Dexcom wins expanded FDA indication for G5 CGM

Dexcom Inc. (NSDQ:DXCM) said yesterday it won an expanded FDA indication for its G5 mobile continuous glucose monitoring system, now approved as a non-adjunctive device for diabetes treatment.

With the approval, Dexcom touted that its device is now the ‘1st and only’ CGM system that can “make daily diabetes treatment decisions” without requiring a blood sample through a finger prick at each reading.

“The expanded indication for the Dexcom G5 Mobile CGM system is an astounding milestone for people with diabetes and it is a critical step to advancing diabetes technology that will drastically change diabetes management. Now, people with diabetes who use the Dexcom G5 Mobile CGM system can make daily treatment decisions without having to perform confirmatory finger sticks. And basing their treatment decisions on a number, accompanied by information on speed and direction from the CGM, will greatly improve their decisions over the information provided by blood glucose meters,” prez & CEO Kevin Sayer said in prepared remarks.

The new label expands the use of the G5 CGM as a replacement for finger stick glucose testing, but the system still requires 2 samples a day for calibration, not entirely removing the necessity of the blood sample.

“This approval is truly momentous for people like me with diabetes as we can now go up to 12 hours without a painful finger prick, we don’t have to carry a glucose meter everywhere we go, and we can make treatment decisions without lancing our fingers. It completely changes the way that we manage our diabetes and gives us a chance to gain much better control of the disease without all of the pain and hassle of constant finger sticks,” Taking Control of Your Diabetes founder & director Dr. Steven Edelman said in prepared remarks.

The news could send Dexcom shares up, according to a Leerink Partners letter to investors, though only modeslty, as a new dosing claim could pave the way for medicare coverage and other positives for the company.

“In our view, a dosing claim should help sustain strong double digit growth given that it: paves the way for Medicare coverage, which would open access to the ~20%+ of Type 1 patients covered by Medicare in hopefully 12-18 months; further validates the accuracy and safety of the technology in diabetes management, which should be incremental in driving increasing awareness, and represents a key step toward ultimately developing a true artificial pancreas; differentiates DXCM from other standalone CGM given that G5 only requires two finger pricks per day for calibration — we believe the convenience provided by “non-adjunctive” will be appreciated and valued by patients,” Leerink Partner Danielle Antalffy wrote in a letter to investors.

In November, Dexcom saw its stock tumble nearly 20% after releasing 3rd quarter earnings that missed expectations from The Street.

The company posted losses of $18.8 million, or 22¢ per share, on sales of $148.6 million for the 3 months ended September 30. That works out to a 55.8% growth in losses while sales grew 42.6% compared to the same period in 2015, according to a company release.

After adjusting to exclude 1-time items, losses per share were still 22¢, 9¢ off what The Street was looking for. Revenue topped the Street’s expectations, with analysts expecting to see $146.3 million.

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