Novo Nordisk - Earnings Call - Q2 2025 London Conference Call
August 7, 2025
Transcript
Speaker 4
Welcome, everybody. I'm James Quigley, European Farmer and SDR at Goldman Sachs. It's my pleasure to welcome you to the Novo Nordisk results presentation. Today we've got Karsten Knudsen, CFO, also joined by Martin Lange, our Chief Scientific Officer, and David Moore, Head of North American Operations, and I hope I've had a product and portfolio staff. Karsten is going to kick off as usual with the presentation, and then we'll go straight into the Q2 analysis. Karsten, thank you for joining us.
Speaker 5
Thank you, James, and welcome to the Novo Nordisk Q2 results meeting here in London, the launch meeting. Thank you all for coming, and thank you to the ones listening in online. We have a good team here. We have Martin Lange in his first day as Chief Scientific Officer of Novo Nordisk. Congratulations to you, Martin, on that one. I think a good timing of becoming Chief Scientific Officer. We'll talk more about that later. Dave Moore from the U.S., a known person, President of our U.S. business, and Ludovic from running Commercial Strategy and our Portfolio Planning. We're going to go through our results briefly, and we're going to host the Q&A session moderated by Jacob Martin Wiborg Rode, our Head of Investor Relations. As always, there will be forward-looking statements discussed today, and forward-looking statements are associated with risks and assumptions.
Unfortunately, that's also what we saw last week with our downgrade because we made some assumptions that unfortunately didn't fully pan through, and that's why we had to downgrade our outlook for the year that I'm sure we'll come back to. Talking about the results in the first half of the year through our strategic aspirations, I would say we continue to expand our patient reach, and I think this is really the core of Novo Nordisk, driving change for patients suffering from serious chronic disease, progressive diseases within diabetes and obesity. Now we're serving more than 45 million patients. We added more than 3 million patients compared to a year ago. It speaks to the scaling of our business and also the future prospects of what we're operating under. On the commercial side, my colleagues will come into it, and the same for R&D and financials.
We delivered 18% top-line growth at constant exchange rates in the first half of the year and 29% operating profit growth in the first half. Operating profit was impacted by an impairment in the first half of last year and then some additional costs due to M&A and cash flow this year. Net-net, operating profit underlying is closer to the 20% growth, but still very healthy operating profit growth. In terms of cash flow generation, that's of course a key premise for the company. We generated here almost DKK 34 billion in free cash flow despite investing DKK 28 billion in CapEx in the first half of the year. We returned also more or less our full free cash flow to shareholders here in the first half of the year. A disciplined approach on capital allocation. I'll hand it over to Ludo for a commercial update.
Speaker 1
Very quickly, from a sales perspective, the region U.S. actually grew 17% in the first part of the year, and the IO grew 19%, which is an overall 18% growth for Novo Nordisk in the first half of the year. If you look at the IO in particular, really double-digit growth on UK and emerging markets and APAC, and a 6% in China. I'm sure we might come back to that at a later stage. From a therapeutic area perspective, you can clearly grow an 18% overall growth logically. GLP-1 diabetes plus 10%, the obesity care 58%, and the rare disease actually back to growth with a 15% growth rate across the board. Of course, with Dave here, we can delve a bit more into that, I guess, at some point.
If you look from an IO perspective, the international operations growth, so 19% driven by the GLP-1 diabetes and obesity care, you had this overall GLP-1 diabetes care sales growth, 10%, as said, with double digits in UK and emerging markets and APAC, and this decrease in China, which is driven by the market itself. It's not a competition issue. It's actually a market expansion discussion. We might want to talk about that at a later stage. On the obesity side, in IO, a growth of 125% versus last first semester in 2024. UK 64%, emerging market 157%, and then 361% for APAC. China is growing a lot, but of course out of a small base. Mathematically, it doesn't make much sense, but really a healthy growth on obesity care in sales and growth for the first six months in IO. Over to you, Dave, for the U.S.
Speaker 2
Thanks, Ludo. When we think about the obesity market in the U.S., everyone knows we're in a competitive environment. We're in a competitive environment with Eli Lilly. We'll talk a little bit about that. We're also in a competitive environment with fake, cheaper alternatives of our medicine that's being imported by China, which we are keenly focused on putting an end to. We go back to competing in the branded obesity market. If you think about the dynamics in the branded market, this is what we typically see when you have the lead, the first mover position, another product comes in. It's an easier position to be in, to go into the doctor and say, switch to my product, start new patients on my product. By the way, I experienced the same thing when I launched Ozempic versus Trulicity, and it works. That's the dynamic that we had.
What we learned in the beginning of the year, I took this job over in January. There was a shift last year just in terms of messaging. Actually, it makes sense. You have select data. It's compelling. It's meaningful clinical data, real-world outcomes. You switch the message to be beyond weight. That was actually the name of the campaign, Treat Beyond the Weight. What we learned is it was a little premature to do that. There probably will be a time to do that. There's a meaningful discussion to have around comorbidities. There are two players in the game, and it's still about weight loss. That's the primary reason for prescribing, is around weight loss. It's what patients are looking for. It's what doctors are looking for. We changed that message in June to go back to driving the weight loss competitive message.
We have real-world data that is head-to-head versus tirzepatide and semaglutide. We have semaglutide data where we follow patients for two years, and we see the average weight loss is 20%. Actually, it just got updated to 21% because we continue to follow these patients in the We Go Together campaign. That's starting to resonate again. We're starting to see the impact of having that weight loss message. Once we solidify that competitively, you move on to the other elements, right? You have a discussion about the other aspects. What we're starting to see is a shift in NBRXs. NBRX is our sign of health. It's the leading indicator. How's your brand doing? From about April, May 2024 to May 2025, the NBRXs were going down. That's a bad indicator of your health of your brand. We're still growing. The market's growing.
You can see there's growth, but the NBRXs were going down. In May, that has stopped, and we're starting to see growth. We're seeing growth with Wegovy competitively, especially versus devices. Nationally, NBRX of Wegovy device passed Zepbound device, and that is in part due to CVS conversion, but that's not all of it. It's also that we're seeing growth outside of the CVS conversion. We will continue in this competitive dynamic. We now have an opportunity to go out and talk about a difference in CVOT outcomes. Once again, we saw outcomes last week with the surpassed data, and our reps are armed to go in and say that this is not a class effect. It's very easy to walk in and say, you know, we have a little bit better data, and by the way, it's a class effect. They'll all be the same. It is not.
They're not the same. 12% is not 26%. That's a conversation with Ozempic. It's also a conversation with Wegovy. Moving forward, in weeks, we'll launch MASH. MASH is a primary indication, one that entire companies have been built upon, and we have an opportunity to go out and differentiate Wegovy further in terms of that strength of the label and go out and start selling in the MASH market. We have a dedicated sales force, small. We've hired about 130 people. They'll call on hepatologists and GIs. There's only about 300 hepatologists in the U.S., and we'll focus on about 15,000 gastroenterologists, and our obesity sales reps will be armed with the MASH launch. Remember, it's about 80% overlap with obesity, 40% overlap with type 2 diabetes. We're not waving any victory flags. We've got a long way to go, but this is a growth story.
It's an expansion of the obesity market story. In the beginning of the year, we'll be launching oral semaglutide for obesity, and we'll come back to that in a little bit. Over to you, Mark.
Speaker 4
Thank you very much. With Dave here, obviously, as you all remember, we filed oral semaglutide for obesity in the U.S. earlier this year. We expect to see an approval of that filing towards the end of this year with a strong U.S. launch starting 2026. Just to remind you of the data, with oral semaglutide in obesity, we saw a 16% weight loss, almost 17% weight loss, with the safety and tolerability profile that we already know very well from semaglutide subcutaneously. We are actually able to achieve the same weight loss, the same safety and tolerability orally as we do subcutaneously. That is very, very strong. Again, 17% weight loss, we think that is going to be unsurpassed for a long period of time.
In addition to that, and this is a potential, we aim to have the comorbidity benefits in the label, starting with the MACE benefits that we know well from subcutaneous semaglutide. A really, really exciting offering in the obesity space to be launched in the U.S. by David and his team early 2026. Broader in the R&D space, you know our focus on diabetes and obesity. We also have other therapy areas, and we see progress and activities across the board. In the diabetes space, it is going to be very exciting to see what CagriSema could do in re-imaging pre, i.e., glycemic control and weight loss in patients with type 2 diabetes for CagriSema. It is going to be very interesting to see the phase two data for amycretin also in the diabetes space. In the obesity space, we continue to progress.
We aim to have a 7.2 milligram EU submission already here in Q3. We aim to see the readout of our triple agonist, and importantly, we will initiate the kagrelantide and monotherapy phase three program also later this year. That is going to be incredibly exciting in the diabetes and obesity space. I would be remiss, Ludovic is no longer so interested in rare disease, but I still had to mention U.S. approval and positive CHMP opinion for Alhimo, and imminent regulatory filing of Mymate. In other disease areas, we closed down Salpermin, not because it was a bad offering. It was just not better than semaglutide. As you know, right now we have, at least in the phase three space, the strongest data in MASH. As Dave mentioned, we expect regulatory approval for that in the U.S. within a couple of months. Finally, the evoked data.
I have to remind you, we see that as high risk, high reward. The readout will come towards the end of the year in Q4, and it is going to be exciting. With that, back to you, Karsten.
Speaker 5
Thank you, Martin. On outlook, which we announced last week, we lowered our outlook linked to predominantly a lower volume growth in the U.S. compared to what we expected back at our Q1 release. Lower volume outlook for Ozempic and Wegovy. Dave was just touching on that we do see positive signs on Wegovy now over the last few weeks and data points. Sales growth outlook now 8% to 14% for the full year and operating profit 10% to 16% for the full year. Currency is updated based on July 31. A slight tweak compared to last week. Now 3 and 5 percentage points lower respectively, mainly linked to the U.S. dollar and the corresponding adjustment to net financials linked to the hedging of our core currencies.
CapEx unchanged, while free cash flow is reduced to between DKK 35 billion and DKK 45 billion, mainly as a function of the lowest U.S. outlook amplified by the gross-to-net payment term in that model. That's really what drives the cash flow delta compared to the Q1 guidance. There are a few comments around cash flow in the second half of the year versus what we realized in the first half of the year. The simple explanation is really twofold. One is higher CapEx spend in the second half of the year compared to the first half of the year. The second reason is that on-account tax payments, mainly in Denmark, is back and bloated into the second half of the year compared to the first half of the year. Adjusting for that, it's way more normalized in terms of cash flow generation across the year.
That covers the financial outlook. Now we're ready to move over to Q&A. Over to you, Jacob.
Speaker 4
Thank you, Karsten. Thank you, Dave, Ludo, and Martin. We played by the usual ground rules. One question per person, please. Please state your name and institution, and we'll start with James, our host. Thanks.
Speaker 1
Thank you, Jacob. James Quigley from Goldman Sachs. A quick question, Martin, on orphaglypharon, phase three data from a team one has just been released. The placebo-adjusted weight loss of around 11.5% at 72 weeks, 24% vomiting, 10% discontinuations at the highest dose. What is your view on the product relative to Wegovy and to oral semaglutide, 25 milligrams? Dave and Ludovic, you had a good slide in the back of the presentation yesterday on the segmentation of the market. Does this data change how you think the competition will develop in those segments? Thank you.
Speaker 4
I think the numbers speak for themselves. If we were to compare 17% weight loss to 12% weight loss, withdrawal rate due to adverse event on the highest dose of 10% versus 7%, overall withdrawal rate on the highest dose 25%, which was, I think, 18% for oral semaglutide 25 milligrams, it speaks for itself. It appears that, and again, it's an indirect comparison, there is a substantial difference in weight loss potential, but also in the safety and tolerability profile between the two offerings. At the same time, we can scale oral semaglutide, and therefore, I think it's fair to say we're super excited about launching that product in a competitive space.
Speaker 2
We're really excited to launch this product. This is a good old-fashioned Novo Nordisk launch where we have a competitive, compelling profile. The reason we decided to move forward with this launch, regardless of oral, was because we had a product with meaningful weight loss, with a known compound, and familiarity and safety in millions of people using this worldwide, in addition to the broadest label. That's the reason we decided to bring it forward. We know what 16%, 17% weight loss means. What we're really excited about is this sort of segment of the market that are not motivated to go and seek treatment today, either because of the way they see their disease or they're not motivated to go and seek a medicine that would require an injection. There is another segment of people out there living with obesity that are very interested in an oral daily GLP-1.
We're going to treat it that way in an unconstrained type of launch in the U.S.
Speaker 1
If you take a step back, the whole idea that we shared, which is this idea that you don't have one single population of people, patients with obesity, but actually subsegments of them, can only be reinforced by that view. We don't believe that, if anything, we believe that the share of the oral market will actually grow significantly given the quality of what you have here, efficacy-wise, tolerability-wise, and including with the cardiovascular benefits, we can really bank that into the profile. That will be very helpful to start unlocking all these groups of segments that are today not really already getting to the obesity market, but we'll get there. We start to have quite precise ideas of who these groups could be. In other words, we believe in the oral part of the market.
We believe that the Wegovy pill has the potential to be the best in class there right now, given the data that we saw this morning. We have a trust that we can really do a super launch in the U.S.
Speaker 2
Yeah, thank you. I mean.
Speaker 5
We're going to team up pretty well as we start putting these things together. You can already imagine the type of DTC I'm thinking about. You know, I'm a pretty simple sales and marketing guy. When you can say your product is better, things usually happen in the marketplace. At least from what we've seen in the first generation sort of oral small molecule, taking the lead from our CSO, we made a good move in terms of thinking about oral semaglutide for obesity. It was a good call.
Speaker 1
Building on that, to finish up your question, it's not only good for the oral market. It's also good because you're increasingly seeing that the patients will have a journey towards obesity. They might start with an oral, get to injectable. They might start with injectable, get to an oral. It's not just the subgroup themselves you're opening. It's actually the full lifetime value of a patient. You can actually multiply by having several different offerings of high quality, which is the one we believe we are bringing to patients today. It's a double whammy in a sense for us.
Speaker 4
Brilliant. Wonderful. Let's move to the front table here, table first, and then we'll go to Simon Baker afterwards.
Thank you. Actually, just a clarification from Martin on CagriSema single chamber. I think you mentioned yesterday the need to run a clinical equivalence study. Can you just help us a bit with the timeline when you think you can start this study? How long it would take? What does the submission process look like for this type of study? I guess the reason I ask this question is just to sort of compare the timeline for CagriSema single chamber with amylcretin subcut, because if they get close, how do you think of one versus the other?
Maybe you do on the timelines afterwards, then Ludo, you can do on amylcretin versus CagriSema?
Speaker 0
Absolutely, we see a benefit in terms of supply flexibility to have the single chamber. I do want to call out we are scaling to have a very strong launch with the dual chamber device, but it will give us that flexibility. It's an upside if we can do it. I had to do the clinical equivalence study. It's going to be smaller and shorter than what you would conventionally think with a phase 3 study. We just had to show similar weight loss and trajectory weight loss and similar safety and tolerability profile. We intend to initiate the study around the turn of the year, and I won't go further into the timelines.
Speaker 4
Are there multiple treatments in the market, Ludo?
Speaker 1
I think the whole question is bringing diversity to the different patient populations. We really believe in the value and efficacy and safety profile of amycretin. By the way, we have the injectable. We have the oral as well, which is not the case for CagriSema. You're offering to the patients a portfolio of options that are really based on helping them adapt the treatments to what they really need and the associated comorbidities. For me, what's really interesting beyond the formats is the kind of programs we're designing. I'm sure that Martin will come to that later on. The idea is to replicate, from a scientific perspective, the diversity of patients that you find in the market and enriching the MAIS program, as an example, with sub-studies or sub-parts and sub-populations on which we're going to study the very specific needed endpoints.
The sleep apnea, we talk of psoriasis, we talk to other benefits that we will enrich the program with. For me, it's not just a format discussion. It's the ability to answer the weight first, because we won't do the same mistake twice, the weight first, and then the comorbidities that are associated with the various sub-populations we're targeting.
Speaker 4
Very good. Thanks a lot, both. Let's go to Simon then, and onwards to Harry afterwards.
Thank you, Simon Baker from Rothschild and Co. Redburn. Let's go back to the market as it stands today. You are seeing encouraging upticks in MBRX, but you've still got the problem of compounding, which you said is pretty much unchanged. Can you give us some sort of help in thinking what is a reasonable timeframe over which to expect that to change? I know it's a difficult thing to ask for, but if things go as planned, would we expect this to be meaningfully low in 2026 or 2027? How long do you, or indeed 2025, how long would it take to have an impact there? Related to that, it doesn't look like you filed a Section 337 complaint with the International Trade Commission to block infringing API coming into the U.S. Is that true? If not, do you plan to do so? If so, when?
Speaker 2
I may let Karsten answer any legal action or comments, but let me focus on U.S. and enforcement right now. We have not seen a meaningful change in the compounding in the U.S. after May 22, which is when compounding became illegal again, except for rare circumstances, which is a grace period after being removed from the drug shortage list. We have seen some change in the dynamics in terms of moving from 503B to 503A, kind of the who is compounding, and moving towards a more mass personalization versus just mass production and compounding. We haven't seen a change in where it's coming from, Simon. We track it. We see it. Most of it's coming in from China, largely from plants that are not approved.
Certainly, the methodology is not approved in terms of the way that they're producing synthetic API, fake synthetic, and the way that it's coming into the country. It's coming in containers that say not for human use, for research purposes only. That is where we're in active dialogue right now with FDA, and we're having meaningful dialogue. You can imagine we've been having conversations for a couple of years, right, since we were put on the shortage list and we saw this compounding. That dialogue has changed to be productive, to be responsive. I can't put a date in terms of when we're going to see something. We do have expectations. We do have timelines we discuss with them, unless it's going to escalate on our end to further action. In terms of how fast does it go away, it's a little bit difficult to say.
The most important thing for us is to get enforcement and to stop the fake API from coming in. We can go into our next order of execution and combating this and bringing it back to what is the rule letter of the law, and it's for rare circumstances. It's not launching a dose that's not even approved in a mass marketing way, and that's what we're really focused on stopping.
Speaker 0
Yeah, just covering the second part of the question around ITC, that's correct. I would say that, building on Dave's comments, all options are on the table. Now, the commercial messaging and the public affairs angle to it, the regulator dialogue, and of course, the litigation pathway on several avenues. We are all in on both capabilities, advisors, et cetera, to have all options on the table. We find the best way forward. For obvious reasons, we cannot comment on yet nondisclosed litigations.
Speaker 4
Very good, thanks. Let's move to Harry.
Thank you. Harry Sefton from UBS. I just want to touch on capacity. You've previously guided to CASM and capacity coming more on stream in 2026, and clearly, you've been ramping up your CapEx since around 2023, so we should expect that to further add to that. Combine that with sales having disappointed this year, what are we looking like in terms of capacity utilization going into next year? What does that mean in terms of looking to compete maybe more aggressively on price to try and boost volumes? Maybe to just wrap into that, you've obviously got the loss of exclusivity of Sema in a number of markets next year. Will you look to compete on price in those markets with GenAX? Thank you.
You offer that one, Karsten?
Speaker 0
Yeah, absolutely. On capacity, clearly ramping capacity, and we see very good progress on the different programs. I can inform you that now all three Catalent sites are producing Wegovy. That builds, of course, a lot of resilience in our system. Our CapEx plan, of course, yields a lot of extra capacity for the company. That's back to my introductory comment about how much we're scaling. We're scaling more than 3 million patients just compared to a year ago. Enabling that future scaling, we believe that the CapEx program, also in light of the significant unmet needs in our portfolio, is spot on what we have to do. In terms of the CapEx program and competition and competitiveness, I would say that clearly we're going for defending our space in this market, and we're going to defend volumes.
With our productivity, our unit cost, and our manufacturing footprint, we're going to fight for our space.
Speaker 4
Great. Thanks, Harry. Thanks, Karsten. Let's move here to Pete.
Thanks, Pete, with old BMP. Just one question. You've talked about the market segmenting. What about price segmentation? I realize you're not going to talk about pricing in detail, but high level, it's pretty obvious you're talking about oral 25 being Wegovy and a pill. I think everyone in the room would think, you know, parity pricing to where we are today. You've got a competitor who had rave reviews about ortho data in diabetes at ADA and have now produced data that is clearly not to the upside. In terms of base case expectations, when you think about that oral GLP-1 segment of the market, are you assuming base case that it's a much lower price segment versus the injectable market? Thank you.
Anyone offer that one, Dave?
Speaker 5
Yeah, happy to.
Speaker 4
Karsten, afterwards.
Speaker 5
Yeah, not guiding, of course, on any pricing strategy, right? We're not in a hurry to race the price down in this category, right? When you take compounding aside, it's still largely two manufacturers. I think there's a shared view of really balancing the value and access. As you said, it is Sema in a pill, and we certainly want to protect that ratio of value to access. There are, of course, segments of the population that open up as price goes down. We're learning from that in the cash channel. We're learning from that and what we see in telehealth and partnerships. That's just something that we're going to continue to watch and get smart about.
Speaker 1
Maybe I'll answer on that side. We're looking at the price as a price point one-off, and it's actually not the way the market is reacting. People are looking at longer view at subscriptions that we can see in some of the direct channels. It's actually much more, again, a lifetime value of a patient throughout the journey of initiation and then maintenance that needs to be taken into account. That's why the one-off doesn't really matter. What matters is if you discount back what you're going to get from a pricing perspective month after month in the whole journey. That's actually what we're experimenting as we speak, more than just having a single price point. That's the thing. It's important. It's also important to make sure that from a cash perspective, we have to preserve a certain consistency, as you can imagine, between all the various channels we have.
Otherwise, it's becoming messy and you have arbitrage that we don't want to create.
Speaker 4
Thanks, Ludo. Thanks, Dave. Then we have Richard Vosser hiding in the corner.
Speaker 1
Richard.
I just have one question. Just stay time globally. How's that evolving? How do you think stay time will evolve in different channels like oral? I can imagine that with the oral semaglutide data, maybe the stay time would be rather short. Do you think payers will use that to step through in the U.S. market? Just different stay times, different market segments, and how's it evolving now?
Absolutely. I think it's very interesting what you're saying. You're right. I think it's going to be by group of patients. We know that right now it's around seven months, if I'm not mistaken, on Wegovy. I think it's more years, several years on Ozempic. We believe that some of these patients, also based on the pricing structure of subscription, etc., might actually have a longer stay time. We might also have patients that are very active for seven, eight, nine months, and then they will pause and start again. I think it's going to be very difficult to have one single weighted average stay time that is meaningful for the variety of patterns and behaviors we're seeing. This being said, everything we're doing is to extend stay time. I'm sure that Dave could comment on that.
We're launching a lot of initiatives to make sure that the longer you stay, the longer you see the benefits. If you think about what we saw with Surplus in the data, we now see that all the GLP-1s are not the same, that the CV benefits are gained in the long run. All this actually pleads for longer stay time for the patients. That's true for Wegovy as much as for Ozempic. We're doing a lot to extend it, but I think that the average would be less and less meaningful with time.
Speaker 4
Thank you, Ludo. We will move here in the middle.
Thanks, Carla Morris from Barenberg. I just had another question on pricing. Obviously, in the cash channel, we've seen a lower penetration for Wegovy than anticipated. We've talked about lots of factors for that. How much do you think that is also to do with price competition with Eli Lilly and Ozempic coming through into that channel in H2 this year? Do you expect to go in at a lower price point than what you've got with Wegovy at the moment? Thank you.
Speaker 5
In terms of the dynamics of our cash channel, I mean, Eli Lilly started about a year before we did in terms of having Lilly Direct and then Zepbound Vial. We have an interest to continue to expand that, and we will. You will see more efforts and initiatives in order for us to expand that cash channel with partners, with NovaCare Pharmacy, and other intermediaries, because we think that market is opening up, and the sort of consumerism of obesity, it's clear and it's apparent. We intend to participate in that. We will have a portfolio of offerings in that cash channel. I think we compete well on price right now with Eli Lilly. I don't think there's a meaningful difference that I can glean from the research. It's a different story in compounding and what dynamic exists there.
It's why all of our efforts are on the table, as Karsten Knudsen mentioned, to curtail that. With respect to Ozempic coming into the cash channel, no specific comments that we would make, but you could probably understand why we would not want those prices to be meaningfully different as Ozempic does participate in the obesity market, even if not by design.
Speaker 4
Good. Let's move over here to Yihan.
Hi, Yihan Li from Barclays. Thank you for taking our question. I think we have one compounding market size because you mentioned currently you still have like 1 million people on the compounding. We are just wondering how confident you are in terms of the projecting of the size of the compounding market, like how bigger or smaller it could be because we previously heard from HIMS that they were saying there are around 1.5 million people on personalized therapy and continues to grow every day. Of course, we know it's not all on GLP-1s, but yeah, it's just like curious, is it possible the compounding market could be bigger? Also, just wondering in terms of your revised guidance, anything you could share that is attributable to this persistence of the compounding market? Thank you.
You want to go first, Dave, and then we'll go to you, Karsten, on guidance assumptions?
Speaker 5
Yeah, I'm happy to start. I think the level of precision that we can get in terms of this fake market, which runs through medical spas, aesthetic clinics, places like HIMS, HERS that are public companies, is certainly not as accurate as we can with our own longitudinal data in IQVIA, right? Even though I think IQVIA was broke this week with MBRX, it's just not as precise. We do it through market research. We do qualitative, we do quantitative, larger studies, and it gives us a good feel in terms of the amount of prescribing that's happening, the number of patients that are on. Our triangulation of that currently is we still believe it's 30% of the market, around 1 million patients. Of course, there's different stay times, people coming on and off and switching, but that's as precise as we're able to get at this point.
Speaker 0
Yeah, on our outlook for the year, we have not included any upside from compounding in our guidance for the year. Even if there were some positive signals, say, from regulators in the coming weeks or months, it's not baked in. The key reason is really that there will be a lag effect before inventories are wound down and everything is stopping. This would more be a benefit into 2026 and 2027.
Speaker 4
Yeah, very clear. Thank you. Let's move to Michael for the next one.
Speaker 1
Thank you. Michael at Jeffries. Karsten, question for you. Novo used to guide for the next year with Q3 a long time ago, and there's quite a few balls in the air for 2026, whether this is Ozempic trajectory, oral launch, cost base. Do you think you'd be in a position to offer a view on 2026, or would you want to with the Q3 results?
Speaker 0
I can only talk generally about 2026 because, as you know, we're only guiding come our full-year results. I believe in the market space we're in now, that's the appropriate point in time to be guiding for 2026. The starting point is really the notion of unmet need and the ramp of patients, as I spoke to before, with more than 3 million patients year over year. That's, of course, our key focus to continue to drive that. We're focused on launching oral semaglutide in the U.S., so that's a key priority. Mymate is also getting closer. It may not be a big positive in 2026, but it's still getting closer. You could say in terms of loss of exclusivity, there's been some discussion.
At the call, I was saying what we're looking into when we take everything we know today in terms of timelines and price points, et cetera, and loss of exclusivity, then it's a low single-digit impact to top-line growth next year. These are some of the key building blocks that we're looking into, but very focused on driving growth.
Speaker 4
Thank you, Karsten. Thank you, Michael. Let's move back to James for round two.
Thank you very much. My question is on healthcare tourism. Next year, Canada will have generics. There's going to be generics flooding into the market. Sandoz were in the FT yesterday or the day before talking about 60% to 70% discounts to a list price. How do you assess the risk of either generic semaglutide or generic Ozempic coming down from Canada into the U.S., or more so if there is branded Ozempic, branded Wegovy in the U.S. that could also potentially be where patients go over and get prescriptions and then come back and potentially create an excess market that way? What are the defenses that Novo Nordisk has to guard against that?
Cross-border trees for you, Dave?
Speaker 5
Yeah, I think we.
Speaker 4
You want to also add, of course?
Speaker 5
Probably build on it. You know, there is not a legal mechanism for a generic product to enter into the U.S. that's not approved, right? You could say that's what we said about compounding, but you know, there's not an incentive for Canada or companies operating in Canada to allow that to happen. If you're talking about border states and crossing the line with your car, that happens today, right? I think what we have to be really clear about is the legal activities that we can take and we can enforce and be prepared for when there are generics that are approved around the world, and make it clear really what our response is here in the U.S. to stop it.
Speaker 0
Yeah, not a lot more to add. It's part of the building block I gave for outlook that is erosion in Canada. It is going to happen in Canada. Of course, our legal and regulatory teams are looking at defending our U.S. business in this context from inappropriate parallel trade.
Speaker 4
Indeed. Thanks a lot. Let's move back to Pete before coming to the mid-table afterwards.
Yeah, Karsten, just to follow on from yesterday's question on CapEx, and I know you've been very clear, low double digit, but you are spending an inordinate amount this year, $10 billion. Let's be fair, if you ask everyone around the room what Novo Nordisk revenue is going to be in three or four years, there's going to be a wide range of expectations. Can I just ask the question differently? When will the bulk, when can you start to get more towards normalized CapEx in terms of not having to spend $10 billion a year? Can I just push a little bit more on that?
Speaker 0
You're always welcome to push on your questions, Pete. The short version is we're very close to the peak, whether it's this year or next year, but we're very close to the peak. You should see our absolute CapEx levels to be coming down from there.
Speaker 4
Good. We move to Simon, and yeah, start with Simon.
Thank you for taking the second one. I just want to go back to a comment you made yesterday about Rybelsis. You said you're adjusting, deemphasizing the commercial focus on Rybelsis. That prompted a client to ask, we have an oral version of an injectable drug, and they're deemphasizing commercialization efforts on it because it's not performing particularly well. Why would obesity be any different? I'm sure there are lots of good reasons why, but can you just say why we should not extrapolate from the Ozempic Rybelsis experience towards the obesity setting?
Speaker 5
Yeah, I'm happy to. From a commercial perspective, Martin and Ludo may have some too. They're very different. In terms of what we've seen, what we've learned about Rybelsis in the diabetes market, and the place that it takes up in terms of a place in therapy is wildly different than obesity. In diabetes, all of the medicines that a patient was on as they sequenced through and their disease progressed were orals, and they were all oral medicines, right up through SGLT2s. The meaningful difference in clinicians was changing that to the injectable, which came in the form of Trulicity, Ozempic, Mounjaro. It didn't have that same sort of level of an upgrade, if you will, in the way it was viewed in type 2 diabetes. Conversely, when we think about oral, we do research and have conversations with oral, it's just the opposite. There's only injectables, right?
Now there's the promise and the openness of I could have a GLP-1 in a pill. You know, I could have Wegovy in a pill. It's viewed very differently in terms of what that unlocks and what the potential is. I think, on the company side, we see more opportunity, more growth, more potential, in Ozempic and Wegovy and then oral Wegovy, than we have seen with Rybelsis and make those choices.
Speaker 4
Anything to add from you, Martin?
Speaker 0
Yeah, I think I fully agree on sort of the preference dynamics, but there's also the fact that with the doses that we have for Rybelsus, the efficacy is not comparable to that of the subcutaneous in the diabetes space. In the obesity space, we've exactly designed 25 milligram oral semaglutide to match what we can do with the subcutaneous. I think from the clinical perspective, that just gives freedom for the patients to choose.
Speaker 1
If you summarize, you also have a brand name difference. That's one. You have the efficacy versus the injectable. Again, the oral Wegovy and the injectable are broadly in line in efficacy and tolerability. You have the fact that we also need to remember that Rybelsus was launched at a moment where we started to make some tough decisions between injectables and orals, which means that in many places where Rybelsus could actually have been successful, even in diabetes options, we had to pull back because we had to dedicate some API to the injectable form, which means that the launch of Rybelsus per se is, for me, not a good predictor of what an oral, irrespective of everything you said, what an oral could be. It's been stop and go. In the markets where actually we could launch, and that's Spain as an example, we actually did pretty well.
I wouldn't use the Rybelsus as the proxy for the normal behavior in the oral market for the reasons that I just mentioned.
Speaker 4
That's great. Thanks. Let's move to Harry, and then we'll go to Tibor afterwards.
Brilliant. Thank you. Harry Sefton from UBS again. If I could go back to compounding, and you've talked about working with the FDA to try and limit some of the API coming into the U.S. Obviously, since the new administration's come into power, we've seen some flux at the FDA. Would you say that, given your conversations with the FDA, that they are acting at the speed that you'd want them to, or would you say that disruption is also adding to the delay in getting this compounding situation sorted?
Speaker 5
Thank you for that, Harry. My answer is I would like it to be faster, but that is true regardless of how fast they move, given what we're experiencing right now, right? We haven't seen, you know, there's been a noticeable disruption in the conversations or the speed because of that, not by any means. The support that we're getting around Congress is also moving with speed. Just last week, we had 80 congressional leaders send a letter to FDA saying this has to stop. We know that there have been live conversations with some of those leaders, with the leadership, as well as legal leadership at FDA. They've assured us that this is a top priority.
Speaker 4
Good. Only in the last 10 minutes, Tibor first.
Yep, thank you. David, if you could just touch on the slowdown of the GLP-1 market, diabetes market in the U.S. If you could sort of come back on the key reasons behind the general market slowdown for GLP-1 in diabetes, are you experiencing any sort of access or reimbursement restrictions as the category becomes more costly for payers, or is it just that the penetration rates are peaking and the market gets a bit more saturated than before?
Speaker 5
Thank you for that. As we discussed last quarter, we are seeing a slowdown in terms of the growth for GLP-1 diabetes. It's still growth, right? I think it's in the neighborhood of 15% first half of the year. I think there is still room for growth in the diabetes market. It's slower than what we've seen before, right? Yes, there's more patients that have been on the GLP-1. I think we're in the 30% range in the U.S., very different than the rest of the world of those that have been on the GLP-1 for diabetes. We're also seeing this changeover, if you will, from our supply situation where the GLP-1 diabetes market participated in the obesity market, not by plan, right? We saw those fluctuations, right?
Now we have that sort of smoothing in terms of what the real sort of growth potential looks like as demand has subsided and our supply issues have subsided. We're seeing it in that range. There's still room for growth. I think if we compare that, that is the area where we see a lot more potential for growth in the future for GLP-1.
Speaker 4
Absolutely. Let's move back to Richard Vosser.
Hi, thanks, Richard Vosser for JP Morgan. Just on amycretin and the phase two diabetes data that you're going to get in the second half or fourth quarter, what do you hope to learn from that trial in terms of the doses, dosing, you know, and, you know, the titration to inform on the phase three?
Speaker 0
It's a really good question. As you know, we've always tried to acknowledge the fact that at least for the GLP-1 biology, the 80-90 for good glycemic control versus weight loss is different. That has led to different doses, actual doses between diabetes and obesity. We see others do it in a different way, which also makes it sometimes a little bit difficult to see full dose response on the clinical doses. That being said, we need to understand fully what does amylcretin biology do to this dynamic? We need more data to fully understand that. Specifically on the titration, obviously, based on everything that we know. Here we can also include redefined one and two.
I don't expect to learn so much on titration, but the actual doses we need to get right for diabetes versus obesity, evaluating are we going for the same doses or are we going for a differentiated dose range?
Speaker 4
Thank you, Martin. Before asking Karsten to wrap up, let's go for a final question with you, Mike Leuchter.
Speaker 1
Thank you. Follow up to that, Martin, on amycretin dosing into phase three. I guess one question coming out of the orphan data today is how well can one actually model PKPD when compounds change and structures change? You've decided to move into phase three quite quickly with amycretin. Are you still confident with the dose selection, and do you have flexibility to maybe change that if needed in phase three?
Speaker 0
The actual doses, of course, we can change, and the dose escalation ranges can also be changed. It is actually by design a little bit, I hate to say it, the flexible approach. Some patients will benefit from titrating every four weeks between the individual dose steps. Some will actually be recommended, if they lose weight very fast or if they experience gastrointestinal side effects, to dose every eight weeks. What we have learned so far, again, combining everything that we know from amycretin, but also from REDEFINE 1 and 2, is giving us confidence that we pick the right doses, and we are also confident on the dose titration and the steps that that will require. We can adapt. I don't think that's going to be relevant. Obviously, as we've also talked to, we've had really good dialogues with regulators who also think about these dynamics.
At the end of the day, we will have to wait and see. At this point in time, we are happy with the doses and the dose steps that we've chosen.
Speaker 4
Good. Before giving it to Karsten, final remarks, just thank you to everyone tuning in online, as well as showing up in the room, and reach out to investor relations in case of follow-ups. Over to you, Karsten.
Speaker 0
Yeah, thank you, Jacob, and thank you to all for attending. I think we actually covered a lot of ground at this launch meeting. I think it's clear that we're driving growth for the long term. We spoke about our pipeline, amycretin, CagriSema, oral semaglutide, competitive profiles. We spoke about all the measures we're taking in the U.S. to get back to stronger growth. We have the portfolio. We have the leadership. Now it's really about executing on what we have. What we didn't talk a lot about was international operations, which in reality is 90% of the unmet need on a global scale.
Just a reminder, 19% growth in the first half and a very consistent portfolio-like approach in terms of driving growth in a very big area with sizable unmet needs and a portfolio that's only started to really roll into those markets with low penetration rates, both in diabetes and Wegovy. This is really the name of the game, driving growth not only through the end of this year, but also into the years to come.
Speaker 1
You want to spend market share.
What are your market share for Novo Nordisk in this?
Speaker 0
Exactly. Thank you for that.
Comment speak.
Thank you for dialing in, and thank you for attending this launch. Thank you to James and Goldman Sachs for hosting. Hope to see you next quarter. Thank you.
Great.