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Dexcom submits 15-day CGM to FDA, beats Street in Q3

October 25, 2024 By Sean Whooley

Dexcom G7 iPhone (1)
The G7 CGM. [Image courtesy of Dexcom]

Dexcom (Nasdaq:DXCM) announced that, following the conclusion of the third quarter, it submitted its 15-day G7 CGM to the FDA.

G7, the company’s latest-generation continuous glucose monitor (CGM), presently has approval for a 10-day wear time.

Shares of DXCM were up slightly at the opening of trading today. Yesterday evening, Dexcom also reported third-quarter results that beat the consensus forecast. Analysts viewed the results as positive.

The San Diego-based continuous glucose monitor maker reported profits of $134.6 million. That equals 34¢ per share on sales of $994.2 million for the three months ended Sept. 30, 2024.

Dexcom recorded an 11.5% bottom-line gain on a sales increase of 2% year-over-year.

Adjusted to exclude one-time items, earnings per share came in at 45¢. That landed 2¢ ahead of expectations on Wall Street. Sales also beat the estimates as experts forecast $991 million in revenue.

Highlights for the quarter, aside from the FDA submission, include the launch of Stelo, the company’s new over-the-counter biosensor. Dexcom became the first company to receive FDA clearance for an OTC CGM when the FDA cleared Stelo in March. Abbott followed in June with FDA clearance for its over-the-counter Libre Rio. (CEO Kevin Sayer spoke to Drug Delivery Business News about the next steps for Stelo at ADA 2024 — read about it here.)

Dexcom also launched the G7 CGM in Australia and rolled out Dexcom ONE+ in France. Additionally, the company executed a $750 million share repurchase program during the three-month period.

The company projects 2024 revenues to range between $4 billion and $4.05 billion, marking growth between 11% and 13%.

“Dexcom’s third-quarter results were in line with our expectations as our team responded quickly to the business dynamics that emerged earlier this year,” said Kevin Sayer, Dexcom’s chair, president and CEO. “We made significant progress over the quarter to drive improved execution, leaving the company on track to continue on our momentum in the fourth quarter and into 2025.”

A leader at Dexcom is retiring

Dexcom announced that EVP and CCO Teri Lawver plans to retire at the end of the year. She intends to continue serving as a special advisor to Dexcom through early 2025. Meanwhile, Sayer plans to assume leadership of the commercial organization while the company conducts a global search for a new CCO.

“I want to personally thank Teri for her strong leadership and dedication, as seen most clearly through the successful launches of G7 and Stelo,” said Sayer. “I look forward to guiding us through this transition phase as we capitalize on the incredible opportunity ahead.”

Lawver assumed the position of CCO in January 2023. Within about a month, she oversaw the U.S. launch of G7.

Before joining Dexcom, Lawver spent two decades in a variety of leadership roles at Johnson & Johnson. Her positions spanned the medical device, consumer medtech and pharmaceutical sectors. Most recently, she served as worldwide VP, immunology at J&J’s Janssen Pharmaceutical Companies.

The analysts’ view

BTIG analysts Marie Thibault and Sam Eiber noted that Dexcom, while beating the overall sales consensus, missed U.S. revenue projections by $19 million. However, management highlighted record new patient starts, progress and momentum on commercial efforts on the company’s earnings call.

The analysts don’t think Lawver’s retirement will slow the company’s U.S. salesforce momentum as Dexcom reported positive feedback for Stelo in the early stages of its launch. Thibault and Eiber called the 15-day G7 submission “another plus,” helping Dexcom compete in the durable medical equipment (DME) channel and improve margins.

“We think this Q3 result and commentary demonstrate [Dexcom’s] issues have been related to commercial execution, not structural hurdles,” Thibault and Eiber wrote. “Even if [Dexcom] shares are a bit weak in Friday trading, we think the positive updates for Q4 and 2025 combined with relatively low investor expectations may allow [Dexcom] shares to move higher into year-end. We think [Dexcom] deserves a premium valuation, since it is more profitable than most of its peers, retains a strong position in a market duopoly, and has a path back to higher growth.”

This story originally ran on Oct. 24, 2024. Updated Oct. 25 with the next-day stock price. 

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), MassDevice Earnings Roundup, Patient Monitoring, Regulatory/Compliance, Technology Tagged With: Dexcom

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at swhooley@wtwhmedia.com.

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