Karen Parkhill: Yes. Travis, thanks for the question. Clearly, next year and beyond, we’re focused on driving that leverage down the P&L that I talked about. And, obviously, when you drive leverage, it’s your bottom line’s faster than your top line. But at this stage, it’s still early. We’re at the beginning of our planning process, and we’re going to give you more on FY ‘25 as we are ready to guide.
Geoff Martha: Hey, Travis. Good to hear from you. You know, on GLP-1s so, you know, so first of all, I just want to make it clear that, like, we see that it’s an exciting class of drugs with a large opportunity. And I’m sure just like you, you know, I talked to many patients that are benefiting from these drugs, from a weight perspective, from mental health perspective, it’s pretty amazing. You know, that being said, we’ve done a lot of work, and outside of the near-term temporary impact on bariatric surgery market we don’t see these drugs impacting our growth outlook, even in the long-term. And then and on the bariatric piece, that as we mentioned, it’s a small part of our revenue, low-single-digits, and the rate of decline has stabilized there, and I think we see that, that coming back here in the coming year even.
So, we did do a lot of work here, and I’m going to you know, it was, like I said, science based and looking at epidemiology and really digging into Select. And what we do have on the call here, our Chief Medical Officer, Dr. Laura Mauri, and I thought I’d, you know, maybe kind of call her in here, bring in a relief picture here on that question to talk a little bit more about Select and kind of what we’re seeing out of that. So, Laura, can you can you chime in here?
Laura Mauri: Sure. Thanks, Geoff. Yes, Travis, the Select trial results that were presented at AHA gave us a lot more detail beyond the top line that we heard about back in August to really look at the endpoints and look at the drug adherence, understand the details of the trial results. And, you know, as you as you know, these were obese patients with a history of cardiovascular disease. And as Geoff said, this is a very important advance for this patient population. But the results didn’t change our overall impression that there will be a negligible effect on the growth of cardiovascular procedure volumes. And that’s based on a couple of things that we saw in the detailed results. First, the number needed to treat was much higher, and that means it’s setting a higher bar for treatment, compared with other things that are used in guidelines.
And then we were — we saw that there was a lack of effect on cardiovascular death and that’s something that if it had been present, would have spurred more adoption, and the lack of that is important because it will not spur the wide adoption and coverage, that we might have been, looking at if that had been positive. And then, you know, the only effect on the composite endpoint was non-fatal MI, not stroke, or cardiovascular death as I mentioned. And as you know, the discontinuation rates we’re in nearly a third of patients due to the nausea and GI side effects. And, clearly, we know from practice that rates of adherence are even lower, and that results in lower treatment effects. And then there were a couple of interesting findings in the trial.
You know, as Geoff mentioned earlier, the higher BMI population didn’t seem to have as much benefit, and there was no significant treatment effect in the North American subgroup, which is certainly something that, I think we’ll want to understand better going forward. So using a range of assumptions, we updated our models across the major cardiovascular procedures, and the inputs to that, we’re looking at U.S. procedure volume, across different procedure areas, using data on the prevalence of obesity for each of these procedure populations. And then a range of penetration adherence assumptions all the way up to including, what we’ve seen over time with statins, which is, you know, are really well-tolerated and just freely available and part of guidelines for the past 30-years.
And then we also input the, obviously, the risk reduction seen in each the endpoints from the Select trial or literature based on weight loss to look at treatment effects. And the bottom line is that the reduction to TAM growth, over the next 10 to 30 years is really negligible on the cardiovascular procedure outlook. I think it’s really important to also note what this analysis doesn’t include, and that’s the that there will probably be offsets in the markets that are really underpenetrated or new, like PFA or Ardian, because of the growth, the rapid growth in those areas. And then there’s in fact potential upside for patients and procedure growth, because of the potentially longer survival or lower BMI that makes a greater funnel of patients eligible for cardiovascular procedures.
So I’ll pass it back to Geoff, I know there was a question as well, about the effect on hemoglobin A1C.
Travis Steed: Yes. Well, what thank you, Laura. You know, and while we’re on the topic, maybe on that one. I mean, Q — any comments on diabetes relative to GLP-1?
Que Dallara: Yes. I mean, we, like, well, Laura mentioned, we spent quite a bit of time studying this, and I think there’s some evidence from Select that would say, there may be a slowdown, in the prediabetic population towards insulin, dependency, and maybe some in Type II will come off insulin, but we believe this number to be very small and more than offset by the fact that there is low penetration of Type II, using AID. And the fact that when you look at the funnel of 3 million to 4 million who require basal insulin with 25 million non-insulin Type IIs, as well as the over a 100 million pre-diabetic population. It doesn’t changed our point of view on the long-term, smart size of the market as well as the growth rates. And as Geoff mentioned, at the beginning, the majority of our business, more than 90%, is in Type I. And so, you know, we remain pretty optimistic about, the growth and market profile in diabetes.