Gubra A/S (GUBRA) Earnings Call Transcript & Summary

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.