Kevin Ronald Sayer - President, Chief Executive Officer & Director Steven Robert Pacelli - Executive Vice President, Strategy and Corporate Development.

Michael J. Weinstein - JPMorgan Securities LLC William J. Plovanic - Canaccord Genuity, Inc. Benjamin Andrew - William Blair & Co. LLC Brooks E. West - Piper Jaffray & Co (Broker) Michael R. Rich - Raymond James & Associates, Inc. Tao L. Levy - Wedbush Securities, Inc. Ryan Blicker - Cowen & Co. LLC Danielle J.

Antalffy - Leerink Partners LLC Erik Ross Shoger - Northcoast Research Partners LLC.

Welcome to the DexCom First Quarter 2015 Earnings Release Conference Call. My name is Anna and I will 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 that this conference is being recorded. I will now turn the call over to Kevin Sayer.

Kevin Sayer, you may begin..

Thank you very much and welcome to our first quarter 2015 earnings call. We'll start off with Steve Pacelli and our traditional Safe Harbor statement..

Thanks, Kevin. Some of the statements that we will make in today's call may constitute forward-looking statements. These statements reflect management's expectations about future events, operating plans and performance and speak only as of the date hereof. These forward-looking statements involve a number of risks and uncertainties.

A list of the factors that could cause actual results to be materially different from those expressed or implied by any of these forward-looking statements is detailed under Risk Factors and elsewhere in our annual report on Form 10-K, our quarterly reports on Form 10-Q, and our other reports filed with the SEC.

We undertake no obligation to update publicly or revise these forward-looking statements for any reason. Additionally, we will discuss certain financial information that has not been prepared in accordance with GAAP with respect to our cash based operating results.

This non-GAAP information is provided to enhance your overall understanding of our current financial performance. 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.

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 the format we established during our last earnings call, Steve will start with a review of our detailed first quarter 2015 financial results and I will follow with our customary operations update and offer some concluding thoughts before opening the lines for questions.

But before I turn the call over to Steve, I want to take a moment to talk about some of our major accomplishments during this first quarter. First, we launched our G4 PLATINUM with Share System in March, just over 30 days after receiving approval. We were planning to launch this product in Q2 and had to accelerate a number of tasks to pull this off.

I want to acknowledge the efforts of all of our fine people involved with this project. Second, we filed the DexCom G5 mobile system in February. We have long dreamed of transmitting sensor data directly to a smartphone as have our patients and we believe that that dream will be realized later this year.

Concerning our commercial activities, we again experienced significant revenue growth in spite of the fact that the first quarter is always the most challenging from a reimbursement perspective. U.S.

new patient growth was exceptional as on a percentage basis, our new patient growth compared to Q1 last year far exceeded our 55% total revenue growth for the quarter. Finally, we made progress on a number of other fronts that we will report on throughout the call. With that, I'll turn the call over to Steve..

Thanks, Kevin. DexCom reported revenue of $72.8 million for the first quarter of 2015 compared to $47.1 million for the same quarter in 2014, a $25.7 million or 55% increase. Sequentially, revenue for Q1 of 2015 decreased $11.5 million, down 13.6% from the prior quarter.

This sequential decline in revenue was not unexpected due to our typical Q1 seasonality together with the financial impact of the launch of our Share Receiver that we will discuss momentarily.

Our gross profit totaled $46.5 million, generating a gross margin of 64% for the first quarter of 2015, compared to a gross profit of $29.8 million and a gross margin of 63% for the same quarter in the prior year.

We'd like to take this opportunity to give you some clarity on the Q1 financial impact of our sooner than expected FDA approval of the G4 PLATINUM with Share. As this approval affected both our revenues and gross profits for Q1, under the terms of the upgrade program we previously announced all U.S.

patients who purchased a G4 PLATINUM system from January 1 until the launch of the Share Receiver in March, have the right to receive a free upgrade to the Share Receiver. This upgrade program required us to defer $800,000 of our revenue in Q1 related primarily to upgrade receivers which were not shipped prior to quarter's end.

However, we expect to recognize most of this revenue in Q2 when we ship the balance of the receiver upgrades. Additionally, we recorded a charge, cost of sales of $2.7 million related to this early launch.

Of the $2.7 million, $700,000 was recorded as a charge to cost of sales with respect to the upgrade receivers and $2 million was a write-down of excess and obsolete inventory related to the prior generation G4 PLATINUM Receiver.

The impact of this revenue deferral and the additional cost of goods sold related to the G4 PLATINUM with Share launch was a decrease of approximately 4 margin points. We do not anticipate any additional charges with respect to this launch. And we expect margins to return to normal over the course of 2015.

Some final thoughts on our revenues and our gross profits. Our mix between durable and consumable products remained steady at approximately 30% durable, and 70% consumable, a mix we expect to remain fairly constant going forward.

ASPs for sensors remained within our stated range of $70 to $75 per sensor, and the ASP for our hardware is approximately $800 to $850 per starter kit. Finally, our international business continued to grow and now represents slightly more than 15% of our revenues.

Research and development expense totaled $19.8 million for Q1 of 2015 compared to $14.5 million in Q1 of 2014, with the increase due primarily to additional payroll related costs and expenses related to work on our near-term product pipeline and work on our advanced product pipeline. Sequentially, R&D expense was down $1.8 million.

However, we remind investors that R&D expense can be variable quarter-to-quarter, and we still expect that R&D expense for the full year will be up approximately 25% on a GAAP basis versus 2014, and approximately 15% on a cash basis.

And similar to prior years and consistent with our commitment to continued innovation, we may take on additional R&D expense if it will better position the business for the future. Selling, general and administrative expense totaled $39.4 million in Q1 of 2015 compared to $27.6 million during the same quarter 2014.

This increase was primarily related to increased head count in our sales organization, including both field sales and internal sales support staff, which was largely completed during Q1, and some increased IT infrastructure cost.

It is also important to note that the year-over-year increase in SG&A expense included $4 million of increased non-cash share-based compensation expense. Our net loss for the first quarter of 2015 totaled $12.9 million and included $18.7 million in non-cash expenses centered in share-based compensation, depreciation, and amortization.

Absent these non-cash charges, together with the impact of the deferred revenue and the increased cost of sales related to the G4 PLATINUM with Share launch, our cash based net income was $9.3 million for Q1. This compares quite favorably to a cash based net loss of $500,000 in Q1 last year.

We also remind investors that, going forward, we expect share based compensation expense to be approximately $21 million to $22 million per quarter through the balance of 2015. Our loss per share for the quarter was $0.17.

With respect to our balance sheet, we ended the first quarter with $84 million in cash and marketable securities, an increase of $26 million over Q1 of 2014. Looking forward we remain comfortable with our fiscal 2015 revenue guidance of $340 million to $360 million.

And before I turn the call back to Kevin, I want to take a moment to acknowledge the outstanding work by our quality and regulatory teams in guiding DexCom through an FDA inspection last week.

The inspection resulted in no observations or findings by the FDA as part of our biannual QSIT audit and the inspection also clears the warning letter issued back in 2013, great work by the team. With that, I'll turn the call back over to Kevin for a business update..

Thank you Steve. Well the biggest event in Q1 was the launch of the G4 PLATINUM Receiver with Share, a huge milestone for DexCom and for our patients. Since that launch, we've been flooded with phone calls and e-mails regarding the benefits of connectivity and sharing data.

Several parents have related stories to us regarding their ability to identify serious low readings of their children, many of them away at college and help those loved ones properly treat their diabetes. We've also received extremely positive feedback regarding data display on the phone for patients.

Again, we're hearing I don't take my Receiver out of my pocket or my backpack or my purse. I just look at my phone and I love it. With Apple's launch last week, several fortunate DexCom patients have received their Apple Watch and are viewing glucose information on yet another new platform.

We're already getting more screen shots from enthusiastic patients and caretakers following their loved ones. For the Android community, our Android DexCom Follow App is scheduled to be released in early summer. This has always been our goal, give our patients and their caregivers glucose information whenever and wherever they want it.

The DexCom G4 PLATINUM Receiver with Share is only the beginning in a stream of innovation that will drive our growth for the next several years and we believe that today is an appropriate time to provide a deeper look into our future plans. Let's start with Gen 5.

As I stated in my opening remarks, the G5 mobile system was filed with the FDA in February of this year. We have had excellent dialogue with the agency regarding the G5 mobile filing and we expect to receive FDA approval and launch the G5 mobile system later this year.

We believe that this system will truly make the smartphone the center of the diabetes universe for our patients and will completely change the DexCom patient experience. The key component of this system is a smart transmitter. The algorithm currently running on the receiver will instead reside in the transmitter.

The smart transmitter will directly send a glucose value via Bluetooth low energy to up to two devices. Patients will no longer be required to carry a receiver for connectivity, excuse me – as they do now. The signal will go straight to the smartphone.

The user-interface for this system has been completely redesigned to take advantage of mobile platform visualization. While our first product offerings are iOS based, we plan to develop G5 mobile apps for display on a number of platforms and devices, giving patients and their caregivers a tremendous amount of flexibility.

The G5 mobile system also incorporates the capabilities of our FDA approved Share platform. With data from our patients going directly to our secure servers, we look forward to the day when we can offer patients, payers, and healthcare professionals advanced analytics to improve outcomes for everyone.

We will have a tremendous opportunity to partner with other healthcare entities to include this data in a complete health profile, and are in discussions with many such partners right now. The G5 mobile platform will have a significant impact on DexCom as well.

The G5 mobile system utilizes our FDA-approved G4 PLATINUM sensor with the improved 505 algorithm so there will be no disruption in sensor operations for this launch. The G5 mobile system can impact our revenue models in a number of ways.

We believe that this system will be a major catalyst in driving new patient growth, therefore increasing our revenues. We also feel that the improved patient interface and data sharing capability of the system could have a positive impact upon patient retention and sensor utilization.

Currently, we believe that the FDA will require each new patient to purchase a DexCom Receiver, which will more than likely be used as a backup.

Receiver upgrade revenues will probably decrease since the Gen 4 PLATINUM Receiver with Share will be compatible with G5 mobile and existing patients will more than likely utilize their iPhones and other smartphones as their primary receivers.

Total transmitter revenue for a patient over a 12-month period will remain constant or possibly increase as the G5 smart transmitter has a shorter useful life than the current transmitter.

Just to remind everyone, the SEVEN PLUS Transmitter had a labeled useful life of one year, the G4 PLATINUM transmitter has a labeled useful life of six months and the G5 mobile transmitter will have a labeled useful life of three months.

Given the need to manufacture more transmitters per patient per year, we are initially anticipating increased costs on the transmitter front.

However, we believe that over time we can eventually make the cost model of our future transmitters equal to the current model through increased volumes, new electronics designs and other manufacturing efficiency projects that are already in process.

The shorter transmitter also provides the DexCom community with another benefit, upgrades to new platforms will be significantly shortened and much simpler.

For example, when Gen 6 is launched, the Gen 6 smart transmitter with its corresponding app will be available to all existing patients during their normal purchasing cycles within a few short months. Shifting to Gen 6, we expect to conduct a pre-pivotal with our next-generation sensor this summer.

After that pre-pivotal study, we will finalize our IDE with pivotal studies coming after that. We currently see Gen 6 as a first half 2017 commercial launch, but that timing could change based on a number of factors. Gen 6 will be an extended wear sensor, most likely 10 days.

Extended sensor life will provide us with yet another opportunity to reevaluate our business model. Gen 6 will also have a reduced calibration scheme and a completely new algorithm architecture.

Based upon the performance we have seen with the sensor to date and the capabilities of our next generation algorithm platform, we believe that calibrations could be completely eliminated with this future system.

However, as we work with the FDA on a non-injunctive claim for our current sensor platform, and as we work with the various artificial pancreas groups around the globe, we've come to recognize that it may be prudent to require the safety of some fingerstick confirmations during a sensor session.

So as the Gen 6 sensor evolves, we may end up with multiple product offerings levering the same core sensor technology with different algorithms, different user interfaces, and different labeling. For example, think of an AP sensor that is labeled for use as part of an automated system, but still requires calibration for safety.

And a non-AP sensor with a different algorithm, a different user interface, that would not require calibration, but might have a different labeled indication. Ultimately, we do plan to eliminate fingersticks for all indications, but that will take some time and some more experience.

The other thing that the Gen 6 platform will offer the company is the ability to expand into other markets, diagnostics for non-insulin using Type 2s, hospitals, pregnancy, even pre-diabetes and obesity.

The performance and future cost reduction features of this system combined with the connectivity and data features carried over from previous generations will provide us with tremendous opportunities in the future.

Not to be lost in all of the Gen 5 and Gen 6 discussions, are our efforts to make improvements in our products that will affect the current system and several generations of products thereafter. Activities related to an insulin dosing plan for our current system continue with the FDA.

The agency has been extremely thoughtful and progressive in this area. We're also actively working on similar labeling in the O-U.S. markets.

We're also making good progress on the next insertion system, a lower cost, higher quality, Wi-Fi enabled receiver and several generations of transmitters, all designed to be more convenient for our patients, and to reduce costs and improve reliability for DexCom.

Shifting to our integration partnerships, Johnson & Johnson reported positive feedback regarding the launch of Animas Vibe in the U.S. during its earnings call a few weeks back. Tandem continues to have discussions with the FDA regarding their integrated system and remains on track for a launch later in 2015.

As we look to the next phase of our integration partnerships, display will be available on the pump or on the smartphone, again glucose where you want it. Our sharing capabilities will also be enabled. Current plans for future integrated systems using our advanced technologies will call for them to do more than display glucose values on a pump.

We are committing future technology to these partners only if they can commit to develop products that go beyond their display and offer some measure of insulin control based on CGM data. We've also committed to provide additional support to these partners, provided they're willing to step up and develop these type of advanced systems.

Innovation at DexCom is not limited to product development. We have committed to simplify our distribution channel and efforts in that area are progressing nicely. We continue to make progress on the pharmacy benefit front, executing some important contracts this quarter.

Legislation has been introduced into both the House and Senate for Medicare CGM coverage and we will continue to pursue the legislative path as well as several others paths to make CGM available to this ever-growing and vulnerable Type 1 population.

Just to remind everyone the majority of these Medicare patients had private insurance coverage up to age 65 and after that, most of them are paying 100% of their CGM costs out of pocket. We've made progress with several Medicaid plans with 10 states now having coverage for CGM and others which have opened up, policy review.

CGM awareness continues to grow, particularly with all of the positive feedback received on the Gen 4 PLATINUM Receiver with Share integrated with the various Apple platforms.

As Steve said earlier on the call, we have completed our sales expansion for the year, but with groundbreaking connectivity and the anticipated launch of G5 mobile later this year, we will be making larger scale investments on the awareness side throughout the rest of the year. I'd now like to open things up for questions..

Thank you. We will now begin the question-and-answer session. And we have a question from Mike Weinstein from JPMorgan. Please go ahead..

Thank you. And good afternoon. Kevin, I want to start with the comment you made in your upfront remarks, just talking about patient growth relative to revenue growth, and I forget how you phrased it.

But I think you may have even used the word exceptional, but the comment was that patient growth this quarter was actually far outstripping revenue growth.

So maybe you can just clarify what exactly you said and shed some light on what's happening there?.

You know Mike, I was pretty proud that I gave that much detail, but what I said is our revenues grew 55%, our new patient growth exceeded that number. So if you compare the new patients we added in Q1 of last year, we added more than 55% more than we added last year..

And the incremental momentum that you think you're seeing, is that in pediatrics or do you have enough of a sense to be able to identify where it's coming from?.

It's all across the board. Pediatrics has been very helpful, but we had pediatrics, I believe – I don't know that we had it in Q1 last year....

February of last year..

Yeah. We had it in Q1 of last year. So it's across the board..

Okay. And then, can you just help – you covered so much on this call, I kind of want to understand a little bit about the comments you made on your partners – on the insulin delivery side.

You made a comment talking about how you're working with the partners and I think, you said you were only going to be supplying the CGM integration capability to companies that basically had a bigger vision, that were looking to do more than dual display.

Could you just expand on that?.

Yeah, Mike. This is Steve, I'll take this one. So, let's talk first and foremost with Gen 5, we moved display to the mobile phone. We've already heard with – even with G4 PLATINUM with Share, nobody is pulling out their receivers anymore. People are ecstatic about interacting with their CGM on the phone.

So, our belief, and I think our partners by and large share this belief that once the data is on the mobile phone nobody is going to pull out their pump just to look at their CGM readings.

So, going forward what we're saying to the partners, and I think most of the partners are understanding and on board with this, for advanced technologies, and moving beyond Gen 5, think Gen 6 and beyond, that they've got to do something with the sensor data other than just display it.

Because, I mean, these projects, they're work for us for our R&D teams too and to put a bunch of resources forward for something that's really not that necessary for a display only, is just not something that we are interested in going forward.

So the comment really just said, partners, you need to step up and commit resources to doing something – not necessarily calling it an artificial pancreas, but something more automated with sensor doing some sort of control of the pump before you're going to get access to our future technologies..

You know and I'll just add one comment to Steve's, Mike. I also said we'd do more to support them and we will. We'll be involved in – if we're going to make more automated systems and systems that do more, we probably know as much about algorithms given our experience with all these artificial pancreas groups as anybody in the world.

So, we – as these companies make their commitments, we will make commitments with them..

Okay.

And then let me ask you just on, so if G5 is approved later this year, can you just talk about the transition for the company from – from G4 to G5 and any incremental thoughts on how that's going to play out and how long that takes?.

You know what, it'll happen the day – as soon as we get approval, it'll be very similar to the Gen 4 launch before. We'll go very quickly, provided we don't get an approval two months ahead of where we planned getting it like we got with this Receiver.

Now our G4 PLATINUM with Share Receivers have the capability to receive the Gen 5 transmitter signal through a software revision, so those patients aren't going to have to buy new Receivers to get the Gen 5 transmitter. They can go directly to that. That transmitter will speak directly to a phone. Patients will have to download the new app.

We're not planning on charging for the app for Gen 5. With respect to sensor manufacturing, it is a G4 PLATINUM sensor, the transmitter is the same – to start, the transmitter is going to be a similar form factor to the G4 transmitter. So we're not going to have to change anything operationally.

We'll be producing the exact same sensor, so it's going to be all systems go from day one..

Okay.

And but the transmitter, that's going to be basically every three months, a patient will need a new transmitter, starting with G5?.

That's what it's labeled for. Our current one is labeled every six months and we know some of our patients get a lot longer than six months out of it. This one will be labeled for three months use, because a Bluetooth radio requires a lot more energy and we did not feel like going a bunch bigger for the patients.

So, we want to keep the same footprint..

Got you. Understood. We have a lot more questions, but we'll let some others jump in. Thank you..

Our next question comes from William Plovanic from Canaccord Genuity. Please go ahead..

Great. Thanks. Good evening.

Can you hear me okay?.

Absolutely..

I am just going to have one question here in a couple parts.

But it really focuses on the whole shift to the pharmacy benefit, and I'm just wondering, can you help us understand how this is going to impact the business, maybe step back and say short-term, what are the pros and cons, and then longer-term how does this play out and impact the overall business?.

Well, longer-term – I'll start with longer term. Longer term, it's going to be much easier for our patients and for us and for everybody involved because if you can go to Rite-Aid or Walgreens or wherever and pick up your sensors and your transmitter every three months, possibly as a bundled package, that makes life much easier.

Pharmacy copays are typically lower than DME deductibles and all the other things involved in that cycle. That will make things much better for the patients. Over the long-term for us quite honestly that will reduce the number of distributors that we manage and ship product to.

We will still have some business always in DME as we look out over three years to five years, at probably a 70% to 30% ratio, that would be our goal, pharmacy versus DME to do that. With respect to pricing, we're in the middle of negotiating pricing contracts for pharmacy benefit, and pricing is – it's going to be different.

It's negotiated differently. But what people tend to forget is we already sell to distributors and give part of our price away to them to begin with, so it's going to balance out over time and what we hope to do is keep pricing relatively constant over time and we go to great measures to evaluate each and every one of these contracts.

And what they do from an operating expense perspective, we think it could be a huge impact for us because we just can't keep – we can't go lease building to deal with all the phone calls on the DME side, it is not a scalable business model for us over time given how many patients we're going to add and use this product.

So we feel the need to as I often say change before you have to and we'll push the business in that direction..

And then, just help us from the near-term, as you're making this transition what's – where are you today in terms of how much of the business is going through PMBMs today? And then how does this impact the P&L short-term? Is this going to cause, I think you said longer-term pricing will stay constant, but is there going to be initial incremental cost or lower pricing upfront or anything we should be thinking about as you go through this?.

Well we've been moving business through that channel and pricing on an overall basis really hasn't changed. We don't disclose the percentage that we moved.

We are going to give everybody really more of a report card on this later on in the fall, as some of the contracts we're in the process of negotiating fall into place which will have an effect on our business probably going forward for the rest of the year.

Short-term it hasn't affected us much yet and I don't think it'll have much effect 2015, because I don't think we can push enough of the business there to really have a big impact. So we'll see how it goes in 2016, but again let's not forget something else.

Then we go to a ten day sensor, so if we can get ten days of reimbursement for a sensor versus seven days for a sensor, that certainly would eclipse anything we would lose on the pharmacy benefit front. So as we go through these business evolutions, we're contemplating a whole bunch of variables while we do this..

And then just clarification, the 10 day sensor that was part of the G6 was it not or will that be a amendment to the G5?.

No, that will be a Gen 6 sensor not Gen 5..

Which is a 2017 event from your comments?.

That's where it's scheduled for today..

Okay. Great. That's all I had, thanks..

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

Hi, good afternoon, guys. Few questions for you if I might.

It appears from the commentary Kevin on the patient adds that you had obviously a very strong quarter there and to fit the total revenues with the 30% contribution from hardware inside what you reported, does that suggest you had a bit more seasonality and purchasing for sensors this quarter?.

You know what, we always have in the first quarter – our existing patients don't buy as many sensors as they buy in other quarters because a lot of them have loaded up in December when all their copays and deductibles and all the other stuff has been met and they still have their flexible spending accounts.

So you have an increase in hardware purchased that's driven to a large extent by new patients who buy receivers and transmitters in Q1 and then buy some sensors and we have some other sensor purchases, but the rest of the upgrade cycle is a little slower in Q1. So that's how the 30:70 ratio remains relatively consistent from Q4 to Q1..

Sure..

But remember, one thing we commented on in our year end call a couple months ago was that we've gotten much much better at processing and pushing product out the door and what we commented on the last call is that we did an exceptional job in Q4 of pushing everything we possibly could..

Could out the door..

In terms of sensor disposables, so....

Sure. Well, I mean, my specific point is, I had 30% patient growth baked into our model to drive towards 360. And if I grow patients at 56% I got to cut sensors in Q1 and it's a bear to hold the model at 360, because then the sensor mix drops down to about 25% – or the durable mix drops to about 25% for the balance of the year.

So my patient numbers for the balance of the year are either really, really too low or you got a spike in patient adds in Q1 and it's going to drop off in Q2 because you had the launch.

So, do you think you're going to grow patients sequentially in Q2? Patient adds?.

You know what, our plans would currently indicate that, how much they grow over Q2 of last year I wouldn't talk about today. But our team is certainly looking forward to adding more patients in Q2 than we did in Q1..

Yeah..

Okay..

The hardware mix, Ben, is also going to be affected with the Gen 5 launch, because then new patients, the new patients may buy receivers but the new receiver upgrade cycle is going to go away, or it's not going to go away it's just going to decrease a lot. So, all these factors are going to affect the business model throughout the rest of the year..

Right.

But is it your intention to maintain roughly the same hardware revenue per patient or total revenue per patient as you switch to the shorter live transmitter?.

I think the revenues – the hardware revenue could go up slightly, but we also think that there could be one of the comments in Kevin's prepared remarks was that, we think that sensor utilization could go up with Gen 5, because we think there is going to be a stronger compliance particularly in the pediatric segment.

I think hardware revenues from a transmitter perspective could go up slightly..

Yeah. But we won't get the receiver updates that we had in the past..

The receiver replacement cycle was 12 months to 18 months, probably extends out because people are going to keep their receiver at home in their briefcase, backpack, desk. They're just not going to use it as much so they're not going to need to replace it..

Of course..

So we'd like to keep patient revenue the same but the split will probably change, so the 30:70 mix as you look at Gen 5 will probably start moving down closer to 25..

Got it. Okay. That's fair..

That would be what we would anticipate..

That would be there..

And then Kevin, how do you think about the dosing claim in terms of either timing or size of clinical studies and when can we expect an update on that because absent the – along with the calibration progress that's an important one for you?.

It is very important and this is largely a function of our meetings and discussions with the agency and we're still in the middle of discussing clinical study sizes and efforts.

I would tell you the biggest effort here, one of the big efforts is going to be human factors because when we have a claim that you can dose insulin with this device, we have to make sure the user interface and the manuals and the training and everything actually teach someone how to use the system and how to dose insulin from it.

So we're headed into some new ground here. I don't have timing for you today. We'll upgrade that more at the end of the Q2 call but I think it's going to be something we work on as we go. And it is independent of the Gen 5 filing. It's independent of the Gen 5 launch.

We're going to have to prepare user guides and cut over to that claim at some point in time but we've kept that effort independent of the core technologies..

Okay.

And then last thing for me is the applicator, is that still kind of early 2016 or has that – is that changed?.

It's certainly – it's certainly – we're hopeful for 2016. It does change depending a lot upon Gen 6 timing, depending upon dosing claim timing, depending upon how we do with Gen 5, it's a little bit fluid.

We have run studies on the applicator system and they have gone extremely well so our design is very much locked down right now and now it's a question of how quickly can we scale up. (35:47).

Okay. Thank you..

Our next question comes from Brooks West from Piper Jaffray. Please go ahead..

Hi. Thanks for taking the questions. Guys, I wanted to circle back to the commentary around the pump partnerships just so I'm clear. The – if you think about even how far ahead you guys are in terms of your technology versus the pump partners.

Does it really, especially with G5 on the horizon, does it really matter given what we know about the current generation pumps and even the next generation pumps if those partnerships exist or not in terms of driving pump sales, because your system almost works better independently and if I'm correct with that thought, then what – obviously short of an artificial pancreas but what do you need to see from the pump guys to really invest more in those relationships?.

You know what, Brooks, we have been involved with enough research projects that we know automated insulin delivery is going to come. Medtronic spends an inordinate amount of time talking about that how, about their 640G, their 670G and their future products. We want a product in that space. We want a partner to be in that space.

We think we can help that group of patients who truly want some type of control, maybe just during the night time, maybe during the day. However they want to configure it, control within a range, there are a number of studies going on. And we do believe in the pump market, those products are going to be important.

We believe our partners can get there, but we don't want to go back and spend a bunch of time re-engineering the Gen 4 or Gen 5 system and continue to have to support it and build it for another 10 years to support somebody who gets a sensor-augmented pump approved in three years. So we're going to – we're pushing to go faster.

We're pushing to go to our future platforms and we're offering to help. We're prepared to run the business.

Our models are as a standalone to a large extent internally certainly for the short-term period but we think as we look out over 10 years and become a force in the diabetes world, bigger than we are, we need products offerings and the fact is patients deserve the best sensor technology, they're not going to get it someplace else..

Okay.

So but – that makes a lot of sense but Kevin do you agree with the statement that maybe over the next year to even three years, it's a nice marketing statement to say a DexCom on board, but does it really drive pump sales? And then would you – you get this question from time to time but would you entertain entering the pump business on your own? Thanks..

We're not in the pump business today. Call us when we're at $2 billion, $3 billion in sensor revenue and we'll think about it. With respect to the pump partners I do think display on their pumps is going to be helpful in the short-term because people do want integrated solutions with DexCom.

I think over the next couple of years as we evolve our products faster than they're able to do, it will be a little problematic for them, but we'll work with them. We'll make these relationships work as best we can..

Great. Thank you..

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

Hey, guys. This is Mike Rich calling in for Jason.

Can you hear me okay?.

Yep..

Yep..

Great. Thanks for taking the questions.

First off, you mentioned the very strong in the user growth in the first quarter, I'm wondering if J&J's Vibe provided a significant contribution to that growth, and if so, can you give us an idea how much?.

It helped. But I wouldn't call it significant..

Okay..

It helped. But it wasn't a large percentage of it. No..

Okay. Thanks.

And then, can you give us an idea what percent of the user base either purchased or upgraded to the Share Receiver in the first quarter and what the pipeline for upgrades looks like going forward?.

We've got certainly as we discussed in the financial section, the upgrades that we promise for free, we have everything – all the revenue on that deferred and that program will be completed by the end of the second quarter.

Other people's receivers will upgrade over the course of their normal upgrade cycle if they choose to and that's just part of our normal sales. We don't have a schedule for that and nor could I tell you what percentage – or would we disclose what percentage of our patients did upgrade in this quarter..

Just anecdotally, does it feel like people are accelerating a receiver upgrade that maybe they'd be due for a few months from now or are they just going to go through the normal lifecycle of a receiver?.

You know what we've learned over time here is our patient community is very pressed on the cost side. And to accelerate an upgrade and pay more than you would pay with a copayer deductible is not something most of our patients do.

Now we have had some pediatric patients in particular the day this thing was announced call up and say I got to have this tomorrow, but that isn't a majority of them. We even learned with Gen 4 when we launched that back in 2012, we offered reduced price upgrades and several things, and not that many people took advantage of them.

So, I don't see that as going crazy. I think it'll typically between – happen during the normal course of use and during normal purchasing patterns..

Okay, great. That's it for me. Thank you..

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

Great, thanks. So, just a quick clarification. I think last quarter, you'd said the starter kit was around $850 to $900, and in this quarter you said it was a little bit lower, it was $800 to $850. Is that more of international, U.S. or ....

No, it's a combination of things. It's a combination of mix between – in the U.S., we sell a portion of our business direct through payer contracts and a portion through distribution. We sell 100% through distribution.

Depends on the mix of distributors in a given quarter – our mix – the insurance plan pricing varies, not dramatically, but it varies enough to move the needle. So, that's all that's going on there..

Okay, great. And you didn't mention the potential price of the G5 transmitter.

Is that going to be at the same levels or...?.

No. We haven't disclosed anything regarding pricing for G5 yet..

What we did say is the cash flow of transmitter revenues on an annual basis should be....

Yeah..

Should be the same if not a little bit more than they were on Gen 4. But all that stuff has to cycle through our payer arrangements and everything, so that's going to take time..

And then just lastly, with the expedited access program the FDA just implemented, how does that factor into your prior discussions with FDA around the insulin dosing claim?.

Our discussions with the FDA have been very aggressive on the dosing or non-injunctive claim from when we started earlier this year, so I don't know if that's the initiative that sparked their interest or got us talking more about that, but they have been very progressive and we have very routine dialogues with them on it.

So I don't – I can't attribute it to that or anything else other than, they know that patients use our sensor to dose, they see patients in the FDA who wear our system and who use it to dose and so they want to put some parameters around that type of activity..

But it's not as if you (43:56) have to apply to that program, get accepted and then pursue -.

We haven't applied to anything like that..

Okay. All right. Thank you..

Our next question comes from Shaun Rodriguez from Cowen & Company. Please go ahead..

Hi. This is Ryan Blicker filling in for Shaun. Thanks for taking my question. So thanks for all the pipeline commentary, that was very helpful. Going back to the backlog commentary you made, how successful you were at clearing the backlog exiting Q4, you also noted the backlog was especially strong exiting February.

Can you provide an update on how the backlog progressed throughout the end of the quarter and did you exit the quarter with similar strength?.

Our pipeline is great..

Okay. Thank you. And shifting to international you mentioned in the past that international patients tend to utilize the sensors less frequently than U.S. patients.

Can you provide an update on where sensor utilization is per patient per month maybe if available in your core European markets like Germany, Sweden, the Netherlands and Italy, and do you have an idea for where CGM penetration is in these markets?.

No, I mean to be honest we don't have great visibility. We only have I think three international employees at this point, maybe four..

Four, we just added our fourth..

We have four. All of our business internationally is through distribution so we don't get great visibility into – we're making estimates based on discussions with distributors and selling patterns into clinics and what not but we really don't have a good sense of what the utilization is.

We know that in Europe there is a much more predominant use of the system as a professional use system, meaning that the clinic or the hospital or the doctor's office owns the hardware and then uses it with multiple patients on a more periodic basis, but we just don't have great visibility there..

Okay. Thanks. Then one last quick one.

What should we expect for timing of the pediatric indication for the G4AP algorithm, and do you know if that algorithm is available for international patients yet?.

That algorithm is not available for international patients yet. We're working on when exactly to drop that in. With respect to pediatrics, we continue to have an open dialogue with the FDA on that. The study results and our filing has been in for a reasonable amount of time, but certainly not to the point where we're concerned about timing.

The dialogue has been ongoing. It should be available little bit later this year, probably in the first half of this year..

Okay. Thank you..

Our next question comes from Danielle Antalffy from Leerink Partners. Please go ahead..

Hey, good afternoon, guys. Thanks so much for taking the question. I was hoping we could talk about the pipeline a little bit more and how we think about the ramp of G5 and then G6 in 2017 if it comes in. You guys have said in the past that these new product cycles are sort of meant to sustain the 40% product growth that you've talked about.

But now in the early days with integrated systems, the Share wireless, do you think that – do you still stick to that 40% long term growth number? Do you think that it could actually be better than that?.

You know what, we will stick to 40% and if we do better like we did this quarter, that is great. Everybody forgets 40% growth means you double every two years, that's a lot of growth and that's a lot to sustain.

I do think we need these new products and these new platforms to expand our markets to get different types of patients, to get more new patients, to get on new patients more quickly, but again if we double our business every two years that is a lot of growth to manage for anybody.

So we'll stick to that and if acceleration continues like this, we'll be thrilled. I mean, we kept up with over 50% growth for something like 10 quarters in a row without a back order. I don't think there are many companies who can do that, so kudos to our team. And we'll just keep driving to keep doing that, but we'll just have to see..

Okay. That's fair. And then, I was wondering if you guys could give an update on where we sort of are with the Type 2 patient population not to get greedy but much longer term of course that's a potentially massive market. I know you guys have some coverage there. Where are we with CGM in Type 2 patients? Thanks so much..

We are gradually and slowly increasing the use of CGM for insulin using Type 2 patients. And many of our payer contracts are now being renegotiated to cover all insulin using patients which would cover the insulin using Type 2s. One of the problems with this is a lot of those are Medicare patients and we don't get to play in that space right now.

As we look out over time and other Type 2 patients who may not be on insulin or who may be needing to make the choice to go on insulin, we really think and particularly as you look at Gen 6 and all the cost improvement models that we are working on with transmitters, insertion devices and all our new products as well that we can offer something very, very economical and a wonderful platform for Type 2s for intermittent use diagnostics, pre-diabetes diagnostics, evaluating the effectiveness of drugs.

We have a reasonably sized, not a huge but a reasonably sized sales effort for clinical studies for diabetes drugs. And some of these drugs when you see how they affect Type 2 patients, on the CGM, it is – it's pretty remarkable. And the glucose curves go down very rapidly with these compounds.

There is no better way to titrate these compounds, there is no better way to determine which ones are effective and which ones aren't, than a CGM warn for a couple of weeks.

As we go to extended wear, as we go to possibly disposable transmitter and some of – and no calibrations, some of the other things we're doing, we think we can play in it very nicely. But it's going to be a little while. We've got enough road to hoe with insulin using Type 2s and Type 1s today.

That'll be our focus and then over time we'll move to the others..

All right. That's very helpful. Thank you..

Our next question comes from Greg Todochek (50:26) from CRT Capital. Please go ahead..

Thanks. Just a couple quick ones.

Number one, I'm assuming definition of new user is number of starter kits sold, is that still correct?.

Definition for us of a new user is somebody who hasn't purchased a starter kit from us ever, or like maybe a two year gap or something like that, yeah, some long period of time, so..

(50:50) for some long period of time.

Okay..

Because you remember, a starter kit could still go to an out of warranty patient if the insurance company will approve both the starter kit and another transfer..

That's why I ask..

Yeah..

Can you talk about market share, where are the new users coming from? Are they Medtronic, distant franchise Medtronic users, are these new – are they new to CGM? I'm just trying to figure out where this big large bolus of new users are coming from..

They're coming from everywhere. We're still getting a nice chunk of MDI patients.

Certainly we find that again there are some Animas users, certainly in the new patient group, certainly more new Animas users this quarter than there have been in other periods because of the Vibe launch, Tandem patients, Insulet patients, many of those patients using our pumps – I mean our sensors.

I don't think disenchanted Medtronic users are the biggest factor in our growth, but I can tell you I have seen independent marketing data that says that we – while we were losing all our – a lot of our patients to 530G when it came out with respect to wearing DexCom sensors, the percentage of 530G patients now using DexCom sensors is beginning to increase.

That's from an independent source, not from what we have here, so we're picking some of that up as well, it is across the board..

And what do you think the percentage of Type 1s in the U.S.

use a CGM?.

It's 15%..

Between 10% and.....

Yeah, 10% and 15%..

Yeah..

Okay. And Kevin do you know when a Vibe user switches on a G4 and they order, do you see that or do you just see a new user and you don't know where it's coming from? And the reason I ask is J&J was talking about the Vibe a little bit more than usual. It's no longer a dead product for them and I'm assuming it has to do with you guys.

Can you expand on that a little bit?.

Yeah, this is Steve, I'll take this one. So, you're right J&J in their earnings call and even subsequent to that has commented that the Vibe is actually helping their sales in the U.S. so I think in response – I think it was Brooks that asked the question about the impact of CGM on pump sales. I think J&J has acknowledged that it has helped.

But you're right that we – when we look at our patient base – when we look at our pump portion of our patient base, certainly a big chuck of them were Animas Vibe users previously. And so, when they come in we would not count them as a new patient. That would not be a net new patient to us.

That would be just a patient who would continue to buy G4 PLATINUM sensors but now they can connect their transmitter directly to the pump..

And they did purchase a new Vibe pump so they can be – have an integrated system. So I – there certainly were some of those sales as well..

Yeah..

And do you think that would drop off a little when G5 comes around?.

I don't know..

I don't know. We'll just have to see..

Okay. But it's certainly helping sell more pumps for J&J..

You know what, as long as we stay on every one of these calls, as long as we sell more sensors, we're happy..

Right. And in terms of buying a pump company, if you said yes, I know Terry would have reached out from wherever he is and strangled you, but we'll leave it at that..

Fortunately Terry is on an airplane and he cannot reach me at this point in time..

Thanks, guys..

Great. Thanks, Greg..

Our next question comes from Erik Shoger from Northcoast Research. Please go ahead..

Hi. Thanks, guys.

I wanted to just drill down on one comment you made earlier about awareness and I think you said making some investments in awareness, and I just want to clarify what – first, what you mean? What that comment meant more generally?.

You know what, we've spent a lot of time in marketing and sales dollars on marketing to the healthcare provider and healthcare professional community, you're going to see over the next year we're going to go to those people.

Everybody understands what an iPhone looks like, everybody understands sharing data, they understand what iWatch's look like beautiful, that iWatch app is beautiful. If you can look at the user digitalization on that.

We have tried to some pilot programs to go more direct to consumer into magazines, into newspapers, we even tried a little bit of a directed television stuff to see what we can do. We're going to get bigger and go out to broader bases. We need to take this message to the people..

So, should I take that to mean doctors maybe not intentionally but are holding it back a little bit, I mean certainly the new patient growth was through the moon this quarter, but obviously I think there is more that could be done to drive additional adoption..

Doctors are doing fine but we think more can be done to drive additional adoption as patients become more aware and we need to drive some of that awareness. One of the most effective ways for patients to get on CGM is to have them walk into the doctor's office and say I've seen this, I would like this.

And we learned that like, Terry and I learned that way back when in our pump days as we drove awareness with some very focused campaigns and we're going to start doing some of that here. So stay tuned, you'll see..

Okay. All right. Great. Thanks for the – thanks for the clarity..

Thanks Erik..

I show no questions at this time..

Okay. All right then, I'll just offer a few concluding remarks and everybody, we can all have a great day.

This was a great quarter for DexCom, our revenues increased by approximately $26 million and even though our financials are a little bit fuzzy here with the launch and the charges we had to take as adjusted our net income on a cash basis was $10 million higher than it was a year ago.

So in essence get pretty close to 35% of everything that we increased on the top-line. Our business model is working very well in spite of significant investments on the commercial and on the product development side. We've always believed that mobile platforms would be a key in moving this company to the next level. It's happening as we speak.

We've also taken on a lot of infrastructure this quarter. We've opened up a new building and we're increasing our manufacturing capacity seamlessly. Finally as you can tell from our enthusiasm on our product pipeline, it's progressing at an amazing pace.

Our commitment to our patients is unparalleled and will never go away, you can continue to expect great things from us. Thank you very much..

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