Tandem lines up FDA review of new pint-sized insulin pump amid lower-than-expected sales

After stumbling a bit in the second quarter of the year, Tandem Diabetes is getting back on its feet, multi-quarter recovery plan already in place.

While those three months saw Tandem’s global sales jump 16% compared to last year, reaching a company record of just over $200 million, that wasn’t enough to keep the diabetes tech developer on track toward its 2022 goals. In an earnings report Wednesday afternoon, the company said it would lower its full-year sales forecast to represent growth of between 19% and 20% over 2021, totaling between $835 million and $845 million.

That’s a mood shift from just a quarter ago, when Tandem took a much more optimistic approach by bumping up estimates from the beginning of the year. It kicked off 2022 with an eye toward total sales between $845 million and $860 million, but after a successful first quarter, it ratcheted up that forecast to land between $850 million and $865 million, which would’ve marked an improvement of up to 23% over 2021’s numbers.

Alongside the lower-than-expected sales, the San Diego-based devicemaker reported an operating loss of more than $12 million and a net loss of $15.1 million—numbers that had been solidly in the black this time last year.

In a call with investors on Wednesday, CEO John Sheridan attributed the downturn to a trio of factors: ongoing “pandemic-related pressures,” growing competition within the U.S. and economic challenges including inflation and the looming recession, according to a transcription of the call.

But with the troubles of the second quarter solidly in the rearview mirror, Tandem is back in optimist mode, with a rosy outlook toward sales of both existing and upcoming technologies.

Chief among the latter category is the Mobi insulin pump. The device is about half the size of Tandem’s flagship t:slim pump and can be fully controlled by a user’s smartphone. It’ll also represent “the first novel form factor launched in our space since we introduced t:slim a decade ago,” Sheridan said on the call.

“We are in the final stages of testing, as well as drafting the submission, and intend to submit a 510(k) to the FDA this quarter,” the chief executive said. He noted that Tandem is already preparing for the pint-sized pump’s commercial launch following FDA clearance, which it’s tentatively expecting to snag in the first half of 2023.

In the meantime, Sheridan said Tandem is also working closely with partners Dexcom and Abbott to integrate its insulin pumps with their newest continuous glucose monitors: Abbott’s FreeStyle Libre 3, which was cleared by the FDA just a few months ago, and Dexcom’s G7 device, whose own FDA review is still underway after an agency request for more information.

It’s already been a busy year for Tandem. It kicked off 2022 with FDA clearance for its t:connect mobile app, which can be downloaded to a user’s smartphone to remotely program bolus dosing through the company’s t:slim X2 insulin pumps.

And just last month, Tandem further expanded its portfolio with the acquisition of Capillary Biomedical, an L.A.-area maker of extended-wear infusion set technology. Financial terms of the deal weren’t disclosed.