Good day, and thank you for standing by. Welcome to the Novo Nordisk conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star one and one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one and one again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Michael Novod, Head of Investor Relations. Please go ahead. Thank you, operator. Good day, welcome to this Novo Nordisk call regarding the top-line results of the REDEFINE 4 phase III trial. My name is Michael Novod, I'm the Head of Investor Relations at Novo Nordisk. With me today, I have CEO of Novo Nordisk, Mike Doustdar, EVP, Research and Development, and Chief Scientific Officer, Martin Holst Lange. 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 4 data announced today, and no further details will be discussed. Today's call is being webcast 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 CagriSema 2.4 mg compared to Tirzepatide 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 CagriSema 2.4 mg versus Tirzepatide 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 1 and REDEFINE 2 phase III trials. As Tirzepatide 15 mg treatment was only commercially available in a pen format, REDEFINE 4 employed an open-label design, in which all investigators and participants were informed of the specific drug administered during the trial. In this trial, CagriSema did not achieve the primary endpoint of non-inferiority of percentage change in body weight relative to Tirzepatide. Beginning from a mean baseline weight of 140.2 kg, if all people adhere to treatment, CagriSema 2.4 mg achieved a 23% reduction in body weight after 84 weeks. In comparison, Tirzepatide 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, CagriSema performed in line with REDEFINE 1. Surprisingly, the comparator performed unusually well on efficacy compared to what has typically been reported in most previous trials of a similar nature. We've noted earlier that not all learnings from REDEFINE 1 to achieve the optimal clinical benefits of CagriSema 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 CagriSema was consistent with data from previous REDEFINE clinical trials. The most commonly reported adverse event in the trial for both CagriSema and Tirzepatide were gastrointestinal related and were generally mild to moderate in severity. These data further support the added benefit of CagriSema, offering clinical meaningful effects to what we have shown with semaglutide biology alone. CagriSema 2.4 mg was submitted to the FDA for obesity in December 2025, based on the REDEFINE I and II trials, we look forward to a decision later this year. The REDEFINE program for CagriSema continues as we aim to explore the full weight loss potential of these complementary biologies. The REDEFINE 11 trial read out is expected during the first half of 2027, we plan to initiate the phase III trial of a high-dose CagriSema in the second half of 2026. With that, I will hand it over to you, Mike. Thank you, Martin. Please turn to the next slide. CagriSema in obesity will allow us to further build upon the Wegovy brand, where we aim to provide patients with multiple treatment options to fit their weight loss and lifestyle needs. Not only does CagriSema 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. It also improves weight loss with the added benefits of amylin. As Martin mentioned, we continue to push the innovation bar with the ongoing and planned phase III trials for CagriSema and CagriSema high dose. CagriSema 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 Wegovy pill. As you know, we have launched the Wegovy pill in the U.S. as the first and the best-in-class oral GLP-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 Wegovy high dose, where we will further maximize the weight loss of semaglutide all the way up to 21%. Wegovy high dose is now approved in EU and U.K., and a U.S. decision is expected by the end of Q1. At the same time, Novo Nordisk continues to drive next generation obesity innovation in our pipeline, charging ahead on the next generation GLP-1 amylin, zenagamtide, where we saw up to 24% weight loss after just 36 weeks in phase II. This product will be available to patients both in forms of injection as well as oral offering. You should also know that we will leverage all the learnings from the REDEFINE program in the zenagamtide phase III AMAZE program, which we just initiated. Furthermore, we will offer our patients cagrilintide monotherapy as a potential option for flexible co-administration and a fewer side effects. Last but not least, we also have two exciting triple agonist 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 Novod. 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. Thank you. To ask a question, you will need to press star one and one on your telephone and wait for your name to be announced. To withdraw your question, please press star one and one again. We will now take the first question. Your first question today comes from the line of Mike Nedelcovych from TD Cowen. Please go ahead. Hi, thank you so much for the question and for the update. My question is about your overarching hypothesis about CagriSema. You've reiterated that REDEFINE 11 could reveal CagriSema's full weight loss potential. I'm assuming there were data points from REDEFINE 4, similar to those from REDEFINE 1, suggesting that efficacy may have been left on the table. Did you once again observe a dichotomy between rapid responders and slow responders, just as an example, and can you confirm whether there was a discrepancy between the arms in REDEFINE 4 in the proportion of patients that reached the target dose? Thank you. Thanks, Mike. That's a question for Martin around learnings going into REDEFINE 11. Yeah, thank you very much, Mike, for that question. 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 CagriSema, and therefore potentially not the full weight loss benefit. That is also something that we see in REDEFINE 4, 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 REDEFINE 11, and therefore we, as we also previously discussed, we couldn't do that, take those learnings into REDEFINE 4. We could do that for REDEFINE 11, and therefore we had to really guide the, the full weight loss potential will be derived from REDEFINE 11. Great. Thank you very much. Next question, please. Thank you. Your next question comes from the line of Michael Leuchten from Jefferies. Please go ahead. Thank you. I'll stick to one question. Could you just talk about the non-inferiority margin you applied and how it was derived in REDEFINE 4? Thank you. That's a question for Martin as well. Yeah. Again, we're not really going into to the data. Of course, we applied a non-inferiority margin. We did not fully achieve that, 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 CagriSema, we also are a little bit surprised about the 25% weight loss that we see with the comparative drug. Great. Thank you very much. Next question, please. Thank you. Your next question comes from the line of James Quigley from Goldman Sachs. Please go ahead. Great. Thank you for taking my question. Martin, could you speculate on why the Zepbound data actually looked better than they did in the early trials, as you said? Was the flexible protocol not applied to the Zepbound arm? Again, following up on the first question, sort of was it 100% of patients just on the 15 mg dose throughout the trial? Again, if flexible dosing was not applied in this case, for Zepbound, why? What happened there? Thank you. Yeah. Thank you. Thank you very much, James for that question. Obviously, we are still investigating the data, but what we can see already now is that, that, yeah, just to step back, both treatment arms received the, the same flexible dosing. And while not disclosing the data at this point, it is very clear that more patients reached the 15 mg dose at some point during the trial for Tirzepatide, as compared to the CagriSema. 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 comparator 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 comparator drug. In part, we probably also had to do ascribe this to biology. These data have never been shown before, as far as I've seen in previous studies. So obviously, this is the one-off. Obviously, we, we, we don't fully appreciate that it happens in our study, but that is what it is. Great. Thank you. Thank you, Martin. The next question, please. Thank you. Your next question comes from the line of Peter Verdult from BNP Paribas. Please go ahead. Yeah, thanks. Peter Verdult, BNP. Mike, just one for you. Just a simple one, but important. You know, at launch, later this year, how are you gonna look to actually differentiate CagriSema, given the data you have right now? And just to kind of squeeze on very quick one, yes or no question, any appetite to redo REDEFINE 4 at either a higher dose or with a more forced titration schedule? Thank you. Yeah. 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. 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 CagriSema's label. 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 that, you know, the 25% or so that we're talking about is neither in their label, nor has it been really seen in their own trials, 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 commercializations. We strongly believe that CagriSema has right now, the best weight efficacy than any product currently in the market. So that, 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, you know, the product is going to be in the in the market. That will help. We also have made no secret, and I think Martin just alluded to it, that we are designing the CagriSema with the higher dosages of it. And you have seen what happens to semaglutide when it goes from 2.4 to 7.2. And, and you could do your own modeling, what that means. So I'm still incredibly optimistic about CagriSema. When you put it in the context of the semaglutide molecule, you know, 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, you know, and, and now, of course, sema with amylin, call it, you know, at at least minimum 23%, we have shown, you know, 2 x that, that shows the projection. Next to it, of course, is the oral offering at 17%. 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, Martin. Your, your appetite- Consideration. Yeah, sorry. Thanks, Mike. Sorry? Yeah. Appetite for doing additional trials, like REDEFINE 4. 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 REDEFINE 11, 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. Thank you. Great. Thank you very much. Operator, next question, please. Thank you. Your next question comes from the line of Harry Sephton from UBS. Please go ahead. Brilliant. Thank you very much for taking my question. Do you have any comments on the relative tolerability profile of the 2 products in the study? Maybe just to touch on, CagriSema again, not getting to the high dose as much as tirzepatide. Could that just be simply a tolerability issue? In this instance, you have a less well-tolerated product with lower weight loss. Thank you. Great. A question for Martin regarding tolerability. Yep, thank you very much. The tolerability that we see in this trial, both for CagriSema, but also Tirzepatide 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. That also makes us believe, because when I say that more patients at some point reach the highest dose of the comparative drugs, 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, that the potential difference in dose 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 comparative drug, rather than any difference in safety and tolerability. Great! Thank you very much. Next question, please. Thank you. Your next question comes from the line of Emmanuel Papadakis from Deutsche Bank. Please go ahead. Thank you for taking the question. Yeah, commiserations on the result. I mean, maybe a question around longer term dynamics. CagriSema looks somewhat obsolete now as a competitive upgrade semaglutide, especially with the 7.2 available, as you mentioned, or as a competitive alternative to Tirzepatide. What can you do to accelerate the zenagamtide? Excuse me, the new name for amycretin. Where are your confidence levels that will look a more convincing solution relative to CagriSema? Thank you. Thank you, Emmanuel. Question for Mike regarding how we want to optimize and also look at the commercial potential for next generations. Yeah, I, I think, Emmanuel, to, to say it's obsolete is quite belittling a, a fantastic drug, in all honesty. Again, when CagriSema will make it to the market early next year as the first amylin-based product, it will have the best weight loss label than any mark, any product marketed at that time. Let, let's start with that. It will have the best weight loss label than any marketed product at that time. Of course, we basically know that sema high dose has now 21%. Let's, let's take the latest results at CagriSema at 23%, but the CagriSema 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. That's the REDEFINE 11. We'll see what the number is once that trial plans itself. We also have said inside CagriSema, that you have seen in, in all of these trials, including REDEFINE 11, there's only 2.4 mg of semaglutide. We are starting a trial soon with 7.2 mg semaglutide in that. Then, basically, you will see that, you know, the life cycle management of CagriSema will pan itself as it is. That's all on the injectables. It has nothing to do with the, 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, so that has its own. There is no other pill that has 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, so they have the small molecule efficacy. So that, I think, is, but that's a whole different, you know, topic on its own. Then you're speaking to zenagamtide, amycretin, which is the whole next generation of the products were coming after CagriSema, and that will also show its benefits. We are taking all the learnings, as I mentioned, from these REDEFINE studies into the AMAZE trial studies, and then you'll see the benefits of that as well. Then last but not least, stand still for the results of the triple agonist that we will basically announce in due course. We have 2 triple agonists, and we are incredibly excited about that as well. Thank you very much, Mike. Thank you. Over to the next, question. Thank you. Your next question comes from the line of Carsten Lønborg Madsen from Danske Bank. Please go ahead. Yes, thank you very much. So the CagriSema high dose that you will be initiating, 2.4, 7.2, what does your internal modeling say about adding 7.2 mg similar to cagrilintide? Why don't you also increase the cagrilintide dose in that trial? Thank you very much, Carsten, and question for Martin on higher dose CagriSema. Yeah, thank you very much, Carsten. I'll 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 the CagriSema 2.4 + 2.4 mg, and with a comparable safety and tolerability profile. Clearly an upside on the efficacy, potentially without having to compromise on safety and solubility. From that perspective, that is a very attractive option then, because we have tested higher doses of cagrilintide in combination with semaglutide without seeing added benefits on weight loss. Therefore, based on everything that we know, also from the STEP UP trial, it makes sense to increase the dose of semaglutide, but not necessarily amycretin. Sorry, cagrilintide. Great. Thank you very much, Martin. Thank you. Over to the next question, and we have one question left. Thank you. Thank you. Your next question comes from the line of Martin Parkhøi from SEB. Please go ahead. Yes, thank you very much. Just on the same topic, of course, you know, last year you also announced that you would drop your DUEL V, where you had tirzepatide as an active comparator. Now we see these results today, and I note that if we look at the trials that you so far have on your 419, you use semaglutide as an active comparator. In AMAZE, you use semaglutide as an active comparator. Haven't you just realized that you cannot beat tirzepatide, and you're using semaglutide as the active comparator going forward? Then just to follow up on the 419, can we talk a little bit about what your goal are with this with respect to are you going for a best-in-class side effect, or is it weight loss that you're going for on that one? Thank you, Martin. 1.5 question to Martin. Yeah, yeah. So, we, we, we obviously will do, compare, comparator studies, when, when there is that opportunity. I think clearly you've heard both me and Mike talk about the open-label nature of REDEFINE 4, and the potential for substantial bias that is introduced, both on the efficacy, potentially also on safety and tolerability, when, when reporting on that. An ability to do head-to-head comparisons with a competitor drug would require the ability to blind. That obviously we are working on as we speak. Great. Thank you very much, Martin. With that, sorry, and 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. Thank you. Thank you. This concludes today's conference call. Thanks for participating. You may now disconnect.