Novo Nordisk A/S (NOVOB) Earnings Call Transcript & Summary

Hello, and welcome to the Novo Nordisk A/S International operations conference call. [Operator Instructions] Today, I'm pleased to present Karsten Knudsen, CFO. Please go ahead with your meeting.

Thank you, and welcome to the Novo Nordisk Topical Investor Conference Call. Today, our focus will be on International Operations and the related commercial strategies and performance of our commercial unit there. As always, we may cover forward-looking statements on today's presentations and Q&A sessions. Such statements are inherently uncertain. And as a consequence, actual results may differ from what we predict. Today's session is structured in a way where following a brief presentation by myself. I'm joined by my 2 colleagues, Mike Doustdar, EVP and Head of International Operations, and Senior Vice President of Northwest Europe, Frederik Kier. We'll go through each of the regions in International Operations, followed by a Q&A in the end. The way Novo Nordisk as a company measures and keeps score of executing our strategy and how we progress there is anchored in our strategic aspirations as laid out already as part of our latest Capital Markets Day in the fourth quarter of 2019. I'll not go through all the four quadrants of our strategic aspirations. However, with International Operations accounting for more than 50% of Novo Nordisk global sales, clearly that operating unit is a key part of Novo Nordisk on most dimensions of the value chain. Today's focus will mainly be on commercial execution. So how do we strengthen our diabetes care leadership and get to 1/3 of our diabetes care value market share? How do we more than double our obesity leadership and sales? And how do we drive a sustained growth outlook for Biopharm? Also anchored in our strategic aspirations is a 6% to 10% sales growth outlook for International Operations between the period from [ when ] we launched our those at our Capital Markets Day until 2025. With that introduction, over to you, Mike.

Thank you, Karsten. There is no secret that a large portion of the world's population lives in International Operations. If you take a look at how we have been doing historically, then you see that International Operations on the back of these demographics has been growing around 6% to 10%, up until more recently. Then a couple of years back, in 2018, that growth started to increase in the last couple of years, we have hit double-digit growth, which also has continued into the first quarter results we just shared with you. So we have seen an acceleration of the growth, predominantly due to a market fit strategy as well as launching various different products and generating a portfolio within all the therapy areas that we're operating in. As you will see in the next slide, I spoke to the largest part of the world's population living in International Operations. You could see that, unfortunately, still, there's a lot of unmet need when you're dealing with diabetes. And most of this, of course, is in IO, which is world -- all of the countries in the world except U.S. and Canada. This is, to a very large extent, the building block of our growth. I would say about 2/3 of our historical growth and maybe even current growth is coming from capturing more and more of these patients every given year, approximately 1 million of them and adding them to the people that we are serving every single day. However, as you see in the middle part of the graph, then unfortunately, despite all of our efforts over the last century, I would say, we still are touching just the tip of the iceberg. Only 23 million people are using our products any given day. And that is just a small portion of it, which I would say, speaks on one hand to our responsibility. But on the other hand, also to the opportunity that holds us for the future when we go forward. Then on the right-hand side of the graph, you could a little bit see that basically, the -- what portion of the population is divided into what parts of the OAD, insulin or GLP-1. The market as a whole is growing around 8%, as you can see, the diabetes market. And then if you divide that into different segments, you see the majority of the growth is coming from GLP-1, although the size is still rather small. And insulin has a solid 5% growth. And then overall, we are again gaining market share now to around 24 percentage points of diabetes market share. I would say this is good news for us because, again, going back for the last decade or so, every year, we were losing market share, and it's only the last 2, 3 years where International Operations has been gaining market share, and a large part of that is maintaining the insulin growth to a stable level as well as, of course, doing much more with GLP-1. If you go to the next slide, then you see that our aspiration, as Karsten alluded to, is to have 6% to 10% sales growth. And we would like to continue doing that in a sustainable way, at least until 2025, which the corporate aspiration is alluding to. Now the strategy behind this is rather simple. It's really 3 pillars. On one hand, basal insulin, we need to get basal leadership. We are not leaders today on -- in the segment of the basal insulin. And then we are doing that slowly and surely on the back of more attention and investments with Tresiba and Xultophy. Then the middle part is equally important for us, and that is expanding the GLP-1 market. The GLP-1 market right now is around 11% of the IOs total diabetes market when you think about the value, but only 1% of the volume. And it's really, really important that we expand this market. And while we are expanding the market, then capture a good part of that growth. And then lastly, it is about obesity, and that pillar is equally exciting for us. Expanding the obesity market on the back of Saxenda and soon semaglutide 2.4 is something that many of my colleagues are very busy with as there is, again, even larger population size than diabetes across IO with that. And we'll go into some of these more in detail as we will divide the IO world into the geographies, as you know, EMEA region, China as well as Rest of World. And with that, I will pass to Frederik Kier, who will start with the EMEA part of IO.

Thank you, Mike. And with that, welcome to Region EMEA, which is home to an expected diabetes population of 171 million, a population expected to also continue to grow in the years ahead. The diabetes market we operate in is worth a bit more than DKK 90 billion and has, during the last couple of years, grown approximately 9%. The largest segment is the OAD, and that is relatively stable in terms of growth, but we are seeing growth coming from SGLT2s. Insulin represents 40%; and GLP-1, while only at this point of time is being 15%, you see the growth being 27% year-on-year with an acceleration happening the last couple of years. As Mike alluded to, we also in Region EMEA, have seen a change in the market dynamics. So in terms of overall diabetes leadership, we are almost at 28% and have, over the last couple of years, seen a turnaround in that dynamic. That has come from a turnaround, significant one in GLP-1, now 55% market share lead and also within the insulin. This improvement in share has led to that the growth in our sales has accelerated the last couple of years to be 9% in '19 and '20. You see insulin contributing to growth. You see GLP-1 contributing to growth. But you see also or at least start to see that obesity, while yet being small, only 3%, is adding to the growth and will continue to do so going forward. If we turn our focus towards the GLP-1 market, there has been a strong underlying change in the dynamics. On the left-hand graph, you will see the share of growth dynamics within the GLP-1 segment. And only within 2 years of launch of Ozempic, we are right now with the latest data capturing 84% of all the growth that is taking place in the GLP-1 segment. That has led to -- and that you will see on the right-hand side, that if we look at the volume traction, Ozempic is now close to 1/3 of the total GLP-1 market and as such, right on track to succeed and be the #1 used GLP-1 in Region EMEA. The underlying dynamics at play here over the last couple of years has been; one, a strong product in Ozempic, showing clear medical benefits, a very fast market fit rollout and achievement of necessary access and reimbursement. We estimate that within the top 15 European countries, we were 7 months faster than that of Trulicity to obtain access to -- with Ozempic. Thirdly, we have invested, will continue to significantly invest in the GLP-1 market. And then lastly, as Mike also alluded to, we are improving our execution and have done so by improving targeting segmentation, frontline incentive systems, so on and so forth. With the launch of Rybelsus, we are opening up for totally new and unchartered territory for Novo Nordisk as we will be able to compete within the oral segment, as I showed you 2 slides ago, that is the largest segment in EMEA. We started the launch of Rybelsus in late summer '20 and currently have it launched in 11 countries. We have and will continue to expand our sales force in order to be competitive within the GLP-1 segment -- the GP segment, sorry, where majorities of all these are being prescribed. As you will see on the graph, and if you take a look to the left-hand side, you see the modern OAD market. So that's basically DPP-4, SGLT2 and Rybelsus. You see double-digit uptake in that of Netherlands and Denmark and then between 5 to 6 in Sweden and Switzerland. On the right-hand side, you see the uptake in the GLP-1 market. And here, around 5% to 10% in the countries that are 2/3 within the year of launches. So we are very confident with the potential that Rybelsus holds and satisfied with the uptake we have. And that uptake has to be seen in the light of the very challenging external environment we operate in. Due to COVID, we have had very limited physical interactions with our doctors and also the doctors, of course, have had very limited interactions with patients. That has all led to that there has been a pressure within the dynamics. So initiations are less than what we are used to. But we do believe that as Europe is opening up, we will see an acceleration and further acceleration of Rybelsus uptake. If we turn to another great growth opportunity, that of obesity, you will be informed that we estimate 280 million people to live with obesity at this point in time, but very, very few obtaining medical treatment. We have, over the last couple of years, significantly increased our investments within obesity, fair to say, starting first and mainly in the Middle East countries has a large obesity population but over the last couple of years now, significantly expanding the investments also in Europe. With those investments, we are building professional, dedicated obesity organizations where people have experience in out-of-pocket selling and also understand how to interact with patients and create patient awareness programs. The vast majority of our sales is currently in the out-of-pocket market, and as you'll see on the left-hand side part of this slide, we are doing a number of initiatives to continue to open this. One, we need to establish infrastructure for treatment of obesity and we, Novo Nordisk, are spending time and energy of helping clinics to be established, educating doctors, creating patient material and so on and so forth. An example of that is in the Middle East where we have threefold increased the number of clinics that are actually treating obesity. Secondly, we need to activate people with obesity to actually understand they have a condition and seek help in order to treat that condition. That we are doing in a number of countries, and we have here brought the example of Italy, where we have made a locate of health care professionals. So they -- basically, the patient can find where do they seek proper treatment. So they go to a doctor who is interested in obesity and can help the patient. Last but not least, we are also pursuing innovative partnership here, exemplified with our partnership with Zur Rose in Germany, which is the largest e-pharmacy in Europe and also collaboration with Lloyds in the U.K., the second largest pharmacy chain. Here, together with these partners, we are building obesity treatment pathways, so that patients are able to get proper and good treatment. The second market, we, of course, also are pursuing to open is that of the reimbursement market. We do believe as authorities take responsibility for this disease as well, reimbursement opportunities will emerge. As you will see on the slide, there are a number of examples at this point of time. We have Iceland and Norway that had reimbursement, individual reimbursement from the get-go. And there, we have seen a very steep increase in sales of Saxenda. We have also been able to obtain reimbursement in Switzerland in April last year, and you will see the change in trajection with the yellow line. The last -- or not the last one, but the last one on the graph is that of the U.K., where we, by end of last year also was able to obtain nice reimbursement. The last one I want to mention is that by the first of July, Finland will join these 4 countries, and i.e., be the fifth European country to ensure reimbursement of Saxenda. With that, back to you, Mike.

Thanks very much, Frederik. So now to something equally as exciting. Region China. China is the largest country in International Operations, the second largest and of course, our business in Novo Nordisk. It has -- it's a country that we've been 27 years with, and we have the full value chain operation in that market with manufacturing, R&D as well as, of course, the commercial operation. It has the largest diabetes populations in the world, no surprise, EUR 129 million. The number you see here, EUR 163 million is actually speaking to Asia Pacific as a whole. But China itself is the lion's share of that. So with 129 million people suffering from diabetes, of course, that is a place that we have to be there. Then when you take a look, we have had solid growth rates, you can see that on the right-hand side, now growing double digits. This last quarter, of course, was exceptionally good at 16% growth. But the last couple of years, I think we have had a very good growth rate. On the back of a few than usual cylinders. And I say that because usually, when we show you sales graphs, then there are more colors to it and they're more divided rather than the one that you see here, and I'll come back to that in a bit later. But then if you take a look, of course, where the source of the business is, the main source is insulin. You see that in the middle part of the graph. And GLP-1 is very, very small. That's the green part in the middle. But growing and for sure, the future as we see it. And then you can also see that after more than a decade of losing market share in China, we are starting to gain, again, and the red line in the middle starts to pick up, which I'm extremely excited and happy about. On the next slide, you'll see that if you dissect the diabetes market in China, you get some interesting dynamics. On one hand, when you look at it from a patient point of view, from a volume point of view, then majority of this market is premix. So a lot of premix is being prescribed there. But from a value perspective, then it's more of a balance and a mix between basal as well as the mix. So 43% mix and 41% basal. Now in the middle, you can see our market share, and you could see that we are completely dominating the premix market, with 78% market share. Now that basically means that majority of the Chinese patients, they are using a Novo Nordisk insulin when it's time to actually inject themselves. You also see that in the basal segment, we are not a leader, and we only have 20%. And it's again due to the fact that perhaps we could not compete effectively with Levemir for many years. But now that we have Tresiba, and we have Tresiba actually reimbursed in the National Drug List from January of 2020. I apologize for the typo there, it should be 2020. Then you notice that we have a very good uptake of market share. We've actually gained 4, 5 percentage points the last few years, which is really, really nice. And then I'm also excited that we're hopefully going to try and see some of the same with Ryzodeg, which is our next-generation of premixed insulin and be able to innovate also in where the largest volume is, i.e., the premix market. Then next slide actually speaks a little bit to China in a nutshell. I would say the title of this slide says it all. Novo Nordisk is well-placed to realize the opportunities and manage the risks within the China policy agenda. China is a big market, a very big market. And that also means China has very big opportunities, but China can also potentially have big risks. And that we are very aware of, and we try to manage that. Now the good news, again, is that the Chinese authorities think very long term, so do research-based pharma companies. So if you understand your partner, well, then it's quite easy to plan for the future because you both have very long-term horizons in place. And this slide speaks to the China health plans, which is very long term. It's Healthy China 2030, government wanting its populations to get healthier and doing a number of different initiatives around this. We, on the other hand, have our own strategy, so-called WIN+2025, trying to match what we do in the company very closely aligned with the Chinese health care strategy. The opportunities that we see coming through that health care strategy, on one hand is -- actually accelerations of allowing innovative medications to come to the market with decent, I would say, market access. And in general, getting a better chronic disease management in the focus of the government than it has been in the past. They have completely revamped their regulatory process. They have revamped their clinical development process. They are now opening their national drug list almost every year instead of once every 5, 6, 7 years. And all of this helps, of course, on the positive side, a company like ours. On the other hand, to get 1.5 billion people healthy with innovative medications and with good health care costs a lot of money. So they have shown an interest and have had a very open dialogue with the pharma industry and all stakeholders that they need to control prices more or they will go bankrupt. And that is, of course, some of the risks that we see and some of the risk that's often talked upon in the context of the volume-based recruitment and so on and so forth. And we can discuss that, of course, a little bit later on. But it is 2 sides of the same coin, I would say. For us, you will see that Novo's ultimate answer to pricing dynamic is our ability to bring new innovations to market, and this is no different in China. This slide is self-explanatory and shows how we are able to bring faster and faster into the Chinese market, our innovations in GLP-1 as well as, of course, hopefully, in insulin, biopharm as well as obesity, where today, we are almost nonpresent when you think about Mainland China. By the way, when I speak to Region China, it is China and Taiwan combined. That's what we refer to Region China. So a lot of exciting news on the science part, I would say, and upcoming product launches as well as, of course, reimbursements is to be seen over the next rather short period of time, 1 to 2, 3 years' time. So that is China. Then I'd also like to quickly touch upon the Rest of World. And the Rest of World for us is really expanding from Latin America all the way to Asia Pacific and Japan. It's a highly diverse area with very good growth potential, as you can see on the graph to the right-hand side. It's also, again, a place with a lot of unmet need. Insulin is very -- historically very much how we treated these people with unmet need. It's really still today half of the business that we have, you can see that on the slide. But GLP-1 is expanding and it's expanding fast and i.e., like everywhere else in the company, it is a big part of our future growth and with immense amount of opportunities, I would say, in this geography as well. We continue to roll out a number of our GLP-1 products. Ozempic is now in 16 markets. Rybelsus, we have it in Japan and hopefully soon in other places. And to put that in context, Victoza, our oldest GLP-1 product, is in 35 markets. So still, there's a lot of opportunities going forward. On the next slide, you actually see some of the things I just spoke to, that 50% of share of our sales growth is driven by Ozempic and Rybelsus in the Rest of World. And that GLP-1 is the fastest-growing segment in the market, and we're benefiting from that. You could see this incredible share of growth, hockey stick in the middle, which we are very proud of. Today, only 8% of the total diabetes value market is in GLP-1. In comparison to U.S. or Europe, which is around 25%, there's a lot of room for improvement. And as mentioned, we continue to launch various different GLP-1 products, predominantly, of course, Ozempic, which is being launched across, and very soon to come we will see Rybelsus. And Rybelsus, of course, holds a very huge opportunity also because many of these markets have a large OED market. But nowhere is that OED market is as large as Japan. Japan is the second largest OED market in the world after the U.S. and this is seriously large in terms of value, DKK 20 billion to be exact. And you can see how that division is made in the pie chart that you see, actually, 50% of this OED market is DPP-4s, which is unusual, I would say. DPP-4s are prescribed in Japan more than metformin, which is very unusual. And success behind that has, to a large extent, be credited to MSD, which has done a phenomenal job with Genovia. We had the chance to, of course, enter Japan on our own or find a partner. We felt that we would be stronger with a partnership in Japan to enter Rybelsus with. We made a good deal with MSD, and we are so far very satisfied, as you can see from the source of the business in the middle. And more than 50% or close to 50% of the business is coming from either DPP-4 alone or DPP-4 and SGLT2, which is, again, unusual. If you put that in the context of some of the other markets, U.S., let's say, it's only around 10% that product or that segment is giving us as the source of the business. So this is speaking to, I think, the partnership that we're having with MSD and how we are jointly able to capture a good part of the business going forward, hopefully. And with that, I pass it back to you, Karsten, to sum it up.

Thank you, Mike. Thank you, Frederik. Based on this presentation, I think it's clear that Novo Nordisk as a corporation, we are clearly pursuing a growth strategy for International Operations. The opportunity that we see in the marketplace is a diabetes market, which will increase more than 50% in the coming decades. With the product portfolio we have, we have attractive opportunities to improve diabetes care for patients across the globe and in International Operations. Both benefiting shareholders, but for sure, also benefiting outcomes for patients, enabling better diabetes care treatment overall to the benefit for societies also. GLP-1, we're still in the early part of the GLP-1 curve in terms of rolling out our GLP-1 medications Ozempic and Rybelsus. Less than 1% of people with diabetes are currently in IO is currently treated with the GLP-1. So a long runway on that respect in terms of enabling that therapy to patients across the region. And then finally, in obesity, you heard some of the activities we're pursuing in Region EMEA. The opportunity is significant. We're looking at close to 600 million people with obesity in the region, of which less than 2% are receiving treatment today. With currently Saxenda in the market and further opportunity in our R&D pipeline, we believe that we have good treatment opportunities for patients for many years to come. So this section now concludes our presentation of Region IO. And hence, we're moving into the Q&A session, where I kindly ask you to limit yourself to 2 questions per person. So with that, back to you, operator.

[Operator Instructions] Our first question comes from Wimal Kapadia from Bernstein.

I'm Wimal Kapadia from Bernstein. Can I just ask how Novo thinks about penetration of GLP-1s in volume terms in IO, given, Mike, you just said they only account for around 1% of volumes in IO today. If we look at the U.S., GLP-1s are about 7% of the volumes, Europe, about 5%. So how should we think about that 1% moving forward? And is the U.S. a good benchmark for IO in terms of growth of the GLP-1 class in terms of market share? Or could it be higher or lower? My second question is just looking to the 1Q slide, actually. It seems the only place where you are not outgrowing the local market across EMEA, Rest of World, in China is actually GLP-1s in China, which is actually a relatively new phenomenon. You were growing faster than the market. Just curious if you could give a little bit of color of the dynamics for the GLP-1s in China with respect to Novo and the competition and what impact Ozempic will have on this dynamic?

Thank you, Wimal, for those 2 questions. They both got you, Mike. So realistic volume penetration in IO versus what we see in U.S. and then specifically, market share performance for Victoza in China.

Yes, Wimal. Let me give you some numbers. So we have, basically, as of today -- well, not today, as of February, where we have the data, 13,000 patients on Rybelsus. We have 530,000 patients on Ozempic, and we have around 1 million on Victoza, just to kind of set the scene. Now this, of course, is a tip of the iceberg. And then you a little bit spoke to it in percentage, but I wanted you to get the absolute numbers. We need to be able to, of course, to continue the growth of the GLP-1, you need a few different things. You need good products. We have that. We have the best products, be it an injectable or the oral medication. You -- when you have the products, then you have created the needs, actually, to a large extent, these products with their benefits on HbA1c as well as weight and CV, get a lot of traction. But you also need probably to place the portfolio better than we were able to do with Victoza alone. We will have a situation where we will have almost like insulin, the human -- you have the human insulin, you have the modern insulin, you have the next-generation insulin. Imagine a world where you have the best once-daily injection, best once-weekly injection and the best tablet at different price points. Then we're able to actually probably do better than we have done and accelerate that growth. Because if you segment the world, then you see that -- you see in a place like India, we actually have not done well with GLP-1 because we have had a single product, Victoza being prescribed to 6,000 patients, approximately. And the reason has been the high price of Victoza and no alternative basically in that portfolio. Hopefully, we're able to change that going forward. And that's why I get super excited, not just about India, but the whole market as a whole. Then coming to China, we actually have a very high market share. In China, phenomenally, and also incredibly high good growth rates. In the last quarter, we announced 80% growth rates in Victoza in China. So the numbers are good. But we need new products. And that's why in my slide showing the pipeline, I was so excited to basically share with you, Ozempic is coming very, very soon. Actually, Ozempic is in the market now. And we will start to list that in the hospitals, starting probably around anytime now, June, July. And then we are hoping that the NDRL opens up within, let's say, 12 months' time or so forth and so on. Then we will be able to negotiate an entry to the NDRL and then we have the second product there. And then we have the Rybelsus coming in, hopefully, in 2023. And then again, we turn on a new engine for the GLP-1 in China. So when you look at it from a quarter-by-quarter and look at the dynamics of the competition, yes, there's a little bit ups and downs. But the future of GLP-1 in China is incredibly bright. I have no doubt about that.

Next question please.

Our next question comes from Jannick Denholt from ABG.

Great. It's Jannick from ABG. Can I ask about some of the rest of the region. I think it's obvious, there's a lot of potential around the entirety. So one thing being China, all this discussion around the volume-based procurement. Do you see any upside as a defense in that regard by having a large local manufacturing footprint, et cetera, having a long-term standing presence in China? Is that anything you guys could leverage in that regard? And secondly, at least when we look back to your 2019 numbers, where you had a different split on IO, what are the risks to, frankly, the Biopharm franchise? Because back then, if we look at '19 numbers, I think Biopharm was in Japan, could be around 37% of sales. In that time was 27% of sales, in Europe, 22% of sales. So quite a bigger chunk of value lying there. So how do you see that playing out as well? Is that a -- could that be a potential major risk? Or is it a matter of defending that and then growing diabetes instead?

Thank you, Jannick. The first question, Mike, on China and our presence and leverage in China. We have a big footprint in China. And then perhaps like how do you see the importance of the Biopharm portfolio and the balance between the Biopharm and the diabetes portfolio and how that works in practice in your region?

Yes. So Jannick, our 27-year history in China and the footprint across not just manufacturing as well as being there early with commercial and R&D matters because we know the market very well. I would go as far as saying that we are seen as a local player in China. We are running the company with a Chinese leadership. Of course, it's a big part of our company, and it's part of Novo Nordisk, but being seen and feeling China from the inside out really, really helps. And then the Chinese authorities also like that. They don't like necessarily companies that just come there and dump their products and sell their products and then they leave. They like that the long-term investments and the commitment to their country is as holistic as ours are. And then I have to say, of course, we're not the only one who have seen the opportunities in China and invested heavily. There are other players, but those who do then are at an advantage. Not least, I would say, what last year COVID maybe taught us, is that when you have in your large markets manufacturing, then when there are potential risks, disruptions and what have you, it is actually a lot easier and better to have the factory at home than try to worry, will the products, in time, get to the large market? Because again, the quantities are large and what have you. So in multiple ways, I would say, the local manufacturing there helps us. And VBP is just a dialogue with the government on how to make ends meet one way or the other. And of course, when we can discuss our investments in that market, then it's a good thing rather than not.

Frederik?

Yes. Regarding the Biopharm business and outlook for that. I think if we look -- if we turn to the strategic aspiration, it says secure a sustained growth outlook for biopharma. That is exactly what we are looking ahead to have in Region EMEA. Right now, it's approximately 20% of our sales, and we are able to keep it at that level. We still and will continue to invest in Biopharm. We have a dedicated business unit set up and we have also managed over the last couple of years to defend the business that's been under increased competition, while also, at the same time, we launched the new innovation in the biopharm arena. So looking forward, Jannick, I do believe that we will secure sustained growth. It will be outperformed by diabetes and obesity, but it will still continue to be an important part of business in Region EMEA.

Next question?

Our next question comes from Peter Verdult.

Peter Verdult from Citi. Two questions. Just firstly for Mike and Karsten. Correct me if I'm wrong, but I believe on an underlying basis, IO growth in Q1 was about 11% or if not, higher. I'm just trying -- you just give a sense of, at least for this year, market [ drooping ] around the world from COVID, the Japan rollout of Rybelsus and GLP-1 IO trends more broadly. What are the headwinds this year that are going to stop you from exceeding that 6% to 10% growth ambition? Secondly, I'm just trying to come back to this split, like it's the elephant in the room, everyone -- it's the question we're asked all the time when speaking to investors, especially the shares where they are right now. I know you can't look into a crystal ball and you can't second-guess the Chinese government, Mike. But eventually representing [ 10% ] or Chinese interest representing 10% of group sales. That we're seeing examples of other companies where there's a bigger impact when they hit the DDP, and there's a very nice volume uplift thereafter. But can you at least help sketch out for us what could be a worst case scenario? I mean is it too fanciful to worry that you leave half your value next year and then your strong volume comes through? Just any help you can give us about how we should be thinking about what's at risk and what isn't would be very helpful.

Thank you, Pete, for those 2 questions. And first question on IO top line outlook, you were accurate in terms of the run rate in Q1. So off to a very solid start. As you recall, then we have 6% to 10% in our strategic aspirations, which is also signaling that there will be some volatility overall in International Operations and top line growth, given the geographies in which we operate. But I'll give the specifics to Mike to talk to risk and uncertainties for this year vis-à-vis IO growth outlook. And then secondly, I think we've been around the Chinese VBP on previous calls, but Mike, if you can talk through what we know and what we don't know at this point in terms of China and VBP.

Yes. So Peter, on the growth rate. If you take a look at the last couple of years, we have been trailing at the top end of the aspiration that we have set. So around 10% growth rates. And it is my personal wish to continue that, frankly speaking. And we do everything possible. And I would say what is really helping us are the product launches. One of the things we did really good and correct last year was we didn't stop launching when COVID hit us. We actually had a dialogue and discussion, should we wait because we didn't know how to launch virtually. So we had to kind of reinvent ourselves. But the fact that the colleagues were able to do that and continue the 88 launches that took place last year is helping us and giving me confidence that the high end of that growth rate is at least my own self target. Now having said this, we keep on continuing dialogue in the 6% to 10% because the world is bigger than just Novo Nordisk. We -- as I mentioned in my slide, we ride off of demographics as well as macro trends that happens in the world. If there is a global recession post-COVID, if there is massive price cuts, if there are, of course, situation -- if there is a commodity price decline, oil goes down in Middle East, and, and, and. Then we have seen over the last number of years, we take a hit in that region. And when 2 or 3 of these regions get hit at the same time, then we are at the low end of that projection. And that's why also since the projection is a longer-term projection until 2025. And as you also said, we don't have a crystal ball, then we end up basically giving a range and what moves that range up and down typically are external factors rather than internal factors. I think we have spent a lot of time and effort building capabilities and know-how to execute these things. We have the products that have shown safety. If anything, I have an upside on those because I don't have all of them available in all my markets. So there are more getting hit by multiple asteroids that can bring that growth rate lower to the range. But we also feel comfortable that, that range is the right range, at the bottom end of it and at the top end of it. Now to China and VBP, it is, of course, one of those asteroids that if it hits, then there is a risk associated to it. We are monitoring it, but I have also said this to a number of investors that this is not something that we are doing the last couple of quarters. I would say that the questions from the investors on VBP has increased during the last couple of quarters, but we are talking during the last couple of years, on this volume base recruitment in China because we have been very much involved in the so-called China Healthy (sic) [ Healthy China ] 2030 dialogue and discussions. As you probably know, the VBP is in its fourth reiteration now. NovoNorm actually got hit in China in the fourth round, and that's about 10% of our business over there. And the numbers that we have projected for this year actually includes that hit. And the hit was very similar to some of the scenarios we had built. So we will somehow manage that, although it's still kind of -- of course, it's there and it's negative. Now the way that I have tried to articulate this is that we really don't know when insulin and which insulins will be joining which VBP. VBP-5 is happening as we speak and probably will be announced in, I would say, July, maybe August and take into effect in October. And VBP-6 will come, but there is no announcements about that. So that's what I know. Insulin -- and for that matter, all products in China at one point or the other, will be going through volume-based recruitment. That's what the government has said. They would like to control basically the prices going forward because they want to make China healthy by 2030. Now the good news is that they did not do this European style, wake up and say, okay, from tomorrow, all products get a 10% price cut. That's why we're in VBP-4 and not in VBP-1. You would say that if this was only about a price reduction game, then they should have taken all the products and put it into VBP-1 and ask for an x percentage. And knowing that the prices in China were actually starting from a good level, probably they would have got some prices out of that, but then people would start reducing investment in China. And that was not the intention of the whole game. And then I would say what we do when we make analysis, we don't only make the analysis on the scenarios that VBP and the price goes down, but we also take a look at how some of these delays are helping us bringing some of the newer products in. I just spoke about Ryzodeg coming in. We are making massive investments on Ryzodeg as we speak, building a really large, what you call it, number of headcounts on top of what we have. So we can move fast and maybe switch some of our NovoMix patients to Ryzodeg. That is response to, of course, eventual VBP that will come in. And at the same time, I would say, Tresiba and what you saw, building and gaining market share in the basal segment that we did not have is, again, a response to all of that. And as we turn on some of these knobs, then we are going to expect that at one point or the other, we were also going to get hit. If all of this happens in the same quarter or different quarters, I don't know. But I know that for as many downsides that China holds for us, we have double or triple upsides going forward if you look at it not quarter-by-quarter wise, but look at it in 2 or 3 years down the horizon.

Next question please.

Our next question comes from Emmanuel Papadakis from Deutsche Bank.

Emmanuel Papadakis, Deutsche Bank. Maybe I ask one on European biosimilar insulin. I think you have more of a rapid facing [ research ] relatively. If you could just give us your latest perspective in terms of how that will operate from a substitutability perspective, on a pricing trend perspective, that would be extremely helpful. What's essentially the outlook you're expecting for those insulin and when they're going to go biosimilar in Europe? And then maybe a question on obesity in IO. You outlined a handful of markets that have begun to reimburse. If you could just give us a bit of color on what kind of commercial agreements you had to reach, what magnitude of price reductions to secure that reimbursement? And what other countries within Europe and more broadly, you think are likely to follow suit over the coming years, potentially capitalized by the launch of more effective obesity therapy? That would be very helpful. Thank you.

Thank you, Emmanuel. I believe this is 2 questions for you, Frederik. So the first one, biosimilars, in EU, vis-à-vis NovoRapid in the short-acting segment. What are you seeing in terms of penetration? And do you see any signs vis-à-vis substitutability in -- of biosimilars. That's the first question. And then secondly, what granularity can you give on obesity reimbursement in different markets? And perhaps in that context, you could also cover what we're doing on out-of-pocket type marketing for [ all these medications ]?

Yes. Thanks, Karsten. Let me start with the biosimilar on NovoRapid in the fast-acting segment. We are seeing the entry of biosimilar as we speak. We have seen it in the Netherlands. We are yet to see it in a number of the other countries. They are on the verge, but we are yet to see them fully impacting. So it's a bit too early to say what's the uptake going to be as we don't have a lot of data to support what it's going to be. Where we have seen this in the Netherlands, and there, they are relatively strict in terms of doing substitution because it's a tender-based country. There, we are competitive and have been able to sustain quite a bit of our business. When it comes to all the other countries, it's a market-by-market situation, some will allow substitutions, or they will just continue a prescription-based outlook. And as such, we don't know how it will turn out. In terms of obesity and a bit of granularity on the reimbursement, as I showed you on the slide, we right now have 4. The 2 easy ones are that of Norway and Iceland, basically getting reimbursement out of the block. It's individual reimbursement, so each and every patient has to be approved. But the limitations are basically on BMI. So where we, in Norway, it's a BMI, above 35 with comorbidities or above BMI of 40 without comorbidities. And in Iceland is BMI above 35. So that's how they have institutionalized it. In Switzerland, it's BMI above 25 -- it's 28 plus comorbidities or without commodities above BMI 35. So it is a relatively uniform way that the authorities are looking upon it. They put restrictions mostly based on BMI, but also on comorbidities. A few of them also puts restrictions in terms of the links by which you can be on substitutes medication. They also -- a few of them have stopping rules if you don't achieve 5% weight reduction within X amount of weeks, it will be taken away. Nonetheless, these restrictions are not impacting our opportunities to have an important business going forward in the reimbursement segment. We do believe that with this, we are opening up and also with the instruction of 2.4, semaglutide, it will further speak to a situation where authorities will take responsibility, and we'll most likely see further reimbursements taking place.

Our next question comes from Simon Baker from Redburn.

I'll stick on the payments theme. A general question. It's always struck me that both diabetes and obesity really lend themselves to outcomes-based payment structures, yet we've never really seen any. I just wonder if you could give me your thoughts on them from your perspective and the perspective of your governmental customers and why we haven't seen that? And specifically on obesity, it looks like now that the BMA and NHS England are talking, we could well get the introduction of the new enhanced service on obesity and weight management in -- certainly in England, and the rest of the U.K. later this year or in 2022. I wonder if you could give us your thoughts on the potential impact of that from a Saxenda and a semaglutide point of view?

Thank you for those questions, Simon. Also coming your way, Frederik. So first of all, what our experience is with the outcomes-based contracting, it sounds intriguing, but it's hard on practice. So what have we seen working in the different markets and what experience do we have? And then obesity in the U.K., we have one contract in place, but forward-looking. And with the activities that the health authorities are pursuing in the U.K. to -- how do we see that impacting Saxenda and particularly on semaglutide 2.4?

Thanks, Karsten. Regarding outcome-based contracting, it is, as being mentioned, intriguing in its setup, but relatively difficult to execute. So we don't have, to be honest, good examples in Europe of it happening. The problem with it is that the follow-up structure that is required in order to assess whether we actually live up to the definitions outlined in the contract is so difficult to do. So we don't have good examples of it. I think as we're entering the obesity arena, we might be able to see it. As you can allude from my previous comments, there are stopping rules in some of the countries in terms of weight loss. And that's a simple parameter and, i.e., hence one countries can pursue. One example outside Europe is that of Israel. I think that there, they have a very, very well-defined and well-structured health care system and do have the capabilities to follow the patients on data, health care out based (sic) [ outcome-based ] contracts in Israel are much more capable of being pursued. So -- but within Europe, it is very, very limited. In terms of obesity in the U.K., we do believe that the first achievement we have with NICE and the approval is very, very good. And will allow us to start seeing more treatment of obesity. It is, at this point of time, restricted to third tier hospitals in the U.K. and that is provided that you need to establish the infrastructure to be able to take the patient through a good pathway. Right now, we don't have a lot of educated doctors that are able to provide proper obesity treatment. And as such, this is a limitation factor. I do believe that the U.K. and also with the fight on obesity that Boris Johnson is outlining, we will see much more activities, especially in the area of upskilling doctors in order to be able to treat obesity. And I think sema 2.4 will fit in very nicely through that journey in the U.K.

Thank you, Simon. Thank you, Frederik. Clearly, exciting with the obesity in the years to come. So we have time for one last set of questions.

Our next question comes from Michael Novod from Nordea.

On obesity in China, maybe you could talk a bit about how China is overall looking at obesity treatment and willingness also over time to actually make a better, say, outcome for getting treatment of obesity. And in the same question, you mentioned the lack of doctors in the U.K., you've also talked about this in the U.S., education around obesity. So in the same question also regarding your investments into the different markets on certification for obesity doctors, clinics, as you've done it in China with diabetes treatment. Maybe elaborate a bit on all the infrastructure going into IO for obesity? And then just a small question on Japan. You said that you did a good deal with Merck. Is it possible for you to elaborate a bit on sort of the deal structure and economics in the deal you've done with Merck in Japan on the doses?

Thank you, Michael. So first, on obesity, Mike, what's the outlook for China, specifically. And then in a broader setting in IO, what are we doing in terms of expanding GP training and as part of our overall market development plan for succeeding in -- with our obesity venture. And then specifically on Japan, our contract with MSD, which Michael, unfortunately, it's confidential, so we cannot give you too many details. But -- so actually, I'll cover that one first. So in reality, the MSD contract is you should see that as a contract sales organization. So we have, of course, evaluated the cost of going alone and going with a partner and the magnitude we're getting and the quality of reps with MSD was clearly the most attractive. And then I don't think there's more to add on the financials on that one. So Mike, on obesity in China and training of GPs?

So yes, similar to, of course, China being the largest country with the population for diabetes is also, unfortunately, the largest country with population for obesity, 124 million people are suffering from obesity. And maybe the numbers are even higher as the data might not be as good, frankly speaking. But we're speaking about a very large market again, and one that we sell basically 0 Saxenda in because we have not done the clinical development and don't have the product registered. So we are not present in China, which is, of course, very unfortunate. Now there is a lot of hope and dialogue and push for getting semaglutide 2.4 into China. And hopefully, within the next few years, we will see that happening, and we're trying to build the market by the time, of course, that happens. But I'd like to speak a little bit on building the market generally, as your question, Michael, was. We are doing all of it. And you actually had a good knowledge and gave an answer to your own question with the clinics and the education that we do and what have you. But one of the areas where I get super excited about this is on the digital front. Frederik a little bit touched upon it with Zur Rose and others. But I think that we might end up seeing that the big solution to capturing the patients with obesity is actually on telemedicine, on online pharmacy and delivery, and consultation as a whole. When you speak to a patient who's suffering from obesity often, they talk not about a fear of their condition, but how they are ashamed. And if you then go deeper into that, and try and basically realize that maybe by providing help and support to them online, while it's very difficult for them to find a doctor outside. We would be able then on the back of the semaglutide 2.4 product being phenomenally effective, then capture a much larger portion of the people who have the need than we are able to do today. And that is also what we have set ourselves for our ambition, and you have seen that also in our aspirations. So that's what we're going to work on. And then I think you touched upon the MSD cost. It's a good deal. I think we're both benefiting from it, but I cannot get into the details of the deal for obvious reasons.

Thank you, Michael, and thank you, Mike. This concludes today's session on Novo Nordisk International Operations. Thank you for your interest in the company. Clearly, you can hear we are pursuing an attractive growth agenda for the region and which aligns perfectly with our strategic aspirations of driving 6% to 10% sales growth in the period lined out. For any outstanding questions, please do not hesitate to reach out to Investor Relations, and then we'll make sure to respond appropriately. And with that, this concludes our call. Have a great Friday and a beautiful weekend when you get there. Thank you.

Thank you. This now concludes our conference call. Thank you all for attending. You may now disconnect your lines.