WRITTEN BY: Todd Boudreaux
Last month, Beyond Type 1 sat down with Dexcom CEO Kevin Sayer at the 13th annual Advanced Technologies and Treatments in Diabetes (ATTD) conference in Madrid, Spain. In a wide-ranging conversation, Sayer touched on Dexcom’s international strategy, questions about the next-generation Dexcom G7, and the company’s response to the Dexcom Follow outage last Fall.
Thanks for making the time to speak with me today, Kevin. Seeing as how we’re here in Madrid, I want to start by asking you about Dexcom’s international growth and strategy. How fast has the international market become a core part of Dexcom’s revenue stream?
I can take you a bit back in time, four years ago at this conference, we had all of three European employees. Three… and now we have several hundred.
A lot of our efforts have been geared toward access and awareness in Europe… And then there are places where we don’t exist yet, not just in Europe, but the rest of the world. We’re not in China, very little in India, almost nothing in Central and South America, and we’re looking at those geographies and going, “Okay, what do we do?” A couple of new geographies we’re launching this year, for example, are Japan and Korea.
So, to the extent within these markets where we can make the experience better, we will, and those are the things we’re pursuing to grow internationally. Right now, international revenue is between 20 and 25 percent of the whole business, but it has been growing faster.
Tell me about the significance of Dexcom gaining CE Mark in Europe for pregnant women with diabetes. Do you anticipate a similar decision will be made by the FDA?
We have some work to do and some discussions to have with the FDA, so I can’t give you a timeframe there. We expect to get there at some point in time. If you go back in history, we’ve always had a contraindication for pregnancy, and we started asking why. It’s mainly because we had not run a study targeted at pregnant women. There are all sorts of data sets all over the world that show CGM and pregnancy works.
Controlling glucose in pregnancy is really important, not just in Type 1 or Type 2 patients, but even gestational patients. My daughter-in-law had gestational diabetes, and she gave birth to twins and was able to extend that pregnancy longer because we got her on CGM. It’s common sense. We’ll eventually have that indication in the U.S., but I don’t even think it should just be for pregnancy and Type 1 diabetes. I think it should be across the board. I think it’s a pregnancy tool.
Dexcom also recently announced they are partnering with Insulet to make the Dexcom G6 and Dexcom G7 compatible with the Omnipod Horizon. How do partnerships like this work?
We have always granted access to our technologies one generation at a time to our partners. The significance of [the recent announcement] also was granting access to the Dexcom G7 to Insulet as well. So we’ll be getting both those products integrated with their system.
It’s important that the world clearly see our relationships and what we’re doing with all the interoperability announcements coming with various algorithms, with various pumps, with other sensors being integrated – people lose sight of what relationships are what. So, what this really did was finalize what we hope to be working on for the next several years with Insulet.
A lot of the pump companies want to integrate in different manners, and we have to figure out what the rules of engagement are as far as connectivity, communication and display of the data. This is a process that, quite candidly, has been evolving for at least 13 years since I joined the board in 2007.
So the Dexcom G7 is already being integrated into partnership deals… When do you anticipate its launch?
We’ll be running this pivotal study in 2020, and the launch will be sometime in 2021. When a person wears the Dexcom G7, they’re not going back.
And so, we’re going to make sure everyone has access at launch. When we rolled out the Dexcom G6, for example, it wasn’t available to Medicare patients, and we’re not going through that again. We might roll it out geographically, and that’s okay, but we’re not going to do what we did last time. We’ll be ready to go.
We thought we were ready with the Dexcom G6, but in all fairness, the demand far exceeded what we planned. So, we will make sure we’re there. We will continue to improve the Dexcom G6 in the meantime on the software front and little product tweaks, reliability improvements, things like that. We won’t abandon the Dexcom G6 as we’re getting ready for the Dexcom G7, and I think there will always be markets for a reusable transmitter and the disposable nature of the Dexcom G7 too.
The Dexcom G7 will be disposable, there won’t be a reusable transmitter?
It will be disposable.
What will the wear time be?
Wear time will depend upon the performance of the system in this study. We’ve designed the system to last for an extended wear period of time.
We also have to meet the iCGM in accuracy standards of the FDA, and we have to meet a reasonable reliability performance metric for our patients. We can’t have a third of them fall off in between days 11 and 15 and replace them all the time because of tape. But if you make the tape so it lasts a month, you’re ripping skin off, and you’ve got the same thing on the other side. So, we’re trying to figure out the balance of all those things. Over time, we know the sensor will be able to perform an extended wear period of time.
We’ve designed the study too, whereby, we can get the product out and approved at a couple of different wear points, and we’ll do what makes the most sense, but 14 to 15 and a half days is what we’re shooting for and that’s still the goal. We’ll see where it ends up.
What size is it?
It’s actually a little smaller than a quarter… somewhere between a quarter and nickel. It’s a wonderful wear experience. You forget you’re even wearing it.
I did want to ask you about the Dexcom Follow outage that happened around Thanksgiving 2019 and your response to that – what lessons did you learn as a company, and what steps have you taken to prevent a similar occurrence from happening in the future?
I think the first and foremost lesson we learned is we have to communicate better with our patients.
We walk a very fine line between medical device and consumer experience. When your plane is late, you get a text message, right? People expect the same from us, and historically medical devices aren’t built or configured that way. We’re medical devices first, and our communication tools were not as good as they should be.
The [Dexcom Server] status page is up and in-app communication will be out in the first half of the year. I think those will both be helpful. We’ve learned we need to be more diligent and better with the servers. We learned exactly what that problem was, and we now have tools we can apply in the future going forward as we see things happen.
We know how important Follow is. I think one of the things we’ll evaluate over time is how we make this better and then how we rely on others who know this better than we knew. Maybe there are other partners, and other technologies, and other things we can get access to that’ll make us more reliable, and we will explore those. It’s a good learning experience, and we’ll be better.