Gubra A S

Welcome to the conference call. For the first part of the conference call, the participants will be in listen-only mode. During the questions and answers session, participants are able to ask questions by dialing pound key five on their telephone keypad. Now I will hand the conference over to the speakers. Please go ahead.

Good morning. Welcome to the Huber investor presentation. My name is Markus Rohrwild, I am the CEO of Gubra. I'm joined here by our chief financial officer, Christian, our chief scientific officer, Luise, our chief medical and development officer, Thomas, the head of Gubra Ventures, Zoe, and the head of the Gubra COO, Trine. I will present an overview about the company and then we will move into the individual units. Just as a reminder, GUPRA is a disease agnostic tech biocompany, and we have deep expertise in peptide therapeutics and preclinical research services. Starting 2006, we will operate in three independent but synergistic business units. First, our GUPRA biotech unit, where we discover and develop peptide therapeutics to clinical proof of concept. our key value driver. Second, the GUPA CRO, where we deliver high quality preclinical research services to external customers, but also to our internal units, biotech units and ventures. And our new business unit, GUPA 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 pre-tax 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 contact research. This is the historic growth journey of Cupra and you can see 2025 stands out as a record year. This is driven by the deal with Appy where we outlicensed our MLN compound and the high upfront payment created the record revenues for 2025. this is our management team since i started in september 2025 as a 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 um so he was recently announced as head of cooper ventures And also we have recently announced Gregor as new chief technology officer. Technology is very important for our innovation. We are a true tech buyer company. So we are very glad we were able to recruit Gregor. A couple of key events in 2025. You're all aware of this. Obviously, the Emmeline 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 Emmeline, early clinical data, which is very promising. We had fantastic preclinical data on our new leaders at UCM2. You will hear and see more about that later in the presentation. And we did a couple of additional deals and partnerships, mentioning the Camus Color Partnership on the collaboration on a new PTH agent. And also Beringer Ingelheim has announced that they are advancing our triple agonist in obesity in the mid-stage clinical development so 2025 was full of very valuable milestones for gupra 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 we this streamline we have a discovery platform which can deliver from an idea to a development candidate, high quality assets in a very short amount of time. And also now we are ready to move into other areas beyond obesity to create more value and more clinical candidates. So if you 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 UCM2, which will have multi-indication programs and of course represents a significant value to our pipeline. we will also look into in parallel license uh complementary assets to our pipeline and we are at the same time we were strengthening our ceo 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 three business units. We have our proprietary AI-based drug discovery platform in Coupa 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 or maximum value creation. The CEO 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 a strategic value enabler also for our biotech unit and our ventures. Our ventures are essentially lean and asset-centric spin-outs 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 the society with Google Green. To be a little bit more specific and clear about where we play in the three business units, I'd like to review this in more detail. So our discovery is primarily preclinically in terms of our COO services. The COO provides multiple high quality models in the area of lead optimization and preclinical validation. Our COO 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 1B results or phase 2A, which essentially is a place of value creation and value inflection for biotech in the area of early drug development. And for Cupra Ventures, it's a little bit more flexible, but generally speaking, we were looking for assets which are at the draft development stage, moving towards clinic proof of concepts and beyond. But it also would 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 Luisa.

Thank you, Markus. So let's take a look at a Streamline platform and how it enables a growing pipeline. So at Gruber, we're peptide experts, and we discover novel peptide-based therapeutics, either alone or with a partner. And all our work is powered by an 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 web lab screening of multiple peptide libraries, thousands of peptides. We use multi-parameter 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 the internal and partnered pipeline. UCN2, a proprietary high-quality weight loss asset now advancing towards the clinic, origins directly from the platform. In addition, ABPV295, the long-acting amylin analog outlicensed to APTI, exemplifies the platform's ability to deliver clinically differentiated candidates. analytics cameras and hema collaborations further validates the platforms reproducibility and track record of consistently generating differentiated peptide acids across therapeutic areas since the last update several important developments have taken place in the early pipeline we have partnered a pth program with cameras This collaboration combines Cupra's parathyroid hormone analog with Canva's fluid crystal technology to enable extended and patient-friendly dosing for patients with hyperparathyroidism. With Amelix, we have now nominated a development candidate, a long-acting GLP-1 receptor antagonist, now advancing into preclinical development. And the HEMA collaboration has likewise progressed into preclinical development. We've also added two new early-stage programs to the pipeline, a differentiated obesity asset and a CACAPTCHA program, expanding a metabolic footprint beyond obesity. At the same time, we have concluded the third collaboration with Berger Ingelheim, a very early target discovery program. And finally, as part of a disciplined portfolio review and prioritization process, we have decided to discontinue I give them monotherapy and a vaccine 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 three of the 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 healthcare 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 account for 20 to 45% of the weight lost. We believe the next generation of treatments will increasingly focus on the quality of the weight lost. In other words, maximize fat mass 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. Gugger's pipeline is strategically positioned to meet these emerging trends. we have the long-acting amylin analog ABBV295, 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 Amblin 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 six weeks of treatment. So these findings reinforce the potential of amylin as a next generation waste loss therapy with improved tolerability profile. The program is currently advancing in a phase one 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 one 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 a next-in-line internal obesity program focused on high-quality weight loss. This program builds on a novel mechanism, along acting UCN2 analog, selectively targeting the corticotrophin-releasing hormone receptor 2, and it's designed for once-weekly dosing. And with that overview, I'll now hand over to Thomas, a CDMO, who will provide further details on the UCN2 program.

Thank you, Luise. 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 recomposition, 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 and 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 two effects. Number one, a direct inotropic effect on cardiomyocytes. and vasodilation, which results in a reduction of pre- and afterload, and together we see cardiac output increase. Longer-term administration of UCN2 also inhibits maladaptive particular hypertrophic and fibrotic remodeling that we see in a number of cardiovascular diseases. So our compound group 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 cardio-renal 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 intend 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 one 2A 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 Trina Hamann, our head of CRO.

Thank you for that, Thomas. I will be presenting GUPRA CRO. GUPRA was founded in 2008 as a preclinical CRO, and throughout the years, the CRO has laid a strong financial foundation for GUPRA. We specialized preclinical CRO, primarily focused on metabolic and fibrotic diseases, where we work with 16 of top 20 farmers and hundreds of smaller farmers and biotech globally. We combine our highly ranked translatable rodent models with advanced technologies, especially our models in mesh and 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 earlier in 2025, we also started working intensively on sarcopenia, which is eight related loss of muscle. Here we see a huge unmet medical need and an increasing age population. There are very few available animals 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 designed 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 handles. For us, AI-driven analysis of large-scale image datasets 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 activate general 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 Goobra Ventures.

Thank you, Trina. Let me briefly frame what we mean by Goobra Ventures, why we believe now is the right moment and how this approach creates value for Goobra. 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 Goobra's strengths, but will benefit from being developed with their own strategic focus, governance and potentially external capital pathways. Second, why now? Goobra'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 Goobra 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 de-risking, sharper focus, and greater strategic flexibility, all whilst preserving Goobra'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 Goobra's strategic long-term priorities. So in short, Goobra Ventures is about focus, speed and thoughtful structuring using what Goobra already does very well to support sustainable value creation over time. And with that, I'll hand over to Christian. Thank you.

Thank you, Zoe. And let's turn to the financials, which is a very pleasant reading. So in all aspects, you know, it's been a strong. in the company's history. Very high revenue of 2.6 billion Danish kroner and a net profit of 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 is 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, 1 billion Danish kroner in an extraordinary dividend. And still, despite that, we have a very strong liquidity position. So a very, very good year in 2025. And a strong outlook for 2026 also. As we already talked about, we have three potential blockbuster markets. obesity drugs in clinical development. And there's also possibility to get some interesting readouts for at least two of them during 26. As Trine talked about, you know, 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 2025, 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, 2024, and The main delta has been the smaller, better customers, especially in the US, where the funding environment for them has been a bit more challenging compared to recent years. So this means longer decision cycles for placing orders at Goobra. We nonetheless have a pretty OK earnings still despite this decline, and we look to improve this 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. Zero 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 by 10% and we expect to grow to 15% in 2026 with decent earnings. With that, I hand over to Markus for some concluding remarks.

Thank you very much, Christian. So what are the things to watch out for Goobra in 2026? I'd like to mention our UCN2 clinical development program. We expect to dose the first patients in the first half of the year. And we will disclose more details on the clinical trial design in the timing of the readouts in our R&D day on June 30th. 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 So we'll certainly aim to do more of these types 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.

If you wish to ask a question, please dial pound key 5 on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial pound key 6 on your telephone keypad. The next question comes from Thomas Bowers from Seb. Please go ahead.

Yes, thank you very much for taking my questions here. So firstly, maybe if you could comment a little bit on the low end of your CRO revenue guidance growth range here. So I guess you have some positive impact from phasing from 25 with these new contracts signed in late 25. um so so why why should we think about uh you only getting to to five percent and also can you maybe comment a little bit on on the us customer segment has that normalized or are you or are you still seeing funding issues for in particular the the smaller biotech customers Then a question on the margin outlook also for the CO segment here. In 2025, you started above 25%, so 25% to 31% if I remember correctly. What was the main driver for you now seeing 22% to 25% here in 2026? Is that mainly because you are now entering new areas like Sarcopenia or what's the main driver here? Then lastly, just on group of ventures. So you can say, given the, I guess, like ,, so should we expect you to, in the medium to near to medium term, sort of in-license new compounds? Or do you think you have plenty of internal non-core assets, you can maybe call them, and for those, seek external funding or capital? Thank you.

Thank you very much for those great questions. The first question goes to Trini. The profitability question goes to Christian. And then Sylvia 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 Christian said, two years of 30% consecutive growth And we have seen headwinds in US, 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's still volatility in the market, I would say, but especially towards the end of 2025 and in 2026, Capital has been floating 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, three to five, six months, we'll see an uptick in the market and that we will benefit from that. We can already see that the clear signs of recovery. Decision cycles still are relatively slow. But we remain positive that we will see increased activity, especially in the US and also among biotechs in 2026.

Another 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 no earnings immediately. So that's why you could 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 say, Thomas. Very good. I think Zoe.

Yeah, happy to take the question and thank you for referencing our shared history with Roy Vent. 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 Goobra pipeline, we are actively looking outside for opportunities. And as I mentioned, these will be opportunities that lie within Goobra's biological strength. So that could be peptide based therapeutics in Goobra. 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. Thank you.

The next question comes from Suzanne Van Forthuizen from Kempen. Please go ahead.

Hi, team. This is Suzanne from Campend. Thanks for taking my questions. 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 good growth from Q1? Second one is on the biotech side. For UCN2, the phase one is very elaborate. There are no timelines on data yet, but any color you can give on, you know, 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 group of ventures assets? Thank you.

Thank you very much, Suzanne. Trini 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 an increase in venture funding and also EU has launched a future 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 uptake in sales.

In terms of the EU3N2 trial, this trial is a very ambitious phase 1, phase 2A 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 in our estimated timelines on June 30. Sorry.

Thanks, Marcus. I think the question was, you know, what will we be looking for? What would be a typical phenotype of an asset for Goobra 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 Goobra'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.

All right. Thank you.

Good. We'll take the next question now.

The next question comes from Theodora Roe-Beetle from Goldman Sachs. Please go ahead.

Hi, thanks for taking my question. So firstly, when should the market expect a data update from the Phase 1 MAD study for ABBV295? 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? Thank you.

This question goes to Louise.

Yeah, so thank you for this question. So with regards to data outlook from the MAD study, what the APRI have communicated is that they expect to see data during this year, and that will guide the progression into phase two, which they also expect to start here in 26. With regards to a competitive position of 295, then again, it has been designed 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 MAB study is that we can deliver substantial body weight reduction with a very nice tolerability profile. So we see no reason as to why group AMI or 295 should not perform equally well as to loralentide.

As a reminder, if you wish to ask a question, please dial pound key five on your telephone keypad.

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.