Conference Transcript - ZLDPF 2026-03-11

Yehan Lee, Analyst — Barclays

Hey, good afternoon, everyone. I'm Yehan Lee, Barclays European Biopharma Active Research Analyst. Today, it is my pleasure to host Zealand Pharma, Fairside Chat with Adam Steinberg, the CEO of Zealand. So thank you for joining us today, and we are delighted to have you here to work us through your story. So actually, the story, I will hand it over to you, Adam, to have a brief introduction of Zealand and do some presentations.

Adam Steensberg, CEO

Absolutely. A pleasure to be here. So, CELAN Pharma, we are here to address what we believe is the biggest health care channels of our time, and that's the obesity pandemic and all the diseases that follows the obesity pandemic. You can actually ascribe more than 220 diseases to the increase in obesity that we see these years, and we need to do something about this as a society. So transforming the future of metabolic health, that is what sealant is about. I will be making forward-looking statements today, as you probably expect. So if you think about our key priorities, then it's to redefine the near-term future of weight management, really focused on our two leading assets, petrinotide, which we have in partnership with Roche, and then cervirutide, which has been partnered out to Berger Ingelheim. So these are the two leading programs where we, of course, spend a lot of efforts and also there will be tremendous focus on this year. But equally important for us is also to build the pipeline that follows these two promising opportunities for weight management. And here it's about leveraging our more than 25 years of history and peptide drug discovery and development, but also working in the metabolic space to really create a pipeline of more than 10 clinical candidates over the next four years. and focusing also on tapping into some of the very big changes that we are seeing in the research, how we do research today, and thereby committing to also getting to industry-leading cycle times from idea to clinic, partly by opening a new research site in Boston, which we expect to open this year, but also in engaging in more partnerships as just also announced, for instance, in December last year, where we partnered up with OTR and small molecules for metabolic diseases. All this and this journey is backed by a very strong financial and solid financial cash position. So we have around 2.3 billion U.S. dollars in the bank. We expect 700 million more to come in this year. And that means that we have a foundation to actually pursue this ambition of transforming the future of metabolic health. If we just take a step back and try to think about what it is we are trying to address when we think about the obesity pandemic and all the diseases that follows, then we are, I would argue, perhaps four years into having seen the launch of the first medicines that can actually help people lose the weight that they are looking for. So it's really, really early in the care of patients. And today we are only targeting 3% to 5% or we only have actually 3% to 5% of the eligible population on treatment. So I think and I hope everybody agrees that we are in such early days to actually address this problem that we see. It's also remarkable to think about that while we have other chronic diseases where I would argue most of them are less complex than obesity, We actually have up to eight different tools, different modalities. We can help address those situations in obesity. We basically have one tool in the toolbox that's called GLD-1-based therapies. And the other thing I really would like to underscore in this world where there's still a hyper-focus on who gets the highest weight loss number. It's actually not what patient tells you if you ask them. most patients are looking for weight loss below 20 percent so we might be excited when we see that a drug can give you 25 or 30 percent weight loss but patients are looking for a weight loss in the majority of patients at least below 20 percent and that also i believe is reflected to some degree with how the current glp1s are being used on the market today so while we are Reduced to high numbers in clinical studies from the GLP-1s, real-world evidence suggests that Vigori provides around 8% average weight loss and cesipatite around 12% average weight loss in how they are being utilized in the real world. So there's been a hyper-focus on the highest number, but that is not how these medicines are being used. and more importantly if we are to address the consequence of the obesity epidemic we need to go away from only having patients using these treatments on average for four months with less than around 20 percent still being on treatment for a year we need to make this a chronic therapy area where patients stay on therapy and today we know that half of the patients that drops off at or the one today is because of GI side effects. So we need to develop tools that can help people stay on therapy and not only win the weight loss Olympics because then you don't get to the true health benefits. And as importantly for us as an industry, you actually don't unlock the value in the market if you don't get to chronic therapy because volume is what will drive the value in the future and not prices. So with petrientide, we are extremely excited about the profile of petrientide, and we really believe it has the potential to redefine the weight management experience. And really, with the data that we released last week in our Phase 2 study, for us, underscores this potential that petrientide can serve as a foundational first-choice treatment option, setting really a new standard for what patients can expect when they embark on a weight loss journey. And we demonstrated in a phase two trial design, which was not optimized for maximum efficacy, double-digit weight loss, and then a placebo-like tolerability profile when it comes to gastrointestinal AEs with not a single patient vomiting. And we just, again, would like to underscore the best medicines are actually the medicines that patient takes. And I would also challenge people to think about if you have a product that can get you to the weight loss that you would like and you can achieve that without going through the hassle with a lot of GI side effects, a lot of difficult titration regimes, stepping up and stepping down. If you can achieve that without all these things, would you choose that or would you choose a product that is more effective but have all these hassles? I know what I would choose. So we are extremely pleased with the data, and we think, as I said before, that Patrinoside has this potential to really redefine the weight management experience. Also with the data, they will further now highlighting this opportunity for the combination product that we are also pursuing together with Rose on the combination with Patrinoside and CT388, where we now have a very tolerable base in Patrinoside, where we can add some CD388 too for those patients who need more weight loss or potentially those patients who need the highest weight loss. So the profile of this combination product has given us even more excitement also around what we can achieve there. And the partnership we have with ROSE is a true partnership where we have profit sharing but also co-development and co-commercialization rights. And Sealand will use those rights to establish our commercial infrastructure in the U.S., and thus also a launch pad for future medicines as we think about our future pipeline. Now, shifting gears to the partnership we have with Roche, with Boehringer Ingelheim, which is on servilotype. This is a product that we licensed to Boehringer some years back, and they're responsible for all development and commercial efforts. We just have high single to low double-digit royalties on sales. What Boehringer said at Obesity Week last year was, see obesity, think liver. And I think they were referring to the fact that a vast majority of obese individuals also have fatty liver disease, and up to 35% of obese individuals, they actually have mass signs of deceased liver. And the opportunity with cervirotide is to not only leverage the biology of the GLP-1, but also tap into glucagon. And glucagon, the prime pharmacology of glucagon is to actually get nutrition out of the liver and thus fat out of the liver. So we think we are looking here at a highly differentiated product that can come out and not only speak to the GLD-1 benefits of reducing your appetite, but also speaking directly into liver health and potentially increased energy expenditure and with positive effects on other organs beyond the liver. because if you reinstall the liver as the metabolic master switch, in theory that should have very positive effects on other diseases such as heart disease and kidney disease. So Boehringer will report the full phase 3 program in obesity this year on cervidotide, and we would hope to see them on the market already next year, which would mean that Boehringer would be the third large pharma company who will get into this space treating obesity. So that leads me to my concluding slide and just highlighting that we are entering the most catalyst-rich year in sealant history. We have further data from the SUPREME program in patients with type 2 diabetes. We plan, we expect to start the phase 3 study with the monotherapy and also start a phase 2 study with the combination therapy for preturientide this year and then the full program on cervidotide. then we will expand our research activities by establishing our Boston Research Hub and also expect news coming from some of our earlier pipeline programs this year.

Yehan Lee, Analyst — Barclays

That's awesome. Like very clear and very helpful. I guess we will start, you know, from your Emeline as that, particularly tied. Just wanted to dig a little bit deeper in terms of your Zoom Room 1 data. So I think a key debate is, you know, it is like the dose response dynamic in this trial. So it seems like the third dose cohort somewhat showed, you know, the best efficacy. And if we really look at the titration schedule, actually this third dose and cohort reaching the highest dose at week 12 versus dose 4 and dose 5 actually reaching at week 16. So just curious, like to which extent do you think this difference in titration timing or exposure actually could have influenced the efficacy outcome across cohorts? And what gives you the confidence just based on the totality of the data? Actually, the third dose is the optimal dose that you will move forward to history.

Adam Steensberg, CEO

We are quite confident that we have shown, you can say, under this study condition, the maximum potential of the trinitide and that is the mid-dose and that we don't get additional weight loss by pushing the doses higher. Remember in this study we used a dose escalation every four weeks which was in contrast to what we did in the 16-week study where we dose escalated every two weeks. What that led to was a quite significant improvement in tolerability and we were already excited about the tolerability profile after the 16-week stage and now we have an even more tolerable approach and we still manage to achieve double digit weight loss in an unoptimized study condition so we really consider this the sweet spot i also again would like you refer you back to what i said before on what is the weight loss that people experience on ticipitide in a real world setting today that's 12 and still you have 50 of patients who stop taking these medicines due to GI side effects, we achieved double-digit weight loss here with not a single patient vomiting. And for me, that is a sweet spot to be in.

Yehan Lee, Analyst — Barclays

Yeah, that's very helpful. And another question I guess people were asking is really, you know, the patient heterogeneity.

Adam Steensberg, CEO

So we see much more with loss of female versus male, and also there's some, you know, inconsistencies between U.S. versus European countries. so I guess like based on this data or like experiences how would you design your best rate population outside mix going forward yeah I mean we have known for a long time that there are differences in how much weight men versus females lose in these studies and basically on drug and again there are differences between men and women so that is expected for certain reasons But we had a higher difference than anticipated with up to 6% more weight loss in women on a placebo-adjusted basis. And we also saw this phenomenon that there was actually 3% more weight loss in the European patients compared to the U.S. patients. A lot of that difference was actually driven by, you know, some centers which performed, you can say, significantly low expectations, especially in the male population. So there's some, you can say, operational aspects we have to look into, making sure that we don't include similar sites in our Phase 3 trial, which contributed to that, you can say, finding. And I think it's something we will, of course, make sure to avoid in our Phase 3 study. So that alone, looking into those underperforming sites would get us into where we had perhaps expected to be with 1% more weight loss. And then, of course, as we think about the phase three trial, we would also anticipate having around 70% females where we have, as you mentioned, significantly more weight loss. So all that gives us the confidence that in a future phase three trial, which is, of course, optimized to show the maximum potential of the drug under the conditions that's being administered, we will get into the weight loss, which we consider the sweet spot for future weight management. And coming back to what I said in the start, I don't think the battlefield in the future is going to be who gets to the highest number. The battlefield is going to be how can you provide the weight loss that patients are looking for in the most pleasant way.

Yehan Lee, Analyst — Barclays

Yeah, actually, to your point, like the pleasant way, so like the treatment persistence. So, notably, like your data for efficacy estimate versus treatment estimate, it seems like the data is relatively small compared to, you know, in creatines or like your peers. So, do you think actually it can be a potential differentiator for petrolene type versus creatine and peers?

Adam Steensberg, CEO

A hundred percent, because the thing is that in real world in particular, but also in clinical studies people have difficulties following the titration schemes for the glp1s and there's all we were getting used to these huge differences between efficacy estimate and treatment estimates which i think reflect how difficult it is to actually get on these drugs and get up with our study there was a very very small difference between these two numbers and as importantly when we look behind the data and see if patients were able to escalate according to plan it's basically all patients who can follow the plan and that's again back to simplicity if you ask a key opinion leader they they would argue they can get any patients to the top dose on the glp1 but it's not easy and you know people want to live easy lives so the that's why i keep coming back to in the future the battlefield is not going to be about who gets the highest number it's about who can offer a treatment that delivers the weight loss that the individual patient is looking for in the most benign way and that's where we think the data set we released with the train type sets a completely new standard for how you can get into double-digit weight loss with a very benign tolerability profile.

Yehan Lee, Analyst — Barclays

Cool. I'm just curious for the full data can you disclose like which conference we are looking for or actually it's still under progress?

Adam Steensberg, CEO

Yeah it's still under progress but we are still progressing on that one but I can reassure you that we are eager to get the data out and discuss them more broadly so we are pushing on all fronts there.

Yehan Lee, Analyst — Barclays

Also, I think another part of is really your collaboration with Roche. So just like based on your data so far, just curious you know, the latest source or like communication between you and Roche, are you on the same page that you will initiate the phase 3A trial, monotherapy trial in the second half of this year?

Adam Steensberg, CEO

You can say we have since the start of this year communicated that we expect to start the study in the second half, and based on the communication that I've had with my collaborators at ROS and at multiple levels of the organization, that remains to be the expectations. Of course, formal decision making only will be taken once you've had interface two meeting, once you've had the full data sets evaluated and so on. But I would say when we look at the data, as I also said in the initial prepared remarks, the tolerability profile is even stronger than what we have seen in a 16-week study. We got into double-digit weight loss and I would say it provides an even more clear positioning and as an alternative to what the weight loss experience is in a GLP-1. So we just see an even stronger foundation for this medicine and also as a first choice. And stepping into combo potential, so what would success look like for this combination therapy relative to your monotherapy like any expectation yeah but that's that's it's a very good question and we are going to very soon start in this first half startup phase two study to really explore the optimal combination of patronitide and ct388 by the way we think ct388 looks to be a great gs1 gip so we are pleased to have that as a combination partner in in the in our collaboration and again for us it's ultimately of course we'll need to see the phase to read out how it reads out but it could be a product for those who need higher weight loss than what petrinotide can deliver on its own or for those who are really looking for the highest weight loss which there's also a subgroup of patients that will be looking for it could be one which speaks more to people living with both obesity and type 2 diabetes where the combinations of an amylin energy v1 also looks really great so there's actually a number of opportunities we can discuss with us for where to position or maybe we'll go forward right and just curious like any updates on the co-formulation or this combo therapy in updates in which way like co-formulation yeah but that is the clear opportunity that this will be a co-formulated product that was i can reassure you that was a deep part of the diligence when we entered the partnership Great.

Yehan Lee, Analyst — Barclays

Just switch gear a little bit to cervical type, of course. So the synchronized one data will be in this hub. So just curious what kind of data release should we expect, for example, like press release first and then full presentation, I guess, at the ADA conference?

Adam Steensberg, CEO

Yeah, so we expect data to be top-lined and then also be presented throughout the year for both the synchronized one and two, but actually also importantly the cardiovascular outcome study, which is also reading out this year and studies in patients from Japan and China. So it's the full phase three program that we'll read out and we do expect top line and then follow with presentations. And you can already see now at the American Diabetes Association that there's a big symposium on cervirotide which we look very much forward to hear what our good colleagues are doing I have to say about that.

Yehan Lee, Analyst — Barclays

Awesome. I think a prior concern for cervirotide or potential concern It's the Toribati profile based on the phase two data. And we know for the phase three, actually you are testing a higher six milligram dose versus 4.8 milligram in phase two. But at the same time, you have four week flexible titration versus two week titration in phase two. So wondering how should we think of the GI tox profile and how confident are you actually phase three can have better decontamination rate, better GI talks that are comparable to our, you know, in creating peers.

Adam Steensberg, CEO

Yeah, we definitely expect that a cervical type will come out with a good number on the weight loss and also that Berger have shown that you can manage the GI side effects just as with any other incutin by applying more flexible titration and not pushing people to dose escalate according to schedule. I think that As we have said for many, for a long time, if people took the time and looked back at how phase two studies read out for tazibritide and Vigol, you would see the same signals in phase two, which magically disappears in phase three, because you apply anti-medic medication, because you do much more flexible dosing. So, of course, we also expect that Bergen have done this in this phase three study.

Yehan Lee, Analyst — Barclays

Looking forward to that. Another thing, as you mentioned, you know, the mantra, see obesity, think liver, treat the heart. So, and also, like, we know the mesh data and also the CVOT data will also be out this year. So just curious, like, how would, you know, for example, mesh data kind of accelerate the potential launch in mesh, and also for CVOT, how cervical diet could treat as a preferred therapy for the high-risk comorbidity patients like yourself there?

Adam Steensberg, CEO

No, but I think it's an area which the community in general has overlooked a little bit. But the fact is that if you can improve liver health, if you can get fat out of the liver and make the liver more insulin sensitive, more than what you can just expect from a weight loss, then suddenly you are reinstalling what I would describe as the metabolic switch that can also help other organs. After all, when you eat a burger, the first organ that will meet that burger is the liver. And that liver, if that can better handle that nutrition, the rest of the body will be better at also handling the situation we live in with abundances of food and what have you. So I believe that not only the liver could improve in this setting, But if you are in a situation where you also have to release less insulin, for instance, so you don't build up as much adipose tissue, which insulin actually does, if you don't have as many inflammatory markers and you also get your lipids in better control, which you should do when you have a better hepatic function, then ultimately that could spill over and actually cause the heart and the kidney and other organs to also benefit as a secondary phenomenon due to the improved liver health that we would expect to see with this product. so I look very much forward to the full data disclosure and of course in MASH which is the biggest underserved need still in obesity there's a huge opportunity for Boehringer to not only lead in obesity with this new mechanism but also come in and become a groundbreaking new therapy for patients not only with F2 and F3 but also their F4 so cirrhotic patients where they're running a last study so um yeah awesome i think that's right on time thank you so much for joining us and thank you everyone for listening um it is our pleasure to have you thank you