Gubra (Copenhagen:GUBRA) Q3 2026 Earnings Call

0:01 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 5 on their telephone keypad. Now I will hand the conference over to the speakers. Please go ahead.

0:23 Good morning, everyone, and welcome to Gruber's conference call covering the third quarter of 2026. My name is Adam Lange, Head of Investor Relations at Groupon and joining me today are members of Groupon's leadership team who will walk you through the key developments during the quarter and discuss our financial performance. We'll do a presentation expected to last approximately 20-25 minutes and we'll then afterwards open the call for questions. Now on slide 2, I need to remind everyone that today, during the presentation and the subsequent Q&A session, we may make forward-looking statements that are subject to risks and uncertainties.

1:08 And with that, I will hand over the call to our CEO, Markus Rohrwild, for opening remarks.

1:15 Good morning. Welcome from my side. Q3 has been very strong for GoPra. We have significant advancements in our R&D pipeline, and we have also seen strong CO performance. On the biotech side, our two partner obesity programs advanced to phase two, a great achievement for Gupra. And also, we're excited to see our group UCM2, EUROCROTIN2 analog entering phase one clinical development. Moreover, the CRO has shown 6% growth year on year and our EBIT margin has significantly improved to 25%, which is great.

2:09 On top of that, we are actively evaluating multiple opportunities on the venture side to augment our innovation pipeline. You have probably participated in our recent R&D investor event and I'd like to again summarize our ambition for 2030. As we are scaling our differentiated drug discovery and development platform by 2030, we would like to see 8 to 10 clinical assets in our Pipeline as well as also bringing forward one to two drug development candidates from our internal drug discovery unit every year.

3:02 Moreover, we will be expanding our therapeutic flagship areas from our stronghold in metabolic diseases and obesity towards functional decline as well as inflammation and immunology. In addition, the company will create value by launching two to three ventures as well as continuing operating a growing specialist preclinical COO under high profitability. And with this, I hand over to the biotech unit, Louise. Yeah, thank you, Markus. So let's take a look at the biotech. And starting with the pipeline, What you see here is an overview of the Cupra R&D pipeline. And this growing pipeline is a direct result of the power and efficiency of a streamlined web discovery platform.

4:00 It covers both our internal proprietary, not yet partnered assets and assets that are being expressed through strong partners. To start with the internal proprietary assets, our most advanced asset is the long-acting UCN2 analog. Currently in Phase 1 for treatment of obesity. And at the same time, we continue to advance the next wave of future opportunities for GUPRA. So, then to the partner programs. This is assets that have been through strong partners with GUPRA collecting milestones and royalties as they progressed. We now have two assets within obesity in Phase 2 clinical development.

4:47 the long-acting ambulance analog with AbbVie and the triple-actionist with Berner Ingelheim. Both companies have initiated phase two this quarter. And at the same time, we continue to advance the next wave of future opportunities for Gruber with the leading biotech companies. This is assets that are being progressed by HEMA, Amelix and Camros, and they really illustrate the platforms for reproducibility and Frank Beckett are consistently evading differentiated acids across a broad range of therapeutic areas. But now let's take a look at some of these acids. Backed with the triple agonist, this acid is a long-acting first-in-class acid targeting the GLP-1, the GLP and the Y2 receptors to engage in complementary mode of action involved in body weight regulation.

5:45 The program was discovered in collaboration with Boehringer Ingelheim, and they're now solely responsible for advancing it through clinical development. And after having seen encouraging Phase 1 data showing a favorable safety profile and an encouraging weight loss profile, Boehringer Ingelheim has now initiated the Phase 2 study. The study enrolled approximately 350 participants, the six active dose groups, and primary endpoints is body weight reduction after 42 weeks of treatment. We really see this as further validation of the asset's potential and of Grigora's discovery capabilities. So next, let me turn to Amelent. And Amelent offers an attractive treatment alternative compared to current standard of care.

6:35 And the class of Amelent has been shown to deliver clinically relevant weight loss with a favorable tolerability profile. and that is exactly why we find this biology so compelling in context of APBV 295. APBV 295 is a differentiated long-acting amyloid analogue discovered at Dubreuil, out-licensed to AbbVie. And 295 has consistently demonstrated competitive clinical data throughout a comprehensive Phase I program. Early signs were seen already in the SAD study and further substantiated in the six-week MAD study, where six-weeks treatment with 295 delivered almost 8% reduction in body weight. In the 12-13-week MAD study, 295 delivered almost 10% reduction. And across all studies, 295 were well-tolerated, 8 were predominantly mild, VI-related and transient.

7:40 That's currently Another phase 1b study ongoing with 295 and the study will enroll a higher proportion of female participants and a broader BMI rate in this to get data in a more representative population. Sublime data here is expected in the first half of 2020. But now let's take a look at some of the data. So this shows a detailed overview of the data. from the 12th-13th week MAD Phase 1 study, presented recently by Abby at EASD. What you see is body weight reduction versus time, and you can see that 295 delivers a dose-dependent competitive body weight reduction of almost 10%.

8:31 I also want you to notice the yellow and the green dose cohorts here. Here, 295 are being injected every second week. And remember that this is in a patient population being predominantly male with a lower BI range. So collectively, what we see is that 295 delivers a competitive body weight reduction. It has a favorable safety and tolerability profile and micro-connective support. Even every second weekly dosing or even monthly dosing. And based on these encouraging results, AbbVie has now initiated the phase 2 trial with 295.

9:19 This is a comprehensive study enrolling approximately 360 participants with six active dose groups and primary endpoint is body weight reduction after 32 weeks of treatment. and this is to support timely dose selection for potential phase 3 studies. Our treatment will continue through week 52. So, beyond obesity, we also have three other highly interesting programs with strong partners. The HEMAT collaboration centers around the long-acting plasma inhibitors discovered in collaboration with HEMAT. This is the treatment of Third Leading Disorders, and HEMAX has now initiated the Phase 1 study with this asset.

10:06 In the AMLEX collaboration, we have discovered a long-acting GLP-1 receptor antagonist for treatment of post-bariatric hyperglycemia, and AMLEX is currently running the R&D-enabling activities here. And finally, we have the CAMRS collaboration. Here, a PTH analog is being formulated and Camus' Blue Crystal technology to develop long-acting treatments for patients with hyperparathyroidism. So collectively, these programs demonstrate the versatility of a platform to generate differentiated assets across multiple disease areas. And with that, I'm happy to turn over to Thomas, a CDMO, who will provide further details on a UCN2 program.

11:00 Thank you, Luisa. I am happy to provide more information about the Museum to Remember program. Obesity treatment is entering an era. Impotent therapeutics have demonstrated how much weight loss is possible with possible pharmacotherapy. The new opportunity is to really improve on what patients lose, what they maintain, and how they function.

11:48 Group UCN2 has the opportunity to address exactly that gap through improvement of body composition, reduction of body mass, reduction of fat mass, and maintenance or actually increase of lean mass. So let's have a look at the biology of UCN2. So UCN2 is an endogenous peptide that signals through a receptor called CRHR2. And the downstream biology involves target tissues that are relevant for the therapeutic strategy, in particular the adipose tissue and the muscle tissue. In the adipose tissue, UCM2 reduces fat mass and results in a reduction in serum triglycerides.

12:41 In the muscle, UCN2 drives antibiotic processes, inhibits muscle catabolism, and improves oxidative metabolism. And that together is the biological basis for thinking about group UCN2 in the context of obesity treatment and improvement of body composition. If validated clinically, this biology also opens up to explore other indications related to loss of muscle mass and muscle function, which includes muscle wasting conditions such as sarcopenia, but also functional aging, where we know that loss of muscle mass and function is relevant. The biology also extends beyond adipose tissue and skeletal muscle into the heart and into the kidneys.

13:37 In the heart, UCN2 improves cardiac output and cardiac function. In the kidney, UCN2 improves renal function, for example, diuresis and atresis. And these are biological processes that open up indication expansion opportunities into the cardioreal space as well. On the right hand side of the slide you see key features of GUP-UCN2, which is our drug product candidate. GUP-UCN2 is a 38 amino acid peptide. It's highly selective for CRHR2 receptor and has excellent physical and chemical properties. It is designed and formulated for once weekly subcutaneous administration.

14:29 So we have explored group UCM2 in a number of pharmacological studies of which we have really quite a few discussed at our recent investor R&D event last month. But I would like to explain a few key highlights from these experiments. On this slide, you do see the experimental results from a study in obese rats that tested group UCN2 as a monotherapy and in combination with tisapetide. And as you can appreciate, monotherapy with group UCN2, which is represented by the green bars, results in significant loss in fat mass, as shown in the middle panel, and a significant increase in lean mass, which is shown on the right-hand side.

15:23 This effect was overall weight neutral, but it tells you that even if you don't have an effect on body mass, you have a substantial improvement in body composition. Tessepatite alone results in the desired and expected reduction in body weight. These are the aqueous bars. and it is driven by a loss in fat mass predominantly. We do see, however, no effect or a slight trend towards reduction of lean mass, which is really undesired. If we now combine both treatments, as shown by the dark blue bars, we do see that we can maintain the body weight loss that has been achieved with just hepatite alone, But we have a significant improvement in body composition through further reduction of fat mass and an increase in lean mass.

16:16 We have tested the concept in combination with other incutin-based therapies such as semaclotide and also with amylin analogs, and the picture is exactly the same, which suggests that GUP-UCN2 might be a useful addition to available obesity treatments. We have also asked the question whether the muscle mass is actually an important part of the improvement in lean mass. And to that end, we have demonstrated that the muscle wet waste increase substantially in this particular model. and we have demonstrated that muscle volume increases through measurement using Gubra's three-dimensional light sheet imaging technology. And this really tells us that, yes, muscle mass is really a part of the improvement of lean mass that we are observing. So overall, the data that we have generated across preclinical models demonstrate that group UCM2 has the potential to be used as a monotherapy as a combination partner with other obesity treatments and potentially as a follow-on treatment once patients have achieved the desired weight loss with available obesity treatments.

17:39 So how do we now test that in the clinic? We have initiated a comprehensive phase one to eight trial in the clinic with the phase one FAD component currently ongoing. This is the trial that assesses the safety tolerability in PK, but also goes beyond that and will deliver early efficacy signals that are relevant to determine the further development strategy for group UCM2. The trial aims at the enrollment of approximately 188 participants. These will be healthy participants in the FAD portion of the trial and participants with obesity in the MAD and 16-week multiple dose portion of the trial.

18:27 These participants will have comorbidities or only obesity. We will test RUBUCN2 as monotherapy and in combination with incretin-based therapy to test how RUBUCN2 forms in different therapeutic settings. And as I indicated earlier, the treatment regimen will be based on a once-weekly subcutaneous administration. What is very important is that we will be looking at body composition and functional endpoints. Body composition will be evaluated based on MRI whole body scanning and functional endpoints will include a short physical performance battery but also strength of time muscles.

19:18 And this is important because it will help us to understand what part of the biology really translates from preclinical species into the clinic and will help us to inform the further expansion beyond obesity into age-related functional decline and potentially also cardio-renal indications. With that, I would like to hand over to Trina, our head of the CRO. Thank you so much. The CRO is Cooper's Core Value Enabler, an advanced synergies The CRO provides deep scientific and translational expertise, reproducible preclinical disease models and advanced technology platforms, and we deliver reliable, high-quality data and execution.

20:20 And in this way, we enable our customers, internal and external customers, to progress their drug discovery projects with speed and certainty. After a period of volatility and uncertainty in the market, the preclinical market is evolving in Gruber's direction again. Biotech funding has rebounded strongly in 2026, and more preclinical R&D has been outsourced, and we see that trend towards 2030 and beyond. And the scientific complexity in drug discovery projects Really increases the value of the differentiated services that we deliver in the CRO.

21:09 In Q3, the CRO has delivered a solid external revenue of 6% sequentially and year-on-year. Also, services delivered to our internal customer biotech business has increased significantly in Q3. and growth in both customer segments has contributed positively to substantial improvement in the EBIT margin that we've seen in Q3. We at 2026 have seen growth in our services delivered to large pharma companies. Obesity is still a larger segment. However, revenue in services related to diseases is up more than 60% for the first nine months of 2026 compared to 2025 and it's now a second largest segment.

22:06 We have a healthy order intake in Q4 and the commercial outlook for the remainder of the year is increasingly positive and we are excited about that. I will now hand it over to Kristian, our CFO. Thank you Steve and as everyone has seen it's been a great quarter for Goobra in Q3. This is the second best quarter in Goobra 3 so we're of course very pleased with that. I will provide just a few words on the Q3 results on the additional level and then I will take you through the outlook. Looking at the biotech business, again Q3 and strongly driven by the milestones from and Tori Engelheim also entering phase two, bringing milestone to Goobra.

22:58 And that, of course, also impacts that we have a very solid earnings business in Q3. Of course, if we compare the full nine months this year compared to last year, where we had the upfront payment from Adelaide, it is, of course, down. But again, a very strong buy-take year in 2016. Thank you very much. and Good Level 4 for Gruba. And I think it's important to understand this year, obviously, it has a lot of fixed costs. So whenever revenue goes up, it dips down to earnings quite immediately. So very good to see the momentum currently. And, you know, as Trina said, I sound a little bit The outlook, I'm just taking the buyback first at the top.

24:22 We reduced cost slightly, and that is mainly due to timing. So, but a very mild reduction. The external revenue, we've narrowed the range as we're now approaching day four here. Skyper 2 to 6% external revenue growth, and a needed margin of 10 to 30%. So, remember, If we have 25% and we were just having a small property in the first half of the year. Just looking at the anticipated news flow, and I think we covered most of the second half already, including, you know, very important messages from our biotech partners initiating phase two and phase one studies.

25:18 and looking into the first half of next year we have of course have UCN2 and also ADVI where there's potential for release of 1D data and similarly for HEMA the initiation of the phase one trial. So all in all repeating myself again a very strong order and with that we 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 Romeo Connor from Kempin.

26:06 Please go ahead. Hi team, thank you for taking my question. Congrats to all of you. I was wondering if you can help us understand how much of that improvement was driven by the higher external customer activity versus better utilization And how sustainable do you view this going into Q4? Because you also mentioned a healthy order intake supporting future growth. And with the kidney-related studies being a strong driver of Q3 growth, is that coming from existing documents or is this an area you expect to demand to remain strong?

27:04 Thank you.

27:14 So Trine, with regards to this question, maybe you take a start?

27:37 Sorry for that. We had that technical issue here. But two questions from Romy. Thanks a lot for those questions. The first one related to the EBIT margin. We will go to the question and then afterwards on the question related to kidney studies and whether that may be from new or existing customers. We will have the head of COO Trine some color on that. Go ahead, Kristian. Yeah, so the EBIT margin, so it is continuing to both growth in external studies and growth in internal studies. And again, as I mentioned, you know, it is a large-term fixed-cost business. So whenever we see both, you know, sound growth in external studies and internal studies, that has an impact on our margin.

28:24 So how we look on the E2-4? Thank you for the question on the customer segment within kidney diseases. We have seen growth over the last couple of years. It's a segment where we have a broad variety of different services servicing different customer segments, sub-segments in this segment.

29:12 And we do see the increase in services this year from both new customers and existing customers ramping up. and also both biotech companies and large pharma companies that are increasing their activity in the kidney area. However, it's a relatively small growth, but still it is a significant growth in this segment. Great. Thank you. Thanks so much. Thank you.

29:48 So we're ready for the next questions. The next question comes from Thomas Bowers from SEB. Please go ahead.

29:59 Yes, thank you. Two questions from me. So, first, just on the budget spending, would you be able to give a little bit granularity on 2017 compared to your current specific guidance process? Some spillover from the adjustments you just made here this morning, but possibly the thing about underlying RMD costs trajectory when we're looking at UCN to progress and also the proprietary pipeline, that would be very helpful. And then, just lastly, just in PI2, the PI2 question, or maybe just a reminder. So, PI is discontinued in obesity, still being explored in other indications. So, I'm just wondering, do you have any insight to whether Bering is actually advancing the assets, or just sort of remain in indication exploration state, or whatever you want to call it?

30:58 Thank you.

31:18 Thanks a lot for those questions, Thomas. I think the first question again here on the potential granularity around the underlying IMD costs, given the reduced guidance on operating costs for the biotech business, we will go to Kristian. And then afterwards, I think CSO Louise can provide follow-up on the NPY2 mono receptor agonist, which is considered neutral for obesity, but now it's growing potentially in other indications. But let's go with Kristian first. Yeah, so it is a very minor reduction to the expected cost in 206, so sometimes it is just a bit of timing when we expect those to occur. We have the biotech cost guidance for 207, and I think we will determine that when we have the annual, so I think I'll leave it with that.

32:12 Yeah, and regards to the Y2, that's the agonist that has been discontinued within obesity. It's true that there's still an indication, an exploration phase, and Berger will provide information about that when they have it, but we don't have any news to disclose now with regards to that.

32:38 and anything on your contract can give you back the asset. From that perspective, that's something that we will communicate about if such things happen.

32:54 That's not something we can provide a comment on for the time. But thanks a lot for the questions, Thomas. Thank you. Are we ready for the next questions? The next question comes from Theodora Roe-Beetle from Goldman Sachs. Please go ahead.

33:14 Hi, thank you for taking my questions. So firstly, on the CRO business, the updated full-year guidance range implies quite a large range in revenue growth rates for the bottom and top end for the fourth quarter. Now, I know 4Q25 was the trough for CRO, but would you be able to give us more colour on what the key drivers would be for you to reach the top end and the bottom end of the full-year revenue growth range? and then secondly could you just remind us of any milestone payments that we should expect for Goobra in 2027? Thank you. Thank you very much. Thank you.

34:49 Thank you Kristian and thanks for the questions for Dora. Any other questions? Then we're ready. All right, no further questions from the teleconference. We have one question in writing, I can see, so I'll just read it up here. You have a new pipeline project using 2-sacropenia, which is currently categorized at the pre-planning stage. In principle, you don't already, don't you already have all the necessary and produce enough API to be able to start a phase 1 trial, but that's using 2-project and sacropenia. So, is it simply the approval of a new protocol that is needed to initiate one clinical trial, or what would be the actual trigger point?

35:57 I think that question I will hand over to Chief Medical Officer Thomas to comment on. To cover yourself Adam, please. Thank you. So for sarcopenia, we would need additional information in order to set up a meaningful development program that indeed includes preclinical assessments on the exposure-response relationship, particularly with respect to effects on the muscle. This is a data package we are currently generating. And then we have, as I indicated earlier, set up the clinical program in a way to generate data that tells us what part of the biology is really translatable from preclinical species to humans. You might recall we have a very comprehensive assessment of muscle composition and muscle function included in our current clinic trial and results from that clinical trial will Thanks a lot and have a good day.