SENS Showcased Real World E365 Reliability/twiist AID Performance at ADA

研报英文原文证据摘录

SENS Showcased Real World E365 Reliability/twiist AID Performance at ADA

trends appear strong, with

management noting a doubling in demand patterns similar to the early U.S. rollout. We continue

to believe that these markets can return to being a growth contributor in 2H26 as the launches

progress and the new CGM-dedicated commercial infrastructure scales, but we would note

that the company has additional work in front of it to revamp the goto-market strategies in

some countries (most notably Germany). SENS is in the process of bringing the commercial

organizations in these markets in-house from Ascensia under transition services agreements

(TSAs) during 1H26, with all four countries expected to be fully under SENS' control shortly,

which management believes will improve focus and execution.

Pipeline Tracking as Expected: Management reiterated that Gemini remains on pace for

regulatory submission by year-end 2026 via the 510(k) pathway with the IDE study currently

enrolling and subsequent commercialization planned for 2027. Freedom is expected to rollout

roughly ~1 year behind Gemini, with first-inhuman feasibility data planned to initiate in 2H26

(animal testing ongoing). Importantly, management clarified that AID integration is expected

for both Freedom and Gemini, though the latter is somewhat more targeted towards Type 2

populations.

Drivers of the Early 2026 Margin Success, and the Scalability of the Long-term Model:

1Q26 gross margin outperformance and the company's 2026 GM guidance raise was driven

by several factors, most notably eliminating the Ascensia revenue-sharing agreement

(+15-20% benefit), manufacturing efficiencies from a unified product platform (E365 launching

OUS, replacing 180- day), and increased mix of higher-margin bundled payment channels.