Welcome to the 2019 Capital Markets Day in Novo Nordisk. On behalf of all of us in Novo Nordisk, a very warm welcome. Thank you so much for coming. This is a very exciting time for Novo Nordisk. I can personally not recall a time where we've had a stronger portfolio than we have right now, leading to more launches than we've ever done as a company.
I might be a bit biased positively towards Novo Nordisk, but I think really we can claim that we have strong products in each and every category we compete in. So we look forward to sharing that excitement with you all here today and talk to how we look at our solid growth outlook. I'm already getting into talking about the future, so I need to get this slide up and remind you that the future includes risks and uncertainties that might turn out to be different than what we treat here. So please study this slide carefully. I think most of you have seen it before.
I will start by introducing our corporate strategy. And I'd like to start by our purpose, why we are here. At a time where the pharmaceutical industry is facing deteriorating reputation, it's really important that all of us stay sharp on what is our purpose, what is our contribution to society, why are we here. For Novo Nordisk, it is to drive change to defeat diabetes and other serious chronic diseases. Our key contribution is to discover and develop innovative biologic medicines.
That's what we do. That's our role as a pharmaceutical company. But that's not enough. So when we talk about driving change, it is as much about securing that the health care systems we serve, the patients that are treated by our products actually have an opportunity to have access to these products. And in the disease areas where we have an opportunity of actually preventing people from getting the disease, we also have to be engaged in preventing, preventing obesity, preventing type 2 diabetes.
That is fundamentally important. That is the Novo Nordisk way. That is the mindset of our founders. It is a mindset that we drive our business based on. Another key mindset is to build our business based on a set of core capabilities, core capabilities where we can be the best or among the best in our industry.
So that's a strategic premise for how we run our business. So during the day, you'll hear both about how we live up to our social responsibility, how we become a sustainable company from a financial point of view, from a social point of view and from a environmental point of view, but also how we continue to invest in our current capabilities, but also expanding our capability base because that's what it takes to drive a sustainable company. So I'll now introduce to you the 4 quadrants of our business. The first one is diabetes care. So our strategy is to strengthen our leadership in diabetes.
And as I just mentioned, we have the strongest portfolio ever in diabetes. We have a strong portfolio of insulins. We have a strong portfolio of DFB1s. And we are now finally turning our market performance around. So we're actually starting to gain market share.
And we're turning around our GLP-one performance. So we're also catching up and starting to lead in the markets where we have launched Ozempic. So very, very strong execution there. We believe we can continue to invest in innovation that can redefine how diabetes is treated. So you'll hear during today not only how we're executing our commercial strategies, how we are starting to win against competition, but you'll also hear about what are our aspirations for future innovation that can lead to improved care and potentially also disrupting how we treat diabetes.
We also believe there are opportunities to leverage digital solutions to drive better outcomes. So we believe in sustained solid growth in our diabetes business. Turning to obesity. This is a large opportunity for Novo Nordisk. It's still very early days.
Many more are living with obesity than people who have diabetes. We have the leading product today. We believe that by investing in building the market, by investing in continued innovation, we can unlock this market and make it a very significant contributor to long term growth of Novo Nordisk. And we have leading capabilities to do that. And you will also during today hear about how we're going to develop that market and what are our innovation aspirations for improving weight lowering even more than what we can do today.
Very exciting opportunity. And also here, there are digital opportunities for complementing medicine in achieving the weight loss we aspire to. Our third priority is the biopharm area, where we believe we can develop a leading position. Again, we have a broad portfolio. We all know that we are facing competition on NovoSeven, which actually turns out to be more resilient than we had actually expected and I think most had expected.
And we can see that by leveraging our portfolio, we can actually complement what we're losing on NovoSeven. And we talked for a couple of years about getting biopharm back to growth, and we're actually doing very well. We still believe the opportunities both by leveraging our in house capabilities to continue to innovate in house and we're also looking at how can we complement that by external innovation. So we also believe that we have a sustained opportunity to drive growth based on our buy from business. And then we are trying to build a presence in all serious chronic diseases.
We have shown that we can end obesity by leveraging assets we have, leveraging knowledge we have. And we have the same view when we go into all serious chronic diseases, leveraging competencies, leveraging assets, knowledge we have, where we can actually make a meaningful play in all serious chronic diseases. And you'll also during today hear about our aspirations for doing that. So this is in all simplicity our one pager corporate strategy. And I would now like to just take a moment to talk through our long term financial targets.
Based on our performance this year, based on our outlook for this year, we expect to meet our long term financial targets by end of 2019. And we are today introducing a set of strategic aspirations for 2025 to replace those targets because we believe it actually takes a more comprehensive approach, a more comprehensive framework for us to articulate how we see the growth opportunities, how we are going to invest in achieving those. I'd like to underline that this change is not based on a view that we cannot achieve our targets. We are still comfortable about that. But it's based on a view that it's too it's a too narrow perspective to operate with a short list of financial metrics to actually explain how we look at our business.
So during today, we will be talking to this framework of strategic aspiration for 2025 in these four boxes. 1 about leading based on purpose and driving a sustainable business based on a set of distinct core capabilities. 1 about driving innovation towards a high innovation bar in a set of focused therapeutic areas, one about making sure that we have strong commercial execution in all our therapy areas, in all our markets? And what about what is our perspective on the financial outlook? So we have to be a bit patient during today because we actually organized today to explain this in great detail to all of you.
And I'll end up the day by actually summarizing what are the specific aspirations. You'll get them throughout the day, but you get the overview at the end of the day. So please be patient and listen carefully to what we explain because this will be how we will be actually holding ourselves accountable towards our future solid growth and we'll be reporting on progressing this quarter over quarter. I would like to end by reflecting a bit on my priorities when I took over as CEO, which is approaching 3 years ago. So I defined 3 priorities.
The first one was that we needed to strengthen our commercial execution. We had a situation where we were losing market shares and it was simply not acceptable for us to lose market shares with the portfolio we had and we have later developed and introduced to the market. So we have spent a lot of time in our organization in turning around our focus in the commercial areas, changing our focus towards winning against competition, changing our focus towards winning market shares, not just delivering on the bottom line, but we simply need to do better, and we need to win against competition. And you will have a great opportunity to listen to our commercial leaders during the day, explain how we have done that. And there will also be breakout sessions where you get to meet the regional heads in International Operations.
So I must say that I'm very proud about how the organization has responded to this challenge. And I'm very proud that we are today getting more out of portfolio than we ever done, and we are gaining market shares. And that's across the business. The second priority was to increase our innovation bar. At a time where there is increasing competition in our markets, we need to make sure that we stay clinically differentiated in what we bring to the market.
So we need to dare to set the ambition bar high. And that's another change because if you have been doing new versions of existing mechanisms for many years, of course, there is a certain feel about that. And if you have to raise innovation by, you need to accept taking more risks and moving to new mechanisms, new approaches, new technologies. So I'm also very proud about how the R and D organization has responded to this. And we are looking at more new innovation than ever.
It's actually not only in R and D, it's across the business. You have no chance to ask product supply questions later on. Also a lot of innovation being brought to product supply, increasing efficiencies, etcetera. And then the 3rd priority was to evolve our culture. No revolution.
We have a really, really strong culture in Novo Nordisk. But if you want to drive a more ambitious mindset in the commercial area, if you want to drive a mindset towards higher level of innovation in R and D, you need to adapt the culture to accommodate that. You need to reward and measure people in different ways. You need to allow for setting targets higher than is potentially possible to achieve them to drive and unlock people. And you need to accept that in R and D, it's okay to failure if you aspire to do something that's at a higher level.
And then you learn from that and you move closer to actually achieve it. So I'm also very pleased on how the organization has responded to this. We're by no means done. This is an evolution, and we are working hard on that. But I just wanted to make sure you understand that we feel we are at a really, really great place in the development of Novo Nordisk.
And we have made significant initiatives to make sure that we can execute strongly. And I think the data documents that we're making good progress. So that's my introduction. I'll now introduce to you the agenda throughout the day. You also have it on your name tags.
But we'll start out this morning by taking a deep dive into diabetes. And I have a number of great colleagues here, Camilla, Mike, Mads, Henrik and Doug, who will take us through both the commercial opportunity as well as what are our research and development priorities. That is followed by a Q and A session where you can ask questions to all of these individuals, including myself. After the break, we take a deep dive into our great opportunity in obesity. And that's again Camille, and it's Martin Lange, who is leading our global clinical development.
Then we go into biopharm. And that's Ljudevik Helfgott, head of our biopharm area. And it's Mads again. And followed by Q and A where you can ask questions. After lunch, we start by diving into the markets.
You will have first Doug Langer giving an update on the U. S. Opportunity, exciting times, many launches. You'll have Mike actually talk a bit to the same, even more launches because there are more countries. And then there's an opportunity for you to get close to the regional heads because we have invited all the regional heads, Matt running region Europe, Ol running Japan and Korea, Christine running China, Feregg running Africa, Asia, Middle East, Oceania.
And then we have Andre running our Latin America operations. All demonstrating fantastic sales growth. So we thought we can take them out of the market for a couple of days to get closer to you and share their experiences. After the regional updates, we dive into what we call emerging therapies. So that's our research efforts.
And here we have MAS again. And we have Marco Schindler, who is leading our drug discovery activities. So very exciting readout on what is the long term perspective on our growth drivers. Then we home in based on Product Supply and Finance. And you might wonder why is Product supply together with finance.
But that's because Henrik is going to brag about how well he is doing in driving efficiencies and lowering unit cost. And Carsten is so happy about that message. So they teamed up to do that together. And then I will wrap up, share with you what are these strategic aspirations for 2025 that we have defined. And we will follow that by a Q and A session where the whole management team is available.
And there you'll see Munich Carter, our Head of People and Operations also available. So that's the plan for today. And we'll wrap it up with some networking. And I'm not sure there might be a bite and a glass of wine to mingle towards the end of the day. So that's our plan.
And I think we should get going. So I'm happy to welcome Camilla to stage and share with us our diabetes outlook and aspirations.
Thanks a lot, Lars. Good morning, everyone, and we'll kick right on with diabetes. Diabetes is, of course, the reason for why this company was founded more than 96 years ago, and it is still the core of our business. So it means that it is more than 80% of our sales. As you know, we are a leading company in diabetes care, and we're also very confident that you'll see a lot of insights into that today that we can even evolve our leadership in the very near future.
So before we get into our business strategy, I'd just like to remind everyone about the big unmet need that we see in diabetes care. And if we start with people living with diabetes, you see that there is a tremendous burden on them. They actually have a life expectancy that is 8 years shorter than people not living with diabetes. We also know that 70% of them are dying from cardiovascular disease. And despite all of that, we also know that it's only 9% of them that are being treated with a glucose lowering agent that actually has proven CV benefits.
So there is a lot of opportunities to do even better in diabetes care. And we will, of course, get into that a little bit later during the sessions. But when we just look at the numbers, you know that we just had new numbers released last week that shows you that there are 463,000,000 people living with diabetes, many of them not even diagnosed. 183,000,000 people are being treated, but you also see that only 29,000,000 are being treated with products from Novo Nordisk. And of those, 27,000,000 are being treated with insulin, but yet just a very small fraction being treated with GLP-one.
So there is a big unmet need both in terms of getting better care, but also a big unmet need in getting more people treated. And that's the business that we are in to help all of these people. And I'll just give you now a few projections as to what we expect that the growth will look like in this area. So here, you see our expectations to the growth in terms of number of people being treated. The 183,000,000 we just talked about now, we expect to grow with 4% annual growth rate towards 2025.
And as you also see, many of them are being treated with insulin, like we just saw on the other side as well. And when we then look at the value of this market, it is a $48,000,000,000 market today or last year, and we expect that to grow with a compounded growth rate of approximately 3% towards 2025. But if we take out the loss of exclusivity on the DBP4 plus the underlying growth we expect to be around 4% in this market. You do see also that a big part of the growth is driven by a very big insulin business as a base, but the real growth is coming from the SGLT2 segment and the GLP-one segment. And that is, of course, where we are very strong and also expecting to be even stronger going forward.
So the dynamics in terms of this is what will drive a big part of our business, but also drive even better treatment and care for people living with diabetes because, of course, as you know, the GLP-1s are able to address not only blood sugar, but also lower weight and also lower the cardiovascular risk profile. So the combination of our business and achieving better glucose results and weight results and cardiovascular risk profile for people with type 2 diabetes really goes hand in hand. We do also expect a few key trends in this area. 1 is around the development of the GLP-one, especially in the oral part that we can contribute to and combination products in the area. This will also, to some extent, offset some of the biosimilar competition that we do expect to see in this field in the future.
At the same time, we also, as Lars mentioned earlier, evolving our digital support tools to patients both in the insulin segment, but potentially over time also patient support programs in the CLP1 segment. VLP1 segment. That, of course, should give patients an even better control going forward. We know that many of them are not seeing the same results in real life as they have seen in clinical trials, and that, of course, we can support them on. I'll get back to that a little bit later.
One thing that we should also expect is an evolving, we call it, payer dynamics, meaning yet pressure on health care systems to fund all of the medication in the diabetes area, but not just in diabetes, but also in many other therapy areas. And of course, it's important that we have good health economic results of the products that we put to market, just like we also have it for Rebersus, and you will we would talk to some of that a little bit later. But access and affordability of medicine is also an issue that a company like ours with a sustainable business approach needs to take a look at. So I just want to confirm to you that as part of that, social responsibility is also core to our business. And you can say that as a pharmaceutical business producing life saving medicines, we have a special obligation to make sure that we bring our products to them.
So innovation will always be important for us as a special contribution to society. But we also understand that not all people are getting access to lifesaving medication and in some cases also not to insulin. So as part of our social responsibility, we also want to make sure that we address that access and affordability issue. In many places, this is a bit different. So the issue is different in the U.
S. Than it is in India or in China, but it is important that it is part of our integrated business approach. As you see here, we already have a number of programs that are addressing this issue, and you should expect that we will see more of that also in the future. And then finally, as a pharmaceutical company in diabetes, in a chronic disease setting, we also need to make sure that we help society rise to one of its biggest challenges, which is really the growing number of one of the bigger ones being Cities Changing Diabetes, how can we help cities address the burden of diabetes, make cities more livable to address the diabetes problem. And that, of course, is something that we are likely embarking on.
Also in the future, we will you will see more programs from our side on this part. So this, we are just sharing with you to make sure that you understand that our approach to the business is a sustainable business approach that also includes the social responsibility, but it actually also includes environmental responsibility. And as you know, we have embarked on a new environmental strategy, Circular for 0, that aims at getting us to 0 environmental impacts from operations and transport by 2,030. This is a new target that we are setting forward because at the beginning of next year, we will be reaching the first target we had set forward, which was to have CO2 emissions from or CO2 emissions from our productions in all that means all of our production sites are running on renewable energy, being it either wind energy, being solar energy or being powered by water energy. And that means that as of Q1 next year, we will have that fully in place.
So as part of Circular for CIO, we're also looking at our suppliers, making demands on our suppliers to also focus on environmental efforts. And we are also, as I mentioned, looking at now how can we get other opportunities to reduce our carbon emissions in total. And then finally, also looking at how can we do circular physio thinking into our development of new products. And this, of course, is mainly the plastic talents that we have in terms of many of our devices comes in plastic. And of course, over time, we need to find a way to make sure we get that back or we find different ways to produce our products for the future so that we don't have a burden on the environment.
And with all of this, we expect to have a company over time that will have 0 environmental impact. So for us, all these three things goes very nicely hand in hand, the financial responsibility, the social and the environmental responsibility. But there are also a couple of other reasons why we are well set out to be able to expand our leadership in Diabetes Care, and I'll just show you some of the core capabilities and advantages that we have in this company that sets us out well to be able to increase our market share. And the first one is about our ability to deliver protein based treatments. You should expect that we will go more into the oral development of this and also into the stem cell area, of course.
And Mads will talk a little more to that later on. But there is innovation to, of course, embark on in this area that we will deliver on. Large scale production is also part of our capabilities. We are building new factories. You will hear about that later from Henrik.
And this, of course, also means that we will be able to continue to work on efficiency parameters for the company, as Lars was just referring to. Finally, on the global commercial REITs, we have a very strong presence worldwide. We also have shown that with the launch of Ozempic very recently, we have, on a global scale, been able to make this a blockbuster in a very short time, actually in a record time. And now, of course, we are embarking on the global rollout of ReBelto's as
the next thing we want
to do, and our strong commercial reach will help us in that regard. And Mike and Doug will talk more to that later. And then finally, we have 96 years of disease understanding. That does not mean we can solve the diabetes problem alone, but it does mean that we are able to embark on new innovations in the area to help patients also reach better outcomes. And one of those is on the connected pens.
Next year, we will be launching a new connected pen, NovoPen 6, means that the data from the pen can be transferred to the doctor, and the doctor can have a dialogue with the patient because we have teamed up with big CGM providers actually covering 99% of the continuous glucose monitoring market. That means that the data you can get from swiping the CGM, you can combine with the data from the insulin pen, suddenly then the doctor and the patient can have a dialogue about why is it that the blood sugar is going too low or too high. And that works in a setting like this in a dialogue with between the patient and the doctor. And the results we have seen from this in our pilots actually means that we can reduce the missed injections because patients do actually miss injections not because they want to, but because they just live a normal life where we forget things. And we can reduce the missed injections with 43% with a connected pen.
That also means a 28% increase in the insulin dose. But even more important, it actually means that a person with diabetes can be in time in range 2 hours more during the day or the 24 hours. And that means that they are likely to get an even better blood sugar control over time. So this is an important innovation that we will be able to offer in NovoPen 6 as of next year. So with that, we feel we are well prepared to compete in the diabetes market and offer good solutions for patients.
We you see here the overview of the market. We have 68% of the market is being treated with all tablets. That of course, you also see the value of that is around 40% of the market. But what you should keep in mind is that more than 50% of these people are not in good control. So with the launch of Rebelsus, we are actually able to make sure that many of these people can get in good control, And we will be positioning Rybelsus as the best oral medication in this space.
At the same time, you might also be wondering how about Ozempic and Victoza, once daily and once weekly GLP-one. There is ample space for them also to be in the market. So we will position Rybelsus as the best ore, and we will also position Ozempic as the 1st injectable and the preferred injectable in this space. So there is an opportunity for us when you look at all the number of people not in good control to actually now be addressing the people who otherwise would have been prescribed an oral treatment, but a treatment that wouldn't get them into good control. Now we have the chance with Reberlxis to do that.
We have a strong insulin portfolio also. We will be able to gain further market share with our insulin portfolio and the new launches coming up, Tresiba, Levemir. But our focus on Tresiba and Sultophy is really where we're going to go on this. And then on mealtime insulin, you see also our opportunities to address that with especially FIESP and the launches of Ryzodeg. So all in all, a very, very strong portfolio of products that are able to address unmet needs and diabetes even stronger in the future than it has been in the past.
So when we look at the $48,000,000,000 market that we just talked about, we already now have a share of growth that is 34%, so slightly higher, 6 percentage points higher than our market share of 28% in the global diabetes market. With the unmet need that I just talked about and with our capabilities, with our launches coming up, especially in the GLP-one segment and the growth of this segment, with our strong presence in insulin and with, of course, the dynamics of the market that I showed you in the beginning, we do expect that we will be able to continue to gain share in this segment. And that means that our strategic aspiration in diabetes is to, by 2025, to gain market share of more than a third of this market. So we are embarking on a strategic target for ourselves that says we are going to grow our diabetes market share from the 28% today to more than onethree of the market by 2025. And this, of course, will be driven by the injectable franchise we have of GLP-1s and of insulins, but it will also be driven by the launch of Rybelsus that we are very excited to roll out in a number of markets, of course, starting with the U.
S, and Doug is going to talk to that a little bit later. So that's the summary of our Diabetes Care strategic aspirations. And now we will just talk you through some of the elements of this. We will start with insulin. We'll get into our pipeline, and then we'll talk about GLP-one also and how we're doing efficiency gains in product supply.
And let's start with the bigger part of our business, which is insulin then when it comes to our turnover. And to do that, I'd just like to invite my colleague, Mike, up here to say a few words about how we're going to do that.
Thank you, Camilla. Yes, 50% of our business, I. E, insulin. Some 10 decades ago, this company was founded on the discovery of insulin. And today, lion's share of our patients are on insulin.
This is part of our DNA. It's going to remain super important for us as we go forward. Now a couple of things on this slide. It shows that insulin on the back of the price pressure in U. S.
Has gone relatively lower as a part of our sales from 61% to 50%. So that's the reality. But during this period, we have gained DKK5 1,000,000,000 worth of absolute sales and growth. We should not forget about that. The other thing I think is interesting about this slide shows that our dependency on the U.
S. Insulin pricing has gone down. It used to be 27%. Today, it's 20% or actually less, 19% of the corporate sales that's coming from U. S.
Insulin sales. So if I was you, the exposure on all the things you're going to hear on pricing in U. S. Is reduced compared just to a few years ago, and that's, I think, good. Perhaps what's most interesting for me and what makes me quite proud and a little bit attached to the mindset change that my boss spoke to is that we are gaining quite a bit of market share in this segment.
We've gone from 40% market share to 40 4%, and it's not easy. It's a very competitive market. Many people say it's commoditized, but yet we're able to win, and I think this is really interesting to see. Now the dynamic on the two side of the Atlantic are quite a bit different. International Operations has been gaining some 5 percentage points year on year when you look at our business over the last 5 years.
It's coming on the back of more or less flat pricing, a little bit declining, but flat pricing, quite a bit of volume, demographics play a big role in our sales in IO, but also the new generation insulins innovations are giving us a really good tailwind in this segment. The 5% comes from volumes and innovation. On the other side of Atlantic, U. S. Specifically perhaps, it's a different story.
A declining sales of about a percentage every year over the last 5 years, It is basically all pricing, as you can see, flat volumes. And even though they do extremely well with the innovation part, launching products like Tresiba and doing extremely well with it, it's not enough against the headwind of the prices that we have seen. But hats up to Doug and the team on the market share that they have been able to gain from 36 percentage points to 43. Again, in a very difficult competitive market, we're gaining share. When you put this together in terms of us versus the market, the market is growing around 2 to 3 percentage points, and we're doing better, 3 to 4.
Now the market has stabilized, the last point at 2%, and we are at 3 percentage points, as you can see. And then as you see from our share of growth being above our market share, it gives me confidence that we will continue to win market share. As long as the dark blue line remains so much above the red, then we should be able to gain market share and grow faster than the market, and that's what we plan to do. We're gaining most of our growth, some 76% of it from the new generation insulins, no surprise. That is basically all the products that was just talked upon.
When you look at the share of growth, historically, 70% of that has been coming from international operations and 30% from U. S, which again I have to say is pretty good knowing that U. S. Is home to only 11% of the patients. Been giving us 30% of the growth.
So, so far so good. Now as we basically go forward, I think we need to take a look at insulin in different segments to make a little bit of sense of all of this. We have 11,000,000 patients that wake up every single day and take human insulin at an extremely affordable price of 2 dKK per day. It's an extremely competitive market. More than 40 players are playing in there, and we're holding on to our market share at half of the world's market, close to 50% of this market.
Very affordable. It's part of our societal responsibility, and we'll remain there for them with this offering. Modern insulin is where we're getting some value upgrade. At 8 bk per day, we have majority of our patients that are taking insulin, dollars 15,000,000 to be exact, on insulin analogs. It's a place where we have lost some market share more recently as more and more players have come, especially with biosimilar golargines, 5 companies now competing in there, and we're trying to hold on tight, and the market is more or less flat.
Where we're getting majority of our growth is where we have the least number of patients right now. The new generation insulins, 2,000,000 patients, a market that's growing at 30 5 percentage. We're gaining 5% market share. And yes, the prices are, of course, substantially larger of those than in human insulin at 18 dKK. Again, putting all of this in the context of our competitors and the markets, if you take the clock back to just a few years ago and put the index at 100, then you see we've done 14 percentage points better than our competitors in this segment, in all three segments actually.
And regardless if you look on this side or that side of Atlantic, we've done better than the competitors. In the U. S, our competitors have gone down by some 26 percentage points. The market is declining. We have gone down as well, but only 15%.
In the rest of the world, international operations, the market is growing, but we're growing even faster than the market. So it's a nice picture, I think, for our insulin and why I get quite a bit optimistic about the future of insulin. Now we can survive the future only if we can innovate and provide access to those innovations, simple as that. Our most innovative products, Tresiba, today has 89% global access. 23% of that came more recently as we launched into some of the larger European markets, as we got the product into the National Drug List of China, we are now at 89%, which is a really good access rate.
So we should be able to do well with that. Saltify, 69%, equally exciting. Many of our European markets are actually having Saltify as their main growth driver today. We have more recently launched it in Japan, and it's doing extremely well. And we have a lot of hopes as we bring this into the rest of the emerging markets.
Ryzodeg, yes, access looks lower than the other two products, but that's simply because Ryzodex is meant for large premix markets. One of those is China. China got the 1st patient on Ryza the day before yesterday. We will launch the product fluid fledged basically in a couple of weeks from now. And then hopefully soon when the National Drug List opens up again in China, we will come and demonstrate the benefits of Ryzodeg, and you'll see that bar phenomenally grow afterwards.
So really exciting for Ryzodeg. And then Fias, take a look how much access we just have gained the last 2 years. Now equaling to Saltify, 69% access for Fios, again, a very key product for us, be it in Europe, North America or where have you. If this continues, then I can put my neck out and say that the next generation insulin volumes will triple until 2025. The value will go up by more than 2, 2.5 percentage points.
Majority of that growth will come from international operations, 93% to be exact and 7% will be coming from North America. But the trick is really to innovate, innovate and innovate and provide access to that innovation. And who can better speak about innovation than our Chief Innovative Officer?
Thank you, Mike. Thank you for being promoted to the CIO. That's the first time. Now we as a company have always served the patients. We are patient centered.
We are innovation centered for about 100 years. And what does that mean in terms of where we're heading on the diabetes R and D strategy? It means that in addition to the notion that more than 50% are not in good control, we need to make safer and even more efficacious drug glucose lowering agents. But as you can also see and as alluded to by Camilla, we have this devastating situation that people die from cardiovascular disease. A lot of them, still way too many, develop diabetic kidney disease, diabetic eye disease and even diabetic nerve disease.
We want to be there for the patients, and that means that a couple of years ago, we revised the R and D strategy within diabetes to focus essentially not only on safe and effective A1c lowering, but also on the ability to deal with complications and comorbidities of the small and big blood vessels that are the problem in diabetes. If we look a little bit at what that means aspiration wise, it means we want to normalize, normalize the life of people suffering from diabetes. Let me give you three examples of where that will take us 10 years from now in the marketplace. 1, in type 1 diabetes, we will have a curative therapy out there, a cell replacement therapy that alleviates and eliminates the need for in gene therapy in people with type 1 diabetes. In type 2 diabetes, we will make sure that all the renal and cardiovascular body weight and A1C and other benefits, maybe even on the brain that are associated with GLP-one therapy, that the norm for treating all of these is a simple one stage tablet.
The version of oral GLP-one from MUBENOIDIX that will be the prevailing one 10 years from now will make needles and injectors old fashioned to the benefit of the patients. The third thing I'd like to mention is that in type 1 and type 2 diabetes, there's a huge, as alluded to by Mike Duster, a huge need for insulin still, and it's not going to go away. But the problem with insulin is the frequent injections, including the blood glucose monitoring, the fear of weight gain and hypoglycemia that holds back the A1C achievements. We intend to have on the market 10 years from now a glucose sensitive insulin that allows for therapy, target achievement in up to 100% of all patients without a risk of hypoglycemia and no need for frequent blood glucose monitorings. Those are the kind of things that Novo Nordisk seeks to have in the market 10 years from now.
Now what does that mean in terms of the innovation cycles that I always talk about? It means on the one hand that we had to can a great number of engine projects back a couple of years ago because commoditization was happening, prices were coming down. But what is really happening today is that we are treading up a new innovation cycle, one where it's possible to make glucose sensitive insulins, insulins with comorbidity benefits and even things that render insulin irrelevant, such as stem cell based replacement therapies, such as immunological intervention in recent onset type 1 diabetes. I'll talk a little bit about that over the next couple of slides. Pipeline wise, we're in a situation where our immunological agent, a benign immune modulator called anti L21, in conjunction with the beta cell nursing GLP-one agonist, liraglutide, has completed Phase II for recent onset type 1 diabetes intervention to preserve the beta cells' ability to still secrete insulin even after disease onset.
If we then look at the insulin side of things, we're in the midst of Phase II with a 1st in class once weekly insulin analog called LAI287 that is freely and easily combinable and mixable with a best in class once weekly GLP-one agonist known as semaglutide. Hence, that is undergoing multiple dosing studies in co formulation such that we are able to deliver into Phase III as soon as possible both of these products, LEI287 and also you can say a once weekly supersultify the lysema molecule. As we move further down, we have in Phase I the ING 965 that I'll show you on the next slide. And in preclinical, entering the clinic next year will be the first ever glucose sensitive insulin and thereafter will follow the cell replacement therapy with stem cell derived beta cells, hopefully before the 100 year anniversary of the discovery of insulin. So let's take a quick look at the once week insulin been up against the gold standard, namely insulin Declodec in early studies in the clinic.
And they suggest that we are able to deliver to patients the same low degree of peak to valley fluctuation and day to day variability even within a week as is the case for best in class I state gene. This we hope to take into Phase III as soon as possible, reporting clinical data during the first half of next year and entering then thereafter pending those data together with semaglutide and also as a standalone first in class therapy. The FSI sorry, the 965 internally called FSI, is an insulin that actually in addition to best in class once daily glucose lowering, offers other metabolic benefits to the body that imply that micro and macrovascular complications of diabetes may be catered for just by the simple use of a once daily insulin. That delivers data during the first half of next year. Now moving into immune intervention.
This is the first time ever we're showing these data. They are from Phase 2. It shows that in patients who have recent onset of 1 diabetes, the combination of the nursing GLP-three-one receptor agonist with the immunosuppressant that safely tapers or levels down the autoimmune attack on the beta cells, we see a significant protection on beta cell secretion of insulin as measured by C peptide such that only 10% is lost in the 1st year where treatment is ongoing as opposed to 40% in those who receive placebo. Moving then on to efforts within the cure of type 1 diabetes. Here are some data from mice.
We are right now scaling up our beta cell derived cell transplantation technology for people with type 1 diabetes. But these are proof of concept data in mice, where you basically inject the beta cells under the renal capsule. And what you can see is that at the point where this happens, the diabetic animals become basically normalized. These differentiation protocols we have worked on for more than 20 years and one of its proponents, our ex CEO is present, I can see today. Here, we are actually heading hopefully into the clinic, as I mentioned, before the advent of the centenarian anniversary of insulin.
Now it's not all about insulin, but I have to say we're more excited than ever about this pipeline. I'm also equally excited about this one. This is GLP-one therapy. This is the decay of the beta cell function over time in people with type 2 diabetes. And today, it is so that normal GLP-one is the first injectable, is the go to injectable.
We would like to see it become placed all the way very early upstreams in the treatment cascade by use of a once daily simple to administer Rybelsus tablet. And we have gotten the U. S. Approval. I will not take you through the label.
You all know it. It's administered in people with tablets, in people with injectables, in people with kidney disease. It even improves health in people with kidney disease, unlike most other agents. And then it has shown A1C and or body weight lowering that is superior to each of the best in class drugs in the SGLT2, DPP-four and once daily GLP-one agonist classes. It is safe, as all other GLP-1s have shown to be, and even numerically reduces the amount of mesylenes from 76 to 61 in the PIONEER 6 program as indicated also in the label.
Now you would have thought that we're getting way up on the innovation cycle vis a vis GLP-one based therapies. I would put to you that we are, but still a lot is going to happen. So if I click one more time, you will see that Rybelsus is perhaps only the end of the beginning of innovation within this sphere. And what I mean by that is that if we want a further efficacy boost, we are going to take into man very, very soon a core formulation between semaglutide with all the package and label benefits of that molecule over time as it grows the label, so to speak, and combine that with a once weekly human GLP molecule in the right fixed ratio that we are now assessing in the Phase I clinical trials such that we get it just right both tolerability wise, but also efficacy wise into the future. Oral semaglutide will also be updated.
There's a unique collaboration between our product supply colleagues and the CMC colleagues in R and D to constantly upgrade the formulation technology, the ability to deliver either higher doses and or higher bioavailability of oral GLP-one therapies and that you'll hear much more about in the next many years to come. Also, it is interesting that we actually have other oral delivery technologies, including those that are co created together with the MIT Institute in Boston and have been published in premier journals such as Science and Nature. This can be developed for peptides like GLP-one, but also for large proteins all the way up to the size of the Factor VIII molecule. And of course, we want to use GLP-one in other indications. This also means though that going all in on semaglutide in many indications calls for more patients to be treated.
We're going to triple the amount of patients within a matter of 2 years such that we will go to between 4,050,000 patient years within the next 2 years. How on earth can we do that without tripling the clinical cost? We can do that because our colleagues in Global Development, because our colleagues in the clinical, medical and regulatory centers all over the world are working smarter, faster using digitalization, optimizing which investigator sites use and so on, so forth. So the marginal cost increase is not negligible, Carsten, but it is something that we can handle within the realm of the R and D budgets. Now this is just a quick snapshot of all the trials.
I am not going to give you a detail of all of those. Suffice to say that temeprotide is now being tested in heart endpoint outcome trials on the eyes, on the kidneys, on the heart, in some studies as REVELSIS, in some studies as Ozempic. But we have a strategy of bridging between the 2, so when one gets a label, the other one gets the same label. And early next year, 2 readouts, in particular, one readout in Alzheimer's disease will make us make decisions as to whether or not to progress into pivotal trials within dementia. So actually, I think that was what we're doing in R and D and Henrik, who else than you can you deliver all the products at high quality and decent cost that we need to supply our patients?
You know the answer to that, Maersk. So good morning. So the collaboration between R D and Product Supply is a fantastic collaboration. But I have to tell you about a headache. And 5 years ago, when we started yes, we have talked about it for a long time, but 5 years ago, we sort of moved closer to reality, Rebecis.
To be honest, coming from a highly optimized manufacturing unit, this was a huge headache to us, at least on a rainy day. On a sunny day, it was a really exciting challenge that we wanted to take upon us. Basically, the last 5 years, this has turned into a fantastic story. You will hear about it later today. But I'd just like to show you the biggest investment that we have ever made in Novo Nordisk history.
It's basically 4 times up our biggest investments. So the price of this beauty is $2,500,000,000 billion, sorry, dollars 1,000,000,000 dollars It's billions. So it's $2,500,000,000 and it's located where we already have production in Clayton in North Carolina. They have, until recently, been 3,000 construction workers working on the site. So we have dragged in construction workers for all over the state and actually also the neighbor state so much that actually the local politicians, they actually told us about it when they came to visit.
Now we are down on that manning because it means that we are soon moving into operations. I'm going there in 14 days from now, and I'm going we are going to move into the offices, and we are going to empty the first bucket out of the spray dryer. So it's really, really exciting times. So here is the latest overview of the site. And basically, those of you that have has been to Kalimbor, this is the little sister of our Kalimbor site here in Denmark.
And we are going to put it into our operations very soon. So it's highly exciting. So as the price of it is USD 2,500,000,000 then you need to work with unicost. And a good thing about this journey, the last 5 years has been, as we made the decision not to build on top of what we already have here in Denmark, we have been able to work with optimizations, both together with R and D, but also within the production area in Denmark. So in parallel tracks, we have optimized the process here in Denmark.
And while we are building in U. S, we have transferred those optimizations into the U. S. Side. So basically, as the PIONEER studies, they were concluded and we got the fantastic results out of that, and we have increased our ambitions within Rebelsus and also all other oral semaglutide products, then we can illustrate it this way that basically we think that based on the same footprint, based on the same plans that we laid out 5 years ago, we think we are at least 3 to 4x up the design capacity already now.
So and we will continue this. I will not promise everything today, but we will continue this journey. We are not done with optimizations yet. So we think that the footprint that we have made will hold a lot of potential for the future. And we can mix our what we can do in Callembore and in Denmark with what we can do in U.
S, we can mix that in many, many ways from a capacity point of view. So now both Mads and I, we are ready. So the question is, U. S, can you sell some of it?
I think we can. And there's nothing more exciting, Henrik, than you showing drone videos, so thank you. It's always exciting. It was hard to follow actually. Thank you for that.
I don't have a drone video, but what I do want to talk to you about is GLP-one. So Mike talked about this opportunity we have to continue to innovate in insulin and that is important. It's part of our history. It's part of our future. But what is really exciting, what I'm thrilled about is GLP-one.
And I have to say, I don't think there is a single company today that is better positioned to be successful at GLP-one. And I say that with confidence because of our portfolio and because of our capabilities. Now is there an opportunity? Camilla touched on a little bit of this, but let me give you the specifics. Today, Today, only 7% of patients on Type 2 diabetes medications are treated with the GLP-one, 7%.
So if you think about the recent guideline changes, EASD, the ADA, suggesting earlier use, suggesting a broader use, still only 7% today. To put that into perspective in the U. S, of the roughly 24,000,000 patients that are treated, only 1,600,000 are treated on the GLP-one. So there is an enormous business opportunity for us. There's also and Camilla mentioned this, an enormous patient unmet need.
50% of those patients that are treated with an OAD are not in good control. So think about the cost and the expense to that. Unbelievable opportunity and certainly a patient unmet need. Now if we think about the growth of this market and what's been happening, if we go back to 2,007 all the way through to 2019 this year, we've seen a growth rate of 25% over that period. That's exceptional growth.
And what's important to note with that growth, it's been event driven. So what does that mean? We can take a look at this. This is event driven from our own Victoza launch, weekly products excuse me, daily products and weekly products. We're also seeing label updates that was our own CV label update with Leader.
Guideline updates as I mentioned and then lastly Ozempic. So what we've seen around the globe is with events that correlates the continued growth and we anticipate that continuing. Now if we take a look at really the globe in the market, we will see regional differences. And I think one of the things you'll hear today from Mike and others is, we have a market fit approach. And what that means is, we have a broad portfolio with NGLP-one and we can position that portfolio for the regional differences or these market events around the globe.
For an example, in China, we launched Victoza in 2011, but it did not receive national reimbursement until 2018. So we see a slower uptick. We also see markets in EMEA and LATAM. These are markets that are very diverse. These are markets that don't have national coverage.
These are markets that in a lot of ways are out of pocket markets. And so we see a slower uptake and maybe markets that you'll hear a lot in the regional breakouts, but not as early to adopt. But we also know We have mature markets in Europe, United States and you can see the adoption there. So our market fit approach actually works for the regional differences around the globe and understanding those differences and how we can support our portfolio within it. Coming in this morning, I was asked about where are these products sourced from.
That's always a question, where do they come from? Now you can see that let me step back one second before I get to the sourcing, right, because it is important. Ozempic, the last market event that I talked about. Ozempic, where we have launched. Now this slide represents the U.
S. And the European countries where it is launched. So again, that was that last market event. I talk about these market events and what they do to the overall growth of the category. Now for Ozempic where it has launched, we know that it has changed the slope of the curve for our overall GLP-one business.
So in the U. S, you can see that the business was declining with the growth in the launch of Ozempic and it was Camilla talked to this. This was has been seen and we're proud of one of the best launches that we've had in reaching a milestone of blockbuster status, but also NBRx leadership, total GLP-1 leadership, we can see we changed the slope of the curve with this market event in the U. S. And the stamp could be set in Europe.
Now to the sourcing that I was referencing, because it was a question I walked in this morning, where these patients coming from. And this also gives us some pause, but also some opportunity. When you look at the largest portion of the sourcing comes outside of GLP-one. Actually, you can argue that a lot of it is in the earlier use. But the use is after some sort of failure.
So what we know, what the guidelines now tell us is that GLP-one should be used earlier in the treatment algorithm. We have the support of EASD and ADA. So when you look at the right side of the screen and where it is used in terms of the line of treatment, it is rarely used in the 1st or second line position. So there is a tremendous opportunity for us to get it used earlier in the treatment. What better product do we have right now to get over one of the biggest hurdles and barriers, which is in the injection barrier and getting an opportunity to use a GLP-one earlier in treatment than Rybelsus.
This is the world's first and only oral GLP-one. I imagine you may suggest that it was the last 10 years in the making, we could argue it was the last 100 years in the making. This is a product that we've seen that has a clinical profile that is like a GLP-one is a GLP-one in the administration of a pill. And we can tell you that in the early experience that we've had not only through the trials with physicians, but what seen just in the 1st couple of weeks in the U. S, physicians are extremely excited about this profile.
This is a profile that the market access community can be excited about. It's the profile of the community with physicians that are prescribing it that can be excited about as well as patients. Just a couple of weeks ago at Novo Nordisk in the U. S, we had the opportunity to interview a patient that participated in the clinical PIONEER trial. Now this was his experience, but he came to talk to the company.
And what he described was a product that actually changed his life, changed his life and his family's life. What an incredible opportunity that we have. So what we know and this slide represents on the left the U. S. From 2018 2019, 2,000,000 patients switched medications because again a big reason for that is not being in good control.
So where do those patients go? Well, we know is only 22% of them go to a GLP-one. So again, we have unique opportunity to get GLP-one in both the oral and the injectable used earlier and more often. It's a unique opportunity that we have. And again, Camilla touched on this, but the positioning we can coexist and we will coexist with 2 products.
To have the 1st preferred oral agent in Rybelsus and the preferred first injectable in Ozempic. Now as I talked about, we do have a market fit strategy and I referenced China. But Victoza is still a product that in many, many markets, it's a very important product to us and will continue to be a very important product to And this is a product that again that we have a market fit approach. But we also know, which is alluded to, we're an innovative company. And in an affiliate like the U.
S, we also know that we have 2 innovative products in REVELTYSYS and Ozempic that we are already positioning in that first oral and first injectable position. So it is a unique opportunity. 7% of the patients, this unmet need and we have a portfolio that is unrivaled. So and just in closing this segment, again, I think it's very, very important that there is an unmet need within diabetes and there is no company that's better positioned than Novo Nordisk. None.
And you heard these from Camilla and mentioned by Lars, but we do have this further ambition to raise this innovation bar. It's who we are. And certainly within diabetes, we are looking to drive the outcomes beyond HbA1c. That is important. We can and will strengthen our leadership position.
And again, the aim is to have more market share, a third well, excuse me, is to have a global market share of more than a third. And lastly, and I would emphatically state within GLP-one and certainly from a global perspective in the U. S, we are the best company right now positioned with our portfolio and our capabilities and with a market that is calling for that and guidelines to support it to be successful. It's really a great time and an exciting time. So with that, I'm going to close this section.
I think we're going to go to Q and A. So Lars, you're going to
To all of the vendors, I'll kindly ask you to come up here, and we'll do a Q and
A. Thank you, Dirk.
So the way it works is that now it's about diabetes. I know you might have a lot of exciting questions, but let's focus on diabetes. And I would like you to limit yourself to one question because then we create room for many questions. So Michael, there will be a microphone coming around. So if you start by stating your name and your organization and then your question, please.
Yes. Michael Novotz from Nordea Markets. It's about the diabetes slide or the Sema slide. Maybe it's not fully related to diabetes, but sorry about that. But I just saw it was with sema, also in Alzheimer's.
We know there's a liraglutide trial, ongoing Alzheimer's, the ELAD trial, but you already list now sema in Alzheimer's. Do you have any insights already now to that this can be taken forward already during next year with sema?
So since we do not have an Alzheimer's session yet, I think we'll allow that to sneak into the diabetes session, Matt?
Yes. Well, Michael, very good question. And the reason why I put it up there is not that Novo Nordisk is doing a Phase II trial. It's that Principal Edison at the Hammersmith Hospital Imperial College is doing one and so are others by the way. And we have a hunch based on what we have investigated both in disease registries, outcomes databases from our own trials and so on, that GLP-one being a neurotransmitter, being an anti inflammatory agent, working on things that remain a bit unknown, could be microglia, could be other distinct neurons even, might actually be neuroprotective in one way or the other.
And what we're seeing is that in the event that Paul and his team come up with exciting data with all the endpoints they have in these relatively recent Alzheimer patients that could cater for a move towards larger scale dementiaalzheimer trials. I think the unmet need is so big that when you talk to the FDA, EMA and others, there is much more of a willingness to accept an academically conducted proof of concept trial even though this does not live to the classic industry standards. The unmet need is just so big.
From JPMorgan. You talked about the sustainability and trying to remove plastic. Maybe you could talk about that in the context of maybe bringing insulin oral. Does LAI287 make that closer? When should we think about oral insulin coming?
Thank you, Richard. I think it's a question to Mads. We started out aiming for oral insulin. It turned out to be oral GLP-one. So still opportunity?
Yes. Actually, to be very pedantic, we started out looking both for oral engine and oral GLP-one. But we did prove the concept in human beings. We published in The Lancet the Phase II proof of concept study with insulin analog called OI-three thirty eight GT. And that proved the concept of oral insulin with a safe and efficacious profile.
The trick was, of course, that despite Henrik's humongous improvements in commercial production, then at that point in time, this could not be made commercially viable. We are going 3 years back now. So where we stand is that we have access to unique technologies that we've co created together with the Bob Langer Group of MIT in Boston, such as the Soma device, such as the Lumi device. You can look them up in the literature or in the scientific journals. So there are options there.
There are also options. As you will recall, the study we did was done with a enhancer molecule called GIPET, sodium caproate. We are revisiting what are options for olefinetin. So I cannot promise you we'll have on the market in years from now, but we have proof of concept and things are technology wise evolving and efficiency wise as well.
So we're not getting up yet. We move over here, yes, in the back. Peter?
Hi, it's Peter from Hansbanken. I have a couple of questions. I'll just stick to one now. One thing that struck me with the eye care review was sort of the cost allocation and value coming from diabetes products. And much of these are sort of the value of cost to treat comorbidities or comes from the comorbidities where chronic kidney disease, stroke, MI, etcetera, they stand for a large portion of the so called benefitcost here, where the sort of the microvascular complications are very small.
That suggests, all equal, that sort of the value and typically to pure blood glucose rolling is sort of commoditized here. So that fits into your perspective about treating comorbidities. But how should we think about diabetes in the future? Is it treating low blood or lowering blood sugar? Or will it increase to be based on treating the comorbidities?
And how should we think about your products in the future? Will they be blood, glucose lowering products? Or will they be a combination of both? And how will you combine will it be combination products, single standard products, etcetera? Thank you.
So I think that was a question to Matt. I think SMS actually talked to it in the presentation. So obviously, it is about lowering HbA1c, but we see that treatment guidelines now including cardiovascular disease and as science documents that are additional benefits and additional indications that can be treated, those will become more and more required to play and also be required to differentiate products. But still, a patient comes into the physician office and it's about initially treating the glucose level and then you'll opt to also have a preference for products that does more. Laurent Maszto, Camilo, do you have additional points compared to what we presented already?
Just one quick comment. You said the license to operate safe and efficacious A1c, Laurie. A1c is a surrogate for microvascular disease. So there is baked value into the A1c calculations on the microvascular side, but not on the macrovascular. So cardiovascular, you every time have to prove the point because there's so many factors that play into CBD.
Yes. In the
back. Thank you. Karsten from SEB. And the first of your new strategic aspirations here is very closely related to sustainability. And when you read some of the industry reports on sustainability from some of the larger specialized houses, they tend to use U.
S. Pricing as a reason to give you a lower score or to at least lower the score. And I was wondering if I could get your view on whether being a sustainability champion, can that go in hand in hand with the raising U. S. List prices in the future?
So I'll refer to Doug. Just an intro comment, a lot of the discussions about U. S. Pricing completely lack insight into what is the price. So Doug, can you share a bit how you look at pricing across channels and
Yes, absolutely. So I'd first start by saying that the prices in the U. S, we have some of the lowest prices in the world, if you look at channels like Medicaid, 340B, even the government channel and Medicare. And we also have higher prices in commercial. So we really talk market fit.
We approach the market per the channels that we plan and there are some of the lowest prices in the world. I'd also say that from an affordability standpoint, we're very proud of and I'll talk to you a little later today, the affordability initiatives that we have. So in the U. S. Whether patients are inside the system or outside the system, meaning insurance or non insurance, we also try to help.
So I won't comment on list price increases when and if we take them, but I would say that we have some of the highest and lowest prices in the world and we do a lot around affordability for those inside and outside the system.
2 weeks back, Doug and I were actually in Houston visiting some of our partners in CD10 diabetes, and we visited some of the local community hospitals. And I was very impressed to see that when you actually get to that level in the U. S, there's actually a very well functioning health care system. So seen from outside, it seems like the health system is broken. But when you get into the ground, you see that there is integrated care being delivered by the local cities.
And when you ask them about what are the instruments you're using, they're using our instruments and they get them at penny pricing, the 340B program or the use of patient decision program. So it works. And they were really, really happy about that we partnered with them, and we actually provided very affordable insulin for those patients they treated. So it's a very complex story, but we should not shy away from what we actually do, which I think we should be really proud about. Well, maybe growing habits.
I think you can get closer to people, so we don't have to walk around with the microphones.
Thanks. Pete with Altice Citi. Just for Camilla, I know you don't want to go there in terms of a hard number, but everything it seems to me, everything you're saying in terms of the strategy for diabetes care, would it be fair to say that minimum expectation for Novo is that you grow that top line for diabetes care around 6% to 7%. Is that a fair interpretation of what you've been saying?
Nice try. So we don't comment on that. You know that.
I can talk to some of the building blocks to it, though, without commenting on what you're saying. And of course, what I showed you was that we do expect that the market will grow 3%. And if you take the DPP-four, loss of exclusivity out 4% in terms of value. And the building blocks of that is, of course, the DLP1 will grow significantly. When you look at the bars, you can see that's where the real increase is.
Our position in DLP1, based on what you've heard this morning, is already very strong and is likely to get even stronger going forward. On top of that, we have a very strong position in insulin that is the biggest part of the base. And here, we're also likely to increase our market share. So when all that sums up to something that is more than a third of our total value share of diabetes, then I think you're smart enough to make out the numbers that fit to that.
Good. Thank you, Camilo.
Marjan Parker, Danske Bank. Just going back to your aspiration of at least onethree market share by 2025. I can see that this is, of course, for the whole organization that you're more much focused now on market share development and profits. Will this demand a higher investment in sales and marketing to drive this market share? And will this be a changed balance between North America and international operations?
And will the market share gains we will see from now on, will these be as possible as profitable as shares you already have?
So we will later on have a financial section where we go through the ratios. So I'd say, it's not that we believe it becomes more expensive to run our business. But of course, what drives our core structure is the number of launches we do. So at a time where we launch more products and generate the platform for future growth, course, we invest more on that. But it's not that we believe that it becomes, in general, more expensive to run our business from a sales and marketing perspective.
But I'll make mention note to make sure that we address it later on because Carsten has a full presentation on how we expect our raters develop across different cost items. So we will cover it later on. Let's go in the back here.
It's Keyur Parekh from Goldman Sachs. Doug, you showed us this really insightful helpful chart on kind of the 2,000,000 patients changing medication every year in the U. S. And where the kind of different medications are used, 1st line, 2nd line, 3rd line. Would love to hear kind of Kamila, Doug and Mike, your thoughts on if we were to look at that chart in 12 months, 24 months 36 months, where do you think Rebelsus would end up in front line, second line, third line?
What would your aspirations be for
that? So Camilla, perspectives
Rebelsus as the best OAD in the market. I think based on the clinical trials you've seen, the PIONEER trials, Rebelsus clearly has the potential to make a huge difference in that segment. It is actually interesting to see today that even Ozempic is also being used, as you saw in the numbers from DUC. It's already being used, of course, in combination with insulin, but also after simple OAD failure. And so when we talk to physicians about working both with Ozempic and Rebecilso, it's clear that there are some patients that are not being moved on to better therapies because of the injection hurdle with GLP-one.
And that, of course, we are able now to address with RIBELSYS. So that is clearly where we would like to position this product. Maybe just to perfect
spot and that's a perfect spot for us to position Rybelsus. So we would anticipate that whether through an injection barrier or just a better clinical profile, we should be able to position it and we'll position that here earlier. Thank
you. Then here at the front table.
Thank you. Mark from Morgan Stanley. Could you help us understand your strategy when it comes to the incretin access more generally and combinations with sema and oral Sema. I'm talking about GIP and glucagon, which other companies think is an important part to combine with GLP-1 activity. And does technology exist to do co formulations of Rybelsus with other categories such as SGLT2s, which is starting to go LOE and 'twenty five onwards.
Thank you, Mads. Future combination?
Yes. So there are 2 ways to go. Combination formulations where you take 2 distinct moieties and combine them in a either oral or injectable version. And then, of course, hybrid molecules that are either co agonist, triple agonist or agonist, antagonist, whatever you want. We have a dual agonist GLP sorry, glucagon GLP, as you know, in trials.
We have triple agonist GLP GIP in trials. And they will read out in the months to come. Now I think you should add to the increasing story Amylin. I always talk about Amylin because the fact is that what you really want is more bang for the buck, whether it be on A1C or secondarily in A1C driven by more weight loss. So right now, we are putting a lot of emphasis on the amylin GLP-one combination, whether it be as a fixed ratio combo or even potentially as hybrid molecules.
But when that is said, the glucagon, we are investigating it, Hopes were extremely high. They've come a little bit down visavis at least some of the companies having terminated their activities and only one company recently progressing their activities. Let's wait and see with our data. I think this is the way to go because you cannot do more than 7 of those with GLP-one alone therapy. Maybe you can either prime the effect like with GIP and get more bang for the buck.
In some way, we need to understand better. Or you can add to the effect by a whole different mechanism like with amylin and other methods. So it's too early to predict the future, but I think we need to be there. And that's why you're seeing a multitude of approaches from our side.
Thank you, Matt. A question here at the front and then we'll go back afterwards.
Sachin Jain, Bank of America. Just a big picture question on GLP-one growth rate going forward. You put up a chart showing it at 25% over the last few years. How do and I think that was greater than what you'd assumed in your prior financial targets at low double digit, I think you quoted in the prior slide. So it clearly exceeded expectations.
You've also outlined the size of the addressable opportunities. How do I think about that growth rate going forward? Do you think this existing growth rate can be maintained on a larger and larger base? Or do you think the absolute add rate is roughly the same per year, so the growth rate sort of fades? Just how do I think about that conceptually going forward?
Thanks.
So we don't guide in detail per, say, product area. But Camilla, some perspectives on building blocks?
Yes. I would say that, of course, GLP-one segment is likely to keep growing. I think you should expect that over time, the growth rate, of course, will be challenged by the fact that the base is bigger and bigger. And I think the weight as to which this will evolve, of course, depends on our speed in terms in rolling out the results globally and also the trajectory with Ozempic. And we're already well underway with that.
But we're not, as Lars said, giving specific guidance on to the cycle.
It's a bigger, bigger base. So it will be harder to sustain that growth level.
But can I add something to it? Even though I think it's bigger, bigger base, Doug showed a geographical picture of how still in many geographies as a percentage of diabetes, we have GLP-one in a very, very low single digit numbers. So at least in my part of the world, I'm hopeful that we can continue.
And maybe one other point to that is, remember, it was event driven, so there's another event and that's for Belsus. So again, to Mike's point and with the addition of the product.
Hello. Marco Sormani, Varang Capital Partners. I have a question concerning pricing environment in GLP-one. So for the time being, it's very positive, very benign. But what we can expect after the Victoza plant expiration in 2023 and maybe some new biosimilar products entering in the market?
Thank you.
Yes. So if you look at the GLP-one space today, as Doug explained, it's the market is developing based on events. So it's the level of differentiation. It's the clinical data. It's the new molecules that drive the growth.
So as such, it's the market growth and the share gain that drives the value of that market. And as products are differentiated, you have less of the competition that you see from the Intuit area. Then obviously, our strategy is to move patients to Ozempic and Rybelsus. So we believe there will be less less of Victoza at the time of patent expiration. And there will be based on the stay time on GLP-1, there'll be a flow of patients where they move to more efficacious products and patients will increasingly prescribe the innovative product, the differentiated product.
So we believe that obviously, there will be people that will try to launch a biosimilar version of Victoza, but it be a different dynamics than what we've seen in the insulin category because of the underlying differentiation of products in the GLP-one category. So we are comfortable about moving patients to more and more efficacious medicines and drive that innovation. So question here.
Thank you very much. Wimal Kapadia from Bernstein. So I know you showed a lot of global data, but if we just take the U. S, 40% of the volumes are metformin, around 13% are the branded orals, so SGLT2s, DPP-4s. So you still have around 13%, 12%, 13%, 14% on these TZDs, SUs, what will that number be 0 in 2025?
And then just tied to this, you suggest that 50% of patients on OADs are well controlled. What is that number for the SGLT2s and DPP-4s? So what I'm really trying to get is a sense of what volume share within the oral market is Rybelsys able to potentially capture?
I think you asked a lot of details about our competitors' products that we might not have the best insights to. But maybe I'm asking some competitive efficacy data when you look across the categories as a proxy for how well patients are treated?
Yes. So basically, if you look at the literature, which I know you have done, most of the comparative studies have been ongoing for either 26 or 52 weeks. So it's rare that you get a good feel for the durability of a therapy. The average GP will put a person onto an HGLT2 inhibitor or a DP4 inhibitor, typically with an A1c, actually in most countries around 7. That will take maybe 40% of the patients below 7 for a brief period of time, and then they will tick upwards.
The most rapidly upwards ticking that we're seeing both in clinical trials and I think in the real world is probably sulfonylureas because they basically burn out the beta cell and then followed a little bit by the DPP-4s, but that's more because of the overall A1T lowering is on the motor
side. It's Mike Leuchten from UBS. A question for Mike. Given the sheer scale of the Rybelsys launch in Europe and elsewhere,
does that work with your
fit to market strategy? Or do you need to deviate from that a little bit to get the effort done before you can come back to it? Yes. So the positioning of the product will be similar typically everywhere. And Camilla alluded to where we plan to position it.
As we have the PIONEER data, then of course, we have to go with the label. We have to wait and see where the various different labels look like. We are now waiting for, of course, Europe and Japan and soon after that, the rest of the emerging markets. And based on that, we'll be able to see to extent are there going to be differences. There's also affordability issues that are quite different from one market to the other in international operations.
Some places have that out of Other places will try to, of course, get it insured as we've done so with the other GLP injectable GLP ones. So I would say it's too early for me to make more detailed comment on it as I have not seen the label, as I have not seen the details.
Good one final quick question.
Florent Ceslet from Societe Generale. My question is a a follow-up of this one. I would like to know if you could share with us your view of the ramp up of the adoption of Rybelsus in Europe given the fact that you won't have the large outcome trial solved before years and how you will compete against some oral products, which cost nothing and also some oral drugs, which have already demonstrated a cardiovascular benefit? Thank you.
Should I get that?
Yes.
Yes. So first, I think, again, we need to get the approval in Europe. So we are extremely excited that we're and I will show this, I think, after launch, that we're planning at least internally to have some 30 launches of Rybalsis over the next couple of years. So that's our internal plans. Having said this, I think quite often when we speak to Europe, we think it's a country.
It's not it's a continent with multiples of different health care systems, with multiples of different affordability. And we've been able to actually see that as we have launched more recently Ozempic in that market. So I'm quite hopeful that we will have Rybalsis penetrated in most of European markets, perhaps one after the other. And I'll be able to, again, give you more details once I've seen the label and the approval first.
Good. With that, we'll break for coffee. And we'll be around. So those who do not get a question in, you can probably still try to catch us if you are fast. So we break for coffee.
What's the hardest part of living with obesity?
The feeling that I'm being judged, whatever I choose to eat.
The look of dread on every passenger next to an empty seat.
The first glance that tells me I failed the interview.
What's the hardest part of living with obesity?
The feeling that I'm being judged. Whatever I choose to eat.
That nagging sense that I'm an embarrassment to my kids. Stares and people who stare.
The look of dread on every passenger next to an empty
seat. The first glance that tells me I failed the interview before it's even started.
Knowing that I just don't fit in to the seats or life in general.
Wondering if I'll ever feel comfortable on a beach.
The fear that I won't be around to meet any grandchildren.
Actually, the hardest part of living with obesity is people thinking that I brought it on myself.
I wish everyone understood.
It is so much more than eat less and move more.
Obesity is a complex disease, not a life choice. Let's help change attitudes.
Let's lose the weight of stigma.
All right. Welcome back from the break. And now we are ready to move in to talk about obesity. And I will start out with that, but I also want to introduce my colleague, Martin Lange, who will support me later on, who is heading up our global development efforts. So in Obesity Care, we are, of course, working on a number of dimensions, but really to strengthen the treatment options that you will hear about later.
But also, we want to work on the market development of obesity because this is a 6 at the burden, many of you know this, 650,000,000 people living with obesity, 120,000,000 children are living with obesity. I think that number might be new to many of us. That is a significant burden also for their life expectancy, their probabilities of getting other serious chronic diseases such as diabetes, cardiovascular disease, some types of cancer in the long run. This is a serious issue, and it's also a serious burden on the health care system. You see here trillions being mentioned, and that's because we already know that the cost of related complications to obesity is a significant impact on the health care system.
So what we I would like to talk about today is how we are going to change obesity as a cornerstone of our corporate strategy, but also to support people living with obesity and also to support health care systems being able to long term afford this dimension. So initially, we will talk a little bit about prevention because also in obesity, we are working on prevention efforts. And one might say, what does that mean for your ability to be able to treat? But I think you can also see with the numbers here that cannot only be solved with treatment. We will come back to better treatment later in this session.
But there are also efforts that we need to do to make sure that we support health care systems in preventing this. And today, we have announced a partnership with UNICEF. And UNICEF, it's a 3 year partnership that focuses on preventing obesity in children. And this partnership is really going to take place in Latin America because that's where the prevalence of obesity in children is especially high. So on a worldwide level, the prevalence of obesity in children between 5 19 years old is approximately 18%.
But in some countries in South America where we will start this project, the prevalence is even beyond 30%. So this is a significant burden to those children, their families, but also the health care systems. So we are very proud that we can launch an initiative like this together with UNICEF to build awareness about obesity in children. And of course, this project has the potential to be expanded when we have learned how do we actually prevent obesity in children. So that's part of the purpose of this project.
In addition to prevention, we are, of course, also working on recognizing this stigma that people with obesity are living with, but also on improving our care. And that's what we will be talking about in this presentation. Our mission is to make sure that obesity is recognized as a health care priority and as a disease, but also, of course, once that happens that we have sufficient treatment solutions in place that can really address obesity. And today, you know the market of anti obesity medication is around 15,000,000 patients. That means 15,000,000 people are living with this disease.
That means that they have complications of it. That means that they're exposed to stigma on an everyday basis. We do expect that by 2025, there will be and sorry, I forgot to say that the blue dot you see here is the number of people that we are able to treat so far with our anti obesity medication Saxenda. In the future 2025, we expect that there will be 24,000,000 people living with obesity. And we also expect to be able to increase our share of that, mainly primarily because of the innovations that we are going to bring to the market.
The global prevalence you see on this chart, it is rising, and it is, in many countries of this world, above 20%. There are also places where it's even worse than that. So the global epidemic of obesity is very real. Saxenda, our obesity product has been launched in 45 countries. We expect to roll it out in even more countries towards 2022, as you can see.
And with that, we hope to help and address some of the prevalence. Obesity treatment like Saxenda has actually, for us, grown very significantly over time. You see here the growth rates year to date, 50%, is now 5% of our total turnover and is also 30% of our share growth year to date. It has a significant impact on our business, but hopefully, an even more significant impact on the people that are living with obesity. We also expect that we can expand our leadership in this place in the future, but our strategic aspiration with obesity is to double our sales by 2025.
So this will be one of the strategic aspirations that you will see at the end of the day in our obesity business. And we know that there's a big need for this, and we will just talk you through how we are going to drive, of course, the care towards people with obesity, but also on how we will be able to double our sales by 2025. Are many hurdles before people with obesity can be treated. You see some of them here. Many first of all, health care systems do not even recognize that obesity is a disease.
People go to see the doctor, but often very late. We know that sometimes it takes an average up to 7 years before a person with obesity realizes maybe I should see the doctor before the person dares to go and speak to the doctor. Often, such a person is sent back and just told to exercise some more and need less. But of course, many of these people have already done that. They've tried everything that they could.
They have a discipline like no one else. We know it from people within our own company also that requires a lot of discipline to live with obesity. Then there's also the issue that physicians have not been educated in medical school necessarily about how obesity works, what's the right treatment. And then there is, of course, also the willingness to pay for the treatment that we have to address. So based on all of this, we have identified 4 areas that we want to work with within obesity, and you see those here.
And I just go through them 1 by 1, starts with the patients, how we can support the patients with better care. Then we are looking at how we can support prescribers with more information. And we are also looking at how we can support payers and policymakers to understand where should they start because obesity is such a big impact on the health care systems. And of course, some of them are concerned. If I recognize obesity as a disease, it means that a third of the population in my country has a chronic disease, and I need to treat that.
And that seems a bit overwhelming. So how do we deal with the evidence of how to treat? So let me just go through some of these things. Where you see we can And that is, of course, not very long. But we have seen from studies when we combine Saxenda with Saxenda Care and we combine it with other behavioral modification programs like Noom, like you see here, we are actually able to increase this daytime at the adherence with 33%.
So it means that behavioral modification in obesity, along with weight loss products, actually gives an even longer stay time and with that, an even stronger ability to lose weight. When we look at the physicians, we are supporting the building of obesity clinics and advancement of care in more than 500 clinics this period of time towards 2022. So it means that hopefully, we can do our part to also support in terms of education of what it takes to treat obesity. And then finally, of course, we're working with a number of international organizations that are looking at how can we improve care in this area and what does it take. I talked about payers and policymakers just before.
So to try and address some of the common challenges across countries, we have established what we call the Obesity Policy Engagement Network. It really consists of policymakers from different countries. Right now, 9 countries, it's U. S, U. K, Germany and so on, some of the big countries that are looking to discuss amongst themselves what is it that can drive down the cost of obesity in my country?
What is it? How do I get started on this? It's a way for us to offer a network for them to discuss this. We're also working on the Treat and Reduce Obesity Act in the U. S.
And that, of course, if approved, that would mean that we would be able to also get treatment into Medicare, which is, of course, also an opportunity for many more people to get help to be treated for their obesity. And then finally, we are doing bigger landmark studies, the SELECT study with 17,500 patients that Martin will talk to in a little while, that can map out what happens to people with obesity, what is their cardiovascular risk profile. And this study has been kicked off. At the same time, we're also looking to get the results of our Phase III data from semaglutide in obesity during the coming year. And that, of course, will also be able to provide us with evidence as to what can be done.
Right now, Saxenda is able to reduce weight with 6% to 8% approximately, but we do expect that Martin will talk to that, that semaglutide in obesity can do even more. And that is just this first and the second generation, but there is still more to come. To support payers, we're also working with outcome based contracts and risk based contracts. That means that we are willing to share some of the risk of people being treated with Saxenda and not all receive the same weight loss. If there's not a minimum weight loss, there's an opportunity for us to agree with payers that then they are not paying for that product for that particular patient.
So there's a lot of opportunities to document cost effectiveness and also the outcome based data. So before I hand over to Martin, I just want to summarize that we are really here to strengthen our leadership in this area. We are here to support patients. And with that, we expect that we can develop and double our current sales towards 2025 from now. And at the same time, we also have to improve disease awareness.
And you saw some of the measures that we are doing, but we're also supporting patients with digital tools in this area. And then, of course, the anti obesity medication usage, the stigma, the prescriber focus is something we will be working on. And then finally, individualized treatment solutions. And that is really what we like to talk a little bit more to now so that you can see some of the clinical data that we have in obesity. And to do that, I'd like to welcome Martin Lange, our Head of Clinical Development.
Thank you very much, Camilla. So as you've heard from Camilla, obesity is a serious chronic disease affecting an increasing number of people basically to the proportion of an epidemic status. It's not only associated with social stigma, as Camilla described, but it's also associated with a large number of comorbidities. Some of the greater culprits in this setting, such as diabetes, such as cardiovascular disease, osteoarthritis, are not only affecting and impairing the everyday life of a patient, but it's also severely affecting the outcomes. Further to that, we also know that obesity and, more importantly, the comorbidities and there was a question to that also to diabetes in the Q and A session, this is really, really relevant.
These things are posing a huge burden on society from an economic perspective, so much so that OECD in a recent report is estimating that as much as 8% of health care expenditure will go towards obesity and chiefly towards the obesity related comorbidities in the years to come across the OECD countries. And specifically in U. S, that number is 14%. So this is serious business. It is potentially crippling from a societal perspective and definitely from a patient perspective.
Now the good news is, obviously, that there's light in all of this. We do know already now that a modest decrease in body weight of 5% to 10% is associated with a beginning decrease in risk of associated comorbidities. At the very least, we can see an improvement in the risk factors or biomarkers of these comorbidities. And that's obviously the aspiration for all of us to then translate that to a direct decrease in comorbidities and a better outlook for the patient. As Camilla already alluded to, we have Saxenda on the market.
It's a successful drug. It is starting to serve the patients and breaking the curve, but it is by no means enough. We do need to work towards normalization in terms of really, really breaking the curve but also serving our patients. We also know what normalization potentially looks like. We have seen in recent years the advent of bariatric surgery, truly efficacious in terms of lowering body weight to the tune of up to 45% and also associated with a dramatic improvement in downright patient outcomes, decreasing the comorbidities I just discussed.
However, bariatric surgery is very invasive. It's associated with a great number of side effects. It's expensive, and it will require a specialist treatment. And therefore, it is currently reserved for the select few and obviously not really targeting 650,000,000 patients across the globe. And our aspiration, Deborah, has to be through medical treatment, through supporting patients through prevention of diabetes to close the gap from what we can currently achieve with what is on the market through what could be a medically induced body weight loss comparable to that of bariatric surgery.
That's also speaking into Lars' statement of us in R and D raising the innovation bar. We do intend to raise the innovation bar. And obviously, we've created, as usual, an innovation curve. The end goal in that innovation curve is obviously normalization of body weight and normalization of the internal set point in the body to secure that these patients actually can lead a normal life, just like the aspiration that Mas alluded to for diabetes. Right now, we are in the beginning of the innovation curve.
We have Saxenda out of the market. The next steps will be various level of further body weight decrease, starting with the potential of semaglutide at approximately 15%. I'll come back to that. But also going beyond semaglutide, trying to reach the bariatric surgery levels of above 20%, potentially up to 30%. That would be really, really mind blowing, but not only for us, but hopefully also changing the lives of our patients.
In our innovation curves, we also are defining that we need to become more patient specific, more patient centric. We need to focus on personalized medicine, optimizing both safety but also efficacy for the individual patients, and we are specifically conducting our development programs in order to further inform ourselves in how to do that. Some of you have also asked about all the available drugs in the setting. And it goes without saying that this is a focus for us. We need to make all the available drugs for these patients.
Now next step on the innovation curve. Most of you have seen this graph before is somaglutide. We've conducted a fairly large scale, approximately 1,000 patients Phase II trial, 1 year of duration comparing semaglutide to not only placebo but also to Saxenda 3.0 milligram being the gold standard of today, demonstrating that with the highest dose somaglutide, we could not only achieve a 16% body weight loss, but more importantly, twothree of the patients actually achieved more than 10% body weight loss, again making this a dramatic new achievement in the management of obesity. I'm a little biased and being told I'm bragging a little bit. We also achieved an 80% retention in the clinical trial.
This is important because in the context of conducting clinical trials in obesity, we normally see retention rates of 40% to 50%. This provides challenges in terms of scientific integrity, but it also provides challenges in terms of regulatory interaction and how to get the good data into the label. And with 80% completion, which is also our aspiration for Phase our Phase III trials, we do expect to have high scientific integrity and good regulatory interactions. But it's also a comforting number in terms of with the highest dose, having 80% still on treatment at end of trial after 1 year of treatment. This is indicating that semaglutide is not only safe but also tolerable to the patients.
They actually do want to stay on this drug. So with those data, we initiated a large scale Phase III program. It is currently planned for at least 8 studies, 6 of which have already been initiated. We call it the STEP program. The first four studies will serve for regulatory submission in U.
S. And Europe. They are all placebo controlled studies comparing 2.4 milligram of semaglutide to placebo in a controlled setting. All of them are, by chance, 68 weeks. The first story called step 1 is basically the pivotal story, almost 2,000 patients randomized to either placebo or semaglutide for a period of 68 weeks, just demonstrating the safety, obviously, but also the efficacy in terms of body weight lowering for semaglutide.
Very similar in design, but different patient population. Step 2 is looking at patients with type 2 diabetes also suffering from obesity. In addition to having a placebo controlled arm in this study, we are also comparing to our conventional diabetes dose, namely 1.0 milligram, allowing us to compare not only to placebo but also to the diabetes dose in this setting. That for us will be very, very informative. If they're free, we look at maximizing the weight loss.
On the background of intensive behavioral therapy, patients will be randomized either to placebo or to semaglutide. This study design will allow us to not only evaluate what is the maximum we can get out of semaglutide on the background of intensive behavioral therapy, what can we really achieve for these patients. But it also puts semaglutide to the test because it allows us to show what semaglutide can do on top of intensive behavioral therapy. We have seen in other contexts that if patients are intensively treated in terms of behavioral therapy, the effect of pharmaceutical therapy is waning off a little bit. We do not expect to see that for some aglotide.
In step 4, we are looking at maintenance. Patients will be run-in for 20 weeks on semaglutide and subsequently randomized to either placebo or continued semaglutide treatment. This will allow us to look at the maintenance of the weight loss of semaglutide. We will again be looking at the weight loss from treatment initiation to end of trial but also allow ourselves to look at the accrued weight loss for the 1st 20 weeks. All of these studies will read out mid next year.
We will write them up, do a fast regulatory submission in 2021, aiming for launch of semaglutide for obesity in 2022. Currently, we have 2 additional studies ongoing. 1 is called STEP 5, looking at the sustainability of weight loss in semaglutide. This is a 2 year study, so substantially longer than the previous four studies. Step 6 is conducted primarily in Eastern Asia with a regulatory purpose focusing on primarily Japan and South Korea.
Step 7 will be China focused to be initiated very, very soon. And step 8 is directly comparing Saxenda 3.0 milligram to semaglutide. As we already discussed, obesity is associated with not only cardiovascular morbidity but also mortality. This we know. We also know that the STEP program serves very, very well both for regulatory but also for payer purposes to demonstrate the weight lowering potential of semaglutide.
But we also and I really, really like the question, I think it was from Peter, we also know and have the ambition to show the potential for semaglutide in terms of reducing the risk of comorbidities. This, at the end of the day, in addition to the actual weight loss, is what really matters not only for the patient but also for society. To this end, as Camilla alluded to, we have initiated, at least in my world, a very large scale ARCOMS trial, 17,500 patients. It's the largest study Novo Nordisk ever conducted. It will recruit over this year and into next year.
And we are currently at almost 10,000 patients, so we will get there in due time. The study is event driven, and it is expected to read out no later than 2024. Now the interesting thing here is not only that Select will serve for cardiovascular purposes, it will also serve to look at other comorbidities as secondary endpoints. We'll be looking at kidney disease. We'll be looking at osteoarthritis in order to further inform us in this setting.
But I also want to be a little bold. Camilla Konta, a landmark story. I want to draw a parallel to type 2 diabetes 25 years ago. In that setting, I went to medical school at that point in time. I just went back to read my old textbook.
Type 2 diabetes was rarely or barely defined as a disease. It was called not insulin dependent diabetes mellitus. Very few treatments available and absolutely no innovation in the space. Most the patients were suffering from really, really severe comorbidities because they virtually received no treatment. And then came U.
K. PDS, demonstrated the impact of intensified treatment on patient outcomes, changing the landscape, establishing type 2 diabetes as a severe chronic disease, generating new innovation and bringing more medicines to market. Our intention with Select is the same. We do want to show the importance of optimized weight management in the setting and look at the impact on comorbidities in the setting, aiming at changing the dynamics for obesity and patients with obesity. But it doesn't stop there.
We have a really, really exciting pipeline. Again, I'm biased, so I would say industry leading pipeline in the area of obesity. Already discussed Saxenda and semaglutide. And Mads alluded to Amylin that is currently in Phase II, but we also have a very, very strong and exciting Phase I pipeline. We know that from a pathophysiological perspective, obesity is a multifactorial disease.
We need to be able to target many different areas of that disease in order to achieve the full potential of weight loss. We also know that actually from bariatric surgery. We may not reach that goal with a monotherapy. So we can achieve up to 15% of weight loss with somagnetide. But if we had to go beyond that, we likely had to combine different modes of actions.
And our Phase 1 programs are clearly dedicated towards that. We want to change that dynamic. Really, really exciting. Our Phase 2 story and all of our Phase 1 story will read out within the next 12 months. So a lot of interesting stuff going to happening there and a lot of big decisions for us.
With the end goal of closing the gap to a bariatric surgery, really achieving the 30% weight lowering that we know that we can see with these drugs. Just one word about Amelim. Currently in Phase II, has the potential to be combined with semaglutide, really achieving substantial weight loss. This is our Phase I, multiple dose. In a period of 56 days, we saw a 6% weight loss in this setting.
This is comparable to the weight loss that we see for semaglutide, really, really efficacious, really, really dramatic. In and of itself, comparable to somaglutide together with somaglutide, 2 different modes of actions. We have a potential to achieve, maybe already in that combination, the aspiration of getting closer to bariatric surgery. So to sum up, as Camilla said, we aim to double our at least double our current sales by 2025. We want to be part of changing the concept of obesity.
We want to change the perception, and we want to make obesity a health care priority. In order to support that from an R and D perspective, obviously, we need to develop the strongest possible portfolio of superior treatment solutions. Today, I only had time to show you our clinical assets. My good friend, Marco Schindler, has a plethora of assets in preclinical that we look very much forward to receiving for clinical testing. And we want to ensure that more people with obesity receive treatment and get improved outcomes.
So with that, I'm very, very happy to invite Ludo with Healthgaard to the stage, talking about our biopharm portfolio.
Thank you very much, Martin. Thank you. Good. So that's the moment you've all been waiting for, biopharm. Jocasile, I'm super happy.
I'm delighted to be with you today in front of you to talk about biopharm and to talk about to what extent biopharm can and will contribute to the long term strategic intent that Lars shared with you this morning. My name is Ludovic Helfgott. I joined the Lars management team 7 months ago now as Head of Biopharm after more than 15 years spent with another Scandinavian originated pharma company also working in the metabolic space. And I would like to share with you today thoughts on how BioPharm will secure a leading position by leveraging its full portfolio and that's very important and expanding into adjacent areas. And while I was thinking about how to share that story with you, I was trying to look for the best starting point.
And actually, I believe that the best starting point for this is the performance of BioPharm because the performance of BioPharm over the past few months actually tells a lot about what's behind the curtain. And this performance has positively surprised you over the past few quarters and I have to spend a bit of time on that. Traditional disclaimers. And let's go now to the performance. As you might have observed over the last of the 1st 9 months of 2019, biopharm actually returned to growth.
It returned to growth and actually grew 4% 1st 9 months versus last year after already a performance in 20 18 that was around minus 1%. But what's interesting in this 4% performance is the fact that it actually affects both portfolios, both the hemophilia portfolio and the endocrine portfolio. As you can see, from a pure growth rate, the hemophilia portfolio, our current hemophilia portfolio is actually growing 5% in the 1st 9 months of 2019 through, of course NOVOS 7, through NOVOS 8, through AFIXIA as well as other products in the portfolio. The same picture can be seen through in the growth hormone franchise through Nordic Tripping, where you can see that our overall franchise is growing 2% in the 1st 9 months of the year and where our market share is actually stable above 30%, between 32% 33% in terms of value across the globe. So the portfolio is growing across both gross hormone and hemophilia.
It's also interesting to observe that it's growing across the existing products as well as the new products. We've launched RafiXia a few months ago, a year ago and we are seeing already the first good signs of Esperoct. I'm going to talk about that in a minute. And it's also interesting to observe that the portfolio, the overall biopharma portfolio is growing in IO, 6% in the 1st 9 months of the year, but also in the U. S, 1% in the 1st 9 months.
So it's growing across regions, across products and across franchise. And that in itself tells a lot on how we believe and why we believe the biopharm portfolio and business, it can actually really contribute well to Novo Nordisk. So let's go behind the curtain and let's try to understand what are the let's say, the members or rather say the building blocks or building bricks, I should say, because I'm learning my day. So it's all about building bricks in this country, building bricks of biopharm. And I think the 1st building block or building brick is this, is the fact that actually biopharm has a portfolio.
In the mind of most observers, biopharm is about norditropine and NovoSeven. Actually, no. NovoSeven is biopharm is, of course, about NovoSeven and norditropin. But it's also about Novo8, Novo13, Refixia and Esperoct recently launched. We launched Esperoct in Europe over the past 9 weeks now.
And just to give you a bit of flavor around that, we already have in 8 weeks, I think more than 24 patients on Esperoct, which is far more than what we saw in the 1st place. But even more interestingly, only 6 of them are actually coming from the NOVAV franchise, actually have all the reasons to believe in their good performance. The second element of this portfolio perspective is that beyond the products, we also have a great set of devices. And as you can see, the change of Norditropin Simplex to the FlexPRO, to NordiLED to NordiFlex are actually each time an opportunity to bring new devices to patients, to physicians that make the treatment easier than by the past. And the last element of this portfolio for me is what we've discussed and we'll continue to discuss over the past few hours is the launches, is this launch culture.
We have more we've already launched RYTHIXA in 15 markets, we're going to launch again in 15 markets over the next 2 years or 3 years, Esperocts starting 2, Germany and Switzerland, 25 over the next 2 years and Odiotrepin 16 and yet another 30. This launch culture is part of the DNA of Biopharm and it's a portfolio, not just 2 brands.
2nd building block
is I believe the characteristics, the features of a real specialty care business. By this, I mean the ability to have a very focused and expert healthcare professional base. So we're not going through dozens of thousands of physicians, really focused on limited number of hospitals and physicians. We have super skilled medical reps, super skilled medical teams that helps us to really connect well with the clinical practices in the markets, far better than we believe many of our competitors. Deep scientific knowledge and history in both hemophilia and growth hormone.
And maybe for me, the one element that I really believe will help us has helped us a lot and will help us even more is this culture of lifecycle management. In most primary care, well, that I know from my past, the first indication launch corresponds to anything between 70% to 75% of the overall value of your drug on the lifetime of your drug. In this sort of super specialty care, the first indication will be something around 15%, 20%. And we'll then continuously bring to the market new indications, new devices, sometimes big, sometimes small that will fundamentally enlarge your portfolio. And I want to give 2 examples of that.
The first one is the Nuunen indication we got for our norditropine in Japan. As you can see, NuNone was launched, I think it was 18 months or maybe 2 years ago in Japan. And the first from a pure, let's say, epidemiology, the first sense was that we would get anything between 180, 200 patients. We actually got after 1.5 years more than 330 patients affected with the NUNA in Japan. And this of course brings a new opportunity to of course help patients, but get more contact with the clinical base.
It's exactly the same on NOVOS 7 where of course we have and we know that we have by definition stronger competition going ahead. But in the meantime, we've launched the acquired hemophilia franchise. In the meantime, we are really focusing a lot of efforts on the breakthrough bleeds on prosthetic treatments. And in the meantime, we're also reinforcing our views, competitive
tension
competitive tension on one side with on the other side new indications is second to none. And a few weeks ago, just a few weeks ago, more than 23 years after the launch of NovoSeven, yet a new indication was approved in Europe around the bolus using Botox pump infusion, which is clinically something that physicians were asking us have been asking us for the past 5 years. So still 23 years after the launch in And that's part of our DNA, this ability to come systematically with new indications. That for me is why this engine is so powerful. 1st building block, a real portfolio.
2nd building block, a real culture of specialty care. The 3rd building block is maybe a direction to go. And on this one, I would like to spend a bit of time taking a step back on the field that we've been exploring so far. On the left hand side of your chart, in front of you, you have the hemophilia market value. The market as it is roughly today, DKK17 1,000,000,000 globally.
And we believe if you look at the external perspective, it grows towards DKK95 1,000,000,000 over the next, let's say, 8 years, which is a moderate CAGR of 2% to 3%. On the right hand side, the growth hormone, smaller numbers, but fundamentally the same logic, moving from DKK21 1,000,000,000 today to DKK29 1,000,000,000 over the 6 years, again, the market. If you are in this place and we are in this place, of course, there's a bit of growth. And we should, of course, make sure that we get that growth in. The point is that if you're really aiming at a larger growth and a larger space capture, you then need to take a step back.
And if you're taking a step back, then suddenly the picture changes a little bit. First of all, you can observe that if you move from the hemophilia to the broader rare blood disorders, you then have a market that is not anymore DKK70 1,000,000,000, but DKK164 1,000,000,000. And this market is actually growing 10% over the next 8 years. Likewise, if you're moving on the right hand side, you can actually see that on the endocrine side, your market is moving from 21,000,000,000 to roughly DKK100 1,000,000,000 and from today and from 30,000,000,000 to crazy DKK200 1,000,000,000 in the next 6 years, growing at 11%. I am not saying, just to be clear, that we are giving any guidance on the growth of biopharm tomorrow morning.
All I'm saying is that there is here space and pace to grow if you select the right battles, if you invest in the right science and if you are focused on innovating and meeting the big unmet needs of many of these patients in this group. That's the 3rd building block. The first one was a portfolio. The second one was the business system behind the Specialty Care Business Unit. And the one is the direction, where to go and that we're exploring with around our commercial product supply and our scientific teams.
And there come the 4th building block. There come maybe the one without nothing could happen, and that is science. That is the ability that biopharm, alongside with our colleagues in R and D, in discovery, but also in development is fundamentally to find sustained growth both internally and externally and to do it within exploiting our core capabilities in our research. And of course, nobody better than Mads could walk us there and explain to us and to you how we might get there in the short run, but I guess as well a bit in the longer as well. Mats, please.
Thank you, Ludo.
Yeah, it's a pleasure to talk, Florent, where you left Ludo. And yes, R and D has done and will be doing also going forward a lot of life cycle management on these very long life cycle compounds, whether they be clotting factors, growth hormones and the likes of it. In fact, I started in biopharm only 2 years after the advent of nodetropin, the first precompetent growth hormone as Head of Growth Hormone Research. So exciting to talk about it again today. Now if we look at internal versus external research, Novo Nordisk has a strong tradition within protein engineering and really creating optimal molecules in growth disorders and in bleeding disorders.
But of course, nowadays, we're increasingly looking to the outside world to see how can we create even greater value out of those assets. And one way of doing that, for instance, is by going down the oral route. Who would not like to go from intravenous infusion of Factor VIII into something that essentially becomes orally available? And to that end, we are investigating whether some of those oral delivery device technologies that I hinted a little bit at a couple of hours ago, namely the Soma device, the Luma device and so on, whether they lend themselves even to oral administration of huge macromolecules such as Esperoct, Factor VIII molecule. So we will support our biopharm colleagues very much by combining internal with external research.
But obviously, our core capabilities have to over time go beyond simple peptide and protein engineering, which is not simple, but which has been around for some time. And to that end, we are looking to the outside world to actually access new technology platforms, and you will later hear from my colleague and Head of Global Drug Discovery, Doctor. Marco Schindler, about one of them, namely RNA interference. That is a technology from the Dicerna company that we will also deploy potentially in the area of biopharmaceuticals. But the likes of it and going maybe even to the next level includes gene editing, where I will show you one example of a collaboration that we as a company are entertaining with the Bluebird Bio Company over the next few slides or towards the end of my slides.
Of course, everything has to do with understanding the disease pathophysiology into the areas you're looking at. So deep and profound biological understanding is a prerequisite for coming up with differentiated offerings to the patients. Now let's look at what is in the pipeline and what is the time horizon. If we start with hemophilia, we will today I will today talk about the clinical assets concizumab, the cross segment hemophilia agent that works in principle in any kind of patient with hemophilia A or B with or without inhibitors. I would also talk to MiMaitre, where we have now cleared the regulatory hurdles for going into Phase I clinical trials.
IND has been submitted, and you'll hear more about how we consider this a new generation of Factor VIII mimicking antibodies, not a me too, but a new generation. I will also talk a little bit well, actually, not really to non invasive therapy apart from the fact that we will see to can we deliver all versions of Factor VIII, of growth hormone, etcetera. I'll end up talking about the cure of hemophilia on my last slide. If we look at the BioPharm pipeline in terms of where are they phase by phase, well, we have just kicked off a rather big around 300 patient program into concizumab, the tissue factor pathway inhibitor monoclonal antibody. That is expected to deliver results early 'twenty one, followed by a rapid BLA submission and marketing authorization application to the U.
S. And European authorities, respectively. We also are into sickle cell disease with a EBIDESTINY001 molecule, decitabine plus a company molecule that is completing Phase I over the next period to come. Mind me, you'll hear about what are the plans for that and what the data we are releasing as we speak actually on that particular molecule. And then I'll wrap up talking about how somapacitan has already been developed for adults with growth hormone deficiency.
It's undergoing regulatory review across the globe, but we're also into now kids pediatric growth hormone deficiency treatment with the REAL4 study and even kids that are born small for gestational age and more about that in a minute. Now let's talk about concizumab. As a company, Novo Nordisk has been devoted to the tissue factor pathway, which is kind of triggered by the NovoSeven Factor 7 molecule. We've even looked at tissue factor pathway inhibitor as a moiety against anti uses and anti thrombotic back in the 1990s. So this is disease biology that we understand probably better than others.
If we look into what it is, concizumab is a high affinity humanized IgG4 subtype or isotype antibody. It's a 1st in class. We believe we can be 1st to the market with this one. It boosts the early initiation phase of the clotting process, the most static cloud formation. It is delivered in a very nice auto injector FlexTouch pen device with ultrathin needle low volume injection, and it has so far been safe and well tolerated with no adverse event reporting in the Phase II trials.
I need to talk a little bit about the science now. How does it work? It's a bit complicated. I'll walk you through it. Essentially, you have up here the tinnase complex as we call This is what in your daily life makes your blood clot when you have a bleeding episode because you fell off the stairs or whatever.
This is what normally triggers the clot. However, to control that, we also have some breaks and some counter regulatory mechanisms. And here's the one we are inhibiting, TFI, look at it. Here it comes, and it blocks the activation, but concizumab unblocks it again. It takes away the inhibitor, allowing the activation process to proceed and the clot formation to happen.
That's the ultrafine ten second version of how concizumab works. We can go into more detail later if you want. Now then to make a very complicated trial design a bit more easy to understand. You may look at all these arms up there. I get confused when I do so.
In principle, what we are saying in EXPLORER 7, that is the inhibitor trial A and B and EXPLORER 8, that is the non inhibitor trial A and B, is that we are basically saying that patients who are coming in on demand, so they are treated with on demand when they have a bleed, they are receiving a coagulation factor, those patients are randomized in a blinded fashion to either prophylaxis with concizumab or to continue for half a year on the on demand treatment. So we actually have a kind of active comparison there. However, patients who are already on prophylaxis and that may be because they have been into the Phase II trial with concizumab, one of the other EXPLORER trials, they are allowed to go directly from the treatment with concizumab in Phase II into Phase III where, of course, they will stay on concizumab prophylaxis. Otherwise, they would not join the trial. And then finally, those who are on prophylactic treatment, either with a Factor VIII compound or a Factor IX compound, hemA and B, respectively, they are also typically allocated to prophylaxis with concizumab.
Big trials, around 300 patients, more than I've seen in the industry in general. So very comprehensive, very aggressive timelines. We are enrolling and we believe that we have the full results set in the first half of twenty twenty one followed by a rapid submission. Now MiMate. MiMate is the next generation fatate mimicking antibody based on the dual body technology.
We have actually created more than 30,000 bispecific antibodies and characterized each of them using machine learning systems and digitalization to speed the process up. We are with a approved R and D ready to move into man. And just to let you understand, what is it that it does? Well, it's like an antibody. The Fc, the big part of the antibody that does nothing is like the scaffold, is then coupled on the one side of it to a factor IXa binding arm and on the other side of it to a factor X arm.
And when these two bridge this complex, boom, magic happens and the clot proceeds just like if you had had Factor VIII to initiate the process. It mimics the pharmacological action and physiological action of Factor VIII. Now what is unique about this one? One is that it has very strong activity as evidenced by in vivo models and because the dissociation constant, I. E, the ability of this antibody to dissociate from the complex on the platelet once it is there is very, very low, we have a minimal tendency for binding the target in circulation, I.
E, there should be very little off target toxicity. And finally, it's also delivered in an innovative device and has a beautiful long half life, at least in animals. Let's hope it gets even longer in men. So these are in vitro data that are being released. I believe it's at the ASH conference almost as we speak.
And what they are really telling the story about is whether you look in thrombin generation assay in hemophilia plasma, can actually see that the dose response curve for MiMate, our compound versus HEMLIBRA, the imicizumab molecule, is shifted to the left, suggesting that we have a more potent compound. And in some animal models, that actually translates into in vivo efficacy that seems to be greater than that of IMLIBRA. It's a bold forward looking statement to come up with, but it's, of course, things we will look into in the clinical trials and maybe use Phase III designs for this molecule that are slightly different from what you're used to seeing to prove just what I said. Then Chegg or thromboelastography, that is also a way of actually looking into how good can you actually in hemophilia like plasma where you add antibodies that block all the clotting factors and then you see how good are you reversing that blockade. There we also see the same phenomenon actually that this mimate molecule has capacities and a potential that goes beyond that of FINIBRA.
So it probably stimulates the Faxate activation and hence the clotting process, both in vitro and in 2 animal models in vivo. It stops even severe bleeds, which is unusual for these kinds of agents in animal models, and we are going to start early next year Phase III trials that can be made adaptive such that we hopefully fast can move into pivotal trials. So much for hemophilia. On the next slide, we move into my old core area of growth hormone research. And here, we are actually speaking about somapacitan, a once weekly fully biodegradable molecule that is using Novo Nordisk core technology, putting a side chain to a native human protein, not creating immunogenicity, not creating reactions at the local site we and submitted for the adult indication.
But what did we see in the kids? Well, in Phase II in the children, in this trial called the REAL III trial, we actually saw a dose dependent growth velocity increase up against the comparison, nordetropin, to the extent that at the highest dose of 0.6 mg per kg per week, we actually exceeded significantly the growth velocity of the standard dose of nautotrophin. This is actually the dose that we are into Phase III with in the trial called REAL4 that is ongoing and recruiting. We are also in the REAL5 trial doing a Phase II trial in kids born small for gestational age because they did not buy into the arguments about exactly what dose do these children need because it tends to be a little bit different from the GHD indication. And then finally, somapacitan in adults, we expect a regulatory clearance or at least decision, both in EU over the next year, and Japan will be submitting for PM Day over the next months to come.
Now my final slide actually goes to gene editing. We are in a collaboration within hemophilia, initially hemophilia A, I. E, Factor VIII with a company called Bluebird Bio that already has an approved gene therapy product. It's using a so called mega tile way of driving into the genome right at the double stranded DNA where you want to cut it out and insert a healthy copy of the gene that is deceased or sick in the patient with hemophilia. This is a very specific and, I would say, very advanced technology.
And the way you do it is you need classically a gene therapy vector, an adeno associated viral vector AAV that carries a very compact factor VIII gene construct of high quality. That has to then enter into the chromosomes, not the episomal, where normal gene therapies, they are actually not copied with the cell copying. They would be diluted, and that's why you cannot treat children with classic gene therapy. Here, the concept is that the megatrial delivery in small lipid nanoparticles actually cuts open the chromosomes and allows for the insertion of the DNA construct that will ensure coding for the healthy factor VIII gene product, potentially for lifelong in a way that you can control because you also control the promoters that are to actually insert and where to insert this construct. So it can be lifelong.
It can be used in children. It's very exciting. It could be one avenue into the future of gene therapyediting. And we do believe that this shows that Novo Nordisk is entertaining, maybe not as the first movers, but I hope at the end of the day as the best movers, new technologies such as gene editing. I think with that, Ludo, over to you for closing the session.
Thank you very much, Matt. Right. So, Matt explained the magic of R and D. I think it's actually more than magic. I hope now you understand why we believe it's not a play of chance, why we believe we have serious fundamentals, certain building blocks in biopharma and why we believe biopharma will really contribute to the long term growth of Novo Nordisk.
Two remarks, two important points. The first one is that we really are looking to secure a sustained growth outlook for Biopharm by leveraging our business system, our commercial competencies and ensure a never ending flow of launches in the market, that's 1. But also 2, that we are really committed to strengthen and progress internally and externally the biopharm pipeline. And with that, I'm happy to call on stage, of course, Lars will moderate the Q and A, but also Camilla, Martin and Mads to answer questions you might have on either obesity or biopharm.
Thank you very much.
So we'll do a bit of innovation because in the break, we did a bit of leaning on how we can move the microphones around. So we'll actually keep the microphone at a location and try to get 2 questions before we move on, not from the same person though. So still one question and we'll start over here and try to centralize the questions around that.
Thank you very much. Wilmar Kapadia from Bernstein. So I'm just trying to reconcile the obesity guidance for a doubling of sales to 2025. Given that Saxenda is growing around 40% globally and given that semaglutide in obesity could also launch in 2021, your guidance suggests a significant slowdown both in a percentage level, but also in an absolute level. So is that guidance a floor Or is there an underlying reason why the growth is going to slow down so much?
Camilla, on Rubista guidance?
Yes. So there are a couple of factors that we have taken into account when we've made the guidance to double our sales by 2025. One is, course, that the current growth rates that you're seeing actually 50% year to date is based on a relatively small base. That, of course, becomes as we talked about earlier, becomes increasingly difficult to expand with the same growth rate on a bigger base. But we've also taken into account that it requires yet another more efficacious compound to be able to sustain growth rates at a stronger base level.
We are expecting that margin will deliver that, but that will not be in the 1st few years of this period. And then the last thing that we have taken into account is, of course, the loss of exclusivity on Textenda. So those are the three elements that we have factored in to get to, I could say, minimum doubling of our growth by 2020.
I think your margin sneak in at least. So it is no, we are trying maybe to a bit more than doubling. So was there one more question around here? Yes, you can move here.
Thanks. Richard Vosser from JPMorgan. Just thinking back to the Select trial, I think you highlighted some comorbidities that you're going look at osteoarthritis and some others. What about liver injury and NAFLD? Can you look at that within the trial and sort of get some idea of reversal of some of those rather nasty things?
And now we have 2 witnesses on stage, but I think we should go to Martin.
We can, in short, and we will. Obviously, the select trial is not specifically enriched for patients suffering from liver disease, but we already now know that approximately 5% of the population in an obese setting will be suffering from some stage of liver disease. So obviously, we will be looking into this.
And we keep going here at the table.
Sachin, Jain, Bank of America. Just a question on the patient numbers you provided as an opportunity for obesity, where you talked about growing from 15,000,000 to 24,000,000. Can you give us some color on how much of the existing and future market you think is out of pocket versus some sort of reimbursement, the geographic split of that and how that changes over time, I think you've been fairly vocal a lot of the growth is out of pocket in some of the emerging markets. And the last one is, you talked about a medication market, but there's a very broad anti obesity market with OTC, gym memberships, all that sort of stuff. When you think about those numbers, how
does that play out? Camilla, on growth reimbursed out of pocket and also OTC considerations?
Yes. So the status today is that, as you know, that most patients are paying out of pocket on their own. And it's actually mainly in the U. S. Where we in the commercial segment has a coverage of up to segment has a coverage of up to 78% of patients.
So when we're looking forward, without going into too many details of that, you could say that there is a tradition for out of pocket pay in the Middle East and in Asia where actually obesity treatment is very strong. So that's slightly different from our diabetes business. But of course, in Europe, there is a tradition for not paying out of pocket. And there, it will be even more important to unlock the reimbursement. And we are going to take that a little bit country by country approach to make sure that we can agree on this with the payers and the regulators.
And on OTC?
On OTC, yes, is a market for OTC, and it's clear that you can see some of the Noom that we have teamed up with is a different type of behavior modification that can also get to a weight loss on some patients groups up to 5% approximately. Difficult to sustain that also over time, but some can do it longer than others. But the combination of the 2 is really what I've shown you in the data is what drives the better efficacy as of now. But of course, with what Martin showed you on the development coming forward, we see that there is a potential for much greater weight loss from the products that we would be able to bring forward in the future. So I would say, yes, it's good to have other types of support at the same time, the combination is good.
But of course, even greater efficacy is what we really would be focusing on in the future.
Coming from Max?
Yes. And talking about efficacy, there is, as Martin alluded to, no landmark study that has shown a benefit in heart outcomes. And reimbursement in a broader context is more natural to follow our demonstration of hard outcome benefits such as stroke mortality, osteoporosis and so
on and so forth.
Okay. Thank you. We'll move over here. And then over there afterwards. Thank you.
It's Michael Leuchten from UBS. Question on stay time and obesity. So when we think about the rebound, when we think about the hormonal changes that are required, in your mind, what's the magic number, regardless of the extent of the weight loss? How long do you think a patient has to stay on therapy to retain the weight loss?
So Martin?
I mean, medically speaking, as far as we can see, the vast majority of patients would be looking at very long treatment in order to sustain weight loss. Most patients stopping and accrued weight loss or stopping treatment after an accrued weight loss will regain part or all of that weight very rapidly. And we I mean, I don't want to take the word lifelong treatment into the vocabulary, but it is a lengthy treatment basically because, as we discussed, the body set point for basically food intake will drive towards taking back the weight that has been lost. So continued treatment is likely the best option.
Take one more question.
Michael stole my question. So I'm going to ask you in a similar way, I guess, which is not the same question, but the same theme of stay time in obesity because you've given yourself a target of meeting bariatric surgery, but the weight loss target you gave us for bariatric surgery was 3 years. And clearly, there is a degree of sustainability given the Is
there
Is there anything biologically that we can see even very early in the pipeline that has the ability to reset some of the biological problems associated with obesity. So that once I've dropped my weight, there's a maintenance therapy that biologically could keep me going. I realize it's many years away, but it seems to be the only way that pharmacologically we're going to solve the problem, whereas surgery has sustainability.
Yes. I guess my named brother, gentleman, also called Mads, who's running obesity research in Marcus Schindler's area, His dream is to find that set point and reset it, so to speak. Take the thermostat and change it so that we reset at a level where basal metabolic rate and energy intake into the body is more coupled to a lower BMI in steady state. So we're pursuing that vigorously. We have academic research collaborations to kind of tease out if that is possible.
But of course, we'd like to understand it in the human species, which is slightly more difficult than treating rats and mice. We do have findings on some of our early research projects that seem to indicate that there might be some resetting of the set point, but that's too early to be optimistic about. So I agree with you. That's the end goal. Martin also had it at the end of his innovation curve, but there will be steps before we get there.
We move over here.
Yes. Martin Parker, Danske Bank. Again to Camilla and regarding this doubling, it is one question, maybe it sounds like more than one for you. But anyway, could you just talk a little about of you have implemented any kind of impact from, I think you call it, investigational use of both Ozempic and maybe also later on, Rybelsus in obesity, and that can maybe slow down obesity growth, at least in the short term, until you have more efficacious products in the market. And if I look at the dots that you make, I think that's very difficult, but
it seems like your volume assumption is somewhat
doubling. So are you thinking about a different average selling price in obesity either because of a stronger growth outside U. S. Or because of a different pricing strategy for semaglutide in obesity? And then just remind me, you have made this you have made I think it's the same area.
You have made this a settlement with Teva on Vitosa and duaclatide on the patent expiry date. How is your position in when have you in calculated potential competition on Victo on Saxenda actually?
So I think there was one question here on how the growth can be considering a bit potential cannibalization pricing. So in the context of that growth assumptions?
Yes. So when it comes to diabetes and obesity, of course, there might be some investigational use in this area. That's nothing that we see that we have sort of that we have seen a big part of. But of course, that varies a little bit from market to market. So I don't think that, that should be something that has a major impact on this.
Then in general, the second part, sorry, I forgot.
The pricing assumptions.
The pricing assumptions, yes. I think we are not guiding on the pricing assumptions. But of course, what you can think of when you look at how things are generally happening is that once you get a broader volume and have an impact, there might be adjustments, but that is more like receiver for the channel mix that already now see in the U. S, for example, that's just a natural evolution of that. So I think you should see things in that context.
On the dots, they are you can go back with and have a look later on, of course, but they are just trying to indicate that we are expecting to take a bigger share of the segment, but that the segment is also growing. And of course, given the channel mix and so on impact over time, it is likely that maybe the patient numbers will grow slightly more than the sales. But that is sort of don't get too meticulous on measuring exactly that difference.
And on a follow on generic or biosimilar product, we have not seen any activity yet, but we assume there could be. Having said that, of course, this is a market that's driven by efficacy. And with the efficacy that we expect to get based on semaglutide, we, of course, assume that with the stay time we about and let's say double up effect, there will be a massive change to a higher efficacy product. But we do assume that there will be some by similar injury.
And specifically to the Teva case, it is implicit that the composition of meta patent that was kind of the decisive point that pertains to Saxenda. And since we now have the pediatric patent term extension of 6 months, we are into the month of June 20 4.
Florent
Cespedes from Societe Generale. One question on the Phase 2 program on the combos in obesity. You're aiming to achieve stronger efficacy, stronger weight loss. But could you maybe share with us if you have observed any, let's say, further side effects? Or could you share with us the tolerance profile of observed so far?
Is it at a cost of some side effects, the stronger efficacy?
So Martin, what do we see in the clinical setting? Yes.
Just a small correction. Phase II is currently in monotherapy. Phase I in multiple doses are the combination therapy. We've actually worked a lot on the titration part for both the semaglutide but also the amylin would expect from a GLP-one analog alone. Okay.
And then just would expect from a GLP-one analog alone.
Thank you. We move over here.
Michael Loehrlein, Nordea. Also for Matt perhaps or Martin on the AM833 and the combo. How far are you in terms of developing the pen? Could actually do the combo because it's going to be 2 separates blending in one pen? Then just a small follow-up on the LOE on Saxenda.
I guess, there's a rationale for a massive and very rapid switch when you have a drop going 2.5 times the efficacy and once weekly. So just difficult to see that if you get on the market 2021, 2022, that there's any impact whatsoever from the 6th end LOE.
Yes. On the device, you're absolutely right, Michael, that the PI, the isoelectric point for the sema and the amylin molecules are quite different, actually decades apart. And that means that you cannot per se co formulate them. So what we've done is developed a device that is really smart because it actually ends up co administering in a way where you don't feel that it's not just a standard single use device. So you do nothing but inject.
And without revealing the secret, they both get to the same side of injection. And the only trick we have to prove to regulators is that the pharmacokinetics are not changed for any of those individual components. In animals, that looks to be the case and promising. In humans, we don't have the data yet, but I would assume hopefully they follow the animals.
Do you cover the loss of exclusivity?
The loss of exclusivity, we still need to take into account that there might be a potential entrant into this space. But of course, we do agree with you on the fact that cevaglutide in obesity is a very strong competitor in this field and has a very clinically relevant profile to upgrade from Saxenda.
And that might be why we don't see a whole lot of activity, but let's see. So we'll take one final question before lunch.
Thanks, Pete Verdult. Just a question from Citi. A question for Ludo. Lots of interesting assets in the pipeline late stage coming in, but that won't affect the strategic aspirations for 2020 to 2025. So I'm not asking for guidance, but I want to understand if you are able to maintain the growth rates that you've seen this year, would that make you ecstatic or is that completely unachievable?
Just how you're thinking about what is good and bad for biopharma?
Well, I
wish to be ecstatic, of course. The we are as you know, we're not guiding giving any guidance on that. What I'm trying to put today is the fact that there are building bricks, building blocks in this unit that I believe are in itself structurally, both from a pipeline and a commercial perspective, all the ingredients to really contribute to the long term growth of Novo Nordisk and that we are both internally and externally always looking for elements to enrich this pipeline in order to make sure that we can really meet this target. But I really fundamentally Esperoct in. With SPARAK in.
With BRAFICIA, with everything we're doing on NovoSeven, with somapacitan and concizumab, we have in our basket, I guess, a lot of great medicines to help patients and provide support to the overall treasury of Novo Nordisk. I'm really confident about that.
Good. Thank you so much. And with that, I think we all have deserved lunch. You'll see that there's nothing like a free lunch because there's actually an opportunity to continue dialogue. And there is a lineup of I think it's the same meal, but different settings.
And you can see on your name tag where you can go if you have a special set of management members you want to join your lunch conversation with. So we'll break for lunch for 1 hour, and there's an opportunity to continue the engagement. Thank you very much.
All right. So welcome back from lunch. Peter, thank you for giving me the short straws we say in the U. S. About having the first presentation after lunch.
I don't know if that's yes, thank you. So the last time other than this morning I was in front of this group was almost 2 years ago exactly at Capital Markets Day in Copenhagen. And one of the things we talked about, if you remember, was we were preparing for the Ozempic launch. And we talked about the changes that we were going to make to the operating model and that we were in the process of finalizing and making distinct changes because we needed to, because the U. S.
Was involved with the challenging market and we want to have the best in class launch ever. If you fast forward to today, 2 years later, we have a product as I mentioned earlier, it was the fastest product ever to $1,000,000,000 and we're thrilled about that. It's a product that now has after 20 months, 21 months NBRx leadership against our chief competitor. If you look at the total GLP-one TRx for the U. S, we're leading there as well.
So it's fantastic. But our work is not done. So what I'm going to describe now over the next 15 minutes is what is still a market in the U. S. That is complex and challenging.
It's also a market in the U. S. That is going through for us a major transition or even you could call it a transformation. And I would say that within that transformation, we try there's the fair balance, we'll skip through that. Within that transformation, we tried to get at least an understanding to give you a picture of what it looks like, to give you a feel.
And we came up with an Indy race car or racing in general. Just give me a second to walk you through this. So in racing, and I don't know a lot about racing, I know a little bit. But in racing, you have to make changes along the way. You have to maneuver differently to the changing environment.
You have to course correct. You have to worry about what your competition is doing. You have to work as a team. And in a lot of ways, that's what North America is doing. So my only comment to Canada now is going to be that Canada has been performing for the last several years.
We're looking at double digit growth. They've done an exceptional job with launches and they're going to continue to do that. That's our aspiration and you can consider them in the pole position in racing terms. The U. S.
On the other hand is probably what we would think of is in a pit stop. It's in a pit stop because we need to continue to change and make those appropriate changes so we can win. It's the only way an IndyCar and a team can actually get to success. So maybe one just way to think of it is that we've taken off the growth tires which were once insulin and now we've changed them with the tires, which are now GLP-one. So we're in the middle of this transformation.
But if you think about what it could be, so aspirationally, so we in the U. S. Could have and the rest of this will be U. S. Oriented, will and could have 2 new blockbusters in the market and that is incredibly exciting.
What's also incredibly exciting is what's in the middle, which is patience. So we've talked about purpose, we've talked about sustainability, doing the right things in an organization, you heard that this morning. Well, we do the same thing part of the largest affiliate. We actually count patients. So we just eclipse the 4,000,000 patient mark in the U.
S. And our aspiration is to put many, many more patients on our products and that's exciting. What's also exciting and a bit challenging is the fact that we are going to have this transition of about 70% of our sales in the next several years. So what was almost 100% of our business in 2015 will be approximately 30% of our business in 2022 and I'll walk you through a little bit of that detail. And that's no easy feat.
And Mike and I in the car this morning, we're talking about I think it was about a movie, we're talking about Netflix. We're talking about how Netflix many years ago changed their model. And now they're they took up streaming, they changed the model, now a $130,000,000,000 company. We just talked about Blockbuster, went in a different direction. So going through a transition is not easy, but it's something that we need to do, so we will be doing it.
So let me give you a little perspective of what that looks like. So we have some legacy products and they are primarily insulin products that have been and this is no news to anyone here, they've been under a challenge from a pricing perspective and a biosimilar perspective and that will continue. Now these slides are illustrative, but they directionally give you where it is headed. So we'll continue to see a challenge in the insulin category moving forward with the anticipation of even more biosimilars entering. We also have a continuing challenge with Victoza as we approach our LOE.
We just had a lot of questions at lunch about this. But again, with the stay time on Victoza, that is a natural progression that's happening. And so we'll manage that as we go, but it is a drag overall on the U. S. Business.
And with biopharm, Ludovic, we did take
a little bit of a
dip because of an innovative product. We also put a new leader in place 2 years ago, and she's done a really nice job of finding those spots where you can compete almost to what Ludovic said and also gearing up for launches. So we're bullish about that opportunity moving forward. Now if you take a look at the entire picture of the U. S.
Business, it really comes down and we could do it on one slide. So the growth and almost all of the growth is going to come from GLP-one. We know that. We're in the pit. We've made those changes.
We've allocated resources appropriately, sales forces appropriately, and we know that's where we have to drive our growth. And the great news is, as I said earlier, we have a best in class portfolio to be able to do that with Ozempic and Rybelsus. Now with obesity, certainly and again, we're just talking about this at lunch, we think and Mads detailed this, we go from 5% or Martin as well, 5% to 15% that is meaningful and in a lot of ways could be game changing for us. We're still selling Saxenda, year over year growth is positive, but now we're also preparing for what could be an excellent opportunity with semaglutide for obesity. The insulin again, and as Mike alluded to this morning, it's less of a sales component for us now, but it is still something that we have to manage and will continue to be a drag as we move forward.
But how we manage it is also very, very important. And I just mentioned biopharm. We have some critical launches coming up and we're going to make sure that we do our absolute best with those launches and we're preparing for them now. So overall, the right hand side of the screen really talks to the picture that I was alluding to earlier, this 70%. But as an organization, we're making the appropriate changes to be able to manage that.
But you can consider the overall U. S. Business to be from a sales perspective somewhat flattish as a result of what we have is pressure in some parts of the business, the legacy parts and where we're going to drive disproportional growth. That's in the short term. In the mid term, we do expect to bring it back to single digit growth.
So the U. S. Business, what does it look like? If you look 9 months to comparative 9 months, it is slightly down, the overall U. S.
Business and you can see that. So it's slightly down. And you do see and Mike alluded to it, we still have the majority of that, 41% is coming out of insulin, so it still is exposure. We acknowledge that. We understand it and we're managing that.
But what's probably more exciting in our own investable thesis is what you see on the right hand side of where all the growth is coming from and where we will continue to compete and that is the GLP-1 and also the SGLT-two. So that is where we will be competing and that is where our focus in energy will be from an investment standpoint and a strategy standpoint. So for us, this is how we're going to be able to manage that transition. What's also important is can we compete and have we competed? As I've mentioned, we're almost halfway through this transition now as we look to get to 22% and I'm talking about this transition of 70%.
But what's important is along the way and again remember 2 years ago, we have been and we'll continue to compete and Mike alluded to it whether it's Tresiba still taking market share, really the only basal insulin to do it, last couple of quarters with biopharm have been productive and certainly with Ozempic, we are extremely, extremely proud internally of the job that we're doing and on behalf of patients. It's fantastic and we'll continue to see that. And overall, we do see the share of the growth, as Mike alluded to earlier, above where our market share is. So it would be impossible for me to go through a U. S.
Presentation if I don't talk to at least some of the complexities and these are well known. So for us as a manufacturer for anybody else, getting from manufacturer to patient is more challenging today than it's ever been. It's more complex. You have government intervention. You have this public debate that happens all the time around affordability, which we want to be in the forefront at and I'll get on that get to that in a second.
We do have the digitalization almost of the entire industry and Camilla spoke to that earlier. We also know that the pair consolidation has not necessarily stopped in the U. S. Though in some ways and we just talked about it at lunch, when you have pure play PBMs that get together with insurers and they now are a little bit more concerned about the medical benefit as well as the Rx benefit, the pharmaceutical benefit, maybe that's not such a bad thing. Although they have scales, I'm not trying to say it's easy.
So just two pieces here. We've had a market access team that has been battle tested for years and we'll get to REVELSYS access in a minute, but feel really, really good about where we are from a market access perspective in terms of our talent and that's important. And then again, I think it's also important that we touch just at least a minute or 2 on affordability, because we have put our I'd say our emphasis and almost our emphatic stamp on saying that we want to be a company because of our purpose and because we do believe that from a sustainability perspective it helps that we are at the forefront. And if you look at not one single offering as it relates to affordability is the answer in the U. S.
It's just not. Lars mentioned it earlier, it is a complex system. So what we know is even for those individuals that have healthcare in the U. S, so they have insurance, they have healthcare insurance. There's a lot of those individuals that still struggle to pay for their insulin in particular.
And so we know we needed to help. It's good for the patient and it's actually good for our business as well. So we have a lot of programs that help people with insurance. We don't abandon them just because we negotiate a formulary position. Could be from a benefit design and things that we have no control over, but we're still activating our efforts to help.
Now we also know through the Affordable Care Act that many, many millions of more patients now have insurance and that is a very good thing for those patients and for a market that does rely on most importantly insurance. But what we also know is there's roughly 30,000,000 Americans that don't have insurance still for a variety of reasons. And so we know they need help and we have programs and services to help them. And lastly, anybody that falls through the cracks, we've had offerings since really going back to almost 1990 with Walmart to help those individuals. So we feel really, really good.
We think it's aligned with our purpose and aligned with our own sustainability. So to the roadmap and this is something that we've now used for 2 years. So as part of this transformation that we've been on, we wanted a simple scorecard or a simple roadmap, I should say, for the employee base to understand that when we have to make strategic decisions around investments that we could all align around it. And this is what we developed. It's not too complicated.
Most in the U. S. Can almost regurgitate this maybe too many times. For those watching, I apologize again for them seeing it, but this is it. This is our roadmap.
GLP-one that is where we're going to see our disproportional growth. So our energy and our effort in the U. S. Is disproportionately aligned to the growth of GLP-one. We also know that obesity, we need to continue to develop this market and drive Saxenda and prepare for some obesity, which we are doing.
What we also know is we have a big component of our business that we need to manage. So we need to manage the erosion of insulin. It's going to happen, but we need to manage it. And the more effectively we can manage it, the better we are. And we still have by the way 3,000,000 plus patients on our insulin business.
So it's important for the patients as well. So in no way are we abandoning them, it's just that we take a different perspective in terms of investment. And then biopharma alluded to a few times. We feel very good about the upcoming launches. So let me zoom into GLP-one.
So we do have a portfolio offering. And as I mentioned, I don't believe that there's any company that is better positioned today to compete in the GLP-one space. Remember, 7%, as I alluded to earlier, 24,000,000 patients treated in Type 2, only 1,600,000 in the U. S. Are on a GLP-one.
And remember that big component of OADs that are not in control. So we have a portfolio offering. And within that, if I just zoom into the innovative products, so that's really where our focus is, we're not putting any promotion against Victoza. I could tell you that when we think about our positioning for the product and I mentioned this earlier, it's probably important that we overemphasize that we do believe there is a place for both products in the market and we are positioning them as such. We do want to have in the minds of a physician clearly the first preferred oral medication is Rybelsus.
The first preferred injectable medication is Ozempic. For us, it's the evidence. As I mentioned earlier, Mads delivered another gift, which over the last 10 years is incredible. So for us, the evidence, what we walk in the evidence? The evidence is right there.
When we think about PIONEER 3 and being able to say the leading DPP-four and the evidence, the leading SGLT-two and PIONEER 2 and the leading once daily in our own product in Victoza. That is our evidence. That does support positioning and it's how we will be successful. And we also, as you know, have the evidence and we'll continue to use this evidence as it relates to injectable Ozempic, which is sustained 7 against dulaglutide, sustained spore against the leading still prescribed basal insulin and the add on to basal. So that's critically important.
We do believe they can coexist. We're positioning them to coexist and we believe the market and the data supports it as well as well as importantly our own evidence. And we're super excited about it. One of the things I forgot to say earlier when you should know is that, Lars talked about people and Monique will be up later as the Head of People and Organization. We do these surveys all the time to test the pulse of the organization.
Maybe I jumped over it, but the bottom was people and organization. And one of the things I can tell you is that we have some of the highest engagement scores ever in the U. S. As it relates to engagement, highly engaged employees that for the right reasons want to be here and that does give us, I believe, a competitive advantage. So it's super exciting to see and we are very excited when we see the evidence and what we're doing.
So when we think about where is the market going, I got a couple of questions at launch. It's almost impossible to predict where the market is going. There's some things that we look at that can predict where it's going. What we do know, as I mentioned earlier, this market is event driven. So we have another monumental event with the world's first oral GLP-one.
This is not just a compressed pill. This is a pill that has the clinical profile to compete and with the oral administration to compete. It's an unbelievable opportunity for us. Now, access is going to be the key to success as it is with any product in the U. S.
That launch. And what I would tell you is that the access that we achieved for Ozempic is a high bar. We did a fantastic job as an organization and we're very proud of the access that we have. It enables us to go out and sell and market this product effectively to turn on DTC and other mechanisms that we use personally and not personally in terms of our promotion. We're out there right now actively negotiating And I'm sure I'm going to get some questions, so maybe I'll eliminate those questions right now by saying there's really nothing I can say about the access other than the fact that we have ambition to get the appropriate access that we need to be successful.
And we know it's critical to the success of the brand. So in closing, before I bring up my partner, I would say in crime, but it's maybe not the right thing. We are transforming this organization. It's not an easy lift. We understand that.
We're in the pit. We're changing the tires. We're making the appropriate adjustments to put us in the best position to win. Of those choices aren't easy, some of them are strategic, but we're making the choices and we have been for quite some time. We started this conversation back in 2017.
We also know that it's going to continue to be a challenging environment in the U. S. There's no doubt about that. I'm not going to say that the complexity and the continued consolidation is not challenging because it is. But certainly, we believe that we have the right profile of products, the right portfolio of products with the right clinical evidence to be successful.
It still is a market that rewards innovation and we have it. And I can tell you that we have a roadmap for success. We do. We have this roadmap that we've used now for quite some time. It's not that we don't make subtle changes, but we do believe that we have the right measure for success.
So with that, Mike, I ask you to come up.
Thank you. Yes. So international operations. First, please pick the future with a pinch of salt. What was this?
Yes. International operations, that's the place home to, I would say, some 430,000,000 people with diabetes, 570,000,000 people with obesity and maybe more relevant for this meeting, a place where about half of the Novo Nordisk value is generated. Now that value has been generated quite sustainably over the last few years with the rate of approximately 4 to 6 percentage points any given year. There has been a number of changes when you look at the regional dynamics during this period. When you added all the numbers up, then historically, IO has been growing some 4 to 6 percentage points.
Last year, we broke away from that trend to 7% growth for 2018. And for the 1st 9 months of this year, we reported 11% growth, and we're predicting that the full year for IO will be around the 10 percentage points this year. Now most of this is coming through demographics. This is the place where majority of the world's population lives. It's coming through value upgrades and the new generations.
Insulin, as I spoke earlier on also in my morning session presentation. What we have not done well in IO is market share growth. You could see from the red line, our market share has been under pressure for a number of years. For more than 10 years actually in international operations, we have lost market share slowly but surely, and we have not been very happy about this. And Lars spoke to that also in his opening speech.
And of course, what that means then for a period of time, and you can see this on the light blue line, we were growing substantially less than the darker blue line. Then something changed some couple of years ago, and it says market fit approach introduction. We have tons of products available to us. They're all supposed to do more or less the same thing with some differences here and there. We also have a lot of countries.
Historically, we took all of our products and we launched them in the same way with the same messaging, same everything actually, regardless of how the countries were different. Countries are very different. Healthcare systems are different. Affordability is different. So we decided to actually take the assets that are available to us and take a look closer into how and which ones are best fitted in which markets.
And the result of that has ended up in more introduction of some of the products that we would have otherwise not maybe launched and for sure growth drivers that with the old type of strategy we would not have had. And now we see that over this period of time, we've really been able to improve our share of growth and as a result, are also growing much, much closer to the market at 9% versus the 10% that the market shows. So historical growth of, let's say, 5%, I would say that's a little bit of history. We are projecting to basically going as we go forward to up that game to about 6% to 10% growth rates. But this is not going to be easy.
It's not going to be easy because, first, we have to protect the light blue section. There is a large amount of products, legacy products, mature products, DKK39 billion worth of sales that a bit of a percentage up and down will make a difference for us. So we need to invest and make sure that the base remains as it is. On the other hand, we also need to recognize that the future growth holds upon us by focusing on 3 and only three elements: doing better in the basal market, insulin basal market selling more within the GLP-one segment and really expanding and making more out of the obesity market. And twothree of the growth going forward to 2025 will come from those three elements.
I'm going to use the next three slides to explain a little bit more in detail each of those elements. If I'll start with insulin, basal insulin, this is by far the largest insulin segment that exists when you compare it to the mix and the volume segment. And this is the place where we are not a leader. In the other two segments, we are leaders. We have approximately a third of the market.
And for a decade or so, we've been fighting in this market with our asset, Levemir, and have not been able to do well better than 30%. Now we have assets that can give us hope. We can also become leaders in this segment. Tresiba, Saltify are going to play a major, major game changer in our market share increase. And as long as we can keep the share of growth above the market share line, as it is now 45%, I am quite hopeful that we can actually achieve this.
But we need to play the Tresiba and the Sultophy game quite correctly. We have Tresiba available in 80 markets today. That's a lot. But more recently, we also introduced it in 3 very large markets, Germany, France and China in the national reimbursement. So this is now giving us a very good base because, of course, after U.
S, we're talking about the second, the third and the 4th largest basal market now having Tresiba, which we didn't have just 18 months ago. So I'm extremely hopeful on this and add to it another 10 launches over the next couple of years. Sulfurfia has become a major growth driver for region Europe, 30 launches we have had, and we are planning to have another 15 across the world, equally really, really exciting for us. So we will protect the base, be it on human insulin or levermere and then push the growth with Tresiba and Sultophy. And then hopefully, we can get leadership in the basal segment as well in due course.
GLP-one, you've heard a lot about GLP-one in the context of U. S. Specifically, but it's also equally important for us in international operations. And this is a place where we have not done well again. Especially, we saw a major headache after our partners on the other side of Atlantic, the American company launched their once weekly.
Then we basically saw that we are not able to run as fast as we were. We got a bit of a boost with the CV label update of Victoza. We got a little bit more boost with Victoza joining the Chinese national drug list, and we really pushed forward with 23 Ozempic launches so far, starting in Europe and a bit in AMEEO. So really, really turnaround picture, as you see, of share of growth, but still, the dark blue line is not as high as our market share, which means if you keep it like this, we will continue to lose market share. So we have to change things around.
And it is basically Ozempic and Rebalus, the same as just Doug explained, for us that will change the picture. And you could see that I changed the graph to only show what happens when we launch Ozempic. In markets where we have only we have launched Ozempic, then we are able to actually gain market share and have a share of growth higher than our market share. So this gives me extra hope that as we roll out Ozempic into 30 launches. So 30 launches of Rybalsis and 40 launches of Ozepic coming up.
And I just heard actually a breaking news that one of those 40 is soon going to be Germany, an extremely important market where we will have Ozempic ready. So that's going to be super exciting. Then obesity. This is this has come as a surprise, I think, to us in international operations. We've done really well with obesity, and that gives me a lot of confidence that we should be able to do well as we go forward as well.
This is a DKK4 billion market in international operations right now, growing around 12%. We are growing around 60% currently with Saxenda adding about DKK0.5 billion. So we're really the only growth driver in this market. And I hope we can continue this as we are standing our launches also with Saxenda, going from 43 to 15 more in the next couple of years. But it's more than just the launches.
It is also building the market, patient support programs. It's a way trying to find out how we can keep the patients longer than the 2 to 5 months they're currently on the product. And in general, building an infrastructure and having as many patients as possible, so when we come with semi obesity, then the platform is right for us. Huge, huge unmet need, and I'm extremely optimistic. So if there is a couple of things you should remember from my slides, then history and our 4% to 6% growth numbers no longer holds water.
We have an ambition to grow 6% to 10%. We can do this by holding our base, but also putting a lot of pressure on ourselves to increase market share in the basal insulin segment, sell more within the GLP-one on the back of Ozempic and Rybalsis and do better with Saxenda in the obesity market until Sema obesity joins us. With that, I think I'll invite Lars for the Q and A.
So we have exciting breakout sessions coming up. But if anyone has some questions to Doug and Mike's presentation, we will entertain them before we break out. So please join me here. And we'll start by only one question this time, Martin.
I promise that. And that is for Mike. 6% to 10% is a very broad range, given that you have been going around saying that it has been very, very stable historically with 5% to 6%. And as I understand it, tender based contracts are becoming less and less of your business in some of the international markets, which should
also reduce volatility. So why this very large gap? So the 6% to 10% is the growth projection we have till 2025. I'd like to say that we hope to be growing at the top of this range as we go forward. Currently, we are doing that right now.
And demographics, good volumes and all the launches that I spoke to speaks to that possibility. But we're also dealing with a region that has possibly any given year risks associated to it. Political risks, macroeconomic risks, pricing risks and as well as currency risks are some of the things that can actually drag the growth rates lower at any given point of time. So I do think when you're thinking about now till 2025, the range of 6% to 10% is a good place to
be. Marco Soovani, Veranke Capital Partners. So I have a question concerning the potential competition and cannibalization between, as you mentioned, the best oral and the best injectable, but it's still the same molecules. So do you see a potential competition between the two products? And how do you position them?
Because if I am a patient in some way unless the oral is more expensive than the injectable, I should prefer an oral version instead of the injectable. So I agree the research has been very good. So you have the best products in both categories. But how do you manage the fact that it's the same molecule behind? Thank you.
So if I give it a shot I don't think patients care that much about what is the underlying molecule. They're looking at is the situation whereby they use the product. So obviously, if you are on, say, an early phase type 2 state, that's where tablets are dominating treatment. So you expect to get a tablet based treatment. So that's where we position Rybelsus.
Obviously, if you have a more progressed type 2 diabetes, efficacy becomes more important, and that's where injectable treatment kicks in. So we don't see it like a way to get one molecule. It's about the disease state you are in. It's about the efficacy and the ease of administration that matters. So there are distinct different categories.
Of course, some of it will be overlapping, but we are going to fish in a way larger pond of patients, and we believe there's significant growth in that. We'll keep one more question over there, and then we'll make a jump to the oil end.
Thanks. Peter Loltz, Citi. Just one for Mike on China and GLP-one, I mean, 1% value share for the class right now. Can you give us any sort of timelines in terms of Ozempic or Ebelsus in terms of approval and reimbursement? How you're thinking about that opportunity?
How we should think about the timelines around that? Yes. So
I think the good news is we are right now on our own with Victoza. So while, of course, we would have hoped to have Ozempic already on the market, our competitor with their once weekly is also not there. That gives us a bit of a competitive advantage over some of the other markets. I would say within the next couple of years, I hope to see Ozempic in China. We're working very hard, of course, to bring it in.
And then usually it takes a year or so, a year or 2, depending on when the Chinese government opens up the National Drug List before it gets reimbursed. But until then, of course, we still can get regional access and work quite hard on it. So that's the timeline. I'm very optimistic that we are able to continue seeing Victoza grow quite nicely until that time.
Great. We'll go all the way to the back. It's not working. Hold on. No mic coming up.
It's Ku Parikh from Goldman Sachs. Doug, One clarification and one question. You said you expect the U. S. To be broadly flat in the short term and to grow single digits in the midterm.
How do you define short and midterm? That's a clarification. And then earlier this year, I think at your full year numbers, the phrase used was you expect REVELSYS to have an unprecedented launch. Do you expect REVELSYS to be a block buster in a shorter period than you did that with Ozempic? Well, that's how we would understand unprecedented.
Yes.
So thank you for that one question around Provelsoz. So firstly, on what was the first one? Did you
They were both. Yes.
So let me start with unprecedented. Again, that was a it's a term that we're trying to motivate the team and it is our intent is to make this as big as possible. But we're not guiding to an exact dollar amount as we did with Ozempic, but we are trying to make this as big as possible. So we're not guiding to a dollar amount this year. So again, that's dependent upon access and things of that nature as you know about.
And now I even forgot the question.
Short to mid term. So what
is short to mid term? So I mean, so short to mid term is 0 to 2 and then 3 plus, I guess, in relative range.
And I think, Doug, this is turning around 70% of the business was illustrated until 2022. So that's kind of indicates. Do you have more questions in the back? Okay. Then we move over here.
It's Peter from Henselbanken. At the Capital Market Day 2 years ago, you were extremely bullish on GLP-1. That has turned out to be true. But also there was a question regarding the impact on insulin volume growth, where you were sort of relatively optimistic that it wouldn't sort of deteriorate, but now we are at flat growth in the U. S.
Assuming that Ozempic really will have an impact on the market and will probably longer stay time on that compound than current oral drugs. And then going on to another GLP-one Ozempic. It's hard to imagine with a flat growth of basal insulin in the U. S. Of 0% that, that will not turn into a negative number over the next couple of years.
So your comment on that one? Thank you.
Yes. Do you
want me to
add? Think we look at a significant price pressure in the U. S. On insulin. So when we look at the value of it, I think the delta on price pressure is bigger than the delta we see on volume growth.
So I think it's actually positive. It turns out that we have lower interim growth than we might have expected. That's a testimony of very strong GLP-one dynamics where we will win more of that. So I would actually welcome that. I think it would be a sign of the strength of actually treating type 2 diabetes based on a GLP-one based treatment rather than going to injectable interim treatment.
So I would welcome that to be honest.
The only thing I'd say Lars is that we have many components. There's channel mix, there is rebate impact, there is affordability initiatives, there is legislative initiatives. There are a lot of things that go into impact the insulin component other than what is another product category that is much more meaningful.
We have one more question on there.
Yes. Thank you, Kartan SV. For you, Doug, you're the only one with little bit of a muted outlook here in the next couple of years. Do you mind describing when you look at the insulin franchise, you made some initiatives that there's maximum $99 There's affordable insulin in Walmart. You have a follow on, Biologics.
Is it fair to say that 2020 could potentially be a much worse year for you in terms of insulin growth than what we have seen in the last couple of years. Just try to give us an idea about how the incremental changes work here with all
the new initiatives. Yes. So I'd first start by saying that I feel like I should move this way so I can I'd first start by saying that flattish growth is something that we're actually we're pretty proud of because of the drag that we have in certain components of the business. I mean, we're going through a transition period. And when you're turning over that much of the revenue in a short period of time, I think we're pretty proud of what we're doing.
Now having said that, I think that the affordability initiatives are just for that affordability. We are not competing against others in that space. We're not competing against our own branded products. We're not trying to post a scorecard about how well we're doing in affordability. We want to make sure we have the right programs for patients that we widely communicate that.
But the majority of patients in the U. S, the majority the vast majority of patients in the U. S. Are in some sort of system that works for them today. So there's a small amount that are in the healthcare system today like I said earlier that are not able to afford it, a small amount.
There's another amount that does not have insurance and there's a few that fall into the cracks. But the vast majority of patients are in the system today and the system is working for them. And that's where we compete with the majority of our products. So it's not to compete with ourselves.
And on the pricing in 2020, not that we guide for 2020 yet, but I think it's fair to say that the competitive dynamics we see will also be there in 2020. There will be continued price pressure by now entering
into 2020. Yes.
Take one more question.
Simon Baig from Redburn. Just continuing on that theme for you, Dub. 2020 is also the year of the U. S. Presidential election and in a campaign which is being dominated by health care and health care which is being dominated by drug pricing and drug pricing which is being dominated by insulin pricing.
How do you see that influencing? And how do you respond to the pressure on DASL going to come under next year? Because from what you've been saying in the previous answer, it seems like this is a communication issue that the system is nowhere near as broken as some politicians would suggest from what you were saying about the provision within the U. S. So how do you respond to that political challenge?
I mean, is this longer term an issue of revisiting the position of rebates? Or what can be done to ease through that period?
Yes. So like Laura's comment as well, he's become almost a resident expert. But I would say this. The system is misaligned. So it's not that the system is perfect.
Most every president that I can remember has tried to reform healthcare in one way, shape or another. And there's a lot of misaligned incentives, which leads to a lot of challenges for people in the U. S. So it's not that it's perfect in any way. And what I would say is that I'm not here to predict any what will happen in presidential campaign.
I would say this is that there is a fundamental debate that's been happening in D. C. For quite some time around and in particular the affordability of healthcare and the challenges of that. And so we play an active role in terms of what we do as an organization. We have an office in D.
C. Where members of pharma and most importantly, we do the right thing with our affordability programs. It's not because we have pressure to do it, it's because it's the right thing to do. And I think that in the end, both sides of the aisle, they're going to continue to play a lot of politics and I'm not sure where that actually ends up. So I wouldn't never want to wager a bet there.
But Lars, you want to I don't know if you
have a question.
Yes. It's probably the topic I spent the most time on standing and following. And you have a point in saying that insulin is in the center of that political debate. But I also believe when politicians, observers, etcetera, actually look into the underlying market structure and the forces of it, it becomes very, very difficult to change it because it's probably the heaviest rebated category in the U. S.
Health care system. So it's a category that funds the most of the health care system. And if you start moving with that, you get a significant funding gap. And I feel like we are actually the one that's suffering besides the patients who struggle in this by having a significantly deteriorating selling price. So our price has been going down for 5 years.
So in this whole change, I think we can still have an attractive business no matter what change is made because we actually take home a significant smaller part than most people think. So it's a combination of a free market and regulation. And whenever you when you combine that, you get some unhealthy gridlock structures compared to when you have a purely regulated market or pure free market. So let's see. We are taking for sure the beating now.
So I doubt that a change can be much worse than the current market structure. I think we have time for one last quick question. We'll do that here.
Sachin Jain, of America and then Everkwik, so apologies. So Rybulsa's and commercial strategy, Doug, for the U. S, you didn't really touch on it much. So just a very high level question. If could compare and contrast how you're doing this versus Ozempic, are there any differences in the strategy or any things that worked well for Ozempic that you're doing more of?
And then a specific, if you could touch on the couponing and sampling program and how we should interpret the very early prescription data, which is driving quite a lot of
excitement? Thanks.
So I'll start with that. It's very, very early. So I don't think that we should make any I don't know. It's way, way, way too early. And I think it's too early for us to start looking at that prescription data and make some sort of assessment based on that.
Certainly, we're pleased with it, but it's way too early. What I would say is that we built a strategy for launch with Ozempic and we spent a lot of time doing that. That was built around access. And we are modeling the same. And so what we don't want is we don't want to send a representative into an office with robust clinical data, get a physician excited about writing a prescription.
They write the prescription, they go to the pharmacy and they either get it rejected or it's at a list price where nobody was that wasn't the intended play because it's not on the formulary. That negative feedback loop that happens could be 12 to 18 months. And so what we do is we go out and we have this beautiful molecule called Ozempic that right now we're still promoting. And we did the same before we had access with Ozempic. And so the roadmap that we follow is that we're going to continue to sell Ozempic until we've built enough market access to turn on Rybelsus in the first position.
And Rybelsus will then be in the first position once we get enough access. What we did that was a little bit different that we learned is that the focus launch, we did bring in about 600 individuals just about 5 weeks ago and those individuals were not only trained on the molecule, but they were trained on the early initiation that we're doing. And so we're out right now with specific targets with specialists and some primary care reps to build the engagement and the excitement with physicians around the molecule. And that's the early experience that we want to gain. And as we do that, we're the plan is to build market access and then we toggle between the 2.
So in a lot of ways, it's the same, but we've improved upon what we did with those EPIC.
On that happy note, thank you for the questions. And we break for the regional recessions. And Mike, you have some of the logistics.
So I have gotten 10 minutes to talk about IO, and that did not do justice for the large geography I'm responsible. But I'm extremely excited that actually we the next 40 5 minutes, you're going to be hosted by one of my team members. In the front, we have a lady and 4 gentlemen that are making me look good every single day with the results that they deliver in the various different regions that they're responsible for. So we're taking you in 2 of these three workshops and trying to have the experts try to explain you specifically on each of these geographies how we do and why we are doing so well. On in room S47, which is basically right to your right hand side when you go out, You will have Matt from Europe and Olef from Japan and Korea moderated by Carsten speaking to Europe and Japan Korea region.
In this room, you'll have Christine touch upon region Camilla as a moderator. And then across the hall, you will basically have in room S05, you will have Fredrik and Andre, together with myself speaking to Latin America as well as AMEEO. You will have about 25 minutes of presentation in each of these workshops, followed by about 10 minutes of Q and A with you and then another 10 minutes of walking around to the next workshop. And if you don't know which and where to go in your little tag then you can see which 2 workshops or breakout sessions you have been assigned to. With that, we are finished for the session.
Yes. Good luck, guys.
All right. Everyone, are you ready to get started on REIT in China? I am happy to introduce to you our SVP and General Manager of China, which is Christine Zhou. And Christine is an expert in China, having worked there for many years, but also worked in the U. S.
So Christine, welcome. You will give a 20 minute presentation. And after that, we will do the Q and A. Yes. Great.
Well, thank you very much, Camilla, for your introduction. Good afternoon, everyone.
Good afternoon.
Welcome to Regine China's session. As Camilla introduced, my name is Christine Zhou. I'm the SVP for REGIN China. And a little bit about myself. Am a physician by training.
I studied medicine for 6 years and practiced medicine for 6 years in Shanghai, China. And then I have been in the industry for 25 years. And I had a chance to work in the U. S. And Malaysia for 11 years, mainly in the U.
S, 3 years in Malaysia. And it is really great honor to lead Novo Nordisk region, China. And I am pleased and also it is a great pleasure to be here to share with you about the reaching China story. Pharma market globally. Really, it is driven by strong unmet medical needs and also supported by the solid GDP growth And the rise in the middle class with increasing disposable income really provides improved patient access to the latest innovative medicines.
Despite the efforts and the progress made, diabetes remain as one of the most health challenging health situations in China. Currently, there are 121,000,000 people with diabetes. However, less than half of them being diagnosed, only onethree of the 121,000,000 people are receiving the treatments, around 16% of them achieving the blood sugar glucose control. So as you have heard today, Novo Nordisk strives to really change therefore, making China as an important market for our company, not only for the business potential, but also really for the huge health care burden of diabetes in China. As with many other markets, it is quite a complex market with a huge diversity across the provinces.
The diversity is reflected by the differences in the economic development as well as the health care and medical sophistications as well as the reimbursement measures at province level. Therefore, applying the market fit approach at the provincial level is often required. The government is aware of the strong unmet medical needs and has put health in the center of government policies. The government encourages innovation, emphasized on the quality and also improves access. 3 important areas I would like to highlight.
The Healthy China Action 2,030 provides very clear framework on delivering the specific health outcomes, health goals in China. 15 projects are being rolled out. Diabetes 15 projects, which is very much aligned with Novo Nordisk ambition and commitment. It has historically taken a long time to get the products approved by the health authority. However, looking at the chart this chart, recently, the time to approval has been shortened significantly, particularly past several years.
This is really driven by the continuous health care reform, and we really appreciate the government's initiatives that they are taking. As a reminder, to ensure broad patient access in China, products need to be reimbursed at a national level, then also implemented at a provincial level as well as listed in the hospital level. Now of course, and as you can see from this chart, there are some very promising and encouraging developments to see how fast now the products can be reimbursed without getting into too much details. But of course, along with the opportunities from the new developments exciting developments, there are particular two challenges I want to highlight. In order to balance the health care budget and to address unmet medical needs, the central government is also quite cautious of the pharmaceutical pricing.
Therefore, the government has rolled out several cost containment measures. One of it is the well known 4+7 model or we call it a value based purchasing. Then of course, the continued price erosion also is happening along with the provincial bidding. Along with the opportunities coming up in the market, the competition continues to intensify from both local and also multinational companies. Novo Nordisk has very strong presence in China.
This year, we are celebrating 25 years of success as well as contributions through our full value chain operations in China. Recently, we have been recognized as 1 of the top 10 Pharma Company Multinational Companies and for the special contributions that we have made to the health care development in China. And we are 8, MNC Pharma and 1 in diabetes market in China. Our strong presence throughout the past 25 years is reflected by the continuous development of our business. After a stretch of quarters of single digit growth, we are pleased to see that we have returned to the double digit growth in the 1st 9 months of this year.
As you can see from the chart, the growth is mainly driven by the modern insulin and the next generation insulin as well as the GLP-one, our Victoza, which is very much aligned with our strategic focus. We have clear strategy, which is called Win plus 2025, to sustain our growth and the leadership. We would like to remain as a trusted partner in diabetes area, and we would like to, through our efforts and leadership, to enable at least 60,000,000 patients to be treated by 2085 from currently around 39,000,000 of patients with diabetes being treated. We will do so by focusing on the following four areas: through maximizing our portfolio, continuously driving the commercial excellence, of course, continuously shaping the market as well as accelerating innovation to the China market. I'm going to walk you through some specifics in next couple of slides on these four areas.
The diabetes care market continues to grow in its dynamic fashion. The insulin will remain as a core segment in China diabetes care market. You know the diabetes care market very well, but I'm going to point out a few segments that are very important to Novo Nordisk. The modern insulin and next generation insulin segment will continue to grow. These segments are very important to Novo Nordisk to continue to lead in.
Human insulin will have its place but will be challenged by the conversion to modern insulin. Now the modern non insulin antidiabetic segment is very different from the other markets you have seen already today. And it is an emerging segment in China and driven by the reimbursement and also the new entrants to the market, including the DPP-four, including the SGLT-two and the GLP-1s and including, of course, our Victoza. Traditional oral and the diabetic segment also has a high market share and is similar to some other markets. However, the growth of OAD segment is slowing down, including our normal norm.
And this market segment may be the hardest hit by the price volume pressure going forward. Insulin in China contributes to half of the diabetes market. We have 47% value market However and our market share currently is under pressure and mainly driven by the human insulin we are not actively promoting and also intensified competition in the premix segment. Talking about premix segment. This segment used to be the largest segment in insulin market in China in both value and volume and now has been surpassed by the Basel segment in value.
However, it is important to point out that the premix segment will continue to be the largest in volume in next couple of years, and it is remains important segment for Novo Nordisk. Basal insulin segment represents a very strong opportunity as you have already heard from Mike earlier. And it is now the biggest the largest insulin segment in China in value, and we have 15% value market share with 11 year only right now. So in line with international operations' strategic goal, it is important for us to become the basal insulin segment leader in region China. It is our goal.
And of course, the bolus segment has solid growth, but it's a smaller segment. Novo Nordisk remains high market share at around 80%. So winning in all three insulin segments is a strategic priority and we have opportunity to achieve that. Tresiba is our new base of insulin. We launched Tresiba in China, and we are very pleased to have Tresiba listed into the National Reimbursement Drug List.
It will be effective January next year. And we have established a dedicated basal sales force, and we have a clear strategy to drive Tresiba uptake. RIZZDAQ is our new offering in premix market space. And as we speak, we are launching RASUDIG into the cities in China, right? We got RASUDIG approved earlier after only 14 months after regulatory submission.
And we are very excited to see the 1st prescription was filled and over the weekend in Tianjin, China. Rigelica will further strengthen our position in the premix segment. However, the real uptake will have to wait until the national reimbursement drug list inclusion. The GLP-one segment represents another very important opportunity, and driving GLP-one growth is the priority for international operations as well as region China. Victoza has done well in region China, particularly after it's included with we've expanded the market access and our investment in commercial and as well as commercial forecast.
We have grown Victoza by 41% over the past 3 years. We have expanded GLP-one class from less than 1% to currently 2% in China diabetes market. We are maintaining the Victoza market share in GLP-one class over 90%. However, it is only the beginning for both Novo Nordisk GLP-one franchise and also for the GLP-one class in China. We are seeing the new entrants come to the market, including Trulicity.
And in couple of next couple of years, perhaps biosimilars will come as So it is very important for Novo Nordisk that to keep driving the commercial excellence, starting with our dedicated VuForce as well as expanding our GLP-one franchise by launching Ozempic and also REVELSYS in next couple of years. Doug alluded earlier that the Chinese GLP-one market is in its infancy as compared to other markets. So if the market dynamics develop as they have been globally, there is expectations that we can see the China GLP-one class continues to grow in the diabetes market. Biopharm market in size is modest. However, we are seeing a good uptake.
In China, currently, the business contribution of biopharm business is not that significant yet. However, the biopharm franchise is very important to the patients we serve in China. So we have NOBL7 and Nodiechopping marketed in mainland China, and we are seeing the good uptake in terms of growth. The key things for growing the hemophilia market in China really is to address the access challenge as well as to bring in the full portfolio, and we plan to do that. Obesity is one of the strategic focus areas for not only international operations in North America, but also the whole company.
And obesity, it is a growing problem in China. However, the market is yet to be established. We have large population right now and having obesity. But the challenge the good thing is that the government actually is aware of that. The government advocates individuals by paying attention to their weight.
That is included the guidance is included in the Healthy China Action 2,030. What this means is that this gives us a greater opportunity for Tinnovo Nordisk to be a part of the solution. This gives us a great opportunity to work together with the government, with the other external stakeholders actually to work together to build the market and bring our innovative medicines to China and to address the obesity challenge. In addition to our core contribution of innovative medicines, because diabetes challenge is a scale of problem, so Novo Nordisk has been working very closely with the government, with the professional societies, with health care providers as well as our partners to shift the market, to build an ecosystem of addressing the diabetes challenge, to make sure enabling diabetes early diagnosis, proper treatment and enable patient to have better control. Starting from 2017, we have contributed to the screening of 640,000 people at risk of developing diabetes, 280,000 people who have diabetes but at a risk of complications.
We have been contributing to the initiatives of building diabetes management infrastructure at the county hospital level and also building the capability by training GPs. We are partnering with digital health companies to build digital health solutions to doctors and also to empower patients to better manage their disease. For example, there's a program called Blue Connect that is an app based digital platform. We are working with a company called We DOCTOR. That platform connects the health care providers and their patients.
That will offer an opportunity for the patients to have online, offline consultation and to have better adherence as well as better control. Coming back to our core contribution of innovative medicines. Novo Nordisk is committed to continue to drive the growth and the quality of that growth, which is means that we continuously bring in the innovative medicines. Right now, we have 15 products approved and launched in China region China market, and we are going to accelerate our innovation through the following three things: we are going to accelerate our innovation by bringing the products to China market faster. We are going to diversify our innovation by bringing innovative medicines that are beyond diabetes, and we are going to accelerate our innovation through simultaneous submission.
And
right now, reaching China, the clinical development has been integrated into the global clinical development. This strategic decision has enabled us to deliver a simultaneous submission as a possibility and also the external environment is ready for that. You have heard the introduction today that LY287. It's our weekly injection insulin. This can very well could very well be the 1st medicine innovative medicines within Novo Nordisk that the Chinese patients may be able to access to in the almost similar time as the patients outside China to access to because the teams are working very diligently and working very closely to strive for the simultaneous market authorization submission.
So in summary, as you all know, the pharma market in reaching China continues to grow, and Novo Nordisk is well positioned to capitalize the growth opportunity. We have a holistic and a clear strategy to drive sustainable growth in the long term. And we have the great pipeline of innovative medicines. We focus on maximizing the portfolio and win in all major segments beyond insulin and beyond diabetes. We would like to remain as a trusted partner, and we will continue to work with the government, health care providers, professional societies and our other partners to make sure join hands, build an ecosystem really to drive the change to defeat diabetes and other serious chronic diseases.
With that, I thank you very much for your attention.
Thank you, Christine. And now we are ready for some questions. I think I can help keep track on who asked first and then you can answer the questions, Christine. That will be great. Let's start here.
Is it on? Yes. Michael from Nordea. Maybe a bit on the NR deal inclusions. They've been extremely volatile historically.
So you showed on the slide that, say, 2 to 4 years for CEMIC, 4 to 6 years for REBELSYS to get fully in the market. And I guess that also indicates reimbursement inclusions. But how good transparency do you have to this? And also in respect to that, how good transparency do you have to competitors getting on the list? Because we know that Trulicity is also likely getting on the list.
I don't know when, but at least there's a chance for it. So also talk about potential competition coming before you coming in with Ozempic.
So the time line, 2 to 4 years, 4 to 6 years is the launch time line that we put it there. In terms of the transparency of national reimbursement drug list, and we are seeing the increased frequency of the NIDAL review update and which is evidenced by this round of National Reimbursement Drug List review. And this actually was only after the last review happened in 2017. Now the future when the NIDL will be reviewed again remains uncertain. Well, we would hope that the government would either increase the frequency of the review at least following the current guidance, but it remains unknown, right?
But the one thing that is actually quite informed is the government also is looking into a dynamic review mechanism. If that happens, and we can see that more frequent NIDL reimbursement review will become a reality. In terms yes, you asked about Trulicity. Yes, Trulicity was approved in late February. And the government in the early this year, the government did roll out the specific criteria of the products being eligible to be evaluated to this round of NIDL.
And that was the cutoff date was the end of 2018. Therefore, Trulicity missed this round of evaluation. Well, I think as I mentioned earlier, then right now, GLP-1 is still in its infancy GLP-one in the China diabetes market, right? At this point, and Victoza has over 92% value of action in GLP-one. In terms of if I understand you correctly, you're asking about the competitive landscape in the GLP-one space.
Then in that case, actually, in the last CMD day, and Baieta was already on the market, along with the local GLP-one that is injected 3 times a day called the Benaglutide, we have not seen them have the traction yet at this point. Now in this round of NIDL, there are a few products eligible to be evaluated and including the 4 GLP-one products, excluding the Tricity. So but the NIDO review result has not been published. So we do not know what the result is and we cannot speculate for that. Yes.
Very good question. Thanks. And then there's a question over here.
Thank you. It's Michael Leuchten from UBS. At the moment, the insulins are outside the scope of VBP. Your visibility on when they might be included. So is there any visibility as to when value based, say, volume based pricing might come into the category?
Yes. When the biologics will be included in the volume based purchasing remains a no, yes, because the government has not mentioned that. And you are right, the current VBP, the scope is limited to the chemical products.
[SPEAKER UNIDENTIFIED COMPANY REPRESENTATIVE:] Very good.
Thanks. We have a question here.
Thanks. Naresh Chauhan from Intron Health. Could you just give us some color around the biosimilars because there are 20 biosimilars expected to launch by 2023, but how many of those are basal and what's the kind of how should we think about the uptake given there are 15 other insulin manufacturers that only have a third of the market? So clearly not taking huge amounts of share, just a bit of color around the impact of biosimilars in
Europe? [SPEAKER UNIDENTIFIED COMPANY REPRESENTATIVE:] Yes. So the biosimilars have been on the market for many years, including the human insulin and biosimilar products. And we can see that at this point, if you look at the market, many physicians and the patients, they do prefer branded products given the proven efficacy and the consistency on the quality and so on, so forth. But biosimilars does have a place in the diabetes management.
However, biosimilars uptake is very different from the chemicals. And the biosimilars when they introduce to the market, they will still need to require they will need to run the clinical trials first to get that approved and also they need to require they need to invest in marketing and sales to drive the uptake. But what's important for Novo Nordisk is that we need to make sure continue to drive our commercial excellence and which you have seen the opportunities that we have in all the three segments. And in the meantime, we need to make sure continue to accelerate its innovation to China market to continue to stay ahead of competition. Very good.
And a question down here.
Simon Megg from Redburn. You've given us a lot of useful color on the evolution of sales within China. Perhaps you could give us an idea about the evolution of the relative profitability of China compared to the group and other regions. Other companies in the European pharma sector, not those as diabetes focused as you, have said that the profitability of China has now reached and possibly slightly
So we actually have a session also
in the afternoon where we get into that a little bit, not in detail, but roughly as a span.
Yes. So Karsten will talk about that, yes. But what I can share with you is that it's very important for us. And I still remember in that last when last came on board as the CEO, he highlighted his three priorities. First is to drive commercial excellence.
The second one is to raise the bar on innovation. The third one is to drive the cultural evolution. For us at Novo Nordisk, what's very important is first, we need to have the patient in the front and center for everything we do. We need to accelerate innovation. In the meantime, we also need to make sure stay agile and also to be connected to the external environment to drive our commercial excellence.
And with that, I do believe that we can not only actually bring innovative medicines, but also continuously and consistently to drive our business by profit or by the top line growth.
So we will get a little bit more into the margin question later in the day also. There's a question over here.
Mark Boutte from Pictou. Just you referenced the local player with the 3 times a day GLP-one. When would you expect local players for daily or weekly injections in the GLP-one space?
[SPEAKER UNIDENTIFIED COMPANY REPRESENTATIVE:] There are some expectation on the biosimilars coming to the market and the GLP-one space. And so we cannot comment on the competitors' information. But and I think along with the expiry of our patent and there's an anticipation on the biosimilar sampling. And there's a
question behind there and then over here and then
Marcos Romani, Varane Capital Partners. So I have a question concerning the obesity. So in how many years do you see a potential development of the market also in China? Thank you. [SPEAKER UNIDENTIFIED COMPANY
REPRESENTATIVE:] Yes. So currently, we don't have obesity treatments launched in China with Novo Nordisk. We do have plan to start our same obesity trial pretty soon. And but what's important is at this point, and I think as Camilla alluded earlier, there are challenges on making obesity as a disease and to helping obesity patients in other markets. The similar challenges we observe exist in China.
What's important is that we work together with the government and to China. So we can expect to see next to come up with this.
Thank you.
It's Matthew Weston from Credit Suisse. You highlighted the government program on Healthy China, but the other government program is to try and get 70% of, I think, biologics manufactured domestically for China over the next 5 to 7 years. And I wondered as the market grows, particularly for biopharma within diabetes and obesity in China, whether or not you feel the need that you're going to have local manufacturing? And if so, are there any plans for that given the lead time it takes?
We have our Tianjin site. We have a large manufacturing site in Tianjin. And actually, that's one of the 5 strategic manufacturing sites in Tianjin. And currently, Tianjin manufactures some insulin products. And we do hope that in the next couple of years, we can localize the manufacturing of some products in China.
Yes, thank you. I cannot comment on the future plan.
Pete with Alt Citi. Just on the basal insulin market in China, can you just remind us today where we are in terms of price points brand versus biosimilar? And then with Tresiba launching in January, what is the commercial strategy here? Are you going at a premium? I mean, is it level with level?
Maybe just a bit more detail about the dynamics of that basal insulin market in terms of price points and restructuring?
There is a biosimilar glycogen in the market. And so largely, the price gap between the current biosimilar to the basal insulin is about 15% to 20%. And for Tresiba, our price is largely similar to the 11 year price.
Year price. Yes, very good. One last question up here and then we need to go to the next question.
Up here, down here.
Down there, yes. That's okay. I
was just thinking about your geographical reach in China. Are you present in all Tier 1, Tier 2 and Tier 3 cities? Are there any unexplored? So you had a lot of new growth coming in because of new launches, new innovations. But how about broadening your footprint in China?
Is that also something you can gain more growth from? And then just a quick question on nautitropin, which in China looks like a rounding error. What's the reason for this?
Yes. So to answer your first question, we deploy our fuel force based on market fit approach and depending on the product life cycle. And for newly launched, perhaps we would start from the key market first. And then we do have broad footprints for our insulin products. To answer your second question, Nodichopy, we just launched Nodichopy in China last year.
This is a great product, the best selling product worldwide for 30 years, but we just launched. But it is a 4,000,000,000 market and with an established local company has been there for 20 years. But we believe our brand, and we are investing in it. Yes.
Thanks a lot, Christine. So we will have to end the session here. If anyone has a question, Christine is also here after the day, after 5 So thanks again. Please take a look at your map where you are and go to the next question.
Thank you.
Welcome.
All right. Yes. So welcome to this session. We are going to talk about region China. And to do that, we have, of course, invited our SVP and Head of Region China, which is Christine Zhou.
Christine has worked for many years in China, but also in the U. S, and we'll start with approximately 20 minutes presentation. And after that, there will be opportunities for you to ask questions. So welcome, Christine.
Thank you, Camilla. Good afternoon, everyone. Welcome to the Region China session. As Camilla mentioned that my name is Christine Zhou. I'm the SVP for Regine China.
A little bit about my background. I'm a physician by training. As you can see that I'm a Chinese. I'm a physician by training, studied medicine for 6 years and had a 6 year clinical practice in Shanghai, China. But I have been in the pharma industry for 25 years.
And I had a chance to spend 11 years working overseas, mainly in the U. S. And 3 years in Malaysia. It is such a great honor to lead the Novo Nordisk region China. And I'm also pleased to have this opportunity and it's a great honor to share with you about Novo Nordisk story in Region China.
China is the 2nd largest pharma market globally. That is driven mainly by the strong mathematical needs and supported by the solid GDP growth. As a rise in the middle class with increasing disposable income, this provides better patient access to the latest innovative medicines. Despite the efforts and the progresses we made in diabetes management, currently, there are still 121,000,000 people with diabetes in China, Less than half of them being diagnosed, only onethree of them receiving diabetes treatment. Around 16% of the 100 and 21,000,000 people with diabetes have reached the blood sugar control target.
In Novo Nordisk, and we strive to change diabetes. Therefore, this has made China a very important market to Novo Nordisk, both from a business prospect perspective as well as helping adjusting the diabetes challenge perspective. As with many other markets, China market is a complex market and with large diversity across the provinces. It is reflected by the differences both in economic development and also the health care and the medical sophistications as well as the different access level in the province. So therefore, applying the market fit approach at a provincial level is often required.
The government is aware of the strong met medical needs and has put health in the center of government policies. The government encourages innovation, emphasizes on quality and also improves access. Three very important things I want to highlight. The Healthy China Action 2,030 provides a clear framework on delivering the specific ambitious health goals. Currently, 15 projects are being rolled out.
Diabetes management is one of the 15 projects, which is very much aligned with Novo Nordisk's ambition and commitment. Historically, it has taken many years to get drugs approved by the health authority. However, recently, the time to approval has been shortened drastically, particularly over the past few years. This has really resulted from the continuous health care reform, which we are very pleased to see that the government has taken the proactive approach to make the progress. As a reminder, to ensure broad patient access in China, products need to be reimbursed at the national level and also reimbursed at the provincial level and listed into the hospital level.
Recently, there has been quite exciting and positive developments without getting into too much details, and we can see how fast the products can be reimbursed, particularly in past 2 to 3 years. Of course, along with the opportunities from the new developments, there are 2 specific challenges I would like to highlight. In order to manage the health care cost, the government's authority is also conscious of the pharmaceutical pricing. Therefore, they rolled out some cost containment measures. One of that is the well known 4 plus 7 model or we call it volume based purchasing.
Then of course, pharmaceutical products pricing continuously erode along with the routine and the bidding activity. And we see the growing opportunities in China market and the competition continues to intensify from both local and multinational companies. Novo Nordisk has a strong presence in China. This year, we are celebrating recognized as one of the 10 MNCs for the special contributions to the China Health Care Industry Development. We are the 8 MNC Pharma and 1 in diabetes market in China.
Our strong presence is reflected in our continuous business growth year on year. After a stretch of quarters of single digit growth, we are pleased that we have returned to the double digit growth in the 1st 9 months this year. The growth is mainly driven by modern insulin and next generation insulin as well as by GLP-one product, which is Victoza. This is very much aligned with our strategic focus. We have a clear strategy to sustain our growth and the leadership.
We call it Win plus 2025 strategy. We would like to remain as a trusted partner in diabetes area, and we would like to strive to see through our leadership and the joint efforts to enable 16,000,000 patients with diabetes to be treated by 20 20 5 from currently only 39,000,000 patients being treated. We will deliver that through the focus on the 4 areas and maximize the portfolio, continue to drive commercial excellence and shaping the market as well as accelerating the innovation to China market. I'm going to share with you some specifics on these four areas in next several slides. The diabetes market diabetes care market in China continues to grow in its dynamic fashion, and the insulin will remain as a core segment.
I know that you know diabetes market very well and I would like to just highlight a few important segments and 2 Novo Nordisk. The modern insulin and the next generation insulin market will continue to grow and these are the important segments for Novo Nordisk continue to lead in. Human insulin will still have its place, but the human insulin will be challenged by the conversion to modern insulin. Now one segment is different and to other markets, as you have heard today, is the modern non insulin anti diabetics market.
It is an
emerging segment in China diabetes market driven by the reimbursement and the new entrants, including the DPP-four, SGLT-two and the GLP-1s, including our Victoza. Oral antidiabetics have larger market share similar to other markets. However, the OADs growth is slowing down, including our normal norm. And this segment may be the hardest hit by the pricing volume pressure going forward. Instantly contributes to 50% of the diabetes market in China.
Novo Nordisk has 47% value market share. However, currently, our market share is under pressure, mainly due to human insulin we are not actively promoting and also increased competition in the premix segment. Talking about the premix segment in China insulin market. As you know, premix used to be the clear leader in insulin segment in both value and volume, but now has been surpassed by the basal insulin segment in value. However, it's important to remember that the premix segment, insulin segment in China will continue to be the leader in terms of volume, and this continues to be an important segment for Novo Nordisk.
The base and insulin segment presents a strong opportunity, yes. Currently, we have 15% value market share with 11 year alone. So in line with the international operations strategy, becoming the leader in basal insulin segment is our important goal in reaching China. Volus insulin segment has solid growth, but it's a smaller segment. Novo Nordisk maintains high market share at around 80%.
So winning in all 3 in selling segments is a priority for us and we have great opportunities to achieve that. Tresiba is our new base of insulin. We launched Tresiba to China market last year, and we are very pleased that to have Tresiba listed into this year's national reimbursement drug list with effective January 2020. We have viewed a dedicated basal insulin sales force. We have clear strategy to drive the Tresiba uptake.
Rizotech is our new offering in the premix space. And we are very pleased that we have got Razodec approval earlier this year only 14 months after our regulatory submission. As we speak, we are launching ResidIQ to the many cities in China. And we were so excited, as Mike shared with you earlier, that over the weekend, we got the 1st prescription field in Tianjin, China. So RIZODEC is going to strengthen our position in the premix space, but the real uptick will have to wait until the next N ideal listing.
Jio P1 market presents another very important opportunity. As you have heard today from both Mike and Doug, that driving the GEO P1 market growth is an important strategic priority for international operations as well as for region China. Victoza has been doing well, particularly since the inclusion of the National Reimbursement Drug List in late 2017 and thanks to Camilla. And with expanded market access and also the investment in the commercial excellence and the focus, we have grown Victoza by 41% over the past three years. And we have expanded GLP-one class in China from less than 1% to currently 2%.
And we maintaining Victoza's market share in the GLP-one class over 90%. However, this is only the beginning for both Novo Nordisk GLP-1 franchise and also the GLP-1 class in China market. And we are seeing the new entrants coming into the market, including Trulicity was approved in later February this year. Therefore, it is very important for Novo Nordisk to continue the commercial excellence, starting with the dedicated sales force. In the meantime, to expand our GLP-one franchise by launching Ozempic and Rebiosis in next couple of years.
As you have heard from Doug, the Chinese GLP-one market compared to other markets is in its infancy. If the market dynamics develop as we have seen globally and there are certain expectations we can see that the GLP-one class increases the market share and diabetes market over the next couple of years in China. Biopharm business is modest in market size, but we are seeing the nice uptake. And although the current biopharm business contribution to the total region in China Novo Nordisko region in China business contribution is not big. However, it is very important to the patients that we are serving in region China.
In Mainland China, we have NOVA7 and Nodichopin launched in the market. And for the hemophilia markets, 2 important things that matters a lot. 1 is the continued to drive the access patient access in hemophilia segment, and we also plan to bring in the full portfolio of hemophilia to help patients in China. Clearly, obesity is one of the strategic components not only for international operations and for North America and for the entire organization. Currently, obesity is a growing problem in China similar to other markets, but the market is yet to be established.
As you can see from this slide, we have large population with obesity in China. What is very important and a very good thing that the government is aware of that. The government actually encourage individual pay attention on their weight. That is included in the Healthy China Action in 2,030. What this means is that it gives us Novo Nordisk a great opportunity next couple of years to actually build the market and bring the innovative medicines and to address the obesity challenge in the next couple of years.
In addition to our core contribution of innovative medicines and because diabetes is really a challenge of the scale of the problem, so Novo Nordisk has been working with government and also the external stakeholders, including professional societies, the health care providers and also our business partners, working very closely to shape the market and to build an ecosystem to tackle the challenge of diabetes to enable early diagnosis, proper treatment and also a better outcome of better control of the patients. Since 2016, we have screened 640,000 people that are at high risk of diabetes, 280,000 people with diabetes, but at high risk of complications. We have been contributing to the initiatives of building the diabetes management capacity and the capability, including the county hospital establishing the endocrinology department and also GP training. We are partnering with the digital health solution companies to develop digital health platform to enable patients better manage their diseases and to improve adherence as well as to achieve the desired outcome. Coming back to our core contribution of Innovative Medicines.
We at Novo Nordisk are committed to continued growth and also the quality of that growth, which is through the innovation and partnership. Currently, we have 15 products approved and launched in China. And we would like to deliver the core commitment and innovation by accelerating our innovation to the markets, which means to get the market's products to the market sooner and also to diversify our innovation, which means we are bringing the innovative medicines that are beyond diabetes. Another very important thing is that we are striving for achieving simultaneous regulatory submission. Just recently, Regine China Clinical Development has been integrated into the global clinical development program.
This strategic decision has enabled the simultaneous regulatory submission possible. Specific example is the LY287. As you have heard earlier today, that is a once weekly insulin. And the teams are working very diligently on this to strive for simultaneous regulatory submission. Slide 287 could be very well could be and the 1st Novo Nordisk innovative medicines that the Chinese patients can access to in the same time as the patients outside China.
So this is our commitment to accelerate innovation, diversify our innovation and also strive for simultaneous submission. In next couple of years, you will see the portfolio you reach in China will be more diversified and will be innovative. In summary, as you all know, the China Pharma market continues to grow, and Novo Nordisk is well positioned to capitalize that. And we have a holistic and clear strategy to drive sustainable growth, and we continue to maximize our portfolio and we in all major segments that are beyond insulin and beyond diabetes. We at Novo Nordisk would like to remain as trusted partner, continue to work with governments and professional societies, health care providers and other business partners to build an ecosystem to drive the changes that will defeat diabetes and other serious chronic diseases.
With
Thanks a lot, Christine. Thanks for the update. And now we have time for questions. I can keep an eye on who has questions, and then you're the best one to answer. So we start with Martin.
Martin Parker, Danske Bank. In the other presentations today, I think we have got a little bit more aspirations on targets and goals to reach than I think that you have something winning 60,000,000 patients. So why don't we get any kind of aspirations on your expectations for your basal share, which I think is you're investing a lot in it. You're saying you're in it to win it, I think. But does that mean you expect to be the largest in the basal insulin market within the period until 2025.
And then also going to the GLP-one, I've just been into the EMEA and Latin American presentation, they are expecting to double the GLP-one sales with the next 3 years. We don't really get any feeling of where you are in China.
Thank you for your question. And as alluded earlier, we are not giving out the guidance. Yes, and the formal guidance will be communicated in February next year and the group guidance. What I can share with you though, and we do have our goal to become the basal insulin segment leader and we have Tresiba as a great opportunity for us to achieve that. And as you said, we actually deployed a dedicated VU4, so we have a clear strategy to drive the uptake.
But at this point and because the national reimbursement drug implementation will only start next year. So and we cannot speculate how fast that uptake is. And in the GLP-one market, we are clearly the leader in GLP-one and we are expanding GLP-one segment. We do have clear plan to launch Ozempic and Rebelsus into China in the next couple of years to continue sustained leadership.
Thank
you very much. Wimal Kapolei from Bernstein. Could you talk a little bit about the competition from local companies? So when I look at the market share trends, companies like Gan and Lee are doing pretty well. They seem very credible and they have a relatively long list of pipeline both in insulin and GLP-one.
There are other companies. So how much of a threat are these companies long term?
I think if I understand you correctly, your question is about biosimilar challenges.
Biosimilars, but also am I incorrect in saying that these companies are also developing innovative products themselves? So the threat from both aspects, please?
Thank
you. Yes. Sure. So for the biosimilar products having on the market for a couple of years, including human insulin, as you mentioned, and from the local manufacturers. And currently, there are many physicians and the patients, they still prefer branded products and given the with the proven consistency and efficacy, but the biosimilars does have a place in the treatment.
Now what we can see is for the biosimilar manufacturers, expectation. But for Novo Nordisk and we are currently the leader in the market, what's important for us to continue to drive the commercial excellence and continue to accelerate our pipeline innovative pipeline launch in China so that we can stay ahead of the competition?
We have a question over here. First, please gentlemen.
Florent Cespedes from Societe My question is on Basel Insulin. Your goal is to become the leader on this segment. Could you share with us how you want to achieve this? Is it a market expansion? Or you will or do you expect to grab market shares from the actual leader on this field?
Yes. So as I shared the answer to the question earlier, similar is that now we have a chance to have broader market access, which Tresiba is listed into NIDL. So through broader access and but it does take time. So as I highlighted earlier, when the products are listed onto national reimbursement checklist, we also need to make sure the provinces implement that. And also the hospitals were listed in innovative medicines.
So it is a long process. So make sure we continue to optimize the access status that we have with Tresiba. In the meantime, we have built a dedicated fuel force we will need to make sure and actually drive the commercial excellence to drive the uptake. By the way, Tresiba is really I'm a physician by training. Tresiba is by far the greater product and for helping patients.
So it offers greater value to the patients.
I see a gentleman over there. Then we can take you again, Martin, because you had one question already.
Thank you. Erika Beigel, Brandt Jan. 4+7 does not impact your business yet since it's not impacting injectables and insulin in particular. Where do you see that kind of threat playing out in China? Is it more short term or medium term issue?
Yes. So 4+7 is a model that government wants to make sure that contains the health care costs by offering the quality products. As you said and at this point, given the nature of Pro 4+7 model, Novo Nordisk is not impacted yet because the scope of Pro Plus7 is limited to the chemical products. However, when or whether biotech products will be included in the similar model government's decision.
Marcio Parke, again. Just on two questions. On premix pricing, we know one of the beauties with the Basal segment is that it's much higher daily treatment price in China than compared to the premix segments as I understand it. And the Ryzodeg include the Tresiba component. So could you talk a little bit to the pricing of Ryzodeg versus Normex?
Now you have treated the first patient, how much did they pay? And also when it entered the national drug reimbursement list? Then the second question, just to the growth this year, because you've seen a phenomenal pickup in growth this year in your other regions in IO, it's been driven by new products. You only have Victoza. So are there any extraordinary factors which have been this growth?
Is it just improved commercial excellence? What is exactly that have been driving?
I think you have multiple questions. So let me try to answer let me try to answer 1 by 1. The first is about when the N ideal will the list resonate, right? Those not so [SPEAKER UNIDENTIFIED COMPANY REPRESENTATIVE:] And the price difference, yes. So I generally cannot comment on the price information at this point, but what I can share with you is the price is similar to the pricing other regions.
And the premix price actually is quite reasonable in China. Daily cost is quite low and the premix segment is reimbursed. So that's one, the information on price. Then the second question is about our growth year to date, whether it is internal and driving commercial excellence or external factor. I would say the talked about GLP-1s, I think you specifically mentioned that Victoza, right?
I think the external factor is that actually the medical society recognizes the GLP-one, the value of GLP-one that offers to diabetes management. As I shared earlier, actually, so the diabetes management situation in China is not an ideal. So I think slowly but surely and after Victoza has been listed into N ideal, I think through the efforts, the medical society is realizing the GLP-one value. I think that is the external factor and that helps the patients. But internally, of course, as you said, and we are driving the commercial excellence and drug market.
Yes, because it's not only Victoza, because the insulin growth has increased quite rapidly also this year. So I was also maybe speaking a little bit to that. If there's anything extraordinary there, has the market picked up because it's much higher insulin growth this year than historically?
Yes. I think as Novo Nordisk is a leader in the market, and so we are trusted partner. That the trusted relationship comes a
factor. But also that the insulin market in general has picked up. And actually, from the IQVIA data, there is a double digit growth in the insulin segment, also growing, as you saw and Christine mentioned, in total, a little bit faster than what we do, mainly because of the human insulin component where we are losing share. So in general, the market has been picked up, and the government has had a very strong focus on driving interim growth to some extent. So we have a question over here, I see.
Thank you. Jimmy from Investec. Just a quick question on GLP. You launched Victoza relatively recently, and you mentioned that Trulicity was approved in February. So I'm just wondering when Ozempic comes to the market, how are you going to manage that GLP strategy GLP-one strategy?
[SPEAKER UNIDENTIFIED COMPANY REPRESENTATIVE:] Victoza was launched in 20 11 and was listed into the National Reimbursement Drug List in 2017. And so that's the facts. Yes, Trulicity was approved in late February, yes. So and I think if I understand your question correctly is you're asking about the GLP-one competitive landscape, the dynamics. Is that right?
Yes. And also our positioning
strategy when SMPI comes on
the market. Yes. So in a nutshell, as Doug alluded earlier, the GLP-one segment in China is still quite small in its infancy and it's only in the beginning. So there is room for us to continue to actually drive the GLP-one growth and because the GLP-one product offers greater clinical benefits to the patients. For us and our strategy is to make sure continue to actually optimize our access and drive the commercial excellence to grow Victoza and in the same time and to bring accelerated development of Ozempic and Rybelsys in China.
So that is our strategy. And we do believe that and different medicines as offers different benefits to the patients and driving the market access is also very important. So we are very closely monitoring the NIDL listing situation. And our strategy is to make sure accelerate the pipeline development and also in the meantime to drive the excess. With believe that we can continue to actually sustain the leadership position in GLP-one.
Yes. So you can say there are 2 types of markets in that we are working with in when we're launching Ozempic versus Witosa. There are markets where we get reimbursement in one go, and then we go all in on Ozempic in general for all new patients so that they can get the benefits Ozempic, but not trying to switch Victoza because some patients also enjoy Victoza and the benefits that, that has. But then there are other markets where we only get gradual reimbursement, and there we take it more of a step by step approach like you've seen in the U. S.
And in China, of course, it's a little bit of a mix between the two models because we will have reimbursement on a if everything works out well, then the reimbursement will open at some point and we might get reimbursement. But there is also a potential to get reimbursement on a more sort of a local level and have also out of pocket pay. So it's a little bit of a different model. But that corresponds more to the U. S.
Model until we get the full reimbursement in that case.
Yes. Yes. And we also believe there's a big volume there and the patients' diabetes is really underdiagnosed and untreated. Yes, absolutely.
So a question over here, please.
Holger Blum, PatentEx Management. It seems that China is catching up in terms of importance for regulatory trials. Do you foresee also in the future China to emerge as a center of excellence in R and D, let's say, if regulatory restrictions might be less tight in certain areas compared to Europe?
Can I clarify your question? You mean the China as a country?
China as a country that you conduct
on that?
Yes. That's a
great question actually. China as a country, we have seen tremendous progress in the regulatory reform front. And early this year, China has formally become the ICH member and which provides the country great opportunity to actually harmonize the regulatory and the measures along with the ICH members. This provides a very good opportunity for China to lead in several fronts and it is possible. But it's yet to see because we need to observe the progress moving forward.
Yes. So at this point in time, we don't have plans like that, but we do have a research center in China that, of course, are into also new technologies and see how we can adapt those in the future. So but it's one of the research centers we have. We have, of course, also research centers in the U. S, in Oxford and then here in Denmark.
Question here?
So maybe it's a little bit too early to push, but just thinking about the potential for reimbursement of obesity medications more broadly in China, have you had any discussions, just high level discussions about how the government and regulators think about obesity as a disease and whether they would be relatively receptive when you bring a product to market?
At this point, we have not had such discussion. And but as I shared earlier, the government is aware of the risk of obesity overweight. The government actually has paid a lot of attention, including that managing weight in the Healthy China 2030 Action Plan.
Yes. I'm just looking around to see if we have one last question. Otherwise, I would say thanks a lot to you, Christine, for presenting region China. And then to the rest of you, there is now a break until 3:30, where we will meet back in this room.
Thank you.
So ladies and gentlemen, welcome. I hope you had some excellent workshops. Welcome to the final session. The best things, as we say in Denmark, always come last, and that is, of course, Emerging therapies. The things that are going to keep the company growing way beyond even the patent expiry of semaglutide in the 30s.
With me, I have our Senior Vice President and Head of Global Drug Discovery, Professor, Doctor. Marco Schindler. No, we're not in Germany, so we don't need to say it like that. I will actually introduce the topic, but it will be Marcus who entertains with most of the slides about the technologies, the have up here is really saying that R and D investments in the company to sustain leadership in diabetes, obesity delivery devices and a strong position in biopharmaceuticals will need to stay there over time. We will continue to invest.
There are areas such as the adjacent metabolic areas to diabetes and obesity, namely NASH cardiovascular disease and chronic kidney disease, where you should expect to see increased investments. And then on the platform technology side of things, it's a well known fact that Novo Nordisk well, it's a well hidden fact that Novo Nordisk has been working on stem cell therapies for 20 plus years, but Marcus will today give you somewhat more granularity on that platform for the first time ever at a Capital Markets Day. Now if we look into the investment pieces of our R and D platform or organization, you should expect to see us grow the amount of clinical assets that we have in the Phase 1 to 3 pipeline considerably in the years to come. And that will be actually even disproportionate to the amount of dollars invested in R and D because of the efficiency gains and modern technologies, digitalization and so on that are being deployed in the anti unit. That we can discuss later, but the intention is to grow sizeably the portfolio.
And the way we will more specifically do it is maybe move from having a industry leading likelihood of success per phase of development. What you have here on the right hand side is the range of industry success rates from the given phase all the way through to market. These are validated data from the Center For Medicines Research and what they show is that Novo Nordisk is actually the top company for each phase, showing that we have had lower attrition rates than the industry over the past decade or 1.5 years. What we want to signal with the blue arrows pointing downwards is that with the advent of biomarker based readouts early on in clinical development, we actually are willing to sacrifice projects, I. E, kill them early if they are not competitive and differentiated versus industry and we'd preferably do that in phases 12 rather than in phase 3, where we would hope to continue to have a 100% hit rate going forward.
That is a forward looking disclaimer statement, but that is the intention based on the things we are doing in translational science, translational medicine and so on between research and development. The last thing I will say is just to note that the way that we are driving the biological adjacencies, CBD, NASH, CKD and so on, is actually by leveraging and spearheading our way into those areas by the use of our wonderful semaglutide molecule. It gives us experience base with key opinion leaders, with investigator sites and with a better understanding of those therapeutic areas than if we had nothing to offer from the get go. So that is a bit in contrast to the old days where we ventured into immuno oncology and immunomodulation in rheumatoid diseases without truly understanding what it was all about. We believe it's different this time, but I think, Marcus, we need to talk about our core capabilities and where all of those take us.
Thank you very much, Mats, and warm welcome to our very analog version of a drone video. We'll lift you off and hopefully broaden your horizon, but most importantly, we're not losing touch with ground control. We are the leading biologics company in our space and this will remain so. And we're working very hard to keep a cutting edge science and you've heard already what we're already doing in the oral space that will continue. And I think you will see actually more exciting developments in this space coming our way.
There is, however, a world outside of biologics, right? And it is important that we can target ideally all the targets out there because our patients really do not care whether we are very good at one particular technology or another. They want to see the best medicines from us. And this is what drives us as scientists, obviously. So over the last couple of years, we've made significant investment, not only in the oral space of biologics.
And just as a very short anecdote, I've just been to Boston to some leading scientists at the WhiteHat Institute. And they said, well, thank you very much, Novo Nordisk. Now we need to rewrite our textbooks because we have written there that oral biologics cannot be applied orally. We have changed it. And I just think if we explore this further and anticipate what is hopefully just around the corner, I think we've come a long way.
We're investing heavily in stem cells, and you might have heard about a new organizational construct, transformational research units, units with a high level of autonomy that act, behave and drive science like a biotech, but they are very much integrated within Novo Nordisk. But we're seeing actually really, really good successes both on the science, on the partnering, but also the culture that is actually created in those units. And that gives us a lot of confidence that even in a company that has a lot of tradition, there's a lot of emphasis here on new ways of working and cutting edge science. You might have seen some news that we have invested very recently with Daesund. I come into this into the oligonucleotide space, a space that is not so far from our home.
We're making first steps into call it gene therapy or gene editing, right, And a space that is really sort of cutting edge right now and the collaboration with Bluebird Bio is the first for us, but I can promise you not going to be the last. And we also do not stop to say, well, if there is a target that is uniquely suited for a small molecule, we find the right partner. We're working with Evotec here usually to actually execute on this target. That doesn't mean we build all of those capability organically, quite the opposite. And I think maybe this is one of the biggest transformations we have seen over the last couple of years is that our way of working will be one where we are very knowledgeable about our core capabilities and what we're really good at, what we supplement and build together with key strategic partnerships.
And the slides or the partnerships that we're detailing here are basically a snapshot of what we have done over the last 18 months or so. The interesting thing here is it is about platforms. It's about single assets in particular diseases, sometimes in disease areas where we're not so knowledgeable in at the start. It's about target identification, but they're all unified by being cutting edge and differentiated. I want to call out a few in particular.
Dicerna, I will detail in a minute. Gilead, a way to actually explore a new disease area, in this case, NASH, where I would say across the industry, we don't have all the data yet, but it's absolutely a disease area we would really like to explore, and we can see a significant opportunity, a large unmet medical need and thus also a potential market. A single asset company, Staten Biotechnology, with an asset to in dyslipidemia, and we'll come back to that in a minute. And then a key enabling universities. And I think see universities.
And I think that is the way of the world that we'll find the best partner that is suited for the task and not one size fits all. So we've just announced a significant platform deal with Dicerna, a Boston based biotechnology company listed on NASDAQ. And broad expertise in the siRNA space. Why are we interested in this space? Because our targets currently or our modalities currently do not enter the cells.
So we wanted to see how we can target intracellular targets. By the best of our analysis, this is actually the majority of targets that we need to find and to be able to deal with. And rather than blocking proteins or mimicking proteins, what if we actually stop them from being produced? And this is what siRNA is all about with a really high fidelity. And we also see increasing confidence in the technology as such because we've seen now Phase III data and even some marketed products.
Having said that, those marketed products right now are in a small, usually rarer disease space. We feel we are the best possible partner for a company like Dessona to take this technology to a very broad cardiometabolic space. And this is why they were also really keen to engage with us on a broad platform collaboration that covers more than 30 targets over the next 3 to 5 years. It's a space, as I mentioned, where the chemistry, nucleotide chemistry is actually not so different to our peptide chemistry. We're also talking about injectables.
It's also a space we know 1 or 2 things about. So we're also seeing here synergies being built up in the areas that we're already comfortable with. So we're really looking forward to this collaboration, which is kick starting very soon, and we have a very high And that, of course, is a beautiful segue And that, of course, is a beautiful segue into one of the key interesting novel disease all estimates, right? Because one of the key elements that is still missing for this field is a simple diagnostic There's a high degree of comorbidity with people living There's a high degree of comorbidity with people living with obesity, right? So weight loss and metabolic parameters and the improvement thereof, I think, are important for the treatment of NASH.
We expect the number to increase that are being diagnosed significantly over the years, but I would lie if I say I'm happy with 1,700,000. I mean, I think there are many more 1,000,000 people who deserve being diagnosed and ultimately that deserve to be treated with the right medicines. So NASH is a progressive disease, right, as nearly all the diseases we're dealing with. If you leave them untreated, it will get worse in most cases, and it will lead to a fatal outcome, liver cirrhosis and death. The good news is there might also be arrows pointing the other way.
So we know the biology might have a level of dynamic that the body actually can respond to some of those damages. What we obviously want to achieve is that the arrow backwards becomes much, much bigger through therapeutic intervention, right? And this is what we're working on. A key element here, and Mats already mentioned the buzzword of translational science. And I think we will see this much, much broader, not just in NASH, but in NASH, it's particularly important to, A, understand really your patient population, in which stage of disease are those patients?
Do we have the right biomarkers that we can measure to understand where those patients are? Do we understand fast progressive people who are particularly prone to progress fast to the next stage of disease? And do we understand biomarkers that are specific for our targets so we can actually predict whether targets are going to work or novel medicines are going to work or not. So rather than having a sort of homogeneous soup of a patient population, all comer population, we will see much more of a fine tuning. And I do usually take some inspiration from our colleagues in oncology who've obviously taken this to perfection with the benefit that you can get biopsies obviously from tumors which we're not able to do.
But we're working very hard on that. We're actually, by the way, also engaged with a number of across industry efforts to find those novel biomarkers, noninvasive methods of diagnosis, which are no longer requiring biopsy and so forth. So we're really firing on all cylinders to explore this particular space. But how do you do this if you've never worked in hepatology and if you really don't have the network of key opinion leaders, if there's no deep signs on, in particular, liver signs, right? On the other hand, obviously, we have a pretty good understanding of obesity, diabetes and similar diseases and a number of tools.
So our answer was to find a partner that actually suits us and we hopefully also suiting the partner. And we chose Gilead and Gilead chose us. So it was a mutual process, a leader in hepatology and in combination therapies, real deep understanding of liver diseases, not only in NASH, also in the viral space and really a very well established network with key opinion leaders. And I would extend that also to having a real good network and dialogue with regulators because that is a difficult space here. We don't really know where the end points will move eventually once we talk about a non biopsy based diagnostic here.
Simaglutide is currently being evaluated in clinical trials in NASH, 3 trials in particular, one which is largely imaging based and we will see whether semaglutide's many effects, and I think Mats highlighted that, will actually have a fundamental effect on NASH progression or worsening of NASH. There is a biopsy driven trial and one trial in particular in a very late stage population of NASH, which will be very interesting because that is actually a space where people suffer the most and they are nearest to liver cirrhosis, right? But it's also probably biologically one of the most difficult spaces because the liver is already severely damaged and can we rescue functionality and get those patients basically back on track. So that will be super exciting in its own right. But here comes a new thing where actually Gilead and we partnered in a combination trial, which I think is a really nice design.
We use 2 of their clinical molecules, an ACC inhibitor, it's an ACC12 inhibitor to be precise, and their version of an FXR agonist, which we believe actually has had a nice differentiation angle to anything else that is out there. And we're combining those two molecules together with Sema. We're combining the molecules individually with Sema. And then we compare and contrast what works most. We don't know what the outcome is, but fundamentally, in the field, we believe that most likely, combination treatments will be important.
They might be combinations at any given point in time. It might be combinations over time, right, because the biology actually of those patients might change. So watch this space. Next year, we'll know more about those really, really exciting data. I don't want to dwell on this too much because both, I think, Camilla and Mats have already spoken to cardiovascular disease and how close this is to both our current patient population, right, but also on sort of the neighboring patient populations.
And just to remind ourselves, with our leading drugs, we show cardiovascular benefit, significant cardiovascular benefit, full stop. So we're already in this space, right? The question is what else do we want to do and how hard will we push this space? Is there an area where our signs and our projects can make a particularly good impact above and beyond semaglutide or Ozempic rebalysis. 2 areas we're particularly interested in, atherosclerosis, largely different from dyslipidemia and heart failure.
We'll get to that in the beginning in the end, sorry. Just to remind you again, you have seen the data, SUSTAIN, PIONEER, SOUL was detailed. IIT is a space where we collect an enormous number and I would say probably one of the world's leading databases of cardiovascular effects of our drug. You've probably heard previously that we have our own version of a PCSK9 inhibitor. I'm sure many of you are familiar with the concept, PCSK9 being the one protein that ultimately binds to the LDL receptor, prevents recycling of the LDL receptor to the surface and by doing so, prevents really a significant uptake of LDL from the circulation.
By blocking PCSK9, we enable the LDL receptor to do its function and consequently LDL levels fall. And that has been shown many times as genetic evidence there are antibodies out there. We have a peptide version of a PCSK9 inhibitor. And the cool thing is this really falls into our technology sweet spot. So we know exactly what we're doing here.
We know exactly how to manufacture this moiety. And rather than to think about this as now and I can see you, God, what are they doing with PCSK9 inhibitor, see it as part of a portfolio build, how we will enter the cardiovascular space, right? That could be the project on its own in various shapes and forms. It could be the backbone of combination therapy. And I think we want to give ourselves optionality in this space where it matters most.
And I already spoke to the stat molecule within which is a sweeping antibody concept for triglyceride particles. So the other sort of bad part of the blood lipids or the remnant cholesterol, which maybe hasn't quite yet gained the traction as LDL, but gains really, really more importance as we speak. And the triglycerides, I think, will be very much in focus of the years to come. So we're very, very happy with those. The stem cell platform, to get to my last two slides here, is obviously 1, and Mats has alluded to that we've worked on the basic science for 2 decades, right?
But a few years ago, we realized this platform is now ready for primetime, so invest heavily in this. And I just want to detail a few disease areas where we started to work on. But it doesn't stop here, right? It's a platform that is versatile, it's scalable, and it actually lends itself to a large variety of diseases, cutting across all our traditional core disease areas, biopharm and actually disease areas we don't even know yet. But we know the technology space.
But more importantly, I would say, and that's coming from an early scientist is many people can make stem cells and make them produce particular hormones or to get a particular phenotype. I think our particular value proposition here is the quality and the reproducibility of making those stem cells, controlling the protocols, getting a GMP manufacturing right. And in a baby version of what Henrik has shown you, we have opened up a small manufacturing site on the U. S. West Coast, which really shows our commitment.
We think this game, this is a competitive game and others are really out there. This is not going to be 1 in the lab or in Phase 1. This is going to be 1 on the market space with the right product, right, with the right quality, the right distribution system and by the way, also the right partner. And I want to end here and hand over to Mats for
the home run. Thank you, Markus. And you can stay up here because there will be time for a couple of questions in just a couple of minutes. What I will actually end up doing is really tell you a story about the news flow that is happening over the next couple of years. It's quite sizable.
If we start out with the other serious chronic diseases, the most important thing to have a good eye for next year is the NASH studies that report in the Q2 on semaglutide and sema plus the loose compost from the Gilead thing collaboration. If we look into biopharm, there's a lot of excitement surrounding getting somapacitan approved in some of the major markets, having Esproduct submitted in China and also, of course, getting into the clinic with new products such as MiMate and getting out of the clinic with a mature Phase 3 projects such as concizumab. As we move then into the space of obesity, we have also here next year in Q2, a clear infection point in that not only does step 1, 2, 3 and 4 readout, I. E, the pivotal semaglutide obesity program, but also the Amlan 833 monotherapy and even in combination with semaglutide, we will have all of those data to form the basis for submission, hopefully, of the NDA for semi obesity and Phase 3 progression for Amylin and its combination partner semaglutide. There's also a lot of earlier research reading out at that point in time.
And because of the crowdedness of this slide, I even had to remove the title up at the top to get space for diabetes. And in diabetes, of course, we cannot shy away from the notion that the cardiovascular indication for Ozempic and Rybelsus are up for decision on January 20 next year, which is truly exciting. As exciting as the LAI287 readout, the Phase II readout in the early parts of next year, that together with the have a number of earlier stage Phase I activities and not to forget the high dose sema, the sema forward that will complete second half of next year. So actually, I think I'll wrap up by saying that, first of all, you've heard us today, now we're wrapping up on the entirety of R and D, that we are, as a company, truly raising the bar further within diabetes R and D and Innovation. We have heard that we are developing a broad, wide, deep and exciting portfolio of anti obesity medications that we will be discussing much with you in the future.
You've also heard from Ludwig that we are strengthening and progressing the biopharm pipeline, giving maybe more hope and expectations for the future than we thought just a year or so ago. And finally, you have just heard that we are establishing a presence initially in the pipeline within other serious chronic diseases such as NASH and chronic kidney disease and already establishing ourselves with the first couple of products, namely Ozempic and Victoza and hopefully even REVELSIS in the field of cardiovascular medicine. So in fact, we have a few minutes to take a couple of questions and for once I will facilitate the discussion. So if the colleagues with the microphones are standing ready, we can only allow one question per person and we'll do it very fast so that we can yes, there's one right there.
Peter from Panzbanken. In terms of establishing a presence in the disease, clearly, right now, it's just a pipeline, as you say. But one of the key secrets or one of the secrets to your high margins is your therapeutic focus. So establishing disease, does that also mean, let's say, more heavier infrastructure going forward, let's say, in 5 to 6 years or whenever that may be relevant? And I hear, of course, think about commercial at Telstra.
Well, really, that's, of course, a question to Camilla and her team. But if you look into the cardiovascular space, as a company, with the advent of the cardiovascular label claims for GLP-one based products, we are already establishing a presence and strong connections with the cardiology community. Of course, there's a difference between going all in with the dyslipidemia drug and being present within the, you can say, the zones around diabetes and cardiovascular medicine, but that is something that will build over time. But I have to say already at this point, we have a sizable network in the field. So it's not an overnight thing.
It's a thing that we'll build over time. The other areas such as NASH, etcetera, are quite often handled either by the endocrinologists that we see and talk to or of course by hepatology specialist centers and there right now of course we're relying on discussing and partnering with Gilead and they are quite a few before we are in the market space. But we can discuss that as the pipeline matures and as we get closer. Disease for disease, it depends on what stage of the disease. If it's kidney disease early on, it's quite often the general practitioner that sees a EGFR that is reduced and refers the patient and that we can handle, of course, their nephrology centers that we do not have access to at this point.
So it will be a multifaceted answer that Camilla can go into great detail with at a later point. Yes, we'll take one over here. Richard?
Hi, thanks. Richard Vosser, JPMorgan. Just thinking about the LAI287 and future development, what sort of program could we envisage for Phase III sort of size, scope, CV trials? Yes.
So generally, I think I'll take that one because it's on the late side. LAI287 is an insulin. And typically, insulin, unless there are signals of danger out there, do not demand cardiovascular outcomes. So the developed kind of thing that we saw in the case of DEGRIDIC should not prevail for bringing patients to target, also in terms of hypoglycemia safety, then that will define the target product profile rather than doing humongous trials of 8,000, 10000 patients as we did in the beginning and boost and sustained programs. This will be a more limited scale, but where we are considering to deploy modern digitalization, dosing algorithms, devices and connectivity in a way that you've never seen before.
So it will be a smaller scale trial program, 3000 to 4000 patients. It will allow inclusion of the Lycema, so that we can piggyback on the factorial benefits of doing drug A and B and A plus B even in the same trials. And then we will seek to get a degree of glucose control that is unprecedented for an insulin driven by some of the technologies that enable us to do so a year or so from now when we start the Phase III program.
Peter?
Peter at All City. Mads and Marcus, lots going on with the pipeline, lots of excitement. I know you're not going to talk numbers, but when you budget and when you do your R and D budget, should we be thinking conceptually that that's going to outpace top line growth or be in line with top line growth? Just I know you're not going to give numbers, but I want to understand make sure I understand conceptually how we should be thinking about what it's going to cost to fund all these programs?
So in reality, Carsten will address that in the next section, talking about the gradual over time increase in R and D to sales ratio, which comes on top of a increasing top line, we have to remind ourselves. What you will see, Peter, is that as some of these major outcome trials come to an end, Select, Soul, Flow, what have you, then you will see a relative redirection, at least temporarily, of late stage outcome trial money into earlier stage, more science like money. So it's also of where do we deploy the resources. And one last question from the same table, and that will be the last of the session.
Emmanuel Papadakis from Barclays. Just a quick one on the stem cell program. What needs to happen between now and the second half of 2021 to get that ready to go in demand? And then how quick could that clinical development program ultimately be?
Yes. So I think the key element here is for the Type 1 program, the device, right, because obviously cells need to be protected in this particular space. So we're very hard on that. That will be through a key partnership, which obviously we haven't detailed and announced yet. So that for us is actually also one of the key elements is apart from the cell production and reliability of our cell lines and the protocols, it's the device for the type 1 program that needs to be accelerated.
And then a number of quality tests, obviously, in preclinical tests. So I mean, the one thing I can assure you that the team in the stem cell unit actually is working at full speed on, in particular, 3 key programs. One is the Parkinson's program, one is the Type 1 program. And we're also creating sort of a master cell bank to be fit for the future. I think that for us is sort of the key elements.
Early on research, we do have an interest in trying to stealth ourselves. So in the future with other diseases, we can get around needing a device. So I think that will be really a huge sort of key enabler for us. And hopefully, next time we meet, I can share more on that with you.
So with that, thank you, Markus. I think, Carsten, are you no, sorry, Henrik, my dear product supply colleague, Henrik, will now host the final session. Thank you very much, Smesh. So
you can interrupt me, Carsten, if I move over my part of the time, but I guess we have a shared session here. But I can start out because we share this kind of introduction to what we're going to talk to you about now. Basically, just building on what we talked about this morning, I just want to spread a bit out the explanation of how we built the supply chain in Novo Nordisk, not only on Reberso's, but actually on our full portfolio. And what you see behind me is actually that we have spent the last years of actually changing product supply from a little squeezed manufacturing unit with a lot of really high utilization level, actually to become a strategic partner, both to R and D but also to our commercial units. And if I just should pick one example that you just saw, then the full pipeline that Mads just showed you.
Basically, in the old days, we only were concentrated on the Phase III programs, and we didn't use any time of looking into Phase I and II. Nowadays, R and D people and product supply people are watching the whole pipeline. Of course, we are not using a ton of amount of Phase 1 in product supply, but we understand what they are doing, and we are preparing the full manufacturing supply chain and try to think in if we are able to actually help very early in the phases. And we are just talking about the long acting insulin 287. And actually, I have already a facility ready for that right now because we have seen it coming so that we can actually one of our existing facilities, we can utilize that for that one.
So it's just that one example. Then you can say, okay, well, yes, but that you have talked about for many years within API that you can do this. But it actually also goes within our aseptic area, our filling area, the tableting and then you can continue like that. Assembly is also a good example where we work together with device R and D actually to develop next generation devices. So we have broadened our perspectives and working much more together with R and D.
And in the commercial side, we have also actually become much stronger in protecting our mature product in the pipeline that we are utilizing a lot, especially in IO to open up new markets where we actually are maintaining one of some of our mature products and the facility behind them keep them in really good cGMP control. And then you can say, okay, well, that's just maintenance. Well, we are using exactly the same efforts in those facilities basically to bring down unit cost even further on the mature products as we do on the newer products, which again open up more markets, especially in EMEA and place in regions like that, so that we can basically develop the markets there. So all in all, I think it's fair to say that nowadays, product supply is delivering increased agility, but actually also expanding the possibilities that we have within Novo Nordisk. And we also find it really exciting to talk about even though we are early Phase 1, we actually also find it really interesting to discuss cGMP levels of stem cell production in California with you even though that you own the phase of the program still?
If I should bring a little bit the footprint into the discussion then, then you can say that it's a well known picture for many of you. We have all the competencies and all the capabilities placed in Denmark close to R and D and close to development, and we keep on maintaining that. But there is some movements on this slide. And actually, now we are producing biopharm API in U. S.
That's the first API ever we have done outside Denmark. Now you saw the drone video earlier today. That means that our North Carolina side can now do not only all semaglutide, the rebelsus, but actually also if we want to do it, it can also do the injectables. So we have built a second platform of API production. And I'll come back to what we're also able to do.
Then we have 3 really high efficient sites. They are similar in size and what they can do. It's in Brazil, it's in France and it's in China. They are running with a really high efficiency and keep on optimizing their outputs, really well functioning sites. And then we added actually a little sister to that in Russia the last couple of years.
That is also a really nice facility. And then we have local manufacturing in Algeria and local manufacturing in Japan. This is, when I see it, a really, really strong manufacturing setup, and we can scale it in many ways. We have a lot of flexibility of So we feel that we have a really solid base for further growth and for further utilization of this network, basically both towards R and D, but certainly also towards all the dynamics within commercials that we see. So we feel, to be honest, really self confidence that we can follow the speed in sort of both ends of the value chain when you speak to that.
Then if you just go a little more into details of the Reberso setup, actually, we put this on paper 5 years ago. And I'm happy to say today that it actually looks better than we thought. Now right now, today, already, Denmark is producing API, And we are really busy 10 kilometers away from here producing tablets and packed the tablets for the U. S. Launch in volume.
And then you saw the Clayton slide. And then we actually here in August, we were really lucky to buy a facility close to our Clayton facility in North Carolina. And the beauty of buying almost a new facility from another partner is actually that we can speed up the implementation of further volumes within all Zimmer and Rebersos. So that we are going to do. And we have just bought it, so it's a little difficult to say when it's up running precisely.
But we have a saying going that we think that they can catch up with the API side. So they will speed up. And then hopefully, they will be ready at the same time as the Clayton facility. And that would be half price of what we paid for the motor side. It will be double the speed and maybe double the capacity.
So that's a good deal. So we'll work with that. Then if we take it from another angle, then we take all our brands and actually also all what we have in the Phase III clinical trials, then you can see that we have you can you can basically claim that we can follow the full pace of all the products. And when we both talk next generation obesity medication, we talk our biopharm our new biopharm products. We know exactly how to do those, and we are working together with R and D on those to develop them into operations.
Then you can also say on the right hand side that we have had a local sort of peak upwards on our CapEx. I think it has been really intelligent investments in this. Actually, the reason why Carsten and I, we are on a stage together is that none of us likes to build facility. We like to optimize. So both of us, we are actually happy that we are now in 'nineteen and we look into 'twenty and the future because it we are coming back to a more what we call normal level of investments in Novo Nordisk.
But that also means when we had a couple of years where we have invested a little bit more, where the majority of this is actually Rebusus, it also means that we hold a lot of potentials for optimizations and that we like. If we should talk a little bit about that, then I'll try to not to reveal what we think about Rebecis over time. Then at least what I can do is that I can show what we have done with the products that we have already produced. And this is the development that we normally see of the APIs that we are producing. And we do not shy away from actually trying to do exactly the same on Rebelsus.
We have initiatives across the value chain, across the supply chain, targeting the different cost structures that we have on that. And as I alluded to this morning is that we have actually after the PIONEER trials, we have increased our expectations to what we are able to do with ReBelarus, which means that the demand on us in product supply has increased beyond the design capacity what we thought we were building. And we have so far followed those forecasts. And that, of course, means that our ambitions of lowering the FMCs will also follow. And that is going to be a really exciting journey in the next couple of years.
So in conclusion and over to Carsten, we think we are well positioned both today and actually also in the future. We have a high manufacturing capacity across the products. We have agile manufacturing setup in a more complex environment. We have reduced manufacturing risk by actually having API on more in more footprints. Some of the initiatives that we have taken within CGMP and actually auto technology has actually removed man away from the lines, which is also a higher safety level.
And then finally, we will never stop driving efficiency and chase lower unit cost. So do you like that, Carsten?
I like that a lot. That's music to my ears and I that's a really good segue to from manufacturing to financials. So think about this, lowering CapEx, no major new CapEx projects in the foreseeable future. And a bullish Head of Manufacturing driving down unit cost, what's not to like? So now you've heard from my colleagues across the value chain about our plans and aspirations for the medium term.
So now it's up to me to kind of pull it together in terms of financial consequences and how we see the financial medium term outlook. I think when what you've heard from my commercial colleagues has proven that we are intensely focused on driving top line, whether it's in international operations or it's GRP-one growth or it's obesity, how big we can make it, Rybals' top line focus, top line obsession, as Mike would talk to, is something that we're really focused on driving each and every day. We just covered manufacturing, driving down unit costs. That's the name of the game. That's what we discuss each and every day.
In R and D, you heard from Mads, Marcus, Martin, we have the pipeline, we have the innovation, we have the investment opportunities for long term growth of the company, future value generating assets in our pipeline. And then from our commercial colleagues, you heard that to drive the top line growth, then of course, we are going to invest in our growth opportunities, whether it's launches, whether it's growth markets, whether So we will actively be investing in driving our top line outlook. So let me take it through each of these elements in a little bit more detail. So pretty much one financial line by time. So first of all, gross margin sorry, I'm moving too fast here.
So first of all, gross margin, So just to take the starting point on gross margin, then we have a gross margin above 80%. When you compare that to most other companies in the industry, this is a very competitive gross margin. That's a function of what Mass presented with a highly successful low attrition internal organic innovation approach. So that's our starting point. What we're looking at for the medium term is a broadly stable gross margin, but there are some different factors impacting the gross margin.
You heard Doug Langer talk to the pressure on insulin pricing in the U. S. On top of that, there will be an impact from affordability programs also and that is a conscious choice that Doug also covered before. So that will have a negative impact on our gross margin. Here I talk to Rebulsus and the unit cost for Rebulsus and the optimization opportunities we have there.
Initially, when we are launching Rebulsus into next year and in the short term, there will be a negative impact on our gross margin, simply due to higher Reberos unit cost initially. The growth profile of the company you heard about with international operations growing faster than North America. So there will be some negative impact on our gross margin. I'll come back to the regional profitability in a later slide. However, offsetting these three factors is, first of all, productivity.
I don't think I have to compare back to that and I covered that very nicely. Given the fact that we have the production network, so we don't have to fool around with investment projects or anything like that, then we can simply just focus on driving productivity and lower unit cost. You heard about our growth opportunities. A very big part of our growth in the medium term will be driven by GLP-one with an above average gross margin. Hence, we will have a positive product mix elements in the medium term.
And then just one final comment for the short term vis a vis the Rybalsis impact. Do note that in 'nineteen, which is the base year of this, we do have a one off related to the asset impairments we reported in Q3 related to the intangible assets. So we do have a kind of a negative impact in our base that we will not have going into 2020. So how are we then going to allocate our gross profits between shareholders and investments in the company? Maersk basically stole the party line just before.
So given the opportunities we have in R and D and our pipeline and given the fact that we are pursuing an innovation based strategy. So, we are an innovation based business, so we will be investing more in R and D in the years to come. Part of that, of course, we get the benefit of a growing top line, so even at a stable R and D ratio, we would be able to spend more in R and D on that in isolation. But beyond that, we are looking at over time gradually increasing our R and D ratio. Markus very nicely covered that, our opportunities in building the pipeline, the increasing number of assets you see on the slide and margin covered the significant increase in patient years in the coming years.
And just to caution, because when you try to translate a tripling in patient years into financials, then the math is not that simple, rather on the contrary, because the tripling in patient years, there's a big element being trial mix. So the cost per patient in many of these outcome trials is significantly lower than some of our earlier trials. And then furthermore, the efficiency drive we have both through digital and basically general process optimizations in Global Development enables us to offset a huge part of the volume increase by productivity and mix gains in R and D. And then one final note, of course, we have a very solid balance sheet. So you heard Ludwig talking about opportunities in broadening our pipeline in biopharma as an example and you heard Marcus talk about in licensing opportunities and partnering opportunities in the more early stages.
So, we have the balance sheet also to accommodate that should the right opportunities arise. Offsetting the gradual increase in the R and D ratio, then what you should expect over time is an S and D ratio that will gradually decline. What we are doing in our commercial investments is and just hearing the buzz in a number of the sessions, resource allocation is really the name of the game these days. So in simple terms, what we're doing is that we are reducing investments in low growth products, low growth geographies and allocating those resources against launch products, growth products, growth geographies. So that's kind of the simple storyline to it.
To give you a couple of examples, then in Japan, we have reduced our promotional efforts and then we've been able to take these resources. And as you've heard recently, then we hired 400 reps in China related to Tresiba national reimbursements. So that's an example where we basically go across geographies, take down one place and increase another place. You saw Doctor. Langer's U.
S. Strategy. So we are defending on our insulins and defending also means that we're optimizing our promotional resources against those products and then we take those resources and deploy against our growth opportunities in GLP-one and obesity. That said, in the short term, when you look at our pipeline and our product portfolio and our approvals, then we're at a very, very special point in time between Ozempic rollouts, we are only in 20 some countries currently and Rebelsus, where we are only launched hardly launched in one country, then the opportunity we have between those products is extraordinarily big. And that opportunity is not something where we say we optimize that for the next year or the next 2 years.
You all know the duration and the lifetime of assets like that. We're talking 10, 15 plus years. So for that reason, it's extremely important for us really to fuel the takeoff of these products and continue to fuel it in the short term. And what that means is that while we are rolling out Ozempic on a global scale, we keep pressure on Ozempic in the U. S.
Marketplace. You see the truly phenomenal market share data and the blockbuster performance in the U. S. So we keep pushing Ozempic once weekly GH1. And then at the same time, of course, we need to roll in Rybelsus.
So without taking our foot off the speeder, then we roll on REBELSES. That means that we have to be really tough on our resource allocation in order to free up resources to invest in Rebelsus, but we also do need to have incremental resources on top of that. So in 2020, you should expect us to invest additional incremental resources against
product.
And then as the other functional areas, then efficiency is also in fashion in commercial. Those of you attending the European session heard Matt Riegen talk about driving efficiency in a European setting. So efficiency, whether it's manufacturing or R and D or commercial, that is part of freeing up resources, so we can invest in our future growth products and platforms. So concluding sorry, and then I promised to bring you kind of our regional profitability, because being a global organization and marketing products in almost 200 countries and having a footprint in almost 100 countries, then there will be profitability differences between each of these countries. That is driven by pricing, product mix, cost of operations, economies of scale and of course the growth potential how hard we're investing ahead of the curve.
However, when I roll all this up on a global level, then actually the differences ends up being moderate. And you see that, for instance, just in our financials for this year, then in the 1st 9 months, where we have all our growth from IO in terms of absolute growth contribution, all growth from IO and no absolute growth contribution from North America, we still have a pre R and D operating profits that's stable compared to last year. So that can only be possible if the regional variances are moderate. Then concluding on it's just a slow shifter, I'll try again. Concluding on our margins and our ratios, we have a fantastic opportunity to drive safe growth.
I think few people disagree on that one. Through productivity gains, we are aiming at maintaining a broadly stable operating gross margin. Over time, we will be increasing our investments in R and D and gradually increase our R and D to sales ratio, whilst at the same time also over time gradually increase our sales and distribution cost ratio decrease our sales and distribution cost ratio. I saw some smiles. And then finally, our administrative cost ratio, we have a long history of reducing our administrative cost ratio and we'll continue to do so through optimization, offshoring, automation, etcetera.
Then of course, the question is, these results, how is that then being kind of allocated in terms of real cash and allocation to shareholders? And what you've seen, historically, we have been converting more than 90% of our net profits to free cash flow and these are reported net profits. So this is not adjusted or business net profits or whatever it's called. These are our reported net profits more than 9% converted to free cash flow. And then from free cash flow to cash return to shareholders, then for the last 3 years as an anecdote, we have returned more than DKK100 1,000,000,000 to shareholders between dividends and share buybacks.
So, we have basically over the past 3 years also been returning more than 100% of our free cash flow, 23 years of increasing dividends per share and a solid balance sheet that can cover any M and A activities and we've been guiding up to $5,000,000,000 as a threshold for what we're looking at for M and A activities. So we can do that without impairing our abilities to have an attractive capital return to shareholders. I'd like to keep score. This is a scorecard for our current set of long term financial targets. This is based on our Q3 numbers.
So of course, we need to totally close it out by full year, but based on our Q3 numbers, more than 9% cash conversion as a 3 year average and operating profit after tax to net operating assets in excess of 100% and average operating profit growth based on our full year outlook for this year of 4.7% compared to a target of 5%. So this is just to confirm, we are on track to deliver on our current set of long term financial targets. So in conclusions, medium term outlook is deliver solid sales and operating profit growth. You heard Mike talk to the 6% to 10% growth in IO. You heard Doug talk to the 70% conversion of our book of business in the U.
S. You heard me and my colleagues talk to driving operational efficiencies in order to invest in growth assets. And finally, you just heard me talk to that we will continue to focus on delivering free cash flow and an attractive capital allocation to shareholders. So with that, I'll hand over to our CEO, Lars Rogel Jurgensen. Thank you, Carsten.
So this is the last presentation today. And I feel the energy is getting a bit low in the room. So I'll try to keep it up, and then we'll wrap up with the final Q and A session. I hope you throughout the day have sensed our optimism, our confidence in the future. We are addressing large markets.
We have the strongest ever portfolio to do that. We have strengthened our execution. I think we are on a very good track, and we can document that in the sales development we have demonstrated. We have lifted performance level in IO. We have launched the best launch ever in the U.
S. And actually, if you look at the additional markets where we launched Ozempic, stellar performance. So we feel really good about where we are as a company. We started the day by introducing the framework for the strategic aspirations. And throughout the day, we have actually given you what those aspirations are.
But let me just summarize them for you 1 by 1. So if you start with the purpose and sustainability quadrant. We believe in the importance of being a purpose led company, a company that adds value to society, a company that's based on a set of core capabilities where we can be among the best performers in the industries we operate in. It's about being a sustainable company from a financial point of view, but it's also about being a sustainable company from a social point of view and to conduct our business with an eye for our environmental footprint. So the specific targets we have defined based on this is that we want to be respected for adding value to society.
There are specific surveys and metrics behind that, so that we can demonstrate tangible evidence on how we track that. Equally important, we want to progress towards having a zero environmental impact. Remind you that already next year, all products from Novo Nordisk will be manufactured based on CO2 neutral power. There are few companies in the world who can actually make that claim. And then we've talked about capabilities a number of times.
So it's important to keep investing in your existing capabilities, but also gradually expand your capability platform and evolve a culture to support doing that. So we have good plans for how to do that across this first quadrant. Moving to the 2nd quadrant, which is about innovation. I hope you also agree with me that we have seen tangible evidence of how we are lifting the innovation bar in Novo Nordisk. Maersk spoke about the ambition to move insulin treatment to be based on glucose sensitive insulins.
That would be a major disruption. It would redefine insulin as product out claim. We also heard about the ambition of simply moving the GLP-one market to all markets, a significant opportunity for patients and for a company like ours in driving differentiation. We had very bold ambitions in actually trying to make procedures into actually a medicine based approach. So, biiatric surgery in an injection.
We heard about that in biopharm, we are having now late stage assets, Phase III assets. And we also have an approach to potentially make the best hemophilia product better than the product that's taking share today. And then we just heard that we have an ambition to move into adjacent areas and also build what I believe is a very interesting stem cell based platform, which is completely different business model than the business model we use today. It's not about deploying reps on the ground, negotiating contracts. It's about curing a number of diseases.
I believe that's a very attractive outlook. And we have defined, as you just saw, a set of also tangible aspirations for 2025 here. So first one is to raise the innovation bar in diabetes treatment. The second one is to develop a leading and superior treatment portfolio for treating obesity. And then we want to strengthen and progress our biopharm pipeline and want to establish presence in all serious chronic diseases.
And for all of these, we also have specific targets that we will be tracking and reporting progress on to all of you. Moving to the 3rd quadrant, the commercial execution and starting with diabetes. We are very proud about the step change we have made in commercial execution. We have gone from losing market share to winning market share. And that's within influence and it's within GLP-1s.
And it's just it's not in one market, it's across our markets. So we are getting more value out of our leading portfolio than we have ever been able to do. Mike spoke to the ambition of tripling our next generation insulin business. We heard about how we believe we can continuously grow both the GLP-one market and our share of that. Last time we had the Capital Markets Day, we were excited about the opportunity with Ozempic.
Now we're equally excited about the opportunity with Welters. It's early days, early sickness are good, but yet we have to land the contracts. But my big nose, my big ears tell my stomach that, that's something we can handle. And the good news is that already over the coming few quarters, we will have tangible evidence of that happening. So next time we communicate to you at the full year, we hope that we can give the first signs of not only scripts in the market based on us supporting patients, affording them, but actually based on contracts.
So we are very excited and actually also very confident on our ability to do that. Turning to obesity and biopharm. Obesity is a huge opportunity for Novo Nordisk. It's an opportunity where we need to develop the market. It's an opportunity where we need to develop more efficacious products.
But you heard that we're doing that. We are opening that market and we are developing those products. In biopharm, we are actually having a broader portfolio also than ever. We are launching more products than ever. And we can see that we can complement the decline we see in OVA 7 based on that.
So that's also there a sustainable growth opportunity. So wrapping up, we have communicated that we want to drive our market share in diabetes to a third. This is more than a third. So more than has kind of sneaked in also here. We talked about the obesity opportunity that we want to more than double sales in obesity.
And with what we have going in biopharm, we want to create a sustainable growth outlook also for our biopharm business. Then to the 4th quadrant, the finance quadrant that we just heard from Carsten. I'd just like to once again remind you about the massive efforts that's going into converting our U. S. Business.
So if you think about converting half of Novo Nordisk business, 70% of half of NorNoise business in a matter of a few years, that's a very, very strong commercial execution. And we are reducing our dependence on insulin in the U. S. Still, we'll be treating millions of patients with insulin in the U. S.
Insulin will not go away, but prices are coming down. But we have a fantastic opportunity in our GLP-one business. And it's growing, I would almost say like there's no tomorrow in the U. S. And we're now finally coming back and taking share.
So that's a huge commercial opportunity. So we need to get out of this medium term turnaround of the book of business to get to growth again. Our colleagues in International Operations, you heard the great commercial colleagues here, talk to their business and how we're getting more out of our portfolio, how we have changed the mindset, how we are moving resources to the growth areas and how we are basically rewarding ourselves more now on driving growth, beating competition than meeting internal profit targets. It doesn't mean that profit doesn't matter. But if you're losing market shares, no, you should not be a hero just because you We are in the business of gaining share, bringing our innovation to patients.
And that we can only be satisfied with when we grow above the market with what we have and that we are now. On the financial outlook, driving efficiencies is fundamental. And I hope nobody is in doubt that Hemmack runs a very tight ship, very strong competitive advances for Novo Nordisk in the manufacturing platform we have. We have a very robust, high quality, highly optimized manufacturing platform, and we can produce a higher quality and lower cost than anyone in the industry. And by having this installed capacity now, there's a continued opportunity to drive down unit cost.
And this is what the colleagues do in product supply. And they actually find that, that's a bit of a sport. So you cannot meet a colleague from product supply unless you have this drive in constantly doing things better. You heard about our cost ratios. We allocate resources to drive top line growth.
We believe in a broadly stable gross margin. We believe that we will gradually have to invest more in R and D. Top line growth obviously drives an ability to invest more in R and D. And Mads spoke to that the composition, it's late stage activities in R and D that's really expensive. Research is relatively inexpensive.
And we are right now having more patients in the narrow end late stage trials, including the CAR REST outcome trials. On the other side of that, there is significant flexibility in R and D spend. But we are gradually going to increase our R and D ratio. But we believe at the same time that we'll have leverage on the S and D ratio. It would be nice to be launching as many products as we do forever after, but that's not realistic.
So there is a bolus, there is a spike in launch of products now. And the other side of that, there will be leverage. And Carsten just went through it. We will stay disciplined on how we manage our balance sheet and how we return cash to our shareholders. So there's no change there.
So in short, the financial outlook is to deliver solid sales and operating profit growth, 6 percent to 10% in International Operations. We heard Mike talk too that he wanted to be in the upper end. But there will be years where there are macroeconomic issues that has a negative impact on our business. So it can be lower, but we're aiming for being in the high end. You heard the 70% change in book of business in the U.
S. So short term, there will be a drag on our growth. So we're down to, say, flattish growth, say, 0% to 2% growth in the U. S. But on the other side of that, we should be back and growing, say, mid single digit.
And it's still we know we do not know exactly how Rebuildsus goes, but it's clear that there's a huge commercial opportunity. So that will be defining for where that steady state growth level would be. And I can tell you, we are investing what it takes to make it go as high it can go. We spoke a lot about leveraging and driving operational efficiencies across the value chain. So it's moving resources across value chain functions, but it's also within the value chain functions.
There's a new discipline in town called reallocation. So for many years, colleagues in the company were used to getting larger budgets. That's no longer the case. Some gets lower budgets. So we reallocate much more than we have ever done.
And then the cash discipline returning an attractive cash in form of buybacks and dividends to shareholders. So this is, in simplicity, our strategic aspiration for 2025. I can tell you that the Board has kept us honest, and there are specific targets behind one of them. We will, in the future, in our quarterly releases, report to you how we're progressing on them. For confidentiality reasons, we cannot share all targets upfront with you, but we will stay accountable vis a vis all of you in how we track on these aspirations.
So with that, I would like to invite all my colleagues on stage, and then we have the final Q and A. And you know the drill of one question and we try to cross it around the tables to get going. So we have an active table over here. So we get the mic.
Sachin Jain, Bank of America. Questions for Carsten on his on the margin side, if I may. So you clearly moved away from prior commentary of EBIT growth in line with sales and an implicit flat margin. So just two questions linked to that. One is, D increase.
Could you provide any color how those balance out? Clearly, SG and A budget is a lot bigger. And then secondly, just to make sure I've not misinterpreted commentary for 2020, you provided some directional commentary on gross margin. You're making it very clear that you will invest what it takes on SG and A for Rybalser, which is completely strategically correct. Could you rule out a margin decline for next year given those two comments?
Thanks.
So if I take my 2020 commentary first, then our formal financial guidance, as you know, will be for 2020 will be issued February 5 of next year. So what you should be looking at is that and what I said was we have a negative impact from Rybelsus launch, but we also have a on gross margin, but we also have a somewhat easier comparator due to our impairments earlier this year. So there you see 2 more or less balancing effects. And then what I said is that it's very, very important that we get Rebusa successfully into the market and that we will have incremental investments into RIBELSYS especially linked to our U. S.
Launch, which is and there you should expect that to be over and above a flat S and D ratio. And then for the medium term, so the our gradual increase in our R and D ratio in the medium term, that is also a function of the opportunities we see a given point in time. So it's not something that we've carved in stone that 3, 4 years from now that the R and D ratio will be x, y, z. But what we are looking at is that we are seeing opportunities to invest in more in our pipeline and that we also see the need to invest more in our research efforts and platforms. So that's why it's important signal that we will be increasing more, but that we also see the leverage in SG and A the medium term, whether it will precisely be offsetting, let's see in the individual year, but it will more or less be offsetting.
Just to add, in my experience, there is a bit of a rate limiting factor in R and D compared to S and D. My experience is that in S and D, it's much easier to spend money because they move a bit faster. In R and D, you actually need to have some activities that you actually run. So the growth we talk about here and the additional spend, it takes smart people to actually put that into good action. So not to kind of harass any of my commercial colleagues, but I think there is a natural rate limiting aspect there.
Richard Vosser from JPMorgan. So this year in 2019, you're guiding for 5% to 6% sales growth. And yet next year, 2020, you're launching ribelsus, which should be additional growth. You've got a smaller donut hole impact next year that we know about. And the pricing environment broadly the same this year as next year as this year.
So that speaks to higher sales growth next year. And yet you seem to be suggesting in terms of the near term that the growth would be the 2 would be similar. So could you just give us some color on that? Thanks.
Yes. So again, as Karsten says, we don't give specific guidance, but your elements there are correct. Obviously, the first launch year of Rebesos will be a limited impact, obviously, depending on when we get the access. So we'll know more about that already when we meet next time. And obviously, our guidance will be a function of that.
We also spoke to that we are launching a number of affordability issues where we're going to support patients who cannot afford our insulins. So that also plays in. And yes, there's continued pricing pressure on the insulins. Insulin. So those are ballparked the moving elements.
But the specific guidance you'll have to wait for January 5. February. Sorry, February 1.
Hi, Narush Johan from Intron Health. Just a question on Victoza. We're seeing volumes coming down and we're obviously seeing the mix getting worse with Medicaid. Should we see a deceleration of sales over the next couple of years in Vitesseo? Should we expect a similar level of declines we've seen through 2019?
Anyone? I don't see any reason why
we would see a broadly different change of the current slope of Vercosa. So I think we have state time, Lars, about 3.5 years. So we know that patients tell on the stand of product and I don't see any other event that would change that slope in the short term. Garth, I don't know if you have it.
No, but I would say historically when we've looked at chronic care products, then they tend to have a longer tail than people normally anticipate. I think we have a stay time on Victoza to the tune of 3 years or so. And we're launching in with Ozempic and Rybelsus. So I think all our promotional efforts are against the new generation innovations and thereby you see a trend where if you take our U. S.
Data points that we're dropping some 10% market share year on year. So that trend you should expect to continue. And then of course, we always have the option, depending on the exact market conditions if we want to be more forceful in terms of our promotional
efforts. Sorry, just
just follow-up on that. Just what might drive the sales down further is if you're seeing Medicaid mix and price cuts in commercial driving the Medicaid price down. So is that potentially another we've seen that mix already. We've seen it happening this year, is that and we've seen that happen on LANSA, for example, where it did decelerate. Should we is there any reasons why we wouldn't see that in this scenario?
What do you say,
Richard? So I think the key point and the key strategic premise for us with Victoza is basically to sell Ozempic and Rybelsus. And then we have no push behind Victoza for all practical purposes, if we talk about the U. S. Market setting, we have lots of push in different markets.
So then you have the normal trend of patients and the stay time and that's the trajectory you see. If there are any changes in some of the channels, then of course, we will evaluate at that point in time what our tactics is. But again, our focus is on Ozempic and Naspers.
So it's the volume dynamics in launching a new product that we believe drives the development of the business the most more than the contracting.
Yes. So maybe I can just clarify that we are with Ozempic focused on new patients, So you saw the preferred injectable, and that's what our focus is. So you also see the decline from coming from that there are just fewer new starts in the U. S.
We move over here.
Yes. Thank you. Florent Cespedes from Societe General. Non financial related question. On Rebersoos and Aurizon Peak, how crucial is the label update expected early next year in the U.
S. On the cardiovascular mortality benefit claim for the success of the product and for the negotiation with payers, if you could give us an update on this point would be great. Thank you.
Yes. Talk
So it's not right now we're in the middle of negotiation. So again, that would be an added benefit. Come January, forget that and we will certainly once approved and able to, we will use that in promotion. So it's not affecting the negotiations with payer
to date, one way or the other.
Good. There's one more question. Holger Blum, Pardinex Management. I think last year you alluded to cardiovascular disease, NASH and chronic kidney disease are future areas for you to focus on. I think today, you presented several projects in cardiovascular and NASH, but nothing yet on chronic kidney disease.
Has it been more difficult there? And what can we expect maybe for the next Capital Market Day, what you can show us then in terms of pipeline?
Yes. Thank you. Yes. You're eager to get in here, I continue. Yes.
So it's not all about finances. So the FLOW trial, I'm not a numbers guy, but the FLOW trial is actually very exciting. It's hard endpoints. It's about death and dialysis and so on. And that should grant us a chronic kidney disease indication for Ozempic that we will then bridge into Rybelsus.
That's the agreement with the agencies, assuming certain factors such that the SOUL trial has the same endpoints as secondary end points, even though it's a CV trial, it has the same endpoints as the FLOW trial and vice versa. So we bridge. And the other thing is we just in licensed a so called VAP1 inhibitor from a company called UBE as late as last week. And that has potential not only in NASH but also in chronic kidney disease. Okay.
Thank you.
Just a question to the financial outlook to the 2 targets you have out there. The 6% to 10% sales growth is pretty easy to understand for Mike. But Doug, you are supposed to transform 70 friends of sales in the U. S. Is there any way you can quantify this?
I mean, what will 10% conversion give us in terms of P and L? And also the footnote is, it says 2015 to 2022. So how much have you actually converted since 2015?
I think Lars addressed it appropriately just a couple of minutes ago. And I would say that as I said in the presentation, we're about halfway through that conversion today. But again, we're not going to get into the specifics of the 70 cent and what that means in a P and L standpoint. I think Lars addressed it nicely in his close.
Yes. So while doing this, modest growth, which we still aspire for having 0% to 2% growth. But on the other side of that, the full kick in, so to say, of the GLP-one growth. So that should yield, say, mid single digits. And we will have a better feel for that when we get further into the Brabantustus launch and see how that uptake is.
It's the initial signals are positive, But as Doug mentioned before, it's on a very early basis. So we cannot really do a straight line based on that. Move over here.
Thank you very much. It's Matthew Weston from Credit Suisse. You've given us guidance for gross margin in terms of 2020. But 2021 'twenty two capture the Clayton plant coming on stream. And obviously, you rollout of Clayton and how the rollout of Clayton and then the full impact of Clayton will add further pressure to gross margin over that period because you obviously don't have the offsetting one times in 2019 that you've talked about?
Yes. So I think it was very clear that for the medium term, we expect a broadly stable gross margin, first of all. And then I covered the dynamics in 2020. And then going into too many details in the following years, I don't want to go there, but it's important to note a couple of elements. So first of all, Hema covered our approach to taking Clayton online.
So it's a staggered approach. So it's not like you get Jang $2,500,000,000 and multiply it by excellent depreciation in 1 year. So first, have the stage approach in terms of when we start depreciations. And secondly, then there's also a phasing vis a vis that when we start depreciations, then the product goes on inventory and then they're being costed in the P and L at a later point in time. So you should see the Rybalsis impact from the Clayton facility as staggered over a number of years.
There was one more question for this, David.
Hi. Susan Che from Everett Harris. Could you provide more detail, I think on why you said the textbooks have to be rewritten on the mechanism of delivery for And what scope of your products might eventually be delivered this way and also a little bit more on the timeline of that?
Good. Great question. Mads, you have rewritten the textbooks, not personally, but
With my friends and colleagues. No, I think any textbook from med will say that molecular weights above 500, 600 daltons, I. E. Dipeptides and above tripeptides will not be absorbable via the human gastrointestinal tract or other species. So it is a rewriting of the textbooks.
We have normally said that peptides up to the size of 30, 50 amino acids are amenable to the absorption enhancers, the GIAPID and the SNAC that we are deploying. And that when we go to bigger proteins, such as Factor VIII being a very big example, then you need to go into orally administered delivery devices that will kind of make sure the absorption takes place directly into the gastric mucosa like the Soma device. We have a strategy. We're not going to talk about it today, but we do have a strategy in this field and that goes both for smaller peptides and how they are delivered orally and for big proteins and how they will be delivered. I suggest it could be a
topic for future deliberations. I don't think we have time for it right now. But we are
going to deliberations. I don't think we have time for it right now. But we are going to go there.
You might call Hermes doing the drinks. And my experience is that he's very guided, so he ends up talking. Over
here? Thank you. Erik Huberico, Bryan Garnier. Maybe some aspiration also to what's conversion from profits into cash flows. So maybe some missing points here.
Should we expect any
given
and maybe also share buybacks or anything like this that could impact this capital ratio?
So I think we are kind of hinting that we will keep the same discipline that we have deployed in the past. But Karsten, some specifics about tax rate, working capital, etcetera.
Yes. So you shouldn't expect any structural changes vis a vis our tax rate, first of all. In terms of our ongoing cash conversion and working capital, so the only change or the only significant change in the working capital that we're looking at is, of course, when you get a new product on, potentially big product like Roblesis, then of course that drives additional inventories. But at the same time, we are derisking our manufacturing network. So we can also adjust some of our risk inventory policies on our work in progress.
So we have some balancing effects there. Nothing major on trade receivables, etcetera. So continued high cash conversion and allocation to shareholders. You saw the CapEx going down in Henrik's presentation. Of course, there might be depending on the opportunities we have, some more spend on business development activities, but net net still very high cash conversion.
So we'll take a final question from the bank.
K. Yur Parekh from Goldman Sachs. So a few kind of things. One, your underlying growth this year is going to be at the midpoint, 5.5% plus, 1.5% of drags, so 7% underlying revenue growth in 2019. Your aspirations as you lay down today, roughly 50% international growth at 6% to 10%, that gives you 4% U.
S, like you said, broadly flat near term, single digit, longer term, gets you to 5%, 5.5% overall growth for the company. You're sitting on flat margins. You're sitting on the biggest product launch you've ever done. So should we think of this longer term strategic aspirations going back to the good old Norwood days of being really conservative when you set initial guidance? And if that's not the case, then why are this why are your aspirations not higher?
And why isn't the board pushing you more towards a higher aspirational target?
Thank you for that question. So I think we have outlined our growth opportunities. And we have said at least a third of the diabetes market at least doubling up obesity. We have a fantastic momentum in our GLP-one business. And we, of course, expect that to be even stronger in the Rybelsus launch.
But we have not seen that launch yet. So the guidance we give is an overall guidance of the dynamics in International Operations moving towards the high end. And then we talk to make sure that everyone understand that we are converting the book of business in the U. S. And that we need to get through to show the real growth potential of the U.
S. I'll not comment on your, say, underlying math that we keep for February 5. But then it's also important that we will be investing in the launch we have coming up. We have shown that when we invest in our launches, we can drive very strong uptake. So we are going to do that on Rigelsoz also.
So there will be 2020 is a year where we will be determining the trajectory for Rebersoz in the U. S. And Doug mentioned that our investment level is a function of when we have access so we can go to strike mode. So if that comes late, obviously, there will be low investments. If it comes early, there will be high investments because can invest for a bigger part of the year.
But then you will also have the sales coming in. And so the higher exit rate flowing in for growth acceleration in 2021. So I think that's as precise we can get it for now. But we will soon be releasing our outlook for 2020. And that will, of course, be based on deeper insight into where we are on the RIBELSEN's launch.
So with that, I'd like to thank my colleagues. I'd like to thank all of you for coming. And this is the drinks voucher. So you need to fill out this survey. And with that in hand, you can get access to management and drinks outside.
Thank you so much for coming and see you outside in a short while.