Envoy Medical (COCH) Q2 2025 earnings summary

Executive summary

• All 10 participants in the pivotal Acclaim CI clinical trial were implanted and activated, with no serious adverse events and one-month follow-ups completed; FDA approval targeted for 2027–2028.

• Five new Category III CPT codes for fully implantable hearing devices became effective July 1, 2025, improving reimbursement prospects for the Esteem device.

• Net loss for Q2 2025 was $5.7M, up from $3.9M in Q2 2024; net loss attributable to common stockholders was $6.94M, with minimal revenue from legacy Esteem FI-AMEI implants.

• Company expects continued losses and increased expenses as clinical development and regulatory activities accelerate.

• Issued two new US patents and three new Australian patents, strengthening the intellectual property portfolio.

Financial highlights

• Q2 2025 net revenues: $78K (Q2 2024: $68K); six months: $124K (2024: $127K).

• Operating loss for Q2 2025: $5.1M (Q2 2024: $4.9M); six months: $10.2M (2024: $9.7M).

• Net loss attributable to common stockholders for Q2 2025: $6.94M (Q2 2024: $5.31M); EPS: $(0.32) vs. $(0.29).

• Cash balance at June 30, 2025: $5.3M.

• R&D expenses for Q2 2025: $2.485M (Q2 2024: $2.6M); G&A expenses rose by $0.5M, mainly due to a $0.3M severance accrual.

Outlook and guidance

• No material revenue expected until Acclaim CI receives FDA approval and is commercialized.

• Expenses expected to rise due to clinical trials, regulatory filings, and commercialization preparations.

• Current cash and anticipated capital raises expected to fund operations through September 2025; additional funding needed beyond that.

• Anticipates completion of three-month follow-up visits for all clinical trial participants in the coming weeks.

• Substantial doubt exists about ability to continue as a going concern without further capital.