德康醫療 (DXCM) 2017 Q3 法說會逐字稿

Welcome to the DexCom Third Quarter 2017 Earnings Release Conference Call. My name is Adrian, and I'll be your operator for today's call. (Operator Instructions) Please note this conference is being recorded.

I'll now turn the call over to Matt Dolan, Vice President, Corporate Development. Matt Dolan, you may begin.

Thank you, Adrian, and welcome to DexCom's Third Quarter 2017 Earnings Call. With us today are Kevin Sayer, DexCom's President and CEO; Steve Pacelli, our Executive Vice President of Strategy and Corporate Development; and Quentin Blackford, our Executive Vice President and Chief Financial Officer. We will begin with our prepared remarks and then open the call up for your questions. (Operator Instructions) I will begin with our safe harbor statement and then pass the call over to 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, and actual results could differ materially from those anticipated in the forward-looking statements. The factors that could cause actual results to differ materially from those expressed or implied by any of these forward-looking statements are detailed in DexCom's annual report on Form 10-K, quarterly reports on Form 10-Q and other filings with the Securities and Exchange Commission. Except as required by law, we assume no obligation to update such forward-looking statements after the date of this presentation or to conform these forward-looking statements to actual results.

Additionally, during the call, we will discuss certain financial measures that have not been prepared in accordance with GAAP with respect to our non-GAAP net loss and 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.

With that, I'll turn it over to Kevin.

Thank you, everyone, for joining us today. I will begin the call with an overview and then hand it over to the team for their comments on our financial results. I would like to start by publicly welcoming Quentin to our executive management team. He's already been a big contributor to DexCom, and we're looking forward to the next leg of our journey together.

DexCom continues to shine with revenues up 24% through the first 3 quarters of the year. We remain significantly underpenetrated in the intensive diabetes marketplace, and the number of covered lives that we have access to has doubled since last year.

From an overall business perspective, our financial picture has never been better. Gross margins are within our targets. Our expenses are scaling as anticipated. The business is generating cash, and we continue to make key investments for our future. Our U.S. business continues to see adoption across the intensive population, where approximately 2/3 of our new patient additions are on multiple daily injections. We continue to believe that CGM should be the first-line device in the management of diabetes regardless of a patient's insulin delivery preference. Internationally, DexCom adoption accelerated again with several markets driving overall growth of greater than 80%. Our strategy outside the U.S. is working even in the face of increased competition. We remain disciplined in driving our value proposition through the clinical benefits of real-time CGM particularly as we see improving reimbursement in these markets.

In the U.S., the team has been working aggressively to fulfill the significant demand we have seen from the Medicare population. As we told you on our last call, early in the third quarter, the billing codes for CGM became effective and we are now servicing and submitting claims for our Medicare patients. I'm pleased to tell you that these early submissions have gone well. In Q3, between our direct and distributor efforts, we estimate that we shipped to more than 4,000 Medicare customers and continue to have a strong Medicare pipeline, totaling close to 20,000 patients. This Medicare roll-out is an unprecedented opportunity for DexCom but it's also been a significant drag on our commercial organization. Patients have simply been waiting too long. To our Medicare patients, please trust me. We have heard you loud and clear, and for this reason, our first priority for the rest of the year is to get the product to you.

Finally, we submitted our G6 PMA with the FDA, as committed to, at the end of the third quarter. Since then, we've had several interactions with the agency. In addition to the once-per-day calibration system we submitted, we believe we have a regulatory pathway to launch a no-calibration, real-time system sometime before the end of 2018. I will dig into this on our product pipeline plans shortly.

With that, I will turn the call over to Steve for a review of our financials. Steve?

Thanks, Kevin. DexCom reported record revenue of $185 million for the third quarter of 2017 compared to $149 million for the same quarter in 2016, a $36 million or 24% increase. Sequentially, revenue was up 8%.

As Kevin mentioned, we began processing our Medicare-eligible patients in the third quarter. The revenue contribution remained relatively small, but considering the monthly subscription model established by CMS as compared to our commercial business, where we generate higher upfront revenues, we expect contribution from this population to steadily increase over the next several quarters. Of note, our early metrics are positive. Both approvals and reorders have been strong. While we were still early in our Medicare ramp, we see significant demand from the field and are optimistic about our commercial team's ability to execute from here.

Our third quarter gross profit was $127 million, generating a gross margin of 69% compared to a gross margin of 68% for the same quarter in the prior year. We remain comfortable with our full year gross margin outlook. As you saw in our press release, our product mix was within our normal historical range at approximately 70% sensors and 30% hardware. Average sensor pricing, again, came in just under $70 due to the strength of our international business, where we have a larger percentage of revenue running through our distributors at a lower ASP.

Operating expenses totaled $128 million for Q3 compared to $120 million in Q3 of 2016, reflecting an increase of 7% year-over-year and down 3% sequentially. Overall, operating expenses were well-controlled relative to our top line growth, and we continue to invest in our key initiatives, including DTC marketing campaigns, OUS expansion and product innovation.

Our GAAP net loss was $2 million or $0.02 per share. Excluding a noncash tax benefit related to our convertible notes, non-GAAP net loss was $3.1 million or $0.04 per share. Absent approximately $30 million in noncash charges, primarily share-based compensation and noncash interest expense and excluding the tax benefit mentioned above, our non-GAAP cash-based net income was $27 million.

We ended the third quarter with $526 million in cash and marketable securities on our balance sheet compared to $124 million at the end of 2016. Our increased cash balance was driven by cash flow from operations and our convertible debt offering earlier this year, offset by higher CapEx primarily associated with our manufacturing infrastructure build-out.

With respect to the balance of 2017, we have narrowed our expectations and now expect global revenue in 2017 to come in at the lower end of our guidance range. This would be consistent with our mid-teens sequential growth last year from Q3 and Q4. As we've discussed, the timing of our Medicare ramp in Q4 creates variability in the revenue contribution from this patient base. Finally, the amount of competitive noise in our marketplace and the uncertainty surrounding several of our partners warrants a bit of conservatism.

With that, I would like to turn the call over to Quentin for some additional commentary. Quentin?

Thank you, Steve. Having been on the CFO seat for 2 months to the day and having witnessed several market-changing dynamics, I can say that I have never been more excited about the opportunities ahead of us here at DexCom. Our CGM technology has applicability far beyond my original assumptions and has tremendous upside to our current penetration levels. Beyond the commercial opportunities of the DexCom technology, one of the aspects that attract me to DexCom was my belief that there were numerous opportunities to identify and drive efficiencies in our cost structure. Those beliefs are now convictions as I've had the opportunity to get into the details and better understand the existing cost structure.

For example, we're in the very early stages of standing up our manufacturing facility in Mesa, Arizona, which weighs on operating margins today and will continue through 2018 but then become a meaningful lever for us well into the future. A large component of our product cost today is manufacturing overhead. As a result, a good portion of our product cost will remain relatively fixed as we scale into the future and the benefits of incremental volume through the plant will drive meaningful cost reductions. Further, the ability to automate a large part of our processes will lead to further efficiencies, translating to cost improvements and enabling meaningful scale at a lower cost.

From an operating expense perspective, we have multiple levers within our G&A spend profile, where we have hundreds of basis points of improvement which can be accomplished with automation and scalability initiatives that we'll begin to implement gradually. Further, similar opportunities exist within our sales and marketing profile, where we can become more efficient without impacting our customer experience.

The multitude of opportunities to address in our cost structure become a meaningful enabler of our ability to continue to out-innovate our competitors and aggressively capture new customers in these rapidly evolving markets. As we continue to introduce a more disciplined approach to capital deployment across the company, you'll hear more from us with respect to our plans to deliver an improved profit profile with meaningful free cash flow generation over time. Kevin?

Thank you, Quentin. Well, as you all know, the diabetes industry is never boring. I will discuss our current market dynamics momentarily, but I would like to begin by affirming our long-term positioning.

In our core intensive diabetes markets around the world, CGM remains less than 10% penetrated. We remain committed to best-in-class performance, increased patient convenience, enhanced connectivity, data analytics and lower-cost platforms. Beyond our intensive strategy, our product initiatives will drive a number of business model innovations for the nonintensive population that, we believe, will fundamentally shift how we serve these patients.

In our U.S. business, the commercial pipeline is as strong as it's ever been even with the Medicare challenges of the past 9 months. We are making strides working through our Medicare backlog, and Steve gave you those metrics. Given the progress we saw in the quarter, we are doing everything we can to get this backlog taken cared of by the end of the year.

To add a little more color on our international markets, of course, Germany has been very strong. But our growth has been broad-based. Our commercial investments are paying off with revenue roughly doubling in nearly all of our direct geographies. It's also worth noting that with our receiver optional configuration, more international patients are choosing to go direct to their phones and not purchasing a receiver. By driving down the upfront cost of CGM, we are seeing a very nice uptick in demand.

Later in the third quarter, the FDA approved Abbott's FreeStyle Libre Flash Glucose Monitoring System. We always believe the FDA would approve the system. And while we understand why it has been labeled as CGM, it is not real-time CGM. The benefits of real-time CGM are clear. Reliable accuracy, actionable alerts and alarms, and connectivity will all drive clinical outcomes in the intensive world and will deliver value in all applicable markets.

Overall, there is a very positive conclusion here for DexCom. We believe the pathway is clearly paved for sensors to replace finger-sticks, and we're going to take this opportunity to move faster. Please remember we have been competing against Libre outside the U.S. for 3 years, and our growth there has accelerated for the fifth consecutive quarter.

Our focus on driving reimbursement based on a differentiated value proposition for real-time, continuous glucose monitoring is resonating with payers around the world. Many international payers have recognized that flash-based systems are not equivalent to real-time CGM and have created different reimbursement categories for each. Early signs in the U.S. suggest that payers feel the same way. We also know that many of our new international patients have transitioned from Libre to DexCom because of these important differences. Ultimately, this is a very, very large and very underpenetrated market.

Last month, J&J Animas announced it is finally exiting the pump business in the U.S. J&J announced this change in direction back in January. And Animas' contribution to our new patient additions has been minimal for some time. At this point, although this decision will ultimately be a drag on our patient base, we view it as manageable.

Now for a pipeline update. Turning to our product pipeline, we submitted our G6 PMA to the FDA at the end of the third quarter. Based on our review of the data, the G6 platform takes real-time CGM sensor performance to the next level especially in terms of its improvements in stability and consistency over an extended period of time. It also carries important ease-of-use enhancements, including a new applicator and smaller form factor. We know patients will be excited by the reliability and convenience of this system. As I mentioned in my opening remarks, since our filing, we have been in regular communication with the FDA. And while it is early, we believe we have a path to bring the first real-time, no-calibration sensor to market before the end of 2018. We will continue discussions with the FDA to bring this important advancement to the diabetes community.

On the app and wearables front, the number of DexCom customers using their mobile phones is rising steadily with the availability of both iOS and Android systems. Patients want to share their data with loved ones, and DexCom's connectivity provides that very important capability. We are also leveraging our connectivity to provide patients' CGM data on alternative displays, like the Apple Watch and Android wear devices. We also recently announced our efforts with Fitbit to provide a display on their new smartwatch. Our open API platform went live during Q3 and received a great response.

Within our insulin delivery partners, development of DexCom integrated systems are making progress. Insulet has shown tremendous dedication to our partnership, and our teams are working hard to bring our connected systems to market. Once launched, we see a number of differentiating features in our combined systems, including an attractive form factor and opportunities for smartphone connectivity. In the meantime, we have embarked on a few commercial activities together, and we'll continue to work with Insulet to deliver attractive options for our shared patients.

Tandem recently launched its G5 sensor-augmented pump, representing the first insulin pump system that carries a non-adjunctive sensor claim. And because Tandem's pump offering is field upgradable, patients won't be locked into a legacy technology and will be able to use enhancements as soon as they're available.

Shifting to our nonintensive strategy. We are making good progress with our pilot programs, and we'll expand our efforts in 2018. We look to complete development of our first-generation CGM system with Verily in the first half of next year. The timing of its commercial launch will be dependent upon the outcome and timing of our no-calibration regulatory strategy. The DexCom and Verily R&D teams are also beginning to accelerate efforts on the smaller, less expensive second-generation system. Our early experience continues to show the value of real-time, connected CGM outside of the insulin intensive diabetes population. Real-time data is intuitive and allows patients and caregivers to quickly optimize drug therapies and behavior.

In conclusion, the DexCom team continues to deliver in 2017, and we have a number of positive catalysts as we look forward to next year. Medicare will become a key contributor. Our OUS momentum should remain very, very strong. Product innovation in 2018 promises to be the most remarkable year in DexCom's history, and we have tremendous opportunities to continue to improve our financial results going forward.

With that, I'd now like to open up the call to Q&A, but before Q&A, I'm going to turn it back over to Matt to go over the ground rules again. Thanks, everyone. Matt?

Thank you, Kevin. (Operator Instructions) Adrian, please provide the Q&A instructions.

(Operator Instructions) And our first question comes from David Lewis from Morgan Stanley.

Could we start, Kevin, talking about the U.S. market in this quarter? I think you talked about in our conference, given the Medicare push, there were some distraction amongst some of the U.S. sales force, Kevin. So just the trends you're seeing in the U.S. marketplace this quarter and how you expect it to trend into the balance of the year. And I had a quick follow-up.

Sure, thanks. With respect to the U.S. market, the noise that you talked about from the Medicare push has been very real. Each of us has been out in the field over the past -- literally in the past month and ridden around in it. And frequently, we walk into a physician's office with our sales rep and get handed a list, "Here is my Medicare patients. When you take care of them, we'll give you some more." And so it has been a bit of a difficult issue for our field team. But now that we've learned how to process these things and we've got -- we think we're over the initial hurdles, we can start getting these patients out the door. Our U.S. commercial pipeline is still very robust and very large. Our digital marketing program continues to generate a large number of leads, and we're getting a good number of leads from the field as well. It's just a matter of execution right now and we need to push through this. But Medicare has had a big impact on us. There's no question.

Okay. I think, Kevin, just -- you talked to some of this in your prepared remarks, and I appreciate that. But it sounds like your strategy going forward is going to continue to -- as it relates to competition, price to value and not compete on price. So I just want to have you kind of walk through that. And have you thought about the pharmacy benefit channel? And is it more important now for the company to start approaching payers more proactively to start talking about these differences between real-time CGM and CGM? And I'll jump back in queue.

Thank you. A couple of thoughts here. First of all, with respect to pricing, as we've been competitive in Europe with Libre for a -- for quite some time, we've been able to maintain a higher price level with them because of the additional features of our product. Because of the actionable alerts, the alarms, the continuous data, the connectivity, the ability to share data, all the things that really make our system unique have a great benefit to our intensively managed patients. And we will continue to emphasize those features as we go forward. With respect to the distribution channel, we push hard on the pharmacy benefit channel for quite some time. And of all our initiatives, this has very much been an uphill battle. We'll win one. We'll lose one. Medicare is in the DME channel. So that's where we're focusing a lot of our distribution efforts right now. With respect to the long term and with respect to cost and pricing everything, please understand we've had cost-reduction initiatives in place for a long, long time, and those things are going to start hitting. Quentin talked about increased volumes, reducing overhead. Longer sensor wear -- or longer sensor labeling certainly reduces our cost per day. We have electronics configurations on the horizon. It will come very quickly with orders of magnitude cheaper than the ones that we make now. We've had cost reduction plans in place for a long time. And as you look out 3, 4 years, then we have our Verily disposable products coming, which really have aggressive cost targets and we hit them. We can compete that way as well. For today, for our intensive world, we're going to stick to value and we're going to go about it that way. Over time, we're prepared to whatever direction the market takes us.

David, I think one other comment on pricing that should not be lost on people has to deal with a real-world -- like what we view as a real-world per day cost for the product, right, because while, on its label, where a 7-day label at around $70, the sensors are $10 a day. People get nervous when they hear Abbott talking -- you hear Abbott talking $4 or $5 a day. But in reality, if patients wearing a sensor for 12 days of 14 days, our per-day price on a sensor -- in reality, the revenue per patient is how we really look at it. The revenue per patient per day is a lot closer to where Abbott is in Europe and, frankly, where we think Abbott is going to come in, in the U.S. So that's an important thing that analysts and investors, frankly, shouldn't be lost on.

And our next question comes from Jeff Johnson from Baird.

Kevin, you mentioned in your prepared remarks that you're seeing some early signs that payers are seeing a difference between real-time CGM and, obviously, the Libre product. I was wondering if you could flesh that out a little bit and maybe talk about what you're hearing from U.S. commercial payers between your product and Libre over time as well.

Yes, this is Steve. I'll take that one. A couple of things, somewhat anecdotal at this point, but there was a call hosted by one of your competitors a few -- maybe a few weeks ago that had a couple of payers, and that was kind of the general theme. "This is not CGM. It shouldn't be priced as the same category." We've seen it in Europe. I mean, Germany is a great example where we certainly receive a premium price on an annualized basis versus the Libre. We're starting to hear the same thing just anecdotally from physicians and from physicians who, frankly, have influence over the payers. So we have to wait and see how it plays out. I think Abbott's path to reimbursement is going to take some time. This is not a -- it's not something that they're just going to flip the switch and have reimbursement overnight. So we'll see how it plays out, but initial indication is there's certainly differentiation among the premium-priced product that we offer.

All right. That's helpful, Steve. And I know we've gone out and talked to plenty of endocrinologists and diabetologists. And I would love to hear what maybe you're hearing in the field. If Abbott would get pharmacy access, obviously, that makes it much easier for the docs to prescribe a Libre over a DexCom system. Just what would your strategy be if there's a big move to pharmacy for Libre versus your products staying largely in the DME channel at this point?

Well, quite honestly, it would be nice if somebody else would go somewhere first instead of us. We've been first everywhere here. So if, in fact, there is a big push to pharmacy and we can get acceptable reimbursement rates there, we'd be happy to follow. With respect to DME in general, like I said, Medicare has put our product in the DME category. And several payers have told us, as we push for pharmacy benefit, that CGM is a DME product regardless of how we want to put it in pharmacy. So it's been an uphill fight for us. If they get pharmacy coverage with payers, certainly, we will take the opportunity to follow if that simplifies distribution and we can generate the type of gross profits that are acceptable to us. In the meantime, we can still sell DME. And while distribution channel does make it easier for people to get our product, ultimately, for people who have this condition, the most important thing is the product that they use and the features that it offers and the benefits it provides. And we believe we went out that way.

And our next question comes from Mike Weinstein from JPMorgan.

Can you hear me? I apologize.

Yes, we can hear you, Mike.

Sorry. I'm still at PCT on my cell phone. So I apologize. So let me just circle back on the updated guidance for the year. So this quarter, obviously, OUS business had a great quarter. U.S. business grew 16%. Your guidance for the year seems to imply that you've been -- the U.S. business grows at a similar rate in the fourth quarter. Am I reading that correctly? Basically, I think the U.S. business grows at about that 16% rate in the fourth quarter.

Yes, that's fair.

Okay. And then I want to make sure I understand, Kevin, your thoughts and plans for Verily. Well, let me step back. So I want to understand your thoughts and plans for G6 and no-calibration. It sounded like you were saying by the end of the year, next year, that you would need to get an initial approval for one calibration and like a supplement on that to no-calibration. So, a, do I understand that correctly? And then, b, the timing of Verily gen 1 is unclear at this point because it may be influenced by what happens with G6.

That piece is correct, Mike. The way we look at this -- and understand we just completed the largest CGM study that the FDA has ever seen. We have matched pairs, almost 30,000 matched pairs in the study to YSI. There's all sorts of data here. And people have seen what our no-calibration G6 data looks like at numerous seminars over the past several months. As we looked at the results for that trial and we looked at that data, we felt the product is accurate enough to go no-calibration now. And we've had open discussions with the FDA about how we would do that. Now the PMA is on file, and we discussed 3 or 4 alternatives with the FDA with respect to how we do that. And one of them is the one you outlined to whereby we get the one calibration a day product approved and then file a supplement on top of that. We're discussing a couple of other alternatives with them as well, and I really don't want to give the whole playbook here because it's all very tentative. Our first priority is to get the product to our patients with no-calibration that serves the current patient base and can meet the cost profile that they're looking for. That's our G6 system as it is now with the reusable transmitter. Once we get through that filing, then the first Verily product becomes a priority. That product has disposable transmitter and will be thrown away. We have decisions to make, for example, about 14-day life versus 10 days and things of that nature that we'll make as we go through these processes. The second-generation Verily product will come after that, and we're accelerating work on that product rapidly because that is our product with the most aggressive cost targets and really with the size and usability that we think our patients want ultimately. And that is a very, very -- it's going very well. It has a very aggressive time frame, and we need to work on that, too. So we've got several things lined up in the pipeline, but they're all dependent upon decisions we'll make over the next 6 months. But I can tell you by the time we're out of the first quarter, we'll know exactly what's happening. We wouldn't say we were comfortable with the no-calibration G6 sensor if we weren't. We're very comfortable we have...

And maybe just one more. I don't know if I could sneak it in. You didn't give a full update on reimbursement in Germany. So can you do that in terms of where you are as well as any progress with other geographies?

Yes. We have reimbursement now, I think, from 43% of the payers have direct contract relationships. So 43% of the payers now and are about to knock off another one of the big ones, which I think puts us up over...

Over 50%.

Yes, we have over 50%, and the other ones approved it on a one -- on a use-by-use basis. We're not having any trouble getting people to pay for product in Germany. It's going very well.

Yes, it's actually covered lives. And that's what we committed to, by the end of the year, was to have north of 50%. That's covered lives under commercial contract.

And our next question comes from Jayson Bedford from Raymond James.

Just to clarify, would you launch G6 with a no -- with a one-cal system? Or are you waiting for the no-cal?

That remains to be seen, Jayson. We'll see what happens as we head down the path.

Okay. And then...

We -- let me just add a little bit to that. We need a new product in the U.S. The G5 is wonderful with its connectivity. We've added Android. We've added things around it, but the fact is our guys need something new to sell. We're going to launch something new next year. And if the fastest path to get something new is that, we'll pursue it. We would prefer to go to no-calibration directly, but we will do whatever is most efficacious and whatever we can work through with the FDA.

Okay, Kevin. And then my question, I guess, in terms of Medicare, it seems like you're progressing well here. At what point do you get more aggressive with the advertising?

We've just started trickling it out a little bit. We've not gotten too aggressive yet, but we have started a little bit out there. It's a very good question. One of the nice things about Medicare is we don't have the seasonality deductibles that we have in our other commercial business in the U.S. I think we'll start pushing harder in the fourth quarter and very much early on in the year next year.

And the next question comes from Kyle Rose with Canaccord.

Can you hear me all right?

Yes.

Great. So I appreciate the additional color at the beginning of the call as far as the patient demographics. It sounded like 2/3 of the underlying patient base in the commercial sector are MDI. I just wondered if you could give us a little more color as far as how you think about the rest of the mix. Maybe break down as far as adults versus peds and then potentially what type of exposure you may have to Animas, say, pumps in particular.

Yes. I mean, we've never given a real breakdown on a quarterly basis of adults versus pediatric adds. What we've said in the past -- and it holds true, is that peds have been trending nicely. Out of the gate, peds were obviously a huge contributor when we got that approval a couple of years ago. But I would tell you today peds are roughly tracking, and they typically track about the estimates of whatever we think the peds represent in the U.S. As far as Animas -- so peds is an important aspect of Animas, the Animas shutdown, a couple of things. Kevin mentioned in his prepared remarks that new patient contribution from Animas has been basically 0 for a pretty long period of time. So this isn't going to impact new patient additions. From a shutdown perspective for existing Animas patients, they -- Animas does do quite well. It's well known Animas does well in the pediatric segment. And so to the extent Medtronic has access to those patients, they wouldn't have access in theory, shouldn't have access to the pediatric patients because they're not labeled -- the 670 is not labeled for pediatric use. I would also add on the Animas front, look, people have chosen Animas pump for a reason. They chose an Animas pump with DexCom connectivity because of superior sensor, right. I mean, to the extent Medtronic is able to fix their sensor manufacturing challenges and actually supply sensors at some point in the future, patients have opted for a far superior sensor with the DexCom technology. So when we say it's manageable, that's what we're thinking. I mean, Insulet's running an aggressive program to target those patients. Tandem is running a program as well. So this isn't something that we're going to lose a whole bunch of patients overnight to the extent we could have some at risk, but we think it's manageable.

Great. I really appreciate that additional color. And then just, obviously, I think the approval with Libre and the label had got -- you caught a lot of people by surprise. I just wanted to see if you could step back and give us a little color on. And how do you think the FDA is just evaluating the risk benefit of CGM in these -- in flash products, overall, from a high level? And it sounds like you guys have moved around or at least evaluating the pipeline, but just high-level thoughts as far as how you guys think about the future regulatory pathways for some of these products?

Well, I think, the regulatory pathways, I can tell you, we're going to be more aggressive. If I can take one learning away from the whole experience and labeling there, I think we're going to push ourselves to do better and to move faster. We need to. And we went through 1.5-year time frame working on that non-adjunctive claim because that was the first they'd ever done and the first they had ever seen. And it's great we got it, but it literally slowed us down for about 1.5 years to work through all that data and with that processing and the panel meeting and all of that stuff. I think moving forward, we can go much more aggressively. I think the statement I made earlier in the call is very applicable. After the shock and surprise, we sat back and said, "You know what, we really can replace finger-sticks. Finger-sticks can go away now. We can make devices that can replace them across the board. And we'll work with the agency to make those devices. What we are focused on and what we'd encourage the committee to focus on, we need to make sure these devices are good. We need to make sure these devices are safe and these devices meet patient needs. We can't have devices where you get into some of the fiascos we've gotten into with finger-sticks, for example, where you have accuracy across the board products out there. And we need to make sure that the devices do what they claim they're going to do and provide the patient the benefit that they need. But I think it's a new day for us, and I think we'll make everybody happy with the pipeline we have coming.

And our next question comes from Doug Schenkel from Cowen and Company.

Two questions. First on CMS, you said you expect to clear the remainder of backlog by the end of the year. Could you give us some more details on how the billing process is working today? And are you ready to really open this up? Or are you still working through just some of the ramp and inefficiencies there? But then the second question is on FDA. Based on everything we've talked about in terms of the evolving environment, what's the outlook for you removing the current requirement in the U.S. to sell a receiver to all new patients?

With respect to the receiver requirement, that really is going to require additional filing for us. And the thing that we're concerned about or contemplating there as we do that, we don't want to mess up our Medicare label, which requires for a receiver to have DME coverage. So we have to balance those 2 things, and we will do that. With respect to CMS and the Medicare patient backlog, we have made some progress. There are 20,000 patients, we said, in the pipeline. I also said we're hopeful we get through the whole backlog. Again, we need to meet the demands of our commercial patients, and the pipeline addition to servicing those. So it's going to be a balancing act, but we need to take care of these people. And with respect to our billing experiences so far, we've been paid quite regularly on claims. The reorder history for those actually eligible for reorders has been solid. It's been very good, but it is still very different than our regular patients. I mean, I had a 5-email exchange with a Medicare patient last year because the birthdate that he gave his doctor is not the birthdate in his Medicare record, and he can't believe that we were so stupid that we couldn't get that processed. And finally, we figured it out, and this was somebody that was acquainted with a dear friend of mine from that past. So I got involved and I had a look into the life of our inside sales people, and I wanted to walk over there and thank him on -- apologize for what they're going through. But this is what's happening and this is how it works, and we just need to learn what the rules are and play by them. We hope to get through that whole pipeline and get them shipped. But as the guy said earlier, again, on a Medicare patient, that first billing is only $500 versus our commercial patients that are $1,500 on average with 2, 3 boxes of sensors, 2 transmitters and receiver. So we don't get the same amount of revenue, but it is probably more paperwork. So it's a balance. We need to take care of these patients and honor our commitments here, and we will do so as best as we can. But that's kind of how it plays out, and that's a big factor we look at Q4 going forward.

And our next question comes from Danielle Antalffy from Leerink Partners.

I was wondering if you could talk a little bit about what changes in the manufacturing process for a no-calibration G6. And depending upon what that change is, do you expect the same level of yield with a no-calibration product as you're getting with the current product?

I'm not going to go into all those details right now. Our manufacturing processes are pretty solid as it is. This does not require a major change or I wouldn't be telling you we'd pursue this as aggressively as we are. We're very comfortable with the procedures we have in place that we can get there. So more to come later.

Okay, that's fine. And then just curious. When you look at Europe and where you're competing directly head-to-head with Libre in the European markets, where there is currently CGM coverage, what are you seeing from a competitive perspective? Is Libre really more of a market expander? Or do you feel like you're competing really directly head-to-head with them? I guess, I'm just trying to get a sense of what you expect here in the U.S., where CGM is well covered. So they don't have the benefit from a cash pay -- a largely cash pay market that they've had in Europe because you look at their installed base and they have hundreds of thousands of patients. Obviously, your installed base is much less than that. Maybe give us some color on why that's the case?

Well, in those markets where we go head-to-head, again, we're up over 80% year-over-year. And I can go through a couple of the geographies. In Australia, for example, where there is government-approved reimbursement, we have over 70% market share in CGM for what the government is paying for. And we're classified as CGM there, compete with them directly. In the U.K., Abbott announced the Libre approvement there, but we're reimbursed under a completely different system in the U.K. We're more than double in the U.K. what we were a year ago. Canada, our business -- we've gone direct in Canada. Our business, again, has more than doubled in Canada. And I think it's more -- it's almost 2 different audience than what we've done. The products are appealing to different people. In the Nordics, where it's a tender process and everything is paid for kind of from the overall general budget, one of the things that's been very successful is our campaign to eliminate the receiver from the original purchase. By taking that large amount of money on upfront, patients could look at that and say, "Okay, I can get into the CGM technology easier than I could before." And we're getting a lot of new patients in the Nordics who are former Libre users. And that market, while it hasn't doubled like the others, since it was our biggest market before, we're still experiencing accelerated growth there from where we were a year ago. Italy is the same thing. Our Italian distributor is doing very well, reimbursement for CGM that excludes flash glucose monitoring. It's come through in a couple of geographies, and we've been very successful in those areas. So it's been a real good year over in Europe. And I just want to remind you all, 2 years ago, we had 3 employees there. And this is a big move for us. And it's been very successful so far. And our team has worked really, really hard to get where we need to be. But we're appealing to a different group of people, I guess, what I would say. And we're going about as fast as we can, to be honest with you.

And our next question comes from Margaret Kaczor from William Blair.

First question from me is given the success that you've seen out of Libre, given their simpler form factor, why wouldn't you launch similar product on the market? Is it specific market indicators that you're looking for that would make you want to launch that? And if you were to do it, how long would it take?

You know what, we certainly could take our technology down a level if we wanted to. For now, we need to finish what we started. A no-calibration G6 system with the performance [accurate] that we have, combined with the sharing and connectivity and the ability to get your data where you want to, we think it's a product that best serves our current patient base and those that we call on now. As far as future product offerings, again, take a look at what we talked about with our Verily systems, low-cost disposable transmitters. They certainly will be very, very competitive, in fact, have features far beyond what Libre offers by a long ways. And those will be the products that we had looked to compete with, against that, versus our current system. We think this ultimately bifurcates into 2 different paths, and we're very prepared and very ready to go down that path.

Okay. And then in terms of your hiring plans, now that you're up against the 2 big players in the marketplace, I know you've known that they're going to come [on blind] for a while, but has this changed structurally, what you think you need from a market presence perspective? And will this have any impact on your advertising budget as we look out over the next year or 2?

I think we'll -- if anything -- and we're in the middle of the planning process right now. So I'm probably speaking a little out of turn. I think we'll stay very aggressive on the marketing and advertising campaign. Particularly, our digital efforts will continue to be there. As far as field expansion, I think we'll give that some more thought. They're going through their field plan right now and developing all their models. And we'll evaluate the payback from field presence versus marketing dollars, and that's an exercise that actually Quentin gets to lead us through because he's been through this several times before, and it's really good to have a new set of eyes, question the return we get on the different investments we make. So we're evaluating that now. We'll give you more guidance after the first of the year.

But Margaret, the one thing I would add to that is when you look at the cost structure here, there's plenty of opportunity for us to be more efficient and thoughtful with respect to how we deploy our capital, which means as we get more efficient in some of these areas, we redirect it into these things that really move the needle and it doesn't become a net reduction to the overall investment or an increase in the investments that we have to make. They balance each other out but much better directed or well directed.

And our next question comes from Matt O'Brien from Piper Jaffray.

This is JP on for Matt. I wanted to ask a question about just kind of when you're going through the (inaudible) Medicare process and how important from that side of the field. Was it that you guys had these alerts and the alarms given the much higher incidence of hypo unawareness? Just trying to really gauge your thoughts on Libre's access there eventually?

Well, we certainly believe that hypo unawareness is one of the key factors in the Medicare patients using -- to use a continuous glucose monitoring. We provide actionable alerts and alarms. I might even add the G6 system has a predictive low glucose alert that will predict when you're going -- well, in addition to the heart alert that has performed very well on our studies and been extremely accurate. We think patients will migrate to that and they will want it, but only time will tell. But that will certainly be what we push, and that will certainly be our message.

Got it. And then I'm not sure what was the [exact facts] that pushed you to the lower end of the guidance? There was a handful of things, but was it more one thing or the other? Was it Medicare? Was it competitor noise?

Yes. I mean, as we kind of mentioned in the prepared remarks, with the competitive noise out there, some uncertainty around a couple of our commercial integrated pump partners, combined with some of the distraction and, even frankly, the near-term revenue contribution, the upfront revenue contribution from Medicare warrant some being conservative at this point.

And our next question comes from Raj Denhoy from Jefferies.

I wondered if I could just maybe ask one question. When you came into this year, you talked about adding, I think, 70,000 patients. Obviously, there's been a lot of changes with Medicare and the competitive landscape. And so, one, are you still comfortable with that level of new patient additions this year? And then when you think about 2018, again, with all the puts and takes with competition mostly, how do you think about that patient number? Are you expecting a higher rate of attrition in your customer base? Do you still expect to add a fair amount of patients next year? Any thoughts on that complexion will be really helpful, I think.

We're looking into the crystal ball, as you speak, and I don't have all the answers. With respect to the 70,000 net new patient adds, certainly, with the growth we've experienced in Europe and adding Medicare patients, we're comfortable that we're going to add that many new patients. The flip side of that argument is, for example, the Medicare patients are all coming back-weighted in the fourth quarter. So they're not going to contribute that much to the revenue. Hence, you'll have a new patient number that grows faster than our revenue numbers do in general. The second thing to consider is even with all the new patient adds outside of Germany, where reimbursement is very, very strong, in most of our European entities, (inaudible) through distributors and our pricing is a bit lower. So the revenue per patient from those new patient adds hasn't been as high, and that kind of reconciles the revenue number versus the new patient adds. But we've done well on new patients this year. With respect to attrition and retention, we'll give a little more color on that as we come out the first half the year with our remarks and guidance for next year. The one thing I would tell you that we've learned as we've studied and looked at this, as we go deeper into these markets and we attract more patients, it's a little bit different than the old days when the people who bought our device or people who really depended on it for life. Now we get customers who call up, say, "Hey, I hear this thing talks to the phone, sounds cool. Can I get one?" And then the thought of using that CGM all the time is a little bit different value proposition than what they're used to. So what we're saying with some of our new patients is a different utilization pattern. They might use it for 2 months and take a month off. We're seeing more variability, and we're learning to live with that. We're great with that. We think it's fine. We want all those people, but we don't want to overshoot. So we're giving more guidance on that at the end of the year.

So that's helpful. Maybe just a -- sort of a follow-up there. But I guess, one of the concerns on the headlines is when Libre hit and obviously, the label that they received, was it -- somehow, it was going to pull away a lot of your patients, right? And certainly, we haven't seen that in Europe or other places. But do you expect that is going to happen? And when you look out into '18, do you expect you're still going to add a fair number of patients on a net basis next year?

Oh, we absolutely do expect we'll have a fair amount of net new patients next year. There is no question. Our market is still underpenetrated. We still have a lot of reimbursement in a lot of places. If you go internationally, we're getting patients. We still have Medicare patients to add next year. That market has just began. We absolutely think we'll add net new patients. We do not see our patience running away to go use the other product. If you'd recall, last year, on this earnings call, we were answering the same question. They were all going to go away for 670G, and it doesn't appear that they have. So we will stick to it and we'll push our folks. We expect to continue to add new patients and grow the business. And remember, as I said on those remarks, more innovation next year than any year in our history. We haven't had anything new to push in the United States for quite a while other than connectivity, but that applicator looks the same way it did in 2006. It works lovely but it's kind of scary. And if you read the blogs and the patient's comments, "Man, I got my new DexCom, but I don't know if I want to push that plunger." That problem is gone when we launched G6. It's pushing a button. And the ease of use of this product and the lower profile, the consistency of the sensor, this is going to give our guys a fabulous story to tell in the field, and they need one. We owe them one, and we're going to give it to them.

And our next question comes from Joanne Wuensch for BMO Capital Markets.

I just want to make sure I have my head around the timing of G6. You're talking about several different pathways, but then you're also talking about it being at the end of next year. Is there a pathway by which it might be earlier in the year?

Joanne, there's a bunch of pathways that we're looking at. As I said, we've been given clear direction and clear guidance in our meetings with the FDA that we think we can get G6 and no-calibration that we would launch before the end of the year. Our last decision on that product will be greatly dependent upon our further discussions with the agency. If it appears we have a path we can get to you sooner by going straight to no-calibrations and sooner pick a date before the 1st of September or something like that, we might go direct there. We also have the option if we wanted to stick with the one calibration a day and go with that when we can. We have a lot of balls up in the air with the agency on G6, and they're all good. And it's all good because of the reliability and accuracy and performance of that system. We just wanted to let everybody know that we will have a no-calibration system out relatively soon, and it's what patients want. And we will meet that need with real-time CGM.

I think that's incredibly clear right now. Just as a follow-up or as my second question, I would anticipate that Libre is going to undergo a fair amount of direct-to-consumer campaigning. Do you have a similar expectation? And if so, how do you plan on countering it or not countering that type of approach?

You know what, we don't have Abbott's dollars to spend on television ads. So we will look and see how that goes. Our commercial guys and our direct-to-consumer campaigns have been really good for the amount of money that we spent. And we'll put in place actions to counteract that. Trust me, if I gave the guys all the money they ask for, we'd go head-to-head but we have a balance sheet and a P&L that balances well. Ultimately, if it creates more awareness for CGM and once people find out what they're not getting with Libre, it might be our best advertising campaign ever.

Joanne, I think Germany is a fantastic example of that, right, where awareness has been created. And ultimately, patients find their way to the best technology in the marketplace. And Germany has shown that time after time.

And our next question comes from Matt Taylor from Barclays.

I guess, I was hoping you could clarify 2 earlier points when you're talking about some of the dynamics outside the U.S. Firstly, could you help us put a finer point on the reimbursement differentials that you're seeing between your technology given the additional features and flash monitors? And then you referenced a couple of times on call that you're converting patients from Libre. Could you help quantify how many patients are converting?

I really can't quantify that number. We don't have that sitting in a statistical bin somewhere. We certainly hear the stories as we go out in the field in our foreign offices. And so we do know that it happens. I don't have that number handy. As far as reimbursement differences, that varies widely, geography to geography. In some places, it's 25%, 30%. In other places, it’s significantly higher. And so it really depends upon the reimbursement agency that we're dealing with.

Okay. And then I just wanted to clarify something in the U.S. with your strategy. This is the first quarter, I guess, that we haven't seen a large amount of growth in the Medicare pipeline. I'm assuming you're taking a foot off the gas a little bit there because it's just taking some time to get through the backlog. Is that right? And do you kind of step back on the gas next year once you've gotten through the people that are waiting?

Actually, we never put our foot on the gas. The pipeline that we created has come simply because of the approval and people looking at our web page. We'll put our foot on the gas later this quarter and certainly early in 2018.

And our next question comes from Tao Levy from Wedbush.

So first, maybe -- since you didn't call it out, I assume it's probably not much of an impact, but anything probably related to the hurricanes and ability to get product to your customers?

Yes, that's not something that I don't believe had a material impact on the quarter. Certainly, it had somewhat of an impact, and the revenue number would have been higher. But it's hard to quantify exactly what that is. I will tell you those are 2 regions in the U.S. that happened to be stronger regions for us. But the exact number, we're not going to put out there.

I would also add that our field sales force and, frankly, even our third-party distributors, our DME distributors really went above and beyond to help get patients product when they needed it. So kudos to them.

Okay. And then just so I can understand, the G6 products that might be coming out next year, I mean, is there a major difference between a no-calibration and a one time a day calibration just from a product standpoint? I mean, can it just be a calibration optional? And the data that you had shown previously, wasn't that just all on the same system whether you calibrate it once or no times?

Tao, that's exactly right. It was the G6 sensor. It's the same configuration mechanically, and the membranes and stuff on the sensor are the same. What changes is the software. And that's what we have to work through. It's how we configure that software for that product. And again, we have several options. We'll clarify that at year-end.

And our next question comes from Suraj Kalia from Northland Securities.

So Kevin, all of us seem to be asking the same question in different ways, and let me try a different approach. It almost seems like cost versus accuracy is the new battlefront that's going to open up. So my first question is, is $10 per day a fixed threshold that you all look at when developing new sensors? I guess, where I'm trying to head out is for the newer products coming online, how much would you all be willing to sacrifice on the $10 per day bogey without sacrificing accuracy? And the sub-part of my question is -- I appreciate the commentary you all made versus Libre, but let's say Suraj comes in and XYZ comes in, and they both need sensors. When you all go head-to-head with Libre, how do those statistics stand up in some of these countries? I understand Germany and others, the reimbursement has propped up things recently and I can appreciate that. But I'm just trying to understand, in Europe, when you all go head-to-head for the same patients coming in, what is your success rate?

So I'll take the first one. As I mentioned in an answer -- in response to a prior question, we're not getting close to $10 a day today for our sensors. So trying to compare a $10 a day sensor to a $5 a day Libre, which is pretty typical in Europe, isn't a fair comparison when you consider that patients are wearing our sensors off-label and wearing them for an extended period of time. In terms of going head-to-head with Libre, as we mentioned, anecdotally, we're seeing patients who -- when we get reimbursement, who have access to our technology, we are seeing them switch. We don't have great data on how many of them, but a full-featured CGM, when patients have access to it, is definitely a preference particularly for an intensively managed type 1 or intensively managed type 2 patient. So we compete quite favorably. We'll continue to push the message of our performance accuracy, connectivity and really try to maintain a premium price point. But trying to evaluate the $10 a day -- or $10 of revenue per day per patient isn't the real world today. So I wouldn't try to do that going forward.

And I'd just add on Steve's comments. Again, a lot of times, it's what a patient is looking for and it depends on the geography. But if a patient is looking to avoid low -- hypoglycemia at night, there's only one product they're going to pick. And if they're looking to manage a child, whereby you can see the child's information from afar, there's really only one product that you can pick. Our feature set is much more robust. So it's not just a cost versus accuracy. It's a cost versus features and what a patient wants and what are the needs of that patient. As far as the future, please understand, again -- and I need to emphasize this. We haven't been just sitting here thinking we're not going to take cost out of the system [or renew]. And we will be competitive on the cost front regardless of where it heads. For us, the most important thing in considering pricing is what does that do to access because having a race to the bottom really doesn't do much for us at all to the extent that we can really expand access and get more people access to the system. We've always been open for different pricing structures with payers, with people that we talk to. It's just -- that's kind of how the business works, but we're prepared for wherever the market goes.

And our next question comes from Chris Cooley from Stephens.

Can you hear me now? Sorry about that.

You're okay.

Okay. I had it on mute. Just 2 quick ones from me at this point I just wanted to clarify. In prior discussions, you had explored the realm of possibility of maybe having a fixed shutoff and I fully appreciate what Steve conveyed now twice in terms of your real cost per use per day really tracking close to about that $6 level, which is an attractive premium or (inaudible) attractive price point for all the end benefit and features that you get. But is that off the table at this point? Or just how do we think about -- maybe you fixed end of use on the sensor? And then secondly, just my last follow-up, you may have mentioned this in the prepared remarks, but did you give us an update on smart pen development with CGM, with 2/3 of your new patients starts now coming for that [FDI] population? Do you think that would be even more attractive on a go-forward basis?

Good questions, Chris. With respect to the sensor shutoff situation, we're evaluating that as we speak and as we talked on the upcoming product pipeline. Certainly, our Verily products are designed to last 14 days, and electronics isn't going to work anymore after that. The battery will be dead. We have to look at our other product platforms and make the right decisions. At some point in time, we know the accuracy of those systems isn't good anymore, and it's actually in the patient's best interest for them to be done. So we'll look at that and consult with the FDA, like our future-generation products. And we're open to both alternatives, and we haven't made any final decision.

Okay. And with respect to the smart pen development, flash integration, we've got a number of irons in the fire. Not really in a position to give update on this call but hope to be able to provide some additional color before the end of this year or early part of next year.

And next question comes from Steven Lichtman from Oppenheimer.

I was wondering if you guys have an early read on adoption among type 2 patients among the Medicare population since the beginning of the roll-out. And can you update us on how you see the potential for expansion into the intensive insulin type 2 patient population commercially as well?

Go ahead, Steve.

Yes. I was going to say I anticipated this question and checked with our commercial team. And quite frankly, we've not done a great job with the initial bolus of patients at capturing type 1 versus type 2. But our guess is that the vast majority at this point are type 1.

Yes. We haven't pushed that yet. I think word of mouth and getting the product out there is going to be key to reaching those patients over time. We certainly have clinical data with our DIaMonD study that shows with intensive insulin using type 2 patients, that CGM definitely provides a benefit. We just -- again, we just need to get our pipeline serviced, and then we'll turn on the faucet and go after those guys.

Got it. And then, Kevin, you mentioned during Q&A, we have -- you guys have some electronic enhancements on the horizon that can significantly reduce cost. It sounded like that was outside of the Verily product pathway? Is that right? And can you flesh out that opportunity a little bit more?

It is actually stuff that has been designed by our people in-house. But we did launch a new receiver this quarter. And while the actual cost profile on it -- to build it isn't any higher, we believe the warranty return rates on it are much less significant, and that will ultimately save us cost. We have a new transmitter coming in the G6 configuration that we (inaudible) we filed but coming not soon after -- not far after we launched. These electronics have been designed with us and one of our partners that cost, again, a lot less to manufacture and much more efficient automated manufacturing processes that we can push into that product as well. And literally, everything we do, we have 3 pillars. Every product that we make, we have to continue to have performance. You've got to take out cost, and you've got to increase patient convenience and compliance. Anything we start has to answer those 3 questions or we shut it down. So everything we're looking at answers all 3 of those.

And this concludes our question-and-answer session. I'll now turn the call back over to Kevin Sayer for final remarks.

Well, I just want to make sure it's not lost on everybody. We had an amazing quarter, the biggest quarter in DexCom's history. You look at the cash we generated from operations, look at the management of our expenses, look at the gross profit line and gross margin lines hitting the targets that we've established. The company had a wonderful quarter, and everybody here should be congratulated. There really has never been a better time to be in our industry than we are now. And our confidence in our new pipeline to deliver the systems we know patient want has never been higher. We'll continue to innovate. We'll continue to drive our business. We'll continue to grow. We'll continue to take new approaches to attack this wonderful opportunity to serve patients who really need this technology across the board. Thanks, and have a great day.

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