Insulet Corporation (PODD) Earnings Call Transcript & Summary
September 14, 2020
Earnings Call Speaker Segments
David Lewis
analystWell good morning everyone and welcome to the Morgan Stanley Healthcare Conference. As we progress through the morning, I am coming to you live from San Francisco. I love saying that. I'm probably going to say it several times during the next several days. But thank you all for joining us. It's a pleasure to be moved to the morning to have with us here another medical device company, Insulet. As many or a couple of you know, we have multiple members from management with us from the company, including Shacey Petrovic, their CEO; Wayde McMillan, their CFO; as well as Bret Christensen, their EVP and COO. You didn't know this, but Shacey has promised exciting updates throughout this presentation. We're super excited to hear some of these updates, and we'll get to it in a second. As you've heard me say, please look at the Morgan Stanley website under Research Disclosures to see interesting funs and facts about myself. With that, Shacey, the floor is yours. I'll turn it over to you for a brief preamble and then we'll get into it.
Shacey Petrovic
executiveGreat. It's so good to be with you today, David. As you noted, the momentum behind our business and our team and some of the progress that we've been making on our strategic imperatives has remained strong at Insulet, even in the face of our current environment. And so today, I know you and so I know that we will hit all of these areas, but we do have great updates across clinical, across our international expansion objectives, even across manufacturing and commercial. And so I'm thrilled to be able to talk about those areas and some of the great things happening here today and great to be with you.
David Lewis
analystGreat. So let's start with the more mundane. Maybe you can let Wayde speak a little bit as we try to keep him cozy as much as possible. Let's talk about the COVID recoveries where we're starting most of our companies this conference. So how are you -- the relative guy, how are you tracking relative to that sort of 30% update you provided last quarter for sort of the third quarter? You gave very specific guidance for the third and the fourth quarter, both U.S. and international. I just want to get an update on sort of how we're tracking relative to those expectations.
Bret Christensen
executiveYes. Dave, I can start with that. Wayde, you could chime in if you want to add something here. But we -- we guided to -- well, first of all, we had a strong guide for the year, and we didn't say what our new patient start guide was for the year. But when COVID hit, we anticipated a slowdown in new starts. In our earnings call, we talked about a reduction from what we thought at the beginning of the year of about 30% to 50% in Q3 and then improving to about 25% below our initial projections in Q4. We are seeing some really encouraging signs across both the U.S. and the international markets. We're tracking really closely the interactions that physicians are having with patients. We noticed still that many of those are telehealth, so about 30% or so are still via telehealth. And all that means is that the world is not normal for us. So there's still some hesitation from physicians to change therapy. And as you know, David, about 80% of our new starts come from MDI. That's a jump in change of therapy from MDI that physicians -- some physicians still might be hesitant to take on during this time. But we are encouraged by the trends, and we do see it improving throughout the year.
Wayde McMillan
executiveYes. And I can help tie that up. Bret and his team are closest to the customers and the physicians, and so it's good insight, Bret. David, if you take a step back, look at the full year, given the guidance that we've provided, it would put us at about 65% to 70%, 75% of our new patient starts for the full year. And that will still be about 20% growth for the year. And so we're not going to get all the new patient starts that we had planned. We're certainly facing a headwind here. And as Bret said, maybe taking down a more micro level, April was the low for us. We saw improvements through June and July in our call and early August. And it's only been a few weeks, so we're not going to provide an update from there. But our guidance shows a continual improvement, 30% to 50% in Q3. And what we talked about is the only way it looks like 50% in Q3 is if it looks like Q2, we're ahead of global lockdown. And of course, we didn't know when we set the guidance what Q3 was going to look like. We sit here in better shape today. And then Q4, continued gradual improvement, as Bret said, to 25%. And I'll just close by saying, we don't know where the pandemic is going. We do see fits and starts across the globe in different countries. Even in the U.S., we see some states opening and then some more challenged. And so at the end of the day, we put these stakes in the ground so that everyone can understand our business model and that we have something to speak to when the actual results come in. That worked well for us in Q2. We came in right at the low end of our global range. Hopefully, Q3 continues, and we can do the same in the Q3. And as Bret said, however, there are still headwinds. Based on the dynamics in the field, we don't think that we're back to normal until we get beyond 2020.
David Lewis
analystOkay. So you've seen steady month-over-month improvement it sounds like. We're not back to normal, but the improvement trend has continued here into July and August.
Wayde McMillan
executiveYes. Through our call, we're not going to provide any updates from first week of August yet because it's only been a few weeks from then, and it's too dynamic to tell. As I mentioned, even in a particular state in the U.S. where we see improvements and our reps are getting access back to physicians and things are starting to look like more normal, then a clinical step-back. Actually, it will be harder for our reps to get there. And as Bret said, the key here is a lot of telehealth happening. Best estimate, around 1/3 of customers are interacting in telehealth basis with their physicians. And the challenge there is less likely to prescribe new technology or change therapy via telehealth. And so that for us is the strongest headwind in the U.S., and it fits and starts across the U.S. Internationally, it is very much a dynamic country by country. We talked on our last quarter call about some countries are almost at no new patient starts still, that they're just not adopting new technology in the clinics, in the hospitals. Other countries are doing great. Even through some of our distributor countries, some of our distributors are doing a great job with virtual training, and it's getting closer to normal. It looks a lot like the U.S. at faster recovery but a very much deeper spectrum outside the U.S. and in our international markets as far as the recovery goes. So this is the biggest dynamic for us. As new patient starts, we'll continue to track it. We like the stakes in the ground that we put out there. I think it gives us some room in Q3 and Q4, but we'll see. It all depends on the resurgence.
David Lewis
analystOkay. And just last question on recovery, then I'll move on to the fancy stuff. My sense was off the second quarter, the U.S. was probably tracking slightly better than expectations and maybe ex U.S. was tracking slightly below expectations. I guess 2 questions is, is that sort of still the case today? And is there anything structural that you're seeing, ex U.S.? You're not the only diabetes company that struggled, ex U.S., in the second quarter. Is there anything structurally, ex U.S., that would suggest to investors that we don't really start to see more significant recovery here as we get into '21?
Wayde McMillan
executiveYes. I'll touch up the guidance then I'll hand it over to Bret on the structural input. So actually, we performed better in both regions in Q2. We had a range of 50% to 75% reduction of our expected new patient starts. We came in globally right at the low end of 50%. The U.S. was slightly better than that, so slightly less than 50%. And international was just above 50%. So the net of the combined global was at 50%. And we had thought that international was actually going to be worse than that, closer to 75% when we set the guidance. So having them both come in on a combined basis at 50%, U.S., a little less; international, a little more, both were ahead of expectations for Q2.
Bret Christensen
executiveAnd then the only thing I'll add to that, David, as you know, and we've said this, but outside the U.S., many new starts happen in the hospital setting. So of course, the impact to COVID has been more of a distraction outside of the U.S. And then Q3 is seasonally our lowest quarter, outside the U.S. is with holidays and things like that going on so this might be a tough quarter to really understand the trends, but again, we do have some encouraging signs in many of our countries, but it's just hit and miss depending on which country we're talking about.
David Lewis
analystOkay. All right. Well let's transition out of COVID here for a little bit here. It's not the only thing we should be focused on. If you see, there's 2 big dynamics going on in the business we're now from a shift perspective, the shift to pharmacy, and obviously, the shift to type 2, and I'm going to talk about both a little bit here. So the pharmacy shift was sort of 30% here in the early part of this year. I'm sort of curious where you think that number is going and how should we think about Omnipod 5 next year in terms of where it's going to be offered. Is it exclusively going to be offered in the pharmacies so you get a pharmacy plus DME? Let's start there.
Shacey Petrovic
executiveYes. Sure. So I'll start a little bit in terms of where this is going and then, obviously, Bret leads the teams for pharmacy. And I think I would point to our new patient starts in terms of where a pharmacy can head. So what we said is it just takes some time for the entire base to transition over. We need to establish access for all of them. And they have to be motivated eventually to change channel if they're currently getting served in the DME channel. But if we look at new patient starts, what we've said is about 60% of new patient starts are starting on DASH, the vast majority of them in the pharmacy channel. So I think that's a good indication of where this can go and also a good reflection of where we've established access. So we now have access established for approximately 60%, 65% of covered lives for DASH, most of that in the pharmacy channel. We see pharmacy as a significant competitive advantage. It offers our pay-as-you-go business model, it offers better out-of-pocket cost for the customer and a better customer experience. And so we're certainly motivated to help drive more volume into the pharmacy channel. And I think Omnipod 5 will be instrumental in helping us make that happen. Right now, for people to be motivated for DASH, it's somewhat of an incremental advantage relative to our legacy Omnipod product. But we know that Omnipod 5, the anticipated demand is such that there's going to be incredible motivation across our current users and new users. And so we do see Omnipod 5 as an opportunity to drive more volume through the pharmacy channel. And Bret, I'm sure you have some color to add there.
Bret Christensen
executiveYes. I mean there's just so much to talk about with the pharmacy channel, David. There's so much that we love about it. All those things Shacey mentioned, the patient experience, the physician experience, but we've often talked about the scale that we gain from the pharmacy channel. And so if you think about how easy it might be for a physician to send an e-prescription to a pharmacy and a patient to pick that order up, for us to potentially virtually train that patient, all of that provides tremendous scale, which will be key to our growth. There's also some really unique things about the pharmacy in the way of marketing them. And one of those, we're in the process now of running 2 different campaigns with some large national pharmacies, something like bag tags, which is something that the DME world is not familiar with, an opportunity that we never had in DME. But when a patient shows up to pick up their insulin at a pharmacy, the white bag that they get will now have like an Omnipod app for some of those patients that would encourage them to go to our site to try a free trial of the product. So all that is an opportunity that we just didn't have in the DME world. That scale is going to enable us to promote things much more heavily. So we talked a lot about awareness and how we've just got to generate a tremendous amount of awareness in this under-penetrated industry. We're in the process now. We haven't talked about this, but we are going to run a test that starts actually today, a broad national campaign for direct-to-consumer marketing. Even today, you might see a commercial on TV for Omnipod. So something the team has been working on for a long time. We know that awareness is the next box that we need to check, so we're really excited to finally be on TV and be running commercials. But it is a small test. And so for the next several weeks or so, we'll be running some ads on national cable and try to just understand the benefit of that campaign for a company like ours to inform what we'll do in the future.
David Lewis
analystOkay. So you're going to target specific regions if you see stimulation in local [ health care ] clinics, you may look to make this a broader national campaign with more covered lives targeted?
Bret Christensen
executiveYes. It's actually a national campaign now, David, but a really small. So channels like CNN, A&E, VH1, FOX News, those will all be having Omnipod commercials over the next several weeks in some limited number. And we'll track our website traffic. We'll track new starts in those areas and just understand what that investment means to us. But it has been something we wanted to do for a long time. We've often talked about awareness. We've scaled our digital marketing quite a bit, and this is really taking the next step to find out what it means for us.
David Lewis
analystSo it's an attractive time to do that, obviously, heading down with Omnipod 5 next year. So kind of a couple kind of MDI questions around that. One, DASH came with a premium, Shacey. Is Omnipod 5 going to come at the similar DASH pricing? Or given the feature set, could come at a more enhanced pricing? And second question, just as you think about the MDI market, it was Medtronic's recent acquisition of Companion, people hear the InPen market getting a large backer, also, that's a competition for MDI. How does InPen change your views about your ability to kind of grow this MDI market?
Shacey Petrovic
executiveSure. So the first question was -- sorry.
David Lewis
analystSorry. I meant -- so just think about Omnipod. Omnipod 5 pricing is our vast premium, are we getting this further premium on Omnipod 5? Sorry. It's my fault for asking 2 questions.
Shacey Petrovic
executiveOkay. I got them both. Okay. So in terms of pricing, and I think what you're highlighting is the tension, our -- we know that the product performs such that it should command a premium. The data so far in prepivotals has been pretty terrific in terms of providing better outcomes, improved time and range, lower hypoglycemia, which is a pretty significant advantage because it drives -- it's one of the main causes of hospitalizations. And so payers obviously are very focused on reduction of hypoglycemia. So we do believe that the product commands a premium. It just takes time to then renegotiate contracts and get established broadly across all of the payers that we want to get established across. And so that then would temper adoption and available access for patients. So we are doing all of that modeling and looking at different premiums, different uptake rates, different rates of establishing access versus the value of the premium in order to determine the right strategy. And ultimately, we haven't landed that plane yet, but I think these are champagne problems to use my work because we're really -- we're balancing very broad uptake versus the potential for premium. Either way, we are committed to pay-as-you-go and the pharmacy model, which means that we will be looking at pricing similar to or better than DASH in terms of having moved the premium into the pod and out of the piece of capital equipment, the handheld. And that's obviously particularly important for Omnipod 5 because we're launching with phone control, and there will be people who don't use the handheld device. So TBD on pricing, but either way, we will look at, at or favorable to DASH. And then the second question was on Companion and smart pens. So we've had smart pens in the market for a little while now. I think there's 2 prevailing lines of thought. One is they could potentially delay a pump or pod adoption because you may see some incremental improvement there. Or they could drive more pump or pod adoption. And I think we sort of lean in that direction based on what we've seen so far. I view it very much as sort of a rising tide for all patients. If you fast-forward -- if you look back a couple of years, you're comparing pens and pumps or pods, you look forward and you're going to be comparing smart pens versus AID systems. And that's a good thing. Both should improve outcomes or improve ease of use. But the really critical trend that we see that drives Omnipod adoption is the adoption of CGM therapy. And when patients get comfortable wearing a wearable, get comfortable getting that data, seeing that they're out of control, they look for tools to provide them better control. And there's just nothing that would lead us to believe that smart pens are going to provide the type of control that Omnipod today or certainly Omnipod 5 next year will provide. And so we feel very confident that if this trend drives more CGM utilization, that's a very good thing for us in the long run. And then ultimately, it's likely to cannibalize on MDI therapy, but there are millions of people who can benefit from these technologies and plenty of value that we can add and growth to be had there.
David Lewis
analystOkay. So a step to partial control and it's going to lead to more people wanting full control, which makes a lot of sense.
Shacey Petrovic
executiveThat's a great way to phrase it. Yes.
David Lewis
analystOkay. So let's talk about type 1, type 2 next for a second here and then the TAM, which is the big question I was trying to answer. And it's funny, when your business moved to sort of 30% type 2, investors started talking about, wow, they're talking about type 2 because they've exhausted their type 1 opportunity. Then you jump on the call in the second quarter and say, I think the type 1 opportunity could double in the next, I think, it was 3 to 5 years. So help us understand -- I actually want to start with type 1 first. What made you say that in the second quarter? Was it just thinking about the enthusiasm for Omnipod 5? Because we think about the type 1 market beating this very stable market for the last 10 to 15 years. All these incremental therapies really haven't done what they're supposed to do which is drive more type 1 pumpers. But then you made that statement in the second quarter. So why did you make that statement now? And is it simply just related to Omnipod 5 enthusiasm?
Shacey Petrovic
executiveYes. So I think it's a bit of both. So the first thing I'll say is this has been Omnipod's value, and our approach is in conversion of MDI therapy. So we are one of the few technologies that is helping more patients get access to pod therapy and the improved outcomes. And we've been accelerating our growth. I mean you've seen this, David, prior to the pandemic, growing at 20-plus percent, approaching 30%, more than 30% in the United States. And so we have been growing that market and we can see the potential there. We remain the market leader in pediatrics. The trends in pediatrics to me are very telling of the trend in terms of what's going to happen in the marketplace. And we see now upwards of 50% of pediatric patients adopting pump, primarily pod therapy. So those trends are very encouraging. What I just spoke to, the inflection point that's happening in CGM adoption, very encouraging. And then when we -- all of our market research indicates that the advantages that we're bringing to market with Omnipod 5, phone control, for example, the data connectivity, the ease of use, these things will drive further adoption. Our market research clearly indicates that. And so that's what gives me great confidence in terms of where the market is growing. And we have seen an increasing adoption of pump and pod therapy over the last couple of years. And so I do think there's reason to believe, based on technologies like Omnipod 5 that are on the horizon and this continued adoption of sensors, that we're going to see continued and really exciting adoption of Omnipod across the market.
David Lewis
analystDo you think it's possible that over the next 3 to 4 years, your type 2 mix in this sort of 35% range actually stays relatively constant because of the traction in type 1?
Shacey Petrovic
executiveI think it's possible. Yes. That said, we see great potential for Omnipod 5 in type 2 and that as a potential accelerator as well for type 2 adoption. We see the CGM companies. And in fact, actually, we just received clearance from the FDA on starting our type 2 study for Omnipod 5. So we're just beginning to enroll for that. We do see that, that technology will have great applicability in the type 2 population. And then we see what's happening with the CGM companies. And so we know that both Libre and Dexcom are pushing into, of course, all type 2s not just insulin-dependent but certainly in the insulin-dependent type 2 population. And so the partnerships that we have with Dexcom and Abbott on Libre and G7 and then starting to look at the clinical utility of our technologies in that marketplace, we do believe that we're going to see continued expansion there. But it's really early days in the type 2 market. I think that's a long runway for us. We are probably -- I would guess we are the market leader in terms of pump use in the type 2 population, but we are low single digits penetrated there. So just a lot of opportunity. And I think as we see more technologies, more CGM adopted, we're going to see that continue to grow. The question is what's going to grow faster, and we're pretty excited about what Omnipod 5 is going to do in the type 1 population next year.
David Lewis
analystOkay. And you touched on this, Shacey. I think a lot of investors are beginning to come around this idea that in Omnipod 5, through of G6, G7 connectivity, is "the killer app." We're also kind of hearing at ADA this year, we're kind of moving away from a world that's just focused on TIR, were focused on sort of the broad feature set. You started to touch this a little bit in your preamble few minutes ago, but what specifically about this product and sort of the market research is going to be significantly a TAM expansion? So kind of just maybe have focus more on some of those items that you think really resonate with the patient or the market research is saying will resonate with the patient.
Shacey Petrovic
executiveSure. I mean I would start, first and foremost, on a sort of high level, but the usability of the system. To your point, these systems are going to be competitive in terms of time and range. We think we may have an advantage there with kids and with a reduction of hypoglycemia if that data holds in our pivotal because the data was pretty compelling in prepivotal. But they're going to be close. They're going to be competitive. I think where Omnipod 5 will be miles apart and where ultimately it will result in an improvement in real-world outcomes, this is my opinion, is on usability. And the reason I say that is I think you just have to look at 670G. 670G had pretty strong clinical results when it was -- when the data was published. And then a year later, data was published that 40% of people retreated across the product because it wasn't very usable. Where we -- the benefit of being third to market is to really understand where there are opportunities to differentiate from the field. And where we saw one, significant one, was in the usability of these systems. And we thought, especially as we move to full phone control of the system, we have an opportunity to provide the most elegant and the easiest-to-use system. And we designed from the outset for the MDI user and for the pediatric user. And so what that results in is a system that is incredibly easy to get onboarded on, may involve just online training if you're coming from Omnipod or other pump therapy. It is a system that can be controlled fully from your Samsung mobile phone and eventually from other mobile phone platforms, and a system that takes a lot of the guesswork and the interaction with the clinician requirements away. And that all comes down to just the elegant user interface and the way that the system has been designed to be adaptable. The algorithm itself is designed to learn with the user with every pod change. It looks at your total daily dose of insulin on your pod and adjust the algorithm accordingly. And so that means that the system will just get improved performance over time and with less tweaking by the patient or by the physician. So those things are very sort of high-level usability advantages. And then, of course, there's all of the thoughtful work that the development and upstream marketing teams did on specific features, things like constant connectivity. We know that parents are always worried about their children, and they don't want to wait for their kids to be in WiFi range to get visibility to their data. Same thing with clinicians, school nurses, loved ones, and so through phone control and through putting a SIM card in the PDM, to offer up like nobody else does, constant connectivity to data is very helpful for clinicians, patients and most importantly, for caregivers.
Wayde McMillan
executiveShacey, maybe just to add on a couple of things here. David, this kind of relates to these 2 questions together, the investments that we're making to support that expansion in type 1s as well as type 2s. Bret talked about investments in DTC or direct-to-consumer for commercial. Maybe, Shacey, I can talk on what we're doing in manufacturing. And then if you want to just mention clinical as well and where we're at with some exciting updates there. So from an international standpoint as well, David, so we kind of got 3 key areas cooking here. So from a manufacturing standpoint, to support the growth that Shacey has talked about, we've made another investment in an extension of our China manufacturing facility. So we have engaged a new third-party manufacturer, Sanmina, and we've got 2 lines of investment going now with the capacity up to 5. And so we'd be able to double our capacity out of our China facility with this initiative. And we're already producing pods, getting them ready for validation, and we'll be ready to start selling salable product off these lines later this year, early next year. And so we're preparing from a capacity standpoint with an investment in this expansion and really excited about getting this expansion -- capacity expansion in place. We've got a strong team over there, and we've got just a lot of supplier base that we can leverage. So it's another quick way for us to double capacity out of our China facility.
Shacey Petrovic
executiveThat's great. So clearly preparing for what we anticipate to be great demand with Omnipod 5. We are on track. David, I know you'd asked about our clinical trial and kind of where we are there. We expect to wrap that up in the coming weeks. Our final few patients are completing our clinical trial. So that puts us on track pretty solidly for our first half launch, which is one of the reasons why we want to make sure that we're in a strong position from a capacity standpoint -- not just capacity but also the resiliency and redundancy of the supply chain and the manufacturing operations. And then as Bret said, we -- this investment in awareness, we're just piloting it at this point. But we believe it will have potential to drive demand as well. And so we want to be in a position to accommodate that through the manufacturing investment as well. And I think one last just clinical, and we should move on to international, one last clinical update is just that we have started enrolling our small PIDs as well. So if you remember, we anticipate launching with an indication down to aged 6 for Omnipod 5 and then we were going to follow with an indication down to aged 2, the 2- to 6-year olds. And we just started enrolling for that clinical study, and we now have a few 2-year olds on the product, very exciting for all of us.
David Lewis
analystOkay. I see you're very confident, Shacey. Clinical enrollment for Omnipod 5 in the U.S. by the fourth quarter and the next year's launch to kind of first half or so by midyear '21.
Shacey Petrovic
executiveThat's right. Yes, exactly.
David Lewis
analystOkay. Any updates on your DASH rollout ex U.S.? Or anything you want to talk about internationally because I wanted to finish up maybe with weight a little bit on margins.
Shacey Petrovic
executiveGreat. Bret, do you want to take that?
Bret Christensen
executiveYes. Yes. David, a couple of things to report internationally. Just we're having really good progress on 2 fronts. One, DASH expansion to our international markets. We talked about doing that the first of 2021, but we're actually ahead of schedule on DASH expansion, and we'll be launching to the majority of the remaining countries internationally just in the coming weeks. So that's very exciting. Remember, that's our first product launch in these countries since we went direct just over 2 years ago. So team is very excited. We're happy to be ahead of schedule there. And then just one more thing to report on international geographic expansion. We also said at the beginning of the year that we anticipated launching in maybe 5 markets by the end of this year. We pushed that to the first half of next year. But we aren't having progress, and we're going to be launching in Belgium, October 1. So hopefully that -- it's a small market, but hopefully, that just signals beginning of our geographic expansion in earnest, which we hope will be just a cadence of international launches over the coming years.
David Lewis
analystOkay. So a lot interesting updates there. Thanks, Bret. And then just sort of wrapping up a couple of things. First of all, with Omnipod 5 coming, why does it make sense to kind of give investors another update in the LRP? Is that sort of a post-Omnipod 5 dynamic? Do you want to complete the other LRP before you do it? What can we expect coming back to investors with the new outlook?
Wayde McMillan
executiveYes. That's it. Exactly, actually. We're thinking about getting Omnipod 5. It's such a big milestone for us. And we've talked about it being an increase in both type 1 and type 2 patients that we think will be eligible to come on to the product and really open up this market. So that's the perfect time for us. It's on the other side of Omnipod 5. It's not to say we don't have a lot of investments and a lot of projects running right now behind Omnipod 5, but we're not ready to talk about those yet, and that would be the perfect time as when we reset the long-range plan on the other side of Omnipod 5. So we'll get it in the market for a few quarters. We'll see if our long-range strategies leading up to Omnipod 5 hold with Omnipod 5, and then we'll reset from there.
David Lewis
analystOkay. And then when you're on the quarter, you signaled that your margin expansion pushed out a little bit here this year despite of COVID-19. And I sort of listen to that, but then I also sort of know you and some of your historical conservatism. So I wonder, are margins really going to be delayed as you suggested?
Wayde McMillan
executiveYes. So there's no question we had some delays. The team's really shifted focus from ramping up our automated lines to making sure our facilities were safe and mitigating all the challenges that came with COVID. And then beyond that, it's been challenging for the teams to travel from our third-party automation experts into our facility. Line 3 has been -- being built up in Canada at our third-party manufacturer. So our teams couldn't get up there to work on line 3. Some of that is starting to loose and the teams are finding ways to get back and forth a little bit now. We have a commitment to get line 3 installed in our U.S. manufacturing facility. It's been a significant investment for us to get line 1 and 2 up. We've got a lot of learnings. Those 2 lines are getting more efficient and ramping up. So we're happy to get line 3 in. And then obviously, we'll be going to work on line 4 to finish that investment in U.S. manufacturing. Speaking specifically to gross margins. We know where we're at so far this year. The business was up around 65%, 66% before we started building product in our less-efficient U.S. manufacturing facility. Now we've got guidance this year for 63%. And we know that we can ramp back up into that 65%, 66% as an existing business. The U.S. manufacturing efficiencies are the single biggest driver to get us up to 70%, and that's our goal. We held on to guidance with 67% to 70% in our 2021 guidance. So we'll see. It really depends how fast the teams can recover, how the automation ramps up and what we look like in 2021. But it doesn't diminish our commitment to get to 70% gross margins. We feel it is a significant differentiator for us. We already have the best gross margins in diabetes. We think we can improve upon that. And if we do, that means we can invest more in innovation over the long term and build a higher bottom line profitable business over the long term.
David Lewis
analystOkay. Well we're a little out of time here. Shacey, I would say a lot of updates here between the Omnipod 5 protocol on success, we have ex U.S. manufacturing DASH in Europe and the DTC campaign. Did we miss anything? Is there anything else? I'll let you get the last word here, Shacey.
Shacey Petrovic
executiveThat's why I said it was perfect timing, so no. Thanks for the opportunity to share what's been going on. It's been tremendous momentum here this year.
David Lewis
analystAll right. Team, thanks so much. Enjoy today. We'll see you here soon in another room. Shacey and team, thanks so much for being with us.
Wayde McMillan
executiveGreat. Thanks, David.
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full-text search, and the recently-added /api/v1/transcripts/recent polling endpoint for ETL pipelines.