DexCom, Inc. (DXCM) Earnings Call Transcript & Summary
September 10, 2020
Earnings Call Speaker Segments
Operator
operatorWelcome to the Wells Fargo Health Care Conference. [Operator Instructions] Also, please be advised that today's conference is being recorded. Thank you.
Larry Biegelsen
analystGood morning, everyone. I'm Larry Biegelsen, the medical device analyst at Wells Fargo, and it's my pleasure to host this session with DexCom. With us, we have Steve Pacelli, Executive Vice President of Strategy and Corporate Development; and Jereme Sylvain, Senior Vice President of Finance and the Chief Accounting Officer. In terms of the format, it's going to be Q&A. DexCom has been kind enough to give us a 1-hour slot. So hopefully, we can cover a lot of ground here. If people want to ask questions, I'm going to ask you just try to email me. So if I'm looking to my left, you'll know I'm just scanning my e-mail to try to get questions from people on the line. We're also going to try to do one polling question, which is -- has actually worked well so far. And so with that, Steve, and Jereme, welcome. And hopefully, you can hear me okay.
Steven R. Pacelli
executiveYes.
Jereme Sylvain
executiveThanks, Larry.
Larry Biegelsen
analystGood. Thanks for being here. So I wanted to start with the upcoming investor meeting in December. And just get some color from you. I know you're not going to provide any specifics but what we can expect from that meeting, it looks like you're on track to exceed almost all of the goals you said at your 2018 meeting. So I'll hand it over to you, Steve.
Steven R. Pacelli
executiveYes. I can start, and then Jereme can jump in. I think -- yes, I mean, we're certainly not going to give you specifics here on this call, but I think you're right in that we've been tracking. We laid out some kind of long-term guidance a couple of years ago, late 2018. And we've obviously -- if things keep progressing, we're on track to meet or exceed that on that 2023 time frame that we've laid out. So I think you would expect that we would kind of update the numbers, broadly speaking, and then really kind of update the -- really, the portfolio and the product road map for the next, call it, 3 to 5 years. So you should expect some discussion around the core around intensive insulin therapy of type 1 and type 2. You should expect us to talk about our inroads into non-insulin-using type 2s. And then we'll talk about the hospital, gestational and probably some broader population health initiatives that we're looking at. Mindful that we don't want to give Abbott, Medtronic and others, our full playbook. So we may be a little cautious of how much on the portfolio and the road map we present. But certainly, we'll give some updated numbers.
Larry Biegelsen
analystOkay. That's helpful. And Jereme, did you want to add anything?
Jereme Sylvain
executiveNo, I think that's exactly it. And we're going through those numbers and updating those now. So we'll certainly be able to provide you really a financial overview of where the company's heading. So we look forward to that, and it will obviously take into account all the performance you see to date.
Larry Biegelsen
analystOkay. The one area -- I mean, you've exceeded, you've met or exceeded. It looks like you're on track to meet or exceed everything, except maybe the international target of 30% of your core business by 2023. Obviously, you still have a few more years. But right now, international is about 21% of total sales. Any comments there on whether that 30% target is still achievable?
Jereme Sylvain
executiveSo I don't think we're willing to update it yet. Although one thing we've always said is we do expect over the long haul, our international business to accelerate past out of our U.S. business. Obviously, this year, the OUS markets, at least for the middle part of the year, I say that I'll call it Q2 performed a little bit less so than the U.S. business. We don't expect that to be the case. If you look at our market share outside the U.S., it's certainly lower than what we have in the U.S. And so we believe that, that's an opportunity over the long haul. And so nothing has really changed from our expectations. But in the event that we do reset any bars, you'll see it at that period. But we've always thought the international market has a much larger runway for us than the U.S. market does.
Larry Biegelsen
analystOkay. Well, why don't we transition to COVID-19 impact. When we look at the IQVIA data, I know you don't want to give any intra-quarter updates. But when we look at total sensor prescriptions and new patient starts, it looks like they're almost back to pre-COVID levels for new patients starts based on this data. Any color? Any reaction?
Jereme Sylvain
executiveWell, I think what we would say is, in general, around IQVIA data. IQVIA data is really through the pharmacy. And so I think you just have to be careful. I think we talked about this maybe last time we spoke about it, but a lot of our business still resides in DME. And there's a migration of DME to pharmacies. You have to be very, very careful in just assuming that one portion of the business or one viewpoint of business is a broad-based assumption for everything. In terms of new patient starts, we won't necessarily comment about our numbers other than there's been public data out there regarding many endocrinologist interviews. A lot of folks have different assessments of inpatient, outpatients. People are looking at IQVIA, Ziten, et cetera. And what we would say is, typically, what we've seen is patient visits are still not where they were pre-COVID levels, and that's kind of what we would have expected just given some folks are seeing massive amounts and not. So it's nothing different than what we've really commented on in Q2. We don't really have a Q3 update. But I think it does give some good context around IQVIA. It's a good data point. I think it's helpful for you to see how things are going and progressing. But I always just want to make sure that you understand pharmacy is only a portion of our business. There's a large portion that still remains in DME. And so it's not a total viewpoint of the business.
Larry Biegelsen
analystOkay. And you talked about endocrinology in-person visits, which we also track, still being below pre-COVID levels. We have heard that it's easier to onboard a new patient to Libre than it is to DexCom to G6. Is that fair? And what are you doing to level the playing field? To onboard through telehealth?
Steven R. Pacelli
executiveYes. I would take exception to that, but for the fact that Abbott has been very aggressive at not pursuing DME. So that they're trying to push product through the pharmacy. And so where -- it's an apples-to-apples comparison, where our patients are picking up their products, the drug store, ordering through the pharmacy channel. I would say the onboarding is identical, where that would ring true potential is in the DME world, where patients are still required to get fingerstick logs or chart notes from the doctor still jump through all those hurdles that we've talked about over the years in DME, which is, again, why we've been so aggressive in trying to push our business into the pharmacy. So I think where there's an apples-to-apples comparison, there wouldn't be a difference in onboarding for a Libre patient versus the DexCom patient. We even talked on our last call, even from a co-pay perspective, the co-pays are very similar, in fact we're often a lower co-pay than the Libre. So I think it just speaks to our continued effort to push the business in the U.S. into the pharmacy channel and away from DME. But as Jereme just mentioned, it's going to take some time because we've got that legacy business that is largely through our third-party DME distributors, it's just going to take some time to convert them from DME over to pharmacy.
Larry Biegelsen
analystQuestion that was e-mailed to me. Are there any sell-in and sell-out dynamics to call out with DMEs in the second half of 2020? I don't know if it's something you had commented on in the past?
Jereme Sylvain
executiveYes. Typically, no. One of the things we've always been mindful of doing, and this is just over time, we don't really have a large -- we don't want to have inventory sitting out in any of these channels for extended periods of time. And so I assume what they mean, sell-in, sell-out is really stocking levels. And we don't enjoy having those stocking levels. We keep them all within a certain amount of days, and that's that we can be nimble with our inventory levels. And that's been the way we've always really run the business. So that's the way we would continue to look at how we operate the business.
Larry Biegelsen
analystOkay. And then recent commentary from Abbott, CMS and even DME providers suggest that CMS is providing interim coverage for CGM. The type 2 patients without regard, the daily testing need or confirmed COVID infection. I know there's been a lot of controversy about this -- that CMS announcement that came out earlier this year. What's your perspective? And what impact do you expect that to have?
Steven R. Pacelli
executiveSo we've taken a conservative review of the CMS language. And in our view, it really is, yes, there has been some laxing of the rules. But I would say our view is that if a patient has diabetes and has COVID, regardless of whether they have type 1, type 2 or even not taking insulin, they would be eligible for coverage during COVID. I would caution, though, I don't think you're going to see a huge influx due to COVID, a huge influx of non-insulin-using type 2s as a result of CMS flexing these guidelines. I just don't think that's going to really move the needle. I don't know, Jereme?
Jereme Sylvain
executiveYes. No, I was going to say that the guidance we read it to be specifically somebody who's contracted COVID, not just any type 2 or anybody that's afraid of getting COVID. If folks have taken the angle, and we've heard some obviously rumblings of folks taking a more aggressive angle. If you want to play auto roulette with Medicare, we don't recommend it. And I think a lot of the suppliers that we've spoke to also don't recommend it, but that's at least been our approach and ultimately how a lot of the folks have applied at least DexCom product into therapy.
Larry Biegelsen
analystOne more on COVID. I mean patients, diabetes patients, with quarterly controlled glucose fair worse if they contract COVID. For lack of better word, maybe silver lining. What are you seeing? Are endocrinologists and diabetes patients more eager to go on CGM to control their glucose in this environment because of that?
Jereme Sylvain
executiveIt's a good question. It's one of the things as we look at the feedback that comes back in, a lot of the folks that are aware of CGM, this can be a catalyst to hurry up and accelerate folks to then move on to CGM. There's no question there. For folks that aren't aware of CGM, and as you get into the primary care space, where folks aren't necessarily up to speed on diabetes, they might have a few diabetics in their practice. That's more of an education thing. And as we educate them, they say, well, why would we die? So we do believe that over time, the move to telehealth, the move to COVID being an impact and who it disproportionately impacts those with diabetes. We do think it's a tailwind. It's hard to know, just given all that's going on with patients and are they coming and who's on telehealth and do PCPs have a telehealth practice? Or are they just slower? There's a lot of ins and outs. But the feedback we've gotten over time, especially as those have realized what our product do is that this is a perfect product for telehealth and telemedicine. And we believe that over time, it could be a catalyst. It's going to be hard to tell. I think it's going to take time to ultimately tell how much of a catalyst it could potentially be.
Larry Biegelsen
analystSo I wanted to transition to G7. Obviously, critically important product for you guys. So we understand the first-line is up and producing units, and you're setting up incremental lines to ensure a smooth launch. Could you provide more color on where you are with G7 manufacturing scale-up and the clinical work?
Steven R. Pacelli
executiveYes. So we're not going to give you a specific update. On our Q2 call what we said is that due to COVID, we expected to push out the clinical trial, just access to the clinics by around 6 months' time frame. So can't give you an update on this call. We'll give you an update on the Q3 call as to where we are with respect to kind of pivotal trial. And remember there's a pivotal trial, if you will, in the U.S. and in Europe. So we'll probably try to give you some color on both on the Q3 call. Yes, we can produce G7 sensors, but I wouldn't suggest by any means that we're at anywhere near close to scale. I would actually characterize what we're producing today as more of a pilot-line, producing product for our clinical efforts and not for mass production from a consumer perspective. So that will continue over the course into building -- bringing in the equipment, building the equipment, building the lines we'll continue through the balance of this year and really throughout the balance of next year.
Larry Biegelsen
analystSteve, is there any reason the G7 pivotal trial will look different from the G6 pivotal trial, which is obviously in the public domain?
Steven R. Pacelli
executiveI think at the end of the day, we have to meet the iCGM standard, right? So you have to power the trial appropriately to achieve the statistical metrics that you need to obtain an iCGM. It's actually, I would suggest that it's a more complex trial than the G6. But in terms of numbers of patients, it's roughly -- there's going to be more patients but not in order of magnitude more patients. So by and large, yes, you're still running patients in the clinic, multiple days during the course of the sensor where you're manipulating blood sugar levels, while they're in the clinic. So in that respect, it's very similar.
Larry Biegelsen
analystAnd you talked about COGS for the sensor being below $15. Eventually, I guess, at scale for G7. Is that accurate? And how does that compare to G6?
Jereme Sylvain
executiveYes. So we've talked about getting it down to right around that range at scale. And so we haven't really talked about specifically comparing it to G6, G7. But what we would say is, as you get it down -- as we ramp upscale, I think we said it in the context that you shouldn't expect to see our COGS to be an issue to compete with our competitors. We believe we can get it down into a similar cost profile as our competitors. We won't comment on where G6 and G7 are right today. But I think in that question, it came down, I think the other question that came up is, well, where can you get G6 over time? And while we didn't give it a specific price as where we are today, a good chunk of the cost of G6 today is fixed overhead, and that fixed overhead is depreciation. And when we get to a fully depreciated line, the incremental cost on G6 can also be pretty low. And so I think that's where we've talked about being able to compete in COGS with really anybody in building that infrastructure to do so. So I think that builds the confidence at least. When you get into lower-cost markets, are we able to compete? We believe we can, and certainly, we believe we can compete with both G6 and G7.
Larry Biegelsen
analystSo just to follow-up on that. It sounds like you're planning to continue to offer G6 after you launch G7 by segmenting the market with a higher and lower-priced offering. Is that what I'm hearing?
Jereme Sylvain
executiveIt may not be in the same market bracket. Maybe a lower-priced offering or a different priced offering in markets where reimbursement is lower and at G7, where reimbursement is higher. It may be for different use cases within those markets as we start to think about which use case we're targeting, whether it's type 2 and in a type 2 environment or type 2 intensive. We're working through those types of items. But I do think you should expect to see G6 lines continue to run and to continue to supply for various groups of folks for foreseeable future. It's a lot of investment we've made. It's a great product. And we can use it to attack certain markets that maybe we're not attacking today.
Larry Biegelsen
analystAnd I know pricing have got a lot of attention 1 or 2 years ago, doesn't seem to be getting a lot of attention right now. But you've talked about a 10% annual price erosion for a couple of years, I think, at least this year. Is there a level where you think the price erosion plateaus?
Jereme Sylvain
executiveI think it's when the transition -- so price erosion if you think about it today, majority of price erosion is actually channel shift as opposed to same store, same SKU type sales. And so if you're in the pharmacy yesterday and you're in the pharmacy today, the pricing erosion isn't quite as there. Same story on the DME space. If you're in DME yesterday and you're in DME today. The issue is, is we have this migration over time of folks in DME into pharmacy, where there is a pretty dramatic price difference. And so where that plateaus is when that migration shift stops. Steve had mentioned, alluded to it earlier, we want folks to go through a pharmacy. We believe that's where you get those barriers to adoption down and that ease of use down, where you get the volumes that will offset it. And then our OpEx associated with serving the pharmacy gets dramatically lower. I think that's where we'll continue to push. So when that migration takes place, we'll certainly continue to see it. We've talked about it being this year. We've talked about it even being next year. We haven't really commented beyond 2021 in terms of pricing. It really depends on how many folks we're able to migrate over time.
Larry Biegelsen
analystI mean, Jereme, when you talk about 2021, it's about the same level as 2020?
Jereme Sylvain
executiveWe talked about the same dollar value, so around that $150 million. So really it's about taking the existing base and moving them. And as you move that existing base, each person comes with an incremental price set.
Larry Biegelsen
analystOkay. And sticking with G7, is the U.S. going to be the first market? Or could it be international given that it seems like a CE Mark are easier to get?
Steven R. Pacelli
executiveThat's still to be determined, and I would also suggest it's not just a function of regulatory, but a function of our capacity and our scale-up. Because remember, the hole we put ourselves into with G6, trying to launch G6 for the first time, it was -- tried to do a global product launch. And we underestimated the demand. And we were living most of last year in kind of a hand to mouth or even oftentimes a backorder situation. We're not going to do that with G7. We're going to be much more thoughtful in how we roll it out. So the U.S. being our biggest market, right? If we're not ready to go in the U.S., we would probably consider launching it somewhere else, but we're still working through that as we work through the clinical regulatory and scale-up process.
Larry Biegelsen
analystOkay. So let's transition to type 2. And I think first question here. I've got a couple of those -- a couple of type 2 questions e-mailed to me already. But just at a high level, I think people were surprised by the 20% figure you provided on the Q2 call for type 2 patients as a percent of your U.S. installed base. Where was that before Medicare reimbursement came into effect in 2019? And how much of growth is being driven by Medicare versus commercial?
Steven R. Pacelli
executiveI would say prior to Medicare and prior to the German reimbursement decision, if you remember that in Germany, out of the gate, we received type 1 and intensive type 2s, I would say, it was very minimal, right? And certainly, less than 5%, probably mostly cash pay. So what we've seen, particularly with Medicare and Medicare has been obviously the key driver for our intensive type 2 business here in the U.S. But then what we've seen is stemming out of Medicare, you saw United, you saw Aetna, there's some others. What we expect now is sort of an acceleration over the next, call it, 12, maybe 18 months that we expect most of the larger payers to fall in line and actually adopt intensive type 2 coverage along with their type 1 coverage. So it is a huge -- it basically -- actually, probably more than depends on whose numbers you believe, but probably more than double the size of the addressable market just in our core intensive business in the U.S. and in Europe. So pretty exciting stuff. I would tell you, though, that the biggest challenge we have with the intensive type 2 is that many of them are not seen by endocrinology. So they're not -- they don't have the education and the access that our -- most of our type 1s have, who are being seen by an endocrinologist who are very well versed in CGM as a category, as a therapy. We're working through our direct-to-consumer campaigns really to target. That's the effort that we're putting forth on these non -- or these intensive type 2s. Just to educate them because the primary care or internal medicine docs, they don't necessarily know. They don't have experience with CGM. So we're having to really educate them through the DTC campaigns, have the consumer get to the doctor to drive the prescriptions.
Larry Biegelsen
analystThat's helpful. So one question that was e-mailed to me that you touched upon, Steve. It's could the pace of coverage for type 2s, could we see more private payers come on before year-end?
Steven R. Pacelli
executiveYes, it's possible. Many of them, remember, payers work in like cycles, right? So there may be things that we have in the works that we are expecting someone to adopt something, but it may come into play January 1, right? Even though we're doing the work now, they often put out revised coverage policies in buckets, as you guys know. So if there's anything material, obviously, we would talk about it on the Q3 call.
Jereme Sylvain
executiveYes, but I think it's worth noting, I mean, 2 of the 5 came in this year in 2020. And so on top of Medicare, you get Unitedhealthcare and Aetna who have moved into type 2 intensive coverage. So you're starting to see that commercial mind shift take place or that private payer mind shift take place. So I think that's certainly encouraging. We believe it's a matter of time, not if and so I think the timing, I think, to your point, is the big question. But of course, we have our access folks working with them daily to look at these items.
Larry Biegelsen
analystAnd the 20% figure you gave on the Q2 call, was that U.S. installed base or global? Steve, it sounds like it was global based on your German comment a minute ago.
Steven R. Pacelli
executiveI would say global, but predominantly U.S. The uptake in Germany with intensive type 2 hasn't been nearly what we've seen in the U.S. base.
Larry Biegelsen
analystSo does that mean -- so 20% applies to worldwide and the U.S.? Or is the U.S. now even higher than that?
Jereme Sylvain
executiveThe comment was worldwide. And I think that's where we left it.
Steven R. Pacelli
executiveStick with that.
Larry Biegelsen
analystOkay. But U.S. should be too different. It doesn't sound like or it could be actually a touch higher, not dramatically different?
Jereme Sylvain
executiveYes. I think what we had said is 20% worldwide. But we don't really get down into patient numbers, U.S., OUS, I think you can take Steve's comment and take it where you want. But I think 20% worldwide is the number we publicly disclosed.
Larry Biegelsen
analystOkay. Fair enough. All right. And I mean, type 2 penetration in the U.S., we got to about 25 -- for CGM, we got to about 25%. We kind of updated our numbers. Based on that comment, we got to about CGM, Q2, in type 2 insulin intensive about 25%, type 1, about, call it, 55%. Are we close, Steve? Or Jereme?
Jereme Sylvain
executiveYes, I was going to say, what we've said on the call is we saw T1 passing 40%. I don't think we had it above 50%, at least that's from our data. And we publicly said that T2 intensive penetration is in the teens. And so I think it might be a little higher than we are, but I don't think it's wildly enough.
Larry Biegelsen
analystOkay. And so what's next with the type 2 non-insulin intensive population? Obviously, that's where there's a lot of focus. We all saw the level 2 program. I guess, maybe what do you -- when do you expect United to roll level 2 out more broadly?
Steven R. Pacelli
executiveYes. So that's a very broad question, right? So we've got multiple shots on goal for the non-insulin taking type 2 patient population. There's going to be a subset, some of the work we're doing, United is a perfect example, the work we're doing with Intermountain Healthcare, with Onduo, with WellDoc with others. Very much a kind of B2B type offering where we're empowering others really to incorporate sensors into these programmatic experiences where they're trying to take other data points and analyze it. So health, fitness tracking data, meal data, that kind of thing. And even in some of these scenarios, they're adding either virtual or actually human coaching. So that's kind of one avenue that we're pursuing is really trying to empower others with our sensor technology to deploy their programs. Level 2 is obviously one of the most exciting, right? Because not only is United offering it to hundreds of thousands of people, United has the balance sheet to really -- when they approach an employer, right now, they're only rolling it out to their fully insured programs. So they're actually taking the risk in the program now. I think we would expect, over time, when they generate the claims data, they know the risk that they're able to bear. You'd see it roll out to a larger, even the self-insured population over time. But United is in a unique position because they hold all the data, right? Not just our CGM data. They have an underlying data analytics engine that looks at multiple data points. They actually have live coaches, they have the Optum subsidiary that actually already do proactive outreach to their Medicare base. So they're uniquely positioned, plus they have the claims data, right? So when it comes down to the economic analysis, they're better suited than anybody to understand the cost savings that we can generate when you use CGM in the non-intensive type 2 population. Intermountain is similarly situated though even you saw the data that we released earlier this year. Small end, right, it was 100 patients. But the cost savings that they extrapolated for patients using CGM was dramatic, tracking $5,000 a year per member per year is huge cost savings, and that was just with the addition of CGM in the Intermountain study. There was no coaching. There was no other intervention. It was literally just half the population got fingersticks, half are on CGM for 6 months, and the cost savings were dramatic. So that's kind of the one big avenue we're pursuing on the kind of the population health side and type 2 is really through a B2B channel. But I think you'll also see us continue to push. And we're exploring what it's going to look like as this thing really broadens. And as it becomes abundantly clear, the benefit that we provide non-insulin-using type 2s with our product, you're going to see some B2C consumer efforts come to life over the next 12 to 18, 24 months, where we're really going to target the consumer directly. And I can't give you too much in the way of details there. But I think you're going to see us take multiple shots on goal there because we recognize that this is a huge opportunity. People often ask, what is the use case going to be? Meaning, is it going to be real time, all the time? Intermittent? I think there's not going to be a single answer there. Some of our market research suggests that patients actually really want to wear it in real-time all the time. In fact, the commentary we're seeing back from this patient population is very similar to what we saw back in the early days with type 1s where they feel naked without it. They become reliant on the technology, even though they're not taking insulin, it's something that just helps them on their day-to-day management of their diabetes. And when you take the product away from them, they really do feel like they're missing something. So this is not going to be this year, kind of huge revenue contribution. But over the next, I would tell you, 3 to 5 years, the non-intensive type 2 businesses is a huge, huge opportunity for us.
Jereme Sylvain
executiveYes. And Larry, just -- you asked the question, how does UNH, what about Level 2? And how do we get a little more insight as to how that rolls out? One of the great things, I think Steve commented on it. This is what they've done is they've put it on their own book of business. And so this is fully insured UNH patients. This is -- they are basically saying, we believe in this so much so that we will take all the risk. I think over time, what you'll find is those self-insured companies that are using the UNH formula, it's about getting them to an ultimately opt-in and using the data to ultimately adopt them. We believe UNH is doing this kind of pilot rollout to prove you can reduce costs. And if I was them, I would use that to then attract a bunch of people to my formulary, my programs, and I would use it as a differentiator.
Larry Biegelsen
analystThat's helpful. So the B2C for type 2 non-insulin intensive was new to me. I don't know if it's new in general. But I did have questions e-mail to me on DTC. But I guess is that -- you said 12 to 18 months B2C, it sounds like sometimes -- yes, consumer outreach, obviously, is that new? Is that something that you started...
Steven R. Pacelli
executiveI would say it's evolving. And really, again, it comes back to reimbursement, right? In the absence of broader reimbursement for that patient population, it's a little bit tougher. Because you'd be asking people to come out-of-pocket for the product. And that's -- particularly for someone wanting to wear it full time, year round, that could be a pretty expensive proposition. But we're looking at a number of options in terms of different configurations of the product, different price points for the product. So again, I can't give you specifics on this call. But yes, I would tell you, it is new in the sense it's evolving. We've always been kind of studying it. I think I'm not optimistic that within the next 12 months, you're going to see the major payers adopt kind of fee-for-service type coverage for non-insulin-using type 2, meaning similar coverage that we have for type 1s where you just get to go to the drugstore and pick it up. But I do think you're going to see some coverage evolve, whether it's through these programs or otherwise.
Jereme Sylvain
executiveYes. And I think, Larry, just so you know, we're already doing B2C outside the U.S. through our e-commerce platform in both Canada and the U.K. We're rolling those out more. And so we're taking some of the learnings in and outside the U.S. trying to figure out how to apply it in other markets. And it really depends, to Steve's point, on the reimbursement landscape and how that ultimately works. But we have experience in it now, and we're going to continue to look for ways to expand it.
Larry Biegelsen
analystI've got a lot of questions e-mailed to me on this. But Steve, I think you kind of hit the nail on the head on type 2 non-insulin intensive and B2C. You typically would wouldn't want to go to a consumer until there's some kind of coverage. So I guess my question is, does that mean that 12 to 18-month comment you made that you expect more coverage? Or you know how you're going to be very targeted and you're going to in your outreach, targeting patients that might be willing to pay out of pocket? I'm trying to understand what the implications are on the payers' side?
Steven R. Pacelli
executiveThat's great insight. It could have been both, right? Because we know there is a subset of patients who can afford it and who may be in at a stage in their type 2 diabetes who are actually willing to afford and potentially a lower cost differentiated product from our type 1 product, certainly from our intensive product. But yes, we do believe there is a subset of that patient population who would be willing to come out-of-pocket as well. So you're right, we're not going to wait until we have broad-based fee-for-service type coverage for the non-intensive type 2 to go to the consumer. That's fair.
Larry Biegelsen
analystOkay. And so a couple of questions e-mailed to me here. Sorry for looking over my shoulder. On DTC, in general, the DTC -- any update on the DTC advertising campaign and expected return on investment from this?
Jereme Sylvain
executiveYes. So we are moving into DTC. For folks that are watching TV, you might see a lot more of our ads. I certainly do. I work here so I pay more attention to it than most. But we are investing in DTC. We believe the return on investment is certainly higher than any sort of hurdle rate you're ever going to ask for us. And so we'll keep those closer to the best in terms of what that return is. But as an investor, you want us investing in this. In terms of how that ultimately plays out and why it works, Steve mentioned it, as you get to consumers beyond your heavy type 1 users and your endocrinologist visitors, a lot of folks that are in the PCP space, whether it's actually the physician, the clinician and/or the individual that happen to be watching TV. They just aren't as aware of it. And so that's where we -- it's about reeking awareness beyond those that are in the know in the space of diabetes. And we found that through those investments, whether they're in place to TV ads and whether they're through other forms of medium. We found that the funnel for opportunities does go up into direct correlation. And so we're going to continue to make those investments. We've started on how those ultimately play out through the conversion cycle, we haven't given guidance on that. It does take a little bit of time for initiation to customer to ultimately pulling on therapy. But we do know it's a good investment, and it's something we'll continue to do so as long as we continue to see the feedback that we've seen early on.
Larry Biegelsen
analystThat's helpful. Why don't we do the first polling question here? Josh, our technician. Can you bring that up, please? It's obviously on type 2. So basically, when do you believe we will begin to see meaningful penetration into the non-intensive type 2 market, obviously, for CGM? Hopefully, that's obvious. 2021, 2022, 2023 or beyond, never, too extensive, not sure? So we'll give everyone 10, 20 seconds to vote. [Voting]
Larry Biegelsen
analystJosh, how are we doing?
Unknown Attendee
attendeeIt looks like we have most of them. So we'll give them maybe 5 seconds.
Steven R. Pacelli
executiveGive me a second on that, I'll be right back.
Larry Biegelsen
analystSteve, you have to tell us, if the consensus is right or wrong, okay? Meaningful penetration. Maybe I should have been more specific, by 2023 or beyond, it's probably a little later than I would have thought.
Steven R. Pacelli
executiveI am actually -- yes, I'm actually good with that combination, right? Because I would have said sometime 2022, exiting '22 into '23 is when I think we're starting -- when you're going to start to see more. Look, for the next 3 years, our revenues are going to be driven by the core intensive business, intensive meaning type 1 and insulin-using type 2s. Simply because of the clinical data, the reimbursement landscape, et cetera. And that we're still so underpenetrated even as a category, both in the U.S. and Europe. That's going to be the driver for the next 3 years. But I do think you're going to start to see. So I guess when we start talking about significant impact or meaningful impact. If you're talking about on a percentage of revenue, I would push that out a little bit. But from what we look at from a business perspective, starting to generate real revenues in that category, I think does happen in the 2022 time frame and into -- certainly accelerating into '23. That's...
Larry Biegelsen
analystThat's very helpful color. I wanted to switch to international. And everybody on the line, please keep the questions coming. So international growth, just a couple of questions here. One, in the second quarter, I think international might have been a little softer than some people expected after -- especially after what was a very strong Q1. And given that you said the U.K. and Canada were good in Q2. It implies, at least to me that Germany might have been soft, given that that's your largest market. So is that fair? And my understanding is you have your own distributor there. So I guess, what happened in Q2? And do you expect Q3 to be better?
Jereme Sylvain
executiveYes. So in Q2, what we did see is -- and we saw it really actually through some of our distributor markets in Europe as well and some of our other distributor markets as well, as we mentioned, Germany, the new patient starts were impacted by COVID. We also, as part of our normal annual assessment on pricing and how we access a bigger population, we naturally go through pricing pressures. And historically, we've added patients at large enough clips, where when you saw price, you didn't necessarily see a slowdown in the growth because you had price, but you had new patients always offsetting that. We did see a soft new patient start in Q2 in those markets. And as a result, you saw the overall OUS business decelerate quite a bit from what we saw in Q1. That's really what happened. It's not inconsistent with what we talked about on the call. I think the question you asked is what happened and then what happens going forward? We haven't necessarily seen a waning of interest in those markets. There's been a lot of interest. We still have a lot of people that are curious about CGM. I think the biggest challenge is how do you get access to CGM in these COVID times. And interesting, a good example is in Germany, a lot of paperwork has to be exchanged, physical delivered hard copy paperwork. And prior to COVID, you actually had to have a nurse to visit you in-person before you could ultimately get on to the product. And so there's just been logistical challenges in terms of getting folks on to product just given this COVID period and as folks adjusts. Now the U.S. adjusted incredibly well to telemedicine. Some other countries haven't and some others necessarily haven't. And so I think it really just depends on how fast we get into this new norm. We're not going to necessarily comment on Q3, Q4. We gave guidance and guidances for the year is where it is. But I think that over time, what's going to be the driver of getting folks back on to therapy is how to get in access to the technology, not that there's no interest in it. And that's just going to take some time as we kind of weave through this new COVID world.
Larry Biegelsen
analystI wanted to ask about Japan. But before Japan, any -- when are we going to -- what's the status of other major markets? I don't know what you said about China and other big markets that you're not in today?
Steven R. Pacelli
executiveYes. I would say with respect to China, it's something we've continued to study. I would say we're probably more active internally with a group focused on China. But again, China is a 2 to potentially up to 3-year process from a regulatory -- clinical regulatory perspective. So you're not going to see us in China certainly next year. Within the next 2 to 3 years, though, I do think we'll be in China. We're studying kind of the market dynamics, who are the appropriate patients? What's the appropriate product configuration, that kind of thing. And then we're looking at India as well. Obviously, these are huge markets, right? They're largely going to be, we believe, are going to be cash pay market. So we wouldn't obviously wait for reimbursement in either. And then -- but I would tell you, again, in the next few years, Japan is probably, if you're looking at revenue contribution in new markets in the next -- new geographies in the next few years, I think Japan is probably the brightest star. I did do some very recent checking with our Japan team. And they're actually, based on your question, they are expecting reimbursement for G6 by kind of middle of next year. In which case, we would look to launch G6 in Japan into a reimbursed environment in the back half of next year. That's kind of the...
Jereme Sylvain
executiveYes. And to your question, Larry, other geographies. There's a lot of smaller geographies that have reimbursement when I say smaller, smaller compared to India and China, which is almost everybody. But there's a lot of other markets that we are looking into that do have reimbursement that we are looking at leveraging platforms to go in there. The reason I brought up the e-commerce channel earlier. Because it's an easy way to accelerate pretty quickly into reimbursed markets. And we're looking at ways to leverage off of that. So I think there's going to be a lot of smaller market entries. We're not willing to give up where those are yet for competitive reasons. But you can assume we are looking at new markets that we aren't in today. And as we move into those, we'll certainly give you guys the heads up.
Larry Biegelsen
analystSteve, on Japan. So that was new to me. Just so I heard it correctly. You said you expect reimbursement for G6 in Japan by the middle of 2021? Is that what I heard?
Steven R. Pacelli
executiveBy the middle of '21.
Larry Biegelsen
analystAnd what was the...
Steven R. Pacelli
executiveI can't give you pricing or anything, but we expect it to be -- we'll be happy with it, is what I believe. Yes. And so that would set us up then. We just made the decision not to launch G6 in Japan at this point because we don't want to launch it into an unreimbursed environment. And we want to make sure, like we've talked about previously, that we have the appropriate reimbursement established for the full-featured premium-priced CGM that we offer. So that's kind of what we're looking at is that we think we can, by middle of next year, have that reimbursement established. And then we would look to start to roll out G6 in Japan in the second half.
Larry Biegelsen
analystAnd the current code is very -- so it sounds like you're going to get a new CGM code because there is a CGM code today. But it's very -- it's restricted to certain facilities, and it's very restrictive on type 2s. Am I thinking about that right? If you're willing...
Steven R. Pacelli
executiveYes. I couldn't even -- I couldn't tell you what in terms of is it going to be broader in intensive type 2s? I don't know at this point. I think yes, the current coding is very restrictive in terms of sites actually have to have people who have actually literally been trained specifically on CGM before they're eligible to actually prescribe it to get reimbursed. I'm not close enough to it to know what sort of parameters might be going away with what we find middle of next year. But it's interesting. Actually, we'll dig into it a little as we get closer.
Larry Biegelsen
analystOkay. All right. Yes. I've been following your commentary on Japan over the like years...
Steven R. Pacelli
executiveThe net is, I think it is exciting. And I think when you look at new markets that could -- new geographies that could be increasingly interesting over the next couple of years with a launch of G6 in the back half of next year would be interesting there.
Larry Biegelsen
analystOkay. All right. That's a great update. And just scanning for questions coming in here. Hospital has been obviously an area of interest. So I guess, first question here, can you share any lessons learned or feedback from CGM use in this setting during COVID?
Steven R. Pacelli
executiveYes. I think that's actually a great way to phrase the question because again, we've never said we don't -- and still don't believe even the balance of this year that revenue from the hospital program is going to be meaningful in any way. But the learnings have been key. I mean, I think the biggest learning is that there is no one size fits all for the hospital segment in terms of perceptions of value, how do we integrate into the workflow is going to be one of the biggest challenges as we look to the hospital. But as you know, the FDA kind of laxed much like with COVID on the type 2 front. With CMS, the FDA actually did as a result of COVID allow us to go into the hospital where we were previously not labeled to do so. I think going forward, let's say, we come out of the COVID pandemic here this year into next year. The FDA is still going to require us to jump through the hoops that we've talked about previously. So when you talk about the drug interference testing and some of the other things that the FDA has been very clear. They're not just going to let us take the current commercial product and run in the hospital, even post COVID. While they're being flexible now, you mentioned before that the impact that COVID has had on people with diabetes, people who enter the hospital with diabetes are dying at a significantly disproportionate rate. So the FDA has recognized that and had been a little lenient. But I'll be honest, our team has done a remarkable job, but it's been very scrappy. I mean we -- cobbling up receivers and phones and stickying phones on the outside of an ICU room so that the nursing staff doesn't have to go in, they can monitor blood sugars. It's been remarkable to watch, and the learnings have been tremendous. But I still think before we have a meaningful hospital, what I would call a defined product and product offering that we're really aggressively attacking the market, it's still a few years away because we've got to do the work from an FDA perspective.
Larry Biegelsen
analystSteve, I've heard you talk more recently about partner in the hospital channel. I mean you obviously you have what I remember 10 years ago with Edwards. Is that -- are you leaning more towards finding a partner now for the hospital?
Steven R. Pacelli
executiveThat's -- list that as one of the to be determines. We're certainly exploring. There are others out there. We -- our current sales organization doesn't have hospitals selling experience, right? They're very, very focused and very good at selling into the endocrinology world. We don't have -- today, we don't have the staffing with the resources to attack the hospital, not to say that where we sit today in size and the balance sheet that we couldn't build that skill set internally. But it may behoove us to go with a partner or partners to better attack that market. That's something that doesn't -- that decision doesn't need to be made today because we're still -- like I said before, we can even sign up a partner and start to give them -- we would enable a partner to sell sensors into the hospital channel. We're just not ready. It's going to be a couple of years before we get appropriate regulatory approvals. And so but it's something we'll consider we can speak to more over the coming months and quarters.
Jereme Sylvain
executiveYes. And I think to Steve's point, I think the other question on hospital is what does the product ultimately look like? And how do you get the data? Do you need to have a phone sitting in hospitals? Or can we leverage off of existing infrastructure to do so? And whether that looks like a partner from a different perspective, that's the big question. I really think you need to work through, which again, we've essentially taken a product that was used for personal use and to Steve's point, we're really scrappy by putting a phone in the corner of the rooms, you can capture the data to put it up into the cloud, so people could use follow, so they could ultimately track them from another part of the hospital. In the future, do you want that to be integrated with the patient's overall vital signs? Or do you want that integrated in another way so they can monitor many remotely. Those are the kind of things we've got to work through from a true what a product offering look like, which will also help educate, not just from a commercial perspective, but a product development perspective.
Larry Biegelsen
analystOkay. I got a lot of questions e-mailed to me that I didn't see. So let me just kind of try to go through a couple of those, if that's okay? Did the price in the pharma channel reflects only higher markups in that channel or also price concessions to be on formulary?
Jereme Sylvain
executiveI don't know, let me try to interpret that. So I think the question was higher markups. So what we've said is pharmacy comes at a lower reimbursement to DexCom than the DME channel. And that's because all of the back-office work is then handled by the pharmacy and et cetera. Could there be price -- does price get driven -- is price reimbursement to us potentially determine where you sit on the formulary? It can. Sometimes what you'll have is you'll have -- somebody say, look, we'd like you to be higher on the formulary, but here's ultimately negotiation on price. If you do so, you'll be a preferred provider. That does come into play in some of these negotiations. Some of it is in the form of they think you have the better product. It really depends on the payer and it really depends on negotiations. So I hope I answered the question? I don't know if I quite got -- but I hope I got it.
Steven R. Pacelli
executiveThe only thing I would add is I think I read into that question. If the question is, are we at a place where we're having to fight Abbott for literally just fighting on price to obtain formulary position? The answer is no. And in fact, we're not -- and I don't -- we're not seeing Abbott aggressively trying to outflank us by lowering their price just to get a preferred formulary position at this point. We're not that low down in the mud.
Larry Biegelsen
analystOkay. A bunch of good type 2 questions came in. So I'm going to rattle them off. Given type 2 patients don't really go to Onduo channel, you broaden the sales force to primary care, do you partner for that market? You bypass the physician channel or reach that channel via Livongo and others like that? A lot of questions there.
Steven R. Pacelli
executiveNo. I would answer it simply all of the above. We could expand. We're never going to look like a pharma sales force, right? We're not going to have 1,500 salespeople calling broadly on primary care. But we may expand the sales force a bit to call on high decile insulin prescribers, for example, as we look to expand out the non -- or the intensive type 2 portion of the business. I think partnerships are great. We've talked about working with -- with Livongo. We work with. We work with a whole bunch of them, right? We work with -- I mean, Level2 is the program we talked about earlier. Onduo is still doing some good work. There's companies like WellDoc, we're not currently doing much with Alameda, but they're out there. There's a whole host of these companies that are all basically trying to offer the same type of holistic solution, right? Where you're taking sensor data and the sensor data is at the core of any of these programs but then offering other data points and really trying to consume other data inputs. And come up with a meaningful recommendation to the patient on how to better manage their diabetes. So I think that is also a way we would look to go-to-market through others. And then direct-to-consumer, like we talked about before, there's going to be a B2C opportunity for us in non-insulin-using type 2s that will develop over the coming years. And so I think the answer to that question is all of the above, we're going to approach it from multiple angles.
Larry Biegelsen
analystThanks, Steve. And then one other one, P&L question e-mailed to me. While confident in gross margin COGS, how do you hit the operating margin goals when you're getting significantly less revenue per patient in the future?
Jereme Sylvain
executiveYes. So it's a good question. A lot of the reduction in price is actually about moving to the pharmacy channel. And so when you move to the pharmacy channel, you actually eliminate a ton of OpEx, and it makes it actually more difficult to hit your gross margin target because your revenue is coming down, the cost of the product is still the same, but you eliminate the back-office costs associated with supporting a good chunk of those back-office costs. We've talked about reducing costs in COGS by, obviously, scale, automation, designing costs out. I think you've seen it over the course of this year, where we've given up on price yet, our margins are improved over the prior year. And I think what you'll see over time is we'll continue to design costs out of the product. That's part of the key tenants for us launching a new product, just thinking about how to design cost out of it. That then makes it easier on the operating margin profile because you can maintain margin, but you can reduce some of those back-office costs associated with it, that's ultimately how we plan on scale. And I think that's where I think when you think about the total profit dollars that you get as a result of every patient in the pharmacy versus DME. While DME is a higher revenue target, the cost of serving it is so much higher. The net operating profit dollars are around the same, if not even more profitable in the pharmacy channel once you get to scale in that channel. And yet the patient experience, to your point, Larry, earlier, getting ease of use on the product is so much easier to the pharmacy channel, you can lose those barriers, which helps obviously then drive adoption and drive volume.
Larry Biegelsen
analystThat's helpful. One other question. You announced to me. What have we learned about how the device functions with all the potential interfering substances? This is in the hospital setting. Does it work poorly in perfused patients in the ICU? Hopefully I...
Steven R. Pacelli
executiveYes. No, you got it right. I would tell you, anecdotally, the feedback we're hearing is good. I couldn't give you any -- we're not hearing any major complaints about the performance of the sensor. So yes, I think we've always been confident that the sensor will work in that environment. We just need to do the appropriate testing to convince the FDA of that. But yes, so far, so good in what we're seeing. Anecdotal, we don't have any hard data to show you guys.
Larry Biegelsen
analystOkay. A couple more questions here. You guys have been very patient with all these questions. So thank you. It takes endurance, I think. So pregnancy, what are the next steps here for pregnancy in the U.S.?
Steven R. Pacelli
executiveYes. So we're much like these other initiatives, where we've got a group focused specifically on pregnancy. The first indication that we would look to obtain in the U.S. would be removing the pregnancy effectively contraindicated for pregnancy. And so that's well underway. Then the next step would really be to look to -- I mean, my dream, of course, is that you replace for all pregnant women, not just women with diabetes, you could ultimately try to replace the oral glucose tolerance test by putting a sensor on to a patient, right? So if you think about we're just starting to roll out our G6 pro offering, what a perfect solution, right? Where you could send -- literally send the box to a woman who's pregnant coming in for a visit, you send it to them a week or 2 in advance, they put the sensor on, collect data for a couple of weeks. The doctor could get such a better picture of what the glucose profile looks like from just a single sensor session. And if they identify there's a problem, that's when you move into an environment where we would hopefully have better reimbursement for gestational or diabetes. If the doctor can identify using a CGM that the patient is at risk, then they probably stay on CGM for the term of the pregnancy. So again, not going to be a big revenue contributor in the next year or so. But as soon as we get -- I think the first step would certainly be pregnant women with wearing CGM throughout the term of their pregnancy is going to be with diabetes wearing it through the term of the pregnancy is going to be the first shot. And then really that diagnostic application to something -- it's going to take some clinical work. We're going to have to run a clinical trial to show -- we get to show the safety and efficacy of using the product as a diagnostic tool in that environment, but I think we can do it.
Larry Biegelsen
analystThat's helpful. And you have trials ongoing for that whole range?
Steven R. Pacelli
executiveWe do. Yes. There's lots of smaller. I wouldn't call anything we're doing a kind of pivotal like trial there. But yes, we've got all kinds of stuff going on.
Larry Biegelsen
analystSteve, just switching gears, smart pens. What role do you see for smart pens in the future?
Steven R. Pacelli
executiveYes. I mean, I've always been -- I probably was one of the early components of smart pens talking at investor conferences early on. I think -- I think to the extent we can either through our type 0 subsidiary or with partners develop appropriate data analytics to marry the CGM data with the data that we can obtain from the smart pen. I think it offers a very elegant solution. It's not a fully automated insulin delivery system, right? But we know that not every patient is going to want to wear a CGM and the pump. So having basically what I would call kind of a poor man's artificial pancreas, if you can take the data from the CGM and have effectively the same data that the pump is aware of based on the insulin that's being delivered. Marry that data on an app on the phone and then be able to feedback to the patient some meaningful information on how to better adjust their insulin dosing based on other factors, too, based on exercise, based on if they had a big meal or a small meal. There's all sorts of opportunity there. But I do think you can deliver a solution like that at a much lower cost than having a CGM and a pump. And so if you can produce outcomes, that are similar. And we have done this and we've seen outcomes that are very similar in patients wearing a pen and a CGM versus a pump and a CGM, then it becomes really a payer question, right? That if maybe become somewhere sort of a step function in therapy where the doctor might put the patient or the payer might require the patient to go on a system that is comprised of a smart pen and a CGM. First, and if they can't meet their goals, if there's other reasons that a patient really should be on a more automated system, great. Those patients will still have access to that. But it may be the case that people can reach their goals in terms of their diabetes management with something that's a little less complex and a lot less expensive.
Jereme Sylvain
executiveYes. And it's such an interesting space, Larry. When you think about the MDI world, right? In the pen world, it's so much larger, especially outside the U.S. than the pump market. And even if the pump market in the type 1 space, and you hear the various, how many folks will ultimately adopt it? How many won't? And the type 2 intensive space is certainly a bit lower. And I think the expectations is the pump adoption is lower. And that's U.S., outside the U.S. it's much bigger. So you're talking about a huge TAM in this space where you can add some smartness to a technology that I think by a CGM and a smart pen, you can add really a lot of value to these folks with the CGM ultimately driving a lot of insights.
Larry Biegelsen
analystSo I mean you guys are agnostic. You're used with pumps and pens. Do you see pens kind of blunting the penetration of pumps in the type 1 population? I mean, the pump companies are obviously trying to drive that penetration higher. Do you -- what's your view on what impact smart pens have on pumps?
Steven R. Pacelli
executiveYes. Certainly, I don't think so in the U.S. where pumps are readily reimbursed. I think as Jereme mentioned, it's really outside the U.S. where it's often much more difficult to obtain a pump, where I think the smart pen CGM combo could have a much greater impact. In the U.S., if you're a type 1 in the U.S., you can have commercial insurance, you can pretty much get the pump, right? It's not -- it's going to be reimbursed.
Larry Biegelsen
analystThat's helpful. Just a couple more here, and let me scan the e-mail. Right. We've got, I don't know, 10 more minutes or so. I think we're actually going to wind up going for an hour and 10 minutes. I've got 70 minutes on you guys. So thank you. 2 last questions here. Well, let me just ask on Libre 2. We didn't really talk about that at all. What are you seeing in the market? Anything different since you've just recently launched after Libre 1.
Steven R. Pacelli
executiveIt's just launched. So what we're hearing out of the field is really -- it looks and feels a lot like a Libre 1, performs about the same. We haven't heard much in the way of the alarm performance, either positive or negative. I read some blog reports and some postings that say people are a little annoyed by the alarm, particularly in the hypoglycemic range because the accuracy still isn't there. But again, that's -- and a very -- very few people and reading on the internet, right? So I think we've always said that the product performance is what will determine the success of this product. And it doesn't appear to us from the data and some of the early reports from the field that the performance of the sensor is really materially different than the Libre 1. So that's kind of where we are today.
Larry Biegelsen
analystOkay. And then Abbott also appears to be developing Libre for measuring other analytes and possibly targeting non diabetes populations. Where are you guys on these initiatives?
Steven R. Pacelli
executiveYes. We have a number of initiatives on the alternative analyte side. I'm not going to get into specifics because it's a little bit kind of close to the vest. We don't need to give Abbott that playbook. The real question really turns on which analytes and which analytes will have the largest addressable market, which alternative -- other analytes, alternative analytes should be sensed continuously. It may not be the case that everything needs to be sensed continuously. We have technologies to be able to sense in a single platform, multiple analytes. We're working on that as well. It's really -- it's a combination of technology development, and then really figuring out what's the appropriate markets to attack, right? Is it lactate, ketones, all the things that we've talked about previously in our public commentary, that's really -- the work on the technology side is ongoing, but the work on the market research side is also ongoing because we need to make sure that we build it and they will come kind of theory, right? We need to make sure there's a real market for these things.
Larry Biegelsen
analystWith, G7, you've said it's only glucose, no other analytes. Is that right?
Steven R. Pacelli
executiveAs of today, it will only be glucose. Correct.
Larry Biegelsen
analystI got it. One question e-mailed to me and maybe our last one. When do we see the next iteration of type 0 algorithm, docs are able to get out free Libre samples in the office? How do you respond to that?
Steven R. Pacelli
executiveSo 2 different -- completely different questions. Yes, type 0 certainly continues to develop next-generation algorithm technology. I'm not going to comment on the timeline there. It will result in some clinical work that would have to be done on that algorithm. As for sampling, you will likely start to see some DexCom sampling in the clinician's offices. There are some regulatory constraints that we were bound by previously that we think we've largely overcome that would enable us to do that. So I think stay tuned in the second half of the year, you're going to see some sampling availability from DexCom.
Larry Biegelsen
analystWhat are the regulatory requirements to sample?
Steven R. Pacelli
executiveIt really has to do with being a provider to the federal government, direct provider to the federal government. We've kind of moved away from that in our Medicare business. And so once we're not providing product directly to the federal government or billing the federal government directly, we're able to do that.
Larry Biegelsen
analystAnd so second half of this year, that implies G6 not waiting for G7?
Steven R. Pacelli
executiveNot waiting for G7. Correct.
Larry Biegelsen
analystAll right. Well, I'm looking at my e-mail. Speak now or forever hold your peace as they say. We'll end a few minutes earlier. If there are no other questions from people on the line. Steve and Jereme, I can't thank you enough. This was very generous of you to do a full hour, maybe even 64 minutes here. Steve, is there anything or Jereme, anything we didn't touch upon or you wanted to communicate?
Steven R. Pacelli
executiveIt was pretty comprehensive. Yes, I mean, I think we covered everything that everybody's been asking post-earnings. So it's great.
Larry Biegelsen
analystAll right. Thank you very much for your time, Jereme and Steve.
Steven R. Pacelli
executiveThanks, Larry.
Jereme Sylvain
executiveTake care. Thank you very much.
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