Insulet Corporation ($PODD)

Earnings Call Transcript · June 8, 2026

NasdaqGS US Health Care Health Care Equipment and Supplies Special Calls 43 min

Earnings Call Speaker Segments

Jeffrey Johnson

Analysts
#1

Good morning. Welcome to Baird and Insulet recap of the 86 session of the American Diabetes Association Annual Meeting. With us today, we're thrilled to have Dr. Trang Ly, Senior Vice President and Chief Medical Officer; at Insulet. I do have to read one disclosure before we get started here, and that is to please refer to the event calendar published research or Baird's website for important disclosures regarding the company's discussed during this event. Dr. Ly good to see you. Thanks for doing this again.

Trang Ly

Executives
#2

Great.

Jeffrey Johnson

Analysts
#3

Yes. Always a good time to go through this. I think we were talking to our sixth webcast, a few at ATC, if you hear at ADA. So it's always a fun time.

Trang Ly

Executives
#4

Always.

Jeffrey Johnson

Analysts
#5

All right. Well, let's get started. First question, and unfortunately, we have to start here. But just on the recall that was announced a couple of weeks ago, a second recall in 10 weeks. I'd love to just hear from you, you're out there. I'm sure talking to docs a lot over the last couple of weeks. Just how has the response been from the physician community and even the patient community, if you've touched anything there? .

Trang Ly

Executives
#6

Yes. I've heard back from both doctors and patients, and people are generally very understanding and actually very appreciative that we proactively find these issues and communicate appropriately to both patients and physicians. I think it just shows that our company cares a lot about patient safety and quality -- and when we find an issue, we notify patients and do the right thing. And I think that means a lot to patients.

Jeffrey Johnson

Analysts
#7

Yes. No, that's a fair comment. How much has that been talked about here at this show. I've been frankly a little surprised. I haven't heard really any chatter about it. We've had a couple of investor events with you and others at the company has barely come up. Is this something that you've heard much about here in Europe.

Trang Ly

Executives
#8

Honestly, no one's asked me about it.

Jeffrey Johnson

Analysts
#9

Okay. Good. And from a sales rep perspective, any -- have they been distracted at all? Have they still been able to be in the field selling -- or is it really holding hands and talking about what the issues have been .

Trang Ly

Executives
#10

There's been no discussion really since after the first initial days, there's been really no further discussion about it. I was actually just in the field on Wednesday Wednesday, Thursday, just before the conference. And I was in New Orleans territory. And it's just really fantastic to see how much we've grown. We are definitely #1 in the region around here. and not 1 of the providers ask me about the recall. We were really -- it was all about what is the future innovation that's coming. It just happened to also be the time that we had released the omnihub 5 algorithm enhancement. So a lot of the discussion was about that and then what was coming at ADA.

Jeffrey Johnson

Analysts
#11

Yes. Well, we'll get into all that, I'm sure you just as you talk about being in the field, I didn't have this on my list of questions, but I think you guys recently expanded your sales force by about 25%. Are you going into yourself going into new offices, primary care office what's that experience like are doctors open to thinking about using a system when they haven't prescribed in the past?

Trang Ly

Executives
#12

Yes. I'll just share and actually, I just found out this contract just this week. So not that long ago, our very first rep in this region. We used to take care of both Mississippi and Louisiana, the entire state with our very first rep. And today, just in the Louisiana region, we have six territories. And so -- what that means is that as we conventionally expand, it's not just a matter of going in further into right space, but it means we can have deeper conversations with our physicians and give them more attention and time, and it means our reps are spending less time on the road, which is really wonderful to see. And I would say I'm really impressed with the amount of interest that we see from primary care providers who want to be offering more states the technology for their patients. And so I genuinely sort of surprised and pleasantly surprised by the interest and enthusiasm from new providers.

Jeffrey Johnson

Analysts
#13

Yes. That's great. Well, maybe we'll as we get into the fully closed loop part of the discussion, maybe we'll talk a little more about the primary care angle and things like that. But let's move on to more positive topics. On pipeline, I know you've had the '05 enhancements that came out a couple of weeks ago. the '06 next-generation Omnipod launching next year. Some of the data came out on that. I referenced the fully closed loop for Type 2. A lot of things to talk about. But I think instead of going '05 enhancements, let's first go to strive in the next-generation Omnipod, omnipod 6, that should launch next year. I guess I'll just open-ended question. Just what do you think the key highlights were? Was it time and range? Was it a reduction in bolosus -- just talk us through what you thought the highlights from STIBOR.

Trang Ly

Executives
#14

Yes, all those things. So I would say just to provide investors a little bit of background, this was primarily a safety study, for Omnipod 6 versus Omnipod 5. So we know Omnipod 5 is a really fantastic algorithm. And when we want to deliver more insulin with our next-gen algorithms, we want to make sure that it's not generating more hyperglycemia than prior generations. So what we did was we've recruited current users of Omnipod 5, and we're already spending a large majority of time at the lowest target. So already reasonably well controlled. And then we wanted to make sure that Omnipod 6 of these patients at the lowest target of 100 would not induce more hyperglycemia . And so it was designed as a noninferiority study primarily looking at safety. And so we met those primary outcomes of noninferiority for safety. So no additional time under 70 under 54. And the improvement in time range was a 4% upward, up to a 4% uplift in time range. And so we saw people coming in at 73% already on Omnipod 5 coming up to 7% Timing range. .

Jeffrey Johnson

Analysts
#15

Those were the type 1 adults. .

Trang Ly

Executives
#16

That was type I adult and then timing hit range increased by 7%. So really impressive finding. But as you mentioned, there was the additional phase called the bolus optional phase. This was a 4 to 6-week optional phase where we asked our users to deliberately bolus 3x or fewer than 3x a day. So so they could bolus 0, 1 or 2 times a day. And the reason why we did that was to really induce a situation where they were bolusing less and allowing the algorithm to deliver more insulin. And so what we shared this week was that even when you -- people were bolusing less that they were able to achieve consistent timing range and time in cap range between Omnipod 6 and with usual bolusing and then Omnipod with fewer boluses. So it was a 40% reduction in boluses and similar timing range. So overall, really impressive results and I don't like to launch it.

Jeffrey Johnson

Analysts
#17

Yes, for sure. And I think a couple of things that I want to unpack. But on that latter point on the fewer boluses, you still have 3 boluses versus 5, I think, in this study, again, that big reduction -- but remind, especially investors, I'm sure physicians get this more -- understand this better than investors do. This is an evolution towards fully closed loop -- and this isn't the final algorithm. Obviously, we'll talk about the EVOLVE study. We'll talk about some feasibilities in type 1, fully closed loop that you're getting ready to start, but you've got to kind of move down that route. And if you go from 5 to 3 here, you've learned some stuff from the algorithm and now a year or 2 from now, maybe you have a stronger algorithm and even more on the fully closed loop side?

Trang Ly

Executives
#18

That's right. Yes. So we see this as a progression towards fully closed loop, which is where the field is heading. And what that means actively speaking is that with every generation at algorithm, we're going to be delivering more insulin so that the patient has to do less. So with our -- what we showed with Omnipod 6 was that the system, the automated delivery component increased, and the total daily insulin did not increase. So essentially, we're doing more patient does less progressing towards less burden for the user.

Jeffrey Johnson

Analysts
#19

Okay. And you alluded to this, that these were patients who are already using Omnipod 5 at the 110 set point, I think, right? They didn't have the 100-point -- at the 110 that point, -- they were well controlled. That was clear by the starting HbA1c, I think, on average, a 7% in your study. I think what Dr. Forlenza said yesterday makes so much sense, too, is that he could have said, and I'm sure most physicians would have said even before we saw the results of the study, there wasn't going to be a significant change improvement in time and ran because it's 7% that already shows those were well controlled patients. But you still got that 3 or 4-point time in range improvement, the 5- or 6-point time and type range improvement. So I guess where I'm going with this is I think back to that retrospective review that looked at AID studies, I think there are over 50 studies over the last 5 years. The S curve kind of that shows -- and Omnipod has been a little bit at the lower end of that just because, again, you guys had higher settings, lower time in range. .

Trang Ly

Executives
#20

How about the meta-analysis that was once on the I want to make sure. I think that's the one. You guys have shown in your own slide deck the one I'm talking about .

Jeffrey Johnson

Analysts
#21

Yes. Yes. I only have 1 bits analysis. I understand. And I'm not trying to argue any points about where you are in time and range on that chart. My point is, now with these results, you will shoot up near the upper end of that if they keep their analysis similar that 76%, 77% time in range, we'll sort you at the higher end of that distribution curve .

Trang Ly

Executives
#22

Yes. Yes.

Jeffrey Johnson

Analysts
#23

And I know it's a very long-winded thing I'm trying to get to here. But what I think you accomplished with STRIVE is as others are moving into the pharmacy channel. -- as others are coming with 2-piece patch pumps, even though they're semi disposable, they're 2 pieces, they are closing or narrowing the gap. You now have time in range days and say, "Hey, our time and range is as good or better thinking if others or better. Even if maybe you're narrowing you as the competitors are narrowing some of the other areas, you can't come at us now on time and range.

Trang Ly

Executives
#24

That's right. That's true. We believe that we have leading performance for algorithm. What I'll -- I'll just -- in providing a little bit of context, like I know that there was a lot of noise in the marketplace about different time range -- different parts. . I'll just go back, and this was actually on our website -- if you look at pivotal trial results in the other 18 and out 1 and overage were I mean, 74% timing range for Omnipod 5. This is Omnipod pivotal study and very low packericing. And this is all on the website that people do see the comparison. And Medtronic was at 75%, and this is for 780G pivotal results. And so very, very similar results there. And so I actually don't think that there are -- even Omnipod 5 on the top side today without enhancements, I don't think it would fair to say that the others have better results. I will say that with the enhancements that are coming and with Omnipod 6, we are definitely going to be ahead.

Jeffrey Johnson

Analysts
#25

Okay. No, that's good to hear. So there was 1 other question I had on that. Oh, just the shift towards looking at time and tight range -- that's been debated back and forth. I think a lot of people have fallen on 1 time or the other. Are you going to worry patients too much if you give them a lower number, if they see a lower number. Now you're leaning on that data a little bit more, is time and tight range going to be something we'll start talking about more in the future? Or do you think time and range is still the main metric that a lot of us will look at 2 or 3 years from now? .

Trang Ly

Executives
#26

I think timing range is still the most clinically relevant parameter do you think as the systems get better in terms of automated insulin delivery, the common type range becomes another feature another parameter we look at. And I think as the algorithms get better, it really is like the timing chart range really enables you to see really how much time perhaps your algorithm is able to really keep the hyperglycemia levels lower. And so in terms of algorithm responsiveness, insulin delivery and that's harder glucose control. It's just another parameter there. I still think timing range is great. And certainly, I wouldn't be communicating to a patient timing range that is new companies across systems is another parameter to examine.

Jeffrey Johnson

Analysts
#27

Understood. One other question is on STRIVE but it kind of goes back to the '05 enhancements as well. When I look at some of the '05 enhancement data that you've shown here recently, I think time and range there did improve from the 110 set point to 100-point by a couple of points. it's not too dissimilar from the improvement we saw from '05 110 set point in your STRIVE data, to 6, which was 2 to 3 points, I think, overall, more than that in the adult type 1. So if the STRIDE 05 users were at 110 if they had been at 100, would we have assumed maybe their time and range would have been higher and the difference between '05 100 that point and 0610 set point wouldn't have been that different at all? Or can I not compare those 2 studies.

Trang Ly

Executives
#28

I think you've had compare, I think, should we talk about we can have.

Jeffrey Johnson

Analysts
#29

I guess, but maybe help us understand what the differences are between the 05 enhancements that are out now and where '06 is different.

Trang Ly

Executives
#30

So what we announced this week was an algorithm here has been to Omnipod U.S. market. And what this means is a new lower target of $100 million and then improved alarm handling so that the patients can stain automated mode for ongoing. I think these are 2 significant advances in the system. I think with the 100 target and it makes sense, right? People are -- it's the lowest set point. So you're going to be delivering more insulin earlier, you can have more insulin on board. So you can -- it makes sense to say you can have more time in range. The early data that we showed yesterday was on 79 users of who were already using Omnipod 5 and majority of them are already using at the 110 target? And then what was interesting to me was when they were offered the 100 target, actually, only 60% of people chose to use it. So that's a interesting 1 factor because people I think that they're not getting tight enough control with on the inside yet, not everyone uses the lowest target all the time. And with that, you're right, we saw a 2% improvement in time and range, 5% improvement came in at range. And if they were using optimized savings up to 83% timing range. Small numbers, but really promising results. I would say the sort of Omnipod incorporates those 2 changes, but it also has a more significant change in the algorithm in terms of the ability for the core algorithm to deliver up to 50% more insulin if the patient doesn't bolus. And so that's a more significant change in the algorithm, which is why we have to do a clinical study to prove that out. So I would expect more significant changes with Omni positive even if you compare that at the same 100 targets.

Jeffrey Johnson

Analysts
#31

Okay. That makes sense. And again, for investors, I'm sure physicians understand this. But right now, the way '05 is designed is when the system delivers a certain amount of insulin if it's reached its maximum amount that they can deliver, that's when it kicks the patient out of auto mode, right? And by increasing the amount of 06 automatically deliver on its own, again, or the time getting kicked out of auto mode should go down and we saw that.

Trang Ly

Executives
#32

Yes. SP1 Yes. So 1 of the biggest complaints that we got about Omnipo5 today, which we've seen with real-world use that we -- to be honest, students in the clinical studies is that if people don't follow consistently than the system, the system responds to hyperglycemia but it says, gosh, I've given you a lot of insulin compared to your total daily insulin, you need need to your CGM. We're not going to continue automated insulin delivery until you confirm that everything will right, then we'll we're happy to go back into automated mode. And I would say the implementation of that was not quite as elegant as we could have designed it. And because of the feedback that we got from a lot of clinicians, hey, when the patients start also did get out and a week to week not in automated mode. Can you do something about that? -- us addressing that change, I think, will mean a lot more patients stay in the automated mode. And it means in the real world, they're going to have better outcomes on 8.5 Omnis today?

Jeffrey Johnson

Analysts
#33

Yes. And I'm sure going back several years ago when first launched, -- you have a lot of pediatric patients. You guys are uber careful about things, and that was probably the genesis of putting in something like that, where it would take you out. Make sure we weren't as confident in PGMs maybe a few years ago as we are today, things like that.

Trang Ly

Executives
#34

I mean, we do pediatric studies, yes, -- but the MARD of certain sensors were 35. -- for sure 35%. So something we care a lot about, which is how long do you deliver insulin based on what looks like a CGM that is not appropriate.

Jeffrey Johnson

Analysts
#35

Yes, Well, let me get us all about that evolution. And it feels like it takes forever, but it's really only been a couple of few years. So remind me the stat -- I think with the '05 enhanced since I don't think I'm getting confused with the STRIVE data the percentage of patients, if they were below 90%.

Trang Ly

Executives
#36

11% improvement.

Jeffrey Johnson

Analysts
#37

Yes, then they went from 85% to 96%, something -- just maybe help us investors because I'm buttering those numbers. Yes. So -- you're exactly right. So what we do now in the limited market relations, we've had people who were not spending over we specifically looked at those from less than 90% time in automated mode. So it was roughly like 84%, but it was an 11% increase in time in the automated mode to 95%. And what that means is people can say automotive mode for longer, they're not getting kicked out as much and just enables the algorithm to do its thing a lot more. So honestly, when I was talking to people in New Orleans, they were more excited about that than the 100 targets to custodial population, where they're like, "I don't always do 1 can anyway. So, but the ability to study in automated mode longer was really welcome.

Trang Ly

Executives
#38

Okay. Great. And last thing I had on the OP enhancements. And again, I think it's the enhancements not described. I think you've also moved the antenna within the right Okay. So '06 will have the antenna slightly moved theoretically, that should improve pairing. Maybe you won't have to, maybe you will, maybe you won't have to where the CGM and the pump on the same side of the body or at least have better activity? It's definitely our design intention to improve connectivity between in CGM. And today, it is important that people wear the devices within line of sight. And what that means, practically speaking, is really as close as possible. So we want people to where the cars any where they win and the omni-product will get us closer to that.

Jeffrey Johnson

Analysts
#39

Okay. And so we talked about kind of that hardware improvement, maybe more time in automated mode. -- higher time and range, all of these improvements, I think the comments yesterday from the physician from King's College or stick click and go or something. Maybe just remind us what he said, Ashley, obviously seemed to like that comment. She repeated you a couple of times yesterday. But I do think it's interesting as these 2 pie semi-disposable patches are coming to market over the next 12 or 18 months, still not going to be sick, click and go or whatever that same was.

Trang Ly

Executives
#40

Yes. SP1 I think you said, Bill, in correct.

Jeffrey Johnson

Analysts
#41

Okay. I know I butchere. Fair enough.

Trang Ly

Executives
#42

We're so fortunate show work with amazing position to say these thousands of patients in these type implanted -- and as many people will know, in the U.K., you see everybody in those types of services. So what is important to him and his clinic is simplicity and ease of use -- and it's not rocket science, you can just imagine the simplest product is the 1 that's going to be most widely adopted. And since the rolled out their funding Omnipod Fibers done incredibly well and has led to many more users being able to adopt. Simplicity to us is a key feature of the product, and it is no longer about just being tubeless. It's about what is that user experience like yesterday, we showed a good area of a 9-year-old. River being able to do apply change on his own. And Ashley, Carol, who's the 87 old woman she uses Omnipod, and she and he started using that 3 years ago at the age 84. And -- it's really important to us that our technology can reach the broadest group of patients possible because it shouldn't just be for the very educated people who are willing to put in the work to manage their diabetes. I think everyone with sites out there doesn't actually want to be thinking about their diabetes and the more we can make the user experience as simple as possible which I think Omnipod does really well, some more patients we're going to reach. I'll say things that are important, just as a reminder for our investors, is our auto insertion of the cannula, the fact that when Dr. Desai still in teammates literally you fill it with insulin. You take the adhesive on you stick it on and then use the PBM to click. And then the tangles automatically inserted and there's no shops to handle. And that is a very easy user experience. And that is the product that's going to win in the market. I mean, I was with an educator just the other day, and she -- and I walked into her office as she had all the products laid out. And I said, how do you talk about the features and benefits of all the systems. And she said, look, honestly, people don't want to be managing to. So I say that Omnipod is the only tubeless product and the that's the 1 that they take.

Jeffrey Johnson

Analysts
#43

Yes. And we'd be interested in that scenario a year or 2 from now if having to put 2 pieces together and maybe put it in into a docking station or not, are those extra steps that still won't look nearly as simplistic and still stick and get or whatever.

Trang Ly

Executives
#44

Yes.

Jeffrey Johnson

Analysts
#45

Okay. And then I know you're not a manufacturing person, but I'm going to ask 1 more that I had in my notes here on Omnipod I think it is going to be configurable over the air as well, right? So today, correct me if I'm wrong, Omnipod comes off full line on the plot 5 comes off the manufacturing line, compatible -- now it's coming off the line another run compatible with Libre 3. But if I'm a DexCom user, and I want to switch to Libre, I can't just use my pot that I got from you last month. I've got to run that inventory down or let's say, Dexcom G8 comes out all your distributors holding G7 inventory, you're going to have to run that G7 inventory down because you can't upgrade deposit. So my point on all that is this should bring some really nice manufacturing efficiencies to the company as well. I'm sure everything you're doing for the '06 for the patient. But on the manufacturing side, it should be the company have some nice benefits as well.

Trang Ly

Executives
#46

Yes, absolutely. So we have said that -- on the Page 6 will come with over-the-air updates to the pod to really streamline manufacturing and inventory management. And I think it's going to be a massive benefit to patients because they'll be able to get our innovation as quickly as possible just from a software drop and not have to run through all their inventory. So yes, that means streamlined manufacturing distribution, all of those things. I think it's going to be a great win for the company.

Jeffrey Johnson

Analysts
#47

Okay. Great. Should we move on to a fully closed loop Yes. All right. Good. So you're a lot more excited about it than I am, I think I'm not capping anyway. Evolution.

Trang Ly

Executives
#48

You should be clapping.

Jeffrey Johnson

Analysts
#49

So you brought on I should be clapping I know, but I'm allied and we'll see where these things go over time. Evolution 3. You have the Evolution 3 data here -- you are starting the EVOLVE pivotal trial for type 2. It is starting you're enrolling that now. Remind me how long do you think it takes to get fully enrolled in that one? And then let's talk about some of the Evolution 3 data.

Trang Ly

Executives
#50

Yes, we -- it's just started. It's a big study for us around 300 people. So we'll be doing that for the majority of this year. maybe we'll see some data next year as.

Jeffrey Johnson

Analysts
#51

But we would think at least 6 months typically to enroll a 300-patient study.

Trang Ly

Executives
#52

At least.

Jeffrey Johnson

Analysts
#53

So last patient in 6 months plus from now, and then it's a 13-week trial.

Trang Ly

Executives
#54

For the primary outcome.

Jeffrey Johnson

Analysts
#55

It is Yes. Yes. Yes. No, we're just always trying to figure out the time lines on that what we said is submission in 2027 and launch in 2028. Yes, understood. All right. SP1 So Evolution 3 was kind of progress from the Evolution 2 study. What was different between 2 and 3 -- and I still am not quite sure I understand that the time and range did come down a little bit in 3 versus 2. Help me understand that a little better.

Trang Ly

Executives
#56

Yes. So in -- so -- so with algorithm development and feasibility studies is important for us to test the algorithm broadly into from population reduces. So what you saw at OCTG was data for Evolution 2 which was we -- although -- so that was a demonstration of fully closed route in 24 patients with type II diabetes. But the setting for that did have to be answered. So we were optimizing the initial settings for what we do the patient came in on. And so really, that didn't incorporate, particularly long activity period. And so what you saw there was really more is algorithm was sort of at steady state what would the outcome be? And again, pretty small, only 24% study, we did see 8% time and range, which is really great and low hyperglycemia. And if you recall, we did these chunks of 4 weeks where we were really trying to the best candidate.

Jeffrey Johnson

Analysts
#57

Yes, I think there were 3 different optimization strategies. Is that right in the Q2?

Trang Ly

Executives
#58

That's right. So it's all about how do we test and learn and do it quickly and innovate and find the best candidate for algorithm. And so we have to do that first, so we knew where we were going. And then this particular study was all about really -- it was more about -- could we start everybody on one single standardized dose and that over time to enable us to reach that steady state. Because if we could remove the need for doctors to enter any setting, that would be a block after product. So it had very different objectives to evolution to. And so what we did was recruits 36 patients for Evolution 3. And they actually a very wide range of internal requirements coming in from 10 units to 150 units a day. And then everybody started on this 1 pad that you didn't have to answer any settings in -- and even in that first part, the range of insulin delivery was 24 to 54 units a day in that very first point. And then over the time, we saw that influencer increase. And actually, I just realized that data was actually insulin used from evolution to that in evolution 3, the overall outcomes that we saw was baseline of 51% going up to 66% by week 6. And then if you look at the last 2 weeks, it was 64% can range. And that's why what we shared in in the poster was a comparison of the baseline versus the final 2 weeks there. I think what it shows though is that the timing range gradually increased over those weeks as the system was adapting to the needs of the user -- and this is what doctors are trying to do in clinical practice. But many times unsuccessfully doing it, because it really requires high contact between the doctor and the physician as a doctor and patient and then really to the patient to really figure out exactly what they're supposed to be getting. So ours is simply do all of that for the user. So they didn't have to bolus during the day for any meal and there were no settings to enter and then we do the order titration over time for the user. So I think that's pretty remarkable. There's no other product on the market that is doing that absolute closed loop is really quite differentiated. And I think it's going to be a disruptive technology.

Jeffrey Johnson

Analysts
#59

Is the vision still and it sounds like it is that when -- well, let me ask it this way, in the EVOLVE study, patients will have to enter settings or physicians won't enter settings and you will not full. -- so it will be completely hands-off.

Trang Ly

Executives
#60

Correct.

Jeffrey Johnson

Analysts
#61

And so the vision is still where there are 25 million patients out there in the U.S., I mean, I guess, let me cut that back down to 2.5 million insulin intensive type 2s and maybe 3 million dls, whether or not basal would ever need a pump. But there's anywhere from 2.5 million to 5.5 million patients out there with almost no pump use today. If you can get into the primary care channel and say, all you do is put this on dock, you don't even know how to -- you don't need to know how to set anything patient, you don't even have to do anything. That is different than a lot of these fullest optional fully closed loop holes open that others are dealing or you're developing which is you can maybe if you want better outcomes, you can bolus a couple of times, you can put some settings in. But if you don't want to, in your time and as what competitors are doing, you guys are trying to go 100% hands off.

Trang Ly

Executives
#62

That's right.

Jeffrey Johnson

Analysts
#63

Yes. Any concern with that, just that I think that some of your competitive systems right now in T1, when you cannot do anything in exercise? -- that becomes problematic for some patients because they don't have an exercise button, something like that. If you don't give patients any chance to us with the system, any concern that, that is going to cut off if ability to work for some patients?

Trang Ly

Executives
#64

Yes. I would say fully closely to Type 2, this product is all about our type II audience who are not getting the care that they deserve today. and that product needs to be as simple as possible. In our study, people whatever they want, they exercise as much as they want, and we have to prove safety under all of those conditions. This is primarily developed for type 2. So very differentiated, and you can't even compare it as any other type 1 system out there. That's how different it is. In terms of our type 1 population, we're going to be leading with Omnipod and continue to do even more studies where we will be delivering more and more and more of that automated insulin delivery. So getting towards more volitional for closed-loop systems we have omnipay platform for all of that. And that's where all the things about exercise announcements, and we have that today with activity mode our system does a fantastic job of that compared to any other system on the market. So we know how to do all of those things for Taco already today.

Jeffrey Johnson

Analysts
#65

And that type 1 feasibility for fully closed loop is getting underway shortly. Yes. would -- should we expect 2 or 3 feasibilities for 5 feasibility studies? And I know it's hard to answer that question.

Trang Ly

Executives
#66

Yes. I -- we are the market leaders today and we know what our patients want and that is more innovation and fast innovation. And so we will -- we need to improve safety in both adult adolescents and children. That's really important to us. We know what happens. We've seen what happens in this space. If you release products that cause more harm than good. And so we care a lot about safety. So it will -- it will be whatever it has Jeff for us to be confident in the overall safety and effect of this profile before we release.

Jeffrey Johnson

Analysts
#67

Understood. All right, 2 topics, 7 minutes. So let's -- you've got good BCG data this week, and there's a few other GLP-1 studies and other kind of incretin studies out this over this weekend. I don't pay much attention to them as a device guy, but there's a little chatter out there, once again, this weekend, like, oh, we're deescalating deprescribing type 2s. They're not going to be on insulin as much. The type 2 market is going to shrink over time. I mean, even with the improvements we saw in retarder, however you say 30% weight loss, I mean, it's fantastic numbers. Where do you think the size of the type 2 market, being, insulin using type 2 market those over the next 3 to 5 years?

Trang Ly

Executives
#68

Yes. I would say we're extremely positive about this market in terms of our ability to help with our products. And I'll say the recasted data, the A1C reduction was really no better than apptilities -- and so we don't really see the core benefit changing at all in terms of diabetes A1C reduction on you? So I shared some new data that we just published from Elders Group yesterday, where it showed pretty recent data from ethnic customer database that today, 41% of people with Type 2 are estimated to be on a GLP-1, 41%, which is pretty high adoption, yet insulin use was still 26%. And if you look at data from the last 10 years, that means GLP-1 has increased 10-fold in the type 2 space. Yet insulin has remained the same. So perhaps in some early -- if you have early diabetes, it can reduce the amount of insulin that you need, but we're not seeing that on a population basis. So I thought that data was really compelling.

Jeffrey Johnson

Analysts
#69

And can I just -- just for investors, again, the first letter and bar back in Becker Hershey, we said their letter, right? And it showed that even through the end of '25, like you said, using the EPIC Cosmo data, even through the end of 25%, 41% of patients on GLP-1. So we know a lot of -- of course, I so we know it's yes, everybody use it. But in 2007, 26% of type 2 patients were on insulin -- and today in 2026, 26% of patients on insulin. So the use of insulin by type 2 patients has not decreased even with a significant increase in GLP-1.

Trang Ly

Executives
#70

That's right. And that's why we're confident that a massive market out there, people in need that we need to go. .

Jeffrey Johnson

Analysts
#71

Yes. Fair enough. .

Trang Ly

Executives
#72

SP1 All right. I said Yes, please just on the GLP-1s, we also did our earnings resources we care a lot also about what's happening peripherally in this metabolic market. And we shared yesterday current data also current data in 2 of people who have type 2 diabetes who have been using GLP consistently for 15 months and looking at their A1C results. So for those on a GLP-1 alone, so no insulin. 43% had an A1c greater than 7%. So not a target. And those on basal insulin alone over half were not at target. And for those on a GLP-1 and multiple daily injections, -- so 2/3 of people were not at target.

Jeffrey Johnson

Analysts
#73

Even with the GLP.

Trang Ly

Executives
#74

Even with the GLP 1. So GLP-1 is not cure diabetes.

Jeffrey Johnson

Analysts
#75

Yes. No, there was another -- this is a CGM comment, not a comment, but a couple of different studies this weekend that showed CGM use, you take off some weight, GLP-1 use, you take out some weight, the GLP-1 plus CGM was faster and greater weight loss. So again, it just seems like technology and GLP-1s can be complementary.

Trang Ly

Executives
#76

Yes. And I'll -- and just on that note, e-mail Evolution 3 study, we had patients who were on everything like CGM, GLP-1, MGI, all this complex intensive therapy, but the median commence study was 8.1%. So these people are out there not achieving in control. We see this in clinical practice all the time. .

Jeffrey Johnson

Analysts
#77

Yes. Understood. SP1 Any other last topic. I think we're down to a couple of minutes, and I'm supposed to check my phone and I'm seeing is a nice game line move for tonight, but other than checking the line on the game tonight. Let me just make sure there's no questions. I don't see any questions that came in for any investors, JD Johnson at RW Baird. If you have a quick question, but 2 minutes. Any last topic we should come.

Trang Ly

Executives
#78

I mean I think we call it everything only 5 with algorithm enhancement, super exciting. Stride, which is only plus cannot wait to bring that and then fully closed with, which you should be applauding. I mean come on Jeff. I mean it is so going from everything out there. There's nothing like it we have proven that it can work and are in a study and that's coming. All right. Well, I'm excited for that. What are we going to.

Jeffrey Johnson

Analysts
#79

Where is ATV next year?

Trang Ly

Executives
#80

I don't know.

Jeffrey Johnson

Analysts
#81

All right. Well, 9 months. We're looking forward to the next 1 in 9 months. So Dr. Ly, thank you again for your time. It's always a pleasure. Enjoy the conversation and best of luck travel back. Thank you.

Trang Ly

Executives
#82

All right. Thank you everyone.

Jeffrey Johnson

Analysts
#83

Good afternoon, everyone, and good morning.

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