Envoy Medical (COCH) Q3 2024 earnings summary

Executive summary

• Received FDA approval to initiate pivotal clinical study for Acclaim fully implantable cochlear implant, supporting future PMA submission.

• AMA approved new CPT codes for totally implantable middle ear hearing implants, enhancing reimbursement prospects for Esteem FIAMEI.

• Gained considerable legislative support for reclassification of fully implanted hearing devices for Medicare coverage.

• Issued new patents in the US and Europe for implantable hearing device technologies.

• Included in the Russell Microcap Index.

Financial highlights

• Net revenues for Q3 2024 were $56K, down $24K year-over-year; nine-month revenues were $183K, down $38K.

• R&D expenses rose to $2.8M in Q3 2024 (up $907K YoY) and $7.7M for nine months (up $1.8M YoY), mainly due to increased headcount and clinical trial preparation.

• General and administrative expenses increased by $665K to $1.7M in Q3 2024, and by $1.2M year-to-date, reflecting higher legal and professional fees.

• Operating loss for Q3 2024 was $5.0M, compared to $3.5M in Q3 2023; net loss attributable to common stockholders was $7.3M for Q3 2024.

• Cash and cash equivalents stood at $4.4M as of September 30, 2024.

Outlook and guidance

• Plans to initiate pivotal trial for Acclaim CI and advance reimbursement strategy for Esteem FIAMEI.

• Expects continued progress in regulatory and reimbursement milestones.