ZEALAND PHARMA A/S (ZEAL) September 2026 Conference Transcript

Cool. Well, thank you all for being here. I'm James Maitchen from the Morgan Stanley Banking Team and delighted to have Adam from Zeeland Pharma here this morning. I guess over the next 30, 35 minutes, we'll dive into a number of areas across the portfolio. But maybe to kick off, we can start with a quick intro to yourself, maybe a short overview on what you're doing as a business, and then we can start to get into some of the detail.

Absolutely. Pleased to be here. And as Ceylon Pharma is a Danish-founded company, we've been 27 years in the making, and we are on a journey towards becoming a leader in metabolic health. In December last year, we kicked off our new ambition, which is called the Metabolic Frontier 2030, with an ambition of having actually five products on the market in 2030, having a pipeline of 10 clinical programs and then also having industry-leading times from idea to clinic. So we are on a very, very, you can say, ambitious journey towards addressing what we believe is the biggest healthcare channels of our time. Not only the obesity pandemic we're seeing, but all the health consequences that follows obesity.

So going beyond weight loss, looking into how we can help people improving their health spand, living longer with a healthy life the way people want to live their lives that's what motivates us and we are on a good journey towards delivering on that Okay, great Now, very exciting times for yourselves and for the broader industry You hinted at it with how the market's changing and clearly you was really one of the leaders within amylin biology and all the benefits that that makes which is really cementing it as one of the the leading next generation mechanisms in obesity. Can you maybe dive into a little bit more detail on why the profile of amylin is so well suited for obesity patients and really how it starts to meet the needs that consumers are needing in the market?

Right. Now, we were, I guess, one of the first to kind of clearly articulate the need to introduce medicines for patients living with obesity that they can actually tolerate, and not only tolerate during the period where they're the most motivated, meaning the first few months where you lose weight, but also once you get into the weight maintenance phase. Because living with obesity is a chronic condition for most people, meaning that if you stop taking a treatment, you will rebound in weight and you will not get all the health benefits. So when we saw the profile of Petrenatide, we already at that time knew that we had something that would be a logical first choice, but also a product that patients would likely appreciate to stay on, overcoming the issues we see with the GLT-1s today where many patients stop within a month and after a year probably only 20% to 30% of patients are still on treatment, meaning we don't achieve the health outcomes. The interesting perspective when looking and thinking about the future landscape of weight management and treatment of obesity is actually, if I'm right here, it would not be dissimilar from what we have seen in other chronic disease areas. If you think about type 2 diabetes, dyslipidemia, hypertension, when we introduced the first therapeutic opportunities for these patients, we were always targeting the most difficult-to-treat patients, and it was often very cumbersome but also effective medicines. As the field then matured, you would see more tolerable, more easy-to-be-on medicines being introduced and actually becoming the therapeutic leaders and the go-to products for most patients, you also see that physicians start to treat earlier and earlier. And what we are actually starting to hear more so this year is that people say, why are we waiting, or physicians are saying, why do we wait with treatment until you get to the highest BMI? Why not start to treat when you pass the 27 or approach the 30? And that is completely in line with the positioning that we are thinking about. The trinotide, the amylin as a broader class that you want to start on a medicine that gives you the weight loss that most are looking for in the most pleasant way. And with PetrionSide, we have a profile which has delivered double-digit weight loss with a placebo-like tolerability profile. So we really think we are, you know, that profile is the profile that most patients would actually appreciate to be on. And only if you desire an even higher weight loss, you would start to think about combination products or getting on the more cumbersome guilty ones.

Okay, great. And I guess that profile is now really starting to emerge with your positive Zupreme 1 data, which emerged earlier this year. Can you remind us all in a little bit more what came through from that data and then really translating that through to clearly going into the pivotal trial, the design of that, and the way that you're thinking about optimizing that route to market?

Absolutely. So it was a pretty comprehensive Phase II program, testing five different doses of petrinitide and also with a lot of patients in each arm, including a balanced exposure to males and females. So we have a very good understanding of how the product behaves, also at the different dose levels. So we are moving into Phase III together with ROSE now with a lot of confidence that we actually have the dose setting right and also that we understand the profile of this double-digit weight loss and placebo-like tolerability. So the focus of the program will, of course, be speed to market because we think it's important, of course, to be among the first to launch into a new category and help defining the amylin class as a first choice, the apuretic class. One of the things that really excites me but also where I know we may still be a little bit ahead of the curve is this thing that if you ask patients, four out of five patients would give you a weight loss number below 20%. So most people are looking for weight loss in the teens. Very few are actually looking for weight loss above 20%. However, many companies and many working in this space have been focused on what I've addressed as the Weight Loss Olympics, being excited when you saw a higher weight loss number, not realizing that that is actually not what patients are looking for. Even with the current use of the GLP-1s that are available today, most often the average dose is half what is approved, meaning that patients never get to those impressive weight loss numbers because they're not interested. At the end of the day, we need to develop medicines that fit the patient's lives, the lives that patients want to live. We cannot think about managing the obesity pandemic And if we require people to fit the lives of a product, it has to be products that fit the lives of patients.

Okay, great. And I guess that translates through to really, there's clearly a commercial edge that's coming with tolerability of different agents. Where do you think that will be once, roll a few years into the future, once Petri is on market? Really, how do you think consumers are going to start to differentiate between medicines and really make those choices?

I think we are already starting to hear the conversation that more people are starting to kind of articulate that the next battle is actually not going to be who delivers a few percent more weight loss. It's going to be around who can deliver the weight loss that patients are looking for with the best tolerability profile. And the one thing that could actually cause a change in perception faster than what you would normally see in other chronic disease areas is that we know that patients are so engaged in this category. So I think it's like around 60% to 70% of all Scripps, it's actually a patient-initiated conversation. So it's a patient who goes up to the doctor and says, I would like to get on a weight loss medication, and I would like to try this product out. So if we can think about a product now which delivers the weight loss that patients are looking for, but in a more pleasant way, where people can actually feel great when they're losing weight, That is a situation where we would envision that the conversations on social media would be very, very firm early on, so you could imagine a take-up that would be quite dramatic because patients are so engaged, so you don't need to go through the normal channels that you normally would launch with focusing on Tier 1, Tier 2, Tier 3, key opinion areas, and then you get to primary care physicians because the patients would drive the narrative around wanting to be on a product like this.

Okay.

And I would also say the other thing which excites us is that we think with Petrenetide, if the profile that we have seen thus far comes true, it will also be a product which will allow patients to stay on therapy for longer. And if you start to think about capturing new patients but also having them to stay on for longer, then that's where you can actually drive up volumes and ultimately value for this category. But also, in the end, truly address the obesity pandemic and all the disease that follows.

Great. No, super exciting. Super exciting. Maybe let's, we talked a bit on mono. Let's maybe think about combo as well. As a reminder, you obviously have the Zynergy Phase 2 trials starting as well in combo with Roche. Can you maybe speak a little bit on aims with that trial, what you're looking to demonstrate, and then translates that through, link that back to the commentary you had before of decision between mono versus combo therapy and how you expect that will evolve over the longer term.

Absolutely. And when we did the partnership with Rose, of course it was important for us to have shared economics, not only on the petrion side opportunity but also on the combination so we could really, in a consolidated and shared effort, build the franchise leadership around petrion side that we are aiming for. So with the combination product, it's a unique opportunity to deliver the strength of each individual molecule. But when you think about combination therapies in the future, you also have to acknowledge that these should be products that are provided to patients who can benefit from both modalities. And just as one example, even in today's market, 15% of patients don't respond to GLP-1. So you also don't want to put such a patient on a combination product. So when we envision what the combination product should do in the future, it's around providing additional weight loss or metabolic benefits for those patients who have already benefited from one of the two components that are within such a product. That's a logical positioning. That could be patients who live with obesity and type 2 diabetes. It could be patients who may be coming from a very high BMI status and thus ultimately requires the deepest weight loss. Once they have started their journey, they may get onto a combination product. So it's really an opportunity to expand not only the amount of weight loss you can achieve, but also perhaps how you address certain comorbidities to obesity.

Okay, great. And trial just starting to get up and running, and maybe a little bit on what the aims are on that trial too?

So it's a clear dose-finding study where we are trying to find the right balance between the one DIP component, meaning CD388, and then the amylin component with petroentide. And it could ultimately also be different profiles for different patient segments. But for us, it's incredibly important to get the ratios right, a little bit in line with what we have talked about with petroentide. But if you think about this market in the future, you need to have the right molecules, not just molecules. And in particular, when it comes to combinations, we need to move beyond just trying to seek the highest weight loss if it comes at the compromise of tolerability. Very few would actually ever get to that in the real world. So we need to find the right balance where we also get the right amount of weight loss when you still consider tolerability.

Okay, great. A little bit more on Roche as a partner And I guess as a reminder, this was a $1.65 billion upfront partnership over $5 billion in milestones and, importantly, the profit share on both the mono and the combo, as you mentioned. Can you speak a little bit around why Roche is a partner? What were the attributes there that really excited you as you stepped into that partnership and selected them?

It was a highly competitive process when we were partnering out with Petrinitide. And what really excited us about ROSE at that time was both Thomas and Teresa's very strong commitments when we spoke with them around how they wanted to be a top three player. They shared their plans around how they wanted to establish a strong manufacturing network and all just where they wanted to take the company. And I must say that I'm extremely pleased to see that everything we discussed at that time has come true. I mean, I think people who follow LinkedIn can see how they are investing in manufacturing capacity, and also I think they've started to be more public in their kind of commitment to how they want to lead in this space going forward. So among all the large pharma companies we spoke to, we just sensed the strongest commitment to actually come in and make a difference for patients in this new category, which I would still think is a new category. Remember, we are four to five years into treatment of obesity and weight loss. So while a lot of people may think these treatments have been around for a long time, it's really novel. We have one category, more or less, with the DR1 class. We have 3% to 5% of patients being treated today in the U.S. There's so much opportunity to come in and lead if you want to do things differently. And that was what we heard from Rose, that they wanted to come in and drive innovation in this space, not only when it comes to molecules, but also how you go to market, how you secure the most effective manufacturing. And that's what we see in the partnership.

Okay, great. Noel, great partner. We'll see how Teresa addresses it over the coming weeks as well with their respective R&D day. Let's turn to second asset within the portfolio, still on obesity versus the other areas, and clearly a different partner with Boehringer and Servodetide. can you maybe frame that as an asset how that is distinctive from the Amalyn where you're looking, where you and your partner see the greatest potential of that product so Servilatide is a licensing agreement we made with Berger so they're fully responsible for the clinical development and commercialization so we just have high single to low double-digit royalties which is a nice situation to be in in particular because Servilatide And we just saw the first data here from the Phase III program here at ADA this year.

It looks to be a very, very strong G1 glucagon molecule when you think about not only weight loss but also metabolic health. What Berger showed at ADA was that while they achieved around between 16% to 17% weight loss in the Phase III program, Most of that weight loss was attributed to losing weight, losing fat, getting fat out of the liver and the intestinal fat, which is normally seen as the bad fat, if you will. So it was predominantly liver and visual fat that was lost. And they also showed data that there was only 10% muscle wasting or muscle loss, which is in contrast to the 20% to 30% we have seen from other GLP-1s. So I think they have a molecule here with cervidotide, which is really going beyond just weight loss and addressing the metabolic health that we're actually all trying to achieve with these weight losses. So we are super excited, and we know Boehringer is super excited about the prospects of cervirotide. And as they say, you see obesity, think liver, because a lot of the metabolic disturbances you have with living with obesity starts in the liver. And if you can really get fat out, that's a major event. They also report the rest of the phase 3 program this year in obesity, and then they have a large program in MASH, including end-stage liver disease that will weed out in the coming years and will hopefully help further underscore the potential to address some of the underlying organ defects that you see with long-standing obesity. The other thing which we are pleased with the partnership is their continuous commitment to invest into the program. So earlier, I think in August, they announced that they started a phase 3 study in type 2 diabetes to really, with the aim of expanding, I guess, the label universe for cervirotide And sometimes in this world of obesity treatments, we forget that the DR1s are still generating more revenue within type 2 diabetes. So it's nice to see that continuous investment. They're investing in women's health. They're investing in heart failure. So they're doing additional studies to really support this product.

Okay, great. So multiple indications and really then looking to de-risk the Pivotal program over the next year. And the MASH data, that comes through the course of 27?

You know, if you look into clinicaltrials.gov, that could be one guess. They will inform the market once the data is there. Okay, great.

Let's pivot again. Let's turn to rare diseases. Clearly a number of products that you have there which are in late-stage development. Let's start on dasoglucagon, clearly in development in congenital hyperinsulinism. Can you frame that as an asset, the strategic value of where the product is and how you think about that asset over the longer term, particularly with the resubmission coming up?

Yeah, so congenital hyperinsulinism is a devastating disease in neonates and small children who are born with this genetic effect where they produce too much insulin, and thus they end up with low blood sugar and really high risk of brain damage. And in a lot of these children, which is still an also rare indication, but for a lot of those who are diagnosed, you cannot surgically remove the affected areas. So they live with these hypoglycemic events and need to be on frequent IV sugar and what have you in order to not get into hypoglycemia. So it's really a devastating disease. And we have a Phase III program now, and patients who have been on treatment for several years demonstrating that we can ease life for these patients. We can basically reduce the number of hyperglycemic events and allow, you know, perhaps families to sleep a little bit more through the night instead of having to wake up every two hours and feed their children. So it's a program that we will resubmit to FDA here in the second half. We hope to have it approved next year. And in parallel with that, we are engaging in partnership discussions. While we do have a commercial ambition that is really focused on going to market with our patronatide alongside Genentech, targeting a large consumer opportunity for the rare disease assets, our ambition is to establish a partnership with a dedicated rare disease company who can help us reach as many patients as possible, starting with the U.S., but we have a global effort on CHI as well.

Okay, understood. Similarly with glepiglutide, your short bowel syndrome asset, can you remind us all there where that stands? I believe the second phase three trial is now ongoing. And similar question, strategic value of the asset versus financial value as you bring this forward?

It's another rare disease asset where we have invested a lot and we have a strong commitment to get improved therapies out to patients living with short bowel syndrome we have just earlier in the year started the second phase tree study to support regulatory approval in the u.s based on feedback from fda so that is up running and recruiting in parallel last year we submitted the file to for for eu potential eu approval and we should hear back from eu this year so for potential approval in the EU. And again, it's an asset where we want to find a partner. So once we have a little bit more progress in these aspects, it could be later this year, we will start partnership discussions and make sure that we are reaching as many patients as possible to a partner. For short bowel syndrome and in particular for glipactotide, it is a market where today, I think, with the short-acting deal, the one that is available is north of 1 billion in cells, so it's a decent market where, you know, we think with glipacotide, if approved, it really provides a significant improvement over current therapies in that it's a very easy injection, and we have also been very pleased with the clinical profile of the product that we have seen thus far, so it's another asset where you can say it's not one which we would where we would invest in bringing it to market ourselves would we would seek a partnership which of course could help us expand the reach and the value of the opportunity.

Okay, great. I'll jump again. Let's go to your early, and I'll come back to obesity once we wrap up, but I guess earlier research efforts started to move into inflammation with a compound going into the clinic. Before we touch on that, maybe just ambitions and how you think about those earlier stage research efforts with a bit of a broadening of the pipeline.

We are hugely ambitious on the early pipeline. So we hope to have five products on the market by 30, but we also hope to have a pipeline of 10 clinical assets, which should arrive from our research effort. So we have really stepped up our research efforts in the past few years. And just to put it into perspective, in the coming four or five years, we're going to spend five times as much on research alone as we did in the past five years. Actually, we're going to invest around 800 million U.S. dollars into research alone. We have a very strong group in Denmark, which is where we're founded. In a few weeks' time, we're actually going to open our Cambridge, Massachusetts research site, which will be equally sized, and we have, I would say, probably 20 to 30 of the people who are going to work there already signed in, so we are ready to hopefully start the first experiment quite fast. There we're going to go beyond peptides, which is where we have historically been mostly active and into other modalities, really leveraging where we see ourselves having a competitive edge in the metabolic research. Not many companies have as much data and as deep understanding in metabolic pathways as sealant, so we will utilize that knowledge, while we will collaborate with modality leaders, do more partnerships just as we did with OTR last year and small molecules. We expect to do partnerships with other modality-based platform companies within the metabolic space to continue to invest. So after investments in between time, it is our key second priority to invest into the pipeline to make sure we continue to innovate and have the products of the future as well.

And I guess the first thing coming out of that is the KV1.3 blocker. In going through the SAD, the MAD now starting to get going, and clearly just given the mechanism broad potential across a range of immune-mediated disorders, um how do you think about that program taking it forward yourself versus maybe a partner in due course and also just indication selection um as i mentioned broad range where do you think the biggest potential and where do you want to take it it's really a super exciting asset which has this pipeline in a product potentially you can you have free there's pre-clinical evidence for almost at least all the autoimmune diseases i can name so of course it's going to be important

to select which one you are going for and in which kind of order. Earlier this year, we initiated a Phase 1B-2A study, a smaller study in patients living with sororities, just to see if we can get the first biological evidence. Now we have already seen engagement on the biological pathways we are targeting in our early exposure, so we can see we have receptor engagement, and we can see we are affecting the immune pathways that we are hoping to see, but could we also pick up an early biological response in patients with psoriasis? We will soon also start another smaller study and another indication. But ultimately, it's also a program where we envision to have it in a partnership with a more established player in the autoimmune space because it is complicated studies, and again, if we want to invest in multiple parallel programs, It's a partnership that we are looking at. So one which is a little bit outside the focus of our other early efforts, but one which could really hold a huge potential in a broad range of autoimmune diseases.

Okay, great. Let's turn them back, and you started talking on it with Metabolic Frontier 2030. you mentioned you remind us ambitions there really how broad you are thinking on taking the business and that big vision and then we can go to partnerships but first of all yeah so we if you think about where we will be in 2030 it's of course our hope that we will be launching our first product alongside Ross Genentech into a very consumer driven market and so we are investing in building what we can describe as a

fully integrated presence including commercial presence to support such a launch in a so so that that reflects our ambition to actually come in and play to become a key player in the metabolic space not only when it comes to early innovation and research and development but also being out there addressing customers in the end the problem that we are looking into when we think not about obesity but all the consequences of how obese the world is becoming with all the metabolic diseases that follows simply requires new ways of going to market, it requires new innovation and we are here to actually take our part in addressing that need, we think we are uniquely set we think it's actually also a unique moment in the history of addressing these kind of metabolic diseases because for the first time we are in a situation where there is actually a huge alignment with what society needs and what each individual person is actually looking for. So we are getting into a situation where preventive medicine suddenly can become reality, something people have talked a lot about, but now we are at that time where preventive medicine can become a reality as long as you develop medicines that fits into the lives of people and you find ways of getting these medicines to people so they can actually stay on them. And that is what excites us as a company. We think we are uniquely set up also with all the changes we see in the data, AI and platforms of how you can actually ultimately reach patients. It's a unique opportunity to actually go for a market like this. Historically, it would have been almost impossible to break into primary care as a newcomer because of the size of the organization you would need. But these things are changing so much, so rapidly these years, and we think it speaks to our benefit that we actually can come in and innovate and participate in getting the products to the patients.

And that sounds like both with partners and internal, you had your partnership earlier this year. I guess why them as a partner? What did they bring as an organization to really fill in the vision or help support the vision that you're bringing forwards? and is this something that you're really looking for as you think about further partnerships?

I think, and this is not only with regard to obesity, but the biggest barrier to success and to innovation is if you think that what you have is what will also make you strong in the future. And when you hear Teresa and Ross talk about it, they talk about innovating, doing something novel, not trying to pretend that there is a primary care sales organization that worked in the 90s that will also be beautifully set up to deliver in this space in the future is about innovating and doing things differently and that's what I hear when I speak to Ross and Janencek that they are here to innovate and then a very strong commitment to lead as both expressed by Thomas and Teresa and that's why they're such a strong partner for us because of course they have a global footprint so you can kind of tick box all the those elements but then the desire to innovate and deliver novel ways of driving a deep sense of wanting to make a difference for these patients and help address the metabolic consequences of where we have gone as a society is what makes them a strong partner I think we fool ourselves if we think that what made companies successful even in the past five years is also what will make them successful in the coming five years because of the changes that we are seeing and we are here to tap into those well it will be a fun next few years let's put it all back together kind of big picture the most important I guess catalyst as we go through the next 12 to 18 months that we all should be we should be looking for I mean we are of course super excited to get the phase 3 program kicked off so people can sense a little bit more reality see the progress in recruitment and getting close to the market with petrinotide. And then we have additional data from a smaller Phase II study with petrinotide in obese individuals living with TAP2 diabetes that we'll read out later this year. We have the COMBO study that is kicking off. And then for cervirotide, we have further Phase III data, including the CBOT study, the cardiovascular outcome study with cervirotide that should read out later this year. and of course at one point the MAS program which is really what could significantly differentiate the cervirotide acid compared to some of the other tiered ones out there then there's the early activities including KV1.3 there's the rare disease programs AMA decision on GLIPA, getting the CHR resubmitted to FDA potential partnerships so there is I would say a very deep and rich set of news flow approaching us in not only the next three, six, nine months.

Great. Well, with that, I think we're coming up to time. So thank you for that. Thank you for being here. Hope you have a good rest of the conference, and thank you.