All right, welcome back. Good afternoon. I'm Larry Bingleton, the Medical Device Analyst at Wells Fargo, and it's my pleasure to host this fireside chat with the management team from Insulet. With us, we have Ashley McEvoy, President and CEO, and Ana Maria Chadwick, Executive Vice President and CFO. The format's fireside chat. Ashley and Ana, thanks so much for being here. I know that, Ashley, this is your first fireside chat as CEO of Insulet. It's an honor to host this. Thank you for the opportunity. Ashley, let's start with some big picture questions. You've been in the CEO seat now for four months. Time flies. I know you conducted a listening tour when you assumed the role. What were some of the key takeaways you can share from investors, physicians, and patients?
Yeah, thank you, Larry. First of all, it's a pleasure to be here representing Team Insulet. I wear my T-shirt today. Listen, I'm not the newest kid on the block. We've got some new additions, but I've spent about four months in a listen and learn tour with many customers and potters and clinicians and partners, investors. I will tell you, a week ago, we hosted our founder, John Brooks, who's actually a local Bostonian, who was in Early Inventor Capital, and we're celebrating our 25th year. He came to speak to our global employee base on Thursday and really told his driving ambition of how to find something better. For him, it was find something better for his son, who's type one. That mindset of finding something better really permeates Team Insulet.
I would tell you, in my four months' reflection, several things really stand out of what really has gotten Insulet to this year in 25 years. Number one is just unbelievable patient centricity. About a third of our employee base are potters themselves. Having patients front and center is very much in the water at Insulet. Number two is this remarkable differentiated technology, the pod. We say patients call us a pod, not a pump. Quite frankly, in 25 years, we've developed this engineering marvel that we continue to plan to innovate over time. I'd say the company has invested ahead of the curve in science, Larry, to go get really through the landmark trial of secure T2D to go get a type two indication, but also really to get broader adoption of AID as the standard of care with the ADA guidelines. Strong science.
Three, invested ahead of the curve on manufacturing excellence. We've invested over $1 billion in the past 10 years. We make tens of millions of these pods in Acton, Massachusetts, right down the street, 45 minutes away. We also were really the pioneer in the pharmacy channel. You've heard a lot about a recent CMS proposal, but we, the Insulet company, really pioneered making a pay-as-you-go business model more available to patients so they could access technology on their term and really procured depths of access in 47,000 pharmacies, as well as getting really broad coverage of 300 million lives. Investing in the pharmacy and then obviously innovation. Those remain very strong and competitive moats, and it's really up to us to honor the past and build for the future for the next 25 years.
That's helpful. Any changes that you're planning to make because of the feedback you received?
No, I think our strategy remains intact of we're going to lead with type one in the U.S. We still have low penetration, and Omnipod 5 has just been out for a couple of years, and we just got the ADA guidelines a year ago. We're going to also take advantage of our first mover advantage in the U.S. with type two. We're going to continue in a very thoughtful, strategic way of geographic expansion, and we're going to continue to invest in platform innovation as well as building out capacity to say yes to future growth.
That's helpful. What are your strategic priorities over the next 12months- 24 months?
Yeah, I mean, I think I spoke a little bit about my learning journey, about understanding what made this company so remarkable. We have a big ambition for the future. While our strategies are intact, you're going to see us also evolve from a mindset of we were born out to be the disruptor to the market leader. We now are the market leader. We're the number one most preferred AID in the U.S. We're number one in new customer starts in the U.S., and we're also number one in the EU, in the countries in which we offer patients our technology. You're going to see us evolve, Larry, to more of a market creator, particularly as you start to think about the type two community where it really is a green field. It's a new indication for the whole space. You're going to see us invest more in innovation.
I would say I'm challenging the team on more agile innovation. How do we be first in the queue of sensor integrations? How do we give broad access to phone control internationally, not just to the U.S.? Interestingly enough, 55% of our podders in the U.S. still use their controller. We know that when patients use their phone control, they get better engagement and better clinical outcomes. We'd like more U.S. patients to do so, but also Outside the U.S. (OUS). We're really going to invest in market development and demand generation and brand management so that more patients are aware of Omnipod and that we start to unlock a little bit more of that clinical inertia going forward.
That's helpful. Ashley, when you started, you laid out some ambitious goals. I'm not going to repeat all of them, but the question is, how do you know those were the right goals and when are you going to be in a position to give timelines?
Yeah, Larry got me on my, like, day one. I'm a little wiser now. We, I would say, stay tuned. Listen, we are hosting our first in the past 10 years. I think it's our second in our 25-year-old history Investor Day. Mark the date of November 20th. We're welcoming people to Acton, Massachusetts, to see our world-class, state-of-the-art manufacturing capability, a lot of advanced automation. You will hear our story on the long-range plan, on what our growth algorithm is about. We're going to share about our pipeline and really reinforce some of those strategic deliverables for the future.
That's helpful. I'd love to hear your thoughts on capital allocation, M&A, and just curious because we have heard there's been market rumors in the past just on vertical integration in the diabetes space.
I would first start with it. I'll turn to Ana, but number one, I mean, we feel like that we're in a very unique position in med tech of revenue growth in the mid-20s. For 10 consecutive years, we've delivered 20% growth. This year, we've accelerated that at 70% GP. We're expanding operating margin. We're cash flow positive, and we have a near $1 billion on the balance sheet. That affords us, Larry, opportunity to continue to invest in ourselves. That's been our primary focus on capital allocation. We participate in a very large underpenetrated TAM, and we still have very low penetrations. We plan to take this differentiated technology to serve more patients.
M&A and vertical integration?
You know, no plans for vertical integration right now. I'll turn it to Ana to add any other comments on cash flow management.
Sure. You said it really well. It's really about investing in ourselves. That drives the highest return. Organically, we drive incredible returns. We have actually worked our balance sheet. We recapitalized with moving into the traditional debt, and we continue to aspire to be investment grade as well. That's going to give us even lower cost of capital over time. In terms of share buyback, we are doing it only to the extent that it avoids dilution from equity compensation, from management equity compensation. To the extent that there's something appealing out there in M&A, some capability that enhances us, something pointed and specific, we will explore those things. You never say never. We put everything through a very rigorous funnel, and investing in ourselves in this large untapped market is the priority.
That's helpful. Let's move on to the type 2 launch.
Sure.
Type 2 new starts accelerated meaningfully in the second quarter by our math. How are you thinking about the type 2 launch trajectory, you know, the rest of this year and beyond?
Yeah, now it's coming up on about our first year anniversary of type 2. I think what we've learned is we're fortunate, again, for 25 years, we've really been a type 1 company. There's a lot of equity and know-how and learning that we're applying to the type 2 community. One, it's a similar form factor technology. Two, it's a similar call point, although we are expanding deeper into the high prescribing PCP. There's a lot of equity and reputation that we're bringing to the type 2. Now, what we're finding is, listen, there's some evolved behaviors there. Type 2s have a broader armamentarium of care than the type 1 community. We need to make sure that we take a lot of the very landmark science that has been conducted, which shows reduced time in range, reduced A1C levels of 0.8, improved time in range.
We work very complementarily with GLPs. We actually don't promote weight gain. We're taking, we actually, at 20% of our patient population's QTT, we're basal only, so that we're not basal bolus. I like to say, those messages unlock some clinical inertia, Larry, that exists in the type two community. A lot of that is just clinical bias to the disease state of type 2 relative to type1 , which is life-saving. It's a lifetime that you're on insulin, whereas type 2 , there are other healthcare tools in the armamentarium. We have very strong adoption, I would tell you. The path will not be linear of type 2 because it's a complex disease, and there are some biases that take time to unlock. Our technology is getting, I think some of the myths that we're busting are that it's a complicated technology. It's actually not.
People in their 70s and their 80s who are type 2 are quite compliant. Number two is we're finding that a lot of grandparents who are type 2 are getting inspiration from their kids, their grandchildren, or their friends of their grandchildren who happen to be type 1. If they can wear a pod, I think I can wear a pod. We have very strong access and affordability, very similar to type 1. That's remained constant, where they pick their insulin up at the pharmacy. It's a pay-as-you-go. They have reimbursement. They have low-payer offs required. That's really a much improved customer experience. We are early at the innings. Ana mentioned on Q2 , customer starts are off to a good start. We also have many different programs from an innovation point of view, Larry, planned that we will talk about on our Investor Day.
We've been public with some of our clinical trials with our hybrid closed loop as well as our fully closed loop, and both of those are in clinical assessment right now.
That's helpful. People are also interested in the differences in utilization and attrition between type 2 and type 1. What can you say?
Sure. Why don't you talk about that, Ana?
Sure. We've been publicly talking about our global levels of utilization remain stable. We've talked utilization in the international market has been a little bit elevated. In terms of retention globally, we remain stable. We are early days still in type 2. We do know type 1 is a stronger retention just by the nature that it's life-threatening. The more important headline is that global retention remains stable.
Do type 2s use more pods? Is utilization higher because their insulin requirement is higher than type 1s?
Actually, it's a great question. What we're seeing in type 2 is that behavior that some people change their pod every two days, and that is allowed and accepted by the insurance plan. There is no friction there. We're also seeing some behaviors on the other end, which their pancreatic function still has some function, and they might take a little pause and a little break. Net-net, we're still working on the early days of understanding all the behaviors. Globally, everything remains stable.
Yeah, and the only thing I would just add to that, Larry, is one, the science has been proven that it's efficacious and safe of a technology. Two, the access and affordability is there. It's really our job is, and the behavior, there's a need. Once type 2 patients hear about Omnipod and they know they have to be on insulin, they're going into their healthcare professional and asking for Omnipod. Now we're really working on the clinician to make sure that they're up to speed on the science, they're up to speed around the access and affordability, and we reduce those hesitations to really, they don't want to put people on insulin. They maybe don't want to put people on a highly effective pod that might create poor behavior. Those are really the biases that exist in the disease management that we're going to educate on.
Got it. You've talked a couple of times about new starts globally and in the U.S. being really strong in Q2. By our math, new starts were up about 43% year over year in the second quarter. Ana, you said the guidance contemplates year-over-year growth in new starts in 2025. How do you see the sustainability of this strong new start growth?
First, let me acknowledge your math is absolutely in the ballpark there. I'm not going to comment really here long term. What we're seeing in terms of the vast market that we have and the rate in which we are penetrating into those markets gives us a lot of the tailwinds to give us the confidence of the delivery that we're doing here in our new customer starts.
That's helpful. Ashley, you talked about 20+% growth for the past few years globally, internationally going gangbusters, and we'll talk about that in a minute. You know, from your listening tour, investors also care about the U.S. growth. How important is it to sustain, and you've had several quarters of 20+% underlying growth in the U.S. How important and durable is 20+% growth in the U.S.?
Yeah, again, I'm not going to give forward projections around our growth for the U.S., but you'll hear more about that on November 20th. We have very good momentum in the United States in type 1. As Ana mentioned, actually, our NCSs keep growing in the type 1 community as we launch type 2. It's been an and, not an or. A couple of things, Larry, when we think about it. One is, you know, Omnipod 5 is still a relatively new technology to the U.S. Two, the ADA guidelines were just about a year ago. While the science and the documentation has established that AID therapy should be given as the standard of care at the point of diagnosis, which is pretty remarkable if you know other healthcare categories where it's second or third line therapy, this is first line at the point of diagnosis.
That's not necessarily translated into clinical practice yet because we need to give a leadership share of voice to the ADA guidelines. That combined with integrating with the latest sensor. You heard us from an iOS and then the G7. You'll hear us talk about Libre 3 next year. You'll hear us talk about when Dexcom launches its 15-day. We'll be there day one. We've been expanding our field force to kind of get the science to the street, I say, David. That is having a really nice impact on adoption in the United States.
You talked about the sales force. Right now, the sales force can cover 40% of the TAM for type 2. Do you need to continue to expand to reach the other 60%?
Yeah, I mean, we are really going through the most convertible clinicians who have adopted AID therapy. Many endocrinologists, as you know, treat more type 2 patients than they do type 1. We're targeting the ones that have already adopted type 1 using AID and taking that know-how and comfort and going after them first. We're turning them into ambassadors to go educate their peer set of high prescribing, let's say, PCPs. We've been having, we've kept a lot of field continuity of call on points. We've just been complementing them in expansion versus replacing and changing over who their rep is to maintain business continuity.
Let's move on to international, which, as we talked about earlier, is growing gangbusters. I think 40% constant currency in the second quarter. A little bit of this is driven by price, if I'm not wrong. Talk about the new markets you're entering, the sustainability of this strong growth.
Yeah, you want to start and I'll follow?
Sure, we grew 39% constant currency in the second quarter. Strong growth over the last few quarters here as the demand for Omnipod 5 is there. Just from perspective in the markets we serve, about 3.5 million people with type 1 diabetes, about 20% penetrated. It's a huge opportunity for us. We see the launch, it kicks off, great. We go out there and we put more sensor integrations. As Ashley mentioned, we want to get phone control with iOS out there and other features. We work our market access and we continue to unleash funding like what we've done in the UK with the NICE guidelines opening up more dollars and funding for AID. We're the net winner when that happens. We see durable growth in international. We are launching in the Middle East at the early part of 2026. We have layers of growth.
Our larger markets continue to be, of course, UK, Germany, and France. They're large. They continue to grow. The nine that we launched earlier this year combined are about the size of the UK and Germany. Again, more growth. This is a compounding effect of our reoccurring revenue model. We do see long-term sustainability. The last thing that I'll mention on price, we anticipate the price to continue, especially because only 50% of our customer base that originally was all DASH has migrated to Omnipod 5. We're going to continue to see that migration over time as well. Strong durable growth in international.
Based on where you are with that conversion, that 50%, the mid-single-digit price you expect outside the U.S. in 2025 should continue in 2026?
It's a fair assumption. We continue to see some price tailwinds, and we'll tell you more as we guide for 2026 and as we talk about our LRP.
Ashley, I was looking at our market model recently and it looks like you've kind of become, you've become number one in the U.S. in installed base. It looks like you're about number three outside the U.S. What is it going to take for you to become number one? You don't play in big geographies like Japan. You have to, you know, enter those geographies.
Yeah, I mean, in the countries, as Ana was mentioning, we actually, in the countries in which we compete outside the U.S. and Europe, like the UK, France, we have commanded the number one position. Really, our focus, Larry, is going deeper on penetration there and making sure that we kind of serve more patients. Obviously, you'll hear more on November 20th about our kind of geographic ambition. The U.S. is our lead market. It's our largest market. There's still a lot of opportunity in the U.S. The G5, there's a lot of opportunity. There's a lot of opportunity, as what Ana mentioned, in the Middle East, particularly Saudi. We haven't even talked about Asia. No declarations here today. Stay tuned on November 20th and we'll share more about what our strategy is from a geographic expansion point of view.
That's helpful. 2026, obviously, you're not going to give guidance today. By the way, on November 20th, are you going to give color on 2026?
It's too early to tell right now. Stay tuned. We definitely will be discussing an LRP on November 20.
The LRP, three-year, five-year, anything you can say?
We're still working through that. There will definitely be a longer view of the company.
Got it. Okay, maybe just on the 2026 question, just some of the puts and takes to consider for next year.
Yeah, I mean, I'll start, which is, you know, we have good acceleration is what I would say. I think we, as a company, maybe underestimated our performance. We were not the first AID therapy in the marketplace, so we were a little bit more conservative in our thinking. As you know, Insulet does, they have unbelievable engineering prowess. When Omnipod hit, it's been really accelerating quarter over quarter in any country that we launch. We plan to keep that acceleration going by the following.
One is integrating with the latest sensors, making sure we have more phone control available to more patients, making sure that we innovate the customer experience from lead generation to retention, making sure that we invest in creating demand, creating brand awareness of Omnipod and asking consumers to go ask their clinicians, training clinicians on peer-to-peer education, as well as direct engagement, both from a marketing point of view as well as a field point of view of selling not just our highly differentiated pod, but selling our unique science as well. I think the combination of that within an expanded field is we plan to continue the momentum.
That's helpful. You've been asked a lot about margins because we hear about investments and growth, but still committed to at least 100 basis points of operating margin growth per year.
Yes.
Okay, just had to check that box. A couple other areas of questions. Sticking with kind of the maybe the outlook of pipeline. You've touched, Ashley, on some sensor integration, talked about the new algorithms. What are some of the product launches and pipeline milestones that are coming this year and next year? The really big ones that you think are most impactful.
Yeah, I mean, you heard us talk about getting connected to the latest sensors has been just a priority. Of course, I'm going to be catching up on G7 and Libre 3 plus. You'll hear about that next year. In the EU, getting the latest connections, getting phone control. We've shared that we are in clinical trial right now on the Strive and Evolution clinical trials. One is related to our hybrid closed-loop, which is really about getting a lower set point at 100, having more agility on the algorithm if you're going high. We're innovating the clinical experience when the clinician is writing the prescription, so they have to have less inputs to make it a less cumbersome experience. We expect to have a readout of that next year. We're also in feasibility of the fully closed-loop, which will be really important, particularly for the type two community.
We'll keep you posted in November more about how that is progressing. Clearly, we're always taking a step back and looking at all the big jobs to get done. We get asked a lot about many different preferences. We'll share a bit of a multi-generational pipeline that the team has been working on for several years, November 20th.
I'm sure people are going to ask about Omnipod 6 at the Investor Day. What are some of the areas? How are you thinking about the areas of unmet need with regard to the form factor?
Yeah, I mean, I would say a couple of things. One is, you know, it's kind of remarkable how in this category there's so many players when it's really hard to make money. I think the sign of that is because diabetes is one of the leading causes of mortality and morbidity in the world in healthcare. It's a huge, large underpenetrated total addressable market. We are always looking at those pain points to say, how do we unlock those pain points of friction? One was really having a very discreet, wearable, pay-as-you-go. It lives with your lifestyle form factor. While there may be others who are trying to catch up to us, I can commit that we're continuing to stay ahead to continue to innovate this.
Now, even though it may look like the external part hasn't changed that much, maybe in years, the inside components, and you look at our patent estate, has had a lot of lifecycle management. As I mentioned, from software releases, from connections to sensors, from innovating the customer experience, that really is going to drive adoption. Quite frankly, the science backs the efficacy and the performance. You'll hear more about our five-plus-year pipeline. The neat thing about the company is we're about 500,000 podders strong. We actually, through a highly private cybersecure way, get data on every podder. We're able to ultimately leverage that data to enable a better experience for them. That's why I jokingly say that we are this unique nexus of a consumer healthcare company, a med tech company, and a health tech company. Larry, what I mean by that is consumer health will warrant 24/7.
It's part of the daily habits and practices of a consumer annuity business. We're also the power of brand matters for brand awareness, brand love. Med tech, we are a medical device, highly complicated engineering. We're also a health tech because data flows 24/7. How we really judiciously use that data to continue to innovate for podders is really the mission of our company.
That's helpful. You may have answered this, but obviously, it's transitioning to competition. Right now, you're the only company with a patch pump. A lot of companies are trying to emulate your success, as you're well aware. How do you sustain your first mover advantage? I mean, it's probably embedded in some of your previous stuff.
I think so. I mean, I'll start and I'll turn to Ana. I mean, Insulet has really created a lot of durable moats, I'd say competitive moats. One is, while this looks simple, it's actually very complicated. It's taken us years to perfect, and we're continuously needing to perfect because we're constantly updating what's inside and all the software related to that. We've invested. It's also hard to make these tens of millions of these at scale at a 70% gross margin. Third, it's around, you know, clinical evidence around showing performance and both efficacy as well as safety. Those three things are hard to replicate. You know, we're aware that there will ultimately be competition at the right point. It's going to take a long time to get up to even comparability of where we think the pod is today.
Maybe let me build on that. The pharmacy access is another significant moat. We've been working on developing this pharmacy access for eight years. I know others talk about entering this space, which is commendable. It takes time to develop. We have the form factor, the disposability that fits the channel. What I mean by it's not all pharmacies created alike. You can have a PBM contract, but you can cover certain lives. Then you have to negotiate with all the payers and everything. You have to get up and up into the formularies and the preferred formularies, right? When you look at the journey today, we cover 300 in the U.S., 300 million out of 317 million lives. 85% of the time, we're in a preferred formulary, which means we've already negotiated the vast majority of the people pay $1 a day out of pocket.
The other thing is that they are accessible in 47,000 pharmacies. It's very reachable, very easy to access, and widely acceptable. It's not all pharmacies created alike, is another big point to mention.
Yeah, also just to balance that, because Larry, you talked about other maybe the noise around pharmacy access. We also have to maintain the clinical advocacy in the practice. That influences the pharmacy and the payers. Maintaining the robust body of evidence that gets the clinical adoption is equally important to the pharmacy access. Insulet has invested in both of those.
You know, on pharmacy channel access, obviously, there's competitive bidding proposed and kind of a pay-as-you-go model, I think, for the durable pumps like CMS, right? The concern that doesn't affect you today. The concern is that CMS will, that's Part B, I think, the concern of your Part D. The concern is that maybe CMS will look at Part D at some point. We could all kind of look at kind of your revenue per patient per year, et cetera, and see how that compares. What's your response? How much of a risk is that that CMS eventually looks at Part D?
Thank you, Larry, for the question. We posted our commentary to the docket on Friday to the proposal. First of all, these things take time. Number two, we actually believe in having patient choice and patient access. Patients have to choose us every three days, and they can change to the technology that they're preferring. They do have patient choice. We support that. Three, we innovated the pay-as-you-go model in pharmacy. Four, we did procure Medicare Part D reimbursement. We are not part of Part B. We work with PBMs and payers where price is already adjudicated. That's been our point of view with them. These are going to play out over time. I would say in the immediate term, we're really focused on execution because a lot of what was being proposed, we're already living into.
Got it. Just one follow-up on type 2, type 1 in the U.S. Sometimes when a company launches kind of a new product, new indication, they take their eye off the ball on the core business, which was type one for you. I was pleased to hear early on in the launch of type 2, it was actually having a halo effect on type 2.
Absolutely.
Could you talk more about that, please?
Yeah, thank you, Larry. I mean, this is where I would share a couple of things. We have a 25-year history of know-how, reputation, credibility, learning in type 1 with endos and high prescribing PCPs who manage patients on insulin. That's really what we've learned over 25 years. A lot of that learning and know-how and a very similar call point with a similar technology is now being applied to type 2. There is beautiful reciprocity, and that's why when Ana was talking about in Q2 , we're seeing NCS's type one continuing to grow and evolve as we're expanding into type 2 . We don't look at it as an either-or. Our strategic focus is to lead in type one, which we're continuing to do, to take advantage of the first mover advantage in type two in the U.S. and thoughtful geographic expansion, and to continue to innovate.
Those strategies remain intact. Unlike other categories, this is a similar call point, a similar technology, similar scientific backing, which actually makes it very capital efficient.
Ashley, you have a lot of consumer experience. Can you give any examples of how you have or plan to apply that to Insulet?
You know, it's a good question around how do we evolve the culture, Larry. I was asked that earlier today. I mean, this is such a can-do, a culture full of ingenuity, entrepreneurship. Again, historically an amazing tech company, supply chain, pharmacy. Now we've disrupted the market leader. Now we need to become the market leader and act like a market leader and scale and really develop the market. It's a beautiful combination of elevating top talent like an Eric Benjamin, who's been at the company for over 10 years, and his leadership helped a lot of the innovation. He's now the CEO of the company.
We brought in a talent like Manoj Ragunandan, who's really spent 20 years building out markets in consumer health and vision, very analogous categories to what Insulet's competing, where you unlock the value of the brand and you create more brand awareness with consumers and encourage them to have the right discussion with the clinician. You do a lot of market development with the clinician. You're in a highly regulated environment. You have to scale with superior, you know, cost of goods. I think you're going to see more of taking advantage of some of the remarkable talent that we have here, but building out some of those market development, commercial execution, mastery, and brand management.
Before I hand it over to you for closing remarks, I'll also congratulate you on hiring Claire Trackman into the IR role.
Right, I see you, Ana.
Hopefully, Claire is listening.
Yes, Claire is listening. She started on Friday. We gave her a moment's reprieve for today so she can tend to things. I am just, I am very grateful for, we have a very strong, passionate crew at Insulet that I am looking forward for you to meet more of. We are going to be adding, I mean, we have doubled the size of the company in three years. We are about 5,000 colleagues strong. I will tell you about half of our company has been at the company less than three years. We are a hyper-growth company with a lot of durability and a large underpenetrated total addressable market. There are not a lot of med tech companies, nor healthcare companies that are growing in their mid-20s in revenue at a 70% gross margin with operating margin expansion, cash flow positive, and a healthy balance sheet.
I intend, as I told our founder on Thursday, a week ago during our global town hall, John Brooks, that we will be very good stewards of his baby. We see a future to a very remarkable next 25 years.
Great. Thanks so much for being here.
Thank you. Thank you.