Dexcom (NYSE:DXCM) shares are up more than 9% today — a day after the company announced it will soon formally seek FDA clearance for its next-gen G7 system.
The San Diego-based diabetes management technology developer yesterday evening posted profits of $70.9 million, or 71¢ per share, on sales of $650.2 million for the three months ended Sept. 30, 2021, for a 1.8% bottom-line slide on sales growth of 29.8%.
Adjusted to exclude one-time items, earnings per share were 89¢, 26¢ ahead of Wall Street, where analysts were looking for sales of $617.8 million.
Dexcom Chairman, President & CEO Kevin Sayer told Drug Delivery Business News earlier this year that the company expects to launch its next-generation G7 continuous glucose monitor (CGM) in Europe this autumn. During Dexcom’s earnings call yesterday evening, he said the company remains on track for a Q4 launch of the G7 upon receiving CE mark clearance.
When it comes to the U.S. market and the G7, Sayer expected Dexcom to make a comprehensive 510(k) submission, including G7 hardware and full Android and IOS software, to the FDA in the next few weeks. He said the U.S. clinical trial for the device has concluded.
“It’s been our experience over time when we deliver what the FDA expects, they move very quickly and are very cooperative with us,” Sayer said. “We have no reason to believe the file we’re preparing isn’t going to meet those expectations. We’re moving along those lines. So again, with the CE Mark filing, we’re on track for an [outside of U.S.] launch later this year, and we’ll update you more on the U.S. as time goes on.”
Dexcom said it expects to post full-year 2021 revenues ranging between $2.425 billion and $2.45 billion.
“We are pleased to once again be in a position to raise our full-year revenue and margin guidance as we drive toward a strong conclusion of 2021 and the upcoming launch of our Dexcom G7 system,” Sayer said in the release.
BTIG analyst Marie Thibault said in a report that they believe Dexcom put forth an impressive three months, especially with its increased guidance.
“We view this as a strong quarter with several incremental positives for DXCM,” Thibault wrote. “With high expectations into the quarter but several medtech companies holding up in trading despite misses and guidance cuts, we think the Q3 result and raised guidance may allow DXCM to trade higher on Friday. With DXCM trading at a significant premium to other fast-growing peers on an EV/Sales basis, we maintain our ‘Neutral’ rating based on valuation.”
DXCM shares were up more than 9% at $622.06 by the afternoon today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was up slightly.
This story originally ran on October 28, 2021. Updated October 29 with stock price and news from earnings call.