0001213900-26-032683
SEC filingEnvoy Medical, Inc. (COCH) reported net revenues of $241K for FY 2025, up 7.1% YoY from $225K in FY 2024, driven by nominal sales of Esteem FI-AMEI implants and components. However, the company posted an operating loss of $22.3M, widening 15.7% YoY from $19.3M, due to elevated R&D expenses of $12.5M (up 22.7%) from Acclaim CI clinical trials, including full enrollment of 56 patients. Total operating expenses rose 15.6% to $22.5M, with G&A up 16.2% amid severance and consulting costs. Net loss expanded to $23.8M (14.2% YoY worse) from $20.8M, reflecting $1.5M other expenses including related-party interest. Net loss per share remained at -$1 on 23.3M weighted shares. Balance sheet shows $8.6M total assets, $3.7M cash, but $20.3M liabilities exceed $12.2M stockholders' deficit. Cash used in operations was $18.2M, offset by $16.6M financing inflows from $10.0M related-party Term Loans and $6.5M offerings. Forward-looking, FDA PMA submission targeted post-12-month trial data, eyeing approval in late 2027/early 2028, with liquidity into Q2 2027 barring warrant exercises.
Envoy Medical reported FY 2025 net revenues of $241K, a 7.1% YoY increase from $225K, from limited Esteem FI-AMEI sales. Operating loss widened to $22.3M (15.7% YoY worse vs. $19.3M), driven by R&D surge to $12.5M (+22.7%) for Acclaim CI trials, where 56 patients were enrolled by March 2025. Sales/marketing fell 29.6% to $1.2M, but G&A rose 16.2% to $7.9M on severance. Net loss grew 14.2% to $23.8M from $20.8M, with EPS steady at -$1 on 23.3M shares. Comprehensive loss $23.8M after $3K OCI gain. Balance sheet: $8.6M assets (cash $3.7M), $20.3M liabilities, -$12.2M equity.
Single reportable segment: hearing health via Esteem FI-AMEI ($241K, +7.1% YoY). Nominal from few implants/replacements; no Acclaim CI sales yet (investigational). MD&A notes new implants <few/year absent reimbursement changes; expects Acclaim dominance post-FDA approval.
Gross loss: revenues $241K vs. COGS $874K (margin negative). Operating margin deeply negative at ~ -9,253% (loss $22.3M on $0.241M rev). Costs up 15.6% YoY to $22.5M; R&D 55% of opex. Non-op other expense $1.5M (warrants, interest). Preferred dividends $4.9M + $1.7M adjustments yield -$28.7M common loss.
Ops cash use $18.2M (net loss adj. non-cash + working cap changes). Investing -$0.2M (PPE). Financing +$16.6M ($10.0M Term Loans, $6.5M offerings, $3.1M warrant exercises; offset dividends $1.8M, costs). Net cash decline $1.7M to $3.7M (end '25); beg $5.5M. Liquidity to Q2 2027 sans warrants. Debt: warrants $6.4M total; related-party extinguished Aug 2025. Current liabilities $11.6M > current assets $6.3M.
Pivotal trial data collection ongoing; PMA submission post-12mo follow-ups, targeting FDA decision H2 2027/H1 2028. Commercialize via 30 initial sites, expand 30/year. Need FDA approval for revenue; raise cap via warrants ($48M pot'l). Risks: trial delays, funding, competition (Cochlear et al.), going concern doubt. Focus: trials, reimbursement, IP (40 US patents).