0001213900-24-043601.txt : 20240515 0001213900-24-043601.hdr.sgml : 20240515 20240515160825 ACCESSION NUMBER: 0001213900-24-043601 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 15 CONFORMED PERIOD OF REPORT: 20240515 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20240515 DATE AS OF CHANGE: 20240515 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Envoy Medical, Inc. CENTRAL INDEX KEY: 0001840877 STANDARD INDUSTRIAL CLASSIFICATION: ORTHOPEDIC, PROSTHETIC & SURGICAL APPLIANCES & SUPPLIES [3842] ORGANIZATION NAME: 08 Industrial Applications and Services IRS NUMBER: 861369123 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-40133 FILM NUMBER: 24950580 BUSINESS ADDRESS: STREET 1: 4875 WHITE BEAR PARKWAY CITY: WHITE BEAR LAKE STATE: MN ZIP: 55110 BUSINESS PHONE: 651-361-8000 MAIL ADDRESS: STREET 1: 4875 WHITE BEAR PARKWAY CITY: WHITE BEAR LAKE STATE: MN ZIP: 55110 FORMER COMPANY: FORMER CONFORMED NAME: Anzu Special Acquisition Corp I DATE OF NAME CHANGE: 20210115 8-K 1 ea0206113-8k_envoymed.htm CURRENT REPORT
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): May 15, 2024

 

 

 

ENVOY MEDICAL, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-40133   86-1369123
(State or other jurisdiction
of incorporation)		   (Commission File Number)   (IRS Employer
Identification No.)

 

4875 White Bear Parkway
White Bear Lake, MN		   55110
(Address of principal executive offices)   (Zip Code)

 

Registrant’s telephone number, including area code: (877) 900-3277

 

Not Applicable

(Former name or former address, if changed since last report)

 

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol(s)   Name of each exchange on which registered
Class A Common Stock, par value $0.0001 per share   COCH   The Nasdaq Stock Market LLC
Redeemable Warrants, each whole Warrant
exercisable for one share of Class A Common Stock at an exercise price of $11.50 per share		   COCHW   The Nasdaq Stock Market LLC

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

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. ☐

 

 

 

 

 

 

Item 2.02. Results of Operations and Financial Condition.

 

On May 15, 2024, Envoy Medical, Inc. (the “Company”), issued a press release regarding the Company’s financial results for its first fiscal quarter ended March 31, 2024. A copy of the Company’s press release is attached hereto as Exhibit 99.1.

 

The information in this Item 2.02, including the accompanying exhibit, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section. The information in this Item 2.02 shall not be incorporated into any filing pursuant to the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit

Number

   Description
99.1   Press Release dated May 15, 2024
104   Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

1

 

 

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 hereunto duly authorized.

 

  ENVOY MEDICAL, INC.
     
May 15, 2024 By: /s/ David R. Wells
    David R. Wells
    Chief Financial Officer

 

 

2

 

 EX-99.1 2 ea020611302ex99-1_envoymed.htm PRESS RELEASE DATED MAY 15, 2024

Exhibit 99.1

 

Envoy Medical Reports First Quarter 2024 Results

 

The Company, a current leader in fully implanted hearing devices, continues to steadily march towards its ambition of disrupting the existing cochlear implant industry with its “breakthrough” fully implanted cochlear implant.

 

WHITE BEAR LAKE, Minn., May 15, 2024 (GLOBE NEWSWIRE) -- Envoy Medical®, Inc. (“Envoy Medical”) (Nasdaq: COCH), a revolutionary hearing health company focused on fully implanted hearing devices, today announces its corporate and financial results for the first quarter ended March 31, 2024.

 

Financial and Corporate Highlights from Q1 2024

 

●All three participants in the ongoing Early Feasibility Study (EFS) at Mayo Clinic (Rochester, MN) have completed their 12-month follow up visits, continue to be enrolled in the study, and report using their devices on a daily basis.

 

●Company continues to field growing interest from both hearing health professionals and potential candidates about its investigational fully implanted cochlear implant. Company likely will have to turn away several leading cochlear implant institutions that have expressed interest in participating as a site in its next clinical study.

 

●Company continues to advocate for its commercial Esteem® device, a fully implanted active middle ear implant, to be properly classified as a hearing prosthetic and not improperly as a hearing aid. The bi-partisan Hearing Device Coverage Clarification Act (H.R. 7254) has added co-sponsors and has continued to get attention.

 

●

Envoy Medical plans to file its application for an investigational device exemption (IDE) to begin its fully implanted cochlear implant pivotal clinical trial later in 2024. The Company filed an earlier version of an IDE application at the end of Q1, but decided to convert that IDE application to a “pre-submission” (sometimes referred to as a Q-submission). Strategically, this conversion allows for additional data collection on the three EFS participants, pending testing to be completed, and further interactive discussions with FDA.

 

●

Upon FDA approval, should it be granted, Envoy Medical intends to target a portion of the significantly under-penetrated adult cochlear implant market in the United States.

 

●In March, the Company entered into a $10 million, five-year lending facility provided by existing investor and billionaire entrepreneur Glen Taylor. The facility is unsecured and does not provide for conversion into equity. Envoy Medical drew an initial $5 million on the facility at its origination.   It is expected that the financing will support, among other things, the process of applying for an investigational device exemption (IDE) to begin a US-based pivotal clinical trial for its breakthrough fully implanted Acclaim® cochlear implant. The terms ensure the long-term commitment of Envoy Medical’s largest investor, instilling confidence in the Company’s direction and long-term positioning. Funds will be available as needed and bear interest at 8% over the term of the loan.

 

“Envoy Medical continues to make steady progress towards our goal of becoming a household name in the hearing loss market,” commented Brent T. Lucas, Envoy Medical’s Chief Executive Officer. “We strongly believe that Envoy Medical has a bright future ahead of it. We look forward to the prospect of disrupting the hearing industry with new competition and significant innovation.”

 

Financial Results for the Quarter Ended March 31, 2024

 

Revenue was $59 thousand compared to $78 thousand for the same period in 2023, the decrease is primarily due to a decrease in the number of battery replacement requests received during the three months ended March 31, 2024.

 

R&D expenses increased approximately $0.4 million for the three months ended March 31, 2024 compared to the three months ended March 31, 2023. The increase is primarily due to an increase in personnel and salary costs for the three months ended March 31, 2024, as we increased headcount across our clinical and engineering departments in preparation for our pivotal clinical study for the Acclaim Cochlear Implant (“Acclaim CI”).

 

 

 

 

Sales and marketing expenses decreased by $46 thousand for the three months ended March 31, 2024 as compared to the three months ended March 31, 2023. The decrease was due to a reduction in headcount.

 

General and administrative expenses increased by $0.7 million for the three months ended March 31, 2024 as compared to the three months ended March 31, 2023. The increase is primarily due to a $0.2 million increase in the cost of insurance coverage, and a $0.3 million increase in personnel-related costs, as we increased headcount in preparation for anticipated future growth, clinical study, and potential commercialization of the Acclaim CI.

 

As of March 31, 2024, cash and cash equivalents were approximately $4.9 million.

 

About the Fully Implanted Acclaim® Cochlear Implant

 

The Company believes the fully implanted Acclaim CI will be a first-of-its-kind fully implanted 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 is expected to be indicated for adults who have been deemed adequate candidates by a qualified ear surgeon and audiologist.

 

The Acclaim Cochlear Implant received the Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) in 2019.

 

CAUTION The fully implanted Acclaim Cochlear Implant is an investigational device. Limited by United States law to investigational use.

 

About the Esteem® Fully Implanted Active Middle Ear Implant (FI-AMEI)

 

The Esteem fully implanted active middle ear implant (FI-AMEI) is the only FDA-approved, fully implanted hearing device for adults diagnosed with moderate to severe sensorineural hearing loss capable of delivering 24/7 hearing capability using the ear’s natural anatomy. The Esteem FI-AMEI requires no externally worn components and nothing is placed in the ear canal for it to function.* Unlike hearing aids, you never put it on or take it off.

 

*Once activated, the external Esteem FI-AMEI Personal Programmer is not required for daily use.

 

Important safety information for the Esteem FI-AMEI can be found at: https://www.envoymedical.com/safety-information.

 

Additional Information and Where to Find It

 

Copies of the documents filed by Envoy Medical with the SEC may be obtained free of charge at the SEC’s website at www.sec.gov.

 

2

 

 

Forward-Looking Statements

 

This press release includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-Looking statements may be identified by the use of words such as “estimate,” “plan,” “project,” “forecast,” “intend,” “will,” “expect,” “anticipate,” “believe,” “seek,” “target” or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters, but the absence of these words does not mean that a statement is not forward-looking. Such statements may include, but are not limited to, statements regarding the expectations of Envoy Medical concerning the outlook for its business, productivity, plans and goals for future operational improvements and capital investments, the availability and benefits of future funding, the Acclaim CI being the first to market fully implanted cochlear implant, the timing of Envoy Medical’s IDE submission and beginning of its clinical trial, the impact of proposed legislation on the hearing health market, reimbursement for the Esteem FI-AMEI device, and the Envoy Medical business, and future market conditions or economic performance, as well as any information concerning possible or assumed future operations of Envoy Medical. The forward-looking statements contained in this press release reflect Envoy Medical’s current views about future events and are subject to numerous known and unknown risks, uncertainties, assumptions and changes in circumstances that may cause its actual results to differ significantly from those expressed in any forward-looking statement. Envoy Medical does not guarantee that the transactions and events described will happen as described (or that they will happen at all). These forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to changes in the market price of shares of Envoy Medical’s Class A Common Stock; Envoy Medical’s success in retaining or recruiting, or changes required in, its officers, key employees or directors; unpredictability in the medical device industry, the regulatory process to approve medical devices, and the clinical development process of Envoy Medical products; 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 Envoy Medical’s suppliers, or disruptions in Envoy Medical’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 Envoy Medical; a loss of any of Envoy Medical’s key intellectual property rights or failure to adequately protect intellectual property rights; the effects of catastrophic events, including war, terrorism and other international conflicts; and other risks and uncertainties set forth in the section entitled “Risk Factors” and “Cautionary Note Regarding Forward Looking Statements” in the Annual Report on Form 10-K filed by Envoy Medical on April 1, 2024, and in other reports Envoy Medical files with the SEC. If any of these risks materialize or Envoy Medical’s assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. While forward-looking statements reflect Envoy Medical’s good faith beliefs, they are not guarantees of future performance. Envoy Medical disclaims any obligation to publicly update or revise any forward-looking statement to reflect changes in underlying assumptions or factors, new information, data or methods, future events or other changes after the date of this press release, except as required by applicable law. You should not place undue reliance on any forward-looking statements, which are based only on information currently available to Envoy Medical. 

 

Investor Contact:
CoreIR
516-222-2560
investorrelations@envoymedical.com

 

3

 

 

ENVOY MEDICAL, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
(In thousands, except share and per share amounts)

 

 

   March 31,
2024		   December 31,
2023		 
Assets        
Current assets:        
Cash  $4,945   $4,218 
Accounts receivable   189    70 
Other receivables   32    176 
Inventories   1,455    1,404 
Prepaid expenses and other current assets   1,109    957 
Total current assets   7,730    6,825 
Property and equipment, net   317    351 
Operating lease right-of-use assets (related party)   433    464 
Total assets  $8,480   $7,640 
           
Liabilities and stockholders’ deficit          
Current liabilities:          
Accounts payable  $913   $1,554 
Accrued expenses   5,621    4,613 
Product warranty liability, current portion   305    311 
Operating lease liabilities (related party), current portion   157    158 
Total current liabilities   6,996    6,636 
Term loan payable (related party)   4,821    — 
Product warranty liability, net of current portion   1,923    1,923 
Operating lease liabilities (related party), net of current portion   378    404 
Publicly traded warrant liability   1,509    332 
Forward purchase agreement put option liability   —    103 
Forward purchase agreement warrant liability   266    4 
Total liabilities   15,893    9,402 
           
Commitments and contingencies (see Note 14)          
           
Stockholders’ deficit:          
Series A Preferred Stock, $0.0001 par value; 10,000,000 shares authorized as of March 31, 2024 and December 31, 2023, respectively; 4,500,000 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively   —    — 
Class A Common Stock, $0.0001 par value; 400,000,000 shares authorized as of March 31, 2024 and December 31, 2023 respectively; 19,599,982 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively   2    2 
Additional paid-in capital   257,581    255,596 
Accumulated deficit   (264,877)   (257,242)
Accumulated other comprehensive loss   (119)   (118)
Total stockholders’ deficit   (7,413)   (1,762)
Total liabilities and stockholders’ deficit  $8,480   $7,640 

 

4

 

 

ENVOY MEDICAL, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(UNAUDITED)
(In thousands, except share and per share amounts)

 

   Three Months Ended
March 31,		 
   2024   2023 
Net revenues  $59   $78 
Cost and operating expenses:          
Cost of goods sold   153    175 
Research and development   2,360    1,927 
Sales and marketing   325    371 
General and administrative   2,119    1,376 
Total costs and operating expenses   4,957    3,849 
Operating loss   (4,898)   (3,771)
           
Other income (expense):          
Loss from changes in fair value of convertible notes payable (related party)   —    (9,377)
Change in fair value of forward purchase agreement put option liability   103    — 
Change in fair value of forward purchase agreement warrant liability   (262)   — 
Change in fair value of publicly traded warrant liability   (1,177)   — 
Interest expense, related party   (36)   — 
Other expense   —    (105)
Total other expense, net   (1,372)   (9,482)
Net loss  $(6,270)  $(13,253)
           
Net loss attributable to common stockholders, basic and diluted  $(6,270)  $(13,253)
Net loss per share attributable to common stockholders, basic and diluted  $(0.32)  $(1.31)
           
Weighted-average common stock outstanding, basic and diluted   19,599,982    10,122,581 
           
Other comprehensive loss:          
Foreign currency translation adjustment   (1)   — 
Other comprehensive loss   (1)   — 
Comprehensive loss  $(6,271)  $(13,253)

 

5

 

 

ENVOY MEDICAL, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
(In thousands)

 

   Three Months Ended
March 31,		 
   2024   2023 
Cash flows from operating activities        
Net loss  $(6,270)  $(13,253)
Adjustments to reconcile net loss to net cash used in operating activities:          
Depreciation   34    27 
Stock-based compensation   123    — 
Change in fair value of convertible notes payable (related party)   —    9,377 
Change in fair value of warrant liability (related party)   —    104 
Change in fair value of publicly traded warrant liability   1,177    — 
Change in fair value of forward purchase agreement warrant liability   262    — 
Change in fair value of forward purchase agreement put option liability   (103)   — 
Change in operating lease right-of-use assets (related party)   31    22 
Change in inventory reserve   89    (14)
Changes in operating assets and liabilities:          
Accounts receivable, net   (119)   (22)
Other receivables   144    28 
Inventories   (140)   — 
Prepaid expenses and other current assets   (43)    (37)
Accounts payable   (641)   1,018 
Operating lease liabilities (related party)   (27)   (19)
Accrued expenses   (357)   (180)
Product warranty liability   (6)   (62)
Net cash used in operating activities  $(5,846)  $(3,011)
           
Cash flows from investing activities          
Purchases of property and equipment   —    (59)
Deposit on equipment not yet placed in service   (109)   — 
Net cash used in investing activities  $(109)  $(59)
           
Cash flows from financing activities          
Proceeds from the issuance of convertible notes payable (related party)   —    4,000 
Proceeds from the issuance of term loan (related party)   5,000    — 
Proceeds from the sale of common stock associated with the forward purchase agreement, net of transaction costs   1,683    — 
Net cash provided by financing activities  $6,683   $4,000 
           
Effect of exchange rate changes on cash   (1)   1 
Net increase in cash   727    931 
Cash, beginning of year   4,218    183 
Cash, end of year  $4,945   $1,114 
           
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  $—   $1,952 
Dividends on Series A Preferred Shares  $1,365   $— 

 

 

6

 

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