UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
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ENVOY MEDICAL, INC.
Table of Contents
i
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
ENVOY MEDICAL, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
(In thousands, except share and per share amounts)
| September 30,
2024 | December 31,
2023 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash | $ | $ | ||||||
| Accounts receivable, net | ||||||||
| Other receivable | ||||||||
| Inventories | ||||||||
| Prepaid expenses and other current assets | ||||||||
| Total current assets | ||||||||
| Property and equipment, net | ||||||||
| Operating lease right-of-use asset (related party) | ||||||||
| Total assets | $ | $ | ||||||
| Liabilities and stockholders’ deficit | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | $ | ||||||
| Accrued expenses | ||||||||
| Product warranty liability, current portion | ||||||||
| Operating lease liability, current portion (related party) | ||||||||
| Total current liabilities | ||||||||
| Term loan payable and accrued interest (related party) | ||||||||
| Product warranty liability, net of current portion | ||||||||
| Operating lease liability, net of current portion (related party) | ||||||||
| Publicly traded warrant liability | ||||||||
| Forward purchase agreement put option liability | ||||||||
| Forward purchase agreement warrant liability | ||||||||
| Total liabilities | ||||||||
| Commitments and contingencies (see Note 14) | ||||||||
| Stockholders’ deficit: | ||||||||
| Series A Preferred Stock, $ | ||||||||
| Class A Common Stock, $ | ||||||||
| Additional paid-in capital | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Accumulated other comprehensive loss | ( | ) | ( | ) | ||||
| Total stockholders’ deficit | ( | ) | ( | ) | ||||
| Total liabilities and stockholders’ deficit | $ | $ | ||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
1
ENVOY MEDICAL, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE (LOSS) INCOME
(UNAUDITED)
(In thousands, except share and per share amounts)
| Three
Months Ended September 30, | Nine
Months Ended September 30, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Net revenues | $ | $ | $ | $ | ||||||||||||
| Costs and operating expenses: | ||||||||||||||||
| Cost of goods sold | ||||||||||||||||
| Research and development | ||||||||||||||||
| Sales and marketing | ||||||||||||||||
| General and administrative | ||||||||||||||||
| Total costs and operating expenses | ||||||||||||||||
| Operating loss | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Other (expense) income: | ||||||||||||||||
| Gain (loss) from changes in fair value of convertible notes payable (related party) | ( | ) | ||||||||||||||
| Change in fair value of forward purchase agreement put option liability | ||||||||||||||||
| Change in fair value of forward purchase agreement warrant liability | ( | ) | ( | ) | ||||||||||||
| Change in fair value of publicly traded warrant liability | ( | ) | ( | ) | ||||||||||||
| Interest expense, related party | ( | ) | ( | ) | ||||||||||||
| Other income (expense) | ( | ) | ||||||||||||||
| Total other (expense) income, net | ( | ) | ( | ) | ( | ) | ||||||||||
| Net (loss) income | $ | ( | ) | $ | $ | ( | ) | $ | ( | ) | ||||||
| Cumulative preferred dividends and undistributed earnings allocated to participating securities, basic | $ | ( | ) | ( | ) | ( | ) | |||||||||
| Net (loss) income attributable to common stockholders, basic | $ | ( | ) | $ | $ | ( | ) | $ | ( | ) | ||||||
| Net (loss) income attributable to common stockholders, diluted | $ | ( | ) | $ | $ | ( | ) | $ | ( | ) | ||||||
| Net (loss) income per share attributable to common stockholders, basic | $ | ( | ) | $ | $ | ( | ) | $ | ( | ) | ||||||
| Net (loss) income per share attributable to common stockholders, diluted | $ | ( | ) | $ | $ | ( | ) | $ | ( | ) | ||||||
| Weighted-average common stock outstanding, basic | ||||||||||||||||
| Weighted-average common stock outstanding, diluted | ||||||||||||||||
| Other comprehensive (loss) income: | ||||||||||||||||
| Foreign currency translation adjustment | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Other comprehensive loss | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Comprehensive (loss) income | $ | ( | ) | $ | $ | ( | ) | $ | ( | ) | ||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
2
ENVOY MEDICAL, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)
(UNAUDITED)
(In thousands, except share amounts)
FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2024
| Series A Preferred Stock | Class A Common Stock | Additional Paid-in | Accumulated | Accumulated Other Comprehensive | Total Stockholders’ | |||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Capital | Deficit | Loss | Deficit | |||||||||||||||||||||||||
| Balance at December 31, 2023 | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||||||||||||||||||
| Dividends on the Series A Preferred stock | — | — | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Sale of common stock through forward purchase agreement | — | — | ||||||||||||||||||||||||||||||
| Stock-based compensation | — | — | ||||||||||||||||||||||||||||||
| Issuance of warrants associated with February 2024 Term Loan | — | — | ||||||||||||||||||||||||||||||
| Foreign currency translation adjustment | — | — | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Net loss | — | — | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Balance at March 31, 2024 | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||||||||||||||||||
| Dividends on the Series A Preferred stock | — | — | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Stock-based compensation | — | — | ||||||||||||||||||||||||||||||
| Issuance of warrants associated with February 2024 Term Loan | — | — | ||||||||||||||||||||||||||||||
| Foreign currency translation adjustment | — | — | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Net loss | — | — | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Balance at June 30, 2024 | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||||||||||||||||||
| Dividends on the Series A Preferred stock | — | — | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Exercise of shortfall warrants | — | |||||||||||||||||||||||||||||||
| Modification of forward purchase agreement | — | — | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Stock-based compensation | — | — | ||||||||||||||||||||||||||||||
| Issuance of warrants associated with 2024 Term Loans | — | — | ||||||||||||||||||||||||||||||
| Foreign currency translation adjustment | — | — | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Net loss | — | — | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Balance at September 30, 2024 | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||||||||||||||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
3
FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2023
| Series A Preferred Stock | Class A Common Stock | Additional Paid-in | Accumulated | Accumulated Other Comprehensive | Total
Stockholders’ Equity | |||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Capital | Deficit | Loss | (Deficit) | |||||||||||||||||||||||||
| Balance at December 31, 2022 | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||||||||||||||||||
| Deemed capital contribution from related party (Note 9) | — | — | ||||||||||||||||||||||||||||||
| Foreign currency translation adjustment | — | — | ||||||||||||||||||||||||||||||
| Net loss | — | — | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Balance at March 31, 2023 | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||||||||||||||||||
| Deemed capital contribution from related party (Note 9) | — | — | ||||||||||||||||||||||||||||||
| Foreign currency translation adjustment | — | — | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Net loss | — | — | ( | ) | $ | ( | ) | |||||||||||||||||||||||||
| Balance at June 30, 2023 | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||||||||||||||||||||
| Conversion of Convertible Notes into Class A Common stock in connection with Merger (Note 3) | — | |||||||||||||||||||||||||||||||
| Conversion of Envoy Bridge Note into Series A Preferred stock in connection with Merger (Note 3) | — | |||||||||||||||||||||||||||||||
| Deemed capital contribution from related party (Note 9) | — | — | ||||||||||||||||||||||||||||||
| Preferred stock subscriptions (Note 3) | — | — | $ | |||||||||||||||||||||||||||||
| Net exercise of warrants (related party) (Note 10) | — | |||||||||||||||||||||||||||||||
| Merger, net of redemptions and transaction costs (Note 3) | ( | ) | ( | ) | ||||||||||||||||||||||||||||
| Meteora forward purchase agreement shares (Note 3) | — | ( | ) | ( | ) | |||||||||||||||||||||||||||
| Issuance of Series A Preferred stock to PIPE Investors (Note 3) | — | |||||||||||||||||||||||||||||||
| Foreign currency translation adjustment | — | — | ( | ) | ( | ) | ||||||||||||||||||||||||||
| Net income | — | — | ||||||||||||||||||||||||||||||
| Balance at September 30, 2023 | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ||||||||||||||||||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
4
ENVOY MEDICAL, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
(In thousands)
| Nine
Months Ended September 30, | ||||||||
| 2024 | 2023 | |||||||
| Cash flows from operating activities | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation | ||||||||
| Accrued interest and amortization of debt discount on term loan payable (related party) | ||||||||
| Stock-based compensation | ||||||||
| Change in fair value of convertible notes payable (related party) | ||||||||
| Change in fair value of warrant liability (related party) | ||||||||
| Change in fair value of publicly traded warrant liability | ||||||||
| Change in fair value of forward purchase agreement warrant liability | ||||||||
| Change in fair value of forward purchase agreement put option liability | ( | ) | ||||||
| Gain on exercise and cancellation warrant liability (related party) | ( | ) | ||||||
| Change in operating lease right-of-use asset (related party) | ||||||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | ( | ) | ( | ) | ||||
| Other receivable | ||||||||
| Inventories | ( | ) | ( | ) | ||||
| Prepaid expenses and other current assets | ( | ) | ||||||
| Accounts payable | ||||||||
| Operating lease liability (related party) | ( | ) | ( | ) | ||||
| Accrued expenses | ( | ) | ||||||
| Product warranty liability | ( | ) | ( | ) | ||||
| Payable to related party | ||||||||
| Net cash used in operating activities | $ | ( | ) | $ | ( | ) | ||
| Cash flows from investing activities | ||||||||
| Purchases of property and equipment | ( | ) | ( | ) | ||||
| Net cash used in investing activities | $ | ( | ) | $ | ( | ) | ||
| Cash flows from financing activities | ||||||||
| Proceeds from the issuance of convertible notes payable (related party) | ||||||||
| Proceeds from the PIPE Transaction, the Forward Purchase Agreement, and the Business Combination, net of transaction costs | ||||||||
| Proceeds from the additional Series A Preferred Shares subscription | ||||||||
| Proceeds from the issuance of term loan (related party) | ||||||||
| Dividends paid to Series A Preferred Shareholders | ( | ) | ||||||
| Proceeds from exercise of warrants | ||||||||
| Proceeds from the sale of common stock associated with forward purchase agreement, net of transaction costs | ||||||||
| Net cash provided by financing activities | $ | $ | ||||||
| Effect of exchange rate changes on cash | ( | ) | ( | ) | ||||
| Net increase in cash | ||||||||
| Cash, beginning of period | ||||||||
| Cash, end of period | $ | $ | ||||||
| Supplemental disclosures of cash flow information: | ||||||||
| Cash paid for interest | $ | $ | ||||||
| Cash paid for income taxes | $ | $ | ||||||
| Non-cash investing and financing activities: | ||||||||
| Deemed capital contribution from related party | $ | $ | ||||||
| SPAC excise tax liability recognized upon the Business Combination | $ | $ | ||||||
| Accrued and unpaid dividends on Series A Preferred Shares | $ | $ | ||||||
| Warrants issued with 2024 Term Loans | $ | $ | ||||||
| Extinguishment of excess warrant liability upon exercise of warrants associated with the forward purchase agreement | $ | $ | ||||||
| Modification of forward purchase agreement warrant liability | $ | $ | ||||||
| Lease liabilities arising from obtaining right-of-use assets | $ | $ | ||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
5
ENVOY MEDICAL, INC.
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
1. Nature of the Business and Basis of Presentation
Envoy Medical, Inc. (“Envoy Medical” or the “Company”) is a hearing health company focused on providing innovative medical technologies across the hearing loss spectrum. Envoy Medical’s technologies are designed to shift the paradigm within the hearing industry and bring both providers and patients the hearing devices they desire. The Company’s first commercial product, the Esteem® Fully Implanted Active Middle Ear Implant (“Esteem FI-AMEI”), is a fully implanted active middle ear hearing device. The Esteem FI-AMEI was approved for sale in 2010 by the United States Food and Drug Administration (“FDA”).
Envoy Medical believes the fully implanted Acclaim® Cochlear Implant (“Acclaim CI”) is a first-of-its-kind cochlear implant. Envoy Medical’s fully implanted technology includes a sensor designed to leverage the natural anatomy of the ear instead of a microphone to capture sound. The Acclaim CI is designed to address severe to profound sensorineural hearing loss that is not adequately addressed by hearing aids. The Acclaim CI will only be indicated for adults who have been deemed adequate candidates by a qualified physician. The Acclaim CI received the Breakthrough Device Designation from the FDA in 2019.
On
September 29, 2023 (the “Closing Date”), a merger transaction between Envoy Medical Corporation, Anzu Special Acquisition
Corp I (“Anzu”) and Envoy Merger Sub, Inc., a directly, wholly owned subsidiary of Anzu (“Merger Sub”) was completed
(hereinafter, the “Merger” or “Business Combination”, see Note 3) pursuant to the business combination agreement,
dated as of April 17, 2023 (as amended, the “Business Combination Agreement”). In connection with the closing of the Merger
(the “Closing”), Merger Sub merged with Envoy Medical Corporation, with Envoy Medical Corporation surviving the merger as
a wholly owned subsidiary of Anzu. In connection with the Closing, Anzu changed its name to Envoy Medical, Inc. The Company’s Class
A common stock, par value $
On April 17, 2023, prior to entering into the Business Combination Agreement, Anzu and Envoy Medical Corporation entered into an agreement (as amended to date, the “Forward Purchase Agreement”) with Meteora Special Opportunity Fund I, LP (“MSOF”), Meteora Capital Partners, LP (“MCP”), Meteora Select Trading Opportunities Master, LP (“MSTO”) and Meteora Strategic Capital, LLC (“MSC” and, collectively with MSOF, MCP and MSTO, the “Sellers” or “Meteora parties”) for an over-the-counter equity prepaid forward transaction.
Pursuant
to the terms of the Forward Purchase Agreement, on the Closing Date, the Sellers purchased
In
addition, pursuant to the subscription agreement, dated April 17, 2023 (as amended to date, the “Subscription Agreement”),
by and between Anzu and Anzu SPAC GP I LLC (the “Sponsor”), the Company issued, and certain affiliates of the Sponsor purchased,
concurrently with the Closing, an aggregate of
6
Pursuant
to the convertible promissory note, dated April 17, 2023, between Envoy Medical Corporation and GAT Funding, LLC (as amended to date,
the “Envoy Bridge Note”), the Company issued
The unaudited condensed consolidated financials include the accounts of Envoy Medical and its wholly-owned subsidiaries Envoy Medical Corporation and Envoy Medical GmbH (Ansbach) (GmbH), which operates a sales office in Germany. All intercompany accounts and transactions have been eliminated in consolidation.
Unaudited financial information
The Company’s unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) for interim financial reporting and with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X. Pursuant to these rules and regulations, they do not include all information and notes required by U.S. GAAP for complete financial statements. In the opinion of management, all adjustments considered necessary for a fair statement of the Company’s financial condition and results of operations have been included. Operating results for the periods presented are not necessarily indicative of the results that might be expected for the full year. As such, the information included in this report should be read in conjunction with the Company’s audited financial statements as of and for the year ended December 31, 2023, which are included in the Company’s Form 10-K, dated and filed with the SEC on April 1, 2024, which is accessible on the SEC’s website at www.sec.gov. The condensed consolidated balance sheet as of December 31, 2023 has been derived from the audited consolidated financial statements of the Company, but does not include all the disclosures required by U.S. GAAP.
During the nine months ended September 30, 2024, there were no changes to the Company’s significant accounting policies as described in the Company’s audited consolidated financial statements as of and for the year ended December 31, 2023.
2. Summary of Significant Accounting Policies
Going Concern
Since
inception, the Company has incurred cumulative losses from operations and has an accumulated deficit of $
Management believes that its existing cash balances combined with future capital raises, and cash receipts from product sales will be sufficient to fund ongoing operations through at least one year from the date the unaudited condensed consolidated financial statements are issued. However, there can be no assurance that the Company will be successful in achieving its strategic plans, that the Company’s cash balances and future capital raises will be sufficient to support its ongoing operations, or that any additional financing will be available in a timely manner or on acceptable terms, if at all. If the Company is unable to raise sufficient financing when needed or events or circumstances occur such that the Company does not meet its strategic plans, the Company may be required to reduce certain of its discretionary spending. The Company may be unable to develop new or enhanced production methods, or be unable to fund capital expenditures, which could have a material adverse effect on the Company’s financial position, results of operations, cash flows, and ability to achieve its intended business objectives. These matters raise substantial doubt about the Company’s ability to continue as a going concern. The unaudited condensed consolidated financial statements have been prepared assuming the Company will continue as a going concern and do not include adjustments to reflect the possible effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the outcome of this uncertainty.
7
Use of Estimates
The preparation of unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Significant estimates and assumptions reflected in these unaudited condensed consolidated financial statements include but are not limited to the useful lives of property and equipment, inventory reserves, warranty liability, stock-based compensation expense, the fair value of the forward purchase agreement put option liability, the fair value of the forward purchase agreement warrant liability and the outcome of litigation. Estimates and assumptions are reviewed periodically and the effect of changes, if any, are reflected in the unaudited condensed consolidated statements of operations and comprehensive (loss) income.
Reclassification
Certain items in prior financial statements have been reclassified to conform to the current presentation.
Concentration of Credit Risk and Significant Customers
Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and accounts receivable, net. Periodically, the Company maintains deposits in accredited financial institutions in excess of federally insured limits. The Company maintains its cash with financial institutions that management believes to be of high credit quality. The Company has not experienced any losses on such accounts and does not believe it is exposed to any unusual credit risk beyond the normal credit risk associated with commercial banking relationships.
With respect to accounts receivable, the Company performs credit evaluations of its customers and does not require collateral. There have been no material losses on the Company’s accounts receivable. There were no customers that accounted for 10.0% or more of sales for the three and nine months ended September 30, 2024 and 2023. There were no customers that accounted for 10.0% or more of the accounts receivable balance as of September 30, 2024 and December 31, 2023.
Cash
The
Company maintains cash balances in bank accounts which, at times, may exceed federally insured limits. The Company is also required to
maintain in a separate account funds of $
Accounts Receivable
Accounts receivable are recorded at the invoiced amount and do not bear interest. The Company grants credit to customers in the normal course of business, but generally does not require collateral or other security to support amounts due. Accounts receivable are presented net of an allowance for credit losses. Management performs ongoing credit evaluations of its customers based on financial information provided by the customer. Accounts receivable outstanding longer than the contractual payment terms are considered past due. The Company estimates its allowance for credit losses by considering numerous factors, including delinquency trends along with ongoing customer credit evaluations. The Company writes off accounts receivable when they become uncollectible. Payments subsequently received on such receivables are credited to the allowance for credit losses. The Company had no material bad debt expense for the three and nine months ended September 30, 2024 and 2023. The allowance for credit losses was not material as of September 30, 2024 and December 31, 2023.
8
Inventories
Inventories are stated at the lower of cost or net realizable value. Cost is determined using the first-in, first-out method. The Company records write-downs of inventories that are obsolete or in excess of anticipated demand or net realizable value based on a consideration of marketability and product life cycle stage, historical net sales and demand forecasts which consider the assumptions about future demand and market conditions. Inventory on hand that is not expected to be sold or utilized is considered excess, and the Company recognizes the write-down in cost of goods sold at the time of such determination. The write-down is determined by the excess of cost over net realizable value. Net realizable value is the estimated selling price in the ordinary course of business, less reasonably predictable cost of completion, disposal and transportation. At the time of loss recognition, a new cost basis is established and subsequent changes in facts and circumstances would not result in an increase in the cost basis.
Property and Equipment, Net
Property and equipment are stated at cost, net of accumulated depreciation. Additions and improvements that extend the lives of the assets are capitalized, while expenditures for repairs and maintenance are expensed as incurred. When assets are retired or otherwise disposed of, their costs and related accumulated depreciation are removed from the accounts and resulting gains or losses are included in operating results. Depreciation is calculated using the straight-line method over the estimated useful life of the asset, which ranges from to years for property and equipment.
Operating Leases
The Company determines if an agreement is a lease at inception. The Company elected not to recognize the right to use an underlying asset (right-of-use “ROU” asset) and lease liabilities for short-term leases, which are those that have a lease term of twelve months or less, and includes renewal options in the measurement of lease liabilities only when the option to purchase or renew lease for the underlying asset is reasonably certain to be exercised. The Company has elected as an accounting policy to account for lease components and associated non-lease components as a single component. The Company leases its headquarters office space under an operating lease with a related party and also leases office space in Germany under an operating lease (see Note 7). The determination of whether an arrangement is, or contains, a lease is performed at the inception of the arrangement and as necessary at modification. An operating lease is recorded on the consolidated balance sheet with the operating lease asset representing the right to use the ROU asset for the lease term, and the lease liability representing the obligation to make lease payments arising from the lease. The Company excludes variable lease payments when measuring the ROU asset and lease liability, except for those that depend on an index, a rate, or are in-substance fixed payments.
ROU assets and lease liabilities are recognized at the commencement date based on the present value of lease payments over the lease term. In addition, ROU assets include initial direct costs incurred by the lessee as well as any lease payments made at or before the commencement date and exclude lease incentives. The discount rate implicit within the Company’s leases is generally not determinable; therefore, the Company determines the discount rate using its incremental borrowing rate based on the information available at the commencement date in determining the present value of lease payments.
Impairment of Long-Lived Assets
Long-lived assets held and used by the Company, including equipment and ROU assets, are reviewed for impairment whenever events or changes in business circumstances indicate that the carrying amount of an asset may not be recoverable. An impairment loss is recognized when estimated future undiscounted cash flows related to the assets are less than its carrying value. The amount of the impairment loss to be recorded, if any, is calculated by the excess of the asset’s carrying value over its fair value. The Company did not incur any impairment charges during the three and nine months ended September 30, 2024 and 2023.
Fair Value of Financial Instruments
The Company calculates the fair value of its assets and liabilities which qualify as financial instruments and includes this additional information in the notes to the unaudited condensed consolidated financial statements when the fair value is different than the carrying value of these financial instruments. The estimated fair value of cash, accounts receivable, accounts payable, and accrued expenses approximate their carrying amounts due to the relatively short maturity of these instruments. The carrying value of the operating lease liability also approximates fair value since the instrument bears market rates of interest. None of these instruments are held for trading purposes.
9
Fair Value Measurement
The Company determines the fair value of financial assets and liabilities using the fair value hierarchy established in Accounting Standards Codification (“ASC”) Topic 820, Fair Value Measurement (“ASC 820”). ASC 820 identifies fair value as the exchange price, or exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. The hierarchy describes three levels of inputs that may be used to measure fair value, as follows:
| ● | Level 1 — Observable inputs, such as quoted prices in active markets for identical assets and liabilities. |
| ● | Level 2 — Observable inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. |
| ● | Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. |
A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. The Company had elected the fair value option for the convertible notes payable (related party) under ASC Topic 825, Financial Instruments (“ASC 825”), with changes in fair value recorded in loss from changes in fair value of convertible notes payable (related party) each reporting period. The convertible notes payable (related party) were converted on the Closing Date and are no longer outstanding for any periods presented in the unaudited condensed consolidated financial statements. The Company’s forward purchase agreement put option liability and forward purchase agreement warrant liability are considered to be Level 3 financial instruments measured at fair value and are described below (see Note 4).
Derivative Financial Instruments
The Company does not use derivative instruments to hedge exposures to cash flow, market, or foreign-currency risks. The Company evaluates its financial instruments to determine if such instruments are derivatives or contain features that qualify as embedded derivatives in accordance with ASC Topic 815, Derivatives and Hedging (“ASC 815”). For derivative financial instruments that are accounted for as liabilities, the derivative instrument is initially recorded at its fair value on the grant date and is then re-valued at each reporting date, with changes in the fair value reported in other income (expense) in the Company’s unaudited condensed consolidated statements of operations and comprehensive (loss) income. The classification of derivative instruments, including whether such instruments should be recorded as liabilities or as equity, is evaluated at the end of each reporting period. Derivative liabilities are classified in the condensed consolidated balance sheets as current or non-current based on whether or not net-cash settlement or conversion of the instrument could be required within 12 months of the balance sheet date.
The Company accounts for its publicly traded warrant liability in accordance with ASC 815-40. Accordingly, the Company recognized the warrant instruments as a liability at fair value and adjusts the instruments to fair value at each reporting period. The publicly traded warrant liability is subject to re-measurement at each balance sheet date until exercised, and any change in fair value is recognized in other income (expense) in the Company’s unaudited condensed consolidated statements of operations and comprehensive (loss) income.
The Company accounts for its Forward Purchase Agreement in accordance with ASC 815-40. Accordingly, the Company recognized the forward purchase agreement put option liability and the forward purchase agreement warrant liability at fair value at each reporting period. The forward agreement put option liability and the forward purchase agreement warrant liability are subject to re-measurement at each balance sheet date, and any change in fair value is recognized in other income (expense) in the Company’s unaudited condensed consolidated statements of operations and comprehensive (loss) income. As of March 31, 2024, the Company no longer had a forward purchase agreement put option liability.
SPAC Excise Tax Liability
The
Company recognized an excise tax liability of approximately $
10
Revenue Recognition
The Company recognizes revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers, which provides a five-step model for recognizing revenue from contracts with customers as follows:
| ● | identify the contract with a customer; |
| ● | identify the performance obligations in the contract; |
| ● | determine the transaction price; |
| ● | allocate the transaction price to the performance obligations in the contract; and |
| ● | recognize revenue when or as performance obligations are satisfied. |
Revenue is recognized as performance obligations under the terms of a contract are satisfied, which generally occurs as control of the promised products or services is transferred to customers. Revenue is measured as the amount of consideration the Company expects to receive in exchange for transferring products or services to a customer (“transaction price”). To the extent the transaction price includes variable consideration, the Company estimates the amount of variable consideration that should be included in the transaction price using either the expected value or most likely amount method. Variable consideration is included in the transaction price if, in the Company’s judgment, it is probable that a significant future reversal of cumulative revenue under the contract will not occur. Estimates of variable consideration and determination of whether to include estimated amounts in the transaction price are based largely on an assessment of the Company’s anticipated performance and all information that is reasonably available.
The Company primarily derives revenue from the sale of its hearing device products. Revenue from product sales is recognized upon transfer of control of the product to a customer, which occurs at a point in time, at the time the Company is notified the product has been implanted or used by the customer in a surgical procedure. The Company also sells extended warranty plans on a limited basis. Revenue from extended warranty plans is recognized ratably over time and was immaterial for each of the three and nine months ended September 30, 2024 and 2023. Amounts received from a customer prior to fulfillment of the performance obligation are included in accrued expenses on the condensed consolidated balance sheets and are immaterial as of September 30, 2024 and December 31, 2023. The Company has elected to account for shipping and handling activities performed as activities to fulfill the promise to transfer the products; therefore these activities are not assessed as a separate performance obligation to its customers.
Revenue is measured as the amount of consideration the Company expects to receive, which is based on the invoiced price. The majority of the Company’s contracts have a single performance obligation and are short term in nature. The Company’s contracts do not include variable consideration.
Payment terms differ by geography and customer, but payment is generally required within 30 days from the date of product utilization. The Company also offers extended payment plans on a limited basis. Amounts due to the Company under payment plans that extend beyond 12 months are immaterial as of September 30, 2024 and December 31, 2023, and therefore the Company did not adjust the promised amount of consideration for the effects of a significant financing component.
Cost of Goods Sold
Cost of goods sold is comprised of the costs of merchandise sold, as well as the related inbound freight costs and labor directly attributable to bringing certain goods to a saleable condition. In categorizing costs, the Company captures applicable depreciation and costs to maintain and run revenue generating technology, equipment related costs and any personnel-related costs as cost of goods sold.
Product Warranty
The Company provides a limited warranty for its implantable components. At the time product revenue is recognized, the Company reserves for estimated future costs that may be incurred under its warranties based on historical experience. The limited warranty liability is recorded in accrued expenses in the condensed consolidated balance sheets. As of September 30, 2024 and December 31, 2023, the amount of accrued limited warranty was immaterial and the Company’s warranty payments were immaterial.
During
2013, the Company offered a lifetime warranty to clinical trial patients to cover batteries and surgery related costs. The Company estimates
the costs that may be incurred under this lifetime warranty and records a liability in the amount of such costs at its present value.
The lifetime warranty is recorded in warranty liability in the condensed consolidated balance sheets. At each of September 30, 2024
and December 31, 2023, the aggregate product warranty liability was $
11
Patents
All patent-related costs incurred in connection with filing and prosecuting patent applications are expensed as incurred due to the uncertainty about the recovery of the expenditure. Amounts incurred are classified as general and administrative expenses.
Research and Development Costs
Expenditures for research and development activities are charged to operations as incurred. Research and development costs include salaries, employee benefits and laboratory testing expenses.
Income Taxes
Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax base and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those items are expected to be recovered or settled. The Company has recorded a full valuation allowance against the net deferred tax asset due to the uncertainty of realizing the related benefits.
The
Company recognizes the financial statement benefit of a tax position only to the extent the position is more-likely-than-not to be sustained
upon audit based on the technical merits of the position. For tax positions meeting the more-likely-than-not threshold, the amount recognized
in the Company’s unaudited condensed consolidated financial statements is the largest benefit that has a
Foreign Currency Translation
The Euro is the functional currency for the Company’s foreign subsidiary in Germany. The assets and liabilities of the Company’s foreign operations are translated into U.S. dollars at the end-of-the-period exchange rates, and the revenues and expenses are translated at weighted-average rates for the respective reporting period. Unrealized translation gains and losses are recorded as a translation adjustment, which is included in the Company’s unaudited condensed consolidated statements of stockholders’ equity (deficit) as well as a component of accumulated other comprehensive loss on the Company’s unaudited condensed consolidated statements of operations and comprehensive (loss) income.
Net (Loss) Income per Share
The
Company’s Series A Preferred Stock certificate of designation entitles the holders to participate in dividends on an as converted
basis when declared on Common Stock. As a result, the Series A Preferred Stock meets the definition of a participating security, which
requires the Company to apply the two-class method to compute both basic and diluted earnings per share attributable to common stockholders.
The two-class method is an earnings allocation formula that treats participating securities as having rights to earnings that would otherwise
have been available to common stockholders. The two-class method requires income available to holders of the Company’s Common Stock
for the period to be allocated between common and participating securities based upon their respective rights to share in the earnings
as if all income for the period had been distributed. In periods where there is a net loss, no allocation of undistributed net loss to
the Series A Preferred Stock is performed as the holders of the Series A Preferred Stock are not contractually obligated to participate
in the Company’s losses. The Company reported a net loss of $
Basic net (loss) income per share of common stock is computed by dividing the net (loss) income attributable to common stockholders by the weighted-average number of shares of common stock outstanding during the period. Diluted net (loss) income per share is computed by dividing the net (loss) income attributable to common stockholders by the weighted-average number of shares outstanding, plus the impact of potential common shares, if dilutive, resulting from the potential exercise of warrants or options, and the potential conversion of preferred stock, into common stock, under the if-converted method. In periods where a net loss is recorded, no effect is given to potentially dilutive securities, because the effect would be anti-dilutive.
12
Stock-based Compensation
Stock-based compensation is measured at the grant date, based on the fair value of the award, and is recognized as an expense over the requisite service period. The fair value of stock-based payment awards is estimated using the Black-Scholes option model with a volatility figure derived from using a determined peer group of other companies’ stock prices since the trading history of the Company’s stock is too short to provide accurate data. The Company accounts for the expected term of options in accordance with the “simplified” method, which is used for “plain-vanilla” options, as defined in ASC Topic 718, Compensation - Stock Compensation. The risk-free interest rate was determined from the implied yields of U.S. Treasury zero-coupon bonds with a remaining life consistent with the expected term of the options.
The Company has adopted the guidance from Accounting Standards Update (“ASU”) 2016-09, Compensation – Stock Compensation (Topic 718): Improvements to Employee Share-Based Compensation Accounting, and has determined not to apply a forfeiture rate and has made the accounting election that forfeitures will be recognized when the actual forfeiture takes place and therefore no estimated forfeiture rate will be recorded.
Segments
Operating
segments are identified as components of an enterprise about which discrete financial information is available for evaluation by the
chief operating decision-maker (“CODM”) in deciding resource allocation and assessing performance. The Company has determined
that its CODM is its Chief Executive Officer. The Company’s CODM reviews financial information presented on a consolidated basis
for the purposes of making decisions, allocating resources and evaluating performance. Consequently, the Company has determined it operates
in
Recently Adopted Accounting Pronouncements
In August 2020, the Financial Accounting Standards Board (“FASB”) issued ASU 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40) (“ASU 2020-06”) to simplify certain financial instruments. ASU 2020-06 eliminates the current models that require separation of beneficial conversion and cash conversion features from convertible instruments and simplifies the derivative scope exception guidance pertaining to equity classification of contracts in an entity’s own equity. The new standard also introduces additional disclosures for convertible debt and freestanding instruments that are indexed to and settled in an entity’s own equity. ASU 2020-06 amends the diluted earnings per share guidance, including the requirement to use the if-converted method for all convertible instruments. For smaller reporting companies, ASU 2020-06 is effective for fiscal years beginning after December 15, 2023 and should be applied on a full or modified retrospective basis. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020, including interim periods within those fiscal years. The Company adopted ASU 2020-06 when evaluating the 2024 Term Loans entered into during the nine months ended September 30, 2024 (see Note 9).
Accounting Pronouncements Not Yet Effective
In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which will add required disclosures of significant expenses for each reportable segment, as well as certain other disclosures to help investors understand how the CODM evaluates segment expenses and operating results. The new standard will also allow disclosure of multiple measures of segment profitability if those measures are used to allocate resources and assess performance. The amendments will be effective for public companies for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Early adoption is permitted. The Company is currently evaluating the impact of this accounting standard update on its consolidated financial statements.
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which requires disaggregated information about a reporting entity’s effective tax rate reconciliation as well as information on income taxes paid. The standard is intended to benefit investors by providing more detailed income tax disclosures that would be useful in making capital allocation decisions. The standard will be effective for public companies for fiscal years beginning after December 15, 2024. Early adoption is permitted. The Company is currently evaluating the impact of this accounting standard update on its consolidated financial statements.
In November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, that requires public companies to disclose, in interim and annual reporting periods, additional information about certain expenses in the financial statements. For public business entities, it is effective for annual periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. Early adoption is permitted and is effective on either a prospective basis or retrospective basis. The Company is currently evaluating the impact that the updated standard will have on the Company’s disclosures within the consolidated financial statements.
Other than the items noted above, there have been no new accounting pronouncements not yet effective or adopted in the current year that have a significant impact, or potential significant impact, to our unaudited condensed consolidated financial statements.
13
3. Merger
As discussed in Note 1 – Nature of the Business and Basis of Presentation, on September 29, 2023, the Company completed the Merger. Upon the Closing, the following occurred:
| ● | each share of Envoy Medical Corporation common stock (‘Envoy Medical Corporation Common Stock”) immediately prior to the Business Combination was automatically cancelled and converted into the right to receive |
| ● | each share of outstanding Envoy Medical Corporation Common Stock, which totaled |
| ● | each outstanding warrant to purchase Envoy Medical Corporation Common Stock, depending on the applicable exercise price, was automatically cancelled or exercised on a net exercise basis and converted into |
| ● | the outstanding Convertible Notes, as defined in Note 9, were automatically converted into |
| ● | each share of Envoy Medical Corporation redeemable convertible preferred stock, par value $ |
| ● | each outstanding option to purchase shares of Envoy Medical Corporation Common Stock outstanding as of immediately prior to the Business Combination was cancelled in exchange for nominal consideration; |
| ● | each share of Merger Sub’s common stock, par value $ |
| ● | the Sponsor forfeited |
| ● | all of Anzu’s outstanding |
| ● | the Sponsor exchanged |
| ● | an aggregate of |
| ● | pursuant to the legacy forward purchase agreements and the extension support agreements of Anzu, the Sponsor transferred an aggregate of |
| ● | the Company issued an aggregate of |
14
| ● | the Sellers in their sole discretion may request warrants of the Company exercisable for shares of Common Stock (the “Shortfall Warrants”) in an amount equal to |
| ● | the Company issued, and certain affiliates of the Sponsor purchased, concurrently with the Closing, an aggregate of |
| ● | pursuant to the Envoy Bridge Note, the Company issued |
The
proceeds received by the Company from the Merger, the PIPE Transaction, and the Forward Purchase Agreement, net of transaction costs,
totaled $
The Merger was accounted for as a reverse recapitalization in accordance with U.S. GAAP. Under this method of accounting, Anzu was treated as the acquired company for financial reporting purposes. Accordingly, for accounting purposes, the Merger was treated as the equivalent of the Company issuing shares for the net assets of Anzu, accompanied by a recapitalization. The net assets of Anzu were stated at historical cost with no goodwill or other intangible assets recorded.
| Class A Common Stock | Number of Shares | |||
| Exchange of Anzu Class A Common Stock subject to possible redemption that was not redeemed for Common Stock | ||||
| Conversion of Anzu Class B Common Stock held by the Sponsor and Anzu’s former independent director into Common Stock* | ||||
| Subtotal - Merger, net of redemptions | ||||
| Exchange of Envoy Medical Corporation Common Stock for Common Stock | ||||
| Exchange of Envoy Medical Corporation Preferred Stock for Common Stock | ||||
| Conversion of Convertible Notes as of September 29, 2023 into Common Stock | ||||
| Net exercise of Envoy Medical Corporation warrants outstanding | ||||
| Issuance of share consideration to Meteora parties | ||||
| Shares recycled by Meteora parties | ||||
| * |
| Series A Preferred Stock | Number of Shares | |||
| Exchange of Anzu Class B Common Stock for Series A Preferred Stock | ||||
| Issuance of Series A Preferred Stock in connection with the PIPE Transaction | ||||
| Issuance of Series A Preferred Stock in connection with the conversion of the Envoy Bridge Note | ||||
15
4. Fair Value Measurements
| September 30, 2024 | ||||||||||||||||
| Level 1 | Level 2 | Level 3 | Total | |||||||||||||
| Liabilities: | ||||||||||||||||
| Forward purchase agreement warrant liability | $ | $ | $ | $ | ||||||||||||
| Publicly traded warrant liability | ||||||||||||||||
| $ | $ | $ | $ | |||||||||||||
| December 31, 2023 | ||||||||||||||||
| Level 1 | Level 2 | Level 3 | Total | |||||||||||||
| Liabilities: | ||||||||||||||||
| Forward purchase agreement warrant liability | $ | $ | $ | $ | ||||||||||||
| Forward purchase agreement put option liability | ||||||||||||||||
| Publicly traded warrant liability | ||||||||||||||||
| $ | $ | $ | $ | |||||||||||||
The
fair values of the forward purchase agreement warrant liability and the forward purchase agreement put option liability were estimated
using Monte Carlo Simulation models, which are Level 3 fair value measurements.
| September 30,
2024 | December 31, 2023 | |||||||
| Stock price | $ | $ | ||||||
| Initial exercise price | $ | $ | ||||||
| Remaining term (in years) | ||||||||
| Risk-free rate | % | % | ||||||
The Company has classified the publicly traded warrant liability within Level 1 of the hierarchy as the warrant is separately listed and traded in an active market. The publicly traded warrant’s listed price in an active market was used as the fair value.
| Forward Purchase Agreement Warrant Liability | Forward Purchase Agreement Put Option Liability | |||||||
| Balance as of December 31, 2023 | $ | $ | ||||||
| Change in fair value | ( | ) | ||||||
| Effect of amendment (see Note 10) | ||||||||
| Exercise of warrants | ( | ) | ||||||
| Balance as of September 30, 2024 | $ | $ | ||||||
There were no transfers between Level 1 and Level 2, nor into and out of Level 3, during the periods presented.
5. Cash Available for Dividend Payments
Pursuant
to the certificate of designation of the Series A Preferred Stock, the Company is required to maintain the funds allocated for the first
four (4) quarterly dividend payments in a separate account, for a total of $
16
As
of September 30, 2024 and December 31, 2023, the Company was unable to maintain this balance and continue funding normal operations.
Notwithstanding its inability to maintain funds in a separate account, as of September 30, 2024 and December 31, 2023, the Company
had accrued all dividend payments required under the certificate of designation of the Series A Preferred Stock, that have been unpaid,
which are included in accrued expenses on the Company’s condensed consolidated balance sheets. As of September 30, 2024, the
Company had paid all required dividend payments under the certificate of designation of the Series A Preferred Stock. As of September 30,
2024 and December 31, 2023, the balance of unpaid dividends in relation to the Series A Preferred Stock included in accrued expenses
was $
6. Inventories
| September 30, 2024 | December 31,
2023 | |||||||
| Raw materials | $ | $ | ||||||
| Work-in-progress | ||||||||
| Finished goods | ||||||||
| $ | $ | |||||||
7. Operating Leases
The
Company leases its headquarters office space in Minnesota and leases office space in Germany. The headquarters office space lease is
with a stockholder, which is considered a related party. During the quarter ended June 30, 2024, the Company and the landlord agreed
to modify the lease to extend the lease term for three (3) additional years through
The lease of the office space in Germany is not with a related party and is immaterial.
| September 30,
2024 | December 31, 2023 | |||||||
| Operating lease right-of-use asset (related party) | $ | $ | ||||||
| Operating lease liability, current portion (related party) | $ | $ | ||||||
| Operating lease liability, net of current portion (related party) | ||||||||
| $ | $ | |||||||
| Nine
Months Ended September 30, | ||||||||
| 2024 | 2023 | |||||||
| Operating lease cost | ||||||||
| $ | $ | |||||||
| Nine
Months Ended September 30, | ||||||||
| 2024 | 2023 | |||||||
| Cash paid for amounts included in the measurement of lease liability | $ | $ | ||||||
17
| September 30, 2024 | December 31, 2023 | |||||||
| Weighted-average remaining lease term - in years | ||||||||
| Weighted-average discount rate | % | % | ||||||
| 2024 (remaining) | $ | |||
| 2025 | ||||
| 2026 | ||||
| 2027 | ||||
| 2028 | ||||
| Thereafter | ||||
| Less: Imputed interest | ( | ) | ||
| $ |
8. Product Warranty Liability
| Amount | ||||
| Balance as of December 31, 2023 | $ | |||
| Utilization | ( | ) | ||
| Balance as of September 30, 2024 | $ | |||
The
assumptions utilized in developing the liability as of September 30, 2024 include an estimated cost per unit of $
9. Debt (Related Party)
Convertible Notes
The Company received several loan financings from stockholders from 2012 to 2024. During the year ended December 31, 2023, the 2012 Convertible Note, the 2013 Convertible Notes, and the 2023 Convertible Note (collectively the “Convertible Notes”) were all converted into equity at the Closing of the Business Combination.
The
Company elected the fair value option for the Convertible Notes and the Envoy Bridge Note under ASC 825 with changes in fair value recorded
in earnings each reporting period. The Company recorded a gain of $
2024 Term Loans
In
the first quarter of 2024, the Company issued a promissory note (the “February 2024 Term Loan”) with a minimum principal
amount of $
18
In
the third quarter of 2024, the Company issued an additional promissory note (the “August 2024 Term Loan” and, collectively
with the February 2024 Term Loan, the “2024 Term Loans”) with a principal amount of up to $
As
a commitment fee, the Company is required to issue warrants to purchase
At
closing of the initial funding of the February 2024 Term Loan, the Company issued Common Stock warrants to purchase
At
closing of the initial funding of the August 2024 Term Loan, the Company issued Common Stock warrants to purchase
The 2024 Term Loans were accounted for as a conventional debt instrument and are accounted for in accordance with ASU 2020-06, Debt - Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity’s Own Equity (Subtopic 815- 40).
As
a result of the issuance of the warrants with the initial closing of the February 2024 Term Loan, which met the criteria for equity classification
under applicable U.S. GAAP, the Company recorded a debt discount and additional paid-in capital of approximately $
As
a result of the issuance of the warrants with the initial closing of the August 2024 Term Loan, which met the criteria for equity classification
under applicable U.S. GAAP, the Company recorded a debt discount and additional paid-in capital of approximately $
| Nine
Months Ended September 30, 2024 | |||
| Risk-free interest rate | |||
| Expected term (years) | |||
| Volatility | |||
| Stock Price | $ |
19
During
the three and nine months ended September 30, 2024, respectively, the Company recognized approximately $
10. Common Stock
As
of September 30, 2024 and December 31, 2023, the Company was authorized to issue
Contingent Sponsor Shares
Pursuant
to the Sponsor Support Agreement,
The Contingent Sponsor Shares meets the definition of a derivative, but meets the criteria to be considered indexed to the Company’s stock and the equity-classification criteria. Accordingly, the Contingent Sponsor Shares are classified as permanent equity.
Common Stock Warrants (Related Party)
During
the nine months ended September 30, 2024, the Company issued warrants to purchase
Forward Purchase Agreement
The
Company previously issued to Meteora warrants to purchase
On
various dates during the three months ended September 30, 2024,
11. Series A Preferred Stock
As
of September 30, 2024 and December 31, 2023, the Company’s certificate of incorporation, as amended and restated, authorized
the Company to issue
20
Pursuant
to the Envoy Bridge Note, the Sponsor Support Agreement and the Subscription Agreement, the Company has outstanding an aggregate of
| ● |
| ● |
| ● |
The holders of the Series A Preferred Stock have the following rights and preferences:
Voting Rights
The holders of the Series A Preferred Stock are not entitled to vote or receive notice of any meeting of stockholders, except in the case that the Company creates any equity or debt instrument that ranks senior or pari passu to the rights of the Series A Preferred Stock or in the case of any adverse change to the powers, preferences or special rights of the Series A Preferred Stock.
Conversion Rights
Each
share of Series A Preferred Stock shall be convertible, at the option of the holder, at any time after the date of issuance into such
number of shares of Common Stock as determined by dividing the issuance price of the shares of Series A Preferred Stock of $
At
any time from and after 90 days following the Merger, if the closing price per share of Common Stock is greater than $
Redemption
The holders of Series A Preferred Stock are not entitled to any redemption rights, other than those under their liquidation rights discussed below. The Company does not have the option to redeem the Series A Preferred Stock.
Dividend Rights
The
holders of Series A Preferred Stock are entitled to a cumulative dividend which accrues at the rate of
The holders of Series A Preferred Stock are also entitled to dividends or distributions (“Participating Dividends”) senior to Common Stock of the Company when such dividends are declared. There were Participating Dividends declared as of September 30, 2024.
Specifically
pursuant to the Sponsor Support Agreement, any dividends arising will accrue and not require timely payment at any time when the Company
has less than $
With
respect to the holders of the Series A Preferred Stock other than the Series A Preferred Stock subject to the Sponsor Support Agreement
held by the Sponsor, the Company accrued $
21
Liquidation Preference
In
the event of any liquidation, deemed liquidation, dissolution or winding up of the Company, whether voluntary or involuntary, the holders
of the Series A Preferred Stock are entitled to receive, prior and in preference to any distribution of any of the assets or surplus
funds of the Company to the holders of any security of the Company that ranks junior to the Series A Preferred Stock, including, but
not limited to, the Common Stock, an amount per share of Series A Preferred Stock equal to the greater of i) $
12. Stock Options
The
Company had a stock incentive plan (the “2003 Stock Option Plan”) that provided for the granting of stock options or other
stock incentives to employees, officers, directors and consultants. In March 2013, the Company and its stockholders adopted a new plan
(the “2013 Stock Option Plan”) on substantially the same terms and conditions of the 2003 Stock Option Plan. The Company
and its stockholders reserved a total of
On April
17, 2023, the Company’s board of directors adopted a new equity incentive plan, and the plan was approved by the
stockholders on September 27, 2023 (hereinafter, the “2023 Equity Incentive Plan”). An aggregate of
| Shares Subject to Outstanding Options | Weighted- average Exercise Price per Option | Weighted- average Remaining Contractual Term (Years) | Aggregate Intrinsic Value | |||||||||||||
| Outstanding at December 31, 2023 | $ | |||||||||||||||
| Granted | $ | |||||||||||||||
| Terminated | ( | ) | $ | |||||||||||||
| Outstanding at September 30, 2024 | $ | $ | ||||||||||||||
| Exercisable and vested at September 30, 2024 | $ | $ | ||||||||||||||
13. Related Party Transactions
The Company had various transactions with a member of the Company’s board of directors and a controlling stockholder of the Company, which is considered a related party.
| ● | The Company leases its headquarters office space in Minnesota from the stockholder. The lease is considered a common control leasing arrangement. The lease liability due to the stockholder was $ |
| ● | The Company received several loan financings from the stockholder between 2012 to 2024 (see Note 9). |
| ● | The Company has a shared services arrangement with a company that is indirectly owned by the stockholder, for certain support services used in the course of business. This arrangement originated on January 1, 2022 with a term of |
22
14. Commitment and Contingencies
The Company is party to various litigation matters arising from time to time in the ordinary course of business.
On
November 14, 2023, the Company, Whitney Haring-Smith (the former chief executive officer and a former director of the Company), Daniel
Hirsch (the former chief financial officer of the Company), and Anzu SPAC GP I LLC were named as defendants in a complaint filed by Atlas
Merchant Capital SPAC Fund I LP (“Atlas”) in the Delaware Court of Chancery (the “Atlas Complaint”). The Atlas
Complaint alleges that Atlas properly requested redemption of its shares of the Company’s Common Stock in connection with the Company’s
business combination transaction and was prevented from redeeming such shares by the Company and the other defendants. Atlas seeks redemption
of the shares of Common Stock in the amount of approximately $
The
Company has business liability insurance to cover litigation costs exceeding $
15. Net (Loss) Income per Share
| Three
Months Ended September 30, | Nine
Months Ended September 30, | |||||||||||||||
| Numerator: | 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Net (loss) income | $ | ( | ) | $ | $ | ( | ) | $ | ( | ) | ||||||
| Less: Cumulative preferred dividends and undistributed earnings allocated to participating securities, basic | ( | ) | ( | ) | ( | ) | ||||||||||
| Net (loss) income attributable to common stockholders, basic | $ | ( | ) | $ | $ | ( | ) | $ | ( | ) | ||||||
| Net (loss) income | $ | ( | ) | $ | $ | ( | ) | $ | ( | ) | ||||||
| Less: Cumulative preferred dividends and undistributed earnings allocated to participating securities, diluted | ( | ) | ( | ) | ( | ) | ||||||||||
| Net (loss) income attributable to common stockholders, diluted | $ | ( | ) | $ | $ | ( | ) | $ | ( | ) | ||||||
| Denominator: | ||||||||||||||||
| Weighted average common stock outstanding, basic | ||||||||||||||||
| Net (loss) income per share attributable to common stockholders, basic | $ | ( | ) | $ | $ | ( | ) | $ | ( | ) | ||||||
| Weighted average common stock outstanding, diluted | ||||||||||||||||
| Net (loss) income per share attributable to common stockholders, diluted | $ | ( | ) | $ | $ | ( | ) | $ | ( | ) | ||||||
The
Company’s potentially dilutive securities below, presented based on amounts outstanding at each period end, have been excluded
from the computation of diluted net loss per share for the nine months ended September 30, 2024 and September 30, 2023, as the effect
would be to reduce the net loss per share.
| Nine
Months Ended September 30, | ||||||||
| 2024 | 2023 | |||||||
| Stock options | ||||||||
| Series A Preferred Stock (as converted to common stock) | ||||||||
| Warrants to purchase common stock (publicly traded) | ||||||||
| Shortfall Warrants | ||||||||
| Warrants to purchase common stock (related party) | ||||||||
16. Subsequent Events
The Company has evaluated all events occurring through the date on which these unaudited condensed consolidated financial statements were issued, and during which time, nothing has occurred that would require disclosure, except for the following:
In
October 2024 and November 2024, the Company received exercise notices pursuant to the Forward Purchase Agreement whereby the Company
issued
23
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following analysis of our financial condition and results of operations should be read in conjunction with the consolidated financial statements and the notes included elsewhere in this Quarterly Report on Form 10-Q (this “Report”), as well as the information contained in the Company’s Annual Report on Form 10-K, dated and filed with the Securities and Exchange Commission (the “SEC”) on April 1, 2024 (the “Form 10-K”), which is accessible on the SEC’s website at www.sec.gov. Unless otherwise indicated or the context otherwise requires, references in this section to the “Company,” “Envoy Medical,” “we,” “us,” “our” and other similar terms refer (i) prior to the Closing Date, to Anzu Special Acquisition Corp I and (ii) after the Closing Date, to Envoy Medical, Inc.
Cautionary Note Regarding Forward-Looking Statements
This Report contains certain “forward-looking statements” within the meaning of the United States Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934 (the “Exchange Act”). All statements other than statements of historical fact contained in this Report, including statements as to future results of operations and financial position, revenue and other metrics, products, business strategy and plans, objectives of management for future operations of the Company, market size and growth, competitive position and technological and market trends, are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements in this Report include, but are not limited to:
| ● | statements regarding the development, performance, and market impact of our products; |
| ● | the timing and outcome of our clinical trials; |
| ● | our future capital requirements and future capital investments; |
| ● | our ability to raise capital for future operations and the potential sources for financing transactions; |
All forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to:
| ● | changes in the market price of shares of our Class A Common Stock, par value $0.0001 per share (the “Common Stock”); |
| ● | unpredictability in the medical device industry, the regulatory process to approve medical devices, and the clinical development process of the Company’s products; |
| ● | potential need to make design changes to products to meet desired safety and efficacy endpoints; |
24
| ● | changes in federal or state reimbursement policies that would adversely affect sales of the Company’s products; |
| ● | introduction of other scientific advancements, including gene therapy or pharmaceuticals, that may impact the need for hearing devices such as cochlear implants or fully implanted active middle ear implants; |
| ● | competition in the medical device industry, and the failure to introduce new products and services in a timely manner or at competitive prices to compete successfully against competitors; |
| ● | disruptions in relationships with the Company’s suppliers, or disruptions in the Company’s own production capabilities for some of the key components and materials of its products; |
| ● | changes in the need for capital and the availability of financing and capital to fund these needs; |
| ● | changes in interest rates or rates of inflation; |
| ● | legal, regulatory and other proceedings could be costly and time-consuming to defend; |
| ● | changes in applicable laws or regulations, or the application thereof on the Company; |
| ● | a loss of any of the Company’s key intellectual property rights or failure to adequately protect intellectual property rights; |
| ● | the Company’s ability to maintain the listing of its securities on The Nasdaq Stock Market LLC (“Nasdaq”); |
| ● | the effects of catastrophic events, including war, terrorism and other international conflicts; and |
| ● | other risks and uncertainties indicated in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on April 1, 2024 (the “Form 10-K”), including those set forth under the section entitled “Risk Factors.” |
Should one or more of these risks or uncertainties materialize, or should any of the underlying assumptions prove incorrect, actual results may vary in material respects from those expressed or implied by these forward-looking statements. Nothing in this Report should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on these forward-looking statements. The Company does not give any assurance that it will achieve its expected results and does not undertake any duty to update these forward-looking statements, except as required by law.
As described above, Envoy entered into a business combination agreement with Anzu Special Acquisition Corp I (“Anzu”) on April 17, 2023 (as amended, the “Business Combination Agreement”). The transactions under the Business Combination Agreement (collectively, the “Business Combination”) were completed on September 29, 2023, in connection with which Anzu changed its name to Envoy Medical, Inc. (and together with its subsidiaries, “Envoy Medical”, the “Company”, “we”, “us” or “our”, unless the context otherwise requires).
You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited condensed consolidated financial statements as of September 30, 2024 and December 31, 2023, and the three and nine months ended September 30, 2024 and 2023, together with the notes thereto included elsewhere in this Report. It should also be read in conjunction with the audited consolidated financial statements as of and for the years ended December 31, 2023 and 2022, together with related notes thereto included in the Form 10-K, which is accessible on the SEC’s website at www.sec.gov.
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Overview
We are a hearing health company focused on providing innovative medical technologies across the hearing loss spectrum. Our technologies are designed to shift the paradigm within the hearing industry and bring both providers and patients the hearing devices they desire. Founded in 1995, our vision is to create fully implanted hearing devices that leverage the natural ear – not an artificial microphone – to pick up sound. In recent years, we have focused almost exclusively on developing the fully implanted Acclaim® cochlear implant (the “Acclaim CI”), our lead product candidate.
We believe that the Acclaim CI is a first-of-its-kind cochlear implant. Our fully implanted technology includes a sensor designed to leverage the natural anatomy of the ear instead of a microphone to capture sound. The Acclaim CI is designed to address severe to profound sensorineural hearing loss that is not adequately addressed by hearing aids. The Acclaim CI will only be indicated for adults who have been deemed adequate candidates by a qualified physician. The Acclaim CI received the Breakthrough Device Designation from the United States Food and Drug Administration (the “FDA”) in 2019.
Our first product, the Esteem® Fully Implanted Active Middle Ear Implant (“Esteem FI-AMEI”), was created and received FDA approval in 2010. The Esteem FI-AMEI is a fully implanted active middle ear hearing device and remains the only FDA approved fully implanted hearing device in the US market. Unfortunately, the Esteem FI-AMEI failed to gain commercial traction, primarily due to a lack of reimbursement or insurance coverage from third-party payors. Despite commercial challenges, approximately 1,000 Esteem FI-AMEI devices were implanted. Some devices were implanted in the early 2000s during clinical trials, providing Envoy Medical with nearly two decades of experience with its implantable sensor technology. Throughout our experience, our sensor technology proved a viable alternative and robust option to external or implanted microphones.
In late 2015, we made the decision to shift our focus from the Esteem FI-AMEI to a new product that would leverage our sensor technology and incorporate it into a cochlear implant. As a result, we now have the Acclaim CI, a fully implanted cochlear implant. We believe the Acclaim CI gives us the opportunity to disrupt the existing cochlear implant market. The cochlear implant market is one that already has established market acceptance and reimbursement pathways. In the United States, before we can market a new Class III medical device, which the Acclaim CI is, we must first receive FDA approval via the premarket application approval process.
In October 2024, we received FDA approval of our application for an Investigational Device Exemption (“IDE”) for the Acclaim CI. The IDE application was approved for a staged clinical trial to begin. The staged trial will allow 10 participants to be implanted before expanding the study to the full cohort. Institutional Site’s Investigational Review Board (“IRB”) approvals are needed before participants can be enrolled and implants can begin. IRB approvals can take several months. At the end of the study, a Premarket Approval (“PMA”) application will be submitted to the FDA. It is likely that a panel review will be requested due to the novel nature of the Acclaim CI. As a result, we currently anticipate obtaining the FDA’s decision on our PMA in 2027. The FDA approval process is uncertain, and we cannot guarantee that we will receive FDA approval on that timeline, or at all.
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We had a net loss of approximately $6.0 million and net income of $1.6 million for the three months ended September 30, 2024 and 2023, respectively, and net losses of $16.2 million and $25.0 million for the nine months ended September 30, 2024 and 2023, respectively, and had an accumulated deficit of $277.5 million and $257.2 million as of September 30, 2024 and December 31, 2023, respectively. We have funded our operations to date primarily through the issuance of equity securities, term debt and convertible debt, and in September 2023, we received $11.7 million in proceeds from the Business Combination (see Note 1 “Nature of the Business and Presentation” of the accompanying unaudited condensed consolidated financial statements included elsewhere in this Report). During the nine months ended September 30, 2024, we also received $15.0 million proceeds from the 2024 Term Loans (see Note 9, “Debt (Related Party)” of the accompanying unaudited condensed consolidated financial statements included elsewhere in this Report), approximately $2.1 million from the sale of shares from our Forward Purchase Agreement, and $0.4 million from the exercise of certain of our Shortfall Warrants. We expect to continue to incur net losses for the foreseeable future, and expect our research and development expenses, general and administrative expenses, and capital expenditures will continue to increase. In particular, we expect our expenses to increase as we continue our development of the Acclaim CI and seek the necessary regulatory approvals for our product candidate, as well as hire additional personnel, pay fees to outside consultants, attorneys and accountants, and incur other increased costs associated with being a public company. In addition, if and when we seek and obtain regulatory approval to commercialize the Acclaim CI in the United States, we will also incur increased expenses in connection with commercialization and marketing of such product. Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our clinical trials, if any, and our expenditures on other research and development activities. We anticipate that our expenses will increase significantly in connection with our ongoing activities, if and as we:
| ● | continue our research and development efforts for the Acclaim CI product candidate, including through clinical trials; |
| ● | seek additional regulatory and marketing approvals in jurisdictions outside the United States; |
| ● | establish a sales, marketing and distribution infrastructure to commercialize our product candidate; |
| ● | rely on our third-party suppliers and manufacturers to obtain adequate supply of materials and components for our products; |
| ● | seek to identify, assess, acquire, license, and/or develop other product candidates and subsequent generations of our current product candidate; |
| ● | seek to maintain, protect, and expand our intellectual property portfolio; |
| ● | seek to identify, hire, and retain additional skilled personnel; |
| ● | create additional infrastructure to support our operations as a public company and our product candidate development and planned future commercialization efforts; and |
| ● | experience any delays or encounter issues with respect to any of the above, including, but not limited to, failed studies, complex results, safety issues or other regulatory challenges that require longer follow-up of existing studies or additional supportive studies in order to pursue marketing approval. |
27
We expect that our financial performance will fluctuate quarterly and yearly due to the development status of our Acclaim CI implant product and our efforts to obtain regulatory approval and commercialize the Acclaim CI implant product.
The Acclaim CI has not yet been approved for sale. We do not expect to generate any product sales unless and until we successfully complete development and obtain regulatory approval for our product candidate. If we obtain regulatory approval for the Acclaim CI, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution. As a result, until such time, if ever, that we can generate substantial product revenue, we expect to finance our cash needs through equity offerings, debt financings or other capital sources, including collaborations, licenses or similar arrangements. However, we may be unable to raise additional funds or enter into such other arrangements when needed or on favorable terms, if at all. Any failure to raise capital as and when needed could have a negative impact on our financial condition and on our ability to pursue our business plans and strategies, including our research and development activities. If we are unable to raise capital, we will need to delay, reduce, or terminate planned activities to reduce costs.
Macroeconomic Conditions
Our business and financial performance are impacted by macroeconomic conditions. Global macroeconomic challenges, such as the effects of the ongoing war between Russian and Ukraine, the Middle East conflict, supply chain constraints, market uncertainty, volatility in exchange rates, inflationary trends, interest rates, and evolving dynamics in the global trade environment have impacted our business, financial performance, and our ability to raise capital.
Furthermore, a recession or market correction resulting from macroeconomic factors could materially affect our business and the value of our Common Stock. The occurrence of any such events may lead to reduced disposable income which could adversely affect the number of Esteem FI-AMEI implants and replacement components sold as a result of customer and patient reluctance to seek treatment due to financial considerations.
Adverse macroeconomic conditions, including pandemics or international tensions, could also result in significant disruption of global economic conditions and consumer trends, as well as a significant disruption in financial markets, reducing our ability to access capital, which could in the future negatively affect our liquidity.
Key Components of Our Results of Operations
Revenue
Currently, we derive substantially all our revenue from the sale of the Esteem FI-AMEI implants and replacement components to Esteem FI-AMEI implants. We enter arrangements with patients to provide them with the Esteem FI-AMEI device, personal programmer devices, sound processor/battery replacements, and/or an optional Care Plan, each of which are outputs of our ordinary activities in exchange for consideration. Revenue from product sales is recognized upon transfer of control of the product to a customer, which occurs at a point in time, when we are notified the product has been implanted or used by the customer in a surgical procedure. New implantations of the Esteem FI-AMEI are not expected to be more than a few per year and may be as low as zero. Although we believe it to be unlikely, Esteem FI-AMEI implantations could potentially increase with favorable reimbursement policy and coverage changes. We will continue our efforts to pursue positive reimbursement changes for fully implanted active middle ear implants. There will be continued nominal revenue from replacement of sound processors for patients who need a new battery.
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Upon commercialization of our Acclaim CI implant product, we expect that Acclaim CI revenues will more than exceed our Esteem FI-AMEI revenue. We are targeting FDA approval for the Acclaim CI in 2026.
Cost of Goods Sold
Cost of goods sold includes direct and indirect costs related to the manufacturing and distribution of the Esteem FI-AMEI implants, including materials, labor costs for personnel involved in the manufacturing process, distribution-related services, indirect overhead costs, and charges for excess and obsolete inventory reserves and inventory write-offs.
We expect cost of goods sold to increase or decrease in absolute dollars primarily as, and to the extent, our revenue grows or declines, respectively.
Operating Expenses
Research and Development Expenses
Research and development expenses (“R&D”) consist of costs incurred for our research activities, primarily our discovery efforts and the development of the Acclaim CI implant product. We also incur R&D costs related to continuing to support, and improving upon where possible, our Esteem FI-AMEI product. We expense R&D costs as incurred, which include:
| ● | salaries, employee benefits, and other related costs for our personnel engaged in R&D functions; |
| ● | service fees incurred under agreements with independent consultants, including their fees and related travel expenses engaged in R&D functions; |
| ● | costs of laboratory testing including supplies and acquiring, developing, and manufacturing study materials; and |
| ● | facility-related expenses, which include direct depreciation costs and allocated expenses for rent and maintenance of facilities and other operating costs. |
Costs for certain development activities are recognized based on an evaluation of the progress to completion of specific tasks using information and data provided to us by our vendors, service providers and our clinical sites.
Our R&D expenses are currently tracked on a program-by-program basis. The majority of our R&D expenses incurred during the three and nine months ended September 30, 2024 and 2023 were for the development of the Acclaim CI.
Our products require human clinical trials to obtain regulatory approval for commercial sales. We cannot determine with certainty the size, duration, or completion costs of future clinical trials, or if or when they may be completed. Furthermore, we do not know if the clinical trials will show positive or negative results, or what those results will mean for regulatory approval or commercialization efforts.
The duration, costs and timing of future clinical trials and development of our products will depend on a variety of factors, including:
| ● | the scope, rate of progress, and expense of our ongoing, as well as any additional, clinical trials and other R&D activities; |
| ● | Interest in or demand for both investigational site and subject enrollment; |
| ● | future clinical trial results; |
| ● | potential changes in government regulation; |
| ● | potential changes in the reimbursement landscape; and |
| ● | the timing and receipt of any regulatory approvals. |
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A change in the outcome of any of these variables with respect to the development of our Acclaim CI implant product could mean a significant change in the costs and timing associated with the development of that implant. If the FDA or another regulatory authority were to require us to conduct clinical trials beyond those that we currently anticipate, or if we experience significant delays in the enrollment in any clinical trials, we could be required to expend significant additional financial resources and time on the completion of clinical development.
R&D activities are central to our business model. We expect that our R&D expenses will continue to increase for the foreseeable future as we initiate clinical trials for the Acclaim CI implant product and prepare the product for possible commercialization, should it gain regulatory approval(s). If the Acclaim CI implant product enters later stages of clinical trials and ongoing development, the product will generally incur higher R&D expenses than those in earlier stages of research and development, primarily due to simultaneously running clinical trials while also iterating the product for commercialization and preparing for the needs of commercialization. There are numerous factors associated with the successful commercialization of the Acclaim CI implant product or any products we may develop in the future, including future trial design and various regulatory requirements, many of which cannot be determined with accuracy at this time based on our stage of development. Additionally, future commercial and regulatory factors beyond our control will impact our clinical development program and plans.
Sales and Marketing Expenses
Sales and marketing expenses consist primarily of salaries, benefits, and other related costs for personnel in our sales and marketing functions. Sales and marketing expenses also include certain indirect costs associated with efforts to secure insurance reimbursement of our products. We expect our sales and marketing expenses to increase in the foreseeable future as we increase our administrative personnel to support our continuing growth.
General and Administrative Expenses
General and administrative expenses consist primarily of salaries, benefits, and other related costs for personnel in our executive, operations, legal, human resources, finance, and administrative functions. Administrative expenses also include professional fees for legal, patent, consulting, accounting, tax and audit services, travel expenses and facility-related expenses, which include direct depreciation costs and allocated expenses for rent and maintenance of facilities, technology, and other operating costs.
We expect our general and administrative expenses to continue to increase in the foreseeable future as we increase our administrative personnel to support our continuing growth, our costs of marketing and selling expenses, our costs of expanding our operations and operating as a public company. These increases will likely include increases related to the hiring of additional personnel and legal, regulatory, and other fees and services associated with maintaining compliance with Nasdaq and SEC requirements, director and officer insurance costs and investor relations costs associated with being a public company.
Gain (Loss) from Changes in Fair Value of Convertible Notes Payable (Related Party)
We elected the fair value option for convertible notes payable (related party), and accordingly, convertible notes payable (related party) are recorded at fair value at each reporting date on the consolidated balance sheets. Gain (loss) from changes in fair value of convertible notes payable consists of changes in the fair value during each reporting period. Effective September 29, 2023, the convertible notes (related party) were converted upon completion of the Business Combination.
Change in Fair value of the Forward Purchase Agreement Put Option Liability
We recognized the forward purchase agreement put option liability at fair value at each reporting period. The liabilities are subject to re-measurement at each balance sheet date, and any change in fair value is recognized in the Company’s consolidated statements of operations and comprehensive (loss) income during each reporting period. As of September 30, 2024, we no longer had a forward purchase agreement put option liability.
Change in Fair Value of the Forward Purchase Agreement Warrant Liability
We recognized the forward purchase agreement warrant liability at fair value at each reporting period. The liabilities are subject to re-measurement at each balance sheet date, and any change in fair value is recognized in the Company’s consolidated statements of operations and comprehensive (loss) income during each reporting period.
30
Change in Fair Value of the Publicly Traded Warrant Liability
We recognized the publicly traded warrant liability at fair value at each reporting period. The liabilities are subject to re-measurement at each balance sheet date, and any change in fair value is recognized in the Company’s consolidated statements of operations and comprehensive (loss) income during each reporting period.
Interest Expense, Related Party
Interest expense, related party consists of accrued interest for the 2024 Term Loans held by a related party, as well as amortization of the debt discount recorded as a result of the warrants issued with the 2024 Term Loans. Amortization of the debt discount is recorded over the respective terms of the 2024 Term Loans.
Other Income (Expense)
Other income (expense) in 2024 consisted of the sale of research and development quality document templates to another company (which is not part of our normal course of business). Other income (expense) in 2023 consisted of changes in fair value of our related party warrant liability.
Results of Operations
Comparison of the Three and Nine Months Ended September 30, 2024 and 2023
| Three Months Ended September 30, | Change in | Nine Months Ended September 30, | Change in | |||||||||||||||||||||||||||||
| (In thousands, except percentages) | 2024 | 2023 | $ | % | 2024 | 2023 | $ | % | ||||||||||||||||||||||||
| Net revenues | $ | 56 | $ | 80 | $ | (24 | ) | (30.0 | )% | $ | 183 | $ | 221 | $ | (38 | ) | (17.2 | )% | ||||||||||||||
| Costs and operating expenses: | ||||||||||||||||||||||||||||||||
| Cost of goods sold | 187 | 189 | (2 | ) | (1.1 | )% | 585 | 555 | 30 | 5.4 | % | |||||||||||||||||||||
| Research and development | 2,757 | 1,850 | 907 | 49.0 | % | 7,708 | 5,901 | 1,807 | 30.6 | % | ||||||||||||||||||||||
| Sales and marketing | 394 | 399 | (5 | ) | (1.3 | )% | 1,216 | 1,153 | 63 | 5.5 | % | |||||||||||||||||||||
| General and administrative | 1,692 | 1,027 | 665 | 64.8 | % | 5,406 | 4,248 | 1,158 | 27.3 | % | ||||||||||||||||||||||
| Total costs and operating expenses | 5,030 | 3,465 | 1,565 | 45.2 | % | 14,915 | 11,857 | 3,058 | 25.8 | % | ||||||||||||||||||||||
| Operating loss | (4,974 | ) | (3,385 | ) | (1,589 | ) | 46.9 | % | (14,732 | ) | (11,636 | ) | (3,096 | ) | 26.6 | % | ||||||||||||||||
| Other (expense) income: | ||||||||||||||||||||||||||||||||
| Gain (loss) from changes in fair value of convertible notes payable (related party) | — | 4,902 | (4,902 | ) | (100.0 | )% | — | (13,332 | ) | 13,332 | (100.0 | )% | ||||||||||||||||||||
| Change in fair value of forward purchase agreement put option liability | — | — | — | n/a | 103 | — | 103 | n/a | ||||||||||||||||||||||||
| Change in fair value of forward purchase agreement warrant liability | (311 | ) | — | (311 | ) | n/a | (329 | ) | — | (329 | ) | n/a | ||||||||||||||||||||
| Change in fair value of publicly traded warrant liability | (426 | ) | — | (426 | ) | n/a | (802 | ) | — | (802 | ) | n/a | ||||||||||||||||||||
| Interest expense, related party | (264 | )) | — | (264 | ) | n/a | (432 | ) | — | (432 | ) | n/a | ||||||||||||||||||||
| Other income (expense) | 15 | 46 | (31 | ) | (67.4 | )% | 15 | (59 | ) | 74 | (125.4 | )% | ||||||||||||||||||||
| Total other (expense) income, net | (986 | ) | 4,948 | (5,934 | ) | (119.9 | )% | (1,445 | ) | (13,391 | ) | 11,946 | (89.2 | )% | ||||||||||||||||||
| Net (loss) income | $ | (5,960 | ) | $ | 1,563 | $ | (7,523 | ) | (481.3 | )% | $ | (16,177 | ) | $ | (25,027 | ) | $ | 8,850 | (35.4 | )% | ||||||||||||
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Net Revenues
Net revenues decreased by $24 thousand and decreased by $38 thousand for the three and nine months ended September 30, 2024, respectively, compared to the three and nine months ended September 30, 2023. The decrease for both the three and nine months ended September 30, 2024 is primarily due to the decrease in the number of battery replacements due to supply chain issues.
Cost of Goods Sold
Cost of goods sold decreased by $2 thousand for the three months ended September 30, 2024 compared to the three months ended September 30, 2023 as a result of decreases in normal operating costs. Cost of goods sold increased by $30 thousand for the nine months ended September 30, 2024 compared to the nine months ended September 30, 2023. The increase is attributable to manufacturing and materials scrap for the Esteem FI-AMEI product of $14 thousand, additional contractors for manufacturing technicians and quality inspections of $22 thousand, and personnel costs of $23 thousand for additional employees in manufacturing and quality inspection, and other operating expenses of $4 thousand partially offset by decrease in professional services for quality testing of $33 thousand.
Research and Development Expenses
The following table summarizes the components of our R&D expenses for the three and nine months ended September 30, 2024 and 2023:
| Three
Months Ended September 30, | Nine
Months Ended September 30, | |||||||||||||||
| (In thousands) | 2024 | 2023 | 2024 | 2023 | ||||||||||||
| R&D product costs | $ | 1,265 | $ | 1,110 | $ | 3,327 | $ | 3,548 | ||||||||
| R&D personnel costs | 1,334 | 619 | 4,074 | 2,003 | ||||||||||||
| Other R&D cost | 158 | 121 | 307 | 350 | ||||||||||||
| Total R&D costs | $ | 2,757 | $ | 1,850 | $ | 7,708 | $ | 5,901 | ||||||||
R&D expenses increased approximately $907 thousand and $1.8 million for the three and nine months ended September 30, 2024, respectively, compared to the three and nine months ended September 30, 2023. The increase is primarily due to an increase in headcount and contractors in our engineering and clinical departments for the three and nine months ended September 30, 2024, as we increased headcount across our clinical and cochlear departments in preparation for our pivotal clinical study for the Acclaim CI. This includes increases due to non-cash stock option compensation of $42 thousand and $109 thousand for the three and nine months ended September 30, 2024, respectively.
Sales and Marketing
Sales and marketing expenses decreased by $5 thousand for the three months ended September 30, 2024 as compared to the three months ended September 30, 2023 due to decreases in normal sales and marketing expenses. For the nine months ended September 30, 2024 as compared to the nine months ended September 30, 2023, sales and marketing expenses increased by $63 thousand. This increase was primarily due to increased legal and professional fees to secure insurance reimbursement for the Esteem FI-AMEI product of $275 thousand plus additional sales and marketing expenses of $6 thousand, offset by a reduction in headcount in that department of $218 thousand.
General and Administrative Expenses
General and administrative expenses increased $665 thousand for the three months ended September 30, 2024 compared to the three months ended September 30, 2023. The increase is primarily due to increased professional and legal fees related to public company expenses of $116 thousand, personnel related costs of $179 thousand, directors and officers insurance of $178 thousand, non-cash stock option expenses of $101 thousand, and other operating costs of $91 thousand, for the three months ended September 30, 2024.
General and administrative expenses increased $1.2 million for the nine months ended September 30, 2024 compared to the nine months ended September 30, 2023. The increase is primarily due to increases in personnel-related costs of $536 thousand, directors and officers insurance of $532 thousand, non-cash stock option expenses of $293 thousand, travel expenses of $103 thousand, loss on lease modification of $135 thousand, and other operating costs of $73 thousand, and was partially offset by reduced professional and legal fees related to the closing of the Business Combination in 2023 of $514 thousand, for the nine months ended September 30, 2024.
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Gain (Loss) From Changes in Fair Value of Convertible Notes Payable (Related Party)
The loss from changes in fair value of convertible notes payable decreased $4.9 million for the three months ended September 30, 2024 and the gain from changes in fair value of convertible notes decreased $13.3 million nine months ended September 30, 2024 compared to the three and nine months ended September 30, 2023, respectively due to the conversion of the notes payable to common stock as a result of the completion of our Business Combination during September 2023.
Change in Fair Value of Forward Purchase Agreement Put Option Liability
We entered into a forward purchase agreement in September 2023 as part of our Business Combination. During the first quarter of 2024, the shares associated with the forward purchase agreement were sold resulting in a gain of $103 thousand.
Change in Fair Value of Forward Purchase Agreement Warrant Liability
During the three months ended September 30, 2024, the fair value of the warrants issued in connection with the forward purchase agreement entered into in September of 2023 as part of our Business Combination increased by $311 thousand compared to the fair value at June 30, 2024. The increase in value was due to an increase in our stock price as well as a modification to the forward purchase agreement in July of 2024. This increase in value resulted in a loss of $311 thousand for the three months ended September 30, 2024.
During the nine months ended September 30, 2024, the fair value of the warrants issued in connection with the forward purchase agreement entered into in September of 2023 as part of our Business Combination increased by $329 thousand, compared to the fair value at December 31, 2023. The increase in value was due to an increase in our stock price as well as a modification to the forward purchase agreement in July of 2024. These increases in value resulted in a loss of $329 thousand for the nine months ended September 30, 2024.
Change in Fair Value of Publicly Traded Warrant Liability
During the three and nine months ended September 30, 2024, the fair value of our publicly traded warrants increased by approximately $426 thousand and increased by approximately $802 thousand, respectively. The change in fair value is the result of an increase of approximately $0.03 and an increase of $0.06 in the closing share price for those warrants during the three and nine months ended September 30, 2024, as compared to the fair value at December 31, 2023, respectively.
Interest Expense, Related Party
Interest expense increased by $264 thousand and $432 thousand for the three and nine months ended September 30, 2024, respectively, compared to the three and nine months ended September 30, 2023, primarily due to the interest costs associated with our 2024 Term Loans which were entered into in February 2024 and August 2024.
Other Income (Expense)
Our other income (expense) decreased by $31 thousand for the three months ended September 30, 2024 compared to the three months ended September 30, 2023 and increased by $74 thousand for the nine months ended September 30, 2024 compared to the nine months ended September 30, 2023. Other income (expense) in 2024 consisted of the sale of research and development quality document templates to another company (which is not part of our normal course of business). Other income (expense) in 2023 consisted of changes in fair value of our related party warrant liability.
Liquidity and Capital Resources
Since our inception, we have incurred significant operating losses. We expect to incur significant expenses and continuing operating losses for the foreseeable future as we advance the clinical development of our products and fund the process of FDA trials. We have funded our operations to date primarily with proceeds from raising funds from issuing equity securities, convertible notes, a term loan and proceeds from the Business Combination. As of September 30, 2024 and December 31, 2023, we had $4.4 million and $4.2 million of cash, respectively.
We proactively manage our access to capital to support liquidity and continued growth. Our sources of capital include sales of the Esteem FI-AMEI implants and replacement components and issuances of our Common Stock, Series A Preferred Stock, warrants, convertible debt, term debt and other financing agreements such as the forward purchase agreement. See Note 1, “Nature of the Business and Basis of Presentation” of the accompanying unaudited condensed consolidated financial statements included elsewhere in this Report.
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We may seek to raise any necessary additional capital through a combination of public or private equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements and other marketing and distribution arrangements. There can be no assurance that we will be successful in acquiring additional funding at levels sufficient to fund our operations or on terms favorable to us. If we are unable to raise sufficient financing when needed or events or circumstances occur such that we do not meet our strategic plans, we may be required to reduce certain discretionary spending, be unable to develop new or enhanced production methods, or be unable to fund capital expenditures, which could have a material adverse effect on our financial position, results of operations, cash flows, and ability to achieve its intended business objectives. These matters raise substantial doubt about our ability to continue as a going concern. To the extent that we raise additional capital through additional collaborations, strategic alliances, or licensing arrangements with third parties, we may have to relinquish valuable rights to our Acclaim CI implant, future revenue streams, research programs or to grant licenses on terms that may not be favorable to us. If we do raise additional capital through public or private equity or convertible debt offerings, the ownership interest of our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect our stockholders’ rights. If we raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring dividends.
Our future capital requirements and the adequacy of available funds will depend on many factors, including those set forth in the section of our Form 10-K titled, “Risk factors – Risks Relating to Our Business and Operations.”
Cash Flows
The following table presents a summary of our cash flow for the periods indicated (in thousands):
| Nine
Months Ended September 30, | ||||||||
| 2024 | 2023 | |||||||
| Net cash provided by (used in): | ||||||||
| Operating activities | $ | (13,561 | ) | $ | (5,946 | ) | ||
| Investing activities | (1,514 | ) | (132 | ) | ||||
| Financing activities | 15,284 | 22,736 | ||||||
| Effect of exchange rate on cash | (3 | ) | (1 | ) | ||||
| Net increase in cash | $ | 206 | $ | 16,657 | ||||
Cash Flows Used in Operating Activities
Net cash used in operating activities for the nine months ended September 30, 2024 was primarily used to fund a net loss of approximately $16.2 million, adjusted for non-cash expenses in aggregate amount of approximately $2.2 million and approximately $0.4 million of cash outflows from net changes in the levels of operating assets and liabilities. The change primarily relates to increases in accounts payable, accounts receivable, and inventories and decreases in other receivable, prepaid expenses and other current assets, operating lease liability (related party), accrued expenses, and product warranty liability. We will continue to evaluate our capital requirements for both short-term and long-term liquidity needs, which could be affected by various risks and uncertainties, including, but not limited to, the effects of the current inflationary environment, rising interest rates, and other risks detailed in our Form 10-K titled “Risk Factors.”
Net cash used in operating activities for the nine months ended September 30, 2023 was primarily used to fund a net loss of approximately $25.0 million, adjusted for non-cash gains in aggregate amount of approximately $13.4 million, and approximately $5.7 million of cash outflows from net changes in the level of operating assets and liabilities, primarily related to increases in accounts payable, accrued expenses, related party payable, accounts receivable, prepaid expenses, and inventories and decreases in product warranty liability and lease liability (related party).
Cash Flows Used in Investing Activities
Net cash used in investing activities for the nine months ended September 30, 2024 was approximately $1.5 million and consisted of purchases of property and equipment, specifically equipment used in the production of finished goods.
Net cash used in investing activities for the nine months ended September 30, 2023 was approximately $0.1 million and consisted of purchases of computer equipment due to increased headcount and purchases of lab equipment.
Cash Flows Provided by Financing Activities
Net cash provided by financing activities for the nine months ended September 30, 2024 was $15.3 million. This increase was primarily driven by the $15.0 million proceeds from the 2024 Term Loans, the receipt of $1.7 million from the sale of common stock associated with the forward purchase agreement as well as the proceeds from exercise of warrants of $434 thousand, partially offset by dividends paid to holders of the Series A Preferred Stock of $1.8 million .
Net cash provided by financing activities for the nine months ended September 30, 2023 was $22.7 million. This increase was primarily driven by the $11.7 million net proceeds from the PIPE Transaction, Forward Purchase Agreement, and Business Combination and was also driven by $10.0 million proceeds from the issuance of convertible notes payable to a related party.
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Contractual Obligations and Commitments
Our principal commitments consist of contractual cash obligations under our borrowings with stockholders, our operating leases for office space, and various litigation matters arising in the ordinary course of business. Our obligations for leases are described in Note 7, “Operating Leases”, and further information on our open litigation matters, are described in Note 14, “Commitments and Contingencies” of the accompanying unaudited condensed consolidated financial statements included elsewhere in this Report.
Off-Balance Sheet Arrangements
During the periods presented, we did not have, nor do we currently have, any off-balance sheet arrangements as defined under the rules and regulations of the SEC.
Related Party Arrangements
Our related party arrangements consist of leasing our headquarters office space from a stockholder and issuing convertible notes and term loans from stockholders. We also accrued interest on the term loans to a stockholder on our condensed consolidated balance sheet as of September 30, 2024. For further information on the related party arrangements refer to Note 5 “Cash Available for Dividend Payments”, Note 7 ”Operating Leases”, Note 9 “Debt (Related Party)” and Note 13 “Related Party Transactions” of the accompanying condensed consolidated financial statements for the three and nine months ended September 30, 2024 and 2023 included elsewhere in this Report.
Critical Accounting Policies and Estimates
Our critical accounting policies and estimates have not changed from those described in our 2023 Form 10-K, under “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Critical Accounting Policies and Estimates.”
Fair Value Measurements
We determine the fair value of financial assets and liabilities using the fair value hierarchy established in Accounting Standards Codification (“ASC”) Topic 820, Fair Value Measurement (“ASC 820”). ASC 820 identifies fair value as the exchange price, or exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. The hierarchy describes three levels of inputs that may be used to measure fair value, as follows:
| ● | Level 1 — Observable inputs, such as quoted prices in active markets for identical assets and liabilities. |
| ● | Level 2 — Observable inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. |
| ● | Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. |
Management uses valuation techniques in measuring the fair value of financial instruments, where active market quotes are not available.
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The following table summarizes the activity for our Level 3 instruments measured at fair value on a recurring basis (in thousands):
| Forward Purchase Agreement Warrant Liability | Forward Purchase Agreement Put Option Liability | |||||||
| Balance as of December 31, 2023 | $ | 4 | $ | 103 | ||||
| Change in fair value | 329 | (103 | ) | |||||
| Effect of amendment | 94 | — | ||||||
| Exercise of warrants | (16 | ) | — | |||||
| Balance as of September 30, 2024 | $ | 411 | $ | — | ||||
The fair values of the forward purchase agreement warrant liability and the forward purchase agreement put option liability were estimated using Monte Carlo Simulation models, which are Level 3 fair value measurements. Key estimates and assumptions impacting the fair value measurement include (i) the Company’s stock price, (ii) the initial exercise price, (iii) the remaining term and (iv) the risk-free rate.
Research and Development Expenses
We will incur substantial expenses associated with prototyping, improvements, testing and clinical trials. Accounting for clinical trials relating to activities performed by external vendors requires us to exercise significant estimates regarding the timing and accounting for these expenses. We estimate costs of R&D activities conducted by service providers, which include the conduct of sponsored research and contract manufacturing activities. The diverse nature of services being provided for our clinical trials and other arrangements, the different compensation arrangements that exist for each type of service and the lack of timely information related to certain clinical activities complicates the estimation of accruals for services rendered by third parties in connection with clinical trials. We record the estimated costs of R&D activities based upon the estimated amount of services provided but not yet invoiced and include these costs in the accrued expenses or prepaid expenses on the balance sheets and within R&D expense on the unaudited consolidated statements of operations and comprehensive (loss) income. In estimating the duration of a clinical study, we evaluate the start-up, treatment and wrap-up periods, compensation arrangements and services rendered attributable to each clinical trial and fluctuations are regularly tested against payment plans and trial completion assumptions.
We estimate these costs based on factors such as estimates of the work completed and budget provided and in accordance with agreements established with our collaboration partners and third-party service providers. We make significant judgments and estimates in determining the accrued liabilities and prepaid expense balances in each reporting period. As actual costs become known, we adjust our accrued liabilities or prepaid expenses. We have not experienced any material differences between accrued costs and actual costs incurred since our inception.
Our expenses related to clinical trials will be based on estimates of patient enrollment and related expenses at clinical investigator sites as well as estimates for the services received and efforts expended pursuant to contracts with multiple research institutions that may be used to conduct and manage clinical trials on our behalf. We will accrue expenses related to clinical trials based on contracted amounts applied to the level of patient enrollment and activity. If timelines or contracts are modified based upon changes in the clinical trial protocol or scope of work to be performed, we will modify our estimates of accrued expenses accordingly on a prospective basis.
Product Warranty
During 2013, we offered a lifetime warranty to clinical trial patients to cover battery and surgery related costs. We estimate the costs that may be incurred under this lifetime warranty and record a liability in the amount of such costs at its present value. The assumptions utilized in developing the liability include an estimated cost per unit of $6 thousand, an average battery life of 5 years, inflationary increases of 3.7%, discount rate, and an average patient life calculated on probabilities outlined in the PRI-2012 mortality tables, published from the Society of Actuaries. Additionally, a discount rate of 4.9% was used in the calculation as of September 30, 2024.
Recently Issued/Adopted Accounting Pronouncements
A discussion of recently issued accounting pronouncements and recently adopted accounting pronouncements is included in Note 2, “Summary of Significant Accounting Policies”, of our unaudited condensed consolidated financial statements included elsewhere in this Report.
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Emerging Growth Company
Section 102(b)(1) of the Jumpstart Our Business Startups Act (“JOBS Act”) exempts emerging growth companies from being required to comply with new or revised financial accounting standards until private companies (that is, those that have not had a Securities Act registration statement declared effective or no not have a class of securities registered under the Securities Exchange Act of 1934, as amended) are required to comply with the new or revised financial accounting standards. The JOBS Act provides that a company can elect to opt out of the extended transition period and comply with the requirements that apply to non-emerging growth companies but any such election to opt out is irrevocable. We have elected not to opt out of such extended transition period which means that when a standard is issued or revised and it has different application dates for public and private companies, we, as an emerging growth company, can adopt the new or revised standard at the time the private companies adopt the new or revised standard, until such time we are no longer considered to be an emerging growth company. At times, we may elect to early adopt a new or revised standard.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
We are a smaller reporting company as defined by Rule 12b-2 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) and are not required to provide the information otherwise required under this item.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Disclosure controls and procedures are designed to ensure that information required to be disclosed by us in our Securities Exchange Act of 1934, as amended (the “Exchange Act”) reports is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial officer or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.
Under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, we evaluated the effectiveness of our disclosure controls and procedures as of September 30, 2024, as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act. Based on the evaluation of our disclosure controls and procedures as of September 30, 2024, our Chief Executive Officer and Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were not effective due to the existence of the material weaknesses in the Company’s internal control over financial reporting described below.
Notwithstanding the conclusion by our Chief Executive Officer and Chief Financial Officer that our disclosure controls and procedures as of September 30, 2024 were not effective, and notwithstanding the material weaknesses in our internal control over financial reporting described below, management believes that the consolidated financial statements and related financial information included in this Quarterly Report on Form 10-Q fairly present in all material respects our financial condition, results of operations and cash flows as of the dates presented, and for the periods ended on such dates, in conformity with GAAP.
Material Weaknesses in Internal Control Over Financial Reporting
As previously disclosed in the Company’s Form 10-K as filed with the SEC on April 1, 2024, management concluded the following material weaknesses existed and such material weaknesses were in the process of being remediated as of September 30, 2024:
| ● | The Company does not maintain a sufficient complement of personnel with accounting knowledge, experience and training to appropriately analyze, record and disclose certain accounting matters to provide reasonable assurance of preventing material misstatements. |
| ● | The Company’s management does not implement a formal risk assessment that addresses risks relevant to financial reporting objectives, including cybersecurity and fraud risks. |
| ● | The Company has not designed, documented and maintained formal accounting policies, procedures and controls over significant accounts and disclosures to achieve complete, accurate and timely financial accounting, reporting and disclosures, including segregation of duties and adequate controls related to the preparation, posting, modification and review of journal entries. |
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| ● | The Company has not designed and maintained effective controls around the interpretation and accounting treatment of the valuation of a material liability and the forward purchase agreement. |
| ● | The Company has not designed and maintained effective controls over certain information technology general controls for information systems that are relevant to the preparation of its consolidated financial statements, including ineffective controls around user access and segregation of duties. |
Considering this, we performed additional procedures and analyses as deemed necessary to ensure that its financial statements were prepared in accordance with U.S. GAAP.
We have continued our implementation of a plan to remediate these material weaknesses. These remediation measures are ongoing and include the following steps:
| ● | hiring additional accounting and financial reporting personnel with appropriate technical accounting knowledge and public company experience in financial reporting; |
| ● | designing and implementing effective processes and controls over significant accounts and disclosure; |
| ● | designing and maintaining effective controls to ensure appropriate accounting for complex technical arrangements, such as the Forward Purchase Agreement; |
| ● | designing and implementing security management and change management controls over information technology systems, including adjusting user access levels and implementing external logging on activity and periodic review of such logs; and |
| ● | reviewing candidate accounting advisory firms to assist with the documentation, evaluation, remediation and testing of the Company’s internal control over financial reporting based on the criteria established in “Internal Control - Integrated Framework (2013)” issued by the Committee of Sponsoring Organizations of the Treadway Commission. |
Changes in Internal Control Over Financial Reporting
There was no change in our internal control over financial reporting that occurred during the fiscal quarter ended September 30, 2024 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
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PART II –OTHER INFORMATION
Item 1. Legal Proceedings
From time to time, we may be involved in various claims and legal actions in the ordinary course of business. We are not currently involved in any material legal proceedings outside the ordinary course of our business.
On November 14, 2023, the Company, Whitney Haring-Smith (the former chief executive officer and a former director of the Company), Daniel Hirsch (the former chief financial officer of the Company), and Anzu SPAC GP I LLC were named as defendants in a complaint filed by Atlas Merchant Capital SPAC Fund I LP (“Atlas”) in the Delaware Court of Chancery (the “Atlas Complaint”). The Atlas Complaint alleges that Atlas properly requested redemption of its shares of the Company’s Common Stock in connection with the Company’s business combination transaction and was prevented from redeeming such shares by the Company and the other defendants. Atlas seeks redemption of the shares of Common Stock in the amount of approximately $9.4 million, pre and post-judgment interest, costs, and reasonable attorneys’ fees. The Company has standard indemnification obligations to Dr. Haring-Smith and Mr. Hirsch. The Company believes that the lawsuit is meritless and has been defending this matter vigorously. The Company is unable to predict the outcome of this legal proceeding.
Item 1A. Risk Factors
As a smaller reporting company, we are not required to provide the information called for by this Item. However, for a discussion of the material risks, uncertainties and other factors that could have a material effect on us, please refer to the risk factors disclosed in the section of the Form 10-K titled “Risk Factors,” as filed with the SEC on April 1, 2024.
Item 2. Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchases of Equity Securities
During the fiscal quarter ended September 30, 2024, there were no unregistered sales of our securities that were not reported in a Current Report on Form 8-K.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
During
the fiscal quarter ended September 30, 2024, no director or officer of the Company
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Item 6. Exhibits
| * | Filed herewith |
| ** | Furnished herewith |
| # | Indicates management contract or compensatory plan or arrangement. |
| † | Certain schedules and exhibits to this Exhibit have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The Registrant agrees to furnish supplemental copies of all omitted exhibits and schedules to the Securities and Exchange Commission upon its request. |
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PART III – SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| Envoy Medical, Inc. | ||
| Date: November 14, 2024 | By: | /s/ Brent T. Lucas |
| Brent T. Lucas | ||
| Chief Executive Officer | ||
| (Principal Executive Officer) | ||
| Date: November 14, 2024 | By: | /s/ David R. Wells |
| David R. Wells | ||
| Chief Financial Officer | ||
| (Principal Financial and Accounting officer) | ||
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