SENS Senseonics Holdings Inc

Item 8.01 Other Events.

On February 11, 2022, the Company issued a press release announcing the approval by the U.S. Food and Drug Administration (“FDA”) of the Eversense E3 CGM system for marketing and sale in the U.S. and providing its 2022 business outlook. In connection with providing this outlook, the Company is providing a business update, including information concerning the commercial strategy in contemplation of the launch of its next generation Eversense systems in the U.S. and, subject to pending regulatory approval, Europe through its commercialization partner, Ascensia Diabetes Care Holdings (AG) (“Ascensia”).

As previously described, in August 2020, the Company entered into a collaboration and commercialization agreement (the “Commercialization Agreement”) with Ascensia pursuant to which it granted Ascensia the exclusive right to distribute the 90-day Eversense continuous glucose monitoring system and the six month Eversense continuous glucose monitoring system worldwide (subject to regulatory approval in certain jurisdictions) for people with diabetes, with certain initial exceptions.

Pursuant to the Commercialization Agreement, in the United States, Ascensia began providing sales support for the 90-day Eversense product on October 1, 2020 and, during 2021, the parties transitioned full commercial responsibilities to Ascensia. In light of the previously announced delay in the FDA regulatory review of the Eversense E3 six month product in the U.S., Ascensia’s commercialization activities have, to date, focused on marketing the 90-day product in the United States, including reinitiating contact with potential prescribers. The Company believes that, following the Company’s temporary suspension of commercial sales and marketing of Eversense for new users during the COVID-19 pandemic and then initiation of commercial activities through Ascensia, a number of potential prescribers and users have been waiting for the commercial availability of the six month product.

As previously announced on January 4, 2022, the Company and Ascensia have been designing the go-to-market strategy for the U.S. six month product, subject to the receipt of regulatory approval for the Eversense E3 six month product. Now that the six month product has received regulatory approval for marketing and sale in the United States, the Company expects that Ascensia will begin commercializing Eversense E3 in the U.S. in the second quarter of 2022. As with any new product, the success of the commercial launch of the Eversense E3 product in the U.S. will be subject to significant uncertainty and risks, and will require time to ramp up. Key areas of strategic focus in the U.S. commercial launch of the six month product where performance will impact the success of the launch will be: (1) growing the installed base of users, (2) increasing patient awareness of Eversense above current levels in order to expand the population of Eversense users, through driving sales and marketing efforts on the Eversense E3 system, (3) increasing awareness and adoption of Eversense by healthcare providers, including high volume CGM prescribers, through expanded targeted marketing efforts, (4) educating patients and prescribers regarding the six month product and its benefits relative to the 90-day product, (5) continuing to grow the base of the authorized inserters through geographically targeted efforts so that potential users locating a qualified inserter of Eversense is not an impediment to adoption, (6) timely establishing and maintaining favorable payor coverage for the product, including transitioning commercial payors from 90-day coverage to six month coverage, and (7) Ascensia’s continued organizational development of its U.S. sales and marketing capabilities relative to CGM.

The Company and Ascensia are also developing plans for the roll-out of the Eversense E3 next generation six month product in Europe, which, subject to receipt of regulatory approval, is expected to offer reduced calibration requirements from the Eversense XL six month product currently marketed in Europe. The roll-out of this next generation product in Europe is similarly subject to uncertainties and potential delays, including regulatory approval and launch timing, and European revenues are dependent, among other things, on success of the following: (1) Ascensia’s continued organizational development of its European sales and marketing capabilities relative to CGM, and (2) more effective tender participation, particularly in Italian markets which favor an integrated offering. The U.S. and European commercialization plans are being designed with a goal of minimizing the impact to patients, providers, and ongoing sales of Eversense CGM systems.

The Company intends to provide more details concerning the commercialization strategy for the Eversense E3 six month product and the Company’s outlook for the year in its fourth quarter earnings release and during its related investor call on March 1, 2022.