DexCom, Inc.
Q3 2016 Earnings Call Transcript

Published: 2 Nov 2016

[Operator:]

Welcome to the DexCom Third Quarter 2016 Earnings Release Conference Call. My name is Adrian and I'll be your operator for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session. Please note, this conference is being recorded. I'll now turn the call over to Kevin Sayer, President and CEO. Kevin Sayer, you may begin.

[Kevin Ronald Sayer:]

Thank you very much and thanks everyone for listening to our third quarter conference call today. We'll start off by turning the line over to Steve Pacelli for our traditional Safe Harbor statement. Steve?

[Steven Robert Pacelli:]

Thanks, Kevin. Some of the statements that we will make in today's call may constitute forward-looking statements. These statements reflect management's intentions, belief and expectations about future events, strategies, competition, products, operating plans and performance. All forward-looking statements included in this presentation are made as of the date hereof based on information currently available to DexCom and are subject to various risks and uncertainties, and actual results could differ materially from those anticipated in the forward-looking statements. The factors that could cause actual results to differ materially from those expressed or implied by any of these forward-looking statements are detailed in DexCom's annual report on Form 10-K, quarterly reports on Form 10-Q, and other filings with the Securities and Exchange Commission. Except as required by law, we assume no obligation to update any such forward-looking statement after the date of this presentation or to confirm these forward-looking statements to actual result. Additionally, during the call, we will discuss certain financial measures that have not been prepared in accordance with GAAP with respect to our cash-based operating results. The presentation of this additional information should not be considered in isolation or as a substitute for results or superior to results prepared in accordance with GAAP. A reconciliation of the non-GAAP financial measures to the most directly comparable GAAP measures can be found in today's press release, which is available on our website. Kevin?

[Kevin Ronald Sayer:]

Thank you, Steve. Joining me today are Jess Roper, our Chief Financial Officer; and Steve Pacelli, our Executive Vice President of Strategy and Corporate Development. Sticking with our usual format, Steve will review our third quarter financial results and I will follow with our customary operations update and offer some concluding thoughts before opening the line for questions. But before I turn the call over to Steve, I want to take a few minutes to discuss recent developments in the U.S. competitive landscape. Approximately a month ago Medtronic announced it had received FDA approval of the 670G hybrid closed loop system. Since that time, there has been significant press surrounding this product, which has created a considerable – which has created considerable confusion in the marketplace. For example, we've recently attended a diabetes charity event where it was declared from the podium that Type 1 diabetes is now being cured because of the FDA approved artificial pancreas. Clearly, this is not the case, patients and caregivers are showing signs of skepticism and frustration due to the over-hype of the promise of this technology. Our review of the currently available data suggests that although this product may be an incremental step in automated insulin delivery, it appears to be an extremely complex system and its real world performance remains to be seen. Earlier that same day Abbott announced FDA approval of the FreeStyle Libre Professional System. This system is not a direct competitor to our core commercial product portfolio in the U.S., as the data generated by the sensor is blinded to the patient and only made available to the clinician retrospectively. Additionally, the first independent studies regarding Libre's performance as a consumer device are beginning to be published, when compared Libre to DexCom G5 where DexCom CGM outperformed on nearly every metric, including improved time in range and reduced time in hypoglycemia. Just last week, at the ISPAD Meeting in Spain, a pediatric study was published showing that Libre accuracy is inconsistent and not reflective of previously published data. Put simply, this form of technology does not achieve the same results in diabetes management as CGM and alerts and alarms and real-time communication are very critical in generating real clinical outcomes. While we are always vigilant of these well resourced (04

[Steven Robert Pacelli:]

Thanks, Kevin. DexCom reported revenue of $149 million for the third quarter of 2016 compared to $105 million for the same quarter in 2015, a $43 million or 41% increase. Sequentially, revenue for Q3 was up approximately 8% from the prior quarter. Our third quarter gross profit was $101 million, generating a gross margin of 68% compared to a gross profit of $75 million and a gross margin of 71% for the same quarter in the prior year. As we mentioned during our Q2 earnings call, our warranty costs remain higher than historical levels due primarily to the receiver recall. This has impacted gross margin by 1 point to 2 points during Q3. However, as expected, warranty costs as a percentage of sales began to decline in Q3 and should normalize before the end of the year. Some final thoughts on our revenues and our gross profits, our mix between durable and consumable products was within our normal historical range in Q3 at approximately 30% durable and 70% consumable. The ASP for our hardware has remained stable and sensor pricing remains within an ASP range of $70 to $75 per sensor. Finally, our international business showed continued year-over-year growth generating $18 million in revenue during the quarter, up 29% from last year. Although, international sales were relatively flat sequentially, OUS revenues are up over 40% year-to-date. Research and development expense totaled $44 million for Q3 of 2016 compared to $65 million in Q3 of 2015, with the decrease due primarily to the $36.5 million non-cash milestone payment to Verily in connection with our collaboration offset by increases consistent with those we have discussed throughout the year. Specific to our near-term pipeline, during the quarter we incurred significant expense associated with our G6 pivotal study, our continued efforts with the FDA to obtain a non-adjunctive claim for our system, and several other recent FDA submissions. We also incurred significant expense related to our advanced product pipeline, particularly expenses associated with our Verily partnership, future generation sensor technologies, and the building out of our data platforms. Selling, general and administrative expense totaled $76 million in Q3 of 2016 compared to $52 million during the same quarter in 2015 with the increase due primarily to year-over-year increases in head count in our customer support organizations as well as a ramp in our patient-focused marketing expenses, higher IT costs, and investment in our OUS expansion efforts. Our net loss for the third quarter of 2016 totaled $19 million, which included $34 million in non-cash expenses centered primarily in non-cash share-based compensation expense across all functional areas of our business. Our net loss was wider than Street estimates and even our own internal expectations due to a number of factors including, one, building out our customer ops and tech support infrastructure to address the customer service issues we experienced during the first part of the year. We believe that these groups are now staffed appropriately to support our anticipated growth and new product launches through 2017. Two, increased direct-to-consumer marketing in Q3, which we expect to further increase in Q4 as our metrics suggest strong conversion rates with our early programs. And finally, we added new senior talent during the first part of the year, which led to incremental compensation expense and some severance expense during the quarter. We also remind investors that our operating expenses this quarter included increased spend on the four strategic investments that we outlined at the beginning of the year, namely our Verily relationship, building out our data analytics capabilities, international expansion, and finally our new manufacturing facility in Arizona. We're now trending to the $40 million of incremental expense we outlined earlier this year. Absent non-cash charges, non-GAAP cash-based net income was $15 million for Q3. Our GAAP loss per share for the quarter was $0.22. We ended the third quarter with $127 million in cash and marketable securities. And with respect to 2016 revenue guidance, we currently believe that we will fall within the mid to upper end of our range of $550 million to $575 million in revenue for the year. However, we do not expect to exceed the top end at this time. With that, I'll turn the call back to Kevin for a business update.

[Kevin Ronald Sayer:]

Thank you, Steve. As many of you know, during the past few years, we have consistently increased our annual revenue guidance on the third quarter call. We're obviously pleased with our continued growth during Q3 and adoption of DexCom CGM remains very robust. More importantly, the majority of our new patient additions are now MDI patients, a long-stated goal of our company. But there are some variables we are currently experiencing that we haven't seen in prior years. First, our hardware sales model has been significantly affected by the issues we've encountered with our receiver and the related product recall. Numerous patients have returned their receivers for new ones free of charge. Historically, these would have been revenue-generating replacement receivers particularly in the fourth quarter as our patients' out of pocket expenses are much lower than any other time of the year. I would like to note, however, that we have completed all of the compliance procedures related to this recall and have filed the appropriate documentation with the FDA to close out this action. Next, our international business grew 29% in Q3, a bit slower than the past several quarters, and our sequential increase from Q2 is relatively flat. In countries where CGM is not reimbursed Libre has gained traction with its low-cost approach. As we consulted with healthcare providers and patients in these markets, we found that these are cost-based decisions not performance-based decisions, and virtually any one we speak to would agree that our system offers so much more. This is exemplified by the recent reimbursement decision in Germany to not cover products like Libre. We remain optimistic about our long-term international growth outlook, particularly in EU, where we have made early progress on the reimbursement front, and other geographies in addition to Germany. Our biggest growth opportunity internationally remains reimbursement for CGM. We knew that going into 2016. And that's why we made the decision to establish our international headquarters and to begin to ramp up our internal sales and support staff. Germany represents a prime example of this strategy. We evaluated the opportunity and determined the best way to attack here was to bring our distributor team into DexCom. We expect to make additional international investment to obtain reimbursement and accelerate growth in reimburse markets in future years. Finally, as I mentioned in my opening remarks, there's a lot of confusion in the U.S. marketplace today. The media blip surrounding what is being called the new artificial pancreas has been deafening. Based on what they've been told, many patients currently perceive that they will no longer need to manage their diabetes if they purchase this product. Therefore, many patients are willing to delay purchase decision until this system becomes commercially available, or they're being directed to purchase the current Medtronic offering, with the promise of being first in line for the 670G. So in the short-term, we intend to focus on the following

[Operator:]

Thank you. And our first question comes from Mike Weinstein from JPMorgan. Please go ahead.

[Michael Weinstein:]

Thank you and good afternoon guys. So Kevin – so the first question is, it sounds like the – it sounds like the approval of 670G and all the discussion around it has basically taken up all the noise in the room and made things a little bit more difficult for the rest of the diabetes players. I don't know if you saw it, but Tandem reported relatively soft results and guided down for the year. So it sounds like that's kind of occupying all the discussion right now in this space. So two questions. One, can you maybe just characterize kind of the tone of business kind of pre and post that? Obviously, it's reflected in your guidance commentary for the fourth quarter, but any other color there would be great. And then, two, how do you change that dynamic? How do you make it, so that you're not spending the next six months trying to get people's attention when Medtronic seems to have dominated the discussion over the last month? Thanks.

[Kevin Ronald Sayer:]

Well, Mike, not only getting their attention, but talking about a product that's not commercially available yet that patients can't see and the perception being created that it truly is an artificial pancreas. Where we're taking the discussion Mike is back to the fact that CGM is the most important tool in intensively managing diabetes. And the outcomes we've achieved in the DIaMonD study, there are several other studies coming out in the not too distant future that are similar to that real world studies, are great outcomes. Our problem – the doctors have been very supportive. They're very much taking a wait-and-see attitude. We've done very well with clinics in getting our message across to them. Again, it's just this confusion or cloud that's hanging above us all. We'll focus on CGM first, quite honestly, in the fourth quarter, in particular the investment in CGM. If somebody's made their (23

[Operator:]

And our next question comes from Ben Andrew from William Blair. Please go ahead.

[Ben C. Andrew:]

Good afternoon. Thanks for taking the question. Kevin talk a little bit about international being flat sequentially. Can you kind of attribute some of that – what amount to the move to direct operation separate of maybe an impact from Libre? And then, second, how should we think about the impact of you guys going direct and getting reimbursement, and when that will begin to impact revenues at least in Germany?

[Kevin Ronald Sayer:]

So there was no impact in Q3 with respect to reimbursement in Germany. And if anything, what we did is, we've significantly increased our operating expenses by adding the operating expenses of our distributor to our own expense line. We are seeing now, as reimbursement is starting to sporadically come in for some of the payers in Germany, there are opportunities of new patients, have gone up quite significantly. I think, there will be a bit of a bump in Q4 for 2016 for Germany. But it really is more of a 2017 event than it is late 2016, probably more Q2 and beyond, again as we have to get reimbursement and insurance contracts signed up. But the – we have the staff to go do that and we're calling on the people we need to meet, we can (25

[Ben C. Andrew:]

So as we think about kind of the transition here while we wait for the other products to show up in the market if they actually – obviously (26

[Kevin Ronald Sayer:]

I'll let Steve start, (27

[Steven Robert Pacelli:]

Yeah. I mean, obviously, Ben, we'll give formal guidance for next year in January; it's something we're still evaluating. I would tell you, we're starting to see new patient adds pick up again. I think, it's too early to tell. I wouldn't even want to speculate on Abbott. The challenge we have with Medtronic, we – as Kevin mentioned, we went through this exact same thing with 530G, it was close to (27

[Kevin Ronald Sayer:]

Yeah.

[Steven Robert Pacelli:]

...I'm not sure how to speculate on the impact.

[Kevin Ronald Sayer:]

I think we need to see what the fourth quarter brings and we need to see what our – we also have a non-adjunctive claim on the horizon, and I believe that could be a very big deal for marketing and positioning DexCom (28

[Ben C. Andrew:]

Last question from me, is it then fair to assume hardware as a percent of revs drops below 30%, just because of the warranty stuff you mentioned and then perhaps the patients starts and replacement of hardware for maybe the next one quarter to three quarters? Thanks.

[Steven Robert Pacelli:]

Ben, what we've said when we started the G5 transmitters is that it was (29

[Kevin Ronald Sayer:]

We were selling (30

[Steven Robert Pacelli:]

We were selling (30

[Ben C. Andrew:]

Thank you.

[Operator:]

And our next question comes from Jayson Bedford from Raymond James. Please go ahead.

[Jayson T. Bedford:]

Good afternoon. Can you hear me, okay?

[Kevin Ronald Sayer:]

Yes, Jayson.

[Jayson T. Bedford:]

Okay. You kind of alluded to it, but have you seen any change in the attrition rate with the launch of G5?

[Kevin Ronald Sayer:]

No.

[Steven Robert Pacelli:]

No.

[Kevin Ronald Sayer:]

No, we have not. We think our patient retention metrics are still very good. I would tell you the thing that may have changed and we're studying this a little bit, and I can't give you complete color, because we study retention all the time. As we enter a broader market of patients – our early adopters were pretty intense on CGM, I need CGM or I'm going to die basically was often the statement that we'd hear from patients. As (31

[Jayson T. Bedford:]

Okay. And you mentioned some of the marketing initiatives that you have, but just given some of the stiffer headwinds, any thoughts on adding to your sales team going forward?

[Kevin Ronald Sayer:]

We are going through our 2016 planning efforts right now. More than likely, we will expand the team. We'll announce how much, and to what extent, in early 2016.

[Jayson T. Bedford:]

Perfect. Okay.

[Steven Robert Pacelli:]

2017.

[Jayson T. Bedford:]

Okay.

[Kevin Ronald Sayer:]

I'm sorry, early 2017. Thanks, Steve.

[Jayson T. Bedford:]

Just, I guess, lastly from me. On Germany, can you just give us any clarity on the level of reimbursement, or how ultimately price will shake out? Are the economics comparable to the U.S. for DexCom?

[Steven Robert Pacelli:]

Yeah, actually without giving you specifics, the preliminary numbers that I've seen look quite favorable, even with respect to – in comparison to what we see here in the U.S. And that, I would tell you, I spoke to John Lister, who heads up our European operation yesterday, and he informed me that we're currently in discussions with approximately 40% of the covered lives, if you want to look at it that way, in Germany, and the pricing looks quite favorable.

[Jayson T. Bedford:]

Okay. Thanks. I'll let someone else jump in.

[Operator:]

The next question comes from Kyle Rose with Canaccord. Please go ahead.

[Kyle William Rose:]

Great. Thank you very much. Can you hear me all right?

[Kevin Ronald Sayer:]

Yeah, we can.

[Kyle William Rose:]

Okay. I just wanted to touch on the G5 and the potential dosing claim. Just any color you can add just – with the conversation with the FDA, as far as potential changes from a product perspective that they may be looking for, whether it be a required number of calibrations a day or sensor shut off, or something along those lines?

[Kevin Ronald Sayer:]

Yeah. No, nothing in particular. I think what the FDA is really focused on right now is really, what sort of standards do they want to set. What bar is going to be the bar for a dosing type sensor, right? Meaning, not just MARD, but we focused in on %20/20 and outliers and things like that. The FDA is focused – we mentioned in the prepared remarks – the FDA is focused on manufacturing standards, manufacturing variability, things like that. So there is a whole bunch going into this, and very thoughtful, frankly, on the part of the FDA; and it's just taking a little bit longer, is all. But we're not going to – I don't expect they come back and ask us to modify the product in any way.

[Steven Robert Pacelli:]

And I'd just add, that's one of the reasons for the post-market study. And after the post-market study, if we see anything, then we would go back and discuss it with them. But for today, there's nothing significant.

[Kyle William Rose:]

Okay. I appreciate the color there. And then just lastly, on the quarter, any comments directionally on new patient additions and what the type of mix was there? I believe last quarter you talked about 50% of patients coming from MDI. Just any sort of color you can give us on this quarter?

[Kevin Ronald Sayer:]

Once again, a lot of (34

[Kyle William Rose:]

Great. Thank you very much for taking the questions.

[Operator:]

And the next question comes from Doug Schenkel from Cowen & Co. Please go ahead.

[Unknown Speaker:]

Hi. This is Ryan Blicker (35

[Kevin Ronald Sayer:]

I think sensor usage for the first nine months of the year is really consistent with what we've had before. What I was trying to do in making my comments was indicate that, again, patients continue to use it long, particularly those where reimbursement is tough for them and they're not covered as well as others, and again, some of the new patients. But I don't think there has really been a significant change in sensor utilization. But as the whole population gets bigger, the portion or just the raw numbers of people who use their sensors longer is going to go up, and so it becomes more visible to us as we look at it, same with the use patterns. We go through exercises, I've got (36

[Unknown Speaker:]

Okay. Thank you. That's helpful. And then, you talked about the impact Libre had internationally. Can you talk more about the features of your first-generation Verily product and how it stacks up versus Libre for Type 2 patients, or maybe Type 1 patients in the near-term who might desire a less comprehensive solution? Thank you.

[Steven Robert Pacelli:]

I mean, certainly the first product – well, let me couch this first by saying, we don't believe the first product that we launched in partnership with Verily is going to be a null (37

[Kevin Ronald Sayer:]

It's a learning experience.

[Steven Robert Pacelli:]

It will definitely be a smaller form factor than the Libre platform. In many ways, similar attributes, no calibration up to 14 days. I think the performance characteristics – and you guys will be pleased when you see the data at DTM next week. It incorporates the core Gen 6 sensor technology. So you'll see some preliminary data on that next week, and you'll understand the levels of performance that we'll be able to achieve with that product. So I think that'll be a real positive for us. But in many respects it's a smaller, better performing version of the Libre.

[Kevin Ronald Sayer:]

Yeah. And I would add one of the things that will dictate the software around that product and the feature set is going to be our non-adjunctive label. Because as we head into particularly intensively in each (38

[Steven Robert Pacelli:]

I should add two key differentiating factors. Of course, that it does have Bluetooth technology and does have real-time alerts and alarms as part of the system.

[Kevin Ronald Sayer:]

Yeah.

[Kevin Ronald Sayer:]

That's an important point not to overlook.

[Operator:]

And our next question comes from David Lewis, Morgan Stanley. Please go ahead.

[John J. Dunn:]

Hello. This is actually John Dunn checking in for David. Thanks for taking the questions. I wanted to go back to the topline guidance. You mentioned the number of times that you see the sustainable growth rate of this business, about 35% to 40% I think is what you've said historically. And the guidance range, as we look into the fourth quarter, I guess, implies just shy of that even at the top end. So should we think of the fourth quarter more as fully baked in for these competitive pressures, and that from that base we can start to recover back to more of a normalized rate? Or do you think that could potentially get larger impact sequentially for a couple of quarters as the launches continue competitively?

[Steven Robert Pacelli:]

The first part of the question, we don't have a crystal ball to tell you, this confusion – there's initially substantial confusion in the marketplace. We're now starting to see some press to the contrary where they're trying to clear up (39

[Kevin Ronald Sayer:]

We need some time. The flip side of that – and I'll cover a little more in my close. Penetration in the Type 1 market for CGM is still not above 20%; there is plenty of runway there. We're not penetrated in someone using Type 2s at all where reimbursement will come there. So I think it'll be a combination of when we can get our new technologies and products out and feature sets, we can expand to broader populations, combined with just market penetration in the current markets where we sit. So we'll just see it over time.

[John J. Dunn:]

Understood. Very helpful. And just a follow-up on gross margins. I mean, you mentioned last quarter they would jump back up to the upper 60%s; they certainly did. Sounds like there's still elevated levels of warranty expense. So normalized for that, is that – is it fair to say that we can get back in towards the 70% levels?

[Kevin Ronald Sayer:]

I think that's fair. Our warranty expense was about 3.5% of revenue versus our historical averages of about 2%, so we have some opportunity there. The margins came up this quarter kind of in combination of lower warranty cost as a percentage of revenues. We also had better yields particularly on our Gen 5 Mobile transmitter, and then of course we had higher sales volume.

[John J. Dunn:]

Understood. Thank you.

[Operator:]

And our next question comes from Joanne Wuensch from BMO Capital Markets. Please go ahead.

[Joanne Karen Wuensch:]

Good afternoon and thank you so much for taking my questions. I really have two. We focus mostly on German reimbursement. Can you give me a timeline of when we might get additional reimbursement? And then, my second question has to do with the non-adjunctive claim. Is there anything qualitatively that you can provide regarding the conversation that you're having with the FDA?

[Kevin Ronald Sayer:]

On the non-adjunctive claim, we're really not going to provide any more details than we have. We need to work through the requirements and standards and really have a clear position before we explain everything to everybody. Again, I'll echo Steve's comments. The discussions have been very good and very focused and very regular. They've been paying significant attention to the process and we hope to get through it soon. With respect to the other geographies, we really don't have timelines. One of the things we're learning as we go to other geographies, a lot of these places are – national physicians are (43

[Joanne Karen Wuensch:]

Okay. Thank you very much.

[Operator:]

The next question comes from Tao Levy from Wedbush. Please go ahead.

[Tao L. Levy:]

Yeah. Hi. Can you hear me?

[Kevin Ronald Sayer:]

Sure.

[Tao L. Levy:]

Okay. Perfect. Great. Just a couple quick questions. Am I right in sort of estimating that there is maybe about a $3 million impact from receivers on the revenue line in the quarter, that kind of ballpark?

[Kevin Ronald Sayer:]

We're not going to quantify it.

[Tao L. Levy:]

Okay. And then, in terms of CMS; it doesn't sound like these are sort of linear discussions where you're waiting for FDA approval of the non-adjunctive and then you'll go to CMS. It sounds like there is positive dialog going on around – ahead of that, is that fair?

[Kevin Ronald Sayer:]

Yeah. That's a fair statement. In fact it's communication together, CMS and FDA and our regulatory folks. So, yeah, there are certainly discussions ongoing. Obviously, we will still need the non-adjunctive labeling before we can really become active with CMS. But I would say this is a – and it's highly visible not just with FDA, but within CMS as well. I do think – our belief is that CMS is going to ask us to go direct with our national coverage decision as opposed to trying to go regional like we had discussed previously. But (45

[Tao L. Levy:]

Okay. Thank you. And then just lastly, in terms of data that's going to come out next week, what specifically – are these patients from the pivotal trial or is this another study that you have going on with...

[Kevin Ronald Sayer:]

With all of our sensors we run several pre-pivotal studies. The data that we'll present next week is from relatively large pre-pivotal studies in our Gen 6 platform. And that will be what's presented (45

[Tao L. Levy:]

Thank you.

[Kevin Ronald Sayer:]

It's not the pivotal data, because we wouldn't open that up till – until it's done, until we submit it.

[Tao L. Levy:]

Yeah. (46

[Operator:]

And our next question comes from Anthony Petrone from Jefferies & Company. Please go ahead.

[Anthony Petrone:]

Thanks and good afternoon. Maybe just a little bit on CGM pricing broadly. You know you have 670G out there and then Libre and I think there is the potential for some other CGM clearances in 2017, if I'm not mistaken. I mean, how do you see pricing kind of shaking out with all the increased technologies on the marketplace at this point? And then, I have just one follow up.

[Kevin Ronald Sayer:]

We've remained relatively consistent on the price front for quite some time. I think future prices will be accepted by the – will be determined by the outcomes one can generate with the technologies. Another big factor on pricing is going to be the length to wear the sensors, because we've talked about our Gen 6 sensor, is a 10-day product versus 7-day product, which gives us an opportunity to either increase price or increase value to the patient and payer and we'll probably end up with a combination of both with the Gen 6 sensor. We prepare internally scenarios for every alternative; we prepare for higher prices, we prepare for lower prices, we prepare for everything you can imagine. And so we've modeled several scenarios, we'll adapt to where the market takes us, and being the leader we want to take the market obviously to the right place. But these technologies have to be affordable for patients and they have to provide outcomes that are worth more than the cost of the CGM system. And that's how we look at pricing in the future.

[Anthony Petrone:]

That's helpful. And maybe just a follow up on 670G, and when you look at the dynamics between pumpers and MDI, it seems to me that the initial low-hanging fruit would be pumpers. But, I mean, how much of a broad push are you expecting from 670G? Are they – do you think it's sort of going to be broad based in those two categories and therefore potentially more competition in the MDI segment of the marketplace? Thanks.

[Steven Robert Pacelli:]

I think – that's the big question, right? So when Terry and Kevin – I'm speaking for Kevin who is sitting here. But when Terry and Kevin sold MiniMed 15 years ago, pump penetration was at about 20% in the U.S.; today it's at about 30%. So 15 years later, four commercial pump companies have been able to drive an additional 17 points (48

[Anthony Petrone:]

That's helpful. Thank you.

[Kevin Ronald Sayer:]

Well, said.

[Operator:]

And your next question comes from Rebecca Wong (49

[Unknown Speaker:]

Hi. Can you hear me, okay?

[Kevin Ronald Sayer:]

We can.

[Unknown Speaker:]

Hi. This is Rebecca (49

[Kevin Ronald Sayer:]

The DIaMonD study has not been officially published in a journal yet. So we remain relatively low key about that data. At this point of time, we know it is under review. Right now, we are going to be a little more aggressive with marking it, because we think (49

[Unknown Speaker:]

Yeah. So can you provide like more color on the timing of the rest of the DIaMonD data to be released this year or...?

[Kevin Ronald Sayer:]

There is a couple of other study arms. There is a Type 2 patient study arm. There is also an arm of the study where some of the patients continue to use CGM for a longer period of time, another group of patients who continue to use CGM, they go to an insulin pump in addition to CGM. I know the studies are winding down. I don't have timelines for you, and they'll be affected (50

[Unknown Speaker:]

Thank you.

[Operator:]

And our next question comes from Jeff Johnson from Robert Baird. Please go ahead.

[Jeff D. Johnson:]

Thank you. Good afternoon, guys. So two quick questions here. One just on G6, it seems like the pivotal is moving very quickly there and FDA has also seemed to be moving fairly quickly in some of their approvals recently. So just wondering how solid you feel on that 2018 commercial launch time? What are the options to maybe pull that forward or see that move up a little bit from a potential launch standing?

[Kevin Ronald Sayer:]

We have a sequence of launches next year, particularly with the new applicator and transmitter of the Gen 5 system, but we need to get those manufacturing processes up and mature really quickly. And that's really important to us. That is a bigger endeavor than anything we've undertaken for a long time. So it's probably better timed the G6 come out a bit after that, because we fully intend to use the new transmitter and new applicator configuration, and we'd be much happier if we didn't have to start from scratch. If we could pull it in, that would be wonderful, and we work to pull it in, but there's a lot of boxes to check. With respect to FDA timing and speeding things up, I would agree they appear minimal to that. We have been discussing non-adjunctive claim for a very long time, and it's not through. So when you get into complex issues, it can become real tough. I think they'll be very cooperative with Gen 6 and I think we can push it through quickly, provided the dataset is reflective of what you guys will see next week. I think it's a tremendous advance in sensor technology that we can get through. But we've got to remain diligent and keep going, but there is a lot to get ready before it comes.

[Jeff D. Johnson:]

Yeah. Understood. That's helpful. And then, Steve, just want to go back and clarify something you said on Germany. So it sounds like the reimbursement rates are coming in, you said pretty solid, especially even relative to U.S. rate. So just wondering, that's the -kind of the sell-in price or the price you are going to recognize for sensors and transmitters and receivers and things like that is on par, or I don't want to put words in your mouth, but relatively good relative to U.S.?

[Steven Robert Pacelli:]

That's – you can put words in my mouth, that's exactly right. And, yeah – I mean, none of this is finalized, right? We still don't expect to see an impact until – really until next year. But I would tell you, so far so good.

[Jeff D. Johnson:]

Okay. And do have any idea the co-pay patients are going to be – are going to have on that system then, in Germany? How that maybe stacks up relative to self-pay for a Libre or something like that?

[Steven Robert Pacelli:]

I don't, but we can certainly – maybe for the next call, we'll have a little more detail...

[Kevin Ronald Sayer:]

We'll have a little more detail.

[Steven Robert Pacelli:]

...or we'll have the contracts signed by that point.

[Jeff D. Johnson:]

Yeah. Understood. Thanks, guys.

[Steven Robert Pacelli:]

Thanks, Jeff.

[Operator:]

Your next question comes from Mike Weinstein from JPMorgan. Please go ahead.

[Michael Weinstein:]

Hi. Thanks. I think it should probably put me (53

[Steven Robert Pacelli:]

Yeah. It certainly could be, particularly as I mentioned, we're in discussions – I had characterized discussions with about 40% of the covered lives. So as we continue to accelerate that, if we can truly contract with something like 15-ish kind of critical payers to get the vast majority of covered lives, Germany could be a much bigger contributor next year. I'm just giving you an example, in the UK, we're actually seeing reimbursement – most of our patients are actually seeing reimbursement these days, but it's a one-off basis and they're having to apply individually. So it's not something that's scalable. So we need to – we really do need to reengage with NICE and push that issue, and really try to make it more formalized. France the same thing, we're in discussions. There's not been any formal action taken in France. The signs are looking positive. So that could be a contributor, potentially as early as next year as well. So yeah, I think you're thinking about it right, Mike, that Europe as a collective, if we get – knock off a couple more of these big countries, it could be a big push for us next year.

[Michael Weinstein:]

Obviously there is something to learn here from what's going on with Libre, right? I mean, Libre is taking off in Europe. There is this demand for diabetes technology in Europe that hasn't been satisfied. And so, when you think about the fact that there's been now, all – couple of hundred thousand patients that potentially are on Libre or tried Libre, better put, at this point, how do you tap into that once you get reimbursement in a country like Germany? What's the launch strategy look like? So I have to think that, with the Libre experience and the enthusiasm that product has seen, that how you think about going to market has to be different than maybe you were thinking a year or two ago?

[Kevin Ronald Sayer:]

Well, I think, Mike, we are very much evaluating product configurations. I'll give you one example. We have seen mark (56

[Michael Weinstein:]

Understood. Thank you guys.

[Operator:]

And we have no further questions at this time.

[Kevin Ronald Sayer:]

Okay. I'll just close with a couple of concluding remarks here. We want to thank everybody for being on our call today, and everybody for their questions, they're very insightful. We continue to address, what we believe is, one of the most meaningful opportunities in all healthcare. The treatment of diabetes Type 1 and Type 2 is one of the leading cost drivers in healthcare all over the world. We're going to continue to focus on what we do best, developing, manufacturing, distributing the world's leading CGM technology. Our future platforms, our sensor platforms, our new algorithms, there are always technology, advance data analytics, we're going to be able to change the conversation of diabetes management over the next several years. Our growth opportunity even in times like we described today is still huge. The Type 1 market is very underpenetrated. There is a completely un-penetrated Type 2 intensively managed insulin market. The global opportunities we've discussed with Germany, the UK, the other places we're seeing reimbursement come up are huge, even in light of the increased competition that's coming. It's a great time to be here at DexCom. We'll continue to deliver great products and great performance for our investors. Thank you.

[Operator:]

Thank you, ladies and gentlemen. This concludes today's conference. Thank you for participating. You may now disconnect.