Item 9A. Controls and Procedures
Item
9A. Controls and Procedures.
Management’s
Conclusions Regarding Effectiveness of Disclosure Controls and Procedures
We
conducted an evaluation of the effectiveness of our “disclosure controls and procedures”, as defined by Rules 13a-15(e) and
15d-15(e) of the Securities Exchange Act of 1934, as amended, as of December 31, 2021, the end of the period covered by this Annual Report
on Form 10-K. The disclosure controls and procedures evaluation was done under the supervision and with the participation of management,
including our chief executive officer and chief financial officer. There are inherent limitations to the effectiveness of any system
of disclosure controls and procedures. Accordingly, even effective disclosure controls and procedures can only provide reasonable assurance
of achieving their control objectives. Based upon this evaluation, our chief executive officer and chief financial officer have concluded
that our disclosure controls and procedures were effective at the reasonable assurance level as of December 31, 2021.
Management’s
Report on Internal Control Over Financial Reporting
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 Securities Exchange Act of 1934, as amended. Our internal control over financial reporting is designed to provide
reasonable assurance regarding the reliability of financial reporting and the preparation of the consolidated financial statements for
external reporting purposes in accordance with generally accepted accounting principles.
Because
of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of
any evaluation of effectiveness of internal control over financial reporting 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 the policies or procedures may deteriorate
over time.
Management,
including our chief executive officer and our chief financial officer, assessed the effectiveness of our internal control over financial
reporting as of December 31, 2021. In making this assessment, management used the criteria set forth by the Committee of Sponsoring Organizations
of the Treadway Commission in Internal Control—Integrated Framework 2013 . Based on its assessment and those criteria, management
has concluded that we maintained effective internal control over financial reporting as of December 31, 2021.
Changes
in Internal Control over Financial Reporting
There
have been no changes in our internal control over financial reporting during the fiscal quarter ended December 31, 2021 that have materially
affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Item
9B. Other Information.
None.
Item
9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.
Not
applicable.
- 64 -
PART
III
Item
10. Directors, Executive Officers and Corporate Governance.
Executive
Officers and Directors
The
following table sets forth information regarding our executive officers and the members of our board of directors.
Name
Age
Position
Marvin
Slosman
58
President,
Chief Executive Officer and Director
Craig
Shore
60
Chief
Financial Officer, Chief Administrative Officer, Secretary and Treasurer
Michael
Berman (1)(2)
64
Director
Campbell
Rogers, M.D.
60
Director
Paul
Stuka (1)(2)(3)
67
Chairman
of the Board of Directors
Thomas
J. Kester (1)(3)
75
Director
Gary
Roubin, M.D.
73
Director
Kathryn
Arnold (3)
49
Director
(1)
Member
of our audit committee
(2)
Member
of our nominating and corporate governance committee
(3)
Member
of our compensation committee
Our
directors hold office until the earlier of their death, resignation or removal by stockholders or until their successors have been qualified.
Our directors are divided into three classes. Paul Stuka and Gary Roubin are our Class 1 directors, with their terms of office to expire
at our 2024 annual meeting of stockholders. Michael Berman and Campbell Rogers, M.D. are our Class 2 directors, with their terms of office
to expire at our 2022 annual meeting of stockholders. Marvin Slosman and Thomas J. Kester are our Class 3 directors, with their terms
of office to expire at our 2023 annual meeting of stockholders. At each annual meeting of stockholders, directors elected to succeed
those directors whose terms expire shall be elected for a term of office to expire at the third succeeding annual meeting of stockholders
after their election, with each director to hold office until his or her successor shall have been duly elected and qualified.
Our
officers hold office until the earlier of their death, resignation or removal by our board of directors or until their successors have
been selected. They serve at the pleasure of our board of directors.
Marvin
Slosman has served as our president, chief executive officer and director since January 1, 2020. Mr. Slosman has served as chief
operating officer for MEDCURA Inc. from May 2019 to December 2019. From September 2017 to September 2019, Mr. Slosman served as a Business
Consultant, overseeing international commercial strategy and market development, at Integra Life Sciences, a leading innovator in orthopedic
extremity surgery, neurosurgery, and reconstructive and general surgery. From 2010 to 2014 Mr. Slosman served as President of Itamar
Medical, Inc., a medical technology company focused on cardiovascular and sleep diagnostics. Mr. Slosman also served as chief executive
officer of Ovalum Vascular Ltd. from 2008 to 2010. Mr. Slosman’s qualifications to serve on the board of directors of the Company
include his significant experience in senior management positions of leading medical device companies.
Craig
Shore has served as our chief financial officer, secretary and treasurer since March 31, 2011 and as our chief administrative officer
since May 3, 2013. In addition, from November 10, 2010 through March 31, 2011, Mr. Shore served as InspireMD Ltd.’s vice president
of business development. Mr. Shore has vast experience in financial management in the United States, Europe and Israel for companies
such as Pfizer Pharmaceuticals, Bristol Myers Squibb and General Electric. His experience includes raising capital both in the private
and public markets. Mr. Shore graduated with honors and received a B.Sc. in Finance from Pennsylvania State University and an M.B.A.
from George Washington University.
- 65 -
Michael
Berman has served as our director since February 7, 2013. Mr. Berman is a medical device entrepreneur who has worked with high-potential
development and early-stage commercial companies since 2014. From 2005 to 2012, Mr. Berman was a co-founder and the chairman of BridgePoint
Medical, Inc., which developed technology to treat coronary and peripheral vascular chronic total occlusions and which was sold to Boston
Scientific. Mr. Berman was also a member of the board of Lutonix, Inc. from 2007 until 2011, when the company was sold to C.R. Bard,
Inc. From 2011 to 2019, Mr. Berman served as a co-founder and director of Rebiotix Inc., a company developing an innovative treatment
for C Diff colitis. Rebiotix was sold to Ferring Pharmaceuticals in 2018. From 2014 till 2018 Mr. Berman served as a director of Mazor
Robotics, a company pioneering Spinal Robotic Surgery. Mr. Berman has served (i) since 2011 as an advisor to, and since 2012 as a director
of, Cardiosonic, Inc., a company developing a system for hypertension reduction via renal denervation, (ii) since 2005 as a director
of PharmaCentra, LLC, which creates customizable marketing programs that help pharmaceutical companies communicate with physicians and
patients, (iii) since 2018 as a Director of STMedical, a medical device company that has developed a temporary stent for the treatment
of chronic sinusitis, (iv) since 2019 as a director of CardiacSense Inc, a medical device company that has developed a smart watch vital
sign monitor, (v) since 2017 as a Director of Owlytics Healthcare, (vi) since 2013 as a Director of ClearCut Inc., a medical device company
that has developed an MRI system for tumor margin assessment, (vii) since 2013 as a director of PulmOne Ltd., a medical device company
developing an innovative Pulmonary Function Testing system, (viii) since 2019 as a director of QArt, a medical device company, (ix) since
2014 as a venture partner at RiverVest Ventures and (x) since 2017 as a Director of Truleaf Medical. Mr. Berman brings to the board his
extensive executive and entrepreneurial experiences in the field of medical devices and vascular intervention, which should assist in
strengthening and advancing our strategic focus.
Campbell
Rogers, M.D. has served as a director since September 3, 2013. Dr. Rogers is the executive vice president and chief medical officer
of HeartFlow, Inc., a cardiovascular diagnostics company, since March 2012. Prior to joining HeartFlow, Inc., he was the chief scientific
officer and global head of research and development at Cordis Corporation (currently part of Cardinal Health, Inc.), Johnson & Johnson,
where he was responsible for leading investments and research in cardiovascular devices. Prior to that, he was associate professor of
medicine at Harvard Medical School and the Harvard-M.I.T. Division of Health Sciences and Technology and director of the cardiac catheterization
and experimental cardiovascular interventional laboratories at Brigham and Women’s Hospital. He served as principal investigator
for numerous interventional cardiology device, diagnostic, and pharmacology trials, is the author of numerous journal articles, chapters,
and books in the area of coronary artery and other cardiovascular diseases and was the recipient of research grant awards from the National
Institute of Health and the American Heart Association. He received his A.B. from Harvard College and his M.D. from Harvard Medical School.
Dr. Rogers’ qualifications to serve on the board include his significant experience in cardiovascular devices, as well as his familiarity
with the operations of medical device companies.
Paul
Stuka has served as a director since August 8, 2011 and has served as our chairman since June 2, 2017. Mr. Stuka has served as the
managing member of Osiris Partners, LLC, an investment fund, since 2000. Prior to forming Osiris Partners, LLC, Mr. Stuka, with 35 years
of experience in the investment industry, was a managing director of Longwood Partners, managing small cap institutional accounts. In
1995, Mr. Stuka joined State Street Research and Management as manager of its Market Neutral and Mid Cap Growth Funds. From 1986 to 1994,
Mr. Stuka served as the general partner of Stuka Associates, where he managed a U.S.-based investment partnership. Mr. Stuka began his
career in 1980 as an analyst at Fidelity Management and Research. As an analyst, Mr. Stuka followed a wide array of industries including
healthcare, energy, transportation, and lodging and gaming. Early in his career he became the assistant portfolio manager for three Fidelity
Funds, including the Select Healthcare Fund which was recognized as the top performing fund in the United States for the five-year period
ending December 31, 1985. Mr. Stuka has been serving as a director of Caliber Imaging & Diagnostics, Inc. (formerly Lucid, Inc.)
since June 2013. Mr. Stuka’s qualifications to serve on the board include his significant strategic and business insight from his
years of experience investing in the healthcare industry.
Thomas
J. Kester has served as a director since September 6, 2016. Mr. Kester has been serving as the chief financial officer of Kester
Search Group, LLC Inc., a private executive search firm specializing in sales force placement for medical, dental and diagnostic device
companies, since October 2014. From 2004 to 2010, Mr. Kester served as a director of Orthofix International, NV (NASDAQ: OFIX), a global
medical device company. Mr. Kester’s experience includes 28 years at KPMG LLP, including 18 years as an audit partner, advising
public and private companies in connection with annual audit and financings. Mr. Kester’s qualifications to serve on the board
include his significant strategic and business insight from his years of experience auditing global companies and serving on the boards
of several public and not-for-profit organizations. Mr. Kester received his B.S. in mechanical engineering from Cornell University and
an M.B.A. from Harvard University.
- 66 -
Gary
Roubin, M.D. has served as a director since October 13, 2020. Dr. Roubin cofounded Essential Medical Inc. in 2010, which has had
success in bringing a large bore vascular closure device to world markets and was recently acquired by Teleflex Inc. From 2002 to 2003,
Dr. Roubin served as Chief Medical Officer of the Medicines Company during the release of its Angiomax product. From 2003 to 2012, Dr.
Roubin served as Department Chairman and Chief of Service of the Lenox Hill Hospital Cardiac and Vascular program in New York. From 1989
to 1997, he served as Chief of Interventional Cardiology at the University of Alabama at Birmingham, to which he joined in 1989 as Professor
of Medicine and Radiology and Director of the Cardiac Catheterization Laboratories and Interventional Cardiology Section at the University
Hospital. In 2001, Dr. Roubin played a pivotal role in the success of Mednova Inc., which was acquired by Abbott Vascular, resulting
in the introduction and marketing in the U.S. of the top selling carotid embolic protection system (NAV6) and stent system (XACT). In
1987, he developed and placed the world’s first balloon expandable coronary stent. In 1984, Dr. Roubin joined Andreas Gruentzig
at Emory University to continue his post-doctoral research. He is also acknowledged for the development of coronary stenting and the
first FDA-approved coronary stent. Dr. Roubin received his M.D. from the University of Queensland medical school and his Ph.D. from Sydney
University. Dr. Roubin is qualified to serve on the board given that he is an internationally renowned interventional cardiologist recognized
for his pioneering work in carotid stenting and embolic and protection devices. He is also acknowledged for the development of coronary
stenting and the first FDA-approved coronary stent.
Kathryn
Arnold has served as our director since May 10, 2021. Ms. Arnold is the Founder and CEO of SPRIG Consulting, a strategic marketing
consulting firm with over a decade of success in the medical space. Prior to founding SPRIG, Ms. Arnold held sales and marketing management
roles with Guidant Corporation (acquired by Abbott Laboratories and Boston Scientific) and Kensey Nash Corporation (acquired by Spectranetics
Corporation / Royal Philips). Additionally, Ms. Arnold is an adjunct faculty member at the Kellogg School of Management at Northwestern
University where she teaches a course specific to medical product commercialization and financing. Ms. Arnold received a bachelor of
arts in environmental science from the University of Vermont and a master’s degree from the Kellogg School of Management at Northwestern
University.
Mr.
Slosman and Mr. Shore are parties to certain agreements related to their service as executive officers and directors described under
“Executive Compensation – Agreements with Executive Officers.”
Board
Diversity Matrix
The
table below provides certain information regarding the diversity of our board of directors as of the date of this annual report.
Board
Diversity Matrix (As of March 7, 2022)
Total
Number of Directors
6
Female
Male
Non-Binary
Did
Not Disclose Gender
Part
I: Gender Identity
Directors
1
5
#
#
Part
II: Demographic Background
African
American or Black
#
#
#
#
Alaskan
Native or Native American
#
#
#
#
Asian
#
#
#
#
Hispanic
or Latinx
#
#
#
#
Native
Hawaiian or Pacific Islander
#
#
#
#
White
1
5
#
#
Two
or More Races or Ethnicities
#
#
#
#
LGBTQ+
0
Did
Not Disclose Demographic Background
#
Family
Relationships
We
have no family relationships amongst our directors and executive officers.
- 67 -
Board
Committees
Our
board of directors has established an audit committee, a nominating and corporate governance committee and a compensation committee,
each of which has the composition and responsibilities described below.
Audit
Committee . Our audit committee is currently comprised of Messrs. Berman, Stuka and Kester, each of whom our board has determined
to be financially literate and qualify as an independent director as defined in the Nasdaq Listing Rules and Rule 10A-3 promulgated under
the Exchange Act. Mr. Kester is the chairman of our audit committee and qualifies as a financial expert, as defined in Item 407(d)(5)(ii)
of Regulation S-K. The audit committee’s duties are to recommend to our board of directors the engagement of independent auditors
to audit our financial statements and to review our accounting and auditing principles. The audit committee will review the scope, timing
and fees for the annual audit and the results of audit examinations performed by the internal auditors and independent public accountants,
including their recommendations to improve the system of accounting and internal controls. The audit committee operates under a formal
charter adopted by the board of directors that governs its duties and conduct. Copies of the charter can be obtained free of charge from
the Company’s web site, www.inspiremd.com, by contacting the Company.
Nominating
and Corporate Governance Committee . Our nominating and corporate governance committee is currently comprised of Messrs. Berman and
Stuka, each of whom qualify as an independent director under as defined in the Nasdaq Listing Rules and Rule 10A-3 promulgated under
the Exchange Act. Mr. Berman is the chairman of our nominating and corporate governance committee. The nominating and corporate governance
committee identifies and recommends to our board of directors individuals qualified to be director nominees. In addition, the nominating
and corporate governance committee recommends to our board of directors the members and chairman of each board committee who will periodically
review and assess our code of business conduct and ethics and our corporate governance guidelines. The nominating and corporate governance
committee also makes recommendations for changes to our code of business conduct and ethics and our corporate governance guidelines to
our board of directors, reviews any other matters related to our corporate governance and oversees the evaluation of our board of directors
and our management. The nominating and corporate governance committee operates under a formal charter adopted by the board of directors
that governs its duties and conduct. Copies of the charter can be obtained free of charge from the Company’s web site, www.inspiremd.com,
by contacting the Company.
Compensation
Committee . Our compensation committee is currently comprised of Messrs. Stuka and Kester, each of whom qualify as an independent
director under as defined in the Nasdaq Listing Rules and Rule 10A-3 promulgated under the Exchange Act. Mr. Stuka is the chairman of
our compensation committee. The compensation committee reviews and approves our salary and benefits policies, including compensation
of executive officers and directors. The compensation committee also administers our stock option plans and recommends and approves grants
of stock options under such plans. The compensation committee operates under a formal charter adopted by the board of directors that
governs its duties and conduct. Copies of the charter can be obtained free of charge from the Company’s web site, www.inspiremd.com,
by contacting the Company.
- 68 -
Code
of Ethics
We
have adopted a code of ethics and business conduct that applies to our officers, directors and employees, including our principal executive
officer, principal financial officer and principal accounting officer, which is posted on our website at www.inspiremd.com . We
intend to disclose future amendments to certain provisions of the code of ethics, or waivers of such provisions granted to executive
officers and directors, on this website within four business days following the date of such amendment or waiver.
Item
11. Executive Compensation.
Summary
Compensation Table
The
table below sets forth the compensation earned by our named executive officers for the twelve-month period ended December 31, 2021 and
2020.
Name
and Principal Position
Year
Salary
($)
Bonus
($)
Restricted
Stock
Awards
($) (1)
Option
Awards
($) (1)
All
Other
Compensation
($)
Total
($)
Marvin
Slosman
2021
410,000 (2)
169,125 (4)
603,856
428,803
24,360 (5)
1,636,144
President
and Chief Executive Officer
2020
366,666 (3)
150,000 (4)
658,981
196,162
10,309 (5)
1,382,118
Craig
Shore
2021
319,569 (6)
164,257 (4)(6)
300,669
130,499
141,867 (7)
1,056,861
Chief
Financial Officer, Secretary and Treasurer
2020
265,004 (3)(6)
138,692 (4)(6)
264,745
78,955
121,626 (7)
869,022
(1)
For
awards of stock, the aggregate grant date fair value is computed in accordance with FASB ASC Topic 718. Fair value is based on the
Black-Scholes option pricing model using the fair value of the underlying shares at the measurement date.
(2)
On
April 19, 2021, our Compensation Committee approved, effective as of July 1, 2021, an increase
to the base salary of Mr. Slosman such that the annual salary will increase to $420,000 from
$400,000.
(3)
On
April 21, 2020, Mr. Slosman and Mr. Shore each signed waivers in connection with the COVID-19 pandemic and certain cost-reduction
measures, whereby Mr. Slosman’s monthly base salary was reduced from $33,333 to $16,666 and Mr. Shore’s monthly base
salary was reduced from NIS 80,125 to NIS 40,063. On June 10, 2020, following the closing of our underwritten public offering in
June 2020, each of Mr. Slosman’s and Mr. Shore’s monthly base salaries were reinstated to $33,333 and NIS 80,125, respectively,
effective as of June 1, 2020. On August 14, 2020, we entered into the fourth amendment which included an increase to Mr. Shore’s
monthly base salary to NIS 86,000, effective August 1, 2020.
(4)
Cash
bonus awards for the 2020 calendar year were approved by the compensation committee in January 2021.Cash bonus awards for the 2021
calendar year were approved by the compensation committee in January 2022.
(5)
Mr.
Slosman’s other compensation for the twelve months ended December 31, 2021 and 2020 consisted of benefits related to health
insurance.
(6)
Compensation
amounts received in non-U.S. currency have been converted into U.S. dollars using the average exchange rate for the applicable period,
except for bonus amounts which have been converted into U.S. dollars using 3.110 NIS per dollar which was the exchange rate as of
December 31, 2021. The average exchange rate for the twelve month period ended December 31, 2021 and 2020 were 3.229 NIS per dollar
and 3.437 NIS per dollar, respectively.
(7)
Mr.
Shore’s other compensation consisted solely of benefits in the twelve months ended December 31, 2021 and 2020. In each of the
periods reported, Mr. Shore’s benefits included our contributions to his severance, pension, vocational studies and disability
funds, an annual recreation payment, a company car or car allowance and cell phone, and a daily food allowance.
- 69 -
Agreements
with Executive Officers
Marvin
Slosman
On
December 9, 2019, we entered into an Employment Agreement with Marvin Slosman, which was subsequently amended on December 31, 2019 (as
amended, the “Slosman Employment Agreement”), pursuant to which Mr. Slosman was appointed as our new chief executive officer
and president. Mr. Slosman’s term of employment commenced on January 1, 2020, was to remain in effect for three years (the “Initial
Employment Term”), unless earlier terminated, and was to be automatically renewed for successive one-year terms after the Initial
Employment Term. Mr. Slosman was also appointed as a Class 3 director, effective January 1, 2020, with a term expiring on the 2020 annual
meeting of our stockholders. On November 8, 2021, we entered into an amendment to the employment agreement of our chief executive officer,
Marvin Slosman, originally dated December 9, 2019, pursuant to which we agreed to remove the definitive term of his employment such that
his employment agreement shall expire if and when terminated by either party pursuant to the terms thereof.
As
consideration for his services as chief executive officer, Mr. Slosman will be entitled to receive (i) an annual base salary of $400,000,
less applicable payroll deductions and tax (“Base Salary”), which will be reviewed by the Board on an annual basis for increase,
On April 19, 2021, our Compensation Committee approved, effective as of July 1, 2021, an increase to the base salary of Mr. Slosman such
that the annual salary will increase to $420,000 from $400,000; (ii) reimbursement of up to $50,000 for any reasonable and customary,
documented out-of-pocket relocation expenses actually incurred by Mr. Slosman in 2019 or 2020 calendar years, in connection with his
relocation to Europe; (iii) annual performance bonuses in an amount up to 50% percent of the Base Salary, as may be in effect from time
to time, for each calendar year during his employment with us based on the extent to which performance criteria/financial results for
the applicable year have been met; and (iv) equity awards as of the date of the Slosman Employment Agreement that represent, in the aggregate,
5% of the Company’s issued and outstanding common stock determined on a fully diluted basis as of the date of grant (the “Equity
Awards”), with 75% of the Equity Awards being granted as restricted stock units and with the remaining 25% of the Equity Awards
being granted as stock options, all of which Equity Awards shall be outside of the 2013 Long-Term Incentive Plan and subject to terms
and conditions of the award agreements entered by Mr. Slosman. In addition, on or before December 31, 2020, Mr. Slosman shall become
eligible to receive an additional grant of equity awards under the 2013 Long-Term Incentive Plan and the applicable award agreements
up to 5% (including the Equity Awards) of the Company’s actual outstanding shares of Common Stock on the date of grant, provided
that the actual amount of the grant shall be based on the achievement of certain performance/financial criteria as established by the
Board after consultation with Mr. Slosman, in its reasonable discretion. For the purposes of the equity award calculation, “fully
diluted basis” is defined as the sum of the total shares of common stock then outstanding, the shares of common stock issuable
upon the conversion of our then outstanding shares of Series B Convertible Preferred Stock and Series C Convertible Preferred Stock and
the shares of common stock issuable upon the exercise of our then outstanding pre-funded warrant. On January 2, 2020, pursuant to the
Slosman Employment Agreement, we granted Mr. Slosman restricted stock units for 182,381 shares and a stock option to purchase 60,794
shares of common stock at $1.10 per share.
In
January 2022, the Compensation Committee approved a reimbursement of up to $50,000 for any reasonable and customary, documented out-of-pocket
relocation expenses actually incurred by Mr. Slosman in the 2022 calendar years, in connection with his relocation to Europe, as well
as $62,500 in expenses on an annual basis for expenses relating to commuting expenses, health coverage and corporate and visa status
costs.
- 70 -
In
the event Mr. Slosman voluntarily resigns without good reason, we may, in our sole discretion, shorten the notice period and determine
the date of termination without any obligation to pay Mr. Slosman any additional compensation other than the accrued obligations and
without triggering a termination of Mr. Slosman’s employment without cause. In the event we terminate Mr. Slosman’s employment
for cause or Mr. Slosman voluntarily resigns without good reason, we shall have no further liability or obligation to Mr. Slosman under
the Slosman Employment Agreement. Notwithstanding the foregoing, in the event that this the Slosman Employment Agreement terminates,
we shall, subject to the execution and timely return by Mr. Slosman of a release of claims, pay Mr. Slosman cash payments totaling $100,000
in the aggregate, payable in equal installments on our regular pay dates that occur during the period commencing on 60th day following
his employment termination date and ending on the last day of the Restricted Period (as defined below); provided, however, that if, at
any time within the period commencing on the date that is 3 months prior to the termination of his employment agreement , we and a third
party execute a definitive, written, and binding agreement (a “Sale Agreement”) to enter into certain transactions described
therein that, if consummated, would constitute a change in control in us, then Mr. Slosman’s termination shall be deemed a termination
by us without cause or for good reason, as of the date such Sale Agreement is executed, provided further that any amounts payable to
Mr. Slosman pursuant to such termination shall be reduced by any amounts previously paid to him upon expiration of the Slosman Employment
Agreement, termination by us for cause or voluntary resignation by Mr. Slosman without good reason.
If
Mr. Slosman’s employment is terminated (i) by us without cause or (ii) by Mr. Slosman for good reason, then we must pay Mr. Slosman,
(a) a severance pay in an amount equal to twelve months of his then-current base salary, (b) his entire performance bonus for any calendar
year for which Mr. Slosman has already worked the entire year but the bonus has yet to be paid, (c) a pro-rated performance bonus in
an amount equal to the target annual performance bonus to which Mr. Slosman may have been entitled for the year in which the termination
occurs that he would have received had his employment not been terminated during such year. In addition, 50% of all unvested stock options,
shares of restricted stock, restricted stock units, stock appreciation rights, or similar stock-based rights granted to Mr. Slosman shall
vest and, if applicable, be immediately exercisable and any risk of forfeiture included in such restricted or other stock grants previously
made to Mr. Slosman shall immediately lapse, and Mr. Slosman may exercise any outstanding stock options or stock appreciation rights
until the earlier of (x) the last date on which such stock options or stock appreciation rights could have been exercised pursuant to
the terms of the applicable award agreement, irrespective of Mr. Slosman’s termination of employment; and (y) the date that is
two years following his employment termination date.
Craig
Shore
We
have been a party to an employment agreement with Craig Shore since November 28, 2010. On May 5, 2014, we entered into an amended and
restated employment agreement with Mr. Shore, which was amended on January 5, 2015, July 25, 2016, and on March 25, 2019. The employment
agreement, as amended, had an initial term that originally was to end on December 31, 2020, and was to automatically renew for additional
one-year periods on January 1st thereafter unless either party gave the other party written notice of its election not to extend such
employment at least six months prior to the next January 1st renewal date. As discussed more fully below, we subsequently amended Mr.
Shore’s employment agreement to remove that certain definitive term of his employment such that his employment agreement shall
expire if and when terminated by either party pursuant to the terms thereof.
- 71 -
Under
the terms of the employment agreement, as amended by the third amendment to the amended and restated employment agreement, dated March
25, 2019, Mr. Shore is entitled to an annual base salary of at least $250,000. Such amount may be reduced only as part of an overall
cost reduction program that affects all of our senior executives and does not disproportionately affect Mr. Shore, so long as such reduction
does not reduce the base salary to a rate that is less than 90% of the amount set forth above (or 90% of the amount to which it has been
increased). The base salary will be reviewed annually by our chief executive officer for increase (but not decrease, except as permitted
as part of an overall cost reduction program) as part of our annual compensation review. Mr. Shore is also eligible to receive an annual
bonus in an amount equal to 60% of his then-annual salary upon the achievement of reasonable target objectives and performance goals,
to be determined by the board of directors in consultation with Mr. Shore. Mr. Shore is eligible to receive the percentage of his annual
bonus corresponding to the percentage of his achievement of such target objectives and performance goals. The annual bonus will be reviewed
annually by our chief executive officer for increase in the amount of the percentage of his then-base salary (but not decrease), as well
as the criteria and the goals, as part of our annual compensation review. In addition, Mr. Shore is eligible to receive such additional
bonus or incentive compensation as the board may establish from time to time in its sole discretion. Mr. Shore will also be considered
for grants of equity awards each year as part of the board’s annual compensation review, which will be made at the sole discretion
of the board of directors. Each grant will, with respect to any awards that are options, have an exercise price equal to the fair market
value of our common stock as of the date of grant, and will be subject to a three-year vesting period subject to Mr. Shore’s continued
service with us, with one-third of each additional grant vesting equally on the first, second, and third anniversary of the date of grant
for such awards.
If
Mr. Shore’s employment is terminated upon his death or disability, by us without cause (as such term is defined in Mr. Shore’s
employment agreement), or upon his resignation for “good reason” (as such term is defined in Mr. Shore’s employment
agreement), Mr. Shore will be entitled to receive, in addition to any amounts he is entitled to receive under the manager’s insurance
policy: (i) any unpaid base salary and accrued unpaid vacation or earned incentive compensation and the pro rata amount of any bonus
plan incentive compensation for the fiscal year of such termination (based on the number of business days he was actually employed by
us during the fiscal year of such termination and based on the percentage of the goals that he actually achieved under the bonus plan)
that he would have received had his employment not been terminated; (ii) a one-time lump sum severance payment equal to 100% of his base
salary, provided that he executes a release relating to employment matters and the circumstances surrounding his termination in favor
of us, our subsidiaries and our officers, directors and related parties and agents, in a form reasonably acceptable to us at the time
of such termination; (iii) vesting of all unvested stock options, stock appreciation rights or similar stock-based rights granted to
him and immediate lapse of any risk of forfeiture included in restricted or other stock grants previously made to Mr. Shore; (iv) an
extension of the exercise period of all vested stock options granted to Mr. Shore until the earlier of (a) two years from the date of
termination or (b) the latest date that each stock option would otherwise expire by its original terms; (v) to the fullest extent permitted
by our then-current benefit plans, continuation of health, dental, vision and life insurance coverage for the lesser of 12 months after
termination or until Mr. Shore obtains coverage from a new employer; and (vi) reimbursement of up to $30,000 for executive outplacement
services, subject to certain restrictions. The severance payment described in (ii) of the foregoing sentence upon Mr. Shore’s death
or disability will be reduced by any payments received by Mr. Shore pursuant to any of our employee welfare benefit plans providing for
payments in the event of death or disability. If Mr. Shore’s employment is terminated by us for cause or by Mr. Shore voluntarily,
Mr. Shore will only be entitled to unpaid amounts owed to him (e.g., base salary, accrued vacation and earned incentive compensation
through the date of such termination) and whatever rights, if any, are available to him pursuant to our stock-based compensation plan
or any award documents related to any stock-based compensation.
Mr.
Shore may terminate his employment for good reason by delivering a notice of termination to us 30 days in advance of the date of termination;
provided, however, that Mr. Shore agreed to not terminate his employment for good reason until he has given us at least 30 days’
notice from which to cure the circumstances set forth in the notice of termination constituting good reason, and if such circumstances
are not cured by the 30th day, Mr. Shore’s employment shall terminate on such date.
Pursuant
to terms contained in Mr. Shore’s stock option and restricted stock award agreements, in the event of a change of control of our
company, the stock options and restricted stock granted to Mr. Shore that were unvested will vest immediately upon such change of control,
in the case of stock options, if such stock options are not assumed or substituted by the surviving company.
- 72 -
If
we terminate Mr. Shore’s employment without cause, Mr. Shore will be entitled, under Israeli law, to severance payments equal to
his last month’s salary multiplied by the number of years Mr. Shore has been employed with us. In order to finance this obligation,
we make monthly contributions equal to 8.33% of Mr. Shore’s salary to a severance payment fund. The total amount accumulated in
Mr. Shore’s severance payment fund as of December 31, 2020 was $206,000, as adjusted for conversion from New Israeli Shekels to
U.S. Dollars. However, if Mr. Shore’s employment is terminated without cause, on account of a disability or upon his death, as
of December 31, 2020, Mr. Shore would have been entitled to receive $270,000 in severance under Israeli law, thereby requiring us to
pay Mr. Shore $64,000, in addition to releasing the $206,000 in Mr. Shore’s severance payment fund. On the other hand, pursuant
to his employment agreement, Mr. Shore is entitled to the total amount contributed to and accumulated in his severance payment fund in
the event of the termination of his employment as a result of his voluntary resignation. In addition, Mr. Shore would be entitled to
receive his full severance payment under Israeli law, including the total amount contributed to and accumulated in his severance payment
fund, if he retires from our company at or after age 67.
We
are entitled to terminate Mr. Shore’s employment immediately at any time for “cause” (as such term is defined in the
agreement and the Israeli Severance Payment Act 1963), upon which, after meeting certain requirements under the applicable law and recent
Israeli Labor court requirements, we believe we will have no further obligation to compensate Mr. Shore.
Also,
upon termination of Mr. Shore’s employment for any reason, we will compensate him for all unused or previously uncompensated vacation
days accrued.
The
employment agreement also contains certain standard noncompetition, non-solicitation, confidentiality, and assignment of inventions requirements
for Mr. Shore.
Mr.
Shore is also entitled to participate in or receive benefits under our social insurance and benefits plans, including but not limited
to our manager’s insurance policy and education fund, which are customary benefits provided to executive employees in Israel. A
management insurance policy is a combination of severance savings (in accordance with Israeli law), defined contribution tax-qualified
pension savings and disability pension payments. An education fund is a savings fund of pre-tax contributions to be used after a specified
period of time for advanced educational training and other permitted purposes, as set forth in the by-laws of the education fund. We
will make periodic contributions to these insurance and social benefits plans based on certain percentages of Mr. Shore’s base
salary, including (i) 7.5% to the education fund and (ii) 15.83% to the manager’s insurance policy, of which 8.33% will be allocated
to severance pay, 5.5% to pension fund payments and up to 2.5% to disability pension payments. Upon the termination of Mr. Shore’s
employment for any reason other than for cause, Mr. Shore will be entitled to receive the total amount contributed to and accumulated
in his manager insurance policy fund.
On
August 14, 2020, we entered into the fourth amendment to that certain Amended and Restated Employment Agreement dated as of May 5, 2014,
as amended on January 5, 2015, July 25, 2016, and on March 25, 2019, in order to, among other things, (i) amend the term of Mr. Shore’s
employment, so that the initial term of Mr. Shore employment will end on July 31, 2022, which will automatically be renewed for additional
one-year periods on August 1, 2022 and on each August 1 thereafter; (ii) increase Mr. Shore’s monthly base salary to NIS 86,000;
and (iii) amend certain terms related to termination of Mr. Shore’s employment without Cause (as defined therein).
On
November 4, 2021, we entered into the Fifth Amendment to that certain Amended and Restated Employment Agreement with our chief financial
officer, chief administrative officer, secretary and treasurer, Craig Shore, dated May 5, 2014, as amended on January 5, 2015, July 25,
2016, March 25, 2019 and on August 14, 2020, pursuant to which we agreed to remove that certain definitive term of his employment such
that his employment agreement shall expire if and when terminated by either party pursuant to the terms thereof.
On
January 17, 2022, we entered into the Sixth Amendment to that certain Amended and Restated Employment Agreement with our chief financial
officer, chief administrative officer, secretary and treasurer, Craig Shore, dated May 5, 2014, as amended on January 5, 2015, July 25,
2016, March 25, 2019, August 14, 2020 and on November 4, 2021, pursuant to which we agreed to increase Mr. Shore’s monthly base
salary to no less than NIS 89,440 effective January 1, 2022, per month (NIS 1,073,280 on an annualized basis).
Change
of Control Agreements
Pursuant
to our forms of our restricted stock award agreement, stock option agreement, or restricted stock unit award agreement pursuant to our
2021 Equity Incentive Plan, in the event of a change of control, any unvested awards shall become immediately vested.
We
do not currently have any plans providing for the payment of retirement benefits to our officers or directors, other than as described
above and under “Agreements with Executive Officers” above.
We
do not currently have any change-of-control or severance agreements with any of our executive officers or directors, other than as described
under “Agreements with Executive Officers” above. In the event of the termination of employment of the named executive officers,
any and all unexercised stock options shall expire and no longer be exercisable after a specified time following the date of the termination,
other than as described under “Agreements with Executive Officers” above.
- 73 -
Outstanding
Equity Awards at December 31, 2021
The
following table shows information concerning unexercised options and unvested shares of restricted stock outstanding as of December 31,
2021 for each of our named executive officers.
Option Awards
Stock Awards
Name
Number of securities underlying unexercised options (#) exercisable
Number of securities underlying unexercised options (#) unexercisable
Option exercise price ($)
Option expiration date
Number of shares of stock that have not vested (#)
Market value of shares of stock that have not vested ($)
Marvin Slosman(1)
1,351
2,702 (2)
16.50
1/2/2030
8,106 (3)
24,480
8,706
17,412 (4)
5.85
8/31/2030
52,235 (5)
157,751
40,000 (6)
6.90
4/19/2031
48,855 (7)
4.12
10/13/2031
146,567 (8)
442,632
Craig Shore
1
-
124,687.50
07/25/2026
133 (9)
403
5,029
10,057 (4)
5.85
8/31/2030
30,171 (10)
91,115
6,667 (6)
6.90
4/19/2031
24,326 (11)
4.09
11/10/2031
72,978 (12)
220,394
(1)
Mr.
Slosman was appointed as chief executive officer effective as of January 1, 2020
(2)
These
options vest annually, with one-half vesting on each of January 2, 2022 and January 2, 2023.
(3)
These
restricted stock units (RSUs) vest annually, with one-half vesting on each of January 2,
2022 and January 2, 2023.
In
case of the holders termination of services for any reason other than by the Company for cause, the Company shall convert the vested
RSUs into the number of whole shares of Common Stock equal to the number of vested RSUs and shall deliver them to the holder.
(4)
These
options vest annually, with one-half vesting on each of August 31, 2022 and August 31, 2023.
(5)
These
RSUs vest annually, with one-half vesting on each of August 31, 2022 and August 31, 2023.
(6)
These
options vest annually, with one-third vesting on each of April 19, 2022, April 19, 2023 and April 19, 2024.
(7)
These
options vest annually, with one-third vesting on each of October 13, 2022, October 13, 2023 and October 13, 2024.
(8)
These
RSUs vest annually, with one-third vesting on each of October 13, 2022, October 13, 2023 and October 13, 2024.
(9)
These
shares of restricted stock vest annually, with vesting on February 4, 2022.
(10)
These
shares of restricted stock vest annually, with one-half vesting on each of August 31, 2022 and August 31, 2023.
(11)
These
options vest annually, with one-third vesting on each of November 10, 2022, November 10, 2023 and November 10, 2024.
(12)
These
shares of restricted stock vest annually, with one-third vesting on each of November 10, 2022, November 10, 2023 and November 10,
2024.
Option
Exercises and Stock Vested
There
were no stock options exercised by our named executive officers during the twelve months ended December 31, 2021.
2011
UMBRELLA Option Plan
On
March 28, 2011, our board of directors and stockholders adopted and approved the InspireMD, Inc. 2011 UMBRELLA Option Plan, which was
subsequently amended on October 31, 2011 and December 21, 2012. Under the InspireMD, Inc. 2011 UMBRELLA Option Plan, we have reserved
13 shares of our common stock as awards to the employees, consultants, and service providers to InspireMD, Inc. and its subsidiaries
and affiliates worldwide. The InspireMD, Inc. 2011 UMBRELLA Option Plan is administered by our compensation committee. The InspireMD,
Inc. 2011 UMBRELLA Option Plan has expired on March 27, 2021. We have no shares of common stock available for future issuance under our
2011 UMBRELLA Option Plan.
- 74 -
2013
Long-Term Incentive Plan
On
December 16, 2013, our stockholders approved the InspireMD, Inc. 2013 Long-Term Incentive Plan, which was adopted by our board of directors
on October 25, 2013.
The
purpose of the InspireMD, Inc. 2013 Long-Term Incentive Plan is to provide an incentive to attract and retain employees, officers, consultants,
directors, and service providers whose services are considered valuable, to encourage a sense of proprietorship and to stimulate an active
interest of such persons in our development and financial success. The InspireMD, Inc. 2013 Long-Term Incentive Plan provides for the
granting of incentive stock options, nonqualified stock options, stock appreciation rights, restricted stock, restricted stock units,
performance awards, dividend equivalent rights, and other awards, which may be granted singly, in combination, or in tandem. The InspireMD,
Inc. 2013 Long-Term Incentive Plan is administered by our compensation committee.
The
InspireMD, Inc. 2013 Long-Term Incentive Plan is intended to serve as an “umbrella” plan for us and our subsidiaries worldwide.
Therefore, if so required, appendices may be added to the InspireMD, Inc. 2013 Long-Term Incentive Plan in order to accommodate local
regulations that do not correspond to the scope of the InspireMD, Inc. 2013 Long-Term Incentive Plan. Attached as Appendix A to the InspireMD,
Inc. 2013 Long-Term Incentive Plan is the InspireMD, Inc. 2013 Employee Stock Incentive Plan, for the purpose of making grants of stock
options, restricted stock, and other stock incentive awards pursuant to Sections 102 and 3(i) of the Israeli Income Tax Ordinance (New
Version), 1961 to Israeli employees and officers and any other service providers or control holders of us who are subject to Israeli
Income Tax.
When
the InspireMD, Inc. 2013 Long-Term Incentive Plan was adopted, a total of 11 shares of common stock were reserved for awards under the
InspireMD, Inc. 2013 Long-Term Incentive Plan.
On
September 9, 2015, our stockholders approved an amendment to the InspireMD, Inc. 2013 Long-Term Incentive Plan to increase the number
of shares of common stock available for issuance pursuant to awards under the InspireMD, Inc. 2013 Long-Term Incentive Plan by 11 shares
of common stock, to a total of 22 shares of common stock.
On
May 24, 2016, our stockholders approved the second amendment to the InspireMD, Inc. 2013 Long-Term Incentive Plan to increase the number
of shares of common stock available for issuance pursuant to awards under the InspireMD, Inc. 2013 Long-Term Incentive Plan by 229 shares
of common stock, to a total of 251 shares of common stock.
On
September 28, 2016, our stockholders approved the third amendment to the InspireMD, Inc. 2013 Long-Term Incentive Plan to increase the
number of shares of common stock available for issuance pursuant to awards under the InspireMD, Inc. 2013 Long-Term Incentive Plan by
144 shares of common stock, to a total of 395 shares of common stock.
On
October 24, 2018, our stockholders approved the fourth amendment to the InspireMD, Inc. 2013 Long-Term Incentive Plan to (i) increase
the number of shares of common stock available for issuance pursuant to awards under such InspireMD, Inc. 2013 Long-Term Incentive Plan
by 178,000 shares, to a total of 178,395 shares of common stock, and (ii) remove the cap on the number of shares of common stock with
respect to which stock options or stock appreciation rights may be granted to certain executive officers of the Company during any calendar
year.
On
March 21, 2019, our stockholders approved the fifth amendment to the InspireMD, Inc. 2013 Long-Term Incentive Plan to increase the total
number of shares of common stock issuable under the InspireMD, Inc. 2013 Long-Term Incentive Plan by 500,000 shares to a total of 678,395
shares of common stock
- 75 -
On
August 31, 2020, our stockholders approved the sixth amendment to the InspireMD, Inc. 2013 Long-Term Incentive Plan to increase the total
number of shares of common stock issuable under the InspireMD, Inc. 2013 Long-Term Incentive Plan by 6,500,000 shares to a total of 7,178,395
shares of common stock.
As
of December 31, 2021, we had 65,496 shares of common stock available for future issuance under our 2013 Long-Term Incentive Plan.
As
of March 4, 2022, we had 65,496 shares of common stock available for future issuance under our 2013 Long-Term Incentive Plan.
2021
Equity Incentive Plan
On
September 30, 2021, at our 2021 annual meeting of stockholders, our stockholders approved our 2021
Equity Incentive Plan.
The
purpose of the InspireMD, Inc. 2021 Equity Incentive Plan is to provide an incentive to
attract and retain employees, officers, consultants, directors, and service providers whose services are considered valuable, to encourage
a sense of proprietorship and to stimulate an active interest of such persons in our development and financial success. The InspireMD,
Inc. 2021 Equity Incentive Plan provides for the granting of incentive stock options, nonqualified
stock options, stock appreciation rights, restricted stock, restricted stock units, performance awards, dividend equivalent rights, and
other awards, which may be granted singly, in combination, or in tandem. The InspireMD, Inc. 2021
Equity Incentive Pla n is administered by our compensation committee.
As
of December 31, 2021, we had 803,004 shares of common stock available for future issuance under our 2021
Equity Incentive Pla n.
As
of March 4, 2022, we had 728,980 shares of common stock available for future issuance under our 2021
Equity Incentive Pla n.
Director
Compensation
The
following table shows information concerning our directors during the twelve months ended December 31, 2021.
Name
Fees
Earned or Paid in Cash ($)
Stock
Awards ($)
Option
Awards ($)
All
Other Compensation ($)
Total
($)
Paul
Stuka
55,739
107,445
32,065
-
195,250
Michael
Berman
36,954
71,062
21,049
-
129,064
Campbell
Rogers, M.D.
27,954
71,062
21,206
-
120,221
Thomas
Kester
42,087
71,062
21,206
-
134,354
Gary
Roubin, M.D.
30,754
71,062
52,280
-
154,096
Kathryn
Arnold
20,930
124,163
37,144
-
182,237
For
the 2021 calendar year, our board approved the following compensation for our independent directors: (i) a $40,000 stipend, payable quarterly
to the chairman of the board; (ii) a $25,000 stipend, payable quarterly to the other directors; (iii) annual committee chair compensation
of $12,000 for the chairman of the audit committee, $8,000 for the chairman of the compensation committee and $5,000 for the chairmen
of the nominating and corporate governance committee and the research and development committee; and (iv) annual committee membership
compensation of $4,000 for members of the audit committee and the compensation committee and $2,000 for members of the nominating and
corporate governance committee and the research and development committee. Effective October 13, 2021, the Board approved an increase
in the annual compensation for the chairman of the board to $48,000, and for all other directors to $30,000.
Directors’
and Officers’ Liability Insurance
We
currently have directors’ and officers’ liability insurance insuring our directors and officers against liability for acts
or omissions in their capacities as directors or officers, subject to certain exclusions. Such insurance also insures us against losses
which we may incur in indemnifying our officers and directors. In addition, we have entered into indemnification agreements with key
officers and directors and such persons shall also have indemnification rights under applicable laws, and our certificate of incorporation
and bylaws.
Item
12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.
The
following table sets forth information with respect to the beneficial ownership of our common stock as of March 4, 2022 by:
●
each
person known by us to beneficially own more than 5.0% of our common stock;
●
each
of our directors;
●
each
of the named executive officers; and
●
all
of our directors and executive officers as a group.
- 76 -
The
percentages of common stock beneficially owned are reported on the basis of regulations of the Securities and Exchange Commission (the
“SEC”) governing the determination of beneficial ownership of securities. Under the rules of the SEC, a person is deemed
to be a beneficial owner of a security if that person has or shares voting power, which includes the power to vote or to direct the voting
of the security, or investment power, which includes the power to dispose of or to direct the disposition of the security.
Except
as indicated in the footnotes to this table, each beneficial owner named in the table below has sole voting and sole investment power
with respect to all shares beneficially owned and each person’s address is c/o InspireMD, Inc., 4 Menorat Hamaor St., Tel Aviv,
Israel 6744832. As of March 4, 2022, we had 8,322,439 shares outstanding
Name
of Beneficial Owner
Number
of Shares Beneficially Owned (1)
Percentage
Beneficially Owned (1)
5%
Owners
Officers
and Directors
Marvin
Slosman
70,405
(2)
*
Craig
Shore
328,342 (3)
3.94 %
Michael
Berman
9,242 (4)
*
Campbell
Rogers, M.D.
29,136 (5)
*
Paul
Stuka
117,612 (6)
1.50 %
Thomas
Kester
44,560 (7)
*
Gary
Roubin, M.D.
155,011 (8)
1.98 %
Kathryn
Arnold
27,784 (9)
*
All
directors and executive officers as a group (8 persons)
782,091
9.28 %
*
Represents
ownership of less than one percent.
(1)
Shares
of common stock beneficially owned and the respective percentages of beneficial ownership of common stock assumes the exercise of
all options, warrants and other securities convertible into common stock beneficially owned by such person or entity currently exercisable
or exercisable within 60 days of March 4, 2022. Shares issuable pursuant to the exercise of stock options and warrants exercisable
within 60 days are deemed outstanding and held by the holder of such options or warrants for computing the percentage of outstanding
common stock beneficially owned by such person but are not deemed outstanding for computing the percentage of outstanding common
stock beneficially owned by any other person.
(2)
Consists
of (i) 6,392 shares of common stock, (ii) 8,106 Restricted Stock Units granted outside the plan that are currently exercisable or
exercisable within 60 days of March 4, 2022, (iii) 26,117 Restricted Stock Units granted under the 2021 Equity Incentive Plan, (iv)
options to purchase 24,742 shares of common stock that are currently exercisable or exercisable within 60 days of March 4, 2022,
and (v) 5,048 warrants to purchase shares of common stock that are currently exercisable.
(3)
Consists
of (i) 15,491 shares of common stock, (ii) options to purchase 7,252 shares of common stock that are currently exercisable or exercisable
within 60 days of March 4, 2022, (iii) 30,170 shares of restricted stock granted under the Israeli Appendix of the InspireMD, Inc.
2013 Long-Term Incentive Plan, (iv) 72,978 shares of restricted stock granted under the 2021 Equity Incentive Plan, and (v) 202,452
shares of restricted stock granted to employees under the Israeli Appendix of the InspireMD, Inc. 2013 Long-Term Incentive Plan held
in trust, and with respect to which Mr. Shore was granted a proxy with the right to vote such shares at his discretion.
(4)
Consists
of (i) 5,378 shares of common stock, (ii) warrants to purchase 2,688 shares of common stock that are currently exercisable or exercisable
within 60 days of March 4, 2022, (iii) options to purchase 1,176 shares of common stock that are currently exercisable or exercisable
within 60 days of March 4, 2022. Excludes 10,710 shares of restricted stock granted under the Israeli Appendix of InspireMD, Inc.
2013 Long-Term Incentive Plan and 17,248 shares of restricted stock granted under the 2021 Equity Incentive Plan held in trust, with
respect to which the trustee has a proxy with the right to vote such shares at his discretion.
(5)
Consists
of (i) 3,688 shares of common stock, (ii) 7,024 shares of restricted stock granted under the InspireMD, Inc. 2013 Long-Term Incentive
Plan, (iii) 17,248 Restricted Stock Units granted under the 2021 Equity Incentive Plan, (iv) options to purchase 1,176 shares of
common stock that are currently exercisable or exercisable within 60 days of March 4, 2022.
(6)
Paul
Stuka is the principal and managing member of Osiris Investment Partners, L.P., and, as such, has beneficial ownership of (A) 28
shares of common stock (B) personally holding (i) options to purchase 1,775 shares of common stock that are currently exercisable
or exercisable within 60 days of March 4, 2022, (ii) 10,620 shares of restricted stock granted under the InspireMD, Inc. 2013 Long-Term
Incentive Plan, (iii) 26,079 shares of restricted stock granted under the 2021 Equity Incentive Plan, (iv) 79,110 shares of common
stock.
(7)
Consists
of (i) 15,083 shares of common stock, (ii) 7,024 shares of restricted stock granted under the InspireMD, Inc. 2013 Long-Term Incentive
Plan, (iii) 17,248 shares of restricted stock granted under the 2021 Equity Incentive Plan, (iv) 4,032 warrants to purchase shares
of common stock that are currently exercisable and (v) options to purchase 1,173 shares of common stock that are currently exercisable
or exercisable within 60 days of March 4, 2022.
(8)
Consists
of (i) 100,826 shares of common stock, (ii) 10,620 shares of restricted stock granted under the InspireMD, Inc. 2013 Long-Term Incentive
Plan, (iii) 17,248 shares of restricted stock granted under the 2021 Equity Incentive Plan, and (iv) 22,880 warrants to purchase
shares of common stock that are currently exercisable and (v) options to purchase 3,437 shares of common stock that are currently
exercisable or exercisable within 60 days of March 4, 2022.
(9)
Consists
of (i) 10,536 shares of restricted stock granted under the InspireMD, Inc. 2013 Long-Term Incentive Plan, (ii) 17,248 shares of restricted
stock granted under the 2021 Equity Incentive Plan.
- 77 -
Equity
Compensation Plan Information
The
following table provides certain information as of December 31, 2021, with respect to our equity compensation plans under which our equity
securities are authorized for issuance:
Plan
Category
Number
of securities to be issued upon exercise of outstanding options, warrants and rights
Weighted-average
exercise price of outstanding options, warrants and rights
Number
of securities remaining available for future issuance under equity compensation plans (excluding securities reflected in column (a))
(a)
(b)
(c)
Equity
compensation
plans approved by
security holders
299,322
5.25
868,500
Equity
compensation
plans not approved
by security holders
10,088 (1)
9.77
-
Total
309,410
5.39
868,500
(1)
Comprised
of awards made to individuals outside the InspireMD, Inc. 2011 UMBRELLA Option Plan, 2013 Long Term Incentive Plan and 2021 Equity
Incentive Plan, as described below:
●
On
January, 2020, we issued to Mr. Marvin Slosman, our Chief Executive Officer, President and Director, 12,159 shares of restricted
stock and 4,053 shares of common stock, as inducement awards outside the Company’s 2013 Long-Term Incentive Plan.
●
On
November 3, 2020, we issued to Mr. Andrea Tommasoli, our Senior Vice President of Global Sales and Marketing, options to purchase
6,035 shares of our common stock, as inducement awards outside the Company’s 2013 Long-Term Incentive Plan.]
Item
13. Certain Relationships and Related Transactions, and Director Independence.
In
accordance with our audit committee charter, the audit committee is required to approve all related party transactions. In general, the
audit committee will review any proposed transaction that has been identified as a related party transaction under Item 404 of Regulation
S-K. A related party includes (i) a director, director nominee or executive officer of us, (ii) a security holder known to be an owner
of more than 5% of our voting securities, (iii) an immediate family member of the foregoing or (iv) a corporation or other entity in
which any of the foregoing persons is an executive, principal or similar control person or in which such person has a 5% or greater beneficial
ownership interest.
There
were no related party transactions that are required to be disclosed pursuant to Regulation S-K promulgated under the Securities Act
of 1933, as amended.
Director
Independence
The
board of directors has determined that Dr. Rogers and Dr. Roubin, Messrs. Stuka, Berman and Kester, and Ms. Arnold satisfy the requirement
for independence set out in Nasdaq Listing Rules and Rule 10A-3 promulgated under the Exchange Act. In making its independence determinations,
the board of directors sought to identify and analyze all of the facts and circumstances relating to any relationship between a director,
his or her immediate family or affiliates and our company and our affiliates and did not rely on categorical standards other than those
contained in the rules referenced above.
Item
14. Principal Accountant Fees and Services.
The
fees billed for professional services provided to us by Kesselman & Kesselman, Certified Public Accountants (“Kesselman”),
a member of PricewaterhouseCoopers International Limited, for the years ended December 31, 2021 and 2020 are described below.
Fee
category
2021
2020
Audit
Fees (1)
$ 176,000
$ 160,000
Audit
– related fees
49,900
$ 53,900
Tax
fees
38,675
$ 39,209
All
other fees
-
$ -
Total
fees
$ 264,575
$ 253,109
- 78 -
Audit
Fees
Kesselman
billed us audit fees in the aggregate amount of $176,000 and $160,000 for the years ended December 31, 2021 and 2020, respectively. These
fees relate to the audit of our annual financial statements and the review of our interim quarterly financial statements.
Audit-Related
Fees
Kesselman
billed us audit-related fees in the aggregate amount of $49,900 and $53,900 for the year ended December 31, 2021 and 2020, respectively.
The fees for the year ended December 31, 2021 mostly related to registration statement on Form S-1 filed with the SEC in February 2021
and to registration statement on Form S-3 filed with the SEC in April 2021.
The
fees for the year ended December 31, 2020 mostly related to registration statement on Form S-1 filed with the SEC in June 2020 and to
our prospectus supplements filed with the Securities and Exchange Commission in July 2020.
Tax
Fees
Kesselman
billed us tax fees in the aggregate amount of $38,675 and $39,209 for the year ended December 31, 2021 and 2020, respectively. These
fees relate to professional services rendered for tax compliance, tax advice and tax planning.
All
Other Fees
Kesselman
did not bill us for any other fees for the year ended December 31, 2021 and 2020.
Our
audit committee pre-approves all auditing services, internal control-related services and permitted non-audit services (including the
fees and terms thereof) to be performed for us by our independent auditor, except for de minimis non-audit services that are approved
by the audit committee prior to the completion of the audit. The audit committee may form and delegate authority to subcommittees consisting
of one or more members when appropriate, including the authority to grant pre-approvals of audit and permitted non-audit services, provided
that decisions of such subcommittee to grant pre-approvals is presented to the full audit committee at its next scheduled meeting. The
Audit Committee pre-approved all of the fees set forth above.
PART
IV
Item
15. Exhibits and Financial Statement Schedules.
Documents
filed as part of report:
1.
Financial Statements
The
following financial statements are included herein:
●
Report of Kesselman & Kesselman, Independent Registered Public Accounting Firm
●
Consolidated Balance Sheets as of December 31, 2021 and 2020
●
Consolidated
Statements of Operations for the Years Ended December 31, 2021 and 2020
●
Consolidated Statements of Changes in Equity for the Years Ended December 31, 2021 and 2020
●
Consolidated Statements of Cash Flows for the Years Ended December 31, 2021 and 2020
●
Notes to Consolidated Financial Statements
2.
Financial Statement Schedules
None
3.
Exhibits
See
Index to Exhibits
- 79 -
Item
16. Form 10-K Summary
Not
applicable.
Index
to Exhibits
Exhibit
No.
Description
3.1
Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 to Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 9, 2015)
3.2
Amended and Restated Bylaws (incorporated by reference to Exhibit 3.2 to Current Report on Form 8-K filed with the Securities and Exchange Commission on June 29, 2021).
3.3
Certificate of Amendment to Amended and Restated Certificate of Incorporation of InspireMD, Inc. (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed on May 25, 2016)
3.4
Certificate of Amendment to Amended and Restated Certificate of Incorporation of InspireMD, Inc. (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed on September 29, 2016)
3.5
Certificate of Designation of Preferences, Rights and Limitations of Series C Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed on March 15, 2017)
3.6
Certificate of Amendment to Certificate of Designation of Preferences, Rights and Limitation of Series C Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed on November 29, 2017)
3.7
Certificate of Amendment to Certificate of Designation of Preferences, Rights and Limitation of Series B Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed on December 12, 2017)
3.8
Certificate of Amendment to Amended and Restated Certificate of Incorporation of InspireMD, Inc. (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed on February 7, 2018)
3.9
Certificate of Amendment to Certificate of Designation of Preferences, Rights and Limitation of Series D Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed on March 1, 2018)
3.10
Certificate of Amendment to Certificate of Designation of Preferences, Rights and Limitation of Series D Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed on April 3, 2018)
- 80 -
3.11
Certificate of Amendment to Amended and Restated Certificate of Incorporation of InspireMD, Inc., dated March 27, 2019 (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed on March 28, 2019)
3.12
Certificate of Amendment to Amended and Restated Certificate of Incorporation of InspireMD, Inc., dated April 14, 2021 (incorporated by reference to Exhibit 3.1 to Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 10, 2021)
3.13
Form of Common Stock Certificate (incorporated by reference to Exhibit 4.1 to Amendment No. 3 to Registration Statement on Form S-1 filed with the Securities and Exchange Commission on March 5, 2013)
3.15
Form of Series B Warrant Agent Agreement and Form of Series B Warrant (incorporated by reference to Exhibit 4.3 to Amendment No.3 to Registration Statement on Form S-1 filed with the Securities and Exchange Commission on March 6, 2017)
4.1*
Description of Securities
10.1+
Employment Agreement, by and between InspireMD Ltd. and Craig Shore, dated as of November 28, 2010 (incorporated by reference to Exhibit 10.21 to Current Report on Form 8-K filed with the Securities and Exchange Commission on April 6, 2011)
10.2+
Form of Indemnity Agreement between InspireMD, Inc. and each of the directors and executive officers thereof (incorporated by reference to Exhibit 10.22 to Amendment No. 1 to Registration Statement on Form S-1 filed with the Securities and Exchange Commission on August 26, 2011)
10.3
Agreement by and between InspireMD Ltd. and MeKo Laser Material Processing, dated as of April 15, 2010 (incorporated by reference to Exhibit 10.26 to Amendment No. 1 to Registration Statement on Form S-1 filed with the Securities and Exchange Commission on August 26, 2011)
10.4
Agreement by and between InspireMD Ltd. and Natec Medical Ltd, dated as of September 23, 2009 (incorporated by reference to Exhibit 10.27 to Amendment No. 1 to Registration Statement on Form S-1 filed with the Securities and Exchange Commission on August 26, 2011)
10.5+
InspireMD, Inc. 2013 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.1 to Current Report on Form 8-K filed with the Securities and Exchange Commission on December 20, 2013)
10.6+
Amended and Restated Employment Agreement, dated May 5, 2014, by and between InspireMD, Inc. and Craig Shore (incorporated by reference to Exhibit 10.2 to Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 7, 2014)
10.7+
First Amendment to the InspireMD, Inc. Amended and Restated 2011 UMBRELLA Option Plan (incorporated by reference to Exhibit 10.3 to Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 7, 2014)
10.8+
Form of Incentive Stock Option Award Agreement under the InspireMD, Inc. 2013 Long-Term Incentive Plan (incorporated by reference to Exhibit 99.2 to Registration Statement on Form S-8 filed with the Securities and Exchange Commission on June 5, 2014)
10.9+
Form of Nonqualified Stock Option Award Agreement under the InspireMD, Inc. 2013 Long-Term Incentive Plan (incorporated by reference to Exhibit 99.3 to Registration Statement on Form S-8 filed with the Securities and Exchange Commission on June 5, 2014)
- 81 -
10.10+
Form of Restricted Stock Award Agreement under the InspireMD, Inc. 2013 Long-Term Incentive Plan (incorporated by reference to Exhibit 99.4 to Registration Statement on Form S-8 filed with the Securities and Exchange Commission on June 5, 2014)
10.11+
Form of Restricted Stock Unit Award Agreement under the InspireMD, Inc. 2013 Long-Term Incentive Plan (incorporated by reference to Exhibit 99.5 to Registration Statement on Form S-8 filed with the Securities and Exchange Commission on June 5, 2014)
10.12+
Form of Section 3(i) Stock Option Award Agreement under the InspireMD, Inc. 2013 Long-Term Incentive Plan (Israeli) (incorporated by reference to Exhibit 99.6 to Registration Statement on Form S-8 filed with the Securities and Exchange Commission on June 5, 2014)
10.13+
Form of Section 102 Capital Gain Stock Option Award Agreement under the InspireMD, Inc. 2013 Long-Term Incentive Plan (Israeli) (incorporated by reference to Exhibit 99.7 to Registration Statement on Form S-8 filed with the Securities and Exchange Commission on June 5, 2014)
10.14+
Form of Section 102 Capital Gain Restricted Stock Award Agreement under the InspireMD, Inc. 2013 Long-Term Incentive Plan (Israeli) (incorporated by reference to Exhibit 99.8 to Registration Statement on Form S-8 filed with the Securities and Exchange Commission on June 5, 2014)
10.15+
Form of Stock Option Award Agreement under the InspireMD, Inc. 2013 Long-Term Incentive Plan (European) (incorporated by reference to Exhibit 99.9 to Registration Statement on Form S-8 filed with the Securities and Exchange Commission on June 5, 2014)
10.16+
Form of Restricted Stock Award Agreement under the InspireMD, Inc. 2013 Long-Term Incentive Plan (European) (incorporated by reference to Exhibit 99.10 to Registration Statement on Form S-8 filed with the Securities and Exchange Commission on June 5, 2014)
10.17+
Form of Stock Option Award Agreement outside the InspireMD, Inc. 2013 Long-Term Incentive Plan (incorporated by reference to Exhibit 99.11 to Registration Statement on Form S-8 filed with the Securities and Exchange Commission on June 5, 2014)
10.18+
First Amendment to Amended and Restated Employment Agreement, dated January 5, 2015, by and between InspireMD, Inc. and Craig Shore (incorporated by reference to Exhibit 10.3 to Current Report on Form 8-K filed with the Securities and Exchange Commission on January 6, 2015)
10.19+
First Amendment to the InspireMD, Inc. 2013 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed on September 9, 2015)
- 82 -
10.20+
Second Amendment to the InspireMD, Inc. 2013 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed on May 25, 2016)
10.21+
Second Amendment to Amended and Restated Employment Agreement, dated July 25, 2016, by and between InspireMD, Inc. and Craig Shore agent (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed on July 29, 2016)
10.22+
Third Amendment to the InspireMD, Inc. 2013 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed on September 29, 2016)
10.23+
Director Offer Letter, between InspireMD, Inc. and Thomas J. Kester, dated September 6, 2016
10.24
Securities Purchase Agreement (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed on November 29, 2017)
10.25
Amendment to Securities Purchase Agreement, dated February 21, 2018 (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed on February 21, 2018)
10.26
Waiver Agreement, dated February 26, 2018 (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed on February 26, 2018)
10.27
Form of Underwriter Warrant, dated March 1, 2018 (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed on March 1, 2018)
10.28
Waiver Agreement, dated March 28, 2018 (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed on March 29, 2018)
10.29
Form of Underwriter Warrant, dated April 2, 2018 (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed on April 3, 2018)
10.30
Letter Agreement, dated June 28, 2018, by and between InspireMD, Inc. and Sabby Healthcare Master Fund, Ltd. (incorporated by reference to Exhibit 10.67 to the Registration Statement on Form S-1, Amendment No. 2, filed with the SEC on June 26, 2018 (File No. 333-225680))
- 83 -
10.31
Form of Series D Warrant (incorporated by reference to Exhibit A to Exhibit 4.3 to the Company’s Registration Statement on Form S-1, Amendment No. 2, filed with the SEC on June 26, 2018 (File No. 333-225680))
10.32
Form of Underwriter Warrant (incorporated by reference to Exhibit 4.5 to the Company’s Registration Statement on Form S-1, Amendment No. 2, filed with the SEC on June 26, 2018 (File No. 333-225680))
10.33+
Fourth Amendment to the InspireMD, Inc. 2013 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed on October 26, 2018)
10.34+
Fifth Amendment to the InspireMD, Inc. 2013 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed on March 21, 2019)
10.35+
Third Amendment to Amended and Restated Employment Agreement, dated March 25, 2019, by and between InspireMD, Inc. and Craig Shore (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed on March 28, 2019)
10.36
Form of Underwriter Warrant, dated April 8, 2019 (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed on April 8, 2019)
10.37
Form of Series E Warrant (incorporated by reference to Exhibit 4.3 to the Company’s Registration Statement on Form S-1, Amendment No. 1, filed with the SEC on September 13, 2019 (File No. 333-233432)).
10.38
Form of Underwriter Warrant (incorporated by reference to Exhibit 4.5 to the Company’s Registration Statement on Form S-1, Amendment No. 1, filed with the SEC on September 13, 2019 (File No. 333-233432)).
10.39+
Employment Agreement, dated December 9, 2019, by and between the Company and Marvin Slosman (incorporated by reference to Exhibit 10.2 to the Current Report on Form 8-K filed on December 10, 2019).
10.40+
First Amendment to Employment Agreement, dated December 31, 2019, by and between the Company and Marvin Slosman (incorporated by reference to Exhibit 10.2 to the Current Report on Form 8-K filed on January 6, 2020).
10.41+
Nonqualified Stock Option Agreement, by and between the Company and Marvin Slosman (incorporated by reference to Exhibit 10.60 to the Annual Report on Form 10-K filed on March 10, 2020)
10.42+
Restricted Stock Unit Award agreement, by and between the Company and Marvin Slosman (incorporated by reference to Exhibit 10.61 to the Annual Report on Form 10-K filed on March 10, 2020)
- 84 -
10.43
Form of Series F Warrant (incorporated by reference to Exhibit 4.5 to the Company’s Registration Statement on Form S-1, Amendment No. 1, filed with the SEC on June 1, 2020 (File No. 333-238247)).
10.44
Form of Underwriter Warrant (incorporated by reference to Exhibit 1.1 to the Company’s Registration Statement on Form S-1, Amendment No. 1, filed with the SEC on June 1, 2020 (File No. 333-238247))
10.45
Form of Series G Warrant (incorporated by reference to Exhibit 4.5 to the Company’s Registration Statement on Form S-1, Amendment No. 1, filed with the SEC on February 3, 2021 (File No. 333-238247))
10.46
Form of Underwriter Warrant (incorporated by reference to Exhibit 4.6 to the Company’s Registration Statement on Form S-1, Amendment No. 1, filed with the SEC on February 3, 2021 (File No. 333-238247))
10.47+
Sixth Amendment to the InspireMD, Inc. 2013 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed on August 31, 2020)
10.48+
Seventh Amendment to the InspireMD, Inc. 2013 Long-Term Incentive Plan (incorporated by reference to Exhibit 10.1 to the Quarterly Report on Form 10-Q filed on August 9, 2021)
10.49+
First Amendment to Employment Agreement, dated November 8, 2021, by and between InspireMD, Inc. and Marvin Slosman (incorporated by reference to Exhibit 10.1 to the Quarterly Report on Form 10-Q filed on November 8, 2021).
10.50+
Fifth Amendment to Employment Agreement, dated November 4, 2021, by and between InspireMD, Inc. and Craig Shore (incorporated by reference to Exhibit 10.2 to the Quarterly Report on Form 10-Q filed on November 8, 2021).
10.51+*
Sixth Amendment to Employment Agreement, dated January 17, 2022, by and between InspireMD, Inc. and Craig Shore.
10.52+
2021 Equity Compensation Plan (Incorporated by reference to Annex A to the registrant’s Proxy Statement on Schedule 14A filed with the Commission on August 12, 2021).
10.53+*
Form of Nonqualified Stock Option Agreement for U.S. employees under the 2021 Equity Incentive Plan
10.54+*
Form of Nonqualified Stock Option Agreement for European employees under the 2021 Equity Incentive Plan
10.55+*
Form of Nonqualified Stock Option Agreement for consultants under the 2021 Equity Incentive Plan
10.56+*
Form of Nonqualified Stock Option Agreement for Israeli employees under the 2021 Equity Incentive Plan
10.57+*
Form of Nonqualified Stock Option Agreement for U.S. directors under the 2021 Equity Incentive Plan
10.58+*
Form of Restricted Stock Award Agreement for U.S. employees under the 2021 Equity Incentive Plan
10.59+*
Form of Restricted Stock Award Agreement for U.S. directors under the 2021 Equity Incentive Plan
10.60+*
Form of Restricted Stock Award Agreement for Israeli employees under the 2021 Equity Incentive Plan
10.61+*
Form of Restricted Stock Award Agreement for European employees under the 2021 Equity Incentive Plan
10.62+*
Form of Restricted Stock Unit Award Agreement under the 2021 Equity Incentive Plan
21.1
List of Subsidiaries (incorporated by reference to Exhibit 21.1 to Current Report on Form 8-K filed with the Securities and Exchange Commission on April 6, 2011)
23.1*
Consent of Kesselman & Kesselman, Certified Public Accountants
31.1*
Certification of Chief Executive Officer Pursuant to Section 302 of Sarbanes-Oxley Act of 2002
31.2*
Certification of Chief Financial Officer Pursuant to Section 302 of Sarbanes-Oxley Act of 2002
32.1*
Certification of Chief Executive Officer Pursuant to Section 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
32.2*
Certification of Chief Financial Officer Pursuant to Section 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101*
The
following materials from the Company’s Annual Report on Form 10-K for the twelve months ended December 31, 2021, formatted
in inline XBRL (eXtensible Business Reporting Language), (i) Consolidated Balance Sheets, (ii)Consolidated Statements of Income,
(iii) Consolidated Statements of Comprehensive Income, (iv) Consolidated Statements of Cash Flows, (v) Consolidated Statement of
Stockholders’ Equity (Capital Deficiency) and (vi) Notes to Consolidated Financial Statements
101.SCH
Inline XBRL Taxonomy Extension Schema Document
101.CAL
Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF
Inline XBRL Taxonomy Extension Definition Linkbase Document
101.LAB
Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE
Inline XBRL Taxonomy Extension Presentation Linkbase Document
104
Cover
Page Interactive Data File (embedded within the Inline XBRL document)
*
Filed herewith.
+
Management contract or compensatory plan or arrangement.
- 85 -
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.
INSPIREMD,
INC.
Date:
March 7, 2022
By:
/s/
Marvin Slosman
Marvin
Slosman
President
and Chief Executive Officer
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.
Signature
Title
Date
/s/
Marvin Slosman
President,
Chief Executive Officer and Director
March
7, 2022
Marvin
Slosman
(principal
executive officer)
/s/
Craig Shore
Chief
Financial Officer, Chief Administrative Officer,
Secretary and Treasurer
March
7, 2022
Craig
Shore
(principal
financial and accounting officer)
/s/
Paul Stuka
Chairman
of the Board of Directors
March
7, 2022
Paul
Stuka
/s/
Michael Berman
Director
March
7, 2022
Michael
Berman
/s/
Thomas J. Kester
Director
March
7, 2022
Thomas
J. Kester
/s/
Campbell Rogers, M.D.
Director
March
7, 2022
Campbell
Rogers, M.D.
/s/
Gary Roubin
Director
March
7, 2022
Gary
Roubin
/s/
Kathryn Arnold
Director
March
7, 2022
Kathryn
Arnold
INSPIREMD, INC.
CONSOLIDATED
FINANCIAL STATEMENTS
AS
OF AND FOR THE YEAR ENDED DECEMBER 31, 2021
F- 1
INSPIREMD,
INC.
CONSOLIDATED
FINANCIAL STATEMENTS
AS
OF AND FOR THE YEAR ENDED DECEMBER 31, 2021
TABLE
OF CONTENTS
Page
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM (PCAOB name: Kesselman & Kesselman C.P.A.s and PCAOB ID: 1309 )
F-3
CONSOLIDATED
FINANCIAL STATEMENTS:
Consolidated Balance Sheets
F-4
Consolidated Statements of Operations
F-5
Consolidated Statements of Changes in Equity
F-6
- F-7
Consolidated Statements of Cash Flows
F-8
Notes to the Consolidated Financial Statements
F-9
- F-29
F- 2
Report
of Independent Registered Public Accounting Firm
To
the board of directors and shareholders of InspireMD, Inc.
Opinion
on the Financial Statements
We
have audited the accompanying consolidated balance sheets of InspireMD, Inc. and its subsidiaries (the “Company”)
as of December 31, 2021 and 2020, and the related consolidated statements of operations, changes in equity and cash flows for the years
then ended, including 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, 2021 and 2020, and the results of its operations and its cash flows for the years then ended 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 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 of these consolidated financial statements 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 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 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 audits 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 audits provide a reasonable basis for our opinion.
Critical
Audit Matters
Critical
audit matters are matters arising from the current period audit of the consolidated financial statements that were communicated or required
to be communicated to the audit committee and that (i) relate to accounts or disclosures that are material to the consolidated financial
statements and (ii) involved our especially challenging, subjective, or complex judgments. We determined there are no critical audit
matters.
/s/
Kesselman&Kesselman
Certified
Public Accountants (Isr.)
A
member of PricewaterhouseCoopers International Limited
Tel-Aviv,
Israel
March
7, 2021
We
have served as the Company’s auditor since 2010.
F- 3
INSPIREMD,
INC.
CONSOLIDATED
BALANCE SHEETS
(U.S.
dollars in thousands)
2021
2020
December 31,
2021
2020
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$ 12,004
$ 12,645
Short-term bank deposits
22,036
-
Accounts receivable:
Trade, net
1,224
476
Other
165
146
Prepaid expenses
522
334
Inventory
1,143
1,415
Receivable for sale of Shares
-
323
TOTAL CURRENT ASSETS
37,094
15,339
NON-CURRENT ASSETS:
Property, plant and equipment, net
632
448
Operating lease right of use assets
1,081
1,265
Fund in respect of employee rights upon retirement
905
725
TOTAL NON-CURRENT ASSETS
2,618
2,438
TOTAL ASSETS
$ 39,712
$ 17,777
LIABILITIES AND EQUITY
CURRENT LIABILITIES:
Accounts payable and accruals:
Trade
893
236
Other
3,454
3,469
TOTAL CURRENT LIABILITIES
4,347
3,705
LONG-TERM LIABILITIES:
Operating lease liabilities
781
999
Liability for employee rights upon retirement
1,052
910
TOTAL LONG-TERM LIABILITIES
1,833
1,909
COMMITMENTS AND CONTINGENT LIABILITIES (Note 6)
-
TOTAL LIABILITIES
6,180
5,614
EQUITY:
Common stock, par value $ 0.0001 per share; 150,000,000 shares authorized at December 31, 2021 and 2020; 8,296,256 and 3,284,322 shares issued and outstanding at December 31, 2021 and 2020, respectively
1
- *
Preferred B shares, par value $ 0.0001 per share;
500,000 shares authorized at December 31, 2021 and 2020; 0 and 17,303 shares issued and outstanding at December 31, 2021 and 2020, respectively
-
- *
Preferred C shares, par value $ 0.0001 per share;
1,172,000 shares authorized at December 31, 2021 and 2020; 1,718 and 2,343 shares issued and outstanding at December 31, 2021 and 2020, respectively
- *
- *
Preferred stock, value
Additional paid-in capital
216,625
180,339
Accumulated deficit
( 183,094 )
( 168,176 )
Total equity
33,532
12,163
Total liabilities and equity
$ 39,712
$ 17,777
* Represents an amount
less than $1
The
accompanying notes are an integral part of the consolidated financial statements.
F- 4
INSPIREMD,
INC.
CONSOLIDATED
STATEMENTS OF OPERATIONS
(U.S.
dollars in thousands, except per share data)
2021
2020
Year Ended December 31,
2021
2020
REVENUES (2020 - net of settlement payment of $ 580 , see note 6 a)
$ 4,495
$ 2,485
COST OF REVENUES
3,741
2,402
GROSS PROFIT
754
83
OPERATING EXPENSES:
Research and development
5,158
2,233
Selling and marketing
2,907
2,103
General and administrative
7,405
6,127
Total operating expenses
15,470
10,463
LOSS FROM OPERATIONS
( 14,716 )
( 10,380 )
FINANCIAL EXPENSES
( 157 )
( 160 )
LOSS BEFORE TAX EXPENSES
( 14,873 )
( 10,540 )
TAX EXPENSES
45
4
NET LOSS
$ ( 14,918 )
$ ( 10,544 )
NET LOSS PER SHARE - basic and diluted
( 2.03 )
( 6.97 )
WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES USED IN COMPUTING NET LOSS PER SHARE - basic and diluted
7,346,022
1,512,439
The
accompanying notes are an integral part of the consolidated financial statements.
F- 5
INSPIREMD,
INC.
CONSOLIDATED
STATEMENTS OF CHANGES IN EQUITY
(U.S.
dollars in thousands, except share data)
Shares
Amount
Shares
Amount
Shares
Amount
capital
deficit
equity
Common stock
Series B
Convertible
Preferred Stock
Series C
Convertible
Preferred Stock
Additional paid-in
Accumulated
Total
Shares
Amount
Shares
Amount
Shares
Amount
capital
deficit
equity
BALANCE as of January 1, 2020
261,075
- *
17,303
- *
34,370
- *
$ 163,015
$ ( 157,632 )
$ 5,383
Net loss
( 10,544 )
( 10,544 )
Exercise of pre-funded warrants
990,427
- *
18
18
Settlement of restricted stock units in shares of common stock
11,000
- *
- *
Issuance of common shares, including at the market offering net of $ 1,110 issuance costs
1,607,251
- *
15,200
15,200
Exercise of Warrants F
191,107
- *
1,418
1,418
Exercise of Warrants G
Exercise of Warrants G, shares
Exercise of Unit Purchase Option
16,906
- *
82
82
Conversion of Series B Convertible Preferred Stock to common shares
Conversion of Series B Convertible Preferred Stock to common shares, shares
Conversion of Series C Convertible Preferred Stock to common shares
24,812
- *
-
-
( 32,027 )
- *
- *
Share-based compensation related to restricted stock, restricted stock units and stock options award, net of forfeitures of 3,717 shares
181,744
- *
606
606
Round up of shares due to reverse stock split effectuated on April 26, 2021
Round up of shares due to reverse stock split effectuated on
April 26, 2021, shares
BALANCE as of December 31, 2020
3,284,322
- *
17,303
- *
2,343
- *
$ 180,339
$ ( 168,176 )
$ 12,163
* Represents an amount
less than $1
F- 6
INSPIREMD,
INC.
CONSOLIDATED
STATEMENTS OF CHANGES IN EQUITY
(U.S.
dollars in thousands, except share data)
Common stock
Series B
Convertible
Preferred Stock
Series C
Convertible
Preferred Stock
Additional paid-in
Accumulated
Total
Shares
Amount
Shares
Amount
Shares
Amount
capital
deficit
equity
BALANCE as of December 31, 2020
3,284,322
- *
17,303
- *
2,343
- *
$ 180,339
$ ( 168,176 )
$ 12,163
Net loss
( 14,918 )
( 14,918 )
Issuance of common shares, including at the market offering net of $ 2,024 issuance costs
3,133,775
1
25,241
25,242
Issuance of common shares, including at the market offering net
of issuance costs
3,133,775
1
25,241
25,242
Exercise of Warrants F
1,093,536
- *
8,120
8,120
Exercise of Warrants G
131,876
- *
1,349
1,349
Conversion of Series B Convertible Preferred Stock to common shares
207,528
- *
( 17,303 )
- *
- *
Conversion of Series C Convertible Preferred Stock to common shares
831
- *
( 625 )
- *
- *
Share-based compensation related to restricted stock, restricted stock units and stock options award, net of forfeitures of 20,822 shares
399,120
1,576
1,576
Share-based compensation related to restricted stock, restricted
stock units and stock options award, net of forfeitures
399,120
1,576
1,576
Round up of shares due to reverse stock split effectuated on April 26, 2021
45,268
- *
-
-
-
-
-
-
- *
BALANCE as of December 31, 2021
8,296,256
1
-
-
1,718
- *
216,625
( 183,094 )
33,532
* Represents an amount
less than $1
F- 7
INSPIREMD,
INC.
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(U.S.
dollars in thousands)
2021
2020
Year ended December 31,
2021
2020
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss
$ ( 14,918 )
$ ( 10,544 )
Adjustments required to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
161
151
Loss (gain) from sale of property, plant and equipment
( 1 )
14
Change in liability for employees rights upon retirement
142
181
Other financial expense (income)
8
( 4 )
Change in operating right of use asset and operating leasing liability
( 14 )
56
Noncash interest income on short-term deposits
( 36 )
-
Share-based compensation expenses
1,576
606
Gains on amounts funded in respect of employee rights upon retirement, net
( 67 )
( 18 )
Changes in operating asset and liability items:
Increase in prepaid expenses
( 188 )
( 247 )
Decrease (increase) in trade receivables
( 748 )
347
Decrease (increase) in other receivables
( 19 )
4
Decrease (increase) in inventory
272
( 179 )
Increase (decrease) in trade payables
657
( 410 )
Increase (decrease) in other payables
( 35 )
962
Net cash used in operating activities
( 13,210 )
( 9,081 )
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of property, plant and equipment
( 344 )
( 88 )
Proceeds from sale of property, plant and equipment
-
22
Investment in short-term bank deposits
( 24,000 )
Withdrawal from short-term bank deposits
2,000
Amounts funded in respect of employee rights upon retirement, net
( 113 )
( 121 )
Net cash used in investing activities
( 22,457 )
( 187 )
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of shares and warrants and exercise of Pre-Funded Warrants and unit purchase option, net of $ 2,024 and $ 1,110 issuance costs, respectively
35,034
16,395
Net cash provided by financing activities
35,034
16,395
EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS
( 8 )
4
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
( 641 )
7,131
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF YEAR
12,645
5,514
BALANCE OF CASH AND CASH EQUIVALENTS AT END OF YEAR
$ 12,004
$ 12,645
SUPPLEMENTAL NON-CASH INVESTING AND FINANCING ACTIVITIES:
Acquisition of right-of-use assets by means of lease liabilities
91
619
Receivable for Shares
-
323
The
accompanying notes are an integral part of the consolidated financial statements.
F- 8
INSPIREMD,
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE
1 - DESCRIPTION OF BUSINESS
a.
General
InspireMD, Inc., a Delaware corporation (the “Company”), together with its subsidiaries, is a medical device company
focusing on the development and commercialization of its proprietary MicroNet™ stent platform technology for the treatment of complex
vascular and coronary disease. MicroNet, a micron mesh sleeve, is wrapped over a stent to provide embolic protection in stenting procedures.
The Company’s carotid product (CGuard™ EPS) combines MicroNet and a self-expandable nitinol stent in a single device
to treat carotid artery disease.
The
Company’s coronary product combining MicroNet and a bare-metal stent (MGuard Prime™ EPS) is marketed for use in patients
with acute coronary syndromes, notably acute myocardial infarction (heart attack) and saphenous vein graft coronary interventions (bypass
surgery). As a result of declining sales of the MGuard Prime EPS, we intend to phase out future sales of our MGuard Prime EPS in 2022.
The Company markets its products through distributors in international markets, mainly in Europe.
As
of the date of issuance of the consolidated financial statements, the Company has the ability to fund its planned operations for at least
the next 12 months. However, the Company expects to continue incurring losses and negative cash flows from operations until its products
(primarily CGuard™ EPS) reach commercial profitability. Therefore, in order to fund the Company’s operations until such time
that the Company can generate substantial revenues, the Company may need to raise additional funds.
b.
COVID-19 Pandemic
The
COVID-19 global pandemic has led governments and authorities around the globe to take various precautionary measures in order to limit
the spread of COVID-19, including government-imposed quarantines, lockdowns, and other public health safety measures. We experienced
a significant COVID-19 related impact on our financial condition and results of operations, primarily during the year ended December
31, 2020, which we primarily attribute to the postponement of CGuard EPS procedures (non-emergency procedures), as hospitals have shifted
resources to patients affected by COVID-19. To the best of our knowledge, the European countries in which we operate reinstated non-emergency
procedures. However, new COVID-19 variants, and potentially increasing infection rates make the current COVID-related environment highly
volatile and uncertain and we anticipate that the continuation of the pandemic and related restrictions and safety measures will likely
result in continued fluctuations in sales of our products and potentially enrollments in our studies as well as potential disruptions
to our supply chain for the upcoming periods.
F- 9
INSPIREMD,
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE
2 - SIGNIFICANT ACCOUNTING POLICIES
a. Use of estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates using assumptions that
affect the reported amounts of assets and liabilities, the disclosure of contingent liabilities at the date of the financial statements
and the reported amounts of sales and expenses during the reporting periods. Actual results could differ from those estimates.
As
applicable to these consolidated financial statements, the most significant estimates and assumptions relate to inventory valuations
and assessing the likelihood of exercise of options to extend the lease term.
b. Functional currency
The currency of the primary economic environment in which the operations of the Company and its subsidiaries are conducted is the
U.S. dollar (“$” or “dollar”). Accordingly, the functional currency of the Company and its subsidiaries is the
U.S. dollar.
The
dollar figures are determined as follows: transactions and balances originally denominated in dollars are presented in their original
amounts. Balances in foreign currencies are translated into dollars using historical and current exchange rates for non-monetary and
monetary balances, respectively. The resulting translation gains or losses are recorded as financial income or expense, as appropriate.
For transactions reflected in the statements of operations in foreign currencies, the exchange rates at transaction dates are used. Depreciation
and changes in inventories and other changes deriving from non-monetary items are based on historical exchange rates.
c.
Principles of consolidation
The
consolidated financial statements include the accounts of the Company and of its subsidiaries. Intercompany transactions and balances
have been eliminated upon consolidation.
d.
Cash and cash equivalents
The
Company considers all highly liquid investments, which include short-term bank deposits (up to three months from date of deposit), that
are not restricted as to withdrawal or use, to be cash equivalents.
F- 10
INSPIREMD,
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE
2 - SIGNIFICANT ACCOUNTING POLICIES (continued):
e. Short-term bank deposits
Bank
deposits with original maturities of more than three months but less than one year are presented as part of short-term bank deposits.
Deposits are presented at their cost which approximates market values including accrued interest. Interest on deposits is recorded as
financial income.
f. Concentration of credit risk and allowance for doubtful accounts
Financial
instruments that may potentially subject the Company to a concentration of credit risk consist of cash and cash equivalents, which are
deposited in major financially sound institutions in the U.S, Israel and Germany, and trade accounts receivable. The Company’s
trade accounts receivable is derived from revenues earned from customers from various countries. The Company performs ongoing credit
evaluations of its customers’ financial condition and, requires no collateral from its customers. The Company also has a credit
insurance policy for some of its customers. The Company maintains an allowance for doubtful accounts receivable based upon the expected
ability to collect the accounts receivable. The Company reviews its allowance for doubtful accounts quarterly by assessing individual
accounts receivable and all other balances based on historical collection experience and an economic risk assessment. If the Company
determines that a specific customer is unable to meet its financial obligations to the Company, the Company provides an allowance for
credit losses to reduce the receivable to the amount management reasonably believes will be collected, which is netted against “Accounts
receivable - Trade”.
g. Inventory
Inventories
are stated at the lower of cost (cost is determined on a “first-in, first-out” basis) or net realizable value. The Company’s
inventories generally have a limited shelf life and are subject to impairment as they approach their expiration dates. The Company regularly
evaluates the carrying value of its inventory and when, based on such evaluation, factors indicate that impairment has occurred, the
Company impairs the inventories’ carrying value.
h. Leases
Operating
leases are included in operating lease right-of-use (“ROU”) assets, Accounts payable and accruals - Other, and operating
lease liabilities. ROU assets represent Company’s right to use an underlying asset for the lease term and lease liabilities represent
obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at the lease commencement
date based on the present value of lease payments over the lease term. In determining the present value of lease payments, the Company
uses the incremental borrowing rate based on the information available at the lease commencement date as the rate implicit in the lease
is not readily determinable. The determination of the incremental borrowing rate requires management judgment based on information available
at lease commencement. The lease terms may include periods covered by options to extend the lease when it is reasonably certain that
the Company will exercise such options, and periods covered by options to terminate the lease when it is reasonably certain that the
Company will not exercise such options. Operating lease cost is recognized on a straight-line basis over the lease term. Lease agreements
that include lease and non-lease components are accounted for as a single lease component. The Company elected the short-term lease recognition
exemption for leases with a lease term of 12 months or less.
i. Property, plant and equipment
Property,
plant and equipment are stated at cost, net of accumulated depreciation and amortization. Depreciation is calculated using the straight-line
method over the estimated useful lives of the related assets: over three years for computers and other electronic equipment, and seven
to fifteen years for office furniture and equipment and machinery and equipment (mainly seven years ). Leasehold improvements are amortized
on a straight-line basis over the term of the lease, which is shorter than the estimated life of the improvements.
j. Impairment in value of long-lived assets
The
Company tests long-lived intangible and tangible assets for impairment whenever events or circumstances present an indication of impairment.
If the sum of expected future cash flows (undiscounted and without interest charges) of the long-lived assets is less than the carrying
amount of such assets, an impairment would be recognized, and the assets would be written down to their estimated fair values, based
on expected future discounted cash flows.
F- 11
INSPIREMD,
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE
2 - SIGNIFICANT ACCOUNTING POLICIES (continued):
k.
Revenue recognition
A contract with a customer exists only when: 1) the parties to the contract have approved it and are committed to perform their
respective obligations, 2) the Company can identify each party’s rights regarding the distinct goods or services to be transferred
(“Performance Obligations”), 3) the Company can determine the transaction price for the goods or services to be transferred,
4) the contract has commercial substance and 5) it is probable that the Company will collect the consideration to which it will be entitled
in exchange for the goods or services that will be transferred to the customer. Revenues are recorded in the amount of consideration
to which the Company expects to be entitled in exchange for Performance Obligations upon transfer of control to the customer, excluding
sales taxes.
Revenue
from sales of goods, including sales to distributors, is recognized when the customer obtains control of the product, once the Company
has a present right to payment and the customer has legal title, and risk and rewards of ownership are obtained by the customer. This
occurs when products are shipped.
The
Company recognizes the incremental costs of obtaining contracts as an expense since the amortization period of the assets that the Company
otherwise would have recognized is one year or less. The costs are recorded under selling and marketing expenses. Disaggregated revenue
is disclosed in Note 10.
The
Company recognizes revenue net of value added tax (VAT).
l. Research and development costs
Research
and development costs, including the costs of our US based clinical trial costs of approximately $ 2,037,000 , are charged to the
statement of operations as incurred.
m.
Share-based compensation
The Company has equity incentive plans under which the Company grants equity awards, including stock options, restricted stock
and restricted stock units (“RSUs”). Employee equity awards are classified as equity awards and accounted for using the grant-date
fair value method. The Company determines compensation expense associated with Restricted Stock and RSUs based on the fair value of our
common stock on the date of grant. The fair value of option awards is estimated using the Black-Scholes valuation model and expensed
over the requisite service period. The Company elected to account for forfeitures as they occur.
The
Company elected to recognize compensation expenses for awards with only service conditions that have graded vesting schedules using the
accelerated multiple option approach.
n.
Uncertain tax positions
The Company follows a two-step approach to recognizing and measuring uncertain tax positions. The first step is to evaluate the
tax position for recognition by determining if the weight of available evidence indicates that it is more likely than not that the position
will be sustained on audit. If under the first step a tax provision is assessed to be more likely than not of being sustained on audit,
the second step is performed, under which the tax benefit is measured as the largest amount that is more than 50% likely to be realized
upon ultimate settlement. Such liabilities are classified as long-term, unless the liability is expected to be resolved within twelve
months from the balance sheet date. The Company’s policy is to include interest related to unrecognized tax benefits within “Financial
expenses - net”.
o.
Deferred income taxes
Deferred
taxes are determined utilizing the “asset and liability” method based on the estimated future tax effects of differences
between the financial accounting and tax bases of assets and liabilities under the applicable tax laws, and on tax rates anticipated
to be in effect when the deferred taxes are expected to be paid or realized. The Company assesses realization of deferred income tax
assets and, based on all available evidence, concludes whether it is more likely than not that the net deferred income tax assets will
be realized. A valuation allowance is provided for the amount of deferred income tax assets not considered to be realizable.
The
Company may incur an additional tax liability in the event of intercompany dividend distributions by its subsidiaries. Such additional
tax liability in respect of these foreign subsidiaries has not been provided for in these financial statements as it is the Company’s
policy to permanently reinvest the subsidiaries’ earnings and to consider distributing dividends only in connection with a specific
tax opportunity that may arise.
Taxes
that would apply in the event of disposal of investments in a foreign subsidiary have not been taken into account in computing the deferred
taxes, as it is the Company’s intention to hold, and not to realize, these investments.
F- 12
INSPIREMD,
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE
2 - SIGNIFICANT ACCOUNTING POLICIES (continued):
p. Advertising
Costs
related to advertising and promotion of products are charged to sales and marketing expense as incurred. Advertising expenses were approximately
$ 290,000 and $ 163,000 for the years ended December 31, 2021 and 2020, respectively.
q. Net loss per share
Basic
and diluted net loss per share is computed by dividing the net loss for the period attributable to common stock by the weighted average
number of shares of common stock outstanding during the period, including 11,696 and 61,515 weighted average shares of common stock issuable
to holders of Series B Convertible Preferred Stock for the years ended December 31, 2021 and 2020, respectively. The total number
of shares of common stock related to outstanding options, warrants, restricted stock, restricted stock units, Series C Convertible Preferred
Stock and placement agent units excluded from the calculations of diluted loss per share were 2,840,179 and 2,166,218 for the years ended
December 31, 2021 and 2020, respectively.
r. Segment reporting
The
Company has one operating and reportable segment.
s.
Fair value measurement
The
Company measures fair value and discloses fair value measurements for financial assets and liabilities. Fair value is based on the price
that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the
measurement date.
The
accounting standard establishes a fair value hierarchy that prioritizes observable and unobservable inputs used to measure fair value
into three broad levels, which are described below:
Level
1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value
hierarchy gives the highest priority to Level 1 inputs.
Level
2: Observable prices that are based on inputs not quoted on active markets but corroborated by market data.
Level
3: Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level
3 inputs.
In
determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of
unobservable inputs to the extent possible and considers counterparty credit risk in its assessment of fair value. The Company
has no financial instruments measured carried at fair value in each reporting period. The fair value of the Company’s financial
instruments approximates their carrying values.
F- 13
INSPIREMD,
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE
2 - SIGNIFICANT ACCOUNTING POLICIES (continued):
t.
Issued accounting pronouncements effective in future periods
Financial
Instruments - Credit Losses
In
June 2016, the FASB issued ASU 2016-13, Financial Instruments-Credit Losses (Topic 326)-Measurement of Credit Losses on Financial Instruments.
This guidance replaces the current incurred loss impairment methodology. Under the new guidance, on initial recognition and at each reporting
period, an entity is required to recognize an allowance that reflects its current estimate of credit losses expected to be incurred over
the life of the financial instrument based on historical experience, current conditions and reasonable and supportable forecasts. In
November 2019, the FASB issued ASU No. 2019-10, Financial Instruments - Credit Losses (Topic 326), Derivatives and Hedging (Topic 815),
and Leases (Topic 842): Effective Dates (“ASU 2019-10”). The purpose of this amendment is to create a two-tier rollout of
major updates, staggering the effective dates between larger public companies and all other entities. This granted certain classes of
companies, including Smaller Reporting Companies (“SRCs”), additional time to implement major FASB standards, including ASU
2016-13. Larger public companies will have an effective date for fiscal years beginning after December 15, 2019, including interim periods
within those fiscal years. All other entities are permitted to defer adoption of ASU 2016-13, and its related amendments, until the earlier
of fiscal periods beginning after December 15, 2022. Under the current SEC definitions, the Company meets the definition of an SRC and
is adopting the deferral period for ASU 2016-13. The guidance requires a modified retrospective transition approach through a cumulative-effect
adjustment to retained earnings as of the beginning of the period of adoption. The Company is currently evaluating the impact of the
adoption of ASU 2016-13 on its consolidated financial statements but does not believe the adoption of this standard will have a material
impact on its consolidated financial statements. In November 2021, the FASB issued ASU 2021-10 “Government Assistance (Topic
832)”, which requires annual disclosures that increase the transparency of transactions involving government grants, including
(1) the types of transactions, (2) the accounting for those transactions, and (3) the effect of those transactions on
an entity’s financial statements. The amendments in this update are effective for financial statements issued for annual periods
beginning after December 15, 2021. However, it is not expected to have a material impact on the consolidated financial results of
operations, financial position or cash flows.
F- 14
INSPIREMD,
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE
3 - PROPERTY, PLANT AND EQUIPMENT
a.
Composition
of assets, grouped by major classifications, is as follows:
SCHEDULE
OF PROPERTY PLANT AND EQUIPMENT
2021
2020
December
31,
2021
2020
($
in thousands)
Cost:
Computer
equipment
$ 361
$ 289
Office
furniture and equipment
157
95
Machinery
and equipment
1,599
1,427
Leasehold
improvements
243
211
Property
plant and equipment, gross
2,360
2,022
Less
- accumulated depreciation and amortization
( 1,728 )
( 1,574 )
Net
carrying amount
$ 632
$ 448
b.
Depreciation
and amortization expenses totaled approximately $ 161,000 and $ 151,000 for the years ended December 31, 2021 and 2020, respectively.
NOTE
4 - LIABILITY FOR EMPLOYEES RIGHT UPON RETIREMENT
Israeli
labor law generally requires payment of severance pay upon dismissal of an employee or upon termination of employment in certain other
circumstances.
Pursuant
to section 14 of the Israeli Severance Compensation Act, 1963, some of the Company’s employees are entitled to have monthly deposits,
at a rate of 8.33 % of their monthly salary, made in their name with insurance companies. Payments in accordance with section 14 relieve
the Company from any future severance payments to these employees.
The
severance pay liability of the Company for the rest of its Israeli employees, which reflects the undiscounted amount of the liability,
is based upon the number of years of service and the latest monthly salary. The severance pay liability is partly covered by insurance
policies and by regular deposits with recognized severance payment funds. The Company may only withdraw funds previously deposited for
savings in connection with the payment of severance. The severance pay expenses were approximately $ 265,000 and $ 276,000 for the years
ended December 31, 2021 and 2020, respectively.
Defined
contribution plan expenses were approximately $ 415,000 and $ 339,000 for the years ended December 31, 2021 and 2020, respectively.
F- 15
INSPIREMD,
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE
5 – LEASE AGREEMENTS
1) The Company’s Israeli subsidiary has a lease agreement for a facility in Israel, which expires on December 31, 2022 with an option to extend the agreement for two additional years until December 31, 2024 under the terms stipulated in the agreement. The Option Period was taken in consideration when calculating the operating lease right of use assets and liabilities. In addition, the Company entered in June 2021 into another amendment to the lease agreement for a lease of additional space in the facility. This amendment was added to the ROU and the Lease liability.
2)
The Company leases its motor vehicles under operating lease agreements.
3)
Operating lease cost for the years ended December 31, 2021 and 2020 was $ 476,000 and $ 370,000 respectively.
Supplemental
information related to leases are as follows:
SCHEDULE OF SUPPLEMENTAL INFORMATION RELATED TO LEASES
December
31
December
31
2021
2020
($
in
thousands)
($
in
thousands)
Operating
lease right-of-use assets
1,081
1,265
Current
Operating lease liabilities
( 420 )
( 400 )
Non-current
operating lease liabilities
( 781 )
( 999 )
Other
information:
Operating
cash flows from operating leases (cash paid in thousands)
( 437 )
( 387 )
Weighted
Average Remaining Lease Term
3
3.9
Weighted
Average Discount Rate
8.38 %
8.38 %
Maturities
of lease liabilities are as follows:
SCHEDULE OF MATURITIES OF LEASE LIABILITIES
Amount
($
in thousands)
2022
433
2023
444
2024
465
Total
lease payments
1,342
Less
imputed interest
( 141 )
Total
1,201
F- 16
INSPIREMD,
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE
6 - COMMITMENTS AND CONTINGENT LIABILITIES :
a.
Litigation:
1. In July 2019, a former distributor filed a suit seeking damages from the Company’s subsidiary for pre-paid goods subject to the voluntary field action (from April 2014) amounting to € 1,830,000 (which is approximately $ 2.0 million), or alternatively € 1,024,000 (which is approximately $ 1.1 million). In January 2021, we executed a Mediation Agreement with the former distributor, pursuant to which the former distributor agreed to release the Company from all claims stated in the Complaint in exchange for a payment of $ 580,000 . Accordingly, the amount of $ 580,000 was recorded as a debit to revenue in the year ended December 31, 2020.
2. On July 28, 2020, we entered into a settlement agreement and release with the prior underwriter, under which it provided us a final, unconditional release from any further obligations arising out of or related to the engagement agreements, underwriting agreements and placement agency agreements which we had been party to with it and with respect to any services which it had provided to us. We, in turn, provided the prior underwriter a final, unconditional release from any further obligations arising out of or related to the prior agreements and services.
As
consideration for the final release provided to us, we paid to the prior underwriter $ 400,000
in cash and reduced, to $ 7.43 ,
the exercise price per share of warrants to purchase 18,277
shares of our common stock that had been issued
by us to the prior underwriter in various offerings that took place between March 2018 and September 2019. That reduced exercise price
represents the exercise price for the Series F Warrants that we issued in our June 2020 public offering. The warrants that were repriced
had existing exercise prices per share ranging from $ 2,812.5
to $ 33.75
and a weighted average exercise price per
share of $ 109.8 .
All other terms of those warrants will remain unchanged. The related increase in expenses of $ 400,000
was recorded to “General and Administrative
expense” within the Consolidated Statements of Operations.
3. In July 2020, a former senior employee of InspireMD GmbH filed a statement of claim at the Munich Labor Court, seeking confirmation of the court that the notice of termination is not effective. On November 10, 2020, we entered into a settlement agreement. As consideration for the final release, we paid the former senior employee 25,000 Eur (approximately $ 30,000 ) which was recorded to “Selling and marketing expense” within the Consolidated Statements of Operations.
b. Distribution Agreement with Chinese Partner
On
February 3, 2021, the Company entered into a distribution agreement (the “Distribution Agreement”) with three China-based
partners, pursuant to which the Chinese partners will be responsible for conducting the necessary registration trials for commercial
approval of the Company’s products in China, followed by an eight-year exclusive distribution right to sell the Company’s
products in China with the term of the agreement continuing on a year-to-year basis unless terminated. Under the Distribution Agreement,
the China-based partners will be subject to minimum purchase obligations. The Distribution Agreement may be terminated for cause upon
failure to meet minimum purchase obligations, failure to obtain regulatory approvals or for other material breaches.
In
addition, the agreement stipulates that if the Distributor fails to obtain the Regulatory Approvals by the time stipulated in the agreement
due to the failure of the clinical trials, and this Agreement was terminated as a result of such failure to obtain Regulatory Approvals,
InspireMD shall reimburse Distributor in an amount which is 50 % of Distributor’s direct out of pocket costs to 3rd parties for
conducting the clinical trials, which reimbursement will not exceed USD 1,000,000 . The financial statements include a liability, based
on 50 % of the Distributor costs incurred up to December 31, 2021. The liability for the year ended December 31, 2021 is immaterial.
See
Note 7 for details regarding an investment transaction with one of the Chinese parties to the Distribution Agreement.
NOTE
7 - EQUITY
a.
Share capital
The
Company’s shares that previously traded on the NYSE American were approved for listing on the Nasdaq Capital Market (“Nasdaq”)
and such shares began trading on Nasdaq on May 21, 2021 under the symbol, “NSPR.” The Company’s warrants that previously
traded on the NYSE American were approved for listing on Nasdaq, and such warrants began trading on Nasdaq on June 8, 2021.
On
April 19, 2021, the Company filed with the Secretary of State of Delaware a Certificate of Amendment to the Company’s Amended and
Restated Certificate of Incorporation to effect a one-for-fifteen reverse stock split of its common stock , par value $ 0.0001 per share,
effective as of April 26, 2021.
All
related share and per share data have been retroactively applied to the financial statements and their related notes for all periods
presented.
F- 17
INSPIREMD,
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE
7 – EQUITY (continued):
Public
Offering s
On
June 5, 2020, the Company closed an underwritten public offering of (i) 509,053 units (“Units”), with each Unit being comprised
of one share of the Company’s common stock, par value $ 0.0001 per share, and one Series F warrant (a “Series F Warrant”)
to purchase one share of common stock, and (ii) 972,427 pre-funded units (the “Pre-Funded Units”), with each Pre-Funded Unit
being comprised of one pre-funded warrant (a “Pre-Funded Warrant”) to purchase one share of common stock and one Series F
Warrant. In connection with this public offering, the underwriter exercised its over-allotment option in full and purchased an additional
222,220 shares of common stock and 222,220 Series F Warrants. The offering price to the public was $ 6.75 per Unit and $ 6.735 per Pre-Funded
Unit. The net proceeds to the Company from the offering and the exercise of the underwriter’s over-allotment option were approximately
$ 10.7 million, after deducting underwriting discounts and commissions and payment of other estimated expenses associated with the offering,
but excluding the proceeds, if any, from the exercise of Series F Warrants and the Pre-Funded Warrants sold in the offering. The pre-funded
warrants exercisable at a price of $ 0.015 per share of common stock.
The
Series F Warrants included in the Common Units and the Pre-Funded Units are immediately exercisable at a price of $ 7.425 per share of
common stock, subject to adjustment in certain circumstances, and expire June 2, 2025. The shares of common stock, or Pre-Funded Warrants
in the case of the Pre-Funded Units, and the Series F Warrants were offered together, but the securities contained in the Common Units
and the Pre-Funded Units were issued separately.
During
the year ended December 31, 2020, 191,107 Series F Warrants were converted into 191,107 shares of common stock. The net proceeds to the
Company from exercise of the Series F Warrants were approximately $ 1.4 million.
Pursuant
to the full ratchet anti-dilution adjustment provisions in the respective certificate of designation for the Company’s Series B
Convertible Preferred Stock and Series C Preferred Stock, the conversion price of the outstanding shares of the Series B Convertible
Preferred Stock and the Series C Preferred Stock was reduced to $ 6.75 per share, effective as of the date of the underwriting agreement
entered for the June 2020 Offering, and the number of shares of common stock issuable upon conversion of the Series B Preferred Stock
and the Series C Preferred Stock had increased as follows:
● An aggregate of 111,028 additional shares of common stock upon conversion of the Series B Preferred Stock and as payment of
the dividends thereunder in common stock, based on 17,303 shares of Series B Preferred Stock outstanding as of June 2, 2020.
●
An aggregate of 18,886 additional shares of common stock upon conversion of the Series C Preferred Stock, based on 26,558 shares of Series
C Preferred Stock outstanding as of June 2, 2020.
for
the purpose of calculating basic net loss per share, the additional shares of common stock that are issuable upon exercise of the Pre-funded
Warrants have been included since the shares are issuable for a negligible consideration, as determined by the Company according to ASC
260-10-45-13, and have no vesting or other contingencies associated with them. The Company has also concluded that the series F warrants
are classified as equity, since the warrants meet all criteria for equity classification.
F- 18
INSPIREMD,
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE
7 – EQUITY (continued):
During
the year ended December 31, 2020, the Company issued a total of 972,427 shares of common stock in connection with the exercise of all
outstanding Pre-Funded Warrants issued in June 2020. In addition, the Company issued a total of 18,000 shares of its common stock in
connection with the exercise of 18,000 Pre-Funded Warrants issued in September 2019. As of December 31, 2020, there are no outstanding
Pre-Funded Warrants.
On
February 8, 2021, the Company closed an underwritten public offering (the “Offering”) of 1,935,484 units (“Units”),
with each Unit being comprised of one share of the Company’s common stock, par value $ 0.0001 per share, and one Series G warrant
(the “Series G Warrants”) to purchase one-half of one share of Common Stock. In connection with this public offering, the
underwriter exercised its over-allotment option in full and purchased an additional 290,322 shares of common stock and 145,161 Series
G Warrants. The offering price to the public was $ 9.30 per Unit. The Series G Warrants are immediately exercisable at a price of $ 10.23
per and expire five years from the date of issuance.
The
Company granted the underwriter compensation warrants to purchase up to 111,290 shares of Common Stock. The underwriter warrants have
an exercise price of $ 10.23 per share and are exercisable immediately and for five years from the date of effectiveness of the registration
statement in connection with the Offering.
The
net proceeds to the Company from the Offering, after giving effect to the exercise of the underwriter’s over-allotment option,
were approximately $ 18.9 million, after deducting underwriting discounts and commissions and payment of other expenses associated with
the Offering, but excluding the proceeds, if any, from the exercise of Series G Warrants sold in the Offering.
On
February 3, 2021, the Company entered into a Distribution Agreement with three China-based partners, See Note 6b. for details about the
Distribution Agreement.
In
addition, and on the same day, the Company entered into an investment transaction with one of the Chinese parties to the Distribution
Agreement, which included (i) a Securities Purchase Agreement (the “SPA”), pursuant to which investor agreed to invest $ 900,000
in exchange for 89,445 shares of the Company’s common stock at a purchase price of $ 10.062 per share.
During
the year ended December 31, 2021, Series F and Series G warrants to purchase shares of common stock were exercised by investors at an
exercise price of $ 7.425 and $ 10.23 per share, resulting in the issuance of 1,225,412 shares of common stock for proceeds of approximately
$ 9,469,000 .
ATM
Offering
During
the year ended December 31, 2020, the Company sold 861,163 shares of its common stock pursuant to its at-the-market (ATM) issuance sales
agreement with A.G.P./Alliance Global Partners. These sales resulted in net proceeds to the Company of approximately $ 4,447,000 .
During
the year ended December 31, 2021, the Company sold 818,523 shares of its common stock pursuant to its at-the-market (ATM) issuance sales
agreement with a sales agent. These sales resulted aggregate net proceeds to the Company of approximately $ 5,453,000 .
F- 19
INSPIREMD,
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE
7 – EQUITY (continued):
Pursuant
to the full ratchet anti-dilution adjustment provisions in the respective certificate of designation for the Company’s Series B
Convertible Preferred Stock and Series C Preferred Stock, the conversion price of the outstanding shares of the Series B Convertible
Preferred Stock and the Series C Preferred Stock was reduced to $ 4.815 per share, triggered by the ATM Facility, effective as of December
14, 2020, and the number of shares of common stock issuable upon conversion of the Series B Preferred Stock and the Series C Preferred
Stock had increased as follows:
●
an
aggregate of 59,491 additional shares of common stock upon conversion of the Series B Preferred Stock and as payment of the dividends
thereunder in common stock, based on 17,303 shares of Series B Preferred Stock outstanding as of December 14, 2020.
●
an
aggregate of 893 additional shares of common stock upon conversion of the Series C Preferred Stock, based on 2,343 shares of Series
C Preferred Stock outstanding as of December 14, 2020.
On
July 7, 2016, we issued 442,424 shares of Series B Preferred Stock in a public offering. Our Series B Preferred Stock has a stated value
of $ 495.00 which currently converted into 207,528 reflecting a conversion price equal to $ 4.815 . The holders of Series B Preferred Stock
are entitled to receive as cumulative dividends at the rate per share of 15 % per annum of the stated value for five years, payable in
cash or common stock, at the Company’s discretion, but excluding effect of future conversion price adjustment, if any.
On
March 14, 2017, we issued 1,069,822 shares of Series C Preferred Stock in a public offering. Our Series C Preferred Stock has a stated
value of $ 96 which currently converted into 3,114 reflecting a conversion price equal to $ 4.815 .
During
the year ended December 31, 2021, 625 shares of Series C Convertible Preferred Stock were converted into 831 shares of common stock.
As of December 31, 2021, there were 1,718 shares of Series C Preferred Stock outstanding, convertible into an aggregate of 2,284 shares
of our common stock.
During
the year ended December 31, 2021, all the remaining 17,303 shares of Series B Convertible Preferred Stock were converted into 207,528
shares of common stock.
As
of December 31, 2021, the Company has outstanding warrants to purchase an aggregate of 1,793,983 shares of common stock as follows:
SCHEDULE OF ISSUANCE OF WARRANTS TO PURCHASE COMMON STOCK
Number
of
underlying
Common stock
Weighted
average
exercise price
Series
E Warrants
198,159
$ 27.000
Series
F Warrants
433,878
$ 7.425
Series
G Warrants
1,092,344
$ 10.230
Underwriter
Warrants
18,277
$ 7.425
Other
warrants
51,325
$ 225.000
and above
Total
Warrants
1,793,983
$
As
of December 31, 2021, the Company has 155,000,000 authorized shares of capital stock, par value $ 0.0001 per share, of which 150,000,000
are shares of common stock and 5,000,000 are shares of “blank check” preferred stock.
In
the event of our liquidation, dissolution, or winding up, holders of Series C Convertible Preferred Stock are entitled to receive the
amount of cash, securities or other property to which such holder would be entitled to receive with respect to such shares of Preferred
Stock if such shares had been converted to common stock immediately prior to such event.
F- 20
INSPIREMD,
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE
7 – EQUITY (continued):
b.
Share-Based Compensation
1) Pursuant to the current Section 102 of the Israeli Tax Ordinance, which came into effect on January 1, 2003, options may be granted through a trustee (i.e., Approved 102 Options) or not through a trustee (i.e., Unapproved 102 Options). As a result of an election made by the Company under Section 102 of the Income Tax Ordinance, the Company will not be allowed to claim as an expense for tax purposes in Israel the amounts credited to the employee as capital gains to the grantees, although it will generally be entitled to do so in respect of the salary income component (if any) of such awards when the related tax is paid by the employee.
2)
During the years ended December 31, 2021 and 2020, the Company granted stock options to the CEO, employees, consultants and directors
to purchase a total of 225,225
and 92,007 ,
respectively, shares of the Company’s common
stock. The options have exercise prices ranging from $ 3.89 -$ 10.05
and $ 4.95 -$ 16.50
per share, respectively, which were the fair
market value of the company’s common stock on the date of each respective grant. The fair value of the above options, using the
Black-Scholes pricing models, was approximately $ 1,026,000
and $ 509,000 ,
respectively. The options are subject to a three -year
vesting period with one-third of such awards vesting each year.
3) During the years ended December 31, 2021 and 2020, the Company granted to the employees and directors 419,943 and 185,461 restricted stock, respectively. The fair value of these restricted stock was approximately $ 1,781,981 and $ 1,051,604 , respectively. The restricted stock are subject to a three -year vesting period, with one-third of such awards vesting each year.
4)
During the years ended December 31, 2021 and 2020, the Company granted to the CEO 146,567 and 90,511 Restricted Stock Units, respectively.
The fair value of these restricted stock units was approximately $ 603,856 and $ 658,981 , respectively. The restricted stock units granted
during the years ended December 31, 2021 and 2020, are subject to a three -year vesting period, with one-third of such awards vesting
each year.
F- 21
INSPIREMD,
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE
7 – EQUITY (continued):
5)
The following table summarizes information about stock options granted to employees:
SCHEDULE OF STOCK OPTIONS GRANTED
Year
ended December 31
2021
2020
Number
of options
Weighted
average
exercise
price
Number
of options
Weighted
average
exercise
price
Outstanding
- beginning of period
91,692
6.20
-
$ -
Granted
205,223
4.90
92,007
6.20
Forfeited
( 7,507 )
5.69
( 315 )
5.85
Outstanding-end
of period
289,408
$ 5.29
91,692
$ 6.20
Exercisable
at the end of the period
28,360
6.26
-
-
6)
The following table summarizes information about stock options granted to non-employees:
Year
ended December 31
2021
2020
Number
of options
Weighted
average exercise price
Number
of options
Weighted
average exercise price
Outstanding
- beginning of period
-
-
-
-
Granted
20,002
6.90
-
-
Forfeited
-
-
-
-
Exercised
-
-
-
-
Outstanding
- end of period
20,002
6.90
-
-
Exercisable
at the end of the period
-
-
-
-
7)
The following table summarizes information about restricted stock granted to employees:
SCHEDULE OF RESTRICTED STOCK GRANTED TO EMPLOYEES
Year
ended December 31
2021
2020
Number
of restricted stock
Outstanding
- beginning of period
185,725
4,642
Reverse
Split Adjustments
59
-
Granted
419,943
185,461
Forfeited
( 20,822 )
( 3,717 )
Vested
( 57,237 )
( 661 )
Outstanding
- end of period
527,668
185,725
F- 22
INSPIREMD,
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE
7 – EQUITY (continued):
8)
The following table summarizes information about Restricted Stock Units granted to employees:
SCHEDULE OF RESTRICTED STOCK UNIT GRANTED TO EMPLOYEES
Year
ended December 31
2021
2020
Number
of restricted stock units
Outstanding
- beginning of period
90,511
11,000
Granted
146,567
90,511
Forfeited
-
-
Vested
-
( 11,000 )
Outstanding
- end of period
237,078
90,511
9)
The following table provides additional information about all options outstanding and exercisable:
SCHEDULE OF ADDITIONAL INFORMATION ABOUT ALL OPTIONS OUTSTANDING AND EXERCISABLE
Outstanding
as of December 31, 2021
Exercise
price
Options
outstanding
Weighted
average remaining contractual life (years)
Options
exercisable
$ 3.89 - 4.12
146,539
9.81
-
$ 4.95 - 10.05
158,819
8.99
27,009
$ 16.50
4,052
8.01
1,351
309,410
9 .37
28,361
The
weighted average of the remaining contractual life of total vested and exercisable options as of December 31, 2021 was 8.65 years.
The
aggregate intrinsic value of the total exercisable options as of December 31, 2021 was approximately $ 0.4 .
The
weighted average fair value of options granted was $ 4.56 for the year ended December 31, 2021. The weighted average fair value of options
granted was estimated using the Black-Scholes option-pricing model.
F- 23
INSPIREMD,
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE
7 – EQUITY (continued):
10)
The
following table sets forth the assumptions that were used in determining the fair value of options granted to employees for the year
December 31, 2021:
SCHEDULE OF FAIR VALUE OF OPTIONS GRANTED TO EMPLOYEES
Year
ended December 31
2021
2020
Number
of restricted stock
Expected
life
5.5 - 6.5
years
5.5 - 6.5
years
Risk-free
interest rates
0.59 %- 1.40
%
0.32 %- 0.42
%
Volatility
129.11 %- 136.78
%
124.53 %- 136.66
%
Dividend
yield
-
-
The
Company does not have sufficient historical exercise data to provide a reasonable basis upon which to estimate expected term. Accordingly,
as to ordinary course options granted, the expected term was determined using the simplified method, which takes into consideration the
option’s contractual life and the vesting periods (for non-employees, the expected term is equal to the option’s contractual
life).
The
annual risk-free rates are based on the yield rates of zero coupon non-index linked U.S. Federal Reserve treasury bonds as both the exercise
price and the share price are in dollar terms. The Company’s expected volatility is derived from its historical data.
11)
As
of December 31, 2021, the total unrecognized compensation cost on employee and non-employee stock options, restricted stock and restricted
stock units, related to unvested stock-based compensation, amounted to approximately $ 3.4 million. This cost is expected to be recognized
over a weighted-average period of approximately 1.01 years. This expected cost does not include the impact of any future stock-based
compensation awards.
12)
The
following table summarizes the allocation of total share-based compensation expense in the consolidated statements of operations:
SCHEDULE OF ALLOCATION OF TOTAL SHARE-BASED COMPENSATION EXPENSE
Year
ended December 31
2021
2020
($
in thousands)
Cost
of revenues
$ 49
$ 22
Research
and development
64
29
Sales
and marketing
182
32
General
and administrative
1,281
523
$ 1,576
$ 606
F- 24
INSPIREMD,
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE
8 – RELATED PARTIES TRANSACTIONS
On
May 10, 2021, the board of directors of the Company appointed a new member. During the twelve months ended December 31, 2021, a consulting
company whose founder and CEO is our new board member provided certain marketing services in the amount of $ 33,775 .
NOTE
9 - TAXES ON INCOME :
a. Tax laws applicable to the Company and its subsidiaries
Taxation
in the United States
InspireMD,
Inc. is taxed under U.S. tax laws. Accordingly, the applicable federal corporate tax rate in 2021 is 21 %. State tax may also apply.
Taxation
in Israel
InspiredMD,
Ltd is taxed under Israeli tax laws. Accordingly, the applicable corporate tax rate in 2021 is 23 %.
Taxation
in Germany
InspireMD
GmbH is taxed according to the tax laws in Germany. Accordingly, the applicable tax rates are corporate tax rate of 15.825 % and trade
tax rate of 17.15 %.
b.
Tax benefits under the Law for the Encouragement of Capital Investments, 1959 (the “Law”):
InspireMD
Ltd. has been granted a “Beneficiary Enterprises” status under the Investment Law including Amendment No. 60 thereof, which
became effective in April 2005. The tax benefits derived from any such Beneficiary Enterprise relate only to taxable profits attributable
to the specific program of investment to which the status was granted.
The
main benefit, to which InspireMD Ltd. is entitled, conditional upon the fulfilling of certain conditions stipulated by the above law,
is a two-year exemption and five to eight years of a reduced tax rate of 10 % to 23 % from tax on income derived from beneficiary activities
in facilities in Israel. The two-year exemption starts only when the Company starts to pay taxes after using all tax offsetting losses.
The tax benefit period is twelve years from the year of election, which means that after a year of election, the two-year exemption and
eight years of reduced tax rate can only be used within the next twelve years. The Company elected the year 2011 as a year of election.
F- 25
INSPIREMD,
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE
9 - TAXES ON INCOME (continued):
In
the event of a distribution of tax-exempt income attributable to “Beneficiary Enterprises” as a cash dividend, the Company
will be required to pay tax at a rate of 10% to 23% on the amount distributed, subject to certain conditions. In addition, dividends
originating from income attributable to the “Beneficiary Enterprises” will be subject to a 20 % withholding tax.
Should
InspireMD Ltd. derive income from sources other than the “Beneficiary Enterprises” during the period of benefits, such income
shall be taxable at the regular corporate tax rate.
1)
Conditions for entitlement to the benefits
The
entitlement to the above benefits is conditional upon InspireMD Ltd. fulfilling the conditions stipulated by the law, regulations published
thereunder and the instruments of approval for the specific investments in approved assets. In the event of failure to comply with these
conditions, the benefits may be cancelled, and InspireMD Ltd. may be required to refund the amount of the benefits, in whole or in part,
with the addition of interest and linkage.
The
Company opted not to apply for Preferred Enterprise status (as defined in the Amendment of the Law for the Encouragement of Capital Investments,
1959).
c.
Carry forward tax losses
As
of December 31, 2021, the Company had a net carry forward tax loss of approximately $ 47 million, of which approximately $ 35 million (arising
before January 1, 2018), expires until 2037 , and approximately $ 12 million, which does not expire, but is limited to offset 80 % of the
net income in the year it is utilized.
Under
the U.S. tax laws, for net operating losses (NOLs) arising after December 31, 2017, the Tax Cuts and Jobs Act enacted on December 22,
2017 (the “2017 Act”) limits a taxpayer’s ability to utilize NOL carryforwards to 80% of taxable income.
In
addition, NOLs arising after 2017 can be carried forward indefinitely, but carryback is generally prohibited. NOLs generated in tax years
beginning before January 1, 2018, will not be subject to the foregoing taxable income limitation and will continue to have a two-year
carryback and twenty-year carryforward period.
Further
to COVID-19 CARES act of the U.S. Treasury, the business tax provision temporarily removes the current law taxable income 80 % limitation
to allow an NOL to fully offset income in tax years 2018, 2019 and 2020. The provision also allows an NOL from tax years beginning in
2018, 2019, or 2020 to be carried back for five years .
As
of December 31, 2021, InspireMD Ltd., an Israeli subsidiary, had a net carry forward tax loss of approximately $ 109 million. Under Israeli
tax laws, the carry forward tax losses can be utilized indefinitely.
d.
Loss before income taxes
The
components of loss before income taxes are as follows:
SCHEDULE OF COMPONENTS OF LOSS BEFORE INCOME TAXES
Year
ended December 31
2021
2020
($
in thousands)
Loss
before taxes on income:
InspireMD,
Inc.
$ ( 4,452 )
$ ( 3,897 )
Subsidiaries
( 10,421 )
( 6,643 )
$ ( 14,873 )
$ ( 10,540 )
F- 26
INSPIREMD,
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE
9 - TAXES ON INCOME (continued):
e.
Current taxes on income
The
main reconciling item between the statutory tax rate of the Company and the effective tax rate is the change in valuation allowance in
respect of tax benefits from carried forward tax losses due to uncertainty of the realization of such tax benefits.
The
changes in the valuation allowance for the year ended December 31, 2021 and 2020 were as follows:
SCHEDULE OF CHANGES IN VALUATION ALLOWANCE
Year
ended December 31
2021
2020
($
in thousands)
Balance
at the beginning of the year
$ 35,145
$ 31,181
Changes
during the year:
Losses
during the year (including foreign exchange rate effect)
4,067
3,964
Balance
at the end of the year
$ 39,212
$ 35,145
f.
Accounting for Uncertain Tax position
Following
is a reconciliation of the total amounts of the Company’s uncertain tax positions during the year ended December 31, 2021 and 2020
were as follows:
SCHEDULE OF RECONCILIATION OF UNCERTAIN TAX POSITIONS
Year
ended December 31,
2021
2020
($
in thousands)
Balance
at beginning of period
$ 52
$ 44
Increase
in uncertain tax positions because of tax positions taken during the year
37
8
Balance
at end of period
$ 89
$ 52
A
summary of open tax years by major jurisdiction is presented below:
SCHEDULE OF OPEN TAX YEARS BY MAJOR JURISDICTION
Jurisdiction
Years
U.S.
2018 - 2021
Israel
2016 - 2021
Germany
2018 - 2021
United
Kingdom
2014 - 2015
F- 27
INSPIREMD,
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE
9 - TAXES ON INCOME (continued):
g.
Deferred income tax:
SCHEDULE OF DEFERRED INCOME TAX
2021
2020
December
31,
2021
2020
($
in thousands)
Long-term:
Allowance
for bonus
-
2
Provision
for vacation and recreation pay
53
63
R&D
expenses
1,000
578
Operating
lease right of use assets
( 248 )
( 291 )
Operating
lease liabilities
276
322
Share-based
compensation
2,849
2,669
Carry
forward tax losses
35,248
31,759
Accrued
severance pay, net
34
43
Deferred
tax assets noncurrent
39,212
35,145
Less-valuation
allowance
( 39,212 )
( 35,145 )
Deferred
tax assets
-
-
NOTE
10 - SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION :
Balance
sheets:
Inventory:
SCHEDULE
OF INVENTORIES
2021
2020
December
31,
2021
2020
($
in thousands)
Finished
goods
$ 92
$ 350
Work
in process
436
376
Raw
materials and supplies
615
689
Total inventory
$ 1,143
$ 1,415
F- 28
INSPIREMD,
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE
10 - SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION (continued):
a. Accounts payable and accruals-other:
SCHEDULE
OF ACCOUNTS PAYABLE AND ACCRUALS - OTHER
2021
2020
December 31,
2021
2020
($ in thousands)
Employees and employee institutions
$
1,510
$
1,236
Accrued vacation and recreation pay
233
278
Accrued expenses
1,136
886
Accrual for settlement payment (see note 6)
-
580
Current Operating lease liabilities
420
400
Other
155
89
Accounts Payable and Accruals - Other
$
3,454
$
3,469
NOTE
11 – DISAGGREGATED REVENUE AND ENTITY WIDE DISCLOSURES :
Revenues
are attributed to geographic areas based on the location of the customers. The following is a summary of revenues:
SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS
Year
ended December 31,
2021
2020
($
in thousands)
Germany
$ 948
$ 708
Italy
981
596
Other
(2020 - net of settlement payment of $ 580 , see note 6 a)
2,566
1,181
$ 4,495
$ 2,485
By
product:
SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRODUCT
Year
ended December 31,
2021
2020
($
in thousands)
CGuard™
EPS
$ 4,309
$ 2,764
MGuard
Prime™ EPS (2020 - net of settlement payment of $ 580 , see note 6 a)
186
( 279 )
$ 4,495
$ 2,485
By
principal customers (2020 - before of settlement payment of $ 580 see note 6):
SCHEDULE
OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRINCIPAL CUSTOMERS
Year
ended December 31,
2021
2020
Customer
A
20 %
21 %
Customer
B
13 %
11 %
All
tangible long lived assets are located in Israel.
NOTE
12 - SUBSEQUENT EVENTS :
In February
2022, Russia launched a military invasion into Ukraine. The Company derived approximately 8.2% of total sales in Russia in 2021.
The Company may have impact on future sales and collection but currently the Company is still unable to estimate any specific impact
to its business, financial condition or results of operations.
F- 29