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ZEAL.CO Q1 2025 Earnings Call Transcript

Adam Lange: Thank you to everyone for joining us today to discuss Zealand Pharma's results for the First Three Months of 2025. You can find the related company announcements on our website at zealandpharma.com. As described on slide 2, I caution listeners that during this call, we will be making forward-looking statements that are subject to risks and uncertainties. Turning to slide 3 and the agenda. With me today are the following members of Zealand Pharma's management team. Adam Steensberg, President and Chief Executive Officer; Henriette Wennicke, Chief Financial Officer; and David Kendall, Chief Medical Officer. All speakers will be available for the Q&A session along with Eric Cox, Chief Commercial Officer. Moving to slide 4, I will turn the call over to Adam Steensberg, President and CEO.

Adam Steensberg: Thank you, Adam, and thanks to everyone for joining today. Zealand has never been in a stronger position than we are today financially, organizationally and in terms of our clinical development pipeline. Our vision is to become a key player in the future management of obesity and we now have the strongest possible foundation to realize this vision. We have a differentiated mid to late stage obesity pipeline and recently entered a historic and transformative collaboration with Roche on petrelintide. The agreement with Roche includes co-development and co-commercialization rights, a 50/50 profit sharing in the US and Europe and adds a new product candidate to our pipeline in the form of petrelintide CT-388. We look very much forward to embarking on this partnership with Roche aiming to establish the leading amylin franchise with petrelintide as a future foundational therapy for weight management. Both of our late-stage rare disease programs have a clear path forward. We remain committed to bringing these programs to patients as quickly as possible, while actively exploring partnership opportunities. During the last two years, we have significantly strengthened the organization to prepare ourselves for this unique next phase of accelerated growth and importantly we have secured enough capital to fund our journey towards profitability. In the last period, we have seen geopolitical and market uncertainty. In general, I believe Zealand is in a strong position to meet these challenges as we expand our operations and invest for accelerated growth. Our strong capital situation allows us to progress towards profitability with confidence and our execution power has been significantly improved both due to the strengthening of our organization and due to the Roche partnership for petrelintide where they are responsible for setting up commercial manufacturing and supply. We believe that amylin analogs host the potential to become the future leading category for weight management. The increasing body of clinical evidence supporting the safety tolerability and efficacy of amylin analogs have derisked the amylin, the petrelintide program as well. In fact there has been a short-acting amylin analog on the market approved for diabetes for more than 20 years and in December, last year we saw Phase 3 data with another long-acting amylin analog that appeared to have a safe and well-tolerated profile further derisking the class. Thus in petrelintide, we are based on the clinical data reported to date and due to the molecular specific attributes confident in a best-in-class potential and thus a unique opportunity to build the leading amylin-based franchise for weight management. Turning to slide 5. We have a strong focus on building the foundation for the next phase of accelerated growth for Zealand. Fueled by the partnership with Roche, we can now increase our efforts on several fronts including significant new investments in the research pipeline targeting obesity and inflammation. Due to the type of partnership agreement that we have entered with Roche for petrelintide we're training equal strategic rights and 50/50 profit sharing in the US and Europe, Zealand has the potential to become a very different company in just a few years and we need to have a pipeline that reflects such a company. In recent months, we have strengthened the organization across all layers. Steven Smith, a recognized leader in obesity and metabolism clinical research has joined us as medical advisor in obesity. Steven will be central in advancing our obesity research and clinical development programs in our pursuit of addressing one of the biggest healthcare challenges of our time. In April, we were excited to welcome Utpal Singh as our Chief Scientific Officer and new member of the executive team at Zealand Pharma. Utpal brings nearly 25 years of industry experience, spanning the full drug discovery and development life cycle most recently as Senior Vice President of small molecule discovery at Lilly where he spent more than 18 years. Utpal will lead the discovery and clinical translation of peptide medicines, leveraging technologies including data science and AI to enhance our discovery process. Hence, Utpal will drive the next wave of differentiated innovative therapies at Zealand Pharma and will be instrumental in building the company into an enduring and generational biotech. This leads me to slide 6. We are focused on developing new and better treatment options for people with overweight and obesity to tackle one of the greatest healthcare challenges of our time. We are still in the very early days of the evolution of this market. In the US, only about 2% of eligible patients with overweight and obesity are on pharmacotherapy today. Despite the availability of once-weekly Tier 1-based therapies, real-world treatment persistence remains a challenge and the number of patients benefiting long-term from these treatments has not yet seen a substantial improvement. There is thus a significant unmet medical need for therapies that can deliver effective weight loss but with an improved tolerability and acceptability compared to current therapies on the market, including a lower frequency and milder severity of gastrointestinal adverse events so that patients may have a more positive experience and can better achieve and importantly maintain a healthy weight loss. In a weight loss, maintenance setting, we believe that gastrointestinal adverse events like diarrhea constipation and this feeling of having lost your appetite experienced by many patients on a Tier 1-based therapy are just as important as the more commonly discussed nausea and vomiting. While all GLP-1s and once-monthly injectable GLP-1s may help expand the overall GLP-1 class, we view them more as complementary approaches rather than distinct alternatives. With the potential for an improved gastrointestinal tolerability profile and differentiated mechanism of action that makes people feel full faster rather than suppressing their appetite, we believe that amylin analogs can be the preferred choice for the vast majority of people with overweight and obesity, both during weight loss and importantly in the weight loss maintenance setting. And with that, let's move to slide 7, as I turn over the call to our Chief Medical Officer, David Kendall to discuss our R&D pipeline. David?

David Kendall: Thank you, Adam. Today, I would like to focus my remarks on the continued advancement of our obesity programs, in particular petrelintide, following the announcement of our exciting partnership with Roche, and I will also provide a brief update on our other ongoing development and regulatory activities. Let's move to slide 8. We now have the opportunity together with our partner Roche to establish the leading amylin-based franchise for weight management and rapidly expand into obesity-related comorbidities. We remain committed to advancing petrelintide as standalone therapy targeting 15% to 20% weight loss and better patient experience with improved gastrointestinal and overall tolerability and acceptability. We believe such a product profile has the potential to address the unmet medical needs for the majority of people living with overweight and obesity thus positioning petrelintide as a foundational therapy. We also maintain that petrelintide has the potential as a best-in-class therapy as this asset is both physically and chemically stable with no fibrillation at physiologic pH and petrelintide was developed so that it can be co-administered and co-formulated with other peptide-based therapies. The broad collaboration scope with Roche allows us to explore and unlock the full potential of petrelintide and reach as many patients with overweight and obesity as possible. Together, we will leverage the advantageous attributes of petrelintide and explore the candidate in combination with other agents, starting with a fixed-dose combination product of petrelintide and CT-388, a potential best-in-class GLP-1/GIP receptor dual agonist and Roche's leading incretin asset. One novel concept that we find interesting with the petrelintide CT- 388 fixed-dose combination product is to maximize the dose of the generally better tolerated non-incretin agent petrelintide, having the optimized dose of the incretin-based GLP-1/GIP therapy for people who both need and desire more weight loss and/or improved glycemic control without materially compromising tolerability. Together with Roche, we look forward to initiating Phase 2 trials with the petrelintide CT-388 fixed-dose combination product in early 2026 and to explore other potential petrelintide-based combination products as we move forward. Turning to slide 9 for an update on the status of petrelintide Phase 2 ZUPREME program. In December 2024, we initiated a large and comprehensive Phase 2 trial with petrelintide in people with overweight or obesity. ZUPREME-1 is a dose-finding trial assessing the safety and efficacy of five doses of petrelintide versus placebo over 42 weeks of treatment. We were also excited to announce the completion of enrollment for this trial in March 2025, just three months after trial initiation and we look very much forward to reporting top-line results from ZUPREME-1 in the first half of 2026. In April 2025, we also announced the initiation of ZUPREME-2 a Phase 2 trial of petrelintide in persons with overweight or obesity and coexisting Type 2 diabetes. In this population data suggests that amylin agonism may potentially deliver weight loss comparable with that observed in the non-diabetes population. Another potentially important differentiation opportunity with amylin agonists as compared to GLP-1 based therapies where attenuation of weight loss has been consistently observed when comparing those with diabetes to those without diabetes. We expect to complete the ZUPREME-2 trial in the first half of 2026. The clinical development of petrelintide is progressing very well and together with Roche we are excited to leverage insights from the ZUPREME program to guide the design of a comprehensive and ambitious Phase 3 registrational program for petrelintide in weight management. Turning to slide 10 for some remarks on Survodutide and Dapiglutide. Survodutide a dual glucagon GLP-1 receptor agonist is in late-stage development for both obesity and metabolic dysfunction associated steatohepatitis or MASH. In the first quarter of 2025, Boehringer Ingelheim completed enrollment in the Phase 3 synchronized cardiovascular outcomes trial marking full enrollment in all trials in the Phase 3 obesity program. We look forward to top-line data from the first Phase 3 trial in people with overweight or obesity anticipated in the first half of 2026. Boehringer Ingelheim expects to launch survodutide in 2027 or 2028 and if successful survodutide could be the third incretin-based therapy to market and it would be the first approved dual glucagon GLP-1 receptor agonist in this exciting era of novel weight loss therapies. Survodutide holds best in class potential for the treatment of obesity and MASH. We are very excited about the ongoing Phase 3 program in people with MASH, which represents the largest ever Phase 3 MASH program with an incretin-based therapy and the only program to also include people with compensated cirrhosis. MASH is one of the most prevalent and serious obesity-related comorbidities with significant unmet medical needs. It is estimated that one-third of people with overweight and obesity have MASH. With best-in-class MASH data presented last year from a 48-week Phase 2 trial, we believe survodutide has the potential to become the preferred therapy in a very large and growing market benefiting patients who urgently need more and better treatment options. Dapiglutide is designed as a potent GLP-1 receptor agonist targeting significant weight reduction and offers the potential to also leverage GLP-2 pharmacology to improve gut barrier function and address the low-grade inflammation associated with metabolic disease. We look forward to presenting the results from part one of the Phase 1b dose titration trial with dapiglutide at the American Diabetes Association's 85th Scientific Sessions in June 2025. In the second quarter of 2025, we also look forward to reporting top-line results from part 2 of the Phase 1b trial investigating higher doses of dapiglutide over 28 weeks of treatment with subsequent initiation of a Phase 2 trial. Moving to slide 11 and a brief update on our rare disease programs. For Dasiglucagon in congenital hyperinsulinism resubmission of Part 1 of our original new drug application and the subsequent submission of Part 2 are contingent on an inspection classification upgrade of our third-party manufacturer's facility. While we await the potential classification upgrade we are implementing a supply contingency plan in parallel including qualification of an alternative supplier to ensure that we can bring this product to patients in need as quickly as possible. For Glepaglutide for the treatment of short bowel syndrome with intestinal failure, we successfully completed the Type A meeting with the US FDA in March 2025. We have now ensured alignment on the trial design Phase 3 EASE-5 trial so that it can support regulatory submission in the US and we remain on track to initiate EASE-5 in the second half of 2025 and we expect to share more details on the trial design later this year. We also still anticipate submitting a marketing authorization application in the second half of 2025 to support the approval of Glepaglutide in the EU. With that I would now like to turn the call over to our Chief Financial Officer, Henriette Wennicke to review our financial results for the first quarter of 2025. Henriette?

Henriette Wennicke: Thanks, David and hello, everyone. Let's turn to slide 12 and the income statement. Revenue in the first three months of 2025 was DKK8 million mainly driven by the license and development agreement for Zegalogue with Novo Nordisk. Revenue from the initial up-front payment of US$1.4 billion related to the collaboration and licensing agreement with Roche will be accounted for upon closing of the agreement which we expect in the second quarter of 2025. Resource and development expenses of DKK290 million are mainly driven by the development of petrelintide, including the large Phase II ZUPREME-1 trial and preparation for the Phase II ZUPREME-2 trial, which was initiated in April 2025. Sales and marketing expenses of DKK 37 million are mainly driven by pre-commercial activities associated with our rare disease assets. General and admin expenses of DKK 65 million reflect the continued strengthening of our organizational capabilities as we prepare the organization for the Roche partnership as well as investment in IT infrastructure and our patent portfolio. Net financial items of DKK 70 million are mainly driven by interest income from the excess liquidity invested in marketable securities. Let's move to Slide 13 and the cash position. As of March 31, 2025, cash, cash equivalents and marketable securities totaled DKK 8.5 billion. As mentioned, we expect to receive the US$1.4 billion upfront payment from Roche in the second quarter of 2025 equal to approximately DKK 9.2 billion. Upon closing of the transaction, this will bring our cash position to roughly DKK 18 billion. I can confidently say that, we are in an extremely solid financial position. On top of this, we will receive in total $250 million in anniversary payments over two years and potential development milestones of up to $1.2 billion, with the vast majority of these development milestones linked to initiation of Phase III trials with petrelintide monotherapy. I'm not only confident that we can fully meet all our financial obligations under the Roche partnership for petrelintide, but also that our solid financial position provides ample flexibility to reinvest beyond petrelintide, including in our early-stage research pipeline targeting obesity and inflammation and to further strengthen our organizational capabilities in preparation for the growth journey ahead. Based on our current clinical and organizational plans, we project that we have the financial strength to take Zealand Pharma all the way to profitability with no need to raise additional capital. This is truly a pivotal milestone for the company. Turning to slide 14 and the financial guidance, I will keep this short as there are no changes to the outlook for the year compared to what we outlined in February 2025. We confirm the financial guidance on net operating expenses, which we are expecting to be between DKK 2 billion and DKK 2.5 billion excluding transaction-related costs associated with the Roche partnership agreement. We expect these transaction-related costs to be approximately DKK 200 million in 2025. And with that, I will move to slide 15 and turn the call back to Adam for concluding remarks.

Adam Steensberg: Thank you, Henriette. The first quarter of 2025 was truly historic for Zealand Pharma, but I'm even more excited about what's to come. Some of the key catalysts over the next 12 months are highlighted on this slide. First and foremost we look forward to initiating our collaboration with Roche once the agreement is closed, which is expected here in the second quarter. Regarding clinical data, we will report additional results from the Phase Ib trial with dapiglutide later this quarter and in the first half of 2026, I'm particularly excited about the Phase II top line results with petrelintide and top line results for the Phase III obesity trials with Survodutide. Moving to slide 16, as a final note, I encourage all of you to save the date for Zealand Pharma's Capital Markets Day on December 11, '25 in London. The event will feature speakers of our management team as well as thought leaders in obesity. We will speak in more details about this day later in the year and hope to see many of you there, either in person or online. Thank you all. I will now turn over the call to the operator for questions.

Operator: Thank you. [Operator Instructions] We will take our first question. And your first question comes from the line of Michael Novod from Nordea. Please go ahead. Your line is open.

Michael Novod: Thank very much. Michael Novod from Nordea. Two questions, one to petrelintide and one to glepaglutide. So on petrelintide, maybe can you try to elaborate more on at least the early discussions you had with Roche when you did sort of the deal? I know, you can't really talk together right now until the deal is closed, but the early discussions around different ratios for the amylin versus GLP-1 in order to try to improve tolerability also with a focus on how the initial data looked on for CT-388. And then secondly, for glepaglutide, I know it's already just out of the gates from one big collaboration but maybe you can try to talk about how you try to plan for out-licensing of glepaglutide. Will we see you already in the second half of this year trying to sort of close the deal on glepaglutide? Or do we have to wait until potential launch in Europe or that you are progressing further towards the market in the US? Thanks.

Adam Steensberg: Thank you, Michael and I will hand over the first question to David and then the second question to Eric to talk about our efforts on petrelintide partner. But David will you take the first question please?

David Kendall: Happy to and Michael thanks for the question. I think while these are early days and to your point, we will only fully engage with our Roche partner on detailed discussions once the clearance period is completed. But in those discussions, and in sharing some detail around the data you and others have seen from their public disclosure of the CT 388 program, there is significant effect at relatively lower milligram doses, with CT 388, I believe the 8 mg dose performed quite well and of course, the very rapid titration scheme that was used in their early phase program has not given full clarity around how one can optimize tolerability of that incrertin-based therapy. But as we said in the prepared remarks, I think our goal once we see Phase 2 data from both ZUPREME 1. As well as the first of the CT 388 programs, we will have a much better sense of where tolerability can be optimized and formulation can be optimized to do, as I described in my remarks maximizing petrelintide And optimizing the 388 program. But to predict on a milligram basis at this point prior to Phase 2 data being available would be premature. But given both what we know about each asset, what we've learned from the CagriSema program, we think we can certainly maximize the weight reducing capacity and further optimize that tolerability and acceptability profile. So, more to follow Michael. And Eric, over to you.

Eric Cox: Thank you, David and Michael thanks for the question. I think with regard to the Roche [ph] partnering I think there's been a lot of interest, prior to even prior to the APRA announcement, so I think we're very encouraged by the dialogue we're having. We'll still see that begin to progress. I don't think, we have a clear timeline on exactly when things will be. We'll be moving forward but there is quite a bit of interest here, which I think is very encouraging as we move forward. So I think just hold tight and we'll better see where we move, with this but we are very encouraged with the conversations we've had and they've been very productive at this point.

Q – Michael Novod: Okay, great. Thank you very much..

Operator: We will take our next question. The next question comes from the line of Andy Hsieh with William Blair. Please go ahead. Your line is open.

Q – Andy Hsieh: Well, great thanks for taking our questions. So, Adam I think you mentioned briefly in your prepared remarks about this topic, but I'm curious about the team's take on the maintenance opportunities specifically, how do you envision designing studies to answer relevant clinical questions? Do you plan to do this in a Phase 2 setting or based on available PK data it could be seamlessly incorporated in the Phase 3 program.

Adam Steensberg: Thank thanks for your question. And me -- I will start by providing some more thoughts here and maybe David will add some flavors. But in general, I think if you look into the space so far most companies have actually focused on weight loss. In order to achieve health, which is why we are here you need to make sure that patient stays in therapy. We think, what we're seeing right now once you let the current medicines in the hands of patients, and they're in a real world setting, many patients struggle to stay on therapy. And as we mentioned before, our understanding is that it's actually not --it's mostly not due to the common, you can say known side effects to the GLP-1 of nausea and vomiting. Many patients once they have achieve their weight loss and get into the weight maintenance phase, it's actually side effects such as diarrhea, constipation and this thing that you lose your appetite, that is a problem. I think the other thing that is a problem is, that if you are too aggressive with how much you push your weight loss. Let's say, a very ambitious patient achieving 30% weight loss, that person may struggle to maintain such a dramatic weight loss, because most people actually once they get further into that, also would like to engage in social gatherings around food and you simply many patients simply feel they have to change their life too much, if they have these dramatic weight losses. So this is why we are super excited about the training side, because we think it has a more benign profile towards GI tolerability and most importantly maybe, because it works on appetite, it makes you feel full faster, so it will basically not reduce your appetite but just make you feel full faster. So the other thing that the industry has failed, a little bit is to explore and I think that is what your question alluded to, how to dose these drugs in the maintenance phase. And this is something that we of course anticipate that we'll discuss further with Roche how to address that because as I said, before we think it's actually the most important phase to focus on, how we make sure that we optimize both for the weight loss, but also for weight maintenance with a drug like petrelintide. So it's clearly something that we expect to discuss further with Roche once we get the collaboration going. David, do you want to add some more to that?

David Kendall: Yes, just a couple of points and thank you Andy, agree and line with Adam that I think looking at the opportunity to both design and execute what I'll call clinically practical, clinical utility studies, how will people utilize petrelintide and or its combination in real life not solely this arms race to a bigger number over a relatively short period of time. And I think we have learned quite clearly that these will not be drug withdrawal studies other than perhaps a switch from one class of agent to another for example, coming off an incretin-based therapy to an amylin-based therapy, if that's a patient's desire or is of clinical interest. And I think in addition to what Adam has provided there are characteristics of amylin agonists some of which we've learned from pramlintide in its history. First is that satiety signal rather than this an hedonic food aversion signal as Adam alluded to that is not appealing to a lot of people, meaning avoiding food. Whereas having the opportunity to maintain some degree of appetite but feeling full fast is important. Remember too, there are mechanisms that we only partially understand and that's the leptin sensitization. If you can maintain sensitivity to the signal that comes from adipose tissue, namely leptin. Will that allow you to continue to maintain a higher quality weight loss not just a greater degree of weight loss. All of these will be parts of what I hope we can assess in these later clinical usefulness, clinical application studies.

Adam Steensberg: Thanks. Thanks Amy.

Operator: Thank you. We will take our next question. Your next question comes from the line of Prakhar Agrawal from Cantor Fitzgerald. Please go ahead. Your line is open.

Prakhar Agrawal: Hi, thank you for taking my questions and congrats on all the progress. I had two on ZUPREME-2 in overweight obesity with Type 2 diabetes. So number one what will be the top doses tested in ZUPREME-2, would be similar to ZUPREME-1 in obesity without Type 2 diabetes? And second question early data suggested weight loss benefit for amylin and Type 2 diabetes should track closer to obesity but we didn't really see that materializing with CagriSema or redefined two trial. So wondering if the team had any thoughts here as it relates to the amylin plus GLP-1combination and would you still expect amylin monotherapy to have similar weight loss in Type 2 diabetes and obesity? Thank you.

Adam Steensberg: Thanks for your question and I'll just provide a few notes and then hand it over to David. We are kind of limited by the top dose that we're also exploring in the ZUPREME-1. So it will be the top dose, similar top those we explore in ZUPREME-2. As David said at his call, we clearly believe that the amylin analog has the potential to provide similar weight loss in patients with Type 2 diabetes and as in patients without Type 2 diabetes. And I think if you carefully look into the CagriSema data and compare that to what was achieved with Sema as a monotherapy, it was actually very significant additional weight loss that Nova observed in a Type 2 obese population probably close to doubling the weight loss. So we think that is a very strong achievement, especially because we don't think that you can say in that molecule you can say the amylin component has been utilized to its fullest extent. We think it's a low dose of amylin compared to what we progress with. So we have a lot of confidence still in this patient group. David any further comments?

David Kendall: Yes, I'll just reemphasize Adam, what you said in that Prakhar is that in the CagriSema program at least our perspective is that once again, if you can maximize the exposure to an amylin agonist and you don't have a profound need for the potent glucose lowering component of a incretin-based therapy, you can either remove or certainly minimize the exposure to the incretin-based therapy. So the Adam's point, I don't think we saw the full potential of the amylin agonist in that program. Obviously, ZUPREME-2 is a standalone amylin agonist only, where we anticipate that the data will tell us that comparable level of weight reduction. And certainly both data historically from the pramlintide studies and more recently the Phase 2 data with petrelintide in the Type 2 diabetes Phase 2 study, support this hypothesis but of course, that's why we execute the trials and I think we will better understand both the dose response which as Adam said, are similar doses at the top end. And the capacity to maintain weight loss potential with an amylin agonist alone.

Prakhar Agrawal: Thank you.

Adam Steensberg: Thank you.

Operator: Thank you. We will take our next question. Your next question comes from the line of Suzanne van Voorthuizen Van Lanschot Kempen. Please go ahead. Your line is open.

Chiara Montironi: Hello, team. Thanks a lot for taking my question. This is Chiara Montironi on behalf of Suzanne Voorthuizen. So I was wondering for the petrelintide Phase 2b readout next year, what should we expect a top line release to include and what would you consider a good result? And yeah, I was also wondering whether this phase two studies will include measurements of body compositions or any biomarkers that may feed into the potential of amyle for better quality of fat versus lean mass loss. Thank you.

Adam Steensberg: Thanks. I'll just start and then hand over to David as well. So we do include measurements of body composition using MRI. Good result. It's actually I would say probably too early to comment on that one. What we're aiming for is ultimately in phase 3 we have a product that demonstrates 15% to 20% weight loss. And of course, the readout here only goes up to 48 weeks and we will continue for phase three studies for longer. So it's not only the number, it's also of course the slope of the curves at that time that defines what a good outcome is. But as long as we are confident that we can achieve that profile we would be more than happy and then as we have also alluded to several times in this call. Very important is to understand the soil profile which we think will be the key driver of differentiation compared to the T2 ones. David, any further?

David Kendall: Yeah, two comments in addition Adam and the first related to MR which I think is an important measure of body comp remembering that this allows us to look specifically at fat mass, not just lean versus non-lean mass so a bit more discrimination which I think will help us better understand what is translated from the data that have been observed in non-clinical models. The second as Adam alluded to is not just the slope of the line, but are we seeing a clear separation of doses so that we can approach the regulatory authorities at the end of phase two and say, we have clear designs on specific doses for phase three execution. I think it is important to remember that given that tolerability is one of the things that we believe will allow us to differentiate petrel and tide is that the titration scheme is monthly. So again as in my response to Prakhar, this is not a race to the greatest number, but rather an understanding of can we support the tolerability and acceptability profile and still see a trajectory that as Adam alluded to takes us to the 15% to 20% GLP-1 monotherapy like weight loss. So in general terms, those are the things we will be looking at the end of phase two and with those top line results.

Chiara Montironi: Thank you very much.

Adam Steensberg: Thank you.

Operator: Thank you. We will take our next question. Your next question comes from the line of Charlie Haywood from Bank of America. Please go ahead. Your line is open.

Charlie Haywood: Charlie Hayward, Bank of America. Thank you for taking my questions. So the first one is, your peer talk yesterday to still seeing an average daytime on the GLP-1 around seven months, so I'd appreciate some of that supply and payer driven, but where do you think or what's your vision for where you could get to for Petrie monotherapy stay time in the future especially in the context of maintenance therapy. And then secondly on your comment about needing a pipeline to reflect the future company and you're saying petrol programs obviously fairly de-risked and acknowledging that your gitists hasn't moved for a while. Can you talk about your ambition for future R&D in this sort of cardio metabolic space beyond the current portfolio? Any targets you see particularly interesting any unmet needs you expect to evolve? Thank you.

Adam Steensberg: Thanks for your question. Yeah and we agreed to the observations around the average daytime for the GLP-1 around seven months. And I think it's really important when you discuss that seven months that you also appreciate that it's in a therapy area where there are not many other choices. So while you can say it may be quite similar to what we see in other chronic therapy areas. The fact is it's not because people get on other brands or other modalities, it's because they stopped treatment, which is super negative because ultimately you only achieve health outcomes if you achieve weight loss and maintain that weight loss. So that's a huge task ahead for the industry to make sure we develop weight loss agents that people can that can help people not only lose weight, but also help them maintain those weight losses. And therefore, we of course have a much higher ambition for how long patients should stay on an amidin. And we really think. It because we have been so excited about seeing now the first tools medical tools that can help people lose weight, I think somehow in that conversation we forgot about the patients. We forgot about we are just humans who want to live a normal life a little bit healthier life. But many patients once they have achieved the weight loss are not ready to make the commitments of carrying the burden of diarrhea constipation and that thing that you have lost your appetite and we think it will create a significant new opportunity with the train side if we can continue to do. They provide the results we've seen thus far. And of course if you think about the market opportunity, if you can maintain patience and treatment for longer that really is something that drives up volumes instead of having to go out and capture new patients constantly. As we see right now is the case for the current launches. So we are, you can say very positive on the opportunity to help patients stay on longer with a category like MNE in particular with the training type. On the future pipeline, it's too early for me to comment on it except that we will increase our investments big time. And then you can say December 11th, that's probably where you will get the full vision for how we think about driving these the pipeline forward. But of course it's also already today obvious from the -- our pipeline chart that we have opportunities within. The chronic inflammation immunology with the KB 1.3 as an example which is right now in Phase 1, which holds potential really to you can say become a pipeline within the program. So, you should expect to hear more in December maybe also a little earlier, but have the full picture at our Capital Markets Day in December. But thanks for the question.

Charlie Haywood: Thank you.

Operator: Thank you. We will take our next question. Your next question comes from the line of Shan Hama from Jefferies. Please go ahead, your line is open.

Shan Hama: Hi thanks for taking my question. Just two for me please. How would you define success in the Phase 2 dapiglutide study that you expect to initiate during the second half of the year? And although I appreciate it's still quite far away, could you give us some initial thoughts on the potential topics for the Capital Markets Day in December? Thank you very much.

Adam Steensberg: Thanks. And I think we are success for us with that that looks that is we are aiming for you can say a confirmation that we can achieve like weight loss with this program once we have extorted the full dosing potential over 28 weeks. And then as David also alluded to -- and maybe David you want to provide more comments, it's really the opportunity to differentiate in how well we address inflammation, which gives us high confidence in this program because honestly speaking, we don't think the world needs that many more GLP-1s unless they are compared to what we already have in late clinical development out there unless they're truly differentiated on parameters that goes beyond just weight loss. I think it's time we move beyond that weight loss number and think about what is the true value you bring to patients with these novel opportunities. On the Capital Markets Day, there's no question that a lot of the theme will be around the obesity, how we see the market develop, how we see our product opportunities fitting into that space, having key opinion leaders also talking you can see around some of the dynamics in the biology. And then we would share more light around where we expect the early pipeline to develop in the coming years. So, it will be hopefully a very content-rich day, which also provides a very clear direction for our ambition in the coming years. David do you want to provide further to the dapi?

David Kendall: Yes, I will add Adam to your comment. I think as is noted there will be myriad GLP-1-based therapies and the differentiation is key. So, we have a number of non-clinical efforts ongoing to look at the biologic plausibility of addressing neuroinflammation, hepatic inflammation, vascular inflammation, generalized inflammation. So, defining success beyond the weight reducing capacity of dapi will be finding those comorbidities or disease state targets where we believe dapi can shine or outshine other incretin-based therapies. And you could say it's threading a needle, but more importantly it is in our mind finding those areas where either persistent or continued inflammation derives the disease process beyond weight management alone. And we believe, as I alluded to, that that could be vascular inflammation, could be hepatic inflammation, could be neural inflammation. So, success will start with the weight reducing effects and then finding those specific areas where we think increase dapiglutide can shine most.

Adam Steensberg: Thanks a lot.

Operator: Thank you. [Operator Instructions] Ollie Burrow Goldman Sachs. Please go ahead, your line is open.

Ollie Burrow: Hello, it's Ollie Burrow on for Rajan Sharma. So, two questions. Firstly on the Amylin competitive landscape. So, we've seen some early data from AbbVie or [indiscernible] and there's some upcoming data from Lilly's [indiscernible] ADA. So could you provide some perspectives on those two assets and why is petrelintide differentiated versus those assets? And then the second question on the Roche partnership. So, could you discuss potential cost share structures on R&D? Are there any caps to spend for Zealand? And just could you give us a sense of how much you and Roche plan to spend both on the development of petrelintide and the combination asset? Thank you very much.

Adam Steensberg: Thanks a lot for your questions. If I start with the Roche deal, it's a true, you can say, 50/50 agreement where we will also share the cost from -- not when it comes to investments in manufacturing or building up the supply chain that is responsibility of Roche, but from R&D perspective, we will share the cost and you can -- as Henriette also alluded to doing her part of the presentation, we are confident that we, with the cash we have at hand and the expected near-term milestones, can cover our part and, on top of that, increase investment significantly. We are not yet providing clear guidance for what that part will be. But we, of course, have a defined clinical development program within the contract, which provides opportunities to expand beyond that, if we decide to do that together with Roche. But we have ample opportunity to increase investments beyond the commitments we have into the program as it stands today in the plans, including pre-launch commercial activities. On the competitive landscape, you can say, of course, as we have also said for a long time, because amylin is such an attractive category, we should expect to see more competition in the future. We feel very confident around the best-in-class potential with petrelintide, which I think is also exemplified by the deal we announced recently and the consistency of the data that we have demonstrated across several clinical studies thus far. Also, you can say when we look at timelines to market, we feel very comfortable in the position that we are sitting in now, in particular also with Roche as a partner. So, we -- as everyone knows, and as you also alluded to, Lilly, they are expected to release data from their amylin-only analog later this year. They have just closed another amylin program, which was based on salmon calcitonin. I think that's a category that has repeatedly been closed, at least in our -- how we understand the market. So -- but now they're solely focused on an amylin-only molecule. And we have not seen clinical data from that program. Whether they're going to pursue only combination therapies ultimately with tirzepatide or also monotherapy, we don't know. The collaboration between Boehringer Ingelheim and AI that was announced recently around that amylin is some years behind us. And you can say so far, at least, our understanding is it's a rather inconsistent data set that we have seen. But, of course, we need to see more data. And ultimately, we would expect more competition in this space, probably together with us. I mean, I would say Novo Nordisk is, of course, leading the effort not only with CagriSema but also with the stated ambition of taking their amylin analog, petrelintide, into Phase 3 development in the coming period. So, but in that mix where you can say Novo is approaching Phase 3 with the cagrilintide and we look to be the next with what we believe is a molecule that has best-in-class potential -- we feel very confident in our, you can say, journey ahead. And ultimately, we would welcome more competition in this space because we truly think this is the category that can solve the topic we have discussed so much in this call about how do we help patients not only achieve weight loss, but also weight maintenance. And we just feel that we are extremely well positioned to lead that category with petrelintide and also, as we discussed here, now that we have the combination with CT-388, which would address specific patient statements further, really building around the petrelintide side as a franchise and as a future foundational therapy for patients with obesity and associated diseases.

Ollie Burrow: Awesome. Thank you.

Operator: There are no further questions. I would like to hand back for closing remarks.

Adam Steensberg: With that, we would like to thank you all for attending and for your questions. We look forward to future announcements and updates and to connecting in the coming weeks and months. Thank you.