NewAmsterdam Pharma Co N.V. (NAMS) May 13, 2026 Conference Transcript

Well, good afternoon. Thank you for joining us on our first day of the annual Bank of America Healthcare Conference in extremely toasty Las Vegas. Ending up our final talk of the day is I'm very pleased to have joined us, the team from New Amsterdam. So this is Ian Somia and BJ Jones, Chief Commercial Officer. Gentlemen, thank you so much for joining us. Yeah, thanks for the invite. Right. Maybe just to start at a high level for those maybe not as familiar with the New Amsterdam story, can you give us a brief overview of the company and Obiseptrip?

Sure. It's been an exciting couple of years. Obviously, we've shared a lot of data with you from our phase three studies for both of our lead programs, Obiseptrip, as well as the combination with azetamide. And really the goal is to help redefine how patients with elevated LDL are being treated today. The data from the phase three studies has been quite consistent with the monotherapy showing somewhere between a 35% and 40% reduction in LDL. The combination with benefit, that's in the 50% range. And the benefit goes beyond LDL. So that's, you know, when I said the opportunity is to redefine the care of patients, is looking at the LDL plus characteristics of the drug. So it's the roughly 50% reduction in LP delay. It's the improvements that are driven by the HDL raising profile of the drug, which include the reduction in the rate of nuance of diabetes, the improvement in kidney function that we recently reported at the ACC, as well as the early Alzheimer's signal, which we're going to be further exploring in short order in a Phase IIb study. So that gives you a sense for kind of what we've shared over the past two years. More recently, and specifically last week, we provided an update on our outcome study where based on an evaluation of the blinded data, What we're continuing to see from now up through the two-year mark is a continued decrease in the overall event rate, which is obviously quite encouraging, although the data remains blinded. The comparisons we can make are to our Broadway study, which was nearly identical in design and was conducted at the same time, the first two and a half years of Broadway, the same two and a half years of prevail and uh and given the overlapping patient populations it's a it's it's a it makes for a very unique uh uh basis for for comparison so the fact that the one-year data of uh prevail on a blinded basis look comparable or in line with what we saw on broadway and now observing the two-year mark where the trends are continue to be quite encouraging uh you know what we decided to do and we announced this last week was introduce an interim analysis which will be triggered by the end of this year and the results shared in the first quarter of next year where we feel good about the potential for that trial for the for the interim to to lead to the trial concluding but if we're wrong and the trial needs to continue then we're looking at an extension that goes into the end of end of next year so overall we think we have two opportunities to to deliver on what we expect to be a positive prevail outcome And that ultimately unlocking what we expect to be a blockbuster opportunity for the drug.

A lot to pick apart there, but maybe let's just start with, is there one output that's truly differentiating between ApoB, LpA, LDL particles, or is it just the overall breadth of what you can lower there?

Do you want to speak to that from a commercialization standpoint? Sure, I'm happy to. The first thing we need to do, and we've done effectively, is just make sure is can we actually address what is the primary metric in some sense, right? And that's what's the efficacy associated with LDL? And we feel very confident in that regard as Ian just walked through that data for you. So we can say that we are consistent and kind of best in class in terms of efficacy around LDL. We can also say that best in class as it relates to safety and tolerability. um we're an oral obviously you're in a space in which um we're not snack technology we don't have to worry about like you know eating and issues of that sort so it's a very different profile and what's either currently on market or coming to market um but that relative benefit that we also see across lp little a and diabetes um and small particles and as ian also mentioned And, you know, the hope and what we see kind of initial in terms of Alzheimer's and APOE4 folks, I wouldn't say it's any one particular incremental benefit. It's the host of those benefits, because what we're doing essentially is like reducing was the overall risk. And so, again, with all the primary research we've done with over a thousand doctors over years now, and basically shown our TTP versus others currently on market or coming. Others will do well. It's a massive market and there's tremendous unmet need, but consistently it shows that OB, OBEZ will do better than those competitors.

You open up a great question. How many patients, you know, don't currently achieve their LDLC goals? To what extent is this going to be structural versus the pharmacological? And then, you know, when you think about how can an asset like Opacetip, you know, both capture and grow share?

Well, I'd say, yeah, is that, you know, when we look at essentially kind of what's happening in the marketplace today, sadly, frankly, you know, tremendous number of patients are actually just not meeting goal. And, you know, they start on statins and they do well, but not well enough. And so what we found is that, you know, even current data basically says there are about 30 million of those folks who are actually not achieving what is their base goal and the target. And now that target is shifting, going to be more difficult to get to, if you will, because of the guidelines, the evolution of guidelines, which is very good for clinicians and for patients to get people actually where they need to be. and so again we're talking about tens of millions of folks who are kind of in that sweet spot of where we would be used in addition to you know the statin um and i would say that again you know it's there's there's you asked the question around is it structural you know in some sense it's just a means of people actually whether they be specialists but especially in primary care is that today there's this apathy not only on the clinician side but the patient side as well in terms of if I just put somebody on a statin it's good enough right like I've done my job and the hope is that in the very near term we start to see a more aggressive nature in terms of prescribing and really looking to achieve the goals that are necessary to get to the outcomes we're looking for to reduce this overall tremendous burden in CV.

And then the most important data set that we've seen to drive home that point is Amgen study, Vesalius, where in this patient population, the benefit that you can provide by effectively managing LDL in terms of reducing overall risk became quite clear. So there was a 19% improvement in their MACE 4 number, 25% when it came to MACE 3. And those are the hard endpoints. And for the first time with that drug, we saw a mortality benefit. So they addressed one of their biggest criticisms from their secondary prevention trial. So there's obviously the guideline changes that BJ spoke to, but there's clear clinical evidence. And this is the way Europe's been treating patients forever. So it's the opportunity for the U.S. to catch up. And that 30 million patient number, we don't know where that number goes. we could easily be looking at an opportunity that's twice as large as what we had only a couple of months ago and that's why really every company, every drug has the opportunity to benefit and as long as we focus on driving that point home manage your LDL, get patients to go, all options available to them will get utilized.

Maybe we could drill down a little bit deeper into this Ian obviously you have the um expanded use of the parenteral pcs canines um in you know first line setting but now the orals as well is that a risk uh at all to to ob yeah i look i i i learn a lot from bj and and obviously those are these are all commercial bend questions so i want to make sure that he has an opportunity to give his answer no absolutely and and we we actually don't see this as a risk in some sense at all frankly as we've said the the market is just so large it's a tremendous unmet need is that it's a good thing for doctors to actually have options and patients have options as well. And so what we see in the near term is tremendous increase in terms of overall utilization of branded meds in this space. And even azetamide, right, is growing at 20% year on year and in the branded space driven primarily of Iropatha is growing at 40% plus. And so we expect that to continue. We look forward to what is the Merck launch in the near term, oral PCSK9. They're going to continue to fuel and promote branded but also unbranded to get to patients to activate. right then and that's all positive and frankly honestly it's wind in our sails because when we enter the marketplace the market will be much bigger and doctors and patients behavior will be changing as well where they're looking now to to address this in a more aggressive way we come to the marketplace with actually a better right opportunity um they can not only address LDL but also the incremental benefits we talked about so we look forward to that um so in order to demonstrate this the superiority can you maybe give us a sense of you know

brooklyn broadway tandem incremental insights that you you provided at acc uh just recently i mean what stands out in terms of efficacy and differentiation and and how did the data position ob relative to these these other approaches so just from a clinical uh perspective If you look at data, whether it's the drugs that are on the market today or the drugs that are in development, the benefit is primarily limited to reduction of LDL, which is obviously, you know, very important.

But the risk that these patients experience goes well beyond that. So as you look at the other populations where, you know, where risk remains, it's the LPDLA aspect of it. And obviously, at some point this year, we'll get data from Horizon, and there are other trials that will follow. We'll have an answer to the question, how much risk is there with LP delay? And when you look at the available options today and the ones in development, we have a pretty dramatic effect on that risk factor. As you think about LDL particles, CETP is central to the production of small particles. And what we've seen in our data set is complete elimination of the small particles. So as we focus on residual risk with a patient that's on a statin or a combination of a statin on the drugs, this is one aspect, one key aspect of it, which differentiates us from other molecules. And the same is true for diabetes. Diabetes is a risk factor. and that's something that we've not only us in terms of Obisetribib in our phase three data but really the CTP class has consistently shown roughly a 15% reduction in the rate of nuance of diabetes and related endpoints. So this is yet another point of differentiation. When you look at statins, the higher the dose of statins the greater the risk of diabetes and if you're on the highest dose of statins your risk increases by roughly 35%. So there is an opportunity for us to be combined with the statin, potentially bring the dose down of that statin, and still get the patient to go. So if we look at the combination data, this is the combination of azetamide and the tandem study results, we're able to get vast majority of patients to go, even the new goal, the revised goal of 55 milligrams per deciliter. So we think this is an ideal product. and the timing couldn't be better, and we spoke to the guideline changes, but when you look at the labels, the labels have all been harmonized now. If you have a successful outcome study, what you inherit is a label for treatment of all patients with elevated LDL. Your MACE benefit is no longer limited to the individual components of MACE where you hit STAT-SIG. You get the full benefit and the label claim for that. So it's the harmonization of the labels, it's the treatment guidelines, is the resetting of the price many years ago, which has opened up payer access. And the benefit of having multiple companies saying the same thing, which is get patients LDL under control.

So with that in mind, then why wait for Prevail before filing? You know, again, if LDLC is recognized as validated surrogate for CV risk, you know, how necessary is kind of that standalone outcomes?

Yeah, so we still operate within IRA. So that's the big consideration for all of us as we contemplate launches in the U.S. And based on the market research BJ and his team have done, what's quite clear is that if we deliver on positive outcomes data, and it's either sort of a yes or no, right? As long as you have the data, we get the broad label and we get broad payer access. So that's what's limiting or informing the timing of the filing and approval in the U.S.

Last one for me. You know, obviously a few days ago with your earnings, you provided an early update on Prevail. What are the key implications here as you look towards the first quarter 27 readout?

Yeah, so the update we provided calls for an interim analysis of the results of the interim becoming known to us in the first quarter of next year. And again, if the DSMB recommends that the trial continue, we'll get to the requisite target event rate by the end of next year. So the implications to the investment community and to us as a company is we just increased the probability success. We feel very good about the trends that we're seeing. We're encouraged by the observed-based event rate, all the individual events as well as the composite, and we believe they're tracking well for us to be able to potentially stop the study at the interim time point. And if we're wrong, or if the DSMB exercises discretion, which they fully have, and recommends that we continue the trial, because they're encouraged by some of their signal that they're seeing in the trial and they want that data to mature, then we'll continue the trial until the end of the year. But if we continue to the end of the year, there will be many more events that will support potentially achieving statistical significance. And as a result, the risk of success increases. So I think we've taken at this point every step we potentially can to de-risk the outcome. And as Michael Davidson, our CEO, likes to say, ensure that the trial is designed and executed in a manner which allows the drug to succeed.

Ian, BJ, thank you so much for joining us and appreciate you coming by thanks for everyone sticking around until the end thanks everyone