DexCom, Inc. (DXCM) Q4 2011 Earnings Report, Transcript and Summary

Welcome to the DexCom 2011 Year-End Earnings Release Conference Call. My name is Christine and I will be your operator for today's conference. [Operator Instructions] Please note, today's conference is being recorded. I will now turn the call over to Terry Gregg, Chief Executive Officer, you may begin.

Thank you, operator. Thanks for joining us today for our conference call. Let me first ask Steve Pacelli to review Safe Harbor statement.

Thanks, Terry. Some of the statements that we will make in today's call may constitute forward-looking statements. These statements reflect management's expectations about future events, operating plans, and performance and speak only as of the date hereof. These forward-looking statements involve a number of risks and uncertainties. A list of the factors that could cause actual results to be materially different from those expressed or implied by any of these forward-looking statements is detailed under the section Risk Factors and elsewhere in our Annual Report on Form 10-K, our quarterly reports on Form 10-Q, and our other reports filed with the SEC. We undertake no obligation to update publicly or revive these forward-looking statements for any reason. Terry?

Thanks, Steve. Joining me today are Kevin Sayer, our President; Steve Pacelli, who you just heard from, our Chief Operating Officer, and Jess Roper, our Chief Financial Officer. Before we review our fourth quarter and full-year 2011 financial results and provide our customary operations update, I'd like to spend a few minutes discussing a very exciting transaction we announced just today. This afternoon we announced that we have entered into a definitive agreement to acquire SweetSpot Diabetes Care, Inc. at an all stock transaction with initial consideration of approximately $4.5 million and performance milestone based earn-out consideration of up to another $4 million. SweetSpot is a healthcare focused information technology company with an advanced platform for uploading and processing data from diabetes devices. The SweetSpot system specializes in turning raw output from patient devices into powerful information for healthcare providers, patients and researchers. SweetSpot and DexCom share the mission of transforming diabetes care through the better use of data. We each offer advanced technologies to help patients control their diabetes and we each believe that diabetes care must and will evolve with a help of connected monitoring devices and the more sophisticated use of data, providers, patients and payers. Today, the SweetSpot platform comprises of SweetSpot Diabetes data management service, a secure end-to-end solution for diabetes data management, automating the retrieval of data from numerous patient devices, managing, processing, and storing data in the cloud and integrating into electronic medical records and other clinical systems for information delivery. The platform is vendor neutral and today data from most common blood glucose meters can be retrieved during a step by step session at a physical kiosk in clinics or through a web-based application. As currently configured, once patient data is retrieved, the service generates a plain English report and pushes it back to the clinic, either to a local printer or directly into the clinics' electronic health record system. Patients can also receive reports via a secure link. Reports contain visualizations of daily and weekly glucose levels, statistical summaries and provide measures of glucose variability and testing frequency. The platform also has the capability to compare a patient's data with their cohorts and can be customized by the clinic to best support physicians and their patients. As we work with SweetSpot to build out this platform, our intention is to use the platform to move and manage CGM data in the cloud. And we expect to add insulin data, and other information considered necessary to better manage diabetes. We will also add more data management tools specifically designed for the patient and additional reporting capabilities for wireless devices such as the iPad. While we believe we are firmly entrenched as the world's leading glucose sensor technology from a competitive perspective our 2 missing pieces remain insulin pump integration in the U.S. and a universal data management system. Our acquisition of SweetSpot combined with our insulin pump partnerships will fill these voids. Looking at future DexCom product offerings, our ultimate objective is to move a patient's CGM data directly and seamlessly from the patient's phone or CGM receiver to our cloud based platform. Not only will this cloud based data provide patients and providers with much more useful information, it will greatly enhance DexCom's ability to monitor our product performance and measure patient utilization patterns. Data driven healthcare services are evolving rapidly. And in addition to building out our data management platform, SweetSpot will continue to pursue its pre-acquisition business strategy, marketing the data management service directly to clinics and other customers including leading academic research centers and integrated delivery networks such as the VA Medical System. SweetSpot will offer a largely independently from DexCom in these activities and its employees and facilities will remain headquartered in Portland, Oregon. Patient-based applications however will be provided to our patients directly through DexCom. It is no secret that our healthcare system is witnessing a rapid expansion in the number of tools and services to support the gathering of health related data creating an unparalleled opportunity to inevitably and forever change the face of how healthcare is delivered. I've often stated that the majority of patients with diabetes are treated by internal medicine and primary care, not endocrinology. We expect this trend to continue and as the burden to manage a growing diabetes population falls increasingly on primary care and even on patients themselves, we need informative tools that are convenient and effective. We believe the future of health care is one in which the patient is presented not just raw data but with simple, easy to use, timely and actionable reports that not only interpret the data but also provide motivational recommendations for positive health behavior change. We also believe that most of the tools and services available today are not taking full advantage of the vast amount of patient data that is being processed. This is where DexCom together with SweetSpot will work to pioneer an integrated interconnected data management solution. We expect the acquisition will close within the next several weeks. I would now like to turn the call over to Kevin Sayer.

Thank you, Terry. I'll start with a financial update. DexCom finished the year strong generating $20.9 million in product revenue for the fourth quarter of 2011 compared to $13.6 million for the same quarter in 2010, a 54% increase. Sequentially, product revenue for Q4 of 2011 increased 26% from the prior quarter. And year-over-year product revenue was up approximately 64% totaling $65.9 million for 2011 compared to $40.2 million in 2010. Total revenue for the fourth quarter was $22.4 million, compared to $15.6 million during the same quarter in 2010. Our product gross profit totaled $10.2 million generating gross margin of 49% for Q4 2011 compared to gross profit of $5.9 million and a gross margin of 44% for the same quarter in the prior year. Sequentially, our product gross profit increased $2.8 million on increased sales of $4.3 million over the prior quarter and our gross margin increased 4 margin points over Q3. Year-over-year, product gross profit increased $15.2 million on increased sales of $25.7 million. Gross profit more than doubled from last year and our gross margin increased 9.4 margin points over 2010. Research and development expense totaled $9.2 million for Q4 of 2011 compared to $6.9 million in Q4 of 2010 primarily a result of additional expenditures related to our future generation ambulatory products, primarily our Gen4 product. Sequentially R&D expense increased 12% which was primarily due to higher development clinical and regulatory costs, again relating to our future ambulatory products and primarily the Gen4 product. We continue - we expect to continue to incur significant R&D expenses as we complete our Gen4 trial in Q1 and complete our PMA filing. Right after our Gen4 filing, we will commence the pediatric trial to enhance our labeling for children and these accounts fall [ph] in during the Q2, Q3 timeframe. We'll then shift our efforts to our Gen5 platform to enable communication with a smartphone and the Roche Tandem insulin pump products. After Q2, we expect things to stabilize a bit but on an overall basis, it will be a year of much activity and we expect R&D expenses for 2012 will increase some compared to fiscal 2011. Selling, general and administrative expense totaled $13.7 million in Q4 of 2011 compared to $10.0 million during the same quarter in 2010. This increase which included $900,000 in additional share based compensation was primarily due to additional selling, information technology costs, and customer support costs to support revenue growth. We note, however the year-over-year SG&A growing 23%, our products revenues grew 64%. We're beginning to see some leverage on our SG&A infrastructure. Sequentially, SG&A expense increased 4% with the increase primarily due to additional selling costs, information technology and customer support costs to support our increased volumes. For full-year 2012 we expect cash based SG&A expenses to increase by less than 20% compared to the whole year 2011. As we continue to expand our marketing and product awareness campaigns, our IT infrastructure and support our revenue growth. Our net loss for the fourth quarter of 2011 totaled $12.3 million and included $5 million in non-cash expenses that are primarily in share based compensation. And the loss per share for the quarter was $0.18. We ended the quarter with $83 million in cash, restricted cash and marketable securities and have working capital of $90 million. Our uses for cash during the fourth quarter can be characterized in 3 areas. First our Q4 CapEx was over $3.5 million as we are working rapidly to complete our clean room expansion and acquire the equipment necessary to ramp up manufacturing to support increased volumes for current and future generations of our technology. Second, we had a negative working capital swing of $4.4 million during Q4 with $3.5 million of this coming from receivables and the remainder coming from increases in inventory during the quarter. Finally, our cash operating loss was just over $7.3 million for the fourth quarter of 2011. As we discussed on numerous occasions, the fourth quarter is typically the strongest of the year for companies in the durable medical equipment business. As annual deductibles had generally been met, meaning patients can obtain the product for little or no out of pocket expense. Our flexible spending account deadlines loom, so patients who participate in these employer sponsored programs must utilize any excess funds they save prior to year end. We attribute our strong performance during the fourth quarter, to typical Q4 seasonality as well as our stepped up efforts to increase awareness and demand for our CGM products. Just as a point of reference our Q4 product revenues exceeded our total revenues of 2009 by 16%. Obviously, our strong Q4 performance begs the question: What will our growth be in 2012? As a remainder, at the J.P. Morgan Healthcare Conference in January, we issued guidance of estimated full-year 2012 product revenue ranging from $85 million to $92 million and we remain comfortable with that guidance. Now we do not plan to provide quarterly guidance going forward. I remind investors that the first quarter is traditionally a seasonally slow quarter in the durable medical equipment businesses and annual insurance deductibles reset and flexible spending accounts are largely unfunded. So I'll remind investors that within years past approximately 40% to 45% of our product revenues have been generated in the first half of the year and 55% to 60% have been generated in the second half. We do not view 2012 any differently. Last year, Q1 accounted for approximately 20% of our annual revenue and we would expect similar performance in the first quarter of this year. I'll now provide you with the Gen4 update. Shifting to an update on our fourth quarter generation sensor system, I am pleased to report that we have successfully completed this pivotal trial for our fourth generation system and we are actively engaged in our data analysis. We expect to file PMA with the FDA by the end of this quarter or early in the second quarter. I am also pleased to report that we submitted our improved Gen4 configuration with our notified body to obtain CE Mark approval and expect to launch the Gen4 standalone system outside the United States during the summer of 2012. Finally, a partnership update. Turning to our development partnerships in January, we announced that we entered into a development and commercialization agreement with Tandem Diabetes Care. We also have [ph] agreement with Roche under the terms of the Tandem agreement, Tandem will pay discount [ph] to technology license fee of $3 million. Tandem will offset our development, clinical, and regulatory expenses and commercialization of the combined system Tandem will pay discount $100 for each CGM enabled handheld sold. Further our patient-centric model we have adopted an open architecture strategy in order to provide our patients the ability to choose a pump system that best fits their needs. We believe the financial framework established under the Roche agreement and married in our Tandem partnership is appropriate for both existing and potential future pump partners that wish to integrate our advanced CGM technologies into their product offerings. Animas continues to commercialize the Vibe system in Europe and is expected to increase the number of available markets over the course of the year. With regards to the filing of the PMA supplement for U.S. approval of the Vibe, we continue to anticipate filing with the FDA approximately 100 days after we file our Gen4 PMA. Finally, the development of our second generation in-hospital glucose monitoring system conducted in collaboration with Edwards Lifesciences continues to move forward as Edwards mentioned in its Q4 earnings call the commercial launch of Gen2 in Europe is expected before year-end as we collectively work on several additional enhancements to that product. I would now like to turn the call back over to Terry for some concluding remarks.

Thanks, Kevin. Earlier this month the fifth annual ATTD meeting was held in Spain. Just under 2,000 registrants from around the globe attended the important technology meeting. And prior to the official start of the meeting, there was a full day review of the current status of the artificial pancreas projects currently being conducted around the world and sponsored by a number of entities including JDRF, the Helmsley Trust, the EU and even the French government. DexCom was clearly the sensor of choice in the overwhelming majority of programs regardless of sponsorship. And in fact the few sites not using DexCom sensors approached the company requesting access to our technology to include it in their ongoing efforts, quite a tribute to our sensor technology. Also during the meeting we presented accuracy data on our Gen4 technology and results from our clinical trial in support of our CE Mark filings achieving a mean absolute relative difference of 12.3% when compared to finger stick. This is real-time prospective accuracy and we believe this is the most accurate prospective data that has been presented on CGM to-date. In addition we discussed our Gen5 product platform that provides for open connectivity to a variety of devices including smartphones, tablets and PCs. Finally, we presented recent human clinical data from an ongoing trial of the DexCom/Edwards intravenous sensor in the critical care arena, achieving an MARD of approximately 5%. That is therapeutic accuracy. My final takeaway from the meeting was the presentation sponsored by the Type 1 Diabetes Exchange. The Exchange is a data repository hosted at the Jaeb Center in Florida through generous grant from the Helmsley Trust. 67 clinical centers around the U.S. participate in providing information from their diabetes patients to the Exchange. To date, there are more than 20,000 patients from these centers that have responded to questions regarding their diabetes. Focusing on the more than 1,100 respondents that have utilized CGM, approximately 80% were pumpers and 20% used injection therapy. Of that group, 43% of the patients reported using DexCom CGM which is remarkable when you consider that our install base is about 60% pump and 40% MDI. The authors also concluded that there was no difference in A1c when comparing injections in CGM versus pump and CGM. And with that, I will open up the call to Q&A.

[Operator Instructions] The first question comes from Tom Gunderson from Piper Jaffray.

So let's start with the new news on SweetSpot, you did a good job of giving us a summary of the concept and technology. Can you give us a little bit better sense of financial impact other than acquisition costs, maybe just a quick summary of what the business equation was and will be for SweetSpot? And secondly, is this going to have any impact on OpEx in 2012?

Yes. Tom, this is Steve. So from a - I'll start with the kind of the OpEx and the expense and revenue side of the business. Today I mean revenue is very, very small. Particularly we don't expect material revenue contribution in 2012, nor do we expect material additions to the OpEx line from this business. It's a very small business. It's a handful of employees, highly skilled technical employees and some very early sales resources. We're going to expect to add a few bodies over the course of the year to help with the technical build out and probably build a few more bodies into that sales organization. But nothing, there won't be material to the overall business in terms of an expense. In terms of the business model, we talked a little bit about it in Terry's prepared remarks but we're kind of looking at this kind of from an almost as an acquisition of 2 distinct companies in one. So the first side of the business that we focused on - focused most of our prepared remarks on have to do with building out the infrastructure that SweetSpot already has in place. So the 510k cleared product that SweetSpot has today can aggregate basically any brand of commercial glucose meter up to their class A system and then report back that meter data back down to the clinic and the patients can also see that reporting. It provides them with really quick output in terms of very crisp clean reports in very clear plain English messaging on kind of trends and key patterns of things to look for in analyzing the finger stick did. Obviously that analysis and the analytics behind it will become much more robust when you start uploading the equivalent of 288 finger sticks a day versus what the patient is probably taking 4 to 6 to 8 finger sticks a day. We would also look at rebuild out that platform. So from a technical perspective we'll build out the platform to include not just finger stick data but the next step would to be to incorporate obviously our CGM data, and then we would look to incorporate insulin pump data as well from the various insulin pump partners. So from a clinic perspective, the clinical kind of a single platform to aggregate basically all patient devices into a single cloud based platform, and then have access to that data again initially directly into a printer in the clinic or directly into the EMR environment. But overtime the clinician and even the patient will have access to it from a mobile device like an iPad or even potentially a smartphone. So that's kind of one aspect of the business, but then we have the other side of the business which is the revenue generating opportunity. And now the profits for that business are somewhat unknown. It's a very, very new business. The concept of selling data services be it into a clinic, and I think there's opportunities to work with payers in aggregating some of this data and providing that data to the payer community. We have a relationship or SweetSpot has a relationship today with the VA. It's in early stage, only in a single site at this point, but its comprised about floating data and actually remotely monitoring patients. So we see some pretty interesting opportunities. Don't really want to comment much further on that, because I think that business is really an evolving business, but I think its surely has separate and distinct part of the company that we're buying that I think we're pretty excited about. I think your 3 questions I kind of covered them?

Yes, just one quick follow-up on that, and also on the website mentions, R&D research -- sorry, applications. Would you see incorporating your clinical trial data both your direct and the ones that you're doing with other companies into this system in the near term?

Good catch, Tom. Yes.

Yes, that's part of the platform as well for sure.

The next question comes from Ben Andrew from William Blair.

Okay, great. Just a couple of follow-ups to Tom, and then something else. Did you look at other businesses in this space and what was the build versus buy timeframe, it's a small acquisition but maybe just describe what you saw as you looked around the industry, are these guys one of a kind, or other people been trying to do this?

No, we did the appropriate diligence of what was available and these were not necessarily one of a kind. They were certainly the most advanced and comprehensive that we saw their current distribution format and the relationships, we talked about the VAs. There are several others that we haven't talked about that they have existing relationships with it, very broad based important relationships that we either today have our own relationships with or certainly will allow us to enter into additional relationships so we're looking across a broad swath of what they can do. And I think that the rough key here and we keep [indiscernible]. So the one thing that we have been missing I think from a standpoint of our ability, we create software. It's in a disc that you put into your computer, PC-based and it's not web enabled. One of the criticisms of DexCom by the physician community has been the inability to pull that information down from a web. For us to build it on our own, which we went back to our own internal IT group, the infrastructure that would be required and the time was enormous, much greater than what we are paying for and having it already integrated. So in many ways we took the advantage of this sophisticated system to buy it now and to build on it with our own IT infrastructure to incorporate it. So that was the decision making.

Okay, that's helpful. And then I mean probably not any time sooner in the current - the scale, but is this the true platform or it could be used outside of diabetes, or just haven't gone there at all, they've been so focused?

It is a true platform. And as we look at data management, if you were to ask me what I thought the future would look like in 3 or 4 years from now, I will tell you that patients will wear a multiple body worn sensors in which they are registering glucoses as well as blood pressure and other, I mean even today heart rate monitors are common using ANT+ technology as an example through Garmin or Nike endeavors. All of this is really the future of healthcare and so yes, this is a platform that can incorporate other vital sign measurements and also in the convergence of that information to either the patient themselves or to a caregiver.

Okay. And then maybe switching gears a little bit, talk about patient adds, if you're giving that number out or and talk to us about any trends you're seeing with retention and kind of utilization. I know the numbers were solid in the quarter but did you see a change in sensors for patient or the length of time that each patient is using a sensor?

Ben, this is Kevin. I'll take that. We've kind of scaled back on what we already disclosed with respect to patient adds and kits sales for a couple of reasons. First of all we've been giving our competitor very clear math of everything that we do. Second of all as we disclose kit sales, we've all interpreted that as a new patient add but as we look at the future when Roche purchases a kit, and puts it in professional offices, is that a kit, is an Animas pump placed in Europe a kit and then another transmitter, another kit. Things are getting blurry so we've kind of backed off on that disclosure. I will give you a mix. Our sensor and hardware revenue is still about 30% hardware and 70% sensors. As we look at utilization we do know and Terry can tell you first hand from his field experiences, the patients are wearing our products for a very long time. We'd love it to be shorter but they use it for a long time. We have seen we believe that our more current patients in particular increase utilization in stickiness as they use the product. So our sensors sales were very strong last quarter and we're feeling very good about what we see right now. So I would say that's our trend there.

The next question comes from the Bill Plovanic from Canaccord.

Fantastic. So just a couple of questions here. Just one on ASPs in the quarter, if you could give us any trending data there in kind of where we sit on the sensors and the kits and then just in terms of one of Ben's questions just any incremental change in attrition rates up or down in patients utilizing the products?

Yes, I'll get back to the last thing. We've never disclosed an attrition rate. What we are seeing is what we think it is some pretty strong utilization right now. The mix between sensors and hardware remains 30/70 with respective to pricing. Since so many of our sales now Bill are through managed care contracts, pricing [indiscernible] offset. So we don't see a lot of pricing moving quarter-to-quarter right now. So things have been relatively consistent with what we've had in the past.

And then just as we try to kind of find [ph] models, any updates on the total number of patients that are currently utilizing this technology at the end of 2011?

I think we made the statement that we thought collectively the penetration in the Type 1 category in the U.S. exited the year at around 6%. And how you factor that into a model and you saw where we just most recently and 1,100 plus patients represented a 43%, if you look at Kelly Close's DQ analysis it said about a 54% share. So somewhere in that range, that's about as far as we can go.

Okay. And last question, can you give us pretty good clarity on what R&D setting and SG&A would be going forward. As we look at the selling [ph], do you have a targeted of 2013, 2014, 2015 when we think you can get to be a cash flow positive or operating positive business?

Are you kidding me? I like my job. It's going to have to be quicker than '14 and '15, Bill. We're looking particularly as we get to the very last part of 2012 to start flipping towards cash flow positive, and certainly during 2013 we're confident [indiscernible]

The next question comes from Raj Denhoy from Jefferies & Company.

This is Amy in for Raj today. Just a question I guess back on SweetSpot, I know previously they did seem to have a direct subscription model for patients, is that still an active business model or is that shifted solely just direct to clinics?

Yes, the 510k approved product is only for clinician use although the patients do have the ability to access the data once they've uploaded it to the clinic. In the future though, we would certainly expect to provide the platform to patients and to all clinicians.

Okay, great. Just kind of switching gears perhaps to the international market, I think wrapping up 3Q, you all know said that a little bit of a tougher market and this quarter Medtronic said that is a very strong performer for them in noting CGM adoption. Could you all talk a little bit about your view of the international markets?

Yes, I am happy to. I've spent over the last 3 months I've probably spent 3, 4 weeks in the international markets between Europe, Asia, and India. I think there is great opportunity. We did finish out the fourth quarter in the international sector very strong. I was quite happy and compared to my comments about the 3 previous quarters, Q1 through Q3 we were underperforming but came roaring back in Q4. And I would say as we look out even now the prospects in the international market, although still as a percent of our revenue will be single-digit, maybe approaching double-digits. But again with the robust opportunity and we certainly applaud the good folks at Medtronic for paving the way, spending the money to build those markets and our goal is to come in and trump them with superior technology.

Great. And then just regarding with Roche marketing to the professional physician group. Has that started in earnest and could you talk you talk a little bit about any experiences thus far?

No, it's actually we were really engaged in the training exercise late last year. It's really not kicking off until just this month with the Roche National Sales Meeting. So we don't really have much of an update at this point. Probably update you in the next couple of quarters as we start to see some traction.

The next question comes from Sara Michelmore from Brean Murray.

I guess I'll hit you with some pipeline questions. First, just on this Gen4 trial, is there a venue where we may see the data from this firstly [ph] this trial. And then on the Gen5, I assume you're thinking right now this should be a supplemental PMA type of route and I am just wondering in terms of the smartphone pieces of submission, how much clarity do you have in terms of what the FDA may or may not require?

All right, this is Terry. I'll take the -- both questions. The first one with regards to the first display or presentation of material clinical results, we're gearing towards ADA at the first part of June in Philadelphia. We believe that multiple investigators will want to present. Obviously we're trying to get the analysis done, file the PMA which would allow them to meet the timing requirements for late breaking abstracts under the FDA - or the ADA guidelines. Secondly with regards to the Gen5, we are in active discussions and face-to-face meetings with the agency on the Gen5 technology. Don't have any definitive answers, the learning curve of FDA and its convergence of healthcare information, mobile applications bought [ph] into a variety of devices is at it's all time high. We actually have Dr. Sharon [ph], Head of CDRH in our offices in January talking about this specific area. I think we will gain greater clarity as to their comfort level as to what we can and cannot do as a tool aid [ph] mobile device. They remain - their primary concern which is well known has been to ensure that the protocol of receipt from transmission of sensor signal from a transmitter is always primary no matter what you do, regardless of the upgrade to your software or adding apps to your phone and there may - we can make that primary but there are some limitations and we just need to ease them along that process to -- for them to understand that no matter what a individual could do on their phone that that sensor signal cannot be corrupted in anyway. So it's a matter of demonstrating all of the testing that we're doing and others are doing as well.

Okay, that's helpful Terry. And then just in terms of the Gen4 sensor, can we just get an update on your thoughts in terms of the cost position of that product and I suspect but don't know that that's part and parcel with having that product out there with the lower cost position. That's going to enable you to deliver cash flow breakeven or cash flow positive results in the near term?

Sara, we've consistently said we can pick up significant margin points when we go to our new manufacturing process. And as we look at internally certainly a SEVEN PLUS margin on sensors once we get there should be achievable based upon the volumes that we would expect to sell. The flip side of that argument is for a year we're going to be manufacturing SEVEN PLUS sensors then we're going to integrate Gen4 sensors. We'll have some blended manufacturing between the 2 but on a pure standalone basis, we're buying [ph] where we think they are going to be. We should have very - we should see a good margin improvement on the Gen4 sensor.

The next question comes from John Putnam from Capstone Investments.

Yes, just to pursue that a little bit Terry, do you think that the gross margin will improve sequentially on a quarterly basis through 2012 then?

This is Kevin. Again based on volumes and timings of product launches it should, but I'll go back to cautioning and the quarter where we've put and we have to manufacture both and support both, there will be a lot of startup costs involved. But by and large our model would indicate our margins improve every quarter as we increase our volumes.

Okay. You didn't mention your relationship with Insulet. Can you give us an update on that?

Yes, I mean not much to update other than Insulet have been focused on the Arrows [ph] system and driving that through the FDA approval process. And obviously we've had our hands full with some things on the Gen4 with the SweetSpot deal. I expect now that both of us can come up for [indiscernible] and Insulet, you see their approval. We're kind of standing by ready to let them go forward with the Gen4.

The next question comes from Caroline Corner from McNicoll, Lewis.

Most of my questions have been answered, just a couple of quick ones. With regard to the former Abbott patients, since that product has been off of the market now since last August, can you let us know how your sales efforts to those patients have been going and how successful you've been able to capture them, you think as compared to Medtronic's efforts to that?

Yes, by the time that Abbott actually exited the markets, there were less than 300 patients that were still on Navigator sensor. So there is no - we did not go after them specifically as I had mentioned previously. Abbott did give us a heads up that they were going to exit the business and that they would be referring their patients over to us versus referring them over to Medtronic. But we don't have any records specifically of how many of those patients elected to use DexCom sensor technology.

Okay. And then my other question is just about the grant revenue line. It looks like that's been fairly strong lately, as we look forward is there any component of that that is recurring that we should model in or is that going to be just on a quarter-by-quarter basis as they come in?

There is 3 elements in the grant revenue line. The first one is when we receive these upfront payments for development contracts, we amortize those over what we think is the lifecycle development agreement. And those are relatively straight forward, those get amortized in. When we get a milestone payment based upon achieving some performance milestone, we take that revenue and immediately similar to what we did with the Animas revenue in Q2 of this year when we received a CE Mark on that combined system. And then the last 6 [ph] months, on many of our partnership agreements we have a component whereby we can bill them for development revenue in a current quarter as we incur costs in every half and those are recognized quarter, relatively inconsistent depending upon the project that we're working on. We'll amortize the rest of the deferred revenue that we have on our balance sheet over the course of the agreements as we set them up and if others things happen, it rolls in.

The next question comes from Ben Haynor from Feltl & Company.

Have you guys continued to see positive momentum on the reimbursement front, and then are there any specific coverage policy review dates coming up that you might have your eye on?

Yes, I mean I guess the shorter answer is it gets better every day. And what I mean by that is we continue to see plans that may have been historically restrictive in terms of the documentation required to enable a patient to obtain coverage is lessening or being eliminated in its entirety. With respect to specific coverage policy dates, there is nothing that comes to mind, I mean we're by and large I would tell you north of 95%, maybe 97% of our patients receive reimbursement for the product at this point. The one kind of hole if I were to identify a hole would be the Medicare side of the business which we've been pretty transparent with the market in our plans there in the sense that we need to conduct a clinical trial specific to the Medicare population but as Terry mentioned or Kevin mentioned in the prepared remarks, in order of priority certainly we view a pediatric trial for the Gen4 for example as much more important in the nearer term to our business than running a trial in the Medicare population. So it's something that we'll do at some point in time. We would probably look to have some help from either an industry organization or potentially the Medtronic to try to do something together for a trial like that, but other than that I think reimbursement. We're not out of the woods in terms of eliminating all restrictions with all payers, but I think it continues to get better.

Okay, great. And then on SweetSpot, do you guys believe that if you get patients using that system or service that that could potentially increase the number of sensors that given patients may use overtime?

Sure, I mean that's only a small part of the strategy but, yes, as patients have a better visualization of their data and there will be component to the SweetSpot system that will roll out over time providing, not just data and analytics but providing motivational support to the patient, really encouraging the patient to maintain better glycemic control, things like that. Sure, we do expect that we do [ph] to better sensor - better and more frequent sensor utilization.

The next question comes from Richard Lau from Wedbush Securities.

My question is about the Type 2 population. What your current thinking is from that market opportunity, I know you guys said recently that you think that that patient group is kind of ready for CGM now. So I just wanted an update there?

Yes, this is Terry. I think it's clearly ready. We have the Robert Vigersky paper in Diabetes Care. He is doing some follow-up work in the Type 2 population that was demonstrated sustainability of effect overtime even with periodic use. So we believe and we've got at least 2 payers that have - in one case it's still letter of medical necessity and they will approve. We are processing some of our patients on Type 2 through insurance and getting that reimbursed, although it's very small. And I would classify those as one-off. But the opportunity is in my opinion enormous in particularly not only restricted to the U.S. and in fact if you look at some emerging countries where you've got a Type 2 patient with a BMI of 22, and then increase in cardiovascular impact on that patient, they are very concerned about their glycemic control because they look at that and the healthcare systems are beginning to look at that as well, are there preventive ways in which to reduce that glycemic variability and a reduction of the potential longer term complications associated with Type 2. So I think the market is robust. It won't be in 2012, we'll continue to make inroad some of these studies that are being done today. Some will be published later this year. You should see some at ADA, some at the AST [ph], but I don't see anything transformational until no sooner than 2013 or possibly even later.

Okay. So it is safe to say you guys probably won't be spending significant marketing dollars behind until 2013?

No, at this point. I mean we do have some investigator initiated trials and we tend to support with product or in kind but not that we are going out conducting $400,000 trials in the Type 2 population.

Okay. And then one more question with regards to your Tandem Diabetes agreement. Can you give us a sense of timing for a potential launch with integrated system there with its own tablet [ph]?

Nothing specific, we're just literally just kicking off that program now between the development efforts on our side and the development efforts required by Tandem. I'd hesitate to give you any specifics at this point.

The next question comes from Jonathan Block from SunTrust.

This is Chris in for Jon. First of all, I just wanted to just make sure that I got the timeline correct for the Gen4, I know you guys mentioned the PMA coming at the end of this quarter potentially early second quarter. But the 100 days after, have you guys in your conversations with the agency have anything incremental that you think you could still get an approval for Gen4 standalone by year-end? Is that slipped to a first quarter '13 event or are you confident that if that happens on a standalone basis by year-end '12? And secondly just a sort of follow-up to Amy's on the international, I know previously we talked about trials for reimbursement concerns international, any update that we could have there would be great?

Sure. On the Gen4 approval it would be too early to speculate as to what the review timeframe is. And the agency as you all know has historically taken longer than the statutory requirements to review things. You counter that versus what we think will be accent [ph] data that they will be reviewing. So I don't know, I really would not want to forecast any timing of it. Obviously from a launch standpoint, the further out we get into the year 2012, the less motivated we would be to actually launch a product in the last 2 months of the year as an example so we would most likely hold that launch until early 2013. With regards to the international sector, I just got back from Spain. I had multiple meetings with investigators. We will do some small trials for reimbursement. There already exists a number of data analyses with regards to the benefit versus economic outlay that have been filed in [indiscernible] some of these countries are already reviewing them from that standpoint. Others even though it's the European communities they are not as harmonized as one would hope for. So we will run small 20 patient trials with a key opinion later in order to generate that type of data. That will actually happen in 2012.

The next question comes from Greg Chodaczek from First Analysis.

Yes, just a couple of quick questions. With regards to Edwards, what is the story with the milestone payments, I know - I think there was about $12 million remaining, has that been renegotiated, just a couple - a little color on that and also is there any type of milestone payment when you file a PMA with Animas?

So I can take both of those, Greg. So with Edwards as we described that we're in active discussions with Edwards but nothing definitive yet. So that sort of a still kind of stay tuned and we'll update you as soon as we have something more definitive. Now Animas if you recall those, the $5 million payment from Animas was based on the CE Mark approval. That was due to the exclusive nature of the Animas pump outside of the U.S. So that the U.S. are non-exclusive. So there is no additional payment there.

So looking at the royalty payments this coming year it's a lot of - there is a not a lot of one-timers coming but a lot of amortization is coming.

The next question comes from Greg Simpson from Wunderlich Securities.

Most of my questions have obviously been answered. But Terry, if I could maybe throw something more anecdotal at you, can you maybe characterize your relationship with the FDA at this point? It seems like its improved dramatically and what I am specifically trying to get at obviously the process for the Gen4, it's been kind of excruciating but it seems you guys are going to come pretty rapid fire with the Gen5 and the Gen6. So can you just maybe just throw that - throw some comments at us with respect to the relationship with the FDA today?

Yes, I would say the relationship with the FDA is at the highest level of collaborative stage that it has been in the past few years. I think to give the FDA all the credit that they richly deserve. They have listened. We have been very open and transparent with Gen4, Gen5, Gen6, other face-to-face meetings, they've been highly receptive to receiving us and making time for us in D.C. to have those face-to-face meetings. As I mentioned Dr. Sharon [ph] was here. And we spent a good 1.5 hours reviewing today's projects, artificial pancreas, future projects with them. And I think there is a real desire for them to try in their best way to accelerate the review process in an efficient, effective way. I will also say though that they have a responsibility that was enabled by the device amendments way back when, that they need to protect the citizens of the United States from adulterated, abusive products. And they take that charter very seriously. So I do think that this world of regulatory science deserved improvement. And that's what Dr. Hamburg and Dr. Sharon [ph] and the people that we deal with have done. It is demanding and it is frustrating for us as well, but in the end I think that the public is better served by having better products. And it forces all of us in industry to actually go the extra mile to produce better, more robust products, to better serve our patients. So I am happy with the FDA at this point in time. I think they are - again, they work in a very collaborative way. If you make the efforts, but you've really got to go out and make the effort on behalf of industry, so the rhetoric that you keep hearing I think is in many ways they can also be an easy excuse. And I think some companies choose to use them in that way. DexCom does not - we view them as a partner in trying to get better products into our patients' hands as soon as possible.

At this time, there are no additional questions. Please go ahead with any final remarks.

Thank you, operator. Well 2011 was an important year for DexCom as we expanded our presence in the diabetes and CGM marketplace. We have long believed that CGM will be the standard of care in glucose monitoring. Although it is not today, we continue to make progress towards that goal in the diabetes community for patients and healthcare providers share our vision. But clearly, it's now apparent that CGM is more than just a continuous glucose monitoring device. As we saw with Dr. Robert Vigersky's Diabetes Care article on CGM on the Type 2 population, it is also behavior modification tool. And this year we will explore its application in pre-diabetes as a financial impact of unprecedented growth of diabetes on a global basis unfortunately continues unabated. DexCom is addressing these challenges and opportunities through strategic partnerships and relationships. We are extremely excited about 2012 as we expand our global reach and CGM takes its rightful place in the entire spectrum of diabetes. Thank you.

Thank you for participating in the DexCom 2011 year-end earnings release conference call. This concludes the conference for today. You may all disconnect at this time.