德康醫療 (DXCM) 2016 Q4 法說會逐字稿

Welcome to the DexCom fourth-quarter and full-year 2016 earnings release conference call.

My name is Ashley and I will be your operator for today's call.

(Operator Instructions) Please note that this conference is being recorded.

I will now turn the call over to Kevin Sayer, President and CEO.

Mr. Sayer, you may begin.

Thank you very much.

And good afternoon, everyone.

We appreciate you listening to our fourth-quarter 2016 earnings call.

We will start off with our Safe Harbor statement from Steve Pacelli.

Thanks, Kevin.

Some of the statements that we will make in today's call may constitute forward-looking statements.

These statements reflect management's intentions, 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.

Actual results could differ materially from those anticipated in the forward-looking statement.

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 cash-based operating results.

The presentation of this additional information should not be considered in isolation or as a substitute for results or superior to results prepared in accordance with GAAP.

Kevin?

Thank you, Steve.

Joining me today are Steve Pacelli, our Executive Vice President of Strategy and Corporate Development; Jess Roper, our Chief Financial Officer; and Kevin Sun, our Vice President of Finance.

Before I begin, I would like to take this opportunity to congratulate Jess on his pending retirement.

We wish Jess the best and thank him for his many important contributions over the past several years.

Jess has helped us scale through a period of tremendous growth and has assembled a very capable team, led by our VP of Finance, Kevin Sun, who will serve as our Interim CFO until we complete research for a new one.

Now let me highlight a few exciting recent developments for DexCom before I turn the call over to Steve to review our fourth-quarter 2016 financial results.

2016 was a very big year for us.

In December, five months after a positive advisory panel meeting, we achieved a landmark milestone in obtaining the first-ever non-adjunctive or insulin-dosing indication from the Food and Drug Administration.

As a result of this approval, a new classification of therapeutic CGM has been established.

This was a monumental achievement and I am very proud of the DexCom team, whose hard work over a number of years helped to make this a reality for our patients.

DexCom G5 Mobile is the only glucose measurement device that is FDA approved for therapeutic decision-making.

And in early January, as a direct result of our label expansion, Medicare issued a positive ruling providing us the opportunity to bring this life-saving technology to our senior population here in the United States.

Together with the advances we are making to our technology platform, we see a clear path to making the vision we had when the Company first started this journey a reality, eliminating finger sticks altogether.

As you can probably tell, we have never been more excited about the work we are doing here at DexCom for people with diabetes.

With that, I will now turn the call over to Steve for a review of our financials, after which I will expand on these accomplishments and provide a business update.

Thanks, Kevin.

DexCom reported revenue of $171 million for the fourth quarter of 2016 compared to $131 million for the same quarter in 2015, a $40 million or 31% increase.

This is slightly ahead of the $168 million revenue estimate we provided in early January during our preannouncement.

Sequentially, revenue for Q4 was up approximately 15% from the prior quarter.

Our fourth-quarter gross profit was $117 million, generating a gross margin of 68% compared to a gross profit of $91 million and a gross margin of 70% for the same quarter in the prior year.

On a year-over-year basis, our hardware gross margin was negatively impacted by sales of our G5 Mobile transmitter, which has a shorter useful life and lower ASP.

In addition, although we are seeing some improvement in our warranty expense rates, we are still experiencing warranty expenses at higher-than-historical levels.

This includes the impact of our receiver replacement efforts in certain European markets.

Note that we reserved for our current estimated exposure for this issue throughout 2016 and do not anticipate a material impact on our financial statements in the future.

Going forward, we anticipate continued decreases in our warranty expense rates throughout 2017.

Some final thoughts on our revenues and our gross profit.

Our mix between durable and consumable products was within our normal historical range in Q4, at approximately 30% durable and 70% consumable.

The ASP for our hardware has remained stable and sensor pricing remains within an ASP range of $70 to $75 per sensor.

Finally, our international business showed continued year-over-year growth, generating $21 million in revenue during the quarter, up 28% from last year and 15% sequentially.

For the year, OUS revenues grew 38% and represented 13% of our overall revenue.

Research and development expense totaled $44 million for Q4 of 2016 compared to $29 million in Q4 of 2015 and flat sequentially.

As we have said on prior calls, we continue to make investments in a number of important initiatives.

These include the G6 pivotal study and multiple submissions with the FDA, including efforts associated with our recently approved non-adjunctive claim.

We continue to make progress on our advanced product pipeline.

And we incurred expenses associated with our Verily partnership, our next-generation sensor technology, and the buildout of our data platform.

Selling, general, and administrative expense totaled $79 million in Q4 of 2016 compared to $61 million during the same quarter in 2015, with the increase due primarily to year-over-year increases in headcount in our customer support organizations as well as a ramp in our patient-focused marketing expenses, higher IT costs, and our OUS expansion.

During Q4, we also increased our US field-based sales force to approximately 130 reps to support our growth in 2017 and beyond.

And remind investors that we did not add any sales reps last year.

Our GAAP net loss was $7 million in the fourth quarter of 2016, which included $34 million in non-cash expenses consisting primarily of non-cash share-based compensation expense across all functional areas of our business.

For the year, our net loss was wider than our original expectations.

As we stated on prior calls, although we budgeted a significant incremental investment in a number of new programs at the beginning of the year, over the course of the year, we made the decision to spend beyond these levels in order to support the growth opportunities we see in front of us.

These include the expansion of our customer ops and tech support infrastructure to support anticipated growth; increased direct-to-consumer marketing, which has demonstrated very positive results so far and will continue to grow in 2017; and continued investment in IT initiatives to support our anticipated growth.

Our Q4 operating expenses also include an increased spend on the four strategic investments that we outlined at the beginning of the year: our Verily relationship; building out our data analytics capabilities; international expansion; and our new manufacturing facility in Arizona.

Absent non-cash charges, non-GAAP cash-based net income was $27 million for Q4.

Our GAAP loss per share for the quarter was $0.09.

We ended the fourth quarter with $124 million in cash and marketable securities.

With respect to 2017 guidance, we provided a detailed outlook early in the year, including anticipated revenues of $710 million to $740 million, reflecting growth of approximately 25% to 30%.

As in prior years, we anticipate the first quarter to be sequentially down due to typical seasonality associated with the annual reset of deductibles.

We remind investors that we have historically seen 18% to 20% of our annual revenues in the first quarter, building throughout the year.

We also remind investors that we grew 60% year over year in Q1 last year as we rolled out the G5 Mobile, making for a tougher year-over-year comparison.

And as a final reminder, although revenues decline sequentially from Q4 to Q1, operating expenses will continue to increase.

We expect a 25% to 25% sequential increase from Q4 to Q1, due in part to approximately $10 million in payroll tax expenses related to annual share vesting as well as one-time charges associated with retirement, severance, and restructuring.

For the full year, guidance for OpEx remains a year-over-year increase of 20% to 25% versus 2016.

With that, I'll turn the call back to Kevin for a business update.

Thank you, Steve.

As I said in my introductory remarks, we are very proud of the milestones we achieved over the past few months, particularly with our non-adjunctive client and Medicare's rapid response to cover CGM as a result.

The dosing claim represents a paradigm shift in diabetes management.

These events are the culmination of a long and thoughtful process, and we appreciate the collaborative efforts of both the FDA and CMS as well as our patient advocates to bring this technology to a population that desperately needs it.

We estimate Medicare-age patients represent approximately 20% of the overall Type 1 market, or as many as 300,000 patients in the US.

Intensive-insulin-using Type 2 Medicare patients could be an even larger addressable patient population over time.

Looking ahead, we are engaging with the MACs to establish the scope of coverage and facilitate reimbursement for our patients on a broader basis later this year.

We believe these achievements were fundamentally driven by the strong performance of our CGM platform, both in clinical trials and in the real world.

Notably, this performance is driving clinical outcomes.

In January, data from both the first phase of our DIaMonD study and the GOLD trial were published in JAMA.

Each trial demonstrated that CGM can significantly improve A1C in MDI patients.

We are already seeing the benefits of this message in our business today, where the majority of our new patient additions are MDI patients.

The publication of DIaMonD and GOLD, both prospective, randomized, controlled trials in a highly respected peer-reviewed journal, will accelerate our awareness campaigns with physicians, patients, and payers.

In addition, we saw an abundance of DexCom CGM data at the Advanced Technologies and Treatments for Diabetes, or ATTD, conference in Paris earlier this month.

Additional data from DIaMonD was presented and concluded that Type 2 patients on MDI also experienced a statistically significant reduction in A1C.

And, although Type 1 patients who switched from MDI to pump therapy did see a slight improvement in time and range, overall the data showed no incremental benefit in A1C reduction and showed increased hypoglycemic time in the pump cohort.

Clearly, CGM can provide an overwhelming benefit regardless of a patient's preference for insulin delivery.

And as a side benefit, we demonstrated that patient adherence to DexCom CGM is very strong, even after a year of wear.

We hope to see additional DIaMonD data published in the near future.

Overall, these data continue to build support for our CGM First message.

Let us be very, very clear.

Based upon the data we currently see, the most significant benefit to the patient in the intensive management of their diabetes comes from CGM.

Also at ATTD, there were continued discussions surrounding the establishment of industry standards for CGM performance.

We support these efforts 100%.

However, we believe any performance thresholds must properly mitigate the risks to people with diabetes who rely on these technologies for their health and safety, particularly if they are dosing insulin.

We were perplexed during a session at ATTD, where several of our purported competitors together proposed raising the minimum threshold for performance from the traditionally accepted threshold of 20/20.

For example, a 90% 40/40 threshold was proposed.

This would mean that only 90% of the glucose values from a system would fall within 40%, or 40 milligrams per deciliter, of a reference value.

90% within 40/40 is certainly well below what we believe and historical data demonstrate a reliable CGM must provide.

And the fact that others in the industry would promote such a standard concerns us.

Just as a point of reference, our G5 Mobile is achieving 20/20 performance of approximately 93% and our G6 pre-pivotal data has our sensor achieving 20/20 performance over 96% of the time.

With our non-adjunctive claim for G5 Mobile and our future public platform that I will discuss momentarily, we are confident DexCom has set an appropriate standard for accuracy, manufacturability, and other performance metrics.

We will continue to work to bring together the FDA, industry, and clinical societies to drive standards and provide transparency across the industry while maintaining an appropriate level of patient safety.

Leaving ATTD, it was clear to us the DexCom CGM has and will continue to raise the bar on CGM performance.

As many of you have seen, we presented data from our G6 pre-pivotal, both with our intended initial one-calibration-per-day label as well as data using the G6 sensor with no calibrations.

The initial accuracy data from these studies is very encouraging, and we are increasingly confident that we can ultimately deliver a no-calibration sensor while maintaining market-leading CGM performance.

It has been a very exciting few months, to say the least.

Beyond these strategic developments, we generated significant commercial growth last year.

We finished 2016 with approximately 200,000 patients worldwide.

To put things in perspective, our fourth-quarter revenue exceeded what we generated in sales for all of 2013.

This growth has not been without its challenges, however.

For example, as we stated previously, we believe our receiver recall accounted for at least $10 million in lost revenue in 2016 and a significant increase to our warranty expenses.

We also had to make unplanned investments in our customer support structure to handle the challenges associated with this level of growth and our shift to a mobile platform.

We have certainly come a long way in a very short period of time, and we continue to see a significant long-term growth opportunity for many years to come.

Internationally we are pleased with our continued growth, as our OUS business kept pace with our robust US growth.

Looking ahead, we are very pleased with Germany's positive national reimbursement decision to cover CGM.

We remind investors that the initial decision includes both Type 1 and Type 2 insulin-using patients and defines real-time CGM as systems that provide alerts and alarms.

We have signed our initial German payer contracts and will have a more substantial portion in the market covered as we exit 2017.

We are also making steady progress in obtaining reimbursement in other international markets and will provide future updates as appropriate.

All in all, we are very pleased with the continued pace of CGM adoption and anticipate ending the year with approximately 270,000 patients globally.

Now for an update on our product pipeline.

We have a number of submissions in front of the FDA that will enhance our G5 Mobile platform, including a new, more reliable touchscreen receiver; our new insertion system and corresponding smaller transmitter; our Android platform, which we hope to launch in the US by midyear; and additional enhanced versions of our G5 Mobile app to provide additional features and functionality, including the incorporation of insulin data.

Our gen 6 pivotal trial continues to make good progress.

Our goal is to file the G6 PMA by the end of Q3 2017, which would allow us to launch in 2018, assuming a positive review by the Agency.

As I mentioned earlier, the early data from G6 has been very impressive.

Assuming this performance is replicated in the pivotal trial, we believe G6 will represent the next major paradigm shift in continuous glucose monitoring performance standards.

G6 will allow us to reduce calibrations initially and provide the foundation for our no-calibration technology.

Turning to our Verily partnership, our collaboration to develop simple, low-cost, disposable CGM systems continues to make good progress.

To remind investors, our initial joint product offering with Verily will be a no-calibration CGM platform based on G6 sensor technology.

We believe the products we develop in our Verily partnership will drive the entry of CGM into the non-insulin using Type 2 market and someday become the basis to establish CGM as a standard of care for these patients as well.

In our experience to date, real-time CGM has demonstrated an ability to significantly improve a patient's average glucose values, time in range, and provide a holistic view of the effectiveness of a patient's treatment regime.

As we explore this market further, it is becoming clear to us that CGM, when combined with knowledge-based decision support tools, will help Type 2 patients optimize their diabetes therapy through better medication management and behavior modification.

Ultimately we look to demonstrate not only CGM's clinical value in this category, but also its impact on the expense of treating one of today's most costly conditions.

From a product perspective, we believe our first Verily product should be commercialized by the end of 2018, and anticipate that the second-generation device will be available in the 2020-2021 time frame.

We continue to conduct human pilot studies with the first-generation device, and we have completed our initial feasibility studies for the second Verily product and remain excited about continued progress on our collaboration this year.

Turning to our insulin delivery partners, our G4 integrated pump offerings remain well liked by our mutual patients.

And we see continued progress in our other integrations with both G5 and G6, with advanced insulin delivery systems, including pumps, smart pens, and other connected diabetes management platforms.

We expect to be able to highlight more specific progress on these integrated systems -- as these integrated systems approach clinical trials and commercial launch.

In conclusion, with our non-adjunctive claim and subsequent positive reimbursement ruling by Medicare as well as our international expansion, our commercial team has plenty to keep them busy over the next several quarters.

Additionally, the data published in JAMA and presented at ATTD were powerful.

The more DexCom CGM is studied, the more we see the value it brings across the diabetes healthcare continuum to patients, to payers, and to providers, all with minimal training and minimal investment along the way.

With real-world studies like DIaMonD and GOLD, we have never been in a better position to drive CGM penetration and capitalize on a healthcare payer environment that increasingly calls for outcomes to bring economic value.

I would now like to open the call up for Q&A.

(Operator Instructions) Mike Weinstein, JPMorgan.

Just maybe want to start, Kevin, with reimbursement.

And let's cover, if we can, the progress both in the US and in Germany.

So I heard your comments on both.

How should we think about the timing of getting reimbursement from all the MACs?

When do you think you will have that process effectively complete?

And then, second, in Germany, could you just give us a sense of how much -- give us a percentage of coverage that you may now have in place and how you expect that you track over the course of the year.

I know you made comments earlier in the year when you were in San Francisco about how strong December was, in particular, for Germany.

So would love to get your updated thoughts there.

Well, things continue to go well in Germany as reimbursement expands.

We only have a partial group of the payers covered with specific contracts at this point in time and we are reaching out to the rest of them.

Those efforts will continue over the course of the year, Mike.

And certainly we like to have a large percentage of them.

I can't really give you where that is.

Obviously we will shoot for 100%.

But inevitably, there ends up being nits along the way.

But so far, so good.

The growth has been very good so far in Germany; the product's being very well received, as I said back in January.

We are doing well with CGM in Germany.

With respect to the MACs, we are just starting those discussions.

And I believe, as I said back in January, as a goal for us, we would love to have all this resolved by the middle of the year.

But again, I also said in January that we were not expecting approval until 2018.

So I -- we have plans we are working on, on presentations, meetings, etc.

We'll go as quick as we can.

But obviously, we're not going to see any benefit from the Medicare expansion this quarter?

If we see a benefit, it will start to accrue in the second quarter?

Is that fair?

Yes, there is no benefit in this quarter.

The only thing that I would note, though, is that we are getting a lot of phone calls from Medicare patients who would like it.

So we are optimistic for the opportunity, once we can really go out and market this and present it to more.

And we have a lot of opportunities today in the pipeline waiting for the coverage.

The G6 filing and the Verily G1 filing -- are you going to do those in tandem?

Is that possible in your dialogue with the FDA?

Or are you going to space those out?

We will file the G6 system first.

That trial will be done first.

And then the Verily filing will reference the G6 filing, particularly all the manufacturing of the sensor.

And then we will see where the filings go and what additional work we have to do.

Obviously, we will have to validate and verify all the electronics configurations and probably run some kind of study with that system since it will be a no-calibration system.

And it will be labeled different, more than likely, than the G6 because of the calibrations.

So we will file G6 first, but the Verily configuration will come certainly not too long after that.

Well, we will push pretty hard.

Okay.

And then last topic is I know there was some question on the Street in terms of what impact Medicare reimbursement would have on your outlook for the year.

Obviously, it's only late February at this point and you still have to discuss with the MACs.

So the question I think probably people have is, one, are you seeing any impact of the FDA label change prior to getting the reimbursement from the MACs?

Separate topics there.

So are you seeing any benefit from that?

And is your confidence in the initial guidance you gave at the start of the year the same, unchanged, or is it higher as a result of the Medicare reimbursement?

Let's start with the non-adjunctive labeling change.

For any of you who have seen our marketing campaigns, we have been marketing to that.

And the response from the public has been very well in our DTC campaigns with the non-adjunctive claim and therapeutic use of CGM.

So we are seeing some benefit to that right now.

With respect to our guidance for the year, we reaffirmed in our call our guidance for the year.

We have not really considered Medicare in those numbers at this point in time, and there will be moving pieces once Medicare gets approved.

And we will update everybody after we have that.

I think Medicare will be very good for us, but we really need to know what group of patients is going to be covered so we can peg it to a population and look at how many of those patients we can add.

And we don't have that guidance yet, Mike.

And when we get that, we will provide you guys with more information.

Very helpful.

Thank you, guys.

I'll let some others jump in.

Ben Andrew, William Blair.

Couple questions from me.

Kevin, maybe is there an update on the G5x timing?

And how do you think about the magnitude of the impact of that as you roll that out over the course of presumably the year or back half of the year?

I don't have an update on timing.

We received questions from the FDA and we are finishing our response to those.

We will submit those.

I would tell you the only factor in G5x timing for us -- this is a very complicated change for us, as I've talked about it before.

We have to change pretty much every manufacturing process that we do with respect to G5x to get that thing launched.

So the sooner we can get started, the better.

But it is complicated because patients will be on G5 and G4 and G5x.

And so there's a very detailed plan that we have to roll out.

I don't have a timing update today.

We will see how our responses are received by the FDA.

And combine that with the complexity of just receiving a non-adjunctive claim as well.

So this is a very thoughtful process by the FDA that they are putting us through and that we are going through and it needs to align with everything that we do.

Okay.

And then on the reimbursement discussion, with the payers relative to the DIaMonD and the GOLD data, particularly the new DIaMonD data, Kevin, how have your conversations changed now that you have that data in hand?

Does it embolden you to consider risk-sharing contracts sooner than you might otherwise?

And can you build on the notion of CGM First as you go through those conversations?

We've had numerous discussions.

Now that the DIaMonD data has rolled out, it does become a very strong talking point that we've never had before.

I would tell you, Ben, internally, we are not opposed to risk-sharing arrangements with the payers, particularly as we look at the DIaMonD data and the type of A1c reduction we achieved, the minimal amount of severe hypoglycemic events that have gone on in our past experience in our studies, where our patients have very few severe hypoglycemic events and not a lot of hospitalization costs as well.

The challenge for us in these types of contracts has not been our willingness to accept risk, it has been figuring out how to structure them based on the information that the payers have about their patients, combined with the information that we have regarding the performance of our systems.

I'll give you a simple example.

If a payer says: I'll do a risk-sharing arrangement with you, but you have to produce a report from the patient.

And if that patient chooses to use the receiver instead of the phone app, we don't necessarily have that patient's data readily accessible.

So it creates some different types of scenarios.

And so we are pursuing all of those.

We've had very active discussions.

They are interactive.

They are lively.

We are willing to accept some risk there, it's we just need to get a few of these done.

I'm hoping for some really good outcomes over the course of 2017 on that front.

Okay, and then last one from me.

You talked about increasing the field organization to 130, I think.

I thought I heard you say that was in Q1.

And what was the number before?

Was it around 110?

It was closer to 100, between 100 and 110.

And most of those reps were added over the course of Q4 and early in Q1.

So we have been through our training and got these people on the street and going.

And I would tell you, whatever you have an expansion of this nature, it is a bit disruptive.

It will take the new ones a bit of time to get up to speed and our existing sales force a bit of time to get used to the readjusted territories.

Okay.

Thank you.

Chris Cooley, Stephens Inc.

Appreciate you taking the questions.

Could you just remind us, maybe Steve, a little bit more in terms of the metrics that you had relative to the 2017 guide?

And maybe more specifically, what you are expecting for attrition rates relative to year-end run rates as we play through the year?

Then I had just one other quick follow-up.

Yes.

So we have never broken out what specifically went into the guide.

Obviously, you can assume obviously US ramp, continued US ramp.

Penetration in MDI patients is something we've talked quite a bit about as we've more recently added a majority of MDI versus pump patients.

That was factored in.

Germany is obviously going to ramp over the course of the year.

We didn't, obviously, when we gave the guidance early this year, at that same time we estimated that Medicare was coming in 2018.

So you should assume in the current guidance there is no ramp from Medicare this year.

But it's kind of the usual stuff.

And then -- sorry; tell me the second part of your question.

On attrition rates?

Yes.

So we have never disclosed a specific attrition rate.

But the color we tried to give at the beginning of this year and in the 8-K, I was trying to let you triangulate it.

Attrition is a complex problem.

It's a complex thing to analyze here because you have different time frames in which we have different attrition metrics, and we are not going to go into that level of detail.

But what we tried to triangulate you guys to was an attrition rate that you could calculate, giving you a single number of somewhere between 8% and 12% on an annual basis.

I know that's a bit of a range, but that was what we were trying to triangulate when we talked about net new adds in 2016 and anticipated gross adds plus net new adds, net total at the end of the year of around 275.

That can get you to a once-a-year attrition rate of somewhere between 8% to 12%.

Thank you.

Just wanted to verify that.

And then, secondly, could you just maybe comment -- and I realize this is a longer-term growth opportunity, but how you would see the potential benefit of, shall we say, smart pens going forward and helping further drive growth for CGM, especially as you are starting to see more of your patients come from the MDI population?

Yes, we think the opportunity is huge, particularly as we look to the future.

And we know ultimately the day will come where this fight is going to be fought, if not being fought today at the payer level even more so.

It's not just in the US, but in the OUS markets, where pumps are really probably less than 10% penetrated and in many markets far less than that.

We are very bullish on the opportunity for smart pens.

We believe many companies, both insulin companies and non-insulin companies, are working on smart pen development.

A number have licensed or are working and announced publicly they are working with different algorithms and different software developers.

So I think over the next 18 to 24 months, it will be pretty exciting to see some of the products that can come to market.

I think, much like our sensors driving some of the work we are doing on the automated insulin delivery systems with some of the pump partners, you are going to see really the real value in these systems.

We will be integrating that insulin-on-board information from a smart pen together with our CGM data in a single unified app on the phone, and we can do some pretty powerful stuff there.

So when you start demonstrating outcomes with a smart pen together with CGM data and providing patients with dosing support information, behavior modification information, really at a fraction of cost of some more complex systems, I think we really have a home run there.

Thank you.

Kyle Rose, Canaccord Genuity.

Thanks for taking the question.

I know it's still early days with regards to the CMS and the Medicare opportunity.

But just wanted to take a step back and think from a high level.

One of the things, I think, or takeaways from 2016 was just the changing needs of the new patients that are adopting the technology at this pace.

Obviously, there was some big customer service investments took place last year.

How do you -- when you think about the CMS population and that being a different demographic just from a user base, just what type of investments do you foresee from an infrastructure standpoint?

And how do you view those patients just from a potential utilization perspective different than some of the previous patients you'd seen in prior years?

From a customer service perspective, obviously, we need to be ready on the phone to talk to these people.

And we've made a lot of investments just in underlying IT tools to make our team more effective and enable them to handle more calls and have more of a knowledge-based type system as they address with and work with these patients.

And we believe we are ready for this.

We are also expanding our call center operations.

In Q2, we are going to take our facility in Arizona and have a second call center over there.

Several of our people actually are moving from San Diego over there to man that.

So we won't have a bunch of startup time to get up and running.

We will have some great people over there working, and that will help us as well.

With respect to utilization, it has been interesting.

As we have gone through analytics on our patient base, forever our most loyal patient group has been the over-50.

The over-50 patients, while they are on this, they have not left us.

They have been very, very loyal.

So I think what you'll see with these patients is very similar to what Steve talked about as we broaden the patient base.

It will probably be a function of -- they will start up and if they don't like it, they will quit fast.

And if they like it, we think we can keep them on for a very long time.

And it's our job and our challenge to make sure that quit fastening doesn't happen.

And we have to make our system -- we have a team called DexCom Care that reaches out to patients and can train them directly on tools like Skype and FaceTime and things like that.

We need to make sure that group is heavily involved with our senior population as we ramp them up.

And we will do that, and we are working on that.

So we are optimistic that they will stay.

Okay, that's very helpful.

And then just another one there.

When we read the CMS rule, it provided reimbursement on a monthly basis.

That includes some of the other related supplies.

I know you are putting the business model together now.

But from a long-term perspective, do you envision a plan where you will provide some of the other ancillary supplies for calibration and things of that sort, at least in the near term?

Or do you plan a partner to add some of those incremental products?

How do you view that getting distributed to the customer?

Yes.

In the near term, it will probably be in partnership with one of our DME suppliers.

But over time, who knows?

I think that looking at the economics broadly speaking, I think particularly as we look to some of our future sensor products which go to 10 days or 14 days, the economics are quite favorable to us.

I think we are pretty happy there.

Okay, great.

And then just the last question from me is, just any expectations to see the initial feasibility data from the Verily?

You know, G1 at some point this year.

And if so, is ADA the most likely place we should think about that?

Probably not.

Not ADA, and hopefully we can see something before the end of the year.

We have initial data in-house, but it's in a limited number of patients, so it's not something that we are -- we typically wait until a study is pretty well baked.

We don't attend patients' in-house studies.

It's something we spent a lot of time talking about.

I can tell you there's a lot of people at Google who walk around with this thing as well.

There's a pretty good data set.

But we are not -- probably not at ADA, maybe later in the year.

Great.

Thank you very much for taking the questions.

David Lewis, Morgan Stanley.

Maybe just two questions for Kevin, one tactical, one strategic.

Kevin, just given the changing competitive dynamics were a big focus last quarter, I wonder if you could just update us on these dynamics in the US and ex-US in the fourth quarter or perhaps early 2017 relative to your commentary in the third quarter.

And what assumptions, if any, were made for 670G or Libre timing in the 2017 guide.

And I had a quick strategic follow-up.

With respect to our 2017 guidance, we built out the model based on what we think we can achieve.

And we do consider the fact that these other products will be out.

I think a lot will depend on how their labeled and how they are going to be used and timing.

So we built our models out with the best assumptions we had at hand, and leave them at that.

So we did consider some of those things.

We do not let competitors drive our growth assumptions.

We hold our people to a standard that this technology and this therapy is important for everybody.

So we don't get to sit back and say, well, there's competition, I'll take my foot off the gas.

We don't do that.

We do consider it, and that would be where that would land.

I'm sorry.

I forgot the other part of your question.

Sure.

So you'd say competitive dynamics, Kevin, were pretty stable in the fourth quarter relative to your commentary in the third?

Go ahead, Steve.

I'd say, coming into that third-quarter call, remember, the 670G had just been approved.

So I think there was considerable additional noise at that point in time.

That has largely died down, I would argue.

We were just at a big diabetes conference in Paris.

And without patting ourselves on the back, I would say DexCom was again the shining star, particularly in terms of our sensor, sensor performance, and the data we released.

So I think it is quieted down quite a bit on that front.

Kevin, just real quick strategically -- I apologize; I'm at an airport here.

But this announced divestiture of J&J, this J&J divestiture has ignited a debate around integrated products.

And I feel like there's two camps.

Right?

Some see value in a second integrated pump CGM player, and others say, given the DIaMonD study and the market opportunity at MDI and T2, why bother with pumps?

I wonder if you provide us your updated perspective.

And I'll jump back in queue.

Thank you.

We continue to support several integrated insulin delivery systems and we will continue to do so.

We have built our Company on the concept that our goal is CGM first.

And as these guys will tell you, I walk around the hall all day long and saying sell more sensors, sell more sensors, sell more sensors.

I think there will be some benefit to the integrated systems.

We have to drive our business based on the information, the reimbursement, and sales dynamics that we have today.

And so we will focus on that and we will see where our investments and our relationships and partnerships pay off over time.

Jayson Bedford, Raymond James.

Thanks for taking the questions.

Just a few cleanup-type questions.

Just to clarify, the expected year-end installed base is still 270,000, correct?

270,000, yes.

Okay.

In terms of the new transmitter and inserter, do you plan on waiting for the G6 to launch these products or are you going to launch them as they get approved?

It will depend upon timing of the approval and the timing of the G6 filing and a number of factors.

Our plan today is launch when they get approved.

But we will consider all that, Jayson, as we look out over the course of the year.

Okay, fair enough.

And on Germany, of the contracts that you've signed, are they covering both Type 1 and insulin-dependent Type 2?

Yes, they are.

And then just lastly for me, on the Medicare opportunity, are you actively selling or marketing into this market opportunity right now?

Or do those efforts get kickstarted maybe in the second quarter?

We are not really actively marketing.

We are getting a lot of inquiries about that.

And it is indicated as CMS approves, so if people call and ask us to market that, the position, individuals can get approved CMS reimbursement on their own if they apply and go through the process of getting individual reimbursement.

We are not leading those efforts.

We are guiding towards getting more clarification from the MACs and CMS in general so we can get it approved and make it easier for the entire population.

Okay, that's fair.

Thank you.

Danielle Antalffy, Leerink Partners.

Thanks so much for taking the question.

Kevin, this question is for you.

As we get closer to a Verily product, closer to a real Type 2 opportunity, how do you see DexCom as a company from a scale perspective, both manufacturing, distribution, etc., evolving?

And how much lead time do you need to get there to where you can handle what is potentially a massive opportunity?

That's a fantastic question and one that we debate and struggle with.

And one of the reasons, quite frankly, you'll see over the next several quarters large capital equipment investments for us as we build out an alternative manufacturing facility in Arizona.

We need to be ready to handle this type of volume.

And it is going to be different.

Many of these patients, for example, won't wear sensors all the time.

They may wear four sensors a year.

So even our relationship with these patients is going to be different.

The call will be different.

We're doing a lot of studies and a lot of work right now to figure out what that market is going to look like.

We think a lot of it will be payer-driven.

These patients don't spend a lot of money on finger sticks today.

For us to go in and offer a solution similar to what Type 1 patients are paying we know doesn't work.

So intermittent CGM will be a reality for these patients.

And how much are we going to spend a year, and how many sensors are patients going to wear?

And what we are working on is just developing thoughts as to what those programs look like and what type of benefit they can provide.

But again, as we've shown in our investor slides, in a two- to four-week period, we can see some of these patients taking their estimated A1C down more than a full point.

And their average glucose values move down significantly because they don't get feedback from anything like CGM.

And it really enables patients to pull the three levers that there are in taking care of Type 2 diabetes: medication, exercise, and diet.

And by pulling those three levers and getting real-time feedback in a mechanism that's easy to look at -- their phones -- say hey, well, maybe I ought to do something a little bit different.

We see dramatic results.

In fact, somebody I talked to the other day was looking at Type 2 study data and said: You realize this is more significant than any Type 2 drug I've ever seen?

And I said: Yes, I do.

And so we know some of the opportunities there.

It is going to be different business model, Danielle.

And we really have to give it a lot of thought and go pretty quickly and develop a lot of data.

I think there will be a lot of exciting announcements from us.

We are going to have to be creative.

We're going to have to think differently than we have in the past, but we are preparing to do that and having a lot of fun trying to put it together.

All right, thanks so much for that.

And then just a follow-up on the Type 2 opportunity.

Do you think the first-gen Verily product that we could see in 2018 -- at the end of 2018, I guess I should say -- is that going to be a product that can open up that Type 2 market?

Or will that be limited to maybe insulin-dependent Type 2s?

Or how do we think about that product and approaching Type 2s in a real way?

We hope to open up the market with that product.

We are doing work now with our gen 5 product, even with the two calibrations a day, and getting very good results from that.

That is one thing we would certainly like to focus on.

If we could accelerate and go faster with our current configuration, we can.

But we are somewhat cost-constrained today due to the cost of hardware and the fact that it is reusable now.

That is a product we will certainly drive this market with.

The app, for example, could look a little different than what we have today, but still provide the same data, just maybe in a little different format.

There's a lot of decisions to be made as we go forward.

Thank you so much.

Doug Schenkel, Cowen and Company.

Thank you for taking the questions.

Maybe my first one is just another one on Medicare.

Given the pent-up demand, upcoming reimbursement, and the huge clinical need for these patients, why can't penetration move to where the broader market rate is today pretty rapidly?

Maybe not this year, but in 2018-2019?

I think that the biggest gating factor would be just education.

We have not at all targeted this patient population historically.

In fact, we spent a lot of time targeting younger patients when we got our pediatric approval.

So I think there's going to be an element of education.

Right now, most folks probably still believe there is not reimbursement for the over-65 patient population.

So it's going to take a little time.

I absolutely think we can get there, if not even higher.

Certainly, with the demand we've seen generated just at the early stages here, yes, that's right.

Okay, thanks for that.

And then I guess a follow-up on some of the Type 2 questions.

You've discussed ongoing programs with commercial payers in the US in an effort to improve Type 2 reimbursement.

Can you give us a status update on these programs?

And do you believe broader Type 2 commercial coverage could come faster than you've previously discussed, given the progress with CMS?

No.

Again, we're still waiting to see what the ultimate scope of coverage looks like out of CMS.

But I think on the private payer side, my belief is that we still need some more data.

The DIaMonD Type 2 data was great.

We showed benefit in that patient population, but I think we are going to need some additional larger studies, particularly as we look outside of the intensively managed Type 2 population into folks on orals or diet and exercise.

We've got to show not just outcomes, we've got to show cost-benefit.

And that's some of the initiatives we have internally.

I'm not going to get into details, but some of the things we're working on internally, we are really starting to look at that data and look at how we will present it to the payers.

But it's certainly not a this-year event.

No, there's a lot of work to do.

I agree, Steve.

Although I guess the caveat that I would add -- if we went by the assumption that Type 2 intensive is insulin using CMS patients without access to CGM, and we could see very positive outcomes there as we gather data from the phone systems, in particular, we would have a very good case to go back to payers with that we don't have today.

So this might provide us a wonderful opportunity to go do that.

We just need to see how it plays out.

Okay, super helpful.

Thank you.

Joanne Wuensch, BMO Capital Markets.

The new hires that happened in the fourth quarter, could you help me understand how these people are going to be focused?

Is it more educational?

Is it more regional?

And is it more countered, detailing all the competitive launches which are currently happening and expected to?

No.

These are folks that -- so as Kevin alluded to when he described the existing sales force getting used to new territories, what happens when we do a field sales force expansion is many territories will end up shrinking.

Quotas go up and territories shrink.

And that's just the nature of a growth business like this.

So no, the people that we added Q4 and maybe a little bit in Q1, these are quota-carrying sales reps who will have their own territory.

Their primary detail will be doctors, will be endocrinologists.

In terms of counter detailing, no; we don't spend our time bashing the competition.

Because frankly, right now, we don't have much competition.

We are out detailing the benefits of our product to doctors.

So these people -- as Kevin said, it takes a little time to get them ramped up.

But they've gone through sales force training and they are currently in the field, so we will start to look for contribution as we look into the latter parts of 2017.

Terrific.

And then just a follow-up question.

It sounds like some of the noise that we talked about on the third-quarter call has quieted down.

Anything particular that drove that other than -- I won't even answer my own question.

What caused that quieter or calmer moment?

The news is out between particularly with respect to 670G.

There was a pretty broad-based media blips surrounding 670G, both from Medtronic and some from other industry advocacy groups.

So it's just quieted down at this point.

They still haven't launched the product and still remains to be seen when they will actually start the commercial launch and to what scale and scope that commercial launch will be when they actually do launch it.

So I think just the noise has certainly died down in the clinics and otherwise.

Very helpful.

Have a good evening, thank you.

Tom Bakas, Piper Jaffray.

Thanks for squeezing me in.

My first question -- I just want to make sure I heard you correctly.

Did you say that the second-generation Verily product is now potentially a 2021 product?

And if so -- go ahead, sorry.

We are focused on 2020.

We added 2021 to be conservative, just in case.

Our focus is 2020 right now.

Okay.

And we just -- you know what?

We did that to give ourselves a bit of a hedge.

I don't think anybody would be happy if we are at 2021.

But you know what?

There's a lot going on in our industry that will be moving between now and when that product gets launched.

And there's a lot of variables that are not under our control at this point in time.

So we did that to be a little conservative.

We have very aggressive timelines for that system and we will stick with them.

Okay, that makes sense.

Thank you.

And then I guess just given all the other developments that have come up over the last few quarters, the transition to the pharmacy seems to sort of taken a backseat.

Just hoping you can update us on the progress of that channel shift and just how important this is moving forward for the Company.

Of all the issues we've started, this is the one that has moved, quite frankly, slower than anything that we've wanted to.

And the key -- there have been two factors that have made it slower than we'd like.

Number one, we want to maintain a certain level of pricing.

So we've had opportunities to move from time to time where pricing is just prohibitive and we are not willing to accept those options.

And the other one, in all honesty, our providers, our payers, everybody does not share the same sense of urgency with our technology that we do.

Whereas we see this opportunity to make it wonderful for people to go to the drugstore and pick this up, by the time somebody from accounting goes back and figures out how many Type 1 patients they have in the system and how many Type 1 patients use CGM, it takes time.

And we've had numerous creative proposals by our payer team to get us to pharmacy, to move more of that, that literally have -- they haven't died, they are just being evaluated beyond belief.

And we would love to go there.

I think as we go forward, in 2020, when we are selling the Verily Band-Aid type product, or 2021 if I go with the conservative, that has to be sold at the drugstore.

We can't handle the demand that we're going to have for this number of patients, even in Type 2. With 20 million patients, as you look at penetrating that in rates of intermittent use much higher than what we have now, those products all have to be sold on the direct store and the reimbursement channel has to change.

For our current Type 1 population, that change has not happened as quickly as we would like it.

And quite frankly, it hasn't had to to sustain our growth.

Over time, we believe that's where our technology needs to be.

And we are going to look at some different approaches, some different contract type approaches, and maybe, quite frankly, keeping some of it in the DME and trying to get it easier for patients to get to system.

One of the things we see in the first quarter as deductibles reset, my emails, my negative emails, bounce around as to what I get.

Now, in the first quarter, what I get from everybody is: Hey, why can't I get my stuff?

And usually the responses from customer service, because their deductible reset, because we have to get all this new documentation and stuff.

So I think what you'll see from us going forward, we will continue to try and go to pharmacy where it makes sense.

In those cases where we are just not going to crack that barrier, what we want to do is decrease the documentation load to try and get it easier for patients to get on and to stay on and make it easier for them to buy the system.

Thanks, appreciate that.

Have a great night.

Tao Levy, Wedbush Securities.

Maybe a quick clarification.

I'm still obligated to ask this question, so I apologize ahead of time.

The agreement that you have with the European countries that's not the same as in the US regarding the receiver, can you explain that briefly, if possible?

Yes.

So in essence, it is the same.

In Europe, it is also a voluntary recall.

But what we did agree, and we agreed in a couple countries, to affirmatively bring product back.

You're going to see other countries posting similar notifications is my guess over the next months, probably.

But as we mentioned in the prepared remarks, we have already -- we accrued for any potential exposure in 2016 and it shouldn't have any impact going forward.

Got you.

So if you have to replace those receivers in the international markets, that shouldn't have a financial impact going forward?

Yes, in the selected financial markets.

And again, remember, we launched the new configuration of our receiver in the fall.

And so as we've sold more receivers, as we've grown since last fall, those receivers won't be subject to this initiative.

But the patients in Europe got the same letter the patients did in the US when we started the recall procedure.

This isn't anything new to us, and we have been talking with many of the countries for months.

And many of the countries have signed off on what we did in the US and felt it was good enough.

We continue to have a patient paper in the sensor box reminding people: please test the autofunctionality of your receiver.

Many of the countries felt that was good enough.

Some of the others are still evaluating.

Some, including the one that we read about recently, have decided it isn't.

They want us to recall the devices that may be subject to autofailure and replace them with the newer configuration in the interest of patient safety.

And we will do that.

Got you.

Okay.

And I didn't hear whether you reiterated your gross margin guidance that you provided at the beginning of the year, that [67% to 70%].

We didn't change anything.

Okay.

And then lastly, you provided in your guidance for the installed base to grow around 35% this year.

But your sales guidance is only -- you are guiding for 25% to 30%.

What's the difference there?

Because normally when I've gone back historically, those two numbers of growth rates are pretty close to each other.

And this year, there seems to be a wider delta.

Thanks.

It's primarily timing driven.

When we add the new patients, we ramp over the course of the year.

And the fourth quarter is always the largest number by sometimes a fair margin, the largest number of new patient additions during a given year.

But those guys don't contribute from a sensor disposable perspective like patients that are already on board.

I guess the other thing I would add is just the size of the installed base already.

Even as we look at our monthly and quarterly numbers, new patients don't move the needle as much as they did in the past because the installed base purchase is so much of the product that's there.

So I think the timing, combined with more from our installed base, are what make those numbers a little different.

Okay, great.

Thank you.

Jeff Johnson, Robert Baird.

Just a couple of last-minute questions here, maybe.

So on CMS, I know we've talked about it a lot.

But Kevin, when the document first came out in January, it looked like it included both T1 and T2 coverage.

I'm assuming that's probably a negotiated point, though, with the MACs.

Just maybe your latest feeling on do we see T2 coverage early on once some of the coverage starts coming in?

And then I had heard -- and I don't remember where I heard this, but that you are maybe not having to negotiate with all 12 MACs, that there's more consolidated negotiating point there that you are dealing with.

Can you just flesh that out for me a little bit?

Yes, it's Steve.

I would say it's too early to tell on the first part of your question.

We are not deep enough in discussions to know what the scope is going to look like.

But you are correct in that under Part B, where we reside, there are only four MACs that we need to actually work together with.

So it's a much more efficient process than under Part D.

That's what I was going to say: just more efficient, easier to get these agreements put in place.

And then Kevin, you talked about your 50-year-old and older patient base being the most loyal portion of the wearers.

I don't know that I've asked this question before, but as patients age into the Medicare population at 65, what is the dropout rate?

Is it a very high dropout rate?

Or said another way, I'd assume your penetration rate in the Medicare population is pretty low.

I just don't know if I've ever heard you answer that question.

It's been very low because they don't have reimbursement.

So our dropout rate has been relatively high unless they want to pay cash.

So it has been a challenge for us.

Yes, and I guess that was my question.

You said they were very loyal after 50.

So most of them know they are loyal until 65 and then they do drop out, so this is a very low penetration rate.

And we get heartbreaking emails from them or from their spouses all the time.

Yes, understood.

I just wanted to make sure.

Thanks, guys.

They just can't afford it.

Thank you.

We have no further questions at this time.

You know what?

I'm going to offer some concluding remarks and then we'll be done.

Thanks, everybody, for the questions and for listening.

Year-end earnings calls are a great time of reflection as we look back at the accomplishments of another year and a year of much confusion and turmoil in the diabetes industry.

DexCom grew our revenues more than 40%, an annual increase of approximately $170 million in worldwide revenue.

A number that's, quite frankly, more amazing than the percentage when you compare DexCom to everybody else in our industry.

We received our non-adjunctive claim, CMS approval came right after the end of the year, and significant advancements have been made on the international reimbursement front.

All these things point to realization of our vision: that CGM will become the standard of care for diabetes, and this is going to happen very quickly.

No company has a product pipeline like ours, and the investments we have made in products, facilities, people, processes, our Verily relationship, and other relationships will put us in a position to remain a leader in this industry and continue to have a major impact on the lives of people affected by diabetes, their healthcare providers, and ultimately upon reducing the cost associated with diabetes across the board.

Thank you very much.

Thank you.

Ladies and gentlemen, this concludes today's conference.

Thank you for participating.

You may now disconnect.