Zealand Pharma A/S (ZEAL) Earnings Call Transcript & Summary

Good afternoon, everyone. My name is Rajan Sharma. I'm European pharma and biotech analyst here at Goldman Sachs. Thank you for joining us for the last session of the conference. So we may say that we saved the best for the last. I'm very pleased to have Adam Steensberg, CEO from Zealand Pharma with us. Adam, thank you for joining.

Thanks for the invitation.

Perfect. Maybe to start, it's been obviously an eventful 12 months since you were here on this stage last year, just ahead of the petrelintide 16-week Phase Ib data. Could you just talk us through the progress that the company has made in that period of time?

And you're absolutely right. It's been one of the most eventful periods of the company. It's something we had actually prepared for, for some time. So when I took over as CEO 3 years ago, we kind of doubled down on the obesity journey. And then a few years back, we decided to really go forward once we have seen -- once we saw the initial data for some of our assets. And then just after the conference last year here in Goldman, we received fantastic data points from a 16-week Phase Ib study, really for the first time, I would say, demonstrating the potential of petrelintide as an alternative and potential foundational therapy for obesity and alternatives to the GLP-1s. We were -- and then later in the year, we started the efforts to partner with a large pharma company. We were very clear on what we wanted to achieve. We wanted to have a true partnership, including profit share and it was a highly competitive process. Ultimately, we decided to team up with Roche on getting petrelintide all the way to the market with the patients because we found that we shared -- we had a very similar view on what it takes to lead in such a space in the future.

Okay. And you've also made some additions to the management team over that period of time. And most of those were in actually newly created roles. So could you just talk us through the rationale for those new roles being created? And what does it tell us about the long-term strategy at Zealand?

Yes. But we have a very ambitious vision for the company. We want to grow and to become a generational biotech. We actually think we have all the pieces in place now to realize that dream. And again, it's a journey that we started from a few years back together with the Board where we said we actually think we have something that can define how obese patients will be treated in the future. And why don't we, together with a big pharma partner, take the lead here. So we have been building our organization to make sure that we could become a true partner once we engage also in later stage development and also as we approach commercialization. And with the hires that you have seen in the last 9 months, we hired a Chief Commercial Officer, second half of last year. Eric, who can help us, of course, with that part of the journey. And then in the last month or so, we have hired in a new Chief Scientific Officer to really focus in on what we would call perhaps life beyond petrelintide to make sure that we have a pipeline that can continue to drive value also into the 30s and 40s. And then Steven Johnson as a Chief Development Officer, to really help take the lead as we progress petrelintide into later-stage development together with Roche. And then David Kendall will, of course, still be around as our Chief Medical Officer to make sure that we will get a much stronger presence in the obesity space because we think we have such a unique story to tell.

And there's obviously, in that period of time, there's also been kind of a lot of evolution of the obesity market, both from a commercial perspective, from a clinical perspective with almost constantly getting new waves of data. So if you would just kind of dial back and think about what your perspective is on the market and how petrelintide fits into the market as it stands?

Right? It is, of course, a highly developing market, and it's not a big surprise because as we have said for a long time, and I think most of the world agreed to that, obesity is probably the biggest health care challenge that we are facing right now with probably soon to be 50% of the global population being obese. And then you have 220 diseases that follows obesity and millions of death every year that you can ascribe to obesity. So it's such a huge challenge. And then we have seen the launch of the 2 first molecules that actually helps patients achieve the weight loss that they are looking for 10% to 20% weight loss. So of course, there's been a period where people will then say, well, now we have these 2 tools that can help people lose weight and look how well they're doing in the launch and so on. It's probably game over, but we kind of thought, well, that's a very naive thought that you can solve the obesity pandemic and the crisis that we see with obesity with only 2 quite similar molecules. Of course, you need very many different tools, especially you need things that can help people not only lose weight, but also maintain that weight loss because if you lose weight and you gain it again, you don't achieve any health benefit. So what we think we have with petrelintide in particular, is a product that can deliver the weight loss that the majority of obese individuals are looking for that's a 10% to 20% weight loss and then importantly, help them maintain that weight loss because we do not see the same side effects as we have seen with the GLP-1 class.

Okay. And then just thinking about kind of commercialization and one pushback that we sometimes get from investors is that given the head start that Lilly and Novo have, it looks like it may be kind of something of a potentially a contracting market. Is that the way that you think about the commercial opportunity? And to what extent have you had conversations with your partners at Roche and how you would kind of circumvent that?

In my book that, of course, you have 2 companies, in particular, Novo, who is leading this effort. They were first movers into the obesity space and then Lilly followed them and could take some learnings from some of the steps that Novo did. And so you have these 2 companies playing in this space right now. But remember, they are first movers in the GLP-1 space. And so of course, it's going to be difficult to break into that space because they have data, they have volumes within that class of molecules. But when you think about novel classes, I think there's significant opportunity to rethink how you actually approach the patients and take some of the learnings from these companies but also do it differently. I think it's a huge advantage, not to be first mover in a field like this that is moving so fast and changing so much. So taking those learnings. And then also when it comes to example -- as an example of manufacturing, built for high volume, high capacity instead of trying to retrofit old factories and so on. I think you can end up being in a very competitive -- having a competitive advantage being a later entrant rather than trying to retrofit what you already have. So I just see a huge opportunity, in particular, if you approach with a novel modality and alternative to the GLP-1s, of course, it's going to be difficult to break into the existing GLP-1 space. But if you have an alternative, it's a completely different story.

Okay. And then the other piece, just to maybe round out on competitive developments the oral piece has been in focus, and we're expecting some additional data at ADA. How do you think about the market long term in terms of split between injectables and orals conscious that there's no oral in the pipeline at Zealand as well?

Yes. So I think if people took the time and to really review the reasons that people stop taking GLP-1s, it's not because they're injectables. People stop taking GLP-1s because they have achieved their weight loss. And if you ask most patients, it's either due to financial reasons or it could be due to the fact that many patients have continuous side effects such as constipation, diarrhea or the fact that you -- when you are on a GLP-1, many patients have that feeling that they have lost their appetite, which is not the most pleasant experience. So your tolerance level for side effects are much less once you have achieved your weight loss. And I don't think an oral therapy address that. Actually, what we have seen thus far, probably you have more of those side effects. So I don't think oral therapies are the -- oral GLP-1s the answer for maintenance therapy. Oral GLP-1s may be an opportunity for those patients who are concerned with a needle. But remember, many patients who get on treatment, but they just stop taking them. So it doesn't seem to be a big barrier to get on the needles. Even compounding is like, what, 30% of the volume in the U.S., that's a vial and syringe. It's not even a convenient injection device. So I don't see that needle being a barrier to getting on therapy, and I don't see orals would be the solution for maintenance therapy because it doesn't solve the biggest issues with the GLP-1s, which is constipation, diarrhea, losing your appetite, I believe.

Okay. And so I kind of hear your views there, but in a scenario where the orals get best traction than you are expecting, how viable do you think it is to have an oral formulation for petrelintide or amylin more broadly?

I think the oral amylin are some way -- some time away because it's much more complex biology to understand amylin. You're hitting -- you have to consider 3 receptors rather than just 1 on GLP-1 and you also need to ultimately, if you want to think about a small molecule amylin make sure that it's easy to manufacture. But conceptually, of course, if you can develop an amylin because they are more tolerable, there could be an upside in an oral if -- because you could skip some manufacturing steps and so on. But I just think it's a very long way out. It's not what we should expect to see in the coming few years. It's more complex, and I'm pretty sure there will have to be many attempts before somebody gets it right.

Okay. And then moving on to petrelintide and the deal with Roche earlier this year, could you maybe just talk us through how that deal came around? I mean during the process, you talked about having discussions with multiple companies, and you took your time to kind of execute on a deal. What made this the right terms and what made Roche the right partner?

I mean we started the process almost 1 year back after we had the data to reach out to all large pharma companies to have a conversation and also share our view on the obesity market really trying to educate also the potential for a monotherapy and alternative to the GLP-1s because at that time, just looking 1 year back, I think most of the world were still a GLP-1 world. And I think that was hugely helpful because we ended up having a very competitive process. There was no question in our minds that when we engage in this process, it was not just about the headline numbers of upfronts and what have you for us. We really wanted to make sure we got a partner who is truly committed to the obesity space. Somebody who shared our vision that they want to come in and lead in this space because we see so much opportunity not just being here because it was hot, if you will. And with Roche, I think they just ticked all the boxes in the sense that they as we all know, acquired Carmot some years back. So they have really thought through what it takes to lead in this space. They had plans in place for manufacturing, as we discussed before, so we can make sure that we can hopefully ultimately manufacture at the lowest possible cost. And then with Thomas, of course, they also had a CEO who really -- who was driving this and have been driving this for a long time. And then there was a strong cultural fit. The other part when -- that was important for us when we decided to go with Roche was, of course, beyond just the financials was also the framework of the collaboration where they were very open to having a full co-development and co-commercialization agreement with profit share in U.S. and in Europe. So that's about retaining the long-term value because we see the potential of petrelintide as being a foundational therapy and potentially the biggest selling obesity drug ever. So it was hugely important for us to retain as much value in the long term as possible. And then another important parameter for us was the cultural fit. We just found in the discussions that we had a very strong cultural fit with the Roche organization.

Okay. And I guess, sort of on the vision for petrelintide do you and Roche share the kind of the same vision. And you've always been quite clear that this is a monotherapy first type approach, its petrelintide first and then other assets fit around that. Is that -- are you confident that Roche shared that?

Yes. I think we have a shared view on that one. Remember, we also have 50% of the value on the combination product. So CT-388 that's Roche's GLT-1/GIP, which we actually -- with the data that we have reviewed. And of course, we did diligence on the asset as well. We think it's probably has the potential to be the best GLP-1/GIP molecule in development right now. And we will have 50% profit on that combination product, again with petrelintide. But it's also clear that if you look into the world in a few years from now, with the number of patients who have been exposed to GLP-1, but also decided never to be on a GLP-1. Again, there will probably be more paid obese individuals who have tried a GLP-1 and said never again, then there will be obese individuals on a GLP-1. So it's much more intuitive to launch an alternative because all those patients will be candidates for an alternative, whereas a combination product will not be a solution for those because they still have GLP-1 within it. The combination product is a fantastic tool for those who are most morbidly obese, those who would otherwise be candidates for bariatric surgery, for instance, or it's a good tool for perhaps patients who live with type 2 diabetes and are not obese because you get the benefit from the HbA1c reductions and the weight loss. But the main value is within the monotherapy, that's the foundation and then the combination is for those who have special needs.

Okay. And you talked about petrelintide potentially being the largest ever obesity drug. How do you think about proportion of revenues that come from the monotherapy versus potential combination?

I personally believe that in monotherapy if we deliver on the target product profile we have, I think it will address the need for weight loss in the majority of the obese population. If you ask patients most patients would tell you they would be looking for a 10% to 20% weight loss. Very few patients are looking for a 25% to 30% weight loss. It is only the most morbidly obese patients. And number two, in order to maintain these weight losses, and we sometimes forget that, you actually have to change your lifestyle a lot. So even if there was 0 side effects, if you want to achieve and maintain a 30% weight loss, you need to change your life so much that many patients are not ready for that. And if you have reached a certain age and you have such a weight loss, your body appearance will also change quite a bit. So I've met a number of patients who, let's say, lost 19% on one of the current molecules. And then they said that's a little bit too much, step down in dosing and then they went down to 16% weight loss. They gained a few pounds and then people coming up to tell them and say, I mean, you look super healthy, what happened? Well, I just gained a few kilos. So -- and it's a little bit back -- sometimes we forget that we are just humans, and we actually want to live lives. So -- and most of our lives involves having a good time around the dinner conversation and also enjoying a glass of red wine once in a while. So we should be careful not to be too ambitious on behalf of patients because the most effective chronic therapies are the therapies that people stay on. If people stop taking these therapies, you don't get the health benefit. So you can have the most effective chronic therapy, but it doesn't work if people don't stay on it. And if you have too much -- if it requires too much effort, many patients will not commit to it.

Okay. And then we've heard from you before in terms of amylin differentiation as a mechanism relative to the GLP-1s. But then within the amylin class, there's obviously a huge amount of development ongoing there. Arguably, petrelintide in the lead after Novo from a monotherapy perspective. How do you think about the differentiation relative to things like AbbVie and Gubra's asset and then you have the Metsera that we saw data for yesterday, Eloralintide from Lilly?

I think you're touching upon a very important aspect here now that most people are starting to realize that amylin actually holds the potential as an alternative to the GLP-1s. Now it's really important that people start to think about the different aspects of the different molecules because it's not just about amylin, it's about 2 different amylin receptors and a calcitonin receptor and the specific pharmacology and physiology related to all of these receptors. We think it's hugely important that you have the right balance in these molecules. What we are learning right now is that you can actually achieve a weight loss probably short term at least with most of these concepts. But the question, of course, becomes then what is the durability and what is the longer-term safety aspects where our understanding of the current space, and we hope to present more data on all these aspects in the coming period is that you need to have a balanced approach on the amylin -3 and calcitonin, not have too much calcitonin. You also don't want to have molecules that are too potent on these receptors. I think Lilly showed us that with the salmon calcitonin backbone. So it's -- there's so much more to this than just the name of amylin, and it's something we will start to educate the market a little bit more on in the coming period.

Okay. And I guess Eloralintide is potentially kind of one of the main focus points given that, that is a calcitonin select -- amylin selective, so is there anything that you may be looking for in that data set that may change your view that you do need the balance as opposed to just having a selective?

From a weight loss perspective, it would be doability. I mean one thing is if you can achieve short-term weight loss, but maybe durability is also something that will last into if you think, chronic therapy because, again, we're talking about chronic therapies and not just short term therapies. And then I think you would also start to hear more about what additional health benefits the different receptors might actually benefit with. So it is actually not just down to weight loss. And if you only drive weight loss targeting let's say, 1, only 2 of the 3 receptors, maybe you have to push them too much and then you might start to see some side effects that are unwanted. In theory, you might consider, well, there should be less if you only hit 2, but in practice, if you want to achieve the most weight lose, you might actually start to see some specific side effects that we know from these systems that we are playing with. If you push them too much, you will start to see unwanted side effects. And that's why I think in order to achieve a molecule that can provide a true alternative with a significant weight loss as a monotherapy, you probably want to be on all 3 receptors. If you're only on 2 maybe you get into some issues at the higher doses where you also see the higher weight losses. That is something we would speculate.

Okay. So you think that -- or your hypothesis is that the weight loss is driven by activity at all 3 receptors?

If you look into animal studies, they are very kind of consistent that the most efficacious drugs hits all 3 receptors amylin-3 and calcitonin being the most important. And you would also see that if you are too much in calcitonin, maybe that's wrong. And I would also speculate that if you don't include calcitonin, you have -- you will probably not be able to achieve the same degree of weight loss without putting the doses too high maybe. But data will have to tell as we progress this. That's our current understanding.

Okay. And then thinking about one of the other factors in terms of petrelintide monotherapy, how do you think -- Novo now confirmed obviously, they're pursuing that as a monotherapy strategy? How do you think that informs the development strategy for petrelintide? And do you think it is a competitive risk?

So for petrelintide for Novo Nordisk, we're actually super happy with the data that we have seen probably as one of the few people in this world. I think CagriSema and also cagrilintide as a monotherapy, it actually looks like it's providing a decent weight loss, especially if you consider the CagriSema that only 60% of the patients reached the top dose, they had to push the doses more, I'm sure you would have gotten the numbers that you all hope for. On cagrilintide monotherapy, they were around 12% weight loss. And in our group, it's a very low dose of amylin compared to where we are going. So we -- it gives us a lot of confidence that we can achieve 15% plus weight loss with our approach because we have the same receptor balance as they have. One of the major differences is that we are stable at neutral pH. We have not seen injection site reactions and immunogenicity to the degree that has been reported with cagrilintide. So we think we can dose higher. And we know we can dose higher. So of course, it's a derisking event to see 68-week data from that molecule because it's very much built on the same construct of how to engage with these 3 receptors. So for us, it's derisking the program big time.

Okay. And if ultimately, you kind of want to position this as a best-in-class amylin, do you think you might need to do a head-to-head study versus Cagri, for example?

I mean I'm not sure I have to, but I would probably be happy to.

Okay. I wanted to touch on the -- sorry, the Phase III program. But just to wrap up on petrelintide from a data perspective, one of the other kind of hypothesize benefits of amylin is obviously the effect on lean muscle. When should we expect the data for petrelintide?

So we have included in our Phase II study, which completed enrollment in February 500 patients, MRI scans. So we get a full assessment of the body composition, which should provide some initial data if there is a potential to preserve muscle mass in humans as we have seen in animals. I mean, early data sets with petrelintide suggest that we can completely preserve all muscle mass in animals when they lose weight. I would not expect to see that in humans because after all we are humans, they are animals. And -- but let's see if there will be a signal here, it would be a very strong thing for petrelintide because if you can preserve just a little bit more muscle we would also expect resting energy metabolism to be higher, so it would be easier to maintain your weight loss than having those more muscle.

Okay. And ultimately, if that kind of holds true, and you see it in Phase III trials. Do you think that could be a label claim? Or is it more about a positioning of the drug relative to come?

Yes, it remains to be seen because I personally believe that it will not be as black and white. I mean it's more of a concept. Can you preserve a little bit more. So I think it's difficult to -- I mean, we need to see the data before I would speculate it if we could ultimately end up in a label, but let's see.

Okay. And I guess the other piece that we're waiting for from the Phase Ib is just kind of relative weight loss in males versus females, and we see that data at ADA. What are your expectations? How would you kind of preview that data?

But it's one of the most known things in obesity that any weight loss program, females they lose more weight than males and how women lose more weight than men. And it's something we also -- we have qualitatively stated that we also see that in our product, and we will present the data now, and it is quite striking, but it is what you have seen and what we have known for any weight loss program. And it is, of course, important when you compare programs across different studies and so on, if you have more females, you will just -- you can expect to see a significant larger weight loss than if you only have males, number one. And the other thing is what is also important is, of course, body mass index. If you have a higher body mass index, normally, you would also expect to see a little bit more weight loss, especially if you're in the lower parts. There's a limit to how much you can lose if you're not a very heavy person.

Okay. And then just thinking about the Phase III development program. So firstly, just you said that you will share interim data from the Phase II trial with the FDA to support a Phase III start. So given that the trial enrolled faster than you expected as you previously told us, when should -- when is the interim and when should we expect that? I know that you're not going to share data with the market.

Together with Roche, we'll review the 28-week data in the second half, and then we will wait with disclosure of the full data set until we have completed the full 42-week study. So it's still planned to be disclosed in the first half of next year. But what it allows us to with the interim -- the review of the 28-week data is, of course, to progress as fast as possible to the end of Phase II meeting with the FDA, set the doses for Phase III and then get the Phase III study started hopefully in the second half next year. So it enhanced our speed, but unfortunately, you guys will have to wait until first half likely to see the data.

And then in terms of Phase III initiations would be second half of '26. Is that?

I think that's the current plan.

And how should we think about what the Phase III program would look like? Would it be a typical kind of obesity trial then a diabetic obese?

Yes. So we have plans in place to study weight loss in obese individuals and also these individuals with type 2 diabetes and then also initiate a very large outcome study, which, of course, we'll do read out later. But we need to discuss now with Roche all the important details of that program, how to make sure we have -- we get the most out of the program, which is going to be a large program. And -- so those are the discussions we're having right now. And of course, in the coming period, we can also disclose more on the designs together with Roche.

Okay. And is the plan to run Phase IIIs in diabetes? Or is it just going to be obesity focus?

We have an ambition to rapidly expand into additional indications. We need to now discuss with Roche what are the most important additional indications and in which order to pursue them because remember, with the combination product, that is really a product that could be tailor-made for obese individuals with type 2 diabetes. So we will have to have some key discussions on how much we want to do monotherapy for diabetes versus more focusing on the combination product for that population. I think personally, I think the monotherapy for obesity is a very attractive product for pre-diabetes or recent onset diabetes because data would suggest that amylins are less effective on HbA1c, but actually more effective on weight loss. So that is the perfect tool for a prediabetic person. It's also perhaps will work on insulin sensitivity rather than just stimulating insulins as the GLP-1s are doing. So -- but these are discussions again, we'll have to have with our new partner.

Okay. That makes sense. And then just thinking about costs. So you probably had a figure in mind in terms of when you're entering into these partnership discussions. How much do you think it costs to bring petrelintide from where it is now to kind of a commercial product, i.e., going through all of the Phase III? We know that outcomes trials are large, long and expensive.

So we cannot share our specific cost estimates, but it was a very important part for us in the discussions when talking about financials that we would always be in a situation where we can honor our obligations into the partnership. And with our models, we have a very healthy balance sheet also once we get to the launch here, which is the most expensive year, which allows us to also increase our investments, big time into the research activities we have. So from a cost perspective, you should, of course, expect Zealand's cost base to go up, but it's only in the launch year and the year before where you will see a step change because that's where you need to invest both in the clinical trial conduct plus in commercial readiness. So we are in a situation where we can see our way to profitability without having to -- the need for additional cash and still increase our investments big time in research and development activities.

That makes sense. And then just in terms of some of the other assets that we want to touch on in the last 5, 6 minutes, dapiglutide we're expecting an update from the higher dose cohort, I think it was supposed to be first half of the year, it's not coming yet. What's the latest there?

Yes. So I mean, it's still expected in the first half of the year. So as you can imagine, it's going to be pretty soon. We look forward to see the data. It's a program which leverage both the GLP-1 biology and weight loss and all the benefits that we know from the GLP-1 class and then it has added GLP-2, which we believe provides additional anti-inflammatory properties. So it should be something that a molecule, if it comes out the way we hope, actually has a huge upside from some of the comorbidities to obesity which have a larger inflammatory component. We'll see the data soon. We'll report the top line, and then we'll have some firm discussions internally how to progress this asset because, honestly speaking, I don't think the world need more GLP-1s just for weight loss. We have enough. So we probably think a little bit more of a niche approach here. Could it be IBD, could it be psoriasis where that inflammation component play a bigger role, where we can really leverage the molecule. And if we were going for only cardiovascular outcome, we wouldn't have the answer until 10 years from now, which is a little long to wait for applications. We will get them much sooner. And also, I see that it's a huge opportunity to go in and provide a complementary treatment in these disease areas where you have mostly concepts available that build on the same narrative of trying to manage inflammation as such and not the underlying disease, which we might be able to do with this product.

Okay. But the update that we get will be sort of weight loss for now, right? On the higher dose, well, you're not going to be able to show any inflammation.

It will be mainly weight loss, of course, that you could expect to see some effects on CIP, but it will be rough estimates because these are generally obese patients, so it's not patients who have heavy underlying low-grade inflammation. So it's probably too rough to make any firm conclusions.

Okay. Makes sense. The other one is survodutide. Obviously, that's already partnered and Boehringer Ingelheim are in control there. But could you just remind us on time lines there, Phase III data should be first half of '26.

Yes. So they have completed enrollment into all their Phase III studies in obesity and are still enrolling in the MASH space. But we expect Boehringer to release top line data from this program in the first half of next year. We actually expect that they will have the data later this year. So -- and then, of course, hope that they will progress quickly towards a regulatory submission. And in our books, I would say, Boehringer is likely to be the third large pharma company to enter this space with survodutide, which is a hugely differentiated molecule with potential not only in obesity, but also in MASH where last year, they reported fantastic Phase II data, groundbreaking as they described them, which I agree to. And it's really, again, leveraging the GLP-1 component, but then adding glucagon into this mix really to get nutritions out of the liver, so you get a more healthy liver. That could have broad metabolic benefits beyond MASH. So I look very much forward to see the data sets also beyond MASH and beyond weight loss because I think the whole concept, we installing the liver as the major metabolic switch, which has been disturbed in many cases for these patients, I think, could have very broad benefits across a range of different comorbidities to obesity. So I think it's a very strong opportunity, which is overlooked a little bit in the current environment, but we have a lot of confidence in Boehringer's ability to deliver and yes.

Yes. Okay. And just going back to the Phase III data, I think there are some people that were a little bit concerned about the tolerability profile that we saw back at ADA, is that a concern to you?

Actually not because it doesn't -- in our book, at least it's exactly the same profile as we seen with the Phase II studies for some of the earlier GLP-1s. And it's something you manage when you get into Phase III, where you do more careful titration, you allow use of antiemetic medication and then you also just work more closely with the patients and are more flexible in how you titrate. As one example, and that's also giving us a lot of confidence, Boehringer is moving forward with higher doses in Phase III than what was applied. And if they had serious concerns about the tolerability, I don't think they would have gone that way. So I am very confident that they have found a way to manage that just as Novo and Lilly found a way to manage that in their Phase III programs, and -- but the data will show soon.

Okay. And then maybe on asset that's arguably forgotten amongst all the obesity assets in glepaglutide. Can you just -- you obviously had the CRL at the end of 2024. Can you just give us an update on time lines here in terms of base case for refiling.

Yes. So we have actually just submitted the marketing authorization application in Europe for the product. So we hope to have that approved by the European authorities next year. And then in the second half, we are starting an additional Phase III study to support the FDA approval in the U.S. because the FDA was very clear they wanted to see more data, substantial evidence as they described it, because -- yes, therefore, we should have more patient exposure. But -- so we are fully committed to progress that. And in parallel, we will also continue to explore partnership opportunities here because, of course, it is not the major part of our equity story anymore, but it is still a product that carries significant potential for a lot of patients and also value for companies who would put full efforts behind that program. But as a company, we'd rather spend our efforts on petrelintide, of course, then also focusing on the value drivers beyond petrelintide.

Yes. And just to that end, I mean, you said it's not the driver of the equity story, which is fair. And could there be like in retrospect looking back given the amount of focus on petrelintide in executing there, which all went to plan, that perhaps there's a little bit less attention paid to glepaglutide, which is why there was the CRL at the end of the year. And then with that said, does it not make sense just to kind of expedite a partnership just to make sure you crystallize the value?

No. I think -- I mean I think we actually did work with FDA for a long time to get Glepa approved. And I think it was ultimately different views on how much once weekly could support twice weekly and so on. I mean it's always a scientific discussion. And actually, it was not a lack of focus that resulted in a complete response data. It was basically just different views on how the data sets could support the ultimate opportunity here. But having said that, it does make sense to move on because it is not the major value driver for Zealand in 5 years from now.

Okay. And then just in the last minute or so, it's obviously last year was a pretty phenomenal year for the stock. This year has been slightly different in line with the sector, albeit. What's your message to investors at this point given that some people may have been affected by the way that the stock has performed?

Yes. But I mean, my message is, and I think it's also the feedback I get back that we are doing everything right. We have fundamental -- the fundamental story and the fundamental data in place. And if you have that in place, things will change at the right moment. So it's actually not something that concerns us a lot those things right now, we think we are doing -- we are on a really strong trajectory to actually lead in obesity in the future, and that's our ambition, and that's what we have -- all the parameters in place to actually pursue now.

Perfect. I think we're right at time. So thank you very much, Adam.

Thank you.