UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
(Mark One)
☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31,2023
or
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from ______ to ______
Commission File Number 001-40133
(Exact name of registrant as specified in its charter)
| Delaware | 86-1369123 |
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| (State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) |
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4875 White Bear Parkway, White Bear Lake, MN 55110
(Address of principal executive offices)
(877) 900-3277
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
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| Class A Common Stock, par value $0.0001 per share | COCH | The Nasdaq Stock Market LLC |
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| Redeemable Warrants, each exercisable for one share of Class A Common Stock at an exercise price of $11.50 per share | COCHW | The Nasdaq Stock Market LLC |
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Securities registered pursuant to Section 12(g) of the Act: None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐No ☒
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐No ☒
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large Accelerated Filer | ☐ | Accelerated Filer | ☐ |
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| Non-accelerated Filer | ☒ | Smaller Reporting Company | ☒ |
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| Emerging Growth Company | ☒ |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.☐
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.☐
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements.☒
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b).☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes☐ No☒
The aggregate market value of the registrant’s Class A common stock, par value $0.0001 per share, held by non-affiliates of the registrant computed by reference to the last sales price of such stock, as of the last business day of the registrant’s most recently completed second fiscal quarter, which was June 30, 2023, was approximately $44.2 million. This calculation excludes shares of Class A common stock held by the registrant’s officers and directors and each person known by the registrant to beneficially own more than 5% of the registrant’s outstanding shares, as such persons may be deemed to be affiliates. This determination of affiliate status should not be deemed conclusive for any other purpose.
There were 19,599,982 shares of the registrant’s Class A common stock, par value $0.0001 per share, outstanding as of March 27, 2024.
Annual Report on Form 10-K
For the Year Ended December 31, 2023
Table of Contents
| Page |
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| PART I |
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| ITEM 1. | Business | 1 |
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| ITEM 1A. | Risk Factors | 24 |
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| ITEM 1B. | Unresolved Staff Comments | 46 |
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| ITEM 1C. | Cybersecurity | 46 |
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| ITEM 2. | Properties | 46 |
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| ITEM 3. | Legal Proceedings | 47 |
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| ITEM 4. | Mine Safety Disclosures | 47 |
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| PART II |
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| ITEM 5. | Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | 48 |
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| ITEM 6. | [Reserved] | 48 |
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| ITEM 7. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 49 |
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| ITEM 7A. | Quantitative and Qualitative Disclosures About Market Risk | 60 |
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| ITEM 8. | Financial Statements and Supplementary Data | F-1 |
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| ITEM 9. | Changes in and Disagreements with Accountants on Accounting and Financial Disclosure | 61 |
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| ITEM 9A. | Controls and Procedures | 61 |
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| ITEM 9B. | Other Information | 62 |
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| ITEM 9C. | Disclosure Regarding Foreign Jurisdictions that Prevent Inspections | 62 |
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| PART III |
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| ITEM 10. | Directors, Executive Officers and Corporate Governance | 63 |
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| ITEM 11. | Executive Compensation | 70 |
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| ITEM 12. | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | 74 |
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| ITEM 13. | Certain Relationships and Related Transactions, and Director Independence | 76 |
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| ITEM 14. | Principal Accounting Fees and Services | 81 |
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| PART IV |
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| ITEM 15. | Exhibits and Financial Statement Schedules | 82 |
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CERTAIN TERMS
Unless otherwise stated in this Annual Report on Form 10-K (this “Report”), or the context otherwise requires, references to:
| ● | “A&R Registration Rights Agreement” means the Amended and Restated Registration Rights and Lock-Up Agreement, dated as of September 29, 2023, by and among Anzu, the Sponsor, certain shareholders of Legacy Envoy and certain other stockholders of Anzu; |
| ● | “Acclaim CI” means the Acclaim® fully implantable cochlear implant; |
| ● | “Anzu” means Anzu Special Acquisition Corp I, a Delaware corporation, which was renamed “Envoy Medical, Inc.” upon the closing of the Business Combination; |
| ● | “Anzu Class A Common Stock” means Anzu’s Class A common stock, par value $0.0001 per share, prior to the closing of the Business Combination; |
| ● | “Anzu Class B Common Stock” means Anzu’s Class B common stock, par value $0.0001 per share; |
| ● | “Board” means the board of directors of the Company; |
| ● | “Business Combination” means the Merger and the other transactions contemplated by the Business Combination Agreement; |
| ● | “Business Combination Agreement” means the Business Combination Agreement, dated as of April 17, 2023, as amended by Amendment No. 1 to the Business Combination Agreement, dated May 12, 2023, and Amendment No. 2 to the Business Combination Agreement, dated August 31, 2023, by and among Anzu, Merger Sub and Legacy Envoy; |
| ● | “Bylaws” means the amended and restated bylaws of the Company; |
| ● | “Charter” means the second amended and restated certificate of incorporation of the Company; |
| ● | “Class A Common Stock” means the Company’s Class A common stock, par value $0.0001 per share; |
| ● | “Closing” means the closing of the Merger; |
| ● | “DGCL” means the Delaware General Corporation Law, as amended; |
| ● | “Effective Time” means the effective time of the Merger; |
| ● | “Esteem FI-AMEI” means the Esteem® fully implanted active middle ear implant (FI-AMEI); |
| ● | “Exchange Act” means the Securities Exchange Act of 1934, as amended; |
| ● | “Forward Purchase Agreement” means the Forward Purchase Agreement, dated April 17, 2023, as amended by Amendment No. 1 to the Forward Purchase Agreement, dated as of May 25, 2023, and Amendment No. 2 to the Forward Purchase Agreement, dated as of September 28, 2023, by and among Anzu, Legacy Envoy and the Meteora FPA Parties; |
| ● | “GAAP” means accounting principles generally accepted in the United States; |
| ● | “IPO” means Anzu’s initial public offering of units; |
| ● | “JOBS Act” means the Jumpstart Our Business Startups Act of 2012, as amended; |
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| ● | “Legacy Envoy” means Envoy Medical Corporation, a Minnesota corporation, prior to the closing of the Business Combination; |
| ● | “Legacy Envoy Common Stock” means Legacy Envoy’s common stock, par value $0.01 per share; |
| ● | “Legacy Envoy Preferred Stock” means Legacy Envoy’s preferred stock, par value $0.01 per share; |
| ● | “Merger” means the merger of Merger Sub with and into Legacy Envoy, with Legacy Envoy surviving as a wholly owned subsidiary of Anzu, pursuant to the terms of the Business Combination Agreement; |
| ● | “Merger Sub” means Envoy Merger Sub, Inc., a Delaware corporation and a wholly owned subsidiary of Anzu; |
| ● | “Meteora FPA Parties” means Meteora Special Opportunity Fund I, LP, Meteora Capital Partners, LP, Meteora Select Trading Opportunities Master, LP and Meteora Strategic Capital, LLC; |
| ● | “Nasdaq” means The Nasdaq Capital Market; |
| ● | “Public Warrants” means warrants issued by Anzu as part of the IPO; |
| ● | “Sarbanes-Oxley Act” means the Sarbanes-Oxley Act of 2002, as amended; |
| ● | “SEC” means the Securities and Exchange Commission; |
| ● | “Securities Act” means the Securities Act of 1933, as amended; |
| ● | “Series A Preferred Stock” means the Company’s Series A convertible preferred stock, par value $0.0001 per share; |
| ● | “Shortfall Warrants” means warrants issued to the Meteora FPA Parties for no additional consideration pursuant to the Forward Purchase Agreement; |
| ● | “Sponsor” means Anzu SPAC GP I LLC, a Delaware limited liability company and an affiliate of certain of Anzu’s officers and directors; |
| ● | “Subscription Agreement” means the subscription agreement, dated as of April 17, 2023, as amended by Amendment No. 1 to the Subscription Agreement, dated as of May 12, 2023, and Amendment No. 2 to the Subscription Agreement, dated as of August 23, 2023, by and between Anzu and the Sponsor; and |
| ● | “Warrants” means the Public Warrants and Shortfall Warrants. |
Additionally, references in this Report to the “Company,” the “registrant,” “Envoy Medical,” “we,” “us” and “our” in this Report refer to Envoy Medical, Inc. (formerly known as Anzu Special Acquisition Corp I), and references to our “management” or our “management team” refer to our officers and directors, other than certain historical information which refers to Legacy Envoy prior to the consummation of the Business Combination.
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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 and Section 21E of 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. 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:
| ● | The Company’s performance following the Business Combination; |
| ● | Changes in the market price of shares of our Class A Common Stock after the Business Combination, which may be affected by factors different from those that affected the price of shares of Anzu Class A 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; |
| ● | 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; |
| ● | The Company’s ability to realize some or all of the anticipated benefits of the Business Combination; |
| ● | 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; |
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| ● | The Company’s ability to maintain the listing of its securities on Nasdaq following the Business Combination; |
| ● | The effects of catastrophic events, including war, terrorism and other international conflicts; and |
| ● | Other risks and uncertainties indicated in this Report, 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.
Summary Risk Factors
Our Company is subject to numerous risks described inItem 1A. Risk Factors and elsewhere in this Report. You should carefully consider these risks before making an investment. Some of these risks relating to our business objectives, our organization and structure and our securities include:
| ● | We are an early-stage company with a history of losses. We have not been profitable historically and may not be able to achieve profitability in the future. |
| ● | We have generated limited revenue from product sales and may never be profitable. |
| ● | If the Acclaim CI contains design or manufacturing defects, our business and financial results could be harmed. |
| ● | We expect that we will need to raise substantial additional funding, which may not be available on acceptable terms, or at all. Failure to obtain funding on acceptable terms and on a timely basis may require us to curtail, delay or discontinue our product development efforts or other operations. |
| ● | Raising additional capital would cause dilution to our existing stockholders and may adversely affect the rights of existing stockholders. |
| ● | Failure of a key information technology system, process or site could have an adverse effect on our business. |
| ● | We have identified material weaknesses in our internal control over financial reporting. If we are unable to remediate these material weaknesses, or if we identify additional material weaknesses in the future or otherwise fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately or timely report our financial condition or results of operations, which may adversely affect investor confidence in us and the value of our stock. |
| ● | Our financial statements contain an explanatory paragraph regarding substantial doubt about our ability to continue as a going concern, which could prevent us from obtaining new financing on reasonable terms or at all. |
| ● | Clinical failure can occur at any stage of clinical development. Our clinical experience to date does not necessarily predict future results and may not have revealed certain potential limitations of the technology or potential complications from the Acclaim CI and may require further clinical validation. Any product version we advance through clinical trials may not have favorable results in later clinical trials or receive regulatory approval. |
| ● | The successful commercialization of the Acclaim CI, if it receives FDA approval, will depend in part on the extent to which governmental authorities and health insurers establish coverage, adequate reimbursement levels and favorable pricing policies. Failure to obtain or maintain coverage and adequate reimbursement for our product candidates could limit our ability to market those products and decrease our ability to generate revenue. |
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| ● | We operate in a very competitive business environment, and if we are unable to compete successfully against our existing or potential competitors, our business, financial condition and results of operations may be adversely affected. |
| ● | We expect to derive most of our revenues from sales of the Acclaim CI. Our inability to successfully commercialize this product candidate, or any subsequent decline in demand for this product candidate, could severely harm our ability to generate revenues. |
| ● | If healthcare professionals do not recommend the Acclaim CI to their patients, the Acclaim CI may not achieve market acceptance and we may not become profitable. |
| ● | We will be dependent upon contract manufacturing organizations and material suppliers, making us vulnerable to supply shortages and problems, increased costs and quality or compliance issues, any of which could harm our business. |
| ● | Our business plan relies on certain assumptions about the market for our product; however, the size and expected growth of our addressable market has not been established with precision and may be smaller than we estimate, and even if the addressable market is as large as we estimate, we may not be able to capture market share. |
| ● | We depend on third parties to manage our pre-clinical studies and clinical trials, perform related data collection and analysis, and to enroll patients for our clinical trials, and, as a result, we may face costs and delays that are beyond our control. |
| ● | We are highly dependent on key members of our executive management team. Our inability to retain these individuals could impede our business plan and growth strategies, which could have a negative impact on our business and the value of your investment. |
| ● | The market price of our Class A Common Stock and Public Warrants has been and may continue to be extremely volatile, which could cause purchasers of our securities to incur substantial losses. |
| ● | While we will pay dividends on shares of Series A Preferred Stock pursuant to the Certificate of Designation, we do not intend to pay dividends on shares of Class A Common Stock for the foreseeable future. |
| ● | We have been and in the future may become a defendant in one or more stockholder derivative, class-action and other litigation, and any such lawsuits may adversely affect our business, financial condition, results of operations and cash flows. |
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