Novo Nordisk A S (NVO) M&A call, October 20, 2025 transcript

And welcome to this conference call regarding the agreement to acquire a cure of therapeutics that we announced earlier today. My name is Jakob Rode, and I'm the head of investor relations at NOVO NORDISK. And with me today I have CEO of NOVO NORDISK, Mike Duster, Executive Vice President, Product and Portfolio Strategy, Ludovic Helfgott, Executive Vice President, Research and Development, and Chief Scientific Officer, Martin Holst Lange.

All speakers will be available for the Q&A. Today's announcement is available at our website, novonordis. com. Please note that the call is being webcasted and a recording will be made available on our website. The call is scheduled to last for approximately 30 minutes. Today's presentation, lasting for around 10 minutes, will be followed by a Q&A session where I kindly remind you that the focus of the call today is on the agreement to acquire a care of therapeutics. Next slide please.

Before I hand over to Mike, 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 our forward-looking statements and risk factors, please see the company announcement for the first six months of 2025, which was released on August 6. And with that, over to you, Mike.

Thank you, Jakob. Please turn to the next slide. Earlier today, we announced that we have entered into an agreement to acquire Acuro Therapeutics. This is the largest research and development related acquisition in the history of NOVO NORDISK, reflecting the strong strategic and scientific fit to our core areas within diabetes, obesity, and their associated core mobilities. The acquisition includes ICERO's late-stage MASH acid, ifroxyformin, or EFX. Over 80% of MASH patients are overweight or obese, making this indication especially relevant for the strategy and the purpose of our company.

NOVO NORDISK is no stranger to the MASH space. In August, we firmly established our presence in this obesity-related comorbidity with the U. S. approval of Vigobi for the treatment of MASH in adults with moderate to advanced fibrosis. As Lulu will tell you, while there has been advancement within the space, there are over 250 million people who are impacted by MASH globally, and therefore, plenty of work to do in developing innovative treatments. The combination of Acuro's robust R&D done to date with EFX, as well as NOVO NORDISK expertise in developing innovative medicines, including the deep knowledge of obesity-related comorbidities, makes this particular acquisition an exceptional fit. Integrating EFX into our portfolio supports NOVO NORDISK long-term strategy of developing innovative medicine and for treating millions of more people living with diabetes, obesity, and their associated comorbidities.

To further elaborate on the unmet need, as well as the commercial opportunity that this will bring, I would like to pass it to Ludovic.

Thank you very much, Mike, and please turn to the next slide. This is indeed an exciting day for NOVO NORDISK, CURO Therapeutics, and most importantly, for the millions of patients worldwide affected by MASH with limited treatment options.

MASH is a serious, progressive metabolic disease where advanced degrees of fibrosis are associated with poor outcomes and a high economic burden on the healthcare systems. As Mike noted, over 250 million people globally are affected by MASH, and prevalence is growing. The progression of disease is classified by stages of fibrosis from mild, F1, to a compensated cirrhosis, F4. Current available treatments, including Wigovi, treat those who fall within the F2 to F3 space. With around 20% of F3 patients advancing to F4 within two years, there is A very narrow window for these patients to receive effective disease modifying treatment. We're excited about the progress of FIGOV, the world's first GLP-1 receptor agonist approved for MASH. Yet, there remains a substantial unmet need for therapeutic interventions.

And this need is particularly pronounced for patients with S4 cirrhosis, where there are currently no treatments available. And there remains an opportunity as well to treat non-responders to the existing treatments in the F2 and the F3 stages. The frixisperamine is a potential means to that end. In addition to promising phase 2 data in the F2 to F3 segment, it is the only FGF21 analogue that has demonstrated fibrosis regression in the late stage A4 segment in a long phase 2 trial, which Martin will elaborate on shortly. We therefore believe that Efretisermine has the potential to become a leading treatment option within the treatment intensification segment of MASH, with efficacy anticipated to out-treat that of Incretins as monotherapy in late-stage fibrosis cases.

Overall, the MASH market is in early stages, and we aim to develop a portfolio spanning across the diseases stages of MASH. Now, Martin, I'll turn it over to you.

Thank you very much, Ludovic. Please turn to the next slide. As already alluded to by Mike and Ludovic, we're very pleased to announce the agreement to acquire Acuron and ephroxyfermin, a once-weekly subcutaneous long-acting FGF21 analog with potential to be not only first but also best in class in the F4 segment. Ephroxyfermin complements a strategic position in NOVO NORDISK MASH pipeline, with MASH being one of the most prevalent and underserved obesity-related comorbidities.

Ephroxyfermin has today demonstrated positive top-line Phase 2b results with a regression of fibrosis and MASH resolution in patients with F2 to F3 as well as F4.

Furthermore, Ephroxyfermin appeared to have a safe and well-tolerated profile in its Phase 2 program. The HARMONY Phase II trial evaluated the FROXID-FERMIN in an F2-F3 population, where 49% of patients achieved fibrosis improvement of at least one stage with no worsening of mesh, and 37% achieved mesh resolution without worsening of fibrosis. Over 96 weeks 29 of the F4 patients in the symmetry phase IIb trial achieved fibrosis improvement of at least one stage with no worsening of mesh In addition the trial showed that 42 of the F4 patients reached mesh resolution without worsening of fibrosis This marks efroxyfermin as the first and also only treatment to demonstrate statistically significant fibrosis regression in a F4 patient in a Phase II trial Please turn to the next slide.

The ongoing Phase III synchrony program is built upon the promising Phase IIb studies of afroxyfermin examining its effects across all mass stages. The first readout of synchrony real-world is anticipated as early as next year. This is expected to be followed by the pivotal synchrony histology trial in F2 and F3 in the coming years and synchrony outcomes for the F4 population around the turn of the decade. As a result, Afroxyfermin has the potential to be the first in class FGF121 analog targeting the F4 population, As well as play a role in F2 to F3 patients, including people who are not responsive to existing treatments.

We look forward to leveraging our capabilities to further optimize the synchrony program trials, assess the potential combinations with our current GLP-1 portfolio, explore opportunities for additional indications, and ultimately aim to bring the first pharmaceutical treatment to market in the F4 With that, I would like to hand it over to Mike for final remarks.

Thanks, Martin. Next slide, please. As we've mentioned throughout this call, the acquisition of Acero and its lead asset is a tremendous strategic fit to our current offering and portfolio, where NOVO NORDISK is uniquely positioned to unlock its full potential. MASH represents a patient segment that's closely linked with those of our core therapy areas. While it is one of the most prevalent comorbidities in obesity and diabetes, it is also one of the most underserved.

FGF21 agonists are emerging as the most promising non-incretin mechanisms of action in the clinical development within MASH. More importantly, afroxyformin is the only one to demonstrate reversal of fibrosis in the F4 stage, which represents the most challenging yet urgent disease segment to treat. On a personal note, this marks the first acquisition since I took over as a CEO of NOVO NORDISK. While many external factors are challenging us on a day-to-day basis, part of my job is to ensure the progress of our long-term aspiration of ensuring leadership in diabetes and obesity and their related co-morbidities. We can only do that by raising the innovation bar to bring innovative medicines to the market and thus impact millions of patients worldwide.

Today's acquisition further strengthens the possibility to do so, which I truly am excited about. And with that, back to you, Jaco.

Thanks a lot, Mike. Next slide, please. And with that, we're now ready for the Q&A session, where I kindly ask all participants to limit her or himself to one question. I remind that the focus of this call, including the Q&A session, is on the agreement to acquire a cure of therapeutics announced earlier today. And with that, operator, we're now ready to take the first question, please.

Hey, Harry, thanks a lot for that. I'll give that to you, Martin, on self-ferment learnings and the competitiveness of EFROXA-Ferman.

Absolutely, thank you very much. So first of all, Harry, I think you've heard at least me talk about from in the GLT-1 space, GLT-1 is not just a GLT-1. We see differences across the different offerings in the GLT-1 space. And based on our own learnings from San Fermin, we tend to see the same in FGS-21. So, as you know, we have discontinued our own internal program, and we saw a clear differentiation between that and the EFROXA-FERMIN, but we also tend to see a superior efficacy and potentially also safety tolerability profile with EFROXA-FERMIN compared to what we've seen out there so far. So we believe that with this acquisition we not only have what has the potential to invest in class, but also, and this is obviously a timing perspective, first in class because it is a more progressed program.

And to your point, then also somewhat more de-risked.

Thanks for that, Martin.

And with that, we are ready for the second set of questions, please.

Thank you for that question. I'll hand that to you, Ludo, on the complementarity to the portfolio.

Absolutely Thank you very much for the question I think the real objective here is to be able to cover a wide range of patients with MASH across the portfolio I think you rightly point out that semaglithides we believe has the best data to date on F2 and F3 But we also know that two things are important in order to really complete the treatment of these patients First is the F4 and the absence of any alternative in the F4 but transplants, which we know have a huge burden on the patient but also on the healthcare system. So there's definitely here the core of the value proposition. I would also say that you have some patients in F2 and maybe even more in F3 that are either poorer responders to the incretin world or that are fast progressors.

And these patients need a treatment as well. So if you sum up the essence data that was shown by Wegovy and MASH, and the data that could be shown here with the chiro-flex firming compound in this subpopulations of F2, F3 that are either non-responding as much as we want to in Cretins, or fast progressives, and the core of it, the FC, you can clearly see the continuum of patients being covered. That's where we believe we can make a difference by this portfolio play. Thank you so much.

Thank you, Ludovic, and Martin briefly adding a few comments.

Yeah, I think it's important to add that we have data from the ephroxyfermin phase 2B trials where a number of patients, one-third of patients, were on a baseline GLP-1 treatment that we see added effect when ephroxyfermin is introduced, so suggesting additivity in this space, which obviously excites us a lot.

Thank you, Martin. And also thank you to you, Simon. Then let's go to the third question, please.

Yeah, thanks very much, Pete. I think I've alluded to both. We have early data suggesting that combining GLP-1 and FGF2N1 potentially is additive in terms of efficacy, and we will definitely explore that. We will also get some data out of the ongoing trials as a number of patients already aren't GLP-1s in those trials. But specifically, obviously, we want to leverage the full portfolio of what we do.

There is already an ongoing trial, and you can actually see that in ALP, and we are currently exploring potentially additional indications, but I don't want to go into that at this point in time.

Thank you, Martin. And thank you to you, please. Let's move on to the next question, please.

Thank you for those, Connor. On the first one with Vigovie uptake in Mesh in the U. S. , it's still early days. And for an update on that, we'll revert after the Q3 call. For the topic of this call, we'll turn to Akira and we'll turn to Ludo on potential for future deals.

Absolutely. I think that Mike said it early on. We are committed to help patients with diabetes, obesity, and their comorbidities. And as long as you see comorbidities with a strong overlap with the core patient populations we're targeting in diabetes and obesity, we'll of course be open to deals. If they are innovative, if they really change the games, if you really have the potential to have a leader in the market. So there's absolutely willingness to continue being in the forefront of the race to innovation, both internally and externally, and in obesity, diabetes, and their associated co-mobility.

That's very clear, Ludo, investments in innovation. Thanks a lot, Connor, and let's move to the next question, please.

Thanks a lot, Mike. Martin, on different mode of actions with the mesh, I'll turn to you.

Thank you very much. So I think it's clear, given the glucagon mechanism of action, we expect to see an impact on steatosis. Exactly how that will read out in fibrosis and outcomes, I think it's too early to say. We are obviously also curious to look at the safety and tolerability profile. I think vis-à-vis potential combination, but also to be honest, in monotherapy FGH21 or FGH21 plus GFP1, we do believe that there is a potential to be best in class as we communicate it, and this is why we strongly pursue these combinations.

Thank you, Martin. Very clear. And let's move to the next question, please. Thank you also to you, Mike, for the question. Let's move to the next question, please.

Thanks for those Mike Stretching your luck with two questions but on those I turn to you Ludo on IP first We can share too much but on IP and then on manufacturing On this one we not sharing On the operating manufacturing side you very right it is not in the platforms but we do not expect to have any capex investment from that perspective We believe in the market today, players with which we could work and CMOS with which we could transact in order to make sure to get the product to patients. But we are not forecasting any capex on the Ecoli platform. Absolutely. So that's a capacity and nothing on IP concerns. So thanks for that, Michael.

And let's move to the next question, please.

Thanks a lot. I think on the CVR, we don't go into specific details. You were right on the data indication tiering, and I think maybe I'll turn to you, Martin, to speak about the synchrony trial in F4 overall.

Yeah, so you're right. As you know, the FDA has a setup, and we know that also from F2 and F3, and we are currently following that setup in F2 and F3 also for the ESMIS trial for WIGOE, where we get a, so to speak, conditional approval or accelerated approval based on histology, that's fibrosis and steatosis. But then you have to also generate outcomes data that's a composite of liver-related endpoints, liver-related death, and CV death. And that's where you see these longer studies.

Thanks a lot, Martin, and thank you also to you, Seamus. And let's move to the next question, please.

Thanks a lot, Thibault, and for that I'll give it to you, Martin.

Yes, thank you very much. Very relevant question, but too early for us to speculate in. Sorry.

Thanks a lot, Thibault, and let's move to the next question, please.

Thank you very much for the question. I would start by saying that first of all, this is an investment in our portfolio. It's something which is important for the future of our overall development of our franchise. And that should be maybe the leading thought when coming into that. If you look at 25, we're not expecting any change in the EOP for 25. We might have a minor cost in Q4 linked to the R&D line and the transition cost, but it's nearly nothing. In 2016, as you saw rightly, we're expecting a negative sort of minus 3% impact on the EOP growth driven by the increased R&D cost. This is really, again, an investment on the R&D cost for the phase three trials that Martin was alluding to earlier on.

So that's what we are right now planning.

Thanks a lot. Thank you, R&D, investments in potential future growth. That's very clear. And thank you also to you, Florent. Then with that, I think we are ready for the last question, please.

Thanks very much, Matthias. So we have been looking at a number of assets for a long period of time. Things didn't start with me taking over as a CEO, but of course, it reflects the fact that, as Martin and Ludovic said, that we are continuously in the outlook for best-in-class and possibly first-in-class assets within our strategy. Today's announcement was a confirmation of what we have figured out, that we have actually something in our hands that we could be very proud of, hopefully help develop it, and bring it to the market. I think it's extremely exciting because it is an asset that not only will help millions and millions of patients very closely connected to the strategy and the leadership we would We'd like to sustain and grow, but also I think it's a very important building block for strengthening our top line as we get closer to the LOE of semaglutide.

So I'm super excited about today's news.

Thanks a lot, Mike. That's very clear. And also thanks for the question. Then with that, we're ready to conclude the Q&A session. We'd like to thank you for calling in and participating. Thanks a lot and have a good day.