Novo Nordisk A/S (CPH:NOVO.B)
Denmark flag Denmark · Delayed Price · Currency is DKK
262.10
-3.05 (-1.15%)
Apr 29, 2026, 11:43 AM CET
← View all transcripts

Earnings Call: Q3 2025

Nov 6, 2025

Richard Vosser
Managing Director, JPMorgan

Welcome to the Third Quarter, 2025 roadshow for Novo Nordisk. I'm Richard Vosser, European Pharma Analyst. It's my great pleasure, and that's at JP Morgan, obviously. It's my great pleasure to welcome Karsten, Martin, and Ludovic from the Novo Management Team to our presentation. There's going to be a short intro, presentation from Karsten and the team, and then we'll go into Q&A. Karsten, over to you. Thanks very much.

Ludovic Helfgott
EVP of Product and Portfolio Strategy, Novo Nordisk

Thank you, Richard.

Karsten Munk Knudsen
CFO, Novo Nordisk

Thank you, Richard, for hosting us, and to JP Morgan also for hosting us. Welcome to the Novo Nordisk Q3 London lunch roadshow presentation. We've been looking forward to seeing you all. We'll kick it off by some 5-10 minutes of presentation, and then we go, as usual, on to Q&A. This meeting is being webcast, so of course, you know, we have a global audience listening in. Forward-looking statements, as usual. Predictions, comments around the future may pan out differently, as we all know, so no changes in that respect. On our strategic aspirations, as was covered also yesterday by the call, we're getting to the tail end of our strategic aspirations, so we'll find a new framework coming into next year.

We're rolling through this year, end of this year with our current framework. We delivered 15% top-line growth for yesterday's numbers, 11% for the quarter, and continued strong momentum for our R&D pipeline build, including business development activities, as my colleagues will come back to in a minute. This is a strategy update. I'll hand it over to Ludo to tee that off.

Ludovic Helfgott
EVP of Product and Portfolio Strategy, Novo Nordisk

Absolutely. So essentially, this is something that Mike shared. First of all, good morning. Thank you for having us. This is what actually Mike shared yesterday in our overall call. This is actually his aim by explaining what is the variation, the change, the sharpening of our strategy that has happened over summer. We have been, for years, of course, more than 100 years in diabetes. I believe you can say we have actually created the overall obesity category. Alongside, these metabolic diseases have some commonalities and convergencies with other comorbidities on the kidney side, on the cardiovascular side, on the MASH side. The point is that what we are doing in a bit different manner today than maybe what we used to be doing before is that we want to treat patients with obesity and diabetes.

We're not treating diabetes and obesity, but patients with. What matters are the core disease and their associated comorbidities. In that sense, we want to make sure that whatever comorbidity we are looking at or investigating from a research and development perspective, there's a high overlap between the patients that have obesity and diabetes and these comorbidities, which means that all these circles you can see here are reinforcing our patient base. If a disease actually has an overlap of patient that is quite remote from obesity or diabetes patients, then we won't go for it. It's a superior focus. It's a sharpening of our strategy. I think it's more an evolution than a revolution, but it has the merits of helping us deepening furthermore in the core patient base that we're looking at, which are diabetes patients and obesity patients.

If and only if these patients have a joint overlap with our core, we're of course looking for the comorbidities. The best example is MASH. There's a huge overlap between the MASH patients and the obese patients. Logically, we want to invest both in R&D and in commercial into MASH. That explains why, by the way, we acquired the company Akero. You might want to talk about that at a later stage. It's really a sharpening, a deepening, a strong belief that the future value is so big in this market, more than 2 billion patients, that there's enough to capture if we are really going deep into this patient situation. Of course, as we always said, we're keeping the rare disease franchise with a clear focus on blood disorders and hematurenal disorders.

Again, we need some BD on that, and we can talk about it. It is a bit, as we have always said, a company within a company, okay, a biotech within, within Novo Nordisk. This is true commercially. It is also true from an R&D perspective. Again, the focus will remain on the core therapy areas and prioritizing the unmet need comorbidities when there is a big overlap with the obese patients, the overweight patients, and the diabetic patients. There is enough space, we believe, to dive into these areas and to create an attractive growth for more than the next decade. Back to the results of the first nine months of the year. As you can see, very balanced growth rates from a geographic perspective.

Overall, 15% growth, 15% in the U.S. and 16% in IO, with different profiles by regions. We can talk about it. From a therapeutic area perspective, it is a bit the same, with, we have again, 15% overall, 10% growth for the diabetes, more mature market. It is very true in the U.S. with the high penetration of GLP-1, as we know, 10%, 10%. The insulin, 3%. The obesity care growth of 41%, 41% with a split of 83% in IO and 24% in the U.S.. And rare disease, back to its normal production situation, growing 13% in a balanced manner between IO and the U.S.. From an obesity perspective and the anti-obesity medications, the market continues to expand in the U.S. with the branded anti-obesity medicine and NBRX continuing to grow up as we discussed, and from Maziar as well.

This is where, I guess, a lot of the discussions will be focused today. We continue to see this market as a huge growth reservoir for us. We're barely scratching the surface with only between, let's say, 3-4 million patients addressed today over the 100 million patients that this market is about. A strong expansion of the out-of-pocket, a strong expansion of the cash channel moving from 4% to more than 10% since only nine months. That's what we have been working a lot over the past couple of months, expanding the direct sales and the telehealth partnerships, recently with Costco as an example. Just launched MASH a couple of weeks ago and continued investment in patient access.

We can clearly see that there are some frictions in the scripts delivery, and we are investing in making sure that the biggest and widest number of patients can access the, the anti-obesity medicine. Last but not least, and again, I'll be quite short because as you can realize, this is still pretty much in discussions. You have here, Metsera, which has been a company that we've been looking for, for quite a while, and we've been in contact with them for quite a while. We believe this company, from a portfolio perspective, has a very interesting and attractive set of products with an S, by the way, not just one, both in single usage and in combination.

They're very helpful because we fundamentally believe that the market of obesity being huge, 100 million patients just in the U.S., is also very fragmented with very different needs, behaviors, categories of patients, but also a way to address their obesity treatment directly, as we said, or through physicians. We believe that the best way to cater for all these different patient needs and patient types and differences, and comorbidities associated, is to have a wide portfolio. We like a lot our portfolio. We believe that in order to be a leader in that space, we need even more products. We need even more products with different kinds of characteristics. That's why we believe Metsera complements well our pipeline. It's not just the pipeline. It's also the capability of this company. We've been knowing them for quite, quite a while.

Their ability to design extremely attractive molecules is certainly one of the reasons why we're so interested, beyond, of course, the medicines and the assets that we'll, of course, kick rather, in the next decade. That is very, very interesting for us. We can discuss that later on. This was the segue to our scientific discussions. That is when Martin comes on stage. Martin.

Martin Holst Lange
EVP of R&D and Chief Scientific Officer, Novo Nordisk

Thank you very much, Ludovic. Staying on the concept of complementarity to our pipeline addressing unmet need in serious chronic disease, we've done two acquisitions, one within MASH. As you know, we did have an internal asset, FGF21. We terminated that for, I would say, lack of superiority over what we already had in our pipeline. We do see a tremendous unmet need in F4. As you know, we just have a semaglutide approved for treatment of MASH in the U.S. for F2 and F3. F4 is basically a huge unmet need with no treatment available. Efruxifermin is the first, I would say, only treatment with true clinical value-adding data in F4. You've seen the data, substantial, both clinical but also statistical reduction of fibrosis without worsening of MASH and also reduction in MASH without worsening of fibrosis.

These are very clinically relevant data in the F4 space, where, again, the unmet need is huge and patients are dying from this condition. Also, in the F2 and F3 space, we see very, very convincing and the potential for best-in-class data. Complementing our pipeline, this makes sense as an acquisition moving into the MASH space for patients living with diabetes, obesity, and MASH. Similarly, in the rare disease space, huge unmet need in the rare blood, rare kidney disorder. These are truly rare diseases. We've seen an opportunity to acquire a novel proposition in the complement system, again, complementing our pipeline and also allowing us to leverage our research, but also clinical as well as commercial expertise to create synergies across the pipeline and portfolio. I look sort of at the broader internal R&D pipeline. You've seen this before.

We see a lot of progress, a lot of momentum across our therapy areas. I do want to call out, obviously, in the space of obesity, we will soon see readout of CagriSema, phase III in type 2 diabetes. We will see, obviously, more exploratory readout for amycretin in phase II, also in type 2 diabetes. In the obesity space, we continue to generate value for semaglutide. Best-in-class oral data for obesity treatment based on a GLP-1 therapy with oral semaglutide, 17% weight loss, well-known safety and tolerability profile, under regulatory review with U.S. FDA as we speak, and submitted to the European authorities. 7.2 mg, same thing, 21% weight loss, the same safety and tolerability profile that we know from the lower doses of semaglutide, filed for regulatory approval in Europe and soon to be also in the U.S..

We'll see readout of further CagriSema studies, specifically redefined four, over the next couple of months. We'll see initiation of CagriSema actually, that happened yesterday, phase III program. We will see initiation of the amycretin development program. I would be very remiss if I did not mention regulatory submission of MyMed in rare disease. I think with that, back to you, Karsten.

Karsten Munk Knudsen
CFO, Novo Nordisk

Yeah. Thank you, Martin. Outlook for 2025 really reflects the script trends we've seen over the last few months. Here at the third quarter, we narrowed our top line guidance range by taking the top end down and narrowed around the low end of our guidance range. Now we are guiding top line between 8%-11%, and then correspondingly adjusting our operating profit growth accordingly. FX slightly adverse, so we updated that. No major changes there, which is being offset in net financials. Finally, you see our CapEx estimates coming down, linked to changes to our CapEx program overall, some optimization there. A lower CapEx run rate this year.

We are looking into, over the coming years, that our CapEx run rate will be coming down as we gradually are finalizing our major CapEx initiatives, both on the API front as well as on fill finish. This concludes the presentation, and we're ready to move into Q&A. On one side note, I would say the plan was for our CEO, Mike Doustdar, to be here today. Unfortunately, he had other priorities for today. I'm sure he'll be back in connection with the portfolio. With that, per tradition, we'll have Jacob and Investor Relations control the crowd and Q&A. Over to you, Jacob.

Jacob Martin Wiborg Rode
Head of Investor Relations, Novo Nordisk

I'll try. Thanks, Karsten. Let's do one question per institution, and let's start with the host, Richard Vosser, please.

Richard Vosser
Managing Director, JPMorgan

Thanks. Maybe I'll start one with Martin. You mentioned the amycretin data in terms of the type 2 diabetes trials. What do you expect to learn from those trials that you can take forward to think about the phase III?

Martin Holst Lange
EVP of R&D and Chief Scientific Officer, Novo Nordisk

You've heard me say before, we'll not progress anything into phase III that we don't believe can be differentiated either on efficacy, safety, convenience, or scalability. Obviously, you know that amycretin, if on par efficacy, safety, it has a scalability upside. Obviously, it would be good to see also an upside, potential upside on efficacy, maybe also on tolerability. We also know that these priorities in type 2 diabetes patients are slightly more difficult to predict than it is in non-type 2 diabetes. Therefore, we have to see phase II study and the data set to fully speculate where would we take this and how will it be differentiated. Based on what I've seen so far, obviously, we have big aspirations, but I need to see the confirmation.

Jacob Martin Wiborg Rode
Head of Investor Relations, Novo Nordisk

Right. Let's move on the left-hand side to Sachin, please.

Sachin Jain
VP, Bank of America

Thanks very much. Sachin Jain, Bank of America. Just one on GLP-1 pricing. Wegovy priced in the quarter, year-on-year fell quite dramatically. It was about 20%. Was that you not called out CVS? Was it something different? How should we think about that into next year? The same question for just pricing trends on Ozempic. Obviously, the question is X, whatever we may hear later today.

Karsten Munk Knudsen
CFO, Novo Nordisk

Yeah. I'll take that one. I assume you ask about U.S. pricing. Specifically for Ozempic, there's really no change to what we've been saying all along. This is a big market which is maturing. We go for open access. We're looking at broadly unchanged access into next year. The price logic we've been seeing in the market for the past few years and what we've been guiding the markets is a net price, year-on-year coming down some 10%-15% or so, something like that. No changes to that commentary. As a general commentary, not a guide for next year. As to Wegovy and pricing trends, you're correct when you do implied value per script. Q3 is a step down, quarter over quarter.

It's always, you know, dangerous to do quarterly net sales linked to, you know, all the uncertainties that goes into a value per script. I think it would be more appropriate to use a year-to-date value per script in terms of seeing where the Wegovy net price and the run rate of that into next year, as at least one data point.

Jacob Martin Wiborg Rode
Head of Investor Relations, Novo Nordisk

Very good. Thank you, Karsten. Let's stay on the second row with, with James.

James Quigley
Executive Director, Goldman Sachs

Great. Thank you very much, James Quigley and Goldman Sachs. I've got a question for Ludo on consumerization of the sales force. As you look at the prescription trends, it looks like it's 60/40 in the reimbursed channel, but maybe sort of 85% 15% in favor of Zepbound in the consumer channel. How are you working to address this? What are the more recent learnings? It seems like that market's change is quite volatile and changes relatively quickly. How are you looking to bridge that gap to get more towards,

Ludovic Helfgott
EVP of Product and Portfolio Strategy, Novo Nordisk

The coffee machine has an opinion on that.

James Quigley
Executive Director, Goldman Sachs

Exactly. Yeah. Kicking off. How do you plan to bridge that gap?

Ludovic Helfgott
EVP of Product and Portfolio Strategy, Novo Nordisk

Absolutely. I think you're right. I would on the volatility of that situation in the consumer market. A couple of things, if you don't mind, to step back. First of all, we're only barely scratching the surface of this market, including the consumerized market. We essentially, as I said, treating between three and four million patients over a hundred million of patients. What's interesting when you are discussing, and we're doing a lot of this, discussing with patients themselves or discussing with physicians or with online pharmacies, is that what is super important for these kind of patients are, the price is one thing for sure. It's also the formats that they're using, which grants them more or less flexibility in their behaviors of treatment. It's, of course, the comorbidities they're looking after.

If you make a long story short, you have two major kinds of comorbidities. You have those that are, we call them the feel and see, typically back pain, mental health, arthritis, sleep apnea. The things that are really felt concretely by patients, then you have the more invisible but equally, if not more dangerous, comorbidities of cardiovascular and kidney comorbidities. If you look at the typology of the patient that are going direct, you certainly have patients that are more sensitive to the former than to the latter. That's one. The second thing that we observe is that what is increasingly, what's increasingly the behaviors of these patients start to fragment and these groups of patients start to be different and different. There's still at this stage a strong importance of the perception of weight loss. Okay?

That is slowly moving. It is moving very clearly with the physicians. It is not moving at the same stage with the patients, which means that the reason why we are so much interested in the 7.2 mg, but also in the pill, is that actually these two elements on both formats give us the opportunity to talk about power again. Now, we said different patient needs, the ability to talk more about power. It's also the ability to be more direct. 'Cause one thing is the behavior of the patient themselves. Another one is, and what they're sensitive to, cardiovascular health or more immediate weight loss or back pain, it's also the way they're purchasing. When you look at this, you can clearly see that there is a real trend for direct, to direct purchase. It's still a prescription.

There's still a physician on the other side of the screen, but it's a screen, not the traditional physician. In that sense, being direct is very important. That's why we are multiplying our efforts with online pharmacies as well as with distributors like Costco. The building blocks are this one, broader number of products to cater for more needs, including formats, etc. Really more needs, the ability to understand equally the patients in their visible needs as well as the visible. And a reinforcement of the power of our medicine. That's why 7.2 mg is important. The pill is also equally important.

Jacob Martin Wiborg Rode
Head of Investor Relations, Novo Nordisk

Very good. Thanks a lot, Ludo. I saw James taking a lot of notes. That's good. Let's go to Simon.

Simon Baker
Partner and Head of Global Biopharma Research, Redburn

Thank you. Simon Baker from Redburn. Really just continuing on James's question, but picking up on something Mike mentioned yesterday, which is the U.K. market.

Ludovic Helfgott
EVP of Product and Portfolio Strategy, Novo Nordisk

Yeah.

Simon Baker
Partner and Head of Global Biopharma Research, Redburn

It, it's almost the same size as the US at the moment. What, about two and a half million people. It's all, it's all consumer. What we've seen over the last year is we've moved from Mounjaro and Wegovy being the same price and Mounjaro having a 70% market share. You then cut price. Lilly's then raised price. I just wonder if you can give us an update on how the sort of dynamics of the share there and the relevance of that price volume dynamic to the U.S. market. One other thing related to this, anecdotally, it feels like the stay time, the duration of therapy in the consumer channel is a lot longer than we were expecting. People aren't staying for six months. They're staying on it more, more long term, albeit at lower dosage. Any thoughts on how that shapes?

Ludovic Helfgott
EVP of Product and Portfolio Strategy, Novo Nordisk

Yeah. No, it's.

Simon Baker
Partner and Head of Global Biopharma Research, Redburn

'Cause it feels like there's a whole chunk of volume that we weren't expecting.

Ludovic Helfgott
EVP of Product and Portfolio Strategy, Novo Nordisk

Two brilliant questions. I think on the first one, on the U.K., that reflects, I think, aligns two things we've been saying. The first one is that if you look right now from a preference share, I think we're more or less neck to neck when it comes to preference share in the U.K. It's very interesting because it means it's a market where we know it's a very price-sensitive market. In spite of that, the quality of our medicines and what we're doing with the medicines is actually being seen by the consumers and the physicians. That for me reflects the fact that there is, let's say, the dice are not cast on what exactly is the performance of a good semaglutide versus the rest. That's the first thing. It illustrates price sensitivity, you're right.

If the market was just price sensitive, we would not have the NBRX we are having in the U.S. Because if you look at the NBRX, you can see the difference between vials and not vials. When you look at devices, we are actually, again, head to head. It means that you have segments that are price sensitive, others that are less price sensitive. Back to the discussion of different preferences in the market. The second thing it actually reflects is the fact that each market in IO has its own special dynamic. I think that is what Mike said yesterday. Again, the competitive situation in IO will be market by market. In some markets, we will win. In some markets, there are more battles. We have markets where we can clearly register strong gains, the case of Australia as an example. The U.K. recently.

Other markets are a bit more difficult based on the structure of this market. Things have to be seen market by market, very importantly.

Jacob Martin Wiborg Rode
Head of Investor Relations, Novo Nordisk

Very good. Thanks, Ludo. I think for the second question of stay time, we'll come back after.

Karsten Munk Knudsen
CFO, Novo Nordisk

We'll come back.

Jacob Martin Wiborg Rode
Head of Investor Relations, Novo Nordisk

One more round. Let's go to Naresh.

Naresh Chouhan
Founder, Intron Health

Thanks for taking my question. It's Naresh Chouhan from Intron Health. Can you just help us to think through 2026 revenue growth, please? Obviously, we can see the Wegovy volumes as they are. Access is broadly flat. Pricing's obviously likely to be down. And then you've got the Medicaid removals, which are, we think, about a high single-digit volume impact, and then whatever competition you wanna bake in from Ortho. And then with Ozempic, clearly, sequentially we're in decline in the U.S. and ex-U.S., you've got the LOEs. As we see where, what are we missing? Where is the revenue growth coming from next year, please?

Karsten Munk Knudsen
CFO, Novo Nordisk

Yeah. Again, as I said yesterday, I'm not guiding for 2026 at this point in time. I think as a company, we're guiding for this year.

We're actually rather elaborate around the trends impacting our business. Then we point to the market around the key one-offs that the market has to take into account into next year. I think I really don't have a lot more to add, beyond saying, of course, Wegovy pill launch, you know, pending regulatory approval, is a key opportunity for the company, starting hopefully beginning of next year. MyMed approval, I think, will be, you know, in the second half of the year and hence have lower impact, but will also be a good, you know, future revenue growth driver for the company. And CagriSema, we're getting ready for submission.

Perhaps it is not into next year, it impacts top line growth, but then the following year, it should start to take off. Ludo mentioned semaglutide also, where we are getting the first data next year. Hopefully, they will be competitive. Not next year, but in the following year. I think we have really nice pipeline progress and optionality. That is really what is going to drive top line in perhaps not so much next year, all of it, but in the coming years.

Jacob Martin Wiborg Rode
Head of Investor Relations, Novo Nordisk

Thank you, Naresh. Thank you, Karsten. Let's move to Harry.

Harry Sephton
Director of Pharma Equity Research, UBS

Brilliant. Thank you. It's Harry Sephton from UBS. I'm gonna try one on Metsera. What if the FTC comes back and says no? Just like you to go through some of the scenarios there because you've quite publicly endorsed this portfolio as being differentiated. Clearly, you don't want this to end up in the hands of some competitors. Just wanna get your thoughts on what if the FTC comes back and asks.

Ludovic Helfgott
EVP of Product and Portfolio Strategy, Novo Nordisk

Absolutely.

Harry Sephton
Director of Pharma Equity Research, UBS

Whether you want to divest any of your own assets.

Ludovic Helfgott
EVP of Product and Portfolio Strategy, Novo Nordisk

Let me take a step back on your question. One, we strongly believe that the market is really big, is competitive. We have gone into, of course, this operation with clear thoughts in mind and clear ideas. We have been also with strong advice. We would never have done such a thing if we did not believe that there was a very solid chance of this being cleared. Okay? However, things are what they are. By definition, the FTC has the right to review any deal. It is perfectly okay. We are ready, and we are ready to discuss the merits of the acquisition. You have two different views. Ultimately, it comes down to the merit of the portfolio. Either we exploit this portfolio industrially, i.e., we own the portfolio.

It's been validated by the FTC, and we integrate the portfolios. We are the shareholders, and important shareholders of a very successful company. It all depends on the data ultimately. That has been the discussion and the thing all around. Given our belief in the quality of the portfolio and the capabilities, products with an S, combinations was also early. Either it's for us from an industrial perspective, we operate it, or we are the shareholders of a very attractive portfolio. That's ultimately boiling down to the quality of the assets we're seeing here.

Jacob Martin Wiborg Rode
Head of Investor Relations, Novo Nordisk

Wonderful. Thanks, Ludo. I saw a hand from Ben next to Harry.

Ben Jackson
Equity Research Senior Associate, Jefferies

Brilliant. Thank you. Ben Jackson, Jefferies. Martin, one for you on Evoke+ , if I may. I think it was originally designed to include 20% of patients with significant small vessel pathology. That protocol got changed, if I'm right. It's not necessarily anything new, but I saw that it was updated in the slide. I thought I'd just bring it up quickly. Do you have any color behind why this happened? Was this something to do with recruitment or a change in thinking of the biology or commercial aspirations in that subgroup? Should we take that as synonymous with the vascular dimension that some Evoke executives are talking about?

Then following on from that, is there enough patients within that group that you have initially ended up recruiting to see a potential signal in there and explore that should you wish in the future?

Martin Holst Lange
EVP of R&D and Chief Scientific Officer, Novo Nordisk

Absolutely. One step back, actually starting where you ended, the original dialogue with the authorities was. By far the most prevalent form of dementia is Alzheimer's disease. The vascular component given GLP-1 biology made sense also to evaluate. From a patient volume perspective, we agreed to be looking for signal, rather than statistical significance. That is why, across the two studies, the vast majority of patients had the Alzheimer's pathology. A little bit reflecting that, it has turned out to be easier to identify and recruit patients with Alzheimer's pathology, versus a very clear vascular pathology, in part because there are overlaps. A great number of patients with vascular pathology also have elements of Alzheimer's pathology. That is basically the reflection.

Now that we are on that subject, obviously, this is a true unmet need. And I'm very proud that we're doing this, but we still have to call out it's very, very high risk. It is a very volatile space to do clinical development.

Jacob Martin Wiborg Rode
Head of Investor Relations, Novo Nordisk

Thank you, Martin. Let's move to Pete in the back on, characteristically.

Yes. Thanks, Jacob. Pete with OBMP. Just one for Karsten. Just, are you sensing any change in the political appetite, in the U.S. to help you, with your quest to, you know, deal with compounders? Is there any, any change in that environment, that you can sense, politically? Thank you.

Karsten Munk Knudsen
CFO, Novo Nordisk

Yeah. Over the last number of quarters, we've been talking about compounding. Of course, our starting point as a company is clearly patient safety in the US. Compounding is sourced from a wide variety of different sources, which are not FDA approved. Of course, that leads to a higher risk level compared to FDA approved manufacturing facilities and products. That is a starting point. There is a concern on our side vis-à-vis patents and the investments we do in bringing products to market and the commercial impacts this has to our business. As a company, we perform a number of lawsuits and litigations vis-à-vis this segment.

I would say the main change would rely on the U.S. administration and the health authorities in the U.S. and the associated regulations vis-à-vis compounding and clarity around can it truly be that more than 1 million patients qualify as being personalized compounding? Specifically to your question, can I be hopeful around changes in that environment? That's forward-looking questions on politics and healthcare reforms are always a little bit tricky. I am hopeful, but there are no guarantees in a space like this. It's an agenda that we are actively pushing. Exactly how and when, et cetera, remains to be seen.

Jacob Martin Wiborg Rode
Head of Investor Relations, Novo Nordisk

Thanks, Karsten. Let's move here to, to Evan in the middle.

Evan Seigerman
Managing Director, BMO Capital Markets

Hello. Evan Siegerman from BMO Capital Markets. In your slide, you say that the Metsera acquisition complies with all applicable law. Yet overnight, Bloomberg reported that the FTC said that the bid may violate the procedural provisions of the HSR Pre-Merger Notification Act. Can you just square that for me, how you believe that you are complying with law when the FTC is saying that it may violate?

Karsten Munk Knudsen
CFO, Novo Nordisk

In short, while I don't want to go into the details around the process for obvious reasons, as a company, you know, it's part of what we call the Novo Nordisk way, that we adhere to all laws and regulations in any jurisdiction that we operate. That includes, of course, when we perform activities like M&A type activity. In this case, we had, you know, done our homework in terms of the requirements vis-à-vis FTC in a scenario like this with the expert external advisors. We do believe that it fulfills the requirement by FTC, as Ludo said before.

Evan Seigerman
Managing Director, BMO Capital Markets

Okay.

Karsten Munk Knudsen
CFO, Novo Nordisk

It was part of our due diligence, as it was with the Catalent transaction not too long ago, where we assessed from an antitrust perspective, like we assess patents, CMC, clinical data. We assess antitrust and the likelihood of closing as part of our due diligence. That was exactly the same with this year.

Jacob Martin Wiborg Rode
Head of Investor Relations, Novo Nordisk

Good. Thanks, Evan. Thanks, Karsten. Let's go to Thibault, also here in the middle.

Thibault Boutherin
Equity Research Analyst, Morgan Stanley

Thank you very much. Thibault with Morgan Stanley. Just a question on the GLP-1 in China. Ozempic and Wegovy soft this quarter. I think for Ozempic, there was some wholesaler destocking, but Wegovy seems underlying. We are going to see some semaglutide generics entering the market next year, obviously Mounjaro competition ramping up. Should we just assume that Ozempic and Wegovy may not really build in China based on this current trend and the headwinds coming?

Karsten Munk Knudsen
CFO, Novo Nordisk

I can take it. I do not think you should assume that. I think the reason why the Chinese market is slow to start is more based on the local regulations of the Chinese market. A big part of the demand in market is driven by direct to patients' demand. In China, from a regulatory perspective, you cannot do it with the obesity products. You can do it with the diabetes, not the obesity products. There is intense dialogue at this stage in China to make sure that we can open the market and make sure that patients can benefit. It is a regulatory limitation. It has nothing really to do with the potential of the market.

Then just building on Ludo's comment, which was related to the obesity market, in the diabetes market, we are on the national list with Ozempic. We have a very competitive market here in China, as you've seen our reportings. Truly, there are some budgetary constraints in the major hospitals that limit the amount of Ozempic utilization. Of course, we have some local commercial plans for, you know, how to continue to expand Ozempic into the marketplace, both online, like in obesity, but also into some of the outer hospitals, the segment, third-tier hospitals, because overall penetration of GLP-1 in China in diabetes as well as obesity is very low compared to most other markets.

Jacob Martin Wiborg Rode
Head of Investor Relations, Novo Nordisk

Thank you, Ludo. Thanks, Karsten. Let's move to Yihan, and then we move to Kerry afterwards.

Yihan Li
VP of Biophama Equity Research, Barclays

Hi. Thanks for taking our question. Yihan Li from Barclays. I just have a question on the Metsera deal. A lot happened overnight. I'm, I think I'm just, like, curious, in terms of, sorry, in terms of the valuation. They do have several pipelines. Could you please elaborate how you value its pipeline separately, for example, like 097 versus 233 versus the early ROs? Also, which part of the portfolio is the most strategically attractive to Novo? Thank you very much.

Ludovic Helfgott
EVP of Product and Portfolio Strategy, Novo Nordisk

Of course, the valuation is part of our discussions, and we can't disclose that. Very clearly, the whole portfolio is interesting. I would say not just the individual assets, but the combination of assets as well, as well as the early ones. They all equally contribute to the valuation, and the ability to really be able to answer the wide untapped demand in the market is the whole portfolio that is interesting.

Jacob Martin Wiborg Rode
Head of Investor Relations, Novo Nordisk

Thank you, Ludo. Let's get the microphone to Kerry, please.

Kerry Holford
Head of Global Pharmaceutical Equity Research, Berenberg

Thank you, Kerry Holford, Berenberg. My question is on Ozempic. Based on your market data, your internal data, is there any residual headwinds in the U.S. in terms of volume growth from off-label, historical off-label use in obesity, or is that now flushed through? You mentioned the higher penetration now in diabetes within the U.S., clearly more significant competition now from Lilly building. Are we now in a scenario where Ozempic is ex-growth in the U.S.? Do you see ways and means of rebuilding that?

Jacob Martin Wiborg Rode
Head of Investor Relations, Novo Nordisk

Yes, I think perhaps a broader question on, on current Ozempic dynamics in the U.S.

Karsten Munk Knudsen
CFO, Novo Nordisk

Yeah. Ozempic and GLP-1 dynamics in the U.S, if you look at the Ozempic scripts currently, totaling around, call it 660,000 or so per week, according to IQVIA, and look at the trend line of the volume growth over the last period, it has been slightly declining, you know, like a few percent, measured in volume. Then you say, what are the key drivers behind it? I would say it's a combination of competition entering into the marketplace, and overall segment slowdown. Now the GLP-1 diabetes market in the U.S. is growing to the tune of, call it, 12% or so in volume, linked to the overall penetration in diabetes.

If you adjust for double counting, then out of the treated diabetes patients, around, close to a third is now on a GLP-1 in the U.S. We see that continuing to go up. It's not like we believe it has reached the ceiling because the broad labels for GLP-1s and especially for Ozempic, yields that there should be more penetration to go for. I think it's natural, as we've seen historically also, you see these long product cycles and then we're building on additional indications. Then we compete, you know, as much as we can with the label we have for Ozempic.

I think the real volume opportunity for Ozempic going forward is clearly outside the U.S. where penetration is much lower.

Jacob Martin Wiborg Rode
Head of Investor Relations, Novo Nordisk

Thanks, Karsten. Let's go back to, to Richard Vosser in the first row.

Richard Vosser
Managing Director, JPMorgan

Hi, Richard Vosser, JP Morgan. Ludo, you mentioned three to four million patients treated with GLP-1s in the US in the obesity market. Have you done any work on return of patients? Just thinking about, you know, how many patients have been treated in GLP-1s since the start of the obesity market and, you know, whether we're getting returns or patients are just dropping off and never coming back.

Ludovic Helfgott
EVP of Product and Portfolio Strategy, Novo Nordisk

Yeah. I think back to the discussions, we're seeing very different patterns of patients, but we can clearly see that the average duration is just an average. It's far more dispersed than what we see. You have patients that are just there for a couple of months. You have patients that already are integrating the fact that it's good for your cardiovascular health to be treated with a GLP-1. These patients are closer to the year. The average per se doesn't mean much. It means even less than any kind of treatment we've been seeing, back to your question earlier on.

What we are increasingly interested in is understanding how you can, with our portfolio, help the patients manage their treatment, not with one single medicine, but with many medicines, switching from oral to injectable, from high dose to low dose, from Cagrilintide to something else. We really have a portfolio approach which will be helpful for us to maintain patients and help them on the long run rather than the short run. Don't look at the average. Look at the dispersion.

Jacob Martin Wiborg Rode
Head of Investor Relations, Novo Nordisk

Thank you, Ludo. Thank you for your time. For a few more, let's go to Sachin.

Sachin Jain
VP, Bank of America

Sachin Jain, Bank of America. Can I take one on MASH? I just want to understand where you are on the cadence of launch from your perspective. It was a number of months ago. You then launched a sales force. You were talking about access. The CVS deal was supposed to be for MASH, and yet we do not seem to have seen anything. I just want to understand your level of optimism and what the unlock from here remains to be, given it feels like we have seen not a lot so far, which is, I guess, a little bit surprising.

Ludovic Helfgott
EVP of Product and Portfolio Strategy, Novo Nordisk

Absolutely. On MASH, I think it's really early days. The data we have is really we have a few weeks of data right now. We can clearly see that there's a good response on MASH from the physicians with whom we are talking. Maybe some of you will be at the ASLD at the end of this week, and we can then maybe address that at a later stage. There's good response on semaglutide. I think there is a good response on the end dose. We need to continue our work with the GPs referring to the hepatologists. It's a growth that is really in its infancy, excuse me.

We're also seeing that we have, and we are looking at the same frictions from the reimbursement in the world of MASH as the friction we're observing under coverage in the world of obesity. We are equally busy trying to remove these frictions. Early days, we'll know a bit more at a later stage. The first feedback we have from physicians is actually quite promising and they're very sensitive to the quality of the F2, F3 reduction, or in steatosis, as well as the safety profile. Last but not least, what's super important to understand for the F2, F3 is that the main cause of morbidity and death is actually cardiovascular disease. The hepatic failures arrive in your F4.

In the F2, F3, there's an overproportionate number of patients suffering from cardiovascular disease. This is where, again, semaglutide can prove very helpful for these patients versus the other treatments. This is what our medical affairs are also discussing as we speak.

Jacob Martin Wiborg Rode
Head of Investor Relations, Novo Nordisk

Thanks, Ludo. Let's move to Evan and then David Evans afterwards.

Evan Seigerman
Managing Director, BMO Capital Markets

Hi, Evan Seigerman, BMO Capital Markets. Thinking about the potential oral market with Wegovy in a pill or 25 mg oral sema, you know, without giving all away the secrets, how are you going to commercialize that against the competition from Lilly?

Ludovic Helfgott
EVP of Product and Portfolio Strategy, Novo Nordisk

Okay. That's good. That's good. That's good, yeah. Absolutely. Absolutely. I think what's super interesting with that market is that we are increasingly convinced that the oral market constitutes in itself a significant part of the market. We've been talking about 25%-35%, between 25%-35% in the end game. That is really the first thing. The second thing is that we're coming to the market with a product that is actually quite interesting because for the first time on an oral, you don't have to trade between efficacy and tolerability. Superior in efficacy, we believe, to any competition. Superior also in tolerability. We've just seen data again and again and again coming on the other forms of oral GLP-1. You're coming here with a drug that doesn't force you to compromise between efficacy and tolerability.

It is quite unique. It is the first time ever it is happening. In the case of diabetes, it was not the case. The benefits are actually quite interesting. Last but not least, the whole arsenal that our U.S. colleagues are preparing right now from a channel of distribution across all channels available, the ability to work on all the typical levers of promotion as well as the more individual level of promotion is really push full throttle. You have a full throttle package across the traditional and less traditional channels. You have a product profile that is, for the first time, not having to trade off between efficacy and tolerability. You have a significant part of the market. Three ingredients why we believe it can really make a difference.

Not even forgetting what I just earlier alluded to, which is the ability to put that oral in the widest portfolio and having people potentially going from injectable to oral or vice versa, depending on what they want.

Jacob Martin Wiborg Rode
Head of Investor Relations, Novo Nordisk

Good. Let's move to David Evans. Afterwards, we'll take away the questions from Martin on R&D.

David Evans
Senior Pharma Research Analyst, Kepler Cheuvreux

Sorry. Thanks. David Evans from Kepler Cheuvreux . Just, I was about to ask about Oral Sema launch also. I mean, given that there are tens of millions of overweight people in the U.S. who just won't use an injection, do you, do you sense that markets and investors you speak to are, are overly cautious on the opportunity near, near term, even in the next couple of years for Oral Sema? I mean, if you could just reiterate or clarify, you definitely won't have any supply limitations, or, or if you could talk through, you know, are there any other reasons we should be a little bit cautious? Because it seems like a game-changing opportunity to me. Thanks.

Ludovic Helfgott
EVP of Product and Portfolio Strategy, Novo Nordisk

We believe that there's a significant part of the market, as you said, that will be sensitive to oral for many reasons. It's not just the convenience of a pill versus an injection. We have been working really, super deep on the various segments of the market that could be interested by oral. The motivations can be very different. They can range from, indeed, I don't like injections. More importantly, getting a pill is, for me, I don't feel sick. I want to regain flex, functionality, but I don't feel necessarily sick. For these patients, and we have significant groups of patients that are entering these characteristics, the oral is actually a good argument.

We believe, we strongly believe that this will be a key way to unlock the market and move beyond the three, four million we were discussing beforehand. What we also know is that each group has its own behaviors, characteristics, way to get to the obesity medicines, motivations. It has to be, it will be gradual, we know. That is why we believe that you cannot, you do not unlock a market, snapping fingers. By the way, this is why the injectable market right now is still in its infancy. With the oral and different messaging for different kind of populations, including on the comorbidities, by the way, we can definitely move to propose the oral to different groups that will be in a staged manner, we believe, not in one single goal, based on what we have seen in the injectable market.

Opportunity, yes, and progressively unlocking.

Jacob Martin Wiborg Rode
Head of Investor Relations, Novo Nordisk

Good. Let's move to James once again. And then after that, a final question.

James Quigley
Executive Director, Goldman Sachs

Great. Thank you, James. Quickly before we move on to Saj. So Martin, Ziltivekimab, you mentioned that yesterday and it got mentioned again today. Could you characterize your expectations here? What are you looking for in terms of a clinically meaningful benefit in the ASCVD population? There are a number of other indications as well, heart failure and in post-heart attack patients. Are there any of the three indications that are more dependent on IL-6 reduction and inflammation reduction and therefore you're more excited or more cautious on across those indications?

Martin Holst Lange
EVP of R&D and Chief Scientific Officer, Novo Nordisk

Yeah. First I have to say, in the space of ASCVD and inflammation, we are still in the exploratory phase. There have been one or two studies documenting that reducing inflammation in these patients improved outcomes actually quite dramatically. They were also associated with some unacceptable side effects and therefore not pursued further. We do believe that Ziltivekimab has the potential to not only reduce inflammation but also do that in a safe way. Given that we are building those assumptions based on, albeit quite substantial, phase II data, we are still assuming a risk, first in ASCVD, subsequently in heart failure with preserved ejection fraction, and finally in MI. If I am, without going into numbers, again, we see this as reasonably high risk but also in a very, very high unmet need space, high reward for the patients.

From a probability of success perspective, I think there's more data established that intervening and reducing inflammation in ASCVD will impact outcomes, slightly less with heart failure with preserved ejection fraction. In the MI space, it's right now primarily correlations but very substantial correlations that prompt us to believe that there is something here. There is uncertainty both on the efficacy side in all three spaces. Obviously, we also have to establish safety and tolerability. I would say with the number of patients that we have exposed at this point in time and given that all studies are monitored by DMC, I'm becoming more hopeful. I don't want to say confident, but more hopeful on the safety and tolerability side. Obviously, everything has to pan out. It would be a first-in-class proposition.

Jacob Martin Wiborg Rode
Head of Investor Relations, Novo Nordisk

Good. Thanks, Martin. Final question from Simon before I give it to Karsten to round off.

Simon Baker
Partner and Head of Global Biopharma Research, Redburn

Thank you. We have Simon Baker from Redburn. Just going back to the question, I tried to sneak past the regulator earlier. In terms of the differences in duration of therapy in the consumer channel, what does that extra duration look like? Is this people on maintenance dose, lower dose, more in, more frequent dose spacing? Because either way, it all feels like volume that we're not assuming or haven't assumed. Thank you.

Karsten Munk Knudsen
CFO, Novo Nordisk

Two things on this one. Two factors. The first one is that many of the direct channels are actually also offering different subscription models, which means that when you, it's like a subscription, you buy your drugs for a year or so, which means that by definition, there's a natural, sort of a loyalty reward if you stay longer on therapy. It's a way of actually pricing the medicine that is influencing this. The second one is back to your question regarding the average. Don't look at the average. Look at the dispersion. You have people that are very convinced of the value long-term that are already integrating the cardiovascular health element or the kidney health element. Others are more volatile in nature. That's what you said early in the first place. Please don't look at the average. Look at the dispersion.

When you look at the overall direct, look at the way people are actually purchasing their medicine. All in all, that tells one thing. We need to be able to cater for the needs of the patient on the lifetime, not just in one go. That is definitely one of the things we are pushing and one of the big value of having a portfolio.

Jacob Martin Wiborg Rode
Head of Investor Relations, Novo Nordisk

Thank you, Ludovic. I'll hand over the word to you, Karsten, to round off.

Karsten Munk Knudsen
CFO, Novo Nordisk

Yeah. Absolutely. Thank you for attending our Novo Nordisk Q3 London lunch roadshow meeting. Great questions, great dialogue. We'll stay around for some additional minutes for some subsequent Q&A. As you can note, the company has gone into a different phase after some years of hypergrowth. Growth has decelerated. The important notion is, we have a plan both in the short term really to execute on commercially launching the Wegovy pill in the U.S. as one of the key levers. I would say the next 12 months, a number of attractive pipeline milestones and readouts. Much more to come in terms of driving future growth for the corporation. Thank you for attending.

Powered by