Okay. We just wanted to welcome everyone. My name is Thibault Boutherin. I am a pharma equity analyst at Morgan Stanley. Thanks for joining the Novo First Quarter 2025 event, post-results. We are delighted to have with us the management team of Novo Nordisk. Lars Fruergaard Jørgensen, Karsten Knudsen, Martin Lange, and Mike Doustdar. Thank you very much for joining us. Without further ado, I will hand it over to you, Lars.
Yeah.
Thank you very much.
Thank you very much. Thank you for hosting us today. Like we normally do, we'll go through a few slides relatively snappily to set the scene and then get into your questions. Now, of course, we'll be talking about the future that might turn out to be different than what we preach from here. Please be careful around that. This is the summary slides. I'll not cover it in much detail. We will, through our few slides, talk to commercial performance. We'll talk to the pipeline and our financial guidance for the year. Firstly, on financial performance, you have seen the reported 18% growth, with, you know, relatively equally contributing regions, U.S. and international relations. It's again the GLP-1 franchise in diabetes and obesity that's driving the growth. We are proud that we are still an absolute volume leader.
We have these slides just to underline how we are scaling. With our big footprint in Mike's part of the world, we have, you know, close to two-thirds of all patients on GLP-1-based treatments. You know that we are investing significantly in keeping that, say, leadership position in terms of serving many more patients for the future. Scaling in manufacturing is happening, and we are quite pleased with that. A key topic for this quarter has been the U.S. development in scripts. Here the slide is. We have seen that we have gone flat in the scripts. That is something we take very seriously. It is impacted by how compounding has developed for Wegovy to a small degree, Ozempic in the US to a degree where we now estimate that it is as big as our own business, more than a million patients.
You have probably seen the announcements from FDA that we are off the drug shortage list. Hence, it's now illegal to do compounding. We have started the NovoCare Pharmacy cash offering. We are building some partnerships with two health providers. We also will have some benefit from the decision by CVS in terms of focusing on Wegovy. We are taking this very seriously, and we believe that as we progress the year, compounding will be dramatically reduced. It's really only for individualized persons in rare cases that will be allowed. We will work hard to make sure that it's limited to that. We expect that will, that should lead to a reflection point in the scripts in the coming second half of the year. I'm sure we'll get into this in more detail.
With that, I'll hand over to Mike for some words on, on IO.
Thank you very much, Lars. Lars showed you how the different regions and international operations have been doing, almost all of them, with very good growth rates. He also mentioned that the growth is really in GLP-1, diabetes GLP-1, and obesity GLP-1. I have decided to use the slide on focusing on GLP-1. The 11% GLP-1 diabetes growth that the company showed, 13% of it comes from international operations. You can see the three products that we have: Ozempic, Rybelsus, and Victoza, and how they are basically delivering their growth rates in each of the four regions we have in international operations. On the other hand, we showed 65% growth rates for the company on obesity GLP-1.
A lion's share of that, 137% of that, this quarter came from international operations on the back of two products: Saxenda, which is slowly going out, and Wegovy, which is very quickly replacing and being launched across the market. We came into the year with close to 20 markets being, being, having Wegovy. As of today, we are very close to 25. We have plans, of course, to roll out Wegovy in many more markets as we go. The growth rates speak for themselves.
Thank you very much.
Yeah.
As you all know, we've reported on REDEFINE 1 , that created a lot of attention and obviously also on REDEFINE 2 in type 2 diabetes. Just as a reminder, we saw a very, very strong weight loss in REDEFINE 1 , 23% weight loss, comparable to that of Wegovy. I mean, we get a lot more weight loss, but with the same safety and solid ability profile. Same thing in type 2 diabetes. It is also important to point out that we've taken some learnings from those trials, chiefly that they were too brief. We did not accrue the full weight loss potential. We do believe that there is maybe more weight loss potential for CagriSema. Therefore, we've extended REDEFINE 4 .
We have initiated, or will initiate in this quarter, REDEFINE 11 , taking the learnings of doing a longer trial, but also focusing on how to re-titrate if titration has been stopped. With that and with these initiatives, we do believe that we will see the fuller weight loss potential of CagriSema. Obviously, given the duration of REDEFINE 3 , that is basically by design already built in. Very exciting still for us. We do see a lot of merit in obviously CagriSema, but also the broader amylin biology. I'll come back to that, both for amyc retin, but also for cagrilintide and , each with their different traits.
The potential offering of CagriSema is obviously unsurpassed weight loss with a very strong safety and tolerability profile and with the comorbidity benefits that we know, and at least I love, from semaglutide, i.e., CV benefits, soon to be liver benefits, maybe, benefits on cognitive function, and obviously in the diabetes space, also kidney benefits. Also, amycretin is something that we have been talking about for some time. Obviously, there's a lot of talk in the town about anything oral GLP-1 analog. Just to remind you, with also amycretin, we see with 25 mg for obesity, 17% weight loss. That is a really, really strong weight loss in this space with, again, a safety and tolerability profile that is not only well known and acceptable to patients, but also established in a very, very large database.
In that, we also have seen the comorbidity, sorry, biomarkers for comorbidities, for example, waist circumference, for example, the lowering in risk of inflammation, for example, also lowering in blood pressure and lipids. That basically means that we have a reasonable aspiration of getting the benefits from these SELECT trials, but maybe also other trials into the, also for obesity label. Again, a very strong offering with unsurpassed efficacy in the oral space, being the first oral GLP-1 for the treatment of obesity, very well established safety and solid ability profile, and potential for CV and other benefits in the label. I can speak a lot to this slide.
The short message is we see progress across all our therapy areas in our phase I, II, III, actually phase IV pipelines in diabetes, in obesity, in cardiovascular, in liver disease, in actually also kidney disease, but certainly also in rare disease. A lot of important things have and will happen, for the duration of 2025. I think most interestingly for today is probably to dwell a little bit on our obesity pipeline. We believe it to be strong and deep and very competitive, building a pipeline that caters to different patient needs across the obesity spectrum. From our perspective, it's naive to think that obesity is one disease. Many patients with different patient needs.
Just to give an example, if you have reasonably low BMI, let's say 30-35, no comorbidities, we are building catecholamine side, currently taking that into phase III to cater to that. If you have a need for, maybe a slightly bigger weight loss and focus on comorbidities, it's Wegovy. If you have bigger weight loss needs, it's gonna be catecholamine, it's gonna be amycretin, and it's gonna be our current internal triagonist. We have also just done an acquisition for an external triagonist being a GLP-1 glucagon GIP. We have also acquired a small molecule with a non-incretin-based mode of action. In the obesity space, a lot of exciting stuff coming in. Obviously also our research pipeline that we are not disclosing, continuously feeding into that, not only looking at weight loss, but also at quality of weight loss and comorbidities.
With that, over to you, Karsten.
Thank you, Martin. We move to Outlook. We are continuing an innovation-based growth strategy, delivering 18% growth in the first quarter on the back of significant growth in the preceding years. The guidance that we updated here in connection with the first quarter is a sales growth now of between 13% and 21%. It is lower than three months ago, and that is really a function of the slower start to the year linked to especially compounding in the US impacting Wegovy. This Outlook is also based on an acceleration of scripts in the U.S. in the second half of the year based on a number of tactics we are deploying. I am sure we will come back to that in further detail during the session.
Operating profit, also lowered compared to three months ago, but it's important to note that the lowering of top line is partially being offset by tighter resource allocation. Very diligent in terms of how we resource the company, still driving growth, but of course gearing the company vis-à-vis the growth that we're seeing. Currencies have moved against the company with the US dollar being down from DKK 7.17 three months ago to DKK 6.56 now. This year we have full hedge on the US dollar. On the net profit we have done that. That's what you see in net financials. Finally, cash flow down compared to three months ago, still very cash generative as a business.
The reason we are lowering is, of course, a function of the lower top line outlook, and then the gearing that is in the U.S. cross-to-net model that further amplifies on free cash flow. That is the outlook for 2025, continued growth. With that, we are ready to move to Jacob and Q&A.
Perfect. Thank you, thank you, Karsten, thank you, team. That concludes the first part of the session, and we will move into Q&A. We will do one question per person, please. We will start with our host of today, Thibault from Morgan Stanley.
Thank you very much. The question is on the CVS agreement, agreement with CVS. Just if you could confirm if there is any timeline associated with the exclusivity and also just if you pegged in an improvement in the opt-in rates on this formulary within your guidance.
Yep. Thank you, Thibault. I think it goes to you, Lars.
Yeah, thank you. We have a longstanding, good relationship with CVS. Based on that, we have made an agreement with them that we will bring also our cash offering into the pharmacy chain. We really focus on giving more access. We have not bid on an exclusive contract. The rates we have provided, you can assume that it's similar for co-preferred and exclusive access. Nevertheless, CVS has decided to go with Wegovy. I think it's linked to obviously the profile of Wegovy, the real world experience in the weight loss it delivers, and also the additional benefits. I know personally that they're keenly interested in MASH. You have a big, say, overlap in patient populations when you look at MASH obesity. There is real unmet need.
It's actually a very, very, say, inexpensive way to get access to MASH coverage, assuming we get this on label in the second half. It's a really good deal for them. For a payer, it works very well to focus on this product. There are a lot of scares about, say, price competition, et cetera. It's not going to be initiated because of exclusivity bids because we will not make that. I doubt our competitor will do that as well. We will see that in a managed way, pricing will come down over time as we've seen in all other categories. That is unlocking larger volumes. It still unlocks growth. I think that's a very good outlook and very good model for us. Thank you.
Thank you, Lars. Very clear. We move to Emily.
Hi, thanks. Emily Field from Barclays. You know, reading through the comments from yesterday's call, it does seem that you are, and with the launch of NovoCare, that you're expecting sort of the cash pay portion of Wegovy to increase in the second half. However, you know, we've obviously seen a lot of consumer-focused companies warn about consumer softness in the U.S., with the economic situation there. Are you, within your revised guidance range, anticipating any consumer softness? If you could just provide context to how you're thinking about, you know, what would still be a relatively expensive out-of-pocket product?
Thanks, Emily. I think it goes to you, Karsten.
Yeah. As I also said at the call, estimating the cash channel for us linked to compounding and telehealth agreements stands on a number of assumptions. The way we've been, a number of assumptions and somewhat limited data quality. That's what we built into our guidance. The way we've done it is basically triangulate from different aspects. One is the amount of people we currently estimate is on compounded product today, especially bulk compounded products, how many will switch to branded and hence get into the cash channel as one element. Then whatever data we otherwise can see in terms of cash channel penetration and telehealth impact.
Based on that, we've made an estimate on what is realistic in our view to put into our guidance on Wegovy cash channel, throughout the, especially the second half of this year.
Thank you, Karsten. We go to Sachin.
Hi there. I wonder if you could just try and put some guardrails around what you mean for real launch for oral sema. The reason I ask the question is you frame the oral segment of the market as a minority. Is a real launch in that context, which would be different from, I guess, the competitor's commentary, which assumes oral segments are a lot bigger? I am just gonna give you two potentials. One, the leave of disclose some inventory. Would you give any color on that? Or, any commentary related to consensus next year, which is DKK 3 billion? Thanks.
Thank you, Sachin. I think it goes to you, Lars, and the real launch.
Yeah, I can talk to the launch and maybe others can chip in on, well, I do not think you are going to get any guidance on sales. Martin described the profile. I think we have a winning, potential winning profile, in terms of efficacy. In any new category, you have to relate to safety. I think it is rare to have a launch where you have as much safety as you have on this. Not least when you have to go up against small molecules that clear in different ways than this product. I think from the get-go, a very, very strong profile. You also know we have been building API capacity and we actually have a dedicated U.S. supply chain for this. We have API in North Carolina.
Typically when we install new capacities, it's defined for a certain, certain output, and then we optimize that over time. This optimization is going really well. On an output point of view, we are encouraged. Of course, we also have different formulation technology generations that also, you know, creates more, say, output. When we say we can go into a full launch, that means that we believe we have the products to be able to do that. We'll not get into, say, sizing the all opportunity. We think there is going to be a large injectable segment. When we ask patients, physicians who are already on weekly injection therapy, that is seen as very convenient. We also know that there are many who prefer a, a tablet-based, oral treatment.
We feel really good about the opportunity we have and the ability to launch and supply the market. I think there will be interesting considerations about the go-to-market model. Do you use the known classical, say, contracting, PBM insurance, or do you go with the channel we have built, or do you do both? We will not disclose all the tactics around that, but I think it is really a great opportunity. I think we have all the elements from supply, commercial go-to-market channels to make that an exciting opportunity for us. Thank you.
Very good. Next up, Lars. Then we have Naresh up here.
Thanks. Just a question on duration of treatment on compounded drug. What data do you have on that? And how should we think about that? Or is there a better proxy ex-U.S. where you've gone out-of-pocket market? How do we think about duration of treatment for those, for those, that subset of patients?
That goes to you, Karsten.
Yeah. So again, not super good data on compounded. It's really market research with all the caveats on market research. I would say that the indications we have is that the average stay time is shorter than the seven months we've been talking to on Wegovy in the compounded segment. So that's the starting point. What I would say, that's an average across all, you know, all the different shapes and forms of compounded approaches. What we are also hearing is, when we have, you know, some of the different telehealth service providers that are selling compounded today, it's important to note that their business is to wrap a service around the product, and a subscription model.
They have a lot of incentive to keep people on product and basically, you know, make a 12-month agreement at a lower price point than a two-month agreement. I think there's some opportunity in telehealth with the subscription model, both in terms of, you know, pricing accordingly, but also the patient services and reminders to patients. Like here in the U.K., we have a collaboration with EMATS, where there are weekly notifications around, did you take your Wegovy injection, et cetera. I think that service to patients should help on stay time. It goes hand in hand with the telehealth providers' incentives as well. I think that's as specific as we can be on it based on data.
Very good. Thanks. Then we move to Simon Baker here in the front.
Thanks so much. A sort of bigger picture question when it comes to the crux of it, about the whole supply-demand dynamic here, that last year this was clearly a supply-constrained market. Is that still the case? It feels like the feedback we get from clients is this is more demand-constrained. Could that simply be that it is supply-constrained? It's just the compounders have been supplying half your market and that's going to go away. Thinking about both demand and your ability to increase supply, how does the CVS deal fit into that? I mean, presumably they must be confident, you must be confident that you can supply all that they need because obviously an outage would not be helpful there.
Just really give us a feel for how the market looks now because the trend from last year, the scripts, these moving parts is not absolutely clear. Any insights would be really helpful.
It goes to you, Karsten, as well. Lars, you can build on if anything afterwards.
Yeah. In terms of supply-demand, and for those of you who read our quarterly announcements very carefully, you'll see the wording around supply has been, and supply constraint has been toned down significantly. If you compare to just three months ago where we said, across markets and products with supply constraints, now we're talking about certain markets and certain products. That is just a clear signal that at a global scale, the supply-demand balance has changed significantly. I wouldn't say that we're totally out of constraints across all markets and all products, but it's much, much better.
You see that also as a function of, significantly more Wegovy launches in, in IO and more in the plan, which is also baked into our guidance, promotional efforts for, for Wegovy, for Ozempic at, at a global scale. That's, that's kind of the macro picture on, on supply-demand. In the U.S., we're fully supplied, for, for our GLP-1 portfolio. There are high inventories, you know, and of course ready to, to service our, our obligations vis-à-vis the, the CVS agreements. Clearly we don't want to get into a drug shortage situation again, neither vis-à-vis CVS or all similar launch, come next year. That leads to the second part of your question, is it, is it then demand constraint?
That links into what we've been communicating this quarter, that the market has actually accelerated super nicely in terms of total volumes. At a global scale, if you take branded products, the obesity market has more than doubled compared to a year ago. I think that's, and it doubled the year before also. The market demand expansion and demand, I'd say data proves that we're penetrating as, or the market is expanding as it should. In the U.S., if you take compounding and then say in obesity compounding is one-third of the market, then you actually get to a really attractive market expansion, also in the U.S. Unfortunately, for us, it's based on compounders expanding in the cash channel.
That is why it is so important for us to get the cash channel built both with NovoCare and partners in telehealth, to service on the patient activation. That is kind of the whole supply-demand picture.
Thank you, Karsten. Let's do it a bit differently. Are there any questions to either R&D or IO? James, smart man.
Thank you, James. Pretty good on the tax. My question for IO is on Wegovy China, and I've got a quick one as well, Karsten. On Wegovy China, it was a very strong quarter. It's only the third quarter of the launch, but is this the start of a trend or should we expect it to continue to be volatile on a quarterly basis? Do you have any other information about potential launch of semaglutide generics in the regions with the upcoming patent expiring in 2026? Any competitive intelligence on China, Canada, Brazil, Mexico, those ones that are going there? A quick other one for Karsten, oral semaglutide 25 mg, the timing of the potential approval seems like it's six months. Have you used the PRV? Did you buy it? Is there an expense coming in the second quarter?
On China and Wegovy, I would say we foresee a fantastic year throughout the upcoming three quarters. There is always, in our part of the world, in China and emerging markets, quarterly fluctuations. It could be one quarter is a little bit better or worse, but I would say we have incredibly high ambition for China's Wegovy, not just this year, but beyond. You should foresee good numbers coming out of that in the context of LOEs and other players. There are, to the best of my knowledge, five or six players right now that are trying to make semaglutide for post-LOE. We are watching them very seriously. Having said that, I would say that they would need to have a certain amount of volume before they become a viable threat.
There has to be a number of them also in the market that gives the government and everyone else confidence that collectively they will be able to again capture a large number of patients. Our success with Ozempic historically, and now of course with Wegovy on the back of getting many, many more patients month by month, is one of our best tools we can have to protect the business for longer. Brand recognition, I have spoken to that in the past, should not be underestimated. A place like China really cares about brands. Historically, we have been seeing that has helped us put many of our products that actually do not have patents in China, but we have leadership. That gives us confidence and the hope going forward.
Of course, as we are ramping up, our economy of scale is at a very different level as many of these players. We also will be able to discuss with the government when the time comes on volumes and prices, perhaps in a position of strength compared to many other players. Those are, I would say, what gives me confidence. You also mentioned Mexico and some of the other players. I would say to a large extent the same thing. We just launched Wegovy in Mexico actually last month, going incredibly well. Mexico was supposed to go LOE next year, 2026. Our legal and regulatory team have done a phenomenal job. Just more recently we have heard that that LOE is now postponed by an additional year. We are very happy about that.
It gives us more time to follow on the bit of a strategy that we're doing in China.
Thank you, Mike. Abiding to the rule of one question per person, I'll take the liberty to move to what just in the corner.
Can I do a question and a clarification? A clarification on that 7.4 months of duration, is the mean different from median or mode? That would really help to understand if you're seeing churn early. The question is, if you indulge me with, you got about, say, you know, 3 million or so patients in the U.S. on Wegovy, right? Not Wegovy, all the brands, right? Across, including compounders. And the 90 million potentially obese patients, let's say a third of them have access with the access you have. We in theory are scratching the surface of a very, of a very large market, right? Your penetration rates are quite low. I'm quite puzzled. You've had Lilly two quarters of peace talking.
Your growth got impaired by compounders in the first quarter when we are scratching the surface of a very large market. All the sell-side brokers, like me, have built their models proclaiming the market is 120, 150, 200. I do not know. Everyone has a big number. Does this make you stop in your tracks and ask a question? Is there any other rate-limiting step in realizing that market size, which might, because I mean, if the market is that large, why do compounders matter at this low level of penetration? I am unable to get my head around it. I am very curious on how you would think about the problem.
Thanks, Lars. And do you have one penetration to you, Lars?
I think it's a great question. I think it started with the classical market structure with PBMs, insurance companies, and ultimately, at large, employers paying. It started with, you know, opting in and relative easy access. Core starts growing, and then a lot of friction is put in, and it becomes difficult to get access. I think in totality, the stack of players have not succeeded in actually unlocking the value of treating obesity because there is actually tremendous health benefits. There was data out recently from Aaron about, well, when you do obesity treatment, there's a cost year one, but actually you start saving cost already from year two. We haven't fully gotten to the perfect transaction model in untangling that.
When we build a cash model, it of course, right now serving individual patients with telehealth, but it's also building the opportunity to actually engage with large payers. If you take a payer that has, a large number of employees, you're self-insured. If you have long tenure among your employees, you'll be accumulating all the cost from the comorbidities associated with obesity. You get the lower work attendance from those who are sick. Actually, there's a very robust financials in actually, helping them understand their own data and how do you actually go about it. You can say in, in European healthcare systems, you have a lot of experience in how do you sanction rational, ranks in, sanction rational use of medicines based on, health technologies. In the U.S., it's like, I have a right to access and there's no discrimination so far.
I'm not advocating for discrimination, but we need to understand individual patient needs and what's the value of doing that. I think this will be coming as more models are built, and that will also put pressure on the existing, say, chain in actually coming up with that solution to payers. I think this will happen over the relative short, short term. I think we'll see that will unlock a lot. You'll have the cash channels, so more channels are being opened up and access will increase.
Anything to add, Karsten?
Yeah, just building on Lars' comments because, clearly, obesity is our top priority because we have a super strong portfolio and very significant unmet need on a global basis. This is the key or the biggest growth opportunity for the company. When we look at rate-limiting factors, we can have that discussion for all markets, including China, where I was just a few weeks ago. In the U.S., you can look at it as the, initially, the rate-limiting factor was supply. As I said before, we have moved out of supply as a rate-limiting factor. The next step is, how is the system a rate-limiting factor?
When you look at the all healthcare system, then in terms of prescribers, today we have around 80,000 GPs that are prescribing Wegovy in the U.S. If you compare that to the number of scripts, then there is significant more capacity in the system. It is not the healthcare system in terms of prescribers and scripts and fulfillment that is a rate-limiting factor. You say, what is then the rate-limiting factor? There, I would say in terms of capacity in the system, financial capacity in the system, then of course things have to fit together in the financial capacity. That is why Lars is talking about access and payers, managing that in the appropriate way.
That is why the cash channel is so important that we built that because that is also part of building capacity in the oral system because that moves it out in the out-of-pocket setting and hence less pressure on insurance companies. Then the last piece is on patient activation. Obesity is a different type of patient activation compared to other disease areas. Again, telehealth providers play a different role than in other disease areas. That is how we are looking about the rate-limiting factors across the different pieces of the system.
Thank you, Karsten. Thank you, Lars. Let's move to Pete Verdult.
Thanks, Pete Verdult, BNP. Just one question for Karsten. You know, rather than asking you to comment on every deal you sign or, you know, comment on every permutation that, you know, President Trump might, might not enact, can we come at it from a different angle, which is when we followed you around the world in the last few years, the messaging has been look, 10%-15% price mix headwinds on the portfolio in the U.S. is a good proxy for us to use. Does that still stand or, I know you're not gonna quantify and say what it is now, but does that still stand or should we just be assuming a step up going forward given everything that's going on? Thanks.
Yeah, thanks, Pete, for that question. I'd say for the 10%-15% is an Ozempic or diabetes comment, and there are no changes to that one. Of course, it's forward looking. Now we are in RA, and we're in the middle of the process. We don't know how that works out, but based on what we know today, that still stands. Yeah. And multiple permutations from there. I would say it's important to note that a lot of the administration and the communication there in terms of different healthcare impacts, we've been commenting on tariffs. In terms of pricing, the main focus is on government channels, whether it's Medicare, Medicaid, or even VA.
For Wegovy that we've been discussing a lot today, Wegovy is not present in Medicare and hence has much less exposure to different pricing mechanisms introduced by the administration than other disease categories.
Perfect. Thank you, Karsten. Let's move to Dave Evans.
Thanks, Dave Evans from Kepler. Just going back, sorry, to the question on access and what's holding back the demand. There are roughly half a year or so where patients do normally have insurance coverage. What is actually making some of those, you know, go to the compounding channel? You know, what actual steps are? I mean, I assume it's the insurance companies just making it really, really difficult for these patients to actually get on the brand, even if they normally have coverage. Could you just talk us through, I mean, what are they doing? Is it just a delay for the patient to get on drug? Are they motivated to go to compounded products 'cause it's quicker or easier? If you could just give us a little more detail on that. Thanks.
Karsten, do you wanna go for that one?
Yeah, the, the.
I can chip in.
The simple question to that is, and it pretty much links to a behavioral theory that people move to the places with least friction. Here, simplicity and ease of access, that has really been a play for compounders and telehealth.
Lars.
I can just add, a perspective that if you have a disease like obesity where, say, half of your population or more have that condition, just intellectually, it does make sense to cover that based on insurance because insurance is, is something about treating the few, and having the many, say, contribute to it. I think we need to get to a different state where we actually look at very large populations need to have treatment and how do you get to, to get the model to, to work, you know, accordingly. The current model is not designed to, to, accommodate, obesity. Just, you know, a thought on, on insurance and obesity.
Thank you, Lars. Let's try with either IO or R&D again. Daniel?
I'm taking R&D one. Martin, give us an update on the co-formulation progress, CagriSema, and its importance to scaling up supply for that asset since you seem to have mentioned supply a few times in recent updates. Then maybe a follow-on, the importance of REDEFINE 4 and REIMAGINE 4 and your confidence on showing superiority on weight loss in the former, HPO and C in the latter. Thank you.
On co-formulation, ongoing studies obviously have to show equivalence to both the pharmacokinetics, but also the clinical equivalence. I have no insights into the results. For us, it's an exploratory measure that will obviously add to our flexibility in the supply chain if we succeed. We are currently aiming to scale the dual chamber device to be able to cater to a full CagriSema launch. That's our base case and that's our plan. On REDEFINE 4 and REIMAGINE 4 , as you know, studies are designed to test for non-inferiority first and then superiority. Again, a base case and an upside. In the wake of REDEFINE 1 , we do believe that the biology speaks to it.
The question is whether it's the extension of, for example, REDEFINE 4 has been timely to really accrue the full weight loss. That remains to be seen. I'm fairly confident on the non-inferiority and we'll have to see on the superiority. I think if we really want to look at the full weight loss potential of CagriSema, we have to await a dedicated prospective study like a REDEFINE 11, which will be ready at time of launch.
Thank you, Martin. We move to Harry from UBS.
Brilliant. Thank you very much. Maybe one on IO. Previously you've talked about the fact that you have two different brands for somaticides, as a potential advantage in IO to access the cash pay channel for Wegovy versus Lilly just with Mounjaro. Just wanted to get an update there as to whether you're seeing the benefits of specifically targeting cash pay channels where Lilly might not be able to if they've got one product that has to be reimbursed and therefore only, reimbursed for diabetes or obesity. Thank you.
Yeah. Definitely we see a huge advantage on having gone for the two-brand strategy in international operations. We have around 6 million patients on Ozempic today in IO, and we have 1.1 million on Wegovy. So 7 million patients. It would be very, very difficult. Of course, Lilly's numbers are much, much smaller than that to have done that with a single brand. As you can see, Lilly was not and has not been able to get reimbursement in the diabetes area to accommodate, you know, those patients. For us, as a company that takes diabetes incredibly serious, we wanted to make sure that we are there not just for the obesity patients, but also for diabetics one. Our strategy has fit us and the purpose that we have with both diabetes and obesity very, very well.
I would say, you also see that, of course, that has, because one product is reimbursed often and the other one is not, has been allowing us to play with the pricing in a way that would not have been possible, of course, if it was all under a single brand. The answer is yes.
Thank you, Mike. Emily again.
Hi, Emily Field from Barclays. I'll ask another R&D question just for Martin. You know, for the monotherapy cagrilintide trial that you're starting later this year, if you could give some thoughts on just how many doses you're thinking of exploring and how far beyond 2.4 mg you may go.
It's a really good question. As you know, we've already done and reported on phase II for cagrilintide, where we tested higher doses than the 2.4 mg, and in that setting, we didn't see a lot of added weight loss. So 2.4 mg appeared to be the optimal dose. Doesn't mean that we'll not test an additional dose level in phase III, really looking towards maximizing the weight loss. I think already, going back to what I spoke to before, having an asset that gives a 12%-14% weight loss with a safety and tolerability profile will fit very nicely into the portfolio that we are building so that we can cater to the full need of the patients.
Perfect, Martin. We have time for two more questions. I think that was the first one.
Hi there. Can I take another question on the cash channel given you talked about the importance of it? Do you have any idea as to what percentage of the 100 million addressable patients in the U.S. can afford your NovoCare price? Where do you sit on potentially, you know, coming back to a syringe and vial cheaper strategy, which does not have read-through to reimbursed channels? I might just take one R&D from Martin. You talked about oral, non-incretin GLP-1. Does that preclude a later stage BD asset in oral that could be an ex-U.S. asset given oral stem is predominantly focused on the U.S.? Thanks.
Question on the cash channel to you, Karsten.
Yeah. The starting point is, where are we today in terms of the cash channel? As we've said, we just begun. We're in the low single digits, with the NovoCare, as share of our total scripts. If you look at competition there, based on the market data, we see there in the high teens of cash out of total. That speaks to the potential in where we are today in the cash channel. As a forward looking statement, I do believe that the cash channel has the potential to constitute a very significant share of the total market.
Approaching the 50% or even more in the medium to long term, exactly what price point that will end up being, that's of course something we'll be looking at as we mature the channel and penetrate other channels. All we do believe that the cash channel is a key channel for the markets. Price sensitivity, I don't want to come too detailed on today in terms of how many can access, can afford the $499 out of the 100 million, 110 million with obesity. Based on the numbers I just gave, there will be a very nice potential already with the $499. Sorry?
Syringe and vial.
Syringe and vial. Sorry. Of course we're looking at different product presentation options, as we announced today. Not that it's a cash play necessarily, but we submitted the FlexTouch PDS 290 to the FDA. Hopefully we'll have an approval for that for Wegovy this year. Of course we are also evaluating other product presentations for the U.S. and globally as we move forward. Simply given, as Lars was talking to, the size of the market, 1 billion people with obesity globally, this market will be served in different segments, whether it's cagrilintide or oral or injectables. There will also be different product presentations to penetrate the market in different countries, et cetera, and price points.
Thank you, Karsten. Let's move for the final question, which is Simon Baker.
One more for me.
One question per person. We move to Simon Baker.
Thank you.
I was gonna sneak, I was gonna sneak a second one, but that's me told, so I won't. Just going back to the impact of the compounders, they've had a surprisingly significant impact from a standing start operating in the shadows. I'm just wondering, has this changed your view on what happens at the end of the curve in 2032 in terms of the ability of, dare I say, proper generic manufacturers to supply the market? Because these compounders, one works the numbers out, they've managed to source 25 kg or so of semaglutide from Lord knows where. How has that, how has their performance now changed your view, if at all, of what the proper players can do, at loss of exclusivity? Thank you.
Thanks, Simon. Lars, I'll give it to you.
No, but I think you need to consider a level playing field and we, when we build, for instance, an API facility, we spend half the time constructing and the rest of the time validating it and build the quality around it to document that it's precisely the same product that comes out every time as what was in the file. When we test the currently compounded products out in the market, those contain a lot of impurities. Some of them even contain substances that are banned for use in drugs. We have seen safety incidents being reported, even death linked to it. If you asked these companies to comply with ordinary GMP rules, there would be supply. Just to put it into perspective.
You can do a lot of, say, tricks short term, but you have to be able to withstand the scrutiny of FDA and inspections, not only of the API, but also fill finish. We have a number of cases where, you know, quite serious inspection reports have been, you know, filed and even FDA, sorry, FBI closing down facilities. You have to factor in what is needed to be a reliable, high quality supplier.
Perfect. Thank you, Lars. Thank you, Simon. Before giving it to you, Lars, my final remarks, a big thank you for the turnout, and for all the good questions. Lars, final remarks from you?
Yeah. Thank you, Jakob. Thank you all for coming. We acknowledge that it's been a, you know, turbulent period. I hope it comes across that we have, I think, a relatively clear field for what we need to execute on in terms of continuously scaling capacity, executing the trials, coming back strongly with CagriSema and, I think, a leadership opportunity in the all GLP-1 obesity category. The commercial efforts are needed both to make sure there's preference for our products and what is needed to close down compounding to really sustain an attractive growth profile and bring innovation to patients around the world. On that, we are quite optimistic and clear on what we have to do. Thank you very much.