Conference Transcript - NAMS 2026-06-03

Dennis Dane, Analyst — Jefferies

Hi, good morning. Welcome to the Jefferies Healthcare Conference. My name is Dennis Dane, biotech analyst here at Jefferies. I have the wonderful pleasure of having Michael Davidson, CEO of New Amsterdam Pharma, here with us. Welcome. Thank you. Before we kind of go into the fireside, we'd love to give you the opportunity to just make some opening comments around New Amsterdam, just some of the incredible progress that you guys have made over the last several

Michael Davidson, CEO

years sure thank you thanks everyone thanks for joining uh this morning um of course we feel uh it's been a really great year of progress for us at new amsterdam uh we um we filed in europe for approval and um we announced just a few weeks ago that you know based on you know what we're seeing in prevail and tracking broadway you know first year events now we're seeing lower events than expected even if you impute a certain decay in the placebo arm which is what you can expect we really feel encouraged by a reduction in in all all endpoints across the board in our second year and then tracking even beyond the second year you know we feel and we're in a good spot to have an interim analysis that would maybe stop the trial a year before otherwise completing so we want to make sure we don't anyway jeopardize the results of the overall trials we've done a lot of digging into you know when do you see the best results and it's roughly year three to four it's we're right in that in that point because then you have to worry about study maintenance and retention and drop in drop out so we feel we're in a really good spot whether the interim is the successful and we we're optimistic about that or we need to go the full you know full four plus years to to get the ultimate number of events that we want to make sure we power the study down to a 15% for the primary endpoint if necessary which we know has been the benchmark for all the other LDL trials so if you look at all the LDL trials last decade it's a range from 9% to 19% so we feel that we want to make sure we can capture that benefit because that still gives us an exceptionally good overall mace benefit that we can then utilize our other or other benefits of obocetrapib in our differentiation in the marketplace so we We feel we're in a good spot, and we're moving forward with Rubens and Rembrandt, our other important trials for labeling, and so, in general, we're very excited about who we are. We are going to announce the, I've been saying, we're going to announce the start of our new Alzheimer's trial, and we're presenting at the Alzheimer's meeting in July a number of exciting insights into that, into our Broadway data still that continues to give us more and more excitement about what Obacetropib is doing in patients that are at risk for Alzheimer's and also at the same time we're seeing the field of Alzheimer's itself evolve in that there's now very much recognition that it's a disease process that begins 20 years before symptoms in other words cognitive decline and so if we can intervene earlier you have a much greater chance of showing a benefit because once neurodegeneration kicks in it's really a very difficult disease to modify and so we feel we're in the right spot with the right drug to make a big difference for that devastating disease and our data is again you know very getting a lot of traction among the key opinion leaders in Alzheimer's and a very large support for what we're trying to do with our next study and more to come on that when we officially launch the trial in a few months.

Dennis Dane, Analyst — Jefferies

So it sounds to me like you know if I take a step back it's really more than just about LDL-C, right? You guys have shown an LPL-A benefit, some, you know, benefit in diabetes. You guys start starting an Alzheimer's trial to try to tease out some of these benefits. Like, I guess biologically, like, what is really driving that level of LDL-plus sort of benefits? Like, do you have a hypothesis about that?

Michael Davidson, CEO

Sure. So, you know, first and foremost about ovacetrapib that I think is not really appreciated much as it should is how well tolerated and very no difference the side effect profile and placebo in our in our phase three trials and that really resonates you know very well with patients and clinicians that's that's that's important differentiating number one because listen I don't I don't know if you talk to your friends about their medical issues but as you know many people are on staff statins, and I guess I'm probably got a biased view as a cardiologist, but almost everybody that I see socially complains about their statin and what it does to their muscles and side effects. I'm getting a, of course, in my lipid clinic, it's a nonstop, you know, I don't want to take a statin, I don't want to get diabetes, I don't want to get muscle aches, I don't want to get Alzheimer's disease. All those things are unfortunate about how statins are being perceived in the marketplace. However, it sets up to be really well differentiated from any other LDL drug when it becomes available because it does whatever statins do that people don't like, it does the opposite. So it lowers the risk of diabetes, lowers LPLA, it lowers the risk of Alzheimer's disease based on our Broadway biomarker data, and it lowers the small particles which statins don't really address in residual risk patients with cardiometabolic disease. So in many ways, it's exactly the right drug at the right time for the majority of patients who want something to address their LDL initially, but also if we can address all these other factors that they're highly motivated about addressing, we feel that we're going to get the lion's share of either the drug to add to statins or, as often the case, people want to prefer a different drug than a statin. And so we feel very, very optimistic about, you know, how this drug's going to go when it starts getting utilized after launch.

Dennis Dane, Analyst — Jefferies

Yeah. So then, you know, you guys are obviously running Prevail, CVOT, almost a 10,000-patient trial. And we just crossed the two-year mark for all these patients. So maybe comment a little bit about, you know, the event rates that you have seen on a blinded basis and how does that track relative to your internal expectations, and also touch a little bit about the new statistical protocol that you guys implemented.

Michael Davidson, CEO

So when you start a trial, you use a certain predicted event rate from other trials that you can look at. And the one that's the most utilized is the Fourier trial by Repatha because it's a chronic heart disease population, LDL 90, about a third have diabetes. So, you know, we looked at Prevail getting started. We felt this was going to be the right, you know, kind of base to judge our outcomes on. So that's where we started from. And then, that's one range. And then if you look at many other trials, there's been 15 CVOTs done in the last decade. And you can match with AI in particular. You can look at all the different placebo event rates over time in all these trials and come up with what you believe would be a good estimate range for placebo event rates. and that's we've done that of course and then which i think is even a better way of thinking about it is that broadway was designed as to be a mini prevail in other words basically the same inclusion criteria the same sites the same dsmb the same steering committee the same course investigators and coordinators so you could not ask for a better like mini de-risking study for Prevail than Broadway. And so when we saw that the first-year event rates in Broadway track the first-year event rates in Prevail very, very closely, and not just four-point, but also three-point, and then every single component, we look at everything, non-fatal MI, stroke, revascularization, death of course all those things tracked very very well with prevail which means that our 21% relative risk reduction that we saw between placebo and and active in in in Broadway that could be exactly what could be applied to prevail as well if assuming the placebo arms are are going to be the same and again there's no reason to believe they would not be then we look at year two and three now follow up and they expect a little bit of decay in the placebo arm over time and that's again you can track that from any other many other trials as well you can see a decay rate and that our reduction in our blended event rate is even lower than expected in that regard so we have again we have to also be cautious of course it's a famous line is you know a good way to lower your risk is to be a placebo patient in a cardiovascular outcome trial so it's you know it's always something you have to be aware of but even taking all that into consideration we look at the ranges of event rates and placebo across the whole spectrum of these trials you know we are in our blended rate looking very encouraging across all these trials so that that gives us I think the reason why we decided to go with the interim is for that reason I mean ideally you want to go all the way to the end and maximize the results but in this situation it's about a year difference and we think that year difference is critical if we feel encouraged by it if necessary we'll go the extra year if we don't stop to the interim but the chance to get on the market a year early and a competitive environment and with this type of data that we're seeing we came to this this conclusion it's the best thing for for the drug and for the info we are we are what we want to go with you know developing the entire spectrum of benefit we want to get ahead of other competitive LDL drugs and you know this is this there's a good reasons to do it but we don't we were hesitant because we didn't anyway want to jeopardize the final results and we feel we're not going to do that either by the power or by the expected relative risk reduction we feel that this is a relatively conservative you know smart decision to make and if we can stop at the interim which we feel encouraged about all we do basically have to match what we saw in Broadway to do that if not we go to the end and and we'll have a still a very very good drug to to launch as well so that's kind of our thinking about the whole process but what a lot of it went into it I just I'm a very conservative decision-maker by nature and I wanted to make sure we don't in any way jeopardize the trial again prevails designed for success we don't want the trial to fail the drug it's always been our main principle because of all the history of other studies in this class we're focusing on HDL raising and not focusing on what was the right type of study for an LDL or a therapy and we feel we've We've done that with Prevail, and we want to see it complete, and we feel this is the right decision going forward.

Dennis Dane, Analyst — Jefferies

So you said something really interesting, which is that you're trying to match it with Broadway. And Broadway showed 21% at one year. So when you're thinking about powering for the interim, can you comment a little bit on how much power you have? I know that's not disclosed yet. maybe we'll get it later this year but just curious how what approach are you taking to that are you assuming like a similar 20% you know like a risk reduction to hit on the interim or we say we're well powered and said two

Michael Davidson, CEO

things we are well powered and we also said that if we do hit the 21% for both four point and three point again the 20% for four point in Broadway that will be sufficient to get a p-value to stop the trial that I think that's as far as we want to go on disclosure because there's a there's always a range of you know it's it the the p-value is determined by the number of events and the relative risk reduction and so we we there's a range there where it could be and we want to we want to be careful until we actually you know lock that time in that you know we that the power could change modestly so we feel right now we have really good power we're projecting at that interim analysis stopping at the end of end of this year with the results in the first quarter of next year but at

Dennis Dane, Analyst — Jefferies

the same time like what do you view as a clinically meaningful mace for reduction right because like you know if they were to show 15 16 70 percent right that's still better than four EA and like Odyssey and some of those studies so like if it does end up being that scenario could the trial also stop

Michael Davidson, CEO

because it could stop yes okay good stuff I mean it's it's it's it's more likely to stop if it's in that closer to 20 percent range but but it still has a a chance to stop it's all depending on on the number of events the actual number events at the end of the day but they're but that's a scenario where you know if you don't hit the p-values that that have been designated which are designated based on the regulatory approvals then then we could go longer and have more more power more events that get us to those those relative risk reductions that are still, you know, quite impressive considering, you know, these studies are, like I said, the range of benefit is a range from 9% to 19% in all the different trials, and ezetimibe, which is 9%, is now widely, widely used. I mean, so it's not about the relative risk reduction that matters. It's about the LDL lowering with its overall profile that matters for clinicians.

Dennis Dane, Analyst — Jefferies

Yeah, I was going to ask, because, like, you know, when you speak with investors, there is some sort of expectation that, you know, the risk reduction would be closer towards the 20% range. But, like, I'm curious, you know, the feedback that you get from cardiologists. I'm sure you're very well connected. You talk to all the leading cardiologists. Like, what is their feedback? Like, does it really matter if it's 15% versus 20% in terms of how excited or enthusiastic they would use, you know, your product?

Michael Davidson, CEO

It doesn't matter. There are some that matters, yes, but not the majority. You know, we've already done, it's roughly, of all the cardiology, maybe 10% it matters for. And those tend to be the ivory tower types that don't really write prescriptions anyway. I mean, so it's, not to be derogatory about the ivory tower, they're all my friends, But the idea is that when you know the drug works, the thing that I know this is getting into the weeds a little bit, but it's actually the amount of reduction per milligram or millimole of LDL lowering, and you can adjust that as well. And that's why the REVEAL study is very important, because the REVEAL study showed that the 11 milligram per deciliter drop in LDL was a 9% benefit. So people said 9%, that's not very impressive. But that 11 milligrams, if you look at how that correlated, that would be more like a 25% relative risk reduction, the amount of aldeolaurin that was achieved. So that's really what's the important parameter. And we're starting to recognize, as people dive into these studies, they realize that's a more and more important parameter. When you adjust for how much aldeolaurin you had in the trial, that, and that, how that relates to the relative risk reduction, that's a much more important number to look at. it's not what the study overall because you have drop-in drop-outs you have lost a few you if you look at on treatment on the drug you know getting great LDL lowering you give a much different number than the overall study results and so we're that's why it's so important for us one of our our most important goals for the company is to maintain a high quality and prevail we're out there we have full-time people going to all the sites we have we've had many, many meetings at the site level to encourage investigators to maintain compliance in the trial. That's what we can do. That's our most value add to Prevail is to really work hard to make sure that every patient that's in the trial, you know, stays in the trial and stays on, ideally stays on drug throughout the treatment period. That's the best we can do, and the more we can do that, the better the results are going

Dennis Dane, Analyst — Jefferies

to be yeah and you know even though the trial might be longer in terms of the full top line the fact that you guys have a very very clean safety should minimize the amount of dropouts over time which you know because mace benefit gets better over time but also that's offset by dropouts right right so so

Michael Davidson, CEO

like like like like like clear outcomes had a pretty high dropout rate that was a little bit of a skewed population was stat intolerant patients and that was It still worked, but the amount of aldeoloring they were hoping for wasn't quite there overall. But that's why what's great about opacentropib is because people that are on the drug, we don't know, of course, who's on a drug of placebo, but we're seeing a low event rate. We also think that, sorry, a low dropout rate, which we think is also, again, a good indicator that the drug is being well-tolerated for patients.

Dennis Dane, Analyst — Jefferies

And can you also comment on just the magnitude of drop-ins in terms of, like, GLP-1s and PCSK-9s?

Michael Davidson, CEO

Those are very low. They're low single digits for all those things. GLP-1, SGLT-2s, and PCSK-9s, and azetamide. We look at all those drop-ins, and they're all quite low compared to the baseline treatment. Remember, we allowed PCSK-9s at the beginning, so there was a few percent. There's just one or two percent more during the study.

Dennis Dane, Analyst — Jefferies

Okay. So, you know, it seems like based off of your own analysis of just, you know, the best CBOT trials over the last 10, 15 years to try to figure out if the lower event rate is really driven by ovocetrapin or placebo, it seems like based off of your analysis, you seem fairly confident that it's not placebo overperforming or performing better than expected, right? So it's mostly ovocetrapin.

Michael Davidson, CEO

Yeah, we're, let's say, cautiously optimistic. It's all driven by a obstetrapeb benefit. So again, because we look for all these other causes. We look for change of care, you know, drop-in, drop-outs. And we're just not seeing those that be any substantive amounts. I mean, remember talking about events that are, you know, 3% to 5% per 100. and if you lose 1% or 2% for drop-in or drop-out, that numbers don't make that much difference.

Dennis Dane, Analyst — Jefferies

So the interim at the end of the year is going to be on MACE 4, but how important is MACE 3?

Michael Davidson, CEO

Well, MACE 3 is important because we want that to also be positive for regulatory purposes, especially in Europe, where it becomes important. And even the FDA has made a comment that it's a review issue if you hit MACE 4, but you don't hit MACE 3. Now, this has not happened before, so people don't, there's no really historical thing to look at to say that. So, but I think it's still important to have MACE 4. Now, what we have said, though, is that if you look at the event, right, so we track all the different forms of the events, you know, revask. But what we see the greatest decline in the years is in the three-point MACE events. Non-fatal MI, stroke, and CHD death is where we're seeing the greatest decline in the blended event rates. So it gives us, again, that gives us more confidence that the three-point MACE rate would be, also efficacy would stop the trial.

Dennis Dane, Analyst — Jefferies

Okay, but the interim is based off of MACE 4.

Michael Davidson, CEO

And 3.

Dennis Dane, Analyst — Jefferies

And 3.

Michael Davidson, CEO

So both would need to hit the P value, yes.

Dennis Dane, Analyst — Jefferies

Okay. Okay, understood. Okay. You guys will probably host an investor day or commercial day later in the year. So I guess what should we expect in terms of incremental disclosure at that event?

Michael Davidson, CEO

Well, I think, I guess the biggest things we want to continue to show is we'll have even more data on the event rates. We'll be, you know, six months later on the numbers that we've been talking about, you know, post our second year announce. And it will be roughly close to that three-year mark overall on the meeting follow-up. and so we want to highlight for the investors who are looking at the interim and of course the final trial we want to show really multiple ways to look at it and one is our LDL lowering, non-HDL, ApoB lowering without taking the event rates what will be the expected risk reduction for the amount of LDL lowering that we get with ovocetrapib, because compared to like 20 other trials that have been done. And then again, I think people feel optimistic about, you know, what Broadway results would translate into a prevail similar LDL-lowering benefit into an outcome benefit. Secondly is reveal itself with the Merck study showing that that amount of LDL-lowering actually outperformed on relative risk reduction you didn't expect. And we have evidence from that upper tertile where that's even, you know, very well you can see the it's all in the public domain that in that aperture tau is simply significant in its own right for a mace reduction with a CT inhibitor does not lower LDL as much as as obacetrapib and then and then of course we'll go into even more detail potentially on on the event rates that we're seeing and why we feel that the Broadway is a really good de-risker of of the results of of prevail and like i said we've done you know 15 other cvots out there to look at their matching of the event rates and we feel good about that as well even taking the if broadway was an outlier for some reason which was very highly unlikely to be the case we have also a lot of other evidence from these other trials that we can pull from to give us, again, an encouraging view that the interim will be able to stop the trial at the interim analysis or at least complete the trial with a very successful study based on what we're seeing. So that's kind of the framework we want to try to highlight for investors on that. They also have a lot of things that have happened in the commercial side of things, in the market itself. You know, the market is getting much better, and we're seeing, obviously, entrants in the market that are going to be competitive to us. And we want to explain, you know, why obacentropia will do very well against these other competitors in a rapidly growing market again for LDL-C lowering. Then we'll talk more about their Alzheimer's data. We're presenting four new studies at the AAIC meeting coming up in July and highlight, again, you know, how impressive the Broadway biomarker data is and how that's helped us design our next study, which will be starting relatively soon.

Dennis Dane, Analyst — Jefferies

So one of the major reasons why I'm so excited about Amsterdam is not even just, you know, in ASCVD, right? I think what's super interesting is just the combinability of Obisetrapib, given the strong safety profile, and it's a convenient once-daily pill, right, with many other sort of mechanisms as well, right? And I feel like strategics would obviously be very intrigued about that sort of, you know, profile. When you look at AstraZeneca, like, one of their strategies is to combine their oral PCSK9 with some of these other drugs. And I think they did start a study with statins. And even Merck, their oral PCSK9, I think they just started, like, a phase one combination, not a fixed-dose combination trial, but with their LPLA oral, right? So I guess, you know, as you think about, you know, New Amsterdam for the next three, five, ten years, like, would you explore all of these different combination opportunities? And, like, how would you prioritize?

Michael Davidson, CEO

Yeah, we are looking at all those combination ideas, and, you know, more to come on that. We believe that it is a pipeline and a pill, and there are other assets out there that would combine very well with ovocetrapib. And so we feel this is a really important pipeline build for the company. And so we feel with a successful launch at a pipeline, you know, will be evaluations that are far higher than they are now, you know, build shareholder value. And that comes with a, you know, with building a pipeline, and we are doing that. We haven't disclosed anything yet, but, you know, more to come.

Dennis Dane, Analyst — Jefferies

Yeah, and maybe that's gated by, you know, FDA approval, right, because getting, like, a fixed-dose combo approved, I think you only just need, like, a bioequivalent study to approve product rates.

Michael Davidson, CEO

Right, and we're studying the status for all those things. Yeah, for all those things.

Dennis Dane, Analyst — Jefferies

In the last minute or two, maybe just comment on, you know, your cash position and just how well positioned you are to interrogate all of these opportunities as it stands today.

Michael Davidson, CEO

We're roughly $700 million in cash, so we feel we're in a really good cash position. And we have enough cash on hand to launch the drug and also potentially do some pipeline build as well. So we're planning on doing that. And so, like I said, we feel really good about where we are in our company, and we're building out the right. We also want to highlight at the R&D Day or Investor Day, how the high caliber of people we've recruited to work on Obacetrapib, I think people are very impressed by the caliber of people that have come to New Amsterdam just for the purpose of this, of the value of Obacetrapib that they believe will happen with patients.

Dennis Dane, Analyst — Jefferies

Perfect. Well, I think that's all the time that we have today. But thank you so much, Michael. It's great to see you.

Michael Davidson, CEO

Thank you, Dennis. Thank you.