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Gubra A S
8/20/2026
Good morning, everyone, and welcome to GroupBus conference call covering our first half 2026 results. My name is Adam, new head of investor relations at GroupBus.
And joining me today are members of GroupBus leadership team who will take the pool Key developments for the company in the first six months of 2026 and our financial results. Following the presentation, we will open the call for questions. Before we begin, I will just caution listeners on slide two here that we may make forward looming statements that are subject to risks and uncertainties. And with that, I will hand over the call to our CEO, Markus, for opening remarks.
Thank you very much, Adam. Good morning, everyone. Welcome also from my side to our webcast. I'd like to give a couple of highlights of the company. In summary, I believe Gruber had a very good first half of the year across our entire business units. Gruber Biotech significantly advanced our R&D pipeline. and in the CEO, I think while we still have work to do, I see a promising trend based on new commercial initiatives and also continued cross-discipline. And we have also now established a platform for Gruber Ventures. This is a new business unit at Gruber and we are currently evaluating multiple deals and over the next couple of months, I hope we can announce the first Gruber Venture. At this point, I'd like to remind you that our business model is unique. Based on three synergistic business units, Gruber Biotech discovers and develops new peptide therapeutics up to Clinically Proof of Concept, Gupa Ventures invests in exciting science adjacent to our flagship areas, and our COO, while serving many external customers, is an integral and very important part of our innovation in the biotech unit as well in our new ventures. Let me highlight a couple of milestones which already have been achieved. In the first half of the year, I'm just going to mention three of them. UPI reported highly encouraging phase one MAD results for the long-acting amylin. I think this is very robust data, and the start of the phase two is imminent. Bernie Inheim has already advanced the triple agonist in clinical phase two, and we now have initiated and ambitious phase one to a trial for our fully owned UCN2 program, our new mega program. And with this, I'd like to hand over to Louise.
Yeah, thank you, Markus. So let's take a look at a Streamline platform and how it enables a growing pipeline. So at Guber, we're true experts in peptide drug discovery. And our core edge is that all the work we do is done using an in-house developed drug discovery platform, Streamline. And the platform takes advantage of the AI driven design and data analysis, and this is combined with high throughput wet lab screening of multiple peptide libraries. So we use multi-parameter optimization. So what this means is that we optimize all key drug properties at once. So ultimately this enables us to save time and identify better molecules at speed. So the Streamline platform has repeatedly delivered differentiated assets across a variety of therapeutic areas. So what you see here is the Goobra R&D pipeline. And since the last update, we have seen important progress. First of all, we have seen the initiation of a UCN2 program entering phase 1. Additionally, Berger Ingelheim has initiated phase 2 development with the triple agonist and at least still plans to initiate phase 2 in Q3. Simultaneously, Hemap has expressed that they expect to initiate first-in-human trials with HMV-003 in the second half of 6-26. And likewise, we have concluded the fourth collaboration project with Berger Ingelheim, a very early target discovery program. So at Dubra, we have been dedicated to treating and understanding obesity since the company's inception. and over the years we have generated deep scientific expertise all the way from discovery to clinical translation. And today we'll take a look at three of the most advanced anti-obesity acids so that each designed with a differentiated profile compared to current standard of care and with blockbuster potential. But before getting into the data, let's just take a step back and take a broader look at the obesity landscape and where the market is heading. Because it's no secret that obesity continues to be a growing global healthcare challenge, and there is a well-recognized need for novel treatment approaches. And for the past decades, the core question with obesity treatment has really been, can we make patients lose weight? Can we achieve clinically meaningful weight loss? And this has been the focus of the first wave and has really been spearheaded by the first generation of incutin-based treatment. The focus on the current wave has been to maximize body weight reduction and improve solubility. Here we see an introduction of complementary and Alternative Mode of Actions. We've seen introduction of amylin analog as well as multimodal therapies, including dual and triple agonist. And the toolbox for patients have been significantly expanded here. But it's also well acknowledged that the body weight reduction is not just fat mass. Lean mass actually accounts for 20 to 45% of the weight loss. And lead mass, it's muscle, it's bones, it's internal organs, so it's all the tissue that we would ideally like to preserve when we're trying to lose weight. Therefore, we believe that the focus for the next wave will be quality, with focus on body composition, maximizing fat mass loss, and preserve or even enhance skeletal muscle mass. That's where the field is going. And group-based pipeline is strategically positioned to meet these emerging trends. Now let's take a look at some of these assets. First of all, we have the triple agonist, long acting, first in class. This asset targets the GLP-1, the GLP and Y2 receptors to engage in complementary mode of action involved in body weight reduction. This asset was discovered in collaboration with Berger Ingelheim, who now have sole responsibility for driving it forward. and after seeing encouraging phase 1 data that demonstrated a favorable safe control ability profile along with encouraging weight loss, Berger Ingelheim has now initiated the phase 2 development here. The study will enroll approximately 300 participants that are treated for 42 weeks. So we really see this as a true validation of both the asset's potential but also grouper's peptide discovery capabilities. So next we have ABPV295, the long-acting amylin analogue that is now outlicensed to AbbVie. A core differentiator with the amylin class of compounds is the potential to deliver clinically relevant weight loss with a better solubility profile. So this means that amylin may represent the next distinct class of drugs for chronic weight management. 295 has consistently shown competitive results throughout a comprehensive phase one program. The data from the MAD study was the top line data was presented by AbbVie in March and here 295 showed a very competitive weight loss profile of almost 10% after just 12 weeks of treatment. And remember that this is in a lower BMI cohort with predominantly male participants. Importantly, 295 also revealed the potential for less frequent dosing. So here, comparable weight loss was observed with the every second weekly dosing or even once monthly dosing. In addition, 295 had a favorable safety and solubility profile. Adverse events were predominantly GI, mild, and transient. So the data from this study will be presented at EASD in September. 295 is being tested in an ongoing phase 1 B trial in people with obesity, higher BMI range and higher proportion of female participants. And AbbVie still plans to initiate phase 2 in Q3. And with that, I'm happy to hand over to Thomas, a CDMO who will talk more about a UCN2 program.
Thank you, Louise. So now let me turn to what makes group UCN2 so compelling. So group UCN2 is a long-acting agonist at the CRHR2 receptor, and that makes it really a very differentiated and novel mechanism of action that addresses key needs for people living with obesity. And as you can see on this slide, in adipose tissue, UCN2 lowers fat mass and lowers triglycerides. In the muscle tissue, which is actually the main The main target tissue for UCM2 drives the build-up of muscle through anabolic and inhibition of catabolic effect, which also has a positive impact on insulin sensitivity. Further evidence points towards additional cardio-renal benefits as laid out on the slide. For me, there are actually two key takeaways on that slide. First, group UCM2 is not really simply about weight loss. It really has the potential to fundamentally improve body composition by reduction of fat mass and by building muscle mass at the same time. The added muscle mass is really expected to provide functional benefit to patients through improvement of strength and physical performance. And that really opens up two really compelling and attractive development paths. On one hand, Using group UCN2 as a differentiated normal therapy, on the other hand, in conjunction with intratin-based therapies. The second key takeaway is that the opportunity is not about ethnicity alone. As I indicated, we have multiple effects on very differentiated tissues, which gives us the opportunity to develop group UCN2 into multiple indications. In particular, if you're thinking about muscle wasting conditions and cardio-medial diseases, which gives group UCN2 really a very broad development potential. So the preclinical data generated to date make the potential really tangible. So I would like to share a data set with you really as an example of a use case for group UCN2 where we investigated it as monotherapy and in combination with simaglutide in rats with obesity due to high fat diet. On the left-hand side, you can see that GUP-UCN2 really profoundly reduces fat mass, which is depicted by the green bar. When combined with semaglutide, we do see an additive effect beyond the effect that we do see with either treatment alone. The middle graph shows really the differentiation of group UCM2. We do see that with this mechanism of action, we can really build lean mass of which muscle is really a predominant part. And we can also rescue the loss of muscle mass that we see with semaglutide in this experimental setting. On the right-hand side, you see actually very nicely why body weight does not tell the full story. Monotherapy alone does not result in a reduction in body weight in this particular experimental study. And that is because we reduce body fat and at the same time balance it with a gain in muscle mass. Hence, the overall effect in this setting is neutral. However, when combined with semaglutide, we continue seeing the weight reduction driven by semaglutide, but group UCM2 really dramatically changes the composition. This is really a very, very attractive drug profile, reducing fat mass, improving muscle mass and having the potential for a functional muscle improvement. So we are very excited about now moving this asset into clinical development and it's really an important inflection point for Goobra, right? Moving a compelling preclinical package into a clinical opportunity. We have now initiated a very comprehensive Phase 1, Phase 2A clinical trial where we involve healthy participants but also people living with obesity and move the assessment from the single ascending dose to a multiple ascending dose. and a total of 16 weeks of treatment duration. Importantly, we are assessing group UCN2 as monotherapy and as combination therapy with an incretin. So in addition to the typical phase one endpoints related to safety, tolerability and pharmacokinetics, the trial was really designed from the outset to provide a very comprehensive clinical data package. Looking at muscle mass and muscle function. And also building the foundation really for indication expansion into muscle wasting conditions and into cardiomyeloma diseases. So we will be able to speak more about the development program of UCM2 at our upcoming RMD event on October 27th. So with that, I would like to conclude and hand it over to Zoe, our head of Goobra Ventures.
Thank you, Thomas. So now we turn to Goobra Ventures, which is our value accelerator and using our internal engine to create additional routes to value via external innovation. So why are we doing this? Well, Goobra Ventures is built around four value accelerators. The first is increasing shots on goal by accessing external innovation, including novel assets and novel technologies that are complementary to Goobra's core. The second is expansion into new diseases and new technology areas. The third is return by future exits, so additional revenue stream beyond that of the CRO and the biotech pipeline. And the fourth is because this will not be a standing start, so we can go faster. We can lower our dependencies on external service providers, and we can also use disciplined capital use to create these opportunities. And why now? Well, Goobra is really uniquely positioned to build on the credible foundations that we've built and amplify those to produce these value accelerator So the first foundation is our scientific and therapeutic area depth, as well as our development capabilities. Secondly, we have a discovery platform that we can use for joint ventures to create new opportunities in the peptide therapeutic space. And third, we'll use our integrated capabilities, know-how and shared infrastructure to bring those opportunities faster to the clinic. So in all these respects, Goobra Ventures will be bringing more than capital. So in summary, we're expanding our innovation footprint by additional routes to return and turning what we do well into further value creation. And with that, I'll pass over to Trina.
Thank you so much for that, Zoe. The CRO is continuously an important value enabler for Goobra. For many years, we've had a strong record of We are considered a scientific leader. We have more than 18 years' experience working in the metabolic space and in particular in obesity. And we serve 17 of top 20 farmers globally. They really choose us because we can deliver complex models with high quality unbiased data at speed and with excellent scientific guidance. So our ambition is really to stay ahead of the curve. We've done that always in the past. Introducing obesity services very early on, mesh and kidney platforms. And now we have introduced this year services in women's health and sarcopenia, so this muscle platform, and really trying to differentiate ourselves and open up new growth opportunities for the future. So it's this combination of deep, deep scientific expertise and the trusted professionals Customer Relationship and Continuous Service Innovation that underpins the long-term strength of the CRO business. After a few challenging quarters, we are seeing early signs of improvement across a number of different market indicators. In particular, biotech funding has rebounded strongly in 2026, and we also see a continued We have clear priorities. We want to maintain our leading position in the metabolic and fibrotic space. We want to also, as I said, expand into new interesting and attractive therapeutic areas. and accelerate the development of the commercialization of our advanced 2D and 3D imaging platforms. Besides that, we are also increasing our commercial activities in particular in US we are expanding and combining this with a cost discipline. We really focus on regaining momentum. We've grown 11% since first and we've also returned to positive profitability so this is there's naturally some uncertainty around the revenue recognition but we see a very sound order book both with our external and internal customers obesity remains our largest contributor revenue wise and we see a rebound in mesh and kidney studies which is Improving the commercial outlook for a second half of the year. So overall, we see we're cautiously optimistic about the next half year and we want to convert this momentum that we're having now into profitable growth while continuing to strengthen the strategic importance of the CRO for the business. And now I will hand it over to you, Kristian.
Thank you, Trine. And just a little bit of clarification on the recognition of revenue. It is not uncertain that we recognize revenue. It's just when we sell in the zero business, revenue will occur when we perform the studies. Not uncertainty, just if we recognize revenue, just as a clarification. So with that, you know, let's look at the financials, right? Taking the biotech business first. So this is a business that naturally has lumpiness in its revenue and earnings. When upfront payments occur and when milestone payments occur. And in the first half of 26, we had some milestone payments, totaling 30 million Danish, but not, of course, to the same level as last year, where we had the upfront payment from 2.4 billion. So this lumpiness occurs each and every quarter. as inherently in a biotech business with partnership collaborations. And we know already in Q3, we will receive 10 million euros from startup of the phase two for the triple agonist from Boehringer. So a very important payment there that is already recognized in the books for Q3. Taking the CRO business, as Trine said, we've seen a sequential improvement We had revenue up 11% compared to the second half of last year. And as Trine also said, we're seeing an overall stronger demand situation, especially for our smaller clients. And the smaller clients are typically the swing factor in Goobra's earnings and revenue in the CRO business. Just as so in 23 and 24, there was a lot of influx of smaller clients in Goobra. And a bit of the opposite in 25. and that has been to a large extent driven by the funding conditions and funding conditions are now improving. So we're looking into a quite sound order book for second half of 26. Earnings Q4, we had a small loss and now we turn that into a small profit in first half and we expect relatively sound earnings in the second half of this year. That brings me into the outlook. So short message, unchanged outlook for 26, starting with the biotech business. Just as a reminder, we only guide on total cost. That means both internal costs and external costs for clinical trials, for example. And they would guide by 330 to 360 million Danish. Zero business revenue growth. We expect growth in the range of zero to 10%. and Yves Martin in the range of 10 to 15%. So again, unchanged compared to the guidance we have provided earlier. Unchanged guidance also for the smaller business units, Ventures and Cooper Green. With that, I give the word over to Markus to speak a bit about the new flow going forward here. Please, Markus.
Thank you very much, Kristian. I'd like to end this presentation The next value inflection points for Gruber and I believe we are entering an exciting period of growth. The next important milestone for us is the start of phase two for the long-acting Emelin and I think this is imminent so there will be good news coming soon. And there will also more details be published about this molecule and the phase one AMAD study coming up. And looking forward in terms of clinical milestones in the first half of 2027, that will be exciting news as well. We have top line data for UCN2 in terms of the first part of the trials, the SAT part. We will initiate the second part, the MAD part. And what is also exciting is phase 1B top-line data for FB295. I want to point out that this is in patients which are truly obese up to PMI of 45 and with a higher female participation. So I think this will be exciting data. and out of our previously mentioned research collaborations with HEMA, also the first compound, will enter first in human studies. On top of that, we will announce our first venture and I am confident that we will see rejuvenated growth out of the COO as well. We have all good reason to be ambitious about the second half of the year, but also for the future of the company. And I'm equally excited to tell you more about our growth strategy at our Huber Invest R&D event on October 27 in London. I will talk about the growth strategy, ambitious growth strategy. We will talk about our pipeline, give some updates. We will present our UCM2 development strategy, its potential, its potential indications and other elements of our strategy. So please join us at the webcast or hopefully in person. It will certainly be an exciting day and I'm looking forward to the presentation.
Good. Thanks a lot, Markus. And thank you to all our presenters as well. That takes us to the Q&A session. So, operator, we are ready to take the first set of questions.
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. A few questions from my side here. So maybe just on UCN2. So the trial is now listed on clinical trials. And I know that there's only one center now recruiting patients. So should we expect this to be a multi-center study? And how about the US side? Should we expect that to come online at some point in time if you're planning for more here? And then secondly, also on UCN2, Maybe just clarification on the primary efficacy endpoint here for the MAD part maybe of the phase 1-2. So are you primarily looking at type 2 diabetes-related muscle loss, maybe also obesity once you combine with the incretin to get this early signal, or do we also expect you to have data from potential cardiorenal... Patients with cardiorenal co-morbidities. And then lastly on UCN, just to understand the incretin part, the combination here, are you looking to sort of mirror the standard incretin titration or are you maybe aiming to just go with a fixed low dose incretin and then use that on top of the UCN2? I'm really curious on how you actually plan to combine this in Italy. And then my last question, just on the CIO business. So you are expecting a recovery here in second half. Are this also reflected that we could maybe come back to expecting double-digit growth beyond 26? Thank you.
Thanks a lot for those questions, Thomas. So I think the first three questions on UCN2, clinical trial sites, single center versus multi center, and some trial design specific questions, we will go to Thomas. And then afterwards, a question on the COO business will go to Trine. But Thomas, on UCN2.
Yeah, I'm happy to take the questions on UCN2. Thank you for that, Thomas. With regards to the clinical trial site, we have deliberately selected one site for the current trial. The reason for that is that we have really complex endpoints around muscle function, muscle volume that really requires expertise at the site. We currently do not plan to expand beyond the site, Dr. Markus Rohrwild, Jacob Jelsing But to address some of your points, we are certainly very interested in understanding how UCN2 performs both as a monotherapy and in conjunction with incutin therapy for the combination arms. We will certainly utilize commercialized products at the prescribed dosing regimens. I think that addresses the questions or did I forget?
I think you covered it all. And then the last question was from COO, expectations for second half of the year and if there's anything we can say on getting back to double digit growth.
So as I said, we see a positive trend in the market and we expect to be able to to follow guidance in the second half of 2026. Looking into 2027, what we have been working on in 2026 is expanding our model portfolio to be ahead of the curve on important growth areas relevant in the market, combined with our cost discipline and initiatives we have taken on that side. So in 2027, My hope is to get back to the long-term guidance, which is 10% growth. This is our ambition.
The Gruber Zero business is a growth case. We've grown over the years by around 14% over the last couple of years, 14% annually. Of course, there are some swings between certain years, but definitely Gruber A The next question comes from Rajan Sharma from Goldman Sachs. Please go ahead. Hi, thanks for taking the questions.
I've got two, one on the CRO and one on the biotech business.
Maybe just starting with UCN2, could you just help us understand what are the most important endpoints that you'll be monitoring to support that target product profile there? What's your internal bar for success and what would you need to see to justify further development for that asset when we see the data next year? And then just on the CRO, I think you talked about expanding into Women's Health. Could you just give us an update on progress there in development? Just looking on your comments on slide 23, it doesn't look like women's health is contributing commercially this year. When should we start to expect some contribution? Thank you.
Good. Okay. Thanks a lot, Rajan. So let's start again with UCN2. Anything in addition that we can add on there? on endpoints and what could justify progression from SAD part into the subsequent parts of the trial. We'll go to Thomas.
Yeah, we will generate data in this trial sequentially. In the SAD trial, we expect results of safety, tolerability and pharmacokinetics that would help us to determine how we We will start off with generating this dataset and then continue generating endpoints around early efficacy readouts in the subsequent parts of the trial. As I indicated earlier, these will be measurements around Thank you very much.
The second question on COO and the new therapeutic areas, women's health and sarcopenia, any color we can add on contribution?
So the question was really to revenue from the women's health area. And there's a huge unmet medical need in the women's health area. And as I said before, we always really strive to be ahead of the curve in terms of developing our services and being ready for a demand. And of course, women's health is an opportunistic bet on our side, but we really want to be ready when investment starts floating into this area. There's an unmet need. We have the capabilities to succeed also due to our advanced Both model capabilities and 3D, 2D and 3D imaging capabilities. So we're well positioned in this space also with the metabolic background that we have. But of course, it does take some time sometimes to build this market. On the muscle platform and sarcopenia, we've seen actually a lot of traction already. And it's a service that we've just launched this year. And in particular from our internal customer, The next question comes from Suzanne Van Forthuizen from Kempen. Please go ahead.
Hi, this is Romy on for Zuzana. Thanks for taking our question. Just another follow up on UCN2. So you highlight several potential indication expansion opportunities beyond obesity. So we're just wondering what specifically from the study next year will determine prioritizations next and how soon can we expect this? Thank you.
I think that question goes to Thomas as well. Indication expansion opportunities.
Yeah. Susanne, maybe two thoughts related to that. Number one, we are continuing to work on our preclinical profiling plan along with collecting the related cardiorenal endpoints in the ongoing clinical trial. And that in conjunction will really help us to determine in which direction to drive the further So we will be looking at cardiomino endpoints also in the multiple dose part of the trial. That is a data set that will not be available at the beginning, but at the end of the trial.
Thanks a lot, Thomas. And currently we do not see any additional questions from the audio platform. We have one question in writing here. So that relates to... Potential ex-dividend date in 2026. So I think the question is around whether we should expect a recurring dividend from a group of CFO. Kristian can address this.
Yeah, we had a very pleasant situation last year where we announced an extraordinary dividend, a bit unusual for a bike company. So remember that was an extraordinary dividend on the back of the upfront payment for the underlying assets. And we have not declared dividends for this year, so So, yes, effectively, we don't pay our dividend in 2026. And, you know, going forward, we will announce whether there will be a dividend or not. Again, remember, Gruber is a biotech company. And, you know, you should not expect recurring dividend each and every year.
Very good. Thanks a lot, Kristian. And thanks to everyone for attending and for the many questions. Thanks a lot. That concludes today's call. Yeah, we look very much forward to connecting with many of you over the coming weeks and months and have a great day.