Item 7. Management’s Discussion and Analysis of Financial
Condition and Results of Operations
The following discussion
contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those
anticipated in these forward-looking statements as a result of many factors. The consolidated results of operations for the years
ended December 31, 2022 and 2021 are not necessarily indicative of the results that may be expected for any future period. The
following discussion should be read in conjunction with the consolidated financial statements and the notes thereto included in
Part IV, Item 15 of this Form 10-K and in conjunction with the “Risk Factors” included in Part I, Item 1A of this Form
10-K.
Business Overview
Vivani Medical, Inc. (“Vivani,”
the “Company,” “we,” “us,” “our” or similar terms) is a preclinical stage biopharmaceutical
company which develops miniaturized, subdermal implants utilizing its proprietary NanoPortalTM technology to enable long-term,
near constant-rate delivery of a broad range of medicines to treat chronic diseases. Vivani uses this platform technology to develop
and potentially commercialize drug implant candidates, alone or in collaboration with pharmaceutical company partners to address
a leading cause of poor clinical outcomes in the treatment of chronic disease, medication non-adherence. For example, approximately
50% of patients treated for type 2 diabetes are non-adherent to their medicines, which can lead to poor clinical outcomes. We are
developing a portfolio of miniature, sub-dermal drug implant candidates that, unlike most oral and injectable medicines, are designed
with the goal of guaranteeing adherence by delivering therapeutic drug levels for up to 6 months or the life of the implant. In
addition, the minimal fluctuations of drug levels dictated by our NanoPortal technology may improve the tolerability profiles for
medicines that produce side effects associated with fluctuating drug levels.
Vivani resulted from the business combination
of Second Sight Medical Products (Second Sight) and Nano Precision Medical (NPM). Since inception, Vivani’s main priority
has been the further development of the company’s lead program, NPM-119, a miniature, 6-month, GLP-1 implant candidate for
the treatment of patients with type 2 diabetes under the company’s Biopharm Division (formerly NPM). In parallel, Vivani’s
new management team remained committed to identifying and exploring strategic options for the Neuromodulation Division (formerly
Second Sight) that will enable further development of its pioneering neurostimulation systems to help patients recover critical
body functions.
In February 2022, we announced the signing
of a definitive merger agreement between Nano Precision Medical, Inc. (“NPM”) and Second Sight Medical Products, Inc.
(“Second Sight”), pursuant to which NPM became a wholly-owned subsidiary of Second Sight. On August 30, 2022, the two
companies completed the merger, concurrent with which Second Sight changed its name to Vivani Medical, Inc. and now conducts the
present business of the Company. In September 2022, we announced the formation of the Company’s Biopharm Division to advance
the assets of the former NPM which includes the further development of the Company’s lead program, NPM-119, a miniature,
6-month, GLP-1 implant candidate for the treatment of patients with type 2 diabetes. Vivani’s new management team remains
committed to identifying and exploring strategic options for the Neuromodulation Division (formerly Second Sight) that will enable
further development of its pioneering neurostimulation systems to help patients recover critical body functions. On December 28,
2022, the assets and liabilities of this segment were contributed to Cortigent, Inc. a newly formed wholly owned subsidiary of
Vivani, in exchange for 20 million shares of common stock of Cortigent.
In March 2023, Vivani announced the filing
of a Registration Statement on Form S-1 with the U.S. Securities and Exchange Commission (“SEC”) for the proposed initial
public offering of Cortigent. Vivani, is expected to continue to be majority-owned by Vivani immediately following the initial
public offering.
61
Funding and Liquidity
Capital Funding
From inception, our
operations have been funded primarily through the sales of our common stock and warrants.
Non-Capital Funding
We were awarded a $1.6 million grant (with the intent
to fund $6.4 million over five years subject to annual review and approval) from the National Institutes of Health (NIH) to fund
the “Early Feasibility Clinical Trial of a Visual Cortical Prosthesis” that commenced in January 2018.
Liquidity
We have experienced
recurring operating losses and negative operating cash flows since inception and have financed our working capital requirements
through the recurring sale of our equity securities and receipt of grants.
Our financial statements
have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in
the normal course of business. We estimate that currently available cash will provide sufficient funds to enable the Company to
meet its planned obligations into the second half of 2024. Our ability to continue as a going concern is dependent on our ability
to develop profitable operations through implementation of our business initiatives and/or raise additional capital, however, there
can be no assurances that we will be able to do so.
62
Recently Adopted Accounting Standards
We believe that recently
issued, but not yet effective, authoritative guidance, if currently adopted, would not have a material impact on our financial
statement presentation or disclosures.
Critical Accounting Policies and Estimates
The following discussion
and analysis of financial condition and results of operations is based upon our consolidated financial statements, which have been
prepared in conformity with accounting principles generally accepted in the United States of America. Certain accounting policies
and estimates are particularly important to the understanding of our financial position and results of operations and require the
application of significant judgment by our management or can be materially affected by changes from period to period in economic
factors or conditions that are outside of our control. As a result, they are subject to an inherent degree of uncertainty. In applying
these policies, our management uses their judgment to determine the appropriate assumptions to be used in the determination of
certain estimates. Those estimates are based on our historical operations, our future business plans and projected financial results,
the terms of existing contracts, our observance of trends in the industry, information provided by our customers and information
available from other outside sources, as appropriate. See Note 2 of notes to our consolidated financial statements for a more complete
description of our significant accounting policies.
Stock-Based Compensation.
Pursuant to Financial Accounting Standards Board ASC 718 Share-Based Payment (“ASC 718”), we record stock-based
compensation expense for all stock-based awards. Under ASC 718, we estimate the fair value of stock options granted using the Black-Scholes
option pricing model. The fair value for awards that are expected to vest is then amortized on a straight-line basis over the requisite
service period of the award, which is generally the option vesting term.
63
Results of Operations
Operating
Expenses. We recognize our operating expenses as incurred in two general operational categories: research and
development, and general and administrative. Our operating expenses also include a non-cash component related to
the amortization of stock-based compensation for research and development, and general and
administrative personnel. From time-to-time we have received grants from institutions or agencies, such as the National
Institutes of Health, to help fund the some of the cost of our development efforts. We have recorded these grants as
reductions to operating expenses.
64
Comparison of the Years Ended December 31, 2022 and 2021
Research
and development expense. Research and development expense increased from $11.0 million in 2021 to $14.2 million in 2022,
an increase of $3.2 million, or 29%. The increase from the prior year was primarily due to increased use of
outside contractors associated with product design, development and manufacturing associated with our products, increased
headcount and professional fees, along with inclusion of new neuromodulation division costs.
65
General
and administrative expense. General and administrative expense increased from $2.3 million in 2021 to $7.1 million in
2022, an increase of $4.8 million, or 205%. The increase is related to a provision for a legal claim of $1.7 million and
increased accounting and legal costs and other expenses related to our merger of approximately $1.5 million and the general
and administrative costs of the neuromodulation division since the merger of $1.1 million.
Net loss. The
net loss was $13.9 million in 2022, as compared to $12.8 million in 2021. The $1.1 million increase in net loss from 2021 to 2022
was primarily attributable to a $7.9 million increase in operating expenses offset by a $6.9 million gain on the bargain purchase
and increased interest income due to rate increases on cash investments.
Liquidity and Capital Resources
We have experienced
recurring operating losses and negative operating cash flows since inception and have financed our working capital requirements
through the recurring sale of our equity securities.
Our financial statements
have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in
the normal course of business. We estimate that currently available cash will provide sufficient funds to enable the Company to
meet its planned obligations into the second half of 2024. Our ability to continue as a going concern is dependent on our ability
to develop profitable operations through implementation of our business initiatives and/or raise additional capital, however, there
can be no assurances that we will be able to do so.
66
Working capital was $40.7 million at December
31, 2022, as compared to $0.4 million at December 31, 2021.
Cash Flows from Operating Activities
During 2022,
we used $18.8 million of cash in operating activities, consisting primarily of a net loss of $13.9 million, offset by $0.4
million from a net change in operating assets and liabilities and non-cash items including $5.3 million for gain on
bargain purchase, depreciation and amortization of property and equipment and stock-based compensation.
During 2021, we used
$11.0 million of cash in operating activities, consisting primarily of a net loss of $12.8 million, offset by a $0.4 million net
change in operating assets and liabilities and non-cash charges of $1.4 million for depreciation and amortization of property and
equipment, stock-based compensation and PPP loan forgiveness.
Cash Flows from Investing Activities
Investing activities
in 2022 and 2021 used $0.3 million and $0.6 million, respectively, of cash for the purchase of equipment.
Cash Flows from Financing Activities
Financing activities
provided $63.4 million of cash in 2022, including $55.4 million from cash acquired in merger for stock consideration and $8.0 million
proceeds from SAFE note.
Financing activities
provided $11.6 million of cash in 2021 from the net proceeds from the issuance of common stock and warrants.
Off-Balance Sheet Arrangements
At December 31, 2022, we did not have any
transactions, obligations or relationships that could be considered off-balance sheet arrangements.
67
Item 7A. Quantitative and Qualitative Disclosures about Market
Risk
Interest Rate Sensitivity
The
primary objective of our investment activities is to maintain the safety of principal and preserve liquidity without
incurring significant risk. We invest cash in excess of our current needs in money market funds. In general, money market
funds are not considered to be subject to interest rate risk because the interest paid on such funds fluctuates with the
prevailing interest rate. As of December 31, 2022 and 2021, our cash equivalents consisted solely of money market funds
deposited at Merrill Lynch and restricted cash as collateral for our lease.
Exchange Rate Sensitivity
In 2022 and 2021,
the majority of our operating expenses were denominated in U.S. dollars. We have not entered into foreign currency forward contracts
to hedge our operating expense exposure to foreign currencies, but we may do so in the future.
Item 8. Financial Statements and Supplementary Data
Our financial statements
and supplementary data required by this Item are provided in the consolidated financial statements included in this Form 10-K as
listed in Item 15(a) of this Form 10-K.
Item 9. Changes in and Disagreements with Accountants on
Accounting and Financial Disclosure
None.
Item 9A. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Disclosure controls
and procedures are designed to ensure that information required to be disclosed by us in reports filed or submitted under the Securities
Exchange Act of 1934, as amended (the “Exchange Act”), is recorded, processed, summarized and reported within the time
periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls
and procedures designed to ensure that information required to be disclosed in reports filed or submitted under the Exchange Act
is accumulated and communicated to management, including our principal executive officer and principal financial officer, or persons
performing similar functions, as appropriate to allow for timely decisions regarding required disclosure. Due to inherent limitations,
internal control over financial reporting may not prevent or detect misstatements. Further, projections of any evaluation of effectiveness
to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that degree
of compliance with the policies and procedures may deteriorate. Accordingly, even effective disclosure controls and procedures
can only provide reasonable assurance of achieving their control objectives.
As of December 31,
2022, management has concluded that our disclosure controls and procedures were effective based upon testing of our key internal
controls. Our management, including our CEO and CFO, has concluded that the consolidated financial statements included in this
Annual Report on Form 10-K fairly present, in all material respects, our financial position, results of operations and cash flows
for the periods presented in this Annual Report on Form 10-K in conformity with GAAP.
This Annual Report
does not include an attestation report from our independent registered public accounting firm regarding internal control over financial
reporting. Management’s report was not subject to attestation by our independent registered public accounting firm pursuant
to our non-accelerated filer status.
68
Management’s Report on Internal Control over Financial
Reporting
Our management
is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rules 13a-15(f)
and 15d-15(f) under the Exchange Act. Our internal control over financial reporting is designed to provide reasonable assurance
regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance
with generally accepted accounting principles. Our internal control over financial reporting includes those policies and procedures
that:
1. Pertain
to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of our
assets;
2.
Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance
with GAAP, and that our receipts and expenditures are being made only in accordance with the authorization of our management and
directors; and
3.
Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets
that could have a material effect on the financial statements.
As of December 31,
2022, based on the criteria established in “Internal Control — Integrated Framework” (2013 Framework) issued
by the Committee of Sponsoring Organizations of the Treadway Commission, management has completed written documentation of its
internal control policies, procedures and controls and has completed its testing of its key controls. Based upon the results of
this testing we have concluded that our internal control over financial reporting was effective as of the end of the period covered
by this Annual Report on Form 10-K.
Changes in Internal Control over Financial Reporting
There has
been no change in our internal control over financial reporting that occurred during or subsequent to our fourth quarter of the
year ended December 31, 2022 that has materially affected, or is reasonably likely to materially affect, our internal control over
financial reporting.
Inherent Limitations on Effectiveness of Controls
The design of any
system of control is based upon certain assumptions about the likelihood of future events. There can be no assurance that any design
will succeed in achieving its stated objectives under all future events, no matter how remote, or that the degree of compliance
with the policies or procedures may not deteriorate. Because of its inherent limitations, disclosure controls and procedures may
not prevent or detect all misstatements. Accordingly, even effective disclosure controls and procedures can provide only reasonable
assurance of achieving their control objectives. In addition, the design of disclosure controls and procedures must reflect the
fact that there are resource constraints and that management is required to apply its judgment in evaluating the benefits of possible
controls and procedures relative to their costs. Also, projections of any evaluation of effectiveness to future periods are subject
to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with policies
and procedures may deteriorate.
Item 9B. Other Information
None.
Item 9C. Disclosure regarding foreign jurisdictions that
prevent inspections
Not Applicable.
69
PART III
Certain
information required by Part III is omitted from this Annual Report on Form 10-K and is incorporated by reference from our
definitive proxy statement relating to our 2023 annual meeting of stockholders, pursuant to Regulation 14A of the Securities
Exchange Act of 1934, as amended, also referred to in this Annual Report on Form 10-K as our 2023 Proxy Statement, which we
will file with the SEC not later than 120 days after the end of the fiscal year covered by this Annual Report on Form
10-K.
Item 10. Directors, Executive Officers and Corporate Governance
Information regarding
our directors, including the audit committee and audit committee financial experts, and executive officers, and compliance with
Section 16(a) of the Exchange Act will be included in an amendment to this Form 10-K or in our 2023 Proxy Statement and is incorporated
herein by reference.
Item 11. Executive Compensation
The information
required by this item regarding executive compensation will be included in an amendment to this Form 10-K or in our 2023 Proxy
Statement and is incorporated herein by reference.
Item 12. Security Ownership of Certain Beneficial Owners
and Management and Related Stockholder Matters
The information required
by this item regarding security ownership of certain beneficial owners and management will be included in an amendment to this
Form 10-K or in our 2023 Proxy Statement and is incorporated herein by reference.
Item 13. Certain Relationships and Related Transactions,
and Director Independence
The information required
by this item regarding certain relationships and related transactions and director independence will be included in an amendment
to this Form 10-K or in our 2023 Proxy Statement and is incorporated herein by reference.
Item 14. Principal Accounting Fees and Services
The information required by this item regarding
principal accounting fees and services will be included in an amendment to this Form 10-K or in our 2023 Proxy Statement and is
incorporated herein by reference.
PART IV
Item 15. Exhibits, Financial Statement Schedules
(a) The following documents are included in this Annual Report on Form 10-K:
70
EXHIBIT INDEX
Exhibit No. Exhibit Description
10.2 Non-Employee Director Compensation Policy*
10.3 Transition funding, support and services agreement dated March 23, 2023
10.4 Employment terms- Cortigent CEO
10.5 New Alameda Lease Agreement
71
23.1* Consent of BPM LLP, Independent Registered Public Accounting Firm
72
24.1 Power of Attorney (included in the signature page to this report)
* Filed or furnished herein, as applicable.
+ Indicates management contract or compensatory plan.
101.INS XBRL Instance Document
101.SCH XBRL Taxonomy Extension Schema Document
101.CAL XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF XBRL Taxonomy Extension Definition Linkbase Document
101.LAB XBRL Taxonomy Extension Label Linkbase Document
101.PRE XBRL Taxonomy Extension Presentation Linkbase Document
Item 16. Form 10-K
Summary
None.
73
SIGNATURES
Pursuant to the requirements of Section
13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
Dated: March 31, 2023 Vivani Medical, Inc.
/s/ Adam Mendelsohn
Adam Mendelsohn
Chief Executive Officer
POWER OF ATTORNEY AND SIGNATURES
The undersigned officers and directors
of Vivani Medical, Inc., each hereby severally constitutes and appoints Scott Dunbar as his true and lawful attorney-in-fact and
agent, with full power of substitution to sign and execute on behalf of the undersigned any and all amendments to this Annual Report
on Form 10-K, and to perform any acts necessary in order to file the same, with all exhibits thereto and other documents in connection
therewith with the Securities and Exchange Commission, granting unto said attorney-in-fact and agent full power and authority to
do and perform each and every act and thing requested and necessary to be done in connection therewith, as fully to all intents
and purposes as he might or could do in person, hereby ratifying and confirming all that said attorney-in-fact and agent, or their
or his or her substitutes, shall do or cause to be done by virtue hereof.
Pursuant to the requirements of
the Securities Exchange Act of 1934, this Report has been signed below by the following persons on behalf of the Registrant and
in the capacities and on the dates indicated.
Name Title Date
/s/ Adam Mendelsohn Chief Executive Officer and Director March 31, 2023
Adam Mendelsohn (Principal Executive Officer)
/s/ Brigid Makes Chief Financial Officer March 31, 2023
Brigid Makes (Principal Financial and Accounting Officer)
* Chairman of the Board March 31, 2023
Gregg Williams
Aaron Mendelsohn
Dean Baker
Alexandra Larson
* By /s/ Scott Dunbar
Scott Dunbar
Attorney-in-fact
74
VIVANI MEDICAL, INC.
AND SUBSIDIARIES
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Page
Report of Independent Registered Public Accounting Firm (PCAOB ID:207) F-2
Consolidated Balance Sheets as of December 31, 2022 and 2021 F-3
F-1
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Board of Directors and Shareholders
Vivani Medical, Inc. and Subsidiaries
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets
of Vivani Medical, Inc. and Subsidiaries (the “Company”) as of December 31, 2022 and 2021 and the related consolidated
statements of operations, comprehensive loss, stockholders’ equity, and cash flows, for each of the two years in the period
ended December 31, 2022, 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, 2022 and 2021, and the results of their operations and their cash flows for each of the two years in the period
ended December 31, 2022, in conformity with accounting principles generally accepted in the United States of America.
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 audit. 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 audit 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 consolidated
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 audit, 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 audit included performing procedures to assess the risks
of material misstatement of the consolidated 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 consolidated financial statements. Our audit also included evaluating the accounting principles used and significant estimates
made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our
audit provides a reasonable basis for our opinion.
Critical Audit Matters
Critical audit matters are matters arising from the current
period audit of the financial statements that were communicated or required to be communicated to the audit committee and that:
(1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging,
subjective, or complex judgments. We determined that there are no critical audit matters.
/s/ BPM LLP
We have served as the Company’s auditor since 2014.
Walnut Creek, California
March 31, 2023
F-2
VIVANI MEDICAL, INC.
AND SUBSIDIARIES
Consolidated Balance Sheets
(In thousands)
December 31,
ASSETS
Current assets:
Prepaid expenses and other current assets 2,452 291
Restricted cash 1,366 —
Deposits and other assets 275 200
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Litigation accrual 1,675 —
Accrued compensation expense 657 —
Current operating lease liabilities 955 910
Long term operating lease liabilities — 902
Commitments and contingencies (Note 12)
Stockholders’ equity:
Preferred stock, no par value, 10,000 shares authorized; none outstanding — —
Accumulated other comprehensive loss 35 —
Total liabilities and stockholders’ equity $ 51,130 $ 5,453
See accompanying notes to consolidated financial
statements.
F-3
VIVANI MEDICAL, INC.
AND SUBSIDIARIES
Consolidated Statements of Operations
(In thousands, except per share data)
Years Ended December 31,
Operating expenses:
Research and development, net of grants $ 14,169 $ 11,002
General and administrative, net of grants 7,072 2,321
Gain on bargain purchase 6,877 —
Net loss per common share – basic and diluted $ (0.36 ) $ (0.39 )
Weighted average shares outstanding – basic and diluted 38,241 33,092
See accompanying notes to consolidated financial
statements.
F-4
VIVANI MEDICAL, INC.
AND SUBSIDIARIES
Consolidated Statements of Comprehensive
Loss
(In thousands)
Years Ended December 31,
Other comprehensive income:
Foreign currency translation adjustments 35 —
See accompanying notes to consolidated financial
statements.
F-5
VIVANI MEDICAL, INC.
AND SUBSIDIARIES
Condensed Consolidated Statements
of Stockholders’ Equity
(in thousands)
Accumulated
Additional Other Total
Common Stock Paid-in Comprehensive Accumulated Stockholders’
Shares Amount Capital Loss Deficit Equity
Options and warrants exercised, net of partial shares adjustment
Repurchase of common stock (60 ) — — — — —
Shares issued for SSMP net assets
Stock-based compensation expense — — 1,668 — — 1,668
Accumulated
Additional Other Total
Common Stock Paid-in Comprehensive Accumulated Stockholders’
Shares Amount Capital Loss Deficit Equity
Options and warrants exercised, net of partial shares adjustment 797 16 — — — 16
Stock-based compensation expense — — 1,296 — — 1,296
Foreign currency translation adjustment — — — 35 — 35
See accompanying notes to consolidated financial
statements.
F-6
VIVANI MEDICAL, INC.
AND SUBSIDIARIES
Consolidated Statements of Cash Flows
(In thousands)
Years Ended December 31,
Cash flows from operating activities:
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization of property and equipment 381 345
Gain on bargain purchase (6,877 ) —
PPP loan forgiveness — (641 )
Non-cash lease expense (36 ) 14
Changes in operating assets and liabilities:
Prepaid expenses and other assets (476 ) 102
Accrued compensation expenses 204 —
Net cash used in operating activities (18,787 ) (10,951 )
Cash flows from investing activities:
Purchases of property and equipment (338 ) (572 )
Net cash used in investing activities (338 ) (572 )
Cash flows from financing activities:
Cash acquired in merger for stock consideration 55,374 —
Proceeds from SAFE note 8,000 —
Net cash provided by financing activities 63,390 11,620
Effect of exchange rate changes on cash and cash equivalents (1 ) —
Cash, cash equivalents and restricted cash:
Supplemental disclosure of cash flow information;
Cash paid during the period for:
Income taxes $ — $ 1
Non-cash investing and financing activities:
Cancellation of SAFE indebtedness in merger $ 8,000 $ —
Net liabilities acquired in merger for stock consideration $ 2,112 $ —
See accompanying notes to consolidated financial statements.
F-7
VIVANI MEDICAL, INC.
AND SUBSIDIARIES
Notes to Consolidated Financial Statements
1. Organization and Business Operations
Vivani Medical, Inc. (“Vivani,”
the “Company,” “we,” “us,” “our” or similar terms) is a preclinical stage biopharmaceutical
company which develops miniaturized, subdermal implants utilizing its proprietary NanoPortalTM technology to enable long-term,
near constant-rate delivery of a broad range of medicines to treat chronic diseases. Vivani uses this platform technology to develop
and potentially commercialize drug implant candidates, alone or in collaboration with pharmaceutical company partners to address
a leading cause of poor clinical outcomes in the treatment of chronic disease, medication non-adherence. For example, approximately
50% of patients treated for type 2 diabetes are non-adherent to their medicines, which can lead to poor clinical outcomes. We are
developing a portfolio of miniature, sub-dermal drug implant candidates that, unlike most oral and injectable medicines, are designed
with the goal of guaranteeing adherence by delivering therapeutic drug levels for up to 6 months or the life of the implant. In
addition, the minimal fluctuations of drug levels dictated by our NanoPortal technology may improve the tolerability profiles for
medicines that produce side effects associated with fluctuating drug levels.
Vivani resulted from the business combination
of Second Sight Medical Products (Second Sight) and Nano Precision Medical (NPM). Since inception, Vivani’s main priority
has been the further development of the company’s lead program, NPM-119, a miniature, 6-month, GLP-1 implant candidate for
the treatment of patients with type 2 diabetes under the company’s Biopharm Division (formerly NPM). In parallel, Vivani’s
new management team remained committed to identifying and exploring strategic options for the Neuromodulation Division (formerly
Second Sight) that will enable further development of its pioneering neurostimulation systems to help patients recover critical
body functions.
In February 2022, we announced the signing
of a definitive merger agreement between Nano Precision Medical, Inc. (“NPM”) and Second Sight Medical Products, Inc.
(“Second Sight”), pursuant to which NPM became a wholly-owned subsidiary of Second Sight. On August 30, 2022, the two
companies completed the merger, concurrent with which Second Sight changed its name to Vivani Medical, Inc. and now conducts the
present business of the Company. In September 2022, we announced the formation of the Company’s Biopharm Division to advance
the assets of the former NPM which includes the further development of the company’s lead program, NPM-119, a miniature,
6-month, GLP-1 implant candidate for the treatment of patients with type 2 diabetes. Vivani’s new management team remains
committed to identifying and exploring strategic options for the Neuromodulation Division (formerly Second Sight) that will enable
further development of its pioneering neurostimulation systems to help patients recover critical body functions. On December 28,
2022, the assets and liabilities of this segment were contributed to Cortigent, Inc. a newly formed wholly owned subsidiary of
Vivani, in exchange for 20 million shares of common stock of Cortigent.
In March 2023, Vivani announced the filing
of a Registration Statement on Form S-1 with the U.S. Securities and Exchange Commission (“SEC”) for the proposed initial
public offering of Cortigent. Cortigent is expected to continue to be majority-owned by Vivani immediately following the initial
public offering.
Agreement and Plan of Merger with Nano
Precision Medical, Inc.
On February 4, 2022, Second Sight Medical
Products, Inc. (“Second Sight”) entered into an agreement and plan of merger (the “Merger Agreement”) with
Nano Precision Medical, Inc. (“NPM”). The Merger was approved by the shareholders of Second Sight on July 27, 2022
and closed on August 30, 2022. Upon consummation of the Merger, NPM became a wholly-owned subsidiary of Second Sight. Concurrent
with to the Merger, Second Sight changed its name to Vivani Medical, Inc. and changed its trading symbol from EYES to VANI, and
trades under the ticker VANI on the NASDAQ market. Certain investors and members of the NPM board of directors are also investors
and members of the board of directors of Second Sight.
Under the terms and conditions of the Merger
Agreement, the securities of NPM converted into the right to receive shares of Second Sight’s common stock representing 77.32%
of the total issued and outstanding shares of common stock of Second Sight on a fully converted basis, including, without limitation,
giving effect to the conversion of all options, warrants, and any and all other convertible securities assuming net settlement.
Second Sight filed a Registration Statement on Form S-4 on May 13, 2022 in connection with the Merger to register the merger shares
effective June 24, 2022.
F-8
On February 4, 2022, in connection with
the Merger, Second Sight and NPM also entered into a Simple Agreement for Future Equity (“SAFE”) whereby Second Sight
provided to NPM an investment advance of $8 million. The Merger Agreement provided that the SAFE would terminate if the Merger
were to be successfully completed. Under the terms of the SAFE, upon successfully completion of the Merger on August 30, 2022,
the investment advance was eliminated. Under the accounting for a business combination, the $8 million adjusted the purchase consideration.
The Merger involved a change of control
and was accounted for as a reverse merger in accordance with accounting principles generally accepted in the United States of America
(“GAAP”). Under this method of accounting, Second Sight was treated as the “acquired” company for financial
reporting purposes with NPM as the acquirer. The assets acquired and liabilities assumed by NPM were recorded at fair value under
Accounting Codification Standard (“ASC 805”), Business Combinations. Accordingly, on August 30, 2022 (the “Acquisition
Date”), NPM (a calendar year-end entity) was deemed to have acquired 100% of the outstanding common shares and voting interest
of Second Sight, Medical, Inc. The results of Second Sight’s operations have been included in the consolidated financial
statements since that date.
The acquisition-date fair value of consideration
transferred totaled $54.4 million, which consisted of the fair value of the 13,136 common shares deemed issued to Second Sight
shareholders, was determined based on the per share closing price of the Company’s common shares on the acquisition date
of $4.14.
The following table summarizes the fair
values of the assets acquired and liabilities assumed at the acquisition date (in thousands):
Property and equipment 99
Prepaid expenses 1,657
Right of use assets 140
Other assets 56
Total identifiable assets acquired 57,326
Current liabilities (3,913 )
Right of use liabilities (151 )
Total liabilities assumed 4,064
Net identifiable assets acquired $ 53,262
The SAFE loan of $8.0 million was cancelled
in the Merger which adjusted the fair value of net assets acquired.
The following table summarizes the calculation
of the gain on bargain purchase (in thousands):
Total consideration $ 54,385
SAFE loan forgiven (8,000 )
Less net identifiable assets acquired (53,262 )
Gain on bargain purchase $ 6,877
Because NPM purchased 100% of Second Sight
and the fair value of identifiable assets acquired and liabilities assumed exceeded the fair value of the consideration, we reassessed
the recognition and measurement of identifiable assets acquired and liabilities assumed and concluded that all acquired assets
and assumed liabilities were properly recognized and that the valuation procedures and resulting measures were appropriate. As
a result, we recognized a gain of $6.9 million.
We recognized $0.7 million of acquisition
related costs that were expensed in the twelve months ended December 31, 2022. These costs are included in the consolidated income
statement in the line item entitled “General and administrative costs.”
F-9
Operating expenses of Second
Sight included in the consolidated statements of operations from the acquisition date August 30, 2022 to the period ending
December 30, 2022 were $2.1 million. Pro forma consolidated net loss as if Second Sight had been included in the consolidated
results was $21.7
million for the year ended December 31, 2021, and $28.3
million for the year ended December 31, 2022.
SAFE
On February 4, 2022, in connection with
the Merger, Second Sight and NPM also entered into a Simple Agreement for Future Equity (“SAFE”) whereby Second Sight
provided to NPM an investment advance of $8 million. The agreement provided that the SAFE would terminate if the Merger were to
be successfully completed.
Under the terms of the SAFE, upon successfully
completion of the Merger on August 30, 2022, the investment advance was eliminated. Under the accounting for a business combination,
the $8.0 million adjusted the purchase consideration.
Liquidity and Capital Resources
From inception, our operations
have been funded primarily through the sales of our common stock as well as from warrants.
F-10
Our financial statements
have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in
the normal course of business. We estimate that currently available cash will provide sufficient funds to enable the Company to
meet its planned obligations into the second half of 2024. Our ability to continue as a going concern is dependent on our ability
to develop profitable operations through implementation of our business initiatives and/or raise additional capital, however, there
can be no assurances that we will be able to do so.
2. Summary of Significant Accounting
Policies Principles of Consolidation
The
accompanying consolidated financial statements have been prepared in accordance with United States generally accepted