Research Reports

Key takeaways

Revenue declined 15.2% to $39.0K versus $46.0K in Q1 FY2025, consistent with the absence of commercial sales from the Acclaim CI system, which remains in late-stage clinical development.

Gross profit was -$274.0K (versus -$180.0K in Q1 FY2025), driven by costs associated with limited device production and evaluation activities, not commercial manufacturing or sales.

Operating income was -$6.0M (versus -$5.1M in Q1 FY2025), reflecting increased investor relations and legal expenses related to litigation, partially offset by reduced salaries and professional services.

Diluted EPS improved to -$0.08 from -$0.29 in Q1 FY2025, a 72.4% year-over-year improvement attributable to the change in fair value of private warrants, which responded to an increase in the company’s stock price during the period.

Capital expenditures remained flat at $6K, underscoring that near-term spending priorities are focused on clinical execution and regulatory readiness rather than infrastructure expansion.

Full analysis

Acclaim CI Pivotal Trial Progress

The Acclaim CI pivotal trial completed enrollment of all 56 patients during the quarter, and first 12-month follow-up data is now available. This milestone represents meaningful de-risking ahead of the anticipated PMA submission, though no commercial revenue has yet been generated from the system.

Revenue and Gross Profit

Revenue totaled $39.0K for Q1 FY2026, down 15.2% from $46.0K in Q1 FY2025. This reflects continued absence of commercial sales — neither the Esteem FI-AMEI nor the Acclaim CI systems have achieved regulatory clearance for commercial distribution. Gross profit was -$274.0K, compared to -$180.0K in the prior-year quarter. The negative gross profit arises from costs incurred in connection with device production, evaluation, and clinical support activities, not from commercial cost of goods sold — consistent with Envoy’s pre-commercial stage.

Operating Expenses and Income

Net Income and EPS

Net income improved to -$4.4M from -$5.0M in Q1 FY2025, and diluted EPS improved to -$0.08 from -$0.29. This improvement reflects a non-cash gain on the remeasurement of private warrants, which increased in fair value due to a rise in the company’s stock price during the quarter — contrasting with a decrease in the prior-year period.

COCHW · Envoy Medical, Inc.