Martin Holst Lange: Yes, absolutely. So with regards to SELECT, as we already discussed, we had one look before the expected final outcome of the trial. That was done by a DMC. So we are not perfect to the data. The DMC is looking at the totality of the data, and there was a pre-specification for — when they could recommend to stop use of the very convincing superiority for semaglutide, i.e., more than 20% difference between semaglutide and placebo. They recommended us to continue the trial, which makes us believe that we are probably still in the realm of the 17% that we have sample sized for. But they look at everything and they can recommend to stop the trial should they feel to do so. With regards to oral semaglutide, both in diabetes and obesity, the trials had assigned and the doses are picked so that we expect to get exposure similar to that of subcutaneous semaglutide, both Ozempic 2.0 milligram, and Wegovy 2.4 milligram.
And we would, therefore aim to have full efficacy and full safety profile comparable to those two formulations.
Lars Fruergaard Jørgensen: So various active product profiles from what we can tell from a commercial opportunity perspective. Thank you, Martin, and thank you, Michael. Next question, please.
Operator: Thank you. We will now take the next question. It comes from the line of Sachin Jain from Bank of America. Please go ahead. Your line is open.
Sachin Jain: Hi, it is Sachin Jain, Bank of America. Just two very simple questions, trying to get a bit more color on what’s in guide. So again, I’ll try my luck. So firstly, on obesity, you’ve noted inherent uncertainty. I think there’s been commentary on pent-up demand and cash flow with the first data points. So I’m just trying to get a sense of how much of a bolus you think this will go over the first couple of weeks and best expectations for a run rate once that bolus comes off? And then secondly, I know Karsten, we’ve discussed this a lot before, but GLP-1 growth rate is the biggest delta to guide. Just from your perspective, are you expecting a trend shift through full-year ’23 from the existing 40% to 50% growth because I don’t think a continuation of existing trends as assumed even in the top end of guide. Thank you.
Lars Fruergaard Jørgensen: Thank you, Sachin. If I try to address the first question on Wegovy pent-up demand and sizing of that, and then Karsten, you can get to the GLP-1. So we know for a fact that patients have been lined up. We have had some 60-plus patients on notice for when products would be available. That’s a quite unusual situation to have. So we know for a fact that there is pent-up demand. It’s really difficult for us to size it, to be honest. We are obviously encouraged by the trend line we see. But we also do believe that there will be a normalization of that as we have gone through that bolus. But it’s really very difficult for us to give any meaningful sizing of it. We’ll be looking at the first, say, a couple of months, say, Q1 to really understand how that looks.
So — but the first data points are really exciting. So we feel we’re in a really, really good place. Karsten, on growth rates, I recall we’ve been saying in prior years that we thought the growth rate would go down. It didn’t happen. So any crystal ball now?
Karsten Munk Knudsen: Yes. Thanks for reminding me on that one. So I’d say for — first of all, that’s one of the reasons why we have a forward-looking statement in our announcement. That is when we start to comment on future market growth rates. And I’d say secondly, that’s also one of the reasons why we are rolling with an unusually broad guidance range this time around. When we look at the market growth, I can start out with the U.S. MAT-wise for — based on the latest monthly data points or at the latest data points overall. We are around 40%, and that would be the same ex-U.S. also. So a global volume market growth MAT-wise, around 40% being the latest data point. If we take shorter data points in the U.S., we’re closer to the 50% mark as a data point.
In terms of what that implies going forward, that’s, of course, a function of our activities and competitor activities as well as supply capacity for the players in the markets. So I’d say we have built our guidance based on continued strong market growth. Of course, I cannot give you our assumptions but more than to say continued strong market growth and GLP-1 in diabetes being a key growth driver for Novo Nordisk also in ’23.
Lars Fruergaard Jørgensen: Maybe just adding to that, when you have a category where you have efficacious products competing against each other, typically leads to market growth more than share gain and that’s what we see in Type 2 diabetes. And I think that’s also what we would expect to see in the obesity category that if the cases products drives market growth more than share play. Thank you, Karsten. Thank you, Sachin. Next question, please.
Operator: Thank you. We will now take the next question. It comes from the line of Richard Parkes from BNP Paribas. Please go ahead. Your line is open.
Richard Parkes: Hi, thanks very much for taking my questions. Just got a couple. Firstly, on CapEx expansion plans. And just on whether you can give us any indication of what that increased capacity could allow you to meet in terms of market expansion kind of by the end of the decade, at least some kind of ballpark range in terms of kind of what market — GLP-1 market expansion, that would allow you to meet supply would be really helpful. And then secondly, on the ONWARDS 1 and 2 trials of insulin icodec. I mean, playing devil’s advocate looks incrementally worse than previously. I think with the HBA1c advantage no longer significant or significantly worse in both trials showing worse hyperglycemia profile. So I’m just wondering how this impacts your expectations for that product over both approvability and commercial potential? Thanks very much.
Lars Fruergaard Jørgensen: Thank you, Richard. So let me try to give a perspective on CapEx. And then Martin, you can get to the ONWARDS side. So for us, this is to create, obviously, ability to supply in a market that we believe will have a very, very attractive growth creates strategic flexibility. And I think in the GLP-1 space, you will have the potential of having one of the biggest, say, drop categories ever seen. So really being able to build that capacity and serve the markets, I believe creates a competitive advantage that is very, very attractive. So we also have pipeline products coming that will be using the same type of capacity. So both from an API and fill/finish perspective, we have a lot of optionality in the footprint we have.
And being able to build this and drive efficiencies is something that’s required to play longer-term in this category. So you should take it as a sign of confidence and trust in the existing business we have and the pipeline we have coming. Martin, ONWARDS and the later stage and what does happen for the potential?
Martin Holst Lange: Yes, absolutely. So first of all, it’s important to recall that both ONWARDS 1 and ONWARDS 6 were originally 52 and 26-week studies. This was the regulatory intent. And in the 52-week period of the ONWARDS 1 study, as you know, we showed a superior A1C reduction with a good and flat and stable, sorry, hypoglycemia profile. We then for regulatory reasons, have to do extensions of those two studies in both Type 2 and in Type 1 diabetes, basically because we need to show safety exposure. So this focus of the extension is safety assessment and establishing the long-term safety profile of insulin icodec in both Type 1 and Type 2 diabetes. If I stay with ONWARDS 1, over the additional 26 weeks, we actually saw a completely flat A1C curve show a maintained glycemic control over time.
We lost the statistical significance. But again, in an open label extension, you also lose a little bit of rigor and power, and we sort of have to expect that, but it certainly confirms the efficacy profile of insulin icodec. With regards to hypoglycemia, first of all, it’s important to recall already at 52 weeks, we saw very, very low hypoglycemia rates. There was a numerical difference between the two insulins, and that difference actually remained completely stable throughout the trial. So when we then see the statistically significant, it’s a function of more events rather than all of a sudden seeing a difference between the two treatment arms. And it’s also important if we put that into a clinical context, to recall with the rates that we have seen, a patient on an insulin icodec in this setting would have to wait two to three years to experience an event of not severe hypoglycemia.
And in that context, I also want to call out that the risk of having severe hypoglycemia with insulin icodec in ONWARDS 1 was almost effect of 10 lower than with insulin degludec. So again, confirming the safety profile of icodec in this setting. So we remain very, very confident from a clinical perspective that icodec is the perfect starter insulin for Type 2 diabetes. And obviously, we’re looking at ONWARDS 6, we had to acknowledge that, we have some work to do with Type 1 diabetes, and Camilla can maybe talk to the commercial potential of both obviously Type 2, Type 1 diabetes.
Camilla Sylvest: Yes. Thanks a lot, Martin. So based on the totality of the data that you just went through and from the total ONWARDS program, we are very confident in the efficacy and the safety profile of once-weekly icodec and also the potential to become standard of care insulin of choice for people with Type 2 diabetes. And once weekly insulin, of course, represents a whole new way of managing insulin that gives a lot of benefits to people as just described, but also on the convenience part. By the way, also has a very positive environmental profile. And to your question about Type 1 diabetes, we would estimate that that is to the tune of potentially 7% of the total potential. So that doesn’t change our overall profile of icodec potential.
