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Baird Takeaways from ATTD 2024

Mar 8, 2024

Jeff Johnson
Managing Director and Senior Research Analyst, Baird

Well, this is our post-ATTD, or near the end of, ATTD conference recap here with Dr. Trang Ly from Insulet. As many of you know, I'm Jeff Johnson from Baird. I do have one disclosure to read here. Please refer to the event calendar, published research, or Baird's website for important disclosures regarding the companies discussed during this event. And without that out of the way, Dr. Ly, you and I are just going to talk a little bit today about Insulet's presence at ATTD and maybe some bigger themes we saw coming out of the conference. So thanks for taking the time.

Trang Ly
SVP and Chief Medical Officer, Insulet

Yeah, of course. Great to be here, Jeff.

Jeff Johnson
Managing Director and Senior Research Analyst, Baird

Yeah, great. Thanks. All right, so, you know, the first thing I wanted to talk about, not to make myself look older than than I already feel with all this gray hair and that, but, I think this is my ninth ATTD and, you're so much younger than me. I know, but you're so much younger than me, but you've still beat me, so you're more seasoned. We'll say that. But I think, you know, I was looking back at nine or 10 ATTDs ago, and I remember pictures of, you know, a little kid hooked up to a laptop and a big pump with all these infusion sites going to the kid and all that, and us talking someday about having automated insulin delivery devices, or what we called back then artificial pancreases. And we're there.

I think what really struck me this year at ATTD more than anything is not only are we there, but these devices are getting so much easier to use, the outcomes are improving so much, the form factors are getting so much better. I mean, we're just, you know, from a high level, where do you feel like we are at ATTD this year technologically than even a few years ago?

Trang Ly
SVP and Chief Medical Officer, Insulet

Yeah, I think there's been really extraordinary advances in the AID technology and just the simplicity and ease of use with all the technology in both sensors and with pumps, and obviously with Omnipod 5. And, yeah, so 10 years ago we were presenting data from, like, 12 patients and 20 patients, really inpatient studies, and now, you know, the fact that Omnipod 5 is on 250,000 people in the world is really extraordinary. So the, the scale and the reach of the product has been really incredible to see, and now we're talking really beyond AID use in Type 1 diabetes, but now also AID use in Type 2 diabetes, really being that next frontier.

Jeff Johnson
Managing Director and Senior Research Analyst, Baird

Yeah, no, that's a great segue to one of the questions I want to ask, but let me back up to Type 1 before we go to Type 2. And then on Type 1, you just published this afternoon or just presented this afternoon your randomized controlled trial data on Omnipod 5 versus non-AID, I guess, open-loop systems, if you want to think about it that way. Tell us about the importance of that trial. It seems like time in range improved by about 16 points, if I, if memory serves, from that trial. And what is, what kind of doors will that study open up for you?

Trang Ly
SVP and Chief Medical Officer, Insulet

Yeah, so we have lots of different data sets, and we're really proud to be presenting the data from the Omnipod 5-003 study. So this was a study in about 200 adults with Type 1 diabetes in the U.S. and France, and they were randomized to either continuing using their pump, their standalone pump with CGM, or randomized to the Omnipod 5 system. And after 3 months we saw a 17.5% increase in time in range, up to about 62%, and this is equivalent to 4.2 hours of additional time in range. And the reason why this is really important is that it is not a population that is commonly studied. So it was a population of people with an A1C that was greater than 8%, 80% of the subjects had an A1C greater than 8%.

These are people who have suboptimal glucose control, so people who are not managing at target. These are the people who are at highest risk of complications of diabetes and all the significance of the morbidity and the lost lives that comes with living with diabetes. Really being able to show that our technology works in this population, that is simple and easy to use and has incredible improvement in glycemic outcomes in that population is really important to show, especially for payers who are always, you know, trying to think about, you know, okay, if we pay for this technology, how much benefit are we actually going to see in the population.

Really being able to show the value of the technology in large populations, and where it's nationalized healthcare is just really important to demonstrate that ongoing value. And that allows us to be in a much stronger position as we negotiate premium pricing for Omnipod 5. And, you know, that is what enables us to continue to innovate and bring better technology for our patients.

Jeff Johnson
Managing Director and Senior Research Analyst, Baird

I'm sure no coincidence that part of the study, I think a third to 40% of the study was run in France, one of the markets that will pay a premium for AIDs if the data's there.

Trang Ly
SVP and Chief Medical Officer, Insulet

That's right, yeah. So we're still in negotiation with the French government, but you know, if there's one thing to say you're coming, but to actually be in the country and have French patients on it and have all of our key opinion leaders advocate for this project and speak with such enthusiasm about Omnipod is just really incredible to see. So that's why we've invested heavily in running our clinical trials outside of the U.S. and targeting specific markets such as France, where that is just that patient advocacy, the physician advocacy is really important for them to be able to offer the best care for their patients.

Jeff Johnson
Managing Director and Senior Research Analyst, Baird

Yeah, that's great. And then one last RCT question, then we'll come back to Type 2. And I'm blanking on that question now, which, oh, I did get a couple emails right after the press release hit. The time in range of 61% in Omnipod 5, again, you addressed it or tie together for me the higher A1C starting point and that time in range of 61% as opposed to this 69%-70% we saw in the Omnipod 5 pivotals.

Trang Ly
SVP and Chief Medical Officer, Insulet

Yeah, so when we look at time in range and A1C reduction, it's really important to understand the population that you're testing the system in. So we generally, if you start with a very high A1C, you generally get a very high delta in terms of time in range improvement. And you really have to see what we understand from our conversations with physicians and payers is really that the magnitude of the difference and really being able to show that it works in a large population of users is really important to them. So the 61% is a vast improvement. It was, you know, pretty much a 15% improvement from their starting time in range.

And that is what keeps people out of trouble in terms of the kidney disease and all the comorbidities that come with diabetes. And that's that population that we really need to reach. And, you know, we need simpler and easier systems to reach that broad population of users. And that's how we get pump penetration in the general population and not just the, you know, the patients who are already at goal. We're not, we're really trying to lift the entire population here.

Jeff Johnson
Managing Director and Senior Research Analyst, Baird

Yeah, no, that's great. And so let's go over to Type 2.

Trang Ly
SVP and Chief Medical Officer, Insulet

Yeah.

Jeff Johnson
Managing Director and Senior Research Analyst, Baird

We talked about increased penetration. This is probably one of the biggest opportunities to increase pump penetration over the next five to 10 years. I think the news coming out of this conference wasn't big news, but, on your conference call, I think Jim had talked about the SECURE- T2D trial, sorry, was almost complete with enrollment. It is now complete with enrollment, and it sounds like we should get a first read of the data off that SECURE trial at ADA, in Orlando this June.

Trang Ly
SVP and Chief Medical Officer, Insulet

Yes, that's the plan. Yeah, we just wrapped up our last patient visit, and we've been working hard to close up all the activities to get that out. So it's really important for Insulet to demonstrate that the product is safe in the Type 2 population and that data will serve as the key clinical data for our FDA submission. So as a reminder for everyone, there is no AID system that is cleared for the Type 2 population today. So it is; it will be new to market. And so we expect, you know, a close review by FDA. And so we, we've said publicly that we'll be submitting at the end of 2024. And so we hope to bring Omnipod 5 out for our Type 2 population beyond that time.

Jeff Johnson
Managing Director and Senior Research Analyst, Baird

Okay, and maybe a couple data points that did come out, at this conference, and I don't know if I can mention Medtronic or, Tandem if you're going to bite my head off if I mention those companies, but,

Trang Ly
SVP and Chief Medical Officer, Insulet

Won't bite your head.

Jeff Johnson
Managing Director and Senior Research Analyst, Baird

You won't bite my head off. Okay, thank you. No, so they both showed some real-world data on AID use in Type 2. Obviously, these Type 2 systems or these AID systems can be used off-label, so, there's data out there. I mean, it looks really impressive. It looks like we're getting time in range improvements to levels that are pretty equivalent with Type 1, maybe even superior to Type 1.

You know, I always describe to investors, Type 2 diabetes, IIT Type 2, is just very similar to Type 1, only you kind of did it to yourself later in life instead of there being a genetic component. Maybe that's not the best description, but for us lay people, it works. I guess, talk to me about the importance of this real-world evidence that truly is showing good improvements and what that might mean for AID penetration in type 2 over time?

Trang Ly
SVP and Chief Medical Officer, Insulet

Yeah, so we've also shown real-world data in Type 2 diabetes. I think we showed it at ADA last year.

Jeff Johnson
Managing Director and Senior Research Analyst, Baird

ADA, I'm forgetting that. Apologies.

Trang Ly
SVP and Chief Medical Officer, Insulet

That's okay. In a few thousand people. And so we showed exactly that last year, and what we showed there was in the population of Type 2 users, very actually very similar time in range to our Type 1 population. And that's an indication that it is highly effective therapy. And so it was a combination of our real-world data, the very real clinical benefits that we see with Omnipod 5 therapy in off-label use, but also the feasibility study that we conducted and published in Diabetes Care, I think last year, the 24 patients that led us to invest in our indication to do the SECURE- T2D study.

So I think we have shown, like the others, that Omnipod 5 use in Type 2 gets really good clinical benefits. And I agree with you. It is, it's actually, if I look at just the individual traces, it's actually hard to tell what is a Type 2 trace versus a Type 1 trace because insulin therapy is so effective and needed in this population. So really, it's really great to see lots of data from the companies, showing the efficacy of AID use in the Type 2 population.

Jeff Johnson
Managing Director and Senior Research Analyst, Baird

Yeah, and then, you know, one of my arguments over the years has been Type 2 patients may, kind of like children, if you look at the two ends of the barbell, older patients and younger children be really drawn to the form factor of a patch pump over a tube pump. So it's maybe a softball question, but when we do start to see more penetration into that Type 2 category, it seems like patch pump over tubed pump might be even more preferred than we're seeing in Type 1.

Trang Ly
SVP and Chief Medical Officer, Insulet

Yeah, well, we've seen that already. And as a reminder, before Omnipod 5 was launched, we had Omnipod DASH, which is our standalone insulin pump. In a world where there was AID and tubed pumps, 40% of our new patient starts were Type 2 users. So it really shows the remarkable impact of having a simple and easy-to-use system on the market and how you're really being able to influence care in that population.

I definitely think once we get the indication, we're going to be the number one pump for the Type 2, just like we are, well, actually we're already the number one pumping Type 2 with Omnipod DASH alone. But you know, today we are the number one pump in the U.S., most prescribed pump in 2023 for Type 1. And there's, I have all the confidence that we'll continue to grow and really change the landscape and on a population level of the type of care that people are able to get with Omnipod.

Jeff Johnson
Managing Director and Senior Research Analyst, Baird

What would be your guess? I know it's, we can look at how many endos exist in the U.S. and how many U.S. counties versus what county, U.S. counties have, and primary cares in that. But I just find it interesting, if not insightful, the way Jim has talked now over the last quarter or two about increasing investments in the PCP channel.

Trang Ly
SVP and Chief Medical Officer, Insulet

Yes.

Jeff Johnson
Managing Director and Senior Research Analyst, Baird

Now we're getting closer to Type 2, where we know Type 2 approval, where we know Type 2 care is significantly delivered more by PCPs over endos.

Trang Ly
SVP and Chief Medical Officer, Insulet

Yeah. So I think that it's sort of new ground for us. And so there's a lot of learnings to be had. I think on the call, Jim said, you know, we're up to 18,500 HCPs prescribing Omnipod, which is like mind-blowing. And you know, I've seen the spreadsheet. It's like a really broad population of healthcare providers. So we're clearly reaching just a lot of doctors, a lot of nurse practitioners, PAs. So clearly people are very confident to prescribe this product.

And also, I'm pretty certain we said this on the call, also just seeing the number of scripts per HCP also rising is just really incredibly encouraging. You know, it wasn't that long ago that I you know was asking how many, what's our top 100 prescriber look like, and we're like miles away from that. So it's really incredible just to see, look, if you've got a simple and easy-to-use product and people prescribe it for a couple of patients, they see their patients do well. Like, the potential for growth for that product is really remarkable.

Jeff Johnson
Managing Director and Senior Research Analyst, Baird

Yeah, yeah. And, you know, do you have personal experience talking to these primary carers? I'm sure the answer is yes. But how hard is it going to be? Because I think a challenge three or four years ago, Dexcom and Abbott, I'm sure, had was, can these primary carers get comfortable prescribing CGMs? I, they, they have. They've clearly become comfortable with that. Yeah, how comfortable can they become, or how quickly can they become comfortable prescribing a pump? And, and how might a tubed pump versus a patch pump help them get there faster? A patch pump versus a tubed pump, I'm sorry.

Trang Ly
SVP and Chief Medical Officer, Insulet

Well, I think simplicity and ease of use and is very, very important in the PCP channel. I went on a ride last year in PCP land, and it's like different medicine is practiced there. And you've really got to make it appealing. You have to show clinical benefit, number one. And so you need to give them a solution that's actually going to help their patients and their challenging patients. You know, they want to give the best care for their patients. They don't want to just like refer on and never see their patients again. So they do want to offer better care. But your, our solution, whatever we deliver, needs to be simple and easy to use. It can't be cumbersome. It can't take 10 hours to train, right?

What companies, like our companies, need to consider is like, how do we best support these PCPs at scale in a way that will ensure that our patients get the best outcomes? And so I think still more to learn from their clientele. So more to learn from that population. And, you know, Omnipod GO, our basal-only product is in a pilot right now. And we're learning a lot on, you know, the doctor's perception of that technology. These are new to Omnipod doctors that we're talking to. And, they're very interested in the whole portfolio of products. Like, what does Dash do? What does Omnipod 5 do? And so really being able to have that conversation about technology and delivering better care is something that, we're very excited to, really, you know, get into.

Jeff Johnson
Managing Director and Senior Research Analyst, Baird

Yep. And Deb is not on this call. I'm sure she would want me to say now, or you to say, don't put Omnipod GO in your models this year. There's a 2025 modeling event. So, we're.

Trang Ly
SVP and Chief Medical Officer, Insulet

Yeah, it's still in a pilot.

Jeff Johnson
Managing Director and Senior Research Analyst, Baird

Exactly. We will declare that. All right, maybe switch gears. I've got maybe two or three other topics I want to cover. You know, in a presentation yesterday afternoon, it was in Bruce Bode's presentation. I think it was, who's the guy from Minnesota? Anders, works with Rich. Yeah, works with.

Trang Ly
SVP and Chief Medical Officer, Insulet

Anders Carlson.

Jeff Johnson
Managing Director and Senior Research Analyst, Baird

Sorry, not Lars. Yeah, yeah, works with Dr. Bergenstal, right? I think? Am I right on that? Okay. Sorry. So in his presentation, he showed some interesting data and a point I hadn't really thought of. And it's some of these Type 2 patients who go on a GLP-1. You know, maybe the treatment protocol becomes they go from metformin to GLP-1 before they go on to insulin. Makes total sense. But as their weight comes down, they still progress to needing insulin, but now all of a sudden they need a lot less insulin. And their insulin sensitivity is upregulated, if you will. And so an AID can actually get better results than if the patient was not on a GLP-1.

Yeah, so all of a sudden, you know, I don't want to steal the words Dexcom uses and the word I think that has helped get investors over some of the concerns on GLP-1 and CGMs, but maybe there's a synergistic effect between GLP-1 and AID use here. And I think some of the examples shown in that presentation were patients who might have been using 110, 120 units a day, if not higher, down to 60 units. Now all of a sudden at 60 units a day, they become a true candidate for an Omnipod. Yeah, so I know that's a lot of kind of background, but talk to me about maybe the ability to synergistically use a GLP-1 and an AID system.

Trang Ly
SVP and Chief Medical Officer, Insulet

Yeah, so there's nothing stopping anyone from using Omnipod 5 or an AID system with the GLP-1. It's exactly what we've been talking about since all of this happened. But it's really great to see people like Anders and actually Greg Forlenza in yesterday's session also talked about this. So it is excellent therapy, but, you know, they're still on 60 units.

Jeff Johnson
Managing Director and Senior Research Analyst, Baird

Yeah.

Trang Ly
SVP and Chief Medical Officer, Insulet

Anyway. I think Greg actually showed a review article where we got it down, you know, with SGLT2s, got total daily doses down from like 160 down to 120. But, you know, as a reminder, they're still on 120 units. So there's definitely a reduction in insulin if you're heavily insulin resistant, because of all the great effects that we, you know, well characterized from GLP-1. So, with the reduction in insulin, it just makes that insulin work a lot more effectively. So what we've seen in some of our early feasibility work with Type 2 diabetes is that when you add in that GLP-1, you get that additional improvement in time in range, just makes it, you know, a little easier to get that lift in time in range. So we see them working together really nicely.

And then, you know, the other thing with GLP-1s that we've seen is that, you know, yes, they, they lose weight. People with Type 2 lose weight, but their A1C creeps up over time. And that's because it's not addressing the underlying disease progression, right? There's no reversal of underlying disease progression. People, A1Cs continue to creep up over time. And we really see that intensive insulin population really continuing to grow over time because it's not curing the underlying disease.

Jeff Johnson
Managing Director and Senior Research Analyst, Baird

Yeah, no, I think those are all fair points. And, you know, I don't know if you even saw yesterday, Cigna came out and said that, they've entered an agreement with Novo and Lilly to not increase their spending on GLP-1s by more than 15% a year. So there's already some pushback now on how, you know, how fast are GLP-1s going to be able to penetrate the U.S. if payers and, and really the employers who put these payment plans together, push back on, on, you know, these rising costs of GLP-1. So, you know, that's good and bad.

I mean, obviously it's good for society that they lose weight and get on these drugs, but maybe a good data point for the pump companies too if we were concerned about GLP-1 and pump use down the road. Good. Well, maybe we'll switch over to one last topic or two, I guess, topics. One, you know, looking forward. Maybe it's forward a couple of years. Maybe it's forward a certain unknown period of time. But you also showed, or one of your physicians from New Zealand showed some data out of the early, early data out of the EVOLUTION study. And that study is on a new algorithm.

Seems like that new algorithm must be focused around mealtime because part of the data that was shown, I think it was 9 Type 1 and 8 Type 2 patients. So a small data set or 9 and 8 that completed. But out of that data set, you know, these were patients who did not bolus at all over a 3-week period using their Omnipod 5 system, and time in range with no boluses at all. But 61%, I believe, in Type 2. And I've got it.

Trang Ly
SVP and Chief Medical Officer, Insulet

65.

Jeff Johnson
Managing Director and Senior Research Analyst, Baird

65, I'm sorry. Yeah. And up 57, upper 50s. You know the numbers better than I, but 57, I think 58 in the Type 1 category. So, you know, one thing, and I talked about it earlier when we, you know, 10 years ago, we were seeing pictures of these kids hooked up to these big computers and that. I mean, we, we're actually, you know, I don't think close to closed loop as in the next year or two. But I also think I'm starting to hear at this conference for the first time some talk about, hey, these can be closed loop if your patients are non-compliant, an 18-year-old who's just not going to bolus, they still get a benefit on these systems because these systems are pretty good.

We see that in some Medtronic real-world. We definitely see that in some Tandem real-world data of patients who didn't bolus for like 11 weeks on average, and they were still a time in range in the 60s%. And then obviously your evolution data early stage, but kind of shows some of the same. So where are we going with closed loop therapy with ability to not bolus at mealtime and things like that?

Trang Ly
SVP and Chief Medical Officer, Insulet

Yeah, so that was one of our big data releases this conference, and we're really proud to be able to share that with the world. And it really is just the first glimpse into our next generation work. And what I'd say is that the algorithm is one component of a successful system. And, really, you know, the remarkable form factor that we have with Omnipod and Omnipod 5 algorithm, a really solid algorithm with very favorable hypoglycemia profile, is what has made Omnipod 5 so incredibly successful.

And so with that system, because we get data from every patient using it, we can really tell from a population level how our patients are using the system, what leads to most optimal glucose control, where are people, you know, not doing so well, and what can we do as a company to really simplify their experience using our systems. And the reality is, you know, even with the systems we have today, even with all the advanced closed loop systems, there's still work that the user has to do in thinking about their diabetes. And we really want all of that to fade into the background.

So what we've done here is really taken the data that we have from all of our patients, and really leverage that cloud connectivity to analyze and make improvements in the algorithm and then get it onto patients as quickly as possible. And it's because of Omnipod 5 that we're able to, you know, make those changes and load it into the system and, you know, get it into the pumps, and get it onto patients quickly. And we're, you know, you know, Martin and I were talking about the study less than a year ago, ATTD, and I was like, yeah, let's go. Let's do some studies. So, you know, the Type 1 population, when you give more insulin, you run into trouble with hypoglycemia. So we really have to understand, you know, what are the risks with that.

So you can, you can give more insulin, but the outcome of that is more hypoglycemia. And we actually see that with some of the other systems when they go too hard, you know, people run into severe hypoglycemia, it becomes dangerous, and then they stop using the system. And that's something that, you know, we wouldn't want, especially because of our dominance in the pediatric population. So we take a lot of care and consideration into what we release into the world, and we want it to be as safe as possible. And so I think that this enabled us to really understand in a very challenging population of teenagers, young adults who, you know, were, had a very high A1C, and really seeing how they did with the Type 1, with our algorithm.

And then we took the same algorithm, actually, and just put them on patients with Type 2 diabetes. Yes, small, small population, eight users, and we got like 56%-65% increase in time in range. What was, to me, really interesting was like all of those patients were either on a GLP-1 or an SGLT2 or both medications and still really having suboptimal A1C and time in range. So being able to see our algorithm being able to deliver actually quite safely in the Type 2 population insulin that is personalized for them and being able to see that improvement and also like the quality of life improvements.

I mean, you know, you saw all the quotes from all the patients about, you know, not having to think about their diabetes and like bringing them joy. You know, like that's the stuff that's going to change the way people perceive therapy. So it's, I would say, the beginning of many great things that we're going to do with our next generation system.

Jeff Johnson
Managing Director and Senior Research Analyst, Baird

You know, from my side of the table, I want that at the end of this year, next year, something like that. But what happens? You take these results, you then go back to the scientists and iterate the algorithms more, do a small trial. I mean, is this something that's multiple years away? Is this in the intermediate term? You know, I'm sure Jim doesn't want you to answer exactly, but.

Trang Ly
SVP and Chief Medical Officer, Insulet

Yeah, well, we don't know. The answer is we don't know exactly. These are part of the things that, you know, you, you need great teams to figure out, right? Like, when are you done? Or, you know, you could keep testing forever and you'll, will you ever be sure? You know, but, you know, I think really understanding how it works in a challenging population of people is really important for our company, but also for any company out there that wants to, to bring technology for users because it really is about, you know, being able to improve care for the people out there who are being taken care of by PCPs and, you know, the majority of people out there who can't see an endo who are living with these conditions and the comorbidities that come with them.

You know, it has to be safe and effective. And so, people can't develop more complications from it. So the safety profile is something we take really seriously and that might take multiple clinical studies to run for us to get comfortable with that. And you know, the great thing is, because we're number one, you know, we have that revenue growth to be able to invest in this type of research and invest in next generation products. And that's incredible.

Jeff Johnson
Managing Director and Senior Research Analyst, Baird

Well, that's 13% EBITDA margin or EBIT margin. Let's go to 14, 15, and 16. Let's not invest it all away, Mr. Hollingshead, or Dr. Hollingshead, sorry. All right. Last two questions. One I skipped over and I want to come back to, and then one a little easier. So, the G7 integration limited launch in the U.S. kicked off in the last few weeks. Any early feedback, any early data points? Patients love it. Patients hate it. What, what's going on there?

Trang Ly
SVP and Chief Medical Officer, Insulet

Patients love it. You know, as, like, I'm never sure, like, is it going to be enough, you know, when they go from sensor to sensor? Like, what do people get excited about? They're very excited about G7, I have to say. The people talk about the shorter warm-up period being amazing and the smaller form factor being a really fantastic user experience. So it's been incredible to hear that feedback. And patients do love it. So we're, you know, super excited and that's scaling really nicely. And, you know, we're looking forward to bringing that to the market.

Jeff Johnson
Managing Director and Senior Research Analyst, Baird

Yeah. And what has to happen to go to a full market release? What, what boxes have to get checked?

Trang Ly
SVP and Chief Medical Officer, Insulet

Yeah, we want to make sure that the user experience is good. And, you know, obviously that we make enough pods. So, there's a lot logistically because, you know, all of, a lot of our current customers are also wanting to get on it. And so we have a lot more customers today on Omnipod 5 than we did, you know, a few years ago. So logistically, it's a big thing. And so really making sure that user experience is, as good as we want it to be and making sure we can, you know, manage that and the demand that will come with that product is, really important to us.

Jeff Johnson
Managing Director and Senior Research Analyst, Baird

All right. Fair enough. The last topic, and this is the one I skipped over, but I want to come back to now. I think it was poster 09595 or something like that, if I remember right. But it was an interesting poster. It really didn't show any data. It was more chart-driven. But it showed that at mealtime, if patients didn't bolus, the system itself delivered a lot more insulin. I think I'm getting the details. Maybe I'm wrong. Maybe they just bolus. I'm not sure. But, you know, I think I can say this. You wouldn't say it because you're a much better person than I am. But Medtronic has been out there, you know, and then look, Medtronic's done some good work, right, with Klue.

They've got their meal detection bolus, whether that's real, whether it's not. But, you know, they've got some things to talk around about at mealtime. But they do tend to then also say, oh, but look, pod can only, or insulin system can only deliver micro boluses or whatever. You know, that the data in that poster, if I'm reading it right, really seems to show that there can be a big delivery of total total daily insulin at one time if the system senses blood sugar going up. Am I right on that?

Trang Ly
SVP and Chief Medical Officer, Insulet

Yeah, that's right. So, you know, when it comes to meal detection, all the systems do it. Our system does meal detection. All the systems do it. There's nothing like special about it. It's, it's basically you're predicting a rise in in glucose and it's most likely coming from food. So we, it's, it's kind of been like so obvious that we didn't even talk about it, you know. So, so for us, the reason why we did that analysis is, you know, we wanted to see how much could the algorithm deliver. And so we actually specifically looked for overnight traces, which were flat. So they would, you know, all start off with approximately the same starting glucose and then watching for the meal rise. And, you know, we had analytics, and we had our own algorithm to figure out, you know, what looks like a meal.

So we looked at 500 meals without a bolus, 500 in the pediatric population and then 500 in the adult population. Then because we can see all the data, we can see the total daily insulin and then we can see how much of the like how much does all the insulin microboluses add up to over a 4-hour period of time, which is what we call the postprandial period, which is the time after someone's eaten. So we searched for these patterns where people didn't bolus afterwards to see like how much could the algorithm deliver. On average, in the pediatric population, we saw 16% of TDI. So you can imagine someone's on 20 units a day. We were delivering 3 units of insulin over that period of time on average if they didn't bolus.

The same in adults. So it was 16%. But actually, so that's the average. And this is the thing is like a lot of these, a lot of companies talk about averages, but they don't talk about the range, right? There's like massive range. And so actually the maximum of 30% of TDI in kids could be given. So that's doubled. So that would be 6 units for a 20-unit person. So that's a good chunk of insulin. And then up to 38% of TDI in the adults. So really showing that our algorithm really has a robust insulin response based upon patterns of meal detection and works as exactly like we designed it to.

Just proving that out and really showing, and so great to be able to show that, you know, beyond just a clinical study, actually in real world, has been really marvelous to see.

Jeff Johnson
Managing Director and Senior Research Analyst, Baird

And if I let me just make sure I take that down to levels. I understand, but for the investors on the call, I won't throw them under. But when you talk TDI, that's obviously total daily insulin. No, no. So my point is what you're saying is if somebody misses a bolus, yeah, the system knows from the few days prior how much total insulin it normally delivers, and that's what it plans to deliver throughout that day.

Yes. And now all of a sudden it says, oh, wait, blood sugar's going up. I can see that I need to give insulin. And it can on its own give up to 30% of that entire day's insulin in the kids, 38% in adults. So it is thinking on its own and saying, wow, I need to do something. That's right. That shows kind of the automation and just the algorithm behind trying to control these blood sugars. Yeah. Is that right?

Trang Ly
SVP and Chief Medical Officer, Insulet

Absolutely. Because we have such a heterogeneous group of patients that we take care of. You can imagine that delivering insulin on a two-year-old is very different to delivering it on a young adult or, you know, 70-kilo male is very different. So that's why we designed the product to scale with the patient, commensurate with their increase in total daily insulin. And that's why we consider it as a percentage of total daily insulin to basically show that, you know, whatever the patient shape and size is, you know, we're able to adapt to that user over time, which is actually a key differentiating feature for some of the other systems where it requires, you know, that fine-tuning of basal settings to really get that optimal glycemic control. So that's a key differentiator.

You know, we hear, we've heard a lot of clinicians say, look, you put them on Omnipod 5, you, you know, you, you're not messing around with the basals. Like two weeks in, three weeks in, four weeks in, you, you just like put it on and get, you know, as long as they're bolusing, then they're getting really good results from the system. So, and so this is just a, again, helpful data to really show clinicians the being able to quantify that algorithm response.

Jeff Johnson
Managing Director and Senior Research Analyst, Baird

I think that's all I've got. What am I missing? Am I missing anything?

Trang Ly
SVP and Chief Medical Officer, Insulet

Libre. Can we talk about Libre?

Jeff Johnson
Managing Director and Senior Research Analyst, Baird

Yeah, I wasn't sure if I could go there. So Libre 2, you're going into the U.K. and Netherlands in the first half of this year. Yes. Still plan to cover the vast majority, the majority of your user base in Europe this year with Omnipod 5. I guess that doesn't necessarily mean with L2, but, so I'm going to ask, I mean, L3 anywhere in the picture or L2 in the U.S. anywhere in the picture? But outside of that, say what you want to say about Libre 2 in U.K. and Netherlands, and then we'll come back to those points.

Trang Ly
SVP and Chief Medical Officer, Insulet

Well, it's really super exciting collaboration with actually both our partners, Dexcom and Libre. And, you know, it's, we're actually in a clinical study in the U.K. and Belgium and France. And it really incredible to be able to see the investigators in person and talk about the amazing effect of being able to give AID to people who've been on injections for so long, and the results that they're seeing. So that's, that study is underway and doing really well. And, you know, with the CE mark and the launch coming, it's super exciting for us. So as you mentioned, you were spot on about Netherlands and U.K. in the first half of this year. And we haven't publicly said when it's coming to other regions just yet, but these are projects that we're super exciting to be working on.

Jeff Johnson
Managing Director and Senior Research Analyst, Baird

Great. Anything else?

Trang Ly
SVP and Chief Medical Officer, Insulet

Top two, G7, Libre. I think we're good. AID everywhere.

Jeff Johnson
Managing Director and Senior Research Analyst, Baird

Yeah, AID everywhere here. I would agree with that. That's all I've got in my notes as well. So thank you all for joining us. I understand there were a few other calls going on around this time in the States. Sorry, I'm looking at the wrong camera. There. You can tell I'm not TV-trained, but a few other calls going on at this time, so for those of you who joined and those of you who stuck with us, thank you. We will say good evening. I tried it in Italian, but that just doesn't sound good with my lack of an accent. Good evening from Florence. I am off to a cocktail and a night in Rome tomorrow morning. So are you heading straight back?

Trang Ly
SVP and Chief Medical Officer, Insulet

Heading back.

Jeff Johnson
Managing Director and Senior Research Analyst, Baird

This weekend? All right. Well, safe travels back. Thank you so much for the time. I know, your time is so valuable. To give us 45 minutes here was fantastic. Appreciate that. Everyone else, you know, we'll catch up on ATTD takeaways whenever you'd like. Take care and have a good evening.

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