Gubra A/S Stock

Good afternoon, everybody. Thank you for everybody attending and listening to this discussion today with Gubra. My name is Cailin McGurk. I'm a member of the investment banking team at Morgan Stanley.

Just before we get started, like other sessions at our conference there are some important disclosures for which you'll need to refer to the Morgan Stanley disclosure research website www.morganstanley.com/researchdisclosures. And if you have any further questions please reach out to your Morgan Stanley sales representative. I'm not sure how much outreach we get on the disclosures, but just for good measure.

So, Markus, it's a pleasure to have, not Gubra for the first time, but you for the first time attending our conference in New York. We were just discussing, it's effectively your 1-year anniversary at Gubra. You know, maybe, and we'll talk a little bit about who Gubra is today, but maybe just 1 or 2 minutes on your background, what attracted you to join this company? And then we've got lots of interesting topics to cover.

Well, thank you very much for inviting me, Cailin. It's a real pleasure to be here. I have a research background. I'm a scientist, a structural biologist. I spent many years in pharmaceutical research and management, more recently more in the biotech environment before I joined Gubra. What attracted me to Gubra was essentially seeing a unique opportunity to grow a company forward. Gubra has tremendous potential, and it's about realizing this potential and also with a great team and a great board, so I got immediately attracted to the opportunity and after 12 months I can really say Gubra is a unique place.

And it is a unique company and for those listening who may be a little bit more or less familiar, how would you describe Gubra today in terms of, you know, what the company, who you are, what your core competencies are, and as you joined and were excited about the opportunity, where you see the most potential value creation going forward?

Yes, in a simple concept, Gubra is a clinical stage bioscience company with a unique business model. We have 3 units; a biotech unit which discovers and develops novel peptide therapeutics to clinical proof of concept. At this stage, we would partner those assets with pharmaceutical companies. Our discovery platform is validated. We have multiple assets in the clinic. Our partnership and business model is validated based on the series of partnership deals the company has done.

On top of this, we have a very successful CRO serving external customers, but being an integral part of our innovation platform. And on top of that, we now have a new unit, Gubra Ventures, which enables us to invest our capabilities into high quality science adjacent to our core therapeutic areas. So overall, I see the vast majority of value growth in the biotech pipeline and that is also our focus.

We've had a couple of your partners also attending our conference. And for those that are less familiar, you've been very successful in terms of the early development and collaborations that you've struck on the obesity side. You now have 2 Phase II assets with 2 very, well-known and well-respected companies being AbbVie and obviously Boehringer Ingelheim. What does that tell you, the audience and us, about Gubra's competence and capabilities. And we'll start in the obesity field because that's obviously very large and important. And certainly you've seen 2 of these programs announced to progress in the very recent months.

Yes, I think I can talk a little bit about how the obesity market is developing and how this is reflected in our pipeline. So the obesity market has grown tremendously, and the field has advanced tremendously. Initially, it was about demonstrating a clinically reasonable loss of weight, how much weight can you lose in a period of time. Now it's more about complementary and additional mode of action which has the promise to deliver additional efficacy, tolerability, or also benefits to particular patient populations. There is additional focus on body composition and muscle health outcomes. And we also believe that combination therapy will be very important to deliver specific to the needs of certain patient populations. So -- and if you look at those 3 areas, I think that is clearly reflected in our current pipeline with the GGY triple partnered with Boehringer, with the amylin partnered with AbbVie, and also our own use of GUB-UCN2, the long-acting urocortin-2 agonist.

And we want to cover all 3 of those. Maybe we'll start because AbbVie recently announced their intention to progress. It's now called ABBV-295. It had a different name when I remember when you did the deal, they've signaled that they're moving that forward. It's an Amylin as you will go into, as you talked about your view on the evolution of the obesity treatment paradigm, what role do you foresee or Amylin broadly and then obviously ABBV-295? And then after that we'll talk about some of the next steps and updates from your partner on that program.

Yes, great. I think for the class, the Amylin class has already shown promising clinical efficacy. I see a favorable tolerability and safety profile and potentially also an opportunity for a more longer treatment cycles, right? So, I think if I look now at ABBV-295 particularly, we have seen great Phase I data, top line data this year, where the compound demonstrated about 10% weight loss in a period of 12 to 13 weeks, and taking a look at the patient population, which was like 88% male and also with a BMI on average around 30, this is actually very meaningful weight loss data and I think that is very, very promising. And on top of that, the compound achieved similar weight loss, with biweekly or monthly administration. So I think it's maybe -- it's going to be a great profile.

And there's some important next steps there on ABBV-295, I think they've talked about presentation at EASD. Relative to the data that's been put out into the public domain, is there anything that you can share in terms of what that update may be, what that patient population may look like relative to the data from earlier this year?

Yes. I think we have seen the top line data. There will be a fuller data set. We get nuances on efficacy and also on the safety and tolerability profile. So that will be important to understand the drug in the full context of this trial. On top of that, there is a Phase Ib trial is running in the U.S. in a more representative study population with BMI between 30 and 45. There's also a much larger portion of female study participants. And this trial runs a little bit longer, 20 weeks. So I think that was going to be a very important data set to inform further development of the drug on top of, of course, the ongoing Phase II trial. But I think taking together those 2 trials that will give us a good indication on how this particular compound will translate into clinical efficacy and safety.

And maybe one more last question on ABBV-295. Obviously, with the very intriguing data that has come out in relation to the broader amylin class, there's some debates about JAK versus selective. Where do you, based on the work that you had done at Gubra, think that the collaboration that you have with AbbVie has the potential to differentiate versus other approaches that are out there?

Yes. I think at the moment, that will be speculation, right? And I probably want to go -- I don't want to go there. What we know for sure is that we have a very long-acting molecule with proven efficacy. And I think the ongoing trials will definitely show what the profile of the drug will be.

Should we maybe change tack to the other Phase II program that you have with one of your partners, Boehringer Ingelheim in the era and with all of the excitement about triples, this is also a triple, but a slightly different triple. So maybe talk about the sort of target selection there and the NPY2 biology?

Yes. So a different triple, but equally exciting. So the concept behind this triple is basically to combine the well-established incretin biology with the central regulator of food intake NPY2. And taken together, you double down on food intake and that should provide the basis -- the fundamental basis to demonstrate deeper and more durable weight loss. So that's basically the concept behind it. And Phase II has now started. And so hopefully, this exciting complementary mechanism will show great clinical efficacy and safety and will give us an indication on the positioning of the drug.

More importantly or as importantly, moving on to your third, you probably have more, but at least the next most advanced obesity program at Gubra, which is against a very exciting new target area of biology, which is UCN2. So you've made great progress here. I think there's -- we've seen some transaction activity very recently in the UCN2 space. What makes you excited about the [ target ] and maybe link that back to some of the trends that you foresee in obesity and where the remaining unmet need is?

So our long-acting urocortin-2 agonist has an exciting biology. Preservation of muscle and muscle health is becoming a more important topic. If you substantially lose weight, you not only lose fat mass, but you also lose lean mass and a part of that is skeletal muscle. Skeletal muscle is very important, and it is a determinant of physical function, mobility and metabolic health. And also for the elderly population, the maintenance of muscle mass and function is super critical to live a healthy life. So I think this is exactly where UCN2 comes in. In preclinical studies, we have demonstrated substantial additional reduction of fat mass. And at the same time, UCN2 prevents the loss of lean mass and even to some extent, increases lean body mass.

So I think this is a very promising profile. And in our ongoing Phase I/IIa trial, we are really looking at this in a comprehensive way to explore the biology, both as a mono compound, but also in combination with incretin-based therapies for maximum impact for patients in different populations. So the trial is quite exciting. It has 3 parts. We start with classical SAD trial in a healthy population, followed by an MAD trial in obese patients for 6 weeks of treatment with multiple doses. And then the third part where we have 16 weeks of treatment with multiple doses as a monotherapy and in combination. So the overall package on Phase IIa study plus our preclinical evidence in totality will be a very rich data set. So we are very excited about this compound.

Now moving into obesity is sort of the clear first step. But we believe there is substantially more potential beyond obesity in areas where muscle health and muscle function is important. So it will also have a substantial commercial potential. So that's an exciting area for us where we will invest significantly going forward. I think you mentioned the recent deal between Genentech and Hanmi. Obviously, that is very exciting to see because it validates the potential of the biology and a first pharma company has made a strategic move into the field. We, of course, welcome additional science in the field. We are among the front runners on the UCN2 biology. And I mean, we as a company, we have made a deliberate decision not to partner UCN2 and to complete our Phase IIa program to maximize the potential of the asset for Gubra when we partnered.

One last question, and we'll move on to some of the other business areas outside of weight management and obesity. Perhaps it's still early days. As you say, you've seen validation of the approach, the recent deal between Hanmi and Genentech. As you sort of scan the competitive landscape for urocortin-2, do you think there is likely to be differences as we've seen in the sort of GLP-1 space or more similar than different, and it's going to boil down to the quality of the package and the quality of the development or possibly just too soon to tell?

Yes, it's a little bit too soon because there's no clinical data published on any of those compounds. I think the field is getting more competitive as more people realize the value of the biology. I think we certainly have focused on the quality of our package. And I think this is how -- for Gubra at least, that is the best way to deliver high quality to potential partners.

Moving on maybe to just sort of more broadly where Gubra sort of sees the opportunity from a development standpoint, your legacy and sort of strength has clearly been in weight management, metabolic disease, clearly validated by the partners that you've attracted. But I think you're increasingly talking about the potential and the interest of Gubra as being more agnostic around therapy area. What -- how should we sort of think about your intention or ambitions to move out of obesity into other areas?

Yes, that's a good question. I think over almost 20 years, Gubra has built tremendous experience in metabolic diseases and obesity. So there is no question that this is an important area for us and also will continue to be an important area for us. Having said this, our streaMLine discovery platform, our translational capabilities and clinical capabilities are relatively disease agnostic. So we can enter in spaces where peptides have high value beyond obesity as well. Of course, we will look at this selectively, and it will be capability-led, right? But we certainly have the capabilities to enter in other disease areas. And that is one aspect we will also cover in our upcoming R&D Day on October 27 in London.

And I'll come back to that just so we can dig into at the end, what's the full agenda that we can expect at that event will be. Maybe moving on to the CRO business. This was part of the foundation of the company, has been an incredibly important and successful business for you historically. But I guess in the context of today's environment with some of the headwinds we had faced from a budgetary and sort of broader spend standpoint, what is your perspective on the environment in which your CRO business is operating today?

Yes. The CRO unit has been very successful. Over the last 10 years, the CRO has delivered about 14% average growth every year, which is quite impressive. We are very specialized in metabolic models where we have gold standards in different aspects of metabolic disease. In the last 12 to 18 months, the CRO market was relatively challenging, and we have seen that directly in 2025, for example. Over the last 6 months, we have seen 11% revenue growth compared to the previous 6 months. So I think I'm quite confident that revenue will continue to grow, profitability will stabilize. So -- and our order book makes me confident about the overall aspiration for the year.

Long term, I think this will remain a very attractive business part. The pharma companies tend to outsource early preclinical work substantially and focus on areas where they can deliver -- focus on and deliver more value. So I believe this will be a market which will continue to grow and where we can compete with our innovative in vivo models very well. So -- but aside from the CRO being a successful commercial unit of Gubra, I really value the strategic aspect of the CRO as it relates to our innovation model and also into developing drugs because only -- because the CRO has the relevant in vivo models today, we can develop drugs from sort of a peptide backbone towards a drug development candidate in approximately 18 months, which is very competitive. So I see the combination of the CRO and the biotech business and the future ventures actually as very synergistic, and it's part of our unique model differentiating us from other biotech companies.

That sort of largely answered my last question on CRO, which was -- this is clearly a very different business from proprietary biotech or proprietary pipeline development. But I think what you were saying is the capabilities and the competency and the expertise is both incredibly important, but also synergistic with the broader business. And when you -- in the first couple of minutes, you sort of talked about the expansion into ventures and your ability to look externally as well as internally for future innovation. Talk a little bit for those who are less familiar about Gubra Ventures. What is the strategy? How do you look to create value? And what types of opportunities are going to be most relevant and most interesting for you going forward?

Yes. So again, Gubra Ventures is an opportunity to invest our capabilities in assets adjacent to our core areas. I think this will give us additional opportunity and to basically leverage what we have today as capabilities at the scale, which in the past, we were not able to do. And we can use this in a collaboration model with strategic and financial investors to quickly advance assets into clinical proof of concept and then long-term share economics on those assets. We are particularly interested in assets with exciting translational biology. So we can design really clinical trials, which are truly clinical proof of concept. So that is important.

And it is also important that we, as Gubra can add more than just capital to those ventures so that our preclinical and translational biology expertise can be fully leveraged. We will talk a little bit more about what we are currently focusing on and how the interaction between the units and the ventures will work at the R&D Day. But essentially, at the moment, we are building an opportunity funnel. We have not necessarily set a specific point where we will do the first venture, but it is important that it's the right quality of venture and that we do the right first deal for Gubra where we can add most value and also generate additional value for the company in the long run.

And any hints or insights into when we might be able to share some specific news or something more tangible in terms of what you've been up to at Gubra Ventures?

Yes, my lips are sealed.

Okay. Maybe October will come back by next year, definitely. Perfect. As you think about -- I think we've covered the out-licensed programs with your partners, your proprietary -- key proprietary program, UCN2, we haven't talked about everything there, Ventures, CRO. How do you sort of think about the optimal configuration between clearly having the ability to secure very attractive partners with the financial and other expertise to drive development versus continuing on your own and sort of developing your own pipeline further. You did allude to this when we were talking about UCN2 and the sort of clear intention and desire to progress that forward. How far do you want to go? Is this UCN2 specific case by case? How are you just thinking about that as you build your own pipeline going forward?

Yes. I think that's a very good question. The partnership model is working very well for Gubra and we have been able to capture substantial value for our partner programs. And that is the right business model for Gubra today. I mean what has changed in -- recently is that we have a better financial foundation that we have more expertise in clinical -- early clinical development. So we can decide on how long or how far do we push our own development versus partnering early, and we will do that based on our portfolio considerations, risk considerations, capital allocation and also what a potential partner can bring in.

Today, we have the option to be more driven towards and keeping some of the high-value assets longer. And UCN2 is a great example because we are investing towards a Phase IIb-ready asset to be partnered, right? It's very different from other deals we have done. And I think it will probably not be for every asset. And for some assets may be that it is actually good to partner a little bit early, but we will look at this in an asset-by-asset decision for sure. But we will focus on what we are good at. We are good at discovering drugs, doing the translational biology and moving assets towards clinical proof of concept.

And in our model, our partners bring in the late-stage development expertise, the commercial expertise, and we profit from those partnerships with long-term economics, which we are really investing into our portfolio. And I think that's a model which is working for Gubra today and will also be working for Gubra in the coming years. The difference will be that we try to capture as much value as possible by keeping some assets a little bit longer.

One last question on that, and then I do want to talk about what we're going to see over the next 12 to 18 months and maybe wrap up on your upcoming investor R&D event. I had the privilege of hosting another one of your collaboration partners yesterday, where you've done much earlier sort of scientific collaborations, which was with the team at Amylyx. I guess for these earlier-stage discovery type collaborations, will those remain interesting more on a case-by-case basis? Or how are you thinking about those going forward?

Yes. First, let me say that the Amylyx deal team are fantastic collaborators. We love to work with them, and they are great people and the collaboration is spectacular actually. So, in principle, the highest value which we can generate is to focus on proprietary assets and bring them forward. However, where there is a scientific synergy and where we believe we can add additional value and we can learn something, those type of scientific collaborations will always be an opportunity for Gubra, and all sorts of interesting things develop out of those collaborations. So I think they have a place in our heart.

And I spoke equally highly of you as a collaboration partner during my session with them yesterday. Maybe just 2 topics in the last few minutes that we have. Over the next 12 to 18 months, obviously, we -- potentially plenty of news and updates from some of your partnered programs. But what should investors be most focused on in terms of news flow?

Yes. I expect quite some news flow in that period. I mean, of course, Central to us is GUB-UCN2 program. We will see the first data from the program, results from the SAD part of the trial, the safety, tolerability and PK data. We will start the MAD trial. So -- and maybe there's also some external data around urocortin-2 agonist. So that will also be supportive for the class. Then, on ABBV-295, certainly, the Phase Ib top line data, we would expect that within the first half of next year, that will be exciting. And I mean the fact that we now have 2 Phase II programs partnered and the successful continued development is already another validation that our compounds can reach late-stage development and hopefully soon commercialization.

So overall, I think investors may have looked at us a year ago in terms of, "Oh, it's a promising company, a unique business model, really interesting early compounds versus next year, hopefully, we'll see some exciting clinical evidence on our molecules." And I think that hopefully will show the value of the company and what we can deliver. Obviously, only as a team across. And I think Gubra has a great leadership team and all of our 300 Gubies are fantastic, our secret sauce.

Very good. And maybe just one last one. Hopefully, investors will have the opportunity to attend in person. You're going to hold an investor R&D event in London, 27th of October. I understand part of the agenda there will be to talk more specifically about your long-term strategy and ambitions towards the end of the decade in 2030. Clearly, you can't prewire everything and give all the good stuff away at our conference as much as we would love you to. But anything further to add in terms of what's going to be interesting and exciting in terms of the updates you provide there?

Yes. So it will be our first R&D Day. And I hope for investors, it will be exciting to hear some more tangible description of our long-term strategy. So that is correct. So we'll describe our strategy towards 2030. We'll talk a little bit about our discovery focus and elements of what we talked before also beyond obesity. We'll talk, of course, about GUB-UCN2 program, the trial and the potential we see on this biology. I will talk more about ventures and our CFO and our whole concept on capital allocation. So it will be hopefully exciting and informative for investors.

Very good. And the Morgan Stanley team will certainly be there. So look, Markus, with that, I'll wrap up. We're bang on time. Thank you so much for attending. I appreciate you and the team making the trip across from Europe as always, and very much forward looking -- looking forward to having you back next year. It's going to be an exciting 12 to 18 months and even more. So watch this space. Thank you very much.

Yes. Thank you, Cailin, for the invitation.

Welcome to the conference call. [Operator Instructions]

Now I will hand the conference over to the speakers. Please go ahead.

Good morning, everyone, and welcome to Gubra's conference call covering our first half 2026 results. My name is Adam, new Head of Investor Relations at Gubra. And joining me today are members of Gubra's leadership team, who will take you through key developments for the company in the first six months of 2026 and our financial results. Following the presentation, we will open the call for questions. Before we begin, I would just caution listeners on Slide 2 here that we may make forward-looking statements that are subject to risks and uncertainties. And with that, I will hand over the call to our CEO, Markus, for opening remarks.

Thank you very much, Adam. Good morning, everyone. Welcome also from my side to our webcast. I'd like to give a couple of highlights of the company. In summary, I believe Gubra had a very good first half of the year across our entire business units. Gubra Biotech significantly advanced our R&D pipeline. And in the CRO, I think while we still have work to do, I see a promising trend based on new commercial initiatives and also continued cost discipline. And we have also now established a platform for Gubra Ventures. This is a new business unit at Gubra, and we are currently evaluating multiple deals.

And over the next couple of months, I hope we can announce the first Gubra Venture. At this point, I'd like to remind you that our business model is unique based on three synergistic business units. Gubra Biotech discovers and develops new peptide therapeutics up to clinical proof of concept. Gubra Ventures invests in exciting science adjacent to our flagship areas and our CRO while serving many external customers is an integral and very important part of our innovation in the biotech unit as well in our new ventures.

Let me highlight a couple of milestones which already have been achieved in the first half of the year. I'm just going to mention 3 of them. AbbVie reported highly encouraging Phase I MAD results for the long-acting amylin. I think this is very robust data and the start of the Phase II is imminent. Boehringer Ingelheim has already advanced the triple agonist in clinical Phase II. And we now have initiated an ambitious Phase I/IIa trial for our fully owned GUB-UCN2 program, our new mega program. And with this, I'd like to hand over to Louise.

Yes. Thank you, Markus. So let's take a look at our StreaMLine platform and how it enables our growing pipeline. So Gubra, we're true experts in peptide drug discovery. And our core edge is that all the work we do is done using an in-house developed drug discovery platform, StreaMLine. And the platform takes advantage of [Technical Difficulty] analysis, and this is combined with high throughput wet lab screening of multiple peptide libraries. So we use multiparameter optimization. So what this means is that we optimize all key drug properties at once. So ultimately, this enables us to save time and identify better molecules at speed.

So the StreaMLine platform has repeatedly delivered differentiated assets across a variety of therapeutic areas. So what you see here is the Gubra R&D pipeline. And since the last update, we have seen important progress. First of all, we have seen the initiation of a UCN2 program entering Phase I. Additionally, Boehringer Ingelheim has initiated Phase II development with the triple agonist and AbbVie still plans to initiate Phase II in Q3. Simultaneously, Hemab has expressed that they expect to initiate first-in-human trials with HMB-003 in the second half of '26.

And likewise, we have concluded the fourth collaboration project with Boehringer Ingelheim, a very early target discovery program. So at Gubra, we have been dedicated to treating and understanding obesity since the company's inception. And over the years, we have generated deep scientific expertise all the way from discovery to clinical translation. And today, we'll take a look at 3 of our most advanced anti-obesity assets, so they are each designed with a differentiated profile compared to current standard of care and with blockbuster potential.

But before getting into the data, let's just take a step back and take a broader look at the obesity landscape and where the market is heading because it's no secret that obesity continues to be a growing global health care challenge and there is a well-recognized need for novel treatment approaches. And for the past decades, the core question with obesity treatment has really been, can we make patients lose weight? Can we achieve clinically meaningful weight loss? And this has been the focus of the first wave and has really been spearheaded by the first generation of incretin-based treatment.

The focus on the current wave has been to maximize body weight reduction and improve tolerability. Here, we've seen the introduction of complementary and alternative mode of actions. We've seen the introduction of amylin analog as well as multimodal therapies, including dual and triple agonist. And the toolbox for patients have been significantly expanded here. But it's also well acknowledged that the body weight reduction is not just fat mass. Lean mass actually accounts for 20% to 45% of the weight loss. And lean mass, it's muscle, its bones, it's internal organs.

So it's all the tissue that we would ideally like to preserve when we are trying to lose weight. Therefore, we believe that the focus for the next wave will be quality with focus on body composition, maximizing fat mass loss and preserve or even enhance skeletal muscle mass. That's where the field is going. And Gubra's pipeline is strategically positioned to meet these emerging trends. So now let's take a look at some of these assets. First of all, we have the triple agonist, long-acting first-in-class. This asset targets the GLP-1, GIP and Y2 receptors to engage in complementary mode of action involved in body weight reduction.

This asset was discovered in collaboration with Boehringer Ingelheim, who now has sole responsibility for driving it forward. And after seeing encouraging Phase I data that demonstrated a favorable safety and tolerability profile along with encouraging weight loss, Boehringer Ingelheim has now initiated the Phase II in development yet. The study will enroll approximately 300 participants that are treated for 42 weeks. So we really see this as a true validation of both the assets' potential, but also Gubra's peptide discovery capabilities. So next, we have ABBV-295, the long-acting amylin analog that is now out-licensed to AbbVie. A core differentiator with the amylin class of compounds is the potential to deliver clinically relevant weight loss with a better tolerability profile.

So this means that amylin may represent the next distinct class of drugs for chronic weight management. ABBV-295 has consistently shown competitive results throughout a comprehensive Phase I program. The data from the MAD study was top line data was presented by AbbVie in March and here ABBV-295 showed a very competitive weight loss profile of almost 10% after just 12 weeks of treatment. And remember that this is in a lower BMI cohort with predominantly male participants. Importantly, ABBV-295 also revealed the potential for less frequent dosing.

So here, comparable weight loss was observed with every second weekly dosing or even once monthly dosing. In addition, ABBV-295 had a favorable safety and tolerability profile, adverse events were predominantly GI mild and transient. So the data from this study will be presented at EASD in September. Currently, ABBV-295 is being tested in an ongoing Phase Ib trial in people with obesity, higher BMI range and higher proportion of female participants and AbbVie still plans to initiate Phase II in Q3. And with that, I'm happy to hand over to Thomas, our CDMO (sic) [ CMDO ], who will talk more about our UCN2 program.

Thank you, Louise. So now let me turn to what makes GUB-UCN2 so compelling. So GUB-UCN2 is a long-acting agonist at the CRHR2 receptor. And that makes it really a very differentiated and novel mechanism of action that addresses key needs for people living with obesity. And as you can see on this slide, in adipose tissue, UCN2 lowers fat mass and lowers triglycerides. In the muscle tissue, which is actually the main tissue, the main target tissue for UCN2, it drives the buildup of muscle through anabolic and inhibition of catabolic effect, which also has a positive impact on insulin sensitivity.

And further evidence really points towards additional cardiorenal benefits as laid out on the slide. For me, there are actually 2 key takeaways on that slide. First, GUB-UCN2 is not really simply about weight loss. It really has the potential to fundamentally improve body composition by reduction of fat mass and by building muscle mass at the same time. The added muscle mass is really expected to provide a functional benefit to patients through improvement of strength and physical performance. And that really opens up two really compelling and attractive development path.

On one hand, using GUB-UCN2 as a differentiated monotherapy on the other hand, in conjunction with incretin-based therapies. The second key takeaway is that the opportunity is not about obesity alone. As I indicated, we have multiple effects on very differentiated tissues, which gives us the opportunity to develop GUB-UCN2 into multiple indications, in particular, if you are thinking about muscle wasting conditions and cardiorenal diseases, which gives GUB-UCN2 really a very broad development potential. So the preclinical data generated to date make the potential really tangible.

So I would like to share a data set with you really as an example of the use case for GUB-UCN2, where we investigated it as monotherapy and in combination with semaglutide in rats with obesity due to high fat diet. On the left-hand side, you can see that GUB-UCN2 really profoundly reduces fat mass, which is depicted by the green bar. When combined with semaglutide, we do see an additive effect beyond the effect that we do see with either treatment alone. The middle graph shows really the differentiation of GUB-UCN2. We do see that with this mechanism of action; we can really build lean mass of which muscle is really a predominant part.

And we can also rescue the loss of muscle mass that we see with semaglutide in this experimental setting. On the right-hand side, you see actually very nicely why body weight does not tell the full story. Monotherapy alone does not result in a reduction in body weight in this particular experimental setting. And that is because we reduce body fat and at the same time, balance it with a gain in muscle mass. Hence, the overall effect in this setting is neutral.

However, when combined with semaglutide, we continue seeing the weight reduction driven by semaglutide, but GUB-UCN2 really dramatically changes the composition of the weight loss that we are seeing in combination therapy. This is really a very, very attractive drug profile, right, reducing fat mass improving muscle mass and having the potential for a functional muscle improvement. So we are very excited about now moving this asset into clinical development.

And it's really an important inflection point for Gubra, right, moving a compelling preclinical package into a clinical opportunity. We have now initiated a very comprehensive Phase I/IIa clinical trial where we enroll healthy participants, but also people living with obesity and move the assessment from the single ascending dose to a multiple ascending dose and a multiple dose part with up to 16 weeks of treatment duration. Importantly, we are assessing GUB-UCN2 as monotherapy and as combination therapy with an incretin.

So in addition to the typical Phase I endpoints related to safety, tolerability and pharmacokinetics, the trial was really designed from the outset to provide a very comprehensive clinical data package looking at muscle mass and muscle function and also building the foundation really for indication expansion into muscle-wasting conditions and into cardiorenal diseases. So we will be able to speak more about the development program of GUB-UCN2 at our upcoming R&D event on October 27. So with that, I would like to conclude and hand it over to Zoë, our Head of Gubra Ventures.

Thank you, Thomas. So now we turn to Gubra Ventures, which is our value accelerator. And the message here is simple. We are using our internal engine to create additional routes to value via external innovation. So why are we doing this? Well, Gubra Ventures is built around four value accelerators. The first is increasing shots on goal by accessing external innovation, including novel assets and novel technologies that are complementary to Gubra's core. The second is expansion into new diseases and new technology areas.

The third is return via future exits for additional revenue stream beyond that of the CRO and the biotech pipeline. And the fourth is because this will not be a standing start so we can go faster, we can lower our dependencies on external service providers, and we can also use disciplined capital use to create these opportunities.

And why now? Well, Gubra is really uniquely positioned to build on the credible foundations that we've built and amplify those to produce these value accelerators. So the first foundation is our scientific and therapeutic area depth as well as our development capabilities. Secondly, we have a discovery platform that we can use for joint ventures to create new opportunities in the peptide therapeutic space.

And third, we'll use our integrated capabilities, know-how and shared infrastructure to bring those opportunities faster to the clinic. So in all these respects, Gubra will be bringing -- Gubra Ventures will be bringing more than capital. So in summary, we're expanding our innovation footprint by additional routes to return and turning what we do well into further value creation. And with that, I'll pass over to Trine.

Thank you so much for that, Zoë. The CRO is continuously an important value enabler for Gubra. For many years, we've had a strong record of solid growth and profitability, building best-in-class services for serving our customers, both externally and internally. We are considered a scientific leader. We have more than 18 years' experience working in the metabolic space and in particular, in obesity, and we serve 17 of top 20 pharmas globally. They really chose us because we can deliver complex models with high-quality, unbiased data at speed and with excellent scientific guidance.

So our ambition is really to stay ahead of the curve. We've done that always in the past, introducing obesity services very early on, MASH and kidney platforms. And now we're introducing -- we have introduced this year services in women's health and Sarcopenia, so this muscle platform and really trying to differentiate ourselves and open up new growth opportunities for the future. So it's this combination of deep scientific expertise and the trusted customer relationship and continuous service innovation that underpins the long-term strength of the CRO business.

After a few challenging quarters, we are seeing early signs of improvement across a number of different market indicators. In particular, biotech funding has rebounded strongly in 2026. And we also see a continued outsourcing trend among pharma companies, especially. And this is really driving demand in our industry. We have clear priorities. We want to maintain our leading position in the metabolic and fibrotic space. We want to also, as I said, expand into new interesting and attractive therapeutic areas and accelerate the development of the commercialization of our advanced 2D and 3D imaging platforms.

Besides that, we are also increasing our commercial activities, in particular, in U.S., we are expanding and combining this with a cost discipline, we really focus on regaining momentum. We've grown 11% since first -- second half of 2025. And we've also returned to positive profitability. So this is -- there's naturally some uncertainty around the revenue recognition, but we see a very sound order book, both with our external and internal customers.

Obesity remains our largest contributor revenue-wise, and we see a rebound in MASH and kidney studies, which is improving the commercial outlook for the second half of the year. So overall, we see -- we are cautiously optimistic about the next half year, and we want to convert this momentum that we're having now into profitable growth while continuing to strengthen the strategic importance of the CRO for that business. And now I will hand it over to you, Kristian.

Thank you, Trine. And just a little bit of clarification on the recognition of revenue. It is not uncertain that we recognize revenue. It's just when we sell in the CRO business, revenue will occur when we perform the studies, not uncertainty just if we recognize revenue. Just as a clarification. So with that, let's look at the financials, right, taking the Biotech business first. So this is a business that naturally has lumpiness in its revenue and earnings when upfront payment -- upstream upfront payments occur and when milestone payments occur.

And -- in the first half of '26, we had some milestone payments, but totaling DKK 30 million, but not, of course, to the same level as last year where we had the upfront payment from AbbVie of DKK 2.4 billion. So this lumpiness occurs each and every quarter as inherently in a Biotech business with partnership collaborations. And we know already in Q3, we will receive EUR 10 million from start-up of the Phase II for the triple agonist from Boehringer. So a very important payment that will -- that is already recognized in the books for Q3.

Taking the CRO business, as Trine said, we have seen a sequential improvement with revenue up 11% compared to the second half of last year. And as Trine also said, we're seeing an overall stronger demand situation, especially for our smaller clients. And the smaller clients are typically the swing factor in Gubra's earnings and revenue in the CRO business. Just as you saw in '23 and '24, there was a lot of influx of smaller clients in Gubra and a bit of the opposite in '25. And that has been to a large extent driven by the funding conditions and funding conditions are now improving. So we're looking into a quite sound order book for second half of '26.

Earnings, Q4, we had a small loss, and now we turned that into a small profit in first half. And we expect relatively sound earnings in the second half of this year. That brings me into the outlook. So short message, unchanged outlook for '26. Starting with the Biotech business, just as a reminder, we only guide on total cost. That means both internal costs and external costs for clinical trials, for example. And there we guide DKK 330 million to DKK 360 million. CRO business revenue growth, we expect growth in the range of 0% to 10% and an EBIT margin in the range of 10% to 15%.

So again, unchanged compared to the guidance we have provided earlier -- unchanged guidance also for the smaller business units, Ventures and Gubra Green. With that, I give the word over to Markus to speak a bit about the news flow going forward here. Please, Markus.

Thank you very much, Kristian. I'd like to end with the next value inflection points for Gubra, and I believe we are entering an exciting period of growth. The next important milestone for us is the start of Phase II for the long-acting amylin. And I think this is imminent. So there will be good news coming soon. And there will also more details be published about this molecule and the Phase I MAD study coming up. And looking forward in terms of clinical milestones in the first half of 2027, that will be exciting news as well. We have top line data for UCN2 in terms of the first part of the trial, the SAD part. We will initiate the second part, the MAD part. And what is also exciting is the Phase Ib top line data for ABBV-295.

I want to point out that this is in patients with -- which are truly obese up to BMI of 45 and with a higher female participation. So I think this will be exciting data. And out of our previously mentioned research collaborations with Hemab, also the first compound will enter first in human studies. On top of that, we will announce our first venture and I'm confident that we will see rejuvenated growth out of the CRO as well. So taken together all those already achieved milestones and our confident outlook, we have all good reasons to be ambitious about the second half of the year, but also for the future of the company.

And I'm equally excited to tell you more about our growth strategy at our Gubra Investor R&D event on October 27 in London. I will talk about the growth strategy, our ambitious growth strategy. We will talk about our pipeline, give some updates. We will present our UCN2 development strategy, its potential indications and other elements of our strategy. So please join us at the webcast or hopefully in person. It will certainly be an exciting day, and I'm looking forward to the presentation.

Good. Thanks a lot, Markus, and thank you to all our presenters as well. That takes us to the Q&A session. So operator, we are ready to take the first set of questions.

[Operator Instructions]

The next question comes from Thomas Bowers from SEB.

A few questions from my side here. So maybe just on UCN2. So the trial is now listed on ClinicalTrials. And I note that there's only one center now recruiting patients. So should we expect this to be a multicenter study? And how about the U.S. side? Should we expect that to come online at some point in time if you're planning for more here? And then secondly, also on UCN2, maybe just clarification on the primary efficacy endpoint here for the MAD part MAD on -- of the Phase I/IIa. So -- so are you primarily looking at type 2 diabetes-related muscle loss, maybe also obesity once you combine with the incretin to get this early signal?

Or should we also expect you to have data from potential cardiorenal patients with cardiorenal comorbidities? And then lastly, on UCN2, just to understand the incretin part, the combination here. Are you looking to sort of mirror the standard incretin titration? Or are you may be aiming to just go with a fixed low-dose incretin and then use that on top of the UCN2 titration? I'm a little bit curious on how you actually plan to combine this initially. And then my last question, just on the CRO business. So you're expecting a recovery in second half. Are this also reflecting that we could maybe come back to expecting double-digit growth beyond '26?

Thanks a lot for those questions, Thomas. So I think the first 3 questions on UCN2, clinical trial site, single center versus multicenter and some trial design specific questions, we will go to Thomas. And then afterwards, a question on the CRO business, we'll go to Trine. But Thomas, on UCN2.

Yes, I'm happy to take the questions on UCN2. Thank you for that, Thomas. So with regards to the clinical trial site, we have deliberately selected one site for the current trial. And the reason for that is that we have really complex endpoints, right, around muscle function, muscle volume that really requires expertise at the site. We currently do not plan to expand beyond the site, but we will see how the trial is going to progress.

With regards to the overall development strategy and details to the clinical trial, Thomas, we will certainly provide an update at the October 27 R&D Day. But to address some of your points, we are certainly very interested in understanding how UCN2 performs both as a monotherapy and in conjunction with incretin therapy for the combination arms, we will certainly utilize commercialized products at the prescribed dosing regimens. I think that addresses the questions or did I forget?

I think you covered it all. And then the last question was on CRO expectations for second half of the year. And if there's anything we can say on getting back to double-digit growth.

So as I said, we see a positive trend in the market, and we expect to be able to follow guidance in the second half of 2026. Looking into '27, what we have been working on in 2026 is expanding our model portfolio to stand and be ahead of the curve on important growth areas relevant in the market, combined with our cost discipline and the initiatives we have taken on that side. So in '27, I am -- my hope is to get back to the long-term guidance, which is 10% growth. This is our ambition.

Just supplementing Trine. So the Gubra CRO business is a growth case. We've grown over the years by around 14% over the last couple of years, 14% annually. So -- but of course, there are some swings between certain years, but definitely, Gubra CRO is in a good position and there -- we want to grow the business 10% annually.

So we are now ready for the next question.

The next question comes from Rajan Sharma from Goldman Sachs.

I've got 2, one on the CRO and one on the Biotech business. Maybe just starting with UCN2. Could you just help us understand what are the most important endpoints that you'll be monitoring to support that target product profile there? What's your internal bar for success? And what would you need to see to justify further development for that asset when we see the data next year?

And then just on the CRO, I think obviously, you talked about expanding into women's health. Could you just give us an update on progress there in development? Just looking on your comments on Slide 23, it doesn't look like women's health is contributing commercially this year. When should we start to expect some contribution?

Good. Okay. Thanks a lot, Rajan. So let's start again with UCN2. Anything in addition that we can add on endpoints and what could justify progression from SAD part into the subsequent parts of the trial. We'll go to Thomas.

Yes. Rajan, we will generate data in this trial sequentially. In the SAD trial, we expect results on safety, tolerability and pharmacokinetics that would help us to determine how and which dose levels to move forward in the multiple ascending dose and in the multiple dose part of the trial. So we will start off with generating this data set and then continue generating endpoints around early efficacy readouts in the subsequent parts of the trial.

And as I indicated earlier, these will be measurements around body composition that really helps us to understand how much fat loss and muscle gain we can generate with this mechanism of action and whether that really translates into a functional muscle benefit, which would be important for us as success criteria.

The second question on CRO and the new therapeutic areas, women's health and Sarcopenia, any color we can add on contributions?

So the question was really to revenue from the women's health area. And there's a huge unmet medical need in the women's health area. And as I said before, we always really strive to be ahead of the curve in terms of developing our services and being ready for demand. And of course, women's health is an opportunistic on our side, but we really want to be ready when investment starts floating into this area. There's an unmet need. We have the capabilities to succeed also due to our advanced both model capabilities and 3D, 2D and 3D imaging capabilities.

So we're well positioned in this space also with the metabolic background that we have. But of course, it does take some time sometimes to build this market. On the muscle platform in Sarcopenia, we've seen actually a lot of traction already, and it's a service that we've just launched this year and in particular, from our internal customer at Gubra, we are seeing a high demand and also from external customers. But -- so here, the trajectory is faster. So -- but thank you for the question.

Good. Thanks a lot. Thanks a lot Trine, Thanks a lot Thomas, thank you for the question, Rajan. We are ready for the next set of questions.

The next question comes from Suzanne van Voorthuizen from Kempen.

This is Romy on for Suzanne. Just another follow-up on UCN2. So you highlight several potential indication expansion opportunities beyond obesity. So we're just wondering what specifically from the study next year will determine prioritizations next? And how soon can we expect this?

Right. I think that question goes to Thomas as well, indication expansion opportunities.

Yes. Suzanne, maybe 2 thoughts related to that. Number one, we are continuing to work on our preclinical profiling plan along with collecting the related cardiorenal endpoints in the ongoing clinical trial. And that in conjunction, will really help us to determine in which direction we'll drive the further development of UCN2. So we will be looking at cardiorenal endpoints also in the multiple dose part of the trial. That is a data set that will not be available at the beginning, but at the end of the trial.

Thanks a lot, Thomas. And currently, we do not see any additional questions from the audio platform. We have one question in writing here. So that relates to potential ex-dividend date in 2026. So I think the question is around whether we should expect a recurring dividend from Gubra, perhaps CFO, Kristian can address that.

Yes. We had a very pleasant situation last year where we announced an extraordinary dividend, a bit unusual for a biotech company. So remember, that was an extraordinary dividend on the back of the upfront payment for the amylin assets. And we have not declared dividends for this year. So yes, effectively, we don't pay out dividend in '26. And going forward, we will announce whether there will be a dividend or not. Again, remember, Gubra is a biotech company, and you should not expect recurring dividend each and every year.

Very good. Thanks a lot, Kristian. And thanks to everyone for attending and for the many questions. Thanks a lot. That concludes today's call. Yes, we look very much forward to connecting with many of you over the coming weeks and months and have a great day.

Welcome to the conference call. [Operator Instructions]. Now I will hand the conference over to the speakers. Please go ahead.

Good morning, everybody. Welcome to our Q1 investor call. I will go through a couple of highlights of the first quarter and then hand over to the team to continue. A quick reminder, Gubra operates via a business model involving 3 distinct but synergistic business units. We have our biotech unit where we discover and develop peptide therapeutics, and we have a validated platform with multiple obesity assets in clinical development. We have our CRO where we provide preclinical research services to external and internal customers. And we have also now established Gubra Ventures, where we invest in high-quality science adjacent to our core areas.

Given I've recently received questions, I also want to be clear that Gubra Ventures is not a corporate venture fund. Coming out a record year 2025. We have started 2026 with great momentum in our biotech pipeline. A few recent events. In the beginning of the year, we have started to expand our facilities here in Boston at the DTU Science Park. So we are significantly expanding our lab facilities, which is beneficial to our internal discovery group as well as our CRO that we can do more studies in the future. We have strengthened our clinical leadership with the recruitment of Thomas. Thomas is our Chief Development and Medical Officer. And given we will focus on clinical development of multiple assets in parallel in the future, this is an important step for the company.

We have also progressed on partner programs like Amylyx has selected a drug development candidate and is moving into IND-enabling studies. That's good news. We have also launched Gubra Ventures and Zoe Johnson has started in March to drive this forward. And in terms of our clinical pipeline, we have submitted GUB-UCN2 clinical trial application for an ambitious Phase I/IIa trial. And this is very exciting. This asset is a major opportunity for the company. On our partnered asset, there is also a great progress. AbbVie released ABBV-295 Phase I MAD data, 10% weight loss within 12 weeks in predominantly male and non-obese populations is actually very, very promising, and you will hear more about that later in the call.

In last week also announced that the triple agonist will move into Phase II by mid of the year. And also AbbVie will proceed with the 295 Phase II in Q3 2026. So this is quite exciting. We will have 2 discovered assets in Phase II this year and also starting the Phase I trial for UCN2. So great momentum in the biotech pipeline. This is our leadership team. You have seen most of them already. And on the lower panel, you see [ Thomas ] who has joined us in the first quarter. So in March, Grigo in February and Thomas in January. We will not talk about our upgrade of digital strategy, but this may be a topic for the future. But obviously, it's very important for us as well that our systems and AI strategy matches our growth ambition for the future.

I spend a moment talking about our business model because our 3 business units create one integrated value creation model. We have our biotech unit where our core discovery and development unit sits. This is clearly validated. We have 3 potential obesity blockbuster assets in clinical development. And we greatly benefit from the CRO by doing most of our preclinical work internally. So there's great synergy and also scientific synergy between the units. The CRO is a stand-alone commercial unit. It's operationally and structurally independent and serves a large number of external customers, both on the biotech and pharma segment.

Obviously, it's great that we also have business coming from our own biotech research and also from the ventures in the future. Our new ventures will greatly benefit from the other units. Of course, we have immediate access both to capabilities on the biotech side in the biotech unit as well as access to doing studies for the preclinical development of venture assets as well. And on top of that, our core functions support our new ventures, which are asset-centric companies, which we operate. So altogether, we have value creation through faster pipeline progression, a broader and more resilient portfolio and our structured capital allocation across the company.

We also have different path to monetization and timing with that business setup. We believe this setup also sets us apart in terms of agility and resilience compared to other companies in the market. We are also clear about where we play. CRO plays in the preclinical discovery segment. The biotech unit covers everything from discovery till early clinical development. Phase Ib/IIa is our sweet spot, which we use to partner our assets with pharma partners. And on the ventures, we are a little bit more flexible depending on the needs of our strategic and financial partners. But generally, that will be assets just by clinical development and enabling studies still also Phase II. With this, I hand over to our biotech leadership, hence our CSO, Louise.

Yes. Thank you, Markus. And just trying to make the camera work. Let's take a look at the StreaMLine platform and how it enables a growing pipeline. As we work with peptide experts, we discover novel peptide-based drug candidates either alone or with a partner. And all our work is powered by in-house developed drug discovery platform, StreaMLine. Using this platform, we can quickly go from idea to a novel IP-protected development candidate. The platform takes advantage of AI and machine learning, which combined with high throughput wet lab screening of multiple peptide libraries. We use multiparameter optimization with set time and enables the identification of better molecules faster. So the strength of our streamlined drug discovery platform is reflected across both our internal and partner pipeline.

UCN2, our proprietary multiple selling program origins directly from the platform. ABBV295, the long-acting amylin analog now out-licensed to AbbVie is another example of the platform's ability to deliver clinically differentiated candidates. Our collaborations with Amylyx, Camurus and Hemab further validate the platform reproducibility and track record of generating differentiated peptide assets across therapeutic areas. Since our last update, we have made important progress across the pipeline, including the CTA submission for UCN2 assets. We've also seen strong progression in our partners' clinical stage obesity program. AbbVie reported positive top line Phase I MAD results for in ABBV295 and it plans to advance the program into Phase II in Q3.

In addition, Boehringer Ingelheim has decided to move the obesity triple agonist into Phase II in mid-'26. So together, this positions us to have 2 partnered assets entering Phase II in '26. So as you can look, we have been dedicated to understanding and treating obesity since the company's inception. And over the years, we built deep scientific expertise in this field from early discovery to clinical translation.

Today, I'll highlight 3 of our most advanced obesity assets, each designed with a differentiated profile compared to current standard of care and with blockbuster potential. But before getting into the details, let me take a step back and look at the broader obesity landscape and where the field is heading. Obesity continues to be a growing health challenge with a well-recognized need for novel treatment approaches. And while current therapies can deliver substantial weight loss, lean body mass, primarily muscle bones and connective tissue accounts for approximately 20% to 45% of the weight loss. We believe that the next generation of treatments will increasingly focus on the quality of the weight loss, in other words, maximize fat mass loss of preserving or even increasing lean muscle mass. Differentiation will likely also come from improved tolerability, multi-target strategies and the ability to address comorbidities.

Gubra's pipeline is strategically positioned to meet these emerging trends. First, we have the long-acting amylin analog, ABBV295 now out-licensed to AbbVie. A key differentiator of the amylin class is the potential to deliver clinically meaningful weight loss with a favorable tolerability profile, supporting the growing focus on better tolerated obesity treatment. Secondly, we have the triple agonist developed in partnership with Boehringer Ingelheim. This asset reflects the trend towards multi-target approaches with potential to enhance efficacy through simultaneous engagement of receptors. And finally, we have the next-in-line UCN2 program. This program built on a novel mode of action, UCN2 is designed to address the emerging focus on body composition with the potential to decrease fat mass while preserving mass and function in combination with weight management therapy.

So let's take a closer look at these programs. Starting with the long-acting amylin analog in development for obesity. A key highlight this quarter was AbbVie reporting positive top line results from the Phase I multiple ascending dose study. In this study, once weekly dosing with 295 demonstrated a clinically meaningful weight loss of almost 10% after only 12 weeks of treatment. And importantly, comparable weight loss was also observed with less frequent dosing, including every other week and once monthly dosing, really highlighting the potential here for dosing flexibility. 295 demonstrated a favorable tolerability profile at all dose levels. Adverse events were predominantly GI-related, mild and transient. So taken together, these results are encouraging and support the potential of 295 to deliver a robust weight loss with a favorable solubility profile. So really further underscoring its potential as a differentiated therapeutic option in the evolving obesity treatment landscape. So the program is now advancing in a Phase Ib study in obese patients aiming for higher female population and the Phase II program is expected to begin Q3 this year.

So additionally, we have the triple agonist developed in partnership with Boehringer Ingelheim for the treatment of obesity. This long-acting first-in-class asset targets the GLP-1, the GIP and the [ NPY2 ] receptors to engage complementary pathways involved in body weight regulation. Following encouraging Phase I results shown a meaningful weight loss and a favorable safety profile, Boehringer Ingelheim has decided to advance the program into Phase II clinical development midyear. We see this as further validation of the asset potential as well as Gubra's scientific innovation and partnering capabilities. With that overview, I'll now hand over to Thomas, our CDMO, who will provide further details on the UCN2 program.

Yes. Thank you, Louise. UCN2 is Gubra's next mega program. Based on the differentiated mechanism of action of urocortin 2, our drug candidate group UCN2 has the potential to address a key unmet medical needs in metabolic and cardiorenal indications. Native UCN2 belongs to the family of corticotropin releasing hormones and is a highly selective endogenous agonist of the CRH (sic) [ CHRH ] receptor 2. This receptor is expressed in multiple relevant tissues and mediates the effect of UCN2. In the adipose tissue, UCN2 administration results in an acute lipolytic effect. Longer-term receptor activation results in a reduction of heat content of lymphocytes hence reduction of adipose tissue inflammation.

In the skeletal muscle, which is the main target tissue of UCN2, protein facilitates protein synthesis, anabolic effects and at the same time, inhibits catabolism. In addition, UCN2 improves mitochondrial function, oxidative metabolism resulting in increased fat oxidation, improved muscle quality. And based on these physiological effects of UCN2, administration of UCN2 is expected to result in both increased muscle volume and an improved muscle function. Cardiovascular effects of UCN2 include vasodilation, including a reduction of pre and after load, which along with the positive inotropic effect result in improved cardiac output. In addition, UCN2 elicits antifibrotic effects, which are thought to improve maladaptive fibrotic remodeling of the heart following injury.

Renal benefits of UCN2 are less in our study, but the expression of the receptor in the renal vasculature and proximal tumors suggest a potential real benefit based on improved renal fusion. Similar to the heart, antifibrotic effects would also contribute to improvement of renal fibrotic remodeling in the context of chronic kidney disease. So our drug candidate GUB-UCN2 is a 38 amino acid peptide engineered for high CRH receptor 2 selectivity and extended the half-life supporting once-weekly subcutaneous administration in humans. GUB-UCN2 has been comprehensively characterized in preclinical studies, each will including preclinical pharmacology studies and high fat diet-induced obese rats.

This slide summarizes results from a study in obese rats demonstrating that GUB-UCN2 selectively decreases fat mass and restores semaglutide-induced lean mass loss. The graph on the left-hand side shows the effect on fat mass. GUB-UCN2 alone drives a significant reduction in fat mass represented by the green bar. In combination with semaglutide, GUB-UCN demonstrates an additive effect on fat mass reduction as shown by the blue bar. So this reduction in fat mass was achieved while preserving and even improving lean mass as shown by the green bar in the middle graph. The loss of lean mass with semaglutide demonstrated by the purple bar was really prevented when GUB-UCN2 was co-administered with semaglutide as shown by the blue bar.

As expected with this mechanism of action, GUB-UCN2 resulted in an improved body composition and maintenance of semaglutide treatment-related weight loss as shown in the graph on the right-hand side. So based on a compelling preclinical package, we are now planning to enter clinical development in the second half of this year. As indicated earlier, our drug product candidate possess the desired pharmacological and [indiscernible] characteristics to support once-weekly subcutaneous dosing. Based on its mechanism of action, we expect favorable effect on body composition with an increase in muscle and decrease in fat mass alongside with an improvement of muscle quality when administered alone or in combination with incretin-based therapy.

As a consequence, we believe that GUB-UCN2 has the potential to improve muscle function and physical performance. We therefore target obesity drug-induced muscle loss as the first indication. But beyond that and based on potential favorable effects on insulin sensitivity and also glucose homeostasis as well as cardiac and renal function, we believe that GUB-UCN2 has very broad expansion potential into metabolic and cardiorenal indications. So we plan to discuss details of the planned trial and development strategy in GUB-UCN2 focused R&D Day following initiation of dosing in the clinic.

However, to provide an outlook already today, we are planning to execute a very ambitious Phase I/IIa trial in approximately 188 participants with the intent to investigate safety, tolerability and initial efficacy of GUB-UCN2 with regards to effects on muscle volume and muscle function, which we believe are very relevant and important endpoints for the indications we are pursuing. We are also investigating that as a monotherapy or in combination with incretin-based therapy. With that, I'm concluding on the UCN2 section and hand over to Zoe, our Head of Gubra Ventures.

Thank you, Thomas. Good morning. Gubra Ventures is our value accelerator, the newest business unit designed to amplify what the group already does exceptionally well. Ventures is a deliberate extension of Gubra's capabilities into external asset creation and company building, leveraging external capital with the group's scientific infrastructure as a competitive differentiator. So why Ventures? The strategic logic for Ventures rests on 4 pillars. First shots on goal. Our biotech pipeline is focused and disciplined, but there are validated biological hypotheses and external asset opportunities that fall outside of our core pipeline prioritization. These opportunities are where we're hunting for Ventures.

Second, disease and technology area expansion. The economic and innovation landscape is evolving rapidly, new biology, new modalities, new competitive dynamics. Some of the most interesting opportunities sit adjacent to our current focus in metabolic disease and immunology and inflammation. Ventures gives us a vehicle to explore those adjacencies with appropriate risk ring-fencing. Third, return on investment. Ventures is designed to generate financial returns through future exits, licensing, M&A or stand-alone value creation. This is a capital allocation story as much as a scientific one, and the BD and M&A levers are central to how that value is ultimately realized.

And then fourth, market intelligence. So by actively building in emerging areas, we stay close to the market to competitive signals and to where the field is moving. And in this case, 3 business units leverage synergies from early target exploration right through to clinical development. So the bottom line is that Ventures will build companies based on externally sourced assets using external capital where necessary and Gubra's infrastructure to deliver pipeline optionality, strategic intelligence and financial return. So why is Gubra uniquely positioned today? Why us, why now? The answer is that 2 things are converging. Gubra's platform is maturing. We have peptide discovery capabilities, optimization platforms, translational pharmacology and deep metabolic disease biology that took years to build. And at the same time, the innovation landscape is shifting. Many innovative ideas and programs are undercapitalized, positioned poorly or spun out without the scientific infrastructure to advance incredibly. And that's exactly where Gubra Ventures can add value. We bring genuine scientific differentiation to bear on externally sourced assets.

The key discipline here is moving beyond obesity in a structured way, expanding into adjacent disease areas where our CRO, peptide and platform expertise give us a real edge, not just a financial position. In terms of risk architecture, I just want to spend a moment here because it's obviously front of mind. And the right way to think about venture risk is at the portfolio level, not the individual venture level. Each venture will sit somewhere on 3 risk axes: scientific risk from novel biology through to validated pathways, technology risk from new modalities through to proven formats and clinical risk from early discovery and preclinical stage through to clinical stage assets. And no single venture needs to be low risk across all 3 dimensions. What matters is the portfolio in aggregate is diversified across those axes. A higher risk scientific fact may be paired with a more validated technology format or a novel biology program might be at clinical stage.

The portfolio construction logic manages exposure at the group level. And this is a meaningful departure from how individual biotech companies think about their pipelines, and it's one of the structural advantages of the ventures model. We're not betting on one asset. We're building a diversified basket of ventures, each lean and asset-centric with Gubra infrastructure underpinning all of them. And so finally, the collaboration model, and this is the heart of what I'm talking about and where the capital efficiency story lives. Ventures will be deliberately lean. We're not building a stand-alone infrastructure from scratch and each venture company will access shared [indiscernible] resources, CRO models and translational capabilities from Gubra CRO, peptide expertise and AI-driven discovery platforms from Gubra Biotech's StreaMLine infrastructure and development functions, including clinical development, CMC and toxicology. And core group functions will be shared across the organization.

What this means in practice is that a ventures company can operate with a fraction of the fixed cost base as a stand-alone biotech while accessing capabilities that most early-stage companies spends years and significant capital to build. And that's our structural edge. Our CRO in particular, is perceived by external partners as a key value enabler for ventures, and it makes the proposition credible and commercially attractive. And so to summarize, Gubra Ventures is a capital-efficient, scientifically differentiated vehicle for external asset creation and company building. It's built on Gubra's existing strengths and structured to deliver pipeline optionality, market intelligence and financial returns. We're at an early stage in the journey, and we're being deliberate about how we build, and we'll share more on pipeline sourcing, ventures and capital structure as those conversations mature. And with that, I'll hand over to my colleague, Trine, to talk about Gubra CRO. Thank you.

Thank you for that, Zoe. As Markus and Zoe mentioned, the CRO remains a core value enabler for Gubra. We've had a strong track record of stable growth in both revenue and EBIT over the years, and this has always laid a solid financial foundation for Gubra. The CRO is considered a scientific leader by our customers and our strategic direction to expand on that position is clear. We still see volatility in the market, and it is recovering slower than expected. Demands remained soft, especially in U.S. and among biotech, small biotech companies. Since Q4 2025, we have had a sequential improvement of 25% on top line growth. However, we are not where we need to be. We still experience longer decision cycles and increased competition on standard studies.

Despite this market outlook, we remain cautiously optimistic about a gradual recovery during the second half of 2026. We are encouraged by improving commercial signals and early indications of more activity across selected large pharma accounts and within obesity and MASH segments. To leverage this momentum and to get back to growth, we have one clear priority, which is to double down on commercial execution. We're expanding our presence in U.S., including an expansion of our sales team with 20%, and we're accelerating the launch of our women's health and sarcopenia platforms. We are also leveraging a key trend to use AI and machine learning in development of our services. This has always been an instrumental part of our way of working for years in 3D imaging and 2D histology, and we also leverage these technologies in our operational excellence efforts to digitalize our workflows end-to-end.

The CRO has a strong differentiated service portfolio, and we're serving 17 of the largest pharma companies globally. They work with us because they know we can consistently deliver complex models at scale with high-quality and unbiased data, and we can deliver at speed with flexibility and excellent scientific guidance. We always strive to be ahead of the curve, focusing on our world-class models and highly specialized technologies. Our newly launched models in women's health and sarcopenia are clear examples of that. And very soon, we will also be launching a new service focused on advanced behavioral analysis. As mentioned, our women's health platform is an example of where we are ahead of the curve. There is a huge unmet need in the entire women's health area. And we're driving innovation in this area, leveraging our preclinical models and advanced 3D imaging capabilities. We've already made strong progress in this area, and we position Gubra as a leading preclinical CRO in PCOS, polycystic ovary syndrome, POI, primary ovarian insufficiency and menopause.

As part of that progress, our 3D imaging team has developed an advanced whole organ imaging platform with absolute surgical quantification and a capability that we believe can be meaningful raising the standards for reproductive biology and toxicology research. This is an important as it enables a more complete and precise evaluation of ovarian tissue than conventional approaches have been able to do. This has a clear potential to significantly improve preclinical decision-making across both women's health and broader safety assessment programs.

We are already expanding commercial engagement across the market from specialist biotech companies to large pharma companies are increasing their focus on women's health. Taken together, our differentiated models, expanding customer dialogues and unique image expertise position us well to become a premium partner in preclinical compound evaluation for PCOS, POI and menopause over the coming years. And now I will hand it over to you, Kristian , presenting the financial results and outlook.

Thank you, Trine. And let's start with the results in the first quarter and the biotech business. As you can see here, we had an improvement in the first quarter, mainly driven by milestone from the Amylyx collaboration. And this is also what you see in different quarters and when we receive milestones, the results can be a bit lumpy as it was last year in a very positive fashion. So -- and we also had this milestone in the first quarter driving up the revenue and that was also the reason behind the improvement in earnings compared to the same quarter last year.

Turning to the CRO business. Here, we saw a strong improvement compared to Q4 last year. So revenue increased by around 26% However, a small decline compared to same quarter last year. The main growth driver continues to be obesity, where Gubra is really, really strong. But as Trine also said, there's still macroeconomic uncertainty that continue to weigh on especially smaller biotech clients and longer decision cycles. Similar trend on earnings, an improvement in the first quarter, turning a small loss in Q4 into a small profit in the first quarter of '26. But again, we want to be at a different level when we conclude the year '26 and with the initiatives and the trends that Trine spoke about here just before.

Rounding off with the outlook and guidance. The Biotech guidance unchanged on the cost we guided for. In the CRO segment, we reduced our growth expectation slightly. So now we expect growth of 0% to 10% revenue growth for external revenue. Importantly, also with the business unit structure, we also sell internally services from the CRO business to the Biotech segment and that we expect to be around DKK 50 million. That's on top of the external revenue. With that, we have concluded our presentation and now open up for questions.

[Operator Instructions] The next question comes from Thomas Bowers from SEB.

A couple of questions. So firstly, maybe just to kick off with GUB-UCN2. Can you maybe elaborate a little bit on the reasons behind, you would say, longer than normal CTA process here? Should we interpret this purely as extended regulatory discussions around, for example, trial endpoints? Or is there anything in regards to the preclinical or tox-related data that has been a concern maybe requesting additional data? And then second to that, just what's your level of confidence in initiating the trial here in the second half? And are we likely looking at Q3 rather than Q4?

And then lastly, on UCN2. So in regards to the U.S. market, clear guidance from FDA in regards to that 5% weight loss guidelines. And with UCN 2, you are likely limited somewhat with the incremental weight loss as monotherapy. So do you see a viable path here without any new guidelines? And then also in addition to that combination with, for example, [indiscernible] should we expect UPN2 to demonstrate incremental weight loss on top of GLP-1? Or do you think a combination compared to placebo should be more than sufficient?

Thank you very much, Thomas. And actually, Thomas will answer those questions.

Yes. Thank you for the questions. So these are multiple questions, but let me go through them one by one. The first question related to the start of the clinical trial. The clinical trial application is still under review by the health authority, which is BfArM in Germany and the associated ethics committee. And this is not unusual for a trial of the complexity that I presented earlier in the slide, yes. Remember, this is a combined Phase I/IIa trial, yes, where we essentially combine 2 trials in one single clinical trial protocol with the appropriate patient population and the appropriate endpoints to really achieve clinical proof of concept, yes. And that results essentially in a very complex documentation with regards to key trial documents and administrative documents, particularly the clinical trial protocol form consent form and administrative documentation.

And for that reason, there are clarifying questions, in particular on the protocol on the ICF from the BfArM and the ethics committee that we are now addressing and discussing with the agency. Nonetheless, we anticipate approval of the clinical trial application in time for trial initiation in the second half of '26. So with regards to the second question related to body weight, here, just a reminder that GUB-UCN2 is not developed as an obesity drug. We do see really the advantage and the benefit for patients with this mechanism of action and the fact that we can favorably influence body composition. We can avoid that patients experience a loss of liver and muscle mass and can drive basically preservation of muscle function with this mechanism of action.

We expect that we have an additive effect on fat mass loss but would not see the drug being positioned within the obesity market. From that perspective, we do see that UCN2 would be used in combination with incretin-based therapies. And we have tested basically multiple incretin-based therapies and actually demonstrated that GUB-UCN2 is effective on top of those. And I just have shown you the semaglutide data today in the presentation. For indication expansions into other metabolic cardiorenal indications, there is, of course, the opportunity to evaluate UCN2 as a monotherapy. And based on the data that we are planning to generate in the clinical trial, I think we have then all options to actually explore the further positioning of UCN2 in the market. Thank you.

Can I just follow up just maybe just as a reminder, I have noted whether you disclosed it. But in the trial design of UCN2, are you also planning to already include a combination with incretin in the Phase IIa path?

So we would be actually discussing that at the R&D Day, which we initiate then after approval of the clinical trial and then we'll discuss really details not only of the trial, but also with regards to the strategy, right, and how we view positioning of the drug candidate in the context of the clinical trial design.

The next question comes from Suzanne van Voorthuizen from Kempen.

This is Suzanne from Kempen. Maybe first on the amylin and triple agonist programs, can you remind us of the partnership economics and what we should be expecting in terms of milestone payments on the start of the Phase II trials for each? And secondly, can you elaborate on the additional Phase I study that AbbVie has started with the amylin? What is similar or different in that study compared to the Phase I we've seen the data from already? And lastly, on the ventures part, does your previous guidance for first venture creation in the second half of this year still stand?

Thank you very much, Suzanne. So Kristian will take the first question, Louise will take then second and the third.

Just starting with the deal packages and the milestones and starting off with ABBV295, the amylin. So there's a number of milestones, both development milestones and sales milestones for a total deal package of USD 1.9 billion. On top of that comes royalties. We don't disclose the details of each milestone. But again, I want to reiterate both development and sales milestones for a total value of USD 1.9 billion. And essentially, the same level of detail that is what we also provide for the triple agonist. However, the deal package is somewhat lower there, is around EUR 240 million. And again, both development and sales milestones and royalties on top of that. But no details on the size and what triggers the individual milestones.

Yes. So to answer the second question here with regards to additional Phase I study that AbbVie is running and the core differences here compared to the former Phase I MAD study. So in the first study, that cohort primarily included male participants of a lower BMI group. And in the next study here that is run by AbbVie, it will be conducted in obese patients. So really aiming for a much higher BMI cohort, 30 to 45 is the inclusion criteria here. And in addition, the ambition is really also to increase the number of the females participating in the study. Then concerning the creation of our first venture, we are on track. We're currently evaluating a number of opportunities in line with the scope that I outlined in the main presentation, and we will be giving more details of those ventures at the R&D Day later this year.

The next question comes from Rajan Sharma from Goldman Sachs.

A couple around the UCN2 asset as well. So I realize there will be more details at the R&D Day, as you mentioned. But could you just help us understand some of the timelines here? And what are your expectations for potential first clinical data both in the obese or the obesity muscle preservation indication and then also beyond that? And then secondly, just maybe following up from a question earlier in terms of definition of obesity drug-induced muscle loss, how should we think about that? And how do you implement that into a clinical trial? There's, of course, an argument that muscle loss is an expected consequence of weight loss. So how do you isolate what may be sort of an unhealthy level of muscle loss in a clinical trial?

The question goes to Thomas.

Yes. So with regards to the trial timelines, I think we will be speaking in more detail about it once we have the trial approved, right, and the first patient to dose because that gives us then the confidence to speak about the timing of the incoming data. With regards to the obesity and obesity indication in the context of incretin therapy induced muscle loss, this is a very important question. And from our perspective, what is really relevant and important is muscle function and physical performance, not muscle volume or muscle mass itself. It's the benefit that we can bring to the patient that would differentiate GUB-UCN2 from other mechanisms in the market. And this is what we are looking to demonstrate in our first clinical program, and we demonstrate that there is a differentiated product from weight loss.

[Operator Instructions]

Okay. I think that seems to conclude the questions from the phone. We received a couple of written questions also. I think one of these has been answered already. Another question is also on our drug discovery programs for obesity and what could come next after the assets already discussed here. So I give that over to Louise.

Yes. Thank you for the question. And I would say that for early discovery programs, we are, of course, working really, really hard on advancing those. But the specific timing on activities here, I would not comment on today. I think we will leave that and then we will, of course, announce when we have anything to share.

Okay. Operator, it seems that there are no further questions. We don't have further written questions either. So I hand over to Markus to just some concluding comments.

Well, thank you very much for participation and your questions. I think Gubra has great momentum, and we have an ambitious growth aspiration and growth phase ahead of us. So we look forward to discuss our progress in the next call in the next quarter. Thank you very much.

Welcome to the conference call. [Operator Instructions] Now, I will hand the conference over to the speakers. Please go ahead.

Good morning. Welcome to the Gubra investor presentation. My name is Markus Rohrwild. I'm the CEO of Gubra. I'm joined here with our Chief Financial Officer, Kristian; our Chief Scientific Officer, Louise; our Chief Medical and Development Officer, Thomas; the Head of Gubra Ventures, Zoe; and the Head of the Gubra CRO, Trine.

I will present an overview about the company, and then we will move into the individual units. Just as a reminder, Gubra is a disease-agnostic techbio company and we have deep expertise in peptide therapeutics and preclinical research services.

Starting 2006 (sic) [ 2026 ], we will operate in 3 independent but synergistic business units. First, our Gubra Biotech unit, where we discover and develop peptide therapeutics to clinical proof of concept, our key value driver. Second, the Gubra CRO, where we deliver high-quality preclinical research services to external customers, but also for our internal units, Biotech unit and to Ventures.

And our new business unit, Gubra Ventures, where we incubate high-value assets adjacent to our core therapeutic areas to create and accelerate additional value, all based in our commitment to society in Gubra Green, partially served by our ESG initiatives, but also we are investing 10% of our pretax profits into green initiatives.

2025 was a record year for Gubra record revenue of $400 million, record operating profit of $325 million. Currently, our advanced pipeline is in obesity, but we will also move beyond metabolic diseases. The company has around 300 employees now, and we are significantly expanding our facilities to do even more research and to even do more contract research.

This is the historic growth journey of Gubra, and you can see 2025 stands out as a record year. This is driven by the deal with AbbVie where we out-licensed our amylin compound and the high upfront payment created the record revenues for 2025.

This is our management team. Since I started in September 2025 as the CEO, I've made some changes to the leadership team. I brought in a new Chief Medical Officer with Thomas, who is strengthening our drug development team. So, we, in the future, can develop multiple clinical assets in parallel. Zoe was recently announced as Head of Gubra Ventures. And also, we have recently announced Grigo as new Chief Technology Officer. Technology is very important for our innovation. We are a true techbio company. So, we are very glad that we were able to recruit Grigo.

A couple of key events in 2025. You're all aware of this. Obviously, the Amylin deal was a landmark deal for us, which not only proved the validity of our business model, but also delivered the strong financial results we are enjoying for 2025. We had a data readout on Amylin, early clinical data, which is very promising. We had fantastic preclinical data on our lead asset UCN2. You will hear and see more about that later in the presentation. And we did a couple of additional deals and partnerships, mentioning the Camurus partnership on -- the collaboration on PTH agent and also Boehringer Ingelheim has announced that they are advancing our triple agonist in obesity into mid-stage clinical development. So, 2025 was full of very valuable milestones for Gubra.

Now, we have a good foundation for growth. We are in a very good liquidity position. We have a world-class peptide and preclinical service company streamlined. We have a discovery platform, which can deliver from an idea to a drug development candidate, high-quality assets in a very short amount of time. And we also -- now we are ready to move into other areas beyond obesity to create more value and more clinical candidates.

So, if we look forward, you can expect that we will expand our pipeline. We will also focus on having multiple mega programs of high commercial value. One example is UCN2, which will have multi-indication programs and, of course, represents a significant value to our pipeline. We will also look into, in parallel, license complementary assets to our pipeline. And at the same time, we will strengthen our CRO by delivering new and innovative models for our customers worldwide.

Just to summarize, how we play and where we play, I'd like to mention that, again, we are now operating in 3 business units. We have our proprietary AI-based drug discovery platform in Gubra Biotech. Here, we will have a pipeline of high-value assets. Now we talk a lot about UCN2, but there is more to come. And we will develop these assets to clinical proof-of-concept for maximum value creation.

So CRO has done very well in recent years, and we have a world-class platform to serve our customers. And Trine will talk a little bit about also our new innovations and services in that space. So, we are very confident that this business will also in the future be very profitable. It's strategic value enabler also for our Biotech unit and our Ventures.

And our ventures are essentially lean and asset-centric spinouts of the company. They are operationally separated, but adjacent to our core areas, and we will do these together with financial and strategic partners to maximize value for us, all based on our commitment to society with Gubra Green.

To be a little bit more specific and clear about where we play in the 3 business units, I'd like to review this in more detail. So, our discovery is primarily preclinically in terms of our CRO services, where the CRO provides multiple high-quality models in the area of lead optimization and preclinical validation. Our CRO plays all the way from drug discovery to clinical proof of concept.

When I talk about clinical proof of concept, what I mean is Phase Ib results or Phase IIa, which essentially is a place of value creation and value inflection for our Biotech in the area of early drug development. And for Gubra Ventures, it's a little bit more flexible. But, generally speaking, we will look into -- for assets which are at the drug development stage, moving towards clinical proof of concept and beyond, but it also will depend on the needs and strategic imperatives of the partners and the particular assets we are playing with.

So, with this, I hand over to the Biotech unit and to Louise.

Thank you, Markus. So, let's take a look at the StreaMLine platform and how it enables a growing pipeline. So, at Gubra, we're peptide experts, and we discover novel peptide-based therapeutics either alone or with a partner. And all our work is powered by in-house developed drug discovery platform, StreaMLine. Using this platform, we can quickly go from idea to a novel IP-protected development candidate. And the platform takes advantage of AI and machine learning, which is combined with high throughput wet lab screening of multiple peptide libraries, thousands of peptides.

We use multiparameter optimization, which saves time and enables the identification of better molecules faster. So, the strength of a streamlined drug discovery platform is reflected across both our internal and partnered pipeline. UCN2, a proprietary high-quality weight loss asset now advancing towards the clinic origins directly from the platform.

In addition, ABBV-295, the long-acting amylin analog out-licensed to AbbVie exemplifies the platform's ability to deliver clinically-differentiated candidate. The Amylyx, Camurus and Hemab collaborations further validates the platform's reproducibility and track record of consistently generating differentiated peptide assets across therapeutic areas.

Since the last update, several important developments have taken place in the early pipeline. We have partnered a PTH program with Camurus. This collaboration combines Gubra's parathyroid hormone analog with Camurus' FluidCrystal technology to enable extended and patient-friendly dosing for patients with hypoparathyroidism.

With Amylyx, we have now nominated a development candidate, a long-acting GLP-1 receptor antagonist, now advancing into preclinical development. And the Hemab collaboration has, likewise, progressed into preclinical development. We've also added 2 new early-stage programs to the pipeline, a differentiated obesity asset and a Cachexia program, expanding our metabolic footprint beyond obesity.

At the same time, we have concluded the third collaboration with Boehringer Ingelheim, a very early target discovery program. And finally, as part of a disciplined portfolio review and prioritization process, we have decided to discontinue our GLP-1 monotherapy and Orexin programs to focus resources on higher priority opportunities.

At Gubra, we have been dedicated to understanding and treating obesity since the company's inception. And over the years, we've built deep scientific expertise in this field from early discovery to clinical translation. And today, I'll highlight 3 of our most advanced obesity assets, each designed with a differentiated profile compared to current standard of care and with blockbuster potential.

But before we go into the details, let's take a step back and consider the broader obesity landscape and where the next generation of therapy is heading. Obesity continues to be a growing global health care challenge with a well-recognized need for novel treatment approaches. And while current therapies have transformed treatment and can deliver substantial weight loss, lean body mass, primarily muscle, bones and connective tissue accounts for 20% to 45% of the weight loss.

We believe the next generation of treatment will increasingly focus on the quality of the weight loss. In other words, maximize fat muscle loss while preserving or even increasing lean muscle mass. In addition, differentiation will likely come from improved tolerability and multi-target strategies, including dual and triple receptor agonists. Gubra's pipeline is strategically positioned to meet these emerging trends.

First, we have the long-acting amylin analog, ABBV-295 now out-licensed to AbbVie. 295 is in development for weight management indication and could be positioned as an alternative on addition to incretin-based treatments. It features a balanced receptor profile on the amylin and calcitonin receptors, just like native amylin combined with an exceptionally long half-life of 11 days.

So, a key differentiating factor of the amylin class is the potential to deliver clinically-meaningful weight loss with a favorable tolerability profile. And interim data from the MAD study support this profile. Here, 295 was well tolerated with adverse events being predominantly mild and GI related and 295 demonstrated a dose-dependent weight loss of almost 8% compared with a 2% increase in the placebo group after just 6 weeks of treatment.

So, these findings reinforce the potential of amylin as a next-generation weight loss therapy with improved tolerability profile. The program is currently advancing in a Phase I MAD study led by AbbVie. Here, longer treatment durations are also being explored.

So, secondly, we have the triple agonist, long-acting first-in-class and developed in partnership with Boehringer Ingelheim. So, following encouraging Phase I data demonstrating meaningful weight loss and a favorable safety profile in patients and individuals with overweight and obesity, Boehringer Ingelheim has decided to progress the program into the next phase of clinical development.

And finally, we have our next in line internal obesity program focused on high-quality weight loss. This program builds on a novel mechanism, a long-acting UCN2 analog selectively targeting the corticotropin-releasing hormone receptor 2 and it's designed for once weekly dosing.

And with that overview, I'll now hand over to Thomas, our CDMO, who will provide further details on the UCN2 program.

Thank you, Louise. UCN2 provides a novel and differentiated mechanism of action for high-quality weight loss. And that actually means a strategic shift from pure reduction of body weight towards body re-composition, a loss of fat mass and at the same time, maintenance or increase of muscle mass, which is functionally very important.

So, UCN mediates its action through a specific receptor called CRHR2, which is expressed on muscle tissue, in adipose tissue and in the cardiovascular system. In the muscle, UCN2 mediates anabolic and suppresses catabolic effects. And it shifts the metabolism towards oxidative metabolism, which also results in loss of intramuscular fat. The result of that could be an improved muscle function and an improved metabolism of glucose.

In the adipose tissue, UCN2 inhibits lipid storage and reduces really significant fat mass and also reduces inflammation of the adipose tissue and the release of pro-inflammatory cytokines. In the cardiovascular system, we do see an increase in cardiac output, which is mainly driven by 2 effects: number one, a direct inotropic effect on cardiomyocytes and vasodilation, which results in a reduction of pre and after load. And together, we see cardiac output increase.

Longer-term administration of UCN2 also inhibits maladaptive, in particular hypertrophic and fibrotic remodeling that we see in a number of cardiovascular diseases. So, our compound, GUB-UCN2 is a long acting Urocortin-2 peptide analog. It's very highly selective for the CRHR2 receptor and suitable for once-weekly subcutaneous dosing.

The benefits we aim at exploring in the clinic are related to the mechanism of action that I alluded to earlier, including improved body composition with increased muscle mass and decreased fat mass; improved muscle function, which is very important from a patient perspective; and additional metabolic and cardiorenal benefits. All these benefits support the primary indication we are currently pursuing of obesity drug-induced muscle loss.

However, based on its mechanism of action, UCN2 also provides the opportunity for broad indication expansion opportunities. On one hand, we intends to explore and leverage favorable effects on metabolism and muscle to look into muscle wasting and loss, for example, type 2 diabetes-related muscle loss or sarcopenia. And based on its favorable cardiorenal effects, we are looking into ischemia-reperfusion injury, heart failure and chronic kidney disease indications.

Our very ambitious first-in-human Phase I/IIa clinical trial has just been submitted to the health authority for review. And it's a trial that was specifically designed not only to support the primary indication, but also to deliver data that would allow a meaningful regulatory interaction on the further development path of UCN2 and also help us to identify the best indication expansion opportunities. It's a trial that will explore UCN2 in 188 participants. These are participants with obesity with or without diabetes, and we will investigate UCN2 as monotherapy and in combination with incretin-based therapy.

We will, of course, evaluate safety, tolerability, PK, but also look at preliminary efficacy and here really focus on muscle volume, fat volume, muscle function endpoints and cardiorenal endpoints, which will help us to really fully unlock the potential of UCN2.

And with that, I would like to hand over to Trine Hamann, our Head of CRO.

Thank you for that, Thomas. I will be presenting Gubra CRO. Gubra was founded in 2008 as a preclinical CRO. And throughout the years, the CRO has laid a strong financial foundation for Gubra. We specialized preclinical CRO, primarily focused on metabolic and fibrotic diseases, where we work with 16 of top 20 pharmas and hundreds of smaller pharmas and biotech globally.

We combine our highly ranked translatable rodent models with advanced technologies, especially our models in MASH, obesity and kidney are best-in-class, and we are known for being able to handle high complexity and large studies. Besides launching women's health as a new disease area early in 2025, we also started working intensively on Sarcopenia, which is age-related loss of muscle. Here, we see a huge unmet medical need and an increasing age population. There are very few available animal models in this space, and we see high synergy with the metabolic space where we are already present.

Let me give an example of where we are world leading. We have, with our 3D imaging platform, built a highly automated whole organ platform with industry-leading throughput. We use custom design robotics and fully-automated light sheet microscopes where we can image up to 500 rodent organs per week. This is a scale that clearly differentiates us from traditional CROs that rely heavily on manual sampling handle.

For us, AI-driven analysis of large-scale image data sets is central to delivering clear and actionable results for the customers. For example, in obesity research, we visualize how the drug access the brain and activates the [ neural ] circuits controlling, for example, appetite. This enables direct comparison of compounds based on regional brain activity. This is highly scientific relevant and of high value to our customers.

So, this was a short introduction to the CRO, and I will now hand it over to Zoe, Head of Gubra Ventures.

Thank you, Trine. Let me briefly frame what we mean by Gubra Ventures, why we believe now it is the right moment and how this approach creates value for Gubra. First the what. A Venture for us is focused company creation around high potential science with a clear translational hypothesis. These are opportunities that sit naturally within Gubra's strengths that will benefit from being developed with their own strategic focus, governance and potentially external capital pathways.

Second, why now? Gubra's platforms and translational capabilities have reached a scale and maturity that allows us to pursue multiple parallel value creation paths. At the same time, external funding environment is increasingly rewarding focus, capital efficiency and clarity of strategy. We also at Gubra have a proven track record of working with trusted external partners, which makes this model practical and not just theoretical.

And finally, the how. Venture creation will allow earlier scientific derisking, sharper focus and greater strategic flexibility, all whilst preserving Gubra's core R&D engine. By placing the right assets in the right structures at the right time, we can support disciplined execution and create optionality downstream while remaining fully aligned with Gubra's strategic long-term priorities. So in short, Gubra Ventures is about focus, speed and thoughtful structuring using what Gubra already does very well to support sustainable value creation over time.

And with that, I'll hand over to Kristian. Thank you.

Thank you, Zoe. And let's turn to the financials, which is a very pleasant reading. So, in all aspects, it's been a strong result in the company's history, very high revenue of DKK 2.6 billion and a net profit of DKK 1.7 billion, of course, driven to some extent by -- or to a large extent by the AbbVie deal. I think the AbbVie deal is really important to emphasize. It's really a very good example of how we want to do it.

We develop novel peptides from our AI platform, take them into clinical proof of concept, then we out-license. So that is the footprint we want to do in other types of assets when we're going forward. So, I think this is a very good example in how we operate in our Biotech business.

We also, as you know, returned a significant amount to shareholders, DKK 1 billion in an extraordinary dividend. And still, despite that, we have a very strong liquidity position. So, a very, very good year in '25. And a strong outlook for '26. So, as we already talked about, we have 3 potential blockbuster obesity drugs in clinical development, and there's also a possibility to get some interesting readouts for at least 2 of them during '26. As Trine talked about, we have a very strong position in the CRO, and we had a good start to the year also here in '26. And with Ventures, we expect to launch our first venture in the second half of '26.

Looking into very briefly on the specific financials. Of course, Biotech business, a huge improvement in '25, driven by the upfront payment from the AbbVie deal and of course, also a significant improvement on earnings. Looking at the CRO business, we're down a bit compared to the record year '24. And the main delta has been the smaller biotech customers, especially in the U.S., where the funding environment for them has been a bit more challenging compared to recent years, so that's meaning longer decision cycles for placing orders with Gubra. We, nonetheless, have a pretty okay earnings still despite this decline, and we look to improve it in '26.

On the outlook, starting with the Biotech business, we'll spend a bit more in '26. That is primarily driven by the very ambitious and comprehensive clinical trial for UCM2 that plays on multiple indications. That is why we increased a bit compared to '25. CRO is a growth over and over for many years. In certain years, we could be slightly down. But in general, looking at the long-term picture, we want to grow it by 10%, and we expect to grow it by -- to 15% in '26 with a decent earnings.

With that, I hand over to Markus for some concluding remarks.

Thank you very much, Kristian. So, what are the things to watch out for Gubra 2026. I'd like to mention our UCM2 clinical development program. We expect to dose the first patient in the first half of the year, and we will disclose more details on the clinical trial design and the timing of the readouts in our R&D Day on June 30.

Moving ahead in terms of our discovery platform, we will invest in opportunities beyond obesity. So, we will add new flagship areas to our discovery and development focus areas. And also here, we will release more about our strategic plans in the middle of the year.

Our partnership model is a success model as shown by the deal with AbbVie. So we'll certainly aim to do more of these type of deals going forward. And pipeline expansion on the Biotech unit is, of course, a key value driver. So, it is very important for us to develop multiple assets in parallel so we can do more deals and we can bring more assets to clinical proof of concept.

So, we stop here and open up for questions.

[Operator Instructions] The next question comes from Thomas Bowers from SEB.

So, firstly, maybe if you could comment a little bit on the low end of your CRO revenue guidance growth range. So, I guess you have some positive impact from phasing from '25 with these new contracts signed in late '25. So, why should we think about you only getting to 5%? And also, can you maybe comment a little bit on the U.S. customer segment? Has that normalized? Or are you still seeing funding issues for, in particular, the smaller biotech customers?

And then a question on the margin outlook also for the CRO segment here. So, in 2025, you started above 25%, so 25% to 31%, if I remember correctly. So, what's the main driver for you now seeing 22% to 25% here in '26? Is that mainly because you're now entering new areas like sarcopenia? Or what's the main driver here?

And then lastly, just on Gubra Ventures. So, you can say, given the, I guess, Roivant like [indiscernible], so should we expect you to, in the medium -- near to medium term, sort of in-license new compounds? Or do you think you have plenty of internal noncore assets, you can maybe call them and for those seek external funding or capital?

Thank you very much for those great questions. First question goes to Trine, the profitability question goes to Kristian and then Zoe and I will talk about Ventures.

Thank you very much for the question, Thomas. So, the results in 2025 should really be seen in the light of, as Kristian said, 2 years of 30% consecutive growth. But we -- and we have seen headwinds in U.S., particularly in the Biotech segment. I will also say that markets have stabilized, and we do see improvement from 2025. So, we are cautiously optimistic about the clear signs of recovery.

There is still volatility in the market, I would say, but especially at the -- towards the end of 2025 and in 2026, capital has been flowing into the ecosystem. We see more IPOs, M&As and general activity also benefiting the biotechs.

So, my expectation would be that we, within the next, I would say, 3 to 4 to 5, 6 months, we'll see an uptick in the market and that we will benefit from that. We can already see that there are clear signs of recovery. Decision cycles still are relatively slow, but we remain positive that we will see increased activity, especially in the U.S. and also among biotechs in 2026.

And on the profitability, I think we invest to make a broader CRO, investing in women's health, investing in sarcopenia, still investing in some other areas. And that, of course, doesn't generate earnings immediately. So that's why you can say that we guide for 20% to 25% in EBIT margin, still a healthy EBIT margin, but it also is a function of investing in new areas, as you said.

Very good. I think Zoe.

Yes, happy to take the question, and thank you for referencing our shared history with Roivant. When it comes down to deciding what becomes a venture, it really comes down to strategic fit. So, whilst there may be opportunities in the Gubra pipeline, we are actively looking outside for opportunities. And as I mentioned, these will be opportunities that lie within Gubra's biological strength. So that could be peptide-based therapeutics in therapeutic areas outside of our core therapeutic area strength or alternative modalities that fit with our core translational capabilities in obesity and metabolism that maybe aren't peptides. So, more on that to come throughout the year.

We'll take the next question now.

The next question comes from Suzanne van Voorthuizen from Kempen.

This is Suzanne from Kempen. I have one for each business unit. Maybe first on the CRO and the growth guidance for the coming year. Timing-wise, how should we expect the growth over the course of the year? Is this more back-end loaded? Or should we already start to see a good growth from Q1?

Second one is on the Biotech side for UCN2, the Phase I is very elaborate. There are no time lines on data yet, but any color you can give on -- or give a sense of how long such a study would take? And I'm wondering if you need the full study enrolled and completed for data or if there's a possibility to release interim data?

And lastly, for the Ventures arm, as you build your portfolio, could you give some color on what that would look like, for example, could you describe the sort of phenotype that you think of currently for the typical Gubra Ventures assets?

Thank you very much, Suzanne. Trine will take the first question. I will take the question on UCN2 and then Zoe can answer the last question.

Yes. Thank you, Suzanne, for that question. As I explained just before, I think we do see a positive trend capital floating into the ecosystem. Q1 has been a solid start for us, but I do expect that Q2, we will be able to see the full effect of the positive trends and the stabilization in the market. Also, we do see positive signs in Europe, where we see increase -- an increase in venture funding and also EU has launched a huge venture program Biotech EU starting in '26, where we will hopefully also see an effect in the latter part of '26. So, from Q2, I really expect to see this uptick in sales.

In terms of the UCN2 trial, this trial is a very ambitious Phase I, Phase IIa trial. So it has multiple parts. And you are right to assume that there are multiple readouts in 2027 and 2028. So, we will disclose the design and our estimated time lines on June 30. Zoe?

Thanks, Markus. Yes, I think the question was what will we be looking for? What would be a typical phenotype of an asset for Gubra Ventures? Well, we would be looking for assets that have some strong preclinical validation so that we have a clear scientific hypothesis that is translatable into early clinical proof of concept. And that would really be to align with Gubra's core strengths. So that would be the kind of scope we'd be looking at late preclinical into early clinical. And then apart from that, I would say we're keeping this very disciplined. We're looking at assets on a case-by-case basis, and we don't have a one-size-fits-all model.

Good, we'll take the next question now.

The next question comes from [ Theodore Robedle ] from Goldman Sachs.

So, firstly, when should the market expect a data update from the Phase I MAD study for ABBV-295? And to what extent do you think that 295 should show differentiation versus eloralintide and versus other amylins, both in terms of weight loss efficacy and then in terms of safety and tolerability?

This question goes to Louise.

Yes. So, thank you for this question. So, with regards to data outlook from the MAD study, what AbbVie have communicated is that they expect to see data during this year, and that will guide the progression into Phase II, which they also expect to start here in '26. With regards to competitive position of 295, then again, it has been designed with a dual -- as a dual molecule targeting both the amylin and calcitonin receptors basically just like native amylin and it has a very, very long half-life. What we have seen in the interim data from the MAD study is that we can deliver substantial body weight reduction with a very nice tolerability profile. So, we see no reason as to why GUBamy or 295 should not perform equally well as to eloralintide.

[Operator Instructions]

Okay. Operator, are there any further questions to the call?

There are no more questions at this time. So, I hand the conference back to the speakers for any closing comments.

Okay. Thank you, everyone, for participating in a record year of '25 and a strong outlook for '26. We speak again at the next quarterly call. Thank you.

Markus. Let us first reflect on 2025, an astounding year for Gubra.

How would you sum up 2025 for us?

2025 was a defining year for Gubra. Record revenue of EUR 350 million, record operating profits of EUR 300 million.

A couple of things to highlight: Our landmark deal with AbbVie around Amylin. It validated our platform, but it also delivered the strongest financial performance in Gubra's history. Second, Boehringer Ingelheim decided to advance our triple agonist in obesity into further development. And thirdly, our partnerships with Camurus and Amylyx, which demonstrated the speed of our AI-driven, streaMLine platform, from idea to drug development candidate.

The CRO had fantastic business growth in the recent years, and we expect the CRO revenue to grow double digit in the coming years as well. Despite macroeconomic headwinds in 2025, our CRO remains a high-quality partner for our customers as well as our internal units.

How will Gubra drive growth from here on?

Starting this year, we will operate in three independent but synergistic business units. We do that to maximize value growth, but also agility in an increasing challenging macroeconomic environment.

Let me start with our latest business unit, the Gubra Ventures. The Ventures will incubate asset-centric, high-value opportunities beyond our own pipeline. Second, our key value driver, our biotech unit, where we discover and develop our own assets towards clinical milestones. And thirdly, our CRO, delivering high-quality research services for external customers, but also for our Ventures and for our biotech unit.

At the core of our business there is, of course, our commitment to the society. We do that partly by our ESG initiatives in all our three units, but also via Gubra Green, where we invest 10% of our pretax profits every year. For example, in 2025, we have built our own solar power plant. And by 2030, we expect to be carbon negative and electricity self-sufficient.

I would like to take a moment to zoom in on our pipeline. Is there anything in particular you would like to highlight from our pipeline?

In particular, I'd like to highlight our UCN2 mega program. It is our third obesity blockbuster going into the clinic, and we will initiate an ambitious Phase I/IIa clinical program in the first half of this year. The obesity market is changing. In the past, it was all about the big drop, how fast can you lose weight? But now it's all about quality. And UCN2 is the right product for this. It was designed to decrease fat mass and at the same time, maintain lean mass such as muscle.

What excites you the most about the year ahead?

Many things excite me at Gubra. It's our UCN2 mega program. It's about the company bringing the third blockbuster into the clinic. It's about our ambition to become a top biotech company in Europe, and it's about our people. The Gubbies, they make everything happen, right? They deliver our key initiatives and they are essentially our secret sauce behind everything. Our people, the Gubbies, are the magic behind Gubra.

Thank you for standing by. My name is Karen, and I will be your conference operator today. At this time, I would like to welcome everyone to the Gubra Quarter 3 2025 Earnings Release. [Operator Instructions]

I will now turn the call over to Markus Rohrwild, CEO. Please go ahead.

Good morning, everybody. Also welcome from my side. My name is Markus Rohrwild, I'm the CEO of Gubra. I'm joined here by Louise, our CFO; and our CFO, Kristian. So we will start with our presentation. I will give a general overview, followed by Louise and then the financial results by Kristian before I wrap up.

As you know, at the core of our strategy, we have a dual business model. We have our discovery and partnerships, our key value driver and our sales services, which are strong enabler for our internal pipeline as well as our partnering. Our CO business has had the market growth over the long run. We had 30% growth year-on-year, and we delivered great data and service to 16 out of top 20 customers who [indiscernible] area. Our primary focus in [indiscernible] demonstrated environment our business model.

Now let's look at the first 9 months, and I think this tough fix for itself office so the or also on the revenue side of [indiscernible] margin side, [indiscernible] fund of sales extraordinary sale, which has a significant utility. In terms of highlights of 2025, of course, our [indiscernible] has demonstrated a fantastic [indiscernible] in the results, and we look forward for instance, asset to begin in the first half of 2026. This program is developed [indiscernible] high-quality vehicle and we will hear more about this from [ BBC ]. I mentioned the [indiscernible] us, and we have also had an extra [indiscernible] dividend of [ DKK 1 billion ] retail. [indiscernible] has shown great results in [indiscernible] 5 now. And stage 1 will stay very good. We also have a good [indiscernible], which is -- so we strongly believe in the [ EBITDA ].

Our CO business has seen a slight decline driven by macroeconomic uncertainties because led to some delays in decision making on our customers [indiscernible] like at the end of the [indiscernible]. And of course, also now from our [indiscernible] company in September this year, and we like to see in the company full potential.

I'm handing over to Louise.

Yes. So thank you. So let's take a look at internal discovery pipeline. At Gubra, [indiscernible] with a partner. For our work is [indiscernible] in-house developed drug discovery platform streamline. Using this platform, we could develop a set target into a [indiscernible] as successive development candidates. The platform takes advances of AI [indiscernible] combined with the good relet screening as notable peptide lasers, thousands of data. He use multiparameter optimization, which this time and enables the identification of the monies part.

So what you see here is an overview of the Gubra [indiscernible] pipeline. This growing pipeline is at the best [indiscernible] of the power and efficiency of a streamline discovery platform and an extensive [indiscernible]. We represent the internal equipment [indiscernible] partner. Unless the launch is using to equipment to high [indiscernible]. We are advancing the diversified portfolio, up early stepped concern a strong growth for future opportunities. [indiscernible] reflecting successful collaborations with leading in discrete players. Key highlights is the top line of our Phase I and footprint is the biggest out licensing fee [indiscernible] for so far. This underscores both design to explain and [indiscernible] pipeline.

[indiscernible]. We have been dedicated to understanding conceding the [indiscernible] misconception of the company. So [indiscernible] expertise in this field for early discovery to several to clinical cases. And today, [indiscernible] 2 of the most advanced [indiscernible] to current standard of care. But let's go line into the data. Let's take a moment and look on the quarter [indiscernible] and what's the next generation [indiscernible] will likely focus on. So it's no secret that [indiscernible] continues to be a growing [indiscernible] opportunity. And [indiscernible] is has substantial below, we need more stores in the [indiscernible] if we want to take our patients [indiscernible]. In addition, this will acknowledge the [indiscernible] accounts its 20% to 40% of the [indiscernible]. There will be a plan shift in the next generation of seed with a focus on quality, [indiscernible].

In other words, we still aim to maximize that mess while serving our [indiscernible]. But this is the next generation of obesity assets to a different to improved solubility profile and [indiscernible] related to mobility. Gubra's pipeline. [indiscernible] is persistent to make this [indiscernible] we have announced active family analog ABBV-295, now outlicensed to [indiscernible]. [indiscernible] is the development for wealth management indication -- how could be persistent book has an alternative or add to interties business. [indiscernible] the results from. So a [indiscernible], it's well [ celebrated ] [indiscernible] of almost 8% in the 2-milligram compared with a 2% we gain in the placebo. After just 6 weeks of treatment. So these signs supports analyst successes to deliver 2 meaningful weight loss to have improved probability profile.

So next in line is the internal obesity program focused on high quality [indiscernible]. This program goes in a new mechanism. [indiscernible] in designed to deliver a set and more sustainable [ Fotios ] program. We have designed a selected new [ CMT ] analog with a target profile of [indiscernible]. You as content the emerging model for this patient, [indiscernible] be competition, increasing much on less, reducing flatness but also operating key obesity related to mobilities such as cardiovascular and kidney diseases. Today, pursuing on the [indiscernible].

Starting with muscle from this study in very good and that prudent extended period of time. We will see that [indiscernible] has a neutral effect on body weight. When it [indiscernible] mass and decreasing [ blackness ]. We can also appreciate the other [indiscernible] such as [indiscernible] and sadness. So when combined with semaglutide treatment. You can see that CMT really prevents the lean mass breakeven increases. [indiscernible] its, resin into macro type pre-feeded beat and CMT firmer completely restore the new mass and content that massive reduction. [indiscernible] business. So we're looking at data biomarker at the end of the study, we saw no retilevels were in line with the reduction in [indiscernible]. We also observed a decrease in plasma for [indiscernible]. This is a [indiscernible] reflecting less fat circulating in the blood stream with no changes in cholesterol. So collectively, this shows the epitope to deliver all beneficial metrified profile.

Looking [indiscernible] we advanced 3D imaging platform, best and live resin microscopy. This technology provides using wanted to attain volume of individual muscles in the [indiscernible]. You've seen this approach. We exit the [indiscernible] increases total loss volume in the highly octane [indiscernible]. Both of monotherapy were important also in combination with [indiscernible]. This indicates that we then tie analyzed muscle tissue. [indiscernible] CMC has concisely is shown to improve project [indiscernible]. Here, we expect these filings using a nonactive [indiscernible] to analog in a rat model of clinic heart failure. In this model, [indiscernible] has increased by permanent placation has the left interior [indiscernible]. This creates impact in the left [indiscernible]. So operating and please control assembly.

1 month after in my induction, once the state impairment is fully established and tie bidding in black. We achieved lower [indiscernible] standard of care combination as soon [indiscernible]. Animals succeeded for [indiscernible], which shows the marked reduction in private [indiscernible] to the animals versus [indiscernible]. In this setting, we [indiscernible] a significantly improved product demonstrating its ability to also improve by a function. [indiscernible] preclinical finance because new CMC has a differentiated by high-quality [indiscernible] with improvements in key obesity [indiscernible]. So we're now [indiscernible] and we expect to start the clinical study in the first half of next year.

So now, Kristian, over to you for an update on the financial results.

Thank you, Louise. And as we said in the beginning, the first 9 months has been nothing but fantastic for Gubra. And we had a revenue in the discovering partnership business of above DKK 2 billion, of course, affected by the AbbVie deal and the upfront payment there. We're also increasing our cost as fully as expected as we drive a number of projects for in parallel, of course, the amylin and [indiscernible] in particular, over and above an extremely strong results for Gubra the first 9 months of this year.

That was the results for the D&P unit. Looking at our CRO business, we have a very strong position in metabolic and fibrotic diseases. And in '25 in particular, we have been building out the women's health area, which is a growing area of importance for Gubra that we will speak more about in the future. We, of course, have our established area, obesity, kidney, mesh and so on. But definitely, women's health is an area that we spend more and more money to build up. And as I said, we will speak more about this in the future. As we also spoke about, we have wide variety of customers from the smaller buying customers to the very large big pharma customers. And we cater to 15 out of the top 20 big pharma customers. I will comment shortly what we're seeing in the first 9 months in the market dynamics, and I'll take that on the next.

So again, coming back to comments earlier. We had an extremely high growth rate for the last couple of years. And in '23 and '24, we grew this -- the [indiscernible] service business by 30% organic growth in both years higher than our overall ambition to grow 10% annually. This year, we've seen a slight decline with down 5% in the first 9 months compared to the same period last year, primarily as we face some macroeconomic headwinds affecting the conditions for our small biotech companies, where they are taking longer time to place new studies. When we look out, we see some signs of improvement, and the funding conditions seems to have improved a bit [indiscernible] company. So we sense a bit of optimism when we're looking at 3 quarters ahead.

Looking at the costs. As I said, we're building up the women's health area, and this is something that we can establish a good decision within. When revenue goes down a bit, it, of course, affects our margins and be hovering around the 20% EBIT margin for the first 9 months. Talking about the outlook for the full year '25. We did a minor revision. And we said that previously, there will be slightly below and we lever in '24 for the CRO segment, and I would say we've [indiscernible] 10% below for the full year margins unchanged and also the function expectations to the cost in our discovery and partnership segment. So overall, again, reiterating a fantastic 9 months for Gubra and record results by all measures.

I will hand over to Markus now for concluding remarks.

Very good. So what should you watch for? I think Gubra is preparing for the next wave of growth to the expansion of our pipeline and increased [indiscernible] efforts. So certainly, [indiscernible] moving into the clinic is for us, I think, the driver, and we are confident that we are on the runner [indiscernible] difference in, say, the gross market. Also, in terms of strategic areas and [indiscernible] where we already have a very, very good stronghold. So we're looking into this right now and there will be more [indiscernible]. To deal is [indiscernible] a good deal for us that, of course, we want to expand our partnership building on the apartment listing and we will still focus on being peptide innovation house and on the edge on designing needs that we [indiscernible].

Now over on the innovation side, of course, also for our CRO, it's extremely important that the brand and the cutting edge of innovation technology. And since it will be very important in support of our [indiscernible] as well as our [indiscernible]. This also our strategic growth levers and [indiscernible] here, and we can now go to Q&A segment.

So operator, we are ready to take questions, please.

[Operator Instructions] The first question comes from Thomas Bowers from SEB.

The next question comes from [indiscernible] from Goldman Sachs.

So firstly, please, could you provide your perspective on the [indiscernible] data from Lilly yesterday? What are the implications do you think for GUBamy? And do you think it can show similar efficacy? And then secondly, what are your expectations for the non weight-lowering benefits for GUBamy and the amylin class? In particular, do you think there's potential for cardiovascular benefit, for example?

Thank you very much for those excellent questions. I'll this question to Louise.

Definitely. So thank you this question. So just on a general notice we usually refrain from commenting directly on clinical data from other companies, but from the -- for the overall amylin plus the data looks promising. We see a huge potential in the class of amylin to deliver clinically relevant weight loss, well in line with the recent published data.

So for the second question regarding did you talk about the cardiovascular benefits or what was it related to?

So just what your expectations are in terms of any non-weight lowering benefits, so cardiovascular would be kind of the first example of that. But in terms of any other impacts you expect from the Amylin class?

6 Yes. So one, expectation is that, of course, we will need to see the true value in the clinical studies, the [indiscernible] clinical studies, but on a general notice losing weight usually translate into an overall improved beneficial metabolic profile also on the cardiovascular side.

The next question comes from [ Rami O'Connor ] from Van Lanschot Kampen.

I have 2, if I may. The first, I was wondering how you expect the areas of NASH and kidney to develop. Is obesity still remain a contributor? Or is your focus on NASH is being made towards the [indiscernible]? And the second, with [indiscernible] are you able to provide some color on anything related to trial design, [Technical Difficulty]? And will you also be exploring cardiac as you're seeing those benefits in a cost savings?

Yes. So definitely. So regarding biggest continues to the CRO revenue then obesity continues to be a key driver for the revenue for the Gubra, of course, we also see a result from [indiscernible] and kidney, but we are constantly expanding on our service option. So as Kristian also alluded to, we are establishing a women's health as a new important area for us to make sure that we'll be more competitive with pipeline of services in the CRO business.

Regarding -- and I lost you a little on the line there on the second question, but I believe you were talking to the trial design for the UCN2 program? So from that perspective, we haven't disclosed much yet on the clinical performance, but of course, we want to explore as many options as possible with such an asset. But usually, the Phase I clinical studies, they are designed to explore safety and [indiscernible].

Yes. I think we can talk more in one of the next calls.

[Operator Instructions] The next question comes from Thomas Bowers from SEB.

So actually, I'm sorry if I'm repeating one question because I sort of missed a few minutes. But I just wanted to ask, first of all, on the CRO business. So in regards to U.S. customers, so with the current order book, would you consider that to be within the normal range to secure that 10% year-over-year growth? Or is there still some catching up to do here in the U.S.?

And then in regards to '26, I know, of course, you're not guiding yet, but should we expect some sort of a catch-up effect from those CRO clients in the U.S. coming back now? So is the order book is going to be a little bit bigger for '26? Or are you still going to stick to your to your 10% limit in order to prioritize D&P? And then I think there was a question also on [indiscernible], but I'll just ask in regards to the whole concept here on selectivity to the eminent receptor, is there anything that makes you think differently now in regards to targeting -- or being more sort of nonselective so both targeting [indiscernible] and amylin or is this still something that is up for grabs, so to say? So any comments here would be appreciated.

Thank you very much. First question goes to Kristian, and Louise will comment on the second.

Yes. So when we talk about the funding climate for biotech customers, I think we have a sense that, that is improving a bit and that impacts the order intake for our CRO business. We have an overall ambition to grow our CRO business by around 10% every year, and we overshoot at this several times during the last couple of years. And in certain years, there are some headwinds as we had this year but again coming up from a very high level in '24.

So I think we see a slight improvement to the -- to help smaller customers see their ability to finance new preclinical studies. Then we'll see when we come back with the annual report how we guide for next year. It is just to provide you a little bit of insight into the biotech customers, which is 1 segment in our CRO business. So we see a slight improvement there and we hope that will continue going into '26.

Yes. So thank you for the second question. It is an ongoing discussion in the field of the amylin biology. To remind you, ABBV-295 as a balanced profile on the amylin [indiscernible] just like net, amylin, we saw a very large result from the MAD study with an almost 10% weight loss delivered by [indiscernible] we see huge pretension in this asset. So no, we haven't changed our perspective on this.

Since there's no one left in the Q&A queue, I will now turn the call over to Gubra management for written questions.

Okay. I can see there are no written questions either. So, Markus?

Well runoff. Thank you very much for your time today. I really appreciate your interest and questions about Gubra, and I look forward to our next call next time. Thank you.

Markus.

After your first few months as CEO at Gubra, can you share some of your reflections and ambitions for the company?

Over the past few months, I've come to appreciate how unique Gubra really is, great Science, strong execution and a financial foundation, which is really solid. Something you rarely see in biotech. At the core of our strategy, there is a dual business model. On the one side, the Biotech unit, our core value driver; and on the other side, our CRO, a powerful enabler, which is setting us apart. Looking ahead, we will expand our pipeline and explore new high-value therapeutic areas also beyond obesity and metabolics and strengthen our technology and preclinical entities to support this growth.

My ambition for the company is clear. We will advance multiple programs into the clinic and expand our partnerships also with the blueprint we have from our recent deal with AbbVie on Amylin. We will further strengthen our leading position as a peptide-centric, disease-agnostic techbio company.

On the biotech business and the internal R&D pipeline, is there a particular asset you would like to highlight?

Yes. UCN2 is our next major project. It's a selective, a long-acting urocortin-2 analog designed for what we call healthy weight loss, reducing fat and at the same time, maintain or even increase lean muscle mass. In preclinical studies, UCN2 has shown impressive results. It prevents lean mass loss typically seen in GLP-1 treated patients. It also improves cardiorenal markers. So it's a great candidate for a potential combination therapy.

In the third quarter, we also confirmed that UCN2 can promote muscle growth using our advanced 3D imaging technology. So as the next step, we will enter first-in-human trials with UCN2, and we remain firmly on track to do that in the first half of 2026.

How did the business perform in Q3? And what's the outlook for the CRO?

Our CRO had enjoyed remarkable long-term growth, over 70% since 2022. In the first 9 months of this year, we have seen a small decline, about 5% compared to the same period last year. That's driven by the market environment, macroeconomic trends, less biotech funding. It's just creating longer decision cycles at our customers.

Having said this, we will continue to drive best-in-class quality and speed, stay close to our customers and let our CRO be a key enabler for our biotech and partnering strategy.

Do you have any final thoughts you would like to share with us today on Gubra's performance and outlook?

I'd like to emphasize the great value potential across our businesses and also, of course, the record year-end results we will deliver as a group in 2025. Over the first 9 months, we have delivered earnings of more than EUR 270 million, driven by an exceptional deal with AbbVie where we licensed our Amylin.

Looking ahead, I think Gubra is well positioned for the next wave of growth. I'm very excited to work with my great and passionate team to unlock the full potential of the company.