Gubra A/S Aktie

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.

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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.

Thank you for standing by. My name is Kate, and I will be your conference operator today. At this time, I would like to welcome everyone to the Gubra Q2 2025 Earnings Release. [Operator Instructions]

I would now like to turn the call over to Henrik Blou, CEO. Please go ahead.

Thank you very much. It's a pleasure for us to present the highlights from 2025 to you today. So with me here, I have Louise Dalboge, our Gubra's CSO; and Kristian Borbos, Gubra's CFO.

At Gubra, we are experts in metabolic diseases and other diseases related to the human metabolism. We have a hybrid business model, where the core research engine that we have built, we use it to sell research services as a CRO and also to advance our own internal pipeline programs towards a Discovery & Partnerships. And we have a long history of growth.

Today, we are approximately 275 colleagues here at Gubra. And in the service business, we are servicing 16 out of top 20 pharma companies in the world. So we have a very strong reputation within our niche.

And the growth history is represented here. The blue part is the revenue stream from the service business. The pink part is revenue stream from the Discovery & Partnerships. So as you can see, these two arms of the business are providing revenue in different ways in the CRO service business, it's quite steady business, whereas in Discovery & Partnerships, it's more lumpy. And that is associated with the nature of deals that upfront and milestone payments come in as a more lumpy fashion than revenue from the CRO service.

And again, as you can see here, a long history of growth. These figures goes until 2024. But if we include just the first half of 2025, it shows the order of magnitude of the revenue associated with the recent deal that was made on the Amylin program, the partnership with AbbVie. So it really puts things into perspective and that also shows that the first half of this year has been by far the most successful half year in the history of Gubra, when it comes to revenue.

Key operational highlights. We were able to pay out a dividend of DKK 1 billion earlier this year, and that was a direct consequence of the agreement that was made on the Amylin program, a deal worth USD 2.2 billion deal, including an upfront of $350 million. And on top of all this, there are royalties. So a strong signal and something that we think shows the strength of the business model that we are able to channel back serious amounts of dividend to our shareholders.

Also earlier this year, we presented very strong data. We believe in the GUBamy program, our Amylin program. It was from the MAD part of the Phase I study. It confirmed what we've seen previously in the SAD part, that the compound is well tolerated, a very long half-life, and we're also able to give a significant weight reduction.

Our next in-line pipeline program, the UCN2 program for high-quality weight loss, healthy weight loss in this program is focused around showing prevention and restoration of loss lean body mass. And on top of that, there are other benefits. And we are preparing UCN2 for the program for start clinic in early 2026. Today, we have some more details on that program for you.

In the CRO business, we have seen a slight decline in revenue versus the first half of 2024. We actually saw a growth in quarter 2 of 12% compared to quarter 2 last year. However, for the full half year, there's a slight decline, and that also led to recent change in our outlook for the full year for the, again, isolated CRO revenue. It's driven by some uncertainty in the important American market, where we still see a solid customer demand in the European market.

And another recent news from Gubra is that, we've been through a planned succession process. I will step down as CEO of Gubra. And from September 8, it will be Markus Rohrwild taking over.

Diving in on the Discovery & Partnerships, the D&P part of Gubra. All our internal programs are based on peptides, and we have a platform, the streaMLine platform, that we use to develop peptides for our internal programs. Using this platform, we are able to generate development candidates in a fast way. And in parallel, we can optimize for a range of important parameters when developing peptides as novel drugs. So a strong platform and using this, we have been able to build a significant pipeline over the years.

And that is represented on this slide. The green ones are pipeline programs that are not yet partnered. So you can see the most advanced UCN2 program. Today, Louise will share some interesting data with you on muscle and also on cardiac.

So again, a range of other programs here that are not partnered yet and also a range of already partnered programs. We have four ongoing collaborations with Boehringer Ingelheim. We have an ongoing collaboration with Amylyx, one with Hemab. And as previously mentioned, the new addition that collaboration with AbbVie on the Amylin program.

So that was a quick run through. And now I'll pass over the word to you, Louise.

Thank you. So now let's dive into some of these programs, starting with the long-acting Amylin analogue, formerly known as islet-pam. And GUBamy is in development for weight management indication and could be positioned as both an alternative or an addition to incretin-based treatments.

The key differentiating features of GUBamy has a balanced receptor profile, an Amylin and Calcitonin receptors, just like native Amylin. It has an exceptionally long half-life of 11 days. And GUBamy has been designed to be physical and chemical stable at neutral pH. This allows co-formulation with other anti-obesity agents.

GUBamy is currently being tested in a Phase I multiple ascending dose study. From Part A, we announced strong interim clinical results in April. This part of the study consisted of two cohorts receiving once weekly treatment for 6 weeks of 1 or 2 milligram of GUBamy.

The data confirmed the general picture from the SAD study with a high degree of consistency within cohorts. The study showed that GUBamy was well tolerated, adverse events being predominantly GI-related and mild, and consistent with data from the SAD study.

GUBamy demonstrated a remarkable dose-dependent weight loss. Mean weight loss in the 2-milligram cohort was almost 8% compared to a mean weight gain of 2% in the placebo arm on day 43. The study also confirmed the long and favorable half-life of 11 days.

So the second part of the study for testing higher doses during a longer treatment period is ongoing and progressing as planned. And we are delighted to see AbbVie expanding development options in this study. So overall, we are excited about the positive results, which further support development of GUBamy for weight management indication.

So beyond Amylin, we're equally excited about a next-in-line internal obesity program focused on high-quality weight loss. This program built in a new mechanism, a long-acting UCN2 analogue designed to deliver a healthier, more sustainable weight loss outcome.

This focus is critical, because the current weight loss strategies, lean mass typically accounts for 20% to 40% of the total weight loss. We believe time has come now to focus on the quality of the weight loss and not just the quantity as a key differentiating factor for the next generation of obesity treatments.

We have designed a selective UCN2 analogue with a target profile of once weekly dosing in humans. UCN2 has potential to treat the multi-morbid obese patients by improving body composition, increasing lean muscle mass, reducing fat mass, while also addressing key obesity-related co-morbidities such as cardiovascular and kidney diseases as well as improving blood glucose.

And today, we'll zoom in on the beneficial effects of UCN2 on muscle and cardiac function.

Starting with muscle. As shown before in diet-induced obese rats. UCN2 improves body composition by increasing lean mass and reducing fat mass as shown on the graphs here in green. You can also appreciate that well-known agents such as semaglutide and cagrilintide lowers both lean and fat mass. So what is really exciting here is when we combine UCN2 with weight lowering agents such as semaglutide, we can completely prevent the lean mass loss typically caused by such treatments and drive the fat mass loss even further.

So again, the ability of UCN2 to improve body composition is evident in this new study. This is illustrated by a neutral effect on body weight, an increase in lean mass and a reduction in fat mass.

So looking at individual muscles, here looking at three different types, UCN2 increases muscle weight as shown on the top graphs. You can also see that UCN2 reduces the unwanted atopic fat distribution in muscle tissue.

In addition, it shows -- as shown on this slide, it lowers blood glucose and plasma triglycerides with no effect on cholesterol. So overall, this highlights the potential of UCN2 to deliver an overall beneficial metabolic profile.

In the scientific literature, UCN2 has consistently been shown to improve cardiac function. Here, we extend these findings using a long-acting UCN2 analogue in a rat model of chronic heart failure.

In this model, chronic myocardial infarction is induced by permanent ligation of the left anterior descending artery. This creates an impact in the left ventricular wall.

Sham-operated animals serve as a healthy control as shown here in gray on the graph to the right. One month after MI induction, when systemic impairment is well established, animals are treated with vehicle as shown in black, lower high-dose UCN2 as shown in green, or triple standard-of-care combination as shown in purple.

Animals are treated for 8 weeks. Cardiac function is then assessed using echocardiography, which shows a marked reduction in ejection fraction and cardiac output in vehicle treated animals versus healthy sham controls.

In this setting, the long-acting UCN2 analogue significantly improves ejection fraction and cardiac output, highlighting its ability to also improve cardiac function.

So these compelling preclinical findings support UCN2 as a differentiated asset, combining high-quality weight loss with improvement in key obesity-related co-morbidities. Building on this strong foundation, we are now preparing UCN2 for clinical development. Primary objective is, of course, as always, safety and PK, and we expect to start the Phase I study early next year.

Thank you very much. Please then turn to a brief overview of the financials, starting with the Discovery & Partnerships business. And as Henrik said, the first half, including the second quarter has been phenomenal for Gubra. We received this upfront payment, which is very, very significant.

So looking at the revenue from this business unit, we had DKK 2.4 billion compared to revenue of DKK 13 million the same period last year. So a very, very significant amount of revenue and earnings from this business unit.

So -- and total cost roughly in line with what we expect, and I will come back to the outlook shortly, which is unchanged for the total adjusted cost we guide for this business segment. So overall, an enormous improvement compared to last year.

Turning to the CRO business, just reminding what the business is. We are a highly specialized preclinical service provider. We cater to both small biotechs and the largest pharma companies in the world. And we serve 16 out of the top 20 pharma companies in the world in our highly ranked translatable animal models.

I think the most important change here compared to what we've spoken about earlier is adding women's health to our service area. So this is a highly unserved area where we think we can play an important role in assisting our clients in developing compounds in this area. So you will hear more from this as we progress, a very interesting area and a new flagship area for Gubra.

Taking the CRO business. And as Henrik said in the beginning, we had an improvement in the second quarter compared to the second quarter last year. But if we look at the first half in total, there's a small decline of 2% compared to the revenue in the same -- in the first half last year.

So what we've seen in '25 is the U.S. market becoming a bit challenging. There's a lot of macroeconomic uncertainty in that region of the world, and we can also see funding opportunities for smaller biotechs, for example, not being as beneficial as it was last year. That includes both ordinary funding and grants to these type of companies. And that impacts their decision time lines for ordering studies at Gubra.

I will come back to the outlook in a second. On the contrary, Europe is progressing well. We have some development there and especially the obesity space where we see strong growth.

On the earnings side, whenever we have a slowdown in revenue, we also see that influencing our earnings. While they were up quarter-to-quarter compared to last year, we see a decline compared to the first half last year. So we have an EBIT margin of 25% in the second quarter, just in the lower end of our guidance we have provided earlier.

We now take the outlook as a concluding comment. We -- yesterday, we were out flagging that we expect the revenue for our CRO business to be slightly below last year. And remember, last year was a record year. We've grown our CRO business massively during both '23 and '24 and really, really successful. And we expect to be just slightly below the level in '24. So a downward revision from a very high level in '24.

And in the same manner, we also reduced our EBIT margin to around 20% compared to the previous assumption of 25% to 31%. Rounding off with the -- we're just reiterating the guidance for the D&P total adjusted cost of DKK 230 million to DKK 250 million that is unchanged.

With that, we have concluded our presentation. And now operator, we open up for questions.

[Operator Instructions] Your first question comes from the line of Thomas Bowers with SEB.

A couple of questions from my table here. So first, diving a little bit into the CRO business. So I guess a recovery in Q2 was sort of expected from U.S. clients and did not materialize and the reasons for the guidance update here. So firstly, do you have any good understanding on the remainder of 2025, now only 4 months remaining of the year? So is there anything that can sort of have much deviation from where you are with the current outlook you have?

And then second question, just on -- so you limited the number of orders going into 2025 to prioritize Discovery & Partnerships segment. Is it fair to assume that you, in principle, could have enough ex-U.S. European customers to secure 10% to 20% growth just in case the U.S. problem or whatever you call it, it persists into next year, 2026?

And then thirdly, just to confirm, is this issue in the CO business, is it primarily lack of investor funding to small cap biotech companies? Or is this primarily biotechs missing out on U.S. government grants? I'm just trying to figure out here whether there will -- could potentially be a risk to companies outside the U.S. also with maybe a little bit less access to capital, making it a little bit difficult for them, maybe eventually to fund studies as well?

And then just lastly, on the EBIT margin guidance. So -- so is there any difference in profit margins between U.S. and European customers? Because I guess, of course, this mostly reflect internal fixed costs, but you also delivered above 30% last year with close to similar revenue levels. So is there anything that I need to understand here?

And then just a final one here, just on the pipeline. Are you able to give us any sort of time lines, indications on when we can expect next data update for GUBamy? So anything possible at obesity weeks on updates on the MAD cohorts? And also, I'm not sure whether you are allowed to give any indication on time lines from your partner on potentially the Phase II start at this point in time, assuming, of course, the MAD progresses as planned. I think I'll stop there.

Thank you very much. And we'll start from one end and then just to remind us if there are stuff that we are not addressing. So starting from the back with regards to the GUBamy program, it is being transferred to AbbVie and they are controlling the development going forward. So we are very delighted to see AbbVie expanding development options in the ongoing study. And I really think it shows the strength of having a player such as AbbVie on board.

For specific information regarding time line and data, you would have to go to AbbVie. So zooming in, I guess, Kristian, you will be talking to the EBIT stuff and around. So that one, I won't take.

So if we're talking to the market conditions currently. So the way we experience it is that it is isolated to U.S. customers. And what we see from our end is that there are prolonged decision time lines for these companies. And it appears that they are considering well before they invest a dollar more than they did previously and perhaps also have to prioritize between various pipeline programs, at least not pushing as hard on the programs they have, not exploring as much in preclinical studies. So this is giving these prolonged time lines. And it's probably a combination of several factors in the U.S. market.

And I think there's an interplay of the funding situation, the grant situation and perhaps also other factors. And therefore, it's -- we've seen now for some time this year. And again, that's also the background for the update to the outlook that we gave recently.

Looking forward, we expect things to normalize, and it's difficult to say exactly when. But we've been in the service business, CRO business for many years. We have seen in previous years, a sudden slowdown. And so far, we've always seen some kind of normalization after a while. We still have our midterm guidance for growth. We definitely expect that. And as mentioned, we see good development in other markets such as Europe and Asia, which is currently a small market for us.

So it's not like we could just fill up with requests from European customers or Asian customers. If that was the case, we would do that. It requires work, marketing and so on to build that further. But that is, of course, some of the initiatives we are doing right now. We are focusing on developing the U.S. market, but also the markets that seems to be a little more well functioning these days.

Kristian?

Yes. And if I would continue on the EBIT margin question, and that's a fair comment, Thomas. And one of the reasons that we lowered the EBIT margin is also we are building up new areas and not least the women's health. And that means adding competent colleagues and setting up models and preparing for selling these studies.

So that we hope, of course, in coming quarters that will add revenue to our zero business. But we're building up the organization planning for success and not least the buildup of the area women's health. So that's probably one -- probably the main explanation why we see a slightly lower EBIT margin compared to what we saw last year with roughly the same amount of revenue.

Your next question comes from the line of Rajan Sharma with Goldman Sachs.

A couple on the pipeline. So just thinking ahead to the Phase I for the UCN2 asset, could you just kind of walk us through how you're thinking about trial design there? Are you expecting to include DEXA scan or MRI in that trial to monitor body composition? And would you use more than one GLP-1 partner?

And then secondly, just on Amylin, it would be great to get your perspectives on Eli Lilly's elorlintide Phase I data, which were presented at ADA in June. I think there's an emerging view amongst investors that elorlintide set a bar for amylin now. So it would be interesting to understand, having seen the data, how confident you are in GUBamy's differentiation, and is there anything in particular that you'll be monitoring for in the Phase II data when that's available?

And then just one on the CRO business. Could you just comment on the underlying trends amongst your large pharma customers in the U.S.? I presume they're insulated against some of the macro factors that you talked to that's impacting the smaller companies. But it would be helpful to understand if demand is still resilient amongst the large pharmas. And to what extent is the exchange rate a headwind in the U.S.?

Yes. So definitely. So starting with the pipeline questions regarding the UCN2 program. So we have not revealed much on our thoughts here on the clinical program. The ambition is to initiate the study early next year, and we're going for high-quality weight loss.

And as I said before, the study will be a typical study looking at the safety and PK, but we will, of course, reveal more in time. So, maybe moving on to amylin and the elorlintide data. So in general, I would say that we refrain from commenting directly on the data from other companies. But I would say that for the broader class of amylin, the data appears strong.

It appears that amylin can deliver clinically relevant weight loss and can be used as a standalone treatment as well as in combination with other incretins.

GUBamy, by itself, has a differentiated profile. So we have a balanced receptor profile on the amylin and calcitonin receptors. Just like, as we said, amylin, we have a long half-life, which definitely also give us some advantages. Again, it's important to be careful when comparing early clinical trials. So we see huge potential in GUBamy.

Sorry. And I can follow up on the CRO part of the question. So if we see a trend in large U.S. clients and their behavior, that is -- there's not a real trend, I would say. It's -- the large pharma segment generally seems to be progressing with what they're doing. There will always be fluctuations, but I think that it's not like we see any kind of strong trend there. It's what you see is mostly related to other client segments such as academia and biotech.

Our next question comes from the line of [ Christine Fernandez with BLK. ]

Apologies if it was already addressed on the call. There is an echo on the line. So on the CRO business, could you elaborate on the decline seen in NASH and kidney? Are you seeing a trend here? And also, how conservative are you on your revised guidance? Could there still be growth happening later this year?

And then secondly, on the triple agonist partnered with BI, any color on what to expect, what level of detail? And is it still expected for the second half of this year?

Yes. So definitely. So the triple agonist program, the Phase I is currently ongoing. And what we have said before is that we expect it to end by or to be completed by the end of the year. But again, it's up to Boehringer Ingelheim to give specific details from the study.

Kristian, you can comment on the other part.

On the kidney part?

Yes.

Yes. I mean, we've -- the clear -- the strongest disease category is the obesity where we see -- on the other hand, we see a slight decline in the two other large areas in Gubra being the MASH space and the kidney space. And again, as Henrik said, it's primarily from the U.S. market and the smaller biotechs and academia. So again, we've seen these fluctuations over the years sometimes. And we think it will normalize once there are more come macroeconomic support.

Yes. And I can follow up here. I think, there's a bit of a coincidence where a lot of kidney activities has been related to U.S. biotechs and therefore, that category is showing a reaction. So for MASH, it's interesting to see what's going to happen with recent approval in that space.

Previously, we've seen stuff like that triggering the new interest, but again, it's too early to say. For the guidance, it's definitely based on the information we have now, order book and so on, where we now guide on slightly below last year. And that is definitely based on the information available to us, that is definitely where we see this year going.

Coming in, was that a question or just...

We don't have any questions from the live questions and also on the webcast.

Okay. Thank you very much. I will actually hand over to the word to Henrik, just to say a very, very friendly comment.

Exactly. So as mentioned, next time, it will be Markus Rohrwild giving you the update. And it's been an immense pleasure for you over the last decade to be part of Gubra journey. And really, we are at a fantastic place. And I am -- it's a very nice feeling to hand over now to Markus and in the future following it from the outside. And also thank you to you for following the Gubra journey so far.

Ladies and gentlemen, that concludes today's call. You may now disconnect. Thank you, and have a great day.