Gubra A S

Thank you for standing by. My name is Karen, and I will be your conference separator today. At this time, I would like to welcome everyone to the Gubra Quarter 3 2025 earnings release. All lines have been placed on mute to prevent any background noise. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star followed by the number one on your telephone keypad. To withdraw your question, you may press star followed by the number one again. I will now turn the call over to Marcus Warfield, CEO. Please go ahead.

Good morning, everybody. Also, welcome from my side. My name is Marcus Warfield. I'm the CEO of Coupa. I'm joined here by Luisi, our CSO, and our CFO, Christian. So we'll start with our presentation. I will give a general overview followed by Luise and then the financial results by Christian before I wrap up. As you know, at the core of our strategy, we have a dual business model. We have our discovery partnerships, our key value driver and our CEO services, which are a strong enabler. for our internal pipeline as well as our partnering. Our CEO business has had remarkable growth over the long run. We had 30% growth year-on-year and we deliver great data and service to 16 out of top 20 customers in the pharma and biotech area.

Our primary focus has been obesity, and I think our recent deal with Appion Ammon has demonstrated and validated our business model. Now, let's look at the first nine months. And I think this chart speaks for itself. Obviously, it's going to be a record year for HUBRA, both on the revenue side as well as the margin side driven by the upfront of the extraordinary business update, which has brought us significant liquidity. In terms of highlights for 2025, Of course, our UCM2 program has demonstrated fantastic preclinical results, and we look forward to bringing this asset to the clinic in the first half of 2026. This program is developed for equal high-quality weight loss, and you will hear more about it from the UC. I mentioned the FB deal, obviously this is a milestone deal for us and we have also had an extraordinary dividend of 1 billion UK. Emeline has shown great results and it's called ABB295 now and phase one was very, very And we also have demonstrated great half-life for the product and significant rate reduction. So we strongly believe in the annual growth. Our CEO business has seen a slight decline, driven by macroeconomic uncertainties, which has led to some delays in decision-making among our customers. But we believe there is life at the end of the tunnel. And of course, also new from my side, I joined the company in September this year and I'm excited to lead the team and the company to its full potential. I'm handing over to Louise now.

Yes, so thank you. So let's take a look at an internal discovery pipeline. At Dubra with peptide experts, we discover novel peptide-based therapeutics either alone or with a partner. All our work is done using an in-house developed drug discovery platform, ScreenLine. Using this platform, we can quickly develop a peptide hit into a novel IP protected development candidate. The platform takes advantage of AI and machine learning combined with the high throughput Red Lab screenings of multiple peptide libraries, thousands of peptides. We use multi-parameter optimization, which saves time and enables the identification of better molecules faster. So what you see here is an overview of the good graph R&D pipeline. This growing pipeline is a direct result of the power and efficiency of a streamlined graph discovery platform and our extensive peptide expertise. Green represents our internal programs, proprietary assets, not yet partnered. Our most advanced internal asset is a UCM2 program for high quality weight loss headed toward the clinic. In parallel, we are advancing a diversified portfolio of early stage programs, ensuring a strong flow of future opportunities. Pink highlights the partner programs reflecting successful collaborations with leading industry players. Key highlights. This is the partnering of our Phase 1 Ameline program with Appy, the biggest out-licensing field for Guber so far. This underscores both the scientific strength and commercial potential of the pipeline. At Guber, we have been dedicated to understanding and treating efficiencies since the inception of the company. Over the years, we've built deep scientific expertise in this field, from early discovery to clinical translation. And today, we'll take a look at two of our most advanced obesity programs, both designed with a differentiated profile compared to current standard of care. But before going into the data, let's take a moment and look at the broader obesity landscape and what the next generation of obesity treatment will likely focus on. So it's no secret that obesity continues to be a growing global health challenge with a well-recognized need for novel treatment opportunities. And while today's therapies can produce substantial workloads, we need more tools in the toolbox if we want to treat all patients efficiently. In addition, it's well acknowledged that lean body mass accounts for 20 to 40% of the weight loss. There will be a paradigm shift in the next generation of obesity treatment with a focus on the quality of the weight loss and not just the quantity. In other words, we should aim to maximize fat mass loss while preserving or even increasing lean muscle mass. Additionally, the next generation of obesity agents will likely differentiate from improved tolerability profile and by addressing pre-obesity-related comorbidities. Google's pipeline is strategically positioned to meet these emerging trends. First of all, we have a long-acting ambient analogue ABBV295, now outlicensed to applicants. 295 is in development for weight management indication and could be positioned both as an alternative or an add-on to infatant-based treatment. It features a balanced receptor profile on the amylin and calcitonin receptor, just like native amylin. It has an exceptionally long half-life of 11 days and has been designed to be stable at neutral pH allowing co-formulation with other anti-obesity agents. In the ongoing phase 1 multiple ascending dose study, interim results from part A showed that 295 was well tolerated. Adverse events were predominantly GI-related and mild. It demonstrated a dose-dependent weight loss of almost 8% in the 2mg cohort. compared with a 2% weight gain in the placebo group after just six weeks of treatment. So these findings support Amelan's potential to deliver clinically meaningful weight loss with an improved fallibility profile. The next in line is an internal obesity program focused on high-quality weight loss. This program builds on a new mechanism a long-acting UCN2 designed to deliver a healthier and more sustainable weight loss outcome. We have designed a selective UCN2 analog with a target profile of once-weekly dosing in humans. UCN2 has the potential to treat the multi-morbid obese patient by improving body composition, increasing muscle mass, reducing fat mass, but also addressing clean obesity-related comorbidities, such as cardiovascular and kidney diseases. Today, we'll zoom in on the beneficial effect of UCM2 on muscle and cardiac tissue. Starting with muscles, from this study in very old diet-induced abuse labs, treated for an extended period of time, we can see that UCM2 alone shown in green, has a neutral effect on body weight, but it improves body composition by increasing lean mass and decreasing fat mass. You can also appreciate that other weight-lowing agents, such as semaglutide, shown in purple, will decrease both lean and fat mass. So when combined with semaglutide treatment, as shown in blue, we can see that QCN2 fully prevents the lean mass loss, it even increases lean mass and further reduces fat mass. At this link, in some aqua-type pre-treated rats, adding UCN2 from week 3, assuming pink, completely restored the lean mass and potentiated fat mass reduction, highlighting UCN2's potential for both a protective and a restorative aging process. in combination treatment. So when looking at plasma biomarkers at the end of the study, we saw lower leptin levels well in line with a reduction in fat mass. We also observed a decrease in plasma triglycerides. This is a favorable metabolic outcome reflecting less fat circulating in the bloodstream with no changes in cholesterol. So collectively, This shows the potential of UCN2 to deliver an all-beneficial metabolic profile. Looking more specifically at muscle tissue, we used our advanced 3D imaging platform based on light street fluorescent microscopy. This technology provides high-resolution quantitative data on volume of individual muscles in the hind leg. and it's powered by AI and automation. Using this approach, we observed that UCN2 increases total muscle volume in the Heimlich of AIDS diet-induced obese class, both as monotherapy, but importantly, also in combination with GLP-1. This indicates a direct beneficial effect on muscle tissue. In scientific literature, UCN2 has consistently been shown to improve cardiac function. Here we extend these findings using a long-acting UCN2 analog in a rat model of chronic heart failure. In this model, chronic myocardial infarction is induced by permanent digestion of the left anterior descending artery. This creates an infarction in the left ventricular wall. SAM operated animals who have a healthy control are shown in grey. One month after MRI induction, when systolic impairment is well established, animals are treated with vinegar in black, mucin-2 lower high dose in green, or triple standard of care combination, as shown in purple. are treated for aphids. Cardiac function is then assessed using echocardiography, which shows a marked reduction in cardiac output in vehicular-treated animals versus swans. In this setting, the UCN2 analog significantly improves cardiac output, demonstrating its ability to also improve cardiac function. So these compelling preclinical findings report UCM2 as a differentiated acid combining high-quality weight loss with improvements in key ethnicity-related co-morbidities. So we're now preparing UCM2 for the clinic, and we expect to start the clinical study in the first half of next year. So now, Christian, Over to you and an update on the financial results.

Thank you, Luisa. And as we said in the beginning, you know, the first nine months has been nothing but a fantastic for Gubra. And we had a revenue in the Discovering Partnerships business of above 2 billion Danish kronor, 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 forward in parallel. Of course, the Amelin and the UCN2 in particular. Over and above an extremely strong result for Gubra in the first nine months of this year. That was the results for the DNP unit. Looking at our CRO business, we have a very strong position in metabolic and fibrotic diseases. And in 2025 in particular, we have been building out the women's health area, which is a growing area of importance for GUBA 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, you know, we have a wide variety of customers from the smaller biotech customers to the very large big pharma customers. And we cater to 16 out of the top 20 big pharma customers. I will come into shortly what we've seen in the first nine months in the market dynamics. And I'll take that on the next segment. So again, coming back to comments earlier, we had an extremely high growth rate for the last couple of years. In the 23 and 24, we grew the zero 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 nine months compared to the same period last year, primarily as we faced some macroeconomic headwinds affecting the conditions for our smaller biotech companies, where they are taking longer time to place new studies. When we look out, we see some signs of improvements and funding conditions seems to have improved a bit for our biotech companies. So we sense a bit of optimism when we're looking at the course ahead. Looking at the cost, as I said, we're building up the women's health area. And this is something that we feel that we can establish a good decision with it. When revenue goes down a bit, it of course affects our margins and we're hovering around the 20% EBIT margin for the first nine months. Talking about the outlook for the full year 2025, we did a minor revision. And we said that previously that we will be slightly below and be levels in 24 for the CRO segment. And I would say we'll fight to 10% below for the full year. Margins unchanged and also the unchanged expectations to the cost in our discovery and partnership segments. So overall, again, reiterating a fantastic nine months for Group Run 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 Google is preparing for the next wave of growth through the expansion of our pipeline and increased in general the effort. So certainly UCN2 moving into the clinic is for us a big value driver. and we are confident that we are a frontrunner in this biology and the difference in the growth market. Also, in terms of therapeutic areas and building a platform to expand beyond obesity and metabolic diseases, we already have a very good stronghold, so we're looking into this right now, and there will be more of this in the next annual report. The deal with Appy was a very good deal for us and of course we want to expand our partnerships building on that department blueprint and we will still focus on being a peptide innovation house and only the edge on designing new therapeutic peptides in different type of therapeutic areas. Moreover on the innovation side of course also for our CEO it's really important and the cutting edge of innovation technology. And this will be very important in the support of our biotech union, as well as our partner efforts as well. So those are our strategic goals leaders, and I'll stop here, and you can now go and see the Q&A section.

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

At this time, I would like to remind everyone in order to ask a question. Press star then the number one on your telephone keypad. We will pause for just a moment to compile the Q&A roster. The first question comes from Thomas Bowers from SEB. Your line is open. Hi, Thomas. You may now ask your question. The next question comes from Theodora Butel from Goldman Sachs. Your line is open.

Hi, thank you very much for taking my questions. So firstly, please could you provide your perspectives on the Elora lintide data from Lily yesterday? What are the implications, do you think, for Gubami, and do you think it can show similar efficacy? And then secondly, what are your expectations for the non-weight-lowering benefits for Gubami and the amylin class? In particular, do you think there's potential for cardiovascular benefits, for example? Thank you.

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

Yeah, definitely. So thank you for this question. So just on a general notice, we usually refrain from commenting directly on clinical data from other companies, but for the overall amylin class, the data looks promising. We see a huge potential in the class of ambulance to deliver clinically relevant weight loss, well in line with the recent published data. So for the second question regarding, did you talk about 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?

Yes, so overall expectation is that, of course, we will need to see the true value in the clinical studies, the larger clinical studies, but on a general notice, losing weight usually translates into an overall improved a beneficial metabolic profile also on the cardiovascular side.

Good, we take the next question now.

The next question comes from Romy O'Connor from Van Lansket Kampen. Your line is open.

Hi, good morning, everyone. Thanks for taking my questions. I have two, if I may. The first, I was wondering how you expect the areas of NASH and kidneys to develop. Is obesity still the main contributor, or is your focus now shifting mainly towards women's health?

And the second, with BCN2 entering the clinic, are you able to provide some color on anything related to child design, patient characteristics, and will you also be exploring cardiac visits as you're seeing those benefits in pre-clinical settings? Thank you.

Yes, so definitely. So regarding biggest contributors to the CRO revenue, then obesity continues to be a key driver for revenue for Cooper. But of course, we also see a result from mass and kidney, but we are constantly expanding on our service options. So as Christian also alluded to, we are establishing women's health as a new important area for us to make sure that we have a competitive 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 platform, but of course we want to explore as many options as possible with such an asset, but usually the phase one clinical studies, they are designed to explore safety and pharmacokinetics.

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

Great, thank you.

next question please should you have a question kindly press star followed by the number one the next question comes from thomas bowers from seb your line is open thank you can you hear me now that was a problem yes thomas it works perfect thank you yeah i was caught off so so actually i'm sorry if i'm repeating one question because i i sort of missed a few minutes but But I just wanted to ask first of all on the CIO 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 regard to 26, I know, of course, you're not guiding yet, but should we expect some sort of a catch-up effect from those COO clients in the US coming back now? So is the order book going to be a little bit bigger for 26 or are you still going to stick to your 10% limit in order to prioritize DNP? And then I think there was a question also on illogalintide, but I'll just ask in regards to the whole concept here on selectivity to the amylin receptor, is there anything that makes you think differently now in regards to targeting or being more sort of non-selective, so both targeting calcitonin and amylin, or is this still something that is up for grabs, so to say. So any comments here would be appreciated. Thank you.

Thank you very much. The first question goes to Christian, and Luise will comment on the second one.

Yeah, so when we talk about, you know, funding climate for biotech customers i think we have a sense that that is improving a bit and that you know impacts the audio intake for our cro business we have an overall ambition to grow our cro business by around 10 every year and we overshoot this you know several times due during the last couple of years and in certain years you know there are some headwinds as we had this year but again coming up from from a very high level in 24. so I think we see a slight improvement to the to how 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 one segment in our CRO business. So we see a slight improvement there, and we hope that will continue going into 26.

Thank you for the second question. It is an ongoing discussion in the field of amylin biology. To remind you, ABPV295 has a balanced profile on the amylin and ketotonic receptors, just like native amylin. We saw a very nice result from the MAD study with an almost 10% weight loss delivered by 295. We see huge potential in this asset. So, no, we haven't changed our perspective on this.

Okay, great. Thank you very much.

Next question, please.

Since there is 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, round off.

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