Kevin Ronald Sayer - DexCom, Inc. Steven Robert Pacelli - DexCom, Inc..

Michael Weinstein - JPMorgan Securities LLC Ben C. Andrew - William Blair & Co. LLC Jayson T. Bedford - Raymond James & Associates, Inc. Kyle William Rose - Canaccord Genuity, Inc. John J. Dunn - Morgan Stanley & Co. LLC Joanne Karen Wuensch - BMO Capital Markets (United States) Tao L. Levy - Wedbush Securities, Inc.

Anthony Petrone - Jefferies & Company Jeff D. Johnson - Robert W. Baird & Co., Inc. (Broker).

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..

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?.

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?.

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 (04:24) competitors and we expect the noise surrounding these offerings to only increase, we will continue to focus on the things that we do well.

A superior performance and feature set of our current and future products, including industry standard accuracy, reliable real-time alerts and alarms and connectivity across multiple platforms leave us well-positioned to remain the leader in CGM. I will now turn the call over to Steve..

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..

new algorithm, new sensor, many new features. Initially, it will provide the basis for reducing calibrations, and we believe it will be the foundation of our no-calibration technology, both with our first Verily products and with our Gen 7 system.

I'm pleased to report that we have commenced our pivotal trial and to date, 40% to 50% of patients have completed the study. The Gen 6 pivotal is the largest pivotal study that we have ever executed, with pediatric and adult patients included in one combined study of approximately 300 subjects.

We could not be more excited about the prospects for Gen 6, in large part due to extremely promising datasets captured during a number of pre-pivotal studies. Early Gen 6 data will be presented next week at the Diabetes Technology Meeting in Bethesda.

All we can tell you now is, we are not going backwards with respect to accuracy and reduction in and/or elimination of calibrations. We are working with several of our automated insulin delivery partners to incorporate G6 into the research and clinical studies, to gather more valuable data on these systems.

Gen 6 will more than likely be a 2018 launch, and we'll provide more color as we get further into the study and the filing. Turning to our partnership with Verily; our collaboration to develop simple, low-cost, disposable sensor systems is one of the most aggressive innovative development opportunities we've ever engaged in.

Our initial joint product offering with Verily will be a no-calibration CGM platform based on the Gen 6 technology. We believe the products we develop in our Verily partnership will not only expand CGM use in Type 1, but will drive entry into the non-insulin using Type 2 market.

As we continue to do research into this Type 2 market, it has become more and more evident that the approach to the treatment of Type 2 diabetes has been historically very hit or miss. For example, roughly 40% to 50% of patients remain partly (17:52) controlled, despite a proliferation of new drug classes over the recent years.

We believe the information our system provides to a Type 2 patient exceeds anything they can learn from the tools that they use today.

CGM paired with knowledge-based decision support delivers healthcare providers a window into glucose variability and enables patients to visually connect the cause and effect the diet, physical activity and medication choices have on glucose, therefore driving sustainable behavioral changes.

Put simply, CGM data advances the potential for treatment optimization and ultimately better clinical outcomes and lower long-term costs. We believe the first product developed in collaboration with Verily should be commercialized in the second half of 2018. And we expect that the smaller bandage-like sensor could be available as early as 2020.

The first feasibility study of the bandage-like sensor is taking place this quarter.

With respect to our insulin delivery partners, our G5 integrated pump offerings remain popular among patients, and all of our partners are making progress on integrating more advanced insulin delivery systems that leverage our G5 and G6 technologies with pumps, smart pens and other connected diabetes management platforms.

Early studies on several of these platforms look promising and we anxiously await the outcomes. In conclusion, we have long-held the largest market opportunity in insulin using patients for our (19:20) product is in the MDI segment, representing more than 70% of patients in the U.S. and more than 90% outside the U.S.

With all the noise in the current marketplace, it appears people have lost sight of how compelling the data from our DIaMonD study actually is. In patients using CGM, we saw full 1% reduction in A1c, which is unheard of in almost any other diabetes study.

Patients on DexCom also experienced decreased time in hypoglycemia and improved time in range, all of these outcomes achieved with a minimal amount of training and without a complicated and expensive insulin delivery system. The CGM first message will continue to resonate.

We also remain extremely bullish on our future market opportunity to change the management of Type 2 diabetes with our CGM platforms. The information we are gathering from patients is fascinating and confirms what we have long believed.

The prototype 2 patient is also the father of one of our scientists, who has Type 2 diabetes and has been using our product. Diabetes has been a series of losing battles for 20 years. CGM has given (20:31) first win. I now like to open up the call for Q&A..

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

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..

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 (23:03) deductable is not tremendously large.

We will offer programs to encourage new patients to sign up. You'll see those come out over the Internet over the next couple weeks to see if we can get – certainly get more patients on. I would tell you from a color perspective, our reorder patterns still remain very strong.

We're not seeing reorders fall out of the queue, we're not seeing new patients. We get signed up a lot of the queue saying we don't want to go over (23:28) the other way. It's just combating the overall noise. And we went through not as much noise with 530G, but we did go through noise with 530G as well.

The difference being that product (23:39) and we knew exactly what we were going after. There have been studies comparing our sensors to theirs and other things. So we could adopt a technical and a tactical approach. This time, there isn't one because again their product is not out.

So we'll just continue to deploy, we'll continue to offer promotions, our DTC campaign has been very effective as far as generating the leads. But that's just where we are today..

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

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?.

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 (25:25) talk to now.

Our direct opportunity in UK – as we said earlier, we've gone direct in the UK. UK was very small for us, it's still not very big, but the fact is our business has gone up at a nice rate since we hired a great team over there.

But we're – again we've hired people who can go drive reimbursement in there, as a percentage of our patients who are getting covered in local geographies there. So I think German reimbursements can help significantly, UK growing reimbursement might help a tad, a bit, but it's not going to be a huge driving factor.

As we look at other countries, we certainly have had meetings and discussions in France. We see reimbursement continuing to be talked about in Italy. Australia is now looking at reimbursement procedure as well. And we've got programs going on in Canada also. So there is a lot of opportunities.

And once we get reimbursement, we think we can grow nicely in those markets. But with respect to cash payers, I'll get back to what I said earlier, our product is very expensive, and there is a reason; it's really good. It provides a lot. And it is a large cash commitment for somebody.

And when offered at much lower cash price upfront, parties have elected to try that. I think over time when we get reimbursement, we can certainly work through that because of the features that our product set offers..

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 (26:55) do with most likely 670G and then whatever label that Libre consumer might get next year, do we think about kind of different growth rates before and after that happens? So if there is a transition where people are holding back a bit and we've come through with kind of maybe subpar revenue growth, but after that gets out there and (27:14) you can message, you got the G5x that you would expect to see patient adds accelerate perhaps in the second half of 2017, is that a fair way to think of it?.

I'll let Steve start, (27:27) start and then I'll add my two sense....

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 (27:49) put us out of business. But we had the benefit of having an actual product and independent investigators had the benefit of having an actual product to test it. I mean, we've scoured their safety statement.

It appears that patients are being recommended to take at least four fingersticks a day to keep the thing running. They also have to take fingersticks every time it drops out of automatic mode to keep it into automatic mode. The false alert rates seem pretty high; in fact, potentially, even worse than the 530G.

And as we know in the 530G context, that's the one thing that patients complain about most in the field is that the false alarms they receive from that system. So, look, we're fighting a ghost for the next six months to nine months and we won't really know what we're up against until we actually have physical product to get a test. So....

Yeah..

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

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 (28:55) other products further even out there, because when there is a sensor that is labeled you can dose insulin off of this thing, I think that will be very compelling for physicians, caregivers and patients, and present a very good story for us.

You've mentioned G5x, so we have G5x coming, which is the smaller transmitter and a much easier insertion system, much more practical and easier experience for our patients. So we have a number of positives, but we're not quite sure of the timing on – that go into this entire discussion as well.

I think you're just going to have to – we'll be a little more concrete in January..

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..

Ben, what we've said when we started the G5 transmitters is that it was (29:50) two for one. We expected our gross transmitter hardware dollars to go up and our gross margin percentage to go down, because we were supplying two transmitters for the price of one. And that has happened.

What has affected us again is the lack of receiver revenues, but there has been an increase in transmitter revenues. We think ultimately the percentage will go down and we'll be more sensor-driven than transmitters that I....

We were selling (30:12) a lot of transmitters..

We were selling (30:13) a lot of transmitters. I don't have percentages to give you where that goes yet. We'll provide more color in January..

Thank you..

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

Good afternoon.

Can you hear me, okay?.

Yes, Jayson..

Okay.

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

No..

No..

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 (31:12) we're entering a group of patients who would say, okay, I'll give this a try, we see their use patterns may be different than our long-time, use it every day, all the time patients. We also see that, just given the reimbursement world, the continued use of our sensor for more than seven days is – remains prolific.

And so that is something we factor into our revenue models and revenue analyses as well. But I don't see a huge increase, we don't see a huge decrease, we think it's remained relatively consistent..

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?.

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..

Perfect. Okay..

2017..

Okay..

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

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?.

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..

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

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

Great. Thank you very much.

Can you hear me all right?.

Yeah, we can..

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?.

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..

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..

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?.

Once again, a lot of (34:42) our patient adds came from MDI than it did from the pump world, so we continue to make inroads there. With respect to numbers, just to get to $149 million in revenues we reported, the new patient number had to be significant. It certainly was within our target.

And quite candidly, year-to-date, based on our internal targets, we are spot on at the end of Q3. So new patient growth remains very – remain very robust for us..

Great. Thank you very much for taking the questions..

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

Hi. This is Ryan Blicker (35:17) for Doug. Thanks for taking my questions. So maybe just starting with sensor utilization, you mentioned that reorder rates haven't changed; but then you also noted that the use patterns of the product may have changed, given the broader patient base you now have.

Can you clarify these comments? And is average sensor utilization in Q3 and through the first nine months of the year maybe closer to the lower end of your historical range?.

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 (36:24) into a lot of detail, but we go through exercises where we pick samples of the new patients in the patient base and try and follow them all the way through, look at their purchasing patterns, look at their use, history, and everything.

And every time we do it, we've learned something different and something new. And those were really the two things that were pointed out from the last group and the last population that we studied, that we still see increased sensor use and maybe the use patterns for some of these patients are not what they were before.

And that's okay, they're still patients and they still derive great benefit from it..

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..

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 (37:28) product and we've said that on multiple occasions, but it will be....

It's a learning experience..

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..

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 (38:19) insulin managed markets, we are not going to give partner non-adjunctive (38:22) label for anything.

Once we get it, we're going to stay there. And we believe our technology is more than robust and that – again, as Steve said, as you'll see next week to maintain that level with reduced and with no calibrations over time..

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..

Yeah..

That's an important point not to overlook..

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

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?.

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 (39:54) the mistaking notion that this is actually an artificial pancreas coming.

But we don't have a perfect crystal ball to tell you what this is going to look like going forward. We're being conservative, obviously, in our guidance. I want to take a step back, we stated 35% to 40% sustainable growth something like four years to five years ago.

So as I look four years to five years out, four years to five years ago, looking forward, we successfully sustained and exceeded that level of growth. At some point, we've said, even on recent calls, that the law of large numbers is such that on a percentage basis growth is not going to continue to exceed 40%, 50% like it has in the past.

So you guys are trying to read a whole lot more into this, I think than (40:38).

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..

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?.

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..

Understood. Thank you..

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

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?.

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 (43:06) very local and it's state-by-state or region-by-region.

We certainly have very good reimbursement in Sweden right now through the tender process. We have the German reimbursement decision that just came. There is reimbursement in Switzerland, Austria.

And there's some other regions, like I said, in the UK where we're getting a little bit of reimbursement and a little bit (43:30) Italy, but there has not been any national decisions. We'll just continue to work on region-by-region and we'll give you more color as time goes on..

Okay. Thank you very much..

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

Yeah. Hi.

Can you hear me?.

Sure..

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?.

We're not going to quantify it..

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?.

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 (45:10) from what we're hearing from our consultants and from our internal folks that they don't think even if the non-adjunctive claim pushes into the early part of 2017 that that will impact our path to Medicare by some time in 2018..

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....

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 (45:51)..

Thank you..

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

Yeah. (46:00). Thank you..

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

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..

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..

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..

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 (48:21) of penetration. I mean, I personally don't believe that 670G is going to move the needle from 30% penetration to 40% or 50% penetration in any meaningful period of time.

I think, particularly, outside the U.S., MDI is going to remain the vast majority of patients' method for insulin delivery.

And I think even in the U.S., I think, patients are – as we continue to improve our technology, improve the form factor, shrink the form factor on the technology, add patients with additional tools, additional decisions support tools with respect to their insulin on board, et cetera, I think the product offering – and then from a pricing perspective, the product offering at CGM and an intelligent insulin pen, for example, will be a very compelling, both from an outcomes perspective and from a cost perspective..

That's helpful. Thank you..

Well, said..

And your next question comes from Rebecca Wong (49:21) from Leerink Partners. Please go ahead..

Hi.

Can you hear me, okay?.

We can..

Hi. This is Rebecca (49:30) on behalf of Danielle.

So have you seen any impact on your patients adds from the DIaMonD data that was released at ADA this year?.

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 (49:57) it's getting closer to publication.

So we will really unleash the DIaMonD blitz over the next – over the month of November here, and hopefully that will add – help increase patient adds, not a lot so far, because we really haven't pushed it..

Yeah.

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

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 (50:45) by publication timelines as well. But the study is pretty much – it'll be wrapped up, the actual patients in and out will be wrapped up by the end of the year. And so the data will come after that..

Thank you..

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

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?.

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..

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.?.

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..

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?.

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

We'll have a little more detail..

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

Yeah. Understood. Thanks, guys..

Thanks, Jeff..

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

Hi. Thanks. I think it should probably put me (53:44) back in from earlier. But just – let me just ask you, just relative to Europe, since Germany was just discussed.

Do you have any greater visibility on the other countries coming through (53:55) as you're aware, our (53:58) checks on Germany have been pretty positive over the last several weeks, just in terms of not only how reimbursement is shaping up, but potential demand.

Do you think that Germany could be bigger in 2017 than maybe you're assuming, or the Street is assuming?.

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..

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?.

Well, I think, Mike, we are very much evaluating product configurations. I'll give you one example. We have seen mark (56:11) for the system without use of the receiver in Europe now. So if a patient wants to use the system, unlike in the U.S. where we get a new patient we are required to sell them a receiver, we don't have to do that anymore.

So we've put ourselves in a position where we can somewhat reduce the upfront cost for patients to get them to start. And as far as enthusiasm; we are enthusiastic. In fact, our German team is going through budget processes and their request per sales heads is remarkable.

So they obviously are very optimistic about their ability to go sell, and poor Jess has to be the bad guy down at the end of the table. But we're going to add significant feet on the street in Germany to go after that. I think one of the other lessons learned is, people do want information.

And if they're co-paying out of pocket and the reimbursement covers this, you know, by offering connectivity and the things that we offer from a feature set versus this product, we think they're going to really lead to fast growth. We will configure future products as we look at it. We're going to offer a no calibration sensor over time.

We're just going to offer one that's going to be accurate enough to meet our standards and to meet the non-adjective claim standards that we believe will be set up by the FDA as well. So there is a lot to learn here and we'll aggressively go after it..

Understood. Thank you guys..

And we have no further questions at this time..

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..

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