ITEM 7. 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 Report, and other filings with the SEC. 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 Envoy Medical Corporation and (ii) after the Closing Date, to Envoy Medical,
Inc. The following discussion contains forward-looking statements based upon Envoy Medical’s current expectations that involve risks,
uncertainties, and assumptions. Our actual results may differ materially from those anticipated in these forward-looking statements as
a result of various factors, including those set forth under the section of this Report titled “Risk Factors” and/or elsewhere
in this Report. Our historical results are not necessarily indicative of the results that may be expected for any period in the future.
All dollar amounts are expressed in thousands of United States dollars (“$”), unless otherwise indicated.
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”), 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 the 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 over two decades of experience with our 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 that 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, like the Acclaim CI, 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, which we began in the first quarter of 2025. 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 by the FDA 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 predict the effects that changes to federal regulatory staffing, funding, and policies
and procedures will have on the timeline and ultimate FDA approval decision. As a result, 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 $20.8
million and $29.9 million for the years ended December 31, 2024 and December 31, 2023, respectively, and had an accumulated
deficit of $284.7 million and $257.3 million as of December 31, 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 proceeds from the Business Combination (see Note 1, “Nature of the Business and Basis of Presentation”
of the accompanying consolidated financial statements for the years ended December 31, 2024 and 2023 included elsewhere in this
Report). We expect to continue to incur net losses for the foreseeable future, and expect our research and development expenses, sales
and marketing 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:
● seek to maintain, protect, and expand our intellectual property portfolio;
● seek to identify, hire, and retain additional skilled personnel;
We expect that our financial
performance may fluctuate significantly from quarter-to-quarter and year-to-year due to the development status of our Acclaim CI product
and our efforts to obtain regulatory approval and commercialize the Acclaim CI product.
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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
Russia and Ukraine, the Middle East conflict, supply chain constraints, tariffs and trade wars, 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 Class A common stock
(“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, 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.
Upon commercialization of
our Acclaim CI 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 2027.
Cost of Goods Sold
Cost of goods sold includes
direct and indirect costs related to the manufacturing and distribution of the Esteem FI-AMEI, 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.
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Operating Expenses
Research and Development Expenses
Research and development
(“R&D”) expenses consist of costs incurred for our research activities, primarily our discovery efforts and the development
of the Acclaim CI 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:
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 years ended December 31, 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:
● 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.
A change in the outcome of
any of these variables with respect to the development of our Acclaim CI 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 product and prepare the product for possible commercialization, should it gain regulatory approval(s). If the
Acclaim CI 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 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.
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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 sales and marketing 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, insurance premiums, 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 expanding our operations and operating as a public company. These increases will likely include 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.
Change in Fair Value of Convertible Notes Payable
(Related Party)
We previously elected the
fair value option for convertible notes payable (related party), and accordingly, convertible notes payable (related party) were recorded
at fair value at each reporting date on the consolidated balance sheets. Gain (loss) from changes in fair value of convertible notes payable
consisted 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 Forward Purchase Agreement
Put Option Liability
We recognized the forward
purchase agreement put option liability at fair value at each reporting period. The liability is subject to re-measurement at each balance
sheet date, and any change in fair value is recognized in our consolidated statements of operations and comprehensive loss during each
reporting period. The forward purchase agreement put option liability has been derecognized as of December 31, 2024 due to the sale of
the shares associated with the forward purchase agreement during the first quarter of 2024.
Change in Fair Value of Forward Purchase Agreement
Warrant Liability
We recognize the forward
purchase agreement warrant liability at fair value at each reporting period. The liability is subject to re-measurement at each balance
sheet date, and any change in fair value is recognized in our consolidated statements of operations and comprehensive loss during each
reporting period.
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Change in Fair Value of Publicly Traded Warrant
Liability
We recognize the publicly
traded warrant liability at fair value at each reporting period. The liability is subject to re-measurement at each balance sheet date,
and any change in fair value is recognized in our consolidated statements of operations and comprehensive loss 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
Other income for the year ended December 31, 2024 consists of sales
of internally created quality management documentation to a third party outside of our normal course of business. Other income for the
year ended December 31, 2023 consists of changes in fair value of outstanding warrants prior to the closing of the Business Combination,
interest earned on cash deposits, and other nonrecurring items.
Results of Operations
Comparison of the Years Ended December 31,
2024 and 2023
Year ended December 31, Change in
(In thousands, except percentages) 2024 2023 $ %
Costs and operating expenses:
Other income (expense):
Interest expense, related party (816 ) — (816 ) N/M
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N/M - not meaningful
Net Revenues
Net revenues decreased $91
thousand for the year ended December 31, 2024, compared to the year ended December 31, 2023, primarily due to the decrease in
the number of Battery replacement sales due to supply chain limitations.
Cost of Goods Sold
Cost of goods sold decreased
$47 thousand for the year ended December 31, 2024 compared to the year ended December 31, 2023. The decrease is aligned with
the decrease in revenue resulting from the reduced number of Battery replacement sales.
Research and Development Expenses
The following table summarizes
the components of our R&D expenses for the years ended December 31, 2024 and 2023:
Years Ended December 31 Change in
(In thousands, except percentages) 2024 2023 $ %
R&D expenses increased
$1.2 million for the year ended December 31, 2024 compared to the year ended December 31, 2023. The increase is primarily due
to an increase in headcount and contractors in our engineering and clinical departments for the year ended December 31, 2024, as we increased
headcount across our clinical and cochlear departments in preparation for our pivotal clinical study for the Acclaim CI. These increases
in headcount included the addition of five new engineers, a clinical research associate, and a clinical research director. The increase
in Other R&D costs for the year ended December 31, 2024 is attributable to additional purchases of computer equipment and supplies
used in R&D and additional employee recruiting costs.
Sales and Marketing Expenses
Sales and marketing expenses
increased $68 thousand for the year ended December 31, 2024 compared to the year ended December 31, 2023. The increase is primarily
due to increased legal and professional fees to secure insurance reimbursement for the Esteem FI-AMEI product, partially offset by a reduction
in headcount.
General and Administrative Expenses
General and administrative
expenses decreased $438 thousand for the year ended December 31, 2024 compared to the year ended December 31, 2023. The decrease
is primarily due to reduced professional service costs in 2024 compared to 2023 related to the Business Combination transaction occurring
in September 2023.
Change in Fair Value of Convertible Notes Payable
(Related Party)
There was a loss from changes
in the fair value of convertible notes payable of $13.3 million for the year ended December 31, 2023. The notes payable were converted
to Common Stock as a result of the completion of our Business Combination during September 2023.
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Change in Fair Value of Forward Purchase Agreement
Put Option Liability
The gain from changes in
the fair value of the forward purchase agreement put option liability was $103 thousand for the year ended December 31, 2024 compared
to a loss of $69 thousand for the year ended December 31, 2023. During the first quarter of 2024, the shares associated with the
forward purchase agreement put option were sold.
Change in Fair Value of Forward Purchase Agreement
Warrant Liability
The gain from changes in
the fair value of the forward purchase agreement warrant liability was $411 thousand for the year ended December 31, 2024 compared
to $842 thousand for the year ended December 31, 2023.
Change in Fair Value of Forward Purchase Agreement
Warrant Liability Due to Modification
The loss from changes in
the fair value of the forward purchase agreement warrant liability due to modification was $881 thousand for the year ended December 31,
2024 compared to $0 for the year ended December 31, 2023. The loss was due to a modification to the forward purchase agreement in
December 2024 to extend the term of the warrants.
Change in Fair Value of Publicly Traded Warrant
Liability
The loss from changes in
the fair value of the publicly traded warrant liability was $330 thousand for the year ended December 31, 2024 compared to a gain
of $942 thousand for the year ended December 31, 2023. This decrease is primarily due to an increase in the Company’s closing price
for those warrants during the period.
Interest Expense, Related Party
Interest expense, related
party was $816 thousand for the year ended December 31, 2024 due to interest incurred related to the issuance of the 2024 Term Loans.
Other Income
Other income decreased by
$80 thousand for the year ended December 31, 2024 compared to the year ended December 31, 2023, primarily due to a reduction
in interest earned on cash deposits since the completion of the Business Combination transaction in September 2023 and amounts recorded
for the year ended December 31, 2023 related to changes in fair value of warrants and other items not recurring for the year ended December
31, 2024.
Liquidity and Capital Resources
Since inception, we have
incurred significant operating losses. We expect to continue to incur significant expenses and operating losses for the foreseeable future
as we advance the clinical development of our products and fund the process of clinical FDA trials. We have funded our operations to date
primarily with proceeds from raising funds from issuing equity securities, term loans, convertible notes and proceeds from the Business
Combination. As of December 31, 2024 and December 31, 2023, we had $5.5 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 issuances of our Common Stock, Series A preferred
stock (“Preferred Stock”), warrants, convertible debt, term debt and other financing agreements such as the forward purchase
agreement, and proceeds from the sales of the Esteem FI-AMEI implants and replacement components. See Note 1, “Nature of the
Business and Basis of Presentation”, of the accompanying audited consolidated financial statements for the years ended December 31,
2024 and 2023 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 our 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, 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 this Report 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):
Years Ended December 31
Net cash (used in) provided by:
Investing activities (980 ) (153 )
Effect of exchange rate on cash (5 ) (3 )
Cash Flows Used in Operating Activities
Net cash used in operating activities
for the year ended December 31, 2024 was primarily used to fund a net loss of $20.8 million and $0.6 million of cash outflows from
net changes in the levels of operating assets and liabilities, adjusted for non-cash expenses in an aggregate amount of $3.5 million.
The $0.6 million of cash outflows from net changes in the levels of operating
assets and liabilities was primarily due to decreases of 1) $0.2 million in accrued expenses due to payment of final expenses related
to the Business Combination, 2) $0.1 million in operating lease liability (related party) due to payments made for rent, and 3) $0.2 million
in product warranty liability due to expected attrition of this liability over time, as well as increases of 4) $0.4 million in inventories
related to the purchase of parts for the Esteem FI-AMEI product, 5) $0.6 million in other receivable due to the recognition of an incoming
income tax refund and 6) $0.9 million in other liability due to the receipt of a tax refund and corresponding recognition of an uncertain
tax benefit. 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 the section of this Report titled “Risk Factors.”
Net cash used in operating
activities for the year ended December 31, 2023 was primarily used to fund a net loss of $29.9 million and $1.0 million of cash outflows
from net changes in the level of operating assets and liabilities, adjusted for non-cash gains in an aggregate amount of $13.8 million.
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The $1.0 million of cash
outflows from net changes in the levels of operating assets and liabilities was primarily due to increases of 1) $0.2 million in other
receivable related to an income tax receivable, 2) $0.9 million in prepaid expenses and other current assets related to an increase in
prepaid insurance and 3) $0.6 million in accounts payable through normal business flows, offset by decreases of 4) $0.2 million in product
warranty liability due to expected attrition of this liability over time.
Cash Flows Used in Investing Activities
Net cash used in investing
activities for the year ended December 31, 2024 was $1.0 million and consisted of purchases of production equipment and lab equipment.
Net cash used in investing
activities for the year ended December 31, 2023 was $0.2 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 year ended December 31, 2024 was $20.2 million and was primarily a result of proceeds from the issuance of the
2024 Term Loans in the amount of $20.0 million, the exercise of warrants in the amount of $1.8 million, and the sale of Common Stock in
the amount of $1.7 million, partially offset by dividends paid to preferred stockholders in the amount of $2.4 million and payments made
on insurance financing loans of $0.9 million.
Net cash provided by financing
activities for the year ended December 31, 2023 was $21.3 million and was primarily a result of the $11.7 million net proceeds from
the Business Combination and from $10.0 million of proceeds from the issuance of convertible notes payable to a related party, partially
offset by payments made on insurance financing loans of $0.6 million.
Contractual Obligations and Commitments
Our principal commitments
consist of our operating leases for office space, a litigation matter arising from the Company’s Business Combination, and term loans
entered into during 2024 with GAT Funding, LLC in several installments totaling $20.0 million in outstanding principal as of December 31,
2024. Our obligations for leases are described in Note 7, “Operating Leases”, information on our open litigation matter
is included in Note 16, “Commitments and Contingencies”, and details on the term loans are described in Note 9, “Debt
(Related Party)” of the accompanying consolidated financial statements as of and for the years ended December 31, 2024 and
2023 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 receiving term loan financings, leasing our headquarters office space, contracting for IT services from a stockholder, and
receiving convertible loan financings from stockholders until September 29, 2023 at which point they were converted to Common Stock. For
further information on the related party arrangements, refer to Note 7, “Operating Leases”, Note 9, “Debt
(Related Party)” and Note 15, “Related Party Transactions”, of the accompanying consolidated financial statements
as of and for the years ended December 31, 2024 and 2023 included elsewhere in this Report.
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Critical Accounting Policies and Estimates
Our management’s discussion
and analysis of our financial condition and results of our operations is based on our consolidated financial statements and accompanying
notes, which have been prepared in accordance with accounting principles generally accepted in the United States. Certain amounts included
in or affecting the consolidated financial statements presented in this Form 10-K and related disclosure must be estimated, requiring
management to make assumptions with respect to values or conditions which cannot be known with certainty at the time the consolidated
financial statements are prepared. Management believes that the accounting policies set forth below comprise the most important “critical
accounting policies” for the Company. A “critical accounting policy” is one which is both important to the portrayal
of our financial condition and results of operations and that involves difficult, subjective, or complex judgments, often as a result
of the need to make estimates about the effect of matters that are inherently uncertain. Management evaluates such policies on an ongoing
basis, based upon historical results and experience, consultation with experts and other methods that management considers reasonable
in the particular circumstances under which the judgments and estimates are made, as well as management’s forecasts as to the manner
in which such circumstances may change in the future.
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:
Management uses valuation
techniques in measuring the fair value of financial instruments, where active market quotes are not available.
The following table summarizes
the activity for our Level 3 instruments measured at fair value on a recurring basis (in thousands):
Change in fair value (411 ) (103 )
Effect of amendments (see Note 10) 975 —
The fair values of the forward
purchase agreement put option liability and the forward purchase agreement warrant liability, which are Level 3 fair value measurements,
were estimated using Monte Carlo Simulation models. Key estimates and assumptions impacting the fair value measurement include (i) the
Company’s stock price, (ii) the initial exercise price, (iii) volatility, (iv) the remaining term and (v) the risk-free rate.
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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 accrued expenses or prepaid expenses
on the consolidated balance sheets and within R&D expense on the consolidated statements of operations and comprehensive loss. 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 five years, inflationary increases, discount
rate, and an average patient life calculated on probabilities outlined in the PRI-2012 mortality tables, published from the Society of
Actuaries.
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 granted through June 30, 2024 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 our stock was too
short to provide accurate data. The fair value of stock-based payment awards granted subsequent to June 30, 2024 is estimated using the
Black-Scholes option model with a volatility figure derived from using the trading history of our Common Stock. We account 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, Share-based Payment. 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.
65
We adopted the guidance from
Accounting Standards Update 2016-09, Compensation - Stock Compensation (Topic 718): Improvements to Employee Share-Based Compensation
Accounting, and we determined not to apply a forfeiture rate and have made the accounting election that forfeitures will be recognized
when the actual forfeiture takes place therefore no estimated forfeiture rate will be recorded.
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 the accompanying consolidated financial statements as of December 31, 2024 and 2023 and for the
years then ended included elsewhere in this Report.
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 7A. Quantitative and Qualitative Disclosures
About Market Risk
We are exposed to a variety
of market risks, including currency risk, credit and counterparty risk, and inflation risk, as set out below. We manage and monitor these
exposures to ensure appropriate measures are implemented in a timely and effective manner.
Currency Risk
Foreign currency risk is
the risk that the value of a financial instrument fluctuates because of the change in foreign exchange rates. We primarily operate in
the United States and Germany with most of the transactions settled in the United States dollar. Our presentation and functional currency
is the United States dollar. Certain bank balances, deposits and other payables are denominated in the Euro, which exposes us to foreign
currency risk. However, any transactions that may be conducted in foreign currencies are not expected to have a material effect on our
results of operations, financial position or cash flows.
Credit and Counterparty Risk
Financial instruments that
potentially expose us to concentrations of credit risk consist primarily of cash and accounts receivable, net. Periodically, we maintain
deposits in accredited financial institutions in excess of federally insured limits. We maintain cash with financial institutions that
management believes to be of high credit quality. We have not experienced any losses on such accounts and do not believe we are exposed
to any unusual credit risk beyond the normal credit risk associated with commercial banking relationships.
With respect to accounts
receivable, we perform credit evaluations of our customers and do not require collateral. There have been no material losses on accounts
receivable. There were no customers that accounted for 10% or more of sales for the years ended December 31, 2024 and 2023.
Inflation Risk
Inflationary factors, such
as increases in our cost of goods sold and selling and operating expenses, may adversely affect our operating results. Although we do
not believe that inflation has had a material impact on our financial position or results of operations to date, a high rate of inflation
in the future may have an adverse effect on our ability to maintain and increase our gross margin and decrease our selling and marketing
and operating expenses as a percentage of our revenue if the selling prices of our products do not increase as much as or more than these
increased costs.
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ITEM 8. Financial Statements and Supplementary
Data
Index to Consolidated Financial Statements
Envoy Medical, Inc.
December 31, 2024 and 2023
Page
Index to Consolidated Financial Statements F-1
Report of Independent Registered Public Accounting Firm - (Firm ID 248) F-2
Consolidated Balance Sheets as of December 31, 2024 and 2023 F-3
F-1
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING
FIRM
Board of Directors and Stockholders
Envoy Medical, Inc.
Opinion on the financial statements
We have audited the accompanying consolidated balance sheets of Envoy Medical, Inc. (a Delaware corporation) and subsidiaries (the “Company”)
as of December 31, 2024 and 2023, the related consolidated statements of operations and comprehensive loss, stockholders’ deficit,
and cash flows for each of the two years in the period ended December 31, 2024, and the related notes (collectively referred to as the
“consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material
respects, the financial position of the Company as of December 31, 2024 and 2023, and the results of its operations and its cash flows
for each of the two years in the period ended December 31, 2024, in conformity with accounting principles generally accepted in the United
States of America.
Going concern
The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed
in Note 2 to the financial statements, the Company has incurred cumulative losses from operations, has an accumulated deficit of $284.7
million as of December 31, 2024, and relies on external sources of liquidity to sustain operations. These conditions, along with other
matters set forth in Note 2, raise substantial doubt about the Company’s ability to continue as a going concern. Management’s
plans regarding these matters are also described in Note 2 to the consolidated financial statements. The consolidated financial statements
do not include any adjustments that might result from the outcome of this uncertainty.
Basis for opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an
opinion on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with
the Public Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to
the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange
Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company
is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of
internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s
internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error
or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding
the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant
estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide
a reasonable basis for our opinion.
/S/ GRANT THORNTON LLP
We have served as the Company’s auditor since 2023.
Fort Lauderdale, Florida
March 28, 2025
F-2
ENVOY MEDICAL, INC.
CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)
Assets
Current assets:
Accounts receivable, net 38 70
Prepaid expenses and other current assets 1,375 1,588
Property and equipment, net 1,275 351
Operating lease right-of-use asset (related party) 879 464
Liabilities and stockholders’ deficit
Current liabilities:
Other current liabilities 573 645
Forward purchase agreement warrant liability 472 4
Product warranty liability, current portion 282 311
Operating lease liability, current portion (related party) 143 158
Term loans payable (related party) 18,716 —
Product warranty liability, net of current portion 1,771 1,923
Operating lease liability, net of current portion (related party) 802 404
Publicly traded warrant liability 662 332
Forward purchase agreement put option liability — 103
Other liability 891 —
Commitments and contingencies (see Note 16)
Stockholders’ deficit:
Accumulated other comprehensive loss (123 ) (118 )
Total stockholders’ deficit (18,842 ) (1,776 )
Total liabilities and stockholders’ deficit $ 11,538 $ 8,271
F-3
ENVOY MEDICAL, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS
(In thousands, except share and per share amounts)
Year Ended December 31,
Costs and operating expenses:
Other income (expense):
Change in fair value of convertible notes payable (related party) — (13,332 )
Change in fair value of forward purchase agreement warrant liability 411 842
Change in fair value of publicly traded warrant liability (330 ) 942
Interest expense, related party (816 ) —
Other (expense) income (26 ) 54
Deemed dividend on waiver of restriction on Class A Common Stock (495 ) —
Cumulative preferred dividends (5,521 ) (1,349 )
Other comprehensive loss:
Foreign currency translation adjustment (5 ) (3 )
Other comprehensive loss (5 ) (3 )
F-4
ENVOY MEDICAL, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’
DEFICIT
(In thousands, except share amounts)