semaglutide, and that also means prices going down. Price going down on a large business that we have with semaglutide, of course, takes an impact, an immediate impact in this year's results. That is the reason behind the growth, albeit, as I mentioned again, volumes are continuing to grow, and you saw just a glimpse of that with the Wegovy pill slide that I showed you earlier.

Lastly, the positive impact of the gross to net adjustments in U.S. during 2026 are not anticipated to reoccur. Now back to you, Lars, for the proposed capital allocation to shareholders.

Thank you very much, Mike. In 2025, Novo Nordisk returned DKK 53 billion to shareholders through dividends. In August of '25, Novo Nordisk paid an interim dividend of DKK 3.75 per share, and the Board is proposing that the final dividend for 2025 is DKK 7.95 per share, which is to be paid this month. Consequently, the total dividend will be DKK 11.70 per share. The capital allocation principles for Novo Nordisk remains unchanged.

Novo Nordisk focuses on internal growth opportunities and dividend payout ratio of around 50% of net profit. In 2026, we have also initiated a share buyback program up to DKK 15 billion. In line with previous years, an authorization to the Board of Directors to buy back shares is proposed at this General Shareholders' Meeting, and we'll get back to this on a later point in agenda point #8. 1. And with this, back to you, Anders.

Thank you to Mike and Lars. That finalizes the presentation for the first 3 items on the agenda, and we have now a number of speakers that have already registered. The first one is Mark Jessen from ATP. After that, it will be Mikael Bak from Danish Shareholders' Association. We also have a few more. Bjorn Hansen have registered, and then we have a virtual participant with a question as well. But Mark, you are first up.

[Interpreted] Thank you. I'm Mark Jessen. I represent ATP, the pension fund. A number of the Board and management are English. I'll continue in English.

Thank you for the report on the developments during 2025. This has not been a year short of topics to address. It has been a busy year both around and inside Novo Nordisk. And I'll focus on the areas we find most relevant for the company's long-term success. Let me begin with a brief comment on the changes in the Board of Directors. When looking at the developments over the last 2 years, I believe most shareholders will agree that changes were necessary. At the same time, many had hoped for a smoother transition.

We noted the Chairman's recent comment in the media that an earlier EGM would have been a better solution, an assessment we support. We also -- we have also observed a broader public discussion about the role of foundation ownership in Danish companies. Across different kinds of ownership, trust is built through long-term performance, but at risk every day. For many years, we have appreciated the collaboration between several foundations and the stock market, a collaboration that has developed some of our largest local companies.

Turning back to the Novo Nordisk Board of Directors. Today, we are electing well-known members with comprehensive experience in health care, drug development, marketing and finance. Looking ahead, we see potential in value -- potential value in adding further consumer-focused experience as well as additional direct insights from the U.S. market. Despite the bumpy road getting to hear, we believe the future Board can guide Novo Nordisk forward.

On the business side, it is impossible not to acknowledge the strong launch of the Wegovy pill in the U.S. Prescription volumes have already exceeded several analysts' full year expectations. Unfortunately, this positive development has been overshadowed by a disappointing 2026 financial guidance and the recent ReDEFINE 4 trial outcome, which contributed to further share price decline.

As we see it, the stock market is now holding its breath until April. When a competing pill is expected to launch, this moment will offer Novo Nordisk a key opportunity to reinforce confidence in the stock market, particularly if the Wegovy pill maintains a strong market share. Ultimately, this will depend on prescriber behavior. So my first question today is, how do Novo Nordisk intend to secure and sustain prescriber preference for the Wegovy pill in an increasingly competitive market in and outside the U.S.

In the longer term, this market will likely not be a winner takes it all. Patients respond differently to treatments, and they have different needs. While the headline results from the CagriSema ReDEFINE 1 and 4 trials did not meet expectations, market expectations, the pipeline is significantly broader. Trials with high-dose versions, zenagamtide, amylin and triagonists are all in progress, but so are competitor trials.

Until now, the competition has largely centered on weight loss efficacy. We expect to see a more differentiated market in the future where aspects such as tolerability and treatment of comorbidities become increasingly important. We hope Novo Nordisk will compete strongly across these dimensions. So my second question today is, what makes the management confident that the current pipeline will be competitive and preferred by prescribers and patients in the long term?

Finally, stepping a bit further back, many major pharmaceutical companies have successfully expanded into new therapeutic areas beyond their historical core. This has been more challenging for Novo Nordisk. Following last year's reshaping, the strategic focus has become narrowed once again. My last question today is, therefore, -- why has it proven so difficult for Novo Nordisk to take significant steps into new therapeutic areas? And what must change for this to become possible one day in the future. With that, I wish everybody at Novo Nordisk all the best for 2026. And if media reports are correct, around 700,000 Danish shareholders and everybody in here are hoping for a brighter and more stable year ahead. Thank you.

Thank you very much, Michael. So 3 questions. Let me try to take them one by one. The first one, how do we secure the pill in and outside of U.S. I think I showed it on my slide, we have a peptide in a pill. This is really, really important. Usually, when you take a pill, then you have to compromise for efficacy. Pills are weak compared to injections, not in this case. And we have seen firsthand with our injectable business that the magnitude of weight loss matters to people. That's why we have been losing a little bit to our friends at Lilly on the injectable side so far.

While on the pill, the picture is completely reversed. At the same time, our pill has shown in clinical development to be much more tolerable than competition, which is the second reason why people go on these medications. They want products with good tolerability. And then, of course, the phenomenal uptake that we have seen so far and continuing will play for us because we will have tens of thousands of people, if not hundreds of thousands of people by the time competition comes. That will be the testament to how they have been satisfied and that also will help us, of course, make the pill successful.

Now we will not be little to competition. We will prepare and we'll make sure that we're ready. But I think the product is helping us here. And as we do that, we also currently are looking into ex U.S. trying to find out where and how should be our next launches. Stay tuned. You will hear of that as we will make it public.

On the second question, the current pipeline being competitive or not, I think we have some of the best pipelines in the industry. We have, of course, the Wegovy franchises that I just spoke to, our current Wegovy in the market, Wegovy pill, Wegovy High-Dose, which is being launched very, very soon. CagriSema with 23% weight benefits. Today, if it was in the market, it would be one of the more efficacious drugs out there. I'm very excited about that. Zenagamtide, which will come both in oral version as well as an injectable are 2 more assets that are coming soon after that. If you're after losing less weight, but with very, very good tolerability, we have cagrilintide mono as an asset for that.

The last couple of weeks, you have seen results of the UBT251, that's the triple agonist, the 3Gs, glucagon, GLP and GIP, all in one, and we have seen phenomenal Phase II numbers on the back of that. And we haven't even shared all the earlier assets, which in due course, we will make public. So I am more than ever today excited about the speed our pipeline is moving at and the products we will bring to the market, which brings me to the last question on the new therapy areas.

Obesity, diabetes and overweight affects 2 billion people. That's a lot of people out there. Today, we and our competitors combined are providing medications, GLP-1 medications to 20 million 1.9 billion people out there are not having any medication today. With the pipeline I explained, we can get further. But we're not stopping there. We're also trying to see some of the comorbidities associated with these areas. We know that obesity is the leading cause of many other conditions. We're looking into all of those and trying to diversify the company in more and more of those areas as we understand the science and have the manufacturing capability to do so. So more to come. Lars?

Yes. Just a comment from me, short one to ATP. Thank you for providing us with a slightly more balanced view of our company than we have seen recently in the press. And then I can't help you asked about further competencies to be added to the Board in the area of consumer goods. Stay tuned. There will be news towards the end of this meeting.

All right. With that cliffhanger, I think the next one is Michael Back from Danish Shareholders' Association.

Thank you for the floor. And I will do this in English as ATP. Having said that, I had the privilege to interview Mike in [ Falconersalen ] in November last year. And I think we spoke about you practicing Danish. So maybe next year, I'll do this all in Danish. But let me begin, my name is Mikael Bak and representing the private investors on behalf of Danish Shareholders' Association. First of all, thanks to the Chair and the management for the presentation. And I would start out with a remarkable fact, I would say, of course, representing the investor culture in Denmark, more than 680,000, 700,000 Danes are now shareholders in Novo Nordisk according to Euronext.

Think about it, it is amazing. And as I would say to you, it comes with both responsibility, but also opportunities. Responsibility to perform and to communicate in the best possible manner. And on the other hand side, also a unique opportunity to show what strong value creation and shared ownership can do not only for Novo, but for the shareholders, for the Danish and for our nation. I have 3 topics I would like to address today.

First, I would like to focus on research and competition. Over the past year, the narrative around Novo Nordisk has shifted in many ways from being looked at as a market leader to now facing challenges and often criticism from analysts and media. Some of them are here today. We have also seen very strong market reactions to Novo's trials results during the last year. Therefore, my first question. I would like to ask if you, the management, in any way, regret the way that the trials were originally planned.

How can we assure going forward that we see a Novo Nordisk that is managing expectations instead of being hit by them? And with regards to competition, are we looking into a future where we -- where Novo should change the narrative and stop playing against Eli Lilly and instead redefine own strengths, maybe also strengthen pipelines. How do you see this dilemma?

And my second topic, I would like to touch upon leadership and the direction set for the company. Last year, from this stage, I was calling for a potential strengthening of pharma experience in the chairmanship. Now year later, we can conclude that we got. But to be frank, it was maybe not the right sort of the way that we expected it last -- sorry, it's not a criticism. However, we have supported the change from the Danish Shareholders' Association over the years, looking at them as necessary.

But at the same time, we have been clear that the deviation from good governance cannot continue and that it comes with responsibility for you and the company to deliver. So we have not seen the positive developments yet. The share price is struggling. And therefore, to my second topic questions, I would like to ask the management to what extent do you see the current situation still being a result of decisions made in the past before you took over or if it's also, to some extent, something that has happened on your shift, so to say? And what are you then going to do to change it?

And then my last question is directly to you, Mike Doustdar, welcome on board. You have, as you also mentioned in the interview we had with you, a background primarily rooted in field operations rather than in headquarters. We agree that this is and can be indeed a strength leading the company in a new direction. However, it could also raise some concerns. When a CEO inherits an organization and a culture that he has not yet built himself, there is a real risk of becoming absorbed into that existing culture rather than reshaping it.

And in that case, even strong visions can maybe struggle to be fully implemented. This is particularly relevant if and when you are in a situation where a former CEO is now also serving as the Chairman of the Board. So my final question is, over the past 8 months, Mike, have you been able to put in place the backroom staff, the team that you need? Or do you still see this as a continuing process in the years to come? And this maybe also could be a topic for Board meeting discussions. So let me just finish by wishing both the management and also all the employees in Novo Nordisk all the best for the years to come. And on behalf of the more than 680,000 private investors, we support you, so please don't let us down. Thank you.

Thank you very much, Mikael. I have to start by saying we very much welcome the 680,000 shareholders, and I enjoy that day being with you, and they're very dear to us. They are our long-term shareholders that have been with us for a long time. So their satisfaction means a lot to me, my management as well as to the Board. To your questions, trial designs was the first question and if you have learned something from that. I think the quick answer is yes. This is an industry with a very long-term product life cycle management.

What you see we are doing today, you will not see the impact of it basically next quarter or the quarter after. You'll see the impact of our work perhaps a couple of years down the road. The same goes, of course, backwards. It's a long-term business. When I think about the trials, I think I can assure you we have spared no minutes looking into all the details. The whole obesity has changed many people's view, this was not a disease area a few years back. Novo created this. That also means that Novo has made its mistakes of not knowing exactly what the patients want, how the market works. And as much as I think the trial designs were made with fantastic intentions at the time, the knowledge available 3, 4 years ago was very different than the knowledge we have now.

Our job is to capture those learnings and make sure that as we move forward, we don't repeat some of the same, and we design our future trials in different ways. And I think my colleague, Martin Lange, has spoken to that more in details that if you think about REDEFINE 11 as an example, is a trial that we have captured the learnings from the previous REDEFINE studies. And of course, all of this is also being poured into zenagamtide trials, and we will continue improving. On the hindsight, I would say, every company when they do clinical trials and when the results comes back, they go back and say we could have done this a little bit better.

So it's a bit, I would say, unfair to just look at the hindsight. On the issue with regards to Novo focusing on its own strength rather than being obsessed with Lilly, I think you have a very good point. Over the last period, I think we looked at our competitor a bit more than we should. A leader should lead and not basically worry about competition and be obsessed with it.

In Novo Nordisk, we have a long legacy of 100-plus years putting the patient in the center of what we do, not the competition. And I think while we should keep our left eye open up nighttimes for competition, but we need to really think about every decision that we make, the patient centricity element of that and are we serving the patients in a better way. And I can assure you that, that is happening right now.

On the question, is this all the results of the past or not? I think I a little bit alluded to it. I don't want to get into what things we could have done better or not. It is a new area for us, and we're all learning. But I can tell you, we're learning incredibly fast. I am much, much more optimistic today than on the day I got the job I feel that the team around is going incredibly fast.

Today, we are being discussed for some of our shortcomings in the media by our shareholders. I have no doubt that tomorrow will be remembered on how quickly we responded to these challenges. So that's what I will hold myself responsible for. And with regards to the cultural reshaping and if I have the mandate from the Board, the quick answer is yes. We feel very comfortable that we have full alignment to do what we need to do. Thank you.

We have received a question from [ Jens Lan Rasmussen ]. It reads as follows. Given the surplus of more than DKK 100 billion in 2025, was it really necessary to carry out the largest layoff of staff in the history of Denmark? Also, I was told that even staff working on ongoing research projects has been laid off. It seems to me that it would be unwise since preliminary results of such projects will be lost. Can the Board confirm or deny that such projects have been stopped?

[ Jens Rasmussen ] thanks for the question. Cost management is a matter of keeping the right balance between income and cost. So therefore, because of the fact that we had DKK 100 billion in profits cannot allow us to let costs go out of control so that they become unsustainable in the long run when if worse comes to worse, the income starts to fail from the top line. So we cannot manage the company, unfortunately, this way. You could say it should have been managed by avoiding the large recruitment that took place when the company was trying to scale for this unprecedented growth the company was looking into.

However, that's a very, very difficult task when trying to meet infinite demand. Is it correct? Also been stopped researchers have been laid off that are working on projects. Yes, it has occurred. What we try to do in that context is, first of all, we try to take the necessary learnings from these projects and see how we can apply that in other areas. And then we are trying to out-license the assets that we have been trying to develop, but which we deem are not worthy considering funding by Novo Nordisk.

As an example, cell-based therapy is an area where I can remember, it started during my time as CEO as a way of trying to cure diabetes. Hence, it was natural that the company pursued this -- but given the difficulties of ensuring a competitive level of such a project, the lengthy development times, I think many of the shareholders here can remember that I made a prognosis that it was 15 years into the future. We would have cured type 1 diabetes. It is still 15 years into the future. So therefore, the company has now decided to out-license all the activities in the cell-based area. And hopefully, these will find new homes, new companies, new financing so they can be realized. Thanks for the question.

Next speaker will be Frank Hon.

[Interpreted] Thank you very much. My name is Frank Hon. I represent kritiske aktionaerer, critical shareholders. I've been here a number of times. Now the report it says very proudly that last year, the company paid out 50.7% in dividend. That's a higher percentage than during the past 4 years, DKK 53 billion counting the buyback program. Why did you do that? And why continue with such great dividends in 2026, while saying that the company is subject to pressure and very hard competition from other pharma companies.

Novo doesn't need happy shareholders. The shareholders don't contribute anything, not even influenced on the management of the company. I mean that's all the Novo Nordisk Foundation. If was anybody in doubt about that? Well, in that case, look at how the management change took place. You, shareholders, had nothing to do with that. You had no say in the matter. And that foundation has lots of capital. So if Novo at some point, and I don't think it ever would happen, but if Novo should need an injection on the capital, well, the foundation has lots of capital. They doesn't have to go into the market to ask for fresh capital from shareholders. There's no reason whatsoever for the company to be managed based on what shareholders would like. It may be that the stock price on the stock exchange dropped. And so what? What did that matter?

Well, yes, some of us lost money, obviously. But the company moved on. It kept running very nicely. It still creates profits. It develops new products, even though it looks so dramatic on the stock exchange. The company should not be managed based on what the stock exchange thinks of this company, what the company needs is the development of new excellent products to be sold as inexpensively as possible instead of a situation where the people who need our products have to pay a lot of money so that the shareholders can profit.

Why doesn't management focus on what should be the most important thing, the development of good products. That was the idea. That's what it used to be like when all of this was rooted in the insulin production. The theme was we need to produce the best possible medication for those who need our products, but nobody should make money on it. That was the management idea back then. But that's not how it is anymore. So I'll get back. I'd say, let's go back to the roots to the original ideas.

And I think the most important message from a meeting such as this should be we need to develop the company in a good direction, not thinking about making as much money as possible. There's something else which could be done with these billions of kroner instead of paying them out to shareholders might be to reduce the CO2 emission of the company. We all know how important it is for Denmark for the world, for all of us to reduce the quantity of greenhouse gases CO2 -- the company has said it wants to do that, but it increases all the time. Novo's emission of CO2 keeps increasing year after year.

Now for the third year in a row, it increased by 19% in 2025 compared to the preceding year. And that's in complete opposition to what we keep hearing from Novo. Now another critical comment while I'm at it, couldn't we get rid of the of all the scandals in our building sites, construction sites, problems with pay, problems with safety and security on the building side, couldn't we work properly with the trade unions and make sure that the trade union has access to construction sites to make sure that conditions are in order because having the trade union to inspect the construction site is the best possible guarantee, which will protect us against more scandals.

So let's open up instead of just saying, oh, yes, we are talking with the trade union. The trade union should have a real chance of seeing whether what has been agreed is really being adhered to. Now somebody mentioned all the redundancies. Of course, a large company needs to adjust the size of its workforce. There's no doubt about that, but it can be done brutally as it happened or it can be done perhaps over a longer period of time. There's always a certain exchange of stuff and people are hired all the time as well. And last year, people -- new people were hired. So couldn't you have said over time, we need to reduce staff where we don't need as much people instead of just firing people.

I mean, you could have afforded to do it in a different manner instead of just making people redundant as brutally saying, perhaps we try to shift people to other department. It would have been better for the employees. It would have been good for the culture among the employees when you have a company where people are just fired that way. Well, then, of course, it has repercussions on how people feel about their work and their company. It was not done wisely. It could have been done differently. Now to end, I'd like to say Novo should go back to its roots.

[Interpreted] Thank you. Lars will answer this one.

The next speaker after Lars will respond to this. If anybody else wishes to speak, please let us know. We have no further questions online. But if there are no further questions, we'll conclude after Bjorn's questions.

[Interpreted] Thank you to Frank Hon. It's not the first time we meet on these occasions. I'm very pleased that Mr. Frank Hon follows the history of this company and remembers the original declaration of intent, which was emitted when taking over the license from Toronto University for the production of insulin in Denmark without profit. That was noble. But I'm of the opinion, Mr. Hon that if an element of profit had not sneaked into it, we'd have been using the same large syringes, which we used back then to treat patients with insulin, which was unstandardized and unclear, impure. It would have been very, very difficult to obtain modern diabetes treatment as we know it today, which is due to companies competing on improving product quality. But of course, we may have different views on how things would have gone.

Now the question of capital. I think we look at capital in different ways. We see capital as a very important element in the creation of a company. Capital, like employees have a right to be remunerated. And that is why Novo Nordisk at an ongoing basis tries to live up to the requirements and demands of employees for better pay, while we also remunerate our capital, our shareholders with a dividend and hopefully also an increased share price so that everybody is happy.

I tend to agree with Frank Hon in the sense that it is a challenge for the company that we increase our CO2 emissions. I think it's something that we need to look at as a company. We need to look at the balance within our sustainability goals, we see large industrial companies in Denmark and we see entire countries who find it really, really difficult to live up to the very ambitious goals formulated within the past 5 to 8 years.

If you ask me personally as Chairman of the Board, I think that the greatest duty of this company vis-a-vis sustainability is to make sure that patients have access to our products. And if that means that we need to produce larger volumes and maybe even at a slightly lower price to make sure that our products are available for patients in developing countries at the expense of emitting more CO2 because we need to cooperate with producers in other countries or work with factories where we cannot control the use of energy.

Well, then I find it more important to treat more patients. That's the most important thing for us. Now concerning the redundancies, I agree completely with Mr. Frank Hon that it would have been better if we had not placed ourselves in a situation where the number of employees was too large compared to the development of the company. If that had been so, we could have avoided these redundancies. It's always easy when you look back on the past, but it's not as easy when you are in the situation and try to handle it as it develops as the former Board and the former top management did.

But I do think that the colleagues who were made redundant were treated fairly and with dignity as we have always done on previous occasion. Now concerning collective agreements and contract, I agree again with Mr. Frank Hon that, of course, we need to have proper contracts for the work done at Novo Nordisk work sites. I think the problem you referred to as some subcontractors who did not have contracts in place. But I think we have arrived at a point where, of course, we have contracts, and we need to follow up on how our subcontractors work with those contracts and also allowing inspection carried out by trade unions. So I believe we have solved that problem. Thank you very much.

Next speaker is Bjorn Hansen.

[Interpreted] I am Bjorn Hansen. I represent private shareholders. First, a bit of a joyful thing. Novo Nordisk has provided an excellent profit, both in '24 and '25. More than DKK 200 billion, all in all, DKK 200 billion. That's world-class. So that is an excellent result. You must have good employees at all the different locations. And in research, -- your research is expensive. I know it's expensive to develop new products. It cost billions, and you can afford it. So yes, capital is required and the plan for the money is required.

Now conversely, something which is not that good, I think, the price of the share. How can it be that the share price goes down to the existing level, the one that we have now. I don't understand it. When you consider the number of shares, over DKK 2 billion, as a fluctuation of DKK 400 million, DKK 500 million. It's a fluctuation there. So a bit of a reservation there. I don't know how much you spend on artificial intelligence, but it would be interesting to know. Now when I look at Nordnet and Danske Bank and Nordea, they -- with artificial intelligence, they provide different figures, right?

A valuation of DKK 400 million, DKK 500 million -- that's not good, I think, if you're interested in the numbers. So how can these mistakes occur for Novo Nordisk? Who checks that, who verifies that at Novo that they give a correct number of shares? I think the private investors, and I think also ATP is not going to affect them as much as private investors. How can you make deductions for your loss at Novo when the tax authorities have other numbers, who is responsible for reporting these numbers? Does that just happen once a year?

I think the tax authorities have problems. They've established a center in Western Jutland. I think in Esbjerg I think, they put out numbers. I thought what's that? And what year is that? And I thought 2002, what are they talking about? Now we're in '26. And all of a sudden, instead of a deficit that you could deduct instead of that, there was 106,000 profit or gain on this year. I don't know how that happened with the tax authorities.

I believe in Novo Nordisk more than I believe in the tax authorities. And the same with A.P. Moller and other companies such as Coloplast. But I'd like to know who we can address about this question. It is a bit of a problem, I think. You have a new CEO now. I'm sure he can speak Danish soon, maybe he can quite soon after 26 years, I don't know.

But I'd like to hear whether in the U.S. if you know the American market, I only know it from a few years and the connections that I have there at the moment. But isn't it a fact that you can sort of say there is Novo Nordisk in the U.S. and Novo Nordisk in the rest of the world so that there are 2 stock exchanges, 2 places or, let's say, Frankfurt and Copenhagen that you can trade in Danish kroner or in euros where you don't have these big variations because of exchange rates because there's a lot of fluctuation there.

In the U.S., if you still get 52% of your earnings from the U.S., I'm sure Lars Rebien, you know about that. You were the CEO for 17 years, I think, and things were going quite well. It was more transparent back then. It is not now, I think. I also expect to reply in writing in Danish. It's okay also if it's in English because the Norwegians that I know, they can understand the Danish, but a couple of them would like it in English. I wish you all the best going forward, and I'm sure the price of the share will get better. Thank you for your attention.

Thank you, Bjorn Hansen, and it will be Lars responding to these questions.

[Interpreted] Yes, you bet. Bjorn Hansen. Thank you for the questions. I'm not certain I understood all of it, but I'll try to give you a reply to what I think I understood. And I hope that that we can have the talk afterwards perhaps. This thing about the pricing of the share, this is really a special matter is normally, the share price reflects future earning capability in the company. What has happened for Novo Nordisk, you can divide into different areas, I think 3 or 4 years ago, the expectation for the obesity market was very high, high expectations. The market has just opened up. Novo was the first player in this market.

Everybody was excited to see how big that market could get. And now we are further down the road on that journey figuring out how to treat people with obesity, what the challenges are and the overall expectation from this market has been reduced somewhat. So price -- the price -- the share price of the Novo Nordisk share, well, it's because expectations from the market have been somewhat reduced. The second part is our own performance or shortage of it, lack of progress or less fortunate progress of development projects.

And finally, the occurrence of competitors, particularly one big competitor, the Arch enemy, if you like, Eli Lilly from the U.S. that we've always been competing against. But as I mentioned it in my introduction, a number of the biggest companies in the world have entered the market. Obviously, that puts expectations from Novo Nordisk under pressure, thus influencing the share price. I think you mentioned something about artificial intelligence and trading in shares and loss on shares. It was a bit complicated for me, I'm afraid.

At the end of the day, however, trading in shares is an individual matter. If you lose money on a share, I think this is a matter to be solved by the individual person and the tax authorities. I don't think that Novo Nordisk can help you there. The numbers that are in the financial statements are correct. And I'm sure that our auditor, who is present can verify that. There was this thing about whether you could see the U.S. separately and take that to the stock exchange in the U.S. I don't think that's going to be a big advantage.

I mean, our share is being traded on the stock exchange in the U.S. and in Copenhagen. You don't really get any benefit from changing the currency. This is just a conversion factor, isn't it? This is going to make it more difficult for people to always have to convert to the currency that you want to use. So we do believe that the access to capital markets, we do have that at the stock exchange in Copenhagen and the stock exchange in New York, but we do not need to go out and raise money. Thank you for your questions.

We have received one last question from the online participants. It has been received from Henrik Viggo Andersen and will be read aloud in Danish. It reads as follows.

[Interpreted] What does the Board intend to do concerning increasing in this shareholders being less and less satisfied with Novo Nordisk. What is the Board going to do about it?

[Interpreted] Right. Well, there's one easy solution to that one. It would have been a lot easier for me if I chose not to present my candidacy for President for the Chairmanship. But being President of the Novo Nordisk Foundation, it is my damned duty and my responsibility to try to lift part of the responsibility of securing the assets of the Novo Nordisk Foundation. And as part of that, last year, last spring, we found it necessary to step in, in the management and asking for a change of CEO. And then as we could not agree with the Board or the composition of the Board, well, then the Board decided to step back collectively.

And then again, I was asked by the Board of the foundation to take on this job for a brief period of time, trying to protect the assets of the foundation, but also to help protect the interest of minority shareholders. I have stressed several times that this is not a permanent solution, 2 to 3 years, not more than that. And if it turns out that we can find a replacement for me quicker than then we can get back to the desired covenant situation in which we have an independent Chairman and 2 representatives representing the interest of the Novo Nordisk Foundation, and thus getting back to the original solution.

Now it's said that there's -- that shareholders are increasingly unhappy. I'd like to correct that because when I look at the votes for me. Well, I've received personally 42% of the free flow, which means that if you add that to the votes of the foundation, I got 60-plus percent, which is an increase compared to the extraordinary shareholders' meeting. So there is a slight increase. But don't be nervous. I'll be out of your hair as quickly as possible.

Thank you, Lars, and we're getting a bit ahead of ourselves with all of this covered by Item 6. With that, I think we have no further questions from the floor and also no further questions from the online participants to the first 3 items on the agenda. So I'll conclude the debate here and just quickly repeat the resolutions that we need to pass here.

First of all, the oral report is accepted by the meeting. Secondly, we have the approval of the annual report for 2025. If there are no further questions to that, I'll conclude that the report is approved. Then number 3 is the resolution for the distribution of profits. And here, Lars presented the ordinary dividend of DKK 7.95 per share, which adds to the interim dividend already paid out last year. There are no further questions or comments to that, I can also conclude that, that is approved -- it is. Thank you.

That brings us to item 4 and remuneration. The first element is presentation of the remuneration report for 2025. And under Item 5, we have approval of the Board remuneration for '25 and '26. And I'll give the floor to Lars to present the proposals.

Yes. Thank you, Anders. Again, this year, we have published a report on the Board and executive remuneration, which is available on our website. As you can read in the report, the Board remuneration was in line with the remuneration policy as it was approved at the last Annual General Meeting. The slight increase in Board remuneration reflects inflation adjustment to the Board fees. On this background, the Board proposes that the general meeting adopts the actual Board remuneration for 2025. Moreover, the executive remuneration was in line with the remuneration policy approved at the Annual General Meeting.

The Board has reviewed the current remuneration level for the Board in light with the general market developments for Board remuneration as well as the development of Novo Nordisk business and found that there was no need for significant changes. On this background, the Board proposes to adjust the remuneration level for 2026, in line with the general salary inflation and thus increase remuneration with 3% as shown on the slide. With that, back to you, Anders.

Thank you, Lars. So any questions or comments to these proposals? If not, I'll conclude that the remuneration report is approved and also that the proposed remuneration for the Board for '25 and '26 has also been approved. That brings us to the next item on the agenda, which is election of Board members, and we cover that together with Item 6, appointment of auditor. Under the Articles of Association, all Board members are elected for a period of 1 year at a time. And this time, it will also be Lars, who will present or start off by presenting the conclusions from the Board's self-evaluation and also provide a few comments on Board composition, and I'll get back and present the proposals.

Thank you, Anders. Let me start with a few words on the collaboration between the Board members and the composition of the Board. On November 14, Novo Nordisk convened an extraordinary general meeting to elect new Board members to the Board. Throughout the past 4 months, the collaboration within the Board between the Board and CEO, Mike Doustdar and the rest of the executive team has been open, productive and forward-looking.

Each year, the Board conducts a Board evaluation. Various improvement actions were implemented during 2025 in view of the focus areas that were identified in the 2024 Board evaluation as outlined in the 2025 corporate governance report. This included leveraging outside in views, external experts to go deeper into key topics as well as a focus on succession planning and talent engagement. Due to the timing of the 2025 Board evaluation shortly before the Extraordinary General Meeting in November, the result of the questionnaires was shared with the Board with me.

However, the conclusions were drawn that since it is not the same Board that's going to implement any recommendations that these actions were deferred. When recommending candidates to the nomination of the Board takes into consideration the desired competencies and experiences, the performance of the individual Board members, the ambition of diversity and independence. With the proposed candidates, we will continue to fulfill our diversity ambition being at least 2 shareholder-elected members of Nordic nationality, 2 non-Nordic nationality.

We will also continue to fulfill our gender aspiration by being 3 female members and 5 male members, thereby having equal gender balance as per definition in the Corporate Governance code. Diversity among Board members across gender and other dimensions remains a key priority. Back to you, Anders.

So that brings us to the specific proposals. First item is election of Chair. And here, the proposal is to reappoint Lars Rebien Sorensen as Chair. Under Item 6.2, the proposal is to reelect Cees de Jong as Vice Chair. Under Item 6.3, the proposal is to elect Stephan Engels and Britt Meelby Jensen and Kasim Kutay or also to elect 3 new Board members, Helena Saxon, Jan van de Winkel, Ramona Sequeira. And here, I also give the word back to Lars to present these 3 new candidates.

Thank you very much, Anders. The Board proposes election of Helena Saxon as a new Board member. Helena is Swedish nationality and currently a Board professional. Helena started her career in investment banking, which included tenure at Goldman Sachs and Investor AB. Later, she became Chief Financial Officer of Syncron and Hallvarsson company. And most recently, she held the role as Chief Financial Officer of Investor AB, which is a Wallenberg company.

She's been on the Board of SEB Skandinaviska Enskilda Banken and Sobi, which is a small specialized pharmaceutical company and currently sits on the Board of H&M as well as the Stockholm School of Economics. The Board proposes Helena as action as she will add important diverse perspective on board through her extensive executive experience and from her leadership position covering industries in the intersection between finance, pharmaceuticals, fast-moving consumer goods.

You can see Helena's CV on the slide and details are provided in the notice convening for this general meeting. Further to Helena, the Board is proposing election of Jan van de Winkel. Jan is Dutch of Nationality and is Co-Founder of Genmab in which he currently serves as President and CEO. Jan started his career in academic research, having various leadership positions at the Utrecht University before becoming appointed Professor in immunology.

In 1999, Jan co-founded Genmab and became Chief Science Officer of the company before taking over the role as President and CEO in 2010. The Board proposes Jan van de Winkel as he will add significant research and development capabilities to the Board from both the career in academics as well as the current executive career at Genmab. You can see Jan's CV on the slide and more details are provided in the notice convening this general meeting.

Finally, the Board proposes to elect Ramona Sequeira as a Board member. Ramona is a Canadian nationality and is professional Board member. She started her career with Eli Lilly, where she spent more than 20 years in various senior leadership roles across Canada, Europe and United States and most recently held the role as Vice President of Sales and Operations of their U.S. franchise. In 2015, Ramona joined Takeda Pharmaceutical Company Limited, Japanese pharmaceutical company, and she became President of their U.S. business unit and from 2020, also added the responsibility for their global product launch strategy and commercialization.

Ramona currently sits on the Board of Organon, another pharmaceutical company coming from a slaughterhouse in the Netherlands that used to make insulin. Edwards Life Science Corporation as well as the Board of Trustees of the University of Health Network in Toronto. The Board proposes Ramona Sequeira's as she will add significant commercial pharma experience with particular focus on the U.S. marketplace. You can see again here, Ramonas CV on the slide and more details are provided in the notice to this general meeting. And with this, back to you, Anders.

Thank you. And I will just mention here also that the employees of the company has held an election for appointment of employee representatives for the Board here in February. And here are the 4 members that were elected, Elizabeth Christensen, Mette Bojer Jensen were reelected, Semsi Kilic Madsen and Desiree Jantzen Asgreen were elected as new members. These 4 will join the Board after this meeting and will have a tenure of 4 years.

And Lars, I think you mentioned that you had a bit of a surprise to describe.

Yes. And this one is for ATP. We only do it for you. No, no. Next, I would like to announce that the Board has decided to appoint Poul Weihrauch as a Board observer for the year '26, '27 with the intention of nominating him for election as an ordinary Board member at the Annual Meeting next year in 2027. Poul is Danish. He currently serves as CEO of Mars Inc. in the United States, one of the biggest privately held companies in the United States with 150,000 associates.

He serves as a member of Henkel's Shareholder Committee and is a Board member of the Consumer Goods Forum. He spent his entire career in fast-moving consumer goods and in the past 26 years of them with Mars. It's a USD 65 billion U.S.-based business, as I mentioned, with 150,000 employees globally. Mars is a global leader in pet care, veterinary services, quality snacking and food products.

Before becoming CEO in Mars in 2022, Poul held a number of senior leadership positions across different geographies and business segments, including President of Mars Pet Care, Global President of Mars Food, Regional President, Mars Wrigley, Europe, et cetera, et cetera. Poul brings a unique combination of U.S. and global consumer marketing and brand building experience together with senior corporate leadership experience to the Board. He possesses very strong capabilities of applying consumer insights and market analytics to drive product innovation and sharpen the commercial execution to accelerate growth. We are very pleased to welcome Poul as a Board of Server for the coming term, and we'll be looking forward to working with him. This also concludes point #63, and I have to hand it back to you again.

Thank you. And as I mentioned, we'll just cover the auditor election as well. And here, the proposal is to reappoint Deloitte as auditors of the company, and that will be both regarding the financial reporting and sustainability reporting. And Lars mentioned who was here represented by Deloitte earlier in the meeting. So with that, I will open up for questions or comments regarding the candidates that have been described up here. It seems we have no questions from the meeting here. Risa, anybody from online? No. And with that, I think we can conclude and congratulate the candidates with their election.

That brings us to Item 8, which are 3 proposals from the Board of Directors. And 2 of them are customary items for the Annual General Meeting, which is renewals of authorization to repurchase own shares and issue new shares. And there's also a proposal to change the articles with regard to where general meetings are held. Quickly, 8.1 is thus a proposal to extend the existing authorization to acquire up to 10% of the company's shares. That's extended until the next Annual General Meeting in 2027. This authorization is subject to customary limitations. So it can only be acquired a number of shares equal to 10% of the share capital. There's a holding limit of 10% and also a maximum deviation of 10% from the share price at the time of acquisition.

Under Item 8.2, we have a renewal of the existing authorizations to issue new shares. So there are 2 authorizations. One is to issue shares without preemption rights and the other is with preemption right, all limited to a cap of 10% of the existing share capital. And under Item 8.3, a slightly technical change here. But in Denmark, the names of the regions have been changed, the geographic region. So what's been referred to as the capital region of Denmark will now merge into something called region of Eastern Denmark with effect from 1st of January 2027, and we, therefore, have to amend the articles to have the right region mentioned.

So these are the 3 proposals relating to the articles, and I open up for any questions or comments. Nobody in the room, nobody online. So that means we can conclude that all these proposals have been adopted. And that actually concludes the normal items on the agenda. We have under Item 9, any other business. And here, there is a possibility to ask further questions. Nothing can be adopted here. Any last questions? No, and neither online. So I'll give the floor back to Lars to conclude this meeting.

Thanks, Anders Orjan and Louise for sharing this -- today's Annual General Meeting. You've guided us, as usual, with professionalism throughout the meeting. Allow me to close with a few reflections. While 2025 was a tough year for Novo Nordisk and the current outlook for '26 presents its challenges, I remain excited about the year ahead and the long-term prospects of this great company.

First, although 2026 will weigh on our financials, we will expand our patient reach this year with more to come in the coming years, living up to our purpose. Second, we are encouraged by the early uptake, as you have also discussed, the Wegovy pill, the world's first peptide in a pill, and we will continue to communicate the value of this important innovation. Finally, I am pleased that we now have a full Board in place to support Mike and management, and I look forward to a positive impact we can collectively make on the many patients living with serious chronic conditions in the years to come.

I'd also like to thank all shareholders for attending this year's meeting and for your continued support. We greatly value our interactions with shareholders, whether in person or virtually. For these participating -- for those participating persons here at the Bella Center, please exit through the doors in the back of the room where you entered. We will be serving coffee outside. And if you borrowed the headset, please return it on your way out. It is not of much use at home. And please remember to take all your belongings with you. And lastly, for those who've signed up, there is a more informal shareholders' meeting taking place at 5:00 here and where all management will be on the podium to take questions. And with this, I declare the general meeting for close. Thank you.

[Portions of this transcript that are marked [Interpreted] were spoken by an interpreter present on the live call.]

Good day, and thank you for standing by. Welcome to the Novo Nordisk conference call. [Operator Instructions] Please be advised that today's conference is being recorded.

I would now like to turn the conference over to your first speaker today, Michael Novod, Head of Investor Relations. Please go ahead.

Thank you, operator. Good day, and welcome to this Novo Nordisk call regarding the top line results of the REDEFINE 4 Phase III trial. My name is Michael Novod, I'm the Head of Investor Relations at Novo Nordisk. With me today, I have CEO of Novo Nordisk, Mike Doustdar; and EVP, Research and Development and Chief Scientific Officer, Martin Holst Lange. All the speakers will be available for the Q&A session. Please note that this call and Q&A will be related to the top line redefined fall data announced today, and no further details will be discussed. Today's call is being webcasted live, and a recording will be made available on our website. The call is scheduled to last around 30 minutes.

Next slide, please. As usual, we need to advise you that this call will contain forward-looking statements. These are subject to risks and uncertainty that could cause actual results to differ materially from expectations. For further information on the risk factors, please see the company announcement for the full year 2025 and the slides prepared for this presentation.

With that, I will turn it over to Martin.

Thank you, Michael. Next slide, please. REDEFINE 4 was an open-label trial, investigating the efficacy set of CagriSema 2.4 milligram compared to Tirzepatide 15 milligram. The trial was mainly conducted in the U.S.

After incorporating some of the learnings from REDEFINE 1, the study was extended to 84 weeks of treatment, while all other parameters were left unchanged. The primary endpoint for REDEFINE 4 was to confirm non-inferiority of CagriSema 2.4-milligram versus Tirzepatide 15 milligram. The trial included around 800 people with obesity with 1 or more comorbidities. Both treatments were administered once weekly with subcutaneous dosing with the same dosing regimen as in the REDEFINE 1 and REDEFINE 2 Phase III trials.

As Tirzepatide 15-milligram treatment was only commercially available in a pen format, REDEFINE 4 employed an open-label design, in which all investigators and participants were informed of the specific drug administered during the trial. In this trial, CagriSema did not achieve the primary endpoint of non-inferiority of percentage change in body weight relative to Tirzepatide.

Beginning from a mean baseline weight of 140.2 kilograms. If all people adhere to treatment, CagriSema 2.4 milligram achieved a 23% reduction in body weight after 84 weeks. In comparison, Tirzepatide 15 milligrams resulted in a 25.5% weight loss over the same period.

There are many factors that could contribute to the REDEFINE 4 outcome. First, CagriSema performed in line with REDEFINE 1. Surprisingly, the comparator performed unusually well on efficacy compared to what has typically been reported in most previous trials of similar nature. We've noted earlier that not all learnings from REDEFINE 1 to achieve the optimal clinical benefits of CagriSema were implemented into the REDEFINE 4 protocol.

In addition, as I mentioned, REDEFINE 4 was an open-label trial, which has the potential to introduce buyers in favor of a well-established, well-known product when it is compared to an investigational therapy. The safety and tolerability profile of CagriSema was consistent with data from previous REDEFINE clinical trials.

The most commonly reported adverse event in the trial for both CagriSema and Tirzepatide were gastrointestinal-related and were generally mild to moderate in severity. These data further support the added benefit of Cagrilintide offering clinical meaningful effects to what we have shown with Semaglutide biology alone. CagriSema 2.4 milligram was submitted to the FDA for obesity in December 2025 based on the REDEFINE 1 and 2 trials, and we look forward to a decision later this year.

The REDEFINE program for CagriSema continues as we aim to explore the full weight loss potential of these complementary biologies. The REDEFINE 11 trial reached out and is expected during the first half of '27, and we plan to initiate the Phase III trial of a high-dose CagriSema in the second half of 2026.

With that, I will hand it over to you, Mike.

Thank you, Martin. Please turn to the next slide. CagriSema and obesity will allow us to further build upon the Wegovy brand, where we aim to provide patients with multiple treatment options to fit their weight loss and lifestyle needs. Not only does CagriSema provide patients the efficacy, safety and health benefits clinically proven by Semaglutide, including established evidence-based risk reductions across certain cardiovascular, renal and liver diseases but it also improves weight loss with the added benefits of Amylin.

As Martin mentioned, we continue to push the innovation bar with the ongoing and planned Phase III trials for CagriSema and CagriSema High Dose. CagriSema, importantly, built upon our current offerings within the Semaglutide family now with more choices for patients seeking weight loss therapy.

One of those new choices for patients is our Wegovy pill. As you know, we have launched the Wegovy pill in the U.S. as the first and the best-in-class oral GLP-1 with a weight loss close to 17%. And we have shared with all of you how great that launch has been so far.

Another option for patients is the Wegovy High Dose, where we will further maximize the weight loss of Semaglutide all the way up to 21%. Wegovy High Dose is now approved in EU and U.K. and a U.S. decision is expected by the end of Q1. At the same time, Novo Nordisk continues to drive next-generation obesity innovation in our pipeline.

Charging ahead on the next-generation GLP-1 Amylin, Zenagamtide, where we saw up to 24% weight loss after just 36 weeks in Phase II. This product will be available to patients both in forms of injection as well as oral offering.

You should also note that we will leverage all the learnings from the REDEFINE program in the Zenagamtide Phase III AMAZE program, which we just initiated.

Furthermore, we will offer our patients Cagrilintide monotherapy as a potential option for flexible coadministration and a fewer side effects.

And last but not least, we also have 2 exciting triple agonist advancing through the clinics, which have the potential to offer even higher weight loss. We will share more of that in due course.

Now back to you, Michael.

Thank you, Mike. Next slide, please. With that, we are now ready for the Q&A, where I kindly ask all participants to limit her or himself to 1 question, including sub questions. Operator, we're now ready to take the first question.

[Operator Instructions] And your first question today comes from the line of Mike Nedelcovych from TD Cowen.

My question is about your overarching hypothesis about CagriSema. You've reiterated that REDEFINE 11 could reveal CagriSema's full weight loss potential, so I'm assuming there were data points from REDEFINE 4, similar to those from REDEFINE 1, suggesting that efficacy may have been left on the table. Did you once again observe a dichotomy between rapid responders and slow responders, just as an example? And can you confirm whether there was a discrepancy between the arms in REDEFINE 4 in the proportion of patients that reach the target dose?

Thanks, Mike. That's a question for Martin around learnings going into REDEFINE 11.

Yes. Thank you very much, Mike, for that question. We're not going into further detail on the data. But I think it's fair to say that what we've seen in REDEFINE 4 very much resembles what we see in REDEFINE 1, a robust around 23% weight loss and a good safety and tolerability profile.

As we also discussed with REDEFINE 1, and as you pointed out, not all patients reached the full dose potential of CagriSema and therefore potentially not the full weight loss benefit. That is also something that we see in REDEFINE 4. And therefore, we are strongly assuming that there is a further weight loss potential to be had when taking all of these learnings into account. We've done that in REDEFINE 11. And therefore, as we also previously discussed, we couldn't do that, take those learnings into REDEFINE 4. We could do that for REDEFINE 11, and therefore, we had to really guide that the full weight loss potential will be derived from REDEFINE 11.

Great. Next question, please.

Your next question comes from the line of Michael Leuchten from Jefferies.

I'll stick to 1 question. Can you just talk about the non-inferiority margin you applied and how it was derived in REDEFINE 4?

Thank you. And that's a question for Martin as well.

Yes. So again, we're not really going into the data. Of course, we applied the non-inferiority margin. We did not fully achieve that. And therefore, we've seen the data that we have. I think it's important to point out that we see a consistent and robust 23% weight loss with CagriSema, but we also are a little bit surprised about the 25% weight loss that we see with the comparator drug.

Right. Next question, please.

Your next question comes from the line of James Quigley from Goldman Sachs.

Martin, could you speculate on why is that bound data actually look better than they did in the Lilly trials, as you said? What was the flexible protocol not applied to that? And again, following up on the first question, was it 100% of patients just on the 15-milligram dose throughout the trial? And again, the flexible dosing was not applied in this case, is that bound -- what happen there?

Thank you very much, James, for that question. Obviously, we are still investigating the data, but what we can see already now is that -- yes, just to step back, both treatment arms received the same flexible dosing. And while not disclosing the data at this point, it is very clear that more patients reached the 15-milligram dose at some point during the trial for Tirzepatide as compared to CagriSema.

We do believe that, that is largely derived from the open-label nature of this study. We do know, and we've seen that numerous times before that open-label storages drive buyers. In this case, more than 40% of the investigators are previous investigators on the comparator drug. They know the drug well. They have probably prescribed the drug and they feel confident in the drug. We know that drives the buyers, and that's maybe why we have seen these surprisingly good data for the comparator drug.

In part, we probably also had to ascribe this to biology. These data had never been shown before as far as I've seen in previous audits. So obviously, this is the one-off. Obviously, we don't fully appreciate that it happens in our study, but that is what it is.

Thank you, Martin. And the next question, please?

Your next question comes from the line of Peter Verdult from BNP Paribas.

Peter Verdult, BNP. Mike, just 1 for you. Just a simple one, but important. At launch later this year, how are you going to look to actually differentiate CagriSema given the data you have right now? And just kind of squeeze on a very quick one, yes or no question. Any appetite to redo REDEFINE 4 at either a higher dose or with a more forced titration schedule?

Yes. So thanks very much. A couple of things. First of all, you have to go back to how products are sold and they're sold according to their label. So the label that we have is, of course, based on -- not this trial, but the previous 1 and the label that our competitor has also is below basically the CagriSema's similar label. So I think we need to just be aware that there is an abnormality with this trial and how the comparator product has done and that abnormality and the 25% or so that we're talking about is neither in their label nor has it been really seen in their own trials, any other trials, you could even argue that in the real-world evidence. So that I think the market figures that out as we go forward. The clinical experience of the physician and the label trumps anything and everything else when it comes to commercialization. We strongly believe that CagriSema has right now the best weight efficacy than any product currently in the market. So that is a very strong belief.

Now going forward, of course, as I mentioned, we will very quickly and soon release the data from REDEFINE 11 when they're available early next year. Not long after the product is going to be in the market, that will help. But we also have made no secret and I think Martin just alluded to it, that we are designing the CagriSema with the higher dosages of it. So -- and you have seen what happens to Semaglutide when it goes from 2.4 mg to 7.2 mg, and you could do your own modeling what that means. So I'm still incredibly optimistic about CagriSema.

And then when you put it in the context of the Semaglutide molecule where you have basically now current somewhere in the market at some 15%, 16% high dose of sema, which is coming up at 21% and now, of course, sema with Amylin, call it, at least minimum 23% we have shown 2x. That shows the projection. Next to it, of course, is the oral offering at 17%. So I think the brand recognition here and the increased percentages as we're getting more and more is how we're going to treat this product when it comes to the market.

And Martin the consideration.

Appetite -- yes, sorry. Thanks, Mike.

Sorry?

Appetite for doing additional trials like REDEFINE 4.

So obviously, we have to look at the data and understand the data as both Mike and I alluded to, we did believe that we now understand the priority and the optimal way of using this biology in clinical trials. That basically means that we expect to see a potentially higher weight loss with REDEFINE 11, but we're also investigating higher doses. When we see the outcomes of those data, I will not rule out that we would do additional head-to-head studies.

Operator, next question please.

Your next question comes from the line of Harry Sephton from UBS.

Do you have any comments on the relative tolerability profile of the 2 products in the study? And maybe just to touch on CagriSema again, not getting to the high dose as much as Tirzepatide. Could that just be simply a tolerability issue? And in this instance, you have a less well-tolerated product with lower weight loss?

Great question for Martin regarding tolerability.

Yes. Thank you very much. So the tolerability that we see in this trial, both for CagriSema, but also Tirzepatide is in line with what we've seen in previous duties. Obviously, we don't have fully insight into the comparator drug, but very much in line.

That also makes us believe because when I say that more patients at some point reach the highest dose of the comparator drug, doesn't necessarily mean that they stayed on that dose, but they then achieve the weight loss potential with that dose. We do believe that the potential difference in dose levels is more derived from the open-label nature of this trial and the fact that a great number of the investigators were very familiar with the comparator drug rather than any difference in safety and tolerability.

Great. Next question please.

Your next question comes from the line of Emmanuel Papadakis from Deutsche Bank.

Congratulations on the results. I mean maybe a question around longer-term dynamics. CagriSema looks somewhat obsolete now as a competitive upgrade Semaglutide, especially with the 7.2 mg available, as you mentioned, or is there a competitive alternative to Tirzepatide? So what can you do to accelerate Zenagamtide -- excuse me, the new name for Amycretin. And where are your confidence levels that will look a more convincing solution relative to CagriSema?

Thank you, Emmanuel. Question for Mike regarding how we want to optimize and also look at the commercial potential for next generations.

3 Yes. I think Emmanuel to say it's obsolete is quite belittling a fantastic drug in all honesty. Again, when CagriSema will make it to the market early next year as the first Amylin-based product, it will have the best weight loss label than any product marketed at that time. Let's start with that. It will have the best weight loss label than any marketed product at that time.

Then, of course, we basically know that sema high dose has now 21%. Let's take the latest results at CagriSema at 23%, but the CagriSema, the 23% is with the design trial that Martin has now alluded to, and we have multiple times mentioned to you that there is an upside to that when the design of the trial is less flexible, that's the REFINE 11. We'll see what the number is once that trial plans itself.

But we also have said inside CagriSema, what that you have seen in all of these trials, including the REDEFINE 11, there's only 2.4 milligram of Semaglutide. We are starting a trial soon with 7.2 milligrams Semaglutide in that. And then basically, you will see that the life cycle management of CagriSema will pan itself as it is. So that's all on the injectables. It has nothing to do with the pill. The pill is doing phenomenal. I think it's the first and the best-in-class pill that you will see for a very, very long time to come. So that has its own. There is no other pill that has shown -- can get anywhere close to the 17% weight loss, and we have explained that also. It's the only pill that's a peptide. All the other stuff is small molecules. So they have the small molecule efficacy. So that, I think is -- but that's a whole different topic on its own.

Then you're speaking to Zenagamtide, Amycretin, which is the whole next generation of the products were coming after CagriSema, and that will also show its benefits, and we are taking all the learnings, as I mentioned, from these REDEFINE studies into the AMAZE trial studies and then you'll see the benefits of that as well.

And then last but not least, stand still for the results of the triple agonist that we will basically announce in due course. So we have 2 triple agonists, and we are incredibly excited about that as well.

Thank you very much, Mike. And our next question?

Your next question comes from the line of Carsten Lonborg Madsen from Danske Bank.

Yes. So the CagriSema high dose that you will be initiating 2.4 mg, 7.2 mg. What does your internal modeling say about adding 7.2 milligrams similar to Cagrilintide, and why don't you also increase the Cagrilintide dose in that trial?

Thank you very much, Carsten. And the question for Martin on higher dose CagriSema.

Thank you very much, Carsten. I'll not guide exactly what our model says on the weight loss potential. But let's say that it's more than what we've seen with the CagriSema 2.4 milligram plus 2.4 milligram and with a comparable safety and tolerability profile. So clearly, an upside on the efficacy potentially without having to compromise on safety and tolerability. And from that perspective, that is a very attractive offer [ open-label nature ]. We have tested higher doses of Cagrilintide in combination with Semaglutide without seeing added benefits on weight loss. So therefore, based on everything that we know also from the step-up trial, it makes sense to increase the dose of Semaglutide but not necessarily Amycretin -- sorry, Cagrilintide.

SP119072186 Great. Thank you very much, Martin. Operator, the next question, and we have 1 question left.

Your next question comes from the line of Martin Parkhoi from SEB.

Yes. Thank very much. Just on the same type, of course. Last year, you also announced that you drop your duels, your going -- you had Tirzepatide as an actual comparator. Now we see these results today. And I note that if we look at the trials that you so far have on your 19, you use Semaglutide as an action comparator in AMAZE 8. You use Semaglutide as an active comparator. Have you just realized that you cannot eat a Tirzepatide and you're using Semaglutide as the active comparator going forward?

And then just to follow up on the 419, can we talk a little bit about what your goals are with this with respect to are you going for a best-in-class side effect? Or is the weight loss that you're going for in that one?

Thank you, Martin, and 1, 1.5 question to Martin.

Yes. So we obviously will do comparator studies when there is that opportunity. I think clearly, you've heard both me and Mike talk about the open-label nature of REDEFINE 4 and the potential for substantial buyers that is introduced both on the efficacy potentially also on safety and tolerability when reporting on that. So an ability to do head-to-head comparisons with a competitor drug would require the ability to blind. And that, obviously, we are working on as we speak.

Great. Thank you very much, Martin. And with that -- I'm sorry, and this concludes the Q&A session. Thank you for participating, and please feel free to contact Investor Relations regarding any follow-up questions you might have.

Over to you, operator. Thank you.

Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.

Excellent. So good afternoon, everyone. I'm James Quigley, European pharma analyst here at Goldman Sachs and it's a pleasure to welcome to this fourth quarter results presentation for Novo Nordisk. We've got a pleasure to be joined by Mike Doustdar, CEO; Karsten Knudsen, CFO; and Martin Lange, Chief Scientific Officer. So with that Mike thanks for joining us. Over to you.

Thank you very much for hosting us. I promised that I'll try to go through these slides because I'm sure you've seen this as fast as possible, so we can actually get a lot of questions into the dialogue of the hour that we have. forward-looking statements. This is a slide you have seen for the last 5 years. We'll retire it very soon and give you a new one at the Capital Market Day. It's 1 that we created back in 2019. basically setting some guidance for ourselves what we want to do. Many of the things have happened. Some of it have positively surprised us, some of it negatively, what we are probably most proud of is as a company, we've been more than doubling our sales and profit since this last 5 years, adding DKK 76 billion to our obesity care. Rare diseases where, I would say, many people don't still put into their models enough has been completely revamped compared to 5 years ago and we are super excited about [indiscernible] launch and [indiscernible] launch. And in general, of course, it's an area where we live to the site, but it's getting healthier and healthier and last year grew by some 9%.

And then of course, the sheer number of the people we're treating today is 16 million more than it was back in 2019. So we have 46 million people on our products. If you look at last year, and I know it's long overdue, I will not spend so much time on it. It was a year of, in some way, disappointment when you think about our triple profit warnings, but forecast that initially was given at ended up to be on the high side. We came on the back of a '24 that was incredibly robust. So we made the 2025 forecast and we ended up doing half of what we basically had forecasted. So we did 10% growth on a back of U.S. and IO growth that you see there, 8% in U.S., 14% in international operations. And pretty much all regions did well with maybe the exception of China, we had higher hopes for China.

The main reason for China being below expectation is simply because Wegovy and the obesity is right now moving fast in the eHealth channels in China. And in that channel, you are not allowed to promote a product that's solely for obesity. And we have Wegovy and we are not allowed to sell directly in online channels. Wegovy while our competitor Mounjaro, being a single brand of diabetes and obesity has a bit of an advantage over us. It's something that we're trying to fix, but that's really why China numbers are below it should be.

In general, I would say the obesity market doubled up, and we were able to capture 31% growth out of that. 73% in international operations on the back of a number of new launches that we did on Wegovy and 15% in the U.S. where we are putting a lot of emphasis on the dialogue over the last couple of days to show some data to you is on the Wegovy pill. It has probably so far been one of the best launches that pharma has seen. I speak a little bit cautiously because not because I'm not excited, but because it's early days. It's 1 month into it. But I have to say that in this 1 month, it has blown our own expectation, how well it has done. When you think about why is it doing well?

And I'm sure we're going to have a lot of questions on it as well. Predominantly, it's because what has hurt us on the injectable side is helping us on the pill side. this obesity market now 2 years into deep competitiveness element of it with Lilly as well as compounders has taught Novo Nordisk is first and foremost about the magnitude of weight loss. I think kidney matters, heart matters, liver matters, but not if you are perceived to have a lower weight loss than your competition.

We've painfully realized that with our injectable franchises, but we equally get incredibly convinced that the pill will do well also when competition arrives because it does 16.6% weight loss, while the competition only does 12.4%. And in addition to the weight loss of course, of 16.6%. Then we have the label from Wegovy injection. So the cardiovascular benefits that we have seen with the injection is translated into the pill. And then this actually gives us that extra plus that we need. As of the latest data point they have shared with you, we have some 50,000 prescriptions -- new prescriptions NBRxs in the U.S., that translates to some 170,000 patients having chosen to go in this direction. And that, of course, is super exciting. And just to put that in perspective, today or the latest data point in U.S. shows no other brand, including those of our competitor is having more NBRxs than the Wegovy brand has. So that's really good. But again, just the first month. And our job, of course, is to continue that as we go forward. And we'll get into that dialogue how we plan to do that as we go forward.

I think it's you or to Karsten? [indiscernible]

Also, yes, you can do it too. I'm going to do it fast also. So it drives innovation is obviously what we continuously have to do. there's a lot of competition out there and having the broadest but also the deepest pipeline in the special diabetes and obesity, but also our other therapy areas is what we do in R&D. 2026 is going to be a really exciting year in diabetes and obesity. I am not going through everything. Lot of readouts, lot of initiations across cagilincide, semaglutide, [indiscernible] and 2 tri-agonists, One being a GLP-1/GIP glucagon, which is an external acquisition, one being the internal GLP-1/GIP amlyn analog. That's really exciting.

And again, a lot of readouts, a lot of initiation, a lot of regulatory decisions across the board. In our comorbidity space, we'll see the first readout of sincedecumab, our anti-L6. The [indiscernible] trial will read out in second half of this year. It's rarely mentioned these days, but high risk, We had to acknowledge it's a first, but also really, really high potential if the data comes out with good efficacy, good safety and tolerability. And then finally, obviously, regulatory approval of [indiscernible] in U.S., in Europe for treatment of hemophilia A with and without antibodies. And the Phase III readout of itabopivat, which is for sickle cell disease, again, a novelty for us. But in this space of huge unmet need, very, very high potential as well. So a lot of interesting things happening in 2026.

Indeed, there is -- and when we look at capital allocation, that's also happening in 2026. Just looking backwards on 2025. So as you've seen, we delivered DKK 100 billion in net profit for the year 2025 and we actually managed to convert that into almost DKK 120 billion in cash from operations. So our cash conversion is really strong. The way we deployed our capital or allocate our capital is DKK 60 billion in what we call CapEx. So that's construction of manufacturing capacity. Then we spent -- sorry, DKK 30 billion on BD/M&A. The bulk of that is linked to the Akero transaction for MASH [indiscernible]. And then we paid out dividends DKK 53 billion related to 2025. So with the dividend that is being proposed at the upcoming AGM will have increased our dividend per share for 30 consecutive years. So a very consistent approach, 50% payout ratio. Looking into 2025, we'll continue to invest in the business, invest in growth, both on the CapEx side coming down the mountain of CapEx.

So we're finalizing our facilities, with attractive assets, we will continue to invest in BD pending that we have attractive assets. And then on cash return to shareholders, consistent approach to dividends you should expect. And then we initiated a share buyback program of [ DKK 15 billion ] just started this week. In terms of outlook for the year, we are guiding between minus 5% and minus 3% on the top line. It's driven by certain extraordinary effects, including LOE in international operations in specific markets. impact from MFN in the U.S. as well as declining prices, mainly in the U.S. linked to a higher proportion of cash business as well as rate enhancements on the insured side. Of course, we continue to drive volume, and we are looking into volume growth and more patients being on Novo products in 2026.

However, the price effect outweighs that. Then with this time around, we have guided in adjusted measures. And the reason why we did that change is due to the fact that here in the first quarter of '26 we have a provision reversal, so a favorable outcome of the so-called 340B rebate provision. So we will have a positive one-off accounting noncash impact in the first quarter of $4.2 billion. So of course, it's not fair to look at the underlying business performance when we have such an effect in our numbers, and that's why we have adjusted measures, both on top line sales as well as on operating profit.

So that concludes the presentation. And now we are over to Q&A, which Michael Novod has promised to facilitate.

Thanks, Karsten. So let's start the Q&A. There's plenty of time and let's start with the host. James?

James Quigley from Goldman Sachs. So first question for me is on the Wegovy launch. So the launch has been very strong, as you said, on the initial scripts. But can you talk to any metrics that you have on current levels of awareness in the U.S., you highlighted your Super Bowl ad, but how much support are you putting behind the product in terms of TV advertising to raise awareness? And how much of a multiple effect are you seeing with partnerships from your telehealth and pharmacy collaboration? And also would be interested to your initial expectations for stay-time demographics and expected trends you're seeing from prelaunch marketing as well as the early stage of launch?

Well, there was a lot of -- one question? So we have gone really all in and here's the Super Bowl ad. But I didn't mention if you would walk into Boston or New York Central Station over the last weekend, you would see probably no other ads than Wegovy pill ad. And I literally mean no other ads than Wegovy pill ad. And we're doing it with our partners, I would say, We have decided that this has the right price point at $149, and we need to really make sure quite quickly we get to high numbers for a couple of reasons.

One is because it's important for us to basically use their first-mover advantage and demonstrate on the back of real patient data that this 30-minute dosing flexibility that our competition is speaking to, is a nonissue. I could tell people it's a nonissue, but why should people believe me, when thousands of people say it's not an issue. It's a very different one. We have 1.5 million people in [indiscernible] that never complain about that. And the 170,000 today also are not complaining about that. And then we will, of course, actually prove that and document that as we go forward before we get competition to really make sure that the world knows when you have seriously differentiated weight loss profile.

On the back of CV benefits, then than like many other medications, all pilot medication, it's okay that you just take the pill and then take a shower and then go downstairs and have your breakfast. And so that's -- I think the more patients initially they're better, and I'm super excited about it. I'm also super excited that many of these patients are new patients. 88% of them, as I have mentioned in the call, are buying the 1.5 milligram dose which, in many ways, is good for us. One, because, of course, we're really expanding the market. But two, price-wise, there's only upside because my lowest dose is the lowest price. So no matter how you look at this, there is a plus in this notion than not. And these patients, of course, will titrate up to a higher dose. To make sure that this continues, we will continue putting a lot of efforts behind it financially. I will not get into the numbers for competitive reasons. But I can tell you that there is a good reason why it has been the best launch ever. We are really putting the best effort behind it together with our partners. I think the sheer number of the partners have been critical joining in at the very beginning.

Matt?

It's Matt Weston from UBS. Can I ask about price? Because I think people are really struggling to triangulate your guidance and price comments. So Lilly was very clear on its call yesterday that they anticipated mid-teens price declines in the market, offset by volume growth. So would you agree with that mid-teens view as an overall price pressure in the U.S. market? Or is there something different happening in the Novo portfolio, whether it's a greater shift to cash or an incremental rebate to insurers to try and keep Wegovy going that means that you have a different price outlook than your biggest competitor.

Yes. So I'll take that one. Thanks, Matt, for that one. It's not for me to comment on Lilly's guidance and guidance metrics. I think what we've been out saying is that pricing is coming down, both for [indiscernible] in diabetes. So we see a continuation of the declining prices for GLP-1s in diabetes, mainly Ozempic. So historically, we've been talking about underlying minus 10 million to 15 million. So that has been kind of the directional guidance. No changes to that. And in obesity, the key point is that the factors we are looking into is rate enhancement in the insured channel mix, i.e., more towards cash and then an MFN impact in terms that both in sales cash pricing, but also Medicaid and Medicare Part D pricing. So if you put all that together, on I would say the Wegovy injectable, then you come to a quite substantial price reduction for the Wegovy injectable than for the oral that we only have a starter price, so we don't have anything in the comparator.

So our -- the decline that we are implicitly guiding for in our U.S. business being, say, in the teens, that is price driven. So I think that's as close as I get it. We're not guiding specifically on price and volume as our competitor.

Pete?

Pete Verdult at BNP. Just 2 questions. Just on Wegovy pill, Mike. Beyond the U.S., I mean Lilly said yesterday, they filed orfor in 40 countries. Could you remind us -- sorry to be on the spot, where you are in your filing strategy for Wegovy pill outside the U.S.? And then secondly, I understand completely that Wegovy pill is your route to salvation. So you've had about 1,000 questions on that in the last 4 hours. So just a different question on Ozempic. We've seen these scripts. We all know it's gentle decline. Is there anything that can be done there? Or is that just the sort of the situation in the U.S., there will continue to be a general decline as you focus all your efforts on Wegovy pill and Wegovy.

Yes. So under registration and regulatory approvals, we have made it quite open, Pete, that we have filed for regulatory approval of the pill in EU and U.K. And when we say that, we don't go ahead and count the number of the countries that are inside European Union, If I was playing the catch-up game and needed some positive news, I probably would say not the EU, but turned it into whatever number of countries that it may be and add 1 or 2 to it. We do know that the process for registration in many of the emerging markets is that you need to have the FDA approval and/or EMEA approval and you use the standard file of those to go to emerging market and get regulatory approval. We know that it's not possible that you basically get parallel registration in Philippine before you have either EMEA or FDA approval. So that I leave for you to kind of read the law and know where the numbers come from. And then for Lilly to perhaps explain that a little bit more in detail.

On the Ozempic element, I would say there a couple of things. Now it's kind of not a secret anymore. If you read the news the last 3 days, there's been articles saying Novo Nordisk is launching Ozempic pill and then that's going to happen. So we are going to actually revitalize a bit of a Ozempic brand around bringing rebases in a different way, let's call it that, into the market. And that you will see this year. Then Emil, who's sitting in the back responsible for international operations, will also tell you that we are moving much faster than before with Ozempic 2.0 in a number of his markets. And we did not do some of those activities before last year. also partially because of supply situation, I have to say.

And now we actually have our hands more open. But on the diabetes part where I think rightfully, a number of you are a bit worried that diabetes has gone down a bit while growth of growth is coming from obesity. I also will say that we have the best insulin in the world, the weekly insulin in the world, and we only have it in 3 markets today. And we didn't again go behind that and launch it in more because we've been busy managing whatever. And I think now it's a good to open up some of those books and then see what else can we do with our diabetes franchise. And all of that, I think, is in the planning.

Richard?

Richard Vosser, JPMorgan. Maybe a couple of questions on international operations. Just thinking about the LOE that you've highlighted, the 5%. I think when we talk to Sandoz and others, there may be some delays there. So just your thoughts on that competition and what you're baking in. And then secondly, in IO, Mounjaro had, I think, very large numbers in international operations yesterday. So just your thoughts on the competition there, maybe last time over speaking, the U.K. you were fighting back. How are you thinking about the rollout of injectable Wegovy and you mentioned the 7.2. In other markets, what sort of growth can we see there?

Very good point. I would say the way the guidance is created for us and probably for Lilly and the other pharma companies is that we take our best guestimates internally for our budgets, at any point of time, then we get it approved by the Board and then eventually a month later, we come and introduce it to you with our upside and downside sheet. When we do that, then we use data that is usually from a month or so before just for no other reason. And in that context, then you learn things along and then we internally, of course, adjust for those with our so-called latest estimates. And quarter-by-quarter, we also let you know where we are up and down. If you just take that as a guiding principle for all companies, Then I would say that I am hearing today more possible upside along the line that Sandoz is speaking to. They did not talk to that a month or 2 ago, but we're moving into it I would say, I'm hopeful that there will be maybe some delays here and there.

And then we can, of course, see some benefits on that on our own targets and what we have announced to you. On the other hand, I've also noticed that the preference share of Wegovy versus Mounjaro or Zepbound in U.S. has a bigger spillover effect to the rest of the world due to social media. Brits and Colombians like go to the same YouTube and learn from the same digital opinion leaders that are based in U.S. And in the U.S., everyone thinks that tirzepatide is a better product slowly as they launch into my neck of the world also they're benefiting, I would say, from that. So we are adjusting to that as we go along, albeit not giving up, and we do hope that with the launch of 7.2 in U.S. initially, we will actually have that spillover effect into the rest of the world and benefiting from it. But we need to see it and it has a delay impact, I would say, that we need to calculate on it.

I think the 7.2 is really, really important for us. besides the financials and what have you, because we fundamentally in our company feel this is being unfairly treated that people have forgotten about those mechanisms of medications and that you actually dose a product higher, you get more out of it. And we just stopped at 2.4 and now we need to bring the 7.2. And then, of course, our hope is that people will make the judgment that now that the weight loss magnitude is on par, should I cheer about the kidney and the heart and the liver that 1 asset has woven and the other 1 not yet and slowly change that.

But the preference share, I think, you know the data as good as I in U.S. is anywhere between -- from 10 patients 7 or 8 go to my competitor. And basically, 2 on a good day 3 comes to me. That we do -- I strongly believe we're going to try to change that. but it will not overnight become 50-50. We have to do this properly. We have to kind of tell people and then let the people tell each other. And that's why I think there's a bit of a delay on it. We share our plans with you. But there is, unfortunately, a bit of a wait and trust me later element into this for no better reason than what I'm explaining.

Sachin?

Sachin Jain, Bank of America. Two questions, please. If I go back on pricing. It's more of a midterm question how do you think about price elasticity sort of price for volume midterm. So you obviously take it down to $150, let's unlock the market. how do you think about $150 in being a floor and what work have you done to say, going to 7,500 unlocking volume? And then how do you think about, as you see data through this year as to whether they titrate up and dose or not your willingness to lower the higher dose oral $299 and even the injectable $349 given you're seeing this demand at the lower price? Just trying to get a sense of we've had a big price reset, how do I think about that from here? And then the second question is for you, Karsten, margins. Obviously, you're guiding to flat margins despite aggressive top line. So just if you could give us some moving parts as to where the savings are coming given the big investment we're obviously talking about in SG&A.

So Sachin, I hope you don't wish that in a large fora like this, with broadcast is also happening, I will give you my whole list of pricing policy for what you call it, for the products. I do -- I'll give you 1 part of the answer, which might resonate well with you. Price is an important element of how much volume gets untangled in this business, no doubt about it. We first saw that with the compounders. The reason, basically, people were picking up a compounding knockoff products was not because they don't want to original. It's because they couldn't afford the original. And we saw how much and how fast they have been able to penetrate. So that was, I think, one, of course, learning element for us. But if you just compare the launch of the Wegovy pill to previous launches where the price level were very different, and you can dig out the prices and then actually see the numbers.

The 170,000 that I spoke to or the 50,000 NBRxs that I'm speaking to. If you take a look at that, that's 15x more than the first month of Wegovy injectable launch at the higher -- of course, much higher price than it was. And still, you can see this is a better business case. at 149 and 15x more than Wegovy was. You could also come back a little bit closer. Wegovy was the first launch, can come closer to the Zepbound launch, And they did actually better than Wegovy, considerably better. And this launch is 2x better than the first month of Zepbound launch.

So part of it, of course, is the molecule and efficacy and what have you. But if it was purely efficacy, people will not go to the compounders. If it was purely efficacy, people will not move and people will still buy Mounjaro because it has higher than 16.6%. So price is a big element of all of this as well. And we believe with what we have announced that it's worth the short-term pain because the volumes were easily bypass it. Again, I have publicized and you know the math better than anyone else that you have to price double the volume, you breakeven. If I didn't think that you have to price and you do much, much better than doubling the volume, we would not go in this direction.

The reason we do is because we strongly believe that there -- and Karsten will now talk to the margin, they strongly believe that there is good business in doing that. But we have also said that you have or we have to see this as an investment that we make short term, the price reduction because medium term, basically, all of this will pan out with the volume increases. And then the question is when is medium-term starting? Medium term started first of January this year with the pill. It comes week by week by week. because all the scripts that I need in doubling, tripling, quadrupling the volumes will not come on the first day that the price goes down. But the question is also, is the margin okay? And do we make money off of this and what have you?

Thanks, Mike. So on margin and resourcing, then you're right, Sachin that when you have a top line decline, which is price driven, that's brutal on a margin in a high mark business. So logically speaking, intuitively, operating profit should be declining much faster than [indiscernible]. The simple version of why that's not the case is, first of all, we have a couple of more discretionary items that we have restructuring costs in '25 that makes for an easier comparator, which are partially being offset by Akero running cost in '26 but it's still a net benefit in this equation on fee development. And the second piece is super disciplined resourcing. So we have been cutting a number of budgets across the company. but it's not like a green harvester. So we are stepping up budgets for our top priorities, for instance, in R&D. So the MA program and some of the key R&D priorities. But in many departments, we are running with lower buckets this year than we did last year. So financial discipline, combined with these 2 discretionary factors.

Rajesh?

Rajesh Kumar from HSBC. Just a clarification on that margin point, and this is not my question because you're talking obviously, you put in a lot of capacity that goes into assets under construction, that depreciation is kicking in. So that's fixed cost, which is going up. And you have done a bunch of head count reduction, you're telling budgets are coming down. So if the pricing, say, commercial channel pricing next year steps down and has a similar effect this year and generic [indiscernible] delay that comes next year. Would that still be true for '27. I know you're not giving the '27 guidance. Just mechanistically, would be helpful to think through. The question I have is a simple one. Thank you very much for explaining how the guidance is constructed, what is the process I'm pretty sure you would have figured out costs and knowing you a week before where the guidance would be. So why was it released a night before? What was the process that you went through that you could not release it when you knew that you were going to be significantly below consensus?

Yes. Two questions for me. So the first question, correct. The math is if prices go down, it hurts on the margin, everything else equal. But when you run a business, then everything is not equal. So of course, the triggers to offset. Logically, we will also have with CapEx coming down, the CapEx flow through into the P&L that we've seen in prior years. So with lower absolute CapEx, we would have a benefit there. And then, of course, we'll be very rational around how we resource the company. It's important to note that it's not -- we don't start with the margin and then we gear everything from there. We start with our top priorities in terms of driving top line and then the execution across the value chain, including R&D, to create value for our shareholders, both the short, medium and long term. So that's the first question.

For the second question around release of timing, what we are looking at, and it's something that we diligently spend a lot of time on, and there are many scenarios in terms of exactly how is the year going to pan out. So we work in a number of scenarios and the number of assumptions and then also getting the latest data in terms of January performance both on the overall, but also on our other major brands and how we started the year in international operations. So getting more data on, agreeing on assumptions and then the reason we came the night before, was that then it's our Board of Directors that approves our guidance based on a very comprehensive work through. And then since we are materially away from expectations in the market, we have to go out immediately. So then we cannot wait for the next morning as is customary and which we would have done if we were closer to consensus. So that's why we came out after the Board. And we had a very thorough assessment around when it's the right point in time when we have enough evidence and a sufficient understanding of scenarios to decide on exactly where do we put our guidance and the associated interest.

[indiscernible]

No, no. Can I actually -- can I try to articulate that what happened last year to us was a great learning that this obesity market is more dynamic than at least we had felt or no. So typically, all the budget formations and the budget approvals that happens internally between me and my direct reports actually at the end of last year was moved to this year. was moved this year. And the reason was we actually -- it's moving and it's changing so much. And a small little change on the level of business that we have is considerable. So we have had a lot of dialogue during the month of January, both with Emil, who heads International Operations; and Dave in understanding exactly what is happening, not least with regards to the these news are going in and out on a daily basis, frankly speaking, leading into what Karsten said the night before or the same day actually, that we made the announcement. And then once we've kind of figured out, okay, this is where we feel comfortable about it, that this is where we feel is the latest information and now we have to soon go to the market. We've had our Board meeting. where then the Board actually listened all our pluses and the minuses. They also understand the elasticity of all of this, then they sign off on the numbers that you have basically been communicated.

[indiscernible] At the moment, if you look at how the [indiscernible]. So I'm assuming there was 1 view which was closer to what Lilly are saying. One is what you came out here or no?

The growth rates are different. The growth rates are different because our dynamics are right now different. They have a situation where they have a lot of tailwind in with regards to the preference of their injectable. This is, to a large extent, what's happening with this injectable market. And by the way, when I talked about 7 to 8, well, 7 or 8, it makes a big difference that they take versus the 1 -- 2 or 3 that I take. These are big differences. I think what is really happening is that we -- in terms of prices, the world dynamic is not so much different. We will not -- as Karsten said, go into the details of the pricing, like our colleagues are going into. But I would say prices those are public information, and it's not that they're night and day different. What is really different is the volume uptake that we had a huge volume uptake in '24. We had substantially less of that in '25 versus Lilly and then '26 is a bit of a question mark. So come back to 7.2 we talked about. .

I tell you why I feel a patient should go on semaglutide 7.2 milligram. What do I know today is it's going to be 5 or 4 or 3 on a given Monday, I don't. We have to have our dialogues and discussions and then put the needle somewhere and hold hands on it.

James?

James Gordon from Barclays. Two questions, please. One -- so the oral Wegovy launched really a key highlight. But what's the duration of the opportunity? Because I think in the annual report, the European pattern is '31, U.S. '32 but is that like a work in progress? Or is this just a 5-year opportunity? Do you think you're going to get much longer IP on it? Or is it the same LOE that you're already going to have a problem with? And then the other question was just M&A, I've heard comments about doing -- willingness to do a big obesity deal. But do you -- how do you balance that with maybe doing some of that diversifies you? Because it seems like obesity as well, every big pharma company is trying to buy something. And so assets look quite expensive. How do you think about maybe we don't get in a bidding war with other people versus like a diversification?

Yes. You get the first question, I'll answer the second.

Yes. So on LOE, the compound LOE is same, whether it's all or injectable. The difference is formulation IP where the tablet formulation yields longer IP. So with the Wegovy pill, we just launched, starting with 1.5 milligram, there we have longer IP into the late 30s.

And I think on this one, the formulation actually really matters because you could take, let's say, someone tomorrow makes the compounded semaglutide tablet Yes. Sorry. [indiscernible] $49. So you're wasting $49 in my opinion, because if you swallow my injection either in a liquid format or a pill format, your gut enzyme will basically get rid of it, and it will not get to your bloodstream. I have no idea what they have done with the comp. I have to read what they're doing. But assuming you just take the compound without the things around it and formulations and what have you, then this just doesn't work. It just simply doesn't work. So it's a little bit different than the injection. On the second question on the overall BD and how do we see this with the obesity. And I think you're a little bit trying to say, should we not diversify more into other areas rather than stick with your diabetes and obesities.

I think you need to look at obesity as a diversified, basically therapy area. We call it obesity, but it's many multiple diseases, and it will be segmented with different products at different price points. And it's not that the whole market will deflate when you're thinking broader. And let me give you a couple of examples. Think about semaglutide, which will go LOE, as you mentioned, when it goes to LOE, I foresee that it's going to be low priced, very low price, and it will become standard of care, in multiple of markets at an affordable high-volume price. Think about obesity in the context of an obese patient who has a fatty liver at the later stage of F4 and they have to change their liver transplant. We have, in our pipeline, a very promising asset called fraxiformin that we bought from Akero 4, 5 months ago. And that gives us actually that flexibility because if you think about the price of a liver transplant in the country, my assumption is about GBP 200,000, something like that. .

So I'm assuming we are not going to price a proxy form in semaglutide price. But whatever, where we see the alternative is and what have you. They're both of these patients. very different segment. And I think actually many people out there are right now looking at this whole area as that, maybe Lilly, certainly us, Everyone else is after a single asset in GLP-1 because it has become quite attractive. And then everyone launched the highest dose of weight loss and that's fine. So people are going after all say 22%, let's go for 23% or 24%, but the market is going to be very different, very, very different in segmentation.

Evan?

Evan Seigerman from BMO Capital Markets. So following up to your comments on diversification and the segmentation. How do you ensure that the obesity market isn't a race to the bottom, like we're all commenting on the HIMSS announcement. I hear what you're saying about their compounded pill how do you ensure that this becomes a market where you can segment and price appropriately? And secondarily, on that, should you be leaning more into rare disease and maybe even adjacencies to obesity to help expand kind of your footprint in cardiometabolic?

Yes. Maybe, Martin, do you want to take that?

Yes, absolutely. So I think it's very, very clear that there is a clear consumer space best. A lot of patients but maybe also a very clear focus on just the weight loss, maybe down the road also on better tolerability. Those volumes we will all compete for. But a little bit to your point, we also see segmentation of the space where we see some populations with very high weight loss needs, so more obesity or comorbidities that require something specific. That's maybe not 100 million patients, maybe that's 10 million patients. It's still substantial, but there we can, to Mike's point, talk about higher volume. So if -- again, if you think about mechanistic that would be a space where it's not just about the weight loss. If you think about cardiovascular disease and diabetes where we're also addressing that not only with GLP-1s but also with anti-inflammation and more specific drugs say about the metabolic disease, but also the comorbidities, then you get a space where there is high volume and maybe lower prices, but there's also a space where there is higher value and maybe lower volume. And in that space, you can continuously develop both monotherapies, but also develop true innovation in terms of new targets. I'm not sure I...

But in an environment where pricing is still pressured, how are you going to convince the payer to give someone a high price or [indiscernible] OBs without having to step through kind of [indiscernible]. How do you get from there? And how do you convince the value for something like MASH because everyone likes the weight loss drug deal better if you have at the disease, it's not a problem until your doctor focuses.

No, I think that's right. I mean if you think about MASH, a lot of patients who are obese have fatty liver. But not a lot of patients who are obese and have fatty liver also have cardiovascular disease. And please remember, in 2 and 3, the most prevalent reason for both morbidity and mortality is not the liver disease. It's actually a cardiovascular disease. And when you move into F4, that becomes even more acute. So you have cardiovascular disease, but now you are also tired and you feel seriously your liver disease. And in that space, talking about 10% weight loss or a 15% weight loss doesn't really make a lot of sense because it's a different patient need. And from a societal, from a payer perspective, our job is then to show the return of investment in treating both diseases where they are.

So it's a fundamentally different approach than going for the weight loss and the big volumes. But with our both scientific development, but also commercial expertise in those spaces, we can actually leverage that. But it's very much about a dialogue talking to payers of where do they see the unmet need and where is the willingness to pay.

I think there's 2 elements that you need to consider. One, who you're competing with and what's your competitors price. I use efruxifermin as an example that if my competitor is not Lilly but liver transplant, then I price it according to that. And then people can figure out what they want. These people have to get a liver transplant or they die or they can go on [indiscernible], basically possibly avoid that, right? So that's, I think, 1 thing you need to kind of consider. I also agree with you that, of course, if there's 5 competitors in exactly the segment then it's difficult to probably come and say I'm 10x more. But I also feel when we think about consumerism, you need to realize there is something around the perception that is created that takes people for certain either brand name or the next best thing and what have you, that we have not seen so much of it in the medicine world, and we started to see that in obesity much, much more. Why is it that people are still picking up a compounded product if basically price was not important. We could also see the opposite. If the price is everything, why the heck is Lilly and I is still selling? Because they also can apparently make people lose weight, right? And even if you can take 2 of their products, jab it twice then you probably get to the same level as us. I don't know, I haven't done it. But why is Mounjaro selling? And then they showed they're going to be, what, 40 billion this year. and what have you.

There must be something more than the simplistic way that you're just a little bit articulate it. It is more of it. The trick, I think, and the winner of this race will be based on a couple of things. One, can you scale? Can you -- because you're -- when segments work well when each segment is not a tiny one, but that there are actually enough people in these segments to do something and what have you. And then to do that, I think many people can have a niche business in this -- but can you actually have a decent business in each of these segments to make something meaningful. So scaling is really important. And I only see 1 other company besides us that's right now thinking about that. And then the second is the breadth of the portfolio. Can you have simply different product presentation and form factors that shows something is different then when you come and ask for the certain products. We have seen and we have learned that from our competitor that when you have 1 product in 1 form factor you're much more restricted on how you can sell it in different channels and the price is different.

We have seen my competitor that they take the same product in different form factors, and we actually do well with it here and maybe less so on this segment at different price points. So it is really about thinking about this as a long-term business like we have done with our diabetes than just coming in and making some fast and quick money. And I'm thinking of the diabetes, insulin just as a proxy. We have half of the world's insulin today. We do it with 11, 12 different types of insulin, not because those insulins are phenomenally different from each other. But because they marketed to different groups of people at different price points and different presentations and what have you. And the cheapest insulin I have, which is sold in rural part of India is something called the [indiscernible] human insulin. And the most expensive 1 I have is the weekly called a weekly sold in 3 other markets. patient pickup price difference between 1 versus the other, I think is 30x, if I'm not mistaken. They both reduce your HbA1c pretty much the same. So you can look at it from an element of what's the problem with the diabetic insulin. You have high glucose. You have to bring the HbA1c to 6.57. They both can the same, but they do it from a different angle.

The last question, very quick, Simon?

Simon Baker from Rothschild & Co Redburn, Mike, you said yesterday from the launch early of the pill, most patients are new to therapy. Is that in line with your expectation? Because that surprised quite a few people yesterday because the expectation was that the oils would effectively serve as a maintenance market rather than an induction. So does that suggest that people are going on this, not so much because it's a pill, but because it's the cheapest option. And what does that mean for the market opportunity? And then just kind of related to that, if we go back to Matt's question at the beginning, about guidance. If we look at what you were saying and what Lilly was saying yesterday, in terms of the threats and headwinds, you're kind of on the same page, but there's a big, big difference in your sight of the opportunity versus theirs. So would it be fair to say that the guidance is effectively reflecting the different levels of confidence. You know exactly what the price environment is, but you don't know what the volume uplift is and that's why the guidance is where it is?

Yes. So let me take the pill question first, you can touch upon the guidance and then maybe I can add to it afterwards. Pretty much 100%. So today or yesterday, I said 88% of the pills I have sold have sold the lowest dose. That's how I can say that there are new patients because I kind of feel -- I haven't asked people, are you new or old. I look at the data, I'm selling the lowest dose, 1.5%, 88% of the time. And then I'd say probably they are new. I'm pretty sure 6 months from now, it will be a different split the exact split, I don't know. And the reason is I feel like the ones that can start -- that started first of January, eventually titrate and go higher and higher, they don't stay on it to a large extent because they want to get the effective 16.6% weight loss.

Some people might stay under 1.5 because they want micro dosing and longevity and everything else that's happening on the Internet about it. So maybe there's some of that. And of course, the new ones probably always go to the 1.5. There could also be a group of people that move slowly from the injection to maintain themselves. Lilly is very much speaking to that, that they're going to push that. And as they do, maybe we get some benefit out of that or not. At the lower dose, but much, much longer stay time so the patient cost or patient acquisition cost -- sorry, patient daytime benefits will be useful to see. I think that for a period of time, Simon, there's a lot of people out there that want to lose weight. -- but don't want to get an injection. The taboo of injection, I think, will play to our benefit. So I still feel that at least short term we will probably see this really is a market expander while we will monitor and share with you as we learn the rest. On the guidance.

Yes. Thanks for that question, Simon. And I would say when we say our guidance and our budget modeling for the year, it's not lack of confidence in our product. So we are super confident vis-a-vis competition with the Wegovy pill. You all remember, 17% versus 12% on efficacy in terms of weight loss, cross trial also indications of better tolerability. So we are very confident on the competitiveness of our product. And by the way, the first mover advantage that we all know about. So that's our starting point. Exactly how lineated their modeling. I have no clue, and I shouldn't have. So -- but there are a lot of assumptions for any product launch, how that's going to pan out. And in obesity, it's even more uncertain and stands on a lot of assumptions. So what's the channel mix between cash and reimbursed? What's the sourcing, what's the cannibalization, et cetera, et cetera. So we put our best brains into it and -- but it caters to a lot of uncertainties, and we put our best assumptions in, and I'm sure they did the same. And then a year from now, we'll see who got closer to the reality. So that's as much as I can say, but full confidence in the Wegovy pill.

Great. Those words, back to you, Mike, if you have any concluding remarks?

Yes. So thanks very much for being here. And our hope, of course, is to, in a transparent way, explain what goes underneath the numbers and what we have done. I will reiterate, of course, that the reason we don't have some of these answers in terms of the magnitude of what can go really good and what can go really bad. And when will the volumes triple and could ripple is simply because we are in a therapy area that's just a lot more dynamic than most others you have seen. Most of the medication today are for serious diseases that are not as much consumer driven and moved to the left or right on a back of social media talk. This one is. And we're learning it faster than anyone else, how to read those social media talks and how to make better forecast. But it's never going to be as predictable as the insulin business.

For us or I think also for our competitor. And they have right now a bit of a tailwind, and we have a bit of a headwind against us. But I also remind investors that have been long term with us that we have competed with Lilly for more than 100 years. And you can ask them, we have won many of the battles and they have won some also. And we both have not declared the war winner yet. And it's our job to, of course, continue this. We find them a very worthy competitor. They make us better. But I also think that they also say that we have taught them a lot of things as well. So we will continue. And I think when you come to our hopefully Capital Markets Day on the 21st of September here in London, we will show you how we have not given up on the fight, be it on the injectable front on the back of what I explained or the pill. We'll also show you that by our focused strategy, we are now able to innovate within diabetes and obesity faster than any of you would have imagined, and we will basically showcase some of the things that we know on pipelines and assets and the speed that I've been talking to.

And hopefully, Karsten will also say to you that we continue to be incredibly financial discipline that I think we are, as a company, always been to make sure that we don't basically save a single dime on investments where it's needed, but save every single time where we don't need it. And we will do our utmost to remain very confident we will not run into manufacturing issues again on the back of the problems we've had in the past. So stay tuned and hopefully, we'll tell that story due on September.

Thank you.

Thanks.

Good day, and thank you for standing by. Welcome to the Q4 2025 Novo Nordisk Earnings Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded.

I would now like to hand the conference over to your first speaker today, Michael Novod, Head of Investor Relations. Please go ahead.

Thank you very much, and welcome to this Novo Nordisk Earnings Call for the Full Year of 2025. My name is Michael Novod. I'm the Head of Investor Relations at Novo Nordisk. With me today, I have CEO of Novo Nordisk, Mike Doustdar; EVP, Product and Portfolio Strategy, Ludovic Helfgott; EVP, U.S. Operations, Dave Moore; EVP, Research and Development and Chief Scientific Officer, Martin Holst Lange; and Chief Financial Officer, Karsten Munk Knudsen. All speakers will be available for the Q&A session.

Today's call is being webcasted live, and a recording will be made available on our website. The call is scheduled to last 1 hour.

Next slide, please. The presentation is structured as outlined on Slide 2. Please note that all sales and operating profit growth statements will be at constant exchange rates unless otherwise specified.

Next slide, please. We need to advise you that this call will contain forward-looking statements. These are subject to risks and uncertainties that could cause actual results to differ materially from expectations. For further information on the risk factors, please see the company announcement for the full year 2025 and the slides prepared for this presentation.

With that, over to you, Mike, for an update on our strategic aspirations.

Thank you, Michael. Next slide, please. In 2025, Novo Nordisk delivered 10% sales growth and operating profit growth of 6%. We sharpened our strategic focus in 2025, doubling down in our core therapeutical areas of obesity and diabetes. This year marks the conclusion of the 2025 strategic aspirations that were established back in 2019. Since then, we have more than doubled our sales and operating profit, and our obesity care sales have increased from DKK 6 billion in 2019 to DKK 82 billion in 2025.

Rare disease is now positioned for sustained growth with the late-stage pipeline assets, Mim8, now called denecimig and etavopivat. Furthermore, over DKK 300 billion has been returned to our shareholders since 2019. Most importantly, we have increased our reach by an additional 16 million people with our obesity and diabetes treatments.

This quarter, we saw several exciting readouts, including the next-generation treatment for type 2 diabetes with the Phase II readout of zenagamtide and Phase III readout for CagriSema. Novo Nordisk also continued to build upon its pipeline across therapy areas. Martin will discuss this in more detail later in the call.

By late 2025, we received FDA approval for the Wegovy pill, the first oral GLP-1 for obesity and submitted CagriSema in the U.S. Dave will speak more to the Wegovy pill later, but we are encouraged by the early uptake of the pill and what we see these milestones mean -- would mean for people living with obesity. We are treating nearly 46 million people with our innovative medicines, reflecting Novo Nordisk commitment to innovation and the ongoing efforts to expand access to our therapies worldwide.

Finally, Karsten will come back to it, but we have released our 2026 guidance, which reflects a year of pricing headwinds. We do not take this lightly, and we will do all we can to pursue the volume opportunities in obesity and diabetes.

Next slide, please. Yesterday, we also announced changes to the executive management team. Dave Moore has decided to leave Novo Nordisk for personal reasons after more than 8 years with the company. Dave began his Novo journey in 2017 and returned to Novo in 2022 after a time outside of the company to lead our global business development area before returning to the U.S. as the Executive Vice President of the U.S. Operations in January of 2025. Dave has moved the needle throughout his time at Novo from driving the blockbuster launch of Ozempic to leading the acquisition of 3 Catalent manufacturing sites, to overseeing the launch of the Wegovy pill in the U.S.

In addition, Ludovic Helfgott has decided to leave Novo Nordisk to pursue new opportunities. Ludo joined Novo Nordisk back in 2019 to lead what was back then called Biopharm business and eventually became our rare disease therapy area. Ludovic's Patient-first leadership is reflected in Novo Nordisk strong presence in rare blood and endocrine disorders today. Ludovic was able to translate this passion across all of our therapy areas over the last 10 months as the Head of Product and Portfolio Strategy. On behalf of Novo Nordisk and myself, I would like to thank Dave and Ludovic for their bold and steady leadership.

After a thoughtful selection process over the last few months, I'm very pleased to announce the addition of Jamey Millar and Hong Chow to Novo Nordisk and the executive management team.

Next slide, please. Starting February 5, Jamey Millar joins Novo Nordisk as an Executive Vice President of U.S. Operations. Jamey brings more than 30 years of extensive leadership experience in the pharmaceutical industry with proven track record in launching major therapies and shaping commercial strategy. He joins us from UnitedHealth Group, where he served as the CEO of Optum Specialty Holdings and brings deep expertise in U.S. market access and product life cycle management.

Beginning February 15, Hong Chow will join Novo Nordisk as an Executive Vice President of Product and Portfolio Strategy. Hong brings deep global leadership experience to Novo Nordisk serving as the Executive Vice President and Head of China and International at Merck Healthcare and leading their global cardiovascular metabolism and endocrine portfolio. Her leadership in advancing innovation, health equity and large-scale product strategies at companies such as Merck, Roche and Bayer demonstrates her outstanding capability to drive our vision forward.

We look forward to welcoming Jamey and Hong to Novo Nordisk this month, and both Dave and Ludo will help to ensure successful transition to their successors throughout the end of this quarter.

I will now hand over to Ludo for an update on our commercial execution in 2025.

Thank you, Mike, and please turn to next slide. The global GLP-1 market grew over 30% in 2025. Novo Nordisk total sales increased by 10% as U.S. operations grew 8% and International Operations grew 14%. Sales growth was positively impacted by one-offs in the U.S. Our GLP-1 sales in diabetes increased by 6%, driven by U.S. operations, plus 5% and International Operations growing 7%. Insulin sales decreased by 1%. U.S. operations increased by 2%, positively impacted by positive channel and payer mix and partially countered by a decline in volume. International Operations decreased by 2%, impacted by market share losses.

Obesity care sales increased 31% in 2025, driven by both operating units. U.S. operations grew 15% and IO grew 73%. In both geographies, growth was driven by Wegovy. Our Rare Disease sales increased by 9%. This was driven by sales increase in the U.S. operations of 7% and in International Operations of 10%. In both operating units, the sales increase was primarily driven by the rare endocrine disorder products, mainly due to Sogroya launch uptake.

Next slide, please. Sales in International Operations were driven by GLP-1 products in obesity and diabetes care. The GLP-1 volume growth in International Operations was 44% in 2025. And Novo Nordisk remains the overall GLP-1 market leader with a 62% volume market share. GLP-1 diabetes sales increased by 7%, driven by the sales growth of Ozempic. In Region China, GLP-1 diabetes sales decreased by 5%, which was negatively impacted by wholesaler inventory movements. Total obesity care sales grew up to DKK 31 billion in 2025.

Wegovy was launched in 35 new countries in 2025, more than tripling the number of launches back in 2024. Sales of Wegovy reached DKK 28 billion in '25, growing 134%. We continue to see GLP-1 market growth in International Operations. A large unmet need remains and penetration rates are low. Looking into '26, we plan to further expand the obesity and diabetes markets in IO through new online channels and partnerships and by bringing new products to patients with the ongoing rollout of semaglutide 7.2 milligram for weight loss and Ozempic 2-milligram for diabetes in certain markets.

And with that, I would like to thank my colleagues and the entire Novo Nordisk organization for a tremendous 7 years. It's been a privilege to work on impactful medicines that have already and hopefully soon will make it to the hands of patients.

And now I will hand it over to Dave for an update on U.S. operations.

Thank you, Ludo. Next slide, please. Sales of GLP-1 diabetes care products in the U.S. increased by 5% in 2025. The sales increase was driven by continued uptake of Ozempic, partially countered by Victoza and Rybelsus. Ozempic sales in the U.S. were positively impacted by gross to net sales adjustments and GLP-1 diabetes market growth, partially countered by market share losses and lower realized prices. Weekly Ozempic prescriptions are currently around 610,000. The GLP-1 diabetes market grew just over 10% in the fourth quarter of 2025 compared to the fourth quarter of 2024.

In the U.S., we continue to meet people with type 2 diabetes where they are, including through our self-pay offering for Ozempic that is currently now around 8,000 prescriptions per week. We also received FDA approval for the updated formulation of the Ozempic pill, formerly known as Rybelsus, and that happened last week.

Next slide, please. As Mike noted earlier, 2025 ended with an exciting milestone for Novo Nordisk and importantly, people living with obesity in the U.S. The Wegovy pill was approved by FDA on December 22. And thanks to outstanding efforts across our entire organization, we were able to bring the first and best-in-class oral GLP-1 for weight management to the U.S. market on January 5. The Wegovy pill is the only GLP-1 peptide formulated into a pill, delivering the weight loss efficacy of injectable Wegovy in a once-daily oral tablet.

When looking separately at the Phase III trial data in obesity for the Wegovy pill and for orforglipron, the Wegovy pill shows around 35% greater reported weight loss. We have seen encouraging early uptake of the Wegovy pill. Our compiled data shows that total prescriptions are around 50,000 for the week ending January 23, with around 45,000 of these prescriptions coming through self-pay. The uptake is over twice that of any prior anti-obesity drug launches in the United States. Though it is still early in the launch, most prescriptions appear to be for patients new to these medications, suggesting the market is expanding.

The Wegovy Pill is offered at over 70,000 retail pharmacies and through NovoCare Pharmacy and numerous telehealth partners. Commercial access for the Wegovy pill is progressing with coverage currently via CVS, Prime, Optum and Anthem, amounting to just below half the covered lives we have for injectable Wegovy. We continue working to develop reimbursed access and broaden reach through more partnerships in order to provide people with obesity an oral therapeutic option with a competitive label of Wegovy and best-in-class weight loss.

Next slide, please. Wegovy sales increased by 16% in U.S. operations in 2025. The Wegovy sales growth was driven by increased volumes, partially countered by lower realized prices. In the holiday week ending January 23, Wegovy had around 230,000 weekly prescriptions. The recent decline in injectable Wegovy prescriptions at the start of 2026 is largely attributed to benefit changes at the turn of the year, including several states that are dropping Medicaid coverage of anti-obesity medicines. The combined injectable and pill Wegovy brand is currently now more than 75,000 weekly NBRxs, and that makes it the leading anti-obesity medication franchise measured by NBRx in the U.S.

In the last year, the branded anti-obesity market has more than doubled in size. U.S. operations has prioritized making our anti-obesity medications available to more people through multiple avenues to meet the outstanding unmet need. Novo Nordisk launched NovoCare Pharmacy in March 2025. And together with retail and telehealth, total self-pay now makes up around 30% of total injectable Wegovy prescriptions. In under 1 year, our increased efforts in the self-pay channel have resulted in close to 120,000 current weekly TRxs across Wegovy and Ozempic brands, and we continue to add more patients daily. Novo Nordisk will continue to invest in the expansion of the direct-to-patient initiatives like the recently announced collaboration with Amazon Pharmacy.

In November, we announced that Novo Nordisk entered an agreement with the U.S. administration, including coverage for obesity medicines in U.S. Medicare Part D via the CMMI pilot program. We are encouraged that more patients will have affordable access to our medicines, and we anticipate that coverage will begin around the middle of the year. In addition to access, we remain focused on bringing innovation to the market. Novo Nordisk submitted the high-dose semaglutide 7.2 milligram to FDA in November. It's under the CNPV pilot program, and we anticipate a decision during the first quarter of 2026. Furthermore, CagriSema has been submitted to the FDA in December, and we expect a decision towards the turn of the year.

As my time at Novo Nordisk comes to an end, I'm excited about its future and proud of the positive impact I've witnessed on patients worldwide, and I look forward to seeing Novo Nordisk continue with this mission.

And now I'll turn it over to Martin for an update on R&D.

Thank you, Dave. Please turn to the next slide. This week, we announced the top line readout from REIMAGINE 2, a Phase III trial for CagriSema in type 2 diabetes. The trial included around 2,700 people with type 2 diabetes inadequately controlled with metformin with or without an SGLT2 inhibitor. People were randomly assigned to receive either CagriSema 2.4 milligram or 1 milligram, semaglutide 2.4 milligram or 1 milligram or cagrilintide 2.4 milligram or placebo. The study assessed superiority of CagriSema versus Semaglutide on A1c as the primary endpoint with change in body weight as one of the secondary endpoints. Approximately 40% of all participants were using an SGLT2 inhibitor before initiating the trial.

Please go to the next slide. In Reimagine 2, CagriSema 2.4 milligram demonstrated superior A1c reduction and weight loss versus semaglutide 2.4 milligram. Assuming all people adhere to treatment and from a mean A1c baseline of 8.2%, CagriSema 2.4 milligram achieved a superior A1c reduction of 1.91 percentage points. This is compared to 1.76 percentage points with semaglutide 2.4 milligram. In addition, CagriSema 2.4 milligram achieved a superior weight loss reduction of 14.2%. More than 40% of the participants treated with CagriSema 2.4 milligram achieved over 15% weight loss and around 1 in 4 achieved over 20% weight loss.

In the trial, CagriSema appeared to have a safe and well-tolerated profile. The most common adverse events were gastrointestinal with the vast majority being mild to moderate and decreasing over time. This data is in line with the recent top line readout of REIMAGINE 3 with CagriSema as an add-on to basal insulin. In that study, people treated with CagriSema 2.4 milligram achieved an A1c reduction of 2.33 percentage points and a weight loss of 12% at 40 weeks, all superior to placebo. Results from the pivotal REIMAGINE 1 trial are anticipated in the first quarter of 2026. In addition, we await the long-term safety and efficacy cardiovascular outcomes trial, REDEFINE 3. Following these results, Novo Nordisk will approach authorities to discuss the regulatory pathway for CagriSema in type 2 diabetes.

In summary, CagriSema has demonstrated superior results in both glycemic control and weight reduction. These results represent a highly effective treatment option for individuals with type 2 diabetes seeking weight management solutions in addition to glycemic control.

Next slide, please. In November, we announced positive headline results from the first evaluation of zenagamtide, formerly called amycretin in people with type 2 diabetes. The trial investigated the efficacy, safety and pharmacokinetics of once-weekly subcutaneous and once-daily oral zenagamtide compared to placebo. The trial included around 450 people with type 2 diabetes inadequately controlled on metformin with or without an SGLT2 inhibitor, a standard of care. About 40% of participants were using an SGLT2 inhibitor at baseline. The trial was a combined multi-ascending dose study investigating 6 subcutaneous doses ranging from 0.4 milligram to 40 milligram and 3 oral doses ranging from 6 milligram, 25 milligram to 50 milligram. From a mean baseline HbA1c of 7.8% once weekly zenagamtide lowered A1c by up to 1.8 percentage points at week 36 in a dose-dependent manner, assuming all people adhere to treatment. The proportion of people achieving A1c below 7% was up to 89.1%.

Furthermore, people treated with oral zenagamtide achieved dose-dependent reductions of A1c of up to 1.5 percentage points by week 36 from a baseline of 8%. Almost 78% of people achieved an A1c level below 7%. The estimated improvements in A1c were all statistically significant versus placebo, confirming the primary endpoint in the trial. Both subcutaneous and oral zenagamtide appear to have a safe and well-tolerated profile, consistent with other incretin and amylin-based therapies.

The data further support the potential of zenagamtide as a next-generation treatment for type 2 diabetes, and we look forward to bringing it into an extensive Phase III program called AMBITION in type 2 diabetes and other indications in the second half of 2026. In addition, the Phase III obesity program called AMAZE will start in the first quarter of 2026.

As a reminder, the Phase Ib/IIa clinical trial with incretin in people with obesity or overweight demonstrated a 22% weight loss with a 20-milligram dose after 36 weeks of treatment. The AMBITION and the AMAZE programs will both investigate the subcutaneous maintenance dose up to 40 milligrams.

Next slide, please. We have an exciting year ahead across therapy areas here at Novo Nordisk. Beginning with diabetes, you just heard about the advances that we made with our late-stage internal assets, CagriSema and zenagamtide. We've also achieved progress through external innovation that we have done throughout the last few years. We expect Phase II data from our in-licensed UBT251 asset, a GLP-1, GLP/glucagon tri-agonist in a Chinese type 2 diabetes population in the first half of this year with plans to initiate our own Phase II study in type 2 diabetes in the second half of this year.

Within the diabetes associated comorbidities, the first readout of ziltivekimab from the ZEUS Phase III trial is anticipated in the second half of this year. The trial is assessing 3-point MACE relative risk reduction on top of standard of care. Ziltivekimab holds the potential to be a first-in-class treatment targeting systemic inflammation in people living with atherosclerotic cardiovascular disease and chronic kidney disease.

In obesity, we expect results from the REDEFINE 4 trial in the first quarter of this year, assessing weight loss efficacy compared to tirzepatide. The study's primary endpoint is percent change in body weight assessed for non-inferiority. We are assessing further CagriSema weight loss potential in the ongoing REDEFINE 11 trial with the results expected early in 2027. And new Phase III trial with CagriSema high dose is also planned to initiate later this year.

For our triple agonist, we expect Phase II data from our in-licensed UBT251 asset in a Chinese obese and overweight population in the first half of this year, and we have already initiated our own Phase Ib/II study in obesity. We would also like to highlight the first human dose trial with our internal triagonist, GLP-1, GIP amylin targeted agonist that was completed in the third quarter of 2025. Single doses up to 1.5 milligram and multiple weekly subcutaneous doses up to 1.24 milligram were tested.

The primary endpoint was treatment-emergent adverse events. The safety profile of the triagonist was consistent with incretin-based therapies. The percentage change in body weight from baseline range from minus 3.6% to 5.3% for the triagonist versus 0.5% for placebo at 4 weeks. The 4-week data confirm our belief in the potential for high weight loss efficacy with the triagonist. We recently initiated a Phase Ib/II trial in obesity with expected readout during the first half of 2027.

In addition, we have several ongoing submissions in obesity in the U.S. and globally. We anticipate the EU's decision on oral semaglutide 25 milligram and injectable semaglutide 7.2 milligram during the second half of this year. We also anticipate forthcoming decisions regarding semaglutide 7.2 milligram and later in the year, CagriSema in the U.S.

2026 is an exciting year in rare disease as well. The Phase III HIBISCUS readout for etavopivat in sickle cell disease is expected in the second quarter of this year. Etavopivat has a novel mechanism of action with the potential to improve both hemoglobin health and vaso-occlusive crisis event rates in people living with sickle cell disease.

Finally, we are awaiting regulatory decision for denecimig previously known as Mim8. Denecimig is a once monthly -- once every 2 weeks or once-weekly prophylaxis treatment to prevent or reduce the frequency of bleeding episodes in people with hemophilia A with or without inhibitors. Regulatory decisions in the U.S. and the EU is expected in the second half of 2026.

With that, over to you, Karsten.

Thank you, Martin. Please turn to the next slide. In 2025, our sales grew by 10% at constant exchange rates, driven by both operating units. In the U.S., sales growth was positively impacted by gross to net sales adjustments. The gross margin decreased to 81% compared to 84.7% in 2024. The decrease in gross margin is impacted by amortization and depreciation related to the acquisition of the 3 Catalent manufacturing sites as well as one-off restructuring costs related to the company-wide transformation we announced in the third quarter.

Operating profit decreased by 1% in Danish kroner and increased by 6% at constant exchange rates, reflecting higher sales and distribution costs tied to Wegovy promotional activities and launches as well as increased early research and development stage investments. The main impact on operating profit was, however, the company-wide restructuring cost of around DKK 8 billion. Excluding this, operating profit would have increased by 6% in Danish kroner and 13% at constant exchange rates.

Please go to the next slide. In 2025, from a net profit of DKK 102 billion, we generated close to DKK 120 billion in cash from operating activities. Our deployment of capital follows our allocation principles of investing in the business with around DKK 60 billion going towards manufacturing capacity expansion through capital expenditure and around DKK 30 billion to expand the R&D pipeline through business development activities.

We also returned around DKK 52 billion to shareholders in the form of dividends. At the Annual General Meeting on March 26, 2026, the Board of Directors will propose a final dividend of DKK 7.95 for an expected total 2025 dividend of DKK 11.70, including the interim dividend paid out in August '25. This is a 2.6% increase compared to last year, making it the 30th consecutive year with increasing dividend per share. Novo Nordisk will continue to deliver returns to shareholders in 2026 with total cash returns anticipated to be over DKK 60 billion. In addition, the Board of Directors has approved a new share repurchase program of up to DKK 15 billion to be executed during the next 12 months.

Please turn to the next slide. In 2026, sales and operating profit will be positively impacted by a reversal of sales rebate provisions of USD 4.2 billion related to the 340B Drug Pricing Program in the U.S. In order to enhance transparency and comparability of underlying operating performance, Novo Nordisk will present outlook and expectations on adjusted sales and adjusted operating profit growth basis at constant exchange rates going forward. This is introduced to exclude certain exceptional and nonrecurring effects, primarily of noncash nature, including the provision reversal.

Adjusted operating profit will likewise exclude the impact of the 340B provision reversal as well as other exceptional and nonrecurring effects related to effects such as major impairment losses and major legal matters.

For 2026, adjusted sales growth is expected to be minus 5% to minus 13% at constant exchange rates. Given the current exchange rate versus Danish kroner, growth reported in Danish kroner is expected to be 3 percentage points lower than at constant exchange rates. The outlook reflects expectations for sales growth within International Operations and expectations for sales decline within U.S. operations.

The global GLP-1 market expansion is assumed to continue in 2026, enabling Novo Nordisk to increase patient reach and expand volumes. However, this is countered by lower realized prices, including impacts from the most favored nations agreements in the U.S. and loss of exclusivity for the semaglutide molecule in certain markets in International Operations. Lastly, positive impacts related to U.S. gross to net sales adjustments during 2025 are not anticipated to reoccur.

In International Operations, the outlook is based on current growth trends, including continued volume penetration from GLP-1 treatments and market expansion, mainly within obesity as well as intensifying competition and negative impacts from the patent expiry of semaglutide in certain markets.

In U.S. operations, the outlook is based on current prescription trends for the injectable GLP-1 portfolio, intensifying competition as well as negative impact from reduced anti-obesity medication coverage in Medicaid. Furthermore, lower realized prices linked to investments in market access are amplified by the MFN agreement with the U.S. administration.

Uptake related to the launch of the Wegovy pill is reflected based on a range of assumptions related to market penetration, potential negative impact on the growth of the injectable anti-obesity medication category as well as channel mix.

Adjusted operating profit growth is expected to be minus 5% to minus 13% at constant exchange rates. Given the current exchange rates versus the Danish kroner, reported operating profit growth in Danish kroner is expected to be around 5 percentage points lower than at constant exchange rates. The expectation for adjusted operating profit growth primarily reflects the sales growth outlook combined with targeted investments in current and future growth opportunities within R&D and commercial.

Other key modeling considerations for 2026 are shown on the slide. Of note, as of 2026, Novo Nordisk defines free cash flow as net cash generated from operating activities less purchase of property, plant and equipment and is expected to be DKK 35 billion to DKK 45 billion. Capital expenditure is expected to be around DKK 55 billion in 2026. In the coming years, the capital expenditure investments are expected to decline following expansion project finalizations. That covers the outlook for 2026.

Now back to you, Mike.

Thank you, Karsten. Please turn to the next slide. Our 2025 strategic aspirations have run their course. And while we acknowledge 2025 presented significant challenges affecting our performance and share price, those adversaries have also made us more resilient. We have plenty of work left to do in order to meet the vast unmet needs for people living with diabetes, obesity and their related comorbidities as well as those with rare diseases, which we treat -- we aim to treat in the future.

We expect to introduce new strategic aspirations as part of Capital Market Day, which will be held on September 21 in London. Until then, we will, of course, continue to report and track progress across key dimensions of the business.

With that, I will turn it back to you, Michael.

Thank you, Mike. Next slide, please. With that, we're now ready for the Q&A. [Operator Instructions] Operator, we're now ready to take the first question.

[Operator Instructions] And your first question today comes from the line of James Quigley from Goldman Sachs.

I got 2, please. So firstly, just to try to triangulate your guidance. You're suggesting low single-digit growth in International Operations. And again, that would [ further ] suggest minus 20% also in the U.S. So could you give us a sense of how this breaks down between volumes and price at a high level, please, particularly given that your key competitor suggested low to mid-teens pricing on a global basis this morning?

And the second question, on the Medicare unlock, how are you thinking about the potential speed here? Again, your competitors suggest the unlock could be pretty fast starting from July 1. But the guidance certainly suggests slower uptake here. So what are the basis of your assumptions around the speed of unlock?

Thank you, James. Two questions, both for Karsten.

Thank you, James, and thank you for listening in and posing your question. As to the guidance first, with the International Operations delivering 8% growth in the fourth quarter of last year and around 10% in the second half that's the run rate we are entering 2026. Then adjust for LOE in specific markets on sema, then you get to mid-single-digit growth for International.

And consequently, based on our guidance, then the residual leaves the U.S. growth to be in the teens in terms of sales decline. So that's the key factors. I would say the U.S. decline is driven by price declines, and it's driven by both investments in market access being a key driver built off the cash channel in the U.S. at a different price point, so channel mix and then the MFN impact where we, a few quarters ago or 1 quarter ago, announced that it will have a low single-digit impact on group sales, so meaning roughly double on U.S.

So the key notion is, of course, with these price reductions, to what extent are we then able to convert that into expanding volume reach and volumes in the marketplace. It's early days. We have built assumptions in. Clearly, we've looked at the first 4 weeks of the Wegovy pill launch, where we're very encouraged, as Dave showed just before. And the same on the Wegovy injectable, we're actually looking at to the tune of 30% of the Wegovy injectable scripts now being cash-driven. So also building that. So we are seeing a volume response to the lower prices. Exactly how the year pans out? It remains to be seen because we have a number of variables at play. But net-net, it is price declines that drive U.S. down.

On Medicare and impact from Medicare Part D and the MFN deal, we do expect that we'll have a benefit starting around mid this year, having Wegovy reimbursed in Medicare Part D and hence, being available for seniors under reimbursed setting. We have included that in our guidance. But at this point, given the lag times of educating physicians and physicians and admin staff understanding how it works and for patient to access that benefit, it will be a gradual ramp with limited benefit this year and a bigger benefit into 2027.

Your next question today comes from the line of Sachin Jain from Bank of America.

I've got 2 more on guidance, if I may, Karsten, and apologies. So maybe framing James' question slightly differently. I asked the pushes and pulls question at the third quarter, and not without misspeaking, but I think you roughly phrased as underlying growth less 3 sets of headwinds or roughly low single digit each. So I'm just trying to understand between 3Q and the guidance today, what shifted you from that sort of low single digit to now minus 5% to 13%. So the mid- to high single-digit delta versus consensus, how much of that is volume and price? And within price, what's the new component, it seems to be cash channel?

And then second, more specifically, a question I had frequently overnight is what needs to happen for you to achieve the bottom end of your guidance? Multiple investors trying to work out how conservative that is, particularly around your oral assumptions being driven by injectable switch.

Thanks, Sachin. Also 2 questions for Karsten on guidance and also on the sort of push and pull between high and low.

Yes. Thanks for these questions, Sachin. And as you recall, I didn't guide for 2026 at our Q3 call. So that's a starting point. And as we also note in our current release, we base our guidance based on the latest trends we see in the market. So the guidance we put out now is based on, of course, the run rate we left 2025 with. So Q4 performance, as I alluded to before, and then whatever triggering events and expectations and assumptions around the future we are building in. So those are really the key points that we built in.

What have we known -- what do we know more today compared to Q3? We have some more nuances on the run rate in International Operations. You see the 8% growth in the fourth quarter. And of course, some more market intel on more specific and detailed pricing and reimbursement choices in some of the markets there. And then in the U.S., what we know there beyond the Q4 closeout was -- is really about, I would say, the Wegovy pill uptake in the first month, as Dave alluded to, which we're very happy with, and then the Wegovy injectable cash business and the response to the lowering of the initiation prices to $199. So that's really kind of the key fundamental changes since 3 months ago.

High, low?

Thanks, Michael, for reminding me on that one. It's important to remember, and we've been experiencing this for some years now. The obesity market is just significantly more dynamic than most other markets where it's much more stable prescription trends through normal GPs. So the macro variable that can both be positive and negative is the dynamics in the obesity market. It's -- we are not concerned about the expansion of the market. We saw it more than double in 2025. So we're very confident in continued expansion of the market space. But the variables I'm alluding to is really, of course, as always, competitive dynamics, as always, gross to net dynamics that are being forecasted with a lag. And then also the sourcing dynamics and channel dynamics impacting pricing and volume of Wegovy pill and how that is impacting both Wegovy injectable, but also how a competitive launch plays into all of this. So I'd say it's classic variables, but it's in a very dynamic market segment.

Your next question comes from the line of Richard Vosser from JPMorgan.

Just one follow-up, thinking about formulary access for Wegovy. You highlighted the access for oral Wegovy in a pill. But how are you seeing and how you're thinking about that access in the commercial channel this year? It seems like maybe employers would be incentivized to maybe reduce access given the availability of products in the cash channel at lower prices. So just thoughts on that and how that might affect the mix and volumes in that channel. And maybe a second question, just compounder volume. Obviously, a very strong oral launch, and you're saying new patients. But any evidence that those lower prices are styming the compounder volume and any idea that you're taking share using the oral from compounders?

Thanks, Richard. So 2 questions for Dave. One on the formulary access and also the other one on compounder.

Yes. Thanks very much, Richard. On the injectable side, we see relatively stable access. And of course, we have discussions every year to maintain that level of access. And as you've heard us talk about before, we're very interested in reducing that friction and making the experience easier for patients. We did have some states that have decided to not cover AOMs, for example, California is a big one. But I will say that with the lower prices that are available today, we will continue to reengage with those states with the hopes that we can increase access in Medicaid as well.

On the pill side, what you heard me mention is we've actually seen some positive progress in just the first month. We started out the month January having CVS covering it right out of the gate. And then we quickly were able to add Prime, Optum and Anthem, and we will continue to build that over the course of the year, expecting that there will be both plans as well as employers that will be interested in covering the pill.

On your second question about compounding, we haven't seen a change yet. It's early days. The compounding market, what we're seeing right now is what we would consider relatively stable. I can tell you, as of this week, we have over 170,000 people that are on the Wegovy pill, and most of that is self-pay. And we get daily feeds because of the way that we went to market. And so we certainly expect that there could be some switching that's coming from compounding, but it's a little bit early to tell, and we don't get any of that longitudinal data, but we'll certainly be researching that as more data comes in.

Your next question comes from the line of Peter Verdult from BNP Paribas.

Peter Verdult, BNP. Two questions. Just firstly, on Martin, I realize you're not going to change the messaging on REDEFINE 4 at this juncture. But can you at least remind us on trial design? Was flexible dosing allowed as we saw in REDEFINE 1? Or is it more fixed in nature for CagriSema and tirzepatide in REDEFINE 4? Basically, any major trial differences we need to be aware of when we compare REDEFINE 4 to 1?

And then Karsten, Mike, forgive me going back to guidance, but I'm not going to ask you to go line by line every assumption. But just the spirit of the guidance you provided, I mean, is this reflecting sort of genuine concerns on cannibalization and competition? Or are you simply starting the year as conservatively as you can to finally prevent this persistent earnings downgrade story from continuing through 2026?

Thank you, Pete. So two questions. First, to Martin on REDEFINE 4. And then second to Mike, on high-level guidance dynamics.

Absolutely. So REDEFINE 1, you're absolutely right. We basically have no new news. So we're not going to change the story. REDEFINE 4 is comparing CagriSema and tirzepatide in an obese population on weight loss testing for non-inferiority first, followed by superiority testing. The dosing was similar to REDEFINE 1. As you recall, we took some learnings from REDEFINE 1, including that we needed to do longer studies. And I think we maintain what we've always said for REDEFINE 4, but we also are looking forward to REDEFINE 11, where we'll see the full weight loss potential of CagriSema.

Very good. So Peter, I think I'll start by saying we have all acknowledged how volatile and dynamic the obesity market is with a lot and lots of moving parts. The way we guide is we discuss and talk, of course, to our operating units. We take a look at the macro trends and we put the latest information we have in place. We start by looking at the last year's finish and the run rate to that, especially Q4, but even more so granularly looking at the 3 months within the Q4 data that we have available. So that's kind of a starting point.

Then we basically go ahead and try to see the new data we have available, Karsten alluded to it. We have 4 weeks of pill data. It's incredibly encouraging, and we consider that. And it's in the guidance basically. Of course, not fully knowing what's going to happen in the next 11 months, but we make some good assumptions around that. Then there are things that we have actually previously discussed with all of you. Think about the LOE in International Operations. That hasn't really changed. It was there before. It is now. We have not seen the impact of that yet. It will come into place starting from Q2.

And so will some of the other things on the upside that will come in, in Q2. We just touched upon it, Medicare. Medicare is a group of people that we would love to provide GLP-1 products to, but we haven't started yet, and it's going to basically get going in the second part of the year. So we make assumptions around that. We put the midpoint and our own targets, and then we give it the plus and minus the 4 points on each side. And that's how we've done it in the past. That's how we've done it this year.

Your next question comes from the line of Mike Nedelcovych from TD Cowen.

I have 2 questions. My first is on Wegovy pill supply. Given the strong launch of Wegovy pill, is there any risk of supply outages in 2026? For example, if adoption persists at this current high level, could Novo service that demand through the end of the year with its current capacity? And then my second question is on CagriSema and REDEFINE 4. Martin, I have to admit your response to the earlier question struck me as somewhat ominous. Why do you think we will have to wait for REDEFINE 11 readout to see the full weight loss potential of CagriSema? Why could it not be revealed by REDEFINE 4 given the changes that were made to the trial?

Thank you very much. Two questions. First, to Mike on the Wegovy pill supply and the second one to Martin on both REDEFINE 4 and REDEFINE 11.

Yes. Thanks very much, Mike. Over the last period, on a number of occasions, I have spoken to how confident we are with regards to the Wegovy pill supply. We basically have said that we launched the pill in the U.S. at a time where we will be confident enough to know we will not run into supply situation anymore. We have seen an incredible uptake, I would say, in the first month. And today, I will reaffirm to you that we feel incredibly confident that we will be able to supply the U.S. market.

Very clear.

Yes. On REDEFINE 4, we always have to think about when we do amendments to ongoing trials, we cannot fully guide what will happen. We can extend the study. But we also had to acknowledge that the learnings that we took from REDEFINE 1 was in part, we needed to do longer treatment duration. But it was actually also paradoxically in part to drive even more flexible dosing, securing that we actually get more patients to the highest target, but using longer time. That we cannot change in REDEFINE 4. We have optimized that in REDEFINE 11.

So the trial duration, we have tried to optimize in REDEFINE 1. But in REDEFINE 11, we have taken all the learnings on titration, what we call flexible titration. I'm not sure I still like the word, but what we call flexible titration and put that to use in REDEFINE 11. And we can already now see that, that does really make a difference to the patients and how they act in the trial. So I still have a lot of optimism on REDEFINE 4, but I think the full weight loss potential, we will only learn when we do the full trial duration and the flexible dosing that really will drive patients to use CagriSema in the optimized way.

Your next question call from the line of Harry Sephton from UBS.

I have 2 on the Wegovy pill, please. Just want to start with what your expectations are for the sustainability of the Wegovy pill demand. If you wouldn't mind, is there any evidence from Novo's Rybelsus experience that points to any variation in the stay time on therapy versus the injectable? And how you think about also the demand for the pill through the competitor orforglipron launch? And then my second question is on the economics of the Wegovy pill. So given the much lower price point and the much higher API demand, how does the gross margin contribution of the Wegovy pill compare to the injectable?

Thank you very much, Harry. Two questions. The first on the Wegovy pill demand and dosing to Mike. And then the second one around economics to Karsten.

Thanks very much. When you think about the sustainability of a growth and demand, then 2 things comes to my mind. One, of course, competitive and competitive pressure as well as how much you push yourself into doing something despite the competitors. Let me start with the first one. We have gone all in. This has been the best launch, partially also because we have really put in all the activities and the promotions that we could think of, not least, of course, what it was alluded to earlier on, the partnership with all of our e-Health players being available in 70,000 retail pharmacies today has been partially due to that -- has been partially the reason behind that incredible uptake.

But then, of course, the question comes, what happens after competition arrives? Can you uphold this? Is it sustainable? I would say that the last 2 years has taught us something very specific with the obesity market. It has taught us that the #1 criteria for a patient picking up anti-obesity medication is the magnitude of weight loss. And when you take a look at this, then you realize based on our latest trial, we have shown that when you take the drug, then Wegovy pill gives you 16.6% weight loss in addition to all the CV benefits and the great stuff that it has, with 16.6% weight loss.

We've also read the data from our competing product, and we have seen that they are at 12.4%. If you round those things up, then you get to 17% and 12%. If you ask pretty much any patients and certainly ask me, which one would you rather take losing 17% weight loss or 12%, I know my answer. And we have seen the answer from 170,000 employees coming on very quickly, recognizing that this is not just a pill. It's a peptide. It's a large protein inside a pill that gives you that incredible efficacy. And that has been giving us a lot of optimism, and we will continue, of course, pushing this through and promoting it. Don't be surprised if you've seen the big game on Sunday, you see us visible. And we will basically make sure that we'll do our utmost to make this pill a success.

Thanks, Harry, for the manufacturing economics question. On gross margin, the short version is that the gross margin on the Wegovy pill is below that of the Wegovy injectable, but it's important to know that it's lower on gross margin level, but it's still an attractive gross margin. So we are all in pushing the pill. And of course, the overarching intention is to expand the markets and not cannibalize from our own products.

Your next question comes from the line of Thibault Boutherin from Morgan Stanley.

First question, just on Ozempic and the timing of implementation of the MFN price. When does the MFN negotiated price kick in for Medicare and Medicaid this year? And is there any associated volume uplift given it's already covered? Or should we expect market share loss to sort of erase the benefit? And then just the second question, I guess, for Martin on the profile of Wegovy pill. Just in order to understand the adherence, could you help us with what happened to a patient if they miss the pill for a day or a couple of days? How does that impact efficacy in terms of weight loss? And then similarly on tolerability, if a patient is in the highest dose and for some reason, miss a few days of pill, can they go back and resume on 25 milligram? And what -- how do side effects look like?

Okay. Two questions. First on Ozempic and MFN for you, Dave. And then the second question for you, Martin.

Yes. Thank you, Thibault . With respect to Ozempic, as you know, we have Medicare coverage right now in the diabetes. And so with respect to MFN as well as MFP. That's more of a 2027 event. Of course, we did make Ozempic available in self-pay. As I mentioned, we're seeing about 8,000 scripts a week now in self-pay for those patients that don't have coverage. But the MFN and MFP is more of a 2027 event.

Yes, absolutely. On the Wegovy pill, we do know that in general, when patients are on chronic treatment, sometimes they skip a dose. It is important to remind ourselves that semaglutide is semaglutide and the half-life of semaglutide once in steady state is very long, basically, as you know, also in the subcutaneous state, allowing for once weekly doses.

That basically means that when you are on a stable dose on the Wegovy pill and then you skip a dose, it doesn't have a huge impact on your blood exposure in that period of time. And you can also then reinitiate at the 25-milligram dose without experiencing any untowards effects. So from that perspective, semaglutide is semaglutide, and we are benefiting from the long half-life of semaglutide also in the oral delivery. Other orals would have with shorter half-life a much different profile because that will both impact the potential efficacy, but also the potential tolerability if you skip 1 or 2 doses.

Your next question comes from the line of Carsten Lombard Madsen from Danske Bank.

In terms of CapEx, where again this year guide for a relatively high CapEx level in terms of billions being spent. Can you confirm that the API build-out is on track because it feels like this entire program is taking longer and is being much more expensive than what we expected some years ago. And secondly, on the high doses Wegovy approval, which we hopefully see soon, also, will you be launching immediately? Can you confirm that? And in which type of pill will you be launching?

Thank you, Carsten. And first, on CapEx to Karsten and then the second question on 7.2 to Mike.

Yes. Thank you for that question, Carsten. And as I said earlier on, then we are moving downwards in terms of CapEx. This is the first step down, and then we expect to see a steeper slope in the coming years. And it really links to finalization of projects approved in prior years. As it is with projects, some are ahead, some are behind. But in the broad scheme, we are on track. Specifically for API, we do expect to have some of the new major API facilities online already this year and more to come in the coming years.

And Carsten, with regards to the 7.2 Wegovy high dose, then as you know, we have filed in December last year under the CNPV voucher program. And we have announced that we should expect the approval, hopefully, in this quarter. As soon as we get the approval, we are ready to launch. So we will not sit on that regulatory approval. And we will go all in again because I think this is really, really important that the world a little bit understands that medicine is dosed differently. And depending on how you dose things, you get different effect of it.

And right now, semaglutide at 2.4 milligram is giving us 15%, 16% weight loss. Tirzepatide at 15-milligram dosing gives you 20%, 21%. We have shown in a step up that when you increase the dose of sema to 7.2, you get very close on par with tirzepatide. And I think it's actually very important that the world gets to know this and then they can judge that on top of on par weight loss, you have also CV benefit, kidney benefits and liver benefits and then people can pick and choose which option they want. So it's very important that we go all in with that, and we're planning to do so. And we will actually -- I think there was a question, and we will launch it in the same type of devices that we currently have available to start with.

Your final question for today comes from the line of Simon Baker from Rothschild & Co.

Two quick questions, if I may. The first one really is just going back to the guidance question that's been repeatedly asked. Conceptually, would it be fair to say that because you have high visibility on price impact and low visibility on volume uplift. That is one of the things -- key things that is reflected in your guidance. And the sort of second part that's related to that. I just wonder if you could update us on your assumptions for generic competition in IO, specifically Canada. The reason I ask is we understand that all of the semaglutide generics have had notices of deficiency slapped on them by Health Canada and the expectation is they will not resolve until the midyear. So generic semaglutide in Canada is a 2H rather than a 1H phenomenon. I'd be interested to get your thoughts on that and the extent, if any, to which that's reflected in the guidance.

Two questions, more or less boiled down to one on the guidance dynamics again, Karsten.

Yes. So Simon, thanks for these questions. Whether -- how -- we detailed build it, I would say for mature reimbursed brands, I think they are very mature established trend lines for volume trends measured as TRx, and we have a good feeling for the prices being contracted, et cetera. So for our mature reimbursed brands, that's -- I'd say that's reasonably straightforward. For where we see the uncertainty is, how can I put it in the self-pay type channel because the price elasticity in the self-pay channel is something that we are still exploring.

And as Dave was covering before, then we've seen a fantastic uptake of the Wegovy pill here in the first 4 weeks. But we also know that obesity self-pay is a super dynamic segment. So exactly how that works across the year, to what extent there are seasonalities, et cetera, stay time, sourcing, cannibalization, competition. Clearly, there are uncertainties there. And we put our best assumptions in. And they -- it can go both ways. We can both have an upside and a downside, and that's why we work with the range.

For Canada specifically, and in our guidance, as we said in prior quarters that sema LOE in international markets will impact group sales by low single digits. Canada is the biggest contributor. And of course, we put in assumptions around timing of generic launches, approvals and launches. We don't have detailed insights into the status of those files and remediation of these notices of deficiencies. But obviously, time is a key variable in terms of impact. I think the direction of travel is the same, but there could be both an upside and a downside to our guidance depending on the pace of approval of generics in Canada. So remains to be seen.

Great. Thank you, Karsten. Thank you, Simon. This also concludes the Q&A session. Thank you for participating, and please feel free to contact Investor Relations regarding any follow-up questions you might have.

Before we close the call, I would like to hand over to you, Mike, again for the final remarks.

Thank you very much, Michael. I want to start by thanking Ludovic and Dave for all you have done for Novo Nordisk over the many, many years. I also want once again to welcome Jamey and Hong and stress that I'm looking very much forward to working with both of you.

2026 will be basically a year where we will face some headwinds, especially on the back of the price declines, and we have shown that in our guidance today. But I'd also like to say that price reduction in some ways, is our investment for the future and for capturing more patients. Perhaps no other company better than Novo Nordisk is geared in improving health at scale within the field of diabetes and obesity, and we're ready to do that. And I believe much stronger than with affordable prices, we can get to those higher volumes faster.

We are looking very much forward, of course, as we go forward to share more information with you, not least about the continuous uptake of the phenomenal Wegovy pill success that we have seen, but maybe also much more exciting readouts and regulatory milestones throughout the year across all of our therapy areas.

With that, I'd like to thank all of you guys for joining us today. Thank you.

Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.

Welcome to the Novo Nordisk session at the 26th JPMorgan Health Care Conference. I'm Richard Vosser, European pharma analyst at JPMorgan. And it's my great pleasure to welcome the new CEO of Novo, Mike Doustdar. He's been about CEO for about 5 months and has been spending that time looking at the strategy, revising the strategy. So he's going to go through a few of those thoughts that he's had on the business with a few slides, first of all, and then we're going to have a nice chat.

Hope so.

So Mike with that, over to you.

Thanks so much.

Welcome.

Thank you very much. It is 5 months only. It feels like 5 years, believe it or not. But let me, I think, start with after showing you the forward-looking statement, talk maybe into what have you changed, if anything at all on the strategy. And then I think that will set the scene for some of the questions that you may want to ask me.

Novo has a 103-year history. And then of course, we are mainly synonymous for doing a couple of things, but doing it better than anyone else. That has not changed. I think if you take a look at the left-hand side of the slide, you'll see that the company has always been about diabetes and remains so. We have more recently moved into the obesity space innovating in that front, and that is also remains very much intact.

Then, of course, when you take the 2 large chronic disease of diabetes and obesity, you recognize that patients suffering from these conditions often have many other issues, comorbidities related to them, chronic kidney disease, CVD, MASH and the likes.

And we have been moving into these adjacencies the last few years more and more. And then we will continue doing that. But with one fine difference, I would say, and that is that the starting point for us will have to be focused around a patient, that's either suffering from high blood sugar, so diabetes or high weight obesity. We will then look into our own R&D shop and try and see what can be built for these patients. Often, the assets we will explore do more than one thing. They will do more than just reduce your weight or reduce your sugar as we have seen with semaglutide and many other assets of similar type. And that's perfect.

We will go into those adjacencies once that happens and, of course, create the indications for them and sell them eventually. But we no longer will try to rush in, let's take CKD as an example. Into CKD if it does not touch an obese patient or one suffering from diabetes. So if I click now, you'll see some of those circles go away. So the difference between actually the strategy before and after I have joined is simply that some of those circles became half circles. And that is simply taking the company back to the DNA that we have. There are a lot of companies here, not least the one you were just speaking to that have a DNA of diversification, and that works very well for them.

For Novo Nordisk, we have realized that we are really good when we focus. So the focus, again, will go back to obesity and diabetes. And for those who then will get a little bit nervous, just a couple of things. I'll remind them that those couple of things have 2 billion people suffering from those conditions. So this is a very, very large unmet need where we and our competition today are only touching the surface when it comes to treatment of these individuals. We have the rare disease business, that's the yellow part in the business, and then that's almost like a biotech company running within our own company, and we will, of course, continue doing that. But we will cater to about 2 billion individuals that are suffering from diabetes, obesity or overweight. The numbers are very large.

And then when you look at the right-hand side, the most right-hand side of the slide, you see that although the population size is very large, the number of the people who are right now getting prescriptions related to these conditions are still very small. So there is a very long runway for this. And knowing that we probably have some of the best scientists in these areas, we certainly can scale second to none in these areas, we have the commercial expertise, again, better than most, it gives me a lot of hope that there is a bright future ahead of us. So that's, I think, this one.

And then into maybe an immediate action that people are a little bit wondering about Novo. After a difficult 2025, what are we going to do? Well, we're going to accelerate our commercial execution. We need to do a couple of things. We need to bring the higher dose of Wegovy into the market, 7.2, and we can discuss why that's important as we go forward.

We have seen that, especially within the field of obesity, there is a -- this acts a lot more as a consumer business than a traditional medication. So the direct-to-patients, I would even dare to say direct-to-consumers and cash channels and mastering that is something high on our agenda.

We definitely feel that we have a phenomenal pipeline. But when you're dealing with a market size of 2 billion people, you're never satisfied. And we are not. So we are going to continue strengthening our R&D pipeline, be it again, using our own internal capabilities or through business development and bringing several diabetes and obesity, late assets into the market, while, of course, developing the early assets into Phase III. [ASAP] is the second pillar. And then, of course, we're going through a bit of a transformation after last year, making sure there is financial discipline on the back of lower growth rates for the time being, reduced prices, which are going to impact us during 2026.

Means that we need to be financially disciplined and make sure that we continue, of course, investing where the investments are needed while evolving our organizations around some of the new capabilities I just touched upon. So that's, in a nutshell, our short-term priorities.

Awesome. And maybe you touched on the difficult '25 and on commercial execution. So when you've analyzed '25 what are you going to do differently? What did you see there? And particularly in the U.S.?

Yes. So first, I'll come up with not an excuse, but a bit of a defense on 2025. '25 was a difficult year. It was difficult for Novo Nordisk, has been difficult for our shareholders. So I will not belittle that one bit.

But I will say, it's the curse of a leader. We went into obesity some 30 years ago. And at the time -- and up until more recently, I would say, many of our peers that have sat in this stage now or will sit here in the future were making fun of us. They basically thought obesity is not a disease. Obesity, there is no money in it. Obesity is something that should be left to individual patients to get on with it, get on with your lifestyle, get on with your exercise and diet and kind of -- this is not for pharma to go there.

I am really happy that I worked for a company that became the voice of 2 billion people and created a scenario that today pretty much almost every participant of JPMorgan is getting excited about entering this field. That's great. That's fantastic. But it also is great and fantastic if we can deal with it and compete with them. Not if we create a scene for everyone else and then leave it to them.

So that basically ended up in '25 being a critical year for us to recognize this. That we're no longer on our own, and we need to hurry up and it cannot be like the previous couple of years where we were left alone just because we had a head start. And through that leadership, of course, number of things. On the hindsight, when I look back, we could have done better. And it's easy for those who are following us to correct our mistakes and make sure that they do a better version of it.

So our job is this year to recognize what were some of the things that we could do better. I touched upon it in my last slide that mastering this cash channel in the U.S. is really, really important. When we came into the registration and the promotion of Wegovy initially, we were told that 55 million of the 100 million Americans that suffer from obesity are covered by insurance. That sounds really good, especially I was responsible for the rest of the world, ex U.S. In my previous job, I didn't even know what insurance means, in that part of the world.

So to hear 55 million people have insurance was really exciting. Only then to get into the details and realize that's a bit theoretical. All the pre-authorizations, the obstacles that the insurance companies have created for many of these millions means that it's not that they're going to be able to get their medicine just because they're obese and/or have insurance. That meant that there had to be a different channel, the cash channel, the e-health channels, a lot of new players, not least the compounders were created on the back of that need. We need to really make sure that now we master it.

We have relaunched our NovoCare Pharmacy on the back of the, what you call, the Wegovy pill. I'm very optimistic about that, but we also realize that that's not enough future. We need to meet the patients where they are. So we have gone into a massive amount of partnerships with Ro, LifeMD, Amazon, WeightWatchers, Costco and really making sure that we make our products available. And then the best example of that is the recent launch of the Wegovy pill because the other thing that we have realized is that we need to expand the market. Right now, we are being judged how many patients are being switched between us and Eli Lilly.

And while that is an important element to not belittle again, us and Lilly combined have probably 10 million, 15 million patients. What about the other 85 million, we need to get to them. And a big part of those people, by the way, don't want an injection. They're waiting for the pill. So going into expanding the market has been very, very important. And again, coming up with better versions of semaglutide and preparing ourselves for the next wave of the battle has been some of the learnings from '25 that we're taking into '26.

You touched on the pill. And we've seen -- at least I've seen the cause circling Union Square...

Yes.

Which look very nice. But you've got a little lead to another player, Eli Lilly with orfo, what can you do to establish Wegovy in a pill ahead of them coming?

Well, first of all, if you allow me to say that I don't see it as a little lead. I think if you're thinking about the time element of it, probably it's a little. Life is longer than -- the distance between us and Lilly's launch. So that you could say it's not what's on my -- top of my head. Actually, our company has done incredibly well in diabetes, always being second to market. So this is a luxury being first in some interesting way.

But I put the emphasis of the lead on many other elements of the pill. When we decided to go, not the small molecule path, but the peptide and protein path, when it comes to the Wegovy pill. Again, there were a lot of skeptics out there saying that this is just not possible. Scientifically, this is impossible to swallow and eat a peptide and not get it dissolved by your gut enzymes before it gets to the bloodstream. We proved everyone wrong.

Now the benefit of that is that we have a very potent drug that if you take it, you reduce your weight by 16.6%, which is equivalent of its injectable sister Wegovy. To the best of our knowledge, today, no one has been able to show that in any Phase III clinical trials. That's a big leap at a time where the magnitude of the weight loss is trumping everything else. A few percentages up and down, we have seen that it matters. So it should also matter on the pills.

Then when you look at it from a tolerability point of view, when you look at our clinical trials, some 7% of the trial participants left us due to tolerability issues. When you look at my competitors, it was around at the highest dose from 22% to 24% that left.

I will make sure that, of course, I take that with some sort of excitement. And again, in the definition of your leap color, that's a big difference between 7% to 22%. So all in all, I think we have a phenomenal drug at hand. And then we have brought this with the Wegovy label, which is really, really important because it is Wegovy. So in addition to all of that, we have the CV benefits in there -- in our label. I think this is going to be good.

Some people talk about the fasting requirements for the Wegovy pill that other drugs don't have, orfo doesn't have. What would you say to that?

Good question. For sure, if I was sitting on the other side, I will try to drill on that one. That's the only thing I can think of one can drill on. And I welcome that. I would say my answer to it is a couple of things. First, we have about 1.5 million patients to the last count I had, on Rybelsus, which is the same drug in the diabetes segment. And we have not seen this being an issue with 1.5 million people. So I beg to think that this should be the same with Wegovy pill.

Having looked at also this a little bit more broader, I looked into -- if you have a thyroid problem, apparently, all drugs with thyroid have that issue, and that's also not a problem. So while I understand if you're sitting on the other side of the table, this would be a good -- a small talk to have. I would say, we have not seen evidence of it in the market. And then, of course, if you really want to dig deep into, he said, she said is that, I have no idea what orfo's label will look like and time will tell.

But I have looked into their clinical trial protocol. And in the clinical trial protocol, I noticed that, if you're taking a specific type of a statin, then you have to wait 2 to 4 hours to take orfo. I don't know about you, but I know how many obese patients take statins.

So we have to take a look and see where the market and how this will be planned out. I certainly expect, of course, my competitor to find things in my profile. And my job is to make sure that I speak to the facts.

And when we think about orals versus injectables, do you think that the orals have a cannibalization effect on the injectables impact the injectables? Or do they sort of broaden the market or address a different segment?

I think to a very large extent, that will broaden the market. I can speak to -- but I think there are some exceptions to it. Let me give you a couple of anecdote and maybe personal stories.

My father in law has been very much waiting for an oral, even though he has been needing and wanting to take a GLP-1. The reason he actually did not want to go for Wegovy has been, he didn't feel like he should get an injection. I think there's a societal taboo on injection.

I told one of the journalists yesterday that if I would -- right now, while I'm talking to take a pill, a headache pill and take a sip of the water, you will not tomorrow morning, remember I did that. If I pull my shirt up and start injecting myself with a shot of anything, believe me, for a while, you're going to remember it. I think that's an important societal understanding that we need to have and realize that this will help a number of people get to where they need to go. And again, efficacy here will not need to be compromised. So it's really, really important. And they can take a pill instead of a pen.

There's also the element of refrigeration. I have a friend in Montana, who basically is -- my competition's drug and mentioned to me the other day that wants to switch to Wegovy pill. And I have to say I was surprised. Why do you want to do that? And I first thought, it was just because he's my friend. But that was not the case. This gentleman travels a lot. And he's simply too nervous about all the time having kept the medication in cold chain. So wants to go with a pill format. And I think there will be some of that. I don't think it will be a massive cannibalization of it. But I think, to a large extent, you will get people coming in expanding the market.

On the injectable market, you touched on semaglutide 7.2. What's the importance there? What does that bring?

It's a really good question. And it's a learning, Richard for us. When we came into designing and figuring out, okay, what should we do with semaglutide. We had, of course, pioneered the field with Saxenda, 5%, 6% weight loss. And we came to conclude that with 2.4% -- 2.4 milligram of semaglutide, you get to around 15%, 16% weight loss. That's really good. At 3x Saxenda, why should we put more stuff into the pen.

And our company is also a bit conservative when it comes to these things. We really feel that we should not overdose patients unless -- it's just -- so we thought 2.4 milligrams, 15%, 16%, 3x Saxenda, fantastic. We went in that direction and the product came out. And we then did a lot of studies around heart, kidney and took it from a very much diabetes muscle memory that we had and developed semaglutide and brought it to the market.

I cannot speak to what my competition has done. I can only imagine that when you are second to market and you're designing your trials, then you look at whatever is existing. So let's assume that Novo Nordisk product has 15%, 16%, and you want to get to 20%, 21%, then you tell yourself well, I've got to go all the way up to 15-milligram of my product to get there and then you design your trials and then you show that you're efficacious.

The world, in my opinion, has a little bit misread this. The world has read this as Saxenda was the first generation of the product. Then it was Ozempic, Wegovy semaglutide second generation. And the most modern thing in the market right now is Mounjaro and Zepbound as the third generation.

My humble nonscientific version of it that medicine to a large extent, often is dose dependent. And you just dial little bit higher, you get more effect. At one point or the other, you have to stop, but there is maybe a long runway before you do that. We did a test on that, and we realized that with step-up trial that we did, if I could say, in quotations, only 7.2 milligram of semaglutide, we're able to get to 20% weight loss. And since the world is putting the weight loss impact above and beyond everything else, heart and kidney and liver and god knows what. Then we have to changed the narrative back that, at the right dose, molecules are giving the same weight loss.

So we changed that rhetoric and then come back and say, there could be something in the magic sauce of semaglutide that in addition now to 20%, 21% weight loss, we're also having cardiovascular benefits and the other benefits that so far has not been proven elsewhere. So then maybe the current market perception that is, in our view, imbalanced, will get a bit more balanced again.

On the injectable market overall, you touched on the price changes that came with the White House agreement and some of the price changes that you and your competitors have been making. What do you think that does to the market? Can we see price elasticity here? Can we see volume increases in different channels?

We have to -- is that simple -- I mean, it's business 101 that you reduce the price, more people start to afford it. But you have to find that sweet spot. And that's what, of course, we have been trying to do with both the negotiations with the White House as well as, of course, our own channels. And looking at our competition, not least the compounders, I'd like to think actually that this 1 million-plus people that went into knockoff products sold by compounders did not want a knock-off product, but they felt like they can have afford $199 and they cannot afford $1,300 box per month. That's why they went there.

So we have considered that. But having said this, I also tell our investors that it's a difficult decision sometimes to make that because when you have a very large base patients on a price and you decide to have the price in the hope that you get more than double the volume to have some gain, while mathematically, that can pan out correctly and as you saw with 2 billion people and only 10 million, 15 million on the product, you see that is the right strategy. The question is, will you accept -- will your investors accept a short-term pain because you know that the prices goes down on one day with the signature between you and the President, but the volume doesn't double on the morning after.

So that comes back to the dialogue and the communication and the transparency that you can have with yourself and your investors to basically say, this is the strategy. It's impossible for us to get to 1 billion or 2 billion patient pool with the current prices. We have to go there, but there is a short-term pain you have to stick with me during the bad period.

And a lot of that 2 billion are ex U.S. So maybe we could just touch a little bit on the IO opportunity and how you see that developing from here? And there's been some supply constraints that have maybe held you back. There are generics coming. There's a lot of moving parts. Maybe you could just talk a little bit about that.

Yes. So I'll start with the part of the question you mentioned, the volume opportunity is in international operations. That's where the world's population is. That's where longer term, of course, both us and our competition has probably built all the factories and the scaling to cater for U.S. as attractive as a market, it is and will remain, from a volume perspective will be the smaller player of the 2 sides of the Atlantic. So that, again, gives us hope.

Now the strength and the good thing about Novo Nordisk is international operations of Novo Nordisk has always been one of its stronger footprint. We have a unit and affiliate in some 80, 85 markets, where we have our own people on the ground, our own management. And that's a competitive advantage because the market knows us.

On the other hand, of course, again, we have to recognize that obesity world is somewhat different. Even you can, without any office come and put on an online shop from a different market and sell your products, so we have to build those muscles. And we will continue, of course, not getting complacent on the fact that we are historically strong in international operations and make sure that the new things that we need to build is also built in IO.

Short term, again, we have headwind in international operations in 2026. We'll not go into all the details of it because we are in a quiet period right now, but I will actually say what my CFO has told the world that because in a number of markets, we have lost exclusivity at this year, we will get competition. And when you have a very high market share, competition will take some of that share away, we need to focus on the market expansion and then again, realize that, okay, we will maybe have a difficult year but a bright future still. We also, of course, have our main competitor, Lilly gearing up and doing well in a number of [TIO] markets.

And we need to make sure with some of the tools I mentioned, be it the pill or the higher dose or new products, compete fairly with them because they're a worthy competitor. So that's the strategy.

Second priority on your slide was strengthening the R&D pipeline. So what are the key elements you're looking to improve here? What are the must wins?

Yes. A very good question. So let me break it down into late stage and then early stage. And both are equally exciting. And then, of course, we can talk about business development on the side, if you want.

We have, of course, the approval of CagriSema, that's semaglutide and amylin in a fixed combo coming up sometime late this year. Super exciting.

The amylin biology, I think just excites a lot of people here, and it's really nice to see that we are one of the first, if not the first, that's kind of going to be able to launch a meaningful product with that. So that is exciting. And then, of course, the other asset that right now is going to Phase III and soon after will, again, we will get excited after CagriSema, it's amycretin. So those 2 are the ones we speak a lot, I would say, initially when we think about late assets.

Now within those, there are going to be a lot of indications that is going to be exciting, different dosing, a lot of the learnings that we have learned from semaglutide will bring it up there, make sure that we don't underdose some of these things and have the right dosages of them, I think. Then we also noticed that take CagriSema initially, I would say 2, 3 years ago, it was CagriSema. Now we're talking about CagriSema as one product but cagrilintide or cagri mono as a whole different product.

And we noticed that, of course, the world is not going to be obsessed continuously on only the impact of the weight loss. So that 23% is better than 21%, which is better than 20%. That's for one segment of the society. There are a number of people that are happy with 12%, 13%, 15% weight loss. If the tolerability is almost like placebo, which we think we can actually achieve with products like Cagri mono. So that becomes incredibly exciting for a segment of the population as a stand-alone product, and we are into Phase III of that, and that's super, super exciting, I would say.

And then if I pivot into early phases, and you will probably hear more of this throughout the year, so I will not have any breaking news here, but expect us to come with many, many more first human doses. Now that we have the focused strategy of diabetes and obesity only, we are able to show and prove that we can actually go much earlier into human dosing with many great assets.

Maybe just a little bit on CagriSema in detail. We've seen obviously, 18 months ago or so, the REDEFINE 1 data, et cetera. And we -- what do you think the profile of CagriSema today brings to the market for you?

Yes. So a couple of things. Again, I think the amylin biology is really interesting. I would say we have so far clocked to 23% weight loss, which is today, if the product was out today would have been the highest efficacious product on the market. So that itself, I think, is super exciting, but it will not be the only thing.

We also had seen, if I remember the numbers correctly, the tolerability of the product is really, really decent. So we had 3.7% discontinuation of the trial due to gastrointestine side effects. That's very good. So that's super exciting, I would say, on that one.

And that's before we learned from what you just alluded to 18 months ago and started looking into redesigning some of our trials. So we have REDEFINE 11 coming up, which I'm quite excited about. And of course, again, higher dosages of this. So we are making no secret that we're looking into CagriSema [forte] in terms of not just using 2.4 milligrams of semaglutide inside, but the 7.2 now that we have. And then you could do the back-of-the-envelope calculations where the percentages will go. But I am, at this point, the data will speak for itself. At this point, my gut feeling tells me I should be excited.

You talked about cagrilintide monotherapy. And I think that seems to be lost in the debate that there's a monotherapy amylin in Phase III for Novo. But there are others as well, different 355, et cetera. What are you looking to do to maximize the profile and the benefit -- the commercial benefit of the amylin biology for Novo?

The first thing I do is I tell my colleagues that I've been with Novo 33 years, so I love the company's culture and the Danishness of the company. But I tell my Danish colleagues that sometimes when you're too humble and you don't talk about things, people won't -- they don't read your mind, so they don't hear it. That's why it gets lost in translation. We need to talk about it. So we're going to start talking about these things a little bit more without thinking that we're showing off too much.

But the molecules you just mentioned, of course, they have not -- they're not into Phase III yet, and we have to wait and see where the data takes us. But again, they are -- we're dealing with Amylin, which has shown and proven to be a really good molecule in weight management. And I'm very excited about it. I think what we would do with cagrilintide mono, again, looking to the dosage of it. And then simply wait till the readouts are there some time from now, and then we'll talk more about it. But I think it's really exciting, albeit the weight loss on its own as a monotherapy, will never get to some of the double and the triple agonist, the tolerability of this will be incredibly exciting for a very large portion of the people right now suffering from obesity and that's what we will target.

Maybe you touched on -- just to finish. You touched on the setbacks to near-term growth. When you're thinking about planning for the long term and thinking about the internal pipeline and business development, M&A, et cetera, how are you thinking about the balance here and what you need to continue the growth in the long term.

So maybe I'll give you a recent example of our business development activity and the purchase of Akero as a company. This is clearly one of the ones that's actually in the sub circles, MASH for fatty liver, right? We have seen that we have a phenomenal drug in semaglutide dealing with fatty liver. 80% of these patients have obesity. So this is very much aligned with our strategy.

But semaglutide is only good in F2 and F3. We have seen that if you really want to be there for these patients and when you talk about the totality of the patient pool, there are a group of people that it's no longer are benefiting from semaglutide, the F4 patients.

We come across their lead assets and recognize that this is, if proven, and if we bring it to the market and if the data we see pans out to be correct, which I hope it does. This can eliminate liver transplant, which is the only option that these patients have. So it's a great way for us to marry something we have not created ourselves with something that we have in-house and address a large population size. So that's just one concrete example of how we look at this. And we will continue searching for molecules, assets, companies that basically are complementary to our own portfolio, and we have increased our BD activities over the last 5 to 6 months. And we will not shy away doing that going forward. So more to come.

And so yes, do you think you need to deploy more capital externally to -- I mean, does the sema LOE in 2032, does that -- is that needed?

If it is, we actually have the possibility for it. So the good news about our balance sheet and our financial structure is we can go really high in doing so. But it really starts first to look and see what you can do internally and then go -- one of the questions that journalist often ask me, especially on the backlash of Metsera. Now that you were basically trying to buy this asset for $10 billion, what is your next amount? There is no next amount. It could be $20 billion, it could be $30 billion it could be $40 billion, we could afford it.

But it has to be worth it. We stopped at $10 billion in Metsera because to us, it was not worth a penny more. So we don't start with trying to -- we start looking at what do we have ourselves. And then we try and see basically how can be complement it keeping those patients in the center of everything we do. And my promise is not right now to make, again, an announcement on how much more do we need to invest in order to be successful. My promise is to make sure we -- you have a promise from our side that we will retain and try to expand on our leadership on the few things that we know what to do with diabetes and obesity.

Brilliant. Well, we're out of time. So this has been a great debate. Great discussion.

Thank you, Richard.

Great chat. Thank you very much, everyone. Thanks, Mike.

Thank you.

Have a good conference.

Thank you.

Good day, and thank you for standing by. Welcome to the Q3 2025 Novo Nordisk Earnings Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded.

I would now like to hand the conference over to your first speaker today, Jacob Rode, Head of Investor Relations. Please, go ahead.

Thank you. Welcome to this Novo Nordisk Earnings Call for the First 9 Months of 2025. My name is Jacob Rode, and I'm the Head of Investor Relations. With me today are CEO of Novo Nordisk, Mike Doustdar; Executive Vice President, Product and Portfolio Strategy, Ludovic Helfgott; Executive Vice President, U.S. Operations, Dave Moore; Executive Vice President, Research and Development and Chief Scientific Officer, Martin Holst Lange; and Chief Financial Officer, Karsten Knudsen. All speakers will be available for the Q&A session.

Please note that the call is being webcasted live, and a recording will be made available on our website as well. The call is scheduled to last a little more than 1 hour.

Please turn to the next slide. The presentation is structured as outlined on Slide 2. Please note that all sales and operating profit growth statements will be at constant exchange rates unless otherwise specified.

Next slide, please. We need to advise you that this call will contain forward-looking statements. These are subject to risks and uncertainties that could cause actual results to differ materially from expectations. For further information on risk factors, please see the company announcement for the first 9 months of 2025 as well as the slides prepared for this presentation.

And with that, over to you, Mike, for an update on our strategic aspirations.

Thank you, Jacob. Next slide, please. In the first 9 months of 2025, we delivered 15% sales growth and 10% operating profit growth. We've also narrowed our guidance range to 8% to 11% on sales and 4% to 7% for operating profit. This is because we expect lower growth for our GLP-1 treatment in diabetes and obesity. Karsten will get back to the guidance update later in the call.

Looking into the R&D in diabetes, Rybelsus is now approved in the U.S. and EU with CV indications based on the SOUL trial. Within obesity, and business development, we have progressed on a number of projects that Martin will come back to later. In rare disease, we have now submitted Mim8 for regulatory approval in both U.S. and EU. We're now serving around 46 million people living with diabetes and obesity. This is around 3 million more people with our GLP-1 treatment compared to just 12 months ago.

Furthermore, I would like to note that 2025 strategic aspirations is our current framework for reporting, and we look forward to updating this next year as the current strategic aspiration runs out.

Next slide, please. Since I became CEO, I have said several times that Novo Nordisk will sharpen its focus on core areas, specifically diabetes and obesity. I want to take a moment to explain how we have refined our strategy. For more than 100 years, we have been guided by a simple purpose: to identify and solve major unmet medical needs. This commitment is unchanged. There are many people who can benefit from expertise in diabetes and obesity, and we believe we can serve them better than anyone else. Going forward, we will concentrate on these areas where we can make the greatest difference.

Our strategy begins with patients at the center of everything we will do. Way more than 1 billion people are affected by diabetes or obesity. We will work tirelessly to develop products that help them live healthier, fuller lives. Some of these products will be developed internally. Others will be added to our portfolio through partnerships and acquisitions. Many of these assets can address multiple unmet needs. We will explore those opportunities and expand indications where appropriate to serve our patients.

Speaking of patients, it is a known fact that obesity and diabetes vary by individual and often comes with comorbidities that lack effective treatments. As with the Akero acquisition, Novo Nordisk will keep pursuing innovation with identification within research and then advancing those to development to address comorbidities within our core and the overlaps with those cores. We are now shaping our focus -- sharpening our focus.

In the past, we spread our resources into areas a bit further away from our core. Think about stem cell research for Parkinson's disease. Therefore, during this last quarter, we have discontinued several noncore assets and redirected resources to areas aligned with our strength.

We will intensify our commercial efforts to strengthen competitiveness. To meet evolving market dynamics and increasingly consumer-like behavior, we will, for example, expand telehealth capabilities across markets.

In short, we remain disciplined about where we will compete within diabetes, obesity and related comorbidities in the years ahead. We will also continue our targeted research and commercial work in rare disease. And to support this strategy, we have launched a company-wide transformation, which I would like to give you an update on its progress right now.

Please go to the next slide. We previously announced a company-wide transformation designed to simplify our operating model, accelerate decision-making and reallocate capital and resource towards the highest growth opportunities in diabetes and obesity. This program supports our strategy to capture rising global demand and strengthening our competitive position in the increasingly consumer-like obesity market.

As part of the plan, we expect a reduction of approximately 9,000 positions globally. While this decision was not taken lightly, it is expected to drive approximately DKK 8 billion in annual savings by the end of 2026. Those savings will be redeployed to expand our diabetes and obesity franchises and fund strategic priorities.

We recognize the human impact of these changes and remain committed to responsible transition for affected colleagues. At the same time, we're confident this transformation will increase operational efficiency and strengthen our long-term future and enhance return for our shareholders.

I will now hand over to Ludovic for an update on our commercial execution for the first 9 months of 2025.

Thank you very much, Mike, and please turn to the next slide.

In the first 9 months of 2025, our total sales increased by 15%. The sales growth was driven by both operating units. U.S. operations grew 15% and international operations grew 16%. Sales growth in the first 9 months of 2025 was positively impacted by one-offs in the U.S. of around DKK 6 billion.

Our GLP-1 sales in diabetes increased by 10%, driven by both operating units growing at the same rate. Insulin sales increased by 3%, driven by U.S. operations growing 18%. The sales increase was positively impacted by gross to net adjustments related to prior years as well as channel and payer mix. This was partially countered by a decline in volume.

International operations sales decreased 2%. Obesity care sales increased 41%, driven by U.S. operations growing 24% and international operations growing 83%. Our rare disease sales increased by 13%. This was driven by sales increase in the U.S. of 14% and in international operations of 13%.

Next slide, please. Sales in international operations grew by 16% in the first 9 months of 2025, driven by GLP-1 products. GLP-1 diabetes sales increased by 10%, driven by sales growth of Ozempic and Rybelsus. In Region China, GLP-1 diabetes sales decreased by 4%, which was negatively impacted by wholesaler inventory movements. Obesity care grew by 83% to DKK 22.4 billion. Sales of Wegovy reached approximately DKK 20 billion growing at 168%, driven by sales growth across all regions.

Please go to next slide. In the combined diabetes and obesity GLP-1 market, Novo Nordisk remains the market leader in international operations with a volume market share of 68%. Rybelsus is now available in more than 40 countries, and Ozempic continues to be the leading GLP-1 diabetes product within international operations have been launched in around 80 countries.

In obesity, Wegovy is now launched in more than 45 countries with more to come. Oral semaglutide 25-milligram or Wegovy in a pill has been submitted in the EU for potential launch in selected EU markets. The GLP-1 class growth of 35% in international operations is encouraging. And while competition in diabetes and obesity across international operations is intensifying, the unmet needs remain substantial.

And with that, I would like to hand it over to Dave for an update on our U.S. operations.

Thank you, Ludovic. Please go to the next slide. Sales of GLP-1 diabetes care products in the U.S. increased by 10% in the first 9 months of 2025. The sales increase was driven by continued uptake of Ozempic, partially countered by Victoza and Rybelsus. Ozempic sales in the U.S. were positively impacted by gross to net sales adjustments and wholesaler stocking. Weekly Ozempic prescriptions are currently around 670,000 in standard units compared to 690,000 standard units in the second quarter of 2025.

The GLP-1 diabetes market grew around 10% in the third quarter of 2025 compared to the third quarter of 2024. In the U.S., we continue to invest in commercial activities and have recently launched Ozempic in our direct-to-patient cash offering.

Please go to the next slide. Wegovy sales increased by 25% in the U.S. operations in the first 9 months of 2025. The Wegovy sales growth was driven by increased volumes, partially countered by lower realized prices. Wegovy has around 270,000 weekly prescriptions compared to 280,000 weekly prescriptions at the end of last quarter. In August, we announced that the U.S. FDA approved Wegovy for the treatment of MASH. In U.S. operations, we have established a sales force targeting U.S. hepatologists and gastroenterologists while we work to build access in this segment.

Generally, we also continue to work on expanding access to safe and authentic Wegovy. Around 55 million people with obesity have Wegovy coverage in the U.S. with more than 10 million people estimated to be covered with Medicaid. However, looking into 2026, Several states have already announced changes to coverage for obesity medicines in response to budgetary concerns, which will affect Medicaid access to Wegovy.

Regrettably, Novo Nordisk market research shows that compounding has continued to increase. Multiple entities continue to market and sell compounded GLP-1s and it is now estimated to be well above 1 million patients in the U.S. that are currently on compounded GLP-1. Novo Nordisk launched NovoCare Pharmacy in March of 2025 and together with retail channel, total cash market is up around 10% of total Wegovy prescriptions.

Novo Nordisk will continue to invest in the expansion of direct-to-patient initiatives like the recently announced collaborations with GoodRx and Costco. We continue to anticipate a regulatory decision regarding Wegovy in a pill later this year, which then we will be ready to launch in early 2026.

Now back to you, Ludovic.

Thanks, Dave. Please turn to the next slide. Yesterday, we confirmed that we submitted an updated proposal to acquire Metsera to further strengthen our research and development portfolio in diabetes and obesity. As we said before, unlocking the full potential of the obesity market will require a broad and deep portfolio with different treatment options, formats, serving differentiation groups and their very different preferences. Obesity treatment is still in its early stage. And in Novo Nordisk, we foresee future patient segments that, for example, could be categorized based on BMI, age, gender, lifestyle behaviors and comorbidities.

We believe that Metsera's innovative pipeline would further enhance our opportunity to meet all these very different needs of all these very different groups. MET-097 is a potential best-in-class once-monthly GLP-1 treatment and MET-233 is a next-generation amylin asset. The pipeline of Metsera also includes a combination of the 2 mentioned above as well as innovative oral and injectable preclinical assets.

Furthermore, Metsera's institutional knowledge and capabilities around peptide engineering and synthesis, half-life extension technologies and oral peptide delivery nicely complements Novo Nordisk's core strength in research. The proposed deal structure includes an upfront payment of USD 62.2 per share in cash, equal to an approximate enterprise value of USD 6.7 billion.

The cash consideration is paid at signing in exchange for nonvoting preferred stock, representing 50% of Metsera's shared capital. In addition, up to USD 2.8 billion in contingent value right CVRs will be issued upon the closing of the acquisition in exchange for the remaining shares. The CVRs are based on the achievement of certain clinical and regulatory milestones.

In total, Metsera is eligible to receive up to USD 10 billion or USD 86.2 per share. Novo Nordisk believes that the proposal, including the structure of the transaction complies with all applicable laws and is in the best interest of patients, who will benefit from our commitment to innovation as well as Metsera's shareholders. The offer highlights Novo Nordisk's commitment to investing in the U.S. and interest in continuing to grow the scale of its U.S. investment.

Now over to you, Martin.

Thank you, Ludovic. Please turn to the next slide. As Mike described, we are intensifying our focus on key therapeutic areas such as diabetes and obesity, while continuing our commitment to related comorbidities as well as rare disease. The strategy aligns with our recent acquisition agreements of Akero and Omeros' zaltenibart assets. In early October, we announced the agreement to acquire Akero's efruxifermin, a once-weekly subcutaneous long-acting FGF21 analog with potential to be first to market in F4 and best in class. Efruxifermin complements a strategic position in Novo Nordisk MASH pipeline.

Current treatment options such as Wegovy, primarily target patients with F2 and F3 disease states. Consequently, there remains a significant unmet need in the F4 cirrhosis population, for which no approved therapies are currently available.

The Phase II data for efruxifermin are encouraging across F2 to F4. Specifically, the SYMMETRY Phase IIb trial demonstrates that after 96 weeks of treatment, 29% of F4 patients show improvement of at least 1 fibrosis stage with no worsening of MASH and 42% achieved MASH resolution with fibrosis -- without fibrosis worsening. This is the first Phase II trial to show statistically significant fibrosis regression in F4 patients for an FGF21 analog.

Efruxifermin is currently in the Phase III SYNCHRONY program with pivotal readouts in the coming years and expected launch by the end of this decade. As a result, efruxifermin has the potential to be first-in-class FGF21 analog targeting the F4 population as well as playing a role in F2 and F3 patients, including people who are not responsive to existing treatments.

We look forward to leveraging our capabilities to further optimize the SYNCHRONY program trials, assess the potential combinations with our current GLP-1-based portfolio and explore opportunities for additional indications such as alcohol liver disease. Also in October, we announced the agreement to acquire the clinical stage MASP-3 inhibitor zaltenibart from Omeros for rare blood and kidney disorders. This action aligns with the rare disease strategy with a key focus on rare blood disorders.

Zaltenibart is currently in Phase II for the acquired rare blood disease paroxysmal nocturnal hemoglobinuria or PNH. Plans are in place to begin a global Phase III program for zaltenibart in PNH. The molecule holds big potential in a number of additional indications within rare disease and kidney disorders, which will be evaluated at a later point in time.

We believe our extensive expertise in the development, manufacturing and commercialization of medicines within these fields makes us well positioned to advance these assets, optimize the value of their innovation and ensure they reach the patients in need of these treatments in a very timely fashion.

Please turn to the next slide. Looking towards our internal pipeline, we recently published a sub-analysis of REDEFINE 1, focusing on cagrilintide. In the trial, cagrilintide achieved 11.8% weight loss at 68 weeks, assuming full treatment adherence. About 1 in 3 patients on cagrilintide lost at least 15% of their body weight. Overall, cagrilintide was very well tolerated. The most common side effects were gastrointestinal of nature. And the discontinuation rate due to gastrointestinal adverse events was 1.3%.

Obesity is a global challenge that requires continued scientific innovation. More treatment options also focusing on tolerability are needed to meet their diverse individual needs and preferences. We are very encouraged by the first Phase III data for cagrilintide from REDEFINE 1, and we look forward to studying it further in Phase III, the so-called RENEW program. RENEW 1 and RENEW 2 will assess the 2.4 milligram dose in people with obesity with and without type 2 diabetes, respectively. Both trials have already been initiated and additional studies evaluating higher doses of cagrilintide are anticipated in the beginning of first half of 2026.

Please turn to the next slide. Turning to the upcoming R&D milestones. We're looking forward to the remainder of 2025 with a number of readouts and milestones. In the first half of 2026, we anticipate the readout of the REIMAGINE 3, which is the first of 3 pivotal trials for CagriSema and people with type 2 diabetes. REIMAGINE 3 is a smaller study with CagriSema as an add on to basal insulin. REIMAGINE 2 is the largest study, which will provide comparison to semaglutide and will read out in the first quarter of 2026. We also look forward to the Phase II results of the subcutaneous and oral amycretin in type 2 diabetes in Q4 this year.

Within obesity, we completed the Phase I trial with our internal GLP-1/GIP/amylin triagonist. The study assessed the safety, tolerability, pharmacokinetics and pharmacodynamics of the triagonist in the trial. All multiple doses tested appear to have a safe and well-tolerated profile. The result of this study allowed progression to a Phase Ib/II trial in individuals with overweight obesity, which was initiated in October of 2025.

Looking forward, we expect the FDA decision regarding the new drug application for the Wegovy pill by the end of this year. Further, the submission of CagriSema as well as the readout of the REDEFINE 4 trial remains on track for the first quarter of 2026.

Within rare disease, we have filed Mim8 as once monthly, once every 2 weeks and once weekly prophylaxis treatment to prevent or reduce the frequency of bleeding episodes in people with hemophilia A with and without inhibitors for regulatory approval in the U.S. and in EU.

Finally, we anticipate the results of the evoke trials in patients with early Alzheimer's disease later this year. While there are a number of high unmet need for the treatment of Alzheimer's disease, it is important to remind you that this represents a high-risk opportunity.

And as the very final remark, while it is not on the slide, I would be remiss if I don't mention that the first readout of ziltivekimab is anticipated to read out in the second half of 2026.

With that, over to you, Karsten.

Thank you, Martin. Please turn to the next slide. In the first 9 months of 2025, our sales grew by 12% in Danish kroner and by 15% at constant exchange rates, driven by both operating units.

In the third quarter, DKK 9 billion in costs related to the restructuring was booked. The gross margin decreased to 81.0% compared to 84.6% in 2024. The decline in gross margin mainly reflects impact of around DKK 3 billion from the one-off restructuring costs and impairments related to a few production assets.

Further cost of goods sold are impacted by amortization and depreciations related to Catalent as well as costs related to ongoing capacity expansions.

Sales and distribution costs increased by 12% in Danish kroner and by 15% at constant exchange rates. The increase in costs is driven by both U.S. operations and international operations and is primarily related to Wegovy S&D costs are impacted by one-off restructuring costs of around DKK 2 billion.

Research and development costs increased by 9% in Danish kroner and by 10% at constant exchange rates. This reflects increased R&D activity across the early and late-stage portfolio, particularly within obesity care. R&D costs are impacted by one-off restructuring costs of around DKK 4 billion and impairments related to the closure of early noncore projects to free up resources for projects in core therapy areas. This is partially countered by the impairment loss related to ocedurenone of DKK 5.7 billion and other impairments of intangible assets in 2024.

Operating profit increased by 5% measured in Danish kroner and by 10% at constant exchange rates. Operating profit adjusted for costs related to the restructuring increased by 16% measured in Danish kroner and 21% at constant exchange rates. Net profit increased by 4% and diluted earnings per share increased by 4% to DKK 16.99.

Free cash flow in the first 9 months of 2020 was DKK 63.9 billion compared to DKK 71.8 billion in the first 9 months of 2024, driven by increased capital expenditures. And finally, in the first 9 months of 2025, we have returned DKK 53 billion to shareholders, mainly through dividend payments.

Please go to the next slide. For 2025, sales growth is now expected to be 8% to 11% at constant exchange rates. The new range reflects lower expectations for sales growth of our GLP-1 treatments in diabetes and obesity. Given the current exchange rate versus the Danish kroner, sales growth reported in Danish kroner is expected to be around 4 percentage points lower than constant exchange rate growth.

In international operations, the updated outlook reflects current growth trends driven by GLP-1 penetration in diabetes and obesity, partially offset by intensifying competition within both diabetes and obesity. In U.S. operations, the outlook is based on current prescription trends for Wegovy and Ozempic as well as intensifying competition and pricing pressure within both diabetes and obesity.

Operating profit is now expected to be 4% to 7% at constant exchange rates, negatively impacted by DKK 8 billion in restructuring costs. Given the current exchange rates versus Danish kroner, growth reported in Danish kroner is expected to be around 6 percentage points lower than at constant exchange rates. The narrowing of the guidance range mainly reflects the lower sales growth outlook and costs related to the agreed acquisition of Akero and Omeros, partially countered by reduced spending.

Novo Nordisk expects net financial items to show a gain of around DKK 2.6 billion, driven by gains on hedged currencies, whereas capital expenditure is now expected to be around DKK 60 billion driven by adjustments to expansion plans.

Free cash flow is now expected to be DKK 20 million to DKK 30 billion, reflecting lower-than-expected trade receivables in the U.S. and reduction in capital expenditure. Furthermore, the free cash flow guidance assumed an impact from the acquisition of Akero contingent on final timing of closing. Potential financial impacts related to the potential acquisition of Metsera has not been included.

For the coming years, Novo Nordisk has previously informed that the compound patent expiry of semaglutide molecule in certain countries in international operations is expected to have an estimated negative low single-digit impact on global sales growth in 2026. In 2026, the agreed acquisition of Akero is expected to lead to increased R&D costs with an estimated negative impact on full-year operating profit growth of around 3 percentage points depending on the timing of closing.

Lastly, Novo Nordisk accepted the Inflation Reduction Act maximum fair price, MFP, for Ozempic, Rybelsus and Wegovy in Medicare Part D for 2027. The estimated direct impact of semaglutide MFP in Medicare Part D had it been introduced first of January 2025, would have been a negative low single-digit impact on global sales growth for the full year of 2025. The MFPs for semaglutide will be effective as of 1st of January 2027 in Medicare Part D in the U.S.

That covers the remaining details on the outlook for 2025. Now back to you, Mike.

Thank you, Karsten. Please turn to the next slide. It's been a busy and productive quarter. Throughout the first 9 months of 2025, we delivered 15% sales growth and nearly 46 million people are now benefiting from our treatments. We have also advanced our R&D pipeline, launched a company-wide transformation program and announced a few strategically aligned R&D acquisitions and agreements.

With that, back to you, Jacob.

Thank you, Mike. Next slide, please. And with that, we are now ready for the Q&A, please. [Operator Instructions]

So with that, operator, let's take the first question, please.

[Operator Instructions] And your first question comes from the line of Carsten Lønborg Madsen from Danske Bank.

I think I'll start -- I have two. I'll start out with sort of a relatively basic question for Mike now that it's the first time you have your sort of a real quarterly conference call here. If we look at your roadshow presentation, you can see that in the combined obesity and diabetes market, the GLP-1 market, you lost 9 percentage points global market share over the last 12 months. That's quite a massive loss of share. We obviously knew about this trend. But still, when you look at what you can actually do in terms of strategic initiatives to turn this around, what is it the intangible initiatives that you are thinking about implementing? You tried pricing in U.S. in Q3. It doesn't really seem to have a sort of a big delta effect on your momentum in the U.S. market. So maybe if you could give some examples.

And question two is for Karsten. The acquisitions you have done or are planning to do will lead to sort of a quite significant cash outflow, especially if you get the Metsera. So if you have Akero, Metsera, you have CapEx, you also need to pay dividends next year, I assume. Is there anything you can talk about the capital planning, capital allocation and also how high in the hierarchy is the dividend payout ratio in terms of being extremely important for our investors, of course?

Very good. Thanks for those two questions. On the first one on market share development and perhaps market growth also will turn to you, Mike.

Thank you very much, Carsten. So as someone who has been part of the commercial organization for so long, then I would not lie and say I don't like losing market share. But our job right now is to focus the company's strategy around diabetes and obesity predominantly because we see a huge expansion potential as we go forward. We are expanding our pipeline through our own activities as well as, of course, acquisitions. We are getting our costs under control to invest and really make sure that no stone is unturned and we're really putting most of our efforts at this point in expanding the markets. There are millions and millions of diabetes and obesity patients out there, including in the U.S. that are not getting their treatments.

Launching new products like our Wegovy pill is one way to go get there. Other ways is through increasing our commercial partnerships. You have seen Costco, Walmart, GoodRx, LifeMD, Ro, all of those are ways for us to expand the market and really make sure that through that we succeed and have a successful future. But it does take time for those measures to take effect. It's a marathon, as I have said a number of times now, not a sprint.

Thank you, Mike. And for the second question on capital allocation, we'll turn to you, Karsten.

Yes. Thank you for the capital allocation question. We have a clearly articulated capital allocation framework, which is invest in the business, provided attractive return, pay out dividend in a consistent manner, do pipeline additions through BD and M&A and finally, if excess cash, do share buyback. So that's our framework, which has remained unchanged for quite a while.

And with that, I'm saying that we do have a consistent approach on dividend and have no intention of changing that. The starting point is clearly to convert our earnings into cash flow, which we focus on each and every day. And then looking at value-generating opportunities, both organically and inorganically as in the case with Akero as an example. So I hope that's clear. Back to you, Jacob.

Thank you, Karsten. And also thanks to you, Carsten, for the two questions. With that, operator, let's turn to the next set of questions, please.

Your next question comes from the line of Peter Verdult from BNP Paribas.

Two questions, please, for Mike and Martin. Mike, don't shoot the messenger, but there are many people that view your pursuit of Metsera as an implicit signal that the -- or your confidence in the internal pipeline has waned over the past 12 months. My question is, where do you see the clinical differentiation between the assets you're looking to acquire versus a cagri, CagriSema and amycretin. Is it just the multi-dosing angle? Or are there other factors at play?

And then secondly, and this is a very simple question. But we've heard overnight from our network that Novo has been contacted by FTC for information relating to Metsera, I know you're not going to go into any details, but can you at least confirm if this is actually the case?

Thank you, Pete. And on the first question, on Metsera, we'll turn to you first, Mike, and then Martin, you can add on the different assets.

Thanks very much, Pete. I would say, Pete, that I am very excited about our own pipeline. I think we have a fantastic pipeline. But when you have an ambition to go to hundreds of millions of people and treat them, then no pipeline is broad enough. So we have been looking at Metsera for a long time. We are very excited about these assets. The proposal to acquire Metsera really supports our long-term strategy. And it's mainly because these assets are differentiated and complemented to our products and portfolio. That's why we are doing it.

I'll pass it on to Martin, who can more easily explain you the differentiation to our own assets, but I would say it works very complementary to what we have.

I can only echo that. What we are looking for is complementary to our pipeline. You've heard us speak to many, many times, obesity is not just one disease, it's many different diseases with many different presentations. Different patients coming in with different age, different BMI, different behaviors, different needs, different body composition and different comorbidities. They have different focus areas.

And for us to really serve the full palette of patients suffering for obesity and their comorbidities, we need a diversified pipeline. What we've seen is differentiation and complementarity. And when we see that, then if we can progress that with diligence and in [indiscernible], then obviously, we're interested.

Thank you Mike. And thank you, Martin. And then on the second question, the FTC we'll turn to you, Karsten.

Yes. So the short answer is that at this point, we don't want to get into any details around the process. It's still TBD where everything lands out. We note that Metsera board assessed our to be superior, and that's what we can relate to. And then I can say as part of this due diligence, as with any other due diligence, we do comprehensive homework in terms of living up to all laws and regulations in order for the deal to close. We always do that, and we did that here also with the assistance and channels of external experts. So we are confident that this deal can close according to regulations.

Thank you, Pete, for those two deal questions. Let's turn to the next set of questions, please.

Your next question comes from the line of Florent Cespedes from Bernstein.

One question, a follow-up. About Medicare, maybe could you share with us your view on Medicare, on one hand, the opportunity if there is a broader coverage of people with obesity on this channel? And the second, about the potential risk or the IRA -- the next step on IRA, you gave some color on the press release about that. So any comments about this opportunity and risk on Medicare would be great.

Thank you, Florent, for those two questions. For both of those, we'll turn to you, Dave, on Medicare potential and then on IRA.

Thanks for the question, Florent. The Medicare opportunity is very important to us and something we've been pursuing since we launched into obesity over a decade ago. And we know that there's roughly 30 million people of Medicare age that are suffering from obesity, and that is something that we feel is really important that those individuals have access to anti-obesity medicines. We can't speculate on what the potential is and how many of those patients will be able to reach, but we do see this as a very important development for us.

Regarding your second question about IRA. As Karsten mentioned, we gave an understanding of the expected impact in the company announcement as well. And it's not something that we are able to comment on. We are under strict confidentiality with CMS, and CMS will be making the announcement of what those prices are at some point in the near future.

Thank you, Dave, and also thanks to you, Florent. And let's move to the next set of questions in line, please.

Your next question comes from the line of Martin Parkhoi from SEB.

Two questions. I have to come a little bit back to the question that's getting from Carsten because I think he was a little bit kind to you, Mike, with respect to market share loss because if we look at the your old area IO and look at reported sales, then Lilly have actually done a sprint. They -- 2 years ago, you had a market share of 80% on all GLP-1 sales on reported numbers. And today, you are at 50%. So can you talk a little bit about what has gone, not wrong for you, but what have they done right in IO to basically capture so much more share than you? Is it commercial execution in IO across the countries? Or is just due to product superiority? Why can they sprint and you cannot?

And then second question is just on device strategy. A bit of a setback for Wegovy FlexTouch in U.S., you had argued for that to be an important part of flexibility in the consumer channel. What are you -- going to '26, are your device strategy overall also with respect to launch of products in vials and in which market would that be relevant?

Thank you, Martin. On the first question on IO, I'll turn it over to you, Mike.

Yes. Thanks very much. So a couple of different ways to answer your question, Martin. There are markets that we are clearly competing well and gaining market share within IO and there are markets that we are losing. So it is market dynamics that dictates IO and averages sometimes cloud the picture. In certain markets, take China as an example, the market is not growing as much as we had anticipated. We have said it in the past. It's predominantly because we have never launched a previous version of obesity drugs in that market. At the same time, we have seen in the same market that we're losing in the online battle to our competitor, predominantly because obesity drugs or Wegovy is not allowed to be sold online, while if you have a mega brand, then it's a very different picture. So that's, I would say, for China.

If you take a look at some of the European markets, take U.K. as an example. We have seen how our share of growth over a period of 1 quarter has now bypassed on initiation our competitors' numbers. So this is a dynamic market that changes. And it is really to be seen on a longer horizon and not quarter-by-quarter. We still have a patient base more than -- 2x more than our competitor in international operations. The volume strategy and the future potential of international is still incredibly attractive for us. But we came to this market with a very high level of market share, 100% on our own.

So losing market share is something that we had anticipated. And as our competitor comes and as we go also into next year, it will not just be Eli Lilly, but also in some of the markets, other players as we lose LOE. So we have to look at this longer term. And when we do look at it longer term, I am incredibly optimistic for the volumes and the level of unmet need that exists in international operations.

Thank you, Mike. And let's move to Dave for the device question, please.

Thank you, Martin. Yes. As you mentioned, it's a setback to receive the CRL on Wegovy FlexTouch. Looking into 2026, we are looking at other presentations. This includes vials. It includes other devices that we're thinking about entering into the market, which would lead to more optionality, especially as we continue to grow in the cash channel as well.

On the FlexTouch specifically, we are in active dialogue with FDA and working through the CRL, but can't comment on any specific time lines yet at this point.

Thank you, Dave. Thank you, Martin, for the set of two questions. And let's move to the next question, please.

Your next question comes from Sachin Jain, Bank of America.

I have two questions please, one commercial, one financial. Commercial on Wegovy pill, just wondering if you could talk about how you're scenario planning around orforglipron pricing given some news overnight and given your API restrictability, your ability to compete on price? And any further color you can give on launch cadence as we think about that launch?

And then second one for Karsten, I'm sure you're expecting the question, but the last couple of years, you've given some high-level color on year forward sort of you'd be willing to just share moving parts as we think about '26. A lot of factors there, gross to net in the base, certain IO patents, Akero, consensus sitting at roughly 7% sales, low teens EBIT, so just any high-level thoughts.

Thank you, Sachin. The first question on oral sema, let's go to you, Dave, in terms of preparedness. Of course, for competitive reasons, we cannot go into any details, but the high-level picture, Dave.

Yes. Thanks a lot, Sachin. We're incredibly excited as we move closer to the approval date of the Wegovy pill. I think this is a big step forward in terms of expanding the market and for those individuals that align better with taking a pill for their obesity. We can't comment on specific pricing, of course. But what I would say is we are going to have the Wegovy pill available in all channels.

And this is different from previous launches because we will have the ability to focus on Medicaid, Medicare and commercial, but also have a cash offering available through all of our different telehealth partnerships as well as our own NovoCare Pharmacy and the retail partnerships that we've aligned as well. This is a new way to launch for us. And we're also thinking about the competitiveness. This is a competitive profile with respect to efficacy and tolerability, and we're really looking forward to bringing this to people living with obesity in the U.S.

Thank you, Dave. That's very clear. And the second question, we'll turn it to you, Karsten.

Yes. Thank you for that question, Sachin. And I think you actually already captured some of the key elements going into your own question. So the starting point is we do not guide for next year today. We'll come back to guide for next year at a later point in time as we normally do. What I can say is, as always, current momentum is the foundation for future trends in the business. Not saying everything continues, but current momentum is where we start.

Then we have a few specific items worth calling out in relation to next year's growth rates. One is this year, we have some gross to net favorability, I would estimate it to around 2 percentage point on group sales growth this year that will not repeat into next year. So that needs to be factored into a growth rate. Then loss of exclusivity in certain IO markets. We've been calling that out for quite some time, including in our release that will have an estimated negative impact of low single digits on next year's sales growth on group sales.

Then on sales, Dave was covering the Wegovy pill, which, of course, is our main launch into next year and upon regulatory approval by the FDA. And then the final discretionary factor to call out is Akero and the step-up in R&D costs associated with that transaction pending closing expected later this year. That will have a 3% negative impact on operating profit growth in 2026.

Thank you, Karsten, and thank you to you, Sachin, for those two questions. Now let's move to the next one in line and those set of questions, please.

Your next question comes from the line of Mike Nedelcovych from TD Cowen.

I have two. My first is actually a follow-up on Metsera. Martin, can you articulate what specifically about the Metsera agents is differentiated from Novo's own pipeline candidates other than the potential for once monthly dosing? In response to the previous question, you've restated that Metsera is differentiated and complementary, but I'm wondering what public data lead you to that conclusion or if those data are not public, can you confirm that? That's my first question.

And then my second question is on the evoke trials. We are now less than a month away from the CTAD presentation. So I'm assuming that Novo has the data in-house and is simply cleaning them up before top line release ahead of the presentation. So my question is, if it is an unequivocally negative result, would Novo cancel its CTAD presentation?

Thank you Mike, for those two questions. Now let's start with the first one on revisiting Metsera and the view on differentiation from your side, Martin.

Yes. Thank you very much for the question. I don't want to go into specifics, but maybe just to iterate what we're looking at, where we look for complementarity to our pipeline. It's data on efficacy, and those can be differentiated at many levels. It's data on safety and tolerability, a little bit of the same consideration. Its scalability. And then obviously, in this case, the dose in frequency. We, on more than one parameter, see complementarity to our pipeline. And therefore, this is an effective proposition for us.

On evoke, I do want to iterate, we do not know the data in-house in this room. If we did, we would actually had to issue a corporate announcement immediately. So no knowledge amongst any of us in this room. Our starting point is to disclose data, good or bad. So we currently aim to present whatever data that we will have at CTAD in the beginning of December.

Thanks, Martin. That's very clear. And also thank you to you, Mike, for both of those questions. Now let's move to next question, please.

Your next question comes from Harry Sephton from UBS.

Two on the U.S., please. So just in light of the agreed IRA direct negotiation discounts on semaglutide. And also some of the press reports yesterday on potential obesity Medicare coverage. I don't want you to comment directly, but it appears you'll end up with significantly different prices for your products across different channels. So I wanted to get your thoughts on how you expect that you're able to maintain this segmented pricing by channel? Or should we assume that all prices gradually trend towards the lowest level?

And then the second one on the U.S., just on the current U.S. market trends. Can you discuss how you're currently thinking about the levers to improve access and commercial insurance coverage on Wegovy and Ozempic going into next year? Or do you expect that the majority of the 2026 U.S. growth is really going to come from the launch of the Wegovy pill.

Thank you, Harry. Noted two questions here. I'll send both to you, Dave. The first one on the pricing dynamics and then subsequently on the current access picture. Over to you, Dave.

Yes. Thank you much. As we mentioned, we can't discuss any of the specifics around IRA or MFN, but we do appreciate the question. And the fact that historically, we have been able to maintain different prices in different channels, given that be Medicaid, Medicare or commercial and now are increasingly expanding cash channel. Of course, we can't speculate what that will mean in the future. But historically, we have been able to maintain the differentiation between those markets and the access that comes with it.

To your second question around the trends in terms of the quality of access, it's something that continues to be really important for us as sometimes receiving an obesity medication can be a challenge because of the friction that exists in the marketplace. So we are continuing to push for and invest in improved access. It's a clear priority for us. This includes both our cash offerings. It's also what we do with payers. But we haven't seen a large uptake yet in terms of that opportunity, but it's something that we're going to continue to push for in 2026 access. We don't really expect the access to be largely changed in 2026, but we do know that each of the payers or Medicaid, as we mentioned earlier, have budget constraints and there could potentially be some loss of coverage as well.

Thank you, Dave, for those two. And also thanks to you, Harry. Let's move to the next question, please.

Your next question comes from Emmanuel Papadakis from Deutsche Bank.

A few follow-ups, perhaps. Maybe taking a step back on U.S. commercial channel trends and obesity. Excuse the background noise. Wegovy scripts are pretty much flat since July despite the NASH launch. Even Zepbound has seen most of the growth coming from the cash channel. So talk us through what you think the obstacles actually are to better penetration in that commercial channel? Is it on the demand side due to product profile, lack of demand beyond the motivated minority? Or is the barrier really on the access side, for example, as you referenced potentially insurance companies making it difficult for patients to actually get on or main on therapy?

Maybe a follow-up on Metsera, the deal structure and the risk associated with that. Can you just help us understand your comfort with the risk around the way you are structuring your offer? It seems there's a reasonable chance you could end up with 50% of the company you don't control to its ultimate benefit preventing someone else from owning them. So why are you comfortable with that possibility? Or how do you expect to avoid it?

And then just a quick clarification on the Medicare access discussions. What would be upper limit discount you're contemplating be? Would that be in line with the MSP or this would be something in addition to that?

Thank you, Emmanuel. I noted two questions there. On the first one on the Wegovy scriptions, I'll turn it to you, Dave. And on the second one afterwards, on the deal structure, I'll turn to you, Ludovic. But first, over to you, Dave.

Yes. Thank you, Emmanuel. As we mentioned earlier, the quality of access remains a focus point and certainly a challenge in the reimbursed channel. Of course, we've got that combined with intense competition. And we also mentioned that the compounding is continuing to increase as well. So that focus and investment in the quality of access, we do think is an important factor with respect to expanding the market. And in addition, you'll continue to see our efforts in expanding the cash channel through more partnerships and certainly having our product offerings available in that channel as well.

Thank you. And now I'll hand over to you Ludovic.

Thanks for the question, Emmanuel. Well, I think everything stems from, I guess, what you feel is an excitement for the portfolio of Metsera. We really believe in the assets. We believe in the team. And we believe that the deal structure that we have now, which, by the way, as Karsten said, has been vetted and discussed with external councils and experts. And believe that it's in line with all legal standards, boils down to the quality of the asset and the data that we -- and the confidence we have in the data that we have.

So of course, we know when you get into such acquisition that this deal will be reviewed, but we're comfortable that even the 50% of the shares that we would have in our pocket would be actually worth a lot if the product stands out to be the way we think it is, products with an edge, by the way, because as you said, Martin, it's a convention of product. So in all cases, as it boils down to science, we believe that we have a good value proposition. Of course, we would prefer at the end to have that in our portfolio from an operational perspective, but the value there, we believe is really, really high in all scenarios.

Thank you, Ludovic. And now let's turn to the last two questions. For the second last question. Please go ahead, operator.

The question comes from the line of Richard Vosser from JPMorgan.

First question, Mike, you alluded to more telehealth involvement, particularly in the U.S. I think the prior arrangements, particularly with Hims, have faced challenges given they continue to bulk compound. So there's been some discussion around continuing or new agreements with Hims, but also the wider involvement of the telehealth. So I wondered what was different this time and whether there's any evidence of any increased pressure around from the FDA or legal pressure to remove the compounders and what could change on that front.

And then the second question, just you mentioned a couple of times about coverage, maybe even getting a little bit worse in Medicaid and maybe even the commercial payers, the barriers staying high. Well, in that case, how should we think about the pricing? Normally, we think about increased rebate levels and increased pricing should remove barriers to get more reimbursement. So how should we think about that going into '26?

Thanks, Richard. On the first one, I'll turn to you, Mike, on the telehealth.

Yes. A couple of comments on that, Richard. There's been no increased pressure to answer your question directly. But what we have been quite consistent with regards to the illicit API that is coming from China and being used by compounders, we find -- since these are not FDA approved, their safety is questionable. And as a pharma company, we don't basically like that. That hasn't changed at all.

We also have been saying that we need to increase our access and we need to find ways to get to many more patients. The cash channel and eHealth is definitely an attractive way to go about it. In that context, we're having dialogue and discussions with multiple players on how we could actually increase our access and then we will see with who we should go into partnership. We've made a number of those partnerships available. So we talked about Costco. We have talked about EMed. We have talked about Walmart. And ongoing dialogues with many, many more are ongoing in pursuit of our market expansion that I spoke to earlier on.

Thank you, Mike. That's clear. And for the second one, let's move to you again, Dave, please.

Yes. Thanks very much, Richard. We continue to have dynamics that we've discussed in the past, continued pressure, both in GLP-1 as well as in obesity with respect to price as we look to unlock more volumes. But I think it's -- I do want to reiterate that the quality of access is a clear priority for us. We are working with payers to make sure that the experience is one that patients are able to receive their medicine more seamlessly. That means lower utilization management, right? That means less of a prior authorization criteria. When we say we're investing in quality of access, that's really what we mean. And that's the focused conversation that we're having with payers.

In 2026, we don't really expect a large difference in terms of access in the commercial channel. As we mentioned, there may be some in Medicaid. But when we look at the commercial opportunity, I think it is important to note that we haven't been making progress in terms of the access. We continue to believe that the CVS opportunity remains there, and that will -- we will see Wegovy as the exclusive brand at AOM, at CVS in 2026 as well.

Thanks a lot, Dave. That's clear. And let's move to the final question before I hand over to you, Mike, for closing. So final question, please.

Your final question today comes from the line of James Quigley from Goldman Sachs.

I've got two left, please. So firstly, on REDEFINE 4, how important is this into demonstrating differentiation from a physician and a marketing perspective versus Zepbound? Have you thought any more about how Zepbound could behave in a flexible dosing scenario versus other trials and real-world data? And can you confirm that you still look to launch CagriSema if REDEFINE 4 shows no statistically significant difference?

And second one, can you talk through the launch preparations for Wegovy in ex U.S.? I mean you've highlighted in the release and in the comments that you could look to launch in select countries versus previously when it's likely to be mainly focused in the U.S. So what's happened such that you consider also launching in the ex U.S.? And how do you balance this with U.S. launch processes and pricing, et cetera, as we head into an MFN world?

Thanks, James. That's two. One on the REDEFINE 4 and one on the orals sema in IO. But on the REDEFINE one, I'll turn it to you first, Martin.

Yes, REDEFINE 4. As you well know, we've taken some learnings from REDEFINE 1 more specifically that we needed to do a lumber study. So we amended the REDEFINE 4 study. That being said, our base case has always been non-inferiority with an upside of superiority. In the case of non-inferiority on weight loss, we still see a potential for upside on gastrointestinal side effects and tolerability. But also we do believe that the CV benefits that we know from semaglutide could also potentially pan out and will read out from REDEFINE 3, thus clearly differentiate CagriSema vis-a-vis potential competitors. But I do want to iterate, there is still the potential for superiority upside. But obviously in an amended study, that should be taken with a little bit of a risk.

And let's turn to you, Ludovic, for the second one, please.

Absolutely. So let's take a step back. The real focus and the priority of our Wegovy pill launch is the U.S. and will remain the U.S. in 2026. As you rightly read, we are indeed opening -- we've filed, and we are opening the option to launch in selected markets in the course of 2026, depending, of course, on how things are ramping up, and we are definitely ready to -- in this market to be able to make the -- the best and the most of the Wegovy pill.

By the way, we're also very quickly transferring some knowledge from the telehealth channels, for instance, in the U.S. into some higher markets. We are very active right now as we speak in many markets across the world, not just in Europe, but also in Australia, for instance, or in other part of the world where we believe that we really are gaining progress on the telehealth side. So again, we're accelerating our overall experience curve on the telehealth and that will be -- we believe will be proven very helpful at the time we launch the Wegovy pill.

It's also not worthy to say that the IO market are also markets where we have some of the nicest experience in Rybelsus in Europe and elsewhere, which means that we can also leverage our experience in the oral markets that have been successful for Rybelsus to build even quicker position with the Wegovy pill. So priority to the U.S., but fully ready to take on some selected markets in IO when time comes.

Thanks, Ludovic. And with that, let's conclude the Q&A session. Thank you for participating, and please feel free to ask in the Investor Relations for any follow-up questions if that's case.

Before we finally round off, I'll just turn it over to you, Mike, for some final remarks.

Thank you, Jacob. Thank you to everyone for calling in. Before closing, I did want to make a few remarks. Although we have narrowed the full year outlook for this year and see currently competitive headwind, the unmet need is huge. The volume opportunity longer term in our core area is enormous. We are sharpening our focus on diabetes, obesity and associated comorbidities in order to address this unmet need. This is our home turf, and this is for us to drive the commercial execution and raise the innovation bar to treat many more patients and treat them better than ever before, and we will not stop until we do that. Thank you.

Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.

Good day, and thank you for standing by. Welcome to the Novo Nordisk to convene Extraordinary General Meeting Webcast and Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Jacob Rode, Head of IR. Please go ahead.

Thank you, and welcome to this conference call regarding the convening of an Extraordinary General Meeting that was announced earlier today. My name is Jacob Wiborg, and I'm the Head of Investor Relations at Novo Nordisk. Given today's announcement, the focus of this call is only on the proposed future Board composition of Novo Nordisk. Therefore, the Chair of the Board of Directors of the Novo Nordisk Foundation, Lars Rebien Sørensen has been invited to join me on this call.

As you all will know, the Novo Nordisk Foundation is the main shareholder in Novo Nordisk. Both today's announcement as well as the notice for the Extraordinary General Meeting are available on our website, novonordisk.com. The press release issued by the Novo Nordisk Foundation is available on their website, novonordiskfonden.dk. Please note that this call is being webcasted live, and a recording will be made available on the website.

Today's call starts with a presentation lasting for around 5 minutes and will be followed by a Q&A session of around 15 minutes. Lars Rebien Sørensen will be available for Q&A.

Next slide, please. I need to advise you that this call could contain forward-looking statements. These are subject to risks and uncertainties that could cause actual results to differ materially from expectations. For further information on forward-looking statements and risk factors, please see the company announcement for the first 6 months of 2025, which was released on August 6.

Please turn to the next slide. Earlier today, it was announced that Novo Nordisk will convene an Extraordinary General Meeting with the aim to elect new members to the Board of Directors on 14th of November 2025. As mentioned in the announcement, it has following dialogues with the Novo Nordisk Foundation not been possible to reach a common understanding regarding the future composition of the Novo Nordisk Board.

The Novo Nordisk Board of Directors proposed a renewal focusing on addition of select new competencies, while also maintaining continuity, whereas the Board of Novo Nordisk Foundation wanted a more extensive reconfiguration. Novo Nordisk Board of Directors has concluded that it is in the best interest of both the company and its shareholders to convene an extraordinary general meeting to elect new Board members to provide clarity on the future governance of Novo Nordisk.

Chair Helge Lund, Vice Chair Henrik Poulsen as well as the shareholder elected independent Board members, Laurence Debroux, Andreas Fibig, Sylvie Grégoire, Christina Law and Martin Mackay will not stand for election. The current composition of the Board will remain effective until the Extraordinary General Meeting has been concluded.

And with these words, I would like to give the word to Lars Rebien Sørensen, Chair of the Novo Nordisk Foundation.

Thank you, Jacob. Good afternoon, ladies and gentlemen. Please turn to the next slide. Today, Novo Nordisk operates in a new reality. The company is committed to meet patient needs and the rising global demand, but also competing in a more dynamic and consumer-oriented obesity market as evident by the recent slowdown in growth for the company. As a consequence, Novo Nordisk has just embarked on a company-wide transformation process to simplify its organization to improve speed of decision-making and reallocate resources towards the company's growth opportunities in diabetes and obesity.

We believe now it's time to bring the new competencies and perspectives also to the Board to support Mike Dolsten and his leadership team in executing the company's strategy, and we agree with the decision for this call for an Extraordinary General Meeting.

Turn to the next slide, please. Earlier today, Novo Nordisk issued the invitation to an Extraordinary General Meeting to be scheduled November 14. At this meeting, the Novo Nordisk Foundation will be nominating the following 5 new members to join the Board of Directors of Novo Nordisk. Myself, I apologize, as Chair of the Board, I will enter the Board with the intention of hold this position for a period of 2 to 3 years. The aim of this period is to support the management and its transformation plans that are being implemented as well as prepare the way for my successor.

Cees de Jong will be nominated Vice Chair of the Board. Cees comes from a long track record in the biotech industry, most recently as President and CEO of Chr. Hansen, and currently the Chair of Novonesis. Mikael Dolsten will be nominated to the Board as Board member. Mikael has been an observer to the Novo Nordisk Board since August '25. He brings a long career from big pharma with him, most recently as Chief Science Officer and President of R&D at Pfizer.

Britt Meelby Jensen will be nominated also as Board member. Britt currently works as CEO of the Danish Medtech Company Ambu. Britt has previously served as CEO of Zealand Pharma, Dako. And before that, she actually served as Corporate Vice President of Marketing here at Novo Nordisk. Stephan Engels will be nominated as a Board member. Stephan brings a long track record previous executive roles in Daimler AG and Commerzbank. Most recently, he served as Group CFO for Danske Bank.

Moreover, it is the intention to identify 2 additional candidates to be elected at the Annual General Shareholders' Meeting in March of '26 and one of them being Helena Saxon to be nominated as Board member at that time. Helena brings experience from more than 10 years as CFO of Investor AB and has a long track record within the investment industry.

Helena is currently a member of the Board of Hennes & Mauritz, Sievert and Stockholm School of Economics. The final candidate will be identified in the process. Kasim Kutay, the CEO of Novo Holdings will remain on the Board. He is unique knowledge and long-standing experience in the life science industry, and he's been on the Board since March 2017.

With Mike Dolsten as new CEO, the transformation plans being implemented and the Board with the proposed composition of new members, I'm convinced that Novo Nordisk has a strong leadership that is fully committed to succeed in both the organizational transformation in regaining growth momentum and delivering on the commitment to pursue leadership in diabetes, obesity and their associated comorbidities, which I'm looking forward to be contributing to myself.

With that, I'd like to hand the word back to Jacob.

Thank you, Lars. And with that, next slide, please. We're now ready for the Q&A. We kindly ask participants to limit her or himself to one question maximum. I remind you that the focus on this call, including this Q&A will be on the proposed future Board composition of Novo Nordisk. So with that, operator, we are ready to take the first question, please.

[Operator Instructions] We will now go to the first question. And your first question today comes from the line of Richard Vosser from JPMorgan.

Question, obviously, for Lars. Just on that Board composition and the amount of expertise that you think you need in terms of the consumer environment. I think you touched on the fast pace and changing world that we live in, in terms of the obesity market. And just thinking about the expertise that you are bringing in there and what you think is needed from that point of view for the Board.

Thank you very much, Richard. This is Lars Rebien. Yes, it is indeed an area which is of great interest to most pharmaceutical companies operating in the United States, but also increasingly abroad. We have had relatively short time to compose the proposed list of Board members. As you can see from the list and as I mentioned, there's Board members that are members of business boards or businesses that are fast moving consumer goods, but it is something that we will be looking at over time to ensure that we fortify that competence as well. And I hope to be able to do that in dialogue with yourselves and with our other investors.

Thank you, Lars. And also thank you, Richard, for that question. Let's move to the second question, please.

Your next question comes from the line of Peter Verdult from BNP Paribas.

Peter Verdult, BNP Paribas. Lars, a question for you, and sorry to be a bit more direct and blunt. But we were in Q2 all on the call when the CEO replacement or Lars leaving the company Lars Søgaard, was announced. At that point, we were told that the Board and the foundation were aligned and something has clearly gone wrong here. So in terms of where the disagreements have been, is on the execution in terms of the trends that you're seeing? Is it on the strategy and pipeline? Is it on the recent BD that you missed out on or that you haven't done? I just want to really understand what's precipitated this quite drastic change in Board structure.

Thank you very much, Peter. This is Lars here again. I can say that when we stated there was an alignment at that point in time, it was an alignment on the candidate, which was proposed. What has transpired since then is the discussion of who to propose for Board members for the coming AGM. And as is stipulated in the announcement, it was impossible to reach an agreement between the views of the current Board and the Foundation Board.

The foundation wanted a faster and more comprehensive renewal of the Board, whereas as stated in the announcement, the current Board wanted a more slow process with addition of separate new competencies.

So it was simply a matter of urgency and a matter of scope in Board renewal that we couldn't agree on, and that led to the Board to basically announce their retirement and call for an Extraordinary General Shareholders' Meeting. So there's no overall disagreement on the overall company strategy. Its ambition and the execution program, which Mike and his leadership team has embarked on since September 10. We are fully aligned behind that. However, we believe in the foundation Board that we needed a fresh set of eyes, new energy to support management on this very important process.

Thank you, Lars, and thank you to you, Pete, for posing the question. Let's move to the next question, please.

Your next question comes from the line of Evan Seigerman from BMO Capital Markets.

This is Conor MacKay on for Evan. Maybe just at a higher level here. Can you share a little bit on the types of new competencies you're looking to bring on with these new Board members and maybe kind of where the gaps were previously?

When we analyze the competence grid, which you always do of Board of Directors, we believe that the now former Board has the right type of competencies. So it was not that we are looking for any specific different competencies. However, what we would like to support management in is faster decision-making. And it is a very comprehensive restructuring program the company is going through to support management in an ever faster moving market driven in some ways by consumerization.

So I think the competencies were there. The roster that you see presented by us have similar competencies. So it's not that we are pointing towards. However, wish for new eyes, new energy to support management.

Thank you, Lars, and thank you, Conor, for raising that question. And let's move to the fourth question, please.

Your next question comes from the line of Michael Leuchten from Jefferies.

Just related to the prior question. Just trying to understand whether the desire to change the Board is to do with the supervisory function of the prior Board not being exercised sufficiently or satisfactorily or whether it is just the speed of action. So was there a shortfall in the way the Board exercised its duties? Or was it just too slow?

I think I would rather phrase it this way that the Board was perhaps too slow in recognizing the significance of the market changes in the United States and thereby also prompting management to take the necessary actions to adjust the base of the company towards the future business environment. So it was a matter of speed and scope basically that we disagreed on. There was also a disagreement on -- initially on exchange of CEO.

We wanted a quick process. The Board undertook a more comprehensive and quite valuable process actually, looking at internal and external candidates and ended up making what we believe is the right choice. So again, here, it's a matter of urgency and scope.

Thank you, Lars, and thank you, Michael, for posing that question. Let's move to the next question, please.

Your next question comes from Carsten Lønborg Madsen from Danske Bank.

I was just wondering whether any of these changes has been discussed with other large shareholders in Novo Nordisk. I'm fully aware that you can decide yourself with all the votes you have, Lars. But in terms of good corporate governance, don't you feel that there will be some new light on your large ownership and large dominating power in Novo Nordisk if this has not been discussed with anyone else?

Thank you for the question. This is, of course, a central question in that we now move from the foundation, move closer into managing the company. This is not at all a procedure and process and governance that we want for the future. However, given the sensitivities around our conversation with the former Board, we were not in a position where we could have an extensive dialogue with all the shareholders given the sensitivity of the topic.

It is, however, our intention in the future to have the normal type of preparatory dialogue with shareholders on company strategy direction and also their view on Board competencies such that we can amend the Board to the ever-changing environment.

Thanks, Lars. That's clear. Thank you also to -- thanks also to you, Carsten, for posing that question. Let's move to the next question please.

Your next question comes from the line of Simon Baker from Rothschild & Co Redburn.

It relates to the additional appointments that are going to be announced. I'm just wondering what competencies from the -- are missing from the existing slate that you need to fill? I mean, one that investors have talked to us about repeatedly is experience of the U.S. -- operational experience in the U.S. consumer discretionary market. Is that a competency that you would be looking to fill with these additional candidates? And if not, what are the gaps as you see them?

Thank you very much for the question. I think you answered the question yourself. It would be the U.S., and it would be ideally some angle of consumer competency or experience that we would like to bring on the Board. I highlighted Helena, who unfortunately could not join as of the Extraordinary General shareholders' Meeting, but will be able to join at the AGM in '26 as she has experience of working for FMCG companies.

So that's what we've been looking for, but also the U.S. We all of us on the Board are running businesses that are exposed in the U.S. So U.S. is our daily bread, so to speak, and we have experience from various different types of businesses, being it medtech to pharma to specialty pharma. And so -- but having more presentation of people that live in the U.S. would be great.

Thank you, Lars. Thank you to you, Simon, as well. And then we're honing in the last 3 questions. Let's move to the first of those 3, please.

Your next question comes from Seamus Fernandez from Guggenheim Securities.

So just trying to get a better understanding. I mean this does look like a bit of a coup on the part of Novo Nordisk Foundation to really drive this movement. You're talking about faster movement across the board. Hoping to get a better understanding of the consistency of decision-making going forward. It seems like there is significant alignment now as it relates to the Board with the resignations. It seems like the EGM is almost forced to some degree.

So trying to get a better understanding of what is the pace of decision-making that is needed here? Is it business development decision-making? Or is it across the Board decision making that just seemed too bureaucratic and slowed down from your perspective under previous leadership?

Thank you for the question. I would not to prefer have it coin as a coup. We actually entered from the Foundation Board into a dialogue with the Chairmanship of the company to discuss what the Board's composition should be after the next General Shareholders' Meeting in '26. That discussion led to the situation where we could not agree the extent to which new competencies should be added. And therefore, the Board elected to call for an extraordinary meeting and basically all elected not to be reelected.

So that's the situation the Foundation Board has been faced with. We have put a Board together, which we think can manage the company excellently, I think, of course, and that we have the similar competencies which the current Board has and maybe added some new. And I think you should be looking for a normal consistency in our governance structure going forward in that. I'm only here for 2 to 3 years.

Hopefully, you'll be able to find an independent Chairman. The Chairman will then, in the future, together with the Nomination Committee of the company proposed members to the Board to the foundation such that the foundation can support these at the upcoming general meetings that are taking place in the future.

So I think we should, as quickly as possible, go back to the normal way of operating that we have been operating the company between the Board and the foundation in the past.

Thanks, Lars, and thanks also for the question, Seamus. Let's move to the second last question, please.

Your next question comes from the line of Emmanuel Papadakis from Deutsche Bank.

Maybe just to come back to the Board competencies. I think we can perhaps understand the desire of some Board renewal under the circumstances. But on the question of competencies with the exception of Mikael Dolsten, the new proposed members don't appear to possess any global pharma commercial industry experience, let alone U.S. primary care expertise.

On balance, it might seem the new Board actually possesses less rather than more commercial large pharma expertise. So just wanted to understand your rationale for selection of those particular members. Obviously, I understand there's potentially some more members coming, who might add more in that regard.

And then the second question, Lars, was just in terms of your role specifically, what are you hoping to achieve as Chair that you couldn't achieve as an observer? What changes haven't happened that you would like to see happen? And do you fully support Mike as the CEO to execute on plans over the period of your expected tenure as Chair?

Thank you very much. I'd hate to promote myself in this context, but I spent myself 22 years in charge of the Novo Nordisk Pharmaceutical business from 1994 to 2016. And in 2017, I became Executive Chairman of Ferring Pharmaceutical, which is also a pharmaceutical company that's operating in the United States. So I would say that my pharma experience is both global and current. In addition to this, Mikael Dolsten has very recently been President and Head of R&D at Pfizer. So his R&D knowledge and business understanding is also very current.

Mr. Cees de Jong has a long track record in bioindustries and will be, I think, very important going forward where we start to get into a situation of maybe even mass marketing of GLP-1s in the future where competencies in protein manufacturing at very large scale at very competitive cost will become a competitive edge for companies in the future.

Britt Meelby has been working both in pharma. She is now working in medtech. So I think that -- as far as that goes, we're pretty covered. We would, however, like to add additional pharmaceutical experience. And we will, of course, be looking to the U.S. to see if we can find those.

Thank you, Lars, and thank you, Emmanuel, for those 2 questions. Let's move to the final question before rounding up the call.

Your final question comes from the line of Kerry Holford from Berenberg.

Most of mine have been asked, but I would just like to hear perhaps another reflection on why make these changes now? Why did we not see proposed changes to the Board back at the time when you made the changes to the CEO role? Why not wait for the AGM? Why here and now? Just love to hear a bit more on that, please.

Well, thank you very much for the question. Well, basically, the Board has resigned. So we have to appoint a new Board. The fact that we could not agree on the scope of change has led the Board to resign and call for an Extraordinary Meeting. So it was not of our wish. You could appreciate perhaps that we could have loved to have had longer time to prepare ourselves.

I think we've done our utmost to meet the responsibility of managing a company the size and importance of Novo Nordisk. And I think with the group that we are proposing, we will be able to do that comfortably. And then together with yourselves, shareholders and others, we will develop the Board to make sure that we have the best competencies also for the future.

Thank you, Lars, and thank you, Kerry. And with that question from Kerry, it concludes the Q&A session. Thank you for participating, and please feel free to contact Investor Relations for any follow-ups that you may have. Thank you.

Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.

Day, and thank you for standing by. Welcome to the Novo Nordisk to acquire at Akero Therapeutics, Inc. Webcast and Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded.

I would now like to hand the conference over to your first speaker today, Jacob Rode, Head of Investor Relations. Please go ahead.

Thank you, and welcome to this conference call regarding the agreement to acquire Akero Therapeutics that we announced earlier today. I'm Jacob Rode and I'm the Head of Investor Relations at Novo Nordisk. And with me today, I have CEO of Novo Nordisk, Mike Doustdar; Executive Vice President, Products and Portfolio Strategy, Ludovic Helfgott; Executive Vice President Research and Development and Chief Scientific Officer, Martin Holst Lange. All speakers will be available for the Q&A.

Today's announcement is available at our website, novonordisk.com. Please note that the call is being webcasted and a recording will be made available on our website. The call is scheduled to last for approximately 30 minutes. Today's presentation lasting for around 10 minutes will be followed by a Q&A session. We kindly remind you that the focus of the call today is on the agreement to acquire Akero Therapeutics.

Next slide, please. Before I hand over to Mike, we need to advise you that this call will contain forward-looking statements. These are subject to risks and uncertainties that could cause actual results to differ materially from expectations. For further information on our forward-looking statements and risk factors, please see the company announcement for the first 6 months of 2025, which was released on August 6.

And with that, over to you, Mike.

Thank you, Jacob. Please turn to the next slide. Earlier today, we announced that we have entered into an agreement to acquire Akero Therapeutics. This is the largest research and development-related acquisition in the history of Novo Nordisk, reflecting the strong strategic and scientific fit to our core areas within diabetes, obesity and their associated comorbidities. The acquisition includes Akero's late-stage MASH asset, efruxifermin or EFX. Over 80% of MASH patients are overweight or obese, making this indication especially relevant for the strategy and the purpose of our company.

Novo Nordisk is no stranger to the MASH space. In August, we firmly established our presence in this obesity-related comorbidity with the U.S. approval of Wegovy for the treatment of MASH in adults with moderate-to-advanced fibrosis. As Ludo will tell you, while there has been advancement within the space, there are over 250 million people who are impacted by MASH globally and, therefore, plenty of work to do in developing innovative treatments.

The combination of Akero's robust R&D done to date with EFX as well as Novo Nordisk expertise in developing innovative medicines, including the deep knowledge of obesity-related comorbidities, makes this particular acquisition an exceptional fit. Integrating EFX into our portfolio supports Novo Nordisk's long-term strategy of developing innovative medicine and for treating millions of more people living with diabetes, obesity and their associated comorbidities.

To further elaborate on the unmet need as well as the commercial opportunity that this will bring, I would like to pass it to Ludovic.

Thank you very much, Mike, and please turn to the next slide. This is indeed an exciting day for Novo Nordisk and Akero Therapeutics and, most importantly, for the millions of patients worldwide affected by MASH with limited treatment options. MASH is a serious progressive metabolic disease where advanced degrees of fibrosis are associated with four outcomes and a high economic burden on the health care systems. As Mike noted, over 250 million people globally are affected by MASH and prevalence is growing.

The progression of disease is classified by stages of fibrosis from mild, F1, to a compensated cirrhosis, F4. Current available treatments, including Wegovy treat those who fall within the F2 to F3 space. With around 20% of F3 patients advancing to F4 within 2 years, there is a very narrow window for these patients to receive effective disease-modifying treatment.

We're excited about the progress of Wegovy, the world's first GLP-1 receptor agonist approved for MASH, yet there remains a substantial unmet need for therapeutic interventions. And this need is particularly pronounced for patients with F4 cirrhosis, where there are currently no treatments available. And there remains an opportunity as well to treat nonresponders to the existing treatments in the F2 and the F3 stages.

Efruxifermin is a potential means to that end. In addition to promising Phase II data in the F2-F3 segment, it is the only FGF21 analogue that has demonstrated fibrosis regression in the late-stage F4 segment in a long Phase II trial, which Martin will elaborate on shortly. We therefore believe that efruxifermin has the potential to become a leading treatment option within the treatment intensification segment of MASH with efficacy anticipated to outstrip that of incretins as monotherapy in late-stage fibrosis cases. Overall, the MASH market in its early stages and we aim to develop a portfolio spanning across the diseases stages of MASH.

Now Martin, I'll turn it over to you.

Thank you very much, Ludovic. Please turn to the next slide. As already alluded to by Mike and Ludovic, we are very pleased to announce the agreement to acquire Akero and efruxifermin, a once-weekly subcutaneous long-acting FGF21 analogue with potential to be not only first but also best-in-class in the F4 segment. Efruxifermin complements a strategic position in Novo Nordisk's MASH pipeline with MASH being one of the most prevalent and underserved obesity-related comorbidities.

Efruxifermin has to date demonstrated a positive top line Phase IIb results with the regression of fibrosis and MASH resolution in patients with F2 to F3 as well as F4. Furthermore, efruxifermin appeared to have a safe and well-tolerated profile in its Phase III program. The HARMONY Phase II trial evaluated efruxifermin in an F2-F3 population, where 49% of patients achieved fibrosis improvement of at least one stage with no worsening of MASH and 37% achieved MASH resolution without worsening of fibrosis.

Over 96 weeks, 29% of the F4 patients in the SYMMETRY Phase IIb trial achieved fibrosis improvement of at least one stage with no worsening of MASH. In addition, the trial showed that 42% of the F4 patients reached MASH resolution without worsening of fibrosis. This marks efruxifermin as the first and also only treatment to demonstrate statistically significant fibrosis regression in F4 patients in a Phase II trial.

Please turn to the next slide. The ongoing Phase III SYNCHRONY program is built upon the promising Phase IIb studies of efruxifermin, examining its effects across all MASH stages. The first readout of SYNCHRONY real world is anticipated as early as next year. This is expected to be followed by the pivotal SYNCHRONY histology trial in F2 and F3 in the coming years and SYNCHRONY outcomes for the F4 population around the turn of the decade.

As a result, efruxifermin has the potential to be the first-in-class FGF21 analogue targeting these four population as well as play a role in F2 to F3 patients, including people who are not responsive to existing treatments.

We look forward to leveraging our capabilities to further optimize the SYNCHRONY program trials, assess the potential combinations with our current GLP-1 portfolio, explore opportunities for additional indications and ultimately aim to bring the first pharmaceutical treatment to market in the F4 segment.

With that, I would like to hand it over to Mike for final remarks.

Thanks, Martin. Next slide, please. As we have mentioned throughout this call, the acquisition of Akero and its lead asset is a tremendous strategic fit to our current offering and portfolio, where Novo Nordisk is uniquely positioned to unlock its full potential. MASH represents a patient segment that's closely linked with those of our core therapy areas. While it is one of the most prevalent comorbidities in obesity and diabetes, it's also one of the most underserved. FGF21 agonists are emerging as the most promising non-incretin mechanisms action in the clinical development within MASH.

More importantly, efruxifermin is the only one to demonstrate reversal of fibrosis in the F4 stage, which represents the most challenging yet urgent disease segment to treat.

On a personal note, this marks the first acquisition since I took over as the CEO of Novo Nordisk. While many external factors are challenging us on a day-to-day basis, part of my job is to ensure the progress of our long-term aspiration of ensuring leadership in diabetes and obesity and their related comorbidities. We can only do that by raising the innovation bar to bring innovative medicines to the market and, thus, impact millions of patients worldwide. Today's acquisition further strengthens the possibility to do so, which I truly am excited about.

And with that, back to you, Jacob.

Thanks a lot, Mike. Next slide, please. And with that, we're now ready for the Q&A session. [Operator Instructions] I remind that the focus of this call, including the Q&A session, is on the agreement to acquire Akero Therapeutics announced earlier today.

And with that, operator, we are now ready to take the first question, please.

[Operator Instructions] We will now go to the first question. And your first question today comes from the line of Harry Sephton from UBS.

So clearly, this wasn't the only FGF21 asset for sale over the last couple of months. And you paid a bit of a premium to what we've seen with the others. So I wanted to get a sense from yourselves whether your own failure in FGF21 with Zalfermin gave you any learnings that makes you confident in the potential differentiation for this asset versus Boston and 89bio. Or would you say that the premium that you've paid more simply reflects the derisked opportunity in F4 and the fact that it's further ahead in development.

Harry, thanks a lot for that. I'll give that to you, Martin, on Zalfermin learnings and the competitiveness of efruxifermin.

Absolutely. Thank you very much. So first of all, Harry, I think you've heard at least me talk about from -- in the GLP-1 space. GLP-1 is not just a GLP-1. We see differences across the different offerings in the GLP-1 space. And based on our own learnings from Zalfermin, we tend to see the same in FGF21. So as you know, we have discontinued our own internal program. And we saw a clear differentiation between that and efruxifermin, but we also tend to see a superior efficacy and potentially also safety tolerability profile with efruxifermin compared to what we've seen out there so far.

So we believe that with this acquisition, we not only have healthy potential to be best-in-class, but also, and this is obviously a timing perspective, first in class because it is a more progressed program and, to your point, then also somewhat more derisked.

Thanks a lot, Martin. That is very clear. And also thank you to you Harry for dialing in up for the question. And with that we are ready for second set of questions please.

Your next question comes from the line of Simon Baker from Rothschild & Co Redburn.

It's kind of slipping Harry's question around. If one looks at consensus for efruxifermin, you've either got the bargain of the century or you have more measured expectations and assumptions for the role of efruxifermin in MASH. So just wondered if you could sort of talk us through qualitatively where you really see the opportunity here. You've obviously got semaglutide in F2-F3, efruxifermin definitely in F4. But in your thinking and how you see the Akero acquisition, where is the overlap? And where do you really see efruxifermin fitting in?

I'll hand that to you, Ludo, on the complementarity to the portfolio.

Absolutely. Thank you very much for the question. I think the real objective here is to be able to cover a wide range of patients with MASH across the portfolio. And I think you rightly point out that semaglutide, we believe, has the best data to date on F2 and F3. But we also know that two things are important in order to really complete the treatment of these patients. First is the F4 and the absence of any alternative in the F4 but transplants, which we know have a huge burden on the patient but also on the health care system. So there's definitely here the core of the value proposition.

I would also say that you have some patients in F2 and maybe even more in F3 that are either poor responders to the incretin world or that are fast progressers. And these patients need a treatment as well. So if you sum up the ESSENCE data that was shown by Wegovy and MASH and the data that could be shown here with the Akero efruxifermin compound in this subpopulation of F2-F3 that are either nonresponding as much as we want to incretin or fast progressers, and the core of it, the Fc, you can clearly see the continuum of patients being covered. That's where we believe we can make a difference by this portfolio play.

Martin briefly adding a few comments.

Yes. I think it's important to add that we have data from the efruxifermin Phase IIb trials where a number of patients, 1/3 of patients were on a baseline GLP-1 treatment, that we see added effect when efruxifermin is introduced, so suggesting additivity in the space, which obviously excites us a lot.

Your next question comes from Pete Verdult from BNP Paribas.

Pete Verdult, BNP Paribas. Just one question to Mike, Ludovic or Martin, just my question is on the future development plans. Is there any rationale to open new studies exploring the combination of GLP-1 and FGF21 in either the F2, F3, F4 segments? And could that start before EFX gets approved? And I think Martin, you hinted at taking FGF beyond MASH. So any further comments there would be appreciated.

Yes. Thanks very much, Pete. I think I've alluded to both. We have early data suggesting that combining GLP-1 and FGF21 potentially is additive in terms of efficacy, and we will definitely explore that. We will also get some data out of the ongoing trials as a number of patients already are on GLP-1s in those trials. But specifically, obviously, we want to leverage the full portfolio of what we do. .

There is already an ongoing trial, and you can actually see that in ALD. And we are currently exploring potentially additional indications, but I don't want to go into that at this point in time.

Thank you, Martin, and thank you to Pete Verdult. Let's move on to the next question, please.

Your next question comes from Evan Seigerman from BMO Capital Markets.

This is Conor MacKay on for Evan. I guess maybe two quick ones from us. Maybe sticking with the theme of MASH, is there any early feedback you can share on the recent launch and approval Wegovy in MASH. And kind of building on sort of that offering, how you're thinking about the positioning of Wegovy versus Akero's asset in that indication?

And then sort of secondarily following today's deal, what would be your appetite to do additional deals? And kind of what would those look like in terms of deal size and therapeutic area focus?

Thank you for those, Conor. On the first one with Wegovy uptake in MASH in the U.S., it's still early days and for an update on that, we will revert after the Q3 call. For the topic of this call, we'll turn it to Akero, and we'll turn to Ludo on potential for future deals.

[indiscernible]23:00 Absolutely. I think that Mike said it earlier on, we are committed to help patients with diabetes, obesity and their comorbidities. And as long as you see comorbidities with a strong overlap with the core patient populations we're targeting in diabetes and obesity, we'll, of course, be open to deals if they are innovative, if they really change the games, if you really have the potential to have a leader in the market. So there's absolutely willingness to continue being in the forefront of the race to innovation both internally and externally and in obesity, diabetes and their associated comorbidities.

Your next question comes from the line of Mike Nedelcovych from TD Cowen.

My question is on the broader competitive landscape. We're not too far away from some late-phase readouts of incretins that incorporate glucagon receptor agonism in MASH. So I'm curious how you think FGF21 plus or minus GLP-1 will ultimately stack up against an incretin that incorporates glucagon receptor agonism across the different fibrosis stages?

Thanks a lot, Mike. Martin, on different mode of actions within MASH, I'll turn it to you.

Thank you very much. So I think it's clear, given the glucagon mechanism of action, we expect to see an impact on steatosis. Exactly how that will read out in fibrosis and outcomes, I think it's too early to say. We are obviously also curious to look at the safety and tolerability profile. I think vis-a-vis potential combination, but also, to be honest, in monotherapy, FGF21 or FGF21 plus GLP-1, we do believe that there is a potential to be best-in-class as we communicated, and this is why we strongly pursue these combinations.

Your next question comes from the line of Michael Leuchten from Jefferies.

Two questions, please. Could you please comment on your IP assumptions around the protection for EFX. And then secondly, on manufacturing, EFX has made in E. coli. I don't believe that's one of your existing capabilities. Just how do we think about investments into capacity?

Thanks for those, Mike, stretching a lot with two questions. But otherwise, I'll turn to you, Ludo. On IP first, we can't share too much for IP and then on manufacturing.

No. On this one, we're not sharing. On the manufacturing side, you're very right. It's not in the existing platform, but we don't expect to have any CapEx investment from that perspective. They are, we believe, in the market today players with which we could work and CMOs which we could transact in order to make sure to get the product to patients. But we're not forecasting any CapEx on the e.coli platform.

Absolutely. So that's a capacity and nothing on IP concern. So thanks for that, Michael. And let's move to the next question, please.

Your next question comes from the line of Seamus Fernandez from Guggenheim.

So I wanted to just clarify the definition of F4 for the CVR or at least the approval dynamics in the CVR itself. Is that an accelerated approval by 2031 for compensated cirrhosis? Or is it a full approval that's required? And can you just remind us what the requirements are at FDA for accelerated approval in F2, F3 versus full approval? And then maybe you can just remind us what you think or what's encompassed in the CVR in that regard?

Thanks a lot. I think on the CVR, we don't go into specific details. You're right on the data indication tiering. And I think maybe I'll turn it to you, Martin, to speak about the SYNCHRONY trial in F4 overall.

Yes. So you're right. As you know, the FDA has a setup, and we know that also from F2 and F3. And we are currently following that setup in F2 and F3 also for the ESSENCE trial for Wegovy, where we get a, so to speak, conditional approval or accelerated approval based on histology, that's fibrosis and steatosis. But then you have to also generate outcomes data. That's a composite of liver-related endpoints, liver-related death and CV death. And that's where you see these longer studies.

Thanks a lot, Martin. And thank you also to you, Seamus. And let's move to the next question, please.

Your next question comes from the line of Thibault Boutherin from Morgan Stanley.

Just a question on the co-formulation or potential for co-formulation of EFX and semaglutide. Is that something you're interested in? Do you see any technical challenge in doing that? And could it be done with something simple like a bridging study?

Thanks a lot, Thibault. And for that, I'll give it to you, Martin.

Yes. Thank you very much. Very relevant question, but too early for us to speculate in. Sorry.

Thanks a lot Thibault and let's move to the next question, please.

The next question comes from the line of Florent Cespedes from Bernstein.

A quick one on the financial aspects. Maybe could you give us a little bit more color on how do you see the impact of this acquisition in the coming years? Is it fair to assume that we should have a kind of low single-digit dilutive impact on earnings in the coming years, if I'm referring to what you stated on the press release on the 3% impact on operating profit for next year?

So thank you very much for the question. And I would start by saying that, first of all, this is an investment for our -- in our portfolio. So it's, for me, something which is important for the future of our overall development of our franchise. And that should be maybe the leading thought when coming into that.

We -- if you look at '25, we're not expecting any change in the OP outlook for '25. We might have a minor cost in Q4 linked to the R&D line and the transaction cost, but it's nearly nothing. In '26, as you saw rightly, we're expecting a negative sort of -- sorry, minus 3% impact on the [ EOP ] growth driven by the increased R&D cost. This is really again an investment on the R&D cost for the Phase III trials that Martin was alluding to earlier on. So that's what we are right now planning.

Thanks Ludovic. There is R&D investments in potential future growth. That's very clear. And thank you also to you, Florent. Then with that, I think we are ready for the last question, please.

Your final question today comes from the line of Mattias Häggblom from Handelsbanken.

A question for Mike. So it's no more than 2 months since you took over as CEO. So how did the BD team have time to apply your strategic lens on how to allocate capital to business development in this short period of time? I guess, said differently, how could you find confidence this was the best use of capital this early in your tenure?

Thanks very much, Mattias. So we have been looking at a number of assets for long period of time. Things didn't start with me taking over as a CEO. But of course, it reflects the fact that, as Martin and Ludovic said, that we are continuously in the outlook for best-in-class and possibly first-in-class assets within our strategy. And today's announcement was a confirmation of what we have figured out that we have actually something in our hand that we could be very proud of, hopefully help develop it and bring it to the market.

And I think it's extremely exciting because it is an asset that not only will help millions and millions of patients very closely connected to the strategy and the leadership we would like to sustain and grow, but also I think it's a very important building block for strengthening our top line as we get closer to the LOE of semaglutide. So I'm super excited about today's news.

Thanks a lot, Mike, that's very clear. And also thanks for the question.

Then with that, we are ready to conclude the Q&A session. We'd like to thank you for calling in and participating. And as always, please contact Investor Relations with any follow-ups that you may make. Thanks a lot, and have a good day.

Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.

?

Okay. We are good to go. Welcome to this Novo Nordisk fireside at the 61st Edition of EASD here in Vienna. Welcome to all of you in the room and also welcome to those listening in online.

Today's call will focus on the R&D and in the pipeline, and we're here today with Martin, who will take us through some of the developments later. Before we get into it, just a usual word of caution in terms of the forward-looking statements and that the future is unpredictable, that pertains, in particular, when it comes to the pipeline.

In terms of the format, Martin will spend a few minutes on some opening remarks. After that, we'll turn it to you in the room where we go around with 1 question each, and we'll take the discussion where you would like to go. As said, we'll focus the call on the pipeline and R&D events, both pertaining to the EASD, but also to the pipeline overall.

So with that, welcome, and over to you, Martin.

Thank you very much. So basically, I'll just talk a little bit about the new R&D organization that has been created in Novo Nordisk. As you know, for the last 5 years, we've had 2 distinct organization, research and development. And we back in August, decided to remerge those two areas.

This was done to create the strategic but also -- and maybe primarily the scientific synergies that we see from early research to the later stage development, but more importantly, also actually feeding the clinical data that we generate back into research, driving not only new targets and target discovery, but also supporting some of the propositions that we are developing in research.

As also, I have to say, a little bit of an efficiency game by collapsing to organizations. So from an execution perspective, we can see already now that we are making faster decisions. We are progressing faster in terms of not only our research, but also our clinical pipeline and obviously, having the new organization in place already, it was announced mid-August. So it's been in place in approximately a month. That is quite gratifying.

So you also heard it from Mike, and we discussed it a little bit at the roadshow in August. Our strategy has not changed. We are diabetes -- we are an obesity company. Our key research but also development focus will be in the obesity, in the diabetes space. But we've received some questions, are we then walking away from commodities? We are not. We are very serious about not only understanding but also treating the comorbidities that are related to diabetes and obesity.

But we allow ourselves to say when we are, for example, looking at cardiovascular disease, there are more than 200 distinct diagnoses in cardiovascular disease. And if you have cardiovascular disease, but not obesity, maybe that's not where Novo Nordisk will do innovation. So we're focused on addressing the cardiovascular, the renal, the kidney diseases that are related to and typically stems from diabetes and obesity. So that's our focus. And then obviously, we also have our focus on Rare Disease. And I guess we'll not discuss that too much today.

This has been a very exciting EASD for us. It to an extent, reflects our obesity, our diabetes pipeline. We have, at this EASD shown new data on semaglutide. You know our pledge, we will continuously serve patients suffering from diabetes, from obesity with semaglutide and generating new indications. But also generating new offerings in this case, in the space of higher doses of semaglutide. So we've now shown that we can accrue a full 21% weight loss with semaglutide in obesity. That together with a well-known safety and tolerability profile and obviously, the CV benefit, the MASH benefits, we believe, creates a unique offering in the space of obesity.

This has been filed for European regulatory approval already as we speak. And as was disclosed yesterday, I think, by me. We also have a plan and intend to do U.S. regulatory filing during Q4 of this year. We are disclosing the details of the oral version of semaglutide for obesity later today, and that is still -- I don't think it's out yet. So that is still under embargo, but you heard me talk about the data, 17% weight loss, well-known safety and tolerability profile. And obviously, with the current U.S. regulatory review, part of our review process is disclosing with the regulators if the CV benefits that we know with semaglutide, the subcutaneous semaglutide can also enter the oral semaglutide label in obesity.

We're moving beyond that. All of our [ CTs ] are obviously very exciting and you have been kind enough to show a lot of interest in those. But you've also often time asked how does that translate into real-world evidence. And we have, at this EASD seen a number of real-world evidence studies. Some -- most focusing on the cardiovascular benefits of semaglutide still, some using a standard of care comparator and then there's one study using an active comparator. In all cases, confirming the benefits that we know from semaglutide.

And also a little bit what we've discussed before, from a numerical perspective, semaglutide does seem to stand out in diabetes. That's where we have the most comparative data with a 26% CV risk reduction. And in obesity, we would expect to see the same, but we also had to acknowledge that at this point in time, semaglutide is the only molecule in the obesity space that has established CV benefits.

But all of that being confirmed by real-world evidence, which is obviously really, really gratifying for us. And then we have shown data from our pipeline, CagriSema and amycretin and so on. So very, very exciting. Doesn't stop there. We'll have a busy year and moving towards the end of the year, we'll see the CagriSema readout for type 2 diabetes, the REIMAGINE program.

I just want to caution you because that will always create noise. The first study to read out is REIMAGINE 3. That is add-on to insulin, and that's maybe not the first study where you will see a good indication of what can CagriSema do in type 2 diabetes. So just to level that the first pivotal study will read out actually after REIMAGINE 3. And that's basically the duration of the studies that is driving that. But just to call that out.

Then obviously, very interesting also in the space of type 2 diabetes, we'll see the readout for amycretin, obviously, that is also going to be very interesting. We primarily see amycretin as an obesity drug, but given the biology of both amylin and GLP-1, obviously, it's prudent to investigate the diabetes potential as well. And then we are aiming to do the resubmission of once-weekly icodec in U.S. As you know, this has been approved in a number of countries outside of U.S. and actually also launched outside of the U.S. and the U.S. resubmission is from a patient-centric perspective, very important to us.

In the obesity space, I almost don't know where to start. Obviously, the regulatory approval of the oral semaglutide, so that we, as per plan, can launch oral semaglutide in U.S. Q1 of next year. That is going to be interesting. The REDEFINE 4 results and regulatory submission in U.S. That's not so much for this year, maybe at least the REDEFINE 4 results. That's for Q1 of next year. So that is also going to be very exciting.

And then I think this year, cagrilintide Phase III initiation, I saw some interesting sort of speculation on what does that mean. And just to spend 2 seconds on that. And I know [ Jan ] will want to go into Q&A. I sometimes get a question, why would you launch a drug that only gives 12% weight loss? And that's very, very clear. And you -- some of you have heard me talk about that before.

We see obesity as a complex disease, a disease where individual patients have individual needs. And just to give you an example, if you have BMI of 30, a 25% weight loss will get you to a BMI of 22, and that is maybe not what patients want. Maybe that patient would like to have 12% weight loss with fewer side effects. And we know from REDEFINE 1 that cagrilintide monotherapy gives exactly that 12% weight loss, at least in that study and approximately half of the gastrointestinal side effects that we saw with the GLP-1 analogs.

So we do believe that there is a substantial proportion of patients living with obesity that will benefit from that treatment. Then the way we think about it, Wegovy or semaglutide, is for a slightly higher weight loss and a focus on comorbidities. And then from a pipeline perspective, moving into the higher weight losses with CagriSema, with amycretin, with our triple agonist and also focusing on comorbidities there.

I think it's important to call out there is room for a moderate weight loss, low gastrointestinal side effect drug in the obesity space. And what we take a lot of comfort in is that we can actually serve all of those -- all that broad spectrum with our portfolio. And then both, as we've just discussed for semaglutide, but also for amycretin the oral offering. And just to point that out, when we initiate Phase III for amycretin, the program will contain both subcutaneous, but also all subprograms, so we pursue both.

We'll see later this year, Phase I results from our tri-agonist. That's going to be the first readout. And just a disclaimer, this is not developing as we did for amycretin. So it's going to be a reasonably small study. It will lead to a Phase II program because I cannot conclude definitively because it is a small and short study, I cannot conclude definitively on dosing, on efficacy and safety. So we'll go into Phase II there, just to call that out.

And then obviously, later we'll see the readout from the other tri-agonist. And I hope all of you know the difference. The first tri-agonist is GLP-1, GIP amylin. And the second one, the [ UPT ] asset is GLP-1, GIP and glucagon, filling our pipeline with a differentiated range of molecules. And then obviously, the newly acquired LX9851 which is the Acyl-CoA Synthetase inhibitor, I really am tongue twisting myself here, which is also going to be interesting. We see that as a potential play as it's a small molecule. So that would be an oral offering also in the space of obesity.

And similarly, in Rare Disease, I think Ludovic is now covering the full spectrum of our portfolio, but he still has a heart for Rare Disease. So he is looking forward to the submission of Mim8. He's been waiting for that -- and then obviously, we are very, very interested in seeing the readout first with the evoke trials in Alzheimer's disease. [ Jacob ] wants to caution me, and I agree with him. This is high risk, the attrition in Alzheimer's by definition because of the nature of the disease and also the nature of how we are allowed to do clinical trials is high, the risk is high. But obviously, we are very, very interested in the data. And then we are also looking very much forward to ziltivekimab readout out in 2026.

So exciting times ahead. And at the same time, with my new job and new title. I'm obviously also focused very much on building the research pipeline and portfolio. And I was about to say something I was not supposed to say. But in the not so distant future, you will hear more about what we plan to do with the research pipeline and how we progress that.

I think with that, we're ready for the Q&A margin. Thanks a lot, clear on the [ reorganization ], the EASD program and then also the pipeline as well as the clarification in terms of optionality for sema and [ sema 7.2 ] submission.

Let's move into Q&A for the next 35 to 40 minutes. One question per person, please. And let's start on the front row with Mr. Parkhoi.

Martin Parkhoi from SEB. Could you maybe set the scene a little bit more on the expectation for the evoke trial? Maybe with the outcome in the baseline and what would be the normal progression of such a patient? And what will be good data?

So now you're asking for a super complicated answer. Martin, I apologize for that in advance. The primary endpoint is a regulatory endpoint. And that is basically the gold standard from a regulatory perspective in both U.S. but also outside of the U.S. It's called CDR sum of boxes, clinical dementia rating. And it consists of 6 domains in which domain you can get a score from 0 to 3, 0 being normal, 3 being substantially cognitively impaired. And you basically then get a sum, hence the name CDR sum of boxes and the highest sum that you can get is by inference, 18, so 6 times 3. And that would basically indicate a very, very, very cognitively impaired person or someone suffering from severe dementia.

Normal is 0. And that basically also means that any delay in progression from 0 towards 18 is clinically relevant. And that means that how I measure success is of statistical significance. That will lead to a label update, and that will be clinically meaningful to a patient.

I mean, let's say, I say -- tell you that I see a 10% improvement of CDR sum of boxes over placebo, doesn't make sense to you. But if I tell you that I can delay the progression by, let's say, 0.5% or a full point that's actually clinically meaningful. That's the difference between moving from mild cognitive impairment to mild dementia to more severe dementia.

And if we can show that study is powered to show a difference of 20%. And again, that would actually -- I mean, what 20% of 18 is. That basically means that's what we've powered the study for, but we also now know that we can actually detect to the low teens in terms of statistical significance. And based on our dialogue with treating physicians, that's still very clinically relevant because it implies a delay of progression to the next and most severe level of dementia. Sorry, long answer.

That's very clear. Thank you, Martin. Let's move to Michael also in the first row.

Michael Novod from Nordea. Just trying to figure out, Martin, how is the thinking around the different CagriSema co-formulation and then comes amycretin. So what happens to CagriSema's normal form dual chamber. If co-formulation is successful, how fast can you progress it from now and we know that you're sort of through the first step. And then sort of the overall split going forward between those 3 drugs, I would say.

Absolutely. It's also a little bit of a talk that you need to have to -- with Ludovic after this. But the co-formulation is to allow us flexibility in terms of how we scale. As you know, we are already planning to scale the dual chamber device quite substantially. So we are prepared for a full scale launch when we get the approval, starting with U.S.

That being said, we also know that the dual chamber device is a single-dose device, and if we can co-formulate and have that co-formulation in our PDS290 or FlexTouch, that will give us more flexibility. And that basically means that these 2 offerings maybe not in the same country, but that remains to be seen. These 2 offerings can coexist. They basically will allow us a global flexibility in how we scale our production. Amycretin, in the base case, amycretin will have the same safety, tolerability and efficacy as CagriSema. It's still a very valuable offering for us because it's 1 molecule. And it definitely goes into a single chamber device because it is only that 1 molecule. And it's 1 API. So from a scalability perspective, at the very least, it's 1 API versus 2 APIs and it can for sure, go into whatever device we need it to go into.

But these are early days, we don't know the clinical profile of amycretin, you've seen the data today, was it yesterday? We presented the data, 60 milligram, 36 weeks, 24.4% weight loss that holds a promise of a substantial weight loss with amycretin. I don't want to sit here and say, I think it's going to be better than CagriSema, but there is that possibility. And it doesn't seem that we need to compromise on safety and tolerability go into that weight loss.

So there is a really, really strong base case for amycretin, but there is also a very exciting upside that we need to show in Phase III.

Thank you, Martin. That's very clear. So for dual chamber base cases launch with a relevant upside for co-formulation. And I'm sure we'll get back to the MACE program later, if I notice one from audience as well. [ Carsten ]?

Thank you. I'm guessing many of us were just at orforglipron presentation, but there was some commentary in the end about patient dropouts and how it has become increasingly difficult to keep patients on clinical trials.

I've heard that too. Yes, I can recognize that...

No, I was just interested in hearing your opinion on that.

I have to say, I mean, we all run trials in different ways, in different countries and at different sites. So we are obviously happy with our model. We have not seen -- and I think this is important. I mean, at this point in time? Including compounding, we are maybe treating 3 million patients in U.S. total.

And that means that an argument of patients dropping in and out because there's availability of in-market drug in a space where we are still not treating just in U.S., more than 100 million people. I'm not sure I fully recognize that. And we don't see that in our own trials. I mean it's -- you've seen us report on trials all the time. I don't think that we've seen that. I don't want to rule it out. I just have to say at this point in time, I cannot recognize.

Very good. Let's move to the next question. Let's go to Kerry and then to James afterwards.

Kerry Holford. Things have evolved more positively for cagrilintide and clearly now progressing the Phase III monotherapy. Can you talk about how you plan to progress in manufacturing of that product as I believe previously, manufactured or planned to be manufactured externally. Is that view now changing? And if so, if you're thinking of now brining this in-house, how do you balance it with the development of sema?

Yes. So I don't want to go too much into detail. You're absolutely right. We have started out by producing cagrilintide outside of our own facilities. But as you also know, we've invested heavily in building facilities over the last couple of years. And that is exactly to get the flexibility across. And I just showed you some of the -- or basically the late-stage pipeline. But with the ambitions that we have from research, we're also moving more into the clinical space.

Obviously, we need to maintain that flexibility. And that means that we will continue to produce I would say, more and more because we get more and more capacity in-house, but I do not want to rule out that cagrilintide or some future molecules will, at least in the beginning, be produced outside...

Question to James.

James Quigley from Goldman Sachs. Just picking up, continuing on the theme of cagrilintide monotherapy into the Phase III. Could you give us a flavor of what the Phase III design could look like? How many trials, whether you plan to do a CVOT, obviously, orforglipron didn't have one and it doesn't seem to matter in terms of the commercial execution at the moment? And then to pick up again on Carsten's point. I think 1 of the reasons why the discussion said the clinical trial dropout rate was higher but also because of the forced up titration. So will that happen in your trials? Or will you have a more of a CagriSema type?

I got beaten up a little bit on REDEFINE 1 because of not doing forced titration. The wonder of it was actually the patients who were allowed to do flexible lost more weight and people tend to forget that. I think you will also see for amycretin, but certainly also for cagrilintide we will not use force-titration. And this is exactly the reason.

In REDEFINE form, we had one-off, if my memory serves me correctly, actually the lowest discontinuation rate in this space. And considering a 23% weight loss, that is pretty amazing. And that's basically because patients were allowed to titrate. So they one, actually lost a lot of body weight. But two, also could manage the speed of that body weight loss and three, and that's to your question, also could manage the gastrointestinal side effect. And just to give you that example in REDEFINE 1, we saw with cagrilintide approximately half of the gastrointestinal adverse events that we saw with the GLP-1 analog.

And for CagriSema, we saw the same gastrointestinal side effects as we saw for the GLP-1 analog. So this works not only from a clinical trial perspective, but also from a, I would say, a real world perspective, we're trying to -- mimicking what we know is happening in real world. And again, I just want to remind you of the patients who used flexible titration in REDEFINE 1, they lost 26% on CagriSema.

So we believe that works, and that is something that we will continuously adjust. I mean, we listen to treating physicians. We obviously also listen to key opinion leaders, but we also listen to patients. And we're trying to understand exactly with different offerings, what is the best way to treat. And I think Ludovic and I share that hobbyhorse of being patient-centric in how we both develop our drugs but also how we approach our patients.

To your question, the initial trials are actually quite simple. Aiming to get a very fast approval. We will build on those trials, also maybe testing higher doses. And we will also generate data in more subpopulations. Too early for me to say if we will do a cardiovascular outcomes trial. I think what you're hinting at is that there has been a notion that CV benefits is a class effect. I think recent data suggests that it's really, really not. I don't belittle that most GLP-1-based therapies have CV benefits. I'll just remind you, 26%, and we only have the comparative data for diabetes, 26% in diabetes for semaglutide, second best is dulaglutide and liraglutide and now tirzepatide with 12%.

And then there is a couple that is even below that. So from a numerical and from volume or the benefit perspective, there is a difference. And then there's always the joke that I love to mention, albiglutide that is -- that was taken off the market, didn't give a very good weight loss, didn't give very good glycemic control, but a 22% reduction in CV MACE. That speaks to there's something in these GLP-1 analogs that we don't understand. That is not generic for GLP-1 analogs. And again, we believe that semaglutide stands out. And I hate to quote Martin Parkhoi, so he can do it himself.

Thanks, Martin. Thanks, James. And then one reminder on trial design is, of course, a keen eye on dose re-escalation as part of it. Let's move to the left-hand side and Richard Vosser, please.

Richard Vosser from JPMorgan. Actually, on cagrilintide again and trial design, but also Amylin 355. Just with cagrilintide, your competitors are doing some maintenance trials, I think, with their small molecule. One area where you could think about that maybe with albiglutide monotherapy as well.

So just your thoughts there on maintenance and probably linked to James' question, if you're going to do maintenance, then do you have to prove a CV benefit for payers? Because that's what they really want. And just Amylin 355, just your latest thoughts on what the best approach to Amylin is calcitonin balance?

For better or worse, until I see that readout. I have to give you my usual answer. None of us really knows. And I really want to see in our hands that differentiated approach. As you know, we have more focus on Amylin and then cagrilintide is a dual acting.

So it's -- that's going to be interesting. On maintenance, I actually agree with you. And that's also, again, why I'm really, really happy with our portfolio. We can think about cagrilintide as a maintenance therapy. I don't want to rule out that CV data will be required in that space. We can think about. And again, in that context, oral semaglutide as a maintenance therapy. We can actually also think about just lowering the dose.

But I do want to call out and I'm doing the same thing. So it's not that most of us think about maintenance in obesity as less intensive than the weight loss therapy. But if we compare obesity to, let's say, diabetes, hypertension, dyslipidemia, also metabolic and progressive diseases over time, more intensive therapy is required, not less.

So what we need to prepare for, these are early days in obesity, none of us really know, is that maybe there is a time where you have to do less intensive therapy because that is okay, the first couple of years. But we cannot rule out that over time, we will also be thinking about more intensive therapy. And again, a differentiated portfolio with drugs that could potentially be added on or be switched to a more intensive therapy. We believe that's the way to go, and that's the way that we serve the full obesity population, not only now and next year but also for the longer term.