Envoy Medical®, Inc. (“Envoy Medical”) (Nasdaq: COCH), a
revolutionary hearing health company focused on fully implanted
hearing devices, today announced its corporate and financial
results for the fourth quarter and full year ended December 31,
2023.
Financial and Corporate Highlights from Q4 2023 to
Date
- Completed Business Combination transaction at the end of
September and began trading on Nasdaq under its own ticker, COCH,
the first week of October 2023.
- Secured up to $10 million in non-convertible, unsecured debt
financing at the beginning of 2024 from billionaire entrepreneur
Glen Taylor – a multi-decade shareholder, largest investor, and
current Director.
- Investigational Fully Implanted Acclaim® Cochlear Implant
(Acclaim® CI):
- Early Feasibility Study (EFS) continues to meet milestones with
all three implanted patients surpassing twelve-month
post-activation visits remaining implanted.
- Announced four additional patents which brings the Company’s
total to 30 issued U.S. patents, 16 pending U.S. patent
applications, 12 issued foreign patents and 28 pending foreign and
international patent applications for both products.
- Esteem® Fully Implanted Active Middle Ear Implant (FI-AMEI):
- Continued efforts to address improper classification of fully
implanted active middle ear implants (FI-AMEI) as hearing aids have
resulted in the introduction of bipartisan Congressional bill –
Hearing Device Coverage Clarification Act (H.R. 7254) – in the
House of Representatives.
- The bipartisan bill aims to rectify the classification issue by
removing FI-AMEIs from the broad hearing aid exclusion imposed by
Centers for Medicare and Medicaid Services (CMS) and properly
designating them as fully implanted active middle ear implants –
thereby making them eligible for coverage as hearing
prosthetics.
“The year 2023 will be one to remember in our ambitious journey
to becoming the leading hearing implant company in the world: we
saw our first podium presentation on the Acclaim® implant in June;
completed a business combination in September; began trading as a
public company under the ticker symbol “COCH” on the Nasdaq in
October; and all three patients in the early feasibility study
completed twelve months of post-activation follow-up in December,”
commented Brent Lucas, Envoy Medical’s CEO. “We are moving forward
with our plans and hope to start our pivotal clinical trial for the
fully implanted Acclaim® cochlear implant in 2024. We are also
excited about the Esteem® FI-AMEI implant’s future and look forward
to providing more updates with our progress in 2024. It is an
exciting time to be in the hearing implant business and we hope
savvy investors start to pay more attention to the space.”
Financial Results from YE 2023
Revenue increased $79,000 for the twelve months ended December
31, 2023, compared to the same period in 2022, driven by growth in
replacement component sales.
R&D expenses increased approximately $4.0 million for the
year ended December 31, 2023, compared to the previous year. The
increase was driven by an increase of $3.0 million in R&D
product costs for the year ended December 31, 2023, as the Company
continued to optimize its fully implanted cochlear implant product
in preparation for the pivotal clinical study. Additionally, there
was an increase of $0.9 million in personnel and salary costs as
the Company increased headcount across the clinical and cochlear
R&D department.
Sales and marketing expenses increased $0.8 million for the year
ended December 31, 2023 compared to the same period in 2022. The
increase was primarily due to market access efforts related to the
Esteem FI-AMEI product, a gradual increase of activity around the
investigational Acclaim CI product, and more activity around name
recognition of Envoy Medical among both end users and
professionals.
General and administrative expenses increased $4.7 million for
the year ended December 31, 2023 compared to prior year. The
increase is primarily due to a $2.8 million rise in professional
and legal fees in 2023 related to the finalization of the Business
Combination in the third quarter of 2023. Additionally, there was a
$1.6 million increase in personnel-related costs for the year ended
December 31, 2023 as the Company expanded its headcount in
preparation for going public.
As of December 31, 2023 cash and cash equivalents were
approximately $4.2 million.
About the Fully Implanted Acclaim® Cochlear
Implant
The Company believes the fully implanted Acclaim Cochlear
Implant (“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.
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
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 Registration Statement on Form S-4 (File
No. 333-271920) filed by Envoy Medical (then known as Anzu Special
Acquisition Corp I), 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
|
|
ENVOY MEDICAL, INC.CONSOLIDATED BALANCE
SHEETS(In thousands, except share and per share
amounts) |
|
|
|
|
|
December 31,2023 |
|
|
December 31,2022 |
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash |
|
$ |
4,218 |
|
|
$ |
183 |
|
Accounts receivable, net |
|
|
70 |
|
|
|
41 |
|
Other receivable |
|
|
176 |
|
|
|
- |
|
Inventories |
|
|
1,404 |
|
|
|
1,295 |
|
Prepaid expenses and other current assets |
|
|
957 |
|
|
|
129 |
|
Total current assets |
|
|
6,825 |
|
|
|
1,648 |
|
Property and equipment,
net |
|
|
351 |
|
|
|
331 |
|
Operating lease right-of-use
assets (related party) |
|
|
464 |
|
|
|
577 |
|
Total assets |
|
$ |
7,640 |
|
|
$ |
2,556 |
|
Liabilities and
stockholders’ deficit |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
1,554 |
|
|
$ |
1,003 |
|
Accrued expenses |
|
|
4,613 |
|
|
|
608 |
|
Convertible notes payable, current portion (related party) |
|
|
- |
|
|
|
448 |
|
Operating lease liability, current portion (related party) |
|
|
158 |
|
|
|
125 |
|
Product warranty liability, current portion |
|
|
311 |
|
|
|
335 |
|
Total current liabilities |
|
|
6,636 |
|
|
|
2,519 |
|
Convertible notes payable, net
of current portion (related party) |
|
|
- |
|
|
|
33,397 |
|
Product warranty liability,
net of current portion |
|
|
1,923 |
|
|
|
2,143 |
|
Operating lease liabilities,
net of current portion (related party) |
|
|
404 |
|
|
|
565 |
|
Warrant liability |
|
|
332 |
|
|
|
- |
|
Forward purchase agreement put
option liability |
|
|
103 |
|
|
|
- |
|
Forward purchase agreement
warrant liability |
|
|
4 |
|
|
|
- |
|
Warrant liability (related
party) |
|
|
- |
|
|
|
127 |
|
Total liabilities |
|
|
9,402 |
|
|
|
38,751 |
|
Commitments and contingencies
(see Note 15) |
|
|
|
|
|
|
|
|
Stockholders’ deficit: |
|
|
|
|
|
|
|
|
Series A Preferred stock, $0.0001 par value; 10,000,000 and zero
shares authorized as of December 31, 2023 and 2022, respectively;
4,500,000 and zero shares issued and outstanding as of December 31,
2023 and 2022, respectively |
|
|
- |
|
|
|
- |
|
Class A Common stock, $0.0001 par value; 400,000,000 and
232,000,000 shares authorized as of December 31, 2023 and 2022,
respectively; 19,599,982 and 10,122,581 shares issued and
outstanding as of December 31, 2023 and 2022, respectively |
|
|
2 |
|
|
|
1 |
|
Additional paid-in capital |
|
|
255,596 |
|
|
|
189,904 |
|
Accumulated deficit |
|
|
(257,242 |
) |
|
|
(225,985 |
) |
Accumulated other comprehensive loss |
|
|
(118 |
) |
|
|
(115 |
) |
Total stockholders’ deficit |
|
|
(1,762 |
) |
|
|
(36,195 |
) |
Total liabilities and stockholders’ deficit |
|
$ |
7,640 |
|
|
$ |
2,556 |
|
|
|
ENVOY MEDICAL, INC.CONSOLIDATED STATEMENTS
OF OPERATIONS AND COMPREHENSIVE LOSS(In thousands,
except share and per share amounts) |
|
|
|
|
|
Year EndedDecember 31, |
|
|
|
2023 |
|
|
2022 |
|
Net revenues |
|
$ |
316 |
|
|
$ |
237 |
|
Costs and operating
expenses: |
|
|
|
|
|
|
|
|
Cost of goods sold |
|
|
789 |
|
|
|
498 |
|
Research and development |
|
|
8,956 |
|
|
|
4,975 |
|
Sales and marketing |
|
|
1,666 |
|
|
|
885 |
|
General and administrative |
|
|
7,276 |
|
|
|
2,585 |
|
Total costs and operating expenses |
|
|
18,687 |
|
|
|
8,943 |
|
Operating loss |
|
|
(18,371 |
) |
|
|
(8,706 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
Loss from changes in fair value of convertible notes payable
(related party) |
|
|
(13,332 |
) |
|
|
(7,090 |
) |
Change in fair value of Forward purchase agreement put option
liability |
|
|
(69 |
) |
|
|
- |
|
Change in fair value of Forward purchase agreement warrant
liability |
|
|
842 |
|
|
|
- |
|
Change in fair value of warrant liability |
|
|
942 |
|
|
|
- |
|
Other income (expense) |
|
|
80 |
|
|
|
(127 |
) |
Total other income (expense), net |
|
|
(11,537 |
) |
|
|
(7,217 |
) |
Net loss |
|
$ |
(29,908 |
) |
|
$ |
(15,923 |
) |
|
|
|
|
|
|
|
|
|
Net loss attributable to
common stockholders, basic |
|
$ |
(29,908 |
) |
|
$ |
(15,923 |
) |
Net loss attributable to
common stockholders, diluted |
|
$ |
(29,908 |
) |
|
$ |
(15,923 |
) |
Net loss per share
attributable to common stockholders, basic |
|
$ |
(2.38 |
) |
|
$ |
(1.57 |
) |
Net loss per share
attributable to common stockholders, diluted |
|
$ |
(2.38 |
) |
|
$ |
(1.57 |
) |
Weighted-average common stock
outstanding, basic |
|
|
12,552,925 |
|
|
|
10,123,169 |
|
Weighted-average common stock
outstanding, diluted |
|
|
12,552,925 |
|
|
|
10,123,169 |
|
Other comprehensive loss: |
|
|
|
|
|
|
|
|
Foreign currency translation adjustment |
|
|
(3 |
) |
|
|
(7 |
) |
Other comprehensive loss |
|
|
(3 |
) |
|
|
(7 |
) |
Comprehensive loss |
|
$ |
(29,911 |
) |
|
$ |
(15,930 |
) |
|
|
ENVOY MEDICAL, INC.CONSOLIDATED STATEMENTS
OF CASH FLOWS(In thousands) |
|
|
|
|
|
Year EndedDecember 31, |
|
|
|
2023 |
|
|
2022 |
|
Cash flows from
operating activities |
|
|
|
|
|
|
Net loss |
|
$ |
(29,908 |
) |
|
$ |
(15,923 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
|
|
|
|
|
Depreciation |
|
|
133 |
|
|
|
75 |
|
Stock-based compensation |
|
|
1,575 |
|
|
|
- |
|
Change in fair value of convertible notes payable (related
party) |
|
|
13,332 |
|
|
|
7,090 |
|
Other expense related to warrant liability (related party) |
|
|
(127 |
) |
|
|
35 |
|
Change in fair value of warrant liability |
|
|
(942 |
) |
|
|
- |
|
Change in fair value of Forward purchase agreement warrant
liability |
|
|
(842 |
) |
|
|
- |
|
Change in fair value of Forward purchase agreement put option
liability |
|
|
69 |
|
|
|
- |
|
Change in operating lease right-of-use assets (related party) |
|
|
113 |
|
|
|
119 |
|
Increase in inventory reserve |
|
|
(99 |
) |
|
|
(41 |
) |
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
(29 |
) |
|
|
47 |
|
Other receivable |
|
|
(176 |
) |
|
|
- |
|
Inventories |
|
|
(10 |
) |
|
|
(194 |
) |
Prepaid expenses and other current assets |
|
|
(828 |
) |
|
|
38 |
|
Accounts payable |
|
|
551 |
|
|
|
342 |
|
Operating lease liabilities (related party) |
|
|
(128 |
) |
|
|
(6 |
) |
Accrued expenses |
|
|
(94 |
) |
|
|
133 |
|
Product warranty liability |
|
|
(244 |
) |
|
|
(520 |
) |
Net cash used in operating
activities |
|
|
(17,654 |
) |
|
|
(8,805 |
) |
Cash flows from
investing activities |
|
|
|
|
|
|
|
|
Purchases of property and equipment |
|
|
(153 |
) |
|
|
(218 |
) |
Net cash used in investing
activities |
|
|
(153 |
) |
|
|
(218 |
) |
Cash flows from
financing activities |
|
|
|
|
|
|
|
|
Proceeds from the issuance of convertible notes payable (related
party) |
|
|
10,000 |
|
|
|
8,000 |
|
Proceeds from the issuance of stock |
|
|
109 |
|
|
|
- |
|
Proceeds from the PIPE Transaction, the Forward Purchase Agreement,
and the Business Combination, net of transaction costs |
|
|
11,736 |
|
|
|
- |
|
Issuance of warrants (related party) |
|
|
- |
|
|
|
92 |
|
Net cash provided by financing
activities |
|
|
21,845 |
|
|
|
8,092 |
|
Effect of exchange rate on
cash and cash equivalents |
|
|
(3 |
) |
|
|
(7 |
) |
Net increase (decrease) in
cash |
|
|
4,035 |
|
|
|
(938 |
) |
Cash at beginning of year |
|
|
183 |
|
|
|
1,121 |
|
Cash at end of year |
|
$ |
4,218 |
|
|
$ |
183 |
|
Supplemental disclosures of
cash flow information |
|
|
|
|
|
|
|
|
Cash paid for interest |
|
$ |
- |
|
|
$ |
- |
|
Cash paid for income taxes |
|
$ |
- |
|
|
$ |
- |
|
Non-cash investing and
financing activity |
|
|
|
|
|
|
|
|
Deemed capital contribution from related party |
|
$ |
18,702 |
|
|
$ |
4,722 |
|
Dividends on Series A Preferred Shares |
|
$ |
1,349 |
|
|
$ |
- |
|
SPAC excise tax liability recognized |
|
$ |
2,248 |
|
|
$ |
- |
|
Convertible debt exchanged for equity |
|
$ |
27,493 |
|
|
$ |
- |
|
Bridge note exchanged for equity |
|
$ |
10,982 |
|
|
$ |
- |
|
Series A Preferred Shares issued to PIPE investor in connection
with the Merger |
|
$ |
10,000 |
|
|
$ |
- |
|
Prepaid forward purchase agreement |
|
$ |
1,384 |
|
|
$ |
- |
|
Grafico Azioni Envoy Medical (NASDAQ:COCH)
Storico
Da Mag 2024 a Giu 2024
Grafico Azioni Envoy Medical (NASDAQ:COCH)
Storico
Da Giu 2023 a Giu 2024