Bigfoot and Lilly announce cooperation agreement to ensure Loop and Inject systems properly interface with Lilly insulins – January 7, 2019

Does not incorporate insulin into monthly bundle; Risk mitigation strategy for Bigfoot, especially for users/investors; launches still 2020, but pivotals pushed back (again) to 2H19

This morning, Bigfoot and Lilly announced a “cooperation agreement” wherein Lilly will support Bigfoot to ensure that the Loop and Inject automated insulin delivery systems and devices “properly interface” with Lilly’s insulins. This is a solid win for Bigfoot, since Lilly is developing competing products in both areas (hybrid closed loop + smart pens with titration; launch in 2019-2021) – having buy-in from Lilly mitigates risk.

Technically, Bigfoot does not “need” this agreement with Lilly (or other insulin manufacturers) to commercialize Inject or Loop. However, there are clear benefits, including: (i) ensuring a high quality, consistent product for users through ongoing development and collaboration with Lilly; and (ii) eliminating investor questions about risk (“What will <insulin manufacturer> say/do,” “Isn't <insulin manufacturer> going to do this anyway,” etc.). Indeed, Bigfoot’s pump for Loop will need compatibility with Lilly’s prefilled insulin cartridges, and Bigfoot’s smart pen cap for Inject will need compatibility with Lilly’s disposable pens.

Shared President Bryan Mazlish in an email to us, “Providing the best possible experience to our users is paramount, which is why we are going to whatever lengths possible to ensure this in the future.” Importantly, this agreement does not include Lilly’s insulins as part of Bigfoot’s planned monthly subscription bundle, though that would be an obvious and welcome extension.

Regarding timing, the near-term news is another delay: the Loop hybrid closed loop pivotal trial is now expected to start in the second-half of this year, back from the previous goal to start in Q2 (which itself reflected multiple delays). The trials for Inject “will likely start in the second half of this year” too. On the plus side, both Bigfoot systems are expected to launch in 2020, which remains doable but is feeling more ambitious with each update.


--by Adam Brown and Kelly Close