Good morning, everybody. Travis Steed, the Bank of America MedTech analyst. Next up, we are glad to have Insulet here. We have Flavia Pease, Chief Financial Officer. Welcome.
Thank you, Travis. Great to be here. Thank you all for your interest in Insulet. I am looking forward to the chat.
Great. Thank you. Maybe we'll start with seasonality in Q1. You know, deductibles getting reset, it's not really a new dynamic and other companies haven't called it out. Why was it kind of stronger than what you'd kind of seen historically in Q1?
Yeah, to your point, deductibles reset every year, and there's normal seasonality in the category. We saw that in 2023 and in 2024. Last year was a little masked. We didn't see the seasonality, as we were in the very early stages of Type 2 launch. This year, not only we didn't have that tailwind, but it was more pronounced than historical levels. What we believe is happening with the categories, even though maybe others didn't, let's say, call out specifically, when we look at other diabetes companies that go through the pharmacy, we did see seasonality in their scripts in the first quarter vis-a-vis the fourth quarter.
When we look at GLP-1s, when we look at CGMs, when we look at insulin, they all saw the same level of let's say, sequential step down as we saw in our business. When we take a step back and we try to unpack what happened, there has been some changes in insurance constructs and coverage, especially with Medicare. Co-pays and co-insurances have increased. What we believe happened is, as you started the year, people took longer to hit their deductibles and have higher deductibles that they had to work through. Once that happened, we saw the NCS pick up to more normalized levels again.
I think the other important thing and why we again, have a conviction and a belief that that was seasonality is this was really only in new patient starts. When you look at our install base, there was sequential growth year-over-year. Excuse me, sequential growth quarter-over-quarter. It's really a dynamic of those new customer starts looking into converting from MDI into AID. We believe that there was a bit of a disproportionate impact of these changes in plans. The other thing is, as our business continues to grow Type 2, that's a more Medicare exposed population, and some of these changes in plans were even more pronounced in the Medicare versus commercial plans.
Okay. That's helpful. U.S. revenue guide for Q2, 18%-20%, was a little bit below what the street was modeling, even adjusting for some of the timing headwinds that you talked about. Help us understand kind of the improving sequential trends in the quarter and kind of gives you where the kind of Q2 factors.
Yep. First, you know, the first quarter performance in the U.S. and more broadly in the company was very strong. Growth in the U.S. was 28%. To your point, there was an impact of some order timing between Q1 and Q2, a more normalized growth was about $10 million, about 200 basis points. Think of it more of a 26% normalized growth. That's the first thing that when you look at it, Q2 versus Q1. Second thing is comps. Last year, the second quarter was the largest quarter in terms of growth for us, we're comping a very high base. I think importantly also, as our business continues to grow, you know, the percentage might be less, but more importantly, the dollars are sequentially higher.
Q2, we're gonna see another step-up in dollars in the U.S., vis-a-vis Q1, even if the growth rate is a little bit lower.
I think there's also people are looking at kind of the second half exit rate and kinda what that means for 2027.
Yeah. I really wanna spend a couple minutes there because I think there's a lot of questions, even as we've been here on the conference around that second half in the high teens, what does that mean for 2027? Do you have concerns on the ability to deliver on our LRP guidance? First, it's important to remind everybody, when we had our investor day last year and we provided a 20%, it's a CAGR, right? It's a CAGR for three years. This year we started with our guidance already above that 20%. The guidance was 20-22. We just delivered strong results in Q1 and increased the guidance for the year to now 22-24. Is that right? Yeah. No, 21-23, so midpoint 22.
We're already above the 20% that we had provided for the LRP. What that means is we believe the ability for us to deliver on that outlook is gonna be driven by catalysts and specifically innovation that plays into continuing to attract people from MDI into AID more so than a certain exit point in any quarter or any half year. I'd like us all to think about that as it's not linear. If you look even at what has happened historically with Insulet, when we launched Omnipod 5, our growth in the U.S. went all the way to 40%, and then it came down. Then we launched into Type 2, and the growth accelerated again. Last year, we almost delivered 30%.
It's really about the innovation catalysts that are gonna continue to unlock the Different levels of growth rate that you experience. As you think about this year, next year, and 2028, and how do we think about our innovation, let's say marrying it up to the growth that is gonna result. This year we're launching Omnipod enhancements to our Omnipod 5 algorithm. We're connecting with the Libre 3 sensor, which is gonna increase our serviceable market by, in the U.S. alone, 550,000 people. That's all about continuing to enhance the position that we have in the market with the current install base and continuing to attract people from MDI into AID.
Next year, you know, I'm sure we're gonna talk about there's new competitors entering the tubeless portion of the market with products not, in our view, as differentiated as Omnipod, but maybe, you know, an evolution of their own offerings. As they are coming into the market, we're gonna be launching Omnipod 6. That is a new hardware, with enhanced wearability, better connectivity, and also our third generation software update with better personalization, less bolusing, better outcomes. As competition comes into the market, we have innovation that is gonna continue to allow us to sustain our leadership.
Into 2028, that's when we're gonna launch our fully closed loop for Type 2, which I love to talk a little bit more about that, because we think about that innovation as another one of those big unlocks, similar to Omnipod 5 or similar to the launch of Type 2. That's really gonna accelerate above the normal, our growth rate. That's how we think about it. Yes, this second half, it's, you know, not gonna be higher than the first half if you just do the squeeze math. I wouldn't read too much into it in the sense of having concerns about the durability of our growth or the confidence and conviction of our ability to deliver on that 20% CAGR.
The highlight of it being a CAGR and not linear, that's more of a reflection of the kind of the second half of this year, right, not really a 2027.
Correct. I think, you know, this year, if you think about this year, the full year is already above that 20%, right?
Right.
you know, first half, second half of this year is different. you know, next year might be below the 20% and then next, you know, the year after might be above again meaningfully. I think it's important in MedTech especially, and we've seen this obviously in our category and in other categories, innovation does move the needle, and I think that's what I'm trying to make sure that people connect the dots.
Right. That's helpful. You mentioned expanding the sales force too. Is that something you're doing ahead of the competition, and kind of what we should see about the commercial sales force expansion on the revenue?
Yeah. We, we are expanding our sales force. It's the second expansion in the last 12 months, actually. We, we are doing it, less from, you know, preparing for competition and more from a, I'd say, a position of strength of continuing to invest in the category and driving that category penetration. This is one of the most important things, I think, to just remind everybody. AID growth is driven by moving people from the sidelines of MDI into AID therapy. 80% of the NCS are coming from MDI, not from, you know, me taking share from Medtronic or us taking share from Tandem or vice versa. In doing that, we need to continue having the ability to drive the category, to drive that penetration. That's the primary impetus for our sales force expansion.
It's not, you know, in anticipation or to defend against competitive entrants. In fact, the fact that other pump companies are gonna continue talking about AID, continuing to talk about the benefits of going from MDI, it's an opportunity for the category to continue expanding. Within that category, for the tubeless portion of the category to become disproportionate as other people try to have kind of patch-like products. Maybe the last thing to talk about as we think about the commercial expansion, why do we have conviction that it is the right thing to do from a returns perspective? You know, why isn't it diminishing in terms of cost to acquire? If you think about rapid acting insulin prescribers in the U.S., there's about 450,000 of those.
About 100,000 of them are the ones that really matter, the ones that are, like, 80%, 80/20, 80% of the volume of prescriptions are concentrated on 100,000 physicians. 40% of those have prescribed an AID device in the last year, so they are familiar with AID therapy. They believed in it. They are comfortable with it. We only call on 25% of that 40%, and our sales force expansion now is gonna allow us to go from 25% - 30%. There's another 1,500 physicians that we're gonna now be able to call on that see another 150,000 people that are eligible for AID therapy.
The impetus or the rationale for the sales force expansion is to continue to be able to increase our reach and frequency and continue to drive the category as we have done for the last five years and growing above the category and bringing people from MDI into AID.
full. Pricing and pharmacy as more competitors move into the pharmacy channel, can you help us understand why that's not a risk in what you're seeing?
You know, we've pioneered the pharmacy channel almost 10 years ago, and made it really a lot easier for people to start on therapy and for prescribers to get their patients on therapy. As other competitors start entering the channel, whether it's twiist last year, you know Tandem announcing that they're gonna move some of their install base, what we've seen is, I would say discipline behavior as they enter the channel. Where they're setting up their WAC, which is, you know, think of it as the price, the list price, is consistent with where our WAC is. It's slightly discounted, for a, I would call it a less differentiated product, which makes sense.
The level of discounting that we've seen from their disclosures, it's consistent with the discounting and the rebating of the category. We have not seen any behavior that would suggest significant discounting. Our price was actually positive in the first quarter as we said, and we expect it to continue. I think importantly, Travis, as they entered, it's important to think about how the dynamics happen in the channel. First and foremost, we continue to be the driver of volume into the category, into that channel. We win in the end at the doctor's offices. We are winning 2/3 of the prescribing that is happening.
We're the number one most requested and most prescribed AID system, as long as we continue to do that, we're gonna continue being the primary driver of volume into that channel. I think our innovation and what I just spoke about is what gives us the confidence that we're gonna continue winning the physicians' offices. Then in addition to that, as they enter the channel, they're entering in a place where we are multiples bigger than they are. You know, if you think about the dynamics and how you get into formulary and trying to displace competition, it would be very difficult, you know, to sort of buy their way to disadvantage us, if that makes sense.
Of course, they have a good tailwind as they change from their DME channel into the pharmacy channel, some of the same benefit we saw when we did that. Other than that, what we have seen in the channel so far, it's a very, you know, as we expected, disciplined way to enter pharmacy.
Then on the competitors launching patch pump in 2027, starting to close the gap on form factor, what are you trying to do to continue your win rate of new patients?
Yeah. I think, you know, the fact that they're trying to come into where we have demonstrated, is where patients and physicians with the type of product that wins, which is a fully disposable, a non-priming, you don't have to charge, automatically inserted device, it's a little bit of I would say a reflection that the jury has stated that the form factor that we offer is the preferred, most desirable offering in the marketplace. I think they folks finally decided to, you know, acknowledge that they need to try to close the gap as close as they can with us. In, in trying to do that, one is, from what we see, the offering is not as they try to move closer, it's not closing the gap fully.
As they try to get closer to us, we continue to distance ourselves from even our current offering today. We're doing already enhancements in Omnipod 5 with 100 set point as well as changes into the algorithm to keep people in automated mode longer. In our limited market release, the feedback has been really positive, and we have shown in a study that by just changing the 100 set point, you can get a five-point enhancement in time in range. Even as at the current chassis, if you will, hardware, with an enhanced algorithm, we are already improving. Next year, we're gonna launch Omnipod 6. At ADA, we're gonna review our STRIVE data. Omnipod 6 is both enhanced hardware and another software algorithm enhancement.
It's gonna drive more personalization, as I said. It's gonna require less boluses, better outcomes. As they're, let's say, trying to close the gap, we keep advancing our own offerings and our innovation to ensure that that separation remains in the marketplace. We feel very confident that our pipeline is differentiated and is gonna continue to allow us to win.
On the fully closed loop, you're closing the loop, you know, I think 2028. Other companies are trying to do the same thing. What makes your algorithm continue to get better and differentiate itself?
Yeah. I'm glad you asked the question because I think first it would be helpful to maybe talk a little bit about what fully closed loop really means. There was a lot of discussion at ATTD, which is a diabetes conference that just happened in Europe, about other people speaking to what they call fully closed loop systems and fully closed loop in Type 1. We get questions, "Why are you doing Type 2 only? Are you late?
Why don't you have an offering for Type 1? The first thing that I would say is what others are calling fully closed loop, we believe are actually enhanced bolus optional, but still hybrid loop system, closed loop systems, which means you still have the ability to bolus, you still have to have settings before you start therapy, which is what we're gonna be offering also with Omnipod 6. We see our innovation on hybrid closed loop systems continuing to be competitive as to what other people are calling fully closed loop systems. Now, our Type 2 fully closed loop system that will launch in 2028, it's truly different. What I mean by that is there is no setting, physicians don't have to tweak with the device before a patient can start.
They write a prescription, the person with diabetes or patient goes to the pharmacy, picks up the device, starts on their own. They can get trained, you know, on their phone, on their homes. They put the device on. There's no meal announcements. There's no bolusing. The device doesn't even allow for bolusing. Think of it as, you know, we use this analogy of a Waymo versus a Tesla. It's like you do not drive at all as opposed to kind of drive assist. The reason why this is important is, especially for the Type 2 population, 70% of the folks that have Type 2 that basal and bolus, they're seen by PCPs, primary care physicians.
Primary care physicians, they, you know, going back to our expansion of the sales force and what is it gonna take to continue to unlock that penetration, they are not gonna start Type 2s on pumps if they have to do a heavy lift to set them up. They are not comfortable with the technology. They are not gonna know to do all those settings. Having a device that is as easy as CGM to onboard is truly what's gonna unlock that big TAM, you know, that total addressable market, to become a serviceable market, to allow us to actually have prescribers be comfortable prescribing and Type 2s, you know, being easy enough for them to onboard. That's why we think that's another sort of S-curve inflection point when we launch that truly differentiated product.
Just as, you know, a reminder, we presented some data from our feasibility study at ATTD on the fully closed loop. It showed a ime in Range increase of 24 points from starting an MDI, getting people to time and range of 68%, which is truly, you know, compelling for very, very little effort and interaction.
On the LRP, you called it 20% CAGR, but Omnipod 6 is 27%, fully closed loop's 28%. How should we think about the cadence of that 20% CAGR?
Yeah, that's what I was talking about a little bit is it's not linear, right? You asked me about the exit of this year, you know, in the second half, so if it's in the high teens, what does that mean for 2027? You know, it means that maybe 2027 is below the 20, and then it re-accelerates in 2028 as we launch, you know, additional innovation. That, again, is consistent with what we've seen, you know, you've seen us do in this space. You know, with Omnipod 5 launch, really accelerating growth, a little bit of a, you know, slowdown in 2024, re-accelerating in Type 2. I think when you look over the last 10 years, we have had 20% or better growth for 10 years in a row.
In addition to the innovation that we're delivering, it's really the fact that we're still in a very under-penetrated category and the fact that that innovation does allow the category to be unlocked. It does allow people to move from MDI into AID, and that has been what the history has shown and what we expect to continue.
Okay. Helpful. I think earlier I meant to ask about retention 'cause it was another topic on the call. If we can just touch on that too.
Yeah. We talked a little bit about that, you know, retention, or said it differently, attrition. You know, as we launched into Type 2 last year, we had a hypothesis that attrition for Type 2 was going to be a little bit higher than Type 1, and we are seeing that happen. I think importantly, it's not different than what we expected. It's playing out pretty much as we expected. As our install base of Type 2 grows, attrition could become higher for overall. I think two important things. One is we're not standing still, right?
As we see this attrition in Type 2, being higher than in Type 1, We're putting in place several interventions to help minimize the impact of attrition in Type 2. What we have seen is it's more pronounced in the first 90 days. It's when they're getting used to the device for the first time. They're doing the first pod change. They're learning how to use it.
We have, and we're using a lot of AI insights to help have a more proactive outreach to that Type 2 population to reach them as they are getting these critical moments, and we are seeing some really good traction in using predictive tools to interject or interfere, you know, before they attrit, and then remediate that or, you know, hold to them and not let them attrit. W hat we have had with some pilots late last year is really substantiated that the value proposition of those interventions, and we're amping those into 2025, 2026, excuse me. The other thing also is even as Type 2 in the U.S. has slightly higher attrition than Type 1 in the U.S., we're actually seeing Type 1 internationally get a lot better.
That is a result of moving from DASH into Omnipod 5 and seeing that stickiness of Omnipod 5 really delivering. For total company, as we look at attrition or retention inversely, it's actually very stable. It was stable last year, and what we're seeing is stability again in 2026.
Okay. Thank you. On margin expansion, 100 basis points a year, is just maybe kind of the levers to get to the 100 basis points. Is there upside to that? Is it more in gross margin or OpEx?
You know, we have a what I would say or describe as a very compelling financial algorithm. When you're growing, you know, 20% and you have best-in-class gross margins in the industry of above 70, you know, it puts us in a great position to be able to do both, to deliver compelling margin expansion of, you know, 100 basis points per year as we guided and continue to make meaningful investments. To your point, where is the expansion is gonna come from? We expect gross margin to continue to moderately increase, you know, even now above 70%, and with a top line growing, you know, 20%, you can get a lot of margin expansion even You know, this quarter we grew R&D 50%, and we still deliver compelling margin expansion.
That algorithm works really well when you have strong top line, compelling gross margin, and it allows you to continue investing to drive that top line and deliver that margin expansion and free cash flow, at a very, you know, compelling pace.
Yeah. I wanted to kind of go back and touch on the U.S. new patient starts. We are estimating they were up high single digits year-over-year, which is sequentially a decline low double digits, which slowed down in the year-over-year growth rate. Just understanding kind of what drove that slowdown in Q1 on new patient starts, then how to think about new starts in Q2, Q3, and Q4 this year.
As we talked, we started the discussion talking a little bit about that seasonality, so that is, to your point, the sequential decline in new patient starts. To your point, still, you know, high single-digit growth year-over-year in the U.S. Very strong growth in Type 2 in the U.S. year-over-year. Little bit, you know, flattish to down in Type 1. Internationally, still very compelling growth year-over-year and sequentially. The seasonality that we talked about was very much a U.S. phenomena. That puts us in a really good position. You know, year-over-year growth in NCS for total company was still very healthy.
We think as the seasonality, you know, doesn't continue into Q2, that we're gonna go back to continued strong growth year-over-year and accelerated NCS through the year.
Type 2 new starts specifically, I think we're pretty similar in a down quarter-over-quarter, but little more seasonality. How should we think about Type 2, especially as you face tougher comps?
Yeah, Type 2, to your point, was maybe a little bit more seasonal in terms of sequential decline versus Type 1 in the U.S., and that's a little bit of that discussion we had on Medicare. Type 2 population is even more indexed, if you will, on the Medicare channel. In Type 2, year-over-year, we saw a very, very strong growth. If you think about it, last year was the first year of our Type 2 indication in earnest, and on that, you know, high basis of growth last year, we still deliver very compelling growth. We feel really good about the Type 2 continuation as a segment and source of growth in NCS for us going forward.
Internationally, just touch on how you're balancing kind of investments in the U.S. versus internationally and how to think about OUS growth.
I'm glad you asked about that because I think a lot of times people don't give credit to international. It's all about the U.S., our international business is, you know, doing incredibly well. Third quarter of above 40% growth. Some of that is price mix realization benefit, which we'll modulate as we continue to, you know, move our DASH install base into Omnipod 5. We're about 65% through that, so there's still runway to get that price mix benefit realization. The preponderance of the volume has been and will continue to be volume. The business is very, very healthy.
We continue to see, even in the markets where we had launched the longest, like the U.K., we had record new patient starts, in the U.K. as NHS continues to expand, not just access, but funding to get people into AID. We continue to see, access gains in newer markets like Canada, where we have expansion of coverage in two provinces. We have new markets that we're gonna enter, like Spain, that we're gonna launch later this year, Travis. We feel really, really good about our performance internationally, and I think importantly, a lot of times people don't give credit because maybe the market, you know, people think it's not as financially attractive.
The margins that we have internationally are very healthy and, you know, you saw us expand margins last year, even as the growth internationally was much higher than the growth in the U.S. It shows that ability for us to expand margins even as we grow more outside of the U.S. than in the U.S.
All right. I think we're out of time. Thank you.