For Insulet, this year has been all about the Omnipod 5 insulin pump—and that dedication is paying off. After kicking off 2022 with FDA clearance for the pump, the diabetes devicemaker launched Omnipod 5 first on a limited basis and then, as of early August, to all eligible patients in the U.S.—a group that grew to include the toddler set in an expanded FDA clearance later that month.
The first few months of that nationwide rollout have already proven it to be a boon to the company. For the third quarter of the year, Insulet reported a 42.4% year-over-year increase in its stateside Omnipod revenues, marking “our highest U.S. revenue growth rate in at least a decade,” CEO Jim Hollingshead said on a call with investors on Thursday.
That brought U.S. Omnipod revenues to $238.1 million, according to this week’s third-quarter earnings report.
The U.S. tally makes up nearly three-quarters of Insulet’s total global earnings from the Omnipod devices, which clocked in at $326.1 million for the quarter. Only about $88 million came from international sales of the insulin pumps—down about 5.5% year over year—but those numbers may soon turn around and follow in the U.S. market’s footsteps, thanks to the CE mark approval of Omnipod 5 that arrived in the final days of the third quarter.
The company’s entire revenue—spanning the Omnipod portfolio and beyond—reached $340.8 million, nearly 24% higher than the same period last year. And Insulet is aiming to further expand its product offerings in the months to come: Hollingshead reported on the call that the company has completed development of a new insulin pod that relies on the Omnipod platform but delivers only basal doses of the medication, rather than both basal and mealtime bolus doses.
“It should greatly improve both the user experience and adherence by completely removing the use of needles. It is the perfect product for people with needle phobia and others who may struggle with adherence to daily or weekly injections,” the chief executive said of the pod.
Insulet is planning on submitting the new device to the FDA for 510(k) clearance “in a few days,” per Hollingshead. Once that green light is secured, the company is expecting to begin rolling out the basal-only option in the U.S. in 2024.
The new pod would specifically target people with Type 2 diabetes. Omnipod 5 is currently indicated only for those with Type 1 diabetes, but Hollingshead said on the call that Insulet is planning to launch a pivotal trial of the pump in Type 2 patients next year.
Those expansion plans come even as Insulet was forced to take a $36 million charge in the quarter. The loss is linked to the company’s plan to replace the smartphonelike Personal Diabetes Manager devices used to control its pared-down Omnipod Dash systems following the discovery of an issue with some of the controllers’ batteries.
Though a mid-October recall notice assured users that the issue was limited only to the Dash pumps’ controllers, Hollingshead noted on the investor call this week that Insulet has since received “a couple of dozen complaints” related to “a potential issue” in charging the Omnipod 5 controller.
“We're going to fully investigate it. And if we have to take any kind of action, we’re going to be really fast,” he said. “We’re going to be completely transparent with our customers, completely transparent with investors and, obviously, with the FDA.”