I think we're gonna get started. My name is Jeff Johnson. I'm the Senior Medical Technology -Analyst at Baird, and our next presentation this afternoon is from Insulet Corporation, a leader in the $3.5 billion global insulin pump market.
With us today from Insulet, we're happy to have Chief Executive Officer Jim Hollingshead, Chief Financial Officer Wayde McMillan, and Vice President of Investor Relations Deb Gordon. Jim, I'm gonna turn it over to you if you have a few minutes of prepared remarks, and then we'll go into Q&A.
Thanks, Jeff, and thanks for having us, and thanks for coming, everybody. Our business has just fantastic momentum. We're coming off of a record quarter with our Q2. We had record new customer starts, a really terrific new customer starts quarter. We grew 32% globally, which is our largest growth number since 2019, and we're a substantially larger company than we were in 2019, and it was our fourth straight quarter of US growth that started with a four. So four straight quarters of US growth, 40%+.
We have... We're very excited that we've launched our flagship product, Omnipod 5, in the U.K. and now in Germany. We have Omnipod Go, which is our new-to-world product in pilot right now, and we have lots of great stuff coming in the roadmap.
So we're very bullish about the market, we're very bullish about our growth, and we continue to have significant momentum, which is why on the Q2 call, we did a significant raise for the second half. So we're very glad to be here today. I know you have a lot of questions, and I have a sense what your first question is likely to be, Jeff, and so why don't we go to that?
Yeah. I would, I would zig just to, to change it up a little bit, but I'm not going to. So, so all the good things I wanna get back to here shortly.
Yeah.
I promise you we're only gonna spend a couple of minutes here on, on the topic that you know is coming but... So on GLP-1s. Obviously fighting a boogeyman there, I get that.
Mm-hmm.
None of us know where things are going over the next five or 10 years. But if I start in T1, this is what came out last week in New England Journal. I think Trang did or Dr. Ly did a good job last week of talking about the honeymoon effect and-
Mm-hmm
And things like that. But at its core, Type 1 is a disease of the beta cells dying.
That's right.
GLPs can wring a little more efficacy out of a beta cell, but when it's gone, it's gone.
Yeah.
So my view, and I just wanna see if this is consistent with yours, is that even if we extend Type 1 time to insulin through this honeymoon period or whatever, three months, six months, one year, Type 1 disease isn't going anywhere, and eventually, in a pretty quick succession, whether it's extended by a bit or not, these patients are gonna need insulin, are gonna need an AID system of some sort.
That's right, Jeff, and I... You know, so Type 1 and Type 2 are different conditions. They're both progressive conditions. And I'm sure most of you in the room know the difference between them some, but I'll just cover a couple of things. So somebody who presents with Type 1 diabetes has an autoimmune condition where their body's immune system is attacking their Beta cells. And often, what happens with those patients is that they don't realize... They may have no family history of Type 1 diabetes.
They don't realize they have the symptoms of Type 1 diabetes. They probably feel like they have the flu. They have flu-like symptoms. They have other things going on. They're very thirsty. And so they present acutely, typically in hospital, and they get diagnosed in hospital as having Type 1 diabetes, which for most of them is a big surprise.
Oftentimes, what's going on with them is their blood glucose is very, very high. It can be north of 300. And so that, in that initial period, what happens is they get treated. They typically get admitted, be treated with intensive insulin and to get their blood glucose back in range. Their glucose comes back down again, and then they go through something that, that Trang Ly, our medical director, covered pretty well last week in a couple of settings.
You know, something that's well known called the honeymoon period, which can last anywhere from 6-12 months, where their blood glucose is kind of more or less normalized because they've been treated acutely, but then they continue to progress because their immune system is killing off their beta cells, and so they're not producing sufficient insulin.
They always end up needing insulin. And so that study that came out last week was 10 patients, no control group, and really, the results of that study are very consistent just with the known honeymoon period.
Yeah.
We've consulted with a number of physicians and KOLs in this space, you know, obviously urgently on the back of that. It's worth reminding everybody that liraglutide was also studied in type 1 diabetes, and the only effect that liraglutide showed in that population was a small reduction in needed insulin, but not, not the avoidance of insulin therapy at all. The reason for that is the same reason GLP-1s have, they produce insulin out of the remaining beta cells.
GLP-1s tend to drive production of more endogenous insulin in people that have beta cells. You can get a little bit of a dose reduction as people are going through that autoimmune cycle, but they always... Type 1 patients always end up needing insulin to survive.
Yep, exactly. And so, yeah, I think the pressure that the diabetes space felt last week on that Type 1 news just seems crazy to me.
Yep
... but I'm sure you would concur. But in Type 2, now that's where we can have a real, you know, debate-
Mm
Or a real discussion, in that we know obesity drives higher fatty acids, which causes inflammation in the body and reduces-
Mm
The body's sensitivity to insulin. We know that fat in the pancreas reduces beta cell activity or inhibits beta cell activity and can cause beta cell death. So if you take fat away, you take fatty acid levels down and quell inflammation, you can, with some of these drugs, potentially extend that time period from initial onset of Type 2 diabetes or diagnosis to when you might progress and need insulin.... Is that unfair with your understanding? And then what do your KOLs and the docs and customers-
Yeah
You talk about that progression timeline extending by how much?
Yeah, I, I think that that's the theory of the case, and I think that that's created a lot of uncertainty for investors. It doesn't create really any uncertainty for us. We know what we're gonna do every day, and we understand our market. And so I'll just, I'll make three broad comments about GLP-1s in Type 2 and their impact on the market and give a little color on each. The first one is, the magnitude of the public health problem of Type 2 diabetes is so large as to be hard to fathom.
It's huge, and, and, and those patients always progress. They're on a slippery slope from, usually from pre-diabetes. So obesity drives pre-diabetes, but from pre, pre-diabetes on, they're on a slippery slope down to insulin therapy, almost always, and that progression continues. So that's the first thing, and we can come back to that.
The second thing is, we've had long experience with the GLP-1 class in the diabetes market. So GLP-1s were first indicated for Type 2 diabetes back in 2004. Liraglutide, very broadly used drug in Type 2, indicated in 2010, and then Ozempic indicated in 2017. So depending on how you wanna think about the class, we've had six or 10 or even 18 years of experience with GLP-1s in the Type 2 market, and so we've already seen some impact. And the impact of, of GLP-1s in the Type 2, they're great drugs.
We don't, we don't have anything... I'm sorry, I hit my mic. We don't have anything against GLP-1s. We think, we think it's great that pharmaceutical companies are innovating in the space. They're trying to help the same patients that we get up every day to help. But the impact of those drugs on the market has yet to materialize in a way that we think materially moves the needle on our TAM. And then the third point I would, and I'll, again, I can come back and give more color on that.
Sure.
And then the third point I would make is that GLP-1s are not a replacement for insulin. They're adjunctive to insulin therapy, and so it's been going on for several years in the market that, that injectable GLP-1s are actually first-line therapy. And GLP-1s have a ceiling on their efficacy, and then patients get insulin added into their therapeutic regime.
And for many of those patients, if they continue sliding down that slope, which they mostly do, vast majority of patients do, eventually, they end up on intensive insulin alone because GLP-1s have hit their ceiling for that patient. But they're used in conjunction all the time, and in fact, GLP-1s make insulin therapy more efficacious. And so we can talk about, all the color on, on those three points if you'd like.
Yeah, look-
Where would you like to go with that?
I don't want to belabor it.
Yeah.
And, over a couple of beers, we could,
Okay.
talk it more at length.
All right.
But I think, you know, the point I think investors need to understand and maybe take away from these kind of conversations is Type 1, probably no impact.
No, no impact on Type 1.
Type 2, a debate on how long that progression can be deferred, delayed, extended to needing insulin, whether it's three years and then it wouldn't matter, it'd all get lost in the noise.
Yeah.
If it's 10 years, then maybe it becomes a little more impactful, a little bit more.
Yeah. Well, I think,
That's the debate we need to have.
Yeah, and where you're steering into, Jeff, is the correct question, which is: What's the incremental impact-
Yeah
On the need for insulin therapy over the GLP-1 experience that's already been going on in the market? GLP-1s have been widely used. If you go and look at data on patients using insulin, very, very many of them are also on GLP-1s.
Yep.
And since we've had multiple years of experience of the GLP-1 class of drugs in Type 2 diabetes, you know, there's already some, and to whatever extent there's a delay to insulin therapy, to some extent it's already baked in the cake. And so the question is: Do the new agents add incremental benefit? And if so, how long?
And again, not, I'm not trying to, you know, counter-detail the GLP-1s, but if you think about what we know about access on the one hand and, persistence or adherence on the other, about half of patients on these new class, the newer GLP-1s, are off the drug at one year, and about 70% are off the drug at two years. And so you've got an access constraint, you've got a persistence constraint, and then we're asking: Is there an incremental insulin need benefit?
That's why we've, you know, we're we have very high conviction that tens of millions, hundreds of millions of people living with Type 2 diabetes are going to continue to need both basal insulin therapy and then ultimately intensive insulin therapy, which is really our end market.
Okay, the last time I will use the word GLP-1 is: Do GLP-1s actually make AID therapy look cost-effective now to these payers?
AID therapy is very cost-effective. As you know, our average customer pays less than $50 a month copay for their Omnipod product. You know, stacked up against the out-of-pocket cost for a GLP-1, it's very, very cost-effective. It's actually... We've priced Omnipod 5 in the market to be about the same range of cost as multiple daily injections. When you look at the out-of-pocket costs we hear about with the GLP-1s, I think there's really no cost comparison at all.
Yeah, and I'm even talking cost to the healthcare system.
Yeah.
If we're talking of what's gonna bankrupt a government here or a government there-
Yeah
You know, AID is much more cost-effective, even when you-
Agree
Fully cost it up.
Fully agreed.
Okay, so with all that, where does Type 2 penetration of AID system use go over the next 5-10 years? Forgetting about how many, so we've-
Yeah
Debated the TAM.
Yeah.
Where does penetration of Type 2 go for AID use, like in Omnipod 5, over the next five, 10 years?
Yeah, we haven't been public with our target penetration number, but we think it can be significant. And if you look at Type 2 diabetes right now and in the intensive population, intensive insulin therapy population, that's penetrated low single digits. I mean, you could say five, which is probably an aggressively high number. And already with Omnipod 5... You know, so just to be clear, we don't have the indication for use-
Yeah
For Omnipod 5 with Type 2, and we are not promoting that product in the Type 2 space. We have two labels, two products on label for Type 2 use. One is Omnipod Go, which is just in pilot, and that's labeled for basal insulin. So our, our intensive insulin therapy product in Type 2 is Omnipod Dash, which we are promoting in the Type 2 space. In Q2, 95% of our new customer starts were on Omnipod 5... and 20% of our new customer starts were patients living with Type 2 diabetes.
So that will tell you that we're getting a lot of off-label use of Omnipod 5. Now, that's without promoting Omnipod 5. We're getting that, and we disclosed last week. We usually don't disclose our new customer start numbers, and we're trying to not set a precedent of disclosing our new customer start numbers. But because there's been so much interest and so much noise over the last two or three weeks, we did disclose that we had our highest ever number of Type 2 patient starts in Q2.
Just over 5,000 patients came on Omnipod 5. Well, actually came on a combination of Omnipod 5 and Dash for Type 2 diabetes. Now, take that number and stack it up against the 2.5 million people who are living right now today in the U.S., who need intensive insulin therapy and Type 2 diabetes, and you can see, we are just touching the market. We're just beginning. One of our competitors has been public on their penetration number, where they say in their entire installed base, they have about 20,000 total patients in Type 2 diabetes.
So you can see the penetration is very, very low, but the opportunity is huge. And the activity for us, you know, we have in field visits now, what we're seeing every day, is physicians are writing off-label. They're either writing Dash for people with Omnipod- you know, for people living with Type 2, or they're writing Omnipod 5 off-label, and that's without us promoting it. So we think that adoption can be very good.
As you remember, when we launched Omnipod 5 in Type 1, adoption was fantastic, and once we can promote, we're very, we're very optimistic about being able to drive penetration. And the last point I'll make on that front is, that's a market where we have the right to win. Because if you're somebody who's living with Type 2 diabetes, you have a lot of things going on in your life, both in, you know, just generally in your life, but also clinically, by the time you get to intensive insulin therapy.
You've got a ton of comorbidities. You're typically struggling with your weight. You might have other conditions that require either pharmaceutical or medical device therapy, and one of the big barriers in that market to putting people on a pump is the great difficulty involved with getting on and staying on tubed insulin pump therapy. That is not an easy therapy to get trained on and stay on.
Omnipod 5 is so simple that we are very confident we'll be bringing customers into the market for pump therapy because of the ease of use, and we'll be taking the lion's share of those patients as they come into intensive insulin therapy.
Yeah. All right. Well, let me follow up on a couple of questions there, then. One, do you think we hit 100,000 new patients for the full US market this year? Last couple of years, it's kind of been about 75,000 new patients coming in through MDI or off MDI into pump therapy. Seems like we could be trending towards 100,000. I mean, are AID's expanding the market that much?
We are definitely expanding the market. I'm gonna turn to Wayde and see if he wants to guide on that number.
Yeah, sure, Jeff.
No, that's a market number, not-
Yeah, yeah.
Yeah.
We agree.
Yeah.
In the total market, yeah, it should be well over 100,000.
Yeah.
As, as Jim just said, given the technologies, even the tube pump technologies moving to AID, and now with Omnipod 5-
Yeah
The acceleration of people with multiple daily injections, recognizing the advantages of AID systems, combined with the simplicity of Omnipod 5-
Yeah
Clearly, we're driving the majority of that, and we do, provide numbers that show that the majority of our new customer starts are pulling those multiple daily injection people into our Omnipod 5 pump.
Yeah.
But yeah, we would agree. It is accelerating, and it's great. I mean, that's what our mission is, to deliver more simple, easier solutions for people with diabetes.
Yeah, and I think pre-2005, you guys were probably at about a 45%-50%, this is our math, kind of win rate of MDI. I've got you closer to 70% the last couple of quarters, if you're feeling generous with numbers, you-
Yeah, it's tough for us to say because we don't know exactly the competitive numbers, so to get a percentage of that total market. But what we would say is, since Omnipod 5 has launched, we do think we're taking more than 50% of the available, new customer starts out there and certainly accelerating. So we would agree with you, Jeff-
Yeah
That we think it's the majority.
All right, and then I asked you the T2 eventual penetration rate. Still thinking, I think, I think you've said this publicly, and, and not, and I don't think-
Yeah
You did and say it or that you said it offline, but is 60%-70% penetration of pump use in T1 a reasonable assumption over the next 5-10 years?
We think so, and we-
Yeah
I think we said that on our Q1 call.
Yeah.
The reason for that is, again, most of the penetration models that you hear people throw numbers around have been built around the idea of tube pump adoption in the Type 1 space. Omnipod 5 is so much simpler to use that we believe those models are outdated. We believe that penetration can follow behind CGM penetration, which we think will continue to grow rather dramatically. Wherever there's a CGM, the road is being paved for Omnipod 5.
Especially when we get to sensor of choice, the whole market will be paving the road for us, and we think it's very reasonable to expect Type 1 penetration for Omnipod, for pump therapy, but really led by Omnipod 5, to get north of 70% within a reasonable timeframe. Again, we'll be bringing most of those MDI customers into the market.
Yeah, fair enough. Competitive conversion's also a nice tailwind to your growth here recently. Wayde, understanding numbers are hard to come by, but, you know, it seems like to us, you guys, if a patient was out there willing to convert or thinking about converting, you guys were winning that about 20% of the time, pre 2005. It now seems like it's closer to a jump ball, 50/50 or so. Is that somewhat ballpark with your estimates, number one?
Number two, you know, one of your competitors has been ceding share pretty aggressively for at least three or four years. Do the number of patients turning over into that potential competitive convert bucket start to shrink here over the next few years? Has your win rate gone up, but are we gonna see consistency to that potential competitive convert... size of the market. Does that make sense?
It does.
Yeah.
Yeah, so again, we can't really put a percentage on it 'cause we're, we know we don't have the-
Yeah
Competitive numbers, but we would agree with you that our win rate has certainly accelerated, in particular, with Omnipod 5. So we saw a steep increase in the number of competitive conversions, in fact, in the very first quarter that we launched Omnipod 5, we saw not only our own customers really hungry to move on to Omnipod 5, but competitive switches. And what we've seen in the four quarters that Omnipod 5 has been out, that competitive switch number has stayed pretty consistent for the four quarters.
What's changed is the number of MDI users for us has even significantly accelerated. And so the percentage of our new customer starts has gone down about 5% each quarter for four quarters.
Yeah.
Inside of that, the number, to your question, the number of competitive switches has stayed pretty consistent.
Yes. Okay. All right, that's helpful. And then if we look at... Where do I wanna go here? Maybe, beyond T2 label expansion, which I know you're working on, for Omnipod 5. You've got the basal pump you're working on it now, or you have it done, and still thinking a 2024 full launch comes there. And, you know, I get labeled as probably one of the more optimistic guys on basal uptake of your pump. I think it could maybe go to 10% penetration over time. Is that... You know, where is that ballpark-wise relative to your expectations?
Yeah, that's why we're piloting Omnipod Go. So Omnipod Go is our basal-only pump, and we are in pilot with it. We've been talking about piloting it in the second half of 2023 so we can commercialize the scale in 2024, which is still the plan.
We're out in pilot with it right now, and just to give you a description of the pump, it's the same simple patch pump form factor as Omnipod Dash and Omnipod 5, but it doesn't require a controller or connectivity, so it's to a CGM. So it's a simple patch pump with different SKUs that are preloaded to deliver a daily basal rate of insulin. So if you're on 10 units, you get the box that are the 10-unit Omnipod Goes.
The way it works is you fill it with insulin, you put it on your arm, it senses that you've taken off the adhesive and put it on your arm, and it waits, you know, 30 seconds or so, and then it deploys the needle without any, without any effort on the part of the patient, just like with our auto insertion with, you know, our overall Omnipod product. Mostly, you don't feel that cannula needle go into your arm, and then it delivers a trickle dose over 72 hours of your daily basal rate. It's a fantastic solution.
It's a very large market of somewhere between 3 million-4 million people who are on daily basal rate insulin. We know that there are two real barriers to them using insulin therapy. The first is, they don't like needles. You know, people delay using MDI insulin therapy because they have a fear of needles, and so we know we address needle phobia. And it also reminds people to use their therapy. So you put it on, you're getting your basal rate for three days.
It then has both an audio and a visual reminder and says, "Hey, it's time to put on a new pod." You know, fill up again and put on a new pod because people forget to take their dose of daily basal rate. So we think we're solving real problems there. We think we're solving real problems for physicians who want something really simple to help their patients initiate insulin therapy, and we're bullish on it.
But we don't know the penetration. It's new to the world, and, if you will, the selling motion is new to us because we're calling predominantly on PCP clinics, which is not... You know, we do call on a few PCP clinics now, but it's not our normal call point, so we're learning how to do that. Because it's so simple, we're learning how to leverage the practice staff for training and setting up patients, and we're doing sampling in the channel. So those are new things for us. We're out piloting it right now.
We're testing different hypotheses, if you will, about the commercial model, and as we understand the commercial model, we'll have confidence to go forward in 2024 and launch at scale. Then we'll have a better sense of how much adoption we can get in the market.
All right, I wanna jump over to the international markets here and ask you about U.K.-
Mm-hmm
Germany uptake, things like that. But before I do that, just whenever I hear sampling, I always, always wanna jump over to Wade then and ask, you know, "What's the margin impact of sampling?" And how do we, how do we model that out? I hadn't necessarily thought of that. But just maybe more broad strokes, you know, you're gonna be, I should remember this, upper single or low, low double-digit operating margin.
This year-
This year, right?
Yeah, and we're at the high end of high single digits for 2023.
Okay.
Yep.
Yeah, yeah, high end of high single. Okay, yeah. So just where's the margin gating expectations maybe over the next 3-5 years? I know it's a big question. You don't necessarily have LRPs out there, but is it 100 basis points a year, 200 basis points a year, more or less than either of those? Just how to think about that.
Yeah, so I think your leaping off point there was Omnipod Go, and it is a really interesting product. As Jim said, it's new to world, and depending on how big a percentage of our revenue it is, it will play a role in gross margin expansion, operating margin expansion over time. As Jim just said, we're testing a bunch of different pilots for how we'll bring the product to market.
If we can be successful with the sampling of it, where we're not spending as much field time and as much training time on the product, it can be a really efficient revenue stream for us. And then, of course-
Lower gross, but-
It could be.
Better-
Lower gross, depending on where the pricing comes in, but certainly, the support for the product is a lot different than our current products which have algorithms and a-
Right
And an associated personal diabetes manager with them. The other potential for it, and one of the things that got us really excited about the product, is the pull-through. So if people start on Omnipod Go as a basal customer, then eventually it will be just natural for them if their insulin needs progress to intensive insulin, basal and bolus, a natural move into Dash or Omnipod 5, therefore really lowering our customer acquisition costs, which are also could be very efficient for us, helping drive the bottom line.
So we do think, we're essentially building into our product pipeline, our portfolio of products, potential for gross margin, operating margin expansion over time. But as Jim said, it's new to world. We have to test these different models and see how they come through. Then moving to the overall operating margin for the business, we haven't put a number on it, as for a long-term operating margin expansion, other than we are committed to operating margin expansion over time.
So it's really just a question mark for us, how much we wanna drive operating margin increases from year to year. And what we balance that with is where we're at in our life cycle, and we are really still in a very early chapter with the business. The way we think about it is we essentially have our first product on an AID system with one CGM, Dexcom's G6. As many of you probably know, we've got a chock-full pipeline of innovation today.
We're working on a G7 product as well as a CGM of choice, where we have Abbott, a program for Abbott's Libre 2 and 3. We're also expanding our phone platforms. Today, we're only on Android. We're adding iOS. We're doing a lot of clinical work to put Omnipod 5, get the indication for use for Type 2 as well, and then certainly we've got a lot of International expansion to go. We're in 24 countries today. We've only launched Omnipod 5 in three so far, the US, just recently, the UK, and Germany.
So we've got a long ways to go to build out that platform of Omnipod 5. And so our choices are really, as we're building the platform, how much do we wanna push the operating margin lever? But once we get that platform built over the next couple of years, then we have a real option to accelerate operating margins, because now we can scale off that platform.
I think what you'll see from us, Jeff, over the next few years is a fairly measured operating margin improvement because we're making significant investments to build the platform, build on our leadership position, but then we'll have an opportunity to really scale the business. As you know from us, we're always focused on that top quartile performance, so we're modeling ways to get there.
Yeah. All right, fair enough. In the U.K. and Germany, just maybe any early feedback, but still on track to launch kind of pan-Europe, in 2024?
U.K. and Germany are both going really well.
Yeah.
U.K. was launched in the middle of the summer. Fantastic results out of the gate, big pent-up demand for the product. We're getting a lot of our own conversions and a lot of MDI on that product, and so, and rave reviews on the product in the U.K., which is terrific for us, actually doubled our order book, out of the gate, and so really, really good results from Omnipod 5 in the U.K. Germany, we just launched, I think we're two weeks into the launch in Germany. Again, really, really great feedback on the product and the experience in the German market.
In both of those markets, we're pay-as-you-pod, as we call it. So it's a pay-as-you-go model in both of those markets, which is really convenient for payers, for the state payers, and for the German insurance companies in terms of no capital cost upfront, just like in the U.S., and is pretty good for us from a margin point of view, and so great launches. With regard to the rest of Europe, what we've said is that we will cascade launches into our European markets, and by the end of 2024, the majority of our customers will have access to Omnipod 5.
Okay, fair enough. And then in those other European markets, I still get confused on reimbursement in many different parts of Europe. Can you launch at one price point and still use the RCT, like for France, for example?
Mm-hmm.
Launch in France at XYZ price point or X, X price point, and then petition for a premium down the road? Or do you wait on France until you have the data to go after that premium, you don't launch pre-...?
Each market is different.
Yeah
Which is why I agree with you.
Yeah.
It's, you know, it's hard to keep track of how reimbursement works in every market. That's why we're doing the randomized controlled trials. Those, the trials that we're doing, both the Omnipod 5 G6 trial, which is a France-US trial, which has already had last patient and is just about wrapped up, and then our Libre trial is a multi-European country trial. Those are both designed to give us evidence to argue for premium reimbursement with Omnipod 5.
And those become those are country by country or payer, depending on the market, payer by payer negotiations. But we need that evidence in kind of our armory to go in and have those arguments. I mean, argument's a strong word, but make the argument for the premium because Omnipod 5 creates so much value, we wanna get a premium reimbursement for it wherever we go, commensurate with the value we're creating with the product. And so far, we've been reasonably successful in those conversations.
But every market's a little bit different. Each one requires a, you know, slightly different approach to an evidence dossier. Each one requires a different approach to negotiations, which is why we're cascading as we go through the launches.
If you get a premium, quote-unquote, "premium reimbursement" in some markets, and France has done that for a couple others in that-
Mm-hmm
But if you do, is that then equivalent or close to equivalent to a U.S., and we should think about any other EU kind of a little bit below that level on a-
You know, I don't know.
On a standard basis?
Yeah, as Jim said, it is very different-
Yeah
By country. A lot of it, Jeff, depends on the selling model for us.
Mm-hmm.
You know, as you know, France-
Yeah
Is sort of a hybrid model with the prescribers. Some countries would go through distribution, some we go through direct.
Yeah.
It is really a mixed bag of different reimbursement structures. What I would say is obviously, gross margins are lower where we go through distribution-
Mm
And some of the hybrid models, higher where we're direct. And, the offset then is typically in operating margin or operating expenses, and so operating margins can be similar, depending on the countries. But it is a bit of a mixed bag out there. As Jim said, that's one of the reasons why we're taking the appropriate amount of time to do the clinical work, to make sure it's well understood, the value of our product, so that we get the right reimbursement structure as we expand globally.
And we've got a significant international expansion opportunity in front of us, and we wanna make sure we do it in the right way, and by the right way, meaning we get good preferential understanding of the value of our product, which gives us support for building our gross margins over time.
Okay, and in the last 45 seconds, I'm gonna goad you with one question. You can't strangle me in 45 seconds. I can run away from you, that's fine. One of your competitors have committed to a Q3 G7 integration launch timeline, a Libre 3 in Q4. We'll see if they deliver to that or not. Any timelines for you on G7 and Libre 3?
Jeff, you know the answer already.
I know.
We don't guide on timelines-
I waited till the-
And waited till the end. Both of those, our integration efforts are going very well with both partners. We're working very closely. We wanna be on market with G7 as quickly as we can. Obviously, you know, that product is launched and is doing well in the market. We wanna get on the Libre family of sensors as quickly as we can. We work closely with both parties. We have to be far enough along with the Libre integration, which is our newest integration, obviously, to be able to put patients on the study we're running.
Yeah.
All right? And so you can take that as some guide that the engineering work there is pretty far along, and progress is being made on both fronts.
All right, fair enough. With that, our time is up, so please, join me in thanking Wayde and Jim here for a wonderful overview of Insulet. As a reminder, next presentation is set to begin at 3:10 P.M. Eastern Time, include R1 RCM, Axonics, Arcturus Therapeutics, and Reneo Pharmaceuticals. Thank you.
Thanks, Jeff.
Thanks.