DexCom, Inc.

Welcome to the Dexcom fourth quarter and full year 2018 earnings release call. My name is Adrienne and I'll be your operator for today's call. At this time, all participants are in a listen-only mode. Later, we'll conduct a question and answer session. During the question and answer session, if you have a question, please press star, then one on your touchtone phone. Please note, this conference is being recorded. I'll now turn the call over to Matt Dolan, Vice President, Corporate Development. Please go ahead, sir.

Thank you, operator, and welcome to Dexcom's fourth quarter 2018 earnings call. We will begin our prepared remarks with Kevin Sayre, Dexcom's chairman, president, and CEO, who will provide a summary of the quarter and fiscal year. This will be followed by a review of our financials and 2019 outlook from Quentin Blackford, our executive vice president and CFO, and then a strategic update from Steve Pacelli, our executive vice president of strategy and corporate development. Following our prepared remarks, we will open up the call for your questions. At that time, we ask analysts to limit themselves to one question and a follow-up so we can provide an opportunity for everyone today. With that, let's review our safe harbor statement. Some of the statements that we will make in today's call may constitute forward-looking statements. These statements reflect management's intentions, beliefs, 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 can 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 statements after the date of this presentation or to conform these forward-looking statements to actual results. Additionally, during the call, we will discuss certain financial measures that have not been prepared in accordance with GAAP with respect to our non-GAAP 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. Please refer to the tables in our earnings release and the investor relations portion of our website for reconciliation of these measures to their most directly comparable GAAP financial measure. Now I will turn it over to Kevin.

Thank you for joining us today as we discuss our year-end results. Simply put, 2018 was an incredible year for Dexcom on several fronts. First and foremost, we broke through $1 billion in annual revenue. Very few, if any, medical device companies have reached the billion-dollar revenue mark while growing revenues organically at greater than 40% year-over-year. Clearly, the fourth quarter exceeded our expectations, delivering growth of over 50% compared to the same period a year ago. The company also posted its most profitable non-GAAP fourth quarter and full year on record, as we continue to focus on growth while demonstrating leverage. Beyond the numbers, we received FDA approval for our G6 system in late March, with G6 becoming a Class II system and being the first to meet the agency's newly established special controls for ICGM. We launched G6 in the U.S. around mid-year and continue to roll it out to additional markets globally. Initial patient feedback for G6 has been outstanding. G6 has truly redefined best-in-class CGM and provides us with a platform that we believe will drive continued growth opportunities for Dexcom. Beyond G6, we saw significant increases in adoption in both the Medicare and international markets, both of which remain significantly underpenetrated. We advanced our interoperability and decision support initiatives, including the acquisition of Type 0. And we solidified our product pipeline by amending our agreement with Verily and strengthened our balance sheet with the convertible note financing that we did late in the fourth quarter. All of these accomplishments have positioned us for continued success in 2019 and beyond. The team at Dexcom has worked incredibly hard for these achievements, and I must recognize all of the effort needed to make this happen. The organization is achieving milestones that few companies ever do, which is gratifying and comes with significant dedication and determination from our team. But going forward, that will not be enough. We must put the infrastructure in place for this business to scale to its full potential. This need, in part, drove the additional announcement that we made today. In light of our meaningful uptick in demand, we have set the aggressive internal goal to double our G6 production capacity by year end. We need to expand our footprint dedicated to manufacturing within the Arizona facility, both to meet our G6 goals and in anticipation of a late 2020 launch of G7. Similar to our scaling of manufacturing capacity, we have had to rethink how we build our customer-facing infrastructure to better serve our rapidly growing patient base, not just for today, but also to build a sustainable infrastructure for the future. We have therefore expanded and reorganized our customer support efforts, which includes an increase of resources on our new Philippines location, as well as outsourcing other functions through third parties. This move will provide the ability to serve our customers with the same high level of quality that they have become accustomed to and grow in a much more efficient manner. This expansion will result in organizational changes, including a reduction in certain staff at both our San Diego and Arizona facilities and despite an expected overall increase in employee numbers in these locations this year. These types of decisions are always difficult, as we have had to increase our support staff significantly over the past several years and have relied on such individuals to meet the demand of our customers. This is a necessary step to continue to adapt and further differentiate our business by maintaining our focus on the patient experience. These changes will occur during a transition period, and we have taken the necessary steps to ensure that they occur as seamlessly as possible while being open with our employees and supporting those impacted over the next several months. Quinton will walk you through the financial implications of this effort. To sum up, Dexcom continues to deliver strong results, and our recent initiatives leave us well-positioned to execute over the next several years. I will now turn the call over to Quinton for a financial update.

Thank you, Kevin. As a reminder, some of the figures that I will refer to on a non-GAAP basis and reconciliations to our GAAP results are available on our website. Today we reported record worldwide revenue of $338 million for the fourth quarter of 2018 compared to $221 million for the same quarter in 2017, representing growth of 53% over the same quarter a year ago on both a reported and constant currency basis. a clear acceleration that drove us to $1,032,000,000 in revenue for the year. Sequentially, revenue was up 27% over the third quarter. This growth was driven by the sustained ramp in awareness that we saw building throughout 2018, particularly in our U.S. commercial business, which was the primary driver of the upside. Notably, this growth materialized despite a decline in revenue per patient, which was in line with our expectations provided on the third quarter call. As a result of our continued shift in channel mix, including continued growth of the international and Medicare businesses, as well as our proactive attempt to move commercial payer contracts into the pharmacy channel, we expected to see some overall pressure on revenue per patient. Nonetheless, we realized accelerating growth throughout the back half of the year as we saw these headwinds begin to play out and delivered an outstanding 2018, and we're particularly pleased with achieving 50% growth in our U.S. business in the fourth quarter. International sales in the quarter were consistent with our expectations and were up 72% over Q4 2017 on a reported basis, or 75% excluding the impact of foreign exchange rate changes. Consistent with the first three quarters of the year, our fourth quarter growth continued to be driven by our direct markets. Fourth quarter gross margins improved from the third quarter as expected to 66%, resulting in a gross profit of $223 million. Operating expenses were $387 million for Q4 2018, including a $218 million one-time non-cash research and development charge related to the amendment of our Verily Agreement. Apart from this non-recurring charge, fourth quarter operating expenses were $170 million compared to $142 million in Q4 2017. This reflects an increase of 20% year-over-year and compares favorably to our 53% revenue growth in the quarter. For the full year, we realized growth of 44%, while non-GAAP operating expenses, which adjust for the non-cash charge related to the amended agreement with Verily, grew at less than half of that rate at 18%. In addition to the better-than-expected revenue result, the organization did a great job of controlling spend in 2018 and delivered meaningful improvements in our profitability profile. Importantly, adjusted EBITDA, which excludes the impact of share-based compensation and and the non-cash research and development fee was $86.3 million, or 25.5% of revenue for the fourth quarter, demonstrating the profitability profile that this business is capable of consistently producing over time. Our non-GAAP net income was $48.9 million, or 54 cents per share. We're incredibly happy with the progress being made on the profitability front and remain comfortable with the long-term financial goals laid out at our investor day back in December of 2018. We fortified our balance sheet, having ended the quarter with nearly $1.4 billion in cash and equivalents, which includes roughly $700 million in net proceeds following our convertible note offering and share repurchase in Q4 of 2018. This offering provides the financial stability and flexibility we need to invest in our key strategic initiatives. We continue to have full availability of our $200 million revolving line of credit. Turning to 2019, as we provided in early January, we anticipate full-year revenues of between $1,175,000,000 and $1,225,000,000. This outlook assumes a higher rate of patient volume growth offset by headwinds associated with the decreased revenue per patient related to shifting channel mix. As you saw in our press release and as Kevin summarized, we announced a corporate initiative earlier today that will better position us to meet the increasing demands of growth in our business. As a result, we expect to incur roughly $25 million in restructuring-related charges that will primarily be incurred in the first half of 2019 and will be excluded from our non-GAAP financial results going forward. With that consideration, we anticipate the following full year 2019 non-GAAP financial results. Gross margin improving to approximately 65%, operating margin increasing to approximately 5.5%, and adjusted EBITDA margin expanding to roughly 18%. We have included a reconciliation of GAAP versus non-GAAP results on our website, as well as a historical trend presenting non-GAAP financial results on a consistent basis for comparability purposes. With that, I will now turn the call over to Steve for a strategic update.

Thank you, Quentin. The continued rollout of G6 remains a primary strategic priority for Dexcom at the outset of 2019. In the U.S., we plan to begin shipping G6 to our Medicare patients in the near term, and we have multiple OUS introductions planned for the balance of the year. 2018 was a year of great progress for our insulin delivery partners, and we look forward to the launch of Tandem's Control IQ system later this year, which includes our G6 sensor platform, as well as our recently acquired hybrid closed-loop algorithm from Type 0. We are excited about the continued progress we are making with Insulet on the Horizon platform, as well as Lilly, as they look to bring both connected pumps and pens to market. Our SmartPen integration program with Novo Nordisk continues to advance since we announced that partnership in October. We will continue to push these and other collaborations forward in 2019 and expect to see Dexcom integrated SmartPen systems that are commercially available in 2020. As many of you saw in November, we amended our collaboration agreement with Verily, strengthening our product development goals and further aligning our interests as we work toward the commercialization of a fully disposable real-time CGM. This amendment eliminates all future royalty payments, significantly improving our long-term profitability outlook. Our next generation, or G7 system, remains on track for a late 2020 or early 2021 release. With G7 on the horizon, we continue to collaborate on pilot efforts in the non-intensive type 2 population, working with UnitedHealthcare, OnDuo, and others as they utilize CGM as a core tool in programs to drive health and economic benefits for people with type 2 diabetes. In addition, we are on track to kick off studies this year for applications in both the hospital and gestational markets. Both of these represent new markets in which uncontrolled glucose presents a major impediment to patient health and an economic burden to the health system. While we remain in the early stages, we are well positioned to leverage G6 as a platform technology that enables us to answer key questions and determine next steps. We look forward to providing updates as these studies progress. As you can see, we continue to drive a number of important strategic initiatives, and we are excited about the pipeline and market expansion opportunities ahead. With that, I will pass it back to Kevin.

Thank you, Steve. 2018 will stand as a year of historic milestones for Dexcom and in diabetes technology in general. Our outlook for 2019 contemplates the growing awareness of the value of CGM. Our leadership position based on G6 technology, the increasingly competitive landscape of and our own proactive moves to optimize distribution channels and position Dexcom for long-term operating efficiency. Given the growing awareness of the benefits of CGM and our accelerating growth throughout 2018, we enter 2019 with excitement around the opportunity that lies ahead. I would now like to open up the call for Q&A. Matt? Matt?

Thank you, Kevin. As a reminder, we ask our audience to limit themselves to only one question with a follow-up. If you would like to ask additional questions, please re-queue, and we will attempt to address as many as possible in the time allotted. Operator, please provide the complete Q&A instructions.

Thank you. We'll now begin the question-answer session. If you have a question, please press star, then 1 on your touch-tone phone. If you wish to be removed from the queue, please press the pound sign or the hash key. If you're using a speakerphone, you may need to pick up the handset first before pressing the numbers. Once again, if you have an audio question, please press star, then 1 on your touchtone phone. And our first question comes from Jeff Johnson from Baird. Your line is open.

Thank you. Good evening, guys. Can you hear me okay? Yeah, no problem. All right, great. Thanks for taking the call. I'm sure there's going to be some revenue questions and things like that. So I was thinking I was going to be deeper in the queue. So my question is pretty simple. Just have you heard anything from Medicare on any kind of updated hospital CGM use initiatives that they could be looking to put in place that you guys could participate in over the next year or two?

Yeah, nothing specifically, Jeff, this is Steve, nothing specifically in terms of programs, but we are aware that CMS has a particular focus on glucose control in the inpatient setting that we think will absolutely lend itself to that business evolving in the relatively near term. You've heard mentioned before of readmissions as a result of poor glucose control not being paid for we're seeing hypoglycemia as a new focal point for CMS, and you should expect that that would obviously, you know, trickle down into the core commercial payers as well. So it's a pretty exciting opportunity. It's still early, but we're, you know, we're all over it.

Yeah, and then, Quentin, you know, we're two months into the quarter, and obviously the 2019 guidance looks to a lot of us to be at least somewhat conservative here. Just any kind of updates on gating and should we be thinking of kind of higher first half growth versus second half or just how we should be setting up models at this point? Thanks.

Yeah, we feel good about where we're at as we start into 2019 here. I think just given the tougher comps that we're up against in the back half of 2019, given the accelerating growth we saw over the course of 2018, you naturally would see lower growth rates. So I think you should expect higher growth rates in the first half, lower in the back half In terms of the cadence, I would just point out we would expect the seasonal trends in the business to reflect more of what we saw in 16 and 17. 18 was a year of tremendous acceleration in the growth profile over the course of the year, which caused the seasonality trends to look a little bit different. So I think thinking about 20% or so of revenue in the first quarter, which is in line with 16 and 17, is probably the right way to think about it.

And our next question comes from Margaret Cazor from William Blair. Your line is open.

Hey, Deb. Good afternoon, guys. Thanks for taking the questions. Maybe just to start off with, just to follow up on the guidance question, you guys obviously delivered 2X, the original 2018 growth guidance. So as you look at 2019 and the assumptions that you guys made, how do those differ from this year relative to last year, including kind of the risk weighting as you were looking into last year relative to this year?

Yeah, well, I think if you go back to the beginning of last year, we laid out some of the headwinds that we anticipated may show up in the business over the course of the year. I think when you start to look back at it, those headwinds did in fact show up, but they showed up much later in the year than what we originally anticipated. So we were very clear early on we expected that there could be revenue per patient headwinds in the business. We didn't start to really see those until the third quarter and then really a full quarter's worth in the fourth quarter. So I think we were contemplating all the right things. It's just the timing of when they started to be impactful was probably a little bit later than we originally expected. When I think about 2019, you know, we're approaching the year in a somewhat similar manner with respect to how we think about the revenue per patient headwinds that we know are in the business, although what's different now is we know they are playing out. We saw it in Q4. We expect they're going to continue to play into 2019. And so when you look at the absolute dollar growth in our guidance, we're guiding to about $150 to $200 million of absolute dollar growth But we've been clear there's about $100 million of revenue per patient headwinds in that guidance. So if you were to normalize back for that, you've actually got a gross increase of about $300 million over the course of the year, which is more or less right in line with what we just delivered in 2018. So the absolute dollar growth is pretty consistent. The growth rate's coming down, obviously, on a much more difficult base that we're growing off of. But I think it starts to make a lot of sense when you look at it that way.

Okay, that's helpful. And then just kind of, I guess, a little bit going on that vein as a follow-up. Can you guys give us an update on the percent of lives that are under pharmacy right now? I think it was about 40% last quarter. And then as you're seeing that grow as a percentage of the mix in coverage, have you seen any change in terms of the patient ad mix driven by pharmacy yet? And how do you expect that plays out throughout 2019?

You know, I'll take that, Margaret. This is Kevin. Our covered lives are over 50% now, slightly above that. And again, let me remind you, just because we have the covered lives over 50 doesn't mean they'll process through pharmacy. Most of our pharmacy plans have a dual benefit with DME and pharmacy. And it's up to us to drive awareness so physicians and patients know that they can be covered through that vehicle. We expect that to continue to accelerate over the course of the year. We've had some very good discussions and some wins. you know, at the local, regional, and national payer level over the past several months and have some really exciting things on tap going into 2019. And I think as Quentin talked about earlier, ChannelMix, we are expecting ChannelMix to shift in that direction. We see a tremendous opportunity for patients if they can pick their product up at the drugstore rather than call us and go through the DME process, which is alive and well in the first quarter. we're in a much better position. So we're definitely driving and shifting the business there and encouraging our field team to do so as well.

And our next question comes from Raj Denhoi from Jefferies. Your line is open.

Hi, good afternoon. I wonder if anybody could ask about the international performance, you know, again, very strong in the quarter. Are there other countries contemplated in the near term in terms of establishing reimbursement, or is it still mostly coming from Germany and some of the markets you're already in?

Yeah, the growth in our guidance is primarily coming from the existing countries that we are operating within. I think we've talked about the fact that we're seeing opportunities open up into countries like Japan, Korea, where there's been regulatory approval more recently. We don't expect those to be big contributors to the overall revenue number in 2019, and I think You know, we'll let the product get into the market and see how it performs, and then we can start to think about how it becomes additive to the overall numbers. But it's all incremental opportunity as far as we're concerned when we look out into the future.

Are there specific countries, though, that you've targeted here for 2019 where you expect to establish more routine reimbursement that could be larger contributors? You know, I think in the past you mentioned UK and some other large markets that might open up.

You know, we're certainly making progress in the UK. We continue to make progress in Italy. There are a couple of geographies where there are large government-funded CGM initiatives, where they're announcing funding over several years and expanding the available population where CGM is available. For example, many of these countries will fund CGM for PEDS only, and now they're saying, okay, we'll expand this to adults and cover more, so we'll take advantage of those opportunities. They're a competitive bidding situation, so I'm not going to go into those details and say where they all are, but we will aggressively pursue those opportunities. We had a situation, for example, in Australia several years ago where they opened up for bid and said they were going to cover not even $10 million in CGM, and within 60 days we had eaten up pretty much that entire budget as patients flocked to Dexcom CGM. So we take advantage of those opportunities rapidly, and we'll take care of the advantage of those where we can next year.

And our next question comes from Steven Lichtman from Oppenheimer. Your line is open.

Thank you. Hi, guys. You've talked in the past that your discussions with payers revolve around the pharmacy, of course, and I think also expanding into the intensive type 2s. I wanted to ask about that second opportunity. How much progress are you making on getting coverage for intensive type 2s, and could that start becoming more of a revenue contributor this year?

We think that it will become more of a revenue contributor. The Medicare coverage decision has been helpful, but it takes a while to get that Medicare coverage decision pushed down to all the individual payers and expand access. A lot of this is in conjunction with all of our pricing and overall access discussions as we ask for access to more patients than what is the pricing model, what is the business model for these people. And so all of these variables are in play, and they've been – We've been talking through all of them. We believe we'll increase our type 2 intensive access. I'd love it to be faster than it is. But in all candor, with Medicare type 2 intensive insulin access, you have a very large portion of the type 2 insulin intensive using population covered already. We just need really to increase awareness within patients and physicians that they can have access to that technology now under Medicare coverage.

Got it. And then as a follow-up, will we potentially get any update on the United non-intensive study and outcomes there this year?

You know, again, we've said this before, Steve. It's not really a – don't think of it as a study with a principal investigator and something that's going to be published into a medical journal. This is real world. The work we're doing, not just with United, but, you know, on a number of fronts, on the type 2 – non-intensive kind of type two non-insulin taking patients is really real world. They come in this real world, but very reasonably large pilot studies. And frankly, the last thing any of these guys want to do is share their findings with the rest of the world, right? Because these guys are all competitors and they hold this data and the programs that are evolving out of these pilots to be very proprietary. And so I don't think you're going to see, you know, certainly we're not going to be permitted to publish anything about the United pilot. I can't imagine United's going to be too vocal about it. So I think the answer is probably not.

And our next question comes from Danielle Antelofi from Lerink. Your line is open.

Hi. Good afternoon, guys. Thanks so much for taking the question. Just curious, and I guess it's more specific to Europe right now than the U.S., but any change in the competitive landscape that you're seeing? I mean, obviously it's not impacting your growth trajectory. That's the first question, specifically as it relates to the updated Abbott product. And then the follow-up question I have is, how do we think about pricing longer term in the U.S.? So I appreciate what you're saying here for 2019. Is it right to think that that sort of pricing headwind is will repeat itself each year and get incrementally worse? Or is this kind of like it and we're at the bottom for pricing for you guys? Thanks so much.

You know, this is Kevin. I'll try and take that, Danielle. That's a very good question. With respect to competition, we take competition seriously all the time. While it hasn't slowed our growth trajectory, I would say, if anything, our vision and our focus on the competitive environment is much greater than it's been before. As we design our products and our future pipeline, we want to take advantage of those things that we do well to continue to thwart competition. With respect to pricing, in the U.S., as Quentin often says, pricing by channel for us has remained relatively consistent. But as we move more business into other channels, for example, the pharmacy channel, and currently the Medicare channel, that's lower priced than we've recognized in the past. We're preparing, as we talked at our analyst day over long term, to be a viable competitor in the pricing environment, whatever it turns out to be. We talked about doubling the capacity of our Arizona factory for G6. We talked about building out the G7 lines. As we look at our cost profile going forward, we're preparing for whatever the market brings. We believe CGM is a very valuable technology. And the fact is, what we've seen in Europe so far is the reimbursement authorities have recognized the value of our technology over others on the market, and we've continued to get a premium price. We will work to those models. We'll work to those models in the U.S. We will grow and adapt to where it ends, but we do think our product, with its accuracy, its performance, its connectivity, and its features, has been worthy of the premium price that we have received, and so far the payers have been amicable to that. That being said, as we've also talked about, if we can increase access and make it easier for patients to get and decrease our operating expenses through better channel mix, we're all for it. and we will take advantage of those opportunities as well.

Yeah, Daniel, I would just add, I think, you know, we're so early in the opportunity of converting folks from traditional, you know, finger sticks to CGM that the opportunity in the way of volume growth from the adoption of CGM technology is so significant that while there's going to be revenue per patient headwinds over time, I think the volume opportunity significantly more outweighs any of those headwinds. And I think as you open up some of these other markets that go beyond the intensive world of diabetes, you may see a different revenue per patient profile there, but the volume numbers, again, are so significant that I think there's tremendous runway in front of us from a growth perspective for years to come.

Got it. Thanks so much, guys.

And our next question comes from Kyle Rose from Canaccord. Your line is open.

Great. Thank you very much. Can you hear me all right? Yeah. Yep. Great. So I just wanted to dig back into the product cadence here over the course of the next 12 to 18 months. I mean, obviously the G6 rollout globally and into Medicare is a priority. I think you reaffirmed the G7 timelines for late 2020, early 2021. I'm just kind of wondering, is there anything that we should be expecting over the interim period there, whether it be the lower cost transmitter, G6 professional version, potentially getting an extended wear time on the G6? Just kind of help us understand what some of the near-term product milestones may be. And then I just have one more question on longer-term margins.

That's a great question and certainly a fun one for me. We always look at interim improvements for our product. If you look at everything we've ever done, every generation we launch, we come, for example, with an algorithm that significantly improves performance not long after we launch because once we have all this data, we can really go model and figure out where it is. We are exploring new algorithms with our G6 technology. We are also exploring longer wear time. We have the caveat around meeting ICGM standards. With that longer wear time, we want to make sure we can meet ICGM standards for that full longer period, whatever that may be. We do have the lower cost transmitter that will be out certainly in broad scale during the second half of 2019. We've got to work through the inventory they have now, but that will certainly be a cost reduction. and help for us. And remember, one of our key features and differentiators is the patient experience and our ability to iterate through software changes. We are really focusing tremendously on software development and offering our patients a better experience and better tools to manage their condition. Certainly not tomorrow, but as we look at the Type 0 acquisition and the tools they develop for decision support and offering patients information to manage their condition better. We intend to bring those tools to market. If we can get them done with G6, we'll get them done and get them in there. If we have to wait until G7, we will do so. But make no mistake about it, we want to make this patient experience more meaningful and better for them each and every day.

Thank you. And then from an operating perspective, I mean, obviously taking some near-term charges to expand some of the operations internationally, but maybe, Quentin, can you kind of Help us understand how we should think about going to a lower-cost region when you're building out some of those operational capabilities, just how that should impact margins over the long term, and then any CapEx guidance this year as you invest in the manufacturing capacity.

Yeah, sure. So I think consistent with what we kind of talked about back at our investor day in December, gross margin expectations for us are to continue in that mid-60s range over the next five years or so. There are several levers that will allow us to improve that in terms of taking costs out of the product, including this lower cost transmitter that we expect later in the year. But we also assume that there's going to be lower revenue per patient headwinds that we're going to be dealing with as well. And so I think the cost savings will ultimately offset the – or those benefits will offset the the headwinds that come from the lower revenue per patient. So think about that as being relatively consistent with where we're at now. And if we can deliver or execute better than great, there's upside to it. I think one of the big areas of opportunity, and Kevin hit on it, is really focusing on how we double our capacity over the course of the year. We see tremendous opportunities in the markets in front of us, markets that we're not yet in but believe there's real potential to be in, and we want to make sure that we have the capacity to address that. So you're going to see some significant CapEx spend over the course of this year, well north of $100 million to build out automated lines, stand up incremental clean rooms in our Mesa facility. and ensure that we're building out capacity just as fast as we possibly can. So I think that's the way to think about it. In terms of operating margin cadence, you know, we laid out a plan to get the 15% over a five-year horizon. That's roughly 300 basis points a year. We're not committed to 300 basis points necessarily each and every year, but I think we're making great progress towards it here in 2019 with our guidance that delivers roughly 200 basis points. And that's in the midst of a year that we're incredibly focused on getting G7 far down the pathway and getting that to market in late 2020, as well as the fact that we laid out this reorganization today And I think it's important that we all understand, you know, we're committed to ensuring that the patient experience is a good one through this transition. And therefore, we're not looking at any reduction in workforce along the way until we're performing at equivalent or better levels than where we're performing in the company today. And then resources can start to come down. And so you've got a bit of cost in the P&L this year that I would call duplicative just to ensure that there's a smooth transition here. Otherwise, you'd see more leverage coming through the P&L. this year alone. But we feel great about where we're at. We're confident we can get to that long-term plan that we laid out and feel good about it.

And our next question comes from David Lewis from Oregon Stanley. Your line is open.

Hi. This is Jay Shotton for David. Congrats on the quarter. Just one for me and one follow-up. I've got – is there any update on the trials for the 14-day sensor for G6, and is that something we could see an approval for later this year?

We're not going to comment specifically on the timing, but it's certainly something that's in the near-term pipeline.

Okay. And then the pharmacy channel, you had 50% covered lives today, 40% last quarter. Should we think about a 10 percentage point increase quarterly going forward, or would you expect that pace to increase over the course of the year?

It's just not that predictable. I mean, we continue to push as hard as we can to transition the business into the pharmacy channel. And remember, the important thing, Kevin said it, but the important thing to remember is when we say we have 50% of the commercial lives that have a pharmacy benefit, that doesn't mean we're processing 50% of our commercial business through the pharmacy channel yet. So it's not just the addition of additional covered lives under contract. It's also then transitioning those folks into the pharmacy channel through education and otherwise.

And our next question comes from Travis Steed from Bank of America.

Thanks for taking the questions. You know, I had a question about CGM. I think we can debate, you know, all day if another competitor can get that or not. But just wanted to ask on a big picture, if one of your larger competitors does get a CGM, you know, how do you think that changes the conversation, you know, for payers, patients, and patients? You know, does it have an impact on the conversation they're having with those customers?

Yeah, this is Kevin. I'll take that. In all honesty, the ICGM designation sets some wonderful standards for us to get products approved and get them through the system quicker. I don't believe, as I sit here today, as we butt up against our competitors in the various payer channel and payer meetings, that they really know that much about what ICGM means, other than they know about the performance of Dexcom sensor. Where ICGM becomes extremely relevant is on two fronts, as I said earlier. Standards for us to shoot for when we get future product iterations approved. For example, the 14-day product we're talking about, we know exactly how many data points we need to have and how that product needs to perform before we fly out with the FDA to get that designation. We love that clarity and we intend to operate in that space. Number two, when we get into interoperability with various software systems, the software around insulin pins, software around the sensor augmented pump systems, and sensor-assisted pump systems and various AP algorithms. Then with an ICGM, you can drop in a different CGM into different systems if they're already approved. And this will give us and others, if they can attain that designation, the opportunity to go partner with more people. We're evaluating that designation. We already partner with a number of people, and it helps us go faster. But in all honesty, we we try and help our partners go faster all the time now anyway. Where it becomes significant is when we change our technology. So when we go to the G7 platform, for example, or we go to a 14-day platform, somebody like Tandem, because we're ICGM or Insulet when they're out on the market, can immediately incorporate our ICGM technology into their system without running another clinical study, just showing that the sensor works properly. In the past, we literally sat in meetings with former partners, and they chose not to integrate our technology with future offerings because they didn't want to do a trial and run a filing and do a filing. So that's where the ICGM comes in. I don't know that it is a big driver on the sales side. Dexcom Performance has always been a driver, and we've always led with that.

And a question – you know, one of your competitors is also talking about, you know, preferred co-pays. Is that something you're seeing gaining traction in the payer community at all? And how important do you think that is in changing customer behavior?

Yeah, I think, you know, there's some of that that probably goes both ways, quite honestly, between the different competitors that are out there. I think, keep in mind, there's well north of a thousand different payer policies and contracts that we're all working through, there's nothing of significance that we could point to in either direction where we've been advantaged or any other competitor has been advantaged to our knowledge. So we hear rumblings of it here or there. Usually it's on a very small scale. So I'm sure it's out there in pockets, but nothing of significance and nothing that concerns us.

And our next question comes from JP McKim from Piper Jaffray. Your line is open.

Hi, thanks for taking the question. I wanted to ask, just given kind of tandem strength from basal IQ, now that you're connected with that, and then the incoming control IQ, have you seen any difference in your patient ads from MDIs versus pumps? Any notable shift in the recent months?

No, I think, I mean, what we've been seeing, you know, we did see a shift over the last several years where, you know, historically we had been more heavily weighted to pump users. I think what You know, again, it's mostly anecdotal. We don't have perfect data, but it appears that we're basically tracking our patient ads to what the market represents, which is, you know, in the U.S., kind of, you know, 65%, 70% of our new patients are MDI patients and the balance are pump patients.

Okay.

That's helpful. And then just one on the pharmacy. You hear more and more of these Walgreens and these large centers that are actually stocking the G6 in-house. And so I'm wondering how much of a, I don't want to say revenue contributor, but how much of a strategy push that is. Is it material enough to call out at this point, or is it just kind of the strategy that you have and you'll see how it evolves going forward?

Yeah, look, there's been no shift in our business model towards stocking distributors or no incremental contribution that would skew the results in any way from stocking-type relationships or orders that would have come through. As a matter of fact, if they were significant enough and meaningful enough, you'd see us call those out in our MD&A of our Qs and our Ks, and that's not the case. So we don't have any of that driving the results at this point. You go back into the fourth quarter, I think what was most encouraging is the number of new patient additions was well beyond what we had anticipated. And honestly, it's accelerated every single quarter of the year. So the momentum has been tremendous there. And I think that's really the driver. There's not anything from a stocking perspective that's drove any of these results.

And our next question comes to Joanne Wench from BMO Capital. Your line is open.

Yes, hi. This is Matt in for Joanne. My question is with regards to expanding the capacity in Arizona. How is that going to impact gross margins in 2019 and 2020? Are you guys able to quantify that?

What I'll lay out for you is kind of how we think about the different moving pieces in 2019. There's not a lot of incremental weight being put on the gross margin profile from standing up that Mesa, Arizona facility. It's already been stood up to a degree, and we're just adding incremental capacity into there at a faster clip. But the unit production is increasing with it, so you're absorbing all that incremental cost. So you don't get any more incremental weight put on your gross margin. What you have playing out over the course of 2019 is really you're going to get a benefit as a result of this lower cost transmitter that we've designed and will roll out in the back half of the year. That benefit, though, will be offset by the headwinds associated with the revenue per patient impacts as channel mix continues to shift. Not getting too far ahead out into 2020, but now you're going to have a full year of 2020 with the benefit of the lower cost transmitter transmitter. You're going to have a more full year impact of the MESA facility, but you will continue to have some of the channel shifts as the international business grows faster, as you now have a full year of pharmacy transition probably baked into the results. Again, I think the right way to think about the long-term gross margin is in that mid-60s, but you will have those different levers playing out over time.

That's helpful. And then just my follow-up, one of your competitors made an announcement that they're partnering up with Noro, Noradisk as well. Does that have any impact with your strategy with them? And thank you for taking the questions.

No, not at all. I mean, as you know, they just announced that relationship. We announced our relationship with Novo back in October, and I can tell you we've been working with Novo for far longer than that. You know, we continue to push forward to develop, you know, software tools, robust software tools to integrate our CGM together with their intelligent insulin pen technologies that will be coming to market. So, no, I don't think that announcement earlier this week has any impact.

And our next question comes from Robbie Marcus from J.P. Morgan. Your line is open.

Hey, thank you. This is actually a question for Robbie. Just had a question on, you know, how you think about the development of Of the overall CGM market, you know, Abbott put out that they now have 1.3 million active users. I know it's been harder for you to track user numbers, but where do you see overall penetration levels for type 1 diabetics for CGM in the markets you compete in? And, you know, where do you see that moving to over the course of 2019 versus, you know, the very rapid acceleration we saw in 2018? Thanks. And then I just have one follow-up.

Yeah, I mean, I'm not going to comment specifically on Abbott's patient numbers because I think much of that will come down to how you actually define what is an active patient using your technology. But, you know, what we've seen, we can track the Abbott prescriptions here in the U.S. and kind of what we know about our patient base. I think from a type 1 perspective, we're probably, you know, pushing 30% penetration here. far lower than that in the intensive and non-intensive type two space. It's a little harder to track in Europe. I think Abbott's been, they've been at it a little longer in Europe, so their patient installed base is probably a little larger over there. But, you know, kind of hard to tell. I think we still, really the story is that we're all still in our infancy here in terms of addressable patients. So we've got a long way to go.

And then the follow-up is just, I know you have the launch of Control IQ coming up midway through this year with Tandem. How should we be thinking about that launch in terms of ASP of sensors that you will sell through that system? And, you know, have you baked in any incremental sales for the launch of control IQ of, you know, an uptick in the business that you do with tandem versus your other partners? Thanks.

Yeah. So we're not going to break, you know, break down the components of our, our guidance. Certainly, you know, that launches is one of the many things that is anticipated in the guidance that we gave you for this year, but, In terms of ASPs on the sensors, there would be no change whatsoever. I mean, the way we process through either the pharmacy or DME won't change with respect to that product, at least in the relatively near term. So there wouldn't be any delta there.

And the next question comes from Ravi Misra from Barenburg Capital. Your line is open.

Hi. Thanks for taking the question. So, Quentin, just I wanted to – kind of get, you have a kind of a range on revenues, but a point figure on gross margin. So I guess my first, uh, question is, you know, how do we think about that between the kind of bottom of the range, the top of the range, any of the cadence there? And is it right to kind of think of, okay, well, you know, you're taking a little bit of a haircut on the per patient revenue, but your margin year over year is essentially flat because of these, uh, lower-cost transmitters? I mean, is that kind of a like-for-like reduction? And then maybe my follow-up is around the restructuring. If you could just help us understand a little bit more around, you know, give us the upfront investment that you're putting forward in the severances there. What kind of savings are you expecting there, and how does that tie into, you know, as you look at risk to continue the tremendous growth that you have in driving? Thank you.

Yeah, so there's a lot there. I'll try to Hit on it, and you can remind me if I don't hit on a part of it. With respect to the lower cost transmitter and how that's playing through the margins, you know, we're only getting the back half of the benefit for that, and that's kind of offsetting a full year impact of the continued transition through the pharmacy channel or towards the pharmacy channel. So it's not a like for like, one for one necessarily if it was a full year annualized basis of all items being considered. In terms of the range on revenue and the point on the gross margin, I think we came out and said approximately 65%. I think you'll find it's going to round into there based upon the different revenue ranges. So it could flex a little bit, but we feel pretty good it's going to be right around that 65%, whether it was on the low end or the high end of that range. With respect to the reorganization that we talked about today, there's going to be about $25 million of restructuring costs that we will incur this year that's primarily related to both severance and retention. Most of that's going to be incurred in the first half of the year as we work through the transition. And most of those costs are triggered when we identify the individuals impacted and we've set a date, which most of that has now happened or happened today. So you've triggered a good part of that expense upon that communication. Therefore, it's going to happen or the expense is going to be recorded in the first half, although those people will continue to be with us over the course of some part of the year until, like I mentioned earlier, we get performance metrics in line or better than what we currently run at today. So we did not separate out any of the duplicative costs. We've left all of those in our non-GAAP results. We're holding ourselves accountable to those, to managing those well. But first and foremost is ensuring a good experience for the patients through this transition, and then we'll start to remove costs where it makes sense. We're not going to quantify exactly what that is. We're not going to quantify that benefit for 2020 at this point, but it certainly will be a nice enabler of helping us to achieve that longer-term 15%. operating margin goal and 25% EBITDA margin goal we've put out there over that five-year horizon.

And our next question comes from Doug Schenkel from Kauan & Company. Your line is open.

Hi, this is Ron. I'm for Doug. Thanks for taking my questions. It appears like your install base grew 50% in 2018. Is that correct? And I'm looking at 2019, even factoring in the revenue per patient headwinds, the high end of your guidance seems to imply that install base growth decelerates a decent amount versus that 50% this year. Is that correct? And if so, why would that occur? I know it's a tough comparison, but it doesn't seem like momentum is slowing.

Yeah, so we're not going to talk about the install base or the patient number. I think Steve laid out earlier the differences in how each of the different players in the market tend to look at it, and everyone's got a different definition tied into it. I think the way to think about it, and we've been pretty clear in our guidance, our volume assumptions in our guidance is about 25% to 30% growth We've layered on top of that the 10 points of potential headwinds coming from revenue per patient or price headwinds that take that down to the 15 or 20 percent. So, our guidance, you know, from a volume perspective up 25 to 30 on, yes, you know, what was much stronger in 2018. But I think you've got to keep in mind a couple different things. You've got a much different base that you're growing off of. It was much more difficult in 2019 growing off a 44% growth base than what 2018 was that grew off a 25% base. And you also had the G6 launch in 2018 that we don't repeat in 2019. So there's a couple reasons why it might slow a bit. I still think 25% to 30% volume growth is something we're going to be very happy with. And if we can deliver more than that, then terrific. There's a lot of opportunities there.

Okay, and then can you talk about ONDUO's expansion plans for 2019? How broadly do you expect them to expand in the U.S.? And can you talk about how they're using Dexcom CGM within their program? How often annually per patient on average? And is this only for specific high-risk patients or more broadly? Thank you.

You know, we're not privy to all of ONDUO's plans. We do talk with them, work with them. We provide them sensors. I believe they'll go as quickly as they possibly can. Their use of CGM is very much as an educational tool and something to reset the bar for people with type 2 diabetes. Similar to other programs that we work with, you know, the type 2 patient typically has not had any information like a CGM ever to help them manage their condition. They're told, eat less, exercise more, and take your pills. And when you get on a CGM, you can figure out, well, gee, this is what exercise more does. This is what eat a little different does. And this is what happens when I take my medications or when I change my medications. We believe CGM will be a critical component in all type 2 diabetes management. There's nothing that can give a patient the information that CGM does, absolutely nothing. And if we present it properly in a manner where patients can implement this information to make changes in their lifestyle and routines, it's going to be fantastic. The question then becomes, how many a year do they use and what is the business model? And I think that's going to be worked out by a number of players through studies over time and be worked out by us as we look at potential different product offerings to serve this market. We view it as a big one and we view it as something that can make a huge difference.

And our next question comes from Isaac Rowe from Goldman Sachs. Your line is open.

Good afternoon. Thank you, guys. Maybe first question, if you could just give us an update on the Verily program in loose terms, what some of the key milestones are for development this calendar year in terms of what's making your expectations, that would be a great starting point.

Yeah, so Isaac, this is Steve. What you heard us talk about in the prepared remarks was G7 and committing to the timeline of launching G7 by the end of next year or the first part of 2020, and that remains on track. That That will be the first launch of a product that incorporates our technology together with Verily. We're not referring to it specifically as the Verily platform anymore. It's really a Dexcom product, and we're going to call it G7 going forward. In terms of milestones, we're not going to comment specifically on the path in terms of clinical trial or regulatory filings at this point, but we'll probably update you guys as the year goes on.

That's fine. Thank you. And then, Quentin, a question for you on the guidance side. Just given the velocity of top line growth, if we combine that with all the moving parts on the P&L from, you know, pharmacy and just, you know, funding the growth in the business, can you just help us think a little bit about the quarterly cadence of operating margin this year? To be said, it may or may not be kind of aligned with revenue seasonality. It would be just helpful if there's any kind of revenue to expense mismatch this year that could be, you know, a little bit non-obvious to us, you know, here in the beginning of the year. Thank you.

Yeah, I think back to this whole point of ensuring that we have a smooth transition in the workforce into our Philippines and third-party service providers, we're going to be willing to run duplicative costs through the P&L for a period of time, which really starts in the first half of the year and is going to continue to be that way through the first half and then start to alleviate toward the mid part, the late part of Q3 and into Q4. With those headwinds, I don't think that you should necessarily expect you're going to have significant improvements in operating margin year over year in the first half of the year, but you ought to see sequential improvements in the operating margin take place over the course of the year.

Our next question comes from Matt Taylor from UBS. Your line is open.

Hey, Matt.

Are you there? Okay, we will move on. Next question comes to Chris Pasquale from Guggenheim. Your line is open.

Thanks. I appreciate the sensitivity around the installed base number, but you guys have also provided some color on new patient ads in the past, and I would think at least their definitions would be pretty consistent. Anything you're willing to share for 2018 to help us chew up our models on that metric?

Well, I'll tell you that new patient ads were the primary driver of overall growth, but very similar to the install base. I think the definition of a new patient is very different across the players in the space. We don't consider a new patient really a patient of ours until they're actually repurchasing and buying in normal purchase patterns for a period of time. I'm not sure that that's consistent across the universe. So even how we define new patients I think is very different across the players in the space. Okay.

And then, Quinn, just trying to nail down the impact of the transmitter and how that flows through, can you share anything in terms of actually quantifying the magnitude of the cost reduction on the transmitter from where you are today to what this next gen looks like?

Yeah, we haven't quantified where it can go. It's significant, I will tell you that. The problem with it is the more volume that you're able to push through the plant and the more that you're absorbing in the way of cost, the better it gets. And so we're not going to see the full benefit of it in 2019. As we get the full production capacity with it in 20, it becomes more meaningful to us, but we're not going to identify the complete difference or the total difference in that new structure, new cost structure.

And our next question comes from Matt Wiseman from Raymond James.

Hi, thanks for the questions. I'm on for Jason Bedford. My question is really about retention levels. So are you seeing with the G6 increased compliance among the user base relative to G5 and G4? And how is adherence trended? And do you still kind of see room for improved retention levels going forward, maybe with the G7? Thanks.

Yeah, I think we're pointing at each other. Our retention levels, we've been very pleased with what we've seen with G6, and the teams here have done a really nice job being focused on it and watching it. We have seen some improvement in our ability to retain folks, although we've always done a really nice job retaining patients once they've got onto our Dexcom technology, but there has been a bit of improvement there.

Yeah, this is Kevin. The one thing I will add is Our retention has largely been a factor of economic circumstances as well. And what will be interesting for us as we map and chart G6, particularly as a majority of those patients use the phone app much more than our G5 patients before, I think we can have better pictures going forward in time as we look at what happens in the first quarter where co-pays and deductibles reset. I think G6, you know, anecdotally we hear everybody likes it a lot better in We still need more data. I mean, with all those sales in Q4, we don't know that those patients are coming back yet. And the biggest reason we lose a patient is money. It's not been the product performance. It's what they can afford and what they can do.

Hello?

Are we still there? Oh, thanks. Yeah, that was my only question. I'm sorry.

I'm sorry. One moment. Our next question comes Suraj Khalia from Northland Securities.

Sure. Good afternoon, everyone. So, Kevin, a lot of pointers you have provided, and I'm trying to get my hands around it. Let's say we assume FY19 around a billion and a quarter revenues. Can you give us directionally in terms of what the expectation is for the pharmacy channel And the sub part of that question is I don't remember you guys giving us a delta between, you know, the DME and the pharmacy channel. I guess the reason I'm trying to ask is, you know, from let's say six quarters ago to now, cross margins are down roughly 500 beeps. I understand the channel mix. I understand, you know, the movement of manufacturing, how you're trying to move the OPEX line item. Agreed. Help us understand or reconcile how your outlook is for the pharmacy channel and what the price delta is so that we can at least kind of put it into a model and make sense of that. Thank you for taking my questions.

This is Kevin. I will take that one. I'll go back to my old CFO days, Quentin, but I won't throw a bunch of numbers out. At the end of the day, When we talk about channel mix and channel shifting and the effect on margins, an average revenue per patient is not just the pharmacy channel. Again, a larger percentage of our business continues to go through foreign markets, and those foreign markets do have lower average revenue per patient per year. And as that increases, our margins, in fact, do come down. Medicare, as we started, was a lower average revenue per year per patient based on the goods that we shipped them versus other ones. That was kind of a margin. deterrent in the beginning. We think over time as our costs come down, Medicare margins will be very good. With respect to the pharmacy and DME mix, we've never disclosed that. And there's no magic formula for what the difference is between DME and pharmacy. It literally varies contract to contract and how we structure each of these arrangements. I think we can do it over time.

Yes, Raj, I would just add to it. You know, the pharmacy model is a very attractive model to us. From an operating margin perspective, we're convinced we can make more profit dollars in that business than we can the DME channel. So we will continue to push for it hard. And while it might weigh on the gross margin a bit, it's going to ultimately be a tailwind for the operating margin. So at the end of the day, it's the right thing to be looking at, and it's going to be a value creator for us over the long term.

And our next question comes from Matt Taylor from UBS. Your line is open.

Hi, this is Eon for Matt. Sorry I was on mute. Thanks for taking my questions. I have two quick ones. So first, what's the percentage of patients currently on G6 versus earlier generations of device? And also, can you give us more color on the feedback you received so far for your pilot activities with disposable G6 CGMs? Thank you.

Well, I can tell you the G6 in the U.S. business, the majority of folks have moved towards G6 in our U.S. commercial business. Obviously, Medicare is still a G5 product. And in the international space, we still have a lot of markets that utilize G5, but transitioning to G6. But in the U.S., it's now moved into the majority of folks on G6 in the U.S. You're going to have to repeat your second question. I didn't get it.

Oh, I'm sorry. So the second question is just the feedback you've got so far from your pilot activities with your disposable G6 PGM.

It's really very small. Nothing really to report here.

Okay. Thank you. And that concludes the question and answer session. I'll turn the call back over to Kevin Sayre for final comments.

Thank you everybody for participating in our call today. Something you may not know is this year is actually Dexcom's 20th birthday or anniversary. We launched our first product in 2006 and after 10 years of commercial activity, we hit the $500 million mark in annual revenues. But we picked up the next $500 million in annual revenues over the last two years. We're positioning the company for the next billion dollars in revenues and beyond and know it's gonna go much faster. This is never easy, but we are fully, fully committed to having the ideal technology in our pipeline to capitalize on this massive opportunity. As you heard today, much of our focus this year, in addition to growing our business and pushing the product pipeline, is to build the infrastructure necessary to enable us to meet those goals. We look forward to a great 2019 and want to thank everybody once again. Have a great day.

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