Thanks for having us. Que, l et's start with the U.S. business, the Q1 results just reported. That business has been weaker than the international business. It saw a nice acceleration in the first quarter, high single-digit growth on an underlying basis, more than 20% growth in U.S. new pump sold. Que, what's driving the acceleration, and what gives you the confidence it's sustainable? We really see traction. One of the things we look at is we look at our daily orders and our daily shipments and our account activity. We've seen a progressive tick-up as we've been releasing new products. If I zoom out, saying that what's happened in the last 18 months, you go back to the first half of fiscal year 2026, U.S. was pretty flat. When we introduced CGM towards December last year, we saw a bit of an uptick. We got to low single digit, mid single digit growth. In this past quarter, with Flex coming in, with Simplera, which represented only five weeks of the quarter, we saw another uptick. Since Instinct has come out with Flex, we're seeing another uptick. It's not one product that's doing it. It's the fact that we are having this cascading release of new products that's really getting people excited and generating a lot of activity that we see. And the sustainability? That's what's sustaining it. It's not just one thing, but it's the fact that CGM, it's been our Achilles heel for a long time. The new pump is getting a lot of excitement. It's the first hardware refresh in over a decade. We see it in our daily numbers. All right. Let's talk about your patch pump. You filed it for FDA approval, Fit. It was pulled forward. Yep. I think, the filing. You plan to launch it, I think, summer of next year. Yep. When you launch it, you could be the fourth patch pump to market, depending on the cadence of the competition. Do you think Fit can be a strong number 2, and if so, why? Look, we think there's every prospect of Fit being a very strong number two contender, and I think in the long run, the number one AID system. There's a lot of companies that have got patch pump approval, but it's a different kettle of fish to actually launch the product. What I love about our patch pump is that it's not a me too. It's got up to seven days of wear. It has a 300-unit reservoir, and it has our world-class SmartGuard, our automation. These are the three trade-offs that a lot of, when we do customer surveys, people complain about in terms of what's available in the patch market today. We're going to be delivering all of that in addition to customer ease of use with Fit. It'll really be the first to market with that feature set that addresses the trade-offs today. The 300 units is more than the competition. Is there-- It is 50% more than the competition. Is there a trade-off on size? It is a little bigger. When you wear it, the payload is the same. We have done those wear studies. I think the number one thing that people look for from the existing patch users in the market is they want it to last longer. If you have Type 2 and you have high insulin needs or you are an adult Type 1, or you are a pedes, you want it to last up to seven days, we are going to be able to deliver that. Talk about what you think these new patch pumps coming to market can do to the market. Do you think it will stimulate the growth of pumps in general? Do you think it will change the ratio of patch pumps to pumps, which is about 60/40 today? What do you think the impact is going to be of all these new patch pumps coming to market? I think generally speaking, patch pumps will grow as a category faster than the overall pump market. We believe that durable pumps will continue to grow, just not as fast. That is evident from what we have seen in the last few years. But the important thing is less about the precise mix between durable and patch pumps. What we are trying to do is actually have a solution for every segment of the market. If you want a smart pen because you do not want to wear something on body, you have our smart MDI solution with MiniMed Go. If you want a patch pump, we are going to be introducing MiniMed Fit next year. If you want a durable pump where you can disconnect and have a smaller footprint on your body, you have MiniMed Flex. That is our goal is to have a portfolio that addresses Type 1 and Type 2, depending on what preferences that people have versus trying to force fit everyone into one solution. That makes sense. I asked about it on the call, just kind of deferrals or pausing ahead of the Fit launch. You did see a little bit with Flex. It sounds like you do not expect to see much deferrals ahead of Fit coming out. Why is that? In the market research that we have done in terms of preference share and the value proposition of Fit, we think that the two cohorts that will be probably the most excited are the MDIs that want a patch pump. We think that is an expanding market, and as we introduce our patch pump with the automation control and including full closed loop next year, we think that will expand the market and attract a lot of people from MDI. Then the second cohort, which is a very sizable number, are the people on patch pumps today that are not getting control, that want longer wear, that want a larger reservoir. We think these are the big two cohorts. That is not to say that some of our install base are not interested in upgrading. I am sure there are. But we think this is less pronounced than what we saw with Flex. That is what our research says so far. Okay. Manufacturing has been, I guess, a concern, a challenge in the past with patch pumps. I think you have said you are going to have capacity for 20,000 units upon launch. Just remind me of what you said on manufacturing. When you think you will have unconstrained capacity. We will have capacity for 20,000 patients, not units. Sorry. It is millions of units, but it is 20,000 patients. Upon approval or launch in the summer? Upon launch. We are working with our lines are set up now, we are running water through the pipes, we are making products. We are working on making sure our yields are at the level we want it to be. We want to demonstrate the capacity we can produce, and we are planning for additional capacity, even now. Then of course, we are preparing all of the launch activities, marketing, market access, commercialization, training the sales team, and so forth. How long until you have unconstrained capacity? We do not think of it as unconstrained. The best maybe analogy I can give you, Larry, is just look at the ramp-up that we had with Simplera. When you are making millions of these units, it takes time to ramp up volume. If I look at the volume that we did last year versus, say, what we are doing this year right now, it is tripled. You should expect some type of ramp-up like that with the patch production. Okay. Then just switching gears, the other update you gave was on Vivera, your fully closed-loops algorithm, which I think you said, now it is fully enrolled the trial. Fully enrolled. You said it is going to launch shortly after Fit in the second half of calendar 2027. I guess the question is, it is a 12-week follow-up study. Should we expect to see the data at ATTD in early 2027, or is that more of like ADA in June of 2027? We haven't disclosed exactly when the data will be ready and when it's going to be published, but it's a pretty good guess whether, they would pick a medical conference to show the data. We're all eagerly waiting what's in there. Okay. You've talked about Vivera being designed to meet patients where they are. Why is that flexibility important? How should investors think about the advantage of one platform which serves both highly engaged and lower engagement patients? I think one of the misconceptions in diabetes technology is that you have one product, everyone behaves the same and uses the technology in the same way, that's just not the case. I think it really is different strokes for different folks. So, meal bolusing is one of the most complained about things that people with diabetes have to contend with every day. It's difficult to do. People guess wrong. The ability to remove meal bolusing or meal announcements or carb counting is really important to really unlock AID, to completely simplify AID. You have a spectrum. You've got people who, like teenagers, who will never want to do anything, you have to be able to deal with that. Then you've got people who are very good at managing their diabetes. They're super fastidious about getting to very tight control, they want to engage with technology. We don't feel that it's right to tell someone like that, "Oh, you can't do anything with the system." Similarly, we don't want to tell the person that doesn't want to bolus, "You've got to do these things and change your behavior." W e've built an algorithm that we're really excited about. It can accommodate both. You don't want to bolus, no problem. You'll get above ADA guidelines. If you want to engage with a system once a day, never, maybe a couple of times a day, it can accommodate that as well on an optional basis. It can really adapt to that full spectrum of behaviors. Actually, most people end up being somewhere in the middle. I think what's great about what we've built is it accommodates Type 1 and Type 2. It makes it easier for the physician because they don't have to think, "Oh, is this therapy good for this patient?" Our algorithm can actually handle both behaviors. I think on the payer side, it should give them more confidence that if they're paying for a therapy, that you don't really need to depend on the patient's behavior for adherence. The patient can still achieve above the ADA guidelines. That's helpful. What do you think the commercial implications are of launching these hybrid, these fully closed loop systems where you eliminate or reduce the burden of meal announcements? I think it will expand the market. Our view is that the easier the AID system, and we believe Fit with Vivera will be extremely easy to use. You just need your total daily dose to get into therapy, so super simple to include into a clinic, that it will expand the market. The ease of the AID, we believe that drives the easier market. It's very similar to when CGM, you remove finger sticks. You took out the behavior, the need to adhere to and be compliant. That's what we're doing with AID, and we think that will open up the market massively. Type 1 and Type 2? Type 1 and Type 2, especially Type 2, because you don't have to do anything. You think Fit will resonate more with Type 2 because of the 300 units? With the 300 units and the longer wear. You are at 40% now, you said new starts are Type 2? Is that what you said? Type 2 in the U.S., yes. Do you think that goes much higher? Because that is pretty high already. Potentially. It will depend on probably unlocking the primary care channel, which I think Fit + Vivera has the potential to do. Do you need to expand the sales force to reach the primary care channel? We expect some sales force expansion as volumes grow up, but not at the same rate as revenue. All right. Type 2, transitioning to. Although we just started. How do Type 2 patients differ from Type 1 in terms of the onboarding and utilization and retention, and how are those impacting your commercial model? I'm generalizing, but typically Type 2s tend to want simpler systems. When you have diabetes and you've been diagnosed as a child, you tend to have to learn all this stuff, and you have pretty good adherence. Type 2s later in life, habits have formed, so you want systems to be simpler. The other thing we see is high insulin usage, so that's why we've designed our pumps to accommodate 300 units. We want it to be a good solution for Type 1, but also Type 2 with the bigger reservoir. So simplicity matters. We've had the Type 2 label indication, not just for 780, but prior to that for a very long time. It's always been part of our U.S. install base. As a result, for many years, long before I joined the business, we've always had programs to help patients onboard to therapy, get success quickly, and stay successful. We call that StartRight. Six months and beyond, we call it Stay Right. We have touch points with the patient throughout their journey. The fact that we go direct where we can, allows us to hold their hand through the process. Is that why, I know you were asked about it on the Q2 call that your retention or attrition is similar with Type 2 and Type 1 patients? It's a little higher than Type 1, but it's similar. It's not dramatically different. The trend we see as we've released new products is that that attrition has come down and our retention go up. It's a combination of having the right product market fit for Type 2, but in addition to that, making sure we support them with our clinical field. There's been a lot of concerns on GLP-1s or about GLP-1s impacting the Type 2 population. Your view is? My view is that we haven't really seen it in our new pumps sold or our new patient starts with Type 2. In the U.S., it's been pretty stable at around 40% quarter upon quarter. Again, we mostly focus on the endo channel at the moment, so that's pretty stable. It makes sense because when you look at Type 2 penetration in the U.S., it's not significant. It's still in the early innings. We think there's a lot of headroom ahead. Even if you assume widespread GLP-1 usage, and maybe it slows down the number of Type 2s that become insulin dependent, the reality, there's just so much adoption headroom that we don't really see an impact on the growth potential. Okay. One of your competitors has talked about the removal of the C-peptide requirement from the NCD for Type 2 Medicare patients. This could be a catalyst for the market if it happens. Do you expect this to happen, and what impact would it have, or could it have? I think it's been a question of 20 years, Larry. I think the industry, the physicians, I think everyone agrees this is a very outdated test and just adds barriers to Type 2s getting, clearing the test in order to get coverage. We welcome anything that can help CMS open up the NCD and revisit it. My understanding is that the guidance, the deadline to change the guidance has passed. I don't think there's a prospect of that changing before the end of the year. Is there a chance? When would be the next opportunity? Well, it will be next year. We are always hopeful that CMS will see the light. That is a byzantine process as far as I am concerned. It will be tremendously great for the whole industry because then Type 2s can get greater access in the DME channel. There are no prospects that I can see at the moment. All right. Let us switch gears to the CGM business, which is actually the largest revenue line in your reported revenue. What are you learning about patient preference between Simplera and Instinct? As you broaden your sensor portfolio, how do you think about the opportunity to drive that attachment rate beyond, I think, the 69% you reported in Q1? Yep. First on the two sensors, we think there is room for both. Each of the sensors, they are both accurate, and they just fulfill. They have different features that different people prefer. For example, some people prefer, obviously, the longer wear. They like the size, and they will pick Instinct. Sometimes the tape does not work for them. For Simplera, we see a lot of users who want to optionally calibrate. They like the weekly routine. The tape works for them. There is just different features that, when people use the sensor, they have different experiences. We think there is room to offer both. Given that we are indifferent as to which sensor we sell, we get really the same revenue, it does not really matter, and we think the choice is important. We do not want to force people who want a weekly routine to have to have one every 15 days. But it would seem, let me just push back a little bit. Yeah. Longer wear, smaller size. You did not mention it, but one is iCGM, one is not iCGM. You calibrate, I think you may have mentioned it earlier, most people do not want to calibrate. That was actually, removing that was a catalyst for CGM. Right. It would seem like Simplera would kind of become the minority. Well, Simplera, you do not have to calibrate Simplera. You can optionally calibrate. For a lot of people, they like that because especially if you are Type 1 and sometimes the sensor can drift, you want to be able to calibrate and be in tighter control. That is the reason why people do it. If you look at the social media posts, you are going to see, "I cannot calibrate the Instinct. Why cannot I do that?" A lot of our install base like to calibrate the sensor because of that reason. They do not have to, but that is why some people do it. I agree. The majority do not want to calibrate, but again, the tip of the pyramid, you are going to have very engaged patients that just want to eke out very, very tight control that may want to do that. Okay. I do not think you have said anything publicly about the split, the share, but like of new starts, but tell me if I am wrong, but do you think the majority is going to be Instinct going forward? It's possible. Right now, both sensors have very sizable scale install bases, and we're seeing both grow, and people have different preferences. I think in the U.S., you're going to see more Instinct users, because we launched that first, and we gave preference to OUS for the Simplera supply. We'll see where it lands. But we're indifferent. We want to give the choice. Then, obviously, as we get into our extended wear sensor that we talked about last week, we'll be able to offer Simplera, the Simplera install base, an even longer wear sensor as well. Remind me how long the new extended wear sensor is going to last. We haven't said, Larry. It'll be longer than seven days. Longer than seven. Yes. But you haven't said if it's longer than 15. We haven't disclosed it. I don't want to get ahead of our regulatory-- Is it at least 15, competitive with the other two? We haven't disclosed any of that. We will in due course. The pivotal trial starts this fall. Starts in October, actually next month. So probably this fall, I guess. Is this like a calendar 2028 launch? Typically, a new sensor trial is about 18 months. Okay, so it could be a little longer than that to approval. Do you think you are going to be able to achieve iCGM specifications? Have you said anything about size? You said earlier Simplera is bigger than Instinct. It is going to be the same form factor as Simplera. What that does is it allows us to leverage all of the manufacturing lines that we have today with Simplera. The only difference is it is a new sensor filament. That way, we can be capital efficient. People like Simplera. They like the feel of it, the low profile. We are keeping that. As to the rest of the features, I do not want to get ahead of ourselves, but obviously iCGM is important, but so are things like reliability, the durability of sensors lasting the full label indication. All of those things are in the mix for our new sensor platform. Remind us now that while we are on CGM, Libre Duo is approved in the U.S. and internationally. Remind me of the timelines they have disclosed, I think, for the different pump partners. Yep. For MiniMed, what is the timeline? How are you thinking about adoption? We're working with them right now on integrating ketone data into our app. We'll have a single app as opposed to two apps that a patient has to juggle. We said it will come out in 2027. We can be more specific. Calendar year? Calendar year, yeah. Calendar year. Where do you think the sweet spot is? What's the kind of the sweet spot for that sensor? Which patient types? I think there's a lot of interest in the pediatric category, some MDI. I think when you're using our AID, you've got an algorithm that's going to get you back in range if you do go high. It tends to be pediatrics, people on MDI, and then maybe on AID, if you're using an SGLT2 off label, you could experience DKA in the euglycemic range. It acts as an airbag there. I think it's early. We'll see. But we're actively working now on really delivering a great user experience, and there's got to be more work being done to study what do you do with ketones if it goes up or if it alarms. Those things still need to be worked out. Got it. Okay. Let's switch gears to pharmacy. Okay. Hot topic in the pump world. I guess the way I'd frame the question is, maybe it's just me, but some confusion among investors around your pharmacy strategy. Can you please help us better understand what the strategy is and how we should think about the economic implications and potential price uplift, please? Yes. I think the best way to answer your question is to go by product, because it really does vary by the nature of the product. Today, we have MiniMed Go, which is InPen, and our CGM is available through pharmacy today. If you compare the pricing of our CGM, which is Simplera and Instinct, in the pharmacy versus DME, they are very similar. That is number one. That is available today. We have pretty good coverage for CGM and InPen, and we also have coverage for our consumables through pharmacy today. What happened in the last, call it 18 months, 12 months, was the introduction of 780G through pharmacy. 780G is on the formulary through Ascent, MSR, and Zinc. That is about 70% of covered lives. We are seeing price accretion when health plans take advantage of that formulary. One of the challenges, though, in the durable pump market is traditionally it has not been through pharmacy, and so a lot of the health plans have medical guidelines in their design where they do not accept the formulary. We are working now with the various health plans to encourage them to accept 780G through pharmacy. That is what we are working on at the moment. We certainly see ASP uplift, and the way that our economics works for 780G is we get paid up front for the pump price. We pay a rebate to the PBM. It is an attractive rebate, but it is not giving away the farm. Then we get paid for the consumable. Then typically, the patient has a co-pay somewhere between $50 and $100 for that pump. That is how 780G works. I think I mentioned in the prior earnings call that we are working right now to get Flex available through pharmacy as well. Cannot disclose very much at the moment, but the conversations are going very well, and so we hope to get Flex through pharmacy very soon, and certainly for the calendar year 2027. Then, of course, Fit. I know there are a lot of products. Fit will be a patch pump product. It has got a disposable element, and so it will be very similar to how the patch pump is going through the market today. You have got a starter kit, and then you have a supply kit that comes through, so it will be a very similar model. Through the pharmacy. Entirely through pharmacy. The CGM and the pump. Yes. Okay. Medicare, too. Medicare Advantage will take a bit longer to do. Yes, that's the plan. You've talked about a revenue uplift, you mentioned, I think. People can run the numbers. They can see your revenue per patient is higher than the competition. So two-part question. A, how much higher can you actually go, given you're relatively high? B, I think the question we typically get, probably you and me is what's the risk, actually, that your actual revenue per patient comes down closer to where the other guys are? Look, I think our fundamental strategy has always been to differentiate through innovation, through our clinical outcomes, through the user experience and the physician experience, and to price for value. We don't try to compete on features. We don't compete on price. We don't think the win, in the end, wins that way. It's about a value proposition that is very compelling. The clinical evidence is there, that's our general approach. That's the same, it will be the same with the patch pump. The way that we've done it to date is we have direct contracts with payers, these are the pricing that they're willing to pay because we serve the intensive insulin population. It's the most vulnerable patient cohort. We're not going after non-intensive. When you amortize this small cohort, their need for this technology over 1 million members and the cost per month, it ends up being very little. It is worth it because when you look at the claims through our CareLink data, payers can look at claims from that cohort and see that if they are doing better than the national average, they are going to have less hospitalizations, less ER visits, less complications, less costs downstream. That is really the argument that we make with the payers, and they are willing to pay us, and we have contracts that prove that. We think that going to pharmacy with a patch pump is a big opportunity because today, if you look at the price for a patch pump in the pharmacy versus what we get through DME, there is a lot of headroom. We intend to be competitive, but there is a lot of space for us to improve the value we can achieve through the innovations we are bringing to market. Okay. You mentioned MiniMed Go. Yes. Since we have time You probably know, well, investors are skeptical. Yep, that is fine. The pens have not been smart pens haven't been super successful, you know that. Is it fair to be skeptical, or are we going to be and how are you going to prove people wrong? Well, I have to admit, I was skeptical, too, about this thing. To be honest, what we're seeing in the market, it is a big opportunity. First of all, the patient pool is huge. You've got 15 million patients on MDI that don't have the benefit of technology. They might have some CGM, but combined with our smart pen solution and our software and our poor man's version of our algorithm in the system, we're getting 70% time in range if you follow the recommendations. We think it's a very exciting solution. One of the reasons why the smart MDI solution hasn't done well in the past is because we had Guardian, and that just doesn't work well with the pen. Now that we have Instinct and we have Simplera and we have one single app, not two. We used to have an app for Simplera and an app for InPen. Now we have one app. We've made it super simple that we're seeing huge interest. At some point we will disclose a little bit more around that. But we're seeing great traction, both OUS and also in the U.S. Okay. All right. You're going to prove us wrong. We're going to earn your trust. Okay. It's interesting, we didn't talk about international. That's been kind of the steadiest, best part of MiniMed over the past few years. Maybe even longer. Low double-digit growth, pretty sustainable, pretty sustained in recent past. How are you thinking about the sustainability of that and the drivers? We feel really good. Two big drivers for that. Number one, our commercial team in 80 countries is really formidable. We've been there for a very long time. We've got a commercial infrastructure, thousands of people that can handle tech support 24 by 7 in 26 languages. We have a lot of scale, and that matters because again, it's not just about the product, it's about can you support the physician? Can you support the patient? We have that infrastructure already there. That team is so strong at execution. Remember, we've had 780 there since 2020, 2021. We haven't had a new pump, and we've had Simplera for only about two years. Now that market is going to get more Simplera. Now we've got Instinct, and we're commercially launching Flex in November. It will be the first hardware refresh and software refresh in about six to seven years. Given how well we perform with the older technology, we are going to do even better with the new innovations that we are bringing out. We are seeing that already, and that is one of the reasons why we think it is sustainable. We do not have to build a new sales force. We understand how the different health systems work in these markets. It is really primed for continuation, if not acceleration. When I looked at the slides, my question is around are there markets that you have had to kind of prune or pull back? Because when I look at the slides, you gave color on the U.S., you gave color on Europe. Both doing well, but it almost implied that maybe emerging markets or some other markets were not that great to get to the averages. If you will. Now that you are not part of Medtronic anymore, Medtronic obviously has a bigger infrastructure than you do. They were competing in a lot of markets. Are you having to kind of pull back in some geographies? Well, I mean-- Or focus on larger ones? Right. I think to answer your other part of the question, I think if you look at our overall growth, we had broad-based growth in every geography. The difference in Q1 was that our new pump sold was not as high in the emerging markets, and that's really a bit of a timing impact from tenders. But overall, emerging markets grew as much as the developed markets did, which is why we had low double-digit growth if you exclude the 14th week. We used to be in 123 countries. Even as part of Medtronic, I was already getting us out of about 40 markets. It didn't make sense. Didn't have scale. That's already happened. We're happy with the 80 markets that we're in. Okay. I want to go back to the guidance in the U.S. I asked a question earlier, but a different way. You posted low double-digit underlying organic growth in Q1 excluding the extra week. You expect the U.S. to continue to accelerate. You said that on the call. But the guidance is 9%-9.5% underlying, excluding the extra week. It doesn't reflect any acceleration in the U.S. Is that just conservatism earlier in the year, or is there something that kind of offsets the acceleration in the U.S.? Philosophically, we try to give you guidance that we have confidence we can hit, and that's been our approach. We have a lot of levers we're pulling. We're not pulling back from the progression we expected to see in the U.S., as well as the welcome news that we have CE Mark early and we're going to launch in November. There's a lot of things to be excited with, but generally, when we give you guidance, we want to give you a number we can hit. Okay. That makes sense. On profitability, 16% adjusted EBITDA margin in fiscal 2027, you reaffirmed that. Yep. You accelerated some of these launches. How do you balance the investment behind Flex, Fit, and Vivera with this commitment to expand profitability? We don't really see growth as being the trade-off for profitability. If anything, growth helps us drive more leverage in the P&L. We continue to invest. What we did in Q1 was we decided to pull forward the launch investments. It made sense. We were able to pull forward the launches, so it made sense for us to pull forward the spend to support those launches. That doesn't repeat itself in the second half of the year. Then we had some favorability on gross margin. Simplera yields and output are better than what we assumed going in. I feel better where we are today than we were even 90 days ago. That helped offset some of the FX headwinds that we saw in Q1. Now we have our hedging program in place. That type of swing we don't think will repeat itself in the rest of the year. All right. Well, we covered a lot. We're almost out of time, but I'll give you the last word. Well, Larry, thanks for hosting us. We're really excited with our first two quarters as a standalone public company. We shared a lot last week and we hope to continue to earn your trust and interest in MiniMed as the year progresses. Sounds good. Thanks for being here. Thank you.
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