Once again, Insulet has broken its own records for annual revenue intake.
In its full-year earnings presentation Thursday afternoon, the diabetes devicemaker reported year-over-year growth of 30%, which sent its 2023 earnings to $1.7 billion, compared to the previous year’s $1.3 billion take.
As CEO Jim Hollingshead noted during the investor presentation, that increase represents Insulet’s “eighth consecutive year of 20-plus percent revenue growth” when calculated on a constant currency basis.
The growth was led largely by Insulet’s Omnipod 5 automated insulin delivery (AID) system, as 2023 marked its first full year of availability in both the U.S. and Europe after racking up regulatory clearances throughout 2022. According to Hollingshead, not only was Omnipod 5 responsible for $1 billion of Insulet’s 2023 revenues, but it also became the most prescribed AID system in the U.S. during the year.
To date, per Insulet, its Omnipod insulin pump systems are being used by approximately 425,000 people around the world—representing 25% year-over-year growth—with about 250,000 of those customers using the Omnipod 5 technology.
“We entered 2024 with significant momentum, and we are looking forward to a year of many growth catalysts ahead,” Hollingshead said.
Despite that optimism for the year ahead, Insulet is taking a relatively conservative view toward its 2024 forecasts. It’s currently not expecting to continue the long-running trend of 20% minimum growth: Instead, it’s forecasting annual growth somewhere between 12% and 17%. Even so, at the high end, that would put the company’s 2024 earnings at close to $2 billion only three years after it first crossed the $1 billion mark.
Most of Insulet’s most pressing plans for 2024 concern expansions to the Omnipod 5 system. Hollingshead told investors that the company this month began a limited U.S. rollout of the system’s integration with Dexcom’s G7 continuous glucose monitor—after previously only being compatible with G6 sensors—to be followed by a full market release later this year.
Meanwhile, he said, Insulet is also on track to begin rolling out the Omnipod 5 system for use with Abbott’s FreeStyle Libre 2 Plus CGM in the first half of this year after recently earning CE mark clearance for the team-up.
In addition to expanding Omnipod 5’s CGM partners, Insulet is also working to expand its operating system partners: The AID system’s app is currently compatible only with Android devices, but Hollingshead said an iOS app for G6-integrated Omnipod 5 systems will launch in the U.S. sometime this year, following an FDA nod last fall.
Other future makeovers to the Omnipod 5 system are currently in clinical trials, including one that would support Insulet’s application to the FDA to expand the technology beyond its current Type 1 diabetes-only restriction.
“We expect the last participant to complete our Type 2 pivotal trial in the coming weeks, and we plan to submit results to the FDA by the end of 2024 for an expanded indication,” Hollingshead said.
He also highlighted an “evolution feasibility study” currently under way in New Zealand, the goal of which is to “make it easier for people to get prescribed therapy, get set up on therapy and use therapy consistently over time.”
“Our intent is to have a next-generation algorithm that will further drive simplicity of use. We completed the first feasibility study in participants with either Type 1 or Type 2 diabetes, commencing initially in supervised hotel setting and then progressing to at-home use,” Hollingshead said. “We are pleased with the preliminary results and are analyzing the data and making modifications for the next round of subjects.”