Gubra A/S (CPH:GUBRA)
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May 6, 2026, 4:59 PM CET
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Earnings Call: Q1 2024

May 7, 2024

Operator

Thank you. I will now hand the call over to Mr. Henrik Blou, Chief Executive Officer. You may begin your conference.

Henrik Blou
CEO, Gubra

Great. Thank you very much, operator. It's a pleasure for us to present here today. I'm joined by Gubra Co-Founder and current CSO, Niels Vrang, and also CFO, Kristian Borbos. And today, we will, of course, be focusing on the first quarter of the year. And, first of all, zooming in, Gubra, what kind of company are we? So really, we are specialized in preclinical services. We've built a core research engine. We have the testing facilities, we have all the labs needed to conduct the analysis when you develop novel drugs. And our area of specialty, that's metabolic diseases. And this core research engine, we can use for two, or we are using for two purposes. One arm of the company is delivering services to biotech and pharma companies who are developing new drugs towards metabolic diseases.

So that's one arm, that's the CRO arm of the company. The other arm of Gubra, that's our discovery and partnerships. This is where we use the, this core research engine to mature our own ideas for new therapies, new drugs. We mature them to the right level, and then we partner with biotech and pharma companies. So these two arms goes very well hand in hand, and there are a range of synergies for us when running our business in this way. So as of today, we are approximately 220, and actually a little more. As now, we are growing rapidly. Employees, most of them, located here in Hørsholm, north of Copenhagen, Denmark. We have, in the service business, more than half of our revenue from customers located in the United States.

We are in the CRO, servicing a range of biotech and pharma companies, and we either have or have had 15 out of top 20 pharma companies in the world on the customer list. So zooming in on the recent highlights, in Q1, we experienced very significant growth of the revenue in the service business, 51% up compared to the same quarter last year. The obesity services were the main driver of this growth, and we definitely feel the increased interest in general across the industry in obesity and especially when it comes to delivering services to other biotech and pharma companies. Really, obesity is the driver. However, we are also, of course, still delivering services within other diseases, such as MASH and other metabolic diseases.

So in the discovery and partnership arm, we have our most advanced non-partner program, that's the amylin program, which is in phase I. We dosed the first patient a little more than five months ago, and that program is progressing according to plan. Also recently, we revealed the target for one of our other obesity pipeline programs, UCN2, and that program is focused on healthy weight loss. These two programs, we will hear a lot more about today when Niels Vrang will share you some more details on that one. Also, recently, at.

As of today, actually, we announced that after July first, the new CSO, Chief Scientific Officer of Gubra, will be Louise S. Dalbøge, and she's currently the Research Director in Gubra and has a long history within Gubra, and has been a key player in developing the pipeline that we have today. That means that our current CSO, co-founder, Niels Vrang, will transition into a new role as scientific advisor to the executive management. However, all this is only to be activated on July first. So zooming in on the core competencies of Gubra, it all started out within diabetes, within obesity, and from there, we've grown into other metabolic diseases, other related disease areas, such as MASH. And we've also built up an extensive catalog of kidney models.

We are setting up IPF lung models, and also we have heart models, brain models, and a range of other services that we deliver. We're also a very technology-driven company. We have a range of very sophisticated technologies that support the research that we are doing. A key strength of Gubra is that we have in-house the in vivo testing facility, and also in-house, we have a range of laboratories used for testing, and that means that we control the research, the studies that we conduct from A to Z, and therefore, we control speed and quality, and that has high value, both in the internal research programs and also when we deliver services to our customers.

And with that, I will hand over the word to our CFO, Kristian.

Kristian Borbos
CFO, Gubra

Thanks, Henrik, and this is just a repeat of what Henrik said, really. You know, we had a great start to the year in growing the CRO business by more than 50%. And the main driver, as Henrik talked about, was the obesity area. And the obesity area, I don't think has become unnoticed by anyone, that there's a very big drive within the whole pharma and biotech industry to develop new compounds in this area. That, of course, benefits Gubra, since, you know, obesity is a stronghold that has been ever since the company was formed back in 2008. So, we're clearly reaping the benefits of being a strong player in this area.

Having strong revenue, it filters down to our earnings, and we had an EBIT margin for the CRO business of 39% in the first quarter. And actually, in absolute terms, it was a doubling of the EBIT level compared to the same quarter last year. So all in all, very good start to the year. And as you'd also mentioned, we'd also see other disease categories growing apart from obesity, but obesity has been the strongest driver in the first quarter. With that, I'll leave the word over to Niels. Niels, please.

Niels Vrang
Co-Founder and CSO, Gubra

Yeah. Thank you, Kristian. Now it's time for a slight change. We'll start by discussing overall our discovery and partnerships business, the D&P segment of Gubra, where we discover, design, and develop peptide-based drug candidates. And we have developed this streaMLine platform over the past 4-5 years, where we actually combine the best from wet lab with the best from machine learning and AI, and this has enabled us to, you can say, accelerate peptide drug candidate identification in this machinery. Also, it has enabled us to enhance and build stronger patents, to secure better IP.

And by having this automated almost platform built up, it also enables us to have a much richer pipeline and actually develop more programs in parallel than we could before with the same number of people. If we go into our pipeline and take a look at that, we have currently five active partnerships. We have four with Boehringer Ingelheim. One is currently tested in a clinical trial in combination with both semaglutide and survodutide. And then we have one that's on its way through preclinical development, and we have two earlier programs with Boehringer in the drug discovery phases.

A testimony to our streaMLine platform is actually the fact that we have a collaboration with Danish biotech Hemab, that's working with bleeding disorders, and they are using our streaMLine platform also to identify potent and long-acting peptide drug candidates. When we look into our own programs, and these are the six green programs that we have shown here, we have, of course, our amylin program that I will tell you a little bit more about. Then we have this newly revealed UCN2 program for healthy weight loss that I will also dive into and show you some preclinical data. We have a GLP-1 agonist program, and we have another obesity program. We also have a program for the two rare disorders.

One, the narcolepsy, and the other is hypothyroidism. These are still in drug discovery, and I'll not come into, or go deeper into that, today. So for our amylin program, as Henrik rightly mentioned, we are in phase I-A with this program, and we are quite excited about the progress of this. It's progressing according to plan. I just want to highlight a few features of this drug when it's given to obese rats. We don't have readouts from our phase I-A study in humans yet. That's also mainly a safety study.

But if we dose this compound to overweight rats, and this is the purple line you see in the middle, the GUBamy compound alone, we can see a substantial weight loss following daily treatment of this molecule for four weeks. However, if we combine it with either a GLP-1 analog alone, a GLP-1 GIP analog, as like tirzepatide, or a GLP-1 glucagon analog like survodutide, we can see a very nice additive weight loss. So suggesting that the GUBamy can be used as a combination partner for any one treatment that is containing a GLP-1 agonist. If we then look at the where we are right now with our first in-human study, we are in phase I-A, as I mentioned.

It's a randomized, placebo-controlled, single-ascending dose trial, and primarily, we are looking for safety readouts, but of course, we will also gain information about pharmacokinetics, and also some pharmacodynamic readouts, and that includes effects on certain hormones. It also includes effects on gastric emptying and potential, some effects on, on weight, although you never know, before you see that. We have included lean to overweight, but otherwise healthy subjects. It's in males. We have, up to six cohorts, so up to a total of 48 subjects, and we are running the study in the U.K. with Quotient Sciences.

First cohort, as Henrik also mentioned, was administered last year at the end of the year, and we are now into the third dose group, and we are enrolling key cohorts and expect to be finalized with that mid of this year. We also anticipate top-line results in the second half of 2024. So again, primary objective, safety, but of course, also some secondary objectives. I will skip immediately now to our other healthy weight loss program, the UCN2 program, and I'll go slightly deeper into the details of that program.

So today, we know that weight loss, there are certain, there are definitely weight loss, drugs on the market that leads to a very substantial weight loss, and that's also, why they have become so successful. A part of this weight loss, however, is also, the fact that you not only lose fat, but you also lose, 20%-30% of lean mass. So that's muscle, bone, different things like that. Of course, it would be great if we could somehow minimize, the loss of lean mass and maximize a lot of fat mass. And the UCN2 program, we aim to do, exactly that. We have data, from preclinical models that I'll show you in a little bit, that supports, primarily loss of fat and actually an increase in lean mass.

So UCN2 is a peptide that acts on actually, the native peptide acts on both, on two different receptors, but we have created a molecule that only activates the CRH2 receptor, so it has no activity at all on the so-called stress receptor, the CRH1R receptor. And we have created a molecule also with excellent properties. So it's an excellent molecule that is very stable and can be formulated, and also can be delivered, according to our models that we use preclinically, as a once weekly injection, in humans. This molecule has excellent properties in the sense that we have seen that in animal models, that it leads to increased fat mass loss, actually an increase in lean mass and indicates that it's muscle, and it also improves glucose homeostasis.

So it does have effects that is very well suitable for treatment of metabolic disorders. It has also shown effects in some animal models on kidney function, in animal models with a diabetic kidney disease, and it also has some positive effects on heart and cardiovascular function. So here are some data, and I'll just try to explain them from the left going to the right. So if you look, this is a study done in DIO rats. In rats, we don't see a long-lasting effect on total body weight. As you can see to the left, the green lines, that is animals dosed with the UCN2 molecule in different doses.

You can see that there is an initial loss of weight, but that weight is regained so that they end up with the relatively same weight as the control animals. However, if we look in the middle graph, you can see that lean mass, so that's muscle mass, bone mass, et cetera, is actually increased when we dose with this molecule. And at the same time, if you look on the right and remember, please, that these are obese rats, you can see that there is a decline in body mass, in fat mass in these animals. So you see a shift from fat to lean mass, which is definitely beneficial in a number of different aspects.

If we look on also a relatively complicated slide here, if we look on the effect of this molecule either alone, if you look on the left graph, you can see that given alone, there is no substantial effect in these obese rats. And if we give it together with either cagrilintide, this is an amylin analog, semaglutide or semaglutide, you can see that there are effects on body weight. They are not additional effects it appears on body weight. But if you look in the middle, you can see that the slight loss of lean mass that you see with cagrilintide or semaglutide alone can be prevented if you give the UCN2 analog together with this. These are the two bars to the very right in the middle panel.

And if you then look on the loss of fat mass, these molecules, of course, give rise to a fat loss on their own. But if you add this UCN2 molecule on top, you can see that the fat mass loss is actually increased. So this suggests that this molecule has beneficial effects on lean mass and fat mass loss, and that it is well suited for combination with other molecules, either of amylin origin or of GLP-1 origin. And this is just to sum up on our, you can say, expenditures in our discovery and partnership. We are, of course, pushing these very promising molecules forward. So that's why we have a slightly increase in our costs in Q1.

We also expect to increase costs slightly throughout the year in our D&P segment. With that, I will hand over the word to Henrik.

Henrik Blou
CEO, Gubra

These investments in green assets. One thing that we're currently looking into, trying to get the permission for, is a solar power panel site in order for us to generate the electricity that we are using on site here.

And with that, I will hand it over to you, Kristian, for the final financial remarks.

Kristian Borbos
CFO, Gubra

Yes. So we round off on a strong note. So, yesterday we raised our financial guidance for this year business, and now we expect a revenue growth of 15%-20%, compared to the expectation of 10%-15%. And in the same manner, we also increased the expectation to the earnings, EBIT margin, now expect 28%-31% for the full year for the CRO business, compared to 25%-28%. So, that's, you know, a function of a very strong first quarter and a solid situation when we look at the order book. As Niels mentioned, on the discovering partnership side, we increased the cost slightly for developing the UCN2 within healthy weight loss.

We also, you know, move as quickly as we can on the GUBamy, so that it is slightly higher cost. So we increase the total cost expectation by, say, around 10% for the D&P business. I think that's concludes our presentation, and I just leave the word over to Henrik, too.

Henrik Blou
CEO, Gubra

Great. Thank you very much for listening so far, and now we are ready to take questions if you have any questions in the room.

Operator

Thank you. We will now begin the question and answer session. If you have dialed in and would like to ask a question, please press star one on your telephone keypad to raise your hand and join the queue. If you'd like to withdraw your question, simply press star one again. If you are called upon to ask your question and are listening via loudspeaker on your device, please pick up your handset and ensure that your phone is not on mute when asking your question. We'll pause for just a moment to compile the Q&A roster. Thank you. Our first question comes on the line from Martin Parkhøi from SEB. Please go ahead.

Martin Parkhøi
Head of Equity Research, SEB

Yes, good morning, gentlemen. Martin Parkhøi, SEB. Just a couple of questions. First, on the growth in the CRO business. You were so kind to wait with the Q1 growth yesterday until today, while you gave the guidance yesterday. So, could you just provide us with some insight to why you're seeing this steep deceleration to growth in... I understand that you're not should not guide 51%, but still, that's a long way from 51% in the first quarter and down to 15%-20% for the full year. So what have you seen in the order book right now that makes you sure the guidance will be back on maybe the original guidance level for the last three quarters?

And then secondly, just on the additional investment in the API for the GUBamy. You say that could potentially speed up development time, and maybe you could elaborate a bit on that. Thirdly, if I may, then just we have since your last quarter seen some activity for some of the big guys, Novo and Lilly, increasing interest in the amylin area, latest with the Lilly starting at phase II. How do you see that impacting the partnership potential for your compound?

Henrik Blou
CEO, Gubra

Thank you very much, Martin. I will be starting out here. So first of all, for the question with regards to the revenue guidance for the CRO. So, we are in a period with a regrowth. We saw very nice growth last year, and we've also seen that here in the first quarter. And we are adding with growth, we did that from the beginning of the year, now we have increased that growth guidance. So, so we definitely we are in a period of growth. Also, we see that going forward, that's the best estimate we have. That's why we have increased the guidance.

However, we also know from our history in this space, that the CRO services, there is some variation from one month to another, and it's difficult to predict the growth half a year from now. So, what we've given now is within a very solid guidance based on what we've seen, a nice influx of studies to Gubra in Q1, in also late last year, and still a nice activity. So we believe a growth this year of 15%-20% is a very solid estimate for where we will end the year. So with regards to investments in API, that's the GUBamy program, so the amylin program, and really that is putting on the glasses for the longer perspective.

We, we have started API production for activities on the other side of the current plan, clinical studies. Really, that's to ensure that there is no loss of time for a partner when partnering this program, that there will be adequate API present. It takes some time to make a new batch of API, and that is why we have initiated this activity already now, front-loading some costs, and thereby ensuring that there will be no loss of time further down the road for the GUBamy program. The last part of your question was this activity we see right now across the industry and the interest in amylins.

And we think Gubra is in a strong position. There are not that many amylin programs around. Across the industry, amylin is a somewhat difficult molecule to work with, and that's also why we're very pleased that we have so strong features built into our amylin drug. So yes, we do see a high level of activity, high level of interest in general across the obesity space. And as we are generating the SAD data, we are, of course, also ensuring to speak to the various parties across the industry and ensure that they are up to speed on our programs. And eventually, when we think the timing is right here, we will also be pursuing a partnership for this program as well.

So yes, definitely positive that we see all this energy and interest in the obesity space.

Martin Parkhøi
Head of Equity Research, SEB

Great, thank you very much. And then, just a follow-up to the UCN2 assets. Maybe a twofold question on that one. How far do you expect to take this through development now, starting preclinical toxicology studies? But what are your plans after that? I guess that you are increasing cost for the asset this year. So should we also expect similarly higher cost for this asset next year? And then maybe also to Niels. What do you see of similar assets out there in the industry?

Niels Vrang
Co-Founder and CSO, Gubra

All right. So yeah, you know that our model is partnering when the best opportunities are there. So, we don't know yet how far we'll take this asset, but we will definitely move it forward now. That's all we have said. And then we'll see how far we'll take it before the right partnering opportunity opens up. For when you look broadly, speaking on the UCN2 molecule and the UCN2 agonist as such, they have actually been in clinical development previously, some years back. That was very short-acting molecules, and that was in the cardiovascular space.

But there are companies taking similar assets forward, not necessarily with the exact same indication as we have, but we have something which is, we see a nice position for this in the healthy weight loss space.

Martin Parkhøi
Head of Equity Research, SEB

And just a final question from my side, and then I let others get to the table. Just, of course, we see all these clinical data from the two big guys and some everybody trying to break the duopoly. And we've seen Amgen bringing, you know, a longer-acting product potentially to market once monthly, maybe even longer. Are you also working on, you know, in early research on molecules with higher, longer frequency than just once weekly?

Niels Vrang
Co-Founder and CSO, Gubra

We are always working on optimizing all parameters that is at all possible, and that includes different administration routes, but it definitely also, of course, includes as long half-lives as possible. And we're looking into this at all times.

Martin Parkhøi
Head of Equity Research, SEB

Thank you very much, and have a good day.

Niels Vrang
Co-Founder and CSO, Gubra

Thanks.

Operator

Thank you. Our next question comes on line of Joseph Hedden from RX Securities. Please go ahead.

Joseph Hedden
Equity Analyst, RX Securities

Good morning. Thanks for taking my questions. You spoke about obesity being the primary growth area for the CRO business. Just wondered if you could put some numbers to that. What kind of growth did you see for the obesity offering versus the other areas? Are they all growing, or are there some areas that are more flat? And is that a result, do you think, of the demand around those services, the general market demand or a need for expansion of those offerings? And then just staying with obesity, what kind of capacity do you have to absorb any further increase in interest in the space? Thanks.

Kristian Borbos
CFO, Gubra

Thanks, Joseph, and it's Kristian. I take the first question. So we've seen, I mean, solid development in almost all disease categories. It's just been that obesity has been, you know, a bit stronger than the other ones. And again, obesity is also quite a large area within Gubra, so it's been the, you know, the biggest growth contributor for this particular quarter. But we also see, you know, some development in the other disease categories. So again, 51% growth is not only driven by obesity, there's also other areas.

Henrik Blou
CEO, Gubra

Sorry, could you repeat the second.

Niels Vrang
Co-Founder and CSO, Gubra

I can take that. So that was regarding the capacity for increasing taking up the influx of requests in the obesity area. And what I can say is that we just recently opened a new animal facility which has increased our, you can say, capacity with about 50%. So we have actually ample of room right now to take in more orders. And it's all about actually. Of course, it's also about staffing up at the same time as studies are flowing in.

So it's not like we don't want to triple or quadruple anything, but we want to make sure that we can deliver and the same high quality that we always deliver and not taking in too many orders, and not essentially focusing on what we have always focused on, not disappointing a single client. That's the most important part, but at the same time, of course, also increasing the number of studies that we deliver.

Joseph Hedden
Equity Analyst, RX Securities

Okay. Thank you very much.

Operator

Thank you. There appear to be no further questions.

Henrik Blou
CEO, Gubra

Great, thank you everyone for listening in. It was a pleasure presenting to you today, and we're looking forward to our next interaction after the next quarter. Thank you.

Operator

Thank you. This concludes today's conference call. We thank you for participating, and you may-

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