Good day, and thank you for standing by. Welcome to the Zealand Pharma Conference Call to discuss collaboration and license agreement with Roche for petrelintide. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you'll need to press Star one and one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press Star one and one again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Anna Krassowska, Vice President, Investor Relations and Corporate Communications. Please go ahead.
Thank you, Operator. Welcome, and thank you for joining us today to discuss Zealand Pharma's global collaboration and license agreement with Roche, announced this morning. You can find the related company announcement on our website at zealandpharma.com. As described on slide two, I caution listeners that during this call, we will be making forward-looking statements that are subject to risks and uncertainties. Turning to slide three and our agenda, the following members of Zealand Pharma's management team are with me today: Adam Steensberg, President and Chief Executive Officer; David Kendall, Chief Medical Officer; and Henriette Wennicke, Chief Financial Officer. All speakers will be available for the Q&A session, along with Eric Cox, Chief Commercial Officer. Moving to slide four, I will turn the call over to Adam Steensberg, President and CEO. Adam?
Thank you, Anna, and thank you to all for joining the call today. This is a historic day for Zealand Pharma as a company. Let's move to slide five. We are extremely pleased to enter a partnership and collaboration agreement with Roche inside our potential best-in-class network. Zealand Pharma and Roche will commercialize petrelintide as a potential foundational therapy for weight loss and rapidly expand into related indications. Our aim is to REDEFINE the standard of care for people living with overweight and obesity by establishing petrelintide as a leading amylin-based franchise. This will be a true partnership between Zealand and Roche. Development, commercialization, and manufacturing activities will be managed through a shared governance structure with joint decision-making leveraging the strengths of each company while allowing Zealand to expand our reach and operations in line with our strategy.
By developing petrelintide both as a standalone therapy and as the foundation in a combination with other agents, starting with Roche's lead incretin mimetic and potential best-in-class GLP-1, GIP receptor dual agonist, we take a patient-centric approach to address unmet medical needs among the majority of people with overweight and obesity. Moving to slide six. During the last few months, we have seen significant interest from large pharma companies to partner with Zealand on the co-development and co-commercialization of petrelintide. In a very competitive process, we identified Roche as the ideal partner to help us maximize the full value potential of petrelintide. Roche has already demonstrated a very strong commitment to strengthening their portfolio within cardiovascular, renal, and metabolic diseases, including obesity.
They share our vision for petrelintide as a potential foundational future therapy for weight management, and we see a very strong cultural fit between Zealand and Roche, which will be important as we join forces to accelerate the development of petrelintide to REDEFINE the standard of care for people living with obesity and related diseases. With industry-leading research and development capabilities, a global commercial reach, and an impressive track record of disrupting new therapeutic areas, as well as an extensive manufacturing network, I'm confident that Roche is the perfect partner to help us unlock the full value potential of petrelintide. Turning to slide seven, 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 have witnessed a substantial increase in the global prevalence of overweight and obesity, rising from around 10% in the 1970s to 40%-50% today. We have seen the approval and successful rollout of the first two once-weekly GLP-1-based therapies to address this global health challenge, but in the US, only about 2% of eligible patients are on pharmacotherapy today. There's a significant unmet medical need for therapies that can deliver effective weight loss, but with improved tolerability and acceptability, including lower frequency and mild gastrointestinal adverse events, so that patients may have more and more positive experience and can better achieve an important and healthy weight loss. Moving to slide eight, this is a non-communicable disease. We are in the very early stage of the evolution of this market. We need many different sizes and different product offerings before we enter the market in the next 10 years.
We believe the success of future medications will be determined by the efficiency on multiple fronts, including improved gastrointestinal tolerability, better effect on obesity-related comorbidities, different delivery methods, and combination therapies for specific patient segments. Our amylin analog, petrelintide, with that, Zealand and Roche to aim to establish a future foundational weight management. Based on the clinical data to date, we are confident in the best-in-class potential of petrelintide and accelerating development even further. With petrelintide as a monotherapy, we are targeting 15%-20% mean weight loss with improved gastrointestinal tolerability for a different and better patient experience and with the potential for high-quality weight loss. By also developing combinations with petrelintide as the foundation, we are targeting the segment of patients who need higher weight loss and/or potentially better glycemic control than what amylin agonism can offer alone.
A patient-centric approach aiming to address the unmet medical needs of the majority of people with overweight and obesity. With that, let's move to slide nine as I turn over the call to our Chief Medical Officer, David Kendall, to discuss the current development status of petrelintide and our obesity pipeline. David.
Thank you very much, Adam. Once again, welcome to everyone, and thank you for joining us. Let's turn now to slide 10. This slide represents an overview of our differentiated mid-to-late-stage obesity pipeline. As most of you are aware, petrelintide is currently being evaluated as a potential best-in-class standalone therapy for weight management in a large comprehensive phase IIb trial in people with overweight and obesity, and we expect to complete enrollment in the ZUPREME-1 trial , the first of our two phase IIb trials, this month. We also remain on track to initiate our second phase IIb trial in people with overweight and obesity and coexisting type 2 diabetes in the coming months, the so-called ZUPREME-2 trial .
With the exciting and transformative partnership announced today, together with Roche, we are also planning to initiate phase IIb trials with the first combination product under this collaboration agreement in 2026. We'll also combine our amylin analog, petrelintide, and Roche's lead incretin mimetic, CT388, to potential best-in-class GLP-1, GIP receptor dual agonist. This fixed-dose combination product has the potential to provide best-in-disease weight loss efficacy and glycemic control. Turning to slide 11 for a brief reminder of the key attributes of petrelintide. Our long-acting amylin analog, petrelintide, is a 36-amino acid acylated peptide based on the sequence of human amylin. Petrelintide has consistently demonstrated a half-life of 10 days, making it suitable for once-weekly administration, and the compound is stable with no fibrillation at physiologic pH levels and can be both co-administered and co-formulated with other peptide-based therapies.
Petrelintide activates both key amylin receptors and the closely related calcitonin receptor, a very deliberate design principle that we believe is important in leveraging the optimal therapeutic effects of amylin analogs. Moving to slide 12, Petrelintide has consistently demonstrated best-in-class potential based on results from early clinical trials completed to date. These trials have shown consistent and compelling efficacy and safety, as well as tolerability, and provide the evidence necessary to rapidly advance the development of Petrelintide as a standalone therapy for weight management. Furthermore, the clinical results have given both us and Roche the confidence to explore Petrelintide as a foundation in combination with other agents, starting with Roche's lead incretin mimetic, CT388. This leads me to slide 13. As outlined by Adam, the vision of Zealand Pharma and Roche is to establish the leading amylin-based weight management franchise with Petrelintide.
Amylin agonism offers a unique and distinct mechanism for achieving weight loss in people with overweight and obesity. Amylin agonism reduces body weight by enhancing satiety and restoring leptin sensitivity, a mechanism that contrasts with the reduction in appetite and prospective food intake associated with GLP-1-based treatments. Furthermore, preclinical data have demonstrated that amylin agonism, including petrelintide, offers the potential to preserve lean muscle mass, resulting in higher quality weight loss. In addition, both our own observations and clinical observations with other amylin analogs have demonstrated improvement in cardiovascular risk factors such as blood pressure, lipids, markers of vascular inflammation, without increasing heart rate, supporting the potential for reducing cardiovascular risk. With petrelintide as a standalone therapy, we have an opportunity to address many of the most important and urgent medical needs among the majority of people living with overweight and obesity, thus positioning petrelintide as a future foundational therapy.
Zealand Pharma and Roche will also explore petrelintide in combination with other agents, starting with a fixed-dose combination product of petrelintide and CT388. Our ambition is to explore and unlock the full potential of petrelintide, reaching as many patients as possible. One novel concept that we find interesting with petrelintide's CT388 fixed-dose combination products is to maximize the dose of the generally better tolerated non-incretin agent, petrelintide, adding an optimized dose of the incretin-based GLP-1, GIP dual agonist for people who need additional weight loss and improved glycemic control without materially compromising gastrointestinal and broad-based tolerability. We are truly excited about this partnership, and we now have the opportunity, together with Roche, to establish the leading amylin-based weight management franchise, offering treatment options in the future for the vast majority of people with overweight and obesity.
With that, I would now like to move to slide 14 and turn the call over to Henriette, our Chief Financial Officer, who will elaborate on the financial considerations of the partnership agreement. Henriette?
Thanks, David, and hello, everyone. Let's turn to slide 15. I am extremely satisfied with the financial terms of this agreement. The total consideration to Zealand from these collaborations amounts up to DKK 5.3 billion. Zealand will receive DKK 1.65 billion in upfront payments, and this figure includes DKK 1.4 billion due upon closing and DKK 250 million in anniversary payments. The DKK 250 million are not contingent on any specific milestones other than time. Just to put this into perspective, this is the largest-ever cash upfront payment in a single-asset collaboration transaction in the pharmaceutical industry across all stages of development and across all therapeutic areas. In addition to the sizable upfront, Zealand is also eligible to near-term development milestone payments of up to DKK 1.2 billion, which are mainly related to initiation of phase III trials with petrelintide monotherapy and sales-based milestone payments of up to DKK 2.4 billion.
For the fixed-dose combination product of petrelintide and Roche's CT388, Zealand will pay DKK 350 million to Roche for the contribution of CT388. This contribution fee will be deducted from the potential future development milestones to Zealand. Zealand and Roche will co-develop and co-commercialize petrelintide and potential combination products. This means that all research and development costs will be split on a 50/50 basis. Most importantly, from a value perspective, we capture the long-term value of petrelintide by sharing profit with Roche on a 50/50 basis in the US and Europe on both petrelintide monotherapy and potential combination products, including petrelintide combined with CT388. The terms of the agreement provide Zealand with great flexibility, including opt-out and opt-in rights to participate in up to 50% of the commercial activities, as well as possibilities to defer costs under certain pre-agreed terms.
Combined with the strong financial position of the company, this structure provides comfort that we can honor our commitments and obligations in this partnership. In the rest of the world, where Roche has exclusive commercial rights of petrelintide and other products arising from the collaboration, Zealand is eligible to double-digit to 19% tier royalties on net sales. Roche is responsible for manufacturing and commercial supply and will carry all CapEx to support the commercial plans for the products under the collaboration. I will move to slide 16 and turn the call back to Adam for concluding remarks.
Thank you, Henriette. I'm incredibly pleased that Zealand and Roche have entered into this co-development and co-commercialization partnership with a shared vision to develop petrelintide as a future foundational therapy for weight management. In Roche, we have found the ideal partner, and I'm convinced that with the strong capabilities of both companies, we have a unique opportunity together to REDEFINE the standard of care to the benefit of people living with overweight and obesity. I consider obesity to be one of the greatest healthcare challenges of our time. This partnership is a step change to realize Zealand Pharma's vision of becoming a key player in the future management of obesity. We want to play a major role in solving the obesity crisis, and we are extremely excited to embark on this journey with Roche, aiming to establish the leading amylin-based franchise around petrelintide. Thank you all.
I will now turn the call over to the operator for questions.
Thank you. As a reminder, to ask a question, you will need to press star one and one on your telephone and wait for your name to be announced. To withdraw your question, please press star one and one again. Please stand by while we compile the Q&A queue. Our first question comes from the line of Michael Novod from Nordea. Please go ahead. Your line is open.
Thank you very much. It's Michael Novod from Nordea. I rarely say congratulations on conference calls, but I guess this time it's appropriate. Congrats with an impressive deal. A few questions. First of all, can you elaborate a bit on sort of how you view the cost in running a global phase III program? Should we assume for modeling purposes that it's the standard $1 billion to $2 billion that then needs to be split between Roche and Zealand? Also, on the approach to commercialization, you do say that you have opt-in and opt-out rights. Where are you right now in terms of what we should assume as the base case around commercialization?
Because I guess if you decide to fully opt-in, wouldn't it also make sense then that you do the glepaglutide alone because you already then have to do some investments, so keeping the rights for your GLP-2 as well in short bowel? Lastly, on the combination, good to see that you're starting the combination trial already in 2026. Does that also mean that we should not expect that you will do exploratory work on other GLP-1 plus petrelintide combinations? Thanks a lot.
Thank you, Michael. First of all, we are going to embark on a very ambitious phase III program together with Roche. In order to establish petrelintide as a future foundational therapy, we will not provide guidance for phase III costs, but I mean, I think it's fair to kind of apply average numbers, as you also suggested, into modeling work. We will only later, together with Roche, provide more clear, you can say, guidance for these costs. It is going to be a very ambitious program, again, that is needed in order to establish petrelintide as a foundational therapy. With regard to the opportunity to participate in up to 50% of commercial rollout, this is something we will decide and communicate on later. It will also, of course, in the partnership, be laid out where we contribute the best and how to operationalize this.
It has been, as we have shared for a long time, important to us to have maximum strategic flexibility here so we can develop the company alongside this fantastic opportunity. In due time, we will be more kind of clear on which role we will take alongside Roche in this partnership. Importantly, we have an opportunity to participate in up to 50% of the commercial rollout. Regardless of the model, we still have a 50/50 profit share ultimately on both petrelintide and the combination product. On your questions on glepaglutide, it is still our ambition to partner this program. We think it has a huge potential to help a lot of patients living with short bowel syndrome.
We plan to initiate phase III additional study here in the second half and in parallel pursue a partner for this program as we, as a company, will focus in on the journey that we now have taken a major step forward on to become a key player in the obesity space. On the combination studies, we will, again, probably we will wait with updating on the specific designs, including if we, how you can say, if we will also pursue additional combination opportunities beyond CT388. That is something we will decide together with Roche in the joint development committee. Thank you for your questions, Michael.
Thanks a lot.
Thank you. We'll now move on to our next question. Our next question comes from the line of Suzanne van Voorthuizen from UBS. Please go ahead. Your line is open.
Suzanne from Kempen, congrats on the deal, and thanks for taking my questions. First, can you elaborate a bit more on the competitiveness of the process and the main drivers for the deal to come together now versus later in the year? Since with your earnings update, the signals appeared more conservative on the potential timing of the deal. Secondly, with multiple phase III trials ahead, can you give context to what extent these obligations are already covered by the cash-in from the deal? And for the opt-in, opt-out, well, the opt-out specifically, is the alternative then royalties, and will these be similar to the rest of the world's royalty rate?
If you allow me to squeeze in a last one, can you provide some color on the way you and Roche will be collaborating in terms of steering committees or splits from who is in the lead where or some color on how the decision-making process is designed? Thank you.
Thank you, Suzanne. As we have communicated for a long period, it has been a very competitive process where we have engaged with a number of large pharma companies. It has been extremely important for us all the time not to rush this process, but also we have, of course, had a certain sense of urgency considering all the work we have ahead of us, including investments in manufacturing and actually building up a leading franchise. In this process, you can say we have had three very important parameters. Number one, and very importantly, we wanted to partner only with a company who has an ambition of leading in this therapeutic area. I think it's probably clear to everyone that with the steps that Roche has taken in the last few years, they have demonstrated that, you can say, willingness and that desire, vision.
That is also what we have clearly seen in the interactions with Roche. That was a clear parameter. The other thing is the vision around petrelintide as a future foundational therapy where we, again, just feel that we are very aligned with the team. Lastly, on the cultural fit, because this is a true co-development and co-commercialization partnership with profit share, of course, it is extremely important that the two cultures align well. As you could say, we do not just want a beautiful wedding. We actually want a beautiful marriage here. We think with all we have observed in the interactions with the Roche team, we really feel there is a strong cultural fit. That leads me a little bit to your third question around we will establish joint steering committee development, manufacturing, and commercialization committees with joint decision-making.
We collaborate on this on all aspects. Of course, you can say when it comes to specific conduct of trials and so on, specific trials will be, you can say, run or guarded by one company or the other. It will be a true collaboration where we will leverage each other's strengths. Of course, we are aware that Roche has an extremely strong clinical trial network, which we will also tap into, including a strong commercial organization. The opt-in and opt-out actually does not have too much to do with regard to profit share. I mean, regardless of our decision to opt in and out of the operational aspects of commercialization, we still have the profit share, 50/50 profit share on petrelintide and on the combination product.
This is, again, back to what I said before, something we'll decide together with Roche as we approach commercialization, what role Zealand will play. For us, it has been important to have the opportunity to contribute with up to 50% of the commercial rollout, but also the opportunity to do less if that is better for the partnership and for how we have decided to develop Zealand. It is clearly an agreement that allows Zealand to grow along the vision and ambition that we have stated for some time that we want to become a generational biotech. We want to develop our capabilities and reach alongside a strong partner. As I said in my prepared remarks, we just see Roche as the strongest partner we could wish for when embarking on this very ambitious journey. Thank you, Suzanne.
Thank you. We'll now move on to our next question. Our next question comes from the line of Charlie Haywood from Bank of America. Please go ahead. Your line is open.
Thank you for taking the questions. Obviously, congratulations on the news. I think you alluded to this in the CT388 fixed-dose combo. Just wondering if you expect that fixed dose to be more amylin-biased based on your sort of prior commentary. In terms of the phase II combo trial, could you look at multiple fixed doses within that with different proportions of amylin to GLP-1 to assess that? Could you also move that strategy forward to phase III with the different proportions? Second question, how should we think of your timeline for planned phase III starts for mono and combo? Given we've seen Roche fairly keen to expedite obesity asset development, do you see any potential for an earlier monotherapy phase III start? Thank you.
Thank you, Charlie. I'll just address the last question and then hand over to David. I think there's no—I mean, as you know, we have been accelerating timelines for the monotherapy since we increased the capital last summer. Of course, now, once we get together with the Roche team, we will, of course, look into potential future further improvements into the program. Also, as we stated, the opportunity to expand into additional indications. There's no question, of course, that teaming up with Roche now allows us to reevaluate if we can do things even faster. Again, this is something we will communicate on once we are a little bit further into the collaboration. David, will you address the combination opportunities and ratios and so on?
Yeah. Happy to, Adam and Charlie. Thanks for the questions. Obviously, we at Zealand and clearly the Roche team are not naive to understanding the incretin-based therapeutic space and 388 while still in the early and mid-phase development. I think from both our prepared remarks and the nature of your question, the answer is yes. In this collaboration, we will look to, I will say, optimize both parts of that combination. This is not, I think, for either of us in the partnership all about chasing the biggest number and tolerability sort of left to the side. As we have said, we think petrelintide at its higher doses can remain very well tolerated. Combining that with what is an optimized dose of an incretin-based therapy like 388 will be part of planning.
Obviously, the results from phase IIb for both assets will be necessary to more broadly understand both the efficacy potential and the tolerability profile of each. In simple terms, maximizing the more tolerable of the classes of agents, which we believe is the amylin agonist, and optimizing the GLP-1 component, which comes with a lot of benefits, including likely greater efficacy on glycemic control and the additive weight loss that we would expect. We will keep our options open. I think the other piece that this allows is understanding, at least from the early data with 388, between their 8 and 22 milligram dose, they saw significant weight reduction.
Whether the lower doses will achieve nearly the same weight loss as the higher doses with better tolerability, if we can combine that optimized dose with what turns out to be the higher and most well-tolerated and efficacious dose of petrelintide, that will absolutely be part of the planning. I think your question speaks exactly to the plans we will form with Roche going forward.
Thank you .
Thank you.
Yep. Thanks .
Thanks. We'll now move on to our next question. Our next question comes from the line of Benjamin Jackson from Jefferies. Please go ahead. Your line is open.
Great. Thank you for the question. It's Ben Jackson at Jefferies. Just two very brief questions, I guess. First, if we think about the data in obesity type 2 diabetics that we saw recently from a peer, are you able to chat about what you think the key learnings are from those headlines? Obviously, fairly limited at this stage, but is there anything that you'd want to comment or flag on there? Secondly, with regards to the deal timing, perhaps a little bit earlier than anticipated, is there any ability to accelerate this beyond what you were initially believing that you could? Or are timings at the very much the same with an internal interim read at the second half of the year followed by potential primary completion over in the first half of next year? Any thoughts or color around that would be fantastic. Thank you very much.
Thank you, Benjamin. I will address your questions. On timing of the deal, I think we have been very consistent in the last nine months and said that we have been exactly where we wanted to be in the process that we have defined and that we have also stated in the last month. We have never guided on unexpected timing. I actually recall at our full year call, some addressed that maybe it's later than anticipated, and now it's earlier than anticipated. I think we have been very consistent that we were exactly where we wanted to be in these discussions. I think we basically deliver at least according to how we had hoped to have this roll out. More importantly, we deliver a partnership with the company we wanted to partner with. That is fantastic for us.
I would say there's not, you can say, other things that have affected our decision-making in this process. This has been with a keen focus to deliver a co-development and co-commercialization partnership with profit share with a partner who we share the vision of this molecule, a partner who wants to lead in this space and one where we see a strong cultural fit. On REDEFINE 2, I think in our minds, the data, of course, follows quite nicely along what we saw from REDEFINE 1, except that perhaps in this setting, even though, again, we only saw around 60% of the patients reaching the top dose, the combination of a rather low dose in our mind, at least of amylin together with GLP-1 almost doubled the response rate, placebo-corrected response rate. I think it holds great promise for what we want to do with the combination therapy.
As David also shared, we would likely have a different approach to the ratio and also how we design the studies in the future. That is, again, something we'll communicate more about. Our confidence in a combination therapy such as petrelintide and CT388 has not changed. I would say, on the contrary, it has reaffirmed that for patients, for those most morbidly obese patients who truly need a very large weight loss or those of these individuals who live with type 2 diabetes, it could be a very strong combination therapy.
Having said that, and as we have also shared on many prior calls, we do think that petrelintide as a monotherapy carries significant potential to deliver the weight loss that the majority of obese individuals are looking for, and hopefully in a more pleasant way with less GI side effects and then this feeling of being full faster rather than having lost your appetite. Nothing has changed. We actually just pursue the vision and ambition that we have set out a long time ago. So far, we have just followed the data.
Many thanks.
Thank you.
Thank you. We'll now move on to our next question. Our next question comes from the line of Hen Boeg from Deutsche Bank. Please go ahead. Your line is open.
Hi. Thank you for my questions. Thank you for the call. I know you said you weren't guiding to any costs for phase III, but if you could give us any sort of expectations of costs towards clinical development over the next couple of years, that'd be helpful. The second question would be, I guess you're starting the phase IIb in 2026. When could we expect to see the first data of the combo trial? Thank you.
Yeah. Again, we cannot provide more clear guidance on the specific cost for the phase III program. What Henriette shared in the prepared remarks is that we have, of course, made sure that we can honor our obligations into this collaboration with how things have been structured. It is an ambitious program. Unfortunately, at this time, you will have to just use generic numbers for cost of similar programs when you try to model this. This will, of course, ultimately depend on the decisions we make together with our partner, Roche. We are very ambitious, including phase III, and CV outcome studies are an important parameter of this program since we want to develop it into a foundational therapy. We will also not guide on expected timelines on the phase IIb for the combination program.
Again, we will guide on this once we have the collaboration up running and decided on all the different aspects together with Roche. Thank you so much.
Thank you.
Thank you. We'll now move on to our next question. Our next question comes from the line of Jacob Mikael from KBC Securities. Please go ahead. Your line is open.
Hi, there. Thanks for taking my question. Congrats on this very nice deal. I have a few, if I may. The first one is, based on the large deal size, can you please elaborate on some of the reasons or key selling points which led Roche to opt for petrelintide over other amylin being developed? I have one on the commercial rights. Now that you've secured 50% and you have that potential route to go through, which commercial models do you think would be a good fit for Zealand? One more I have. Based on your conversations with Roche, how much interest is there from them to do additional deals? Could they have interest in, for example, going for glepaglutide further down the line?
Thank you for your question. I think, as we also shared in the start, it's our clear understanding that Roche, they have a strategy of leading in this space in the future. Therefore, also how we at least understand that is that they're only going for molecules with best-in-class potential. That is why I think they have focused in so much on petrelintide in this environment. We, as we have said for a long time, truly believe we have a molecule that can deliver the weight loss that the majority of obese individuals do. We think we have the best-in-class within the amylin class molecules. I think that is the reason that Roche chose us in this collaboration. Of course, they will have ultimately to speak for themselves. On the commercialization strategy, it is too early for us to comment on the exact setup.
This is, again, something we will discuss within the partnership to make sure that we optimize for, you can say, making sure that we capture the full value potential of this molecule. This is something we will agree in partnership with Roche, how we ultimately set up the commercial rollout and our contributions into the operations. Importantly, we have shared decision-making. Ultimately, depending on where we are at that time, we can opt into or we can have up to 50% rights of commercial rollout, but we could also choose to do significantly less. This is something we, again, will define in the partnership. I think your last question was around additional deals. I think our key focus on the deal on this has been on petrelintide. We have actually not discussed other opportunities in our pipeline. I cannot speak for that. Thank you.
Okay. Thank you.
Thank you. We'll now move to our next question. Our next question comes from the line of Prakhar Agrawal from Cantor Fitzgerald. Please go ahead. Your line is open.
Hi. Thank you for taking my questions and congrats on the deal. Maybe firstly, obviously, Adam, you have talked about potential for amylin as a monotherapy. Now, after running the process and as part of the collaboration, where do Roche and pharma companies see amylin monotherapy fitting in relative to GLP-1s or GLP-1 GIP monotherapy? Is there anything new that you learned based on these discussions over the last few months regarding amylin monotherapy and its positioning in this competitive space? Just as a quick follow-up, maybe how much of the deal value or consideration was for monotherapy versus future combinations? Lastly, a quick clarification. I think the press release also mentioned other products arriving from the collaboration, including next-generation petrelintide combo. Maybe if you can clarify what products or targets are part of this and where are they in development. Thank you so much and congrats again.
Thank you, Prakash. If I just add, you can say this is a true co-development and a co-commercialization partnership that we have announced with Roche, where, of course, our ambition is to establish petrelintide as a leading franchise, as a new foundational therapy for weight management. It is at least our understanding that that vision is what carries the majority of the value. Because imagine you can say the GLP-1 class will be a quite established class. It already is, I guess. To launch into this space with a new modality for the many patients already at that time who cannot tolerate or have decided not to be on GLP-1 therapies is a fantastic opportunity.
Really, the opportunity to also address weight maintenance in a better way, if you can say, for the patients who find it difficult to stay on therapy when they are on a GLP-1, that is the key theme here. It is at least our understanding and from the parties that we have discussed with, the pharma parties, including Roche, as you can imagine, that that opportunity to actually provide an alternative to the GLP-1s was a huge driver for the agreement that you look at today.
Having said that, there's no question that for the most morbidly obese patients or obese individuals, for instance, living with type 2 diabetes, a combination therapy is a fantastic opportunity and carries significant value, especially if we can think a little bit differently around the relative ratios and optimize for the patient experience and not just, you can say, the ultimate weight loss. We see a huge opportunity for the combination product as well. I think that it is this vision to establish a new foundational therapy that has been the main driver for this partnership. Thank you.
Thank you. We'll now move on to our next question. Our next question comes from the line of Laura Hindley from Morgan Stanley. Please go ahead. Your line is open.
Hi. Thanks for taking my question, Laura Hindley from Morgan Stanley. Congratulations on the deal. Firstly, can you just remind us of the latest IP protection on petrelintide? Do you expect the fixed-dose combination with CT388 will offer an extension? Just going back to commercialization again, you've mentioned that Zealand will decide to opt in or opt out as you move through the development process. What are some of the factors or indicators that you'll be monitoring that would drive Zealand's opt-in or opt-out decisions? Last one, just to confirm, will you still be running a phase Ib trial for petrelintide with a marketed GLP-1, or is that replaced by the phase IIb with CT388? Thank you.
Thank you, Laura. I think we have a very long IP protection for this program. I think it takes us, as we believe, into the 2040s, but we will have to follow up on that later. You can say what will drive specific decisions around opt-out and opt-in? It is honestly too early for us to share that. We have been very clear that we want to—we are extremely ambitious with where we want to take Zealand Pharma in the journey over the next five years. We do see what we have established last year as a foundation for accelerated growth. We want to continue to develop as a company alongside Roche in this fantastic partnership.
We will, at a later time point, communicate to the market how we anticipate to play a role in the commercial rollout, which, of course, also will be in detailed discussions with Roche over the next years. It is important, however, to say that we have the opportunity to contribute with up to 50%, and then we can decide to do less if we want to. On the phase Ib study that we have planned for with an existing GLP-1, it is also too early for me to guide on what we will do there. Clearly, we have the plans in place. We will update the market later on any decisions if there are changes on that. Thank you again for your questions.
Thanks. Thank you. We'll now move on to our next question. Our next question comes from the line of Alexandra Ramsey from William Blair. Please go ahead. Your line is open.
Hello. Thanks so much for taking our question and congratulations on the great deal. Regarding the combination with CT388, we were wondering if you could share with us your view on sort of weighing the pros and cons of co-formulation, as mentioned in the press release, and designing a bifunctional molecule, something like amycretin. Thanks.
Thank you. It's, of course, in our minds, at least a clear upside to be able to co-formulate rather than having something that has already been locked from the start. Because ultimately, we need to find the right ratio between amylin and CT388 in humans to deliver the benefits that we are looking at without compromising on solubility. It's only a benefit if you can truly co-formulate, as we do believe we have an opportunity with here. Of course, if you cannot have the two molecules in the same solution, it could become difficult from a manufacturing perspective. We see a huge opportunity here to actually, you can say, make sure that we develop the optimal ratio between the two modalities to achieve the benefits that we are looking for without compromising on solubility and other issues.
We see it as a huge upside compared to a molecule where the two modalities are glued together from the start. Thank you.
Thank you. We'll now move on to our next question. Our next question comes from the line of Thomas Bowers from SEB. Please go ahead. Your line is open.
Yes. Thank you very much. Congratulations on a great deal here. I have three questions remaining. To kick off with the CapEx, I understand that Roche will cover all that for API. Is there anything in relation to the deal that made you have to pay a plus on the COGS to cover part of the investments done by Roche? On the royalty for the rest of the world, and maybe also just to confirm in regards to the co-promo, is there anything that relates to patent expiration regarding the tail of the income globally or just for the rest of the world? I am just wondering if there is something that we should be aware of, for example, after the composition of matter, the patent expires at 2037.
Lastly, just to confirm, is there anything regarding the combination with 388 that should argue against that you could potentially not be able to make this as a premixed combination solution? Thank you.
Thank you, Thomas. With the deal that we announced today, as you're right, Roche will be responsible for making all these investments into manufacturing and be ready to supply the market. They will not carry a cost premium for us. That is the good news here. Again, of course, a very important parameter as we make decisions in this process because we do understand how big of an undertaking it is to establish the right manufacturing and supply network. It is our belief that we will be able to co-formulate the two molecules, but that is, again, something we, of course, will have to provide further updates on as we progress this collaboration. On the tail, on royalties and what have you, these are very standard terms. I would say, of course, they continue on, I would call them, favorable standard terms. Thank you.
Okay. Nothing that could change after 37?
Yeah. I cannot comment on the specifics, but we think we have IP protection that takes us into the 2040s.
Okay. With the same terms. Okay. Thank you.
Thank you. There are no further questions at this time. I'll hand the call back to Adam Steensberg for closing remarks.
With that, we would like to thank all of you 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.