Zealand Pharma A/S/ADR (ZLDPF) June 2026 Conference Transcript

Brilliant. Thank you all for coming. Today I'm joined by the Zealand team, both Henriette, CFO, as well as Uppal, the CSO. We've got a Q&A lined up that we'll jump straight into, but I mean, I think what's perhaps most interesting to me from here is back in December, you did talk about a metabolic frontier 2030 strategy.

Do you want to talk about what progress you've made, probably for Uppal, for you to begin with here? what progress have you made on the on the research side um and what kind of research are you focusing on going forwards from here and then we'll dive right in with the assets after that that we can talk about yeah no thank you for the question i think on the metabolic uh frontier there are really three approaches that we have there first very much continuing our focus around weight loss but looking at non-aversive pathways so that you can continue to get a double-digit weight loss better tolerability and continue to look at outcomes but what's the second pillar is the one that I think is really counterintuitive and one that I don't you don't see a lot of attention in but one that has been a central thesis for us folk going forward is around the improving metabolic capacity and metabolic flexibility and this really gets into the whole insulin leptin access and thinking about the weight independent insulin sensitization if you think about where pure good zone and others had delivered the outcomes if it weren't for some of the adverse events that came along with that target-specific biology, those outcomes were unprecedented and something none of the incretin-based therapies have really been able to deliver. So the idea is how do we continue building on obesity but also get to weight-independent insulin sensitivity that addresses broader metabolic health? And finally, the third pillar is recognizing with the science that's evolving and breaking in the space is much of peripheral metabolism is actually controlled by the brain. So starting to think about targets that are shuttled directly to the brain to control our peripheral metabolism. As we do that, we recognize that peptides will still be our core, but that platform has to expand. You saw our first push into that early or late last year with signing our deal with the small molecule company and China very much focused on developing oral therapeutics for validated targets. You'll continue to see more efforts on the business development side, focused on research partnerships to expand our platform. We're starting to build out our capabilities in Cambridge, very much focused on starting to go into adjacencies of peptides with antibodies, antibody peptide conjugates, to expand the pharmacology that we can exploit.

It's super exciting, there's a lot to go into. I do want to dig into the early stage stuff at the end, but I think we first have to begin with what is perhaps most topical going into this weekend at ADA, the first of which I'm going to start with is petrol inside, so the AMLIN side of things. So starting really broad, we've had the phase two top line data. What is it this weekend that investors should be thinking about into that presentation, and what would you advise us that we focus on?

Okay, so I think, look, what's remarkable at ADA is not only petrol inside, but also so the server-to-tide data readouts. And if you think about a company our size, to have two practice-changing medicines read out at the same conference is pretty remarkable. I think on petrol and tide, I think really just seeing more color coming out of our Zupreme study, and I would point out I think the tolerability profile that you see there is really going to drive adherence on that. And I think as you've seen lately, there's some really interesting publications publications that talk about how it takes a while for a lot of the cardiovascular outcomes to take shape for people on these therapies. But once they're off therapy, within six months, they're all gone. What we see with amuline-based therapeutics is patients will stay on therapy for a much longer time.

And the thesis around tolerability has borne itself out, seeing just game-changing acceptability, placebo-like acceptability and tolerability in our phase two studies so you'll see a lot more color commentary around that super useful I mean let's let's do it let's stick on ADA then you mentioned servo I don't mean to jump between assets but I think we should address it as well we get to two readouts there in the symposium the synchronized one and this synchronized mazel d as well and my understanding is you guys haven't seen any of that you're still to see it for the first time given it's under the partner but again what is the focus there for what you're looking for to build confidence in your royalty stream and payments going ahead in those presentations?

So maybe I'll start on the science, then you can speak. But look, I think BI has not been very public or very vocal about this asset. And to me, I've been tracking this asset for a while, and I think it's really the hidden gem in the industry. I love their framing, and I think the framing really speaks volumes about see obesity, think liver, treat heart. I think the market reacted to a 16.6% weight loss, but the reality is that misses the point of what else cervidotide brings in. The glucagon component really results in this being the first in class for a U.S. launch of a GLIP glucagon, point number one. Number two is the fact that that glucagon component isn't coming in with a hammer, but you're just touching the receptors, a 10 to 1 balance approximately between GLP to glucagon, and it's directly acting on the liver. So the MASH data that you've seen coming out of phase two is just truly remarkable and something that none of the current GLP-1-based therapies achieve. So my encouragement is continue to think about some of the data readouts on obesity, but also pay close attention to what you see on liver and then continuing data readouts into next year and beyond for some of the outcome studies where they're running one of the largest liver outcome studies in the industry to date.

On the royalty side, anything you're specifically looking for to build that confidence?

I think we have great confidence in that asset, actually. And I have to say that, I mean, Berger is going to be a third company to market in this field, but they're truly differentiated, as Utpal also put it, GLP-1. So one thing is, of course, the treating obesity. Another thing is all the comorbidities they're positioned up against. It's right we don't have any insights into commercial rollout plans. If you look at the clinical trials they're conducting, they can file as early as end of this year, meaning that they can actually launch and put the products into the hands of patients next year. And, of course, then we will see the royalties coming our way. We have high single digit to low double digit royalties on the product.

So, clearly, the data we saw both from patrilatide and, of course, savudutide was two major de-risking events from a clinical point of view from our side and it feels like we talk about in the in the upcoming ada synchronized one a lot but there's also synchronized masal d so do you want to just briefly touch on what that's actually going to tell us um in terms of the liver side of things and how that could build confidence going into the liverage programs that we may actually see next year or or slightly further on yeah so look i think a large percentage of patients living with obesity also have MASH.

So I think if you start thinking about that Venn diagram, this has a huge opportunity. So I think it comes down to, across both of those studies, is this is not just another me-too obesity therapy, but it actually addresses a lot of the comorbidities that current GLP-based therapies aren't able to meet through the glucagon component acting directly on the liver um i think look we'll see the data for the first time much like you guys will so we're just as excited as you are to uh see that at ada good so that look that's that's ada cleared off let's talk a little bit more about petrol inside then and and go into that so we've got the phase two headlines as we said we get it at ada ultimately what are you looking to uh to see in a phase three

study with your partner rosh that will build your confidence and where this is going to be positioned ultimately i think basically we just need to confirm what we saw in in phase two i think what we saw was was clearly a safe molecule tolerability that is not seen with any other molecules out there a extremely clean profile and then delivering weight loss double digit which is most but what is most look is actually looking for a today so i think of course phase two we're extremely happy with the data we we had at hand and the and then there are different levers we can pull in the phase three to optimize of course the study design and so of course we're going into a phase three there is always the gender balance you can you can actually get more females into the into the study we will do that as well we will have a longer duration of the study and and then of course it's also down to to side selection so so all together i think if we can confirm what we had in the phase three maybe get a bit more efficacy out what we also said is to to get into the teens but clearly we need to confirm the tolerability profile. This is the position of the product. This is the differentiating angle coming into the market where you will actually launch a product which people can stay on for a longer period of time. The main issue today is that people drop off. 80% are off treatment within the first year, and within the first month, 30% is actually off treatment. This is a major issue, and not only to achieve the health outcomes, but also because then people get this yo-yo effect in terms of bouncing off an arm and get this in balance. So we need people to stay on treatment, and I think this will be the solution that you... and the first choice that many can actually start their weight loss journey on.

It's a very clear idea that you've set there about the positioning of amylins overall. I guess if I had to push you and say, for petrolintide itself, what would you point to that differentiates it from other amylins, perhaps? And can I go even further than that? Is there a consensus yet about whether we should have dual targeting approaches or biased approaches and where that sits now in the scientific community?

Yeah, so look, let's unpack the last one. I mean, this is one that obviously we can write a dissertation topic on this and we could talk ad infinitum on this. But the reality is we could talk about receptor selectivity. At the end of the day, it's academic because from a patient standpoint, they don't care. What patients want is double-digit weight loss and tolerability. What we see is a dual amylin calcitonin receptor agonist, a dual balanced profile, is able to deliver the unprecedented tolerability. At some of the higher efficacious doses, we're not seeing any vomiting at those doses. So the reality of it is the balanced profile is able to deliver value and deliver outcomes to the patients that they're looking for. That's point number one. Number two is I would remind teams that people to think about the GLP-1 biology. It took 40 years to unravel that biology. And every five years, there's a new molecule where a new molecule helped you understand the pharmacology that then helped you get a better molecule that helped you understand the pharmacology. And that cycle continued every five years for about 40 years. I think what you're seeing now in amylin is after the first generation amylin therapeutics, there's been a 25-year lag before the next one's going to be approved. So there's a lot that we're going to learn from the clinic. Finally, I would say from a differentiation in the class, I guess I would point out for petrolentide, if you see across 600 patients that we've looked at from phase one and phase two, we have seen exceptionally clean profile. There's been not a single safety finding or an adverse events of special interest. I think that alone differentiates it relative to what other competitors are in this class. and I think that's where we're hanging our hat on is around the clean safety and exceptional tolerability.

It's very clear and I guess if I push yourself to have a think about the obesity market that we're going into I think some of the big debates we're having at the moment is perhaps one around pricing so how do you plan or think about pricing going three to five years ahead and the second is also about this consumerization angle as well so is that something that's a key thought in the way that you run the development programs with Roche so clearly on the latter part clearly it is I mean we see that this is consumer driven the majority of all scripts today are initiated by by the patients and by the consumer and I think especially patriline type fits nicely into that because we what we are looking at is the patient experience that we actually

don't look to to provide a product that you can actually stay on and you can actually enjoy your life but you can still achieve the weight loss you're looking for. Not having all the GIAs and side effects, which you probably would live with today, but the solution that is out there. So clearly, we have the consumer center of everything we do and we need to prepare our launch and our pre-launch commercial activities based on that to say how do we actually capture that experience the best. Then you can say on the other question around pricing, clearly the price erosion we have seen over the last couple of years has been faster than I think most expected. But I will also say when we were sitting there and negotiating the deal we did with Roche and going through that process and doing our modeling work, we did expect prices to come down. But we also expect volume to be a very different place than where it is today. And there is a number of factors that will play into that. One thing is today you only have very few solutions in the market. You now see oils launching with great speed, great uptake curves, also expanding the market. When there is new modalities coming in, like amylin, there is also an opportunity, of course, to expand the market. So we will likely look at very different volumes also when we are to launch. And a key component of that is, of course, also that people stay on treatment. So number one issue today is that you need to capture a majority of your patient almost every month, 30% dropping off every month. Then you need to capture that the next month just to stay on the same volume base. So if we can have patience to stay on, of course, that is one element of actually changing that dynamic. And then what we can control today, I will not comment on what the price point will be when we are set to launch. We will price based on value. So what are people willing to pay and what benefits are we delivering? But, of course, what you can control today is your cost base. So how do you build up your production facilities? How do you optimize that you actually can work with your cost of goods? And how do you get scale into your marketing? And that's back to the volume game. So all of that is what we actually are preparing for right now in order for us to be ready to scale and have flexibility as we launch the product.

Very clear. So I think that's a really good summary of obesity. There is another side to this development program, which is obviously Zupreme 2, which is more on the type 2 diabetes side. So do you see amylin as having a role for diabetes, for type 2 diabetes? And what could we learn from Zupreme 2 that could build that kind of confidence that you could have?

Yeah, so certainly we'll see, you know, we've seen with GLP-1-based therapies a significant drop-off in efficacy between patients with obesity and patients with type 2 diabetes. We'll see how that translates for amylin-based therapeutics. So that will certainly inform what we do with that going forward. Very clear.

And not only that, but there's also a combination trial phase two that's soon to be started around middle of this year. I think we're going to get some more details from your partner around ADA about what that might look like as well. Is there anything, any kind of details or information you can think about how you're thinking about a combination approach going forward, given you also get the financials on that side too?

Yeah, so look, I think this is where the foundation is still the same, right? The focus is on tolerability. So you're starting with petrolentide as a backbone and then sprinkling on different amounts of CT388 to see how can you get the weight loss but not compromise on tolerability. So I think we're looking at three different ratios of CT388 and petrolentide. But again, the idea is to use, to maximize your experience and optimize your experience going forward, recognizing that some patients may want slightly more weight loss.

And on the financials, I mean, this is the beauty of the deal we did with Ross a bit more than a year ago, that this is a 50-50 co-promote deal. and we profit-share both on patrilite and monotherapy, but also the combination product with CD388. So we have fully shared incentives in putting these two products into the market and optimise the value.

And I think also it seems like it's building a bit of a franchise here, a bit of a portfolio around amylins, and you've seen some of your competitors go into different kind of approaches, whether that's longer, whether that's more molecules for orals. Is that part of the consideration going forward, and are you working on that now?

Yeah, absolutely. I think we talked about that at Capital Markets Day. We will absolutely have, we actually have programs internally focused on that. I think we recognize that, look, different patients are going to have different options, that they'll want different options. And from a Zealand standpoint, we want to make sure that we have a solution for them. So most certainly we talked about those, and those programs are progressing as planned. That's clear.

I think when we look historically, Zealand is very much seen as a biotech research and development company. There is this potential to opt in to the commercial side of things as well with Roche in certain regions. What are you thinking about when considering that? And is that something you see Zealand as building out and becoming more of a commercial biopharma, let's say, rather than the biotech we see today?

Yes, and that's, of course, a good question, which we have not really decided on exactly what to do yet. But one of the beautiful things around this deal we have with Roche is one thing we have 50-50 profit sharing in Europe and U.S., but we also have the opportunity to opt into 50% of the commercial activities. That will not change whether we get 50% of the profits. It's just a way for us to develop the company over time. And how much we decide to do that between 0% and 50%, time will show what segments, what would make sense for us to contribute, and of course what we are looking at together with Roche is to optimize the value of the assets, but yes, I think this is an excellent opportunity for Sealand to build out over the years, and yes, we have paternity as leading assets, we have more in the pipeline to come, and we are building a generational biotech that are here to last, so time will show exactly how we are going to play that out.

Yeah, that's clear, and I guess moving away from Amalyn, but staying around this kind of capital expenditure area. We recently saw the buyback that you initiated. How are you thinking about this capital allocation strategy going forward? Could you see more return to shareholders as these milestones come in? And what are you thinking about when making those decisions?

So clearly our capital allocation is actually pretty clear and pretty straightforward as we also communicate at our capital market day. It's about maximizing the value of Petrolatide. We are building a fan size around Petrolatide. to offer that to patients then it's about our research really expanding our efforts within research we are investing over the next five years 800 million dollars into this space so that's of course in denmark it's in boston but it's also collaborations we are looking at doing more collaborations across the field and then of course now we decided to hand back to shareholders 200 million dollars the rest of year here and we just had as a company two major de-risking events On the clinical side, so you would do tight, but also financial de-risking. Because, of course, clearly now on so you would do tight, we'll see royalty streams coming in from next year's. And patrillion tight, we just secured $700 million coming from Osh this year and potentially $700 million coming next year. So we thought the time was right to give it a bit back to shareholders. We have had many good long-term supporters, $200 million this year. And, of course, now this is the tool we have in the toolbox. and let's see exactly how we'll apply it. But we had the financial flexibility to do it now.

Got it. And you've had several early-stage partnerships ongoing as well. You mentioned some at the start. So perhaps could you give us a little bit more colour on how they're progressing? And could I push you to say, is there a time frame when we could see the first end of the clinic at all?

Yeah, so we're not going to speak to the timeline. I think we'll announce that when the time is ready. I think from a partnership standpoint, we're actively in conversations with a number of partners our focus is very much on the research platform to on a research front to expand our scope of platform as I mentioned earlier we're now started with being peptides with extracellular targets I think now we're moved into small molecules I think you will see in Cambridge and expansion both internally as well as the collaboration around antibodies anybody peptide conjugates but I think you'll see by end of this year, we will have a lot more tools in our toolbox than what we did 12 months before that. And a lot of that's going to be through partnerships, not just growing internal headcount to do that. So that's going to be part working with Henrietta to just very intelligently allocate capital to maximize our impact on the portfolio. But very clear, to be honest, when we're doing these research platforms, these aren't build it and they'll come. They're very specific problems that we're solving.

They're very specific targets that we have in mind and the idea is to bring tools into the toolbox directed at those targets that's clear and zealand obviously has much more going on than just kind of the obesity metabolic side of things you do have the rare disease assets still as well could you remind us where you are in the uh the progress of that and also seeking a partner how how is that progressing and what are you looking for in potential partners for those assets yes so uh glad you actually asked about Now, these two assets, which we tend to forget once in a while, no, they are progressing nicely.

And CHI, I mean, we actually look to file in the second half of this year, so it could be in the hands of patients already next year, which is, of course, extremely exciting. It's a program that's been on the way for some time, some hurdles, but we now have a path towards bringing it out to patients. We are looking for potential partners. Clearly, we probably need to see the file coming in and regulatory hurdles to be overcome. with the third-party manufacturer we had some issues with. We are transferring that entire process to a new manufacturing site, and that is progressing nicely. So we will look for a partner. It's a nice opportunity. Of course, it's also rare. So 800 patients in the U.S. It's small kids, but this is really changing their life. It's also ultra rare pricing. So, of course, it's a very nice opportunity that is soon to make it to the market. And then, of course, Gleper and short bowel syndrome, the same. We are progressing on the phase two, the phase three, the confirmatory phase three we are conducting. And let's see how long it will take to recruit. It's more difficult, surely, to recruit than in obesity. But this is truly a good opportunity, which we will partner out when time is right. I mean, it will be next generation. It's a market that is continually growing above 20%, and it's clearly an opportunity. You have Tequila down out there with Gatix, north of a billion dollars, so clearly a good opportunity for an exploration product. So we can progress it. We can progress to phase three, but when time is right, someone is ready to engage, we will do that.

That's very clear. And I guess there was initial chatter, I think, early in the year about KV13, Iron Channel Blocker. Talk to us a little bit more about that opportunity. When can we see the next data coming from that? Because I, again, think this is something that no one really talks about, given the focus on the other two big assets.

I could speak to that a little bit. But I want to add something that Henrietta said, and this was a reflection I had when I joined Zealand just a year ago. This is a company of 500 that will now have potentially two molecules into the FDA for approval by end of this year and two in phase three. And this is for a company of size of 500. and all of that were homegrown molecules. I think when you just take a look at the sheer magnitude of what that means, that's pretty incredible for a company of 500 in terms of what that innovation engine is. And that's one of the big reasons why I decided to come to Zealand was for that. I think on KV 1.3, you know, we've shared some of the high-level information, but there's a lot of additional insight that we gained from our SAD study that we will not be communicating externally, and that gives us a lot of confidence about some opportunities going forward. You know, rarely do you see a novel target in our industry that has the PK profile, the clean tox profile, safety profile, as well as some interesting PD data that gives us confidence about what that molecule could do going forward. There are certainly a lot of opportunities in the immunology space as you think about where the effector T memory cells can operate from an autoimmune space, but there's also been a really interesting evolution in the industry around the Venn diagram of metabolic health and autoimmunity and how that come together. So the opportunities are pretty significant, but you're right, that's another one that doesn't seem to show up in the headlines, but it's a pretty significant readout that we had earlier this year.

Sorry, Clint. To wrap up, I want to kind of tie this all together and think about the story going forward for the next 12 months. Let's imagine we get past ADA. we've got several readouts look forward to including some of the synchronized CVO stuff on the Böhringer side and eventually hearing about a combo but do you want to just set the stage for what we should be looking for over the next 12 months in terms of readouts and proof points that Zeeland is moving forward and continuing progressing with this R&D yes so so clearly I should say right now it's focused on getting into phase three every patrol so I get that trial moving you will have the as you say the supreme two also reading out and in the second half.

And then, of course, also to fix those combinations that will start soon as well, going into phase two. Then, if you look at it, clearly more readouts from Bering are coming, getting that product ready to market. That's, of course, Bering are driving those efforts. We'll have more data on a KB 1.3 also coming out in the second half, and then potentially filing for a CHI. So I think there is a lot of things cooking, and then potentially more to come that will come out of the research engine, of course.

And with that, I can wrap up at time. Very much looking forward to ADA at the weekend and looking to see what's being shared there, looking forward to the communication around that too. But for now, it leaves me to say thank you so much for joining me, both of you. Thank you all for joining, and best of luck for the rest of the conference.

Thank you all.