Insulet Corporation (PODD) Earnings Call Transcript & Summary

September 4, 2024

NASDAQ US Health Care Health Care Equipment and Supplies conference_presentation 36 min

Earnings Call Speaker Segments

Larry Biegelsen

analyst
#1

All right. Welcome back. Morning. I'm Larry Biegelsen, the med tech analyst at Wells Fargo. And it's my pleasure to host this fireside chat with the management team from Insulet. With us from the company are Ana Chadwick, the CFO; and Eric Benjamin, Executive Vice President, Chief Product and Consumer Experience Officer. The format is fireside chat. If anybody has a question, just raise your hand. We'll come around with a mic. Ana and Eric, thanks so much for being here.

Eric Benjamin

executive
#2

Our pleasure.

Larry Biegelsen

analyst
#3

And of course, sorry, we have Deb Gordon in the audience, the Head of Investor Relations.

Larry Biegelsen

analyst
#4

So let's start off with the exciting recent news. The type 2 approval last week. I think it was about 4 months ahead of our expectations. For Eric or Ana, just talk about the launch plan, please?

Eric Benjamin

executive
#5

Very great place to start. Our business is firing on all cylinders as we shared on our Q2 call just a couple of weeks ago. We raised guidance across the board, top line up to 16% to 19%, gross margin now at the high end of our guide at 69% and 14% operating margin. So we're seeing the core business accelerate. We've got exciting catalysts to come in the second half. And we just added on top of that the type 2 indication coming early as of last week. So a really exciting time at Insulet. That launch, we have an incredible opportunity to start right where we have strength today. So as a reminder, the label that we got for Omnipod 5 is for all insulin-requiring people who live with type 2 diabetes. We think of that as 2 markets. That's about 2.5 million people who live with insulin-intensive type 2 diabetes. They're already on prandial insulin. Their insulin needs look a lot like those who live with type 1 diabetes. It's also 3 million to 4 million folks who take basal insulin. We can talk a little bit about why we have some excitement about that market down the road. But where we're going to start is right where we have strength. So this is 2.5 million people with -- who live with insulin-intensive type 2 diabetes. That market is under 5% penetrated today. So the first thing that we began doing last week when the clearance came early, was bringing that new indication to our existing call point. We know that there's a lot of surprise actually in the health care community about how well technology can do to improve the lives of people who live with type 2 diabetes. We demonstrated extraordinary clinical outcomes in our type 2 study, the SECURE-T2D trial. One of the many positive surprises from that trial was actually how well people who live with type 2 diabetes did with technology. So we are going to start where we have strength. We're going to help educate the folks that we call on today that type 2 diabetes can be treated with Omnipod 5 and deliver great clinical outcomes. Second stage of the launch, we have really strong direct-to-consumer advertising capabilities. We get -- about half our leads today are folks who live with type 2 diabetes. For the last 18 months, we've had to pivot those folks to our DASH product when they've reached out to us asking for assistance, getting on product. We now have an opportunity to engage in the conversation that those patients want, which is to help them get on to Omnipod 5. So we've got a near-term opportunity to just be more effective [ in ] the commercial channels we have now. And then in the next few months, we'll also be expanding our sales force. That for us is doing more of what we already know how to do. We cover endos and some endo-like primary care providers today. When we look at the opportunity, we can make a modest rightsized expansion of the sales force, make the most of the type 2 indication in 2025. Again, we look at a massive opportunity of 2.5 million people who live with insulin-intensive type 2 diabetes. We're going to go after that in stages.

Larry Biegelsen

analyst
#6

But the pieces are in place, commercial coverage, everything, it's covered.

Eric Benjamin

executive
#7

Yes. So great clarification. We have coverage. So Omnipod 5 is very well covered for type 2 diabetes today. Essentially, the coverage that we have for Omnipod 5 directly applies to type 2. There are a few little opportunities to bring those into parity, but they're at the margins. We're coming out of the gate with coverage for type 2.

Larry Biegelsen

analyst
#8

And the label, is there any difference? You have DASH at a type 2 indication, right?

Eric Benjamin

executive
#9

Correct.

Larry Biegelsen

analyst
#10

Is there any difference between the labels for DASH and for Omnipod 5 for type 2?

Eric Benjamin

executive
#11

The wonderful thing both DASH and Omnipod 5 are covered for insulin-requiring people with type 2 diabetes. So this is a sale that we got good at when we were -- before the launch of Omnipod 5, and now we have the opportunity to leverage that strength as we go bring Omnipod 5 to those who live with insulin-requiring type 2 diabetes.

Larry Biegelsen

analyst
#12

And I know it's not the primary target but the basal population. Why would a basal patient want or benefit from a pump?

Eric Benjamin

executive
#13

A couple of pieces on that one, Larry. So starting with the Secure-T2D trial, we enrolled about 300 folks in the SECURE-T2D trial. That was our study of Omnipod 5 and those with insulin-requiring type 2 diabetes. We enrolled 20% to 25% of the subjects in that study who were on basal insulin. One of the things that we felt very strongly about is we wanted this to be an incredibly real-world study. So we took people as they were. We didn't try to teach them new things about diabetes, we just helped them get on to Omnipod 5. So 20% to 25% people in the study on basal-only insulin. The reason that, that makes sense is when one lives with insulin-requiring type 2 diabetes, the largest glycemic excursions happen around meals. So what people who live with type 2 diabetes really need is insulin for meals. We tend to give them long-acting insulin because we're not convinced that we can get them to take insulin at meals. But physiologically, what they need is insulin and meals. What Omnipod 5 does is it just gives them a much more physiologic way, automated insulin delivery every 5 minutes to get them the insulin that they need. So if they get on to Omnipod 5, they get glycemic excursions down around meals. At times, they don't need insulin, they get less insulin. So they get all of the benefits of automation. They get better clinical outcomes, and they feel better.

Larry Biegelsen

analyst
#14

Got it. And sales force expansion. How many? And what are the margin implications?

Eric Benjamin

executive
#15

Not ready to guide on the how many. It will be incremental. So again, a model that we know well. So we're going to take the selling model that we do today, we're going to go to the next tranche of natural prescribers, folks who write a lot of CGM, folks who write a lot of rapid-acting insulin, for whom our current commercial model is a good fit. So we'll grow that footprint. And we'll do that in a way that is consistent with our plan to continue expanding margins. But I'm sure Ana would like to weigh in.

Ana Chadwick

executive
#16

So I'll touch here for 2024, which is where we provided guidance. We were anticipating some increase in our sales force. So that's already baked into the guidance. And part of the reason we were doing that is because we wanted to prepare for the bigger launch with the type 2 indication. It came in a little earlier, but we were hiring those people, making sure they're trained because there's a lead time. So it's just a matter of a few months, but we already had in our guidance, baked in some increase in our sales force.

Larry Biegelsen

analyst
#17

And historically, Ana, you've talked about increasing the operating margin by about 100 basis points or at least 100 basis points a year. I just want to confirm that this expansion doesn't take you off track from that beyond 2024.

Ana Chadwick

executive
#18

No, actually, I would argue it gives us more confidence because a lot of our margin expansion comes with scale. And this only reiterates our larger scale. And what I mean by that margin expansion is over time. I mean not every quarter will be perfect in terms of the exact amount, but over time, 100 basis points should be a floor.

Larry Biegelsen

analyst
#19

Okay. And then I guess maybe the last piece on type 2 is you talked about -- well, I have a couple more questions, but you talked about it coming a little bit earlier. And I guess how does this impact your new-start growth in -- the ramp in the second half and full year. Maybe just remind us or tell us now -- update us on your latest thinking about U.S. new starts because you know as well as I, it's a pretty big focus for investors.

Ana Chadwick

executive
#20

Absolutely. So what it does is, the type 2 indication coming earlier, it gives us more confidence to what we have stated. And I just want to recap what we stated before. We are seeing sequential quarter-over-quarter growth. Second quarter, we saw that. We anticipate that in third and fourth quarter. We also anticipate the second half of 2024 to be higher than the second half of 2023. And going back to your point, receiving this indication months earlier than we anticipated, just gives us more confidence. The other thing I wanted to point out is new customer starts are -- we know are hugely important. The financial benefit in terms of revenue goes into our annuity model and most of that will be felt in our financial profile in 2025, especially as we move into the second half of '25 and beyond. And more to come as we are paving this new path with type 2. We'll come back to all of you guys and give you a view of 2025 once we wrap up 2024.

Larry Biegelsen

analyst
#21

That's helpful. One follow-up. Just could you remind us of what your latest thinking is on full year '24 year-over-year growth in new starts in the U.S.? It was a little unclear at the end of the call. You made some comments. It wasn't clear to me if you're talking about the second half of the year or the full year. So the question is, do you expect full year '24 new starts in the U.S. to be higher? A. And then b, what about Q3? I heard you say second half higher, what about Q3?

Ana Chadwick

executive
#22

Sure. Let me clarify that. We expect second half U.S. new customer starts for the second half of 2024 to be higher than 2023. Let's go back to the calendar year of 2023 full year. That was a massive Omnipod 5 launch year. So at the moment, just to reiterate, for the U.S., we expect the second half of 2024 to be higher than the second half of 2023. To call exactly if third quarter will be higher or not, it's very hard. We -- the way we have it modeled, it happens somewhere in between the third and fourth quarter. So it's a little bit hard to call. Now with type 2 indication, maybe we get a little bit more confident. But I think the essence is let's not split hairs between third and fourth quarter. It's the overall trend and that sequential growth we're seeing second, third and fourth quarter.

Larry Biegelsen

analyst
#23

Okay. That's helpful. I mean, Eric, you and I have talked about this before, the way we think about it -- one way to think about it. Obviously, the penetration you talked about in type 2 being sub 5%. But another way we look at it is before Omnipod 5 when you had DASH, it was 35% to 40% of new starts were coming from type 2. Today, it's 25%. So we can like look at all else being equal for type 1, what if new starts, it goes at 25%, it goes to somewhere between 35% and 40%, what are the implications? I guess do you expect maybe starting -- do you expect that to go back to 35% to 40% of new starts to come from type 2 like you saw with DASH. Is that one way of thinking about it?

Eric Benjamin

executive
#24

I don't think we've guided to a mix on type 1, type 2, Larry, but maybe a couple a couple of ways that we do think about what this looks like now with the type 2 indication. First, we think of the type 2 indication as incremental. So we do, therefore, expect that the fraction of our business will move towards type 2. The other thing, as I was talking through the components of the launch, we have a lot of confidence that we can start with the commercial model that we have to drive leverage out of that. So that also means we have an opportunity to get impact in a reasonable length of time, which is terrific. The thing that we're just very conscious of is there's work to do in the market to help the market fully embrace technology for those who live with insulin-requiring type 2 diabetes. We're excited to go do that work. We've got best-in-class clinical data to make it happen. And that's what our team is out there doing is bringing the benefits of our -- of Omnipod 5 to those who can prescribe it to those with insulin-requiring type 2 diabetes. So we're excited to see incremental growth. We're going to start with the commercial model that we have and drive from that.

Larry Biegelsen

analyst
#25

And I'll push my luck a little bit with one more for Ana. Growth in the new starts in the U.S. in the second half, I heard that people care about '25, you know that. Does this -- it seems like growing in the second half, new starts. And with the type 2 indication just ramping, it bodes well for growth in new starts in 2025, in my view. Would you agree?

Ana Chadwick

executive
#26

I think it's a very accurate view.

Larry Biegelsen

analyst
#27

Okay. Okay. Fair enough. Okay. Let me ask a couple of questions on competition. Just switching gears. Anything else, Eric on type 2, you want to add? Do you think we covered type 2?

Eric Benjamin

executive
#28

I think we covered it. Maybe just to close. It's a huge underpenetrated market, how do we think about it. We're going to drive short-term impact as we've got commercial leverage. But we've got 2.5 million people with insulin-intensive type 2 diabetes that we're going to go bring the technology to. We've also got 3 million to 4 million folks with -- who take basal insulin today, and we've shown they will get benefits from Omnipod 5, that's not a today, but that's a down the road. And as we do the work to educate the market and drive growth, we're really excited about the opportunity for both of those markets.

Larry Biegelsen

analyst
#29

All right. So shifting gears, competition. There's more competition Tandem is out there with Mobi. Medtronic with -- it's coming with 780G and Simplera. There's a private company out in the market that had some -- gotten some traction. What's your view of increased competition in the U.S.?

Eric Benjamin

executive
#30

We see 2 things, Larry. The first is our business is really strong. And we see -- we're confident in the strength of Omnipod 5, our leadership position, and we're really excited about the catalysts that are coming in the second half of the year. I think the other thing we see is the space is getting a little stickier across the board. There are fewer customers switching from one brand to another. And that's okay because it isn't our focus. Our focus is bringing the benefits of technology to those who are currently not yet benefiting from technology. Those are the big 2. When we think about how our business is performing in the eighth quarter of the Omnipod 5 launch which was the second quarter of 2024. That was 8 quarters into the Omnipod 5 launch. We delivered sequential growth after 3 competitors had entered the market. And that was right before we launched our G7 integration, which is a tailwind for us second half before the type 2 indication came early and before our Libre 2 Plus indication, which is coming to the U.S. before the end of the year, also before our iOS limited market release and full market release, which are coming before the end of the year. So when we look at the setup, we see huge strength that we're proud of the team for delivering in the second quarter and a whole series of catalysts that are going to help us continue to maintain the leadership position we enjoy in the market.

Larry Biegelsen

analyst
#31

IOS, I got at an e-mail alert that it's like now available. So you said like the full -- is it fully launched now, iOS with Omnipod 5?

Eric Benjamin

executive
#32

We just sent a notice to all of our customers that will be in the App Store in the middle of October.

Larry Biegelsen

analyst
#33

Got it. And iOS and G7, when will that be available?

Eric Benjamin

executive
#34

Omnipod 5 with G7 will come in 2025.

Larry Biegelsen

analyst
#35

Omnipod 5, G7 iOS you mean.

Eric Benjamin

executive
#36

Thank you. Omnipod 5, iOS G7 will come in 2025.

Larry Biegelsen

analyst
#37

Got it. Not easy to keep track.

Eric Benjamin

executive
#38

Indeed.

Larry Biegelsen

analyst
#39

And while we're on competition, what's your take on the Abbott Medtronic integration?

Eric Benjamin

executive
#40

We're really happy with the fact that we get to partner with 2 great sensor partners to bring the benefits of automated insulin delivery to people who live with diabetes. It helps to have great partners in the market who give us the option to bring sensor of choice to customers. If we think about who in the market has not yet adopted technologies, so we just put ourselves in the minds of a person who is walking into a health care provider's office, who lives with diabetes. And they're not yet using technology. A couple of things: One, they probably know about legacy technology because legacy tubed pumps have been on the market for almost 40 years, and they've just not chosen those. And the second thing, they're probably on CGM. So those are sort of the 2 market facts that we think about when we think about who our future customers are. And so a lot of the choices that we make as we're going to market to drive growth is about how do we make it the shortest distance for those customers to enjoy the benefits of Omnipod 5. And so we want to make that as easy for the customer and for the healthcare provider who cares for them. By offering sensor of choice, we make that easier because if somebody is already on a great sensor, we can bring Omnipod 5 to them without them having to change sensor. Not a huge obstacle, but it helps bring that burden down, makes it easier to get onto Omnipod 5. That's why G7 is a nice tailwind for us in the second half of the year. It's also a licensor of choice is the benefit going forward. So we're really proud of having 2 great sensor partners with whom we can offer a choice. When we look at the move that one of our partners made with one of our competitors, we don't see it affecting that choice, and we don't see it affecting the fact that we benefit from differentiated technology that gives us leadership in the market.

Larry Biegelsen

analyst
#41

Okay. I would be remiss if I didn't ask about the latest competitor that was just cleared, Embecta, patch pump. It's an open system. So it's not integrated with CGM. So that's a big difference, but they're developing a closed-loop system, what they've said publicly. What's your -- just I'd love to get your reaction to it. And they're highlighting the -- just 300 units versus your 200 units. What -- a couple of questions, but I'm just curious to get your high-level thoughts.

Eric Benjamin

executive
#42

Yes. Larry, maybe 2 perspectives, one on sort of general small-scale competitors and one on the size of reservoir. I guess a couple of things. Insulet got its first clearance for an open-loop patch pump in the mid-2000s, so about 20 years ago. So when we just think about where would the patch pump competitor is in the life cycle to get to the place that we're going, which is phone control, at scale, cost effective, high quality, high reliability, integrated with multiple sensors and cloud-connected AID system, we just don't see anybody who's close. And recent news is very much in that bucket of not close. When we think about reservoir, that's a really important question, given our -- the way we started this conversation about type 2 and a couple of -- one of the really interesting nuggets from our type 2 pivotal study was actually that the amount of insulin that people need when they get insulin physiologically goes down significantly. So the headlines on that are in the entire study, insulin use went down about 30%. So we didn't have any restrictions on total daily insulin going into the study. We had folks in the -- I think low double digits was the low end. I'd have to double check that one and up above 300 units a day at the high end because we didn't restrict it. We took all comers. And that whole population, 30% reduction. Those who were on more than 100 units a day in the study saw a more than 50% reduction in the insulin that they needed when they got insulin with Omnipod 5. So what that says to us is the data shows Omnipod 5 is going to provide a great experience with adequate capacity for a lot of the people with insulin-requiring diabetes because they're getting insulin more physiologically and therefore, require less insulin.

Larry Biegelsen

analyst
#43

Let me play devil's advocate. There are some patients that are going to need more than 200 over 3 days, and I've looked at your data, SECURE-T2D data pretty closely. And why is 300 not better than 200? Why is more not better? What's the drawback to having more?

Eric Benjamin

executive
#44

In sort of an apples-to-apples world, more may be helpful. I think in the particular competitor in question, it's quite a large device. And I think when we look at all of the choices that one weighs when they're making a choice about the technology, they adapt -- they adopt, size on body is a really important consideration. And so when we look at what does Omnipod 5 offer? Plenty of insulin capacity, great clinical outcomes, reliable, affordable through the pharmacy channel, we've got the right product to go win in the type 2.

Larry Biegelsen

analyst
#45

Okay. That's helpful. So let's transition to international, which was obviously -- one of the standouts, if not the standout, right? On the Q2 call or the Q2 reported results. I guess the question is, given these new market launches and the business model, why can't you continue this momentum in the second half and maybe even beyond?

Ana Chadwick

executive
#46

Yes. No, I'll start with that. As you know, everywhere, Omnipod 5 goes, it's been a winner. And we have increased our guidance for international 500 basis points at the end of 1Q for the full year and another 600 basis points. So 1,100 basis points so far for 2024. So that tells you -- even exceeded our expectations that were of significant growth. So we're very excited by that. Second thing is we're moving as fast as we can. As you know, we're in the U.K., Germany, France, and we talked about more countries in the coming months here. So we're going to continue to play that same play that we know how to do, and we anticipate that continued growth in international to carry us into 2025 and beyond.

Larry Biegelsen

analyst
#47

Are there any major markets that you're not in yet with Omnipod 5?

Eric Benjamin

executive
#48

There are a few. So maybe just a couple of quick fill ins. So we announced we entered France in June, but we're very early in that launch. So that's kind of the next big market that will get the benefit of Omnipod 5. We also shared on our Q2 call, we'll be bringing Omnipod 5 to Canada, Australia, Switzerland, Belgium, Nordics and Italy, and we're kind of deep into launch planning for all those. Canada is a pretty big market for us and the Nordics are very good markets for us.

Larry Biegelsen

analyst
#49

But you didn't give any timing -- France, so did France contribute much in Q2? So is that -- I'm trying to just understand, it is a big market. Is that more of a second half '24 contribution?

Eric Benjamin

executive
#50

We announced -- we just announced that we entered France right at the end of the second quarter. So we entered the market in the second quarter again with our...

Ana Chadwick

executive
#51

France has more ahead of us.

Eric Benjamin

executive
#52

Yes.

Ana Chadwick

executive
#53

Much more ahead.

Larry Biegelsen

analyst
#54

And these other markets that you mentioned, Eric, did you give a timing? Is that '24, '25, no timeline?

Eric Benjamin

executive
#55

All in '25, haven't yet given specifics so in '25.

Larry Biegelsen

analyst
#56

All in 2025, so Nordics, Canada, Italy?

Eric Benjamin

executive
#57

Yes.

Larry Biegelsen

analyst
#58

Okay.

Eric Benjamin

executive
#59

And actually, one quick update on that. We'll also -- because we've built Omnipod 5 as a platform now that we have the benefits of sensor integrations, we'll also be bringing G7, for example, to international markets in 2025 as well. The work to do that is mostly about supply chain, regulatory and local market access. So we'll just do it market by market as it's time to do the local market work.

Ana Chadwick

executive
#60

And I want to do a quick build on international that I think it's important around pricing. One of the interesting things we're seeing as we're going into these international markets is the value of customer experience and outcomes that Omnipod 5 brings is being valued as we negotiate price. So what we're seeing as we're launching in the international markets that reward in the pricing is coming through. So we expect that to also be a tailwind as we have been doing in the current launches and as we move into 2025.

Larry Biegelsen

analyst
#61

You're getting a price premium?

Ana Chadwick

executive
#62

Correct.

Larry Biegelsen

analyst
#63

Have you quantified that?

Ana Chadwick

executive
#64

Again, every market is different. Every market goes through slightly different adoption, so we haven't been specific, but you're seeing that appreciation of the value that it brings being rewarded.

Eric Benjamin

executive
#65

And just a reminder, Larry, we've been investing in evidence as part of that strategy for a number of years. So we did a randomized controlled trial against open-loop pumps, the folks on an open-loop pump versus those on Omnipod 5 and also against MDI, we've done that -- we've done evidence with each of our sensor partners. The body of evidence that we're building for Omnipod 5, which all sits on top of our very strong real-world evidence is a big part of helping ensure that we get appropriate value for Omnipod 5.

Larry Biegelsen

analyst
#66

And you talked about G7 integration next year. You have Libre 2 integration, 2 Plus integration in I think, U.K. and Netherlands. What's the plan for Libre 2 Plus integration outside the U.S. with Omnipod 5?

Eric Benjamin

executive
#67

So just -- like we just said on G7, bringing additional sensor integration is kind of a market-by-market decision. It's really supply chain, regulatory and then local market access. And so we'll be bringing additional sensors to global markets, market by market.

Larry Biegelsen

analyst
#68

And you talked about the evidence generation, Eric. Are there any of these major -- I have a list in front of me. You've got a few studies ongoing. Any major ones like where do you expect data, second half of this year, early next year?

Eric Benjamin

executive
#69

The couple of studies that we announced at ADA that we're really excited about, Larry, but they're just at the beginning phases. We're doing the next of our EVOLUTION series of trials. That's the fully closed-loop research that we're doing. We did the first of those studies in New Zealand late 2023, presented that data at ATTD in the first quarter of this year. We'll be doing the next phase of that fully closed-loop research. We also announced that we'll be starting what we're calling our [ STRIVE ] study, and that's a study with -- building on some learnings from the work we're doing on fully closed loop, we see an opportunity to do more of an iteration on the Omnipod 5 AID experience. And that will be testing a lower set point and some other user experience benefit. So we've got a continued clinical development pipeline coming as well.

Larry Biegelsen

analyst
#70

That's helpful. Ana, we touched upon this a little bit earlier, 2025. I mean, to us, it looks like it should be a strong year for Insulet, full impact of type 2, Libre integration in the U.S. you've talked about and that's Libre 2 Plus, right?

Eric Benjamin

executive
#71

Correct.

Larry Biegelsen

analyst
#72

And then continued momentum outside the U.S. What are some of the puts and takes we should consider for next year? And is there any reason growth would decelerate next year just as an aside, you do have kind of a net stocking negative impact in '24 that creates a little bit of an easier comp next year.

Ana Chadwick

executive
#73

Yes. So again, we're not providing guidance here for 2025. But you've hit on a lot of the moving parts that make all of us at Insulet feel very proud of the investments we've been making coming to fruition. So we feel we have really good momentum. And -- I mean you mentioned them. I think it's what our CEO sometimes says, there's so many that you can't keep them in your short-term memory because, I mean, there's G6 iOS, there's -- you're just -- G7, G6 iOS, there's a lot going on with T2 in the U.S. So as I said before, we want to really wrap up 2024, see more evidence of how we're paving the way here in T2, and we'll come back with more specifics in 2024. But you're absolutely right. I mean, we see a lot of good tailwinds. And these are not coincidence. These are all the investments we've been, as a team, working towards and preparing, so more to come.

Larry Biegelsen

analyst
#74

That's helpful. We touched about margins already. You're committed to 100-plus basis points...

Ana Chadwick

executive
#75

Yes. I actually -- let me give some additional color on margin. So when you look at gross margin, we said we're going to be in 2024 at the high end of our guidance of 69%. That is inclusive of our decision around Omnipod GO, which is a fantastic decision to just use one platform, Omnipod 5, for basal and for all of the insulin needs. So we will have better product life cycle management. The reason I wanted to mention the gross margin is a lot of the gross margin expansion we've experienced over the last few years have come from pricing in the U.S. as we penetrated into the pharmacy channel. Now we're very high 90s, penetration in pharmacy. We continue to expect to hold that, but the go-forward margin expansion is going to come from our scale. So that's, as I said, type 2 is going to provide even more of that scale, type 1, international growth. The other thing is really hardcore manufacturing. We do the Kaizens, the leans and all of those things. So -- and in addition, you might have seen our launch of the Malaysia plant. Malaysia is going to be a super competitive plant in our mix of manufacturing capabilities and also in the competitive nature of the production that they'll be doing. So again, we feel very confident at the gross margin. And then when you take it down to the op margin level, because of that volume growth we're seeing, our revenue expectation will continue to grow. It just provides more of that fixed cost leverage. So...

Larry Biegelsen

analyst
#76

Historically, I think you had a goal of 70% gross margin. Is that right?

Ana Chadwick

executive
#77

Correct.

Larry Biegelsen

analyst
#78

You're almost there. You kind of hit there, I think, in Q2 on an underlying basis, right? What -- so the ceiling is obviously higher. I guess the question is how much higher? What kind of headroom do you see for the gross margin?

Ana Chadwick

executive
#79

So we'll come back and provide more color in '25. But what I was trying to describe here is that the effort to bring that margin expansion, which we're highly committed to is going to be more from volume and from hardcore manufacturing improvement and less from that pricing benefit that we saw especially with the U.S. pharmacy channel. So there will be pricing. There will be margin expansion. It's just going to come at a slightly different pace than the windfall we've seen over the last few years.

Larry Biegelsen

analyst
#80

And Malaysia should be helpful as well.

Ana Chadwick

executive
#81

Absolutely helpful.

Larry Biegelsen

analyst
#82

So 70% is not the ceiling. That's the message?

Ana Chadwick

executive
#83

Correct. But the rate of growth is not like -- you shouldn't model this looking at the prior rate of growth. The rate of growth will continue to grow but at a slower pace.

Larry Biegelsen

analyst
#84

Got it. And Ana, is there any updated thoughts on an Investor Day or any kind of outlook, LRP or just more long-term view. Where do you stand on that?

Ana Chadwick

executive
#85

No, it's a very timely question. We're still working through it. Stay tuned. We're trying to define whether we do it in the next few months or early in the new year. So we're just still working out the details on the timing. But stay tuned, we definitely owe it to all of you guys, and we want to be out there providing more of a long-term plan for everyone.

Larry Biegelsen

analyst
#86

And Eric, just jumping around, I guess I'll ask on the GLP-1 question. I didn't ask about it during the type 2 conversation, but that's where I think it's most relevant. You probably saw the stock reaction when Lilly provided the top data on, I think, the 94% headline prediabetes, prevention to diabetes progression. I guess, what's your view? And why doesn't this -- why isn't this a headwind for the type 2 opportunity?

Eric Benjamin

executive
#87

A couple of perspectives on that one, Larry. First place to start, there are 2.5 million people who live with insulin-intensive type 2 diabetes today in the U.S., that market is under 5% penetrated. There are a lot of people who need our help. And those are the first people who are going to go drive impact with our Omnipod 5 type 2 indications. Secondly, when we step back, that data is consistent with data that's been previously shown on semaglutide. And what we know from the research that we published on our investor website about GLP-1 is about 55% of people stopped using the GLP-1 after 1 year to get the benefits shown in SURMOUNT, folks have to be on those drugs forever. So if we step back, what does that mean in order to reduce the number of people who require insulin in the U.S.? It means a very large portion of the 30 million people with diabetes would have to stay on GLP-1s in perpetuity. There's not evidence that that's possible. The economic reasons and the tolerability challenges, which show up in the data and explain why 55% of people stop taking them after a year, just we don't see it. And so we don't actually see an impact on the number of folks who require insulin over time.

Larry Biegelsen

analyst
#88

Okay. And Libre 3, I know you're going to Libre 2 Plus in the U.S. what's the process to get to Libre 3 beyond that?

Eric Benjamin

executive
#89

We're starting with Libre 2 Plus. It's a terrific sensor. It's on the market now in the U.K. and Netherlands and helping us drive impact there. We haven't yet shared timing for Libre 3, Larry. We're getting better and better at sensor integrations as we go, and we're excited to share that update.

Larry Biegelsen

analyst
#90

We're almost out of time. I want to give you guys the last word. You guys -- I'll throw it out to either of you. But maybe, Ana, since you've been here now for about 6 months?

Ana Chadwick

executive
#91

Actually, 4 months.

Larry Biegelsen

analyst
#92

Four months. What are you most excited about?

Ana Chadwick

executive
#93

Yes. So I'll start by saying I joined Insulet because it's a 20-plus percent company revenue growth for 8 years and a trajectory for that to continue and I validated that. It's a great team. We have a great culture with a ton of innovation. And if there's one thing that has surprised me as I've looked under the covers of our research and development and innovation is our problem is that we have a lot of ideas and a lot of prioritization to be made. And that's why I think it's sometimes hard for us to answer precisely what -- when things will launch, but that's a really good problem because we are ahead of the market, and we're just going to stay even further ahead as we continue to make really good decisions. The last thing I'll say is, as a company, we're sustained. We are free cash flow positive and growing. So we are in a very, very unique position financially to support all the people with diabetes and to support our shareholders with investment returns.

Larry Biegelsen

analyst
#94

Great. Great place to end. Thank you for being here.

Ana Chadwick

executive
#95

Thank you.

Eric Benjamin

executive
#96

Thank you, Larry. Appreciate it.

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