Insulet Omnipod's 'higher-than-expected demand' helps set new revenue record

Insulet broke new ground in 2021 as its annual revenues surged past the $1 billion mark for the first time—even without a splashy new product launch that year. So, when 2022 kicked off with the long-awaited FDA clearance of the Omnipod 5 insulin pump, it was only a matter of time until Insulet broke its own newly set record.

Indeed, for all of 2022, the company took in $1.3 billion, an increase of more than 18% over the previous year’s $1.098 billion total, according to an earnings report published Thursday.

Without factoring in changes in currency exchange rates, the year-over-year increase grows to 22%, well above Insulet’s own predictions for 2022: At the start of the year, it forecasted constant currency growth between just 12% and 16%.

Even while running up its revenue, however, Insulet took a hit to its net income for 2022. It reported only $4.6 million in the category, barely a quarter of 2021’s $16.8 million. But the year’s profit could’ve reached as high as $91.1 million, according to the company, if it hadn’t had to take a $57.9 million charge to replace the potentially faulty controllers used with its Omnipod Dash and Omnipod 5 pumps, plus a $25.2 million charge for legal costs and $3.4 million in CEO transition costs.

The bulk of the company’s earnings—nearly $1.25 billion—came from Omnipod sales, which grew more than 23% compared to the prior year. During a call with investors Thursday afternoon, CEO Jim Hollingshead specifically highlighted the “higher-than-expected demand” for the latest iteration of the pump, which he described as “the product our company was founded to make.”

At the end of the third quarter, several months into the Omnipod 5’s U.S. rollout, Insulet reported a year-over-year revenue increase of 42% in the region, which Hollingshead said at the time was “our highest U.S. revenue growth rate in at least a decade.” Once again, however, Insulet quickly one-upped itself, with U.S. Omnipod sales growing by 45% in the fourth quarter.

International sales of the Omnipod portfolio also turned around at the end of the year, climbing 5.7% in the fourth quarter, compared to a decrease of about the same size in the previous period. That turnaround came after Insulet secured CE mark approval for Omnipod 5 in the final days of the third quarter—even though the company has yet to begin the European rollout of the device.

As Hollingshead explained on the call, the new pump is set to launch in the U.K. in the middle of this year and in Germany later on in 2023. From there, he added, “We plan to launch Omnipod 5 more broadly internationally during 2024”—all of which is expected to help Insulet overcome the “headwinds” of competition in the automated insulin delivery space on the continent.

Also on the horizon for Insulet is a plan to sunset the original Omnipod in the U.S. and transition all current users of the device to either the Omnipod 5 or Dash model, according to Hollingshead.

Meanwhile, the company is awaiting an FDA decision on its recent 510(k) application for a Pod that would deliver only basal insulin, which is expected to be ready for rollout in 2024 and is part of Insulet’s efforts to increase use of its devices by people with Type 2 diabetes. That work also includes the upcoming launch of a trial of Omnipod 5 in the Type 2 population, which Hollingshead said will mark “the largest clinical study we’ve conducted to date.”

Even with a busy 2023 in its sights, however, Insulet is once again taking a toned-down approach to its year-ahead predictions. After seven straight years of at least 20% growth on a constant currency basis, the company is expecting to see this year’s revenues grow somewhere in the range of 14% to 19%—though U.S. Omnipod earnings could climb up to 26% higher than 2022’s tally.