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43rd Annual J.P. Morgan Healthcare Conference

Jan 13, 2025

James Gordon
Analyst, J.P. Morgan

Good afternoon. I'm James Gordon, JP Morgan European Pharma and Biotech Analyst, and I've got the pleasure of introducing the Zealand presentation today, and we're going to hear from Zealand's presenter, Adam Steensberg, so thank you very much for joining us today, and look forward to the presentation.

Adam Steensberg
CEO, Zealand Pharma

Thank you, and great to see you guys. Yeah, so I'm here to talk about Zealand Pharma and really our ambition to become a key player in the changing obesity market, and of course, I will be making forward-looking statements as I go through the presentation and I guess during the Q&A session as well, so what gives us the confidence to really aspire to become a key player in this growing market is really based on 25 years of peptide experience, R&D experience, so we have been, as a company, active in the metabolic space and more specifically developing peptides for metabolic diseases for more than 25 years, so it's not something that is new to us.

And if you look into how we have, you can say, transformed the company over the last three years, we consider ourselves in an extremely strong position to grow from here, not only when we look into the pipeline, which I will review in more detail, but also when you look into our financial situation. So we're really set up for accelerated growth in the coming years ahead of us and leverage all the experience and the know-how we have in the company. So narrowing in on next year, which looks to be a very, very busy year from our perspective, and really a year where we expect to see significant advancements of the obesity opportunities that we are pursuing.

You will hear much more about petrelintide as a crown jewel in our pipeline and probably the key asset which is driving most of our, you can say, equity story currently. The reason that we are so excited about petrelintide is because it offers the first non-incretin mechanism to actually provide the weight loss we believe that most obese patients are looking for. So we just initiated a large Phase 2b study and expect to complete that study this year. We will also initiate a large Phase 2 study in patients with diabetes. And then we will, later in the year, initiate a small combination study. Not that it's core to our strategy with petrelintide, but we recognize the potential of also combining petrelintide with a GLP-1-based mechanism.

Dapiglutide is a very differentiated GLP-1 containing molecule, GLP-1, GLP-2, where we will report data from a 28-week data study in this first half. We also expect to push this molecule into a large-scale Phase 2b study here in the first half of the year and thus see significant progress for this program. Then survodutide, which is being developed and commercialized by our partner Boehringer Ingelheim, we expect them to actually complete the Phase 3 trials in obesity with survodutide and then also have significant progress within studies in Phase 3 targeting MASH. I really think that a lot of investors and people looking into Zealand Pharma tend to overlook this opportunity because Boehringer is a private company.

But in our minds, Boehringer Ingelheim looks to be the third large pharma company who can actually enter the obesity space with a very, very differentiated molecule, which I'll also talk a little bit more about. And then we have opportunities in rare diseases and chronic inflammation, which I will also talk about. Looking at our pipeline, which is really what excites us and where we spend all our energy, as you can see, we have a very rich pipeline in obesity. We actually believe we have one of the strongest pipelines in obesity across the industry and a huge opportunity to drive, you can say, differentiation for the future. We truly believe that it's, you can say, it's time to move on. We need to think about differentiated approaches rather than just seeing more of the same. And that's also something I will discuss more today.

If we look below the obesity opportunities, then we have two rare disease programs in late stage development and in the regulatory Phase, which used to drive the majority of Zealand's value, and they are still highly valuable assets. It's molecules that have a huge potential to make a difference for patients living with either congenital hyperinsulinism or short bowel syndrome, so we are continuing to invest in these programs and make sure that they reach the patients. But of course, when we look into the magnitude of the opportunity, the obesity opportunity outshines these today, then, as I said before, we have a rich history of more than 25 years of peptide R&D, and we continue to innovate. We have actually scaled up our innovations and are accelerating our innovation and utilizing the platform, which has delivered plenty of molecules into clinical testing and two molecules to the market.

Where you can expect to see more innovation from Zealand in the future is within chronic inflammatory diseases and then within new and novel targets within obesity. That's the key focus area for our R&D pipeline, early R&D pipeline. Let's just take a step back before I discuss our specific approaches to obesity and remind ourselves why it's so important to talk about obesity. That is, of course, because there are 220 diseases which you can ascribe to obesity. It's not just diabetes. It's not just cardiovascular disease, which we all like to talk about. 220 diseases. It's quite scary to think about. Already today, there are five million excessive deaths every year you can ascribe to the obesity pandemic.

If you really think about it, then what we're looking at today is still mostly, you can say, the consequence for people who have lived with obesity since they were young adults or adults. Very, very soon, we will start to face the consequences for people who have lived with obesity since childhood. This is so important to remember. It's not about being obese or not obese. It's the duration you live with obesity that causes organ damage. At least at Zealand Pharma, we speculate that a lot of these 220 diseases, which we know can be to some degree associated with obesity or obesity as a driver, we will see significant increasing prevalence of these diseases in the future. That's why we have to do something about it. As I said before, it's not about obese or not obese.

It's about tackling what we consider the biggest healthcare challenge of our times. It's just not something we feel to the same extent as other challenges because it's a slow-moving challenge that has been coming over us for 50 years. It's quite remarkable to think about it that humans have lived on this earth for 300,000 years. And for all those years, we have been able to maintain a more or less stable BMI average. When I was born 50 years ago, the average obesity trends were around 10% of the population was obese or overweight. Today, it's approaching 50%. And this is not people who have changed. This is society that has changed. So we have now developed a society which actually doesn't work for people who have developed, all of us, fantastic skills to seek food and preserve energy.

It's not natural for us to say no when there's energy around. It's actually a survival instinct to say yes, please, and then preserve that energy. That's how we have survived for hundreds of thousands of years. In the last 50 years, we have created an environment which doesn't work for most of us and many of us. So we need to do something about it. Otherwise, we're going to be facing so many healthcare challenges that it will break the healthcare systems in the future. And that's why we are in this space. It's also important when we think about the seriousness of this disease and the serious implications of this disease that we start to move away from this arms race or the Olympics of weight loss, who gets the most weight loss. That is not the goal.

It's not the goal for future medicines to develop the highest degree of weight loss. It's the goal to develop a healthy weight loss. And what we are seeing, what we have known for a long time when we ask patients, they're looking. Most patients are looking for a 15%-20% weight loss. And if they achieve that, they say, that's fine. I don't need the 30% weight loss, which the industry has been talking about for a long time because that is what you achieve with bariatric surgery. But bariatric surgery is not something you offer to the majority of obese individuals. That is something you offer to the most diseased, most obese patients. And we just see repeatedly also now from clinical studies that if you give patients the choice, they will not go for the highest weight loss.

They will go for a weight loss that is fit for them. And the good news is what we have also seen from clinical studies is you don't need 30% weight loss to have very significant health benefits. Likely 10%-15% is what gives you a lot of health benefits. So let's start to move away from this, you can say, Olympics of weight loss, who gets the most into more reasonable thinking, more mature thinking about how we address this obesity pandemic. Like with any other chronic diseases, we need many choices, and we need choices for different patient categories. We don't need more of the same in our minds. It's also really important, again, to consider that there are two, you can say, leaders in this space, two front runners who have products on the market today.

Then there's a very, very rich pipeline of mostly early stage assets. Most of those are built on the backbone of a GLP-1. You have added different pharmacology or different, you can say, properties to those molecules so they can have slightly different, you can say, product presentations and differentiation. It's not a crowded area when it comes to developing novel medicines for obesity because most, if you are a patient, the patient experience is more or less going to be the same if you have GLP-1 in your molecule. What causes patients to stop taking these molecules is the experience, it's not the lack of efficacy. We need different tools.

We think, as we'll discuss more later in this presentation, that amylin as a category and petrelintide, our molecule in particular, present the first alternative, potential alternative to the GLP-1 category, the first alternative tool, not just a new hammer if you're looking for something else or an improved hammer. Of course, there will be more. Ultimately, obesity being the biggest healthcare challenge of our time, we need to, once that will be a mature therapeutic area, once there are four to five different categories which will each have different modalities within that category. We are not by far there yet. We are not even, I believe, at the end of the beginning of how to tackle this problem. We need novel categories. I've just listed some of the examples of how you can differentiate in the future.

So again, as I said before, we have seen in clinical trials, we also hear from real-world evidence that GLP-1-based therapies are fantastic tools to help people lose weight. It's the first time we are seeing medicines that actually help people achieving their goals of this 15%-20% weight loss that most people, if you ask them, would say, that's my goal. But it's also a fact that they are associated with significant side effects, GI side effects. And what we see in real world, you can say, use of these medicines, not in clinical trials because we are good at keeping people in clinical studies. But once it's being used in the real world, we see that up to 30% of patients, they drop out of these treatments within one month. We speculate a lot of that has to do with side effects.

And then a year into treatment, we have less than 30%-40% who are still in treatment. I think today the average time on a GLP-1-based therapy for obesity management is five months. That's actually a huge problem. It's not just about commercial opportunity here. It's a big problem because I would say all learnings from former health and weight loss programs teach us that if you stop being part of a program, you will regain your weight. And one of the most unhealthy things when it comes to weight management is to do this yo-yo where you lose weight, regain weight, and lose weight. And the even bigger issue is there is a tendency once you have lost weight that you just put a little bit more on the next time. So we need to find solutions.

And we need to start to have, you can say, a conversation not around weight loss, but how we help people achieve the weight loss they're looking for. And then more importantly, weight maintenance. How do we help people remain on therapy and maintain their weight loss? And that is back to offering patients tools that are more easy to live with, things that you can actually, which you are also willing to accept once you are through that initial excitement about your weight loss because that's the other thing we know. Obese individuals and people are extremely motivated to lose weight. But we all know how it goes. Once you are a little bit further into that and you have achieved your goal, it's much more difficult to maintain that weight loss.

So we need things which people, new therapeutic categories which patients are also, you can say, interested in staying on in the maintenance Phase. The target product profile we have for petrelintide is, and I'll try to back up that target product profile with data that we have generated over the last few years, is to achieve a weight loss of 15%-20% in long-term studies. And we are here talking about a high-quality weight loss with the potential to preserve muscles to a larger extent than with the GLP-1-based therapies. It's also hugely important to understand that it's a different mode of action. While the GLP-1 makes people lose their appetite and basically works on prospective food seeking. So you turn up at the buffet and you say, not hungry, get me out of here. I don't like the view of food.

Amylin works in a different way. And we speculate it is a more natural way by, you can say, overcoming the leptin resistance that many obese individuals experience. So leptin is the satiety hormone. That is the hormone that makes us feel full once we have eaten. And amylin stimulates that pathway. So in theory, you will turn up at the buffet, you will start to eat, but you will just stop earlier. So that's the way you will reduce your calorie intake by eating smaller portions and not supersizing ourselves all the time. And we think it's a more pleasant experience. And then extremely importantly, which I can also, you can say, review in the coming slides, what we have seen thus far with petrelintide, it carries significantly better tolerability profile when it comes to GI side effects compared to the GLP-1 class.

These are data that we released in June last year. And we, at least, were extremely pleased to see the outcome of this 16-week study. And when we look into the weight loss curves where we achieved up to 8.6% weight loss, it's really important to keep in mind that it was 80% males and it was not a very obese population. So we all know that obese individuals, and especially females, they lose more weight on these medicines. So this is really an impressive weight loss achieved in a classical Phase one study, which normally recruits mostly males. And when we look into the side effect profile, which is of course always the other side of the coin, then we achieve those weight losses with, you can say, only one event of vomiting.

And that was a patient who received a higher starting dose than what we are proceeding with in the Phase 2 study and very, very low rates of nausea and close to no constipation and diarrhea. And when we talk about the GLP-1 class, we always talk about nausea and vomiting because that's the immediate experience, negative experience some patients have. But what makes it troublesome in the medium to long run is very often other GI side effects such as diarrhea and constipation. So you can say the side effect profile of our amylin stands out completely compared to at least our experience with other GLP-1s. And yes, it's an early data set, 16 weeks in a classical Phase 1 cohort.

What excites us is it's actually just a continuum of the observations we have seen from the earlier studies as well, including the single ascending dose study and the multiple ascending dose study. It also gives us confidence as we progress into Phase two that short-acting amylin has been around for a long time. There is knowledge around that class of medicines. We have seen normal releasing data for CagriSema, but more important for us, cagrilintide. Now we have, you can say, safety data from thousands of patients who have been exposed to a long-acting amylin. We actually move forward with a lot of confidence in the class and what I consider really best in class data so far in this amylin class. The Phase two speed study was started in December. As you can imagine, it's recruiting extremely well.

I think we are even beating our own optimistic timelines. We expect to complete enrollment in this first half, complete the study. As I said before, it's a 42-week study, and then you can say release the data early next year, so you will also see this is a thorough study. We are not in the camp of trying to bypass Phase two. If you truly want to develop a molecule to become a future foundational therapy with the potential to become first line, you need to do it right, and the most important part of any drug development program is Phase two. You don't want to skip Phase two. You want to make sure you get the right doses and the right, you can say, decisions before you move into the last Phase three programs.

So we think we have a very unique opportunity here to come in with a product that delivers the weight loss that patients are looking for with significant improved GI tolerability, potential for improved quality of the weight loss with muscle preservation. It's a unique mode of action that doesn't work on the GLP-1 pathway. And then one thing we also forget to talk about, somebody has to prescribe these medicines. And if you prescribe a medicine and you get a call back two weeks later to say, I cannot tolerate that dose or what can I do, doctor, that's a problem for most doctors because they don't have time for those repeat interactions with patients. And we think we have something which actually is not just something that patients would appreciate, but potentially also prescribers. Shifting gears because of course the GLP-1 space is not completely dead.

I'm not there yet, but it is, you can say, as I said before, providing the first tools to help people lose weight. It's complicated tools for many to be on, but they are wonderful tools not only in how they achieve patients' ability to lose weight, but also how they work on comorbidities such as diabetes, liver disease, cardiovascular disease, sleep apnea, osteoarthritis, a lot of other of those 220 diseases that are associated with obesity. What we're doing with dapiglutide, our GLP-1, GLP-2 receptor agonist, is leveraging also anti-inflammatory potential of the GLP-2 component of this molecule. A lot of the organ damage that you see with obesity is believed to be caused by low-grade inflammation, and we think we have a molecule here which can not only provide you with a weight loss, but also will be even stronger in controlling inflammation.

So for this program, we will report 28 weeks data from a Phase 1 study, as I said before, later here in the first half. And then we'll start a large Phase 2b study as well. And then to the program that Boehringer is responsible for, where we just have a license agreement with them receiving high single-digit to low double-digit royalties. A few years back, they reported this, what I consider actually a very strong data set in obesity, suggesting at least to us that survodutide has the potential to give you north of 20% weight loss in a Phase 3 setting. And it's a molecule that is based not only on GLP-1, but also glucagon. Glucagon is, you can say, from a textbook perspective, the molecule that gets energy out of the liver. It increases lipolysis.

So it might actually beyond just providing, you can say, the classical GLP-1 effects. It might actually also increase energy expenditure slightly by increasing the lipolysis to the burn of fat. And it looks very competitive in the obesity space, but it's not what will make it a leading molecule. What the edge is for this molecule is what also Boehringer presented last year, first half of last year, and presented as groundbreaking results within fatty liver disease. It is its potential to address actually fibrosis in patients living with fatty liver disease. And again, because there's no treatments, at least there's only one approved specific treatment for NASH today, but it's been an overlooked area from a there's not been many treatments around for patients. It's also been a little bit overlooked in the, you can say, clinical society.

But if you look in behind the data, it's actually 35% of all obese individuals who have some degree of fatty liver disease. It's a much higher number than diabetes. And Boehringer, they have a program here which, in our minds at least, again, have shown best in class within the GLP-1 containing molecules in addressing liver health. And they have just last year started what we consider the biggest program ever in people living with NASH, including people with F4, so the most diseased livers. So that leads me to my concluding slide. And we have a very exciting year ahead of us with a significant amount of progress expected within the obesity pipeline and also the other programs. But it's fair to say that our key focus is on the obesity programs also this year.

James Gordon
Analyst, J.P. Morgan

Thank you very much. We've now got some time for questions.

Is this one? Can you hear me now? Testing?

Adam Steensberg
CEO, Zealand Pharma

Yes.

James Gordon
Analyst, J.P. Morgan

While they're sorting out the microphone, I think with that, does anyone in the audience have a question they'd like to ask? Otherwise, I've got one lined up. Maybe I'll start with the question then on amylin. It's been quite a busy couple of weeks for amylin. We've had another company announce the CagriSema data, so another amylin therapy. The market's reaction wasn't that positive. What do you think of the data and what does it mean for amylin as a class? Does this change how we should think about your amylin petrelintide?

Adam Steensberg
CEO, Zealand Pharma

Yeah, you will probably be surprised when I say this, but I actually think it's good data.

You know, but of course, if you have a very, very effective combination, which we believe a combination of a GLP-1 and amylin is, then and you allow patients to make decisions if they want to get to the highest doses, you cannot expect to see the maximum potential of that combination because at least in our minds, as I also discussed before, when people reach a 15%-20% weight loss, most say, I'm happy with that. In our minds, a product like CagriSema is better suited for those most morbidly obese patients. And if you want to get those patients, most of those patients to have that 30% weight loss, you need to have, I would say, very significant physician engagement where the physicians continue to work with the patient and convince them why it's important to get that extra 10%.

So it came out actually when you allow that flexibility, which was new to us that they had allowed that degree of flexibility. But if you allow that degree of flexibility, that's what you achieve. So it basically just underscores what I said before in our minds, at least that patients are looking for 15%-20%. And then I would say, more importantly for us, and this might also be a little bit overlooked, cagrilintide was also tested in a mono arm where it was only cagrilintide. And that provided around 12% weight loss with a dose of 2.4 milligrams, which we consider a very low dose of an amylin analog. Remember, we are dosing up to 9 milligrams with our amylin analog. And we also believe we have significantly higher bioavailability of 80% compared to maybe 30%. That's our estimate for cagrilintide.

So you can say six times more. So that, again, underscores the potential to get into that range of 15%-20% weight loss with petrelintide. And then, as importantly, we now have the first data set in thousands of patients being treated for more than a year with a long-acting amylin that has a very similar receptor biology as ours, which is a hugely de-risking event for Zealand because we are still early with our program. Thank you.

James Gordon
Analyst, J.P. Morgan

Sorry, the question to the person with the hand up there. If you could wait for the microphone one second just so everyone could hear it. Thank you. Thank you. I have two questions. One you just mentioned, people looked at in general, females look more sensitive to GLP-1 related drugs. Where do you get this conclusion? This is a question. Where did I?

I think it was the question about the weight loss by gender and the data to support men. I think it's the women lose weight more quickly versus men was the question. Right. Right. Where do you get the conclusion?

Adam Steensberg
CEO, Zealand Pharma

Yeah, but I mean, it's seen in all the programs. And I would also say we present data later in the year. It's a very small data, but you will see the same trend. And I would also say look into the clinical studies that are being conducted. You always see, let's say, 70-plus% females. And that's by design, not by coincidence. So the data out there to support that females lose more weight on the GLP-1 class.

We don't have robust data yet for the amylin class, but I would say the observations we had in our small studies should support that it would be the same phenomenon.

James Gordon
Analyst, J.P. Morgan

Another question is, you just talked about when patients are given GLP-1 related drugs, when they go to the restaurant, they couldn't suffer the environment.

Adam Steensberg
CEO, Zealand Pharma

Could you hold the microphone like that?

James Gordon
Analyst, J.P. Morgan

Oh, yeah. Thank you very much. You just joke about when people are given with GLP-1 drugs, they couldn't suffer the restaurant, they couldn't go there, right? And I totally agree with you. The preservation of the present sensations is very important for patients. But have you looked into how much appetite has been left when people are receiving your drugs? How much? How much appetite? How much appetite has been left?

Adam Steensberg
CEO, Zealand Pharma

It's a very good question.

And these are pretty rough scales that you still have on, you can say, how you report appetite. So we don't have the data yet. But I also, again, remember there is a short-acting amylin pramlintide, which has been on the market actually and been around for 20 years. And there were a lot of small studies done at that time that kind of evaluated also in humans how it affected eating behavior. And if you take animal studies, what you see is that they will not change the meal. You can say they will keep the same eating frequency. They will just eat smaller meals. So it kind of underscores that observation. So a lot of this also has to do with, you can say, personal reporting. But with the old pramlintide studies, there were data that were generated also in humans at that time.

James Gordon
Analyst, J.P. Morgan

Question from the lady in front, please.

Quick question. You've cited that you think the reason why the cagrilintide arm didn't do quite as well as what you expect for petrelintide is because it's underdosed, if I understood correctly. But there also appears to be a suggestion that as you go from, I think their data initially was at about 36 weeks to 68 weeks, there wasn't a material change in the weight loss profile as you would normally see with the GLP-1. How do you think? Because I'm thinking about your target profile, and on the one hand, you adjust for having more females, and I get that. They're much more compliant. On the other hand, you're going to have a much higher dose, but just what about the improving weight profile over time?

Adam Steensberg
CEO, Zealand Pharma

Yeah. I mean, it's again important to remember this was a Phase 1 study.

We didn't include diet and exercise, and this was also relatively lean individuals. So there's a limit to how much weight they can lose, I mean, unless you want to start to lose muscle. It would be only natural that you start to see a plateau here in particular because we also did not have diet and exercise. The best place to look is probably into some of the studies that Novo have reported in Phase two with cagrilintide, where you will see continuous weight loss. They get north of 10% over 26 weeks with higher doses of where they implement diet and exercise, and they also have a more obese population, which we will of course also have in our Phase two study.

I think another thing which may have been overlooked, if you look into some of the data that has also been presented with cagrilintide, even at the lower dose of 2.4 in patients living with diabetes who are known to not have a lot of weight loss where they get on a GLP-1, the low dose of amylin of cagrilintide actually provided 40% more weight loss at 32 weeks compared to semaglutide. We believe amylin will be an even more effective though category of weight loss medications for people living with diabetes compared to the GLP-1 category. The potential from a weight loss perspective is great, not only in, I mean, also in patients with type 2 diabetes.

James Gordon
Analyst, J.P. Morgan

Could I ask in terms of partnering? If you could remind us where we are with petrelintide partnering, what still needs to happen?

Do we need any more clinical data from your point of view, or is there any more Zealand data or any other competitor readouts, or is the path now clear?

Adam Steensberg
CEO, Zealand Pharma

No, I mean, we have started the process and we've been pumping around that, and for us, it was important to make sure that all large pharma companies got like the story that how we see the future, and I think we have spent some time on that. I think we are exactly where we want to be in the process. I think we have generated significant excitement, and I think it's again back to if you are a large pharma company who are not deeply invested in this space yet, it's not difficult to see that it would probably be a good idea to be there.

But it's also quite frightening if you want to compete within the GLP-1 space because it is you have two giants who are extremely well established and they will have significant data there. So with us now that we come and present an alternative, a new novel category that has created, I would say, significant excitement. And we believe this will become a very competitive process. That's where we are right now. We have also, as I shared before, secured enough financials so we are not forced to do something. So you can say for us, we recognize we need to have a partnership and we also feel strongly that we will get one at the right time. It's the significant interest, but we also don't want to rush things. Remember, this partnership from Zealand's perspective is going to define the future for us.

We believe we have what could become the leading molecule in the leading category for weight management. And such an opportunity you don't see often in our business when you consider the magnitude of the obesity pandemic. So we really, really want to do this right. And we want to make sure we partner up with somebody who shares our vision for this, who have the, you can say, who also want to win. We're not interested in just playing in this space. We want to win in this space in the 30s. And we see very good feedback and see some progress, some great discussions right now.

James Gordon
Analyst, J.P. Morgan

There's a question over there, please. Oh, so one that was to that one and then that one. Yeah.

Hi. Could you comment on the opportunity for an oral drug here just in terms of how much share that could take for the market and for you as well?

Adam Steensberg
CEO, Zealand Pharma

For me personally, it's one of those statements again, like it's again at one point we need to have a little bit more mature view on what is it we want to achieve. Just as we have been discussing who gets the highest weight loss. I mean, a patient doesn't care if something gives them 2% more or 2% less. It doesn't matter to the patient because if you have a good response, it's fine. If you don't, then you're in a category where you need something else. When it comes to oral therapies, of course, it sounds great to take an injectable and make it into an oral, a small molecule, easy to take.

Number one, we have to remind ourselves that once a week injection is actually quite convenient because then you can forget about your treatment for the next six days, and we know how motivated obese individuals are to get on treatment, so it's not a barrier to get on an injectable. Number two, an oral GLP-1 does not remove the biggest issues for the GLP-1s being GI side effects. If anything, I would say the data so far suggests that it would even increase those side effects, and it's not because of injections that people stop taking these medications. It's because of side effects, so will they play a role? Yes. Will they revolutionize the opportunity? I don't think so.

James Gordon
Analyst, J.P. Morgan

Thank you for the presentation. I had two quick questions on your intended Phase one B trial in combination with GLP therapies, which you mentioned on the first slide.

First, it's not mentioned here on the timeline for 25. I assume that's because it's kind of in flux when that would begin. Curious what the puts and takes are or what might lead into that being initiated quicker or later. So that's the first part. And then the second question is, when you're designing the Phase 1b or thinking about the right combination partner, is there anything you're looking to see from the full Cagri Sema data that's going to help you determine anything about the trial design or the combination partner? Thank you.

Adam Steensberg
CEO, Zealand Pharma

Yeah. On the combination study, I mean, with what we have seen from CagriSema and other things, we know it will work. I mean, any preclinical study where you combine an amylin with a GLP-1 provides additional benefit for us. It's really for what we want to learn in the combination studies.

What we really think about is that why would you take the most effective drug of something that is quite intolerable and then add a tolerable drug, a low dose of a tolerable drug on top of that? We would rather turn it around and say, let's identify the most effective drug, most effective dose of petrelintide, and then perhaps just add a little bit of GLP-1 on top of that. So it's a little bit changing the concept 180 degrees because we do recognize the potential for those patients who really need the highest weight loss. The good news is even low doses of GLP-1, as we used to use in diabetes, they provide a lot of clinical benefits. You don't need to get into the obesity doses to see the clinical benefits.

We have known for more than 10 years that low doses of GLP-1 that are being utilized in diabetes are hugely beneficial for a lot of outcomes. So we rather turn it around, develop the optimal dose of amylin, and then consider a concept where you add potentially a little bit of GLP-1, a GLP-1 containing molecule on top of that for those patients who need a higher weight loss. At that time, that's also where most of such patients would actually move into a specialist prescription segment. It will be a more educated, more, you can say, yeah, prescriber at the specialist level who will take over, I think. And we don't provide timelines and we don't discuss which GLP-1s, but I think it's fair to assume that the first studies will be with a marketed GLP-1 because you want to keep simplicity.

James Gordon
Analyst, J.P. Morgan

Great.

I think given the time, we better wrap up there. But thank you very much.

Adam Steensberg
CEO, Zealand Pharma

Thank you.

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