Zealand Pharma A/S

CSE:ZEAL

Good day, and thank you for standing by. Welcome to the Zealand Pharma Results for Q1 2025 Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Adam Lange, Vice President, Investor Relations. Please go ahead.

Thank you, operator, and thank you to everyone for joining us today to discuss Zealand Pharma's results for the first 3 months of 2025. You can find the related company announcement 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.

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 for petrelintide. The agreement with Roche includes co-development and co-commercialization rights, a 50-50 profit sharing in the U.S. 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 2 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 analog holds 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 petrelinitide 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 III 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 retaining equal strategic rights and 50-50 profit sharing in the U.S. 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 a 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 health care 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 health care challenges of our time. We are still in the very early days of the evolution of this market. In the U.S., only about 2% of eligible patients with overweight and obesity are on pharmacotherapy today. Despite the availability of once-weekly GLP-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-dose 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 GLP-1-based therapy are just as important as the more commonly discussed nausea and vomiting.

While oral 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?

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 stand-alone 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 lead 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 II 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 II ZUPREME program, in December 2024, we initiated a large and comprehensive Phase II trial with petrelintide in people with overweight or obesity. ZUPREME-1 is a dose-finding trial assessing the safety and efficacy of 5 doses of petrelintide placebo over 42 weeks of treatment. We were also excited to announce the completion of enrollment for this trial in March 2025, just 3 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, the Phase II 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 nondiabetes 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 III 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 NASH. In the first quarter of 2025, Boehringer Ingelheim completed enrollment in the Phase III SYNCHRONIZE cardiovascular outcomes trial, marking full enrollment in all trials in the Phase III obesity program. We look forward to top line data from the first Phase III 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 III program in people with MASH, which represents the largest ever Phase III 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 1/3 of people with overweight and obesity have MASH. With best-in-class MASH data presented last year from a 48-week Phase II 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 1 of the Phase Ib 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 Ib trial investigating higher doses of dapiglutide over 28 weeks of treatment with subsequent initiation of a Phase II 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 U.S. FDA in March 2025. We have now ensured alignment on the trial design of the Phase III EASE-5 trial so that it can support regulatory submission in the U.S. 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?

Thanks, David, and hello, everyone. Let's turn to Slide 12 and the income statement. Revenue in the first 3 months of 2025 was DKK 8 million, mainly driven by the license and development agreement for Zegalogue with Novo Nordisk. Revenue from the initial upfront payment of USD 1.4 billion related to the collaboration and license agreement with Roche will be accounted for upon closing of the agreement, which we expect in the second quarter of 2025.

Research and development expenses of DKK 290 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 USD 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 2 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.

Thank you, Henriette. The first quarter of '25 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 '26, 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 Instructions] And your first question comes from the line of 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 U.S.?

Thank you, Michael. And I will hand over the first question to David and then your second question to Eric to talk about our efforts on clever partnering. David, will you take the first question, please?

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-milligram 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 incretin-based therapy. But as we said in the prepared remarks, I think our goal, once we see Phase II 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 II 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.

Thank you, David. And Michael, thanks for the question. I think with regard to the glepa 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 time line on exactly when things will be moving really 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.

Your next question comes from the line of Andy Hsieh from William Blair.

So Adam, I think you mentioned briefly in your prepared remarks about the topic. But I'm curious about the team's take on the maintenance opportunity. Specifically, how do you envision designing studies to answer relevant clinical questions? Do you plan to do this in the Phase II setting or, based on the available PK data, it could be seamlessly incorporated in the Phase III program?

Thanks for your question. I will start by providing some more thoughts 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 on therapy. We think what we are seeing right now, once you get the current medicines in the hands of patients and 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-1s of nausea and vomiting. Many patients, once they have achieved 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 life, also would like to engage in social gatherings around food. And 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 petrelintide, because we think it has a more benign profile towards GI tolerability and also, most importantly, maybe because it works on appetite -- sorry, where 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 do 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?

Yes. Just a couple of points, and thank you, Andy. I agree and align 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 agonist, some of which we've learned from [ petrelintide ] in its history. First is that satiety signal rather than this anhedonic 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.

Your next question comes from the line of Prakhar Agrawal from Cantor Fitzgerald.

Congrats on all the progress. I had 2 on ZUPREME-2 in overweight obesity with type 2 diabetes. So number one, what will be the top doses tested in Supreme 2? Will it be similar to ZUPREME-1 in obesity without type 2 diabetes? And second question, early data suggested weight loss benefit for amylin in type 2 diabetes should track closer to obesity, but we didn't really see that materializing with CagriSema [indiscernible] trial. So wondering if the team had any thoughts here as it relates to the amylin plus GLP-1 combination? And would you still expect amylin monotherapy to have similar weight loss in type 2 diabetes and obesity?

Thanks for your question. And I will 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 ZUPREME-1. So it will be the top dose, similar top dose, we explore in ZUPREME-2. As David said at his call, we clearly believe that 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 Novo observed in the 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?

Yes, I'll just reemphasize, Adam, what you said, and 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 incretin-based therapy, you can either remove or certainly minimize the exposure to the incretin-based therapy. So to Adam's point, I don't think we saw the full potential of the amylin agonist in that program. Obviously, ZUPREME-2 is a stand-alone amylin agonist only where we anticipate, but the data will tell us that comparable level of weight reduction. And certainly, both data historically from the cagrilintide studies and more recently, the Phase II data with cagrilintide in the type 2 diabetes Phase II study supports 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.

Your next question comes from the line of Suzanne van Voorthuizen from Van Lanschot Kempen.

This is [ Karum Kironi ] on behalf of Suzanne van Voorthuizen. So I was wondering, for the petrelintide Phase IIb readout next year, what should we expect a top line release to include? And what would you consider a good result? And yes, I was also wondering whether these Phase II studies will include measurement of body compositions or any biomarkers that may feed into the potential of amylin for better quality of fat versus lean mass loss.

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 are aiming for is ultimately in Phase III to 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 III 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 also alluded to several times in this call, very important is to understand the tolerability profile, which we think will be the key driver of differentiation compared to the GLP-1s. David, any further?

Yes. Two comments in addition, Adam, and the first related to MRI, 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 nonclinical models.

The second, as Adam alluded to, is not just the slope of the line, but are we seeing clear separation of doses so that we can approach the regulatory authorities at end of Phase II and say we have clear designs on specific doses for Phase III 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 petrelintide, 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, at the end of Phase II and with those top line results.

Your next question comes from the line of Charlie Haywood from Bank of America.

Charlie Haywood, Bank of America. So the first one is your peer talked yesterday to still seeing an average stay time on the GLP-1 of around 7 months. So I appreciate some of that’s supply and payer driven. But where do you think or what's your vision for where you could get to for petre 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 sort of saying the petre program is obviously fairly derisked and acknowledging that your GIP agonist hasn't moved for a while, could you talk about your ambition for future R&D in this sort of cardiometabolic space beyond the current portfolio? Any targets you see particularly interesting? Any unmet needs you expect to evolve?

Thanks for your question. Yes. And we agree that the observations around the average stay time for the GLP-1s is around 7 months. And I think it's really important when you discuss that 7 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 stop treatment, which is super negative because, ultimately, you only achieve health outcomes if you achieve weight loss and maintain that weight loss. So there'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 amylin. And we really think, 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 their weight loss, are not ready to make the commitment 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 petrelintide if we can continue to provide the results we have seen thus far. And of course, if you think about the market opportunity, if you can maintain patients on 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 amylin, in particular, with petrelintide.

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 11, that's probably where you will get the full vision for how we think about driving the pipeline forward. But of course, it's also already today obvious from our pipeline chart that we have opportunities within the chronic inflammation immunology with the Kv1.3 as an example, which is right now in Phase I, which holds potential really to, you can say, become a pipeline within a 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.

Your next question comes from the line of Shan Hama from Jefferies.

Thanks for taking my questions, 2 for me, please. How will you define success in the Phase II 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?

And I think we -- success for us dapi, that looks -- that is -- we are aiming for, you can say, a confirmation that we can achieve GLP-1-like weight loss with this program once we have explored 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 are 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 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 say, 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 that?

Yes. I will add, Adam, to your comment. I think, as is noted, there will be myriad GLP-1-based therapies and that differentiation is key. So we have a number of nonclinical 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 drives the disease process beyond weight management alone. And we believe, as I alluded to, that could be vascular inflammation, could be hepatic inflammation, could be neuroinflammation. So success will start with the weight-reducing effects and then finding those specific areas where we think dapiglutide can shine most.

[Operator Instructions] Your next question comes from the line of Oli Burrow from Goldman Sachs.

It's Oli Burrow on for Rajan Sharma. So 2 questions, firstly, on the amylin competitive landscape, so we've seen some early data from AbbVie or [ Cooper’s Vudami ] and there's some upcoming data from Lilly's eloralintide ADA. So could you provide some perspectives on those 2 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? 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?

Thanks a lot for your questions. If I start with the Roche deal, we -- it's a true, you can say, 50-50 agreement where we will also share the cost from -- in R&D, not when it comes to investments in manufacturing or building up the supply chain. That is the responsibility of Roche. But from an R&D perspective, we will share the cost. And you can -- as Henriette also alluded to during her part of the presentation, we are confident that, with the cash we have at hand and the expected near-term milestones, we 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 prelaunch commercial activities.

On the competitive landscape, 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 time lines to market, we feel very comfortable in the position that we are sitting in now, in particular also with Roche as a partner. So 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. But now they are 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 [ facinitide ] or also monotherapy, we don't know. The collaboration between Gubra and AbbVie that was announced recently around that amylin analog are 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 in this space, probably together with us. I mean, I would say Novo Nordisk is, of course, leading the efforts, not only with CagriSema, but also with the stated ambition of taking their amylin analog cagrilintide into Phase III development in the coming period. But in that mix, where you can say Novo is approaching Phase III with cagrilintide, and we look to be the next with what we believe a molecule that has best-in-class potential, we feel very, 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 on this call about how do we help patients not only achieve a weight loss, but also weight maintenance. And we just feel that we are extremely well positioned to lead that category with petrelintide. Also, as we discussed here, now that we have the combination with CT-388, which would address specific patient segments, further really building around petrelintide as a franchise and as a future foundational therapy for patients with obesity and associated diseases.

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

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.

This concludes today's conference call. Thank you for participating. You may now disconnect.