Insulet Corporation (PODD) Earnings Call Transcript & Summary

February 27, 2020

NASDAQ US Health Care Health Care Equipment and Supplies conference_presentation 25 min

Earnings Call Speaker Segments

Danielle Antalffy

analyst
#1

Okay. Good morning, everyone. Thank you so much for joining us. My name is Danielle Antalffy. I'm one of the senior medtech analysts here at SVB Leerink, and we are very lucky to have with us Insulet management team. We have CFO, Wayde McMillan; and we have CCO, Bret Christensen. We also have Deb Gordon, Head of Investor Relations in the audience there. We're just going to launch into Q&A. This is a fireside chat format. If you have any questions, feel free to raise your hand, and we'll get a mic to you. So guys and gals thanks for joining us.

Danielle Antalffy

analyst
#2

Why don't we start. You guys did just report earnings, Q4 earnings on Tuesday night, and you did issue guidance of 14% to 18% for 2020. And I think one of the questions I've been getting as it relates to guidance is sort of it feels conservative. Just trying to get a sense of what's in the guidance. It feels like there's a lot of momentum in the business. It doesn't feel like anything structurally changed that would drive a slow -- any sort of meaningful slowdown after putting up, I think, what was it like, 30% growth in Q4. So maybe talk a little bit about what's driving the guidance. How much of it is conservatism versus something you're seeing in the business that maybe people aren't aware of?

Wayde McMillan

executive
#3

Yes, sure. Good morning, Danielle. Good morning, everybody. So I think one of the -- well, first of all, we have a lot of momentum in the business. Our business is strong. We have a lot of catalysts, many of which was the strategy in the making for the last several years that really started to take hold in the second half of last year. The largest drivers are our biggest new innovation with DASH, our move into the pharmacy and the Part D designation and then our pay-as-you-go model. That's very disruptive and really changing the market paradigm for both type 1s, but in particular, type 2s. Having said that and just having an opportunity to speak with people now since the call, getting this question a lot, one of the things that people miss the most or really just didn't quite understand was the drug delivery piece of that 14% to 18%. So what we've started with -- for people is just getting to understand the Omnipod, the really core driver of our business. And the guide there is 18% to 22%, with 20% at the midpoint. So we think that's a very strong guide for our Omnipod business. And just highlighting for people that the drug delivery side of the business for us is really controlled by our partner. We don't have any impact to the end-user sales or end-user market there. We are just an OEM manufacturer of our pod for our partner there. So our forecast is basically dependent upon their ordering patterns and their forecast. So if you set drug delivery aside and focus on the Omnipod piece of the business, we think it's a very strong guide because we looked at last year and said, if we can grow similar dollars, it's what we did in a fantastic year last year, then we'll put up a good year. And what we weren't going to do is put our guidance at a trajectory off of last year. If we talk about the U.S. business, in particular, we had record new patient starts every quarter for 4 quarters. And we weren't going to drive trajectory line and say that's momentum. We think momentum for us is a business that's growing in the 18% to 22% range. Again, 20% at the midpoint on a business that's approaching $1 billion. So we feel if we can grow the same dollars as last year, that will put us at the high end of the range. We do have a lot of strength and the momentum you mentioned, Danielle, that could put us above that range. But it's early in the year. It's a very similar setup that we had last year, and we'll see how the year progresses.

Danielle Antalffy

analyst
#4

Okay. That's fair. Just if I could follow up on that. So as it relates to the 18% to 22%, it would -- doing the math, the numbers would assume a pretty -- I don't want to say meaningful, but a slowdown in new patient adds. So much fewer new patient adds this year versus last year. And I guess, just given the shift to the pharmacy, given the fact that 30% of your new patient adds, I think, was the number in Q4 came from type 2 patients, which is phenomenal. Why would new patient adds slow down so much? There's still a lot of penetration to go in this market.

Wayde McMillan

executive
#5

Yes, I think it's exactly what I said. We're not going to draw that trajectory line and say that we're going to continue to accelerate from here in guidance. Our strategy certainly is that we hope to continue to accelerate. We have many factors within our strategy that should give us the opportunity to do that. We're just not going to guide at those levels.

Danielle Antalffy

analyst
#6

Sure. That's fair. So it's more like, I guess, some of the concern is around always the low-hanging fruit. Have we reached sort of near-peak penetration? And I -- my answer is, no.

Wayde McMillan

executive
#7

Yes. Why don't I start that one and then I'll hand it off to Bret, just from a guidance perspective, and then I'm sure Bret will weigh in on the market dynamics. But our -- I'm glad you brought this one up. It is early days. We are 6 months into significant changes to our strategy. It is early days for our patch pump design really with a new product launch in the middle of last year, really being very competitive in this marketplace. And then there's a lot of drivers in the market, getting people more aware of their glucose levels and looking for better control, and we want to be the best answer for those people.

Bret Christensen

executive
#8

Yes. And I think we've been very deliberate in calling out certain things with new starts. We have called out record new patient starts. So again, on this last earnings call, we called out record worldwide new patient starts or new starts. We've also got really more specific with type 2 because that we -- that's something we've talked about now for 3 quarters in a row. It's a trend that is positive, and we were specific with that 30% on the call, just to give you an idea, but that is something that we think is sustainable. This -- we're still trying to assess the true demand there because what we did for years, for tens of years as we conditioned physicians to not even talk about pumps or pods with type 2 patients because they knew they weren't going to get access to it. There were too many restrictions in the DME channel. And so what we're seeing is probably the true demand for type 2 just in the endocrinology offices and things that we call on. So it's encouraging, and we think it's sustainable.

Danielle Antalffy

analyst
#9

Yes. Okay. That's great. One other question, while we're on this, what questions have we been getting since the earnings call, on COVID-19 and the impact there. And you guys did talk about this, but I think what folks are trying to get a handle around is, is there any risk to the guidance? Or do you feel like this is very much under control and reflected in the guidance from a supply perspective, you obviously don't sell into China?

Wayde McMillan

executive
#10

Yes. So no impact to the guidance at this point. What we said on our earnings call on Tuesday was that we had sufficient inventory going into the quarter. We are lucky enough to be one of the people in China that has our employees ramping up at the plant. We are manufacturing at the plant. We're shipping, and we also have our U.S. manufacturing with our first-line ramping up here in the U.S. So that's providing us some redundancy already. It's still early in that line 1 and the yield coming off that line, but it is starting to contribute. So between our China manufacturing ramping up, our U.S. manufacturing starting to produce and the inventory we had, we feel confident at this time. As Shacey said on the call, our #1 concern is our employees there and our people traveling. And so we're monitoring that very closely. We're also monitoring our ramp-up over time. It is a day-to-day thing. Our team is very focused and working with our third-party manufacturer, literally, daily. We have a very strong team here, experienced team working it. So that gives us the confidence that we'll be able to continue to ramp in our third-party facility. We'll continue to ramp in the U.S. and gives us the confidence that we'll be able to manage through this. Having said that, I don't think anybody really knows where this thing is going to go over time. And so we just have to continue to manage it literally day-to-day.

Danielle Antalffy

analyst
#11

Right. Okay. I guess another way to ask this question. Well, first of all, so to know your manufacturing is open and running right now in China and not shut down, yes. So another way to ask the question is, how much supply, like based on your guidance, do you have supply through Q1? Do you have supply through the first half of the year?

Wayde McMillan

executive
#12

Yes. We didn't provide that on the earnings call. We're not going to update that at this time. We're just managing it. And we believe, based on our current ramp and where we're at that we'll be able to manage through it.

Danielle Antalffy

analyst
#13

Okay. Great. So you do have a new product launch coming up here. And late this year, early next year, it sounds like Horizon. So another thing that I think folks are trying to get a handle on myself included is, how to think about the incremental ramp with Horizon to be your first truly integrated system with the CGM? We saw one of your competitors, when they launched an integrated system, they saw a big step-up in new patient adds. Is that something that can happen with Horizon? I know it's off a much larger base. So curious how to think about the contribution from Horizon. And it sounds like, is there anything in 2020 guidance for Horizon? Or that's really a 2021 contributor?

Wayde McMillan

executive
#14

So I get the last piece, maybe guidance, and hand it over to Bret. So we do not have a large step-up from Horizon in our guidance. We're planning to launch it in the second half of the year. It will be on a limited basis to start like we typically do. So we don't have a large inflection in our guidance for 2020. And when we do get to that full market release then we'll include it in our guidance. So depending on when it is in 2020. But Bret maybe...

Bret Christensen

executive
#15

Yes. And we're obviously excited about Horizon, right? We've talked about some of the features that it will add that we don't have today the algorithm on the pod, phone control, which effectively eliminates one component of the system. It will still be a pay-as-you-go model, right? In the pharmacy channel, the strength of that algorithm, the integration with Dexcom, you see there's a lot of boxes that it checks today. We know today with record new patient starts, why users have chosen Omnipod. And we even get some good research on why maybe they didn't, right? And so what excites us about Horizon is that it checks some of those boxes. The real -- yes, sure. So DASH actually added a lot of those checkbox right. Our #1 request for years was a touchscreen display that looks like a smartphone device. We check that box with DASH. CGM integration, of course, is a big one. And the CGM utilization has increased in the U.S., particularly in worldwide. Those patients have overcome some obstacles of wearing a piece of technology on their body, and now they want it to talk to their Omnipod. And so we're excited about those features. We haven't guided to anything, obviously, about what it means to growth. But certainly, it's checking a lot of the boxes that we don't have today, and so we're excited about it.

Danielle Antalffy

analyst
#16

Got it. Okay. So as it relates to -- let's talk about the overall market. And I think that's another thing that folks want to get a handle on because you've got the insulin pump market, you've got the CGM market. It feels like the CGM market, it's like sky is the limit apparently. For the insulin pump market, it does feel like that's a more sort of discrete market. Can you talk about where we are from a pump penetration perspective today? I'd love to take this to type 1 versus -- and then separately type 2. So let us first talk about type 1s where peak penetration can truly go in this patient population. And what are the barriers that do still exist that need to come down to get to that peak penetration?

Bret Christensen

executive
#17

Okay. I can start with that, and Wayde can add. But I'll start with the barriers, right, because we've been getting this question a lot lately. And I think it stems from, why isn't everybody on pump or pod, right? And why is penetration not higher? And it's a good question, but it's a question we didn't get a lot years ago because -- and I think because it was understood. And pumps and pods were for a certain segment of users. So for type 1 patients, we'll start with -- pumps have been around for 30-plus years, right? And we still talk about penetration within the type 1 market being around -- probably north of 35%, right? And the question comes from, why isn't everybody on these cool pieces of technology that come out? Well, those pieces of technology are new, right? Some of what we've done with innovation is new. So there's 3 obstacles, I think, to penetration. One has always been cost, and that's been the one that everyone is excited. So what we did with DASH with removing the upfront fee, moving to a pay-as-you-go model has been instrumental. So patients now have a predictable co-pay, the way they do with their prescriptions, with their insulin, with anything they get from a pharmacy, that's been the key. Technology has been lagging in this industry for a long time, but moving very quickly now. And so as we talk about DASH and with Horizon in the future, we're checking some of those boxes. And then the third one is just awareness. So where can it get to for just type 1s? What I'd like to point to is the pediatric segment because type 1 patients are diagnosed at a young age. Today, more than half of pediatric patients are on a pump. We lead in that segment of the industry. So we're the leader in pediatrics. And I think that as technology improves, you'll see more and more patients, as they are diagnosed, move to pods and pumps more quickly. And that's a -- it's an indicator where it will go. So if more than 50% of those patients are already on a pump of some kind, as they age, will exceed that 50%. So I don't know where it can go, but certainly, as technology improves, as costs come down, and then as we generate more awareness, you'll see penetration move much more rapidly.

Danielle Antalffy

analyst
#18

Got it. And just on the pediatric. So if there's over 50% of patients are -- pediatric patients are on a pump, but then pump penetration overall is something like 35%. Why does the peds, as they age, drop off a pump? I mean what's causing that? And can...

Bret Christensen

executive
#19

Yes. I don't think that they do. I mean certainly, some do, right? But I don't think it's a trend that they drop off. I think that it's that they didn't adopt patients who are our age, right, when we're diagnosed did not adopt pump therapy. And as you get into a routine in diabetes, you don't want to change. And so you have to be -- really significant technology changes to get an older patient that's used to MDI to move to this technology. And so that's why I think what's happening with pediatrics is they're getting on pumps and pods, and they're staying on it, but they're younger, right? And so they'll -- will grow into that.

Danielle Antalffy

analyst
#20

Okay. Got it. And then -- so type 2s, that's been a big success story. I think safe to say, surprised you guys to the upside, the interest in type 2 so early, maybe tell me if I'm wrong there. But where can we go in the insulin-dependent type 2 market?

Bret Christensen

executive
#21

We've always thought our product is a great product for type 2s, right? And as we look at the research and as we understand what type 2 patients want, they love discretion. They want ease of use. We've always thought Omnipod was a best-in-class product for those things. There has not been a lot of demand that we've seen, and that is because, again, all of these restrictions that exist with type 2 patients. So that's a really underpenetrated market, low single digits in the U.S., less probably outside of the U.S. But we know the product is good. We know that patients would try it, it's just there's been these restrictions. So 2 key things happened for us over the past 1.5 years or so. We got a CMS decision that was a Part D decision saying, one, we can finally get Medicare reimbursement. We were the only pump on the marketplace that didn't have that for years. That's key because 40% of type 2 patients are over the age of 60. So without Medicare, you're already -- limited yourself. And then just these barriers that have existed in the durable medical equipment channel of C-peptide test, BG logs have really restricted type 2 patients from getting any type of pump. So the move to pharmacy, there aren't those barriers. type 2 patients are treated just as type 1. And so what's exciting for us, Danielle, is we're starting to see the true demand for -- again, for the limited awareness that we have within our call points. Physicians are getting comfortable that if I write a prescription for a type 2 patient in pharmacy channel, they're going to get on Omnipod. And so that's why we've called out the 30%, and we're really excited about what that could mean.

Danielle Antalffy

analyst
#22

Is there any difference in the characteristic of a type 2 patient versus a type 1 that you're getting? So you're obviously very successful with pediatrics, the type 2s are usually adult, I think. So -- and also from a utilization perspective, any difference you're seeing between the 2?

Bret Christensen

executive
#23

Yes. Probably too early to talk about utilization, but this is the one thing I'll say about type 2 patients is, it's more difficult to bucket type 2 patients and say they're different, right, and they progress in their disease. And so we segment that group by insulin intensive. Those are the patients that need basal and mealtime insulin in the same way that type 1 patients feel. And so that's the target market. They reside in different places. Their needs vary. The #1 thing they say they want in a piece of technology is phone control, makes a lot of sense. And if you think about what you would want, you'd want to put a pod on and you want to operate it from your smartphone. You'd want to deliver bolus when you're in a meeting as you're checking your e-mail. So that makes a lot of sense, but they do vary. But again, we're excited with what our current offering offers them in that pharmacy channel, and we'll see where it goes.

Danielle Antalffy

analyst
#24

Okay. Let's talk about international a little bit too, also an underpenetrated market. It feels like a stickier market, too. I think attrition is lower internationally. So where are you guys from an international perspective, and specifically, as it relates to 2020 and the guide internationally? And where can that market go?

Bret Christensen

executive
#25

Yes. So we're in a limited number of primarily European countries today. What we have said is that we want to start expanding internationally in earnest really this year. We will enter probably 5 markets this year in the later half of the year. It won't mean as much to our guidance and revenue early on because remember, we're this annuity model. And so we're not taking a lot upfront from Omnipod. We've just got to build a user base that will add to revenue in a predictable way over time, but there's a large opportunity internationally. I just got back from ATTD in Madrid last week, and I can tell you, I mean, there's distributors everywhere that want to sell Omnipod, but we've got to do it in the right way. So we talk about the commitment that we make to a user for life. We don't want to get into a situation where we're launching Omnipod and point out of a market. So we're making sure that the reimbursement landscape is strong, that demand is there. We've got good partners if we go into a distributor market. But you're right about attrition in that many of the payers outside of the U.S. are governments. And so when you get diagnosed and you get reimbursed, that's a more predictable reimbursement over your lifetime. You're not switching from private payer to private payer as you are in the U.S. And so we do see attrition as lower outside of the U.S.

Danielle Antalffy

analyst
#26

And the international model, are you giving DASH away in the international market? And how does -- is that also a pay-as-you-go?

Bret Christensen

executive
#27

It will vary. But we would love to do pay-as-you-go everywhere, but there are restrictions outside of the U.S. And look, we couldn't even do it in the U.S. for a long time. It requires change with many of the market access landscape. So we'd love to do it. The reality is they vary. And so we'll adapt to whatever payment model is in place, and we'll work towards pay-as-you-go over time.

Danielle Antalffy

analyst
#28

Okay. And then as far as kind of -- one more question on international. As far as coverage goes, are insulin using -- is it all insulin using patients get coverage for pumps? So I guess my question is, do you have access to the type 2 patients internationally, too?

Bret Christensen

executive
#29

Varies by market. And -- but I will say it's generally, right now, less access for type 2 patients. So especially if you consider what we've got in the pharmacy model in the U.S. today. So that's something we need to work on establishing outside of the U.S.

Wayde McMillan

executive
#30

Which means it's really similar to the U.S. where type 2 has really had a challenge getting a better solution than MDI. And so I think we're -- as Bret said, we're being very systematic about the way we're looking at entering new countries because we can just enter in the same reimbursement structures that are there. But if we take our time and help the payers understand our value proposition, especially with the pay-as-you-go model, we're really just like we're changing the market paradigm in the U.S. We're potentially changing the market paradigm outside the U.S. And so it's slower to come into those countries, but if you get the right reimbursement structure, then we'll have -- over the long term, we should have a better gross margin profile.

Danielle Antalffy

analyst
#31

Got it. Another question on guidance because you do have a few new -- in the market, new product launches. So you have Horizon, you have one of your competitors that's launching a pump now. You have another competitor that expects to launch a pump at some point this year. And one of your competitors did call out a pause ahead of their new product launch. And I'm just curious, what you guys have reflected, if anything, in guidance? And is that something you normally see when you're launching a product or ahead of your product launch a sort of market pause where patients, I guess, are waiting for the new technology?

Bret Christensen

executive
#32

Yes. Well, so our first chance to experience that really was with DASH, right? So when we launched DASH last year, there was a chance that patients entering into DASH could have said, you know what, I'm going to hold off on DASH or I'm going to hold off on our legacy Omnipod because I know DASH is coming, right? And we did a pretty good job talking about this pay-as-you-go model, talking about the removal of these restrictions in the lock-in period that started in earnest with DASH. And we didn't see that pause in new starts. And so that was encouraging. I don't think we'll see it with Horizon as well because, again, in a pay-as-you-go model, regardless of when you've got DASH, that shouldn't have any implication on when you get Horizon. We're not billing that large upfront fee to payers. Before, there's not that lock-in period. And it's just a matter of how well we educate current users and new starts on that option so that there isn't that pause.

Danielle Antalffy

analyst
#33

And another thing that I get -- that I think gets lost sometimes is, it feels like Insulet is less exposed to competitive product launches than others because the product is so differentiated. Can you talk about how many of your patients are new to pump therapy entirely versus competitive switches? And have those numbers or has that trend changed at all over the last 2 years?

Wayde McMillan

executive
#34

Yes. That's, I think, a helpful way to think about it, the way you're laying it out, Danielle, in the sense that we haven't seen it to date. As Bret said, either when we've launched a product or certainly in Q4, to your previous question, we didn't see it. We had a very strong quarter. And some of the metrics from Q4 that help us understand that is our number of new patient starts coming from MDI. So new users actually went up a little bit in Q4 to 80%. And then our growth in type 2s is now 30% of our new patient starts, and that's really where we have a differentiated option for them. And we don't really compete with the 2 pumps on that side of it. So most of our new patient starts come from MDIs. And we know we certainly haven't seen historically our subject to tube pump renewal cycles because, again, most of our new patient starts. We're really growing the market, right? We're providing a better -- Bret talked earlier about tube pumps have been in market for 30 years. We're not trying to focus our strategy on converting tube people to patches. We're looking at people who are still using multiple daily injections, and it's a really challenging solution to their disease state. And we're trying to provide a better solution for that. So that's why I think our focus in most of our new patient starts are coming from MDI and growing the market with a larger percentage now coming from type 2. I mean we're really excited about it, but we talked about early days before. I just want to highlight the strategy that was put in place 3 or 4 years ago, was built into the innovation cycle, and what would be the new product with DASH, and to be launched Horizon. We're a little over 9 months into DASH. We're a little over a couple of quarters into the pharmacy, and the new pay-as-you-go model. So the strategy that was designed to go after better solutions for type 1s, but to open the larger piece of the market type 2s, we're only a few quarters into that. And so we think we've got a long runway here. We think we've got a lot of strategic moats built into this as we build it. So we're pretty excited about what's in front of us.

Bret Christensen

executive
#35

Yes. And Danielle, we do get some insight into patch pump competition outside of the U.S. There are some out there. And I think what it does for me and the benefit for being -- for owning the international business is that we see those competitors, we see them launch. We see the effect they might have or might not have. It gives us an appreciation for the moats that we have built, how difficult it is really to build a patch pump, to scale with it, build it at quality, and something that's [ easy ] for use. So we have some insights, and that's a good thing. So there will be some competition, but again, it's a really hard thing to do, and we're happy with the moats that we've built.

Danielle Antalffy

analyst
#36

All right. And with that, it looks like we're out of time. So thank you, Bret, Wayde, Deb very much. Thanks, everyone.

Bret Christensen

executive
#37

Thank you.

Wayde McMillan

executive
#38

Thank you, Danielle.

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