During an earnings call, Dexcom CEO Kevin Sayer noted that the 510(k) submission remains under review with FDA. The San Diego, CA-based company originally submitted for FDA clearance late last year.
“As part of this process, we are making a subtle change to the G7 software based on feedback from FDA, slightly delaying our expected timelines for clearance and U.S.,” Sayer said according to a transcript of the call from The Motley Fool. “We expect FDA clearance and limited launch later this year and a large commercial launch in the U.S. in the first quarter of 2023.”
A bit later in the call, during the Q&A portion, Sayer said, “FDA had some questions about some of the things that we’ve done and put in it. We discussed several options that we had. We decided the best option at this time was to revise the software and file it differently, and we’ve added a few other features to it as well based on our discussions with them. We’re in the middle of revising the software for that and have to run it through the complete validation and verification process and resubmit.”
In June, Sayer was a guest on the Let’s Talk Medtech podcast and played it a bit closer to the vest on when the technology could be greenlit by FDA.
“With respect to approvals and dates we really don’t give dates,” Sayer said during the Let’s Talk Medtech interview. “We are in the middle of back-and-forth discussions with FDA and answering their questions.”
As a result of the delay, Marie Thibault, an analyst with BTIG said, “we reduce our 2022 sales forecast and push some 2H22 revenue into 2023 to reflect the G7 FDA timeline.”
Dexcom’s earnings took a bit of a beating this quarter.
The company reported $696 million about $3 million below consensus revenue estimates and adjusted earnings per share of 17 cents, two cents below consensus. The company noted that U.S. channel mix, as well as prior quarters of softer new patient adds, impacted this quarter’s revenue; $12 million in foreign currency headwinds also hit the top line.
Because of the news, shares were down about 7% on Friday.
G7’s delay gives Senseonics, its chief rival in the CGM space, larger leeway in the market. The Germantown, MD-based company launched its Eversense CGM in April after it won FDA approval for the device in February.
Eversense, which was one of the 10 most anticipated new medical devices of 2021, is a 180-day CGM. Senseonics faced delays obtaining a nod from FDA, too. The company said COVID-related backlogs at FDA delayed the potential approval.