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DexCom, Inc. (NASDAQ:DXCM)

Deutsche Bank dbAccess Health Care Conference Call

May 29, 2013 12:00 ET

Executives

Steve Pacelli - Executive Vice President, Strategy and Corporate Development

Analysts

Kristen Stewart - Deutsche Bank

Kristen Stewart - Deutsche Bank

Alright. Thanks everybody for joining us for another session. My name is Kristen Stewart, the Medical Supplies and Devices analyst here at DB. I’m pleased to introduce Steve Pacelli from Dexcom. He is the Executive Vice President, Strategy and Corporate Development. The way we’re going to run this session is that he is going to give a brief overview just kind of on Dexcom, we are going to move into then some Q&A as a reminder you can raise your hand we’ll bring the mic to you if you would like to ask a question or you can also submit them through the Yorn app, the website address for that is yorn.com/db and it is anonymous so feel free to ask whatever questions you would like. So without further adieu I’d like to turn it over to Steve. Thanks again for coming.

Steve Pacelli - Executive Vice President, Strategy and Corporate Development

Great, thank you and good morning or good afternoon I guess welcome. I’m going to spend a few minutes as Kristen said introducing Dexcom and then be happy to field questions. So, before I do the quick obligatory Safe Harbor statement. I will be making some forward-looking statements today so please refer to our SEC filings; we’re not going to be updating these other than on quarterly and annual earnings calls. So as you all know diabetes is a global epidemic.

Just a short time ago, 20 years ago worldwide about 135 million people expected to have diabetes, about 10 years ago that number was pushing 200 million, today a staggering 366 million people worldwide are afflicted with diabetes. And then in the not too distant future 2030 it’s estimated that over half a billion people worldwide will be afflicted with diabetes. The U.S. is no different, not spared; everyday in the U.S. one in three children born will develop diabetes, everyday 5000 people will be diagnosed with diabetes, 55 people will go blind as a result of complications from diabetes, 230 amputations will be performed and 120 people will enter treatment for end-stage kidney failure.

But the most staggering statistic here is that one in 10 healthcare dollars today is spent treating either direct or indirect consequences associated with diabetes. So what’s the problem? To effectively treat diabetes you really need to know where you are going, you need to know the speed and direction of your blood sugar above all else, before you can effectively treat it, before you know how what tools whether you take insulin, whether you need to ingest carbohydrates, it’s really all about speed and direction of blood sugar. And so the management of diabetes is really the patients are trying to maintain a delicate balance between hyperglycemia or high blood sugar and hypoglycemia or low blood sugar. When patients are high or have hyperglycemia, they don’t really have symptoms, symptoms that they can feel, it’s really - but the high blood sugar really leads to all the chronic complications associated with diabetes, all the micro and macro-vascular damage that leads to cardiovascular disease, blindness, kidney failure, neuropathy, retinopathy. But it’s the time that patients spend lower hypoglycemic the patients actually fear the most because hypoglycemia has severely acute consequences associated with it.

Patients who go low start by experiencing maybe they start sweating, feel a little bit shaky, they start to experience diminished cognitive function and if not treated, if they don’t ingest carbohydrate the patients can drift off into a coma. This is when you hear about patients with diabetes who pass out while driving home from work and crash their car who have nocturnal hypoglycemia where they go low at night and if not treated these patients can actually drift into a coma and ultimately die. And so patients out of fear of hypoglycemia historically tend to ride relatively high with their blood sugars on average which of course as I just mentioned leads to all the chronic complications associated with the disease.

So today’s standard of care at the single-point finger stick it doesn’t tell the whole story, let me give you an example. This is a day in a life of a patient with Type 1 diabetes pretty typical patient on insulin would take somewhere between four to six finger sticks a day. So, this is a pretty typical patient here, takes a finger stick with their breakfast, takes a finger stick at lunch, at dinner and at bed time, just go and check their blood sugar. Well the finger stick companies would have us believe that you could connect these dots and somehow start to see a trend and understand what the patient’s blood sugar profile over the course of that 24-hour period was.

Unfortunately when you overlay Continuous Glucose Monitoring on top of it you see a much different picture, right. As patients trying that gray bar across the middle is the target range, patients trying to maintain their blood sugar within that target range and as you can see overlaying the benefits of Continuous Glucose Monitoring patient with above their target range for over 13 hours the patient had a dangerously low hypoglycemic episode for over an hour in the middle of the night and they spend above 210 milligrams per deciliter which is relatively elevated for almost five hours. So the solution for Dexcom peace of mind with a push of a button I’m going to play a short video to introduce you to our latest commercial product the G4 Platinum.

(Company Advertisement)

So the Dexcom G4 Platinum was approved by the Food and Drug Administration back in October of last year with a full PMA was improved in record time in 177 days which is many of you in this business know that’s an extraordinary feet by our regulatory organization we commend them. That’s the only CGM on the market today labeled for seven continuous days of use, it’s a smallest sensor, smallest body worn and footprint, smallest sensor that resides under the skin, it’s about the size of two human hairs that sit under the skin, certainly the most accurate device available, it’s between 20% to 30% more accurate than our prior commercial product the SEVEN PLUS, it’s particularly accurate, 30% more accurate than the SEVEN PLUS in the hypoglycemic zone which is we know as extremely important to be accurate in the low zone.

We have an increased transmission range with the G4 Platinum so we have in (three hair) somewhere between 30 or 20 and 30 feet transmission range for the transmitter to receive to the receiver. It’s a more consumer-friendly design, user-friendly controls, color traces if you look at the device that looks a little like an old iPod nano. So much more of a consumer feel to it than our prior products. We’ve improved our hypoglycemia alert which again is important, all important in that critical hypoglycemia area.

The product has favorable physician statements from all of the major advocacy groups in diabetes, it’s covered by virtually all of the private payor, commercial private payors, still don’t have Medicare policy but that’s something that’s a near term priority for us we’ll be working on Medicare coverage within the next several years. So where is Dexcom headed as a company? Okay. I’ll just talk you through in my slides just seems to be locked up. So we commercialized our first-generation product the STS three-day system which was a three day center back in 2006, followed that up very quickly in 2007 with the introduction of the SEVEN which was the first sensor labeled for seven days, then again iterated on the SEVEN which we call the SEVEN PLUS back in 2009 and ultimately culminated this just this past year with the launch of the G4 Platinum which I have to tell you that the clinical and the patient clinical reception has been nothing short of remarkable, but we’re not going to stop there.

So where is Dexcom headed as a company? Next generation technologies include an advanced algorithm for the G4 Platinum, we expect to file with the FDA before the end of this year. We expect to - but we’ve actually filed in the first quarter for seeking a pediatric indication for the product and we hope to have that pediatric indication approved by the FDA before the end of this year and commercialized into the pediatric market and why that’s important for Dexcom is that virtually all children, all patients under the age of 18 are seen by a pediatric endocrinologist and they are only somewhere between we estimate 800 to a 1000 certified pediatric endocrinologist practicing in the United States.

So what pediatric indication does for us is it gives us a very concentrated group of touch-points that hold a very large number of addressable patients for us so really excited about that. We also have filed with the FDA actually Animas, a J&J company has filed first-generation sensor-integrated pump system we call the Animas Vibe product that’s also pending before the FDA, we’re hopeful that we seek an FDA approval before the end of the year. They are in Animas will actually be responsible for commercializing that product with the support of Dexcom.

But again we won’t stop there. What is our ultimate goal? Our ultimate goal is to replace finger sticks. So we’ve got technologies that are in humans today that we think will achieve the level of accuracy necessary to seek an indication from the FDA to tell patients that they no longer have to prick their finger, that they can put in a sensor and wear it for seven days, 10 days, 14 days without the need to prick their finger to check their blood sugar and we think that’s super-compelling. One of the other key initiatives within the company is to get to mobile technologies.

So we announced recently we’ve developed an interim step called the Dexcom Share product that we’ll be filing later this year. It’s more of a device to use for nocturnal monitoring for hypoglycemia, what it does, it allows the patient to plug their receiver into sort of a charging cradle that is wirelessly enabled and not allows the patient’s data to be transmitted to a caregiver cell-phones, not only the patients interact with their glucose on the receiver but a caregiver can monitor the patient and know when there is a impending hypoglycemia alert or even a high alert think about parents at night, kids sleeping in the next room, that parent wouldn’t necessarily have to get up to go check the blood sugar every couple of hours, parent can just rollover and look at the iPhone or have alarms on the iPhone to alert the parent if the child is going low.

The ultimate goal that’s an interim stage product, the ultimate goal is to be transmitting directly to a smartphone. And so over the next several years you will see several iterations down the path but ultimately the goal is for the body worn component transmits directly to the cell-phones so the patient can simply interact with their glucose values on the phone that they are carrying with them every day. Just quickly to summarize before we get into Q&A. From a revenue perspective we ended 2012 approximately $93 million in revenue, we’ve given revenue guidance, product revenue guidance for this year of $120 million to $130 million so roughly up 30% to 40%. The Q1 revenue was slightly down from Q4 which was expected we have a bit of seasonality in the Durable Medical Equipment business. We did just shy of $28 million in the first quarter but on a real highlight for the company as we’re very rapidly approaching profitability we had a net cash burn of about $3.4 million in the first quarter.

So with that I’ll turn it over to Q&A.

Question-and-Answer Session

Kristen Stewart - Deutsche Bank

Alright. Just as a reminder if anybody has a question just feel free to raise your hand. As long as we can maybe just further expand it, it certainly sounds like the rollout of G4 Platinum is going very, very well. Can you maybe just give any anecdotal like comments in terms of whether or not it’s prompting perhaps some (indiscernible) the technology to - it breaks a little bit more or just any sort of added color would be helpful?

Steve Pacelli

Sure. I mean you read the blogs that was interesting, I had an investor call last week and someone new to the store hey they said look we’ve been scaring the blogs, we’ve been scaring the literature, we can’t find anything wrong with this product and they kind of laugh I said look we still have occasional patient complaints but I think most telling is there was a meeting here very world-renowned diabetes clinic here in Boston, we hosted some investors a month or so ago. And this was a clinic that was historically very reticent to prescribe CGM, didn’t believe the technology was ready for primetime, didn’t believe it was ready for all patients.

And I think fast-forward with the launch of the G4 Platinum we’ve seen a complete mind-shift there that the things we’re hearing and these were not prompted by Dexcom whatsoever, these were clinicians within the Joslin Clinic saying look we need CGM on all patients, all Type 1 patients need this technology. If they want to pump, a pump is nice, but a pump is really just a convenient way to deliver insulin, patients need to know where their blood sugar is whether it’s rising, whether it’s falling and at what rate in order to manage their disease and if they want to use a pump fine if they don’t they can use injections and achieve basically the same outcomes. So that’s a huge mind-shift for us from where this same clinic was. And again this is a world-renowned diabetes clinic so you have to feel that, trickle down the facts into smaller clinics.

Kristen Stewart - Deutsche Bank

Okay. And I knew Medtronic I guess I was talked about bring in and play, it’s in light sensor, maybe talk about from what you’ve heard about that, what do you think it kind of compares can be headed with?

Steve Pacelli

Yeah we don’t know I mean on their recent earnings call I guess it was a week or so ago, it sounds like they pushed the timeline out slightly I think at one point it was supposed to be kind of spring to summer timeframe now I think they are saying ended the year that’s interesting they - we don’t have that much inside into what goes on in the diabetes business in Medtronic as they don’t disclose a whole lot but what we do know is that the sensor that they talked about is part of this Veo System their next generation pump system. The sensor they talked about last year at the American Diabetes Association and the data they presented on a poster doesn’t quite match up with the actual data as what we’re starting to understand and I say that because they presented some data last year at the ADA that would have you believe that their sensor performed much like our G4 Platinum, the data was very similar.

We’ve been able to obtain some of the sensors out of Europe, some independent investigators here in Boston have done the same and running through some very rigorous testing and we’ve not been able to get them to perform anywhere near as well as the G4 Platinum in fact we can’t get them to perform as well as even our prior technology as the SEVEN PLUS, same results produced by the independent investigators here in town.

And so interestingly at the Diabetes Technology Meeting in Paris back in February they kind of came clean, they said you know taking this sensor and using it and looking at the data as patients would actually use the technology meaning calibrations twice a day as opposed to four multiple additional calibrations using it prospectively not running the data through a retrospective algorithm to kind of clean it up. That the accuracy of the sensor really isn’t all that good, it isn’t what they had at least reported it to be is your prior. So I think that might be part of the problem that they are having now with the FDA is that they have to show everything to the FDA, you don’t get to pick and choose which data you present to the FDA so they had to present the entire dataset. And so here we are - they’re pushing out timeline so absent that we don’t really know where they are headed with it.

Kristen Stewart - Deutsche Bank

Right.

Steve Pacelli

They’ve been talking frankly at that same meeting in Paris they were talking more about (NY2) their next generation sensor is being the one that maybe the more accurate sensor.

Kristen Stewart - Deutsche Bank

Okay. Question.

Unidentified Analyst

As you’ve been talking about closed-loop sensor combined with pump, how do you think about disposable pumps versus permanent pumps? Do you think which technology will be misleading or would be more successful?

Steve Pacelli

Well I mean I’m a big fan of disposable pumps. I think there are some great work being done by Insulet I don’t know if you’ve seen the new Insulet and OmniPod the (era) system is a much smaller form factor, I think it’s a great little product. When you think about artificial pancreas though I don’t know the need to distinguish between durable or disposable pump really the key to the artificial pancreas is the complex algorithms that control, that take inputs from the glucose sensor and then lead to output on either basal delivery or basal bolus delivery on the pump. I’m not sure I know Medtronic that’s a real focus of Medtronic in fact that’s when you listen to their kind of future product development, product technology pathway that’s all they want to talk about is these super-complex, super-automated systems regardless of whether they do with it their traditional durable pump or say whatever build or require a patch pump. We’re going in a much different direction so we’re participating in most of these artificial pancreas programs around the world because they need best-in-class sensor technology in order to function.

So we provide them with sensor technology, but we’re not as Dexcom as a company we’re not looking to be common artificial pancreas company, we’re not going to - we’re not - don’t want to be a pump company, don’t want to be an artificial pancreas company, we’ll enable these companies because we’re ultimately a disposables business and if any of these things actually ever see the light of day commercially we would be happy to support them with sensor technology. Where Dexcom is headed as I mentioned in terms of wireless technology over time our sensor will be good enough, we’ll be at a point within the next couple of generations of sensor I believe that we don’t need to continue to iterate on the sensor performance attributes then it becomes really a game of consumerization of our technology, we mentioned getting into the iPhone, miniaturizing the body worn component so that its truly minimally invasive. So the patient could ultimately just swap a sensor on wear it for seven, 10, 14 days have it communicate with their phone, really doesn’t disrupt the lifestyle of the patient at all and have it super-minimally invasive, it needs to communicate with a more complex system is that’s what the patient chooses great, we will allow someone else to do that but we’re not going to chase that path ourselves.

Kristen Stewart - Deutsche Bank

And then you also maybe just give a little bit of update you had mentioned the Animas Vibe and that might see approval later this year I think, another partner working with is Tandem Diabetes. So I guess what because how are you just approaching I guess just partnerships at this stage and I guess you guys did discontinue the relationship with Insulet I guess related to (indiscernible)?

Steve Pacelli

Right. So, I think that the most important thing you need to distinguish between Tandem and Tandem Animas versus Insulet or even we also somewhat discontinue our relationship with Roche on the development of an integrated system. Both Animas and Tandem have what we call tethered pumps. So, those pumps are attached to the patient at all times by means of an infusion side of tubing that delivers the insulin into the patient’s SubQ tissue.

Insulet and Roche on the other hand were developed - Insulet has a handheld, on Roche is developing a handheld; it’s a handheld controller that can control insulin dosing. But those patients aren’t required to carry that around all the time. And so I think the big difference is that it makes perfect sense commercially to have – if you’re going to have something attached to your body to be able to integrate insulin and CGM in the same device. But if you speak to the folks at Insulet they will tell you that their patients don’t interact with their device maybe more than five or six times a day, meal time bolusing maybe making a basal adjustment but they are not constantly interacting with it. So, couple that on the Insulet side with the fact that say that multiple times now that our goal is to get to a smartphone just spend a few million dollars to integrate into a handheld that patients already don’t carry to have a obsolete that within six or nine months with a device but transmits directly to an iPhone doesn’t make a lot of sense.

Kristen Stewart - Deutsche Bank

Right.

Steve Pacelli

So, we’ve continued to commercialize we think the Animas project, the Animas Vibe is filed with the FDA expecting an approval before the end of the year. I think that product will compete very favorably with the current Medtronic System on the market. In fact, the future Medtronic System, Medtronic Veo System which is pending here in the U.S. is actually commercially available in the EU as of the Animas Vibe system and by J&J’s numbers they told us and the world in the Analyst Day that in markets where the Vibe is commercial they’re seeing 35% to 50% market share gains versus Medtronic. So we’re very excited about bringing that first generation product to market hopefully in the fourth quarter this year.

Kristen Stewart - Deutsche Bank

Okay. And I guess just thinking more globally I mean at this stage most of our sales are kind of going more U.S. Do you have any plans to kind of expense globally I think on the most recent call you talked about exploring opportunities in China, Japan and other geographies maybe just talk about that?

Steve Pacelli

Yeah, I mean we continue to expand globally but because of the success of the G4 Platinum in the U.S. it’s kind of stated that little less than 10% of our product revenue is kind of OUS.

Kristen Stewart - Deutsche Bank

Right.

Steve Pacelli

Europe still is the bulk of that. My - one of my personal projects for this year has been to explore Japan and China, I’m still looking through there are some regulatory challenges particularly with China. We tend to iterate our products fairly rapidly and the regulatory timeframes in China are such that each time you iterate a product it starts over a new 2 to 2.5 year cycle and so you’re always going to be a generation or two behind and so its kind a picking that timing of which is the right product generation to go to China with similarly in Japan. But I think Japan is probably a near term opportunity for us now, I would have handicapped China and how we started running in some of these regulatory hurdles. The good thing is as according to our regulatory consultants that landscape for medical device approvals in China is sort of a transforming landscape. And we’re told that they’re trying to mimic a little bit more like the process, approval process for the FDA so that probably bodes well for the technology.

Kristen Stewart - Deutsche Bank

Okay. And then one other partnership I probably should have meant before skipping across that question is you’re developing with Edwards GlucoClear system. Can you maybe just give an update it seems like Edwards has been pretty optimistic on that and just remind us I guess kind the economics for you guys at that?

Steve Pacelli

Sure, sure. So, we now have CE Mark approval of the second generation of GlucoClear too, Edwards is commercialized on a very limited basis right now. They’re taking into the some clinics, it’s really think of it more is like a clinical trial type commercialization, it’s not really a full born commercialization, they probably plan to do that starting next year. I’m still exploring the FDA path, it’s really incumbent upon Edwards to drive the FDA path forward of course we’re obviously assisting in there, but pretty excited about it. I think the economics are a little bit inflects right now because the economics depends on whether we manufacture the sensors and they purchase them from us or whether we transition some of the manufacturing to them then they just pay us a royalty. And so I would tell you when we sit out on this project back in 2008, the goal was to really leverage our sensor manufacturing operation, but the two products that diverged pretty substantially. So, we can’t manufacture the Edwards GlucoClear sensors on our existing G4 platform. So, at some point it makes sense to transition that over to Edwards but we’re still exploring that, today we’re still manufacturing the sensors and they’re purchasing them from us.

Kristen Stewart - Deutsche Bank

Got you. Okay. And I guess just kind of bigger picture I mean you talk about kind of demographics of diabetes and what not, where and obviously the success that you’ve been having with the G4 Platinum and then the number of products within the pipeline? Just how do you think about the longer term growth prospects for Dexcom and you had mentioned starting to turn kind of from a profit standpoint, how should we just think about as things ramp up and the outlook from a margin perspective and what are the goals call it in the next five years or so?

Steve Pacelli

Right, it’s a lot of questions. So the goal in the next five years.

Kristen Stewart - Deutsche Bank

Yeah.

Steve Pacelli

Is to replace finger sticks let’s start with that.

Kristen Stewart - Deutsche Bank

Yeah.

Steve Pacelli

So we would like an FDA indication the patient doesn’t need to prick their finger anymore that is a companywide goal. To get there we will go through several iterations of product introductions each successively better in terms of - particularly in terms of accuracy and then all the stuff we’ve talked about in terms of consumerization of the product. From a gross margin perspective we’re still very volume dependent but what we’ve said previously is that with the G4 Platinum at scale probably 1.5 million sensors to 2 million sensors we can get to somewhere between the 70% and 75% gross margin on the disposable, ultimately to push kind of that 80% gross margin longer term target we need substantially more volumes, we need to automate some of the manufacturing steps but you can’t automate till you have the volumes to support the automation and you probably need to tweak some of the components to this system and particular the applicator believe it or not that the plastic disposable applicator becomes one of the more expensive components of this system at that point.

But long-term five years could I see an 80% maybe 75% to 80% gross margin target for the disposables that I think that’s fair. We stated publicly that we expect to turn the corner from a cash operating profit perspective probably in the fourth quarter of this year is a goal with one of our other targets that we talked about publicly is having a cash operating loss of $10 million or less for the full year this year with being cash flow profitable next year, we’ll probably profitable on a GAAP basis, the best guidance we’ve given is 2015, we have a significant amount of non-cash expense particularly in stock-based comp based on our equity plans that pushes that our or probably 2015.

Kristen Stewart - Deutsche Bank

Perfect. Any other questions in the audience? Is there anything that within – already you talk about that I’ve just kind of been coming up since you guys last reported in terms of the quarter seems that just looking at your guidance of $120 million to $130 million this street certainly already is at the higher end of the range. So it seems like the market certainly has a lot of confidence and you’re (ready) to get there, I guess what would be some of the factors that would cause you not to get there or I guess it seems given the success that you’ve had there is a probable pumps I guess possibility that you could come in higher. So maybe just talk through maybe if there is any kind of puts and takes this year to consider and just kind of timing of rollout and what could go better than expected and where could be some samples that you might encounter?

Steve Pacelli

Yeah I mean we’re certainly hitting on all strategy right now. We’ll obviously be - we don’t give quarterly guidance so our annual guidance of $120 million to $130 million you’re right most of the analysts have us at the higher end of that range and we’ll evaluate it and if we need to update it on a quarterly basis we’ll do so. What could cause it, what could cause this to miss I mean scale up in the back office.

Kristen Stewart - Deutsche Bank

Yeah.

Steve Pacelli

I think manufacturing we’re very, very pleased with where we are today in terms of yields on the Gen4 and the scale up that our manufacturing ops people have been able to achieve as we ramp the G4 Platinum. So that doesn’t really give me a cause for concern. One of the biggest limiting factors in a business like ours is that we’re still classified as Durable Medical Equipment and so that requires a significant amount of just paper work and processing time to get a new patient, it isn’t as simple as having a patient give us a prescription collects $20 co-pay and ship them a product.

We typically have to support medical policy for the insurance company with some form of documentation; it could be as simple as a check the box form certifying from the doctor that the patient needs medical criteria it can be as onerous still as collecting finger stick data collecting chart notes from the physician. And so scaling up that portion of the business and being able to process literally process the volume of patients through this system could be a slight bottleneck, we’re doing fine right now and again hiccups, scaling a business at this rate, growing a business 30% to 40% year-over-year.

Kristen Stewart - Deutsche Bank

Right.

Steve Pacelli

It’s not easy but those are very similar focus of the company keep your head down and execute right now.

Kristen Stewart - Deutsche Bank

Right.

Steve Pacelli

That’s really what everybody is driving to.

Kristen Stewart - Deutsche Bank

It seems like there would be really no reason to think that those would be likely but those would definitely, I don’t mean to accentuate that?

Steve Pacelli

No, no, no, no problem.

Kristen Stewart - Deutsche Bank

Okay, perfect. I guess anything else otherwise I recognize that understanding between you guys in lunch. So..

Steve Pacelli

Good.

Kristen Stewart - Deutsche Bank

And I feel like I have low blood sugar so I definitely need these. So..

Steve Pacelli - Executive Vice President, Strategy and Corporate Development

Good. Thank you.

Kristen Stewart - Deutsche Bank

Perfect. Thank you again for your time.

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