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Goldman Sachs 44th Annual Global Healthcare Conference

Jun 14, 2023

Rajan Sharma
European Biotech Analyst, Goldman Sachs

Good afternoon, everyone. My name's Rajan Sharma. I'm a European biotech analyst here at Goldman Sachs. Thanks for those of you in the room for making it through to the last session of the day, and pleased that we have Adam Steensberg, who's the CEO of Zealand Pharma, with us this afternoon. Adam, thank you for joining us, and again, thanks for fighting through the jet lag.

Adam Steensberg
President and CEO, Zealand Pharma

Thanks for the invitation.

Rajan Sharma
European Biotech Analyst, Goldman Sachs

Great.

Adam Steensberg
President and CEO, Zealand Pharma

Happy to be here.

Rajan Sharma
European Biotech Analyst, Goldman Sachs

So, I guess maybe we'll just start kind of high level. And, you know, you've been in the CEO seat for just over a year or so now at Zealand. So, do you want to kind of run us through where the company is versus when you first started and kind of key changes over the last 12 months?

Adam Steensberg
President and CEO, Zealand Pharma

Absolutely, so I think we are in a very different place. I mean, last year we actually had some fantastic clinical data readouts from our two rare disease assets, phase III, so we're approaching NDA submissions for those programs this year, then we had, you can say, significant progress in our obesity pipeline, which is really a big theme for us at the moment, and look forward to share further data on those next week, and then on top of that, we managed to raise enough capital so we have a very strong balance sheet today, which gives us the ability to focus on deliver on what we want to achieve, namely progress these molecules forward.

Rajan Sharma
European Biotech Analyst, Goldman Sachs

Okay. And then maybe to start on the obesity piece, which is obviously kind of a big thematic within the sector, and you have different assets in development, do you want to just kind of run us through what you have in the pipeline?

Adam Steensberg
President and CEO, Zealand Pharma

Absolutely. Yeah. So we have, I would say four different products in development. One is a little bit ahead of some of the others. So that's the GLP-1 glucagon analog that we have in collaboration with Boehringer Ingelheim, where they will present phase II data next week. Then we have two programs in phase 1. The one just started the phase IIa study. That's the one. It's a GLP-2 molecule that contains GLP-1 as a backbone, but then it also plays into GLP-2 biology. And then the other one is a non-incretin amylin, which we see as a potential alternative to GLP-1 treatment for weight management. And then we have a GIP analog, which could be a combination opportunity with other GLP-1s.

Rajan Sharma
European Biotech Analyst, Goldman Sachs

Okay. And then within that, maybe we'll start at the kind of most advanced piece of the pipeline, so the GLP-1 glucagon. Obviously, we've seen some initial top-line phase II data, and as you mentioned, we're getting full data at ADA. Could you maybe just talk to, firstly, what we saw from the top-line perspective, and then kind of expectations into ADA?

Adam Steensberg
President and CEO, Zealand Pharma

Absolutely. So we, as you said, we have released the top line together with our partner, Boehringer, who are responsible for the program. And that was, you can say, a 15% or around 15% weight loss after 46 weeks in the planned dosing group, so of the highest dose. So what we will also show at ADA is, you can say, weight loss achieved in the patients who got to the actual doses that they were meant to be at, which, and we have put that out in the press releases, is more weight loss than what we saw with the planned group.

Rajan Sharma
European Biotech Analyst, Goldman Sachs

Okay. And on that point, is there, you know, what's the rationale for not all patients getting to kind of that higher maintenance dose?

Adam Steensberg
President and CEO, Zealand Pharma

This study was, I mean, as you do with phase II studies. I mean, the main purpose of a phase II study is, of course, to inform for your phase on your phase III design and not just, you can say, markets. It was a way to really understand the best way of titrating, but also to fully understand what you can achieve at the different dose levels. Boehringer has specifically used a 20-week titration phase and then the fixed doses, whatever dose you were at, at that time. Then you were not allowed to change the dose in the last part of the study. There could be, if you had too much nausea and vomiting, of course, then you would not get to the highest dose.

It could also be if you were just happy with the weight loss, I mean, then maybe patients would not like to go to the next dose level, so I think there's a lot of details into that. For us, the importance is to really understand how to use, I mean, you could say, the dose titration and also what to expect for phase III, and we think this study actually informs of that, and I hope the market will see that as well next week.

Rajan Sharma
European Biotech Analyst, Goldman Sachs

Okay. And then in terms of kind of, you know, the better data that's still waiting to be seen at ADA in terms of that higher weight loss, how do you think about what the bar is for kind of a phase II trial in the setting?

Adam Steensberg
President and CEO, Zealand Pharma

Yeah. Actually, I think it's changed slightly over the years. We've been in this game for a long time and have made a lot of thoughts about obesity. For a long time, it was this thing about approaching bariatric surgery weight loss. I think what we're seeing right now, and this is also based on real-life experience from people taking GLP-1s today, is that probably if you get into this 15%-25% weight loss, that is basically what most people desire. And there's not that many patients who would need more. I would say for a GLP-1-containing molecule, you probably need to be above 15% and closer to 20% on the mean, and then to be really, really attractive in the future marketplace.

Rajan Sharma
European Biotech Analyst, Goldman Sachs

Okay. And then also the other, obviously, a big part of the profile is also the tolerability. And again, we haven't seen anything from the top line and release from that. So how are you thinking about it? And I know kind of you talked on your Q1 call about being in line with other GLP-1s, and your partner, BI, have said that publicly as well.

Adam Steensberg
President and CEO, Zealand Pharma

Yes.

Rajan Sharma
European Biotech Analyst, Goldman Sachs

So I guess, you know, what do you think is the bar for a phase II trial, in terms of tolerability?

Adam Steensberg
President and CEO, Zealand Pharma

Yeah. But again, the data you have to look into the details of the study. And of course, you know, with these molecules, there are tolerability issues in the early phase of titration, nausea and vomiting. And you, I think what you need to be on par with other GLP-1s out there. And then we also have to understand that a lot of these things you can actually deal with in a longer-term study in a titration where you allow step-downs and so on, and perhaps longer time to achieve the higher doses. So on par with what has been seen with in other phase II studies with similar, or with GLP-1-containing molecules, that I think is the bar. And then it's important to understand that you can actually address a lot of that in a phase III setting.

Rajan Sharma
European Biotech Analyst, Goldman Sachs

Okay. Okay. And can you just talk a little bit about how, you know, there could be potential to address some of the tolerability as you move from phase II to phase III? And is there any precedent for that?

Adam Steensberg
President and CEO, Zealand Pharma

Yeah. I mean, if you take the tolerability, Lilly's GLP-1, GIP, I think, if you look at the tolerability profile in phase II compared to what they experienced in phase III, it's two different, very different experiences. And that is what some of that has to do with how frequent you do the dose escalation. And others, of course, have to do with the ability to just pause dose escalation or step down a little bit before you then push up again, which are things you can do in phase III. And some have to do with how frequent you have patient monitoring visits and so on.

Rajan Sharma
European Biotech Analyst, Goldman Sachs

Okay. So I guess, if you show kind of, and then maybe thinking ahead to kind of a phase III, and if you think about kind of the ultimate target profile, if you show weight loss in line with the GLP-1-based products that we have right now, tolerability again kind of consistent with that, is that a sufficient profile in your view to kind of have a meaningful place in the market?

Adam Steensberg
President and CEO, Zealand Pharma

Yeah. I think it's a sufficient profile to actually address the weight loss part of these molecules. But of course, there's much more to this, and I think the key parameters for differentiation in the future is also going to be how you address different comorbidities and other aspects. So you need to differentiate beyond weight loss. I think you need to pass the bar to be in a relevant weight loss, and likely in the higher end, I mean, at least compared to the GLP-1 monoagonists that does not carry dual pharmacology, but you really have to focus on how you can differentiate beyond weight loss in the future, I think.

Rajan Sharma
European Biotech Analyst, Goldman Sachs

Okay. And I guess something you've talked about in the past is with the GLP, the glucagon component on liver, benefits and kind of reducing fatty liver levels. Could you maybe just talk about how you think that is a differentiating factor and, you know, provide us some, if you could, to quantify it in terms of number of patients that you may be able to target there?

Adam Steensberg
President and CEO, Zealand Pharma

Yeah. I think for this molecule with the GLP-1 glucagon component, it is a potential very important aspect. And I think there's a lot of, you can say, data out there that suggests that if you combine a GLP-1 and glucagon approach, you actually have a potential, a very strong potential to reduce liver fat. And we have such a molecule here. And I think it's been underestimated broadly how many overweight obese individuals actually have NASH and NAFLD. And these numbers are higher than the number of overweight and obese individuals that have diabetes, for instance. So in order to address, you can say, so that comorbidity could be a very significant differentiator.

I think it's in the range of north of 30% of overweight and obese individuals who actually have NASH, which you can say is higher than diabetes, for instance.

Rajan Sharma
European Biotech Analyst, Goldman Sachs

Okay.

Adam Steensberg
President and CEO, Zealand Pharma

And, on that note, I think it's also important to understand that, at least in my mind, there will be a different approach to molecules that can introduce weight loss and then NASH molecules that can introduce the weight loss versus NASH molecules that only address, let's say, NASH specifically, either anti-fibrotic medications, because here you're more looking at an opportunity to address the weight loss and then also a comorbidity to that situation.

Rajan Sharma
European Biotech Analyst, Goldman Sachs

Okay. And then just kind of, you know, coming back to the, I guess, mechanistically, what do you think is kind of the incremental benefit of the glucagon? Is there anything on weight loss, or is it really on the?

Adam Steensberg
President and CEO, Zealand Pharma

I think it's actually both on weight loss. That's, I think, that is why we still expect to see very significant weight loss with this molecule. And that is, I mean, in addition to changing your appetite, which is what the GLP-1s are doing, we also expect that GLP-1 will contribute to weight loss by increasing energy expenditure. Specifically, it will also address the hepatic fat content and thereby be targeting NASH as well. But I mean, that energy expenditure is something where we could hope that also in the longer-term studies, you will actually see that you continue to have a weight loss compared to GLP-1s.

Rajan Sharma
European Biotech Analyst, Goldman Sachs

Okay, and of course, you're not the kind of only company yourselves and Boehringer and Zealand are the only companies with a GLP-1 glucagon co-agonist in development or have developed one. Could you maybe just talk about how you think you maybe differentiated between kind of Altimmune? We saw some data from Merck this week, and Astra also have an asset. So how do you, how do you feel that kind of you fit there?

Adam Steensberg
President and CEO, Zealand Pharma

Yeah. You're right. There have been a lot of attempts to address this pathway, probably, I mean, because it is, of course, exciting if you can address energy expenditure and also hepatic fat levels. But a lot of these other approaches have been with very balanced molecules where they would be having equal efficacy on the GLP-1 and glucagon receptor. We have one which is eightfold more potent on the GLP-1 receptor. We think it's important because what we have learned over the last years is that you need to push the GLP-1 doses to very high levels in order to achieve your weight loss. And likely, you will not want to have as high exposure on the glucagon receptor because you probably start to see then negative effects on glucose control and also maybe other side effects from the glucagon component.

We feel we have gotten the balance right by having something that is more active on the GLP-1 but still managed to activate hepatic glucagon receptors. If you look back, I mean, several years back, AstraZeneca and Johnson & Johnson, they have also released data that perhaps it's not the best approach in a diabetes setting, at least, to have a balanced molecule.

Rajan Sharma
European Biotech Analyst, Goldman Sachs

Okay. And maybe some of the safety signals that we've seen with other GLP-1 glucagon co-agonists, what's your confidence that you kind of may not run into the same, same issues?

Adam Steensberg
President and CEO, Zealand Pharma

You know, I build my confidence on the fact that I know Boehringer as a very thorough company, which have very much patient-centric focus and safety. We have now completed a phase II study in type 2 diabetes. We have completed a phase II study in obesity. They communicate clearly that they're moving as fast as possible towards phase III. So if there were any serious safety concerns, I don't think we would be where we are right now.

Rajan Sharma
European Biotech Analyst, Goldman Sachs

Okay. And then just again, I realize you kind of have a little bit of limited visibility on what your partner might be doing. But is there any sense or any idea why a phase III trial hasn't already been initiated, or what Boehringer might be waiting for?

Adam Steensberg
President and CEO, Zealand Pharma

No. And I, I think, I would say Boehringer will have to comment on these things. What we have to understand is, of course, this is the first indication that they move into. I mean, some of the other molecules, they were already developed in type 2 diabetes. So of course, it takes a little bit more time to understand how to best titrate this molecule, etc., etc. So we are actually extremely happy with how they progress and, and their commitment to how they move forward. And, and if you, I think if you look back, whenever they have made these decisions, they have, they have been extremely thorough, and they have followed through. They're one of the companies who were first to invest in cardiovascular outcome studies in diabetes with the SGLT2. So, so I, I think they are doing a thorough approach here as well.

Rajan Sharma
European Biotech Analyst, Goldman Sachs

Okay, and then talking about cardiovascular outcome studies, we have one coming up later this year, so the Novo SELECT trial. Could you just talk about how you think that may kind of, in a positive or negative scenario, impact kind of the view on the overall GLP-1 space?

Adam Steensberg
President and CEO, Zealand Pharma

Yeah. It's, of course, on everybody's minds because, I mean, with the diabetes doses of GLP-1, we have seen cardiovascular benefit. And I guess most people would also expect to see benefits, with the obesity doses. And then I hear a lot of speculation if in a less diseased population, if you will still be able to pick up a signal and so on. I would say I would be, of course, surprised if they, if there's not a signal, and I would also expect it to be statistically significant. I think it's important for the specific GLP-1, of course, to have those arguments around, for payer interactions and so on.

But I would say, in general, I think there's so much evidence around the GLP-1 class that it, I mean, if it's a failed study in the sense of not meeting statistical significance, I think we would have to look into the details of the study and then see how to design future studies in order to demonstrate what has been seen in diabetes.

Rajan Sharma
European Biotech Analyst, Goldman Sachs

Okay. Okay. And then, staying with obesity but maybe moving on to amylin. So we obviously saw with your amylin analog. We've seen some phase I data, and we're getting an update at ADA. So could you just maybe put the data into context for us and then kind of help us understand what we may be seeing later this month?

Adam Steensberg
President and CEO, Zealand Pharma

Yeah. We are extremely excited about our amylin analog because we think it has potential to actually create a new class for weight management that is non-incretin based. It doesn't use GLP-1 as a backbone, which all the other approaches that we are talking about right now are utilizing. It's really an alternative to GLP-1 for people who can perhaps not tolerate a GLP-1 or who doesn't appreciate to be on it. The reason that we think it can become an alternative is I mean, our own data single ascending dose study. We have released top-line data showing almost 5% weight loss compared to placebo following a single dose of the compound. We've seen data from Novo's amylin program where they get close to north of 10% weight loss in shorter-term studies.

Then even looking back at pramlintide, this mealtime insulin, there were clear signs of weight loss with a product that has a very short half-life. So we actually think we can get into quite significant weight loss and have a product that is an alternative to GLP-1-containing molecules. For us, next steps are to complete our multiple ascending dose studies. Here we will report the outcome of the six weeks. So that's part one of that study in the second half. Then we will initiate the 16-week multiple ascending dose part also this year, which should really, you can say, present the full potential of this molecule.

Rajan Sharma
European Biotech Analyst, Goldman Sachs

Okay. And then I guess just kind of to be clear, is your focus with the amylin right now is a monotherapy? So you're confident that that can be kind of a standalone monotherapy that can compete with the, the GLP-1-based products?

Adam Steensberg
President and CEO, Zealand Pharma

I mean, we are quite confident based on the data we saw from our single ascending dose, but also, of course, the data that Novo have released on their amylin analog. We know they are, of course, right now, pursuing only a combination with sema, but we think it has standalone potential. I think we really need in the future alternatives to GLP-1s because we do see patients who stop taking them and couldn't for different reasons. So I think it's a great opportunity to also help these patients in the future. And in our mind at least the way we see this is a very different way of introducing a weight loss when you're on an amylin.

The hypothesis at least is that it works more on satiety and potentially restoring leptin sensitivity, which is one of the hallmarks of obese individuals. They have lost this leptin sensitivity, which is a signal from the body to tell the brain that you're full, you don't have to eat more, and if we can restore that, we actually see it as a more natural way of stopping not eating than maybe as we are seeing with the GLP-1 class, where it's more about appetite.

Rajan Sharma
European Biotech Analyst, Goldman Sachs

Okay. And then again, kind of maybe just thinking a bit more broadly about the obesity space, there's obviously a huge amount of work going on. How do you think about how the market plays out in the long term in terms of with all the different mechanisms and how they may fit?

Adam Steensberg
President and CEO, Zealand Pharma

Yeah. I think it's, of course, extremely early days right now. We have seen the first, very significant, molecules that can actually meet the needs of the patients. But I think in the future, if we think about the future treatment landscape, it will be a very complex setting. There'll be a focus on weight loss, weight maintenance. There's gonna be a huge focus on co-morbidities. Then you're gonna have molecules that are, either oral or injectables. You're gonna have different modalities. And I think what you, if at least if we look into other chronic disease areas, you will often see patients shifting around. They will not stay, like, for a lifetime on one single product. Then you will, they will try something else, get back to something, and maybe even have, you can say, multiple treatments.

So it will be a much more complex setting than what we envision today. There'll be multiple players and multiple approaches to both weight loss and weight maintenance. And then it's also, you can say, one of those. It's probably the first time where we have seen such a big willingness to pay out of pocket, which we also have to address in the future.

Rajan Sharma
European Biotech Analyst, Goldman Sachs

Okay. And then in terms of the GLP-1, GLP-2 that you have in development as well, could you just maybe help us understand the mechanistic rationale there? Because, you know, in theory, the GLP-2 component could be having an opposing effect to GLP-1. So how do they fit together?

Adam Steensberg
President and CEO, Zealand Pharma

So we have this. The whole concept is based on observations that obese individuals they actually have a leaky gut, meaning that you have intestinal bacteria that will leak into the bloodstream and then drive some of the low-grade inflammation, which has been known for a long time to take place in many metabolic conditions. If we can apply a little bit of GLP-2 and thereby you can say prevent the leakage of bacteria into the bloodstream, so increase the barrier function of the intestines, we believe we can actually reduce the inflammatory load that you see in obesity but also in other metabolic conditions and thereby have positive effects on liver, cardiovascular, and kidney. There has been historically several attempts to address low-grade inflammation in metabolic diseases by antibodies targeting IL-6 and other targets. So far, they have not been successful.

And we believe it's, they're perhaps a little bit too upstream because it's such a complex system, the inflammatory system. We think we are more at the root cause here. That's what gets us extremely excited about this molecule. And then the second benefit, and these are small data sets still, but there are data that shows that if you co-inject a GLP-1 and a GLP-2, you actually have less nausea and vomiting. So it could also be a molecule that is actually more tolerable than the other GLP-1s.

Rajan Sharma
European Biotech Analyst, Goldman Sachs

Okay, and then I guess what's the next data point that you need to see to kind of validate that thesis?

Adam Steensberg
President and CEO, Zealand Pharma

Yeah. We just started a phase IIa study with which we'll read out next year. In parallel, we'll actually do further dose escalation in the phase 1 setting to try and push doses higher. I would say next year we should have more mechanistic insights into if we have actually addressed this inflammation and then also see the full potential in a 16- or 13-week study for weight loss.

Rajan Sharma
European Biotech Analyst, Goldman Sachs

Okay, and maybe we'll kind of just switch focus onto the other part of your business, which is kind of the rare disease piece, and maybe start with glepaglutide. So, obviously, you're kind of aiming for a filing at the end of this year. Could you just talk about your confidence in that asset and particularly on the safety piece and, you know, how confident you are that you have enough patients in the safety database?

Adam Steensberg
President and CEO, Zealand Pharma

Yeah. So I mean, for any rare disease indication and clinical program, of course, you are low in numbers because, I mean, there are only so many patients around. And if you look into the number of, you can say, approachable SBS patients that we have gotten into the program, I think it's actually a high ratio. The phase and then ultimately patient numbers, it's what drives the numbers is the ability for regulators to assess the risk and the benefit of the program. And I think from the benefit point of view, we have actually addressed that extremely well with the clinical outcome we have seen. We are very happy with not only the ability to reduce parenteral support but also the 15% of the patients who actually were able to get completely out of the need for parenteral nutrition.

Safety-wise, it's, of course, a matter of individual patient exposures and also length of patient years. And I think we feel comfortable in the patient years because we had some delays in the program, meaning that we actually had a lot of exposure to individual when it comes to patient years. And then I would also say on the patient numbers. I mean, we feel we believe we have enough. But I mean, that's the name of the game.

Rajan Sharma
European Biotech Analyst, Goldman Sachs

Okay. And then just in terms of the filing, so you're expecting to file it once weekly and twice weekly, or is it just the?

Adam Steensberg
President and CEO, Zealand Pharma

I mean, I would say the data from our phase III study suggests that the twice weekly is the most effective. That was the one that reached statistical significance. It's clear that we also saw effects of the once weekly. We had patients who weaned off on the once weekly product and none in the placebo group. But I mean, when we are talking about a severe indication like SBS, I think efficacy is the most important parameter. So I think it's fair to think that twice weekly is probably the dose that.

Rajan Sharma
European Biotech Analyst, Goldman Sachs

Okay. And then I guess there's a potential competitor that's in development, and they're looking at a once-weekly administration schedule. How do you think kind of glepaglutide's intended profile or what we've seen so far kind of stacks up if there's a potentially once-weekly in the market?

Adam Steensberg
President and CEO, Zealand Pharma

Yeah, so we are extremely happy with the profile of our drug, not only from an efficacy point of view, where we are happy to see the data, but also how it presents itself. We have a product that is actually stable in solution. We have also developed it in an autoinjector . It is a very simple product. It is actually similar to the ones that are being used for treatment of obesity. It is not something that patients with rare diseases would normally see. We think it is a very, very attractive profile where you basically just take off the cap and then inject. Furthermore, we do not have to adjust for weight. And also our renal impairment and stuff like that, we do not have to adjust for, we believe. We think we have a very convenient product presentation.

And that's in contrast to both Gattex on the market. And we would also believe for apraglutide, where you need to mix the products because they're not stable in solution and adjust for weight and so on. So yeah, we think we have a very attractive profile.

Rajan Sharma
European Biotech Analyst, Goldman Sachs

Okay. And then I guess maybe just to dig a bit deeper on the context, you know, the profile relative to Gattex, are you looking at this as an efficacy play, or is it just on the convenience side?

Adam Steensberg
President and CEO, Zealand Pharma

You know, I mean, the convenience side is, of course, very clear because you can see the daily mixing and, and adjusting for weight compared to what we have. But, and from an efficacy point of view, I can just say that we are extremely happy with the clinical outcome, especially on the number of patients who were able to wean off. So of course, that's something we will talk a lot about. But, but again, we did not do a head-to-head, so we cannot claim superiority. But I think we have a very strong clinical package to, to present to if approved.

Rajan Sharma
European Biotech Analyst, Goldman Sachs

Okay. And then I guess finally on that, so how do we get to a filing from here? What still needs to be done on glepaglutide?

Adam Steensberg
President and CEO, Zealand Pharma

Yeah. So we have the pre-NDA meeting coming up later this summer. And then we have all the data in hand now for that meeting. So then it's just getting.

Rajan Sharma
European Biotech Analyst, Goldman Sachs

Okay.

Adam Steensberg
President and CEO, Zealand Pharma

The pen and paper.

Rajan Sharma
European Biotech Analyst, Goldman Sachs

Yep. And then in terms of kind of commercialization, so you've been quite clear that that's not something that you're not gonna commercialize this alone, and it's something that can be partnered. So I guess two questions on that. Firstly, timing. What's the ideal timing to do a partnering deal on glepaglutide?

Adam Steensberg
President and CEO, Zealand Pharma

Yeah, so we will open the data room later this year for potential partners who are interested, and we have a lot of interest, so we expect to open the data room later this year and then engage in a partnership when we have identified the right partner.

Rajan Sharma
European Biotech Analyst, Goldman Sachs

Okay. And then I guess the second piece is what would the ideal kind of partnership look like in the sense of do you want to still kind of maintain a reasonable level of the economics, or would you prefer the?

Adam Steensberg
President and CEO, Zealand Pharma

Yeah.

Rajan Sharma
European Biotech Analyst, Goldman Sachs

The bigger upfront cash?

Adam Steensberg
President and CEO, Zealand Pharma

No. I think for us as a company, the focus is really on long-term value creation for sure. I mean, and from a partner perspective, I would say anyone who has significant rare disease infrastructure and also commercial presence because that's what we will not build ourself. We have the capability to support when it comes to manufacturing, when it comes to other aspects. But so that's the preferred partner enough. Yeah.

Rajan Sharma
European Biotech Analyst, Goldman Sachs

Okay. And then we also have well, you also have dasiglucagon in CHI. And again, that's kind of another program that you've flagged as being one that you would partner.

Adam Steensberg
President and CEO, Zealand Pharma

Right.

Rajan Sharma
European Biotech Analyst, Goldman Sachs

Could you just kind of provide us a bit of an overview of, of where you are with that?

Adam Steensberg
President and CEO, Zealand Pharma

Yeah. So there we are a little bit further. So we expect to submit the NDA in this, actually, this month. So, that's approaching. And then we are, you can say, further progressed when it comes to partner discussions. So we have open data rooms and expect, of course, to, you can say, sign a deal this year because with an NDA submission this year, then we could face an approval already first half next year. And then we need to have the partner in place to commercialize.

Rajan Sharma
European Biotech Analyst, Goldman Sachs

Okay. And I guess in terms of an ideal partner there, what could that look like?

Adam Steensberg
President and CEO, Zealand Pharma

I would say for us, it would be any commercial entity with rare disease infrastructure. It's a completely novel opportunity with where we don't see any existing players. So you can say you don't need a lot of sales. You need just to be able to reach the clinics and payers and patient support. So we are yeah. It's a committed player with rare disease commercial infrastructure. That's the ideal partner for us there.

Rajan Sharma
European Biotech Analyst, Goldman Sachs

Okay. And in terms of kind of commercial opportunity, I guess it's kind of partly driven by who that partner may be. But as you kind of hold the asset right now, what do you think is a reasonable commercial opportunity there?

Adam Steensberg
President and CEO, Zealand Pharma

Yeah. So we don't really guide on it right now. I mean, we believe that there are around 800 patients if you just look at the number of children with CHI around. Of course, these numbers can be somewhat uncertain since there's no treatment available today. But these patients are concentrated at a few clinics. So we feel pretty good around that number. And then you can say, of course, it then depends on the price that they will launch with. And that ultimately will be set by the clinical benefit we can offer.

Rajan Sharma
European Biotech Analyst, Goldman Sachs

Okay, and in terms of kind of analogs for pricing, is there anything that you've thought about?

Adam Steensberg
President and CEO, Zealand Pharma

Yeah. But I think it's, I mean, other rare diseases. I mean, all launches into rare disease. I think that's probably the best models you could choose.

Rajan Sharma
European Biotech Analyst, Goldman Sachs

Okay. And then I guess kind of just, probably a little bit further back in the pipeline or just the complement, asset that you have partnered with Alexion or, or I guess AstraZeneca now, anything that we should expect on that this year?

Adam Steensberg
President and CEO, Zealand Pharma

I mean, we're extremely excited about this program. We think it has a huge potential and also really like the profile of the drug. The agreement is that we have been responsible for driving all the efforts up until IND. Then Alexion and AstraZeneca will take over from there. That will happen this year. Then it's their, you can say, responsibility to take it into the clinic, which we expect will happen late this year, early next year.

Rajan Sharma
European Biotech Analyst, Goldman Sachs

Okay. And can you just remind us of the economics on that?

Adam Steensberg
President and CEO, Zealand Pharma

Yeah. So it's actually also quite rich economics in the sense there was a preclinical deal. So it's high single-digit, low double-digit royalties, and I think north of $600 million in outstanding milestones.

Rajan Sharma
European Biotech Analyst, Goldman Sachs

Okay. Okay. And then, just in terms of cash and liquidity, can you just remind us you obviously did a raise earlier this year? So where does that bring you in terms of your cash position?

Adam Steensberg
President and CEO, Zealand Pharma

Yeah. So with the plans we have ahead of us and without, you can say, further revenue coming in, then we have a runway until mid-2026. So we think it's a quite healthy runway. Our OpEx is around DKK 800 million-DKK 900 million, and we have around DKK 2.5 billion available. So we are in a quite comfortable situation right now, and of course, then with the partnerships coming up and so on, there's opportunities to strengthen that cash balance even further.

Rajan Sharma
European Biotech Analyst, Goldman Sachs

Okay. And then I guess with the cash that you have on hand and that runway, what do you hope to achieve with it? So is that aiming to kind of phase IIa?

Adam Steensberg
President and CEO, Zealand Pharma

I mean, this is the current plans we have on for each of the programs. And as you can imagine right now, we are completing two rare disease programs, phase III programs. So they have been carrying a lot of cost this year. They will be ramped down next year. And so we can really invest much more in obesity and not without increasing the OPEX a lot. So it you can say that is doing just what we have discussed today, so.

Rajan Sharma
European Biotech Analyst, Goldman Sachs

Okay. Okay. And then you've obviously talked about partnering amylin eventually and potentially some of the kind of the earliest, so the GLP-1, GLP-2, and the GIP. What do you think is kind of optimum timing to do that in terms of being able to extract the value but then also it being in the hands of kind of a probably a developer with deeper pockets to really kind of drive?

Adam Steensberg
President and CEO, Zealand Pharma

Yeah. I mean, we feel we are fully equipped to drive these programs through phase IIb and also do, you can say, all the preparations with that you need to do with regards to upscaling and so on. And then a good time to partner is before we engage in phase III because, I mean, it's much more than just clinical studies. It's also manufacturing and so on. So that's a big commitment.

Rajan Sharma
European Biotech Analyst, Goldman Sachs

Okay. And then, in terms of, you know, partnering these assets, what's the preference? Would it be, I guess, it'd be simpler to kind of do multiple with one company, but is that necessarily the way that you want to do it?

Adam Steensberg
President and CEO, Zealand Pharma

Yeah. I mean, time will have to tell. I think for us it's important that whenever we engage in a partnership it's a truly committed partner who sees value in the assets that we partner, and then if it's one or two companies or three companies that see, and so for us it will be important also to consider co-development. We think we have a lot to offer. We see ourselves as the leading company, one of the leading companies in peptide drug discovery and development, and some of the potential partners don't have that much experience in peptides, so we think we can actually offer much more than just the programs themselves. We can also offer expertise and know-how.

Rajan Sharma
European Biotech Analyst, Goldman Sachs

Okay. And then we haven't really touched on the GIP asset. So could you just kind of give us an update as to where it is, what we've seen, what you've seen so far in terms of the data?

Adam Steensberg
President and CEO, Zealand Pharma

Yeah. GIP is still in the preclinical phase. We expect to push that into the clinic late this year. You can say GIP is a little bit of a strange opportunity. I mean, you know, we have several approaches for GIP for GLP-1 GIP agonist or GLP-1 GIP antagonist. Nobody really knows how GIP works in an obesity setting. It seems to do something. It's probably addressing nausea, actually making GLP-1s a little bit more tolerable. That's one thing. Also in our hands, if you give it to an obese animal, I mean, it has very little effect if you give it alone. But if you get it on top of a GLP-1, then you actually will double the weight loss.

So we need to now get it into the clinic and explore this potential maybe more in the setting of achieving more weight loss for people who are already on a GLP-1 than as a monotherapy. So it's where we have to learn more in the clinic, I would say, on this molecule.

Rajan Sharma
European Biotech Analyst, Goldman Sachs

Okay. And could you potentially do kind of combinations between assets that are in your own pipeline and, you know, if you think about maybe the GLP-1, GLP-2 with amylin, for example, because it's not a inclusion?

Adam Steensberg
President and CEO, Zealand Pharma

Yeah. It's been a key design feature for actually all our obesity programs that we have tried to make them so they can be co-formulated. So we are and that's a matter of making sure that, first of all, you can keep them at the same pH levels, for instance. So we have done that with these molecules so they can be co-formulated. And so amylin in particular, of course, could be co-formulated with our GLP-1, GLP-2, or any other GLP-1 out there. But we see the biggest potential actually at monotherapy. But we could co-formulate the same for the GIP. That's also a product that could be co-formulated with any of the other molecules we have.

Rajan Sharma
European Biotech Analyst, Goldman Sachs

Okay. Perfect. Well, we're right up on time, and I realize it's kind of pretty late in the day, please. So, yeah, thank you for taking the time to talk to us.

Adam Steensberg
President and CEO, Zealand Pharma

Thanks.

Rajan Sharma
European Biotech Analyst, Goldman Sachs

All right.

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