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JPMorgan Healthcare Conference

Jan 10, 2023

Robbie Marcus
Managing Director and Senior Medical Technology Analyst, JPMorgan

Hello, everyone. I'm Robbie Marcus, the med tech analyst at JPMorgan. Really happy to bring up our next session, Insulet, gonna introduce the CEO, Jim Hollingshead. We'll do a presentation then a little Q&A. Jim?

Jim Hollingshead
President and CEO, Insulet

Robbie, thank you very much. It's great to be here with all of you. Thank you all for coming today. I wanna start with an introduction. On the slide here, you can see Christian. Christian is six years old. When he was three, he was diagnosed with type 1 diabetes. What he likes to do is he likes swimming, he likes hoverboard, and he likes playing with his sisters. If you look really closely in the photo there, you can see just on the back of his arm, the Omnipod 5. That's the device on the back of his arm. Christian and his parents love the Omnipod 5 because it allows him to run around and be a kid and play and do all that stuff.

It allows him to go to sleep at night, all staying with Time in Range, keeping his blood sugar Time in Range. It's the reason we get out of bed every day is we like helping people like Christian and people all over the world to manage their diabetes. I'll just flag for you because we have a lot of these photos in our presentation. Every photo in the presentation is an actual user of our products. We call them Podders, and every single one of them has a story. I'm not gonna stop and tell you the story of every Podder we have in the deck, but everyone has a story. We're so excited, especially now with Omnipod 5, to see the impact that we're having on real people's lives every day, and Christian is just one of them.

I know you guys see these disclaimer statements all day long. I'm just gonna say they're important. I'm gonna inevitably talk about forward-looking statements. I'm gonna inevitably talk about non-GAAP numbers. Please refer to our website for other guidance and details. I will also remind everybody that I'm working off of our Q3 numbers. We're not guiding for Q4 in this session today. We're working off of Q3, just as a reminder. What I wanna do today is take you through four topics. The first thing I wanna do is share with you why we think we have such a massive market opportunity at Insulet. We have a huge, underserved, underpenetrated market that we're playing in. The next thing I'm gonna do is explain to you why we think Omnipod 5 is a truly revolutionary product. I wanna turn to our innovation portfolio.

I'm have an emphasis on what we're doing in type 2 diabetes, but I'll talk broadly about what's in our portfolio. Finally, I'll close with a few comments on our commitment to growing the business and driving shareholder returns. Insulet's mission is to simplify life for people living with diabetes, and we do that with some basic fundamental tools. The first thing is, of course, our Omnipod platform. Wearable, disposable, tubeless insulin delivery pump. We've been very successful with that product. It's patient-preferred everywhere we go. Now we've launched our 5th generation product, the Omnipod 5, and I'll talk more about that. What our offerings do is reduce the burden of living with diabetes. People with diabetes have a lot they have to do to manage their disease, and I'll talk a little bit about that.

It's a big burden, both for people with type one diabetes and people with type 2 diabetes. There's a lot they have to manage, and our offerings are designed to reduce that daily burden of living with diabetes. We also improve outcomes. By managing your condition better, you have better Time in Range, you have better health outcomes, you have better quality of life, and now we've automated that with Omnipod 5. We have several advantages as a company. The first and foremost I would say is we have great people. I've been in the CEO seat now for seven months. I have to say, I've spent a lot of time getting to know people around the company. One of the things that most impressed me, I had been sitting on the board.

I knew our fantastic executive team. I've spent a lot of time going around meeting people in sites. I've been doing a lot of because of the nature of how we all work now, I've been doing a lot of one-on-one meetings with people in the company on Zoom, you know, remotely. I am just massively impressed by the quality of the talent that Insulet brings to bear, the people that we brought into the company, and really impressed and amazed at the level of commitment and dedication they feel to our mission. We have a huge advantage in our people. We have a phenomenal innovation engine. We have fantastic engineering. We have fantastic product development, fantastic commercial and marketing operations. We continue to innovate the market. It's a big advantage for us.

We're to the point now as a company where we're also operating at scale, that really represents a set of advantages for us that are very important. We were large enough now that we're not only at scale, we not only have very robust manufacturing at high volume. It's a very difficult thing to do with a patch pump offering like what we build. We can continue to scale and drive more efficiency in our business because of the size we're at, we'll continue to do that. Finally, just briefly, Omnipod 5 in particular is a cloud-connected offering. We have a huge advantage in the cloud connection of our offering and in the data infrastructure that's required to make that work for patients.

That's another area where we have real advantages and where it'd be very difficult for people to replicate what we're doing. What that leads to is market-leading technology, market-leading revenue growth, and long-term value creation for our investors. As I turn to the market opportunity, we have a massive unmet need that we're tackling with people with diabetes. More than a half a billion people worldwide live with diabetes, and more than 60 million of those people require insulin injections. That's huge. It's a massive unmet medical need across the world, and it's a growing global epidemic.

In the markets in our geographies where we currently play in our current markets, we estimate the total addressable market of being about 11 million people, and that's split 40-60, people with type 1 diabetes, people with type 2 diabetes. We just announced on our Q3 call that we're filing for a new product, a new-to-world product called the Basal- Only Pod, and I'll talk a bit more about that in a second. By adding that product into our portfolio, just in the U.S., we add another 3 million people to our TAM. In our current markets, with what's in hand for us, we have a TAM of about 14 million people. Now, I get asked this question a lot. People ask me, you know, "What's the market size here? What's the market size there?" There's different estimates, and you'll all see different estimates.

To put this number in perspective for all of you, that 14 million person number represents somewhere between 30 and 40 times our current installed customer base. We have a huge growth opportunity as we try to work to tackle this huge global epidemic. We have lots of runway for growth. The Omnipod platform has been unlocking the biggest part of that opportunity. I'm gonna talk about the platform first, and then I'm gonna talk about Omnipod 5. Here in the middle of the page, you can see Alicia. Again, if you look closely, you can see Alicia is wearing the Omnipod 5 on the back of her arm. That's the Omnipod sitting right below her. What are the alternatives to Omnipod? Omnipod is such a fantastic user experience because it's small, it's easy to use, it's disposable.

There are no needles. There's no tubes. There's nothing to get stuck on a doorknob as you walk through the room. It's waterproof. I mean, it's just fantastic form factor. The alternatives to that are first, and this is often what people talk about when they look at the company. One alternative to that is to use a tubed insulin pump. There's a photo here on the left of somebody using a tubed insulin pump. He's got it in his hand. He's controlling it. He's got a cannula tube going up to an insertion set. Now, that total penetration globally for insulin pump therapy represents only 5% of the current market opportunity. With Omnipod 5, actually, we've competed brilliantly with Omnipod DASH for years because of the form factor.

With Omnipod 5, we're taking even more share in that part of the market that is the tubed pump or the pump market. Really the opportunity, both globally and in the markets we compete in now generally, is to bring people into the market away from their typical therapy, which is multiple daily injections. What this slide shows is, you know, there's a handful of syringes on the right. This is what you're doing if you're not on a pump. You're injecting yourself multiple times a day. Over the three days of wear that Omnipod provides, probably injecting yourself 13, 14, 15 times in that span. The Omnipod removes the burden of self-injection with multiple daily injections. You can see it's by far the largest part of the market opportunity.

95% of the world is still doing multiple daily injections. Our offerings are designed to bring people out of multiple daily injections, significantly remove the burden of caring for themselves, and bring them into streamlined, simplified care on the Omnipod platform. We've been incredibly successful with that over the last several years. That's the platform. Omnipod 5 is our next generation platform that we just launched in full market release in the U.S. in early August. Omnipod 5 wins on all dimensions in this space. First, it has all of the benefits of the form factor in the Omnipod platform. No needles or tubes. It's discreet, it's wearable, it's disposable, it's waterproof. It brings pay-as-you-go economics. It's a really important point. If you're using a tubed pump, one of our competitor products, you're paying up front for the capital equipment.

Your payer is paying up front for the capital equipment. In effect, if you don't use the therapy, both you and the payer are out of pocket on several thousand dollars of investment before you're on care. With Omnipod, it's pay as you go. You're basically paying for the pods as you use them. It's a huge benefit to customers because their copays are much lower. Our average copay in the U.S. for a patient per month is less than $50. Most patients pay much less than that. Many of our patients pay $0 in copay because of the coverage we've been able to develop on the Omnipod platform for both Omnipod DASH and Omnipod 5 in the pharmacy channel. The pharmacy channel is also a fantastic benefit for everybody because of the ease of access.

Very easy for patients to get the product, very easy for physicians to write the script, and we remove the upfront capital outlay for payers. Already we've got huge benefits with Omnipod as a platform. When you turn to Omnipod 5, what we've added is an automated insulin delivery algorithm, which is a fantastic algorithm. It's a unique algorithm. I'm not gonna try to walk you through the graphic in the middle of this slide, but what that does is it depicts how our algorithm works, which is it tracks, it connects to the Dexcom G6, takes a signal from that CGM, is tracking blood glucose. Every five minutes, it looks at the level of blood glucose and the trend, and then the algorithm determines whether or not it needs to do a microbolus of insulin or not.

If the trend is up and the glucose is higher, it will do a micro dose. If not, it won't dose. It's very streamlined, very smooth curve, fantastic results for our customers. It's a novel algorithm. We have industry-leading Time in Range. We do very well, in particular with this algorithm, with preventing hypoglycemia. We're approved now in the U.S. down to age two, really strong position in the pediatric market. When you put those two things together, all the benefits of the Omnipod platform, along with the industry-leading and novel AID algorithm we've introduced in Omnipod 5, Omnipod 5 becomes the obvious choice. It's clearly the leading offer on the market. In fact, we get asked all the time, "Why would somebody choose something else?" To which we say, "Exactly.

Why would somebody choose something else?" This is a revolutionary product, and it's out of the gate very strong. I know, I know you've all looked at our Q3 results. Growth for Omnipod in the U.S. of 42% in Q3 is. The market speaks for itself. This is a life-changing product. That's the feedback we get from our customers, and the market is showing it too. Let me turn a little bit to where we're going next, because you could say, well, Omnipod 5 is the product that Insulet was founded as a company to launch. Here it is, wearable, disposable patch pump AID, fantastic results. That's true, we're certainly not stopping. We have a fantastic innovation roadmap, I wanna start a little bit with what we're doing with Type 2 diabetes, the market for Type 2 diabetes.

Let me start just first with the patient journey. Type 1 diabetes and type 2 diabetes are actually quite different conditions. For people with type 2 diabetes, they go through a patient journey that starts on the left when they get diagnosed with a prescription for diet and exercise. Basically, you know, behavioral prescriptions. Watch your diet, exercise more. As their condition advances, as it generally does, they get medications, oral medications, they might get some injectables. At some point, what happens is their doctor says to them, "You need insulin therapy." They go on what's called basal insulin, which is a daily base rate of insulin, so that they can manage their blood glucose levels on a kind of a baseline basis.

Eventually, almost always, they progress to basal plus bolus, or sometimes called intensive insulin, where they have to do both the base rate and then injections for when they're gonna eat. That's a very complicated patient journey for people to go through. There's a lot for them to manage. We're already the market leader for insulin pump therapy in the type 2 diabetes market. Omnipod DASH, which is our fourth generation product, has an indication for use for type 2 diabetes in the U.S. Up until our recent launch of Omnipod 5, people with type 2 diabetes represented roughly a third of our new customer starts for the previous several months. Already leading offer for type 2 diabetes. What we announced in Q3 was that we're filing with the FDA, and we did in fact file.

We said on the call we were imminently going to file. We did in fact file in November for a 510(k) with the FDA for a new-to-world product that is the basal-only Pod. We haven't yet branded it. I'm sure it will have a brand. Right now we're just calling it the basal-only Pod. What that offering does is it removes needles. There are a lot of people who are trying to transition onto insulin. A lot of people are needle phobic. It's one of the big barriers to starting insulin therapy. It removes the need for needles, and it doesn't require a controller, and it doesn't require a CGM.

Basically what it does is the patient will fill that Pod with insulin, put it on their arm or their stomach, and it will deliver a trickle rate of their basal therapy over the course of 3 days. We think that that's going to remove insulin hesitation, which is important because many endocrinologists will tell you that people should get on insulin earlier in this journey for better outcomes. We think it will remove barriers because of needle phobia, and we think it will drive up adherence to insulin therapy. The other thing it does for us as a business is it gets us upstream in the patient journey in this very large market. This, going to the left here, as I said before, increases our TAM by about 3 million patients alone in the US. A very significant increase in our TAM.

More than doubles our total addressable market with people with Type 2 diabetes in the U.S. market. It gets those patients, those customers used to the Pod. It familiarizes them with the Pod. As their needs progress, as their condition progresses, they'll be transitioning off of a basal-only Pod onto a basal-bolus Pod. Right now that would be Omnipod DASH. We also said on our Q3 call that we will do a pivotal trial in 2023 for Omnipod 5 to get the indication for use for Omnipod 5 in Type 2 diabetes. We're at work right now defining that protocol, and we will launch that trial here in the U.S. Probably most of the market who goes on basal Pod will end up transitioning seamlessly onto Omnipod 5.

We know from our pivotal trial, which we published last year at ATTD, the impact of Omnipod 5, the outcomes for people with type 2 diabetes, Omnipod 5 is outstanding. Dramatic increases in Time in Range, and interestingly, dramatic reduction in total use of insulin. That is a fantastic product for people with type 2 diabetes who need insulin therapy, intensive insulin therapy, and will move upstream with the basal Pod and then have those patients transition onto Omnipod 5. With those offerings, we will have the broadest range of insulin delivery solutions for people with type 2 diabetes on the market. Let me tell. That's. Type 2 is just a subset of what's in our roadmap and, you know, I can't even get everything that's in our roadmap on this page.

Let me just talk more broadly then about our innovation and the horizons of growth that we see coming, the things that will drive our growth. First, on the first horizon here, we're gonna continue to drive U.S. growth with Omnipod 5. It's out of the gate very strong. We're getting fantastic customer feedback, and you've seen the growth results. We will then launch, as we've been public, we'll launch in international markets with Omnipod 5 starting in the middle of 2023. Our intent is to launch a first market in the middle of the year and a second market towards the end of the year 2023 internationally. We will then cascade those launches over the next year and a half or so to get into our international markets with Omnipod 5.

We're going to expand our connectivity with our CGM partners. Right now, as I said, we connect with the Dexcom G6. We're working really closely and very happy with our relationships with both Dexcom and Abbott. Our intent is to get to a sensor of choice offering so that an Omnipod 5 customer can choose, can say which sensor they're on, and they can use really any iCGM sensor enabled. We're working on that very hard. I think everybody in the room probably knows we've been working on our iOS control app, our phone control with iOS. That work continues. It's going very, very well. We have some work still to do on that app, and we'll let you know when we file that we've filed with the FDA.

That work is going well. Second horizon is really to continue to expand our total addressable market. As I said, type 2 diabetes represents a huge TAM expansion for us with basal-only Pod and with Omnipod 5, with an indication for use in the U.S. We will continue to expand geographically. Right now we're in 24 markets, we'll continue to look at other geographic expansion. We will begin to launch data products for providers and our customers that will further streamline the experience on Omnipod and Omnipod 5 products. Finally, we have a lot in our roadmap for the future. We're working on next-generation algorithms. We're working on next-generation hardware and improved form factors for our offerings.

We will build right now, we'll continue to build out the capability to use all of this data. Omnipod 5, very, very novel offering and its cloud connectivity. We get a lot of usage data. We'll be able to use that data with AI and machine learning to constantly improve the patients, the customers' experience of care, and constantly improve workflows for physicians and providers. That's something that's at work. I think it's a massive opportunity for us and quite unique to our offerings. You can see we have this massive market in front of us, and we have a really robust roadmap. I wanna say that what that has produced for us is obviously fantastic top-line growth.

On this slide, you can see we had 22% growth CAGR over the last five years, with six straight years of 20%, 20%+ top-line growth. What we do with that growth is we reinvest it. As I've said, we have this massive TAM, this huge opportunity. We're reinvesting to capture that opportunity. You can see our investment in innovation and R&D has grown 19%, slightly below our revenue growth. Get a little bit of leverage there. We're investing to capture this huge opportunity, and we have consistently expanded our operating margins. What's interesting about these numbers is that these are backwards-looking numbers. These are backwards-looking numbers off of the products and the offerings we've brought to market over the last five years. This is just the beginning of the story. Omnipod 5 is a threshold event for Insulet.

As I said before, it's the product that Insulet was founded to create. We're now out in the real world with it. It's going great. We have an incredibly exciting chapter in front of us with Omnipod 5 and with the offerings we're building now. I'm just gonna summarize and then quickly close. As I said before, just recapping what I've said, we're playing in a very large under-penetrated market. We have a massive growth opportunity. Omnipod 5 is a revolutionary offering and is driving real changes in people's lives. We're gonna penetrate and grow in the type 2 market as just part of a very robust innovation portfolio. We're committed to driving top-line growth and real results shareholder value for our investors. I'll just finish where I started. I wanna introduce you here to Grant. Grant is nine years old.

He was diagnosed with type 1 diabetes while he was on vacation. He was briefly hospitalized. His doctors said to his parents, "Listen, we wanna put Grant on an insulin pump, but we wanna wait until he's stabilized." He came back from the hospital. His mom went to the endocrinologist's office. Grant got online and did his research on insulin pumps. 9-year-old boy. When his mom came home with brochures, he said to her, "Mom, that's an Omnipod 5. That's the one I want." That's what he's on. He's obviously a very bright young man. This is a photo that was taken. I think this is actually a clip from an Instagram video that his parents put up online that chokes me up every time I see it because he's so excited when his Omnipod 5 arrives at his house.

This is why we do what we do, to have this kind of impact on people's lives. I think it's really remarkable. There are millions of people who need our help. We're just getting started. I'll close with that. Thank you very much.

Robbie Marcus
Managing Director and Senior Medical Technology Analyst, JPMorgan

Well, great. Lots to talk about in terms of the company and the updates here. I wanna start with a question for you on Omnipod 5. It historically had been a product and a decision tree where people would start with, "Do I want a tubed or a tubeless pump?" If you wanted tubed, you go elsewhere. If you wanted tube, or vice versa.

Jim Hollingshead
President and CEO, Insulet

Yeah.

Robbie Marcus
Managing Director and Senior Medical Technology Analyst, JPMorgan

Tube-tubeless to Insulet, tube to the other competitors. There wasn't traditionally a whole lot of switching between tubed and tubeless.

Jim Hollingshead
President and CEO, Insulet

Mm-hmm.

Robbie Marcus
Managing Director and Senior Medical Technology Analyst, JPMorgan

We're starting to see that change now with Omnipod 5. Maybe you could talk about the trends that you've been seeing since the Omnipod 5 launch. Anything you could comment on fourth quarter if you want. What's your expectation for the competitiveness of Omnipod 5 versus those two pump platforms?

Jim Hollingshead
President and CEO, Insulet

I'm not gonna comment on Q4. I'll just stick to Q3. What we've seen is new customers' demand coming from all places. You know, our target market is, as I said in the slides, are MDI users. That's a market growth play for us. Historically, our new customer starts came about 80% out of patients using MDI and about 20% out of competitive switching from tube pumps. What we saw in Q3 was a shift mix on that, so or a mix shift on that. We saw about 60% of our new customer starts come from MDI, and then about 40% come from competitor pumps, which is, you know, a big increase in the number. I think there's lots of reasons for that.

The main one is just that the Omnipod 5 offering is just so compelling for people. You don't have to, you don't have to wear a tube. You don't have to wear a needle. It's, you know, I went through all this and, you know, all the advantages economically, all the advantages of the wear experience. fantastic demand. Also, I should mention, we also had really high demand for conversion from our own platform. We had very high demand for converting from Omnipod DASH on Omnipod 5. There's a lot of things going on there, but I think a lot of it is people have been waiting for a patch pump AID. To your point, Robbie, it was, "Do you want a tube pump?

Do you want a patch pump?" Now it's you don't have to choose. You can get AID and a patch pump. We're first to market with an AID-based patch pump. People often talk about us as third to market with AID, we're first to market with a patch pump that has AID. I think the offering has been incredibly compelling. Just to give you a sense of the scale. We had record new customer starts in Q3. If you took that 60/40 split and kind of notionally took the 40% of competitor switching, cut it in half, and made it sort of 80/20 again, we still would have had record new customer starts.

Omnipod 5 is, it's an offer that people have been waiting for, and it solves so many problems for customers that I think it will continue to have very high demand.

Robbie Marcus
Managing Director and Senior Medical Technology Analyst, JPMorgan

One of the other things, I guess you had three tiers in the future of innovation. One of them, you talked about was an iOS app.

Jim Hollingshead
President and CEO, Insulet

Mm-hmm.

Robbie Marcus
Managing Director and Senior Medical Technology Analyst, JPMorgan

Is that something we might see in 2023?

Jim Hollingshead
President and CEO, Insulet

We're working as fast as we can. You know, we really wanna get that offering out on the market. It's actually our most requested product feature, you know we've been working on it. I'll say a couple of things about it. First one is, our anecdotal sense, we don't have great data on this, but our anecdotal sense is that people are not waiting to go on Omnipod 5, mostly, for the most part, for the iOS app. I do think we wanna get it out there. We wanna improve and streamline the customer experience, which is very much what we're about in general. We're working on it very hard. You don't have to wait.

You know, if anybody's listening out there is thinking about this as a customer, you don't have to wait because the iOS app will really only remove, you know, it'll allow you to control your bolus. It allow you to leave your, what we call the PDM or the controller at home. You can get a great experience already without the iOS app. We wanna get it to market as soon as we can, and we'll update you all as we get closer.

Robbie Marcus
Managing Director and Senior Medical Technology Analyst, JPMorgan

What is it, that's taking longer than the Google platform?

Jim Hollingshead
President and CEO, Insulet

Well, it's a totally new software platform, and it is a medical device. you know, we've done a lot of build and verification and validation, and now there's just that tail cycle of finishing out the app. Then, of course, we have to file with the FDA, and they have to review it.

Robbie Marcus
Managing Director and Senior Medical Technology Analyst, JPMorgan

One of the other things in that same bucket of near term was integration with other CGM platforms.

Jim Hollingshead
President and CEO, Insulet

Mm-hmm.

Robbie Marcus
Managing Director and Senior Medical Technology Analyst, JPMorgan

I could think of two assets, and I could think of Dexcom's new G7. How should we think about the timing for each of those? You know, Dexcom is now approved with G7.

Jim Hollingshead
President and CEO, Insulet

Mm-hmm.

Robbie Marcus
Managing Director and Senior Medical Technology Analyst, JPMorgan

How long till we can see an Omnipod 5 with the G7 and vice versa with Abbott-?

Jim Hollingshead
President and CEO, Insulet

Yeah, yeah.

Robbie Marcus
Managing Director and Senior Medical Technology Analyst, JPMorgan

once it's approved?

Jim Hollingshead
President and CEO, Insulet

We haven't guided, Robbie, on the timing of those things. We don't talk about those timelines. I will say that we're working really closely with both Abbott and Dexcom. As I think I said in the remarks, we're really pleased with the level and kind of engagement and collaboration with both partners, but we haven't guided on timing, and I don't wanna get out in front.

Robbie Marcus
Managing Director and Senior Medical Technology Analyst, JPMorgan

It's funny 'cause they said, "We'll leave it to Insulet to update anything on that.

Jim Hollingshead
President and CEO, Insulet

That's great. I think we were presenting third, so they just kicked it to us, right? Yeah.

Robbie Marcus
Managing Director and Senior Medical Technology Analyst, JPMorgan

One of the other things, like you said, it was the first announced on the third quarter earnings call was this basal pump. I think a lot of people, including myself, were caught by surprise. Historically, it hasn't been a patient population that's been thought of for use with a pump.

Jim Hollingshead
President and CEO, Insulet

Mm-hmm.

Robbie Marcus
Managing Director and Senior Medical Technology Analyst, JPMorgan

Maybe spend a minute and tell us, one, how this is different than your basal-bolus product?

Jim Hollingshead
President and CEO, Insulet

Mm-hmm

Robbie Marcus
Managing Director and Senior Medical Technology Analyst, JPMorgan

... both from a platform and also maybe what's on the inside that's different. How do you see this fitting in with this patient population, which historically hasn't really been a tech-forward type of population?

Jim Hollingshead
President and CEO, Insulet

First, how, you know, what does the offering look like? It's, it's essentially the Omnipod platform offering. It's the same form factor, you know, same auto insertion, all of those things. Really, really easy to use. The patient will load the Basal- Only Pod with insulin, put it on their arm. It will come in different SKUs that have different basal rates. It's all automated, and therefore, it doesn't require connection with a CGM, and it doesn't require a phone controller. It's very, very simple, easy to use. Go to the pharmacy, pick it up with your dose that your doctor has prescribed, put it on, and for three days, you get, you know, at a trickle rate, you get your daily basal rate. It's super simple.

We think it will drive up adherence and, you know, no needle phobia. On this, you know, why these customers? It's a huge market. We know that people get on insulin too late. We know that people are afraid to inject themselves. We think the time is right for this offering. You know, we're very happy to see, for example, the reimbursement that will come for basal rate patients with CGM. That's gonna pave the road for us. It doesn't require connectivity to do it. One of the benefits for us of both Abbott and Dexcom developing markets is they've constantly paved the road for us, and people are more and more used to wearables and more and more used to managing their care that way.

We think it's a very, very timely offer and will be a great experience for patients.

Robbie Marcus
Managing Director and Senior Medical Technology Analyst, JPMorgan

Uptake is just one or demand is one component of it.

Jim Hollingshead
President and CEO, Insulet

Mm-hmm

Robbie Marcus
Managing Director and Senior Medical Technology Analyst, JPMorgan

... the second. What are you doing as a company to help drive reimbursement? Are there studies that you think will be needed to get insurance companies to wanna pay for this?

Jim Hollingshead
President and CEO, Insulet

Yeah. One of the reasons we announced in advance of filing, which we don't typically do on our call, is because it allows us to go and engage with payers right now about reimbursement. We're in those conversations now. We're confident we can get coverage for it.

Robbie Marcus
Managing Director and Senior Medical Technology Analyst, JPMorgan

Mm-hmm.

Jim Hollingshead
President and CEO, Insulet

We'll build up an evidence base on the back end of it, once we get into market.

Robbie Marcus
Managing Director and Senior Medical Technology Analyst, JPMorgan

That third bucket was all future artificial intelligence.

Jim Hollingshead
President and CEO, Insulet

Mm-hmm

Robbie Marcus
Managing Director and Senior Medical Technology Analyst, JPMorgan

... and next gen platforms. It seems like if I just kind of paraphrase all of the diabetes companies, it's software is going to be really important down the road. Do you agree with that? Really, how should we think about the next level of innovation? Is it hardware, or is it software, or is it both?

Jim Hollingshead
President and CEO, Insulet

I think it's both and. I think it's really important to understand that. You know, the Omnipod platform. You could look at it this way. Omnipod DASH is a hardware product with some software. Because we've got an AI algorithm in Omnipod 5, and we have software controlling them. Over time, what will happen is it will be both and in such a sense that you'll need the hardware. By the way, really the hardware is what you're reimbursed for, right? The product, the therapy product itself is the economic engine. That's what's delivering care to the patient. Software will become increasingly. It's already important. It will become increasingly important.

The vision we have is that as we have, you know, tens of thousands, hundreds of thousands of patients on Omnipod 5, we'll have lots of usage data, and we will be able to use that data, private, secure, de-identified data, to constantly improve the patient's experience, the customer's experience of care. We'll be able to touch them all the way from diagnosis out to using pods forever. We'll be able to learn from usage patterns, increasingly segment our offerings, drive coaching engines, things like that. That's relatively easy to envision how that can be reinforcing. The better we make the patient experience, the better we streamline workflows, the more we'll have product preference, the more data we'll have, and it will be a flywheel in effect that feeds on itself.

I think that in future, I don't really see an insulin pump without a software side and an analytic side attached to it in future. That's where we're gonna play, and that's where we'll continue to lead.

Robbie Marcus
Managing Director and Senior Medical Technology Analyst, JPMorgan

Great. Omnipod 5 gonna be launching, second half of this year in Europe, I believe more robustly in 2024 across Europe. You know, that's a market where you don't have the benefit of the pharmacy-.

Jim Hollingshead
President and CEO, Insulet

That's right.

Robbie Marcus
Managing Director and Senior Medical Technology Analyst, JPMorgan

with lower reimbursement. Maybe how should investors think about Insulet's competitiveness in Europe, where it's you have this great benefit in the U.S., but not there? Is Omnipod 5 gonna be able to get to the same levels of share and new patient growth that you've seen in the U.S. so far?

Jim Hollingshead
President and CEO, Insulet

Yeah. That's a terrific question. First thing I'll say is that the Omnipod 5 platform, we know there are patients waiting for it in Europe, just like there were patients waiting for it here. I think that the appeal and the demand for the product will be very high. You're right, we don't have the pharmacy channel in Europe. Each market in Europe, as you well know, is a little bit different in how they operate, how they reimburse. In order to address that's why we're doing our randomized controlled trial with Omnipod 5, because we wanna develop the right level of evidence to go and get premium reimbursement over our current offerings in Europe as we launch Omnipod 5 to improve that.

I do think that we'll be able to drive significant share growth as we get into different European markets. Because of the lock-in periods across most of those markets, it won't be quite the same as in the U.S. I think it'll be a somewhat slower ramp, somewhat lower reimbursements. Huge volume growth for us, great market opportunity, but the margin, the margin and share profile will be a little bit different and a little bit slower to ramp.

Robbie Marcus
Managing Director and Senior Medical Technology Analyst, JPMorgan

Maybe I'll pause. Any questions in the room?

Speaker 3

I'm wondering if you can talk about the opportunity as you look to help even more people with type 2, to invest some of the manufacturing gains that allow us to expand volume, you know, into programs on awareness and education and access that can help all populations, traditional and underserved. Also just wondering if it was well understood how much the adherence training is or how much there is implementation gains, the infrastructure gains in health clinics to help more populations, more people with type 2, more of that population?

Jim Hollingshead
President and CEO, Insulet

Those are both great questions, Kelly. On the first one, we really wanna focus on helping expand access just in general.

Speaker 4

Sorry. Can you repeat the question?

Jim Hollingshead
President and CEO, Insulet

Oh, yeah. I'm sorry. There were two sides to the question, and keep me honest. The first one was, how do we think about investing as we grow type 2? How do we think about investing to make sure that there's access for all communities, including underserved communities? I think. Is that a fair paraphrase? The second question, remind me, Kelly, what was the second part of the question?

Speaker 3

Yeah. Just if it's well understood, the training component.

Jim Hollingshead
President and CEO, Insulet

The training. The training bit. Yeah. Okay. The first one on the underserved communities. First of all, we're very focused on access in general and, you know, kind of real access to our products, and that's one of the reasons we made the decisions we have about pricing and coverage. As I said, you know, we have an average copay of less than $50 a month, and a lot of our patients pay zero. We're well covered by Medicaid, but, you know, we're very mindful of increasing our reach into underserved communities, and we actually have conversations. I'm not gonna make anything public. We do have conversations with various advocacy groups about how we can continue to do that. Everybody needs care. We really wanna make sure we're driving that.

The other thing I'll say is that patient journey for people with type 2 diabetes is so complicated that we really wanna make sure that it's not just a physical product offer. That we're whether we're building something ourselves or partnering with others, we really wanna make sure that it's part of their journey. On the second part of the question with training, actually, I'm glad you raised it because I think it is not fully understood how much easier it is to train on Omnipod 5. Just to give you a sense, you know, if you do an in-person training on Omnipod 5, it's about an hour, and we do some of those.

If you do virtual training with an Omnipod 5 and you're coming from our current platform of Omnipod DASH, takes about 30 minutes. A lot of that can be self-serve. A lot of it is actually over a telehealth, you know, over a Zoom, effectively a Zoom type product. Our competitor products, you know, are doing training in the multiples of hours. I think one of our competitors trains for 10 hours over three sessions for the product. That's obviously a massive benefit to customers coming onto care. Kelly, I think the point you're making is it's a huge benefit to clinics because the amount of effort that goes in to training a patient for 10 hours is a huge burden on any diabetes clinic, no matter where they are.

By streamlining that front end, what we've effectively done is removed a lot of the work for the clinician, for the physician and you know, the diabetes educators and so on. Just like the algorithm removes a lot of the work of managing your daily injections and your insulin dose. The whole thing is designed to streamline care and remove burden for patients, for physicians, providers, and educators.

Robbie Marcus
Managing Director and Senior Medical Technology Analyst, JPMorgan

We did have a question come in here. Still some complaints of long customer service wait times online and onboarding trouble. One, are you hearing that as well, and what are you doing to help resolve that?

Jim Hollingshead
President and CEO, Insulet

Yeah. I'm very happy to tell you all that just in the last couple of weeks, we've crossed over the threshold, and we've by doing a lot of investment on the supply side of support, we've gotten back to basically where we intend to be on customer service levels. I won't talk about the specific metrics or so on. We had so much demand out of the gate for Omnipod 5 that effectively our call volumes almost doubled. It's very difficult to scale product support because you have to train people, right? We had planned for a high case. We got a high case. We got more product support requests, and we thought a lot of that was because of conversions, competitor conversions and so on. Some more complicated questions from customers.

The team has done a great job over the last two or three months in really ramping and scaling, I'm not gonna say there are no, you know, there's no noise out there, but actually we've just crossed over here at the end of the calendar year into the new year, getting back to the service levels we aspire to provide.

Robbie Marcus
Managing Director and Senior Medical Technology Analyst, JPMorgan

Great. Well, I think we're out of time. Maybe we can end it there.

Jim Hollingshead
President and CEO, Insulet

Okay.

Robbie Marcus
Managing Director and Senior Medical Technology Analyst, JPMorgan

Thanks so much, and thanks everybody for listening.

Jim Hollingshead
President and CEO, Insulet

Thank you, everybody.

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