Insulet Corporation (PODD) Earnings Call Transcript & Summary

June 24, 2024

NASDAQ US Health Care Health Care Equipment and Supplies special 45 min

Earnings Call Speaker Segments

Jeffrey Johnson

analyst
#1

Thank you. Good afternoon, [indiscernible] everyone. Thank you for joining us for Baird's ADA 2024 webcast takeaways from the American Diabetes Association Conference that is wrapping up as of today, and we would have spent all weekend here. With us today, we're thrilled to have Insulet's SVP and Medical Director, Dr. Trang Ly. Insulet has probably been -- had probably the most data, the most updated data and the fullest pipeline coming out of ADA this week. So I thought it would be a good opportunity here to talk with Dr. Ly about some of the study results we saw this weekend and maybe go over some of the other key takeaways from the conference. I do need to read one disclosure. Let me get to that. That disclosure would be, please refer to the event calendar, published research or Baird's website for important disclosures regarding the companies discussed during this presentation. With that, Dr. Ly, thank you. Good to do this again with you.

Trang Ly

executive
#2

Great to do this. Thanks for having us, Jeff.

Jeffrey Johnson

analyst
#3

Yes. Happy to do so. All right. So I thought we'd start where most of the new data came out from, which was the SECURE-T2D study. I have a hard time saying that every time. Obviously, that was your type 2 pivotal trial to try to extend the label on Omnipod 5 to type 2. 305-patient study, 13-week study, I wanted to start with the study population. It was a diverse population. I think there were 24% black and non-Hispanics, 22% Hispanics. You had 1/3, 1/3, 1/3 that were high school diploma, post-secondary, undergrad, 28% of the population under $50,000 in annual income. Why was that so important to Insulet and really to the industry in starting with such a diverse patient population?

Trang Ly

executive
#4

Yes. Thanks, Jeff. So we're incredibly proud of the results from SECURE-T2D. And I think the use of AID in type 2 diabetes is still brand new. And it's really the next frontier for technology. And what we've done has never been done before. So we -- I'd say, a couple of years ago, we first started with feasibility data. And because there were still some disbelief that type 2 diabetes would really even need automated insulin delivery. And so we had done that feasibility data, and we'd also done some studies inpatient, in hospital with people with type 2 diabetes. And what we saw was such great results in A1c reduction as well as improvement in time, in range and very minimal hypoglycemia. So that led us to think more seriously about expanding our indication for type 2 diabetes. So today, we already have an indication for type 1 diabetes for children down to the age of 2 years of age, and we are the #1 most prescribed automated insulin delivery system in the U.S. However, type 2 diabetes is still brand-new. Pump penetration, as you know, is very low in that space. And so it was very important to us to recruit a diverse population of people. And so how we did this was we went to sort of nontraditional sites, including PCP sites, in fact, not just endocrinologists, and it was important to us to recruit both people -- the people who we see actually who are not getting great outcomes in the real world, and that includes people who are on multiple daily injections as well as a really large population of people who are on base or only insulin who do not get insulin intensification because of fear of hypoglycemia. And then on top of that, it was important for us to recruit a population that is in need of better care so a representative population of the U.S. population. So as you said, 305 patients, 21 sites across the U.S., endos, PCPs, and what we saw there was a very diverse population. Everyone I've spoken to you at the conference who does type 2 diabetes is just amazed at how we were able do this, and it is the largest and most diverse study in diabetes technology, which we're incredibly proud of, and it has taken the work of many, many investigators and research teams for us to get there. And so it's a remarkable testament to the simplicity and ease of use of the product that allowed us to enroll quickly and finished the study and get incredible results and then submit to FDA. And I think it's because our product is differentiated. So it's not just the fact that it's automated insulin delivery. It's the fact that it is a tubeless system, and it's simple and easy to use, clinicians can use it, patients can use it. And at the end of that study, which I know you were just getting started. But at the end of the study, patients were highly satisfied, and they wanted to continue on the product. And so to us, if we could show that it works in a diverse population, then we know that it's going to work in the real world, where today, pump penetration is low, and there's enormous opportunity for us.

Jeffrey Johnson

analyst
#5

Yes. Well, you brought up a few different points. I'm going to come back to on the primary care side and maybe some of the other outcomes related. I'm going to go off my script already and ask you one question. How nervous have you been over the last year, 1.5 years when you start in that diverse patient population, that maybe compliance wouldn't be as good as you hoped and then results might not look as -- because they were fantastic results. Were there some sleepless nights on, oh, I hope we didn't -- we were right in not cherrypicking and having those patients we knew we're going to be highly compliant, and we knew we could lock in good results?

Trang Ly

executive
#6

Yes. Yes. There's a lot of -- been a lot of sleepless nights. And I'd say, if you have confidence in your product and the results that we've seen and the results of Omnipod 5 in our real-world use with both type 1 and type 2 diabetes has been pretty extraordinary. And so our success on a clinical level as well as a commercial level has given us the confidence that this would work in a very diverse broad population because that's what we see every single day in -- amongst our commercial teams. But I would say every time you do a clinical study and you go to sites that maybe don't do this every single day and maybe have summer interns as research coordinators that you know that there's going to be risk and -- but it was important to us and important to our investigators that this technology could be proven to be used by a broad population. So we worked really hard to make Spanish option available as well as our English options that we had specific consent forms specifically targeting that population, and we had specific enrollment targets to fill. And we went to investigators who see these people every single day. Our Chair, [ Francisco Pascal ], who presented at product theater, they recruited almost 10% of our population and 90 -- more than 90% of his patients were Black or Hispanic. So these are people who are underrepresented in clinical trials. And not just that, if we can -- as I said, if we can show that it works in this population, then you know that the adoption is much more likely in the real world.

Jeffrey Johnson

analyst
#7

Let's jump into maybe some of the results. Obviously, on the A1c side, you saw a 0.8% reduction. That's pretty much right in line with what you see in type 1 studies. So obviously, good results there. Why are we still leading in clinical trials with A1c reduction? Is that something doctors still look at? I just think from the investment community, we've talked time and range more than A1c over the last probably 5 years more or so than A1c. Is that still the first number physicians will look at is that A1c reduction?

Trang Ly

executive
#8

Yes, absolutely. And I agree with you, Jeff. I think people who are in the diabetes space and do this every single day, really understand the correlation between A1c in time and range and it totally makes sense. I'll tell you, I've done field visits in PCP land, where it's the A1C that gets people's attention. So I witnessed a rep having -- showing a marketing material, where they were able to show, look, with Omnipod DASH and A1c -- baseline A1C greater than 9%, got us to 2% reduction, like the guy like literally turned around and it was like, okay, tell me more about it. And I was like, "Oh, damn, they still care about A1c." So...

Jeffrey Johnson

analyst
#9

All right. Well, you did get that 2.1% reduction in A1c in the 9% higher in this study, too, right?

Trang Ly

executive
#10

Yes.

Jeffrey Johnson

analyst
#11

So good, maybe you'll get a few more docs to turn around on that 2.1 data point. One of the data points I thought interesting on the A1c side. You had a very similar, I forget the exact numbers, 0.8 and 0.7 or something like that reduction in GLP and non-GLP 1 users. So 55% of your patients, which we didn't bring up earlier were on GLP-1.

Trang Ly

executive
#12

Yes.

Jeffrey Johnson

analyst
#13

What does that tell us? I think I know what it tells us, but if you get a similar A1c reduction in GLP's users and non-GLP users, to me, that says there's still help these GLP users need that they can benefit. It's not -- GLP wasn't the magic bullet that they can't benefit from something else like in O5.

Trang Ly

executive
#14

That's right. So what we've said all along with all of the news with GLP-1 is that it's not reversing the underlying disease progression. And so what we see in clinical practice is even with GLP-1s in type 2 diabetes, there is a sort of maximum glucose-lowering effect that we see. And so we recruited patients who already on a stable dose of either GLP-1 or SGLT2, we brought them into the study and then we gave them Omnipod 5. And then, as you mentioned, we saw a similar increase in time and range in A1c reduction in both GLP-1 -- people on GLP-1 and those who are not. And a very high percentage of those patients were actually on semaglutide and tirzepatide as well. So it again, just reinforces and completely validates everything that we've said about these being complementary treatments and that you really need insulin to be around in order for GLP-1 to work. So as an example, Francisco presented yesterday in product theater, a case where the patient was already on SGLT2 and a GLP-1, stable dose, maximum dose and had an A1c of 9% and that's what's being seen in clinical practice all the time. And so these people need escalation of therapy in order to avoid complications. And I don't know if you noticed the other thing about the cases yesterday, but these were young patients as well. So they're not getting the appropriate treatment and escalation of treatment in the real world. And so options such as Omnipod 5 is just so -- just really gratifying to see that we're able to help this population and bring their A1c down, even in addition to GLP-1s and SGLT2s.

Jeffrey Johnson

analyst
#15

Yes. And maybe you brought up those cases. I mean I think in 1 of the 2 cases, if I remember correctly, the insulin dose also came down meaningfully on O5 in type 2. I think in your study data, I've got it somewhere here in my notes, but I think the average unit reduction total daily dose was 23 units.

Trang Ly

executive
#16

That's right. Yes.

Jeffrey Johnson

analyst
#17

And in the high insulin users, if you started over 100 units a day, which would not make you a good candidate for Omnipod 5, right, at a 200 unit, a 64% reduction in...

Trang Ly

executive
#18

Yes, 65%, actually.

Jeffrey Johnson

analyst
#19

65%. Okay. I'm off by a point. I'll give you the point, but 64%, 65% reduction in total daily dose of 100 units, that's a patient who probably wouldn't get an Omnipod 5 in the real-world study and now can.

Trang Ly

executive
#20

That's right. That's right. Yes. I -- So when I saw the data, the baseline data, compared, I was like, "oh my God." Like the maximum total daily dose was 357 for 1 of our patients.

Jeffrey Johnson

analyst
#21

Daily?

Trang Ly

executive
#22

Yes. And so there's a lot of patients out there who I think also doctors prescribe it, but patients don't necessarily get all of it and so -- for multiple reasons. But we believe there's a large segment of patients, like as you said, I think there were 85 patients in the greater than 100 units a day needing segment at baseline and came down 65% reduction there. So I think just with what -- and that's not really a new finding. We've seen that before with Omnipod DASH in our previous publication with Dr. Anders Carlson from a couple of years ago, where there was also a 30% reduction in insulin as well. So now we've seen that with DASH and with Omnipod 5. And I think it's -- number 1 reason is it's much more physiological insulin delivery. And so people are getting it when they need it. And so that's important. And then it's -- when you're delivering insulin subcutaneously continuously, it's much more effective insulin as well. So really great to see that large reduction from multiple daily injections.

Jeffrey Johnson

analyst
#23

Okay. And maybe let's talk about the time and range results. Again, I think investors understand the time and range results or it means more to them. We've seen in the pivotals for O5, we've seen in the pivotals for Control-IQ, some of the other AID systems. In type 1, I think investors think 70% or higher is kind of where that time and range should settle out to be a successful study, yours was 65%. But I think what...

Trang Ly

executive
#24

66%.

Jeffrey Johnson

analyst
#25

66%. See, I'm off by a point in all that. Sorry. I wrote 65%. So either I'm wrong or you're wrong. I mean...

Trang Ly

executive
#26

No, it was 66%.

Jeffrey Johnson

analyst
#27

Okay, 66%. Point being, talk about, again, the diverse patient population. And I think when I talk to KOLs about this yesterday and over the last couple of days, it's that 20-point improvement. You started at such a low baseline time and range of 45%. When I went back to your pivotals for -- and I might be getting you guys in Control-IQ mix up, but when I went back to the O5 and the Control-IQ pivotals, for type 1, I think those starting time and ranges were like 50, 55. Yes, you went to 70%, but it was like a 13 or 15 or 17 point increase. You guys saw 20% -- 20-point increase. So talk to me about one that 20-point increase, how clinically relevant is that and how much that will mean more so than the absolute time and range?

Trang Ly

executive
#28

Yes. I mean, Jeff, it's an additional 5 hours a day that people are spending in range where they're thinking better and feeling better because their glucose is in the range. So it's an incredible result. And where -- if we can get mass adoption that's going to add years of life and reduce complications with people. It's an incredible result. So I think we spend way too much time talking about time and range and comparing between systems. The most important thing is unless these devices get out and get on to people, no one's really benefiting. So it has to be able to reach a broad population of users. And what we see every day in the real world, people don't go see their endocrinologists, they're stuck in PCP land, and they don't have great outcomes. And so it's not a surprise to me that people came in with a lower time and range. What traditionally happens with type 1 studies, and I can say this because I've recruited for many is people have a waitlist of people who are eager participants of research studies. And there -- they have financial stability and time to come and do research, but that's often not the typical patient that exists in the real world with at living and trying to manage their disease and not reflective of the general population. So I think the time and range of 45% starting for us is pretty typical of the general population. If anything probably a little higher than what the majority of people live with out in the real world. And so seeing that 20% reduction -- in fact, Francisco and I were arguing, he's like, "Well, I like the time and range more." And I'm like, "well, A1c is important, too." So we could not be excited about value that he said, but I'm really excited about the time and range. And I said, "well, absolutely." But it's because of that, that we get the A1c reduction. So I think that if you want to compare us to other systems, show me the diversity, show me the baseline A1c and time and range and show me that a broad population of people can use your technology.

Jeffrey Johnson

analyst
#29

Yes. And maybe we can talk about where that time and range came from, that improvement came from because I think that's just as important if we're talking especially from a payer perspective, which is bringing down the time and hyper. And I think the payers are starting to understand -- and you tell me if I'm wrong, you probably know this better than I do, but they're starting to understand that micro macrovascular complications are driven by those hyper times. And I just wrote them down here, time above 180, down 20%; time above 300, which is pretty darn high only down 5%, but it fell from 8% in baseline down to 2%. You almost took it away, above 300. Is that going to be the kind of data you can put in front of payers and kind of support the reimbursement. Obviously, you already have it kind of, I mean, payers are paying in for O5 and don't really differentiate T1, T2. But I got to think that just helps you when you go to payers next year and the next few years when maybe competition is coming in and saying, "look, we are going to save you money over the long term."

Trang Ly

executive
#30

Yes, absolutely. I think these are incredible results. And exactly as you say, not just hyperglycemia reduction, but in that high range. The high range that is what causes complications, and complications are a very real thing. It's not something off in the far future. People -- it absolutely is direct correlation there. So I think, as you mentioned, we have great reimbursement today over the 90% of covered lives in the U.S. Majority of our patients pay less than $50 out of pocket, a third actually pays 0 dollars out of pocket for their Pods per month, which is incredible. So we're in a great position, but clinical data is what will ensure that payers see the value of this product and clinicians see the value and will continue to advocate for this type of product for their patients.

Jeffrey Johnson

analyst
#31

Yes. And because you have that -- the payers already covered this essentially, so your doctors have to write it off label -- thank you, to go to type 2 since you don't have the label for O5. I've heard Jim's explanation, but he's biased. He's going to maybe not lie, but he's a little biased.

Trang Ly

executive
#32

Is he biased?

Jeffrey Johnson

analyst
#33

Yes, he's a little biased. You being down in the trenches and really as a position understanding this. Is it going to help when you can now go in or when your sales reps can go in and really talk openly about type 2 use of O5 and things like that? How much will getting in on-label T2 use of O5 really helped in the field?

Trang Ly

executive
#34

Yes. Well, as I mentioned, it's off-label today...

Jeffrey Johnson

analyst
#35

Right. Let's say, 6 months from now, or whenever you get approved?

Trang Ly

executive
#36

Yes, I think that it's going to open up tremendous opportunity for us. And I would say, on 2 fronts. One is that doctors don't prescribe what -- unless there's a rep around to tell them the benefits, that's clear from my interactions. They're short on time, short on cognitive space to think about these things. So it's really -- marketing is incredibly important and having people talking about it and their peers understanding is really important. So we've got some work to do to really prep the market. When -- we believe that when we get clearance for this product and commercialize next year, we will be first to market. And so with those market development work that we need to do to share the story and show people the results of the study and show people how to be able to feasibly in their practice, they're busy practice of prescribing if they've never prescribed it before. So we think that obviously, in endo practices who are already prescribing Omnipod 5 today for their type 1s, that's not going to be a huge change for them, but in the PCP practice where they're not used to using technology, then there's a lot of -- there's some work that we need to do there. So enormous opportunity, but that's going to take investment and market development on our part as well.

Jeffrey Johnson

analyst
#37

And you brought up that maybe being on label will help even more in the PCPs, I think, is kind of what you're saying. Talk to me about the PCP channel. You had a poster out this weekend that showed Omnipod 5, you could virtually train kids and adults. And I think you segmented the data of both kids and adults. And they had just as good onboarding experience, just as good, I believe time and range and other things after a certain amount of time as opposed to those patients who went in and got their handheld and went through a pump class, a 2-hour, 3-hour, maybe multiple visits, things like that. How many PCP offices out there today or even over the next few years, do you think could truly take on training in office, 2 or 3 hours, pump classes versus how important is it that if you could just put it Omnipod on, they go home, they virtually train and they get great results?

Trang Ly

executive
#38

Yes. So I think it's still work that we're exploring and better -- to better understand what's going to work in the PCP market. So I don't think we have all the answers yet. But as you mentioned, what the poster showed and that actually was from 70,000 real-world users of the product. And what we showed there was really great outcomes regardless of whether it was in person or virtual or self-guided training. And I think that's just so important to show because there's many parts in the world, where there's a long wait list, and we need a more scalable model. So in the PCP world, we're going to need a scalable model for sure. But we wanted to understand and learn, and that's why we've worked with PCP physicians, such as Sean Oser and Tamara Oser and others to really understand the workflow and how to best bring Omnipod 5 to that market.

Jeffrey Johnson

analyst
#39

All right. And then maybe just bring it home on the SECURE-T2D trial, pump penetration in type 2, currently about 5%, probably even less than that in the U.S. Pump penetration for T1, about 40%. Pediatrics pump penetration in T1, probably, what, 70%, 80%. I think the 88%...

Trang Ly

executive
#40

Possibly.

Jeffrey Johnson

analyst
#41

Okay. Maybe not quite that high, but at least 70%, 80% of newly diagnosed going on pumps. Does that sound like a fair number? I thought I saw that from...

Trang Ly

executive
#42

Yes, that sounds right.

Jeffrey Johnson

analyst
#43

Okay. So I've always used that as a 70% or 80% of newly diagnosed are going on pumps in type 1. We waited out in generation, that's where penetration can eventually be for all pumpers in type 1. So I feel pretty relatively comfortable, pump penetration is going to move from 40% to something closer to 70% or plus percent in type 1 over time. Where do you think type 2 can go? Can type 2 look and walk and talk like type 1, so penetration gets similar there? Or is it always going to be notably lower? Just -- what's your -- well, you're guess 5 years from now? I don't know what the words I was looking for.

Trang Ly

executive
#44

Yes, I think it's really hard to predict, and I don't think publicly we've given numbers out. But what I'll say is that even in type 1 diabetes, Jeff, we showed a case yesterday. There was a woman who was on MDI for 31 years, who just started Omnipod 5 and G7 this year. And Larry Hirsch, who's a well-known physician endocrinologists, he started after 66 years, and he said to me, " Trang, I do want to use a tubed pump." So I think there's still a significant portion of people out there who are on multiple daily injections who are coasting along, and the physicians just haven't put that option on the table for them. So I think there's still a [ north ] opportunity in the type 1 space. And a lot of patients are actually taken care of in PCP land as well and don't always have the conversation about pump technology because in the past, it's been that, well, if you're on injections and you're doing okay, why rock the boat, why add more complexity. But actually, Omnipod 5 is a simpler solution than injections, which is what makes it differentiated from other technologies. So I think we are really leading the way in terms of expanding that T1 penetration in both endos, PCPs for all of our patients, not just new but also existing patients. So point number one. And then type 2 diabetes, probably less than 5%. I mean, I talked to a lot of endos, and they're not really prescribing pumps for type 2s. So they're -- I think, enormous opportunity there. And I think the fact that CGM has been so incredibly successful in type 2 gives me a lot of optimism about our runway because if they're using CGM, then they're going to see their glucose excursions and they're going to need insulin. And what we're going to show is that our product works better than anything else. And if you're thinking about insulin, then you should think about Omnipod 5. So that's where we -- that's how far we want to advance our treatment in the treatment pathway.

Jeffrey Johnson

analyst
#45

Yes. Okay. And we've kind of moved into type 1, so let's continue there, and then I want to come back to some of the GLP-1 data that you guys posted on your website earlier this weekend as well or over the weekend. But on the type 1 side, we see a couple of new competitors trying to get into the market, talking about coming into the market, things like that. What is the bar to get into the market today. I mean obviously, Control-IQ is a good -- very good tubed pump. You've got an improved form factor with Mobi there. So if you want a tubed pump, you even got now choice in wearability. Obviously, the patch pump with O5 is a fantastic patch pump. Do you have to solve for something that those 2 pumps are not solving for? I just think as a physician and a former doctor, I think about something -- why would I go with something that doesn't have a track record that O5 now has that even Control-IQ has, unless they're doing something different? Are there things that pumps don't do today that other companies could come in and exploit?

Trang Ly

executive
#46

I would say that the bar is pretty high now. I do see that there's emerging technology. But I think people are looking for a patch pump and they're looking for AID. And so when people talk to me about technologies, I'm like, "guys, the world doesn't need another stand-alone pump, like the world wants AID and they want patch pump technology." So that's where I see it headed in terms of technology. And I think that where we can do better what Insulet, Omnipod can do better is actually doing more in the space with the technology we have, and we already have a head sight there. So what we need to be focusing on what the market wants is actually more reduction in burden for all of values is both type 1 and type 2. So today, all the hybrid closed-loop systems that are available require premeal bolusing and still require a user interaction. And so there's more that we can do there to even further simplify the user experience. And what I will say just back to SECURE-T2D for a second is that we -- so we showed improvement in A1c, whether the people came from multiple daily injections or basal, whether they came from GLP-1s or not, but also CGM or not. And then when they were on Omnipod 5, whether they were carb counting or using small, medium, large fixed numbers, it didn't really matter just as long as they were getting insulin and as long as they were doing some bolusing. And that was a really refreshing outcome from the study because in the past, we've just split so many barriers up for patients to access technology, like, "oh, you need to be able to carb count," which nobody can do in the real world anyway, properly. And so it's -- people -- you have to do that, you have to check your blood sugar levels. You have to know how to give injections for 6 months. Like all of these barriers have made pump adoption much harder. And so to be able to show how simple and easy the product is incredibly important. So we're doing that. Insulet is doing that in terms of, okay, where can Omnipod 5 get better? And how can we improve the user experience for our patients and clinicians as well? So how do we reduce onboarding requirements for clinicians so that they don't have to figure out insulin-to-carb ratios and things like that. So we're looking at all of those things to improve user experience for patients and doctors so that device adoption can go -- can accelerate and so we can help more people.

Jeffrey Johnson

analyst
#47

Okay. And maybe if we put some formal structure around that, you did talk about yesterday to strive program, the SmartAdjust 2.0, is that right?

Trang Ly

executive
#48

Yes.

Jeffrey Johnson

analyst
#49

SmartAdjust 2.0. How are we, as investors, going to see that? Will there be feasibility trials? Will there be small samples of trial patients that we see over the next 6, 12, 18 months? And just to be clear, that is primarily going to bring set points lower than the 110 set point. So give even additional tighter control for those patients who want it who maybe aren't as worried about hypo. And what other features -- and I know you haven't really said and so that's probably what you'll tell me, but anything else that you'd be comfortable saying that might get worked in there on a strive -- SmartAdjust 2.0 pump?

Trang Ly

executive
#50

Yes. Thanks for the mention. So what I will say is that today, Omnipod 5 is a really fantastic product, and we built it to have a SIM card in each controller. And so we get data from every single user in the U.S. and actually over 95% of our users internationally as well who consent to give us data. And what we -- and what that allows us to do is have a population perspective on how all of our users are doing. And that's really important because in the past, the big data sets you've seen coming out of other pump companies have been heavily reliant on people who manually upload. And so they're only seeing a segment of the population. They're not seeing all the ones...

Jeffrey Johnson

analyst
#51

And probably a bias segment, right? Of those patients who are more willing to be involved in there...

Trang Ly

executive
#52

Yes, absolutely. That's been proven out and published that, that is a biased, more engaged population who have better outcomes. So we have that advantage of seeing data from everybody. And so with this [ one data ] set, we've been able to say, look, we just need to make small tweaks here and small tweaks there and we could actually lift the outcomes for so many of our patients. And then the other thing I'll say is that, actually, I know our competitors talk a lot about our algorithm, but our algorithm performs incredibly well. I mentioned yesterday's 71% time and range for people who come straight on to injections, onto our product from our real-world data set. And -- so when we looked at the big data sets, we also look at the utilization of our targets, and Greg showed this yesterday. So roughly 50% of our users are using the lowest set point of 110. And what that tells me is that actually, there's a lot of people who are running very comfortably at those higher targets, and they may be getting 65% time and range, but they're very happy about hypoglycemia protection, and they're not wanting to lower their targets. So I think that's great because we design our products specifically with multiple glycemic targets to fit everybody's needs. And what we saw in the type 2 study actually was people who had A1cs in the teens it's actually dangerous to bring them their blood sugar down quickly. You can exacerbate the risk of retinopathy if you -- if they suddenly get a lot of insulin without running to edema and other complications. So what's useful with our system with the higher targets is you can bring people down and bring that glucose range down slowly over time. So we had patients in the study started at 150, slowly brought them down to 130, and they sat very comfortably at 130 for the rest of the study and they're happy about it. So I think our competitors talk about low targets and things like that, but that's not all we care about. We care about patient satisfaction, safe insulin delivery, hypoglycemia data is pristine, right. Across type 1, type 2, it's pristine. That's why the moms and dads prescribed, want this product for their patients and why we -- people from all over the world want this product. So I think it's a clear advantage for us. But we want to continue to meet the needs of all of our users. And so that's why our next algorithm will have lower targets as well as a number of enhancements to...

Jeffrey Johnson

analyst
#53

Unnamed enhancements?

Trang Ly

executive
#54

Unnamed enhancements. And we -- that's full competitive reasons as well. In terms of feasibility, we have a lot of in silico data that we were able to generate just because of the incredible data sets we have. But we will be entering studies in clinic shortly with that to prove it out because anytime you are making adjustments to the algorithm that may deliver more insulin, you're going to increase the risk of hypoglycemia. And so that's something we clearly care deeply about, and we want to make sure that the product is safe.

Jeffrey Johnson

analyst
#55

Yes. Well, I think it's a natural evolution of your company, right? I mean you're so over biased towards kids, and then, of course, you wanted hypo protection initially. And now as you expand more into the adults, is that an oversimplification on my point?

Trang Ly

executive
#56

No. I -- we've always cared about the whole spectrum. The very first studies were done in adults and then we gradually moved it down. And actually, when we moved it down to kids, we saw a fair bit more hyperglycemia. So we had to dial it back a little bit. And so we've invested heavily in prospective clinical trials that in a diverse population also in terms of insulin needs to really understand how our algorithm performs across the space. And so that's why Omnipod 5 is so successful. And I think also -- we have a lot of experience in algorithms. In the early days and even today, sensors are not perfect. And so you've got to be really careful if there is a sensor that's over reading and the risk of hypoglycemia. So you need actually constraints within the algorithm that are non-CGM constraints. So you need a really robust algorithm to handle all of that. And so I know that there's other algorithms out there, but our algorithm is incredibly safe, both safe and effective, and we -- it's validated through our real world evidence.

Jeffrey Johnson

analyst
#57

Okay. We're down to 5 minutes, I'm going to ask you just maybe 4 or 5 quick questions, 30 seconds each. You and I both have a propensity to talk. So let's try to keep it...

Trang Ly

executive
#58

Are you saying I talk too much?

Jeffrey Johnson

analyst
#59

No. That's not at all what I meant by that. I have a propensity to talk.

Trang Ly

executive
#60

Okay. All right. Let's go.

Jeffrey Johnson

analyst
#61

Okay. O5, G7. How excited are the docs to get O5, G7? Do you think there truly have been G7 MDI patients out there just waiting to get O5?

Trang Ly

executive
#62

Yes, yes, yes.

Jeffrey Johnson

analyst
#63

Yes. That's simple.

Trang Ly

executive
#64

Let's go. Yes.

Jeffrey Johnson

analyst
#65

Okay. Now I see you're throwing me off my game. Now I'm confused where I'm going. Let's go back to, you mentioned closed-loop therapy. We're probably several years away from that I would assume, maybe at the earliest. You did show some data out of New Zealand, very small sample size. Will we see progressively bigger data sets? I know you've had to go back and rejigger even off that small little feasibility. How do we think about the time line there?

Trang Ly

executive
#66

Yes. We -- the -- it's really important to test clinical trials, as I mentioned. Early studies in New Zealand were really fantastic. It was a type 2 population. I think we got to 65% time and range in our type 2 without bolusing, which is incredible. But we need to continue to invest in clinical studies there to really prove that out before we can go there. So no time lines yet, except we did say that EVOLUTION 2.0 is about to start. So that sound next iteration...

Jeffrey Johnson

analyst
#67

Okay, I didn't realize that.

Trang Ly

executive
#68

Yes. I think you -- may be you had an investor tour yesterday, so you had -- maybe you...

Jeffrey Johnson

analyst
#69

Maybe I wasn't even listening. It's been a long weekend. Okay. Let's move on...

Trang Ly

executive
#70

So that's coming.

Jeffrey Johnson

analyst
#71

EVOLUTION 2.0 is coming. Okay. iOS G6. Is iOS G6 as important as G7 O5?

Trang Ly

executive
#72

I would say G7 O5 is important in terms of our growth, and that's really important for growth. And so G7 is important, but we have started our iOS G6 limited launch, just this -- on Thursday, we announced that. So that's super exciting. That's going to be an incredible product [indiscernible] for our current users, we believe. And so our current base is incredibly excited about that. We're going to launch and then grow the launch slowly or quickly as the data comes in and to get that out to as many people as quickly as possible. So that's really important. We're super excited. We showed a video yesterday. It was beautiful. But G7 is very important for us in terms of growth.

Jeffrey Johnson

analyst
#73

G7 O5.

Trang Ly

executive
#74

Yes.

Jeffrey Johnson

analyst
#75

Yes. And what about G7 iOS? I think it...

Trang Ly

executive
#76

It's coming. We have an announced timing.

Jeffrey Johnson

analyst
#77

I do think Eric said yesterday in our booth tour, so I do remember some things from that. You weren't here, he said it, Eric can confirm...

Trang Ly

executive
#78

What did he say? What did he say?

Jeffrey Johnson

analyst
#79

He said that the heavy lifting was getting to iOS G6.

Trang Ly

executive
#80

That's true.

Jeffrey Johnson

analyst
#81

The data and communication security protocols for G6 to G7 are not like a whole new process. So he made it sound like there can be a quicker move from iOS G6 to iOS G7 as opposed to what we hear L2+ and L3 are two different -- completely different communication security protocols that, that's like just starting an entirely new project.

Trang Ly

executive
#82

Yes. That sounds right. Yes. So it's not starting...

Jeffrey Johnson

analyst
#83

Well, I think we're down to about 1 minute. I'm going to leave it to you. Is there anything I didn't ask about. I know some GLP-1 stuff we could have gotten to and things like that. But any message you want to leave investors with or leave me with.

Trang Ly

executive
#84

Well we talked about G7. You know you always live out Libre, Jeff. You left out...

Jeffrey Johnson

analyst
#85

I'm a Dexcom guy. And Abott doesn't like me because I'm a Dexcom guy. So that -- okay, yes.

Trang Ly

executive
#86

No, U.K., Netherlands, full market release of Libre 2 Plus, Omnipod 5 sensor, that means our patients can choose their sensor of choice with the best tubeless option in those countries, and we're incredibly proud. We announced that on Thursday as well. So...

Jeffrey Johnson

analyst
#87

Yes, fair enough. I will say the response I've seen from U.K. docs is far ahead with O5, both Dexcom and -- I haven't checked on Libre yet. Are there -- but I mean, what is it about O5? Is there a U.K. reason? I just -- I've been surprised at how passionate some of the U.K. docs I've talked to have been about adopting O5.

Trang Ly

executive
#88

Because it's the best.

Jeffrey Johnson

analyst
#89

Maybe we'll just leave it there because it's the best. We'll just leave it there. Trang, or Dr. Ly, thank you so much for your time. This was fun again. I appreciate the time. Hopefully, it wasn't too heavy on the science and the data...

Trang Ly

executive
#90

Always a pleasure, Jeff.

Jeffrey Johnson

analyst
#91

Mine as well. So thank you, everyone, for joining us. And hopefully, that's a wrap on ADA 2024. Have a good day.

Trang Ly

executive
#92

Thanks, everyone.

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