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, everyone, and welcome to Gubra's conference call covering our first half 2026 results. My name is Adam, new Head of Investor Relations at Gubra. And joining me today are members of Gubra's leadership team, who will take you through 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 would just caution listeners on Slide 2 here that we may make forward-looking 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 Gubra had a very good first half of the year across our entire business units. Gubra Biotech significantly advanced our R&D pipeline. And in the CRO, I think while we still have work to do, I see a promising trend based on new commercial initiatives and also continued cost discipline. And we have also now established a platform for Gubra Ventures. This is a new business unit at Gubra, and we are currently evaluating multiple deals. And over the next couple of months, I hope we can announce the first Gubra Venture. At this point, I'd like to remind you that our business model is unique based on three synergistic business units. Gubra Biotech discovers and develops new peptide therapeutics up to clinical proof of concept. Gubra Ventures invests in exciting science adjacent to our flagship areas and our CRO 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 3 of them. AbbVie reported highly encouraging Phase I MAD results for the long-acting amylin. I think this is very robust data and the start of the Phase II is imminent. Boehringer Ingelheim has already advanced the triple agonist in clinical Phase II. And we now have initiated an ambitious Phase I/IIa trial for our fully owned GUB-UCN2 program, our new mega program. And with this, I'd like to hand over to Louise.

Yes. Thank you, Markus. So let's take a look at our StreaMLine platform and how it enables our growing pipeline. So Gubra, 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 [Technical Difficulty] analysis, and this is combined with high throughput wet lab screening of multiple peptide libraries. So we use multiparameter 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 Gubra 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 I. Additionally, Boehringer Ingelheim has initiated Phase II development with the triple agonist and AbbVie still plans to initiate Phase II in Q3. Simultaneously, Hemab has expressed that they expect to initiate first-in-human trials with HMB-003 in the second half of '26. And likewise, we have concluded the fourth collaboration project with Boehringer Ingelheim, a very early target discovery program. So at Gubra, 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 3 of our most advanced anti-obesity assets, so they are 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 health care 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 incretin-based treatment. The focus on the current wave has been to maximize body weight reduction and improve tolerability. Here, we've seen the introduction of complementary and alternative mode of actions. We've seen the 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 lean mass, it's muscle, its bones, it's internal organs. So it's all the tissue that we would ideally like to preserve when we are 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 Gubra's pipeline is strategically positioned to meet these emerging trends. So 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, GIP and Y2 receptors to engage in complementary mode of action involved in body weight reduction. This asset was discovered in collaboration with Boehringer Ingelheim, who now has sole responsibility for driving it forward. And after seeing encouraging Phase I data that demonstrated a favorable safety and tolerability profile along with encouraging weight loss, Boehringer Ingelheim has now initiated the Phase II in development yet. 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 assets' potential, but also Gubra's peptide discovery capabilities. So next, we have ABBV-295, the long-acting amylin analog that is now out-licensed to AbbVie. A core differentiator with the amylin class of compounds is the potential to deliver clinically relevant weight loss with a better tolerability profile. So this means that amylin may represent the next distinct class of drugs for chronic weight management. ABBV-295 has consistently shown competitive results throughout a comprehensive Phase I program. The data from the MAD study was top line data was presented by AbbVie in March and here ABBV-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, ABBV-295 also revealed the potential for less frequent dosing. So here, comparable weight loss was observed with every second weekly dosing or even once monthly dosing. In addition, ABBV-295 had a favorable safety and tolerability profile, adverse events were predominantly GI mild and transient. So the data from this study will be presented at EASD in September. Currently, ABBV-295 is being tested in an ongoing Phase Ib trial in people with obesity, higher BMI range and higher proportion of female participants and AbbVie still plans to initiate Phase II in Q3. And with that, I'm happy to hand over to Thomas, our CDMO (sic) [ CMDO ], who will talk more about our UCN2 program.

Thank you, Louise. So now let me turn to what makes GUB-UCN2 so compelling. So GUB-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 tissue, the main target tissue for UCN2, it drives the buildup of muscle through anabolic and inhibition of catabolic effect, which also has a positive impact on insulin sensitivity. And further evidence really points towards additional cardiorenal benefits as laid out on the slide. For me, there are actually 2 key takeaways on that slide. First, GUB-UCN2 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 a functional benefit to patients through improvement of strength and physical performance. And that really opens up two really compelling and attractive development path. On one hand, using GUB-UCN2 as a differentiated monotherapy on the other hand, in conjunction with incretin-based therapies. The second key takeaway is that the opportunity is not about obesity alone. As I indicated, we have multiple effects on very differentiated tissues, which gives us the opportunity to develop GUB-UCN2 into multiple indications, in particular, if you are thinking about muscle wasting conditions and cardiorenal diseases, which gives GUB-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 the use case for GUB-UCN2, where we investigated it as monotherapy and in combination with semaglutide in rats with obesity due to high fat diet. On the left-hand side, you can see that GUB-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 GUB-UCN2. 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 setting. 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 GUB-UCN2 really dramatically changes the composition of the weight loss that we are seeing in combination therapy. This is really a very, very attractive drug profile, right, 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 Gubra, right, moving a compelling preclinical package into a clinical opportunity. We have now initiated a very comprehensive Phase I/IIa clinical trial where we enroll healthy participants, but also people living with obesity and move the assessment from the single ascending dose to a multiple ascending dose and a multiple dose part with up to 16 weeks of treatment duration. Importantly, we are assessing GUB-UCN2 as monotherapy and as combination therapy with an incretin. So in addition to the typical Phase I 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 cardiorenal diseases. So we will be able to speak more about the development program of GUB-UCN2 at our upcoming R&D event on October 27. So with that, I would like to conclude and hand it over to Zoë, our Head of Gubra Ventures.

Thank you, Thomas. So now we turn to Gubra Ventures, which is our value accelerator. And the message here is simple. We are using our internal engine to create additional routes to value via external innovation. So why are we doing this? Well, Gubra 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 Gubra's core. The second is expansion into new diseases and new technology areas. The third is return via future exits for 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, Gubra is really uniquely positioned to build on the credible foundations that we've built and amplify those to produce these value accelerators. 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, Gubra will be bringing -- Gubra 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 Trine.

Thank you so much for that, Zoë. The CRO is continuously an important value enabler for Gubra. For many years, we've had a strong record of solid growth and profitability, building best-in-class services for serving our customers, both externally and internally. 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 pharmas globally. They really chose 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, MASH and kidney platforms. And now we're introducing -- 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 scientific expertise and the trusted 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 outsourcing trend among pharma companies, especially. And this is really driving demand in our industry. 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 U.S., we are expanding and combining this with a cost discipline, we really focus on regaining momentum. We've grown 11% since first -- second half of 2025. 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 MASH and kidney studies, which is improving the commercial outlook for the second half of the year. So overall, we see -- we are 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 that 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 CRO business, revenue will occur when we perform the studies, not uncertainty just if we recognize revenue. Just as a clarification. So with that, 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 payment -- upstream upfront payments occur and when milestone payments occur. And -- in the first half of '26, we had some milestone payments, but totaling DKK 30 million, but not, of course, to the same level as last year where we had the upfront payment from AbbVie of DKK 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 EUR 10 million from start-up of the Phase II for the triple agonist from Boehringer. So a very important payment that will -- that is already recognized in the books for Q3. Taking the CRO business, as Trine said, we have seen a sequential improvement with 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 Gubra's earnings and revenue in the CRO business. Just as you saw in '23 and '24, there was a lot of influx of smaller clients in Gubra 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 turned 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 there we guide DKK 330 million to DKK 360 million. CRO business revenue growth, we expect growth in the range of 0% to 10% and an EBIT margin 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 Gubra Green. With that, I give the word over to Markus to speak a bit about the news flow going forward here. Please, Markus.

Thank you very much, Kristian. I'd like to end with the next value inflection points for Gubra, and I believe we are entering an exciting period of growth. The next important milestone for us is the start of Phase II for the long-acting amylin. 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 I MAD 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 trial, the SAD part. We will initiate the second part, the MAD part. And what is also exciting is the Phase Ib top line data for ABBV-295. I want to point out that this is in patients with -- which are truly obese up to BMI 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 Hemab, also the first compound will enter first in human studies. On top of that, we will announce our first venture and I'm confident that we will see rejuvenated growth out of the CRO as well. So taken together all those already achieved milestones and our confident outlook, we have all good reasons 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 Gubra Investor R&D event on October 27 in London. I will talk about the growth strategy, our ambitious growth strategy. We will talk about our pipeline, give some updates. We will present our UCN2 development strategy, 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.

[Operator Instructions] The next question comes from Thomas Bowers from SEB.

A few questions from my side here. So maybe just on UCN2. So the trial is now listed on ClinicalTrials. And I note that there's only one center now recruiting patients. So should we expect this to be a multicenter study? And how about the U.S. 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 MAD on -- of the Phase I/IIa. So -- 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 should we also expect you to have data from potential cardiorenal patients with cardiorenal comorbidities? And then lastly, on UCN2, just to understand the incretin part, the combination here. Are you looking to sort of mirror the standard incretin titration? Or are you may be aiming to just go with a fixed low-dose incretin and then use that on top of the UCN2 titration? I'm a little bit curious on how you actually plan to combine this initially. And then my last question, just on the CRO business. So you're expecting a recovery in second half. Are this also reflecting that we could maybe come back to expecting double-digit growth beyond '26?

Thanks a lot for those questions, Thomas. So I think the first 3 questions on UCN2, clinical trial site, single center versus multicenter and some trial design specific questions, we will go to Thomas. And then afterwards, a question on the CRO business, we'll go to Trine. But Thomas, on UCN2.

Yes, I'm happy to take the questions on UCN2. Thank you for that, Thomas. So with regards to the clinical trial site, we have deliberately selected one site for the current trial. And the reason for that is that we have really complex endpoints, right, around muscle function, muscle volume that really requires expertise at the site. We currently do not plan to expand beyond the site, but we will see how the trial is going to progress. With regards to the overall development strategy and details to the clinical trial, Thomas, we will certainly provide an update at the October 27 R&D Day. 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 incretin 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 on CRO 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 follow guidance in the second half of 2026. Looking into '27, what we have been working on in 2026 is expanding our model portfolio to stand and be ahead of the curve on important growth areas relevant in the market, combined with our cost discipline and the initiatives we have taken on that side. So in '27, I am -- my hope is to get back to the long-term guidance, which is 10% growth. This is our ambition.