Novo Nordisk A/S (NYSE:NVO) Q3 2023 Earnings Call Transcript

Daniel Bohsen: Thank you, Martin. Thanks for the question. And we are ready for the next question.

Operator: Thank you. We will now take the next question. And the question comes from the line of Richard Vosser from JPMorgan. Please go ahead.

Richard Vosser: Hi. Thanks for taking my question. Question on the European rollout of Wegovy first. Obviously we know in Denmark, in May, there was a substantial demand for Wegovy in about 1% of the population. So I was wondering how that has developed since then, both in terms of volume and how you’re seeing patients staying on the drug, through Denmark, given it’s an out-of-pocket market. And then the second question is on your KP Bioscience product. Just wondering how that differentiates from other MR antagonist, particularly KERENDIA from Bayer, but there are also others in development from AstraZeneca et cetera. Just your thoughts on how this is different. Thanks very much.

Daniel Bohsen: Thank you, Richard. Camilla, the first one to you, Wegovy rollout in Denmark and the impact.

Camilla Sylvest: Yeah, so in Denmark we see, a continued interest in Wegovy and Wegovy continues to perform very well, and it is more than 1% of the population at this point in time. In terms of how many states on the product, we also have, it’s too early to give you exact date and numbers, but we do have, I could say anecdotal evidence that there is a high number, a very, very high number of the people that stay on the product from the beginning of the year when the product was launched.

Daniel Bohsen: Thank you, Camilla. Martin, reflections on ocedurenone.

Martin Holst Lange: Yes, absolutely. So what we’ve seen with ocedurenone is a molecule with a very high affinity for the receptor and also a very high half-life. That actually means that we expect to see differentiation not only on efficacy, but it also appears to have a potential upside on the safety side specifically on hyperkalemia. So we do expect to see a differentiated drug in this space.

Daniel Bohsen: Thank you, Martin. Thank you, Camilla. Thanks, Richard for the question. We are ready for the next.

Operator: Thank you. Your next question comes from the line of Peter Welford from Jefferies. Please go ahead.

Peter Welford: Hi. I hope you can hear me. I’ve got two questions. Firstly, if I could come back on the gross margin. I appreciate the commentary year-to-date, but in the third quarter it seem to trend down quite a bit, which I guess it’s somewhat unusual given the quite significant improvements we saw in the gross to nets in your most profitable market for both Wegovy and Ozempic. So can you just talk a little bit about in the third quarter, what the incremental costs or whether perhaps any write-downs or swing of inventory or something that could potentially depress the gross margin in what would normally be a more profitable quarter? And then secondly just coming back to the comment that was made on stay time, thinking about it a different way, which is in the past you cited for Saxenda that around 25% or more of patients are on the drug for at least a year and most of those are treated by obesity experts.

I appreciate it’s still early for Wegovy to necessarily give comments on the US for stay time, but can you sort of talk about whether you’re seeing different trends than those of Saxenda both in terms of the obesity experts versus those on and also the number of patient perhaps who are reaching a year at this point. Thank you.

Daniel Bohsen: Thank you, Peter. So first of all to Karsten on the gross margin and then later talk on what we see on stay time in the US for Wegovy.

Karsten Munk Knudsen: Yeah, Peter, well spotted gross margin in Q3. And just a word of caution to begin with looking at gross margins at a quarterly basis. It’s always tricky due to fluctuations over the year, but if I’m to comment specifically on the quarter then, at constant exchange rates, the gross margin is flat compared to last year. So the decline compared to last year is FX driven. And then you can say, why is it not increasing compared to last year given the gross to net adjustment and the product mix and thereby two pieces to it. First of all, remember the starting point. Our gross margin is already high at 84% or so. And then secondly, what is different compared to prior years is that the amount of CapEx we are running these days and just from an accounting policy standard point of view we are realizing more costs related to our capital expenditure projects into the P&L, so it doesn’t all go to the balance sheet.

Some of it also hits the P&L and that is basically what is offsetting the benefit from product mix.

Daniel Bohsen: Thank you, Karsten. And over to you, Doug, any insights on stay time on Wegovy in the US so far?

Doug Langa: Yeah, Peter. Thank you. Because generally you’re right, we expect to be able to say more about stay time in 2024. Obviously it’s been difficult given the few time periods with unrestricted supply, but what I can say is based on early data from multiple sources persistency on Wegovy it looks better than Saxenda with fewer patients dropping off in the first 12 months. But we’ll have more to say in 2024.

Daniel Bohsen: Thank you, Doug. Thank you, Peter. And we are ready for the next question

Operator: Thank you. Your next question comes from the line of Mattias Haggblom from Handelsbanken. Please go ahead.

Mattias Haggblom: Thank you so much. R&D question. In this scenario that both high-dose sum up 7.2 milligram as well as CagriSema works in Phase III. Can you help me think about the regulatory pathway for a fixed dose combination with CagriSema isn’t the high-dose sum up, and whether that would require a new Phase III or if a small pitching study would be enough? Thanks so much.

Daniel Bohsen: Thank you, Mattias. Martin.

Martin Holst Lange: Yeah, absolutely. Thank you for that question, Mattias. That would most likely require a reasonably, I think, we can bridge some safety data, but we will still have to establish both safety and efficacy. So we actually see that as a potential opportunity, but we see that as a lifecycle management activities.

Daniel Bohsen: Thank you, Martin. And we have time for two more set of questions. So we are ready for the next one.

Operator: Thank you. The next question comes from the line of Emmanuel Papadakis from DB. Please go ahead.

Emmanuel Papadakis: Thanks for taking the question. Hopefully you can hear me, okay. Maybe a follow on for Karsten on supply. Karsten, you said you’re going to quote-unquote significantly increase supply in ’24 versus ’23 as you did in ’23 versus ’22. Eyeballing data, it looks like it was approximately a five-fold increase ’23 over ’22. So you’re telling us you’re going to have another five-fold increase in 2024? And if not, could you help us with the approximate quantum. And then a follow-on also on FLOW, Martin you were helpful enough on SELECT to give us an indication that the contribution of components have been approximately equal well balanced in SELECT, is that also the case at FLOW, or how should we think about the contribution of the composite endpoint components? And what should we expect in terms of labelling? Thank you.

Daniel Bohsen: Thank you, Emmanuel. First, Karsten, any additional supply.

Karsten Munk Knudsen: Yeah, and thanks for triangulating that way around Emmanuel. I’d love to give you further flavor. But, as you know, we are guiding for next year, our full year results late January. So that’s why we will be doing our financial guidance for ’24 and giving too much granularity into scaling of [indiscernible] gets too close to guiding for next year. So I’m sorry but I’ll have to provide that at a later point in time.

Daniel Bohsen: Thank you, Karsten. Martin, can you share more from FLOW?

Martin Holst Lange: And I think it’s a great question and maybe just want to clarify, I don’t think we’ve seen equal contribution from the three components, we just say that they all contributed. And obviously, again, we have to wait November 11 until we see the full dataset, specifically for FLOW I would really love to be able to answer you, but due to the nature of an interim analysis, we have not seen the data, so for better or worse. I know absolutely no more than you do at this point, so I can’t speculate.