Dexcom (Nasdaq:DXCM) shares are up today — a day after it reported third-quarter results that came in ahead of the consensus forecast.
DXCM shares were up more than 17% at $118.78 by the afternoon today. MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was down more than 1%.
The San Diego-based continuous glucose monitoring (CGM) technology developer posted profits of $101.2 million. That amounts to 24¢ per share on sales of $769.6 million for the three months ended Sept. 30, 2022.
Adjusted to exclude one-time items, earnings per share came in at 28¢ apiece. That registers 4¢ ahead of expectations on Wall Street. Revenues beat The Street as well after analysts projected sales of $750.93 million.
Dexcom registered a 15.9% bottom-line gain on sales growth of 18.4%. The international rollout of the next-generation Dexcom G7 CGM marked the major highlight of the quarter.
The Dexcom G7 CGM is yet to receive U.S. approval but won CE mark in March. The company had to apply software tweaks based on FDA feedback earlier this year. This threw a wrench in the expected timelines for FDA 510(k) clearance and the subsequent U.S. launch. The company still expects FDA clearance and a limited launch this year. It plans for a large U.S. launch to follow in the first quarter of 2023.
Kevin Sayer, Dexcom chair, president and CEO, said on the company’s third-quarter earnings call that it is preparing for the largest product launch in its history. He confirmed that G7’s regulatory timeline in the U.S. remains on track from the projections made last quarter. Dexcom completed the software update and subsequently validated it, he noted.
Dexcom set for a “strong conclusion” to 2022
“In the third quarter, Dexcom executed on a number of key initiatives, which included the launch of G7 in five countries,” said Sayer. “With the international roll-out of G7, strong momentum in our U.S. business, and ongoing efforts to broaden global access, we are well positioned for a strong conclusion to the year.”
Dexcom set its full-year revenue guidance for between approximately $2.88 billion and $2.91 billion. That represents 18%-19% growth. It also marks an uptick from the low end of last quarter’s projection for between $2.86 billion and $2.91 billion.
On the earnings call, Sayer also touted a potential reimbursement win for Dexcom. Earlier this month, The Centers for Medicare and Medicaid Services (CMS) published a new proposed local coverage determination (LCD). It aims to modify coverage criteria for continuous glucose monitors (CGMs). The modification includes people with diabetes who receive insulin treatment or have a history of problematic hypoglycemia.
This story originally ran on Oct. 27, 2022. Updated Oct. 28 with the next-day stock price.