The Tandem Q2 2020 conference call was held on July 30, 2020. A transcript of the call is available at https://seekingalpha.com/article/4362726-tandem-diabetes-cares-tndm-ceo-john-sheridan-on-q2-2020-results-earnings-call-transcript
Here’s the news that interested me.
The business is good despite Covid. They reiterated previous news that the US FDA approved Control-IQ for children 6 years and older. Tandem bought Sugarmate. UnitedHealthcare now covers the t:slim x2 rather than insisting that they will only reimburse Medtronic pumps. Tandem cross-licensed their patents with Medtronic to avoid the potential for litigation that potentially could slow Tandem’s intention to stay ahead in terms of features, usability, and clinical results. Tandem has rolled out Control-IQ in the UK and South Africa, and they expect to distribute it to more countries throughout the year. They are expanding the roll-out of the t:connect mobile app, which automatically uploads and displays pump information on the mobile phone. (No need to plug in a USB cable and download data from the pump during the endo visit.)
In the Q4 2020 they will file with the FDA for approval of a mobile app that can administer a t:slim pump bolus. They hope for approval in Q1 2021.
As a later step this app will be extended to full pump control but they didn’t say whether that’s for the t:slim. They did say the feature will appear initially for the t:sport, which will be controlled exclusively from the mobile phone app.
Recall that the t:sport is the smaller, non-disposable patch pump that will be half the size of the t:slim, will hold 200u insulin, and will be taped to the body with an inches-long tube to a cannula/infusion set. The idea is that this pump will be discreet — nothing hanging on your belt, no tube sticking out anywhere, all control from the mobile phone — and if there is a problem with the cannula you can change it without throwing away the remaining insulin. And infusion set changes are decoupled from insulin cartridge changes, like with the t:slim: unlike the Omnipod, nothing expires and forcibly stops working after 3 days. Tandem has filed for FDA approval of the t:sport with a separate controller device, perhaps in Q4 2020. But this is just an interim step; that configuration is not intended for wide release. The t:sport product launch happens after the second FDA filing is approved, consisting of the t:sport with the full mobile phone app rather than a separate controller device. They hope for that approval in Summer 2021, followed by broad commercial availability. They don’t know whether there will be approval delays because of the current FDA focus on Covid.
They are planning to release for download the next, improved version of Control-IQ in the second half of 2021, with additional improvements over time. For the 2021 version of Control-IQ they focus on algorithm improvements, increased ease of use, and more personalization (my thinking is that this would include an adjustable BG target and such although they explicity declined to reveal any features yet).
They are integrating with Abbot/Libre CGM, but the planning has not yet settled on timelines, and they won’t say whether it will be Libre2 or only Libre3.