Novo Nordisk A S (NVO) FY 2026 earnings call transcript

Good day and welcome to this NOVO NORDISK call regarding the top-line results of the Redefine IV Phase III trial. My name is Michael Novart, and I'm the head of Investor Relations at NOVO NORDISK. With me today I have CEO of NOVO NORDISK, Mike Duster, and EVP Research and Development and Chief Scientific Officer, Martin Holzlange. All speakers will be available for the Q&A session.

Please note that this call and Q&A will be related to the top-line Redefine IV data announced today, And no further details will be discussed.

Today's call is being webcasted live, and a recording will be made available on our website. The call is scheduled to last around 30 minutes. Next slide, please.

As usual, we need to advise you that this call will contain forward-looking statements. These are subject to risk and uncertainty that could cause actual results to differ materially from expectations. For further information on the risk factors, please see the company announcement for the full year 2025 and the slides prepared for this presentation.

With that, I will turn it over to Martin.

Thank you, Michael. Next slide, please. Redefine 4 was an open-label trial investigating the efficacy and safety of Cacrosemma 2.4 mg compared to Tisabatide 15 mg. The trial was mainly conducted in the U. S. After incorporating some of the learnings from Redefine 1, the study was extended to 84 weeks of treatment, while all other parameters were left unchanged.

The primary endpoint for Redefine 4 was to confirm non-inferiority of caracusema 2.4 mg versus tisepatide 15 mg. The trial included around 800 people with obesity with one or more comorbidities. Both treatments were administered once weekly with subcutaneous dosing, with the same dosing regimen as in the Redefine I and Redefine II phase 3 trials. As the Sepatide 15 mg treatment was only commercially available in a pen format, Redefine IV employed an open-label design, in which all investigators and participants were informed of the specific drug administered during the trial. In this trial, Cagrycema did not achieve the primary input of non-inferiority or percentage change in body weight relative to disepatide.

Beginning from a mean baseline weight of 140.2 kilograms, if all people adhere to treatment, Cagrycema 2.4 milligram achieved a 23% reduction in body weight after 84 weeks. In comparison, tisepatide 15 mg resulted in a 25.5% weight loss over the same period. There are many factors that could contribute to the Redefine 4 outcome.

First, Cagre-Sema performed in line with Redefine 1. Surprisingly, the comparison performed unusually well on efficacy compared to what has typically been reported in most previous trials of similar nature. We have noted earlier that not all learnings from REDEFINE-1 to achieve the optimal clinical benefits of CACOSEMMA were implemented into the REDEFINE-4 protocol. In addition, as I mentioned, REDEFINE-4 was an open-label trial which has the potential to introduce bias in favor of a well-established, well-known product when it is compared to an investigational therapy. The safety and tolerability profile of Cagre-Sema was consistent with data from previous redefined clinical trials.

The most commonly reported adverse events in the trial for both Cagre-Sema and Tasebutyde were gastrointestinal related and were generally mild to moderate in severity. These data further support the added benefit of Cagre-Sema offering clinical meaningful effects to what we have shown with semaglutide biology alone. So, Cagrysema 2.4 mg was submitted to the FDA for obesity in December 2025 based on the Redefine I and II trials, and we look forward to a decision later this year.

The Redefine program for Cagrysema continues as we aim to explore the full weight loss potential of these complementary biologies. The Redefine 11 trial reads out and is expected during the first half of 27, and we plan to initiate the phase 3 trial of a high-dose Cagrysema in the second half of 2026. That, I will hand it over to you, Mike.

Thank you, Martin. Please turn to the next slide. Cagrysema in obesity will allow us to further build upon the Vigobi brand, where we aim to provide patients with multiple treatment options to fit their weight loss and lifestyle needs. Not only does Cagrecemia provide patients the efficacy, safety, and health benefits clinically proven by semaglutide, including established evidence-based risk reductions across certain cardiovascular, renal, and liver diseases, but it also improves weight loss with the added benefits of aminone. As Martin mentioned, we continue to push the innovation bar with the ongoing and planned Phase 3 trials for Cagricema and Cagricema high-dose.

Cagricema, importantly, builds upon our current offerings within the semaglutide family, now with more choices for patients seeking weight loss therapy. One of those new choices for patients is our Vigobi pill. As you know, we have launched the Vigobi pill in the U. S. as the first and the best-in-class oral GOP-1 with a weight loss close to 17%, and we have shared with all of you how great that launch has been so far. Another option for patients is the Vigobi high dose, where we will further maximize the weight loss of semaglutide all the way up to 21%. The GOLD-V high dose is not approved in EU and UK, and a US decision is expected by the end of Q1.

At the same time NOVO NORDISK continues to drive next obesity innovation in our pipeline charging ahead on the next GLP amylin xenogamotide where we saw up to 24 weight loss after just 36 weeks in Phase 2 This product will be available to patients both in forms of injection as well as oral offering You should also note that we will leverage all the learnings from the redefined program in the xenogamotide phase 3 AMACE program, which we just initiated.

Furthermore, we will offer our patients cagrenotide monotherapy as a potential option for flexible co-administration and fewer side effects. And last but not least, we also have two exciting triple agonists advancing through the clinics, which have the potential to offer even higher weight loss. We will share more of that in due course. Now back to you, Michael.

Thank you, Mike. Next slide, please. With that, we're now ready for the Q&A, where I kindly ask all participants to limit her or himself to one question, including sub-questions. Operator, we're now ready to take the first question.

Thanks, Mike. That's a question for Martin around learnings going into Redefine 11.

Yeah, thank you very much, Mike, for that question. And we're not going into further detail on the data, but I think it's fair to say that what we've seen in Redefine 4 very much resembles what we see in Redefine 1, a robust around 23% weight loss and a good safety and tolerability profile. As we also discussed with Redefine 1, and as you pointed out, not all patients reached the full dose potential of CACRASM and therefore potentially not the full weight loss benefit. That is also something that we see in redefined form, and therefore we are strongly assuming that there is a further weight loss potential to be had when taking all of these learnings into account.

We've done that in redefined 11, and therefore, as we also previously discussed, we couldn't do that, take those learnings into redefined form. We could do that for redefining 11, and therefore we have to really guide that the full weight loss potential will be derived from redefining 11.

And that's a question for Martin as well.

Yeah, so again, we're not really going into the data. Of course, we applied a non-inferiority margin. We did not fully achieve that, and therefore we've seen the data that we have. I think it's important to point out that we see a consistent and robust 23% weight loss with cashmere, but we also are a little I'm a little bit surprised about the 25% weight loss that we see with the comparative drug.

Thank you very much, James, for that question. Obviously, we are still investigating the data, but what we can see already now is that, just a step back, I think both treatment arms received the same flexible dosing, and while not disclosing the data at this point, it is very clear that more patients reached a 15 milligram dose at some point during the trial for tisabatide as compared to cacusemia. We do believe that that is largely derived from the open label nature of this study. We do know and we've seen that numerous times before that open label studies drive bias. In this case, more than 40% of the investigators are previous investigators on the comparative drug. They know the drug well.

They have probably prescribed the drug, and they feel confident in the drug. We know that drives the bias, and that's maybe why we have seen these surprisingly good data for the comparative drug. But in part, we probably also had to ascribe this to biology. The data had never been shown before as far as I've seen in previous studies. So obviously, this is the one off.

Yeah, so thanks very much. A couple of things. First of all, you have to go back to how products are sold, and they're sold according to their label. So the label that we have is, of course, based on not this trial, but the previous one, and the label that our competitor has also is below, basically, the Cagre-Semmars label. So I think we need to just be aware that there is an abnormality with this trial and how the comparator product has done. And that abnormality and the 25% or so that we're talking about is neither in their label nor has it been really seen in their own trials or any other trials. You could even argue not in the real world evidence.

So that I think the market figures that out as we go forward. The clinical experience of the physician and the label trumps anything and everything else when it comes to commercialization. We strongly believe that Kagris SEMA has right now the best weight efficacy than any product currently in the market. So that is a very strong belief. Now, going forward, of course, as I mentioned, we will very quickly and soon release the data from Redefine 11 when they're available early next year, not long after the product is going to be in the market. That will help. But we also have made no secret, and I think Martin just alluded to it, that we are designing the Cagrycema with the higher dosages of it.

And you have seen what happens to semaglutide when it goes from 2.4 to 7.2. And you could do your own modeling what that means. So I'm still incredibly optimistic about Cagriss SEMA. And then when you put it in the context of the semaglutide molecule, where you have basically now current SEMA in the market at some 15%, 16%, high dose of SEMA, which is coming up at 21%. And now, of course, SEMA with Hamelin call it at least minimum 23%. We have shown two times. That shows the projection. Next to it, of course, is the oral offering at 17%. So I think the brand recognition here and the increased percentages as we're getting more and more is how we're going to treat this product when it comes to the market.

Thanks, Mike. And Martin for the consideration.

Yeah, sorry. Thanks, Mike. Sorry? Yeah. Appetite for doing additional trials like redefine form. So obviously we have to look at the data and understand the data as both Mike and I alluded to. We do believe that we now understand the biology and the optimal way of using this biology in clinical trials. That basically means that we expect to see a potentially higher weight loss with redefining lab, but we're also investigating higher doses.

When we see the outcomes of those data, I would not rule out that we would do additional head-to-head studies.

Yeah, thank you very much. So the tolerability that we see in this trial, both for CAC waserma, but also his hepatite is in line with what we've seen in previous studies. Obviously, we don't have full insights into the comparative drug, but very much in line. And that also makes us believe because when I say that more patients at some point reach the highest dose of the comparative drug, it doesn't necessarily mean that they stayed on that dose, but they did then achieve the weight loss potential with that dose. We do believe that the potential difference in those levels is more derived from the open label nature of this trial, and the fact that a great number of the investigators were very familiar with the comparison drug, rather than any difference in safety and solubility.

Again, when Kagrysema will make it to the market early next year as the first amylin-based product, But it will have the best weight loss label than any product marketed at that time. Let's start with that. It will have the best weight loss label than any marketed product at that time. Then, of course, we basically know that SEMA high dose has now 21%. Let's take the latest results at Cagri-SEMA at 23%, but the Cagri-SEMA 23% is with the design trial that Martin has now alluded to, and we have multiple times mentioned to you that there is an upside to that when the design of the trial is less flexible. So that's the redefine 11. We'll see what the number is once that trial plans itself.

But we also have said inside Cagrisemide that you have seen in all of these trials, including the redefine 11, there's only 2.4 milligrams of semaglutide. We are starting a trial soon with 7.2 milligrams semaglutide in that. And then, basically, you will see that the life cycle management of Cagrycema will pan itself as it is. So that's all on the injectables. It has nothing to do with the pill. The pill is doing phenomenal. I think it's the first and the best-in-class pill that you will see for a very, very long time to come. So that has its own. There is no other pill that, as shown, can get anywhere close to the 17% weight loss. And we have explained that also.

It's the only pill that's a peptide. All the other stuff is small molecules, so they have the small molecule efficacy. So that, I think, is a whole different topic on its own. Then you're speaking to xenogamotide amacritin, which is the whole next generation of the products that were coming after Cagre SEMA, and that will also show its benefits, and we are taking all the learnings, as I mentioned, from these redefined studies into the AMAZ trial studies, and then you'll see the benefits of that as well. And then last but not least, stand still for the results of the triple agonists that we will basically announce in due course. So we have two triple agonists and we are incredibly excited about that as well.

Thank you very much, Karsten, and a question for Martin on higher dose Cacrylncide.

Thank you very much, Karsten. I will not guide exactly what our model says on the weight loss potential, but let's say that it's more than what we've seen with Cacosema 2.4 plus 2.4 mg and with a comparable safety and solubility profile. So clearly an upside on the efficacy potentially without having to compromise on safety and solubility. And from that perspective, that is a very attractive offer of manobitone. We have tested higher doses of cagrillentide in combination with semaglentide without seeing added benefits on weight loss. So therefore, based on everything that we know also from the step of trial, it makes sense to increase the dose of semaglentide, but not necessarily emigretin. Sorry, cagrillentide.

Great, thank you very much, Martin.

Thank you, Martin.

And one and a half question to Martin.

Yeah, so we obviously will do comparative studies when there is that opportunity. I think clearly you've heard both me and mine talk about the open label nature of redefined form and the potential for substantial bias that is introduced both on the efficacy, potentially also on safety and tolerability when reporting on that. So, an ability to do head-to-head comparisons with a competitor drug would require the ability to blind, and that obviously we are working on as we speak.

Great, thank you very much, Martin.

And with that, this concludes the Q&A session. Thank you for participating, and please feel free to contact Investor Relations regarding any follow-up questions you might have. Over to you, operator.