Shares in the US manufacturer of continuous glucose monitoring (CGM) sensors for diabetics fell sharply at the end of last week after the publication of a report by Hunterbrook Media accusing Dexcom's flagship product, the G7, of serious safety failures.
The G7 continuous glucose monitoring device is accused of providing inaccurate readings that have led to hospitalizations and even patient deaths. The central element of the allegations stems from an FDA inspection that allegedly revealed an unauthorized design change: in December 2023, DexCom allegedly substituted the coating on the G7 sensors with an internal formulation, without regulatory approval, even though the company's own tests deemed it inferior on every accuracy metric. Despite this, the product was allegedly marketed.
Hunterbrook documents patient cases, including the death of Billy Sosbe last June, a six-year-old girl rushed to the emergency room after massive reading discrepancies, and a driver who fainted due to a lack of hypoglycemia alerts. Complaints have reportedly fueled a Facebook group of nearly 60,000 members in just over a year. Some endocrinologists report disproportionate inaccuracies, repeated failures, and adhesive and connectivity issues. The marketing promise of "the most accurate CGM" now seems far from being fulfilled.
The competitive environment is making things even tougher. Abbott claims greater accuracy with its Libre 3 product and is preparing a new generation that combines glucose and ketones (the molecules produced by the liver when the body lacks available glucose). Hunterbrook writes that patients are returning to the G6 or switching to competitors, while the market is becoming more complex with GLP-1 treatments (Novo Nordisk, Eli Lilly) that are likely to slow the progression of type 2 diabetes. There is also the plan to open CGMs to competition through the Medicare health insurance program and the false start of Stelo (DexCom's OTC CGM), marred by user complaints.
The report does not spare governance. It highlights a management exodus (vice president of global operations, director of commercial activities, engineering management) and the unexpected departure of CEO Kevin Sayer, who had been at the helm since 2015 and was expected to remain until the end of 2025. "Keeping it in the family", the new CEO is the son-in-law of a former CEO.
On the financial front, Hunterbrook points to "aggressive tactics" that enabled the company to exceed consensus estimates in the second quarter, even though indicators have deteriorated, with, for example, an average collection period exceeding 100 days (106 days in the last quarter cited, compared with a normal range of 30-90). The gross margin is said to have fallen to 59.5% in Q2, marking 15 consecutive quarters of annual decline.
Hunterbrook Capital (the group's investment fund) has declared that it is shorting Dexcom. The stock has fallen back to levels last seen in April.
https://www.marketscreener.com/news/dexcom-is-under-fire-from-accusations-ce7d58dfd18ff026
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