NewAmsterdam Pharma Company N.V. (NAMS) Earnings

Management highlights

Michael Davidson provided an update on the clinical development of Obacetrapib, including the latest timelines for the PREVAIL trial. They marked the two-year anniversary of the last patient enrolled, observed encouraging trends in blinded data, and decided to conduct an interim analysis in the fourth quarter of 2026 with results expected in the first quarter of 2027. John Kastelein discussed the similarities between the Broadway and Prevail trials, the visual representation of similar event curves, and the importance of baseline characteristics. They are optimistic about the treatment effect seen from the trend in events from year one to year two.

Guidance

They plan to conduct an interim analysis in the fourth quarter of 2026 with results expected in Q1 2027. If the trial doesn't stop for efficacy at the interim, they anticipate completion by the end of 2027. The timing aligns with a minimum 2.5-year follow-up and the interim analysis now has more events for the primary MACE4 endpoint but unchanged statistical power for a 3-point benefit.

Analyst Q&A

• Q: About the interim analysis, could you speak a little bit more about why for Q26 and maybe the timing on that and whether you think the interim analysis might be able to impact the statistical plan if there's any concern about a penalty there? And then just about Pella Carson's Horizon study coming out in early to half 26. Can you talk a little bit more about potential read through to prevail and their expectations there?

  A: 2026 is the timing due to the two-and-a-half-year minimum follow-up. The fiscal penalty is minimal. Regarding Horizon, John Kastelein discussed that if Horizon is positive, there could be a read-through to Obacetrapib, and if not, the Broadway data still supports the drug's potential.

• Q: Regarding the year one to two event rate being lower than expected compared to historical trials, Can you elaborate specifically on what trials you're comparing to and your confidence in that analysis, given that the comparison is to trials in the past and standard of care potentially might have changed since then?

  A: They used AI technology to model outcomes from recent trials like Fourier, Clear Outcomes, etc., and compared to Broadway. They're encouraged by the quality metrics in Prevail.

• Q: When you report the interim results in 1Q27 and if Prevail does not stop for efficacy, what specifically gets disclosed and how should investors think about continued outcome. Is that neutral or could the magnitude of the trend that interim itself be informative for the final readout?

  A: If the interim doesn't stop the trial, they won't know anything other than the study continues. The study will continue until full event rates are achieved.

• Q: You've previously said that for prior CVOTs, the trials failed the drug and not the other way around. So I guess, what are some of the pros and cons that you considered in doing this interim analysis, which potentially pulls forward the data by about a year, but at the expense of statistics? And as a quick follow-up, how should we think about the filing strategy, assuming the interim was positive? Did you meet with the FDA on this plan? And did you get buy-in from the FDA.

  A: The fiscal penalty is minimal. The driving factor is seeing encouraging data. They're working closely with the FDA on filing timelines.

• Q: Is sort of as it relates to this interim, the minimum effect size you're powered for, sort of like the minimum stopping criteria, is that the like 20 to 21% base? Or, you know, what happens if you show like a 15% base benefit in this interim? And then two, just a quick kind of clarification on these other trials. Is there like a couple, you know, one or two key trials that you think are good analogs for declining event rates that were, you know, an encouraging sign? Or do you think kind of all of these trials, like all the PCSK nines, et cetera, all sort of follow this trend that have had positive outcomes?

  A: Stopping rules are based on p-values. They've looked at many trials like Reveal, Fourier, etc.

• Q: Most of them have been addressed, so maybe I'll touch upon the recent South Korean intensive LDL-C lowering study published in the New England Journal about a month ago, and how that could be sort of a harbinger for what we could see in Prevail. And if you were to sort of strip out Lp and your traditional LDL-C reduction from the discussion, What do you think is the effect of elimination of small LDL-C particles on the overall lower event rates that you're seeing?

  A: The South Korean trial was a landmark showing intensive lipid lowering benefit. Eliminating small LDL particles likely contributes to the lower event rates seen due to the drug's effect on CETP.

• Q: A three-part question. All just clarifications, though, I think. Hope that's okay. So first, just can you quantify maybe the event rate through two years and just share how much it has changed in year two relative to year one? Second, Have you conducted any analysis of the total events sort of so beyond year two in those patients where the data is available and have a sense of how it's tracking beyond year two? And then it sounds like since you're looking at MACE3 and MACE4 that you might have blinded analysis of sort of the individual components. Curious if you can share if it's sort of proportionally less across components or if there's a particular driver of the lower than expected event rate in year two?

  A: They're not sharing actual event rates yet but are looking at all components which are going in the right direction.

• Q: The early stop scenario. I mean, is there a scenario where p-value meets the DSMB early stop criteria? but then that still leaves hazard ratio benefit on the table that may make OB more appealing to prescribers. I know you guys have talked that alpha and statistical powering does take that into consideration, but just wondering if maybe there may be benefits even continuing the study even beyond the interim analysis if the p-value were to hit. And then a second question on the placebo rate and event rate decay is, I know you guys take a look at everything holistically, PCSK9s and SGLT2s and GLP1s, but specifically for CETP studies, have those historically shown a precedence in event rate deceleration?

  A: If p-value meets criteria, there may still be benefits in continuing. CETP studies have shown some event rate deceleration.

• Q: The South Korean EZ-PAVE trial was touched upon a little earlier. I thought during that presentation at ACC, the presenter mentioned there weren't enough events in that study. And I think the New England Journal paper also stated as such. Have you had the chance to look at that study and understand whether, and of course that study had a 33% risk reduction. for the more aggressive targeting versus conventional targeting. Have you had the chance to look at whether that trial had a fewer event than expected due to the more aggressive targeting arm? or is it because both arms kind of underperformed or had less event than expectation? My second part of the question is, you talked a lot about the placebo arm in prior trial and how to think about degradation. I was wondering in the treatment in active arms of prior trials, do you see typically that the effect come on more after the second year, i.e. not a linear effect from year one throughout, but rather have some kind of acceleration after second year?

  A: Trials with two treatment arms don't help. They've looked at meta-analyses showing effect size by year.

• Q: I'm just wondering, when you are looking at these blinded curves for those components, is there anything that stands out to you that is differentiated from other components? cardiovascular drugs. And can you maybe also speak to the importance of these individual MACE components for the eventual label in the marketing of Obesetabit?

  A: They're seeing consistent benefit across components. The FDA has harmonized labeling, so they don't need each component individually significant.

• Q: A question regarding some data that you presented at ACC where you showed slower EGFR decline and nominally pure renal events. I was wondering if you can help put this in context for us. How meaningful is the difference that you saw in EGFR and the lower renal event risk? And how does this impact the broader profile of OB from a competitive standpoint?

  A: The improvement in EGFR and lower renal events is clinically relevant and gives a competitive edge as no other drug raises HDL like Obacetrapib.