With a major product approval and launch in its sights, Dexcom prepares for a big year in 2022.
Across 2021, Dexcom (NSDQ:DXCM) took several steps forward.
The company touted its next-generation G7 continuous glucose monitor (CGM) and announced a significant regulatory nod and partnership for real-time application programming interfaces (APIs), to list a couple.
As the new year gets underway, expectations for the coming year are even higher.
“2022 holds about more activity than we’ve ever seen in a given year,” CEO Kevin Sayer told Drug Delivery Business News. “It’s going to be a year of many of the same activities, but some very big advances on the product front. And then, once we get the hardware platforms out there, we’re hopeful we can then start coming up with several software solutions that are going to be different than what we’ve had in the past. It’s going to be a fun year.”
Speaking after presenting at the 40th Annual J.P. Morgan Healthcare conference, Sayer was bullish on the year ahead, with the G7 at the heart of what’s to come.
G7 features a 60% size reduction from the previous generation, the G6, plus a 30-minute warmup period (down from waiting two hours for glucose readings to begin in the past), more information in one place with personalized insights, extended-wear design and more. Sayer pointed to the simplicity of the wear experience, with the process consisting of unscrewing a cap, putting the sensor on your body and pushing a button. The device is turned on and can be paired with a smartphone and “you’re off to the races.”
To add to the anticipation over G7, Sayer presented new data for the CGM at J.P. Morgan that demonstrates that G7 outperformed ICGM standards established by the FDA across the board with its time-in-range performance, with overall time-in-range (measured by percentage within 20%) at 93.3% compared to the FDA standard of 87%. In addition, mean absolute relative difference (MARD) for G7 registered at 8.1% in pediatric patients and 8.2% in adult patients, highlighting consistency to accompany the performance.
“That gives patients and our customers an opportunity to really make accurate decisions, not only for insulin delivery, but as they use our sensor for other things regarding lifestyle or the foods they eat,” Sayer said.
The data presented was submitted to the FDA as Dexcom seeks clearance in the U.S. and Europe. No clear timeline for expected approval exists, but the company has planned for the approvals and launches to come this year.
“We can control our ability to manufacture the product, our ability to control the supply chain and get the components that we need to build the product, those things we’re controlling and managing very, very strongly,” Sayer said. “We can’t manage the regulatory agencies. As I’ve learned over many years in this industry, their sense of urgency is never the same as myself.”
Differentiating the product portfolio
Despite the craze over G7, Dexcom officials remain excited about other offerings, too, including the recently launched Dexcom One CGM in a handful of European countries at the end of last year. Dexcom One uses the G6 hardware platform with a different software experience, marking the company’s first foray into a differentiated product portfolio.
The Dexcom One platform is currently available in Bulgaria, Latvia, Estonia and Lithuania.
“We launched that as an e-commerce platform only and a cash-pay product in those countries with pretty good results,” Sayer said. “It’s a good experience for the individual, and it’s very easy to use. We look at that as a really good expansion opportunity for us, particularly in foreign markets going forward.”
One of the biggest steps forward for Dexcom was the introduction of application programming interfaces (APIs) in 2021. The company received FDA clearance in July for real-time APIs to enable invited third-party developers to integrate real-time continuous glucose monitoring (CGM) data into their digital health apps and devices.
In October, Dexcom announced Garmin as its first partner for APIs. Garmin launched apps to provide people using the Dexcom G7 continuous glucose monitor (CGM) with Type 1 and Type 2 diabetes a way to quickly see glucose levels and trends, even while working out. Apps compatible with the Garmin smartwatch or cycling computer.
Another company, Sugarmate — owned by Tandem Diabetes Care — now has live APIs that users can see through a partnership with Dexcom as well.
Sayer said Dexcom has realized that not everybody wants to receive their CGM data the way the company offers it. The situation creates an opportunity for partnerships to create a way for users to continue utilizing Dexcom’s products while taking the glucose data in a way they prefer.
“Credit to Garmin for being the first to go,” Sayer said. “We believe this unlocks other partnerships as well. I think you’ll see more of this. I think there are other opportunities with other companies going forward where this may work.
With G7, Dexcom ONE and APIs, Dexcom’s 2022 already looks bright. Sayer also pointed to plans for launches in other geographies, the integration of CGM data into patients’ medical records through the cloud and the expected launch of Insulet’s Omnipod 5, which can pair with a Dexcom CGM through the companies’ longstanding partnership.
According to Wells Fargo analysts Larry Biegelsen, Nathan Treybeck, Vik Chopra, Lei Huang and Charles Ellson, the company will look to penetrate the type 2 diabetes patient class, the analysts said, while entering new markets with Dexcom ONE. Additional headwinds could come from the FDA warning letter sent to Medtronic that may delay its next-generation insulin pump and glucose sensor.
There is a sense among the analysts that G7 could receive FDA approval by June, while CE mark approval is “relatively close,” as Dexcom could get off to a hot start in 2022.
“My people tell me in my own evaluations, ‘You’re not very good at celebrating, you always want to push,’ but we recognize what a great year this company has had — really the past two years during these trying times,” Sayer said. We’ve grown almost a billion dollars in revenue in two years when the world has been nearly at a standstill. That’s awfully, awfully amazing. It’s been a great time period for us.”