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, 2020, 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, 2020.
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, 2020. 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, 2020.
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, 2020 that have
materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Item
9B. Other Information.
Not
applicable.
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
57
President,
Chief Executive Officer and Director
Craig
Shore
59
Chief
Financial Officer, Chief Administrative Officer, Secretary and Treasurer
Michael
Berman (1)(2)
63
Director
Campbell
Rogers, M.D.
59
Director
Paul
Stuka (1)(2)(3)
66
Chairman
of the Board of Directors
Thomas
J. Kester (1)(3)
74
Director
Gary
Roubin, M.D.
72
Director
(1)
Member
of our audit committee
(2)
Member
of our nominating and corporate governance committee
(3)
Member
of our compensation committee
- 64 -
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 2021 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 over 30 years of 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.
Michael
Berman has served as our director since February 7, 2013. Mr. Berman is a medical device entrepreneur who works with high-potential
development and early-stage commercial companies. From 2005 to 2012, when the company was sold to Boston Scientific, 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. 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 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 2014 as a director of SoniVie, 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.
- 65 -
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 40 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, 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.
Gary
Roubin, M.D. has served as a director since October 13, 2020. Dr. Roubin cofounded Essential Medical Inc., 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.
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.”
Family
Relationships
We
have no family relationships amongst our directors and executive officers.
- 66 -
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 under Section 803(B)(2) of the NYSE American rules.
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 Section 803(A) of the NYSE American rules. 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 Sections 803(A) and 805(c)(1) of the NYSE American rules. 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.
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,
2020 and 2019.
Name and Principal Position
Year
Salary
($)
Bonus ($)
Restricted
Stock
Awards
($) (1)
Option
Awards
($) (1)
All Other
Compensation
($)
Total
($)
Marvin Slosman
2020
366,666 (2)
150,000 (3)
658,981
196,162 (7)
10,309 (4)
1,382,118
President and Chief Executive Officer
Craig Shore
2020
265,004 (2)(5)
138,692 (3)(5)
264,745
78,955
121,626 (6)
869,022
Chief Financial Officer, Secretary and Treasurer
2019
269,758 (5)
60,000 (5)
57,000
-
114,395 (6)
501,153
- 67 -
(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 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.
(3)
Cash
bonus awards for the 2020 calendar year were approved by the compensation committee in January 2021.
(4)
Mr.
Slosman’s other compensation for 2020 consisted of benefits related to health insurance.
(5)
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 3.215 NIS per dollar which was the exchange
rate as of December 31, 2020. The average exchange rate for the twelve month period ended December 31, 2020 and 2019 were
3.437 NIS per dollar and 3.564 NIS per dollar, respectively.
(6)
Mr.
Shore’s other compensation consisted solely of benefits in the twelve months ended December 31, 2020 and 2019. 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.
(7)
182,381
shares of common stock issuable upon the exercise of Restricted Stock Units outside our 2013 Long-Term Incentive Plan.
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, which will remain in effect
for three years (the “Initial Employment Term”), unless earlier terminated, and 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.
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; (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.
- 68 -
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 the Slosman Employment Agreement
expires, or 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 expires as a result of our decision not to renew the Slosman Employment
Agreement, 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 expiration of the
Initial Employment Term or the then current renewal term, as applicable, and ending on the date that is 3 months following the
expiration of the Slosman 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, has an initial term that ends on December 31, 2020, and will automatically renew for additional
one-year periods on January 1st thereafter unless either party gives 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. If a change in control occurs when less than two
full years remain in the initial term or during any renewal term, the employment agreement will automatically be extended for
two years from the change in control date and will terminate on the second anniversary of the change in control date.
- 69 -
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
during the term of the employment agreement, 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, during or after the term of his employment agreement,
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.
- 70 -
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)
Change
of Control Agreements
We
do not currently have any plans providing for the payment of retirement benefits to our officers or directors, other than as described
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.
- 71 -
Outstanding
Equity Awards at December 31, 2020
The
following table shows information concerning unexercised options and unvested shares of restricted stock outstanding as of December
31, 2020 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)
-
60,794 (2)
1.10
1/2/2030
182,381 (3)
62,010
-
391,762 (4)
0.39
8/31/2030
1,175,287 (5)
399,598
Craig Shore
11
-
8,312.50
07/25/2026
4,000 (6)
1,360
-
226,278 (4)
0.39
8/31/2030
678,834 (7)
230,804
(1)
Mr.
Slosman was appointed as chief executive officer effective as of January 1, 2020
(2)
These
options vest annually, with one-third vesting on each of January 2, 2021, January 2, 2022 and January 2, 2023.
(3)
These
RSU’s vest annually, with one-third vesting on each of January 2, 2021, January 2, 2022 and January 2, 2023.
(4)
These
options vest annually, with one-third vesting on each of August 31, 2021, August 31, 2022 and August 31, 2023.
(5)
These
RSU’s vest annually, with one-third vesting on each of August 31, 2021, August 31, 2022 and August 31, 2023.
(6)
These
restricted shares vest annually, with one-half vesting on each of February 4, 2021 and February 4, 2022.
(7)
These
Restricted Stock vest annually, with one-third vesting on each of August 31, 2021, August 31, 2022 and August 31, 2023.
Option
Exercises and Stock Vested
There
were no stock options exercised by our named executive officers during the twelve months ended December 31, 2020.
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 11 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 currently consists of three components, the primary plan document that governs all awards
granted under the InspireMD, Inc. 2011 UMBRELLA Option Plan, and two appendices: (i) Appendix A, designated for the purpose of
grants of stock options and restricted stock awards to Israeli employees, consultants, officers and other service providers and
other non-U.S. employees, consultants, and service providers, and (ii) Appendix B, which is the 2011 U.S. Equity Incentive Plan,
designated for the purpose of grants of stock options and restricted stock awards to U.S. employees, consultants, and service
providers who are subject to the U.S. income tax. On December 21, 2012, the stockholders approved the awarding of “incentive
stock options” pursuant to the U.S. portion of the plan.
- 72 -
The
purpose of the InspireMD, Inc. 2011 UMBRELLA Option 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. 2011 UMBRELLA Option
Plan is administered by our compensation committee. Unless terminated earlier by the board of directors, the InspireMD, Inc. 2011
UMBRELLA Option Plan will expire on March 27, 2021. We have no shares of common stock available for future issuance under our
2011 UMBRELLA Option Plan.
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
- 73 -
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, 2020, we had 2,306,956 shares of common stock available for future issuance under our 2013 Long-Term Incentive
Plan.
As
of March 8, 2021, we had 2,234,642 shares of common stock available for future issuance under our 2013 Long-Term Incentive Plan.
Director
Compensation
The
following table shows information concerning our directors during the twelve months ended December 31, 2020.
Name
Fees
Earned
or Paid in Cash
($)
Stock
Awards
($)
Option
Awards
($)
All Other
Compensation
($)
Total
($)
Paul Stuka
47,250
93,191
27,792
-
168,233
Michael Berman
29,750
61,633
18,381
-
109,764
Campbell Rogers, M.D.
21,875
61,633
18,381
-
101,889
Thomas Kester
35,875
61,633
18,381
-
115,889
Gary Roubin, M.D.
5,503
78,854
23,516
-
107,873
For
the 2020 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 for members of the
nominating and corporate governance committee and the research and development committee. Notwithstanding the foregoing, effective
April 1, 2020, the Board approved a 50% decrease in the annual cash compensation for non-employee directors from an aggregate
amount of $154,000 to $77,000, and on July 1, 2020, the Board reinstated the original annual cash compensation for non-employee
directors.
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 8, 2021 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.
- 74 -
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 8, 2021, we had 117,832,226 shares outstanding
Name of Beneficial Owner
Number of
Shares
Beneficially
Owned (1)
Percentage
Beneficially
Owned (1)
5% Owners
Armistice Capital, LLC
9,677,415 (2)
8.2 %
FiveT Capital AG
7,258,050 (3)
6.2 %
Officers and Directors
Marvin Slosman
252,638 (4)
*
Craig Shore
1,499,251 (5)
1.27 %
Michael Berman
120,976 (6)
*
Campbell Rogers, M.D.
160,650 (7)
*
Paul Stuka
243,634 (8)
*
Thomas Kester
392,081 (9)
*
Gary Roubin, M.D.
1,046,291 (10)
*
All directors and executive officers as a group (7 persons)
3,715,521
3.14 %
*
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 8, 2021. 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) 6,451,610 shares of common stock purchased in connection with the February 2021 Offering, and (ii) warrants to purchase
3,225,805 shares of common stock, at an exercise price of $0.682 per share, purchased in the February 2021 Offering. We are
not aware whether this stockholder has sold any of the foregoing securities it purchased in the February 2021
Offering.
(3)
Consists
of (i) 4,838,700 shares of common stock purchased in the February 2021 Offering, and (ii) warrants to purchase 2,419,350 shares
of common stock, at an exercise price of $0.682 per share, purchased in the February 2021 Offering. We are not aware whether
this stockholder has sold any of the foregoing securities it purchased in the February 2021 Offering.
- 75 -
(4)
Consists
of (i) 95,870 shares of common stock, (ii) 60,794 Restricted Stock Units granted outside the plan that are currently exercisable
or exercisable within 60 days of March 8, 2021, (iii) options to purchase 20,264 shares of common stock that are currently
exercisable or exercisable within 60 days of March 8, 2021, and (iv) 75,710 warrants to purchase shares of common stock that
are currently exercisable.
(5)
Consists
of (i) 4,021 shares of common stock, (ii) options to purchase 11 shares of common stock that are currently exercisable or
exercisable within 60 days of March 8, 2021, (iii) 680,828 shares of restricted stock granted under the Israeli Appendix of
the InspireMD, Inc. 2013 Long-Term Incentive Plan and (iv) 814,391 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.
(6)
Consists
of (i) 80,642 shares of common stock, (ii) 40,320 warrants to purchase shares of common stock that are currently exercisable,
and (iii) options to purchase 14 shares of common stock that are currently exercisable or exercisable within 60 days of March
8, 2021. Excludes 160,633 shares of common stock and restricted stock granted under the Israeli Appendix of InspireMD, Inc.
2013 Long-Term Incentive Plan held in trust, with respect to which the trustee has a proxy with the right to vote such shares
at his discretion.
(7)
Consists
of (i) 1,736 shares of common stock, (ii) 158,899 shares of restricted stock granted under the InspireMD, Inc. 2013 Long-Term
Incentive Plan, (iii) options to purchase 14 shares of common stock that are currently exercisable or exercisable within 60
days of March 8, 2021, and (iv) one warrant to purchase a share of common stock that is currently exercisable or exercisable
within 60 days of March 8, 2021.
(8)
Paul
Stuka is the principal and managing member of Osiris Investment Partners, L.P., and, as such, has beneficial ownership of
(A) (i) 264 shares of common stock, (ii) warrants to purchase 6 shares of common stock that are currently exercisable or exercisable
within 60 days of March 8, 2021 in addition to (B) personally holding (i) options to purchase 15 shares of common stock that
are currently exercisable or exercisable within 60 days of March 8, 2021, (ii) 240,250 shares of restricted stock granted
under the InspireMD, Inc. 2013 Long-Term Incentive Plan, (iii) warrants to purchase 7 shares of common stock that are currently
exercisable or exercisable within 60 days of March 8, 2021, and (iv) 3,092 shares of common stock.
(9)
Consists
of (i) 172,694 shares of common stock, (ii) 158,899 shares of restricted stock granted under the InspireMD, Inc. 2013 Long-Term
Incentive Plan, (iii) 60,480 warrants to purchase shares of common stock that are currently exercisable and (iv) options to
purchase 8 shares of common stock that are currently exercisable or exercisable within 60 days of March 8, 2021.
(10)
Consists
of (i) 464,153 shares of common stock, (ii) 238,950 shares of restricted stock granted under the InspireMD, Inc. 2013 Long-Term
Incentive Plan, and (iii) 343,188 warrants to purchase shares of common stock that are currently exercisable.
Equity
Compensation Plan Information
The
following table provides certain information as of December 31, 2020, 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
1,169,665
37.69
2,306,956
Equity compensation
plans not approved
by security holders
205,615 (1)
50.36
-
Total
1,375,280
39.59
2,306,956
- 76 -
(1)
Comprised
of awards made to individuals outside the InspireMD, Inc. 2011 UMBRELLA Option Plan and 2013 Long Term Incentive Plan, as
described below:
●
Options
issued to former director: In November 2011, we issued options to purchase an aggregate of 3 shares of common stock to Dr.
Barer, then chairman of our board of directors who resigned from the board of directors effective as of June 2, 2017. The
exercise price of these options is $3,412,500 per share and the options may be exercised at any time prior to the tenth anniversary
of the grant date, pursuant to the nonqualified stock option agreement, as amended on June 2, 2017.
●
On
January, 2020, we issued to Mr. Marvin Slosman, our Chief Executive Officer, President and Director, 182,381 shares of restricted
stock and 60,794 shares of common stock, as inducement awards outside the Company’s 2013 Long-Term Incentive Plan.
●
On
October 6, 2020, we issued to Mr. Patrick Jamnik, our Vice President of Business Development and Strategic Initiatives, options
to purchase 54,307 shares of our 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
90,511 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 Messrs. Stuka, Berman and Kester, satisfy the requirement for independence
set out in Section 803 of the NYSE American rules and that each of these directors has no material relationship with us (other
than being a director and/or a stockholder). 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 immediate family or affiliates
and our company and our affiliates and did not rely on categorical standards other than those contained in the NYSE American rule
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, 2020 and 2019 are described below.
- 77 -
Audit
Fees
Kesselman
billed us audit fees in the aggregate amount of $160,000 and $160,000 for the years ended December 31, 2020 and 2019, 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 $53,900 and $60,000 for the year ended December 31, 2020 and 2019, respectively.
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.
The
fees for the year ended December 31, 2019 mostly related to our prospectus supplements filed with the Securities and Exchange
Commission in April 2019 and to our registration statement on Form S-1 filed with the Securities and Exchange Commission in August
and September of 2019.
Tax
Fees
Kesselman
billed us tax fees in the aggregate amount of $39,209 and $38,675 for the year ended December 31, 2020 and 2019, 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, 2020 and 2019.
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, 2020 and 2019
●
Consolidated Statements of Operations for the Years Ended December 31, 2020 and 2019
●
Consolidated Statements of Changes in Equity for the Years Ended December 31, 2020 and 2019
●
Consolidated Statements of Cash Flows for the Years Ended December 31, 2020 and 2019
●
Notes to Consolidated Financial Statements
2.
Financial Statement Schedules
None
3.
Exhibits
See
Index to Exhibits
- 78 -
Item
16. Form 10-K Summary
Not
applicable.
Index
to Exhibits [Subject to additional analysis/review]
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 April 1, 2011)
3.3
Certificate of Designation, Preferences and Rights of Series A Preferred Stock (incorporated by reference to Exhibit 3.1 to Current Report on Form 8-K filed with the Securities and Exchange Commission on October 25, 2013)
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 May 25, 2016)
3.5
Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred Stock (incorporated by reference to Exhibit 3.5 to the Quarterly Report on Form 10-Q filed on August 9, 2016)
3.6
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)
3.7
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)
3.8
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)
3.9
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 December 4, 2017)
3.10
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)
3.11
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 22, 2017)
3.12
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)
3.13
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)
3.14
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)
3.15
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 July 5, 2018)
- 79 -
3.16
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)
4.1
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)
4.2
Rights Agreement dated as of October 22, 2013 between InspireMD, Inc. and Action Stock transfer Corporation, as Rights Agent, including exhibits thereto (incorporated by reference to an exhibit to the Registration Statement on Form 8-A filed with Securities and Exchange Commission on October 25, 2013)
4.3
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)
4.4
Description of Securities (incorporated by reference to Exhibit 4.4 to our Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 10, 2020)
10.1+
Amended and Restated 2011 Umbrella Option Plan (incorporated by reference to Exhibit 10.1 to Current Report on Form 8-K filed with the Securities and Exchange Commission on November 4, 2011)
10.2+
Form of Stock Option Award Agreement (incorporated by reference to Exhibit 10.2 to Current Report on Form 8-K filed with the Securities and Exchange Commission on April 6, 2011)
10.3+
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)
10.4+
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)
10.5
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)
10.6
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)
10.7+
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)
10.8+
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)
10.9+
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)
10.10+
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)
10.11+
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)
- 80 -
10.12+
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)
10.13+
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)
10.13+
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)
10.14+
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)
10.15+
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)
10.16+
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)
10.17+
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)
10.18+
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)
10.19+
Employment Agreement, dated July 14, 2014, by and between InspireMD, Inc. and James J. Barry, Ph.D. (incorporated by reference to Exhibit 10.1 to Current Report on Form 8-K filed with the Securities and Exchange Commission on July 18, 2014)
10.20+
Amendment to Employment Agreement, dated January 5, 2015, by and between InspireMD, Inc. and James J. Barry, PhD (incorporated by reference to Exhibit 10.2 to Current Report on Form 8-K filed with the Securities and Exchange Commission on January 6, 2015)
10.21+
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)
10.22+
Amendment Number Two to Employment Agreement, dated February 22, 2015, by and between InspireMD, Inc. and James J. Barry, PhD (incorporated by reference to Exhibit 10.1 to Current Report on Form 8-K filed with the Securities and Exchange Commission on February 25, 2015)
10.23+
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)
10.24+
Third Amendment to Employment Agreement, dated March 28, 2016, by and between InspireMD, Inc. and James J. Barry, PhD (incorporated by reference to Exhibit 10.66 to the Annual Report on Form 10-K filed on March 28, 2016)
10.25
Form of $25,812.50 Underwritten Warrant (incorporated by reference to Exhibit 10.2 to Current Report on Form 8-K filed with the Securities and Exchange Commission on March 16, 2016)
- 81 -
10.26
Form of $32,265.63 Underwriter Warrant (incorporated by reference to Exhibit 10.3 to Current Report on Form 8-K filed with the Securities and Exchange Commission on March 16, 2016)
10.27
Form of $25,812.50 Private Placement Warrant (incorporated by reference to Exhibit 10.5 to Current Report on Form 8-K filed with the Securities and Exchange Commission on March 16, 2016)
10.28
Form of $32,265.63 Placement Agent Warrant (incorporated by reference to Exhibit 10.7 to Current Report on Form 8-K filed with the Securities and Exchange Commission on March 16, 2016)
10.29+
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)
10.30+
Fourth Amendment to Employment Agreement, dated June 6, 2016, by and between InspireMD, Inc. and James Barry, Ph.D. (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed on June 7, 2016)
10.31
Warrant Agreement, dated June 13, 2016, by and between InspireMD, Inc. and Hercules Capital, Inc. (incorporated by reference to Exhibit 10.6 to the Current Report on Form 8-K filed on June 14, 2016)
10.32
Placement Agent Unit Purchase Option, dated June 7, 2016, issued to Dawson James Securities, Inc. (incorporated by reference to Exhibit 10.12 to the Quarterly Report on Form 10-Q filed on August 9, 2016)
10.33
Warrant Agent Agreement and Form of Warrant, dated as of July 7, 2016, between InspireMD, Inc. and Action Stock Transfer Corporation, as Warrant Agent (incorporated by reference to an exhibit to the Registration Statement on Form 8-A filed with Securities and Exchange Commission on July 26, 2016)
10.34+
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)
10.35+
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)
10.36+
Director
Offer Letter, between InspireMD, Inc. and Thomas J. Kester, dated September 6, 2016
10.37+
Fifth Amendment to Employment Agreement, dated September 5, 2017, by and between InspireMD, Inc. and James Barry, Ph.D. (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed on September 7, 2017)
10.38
Securities Purchase Agreement (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed on November 29, 2017)
10.39
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)
10.40
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)
10.41
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)
10.42
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)
10.43
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)
10.44
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))
- 82 -
10.45
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))
10.46
Form of Pre-Funded Warrant (incorporated by reference to Exhibit 4.4 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))
10.47
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))
10.48+
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)
10.49+
Amended and Restated Employment Agreement, dated February 4, 2019, by and between InspireMD, Inc. and James J. Barry, Ph.D. (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed on February 6, 2019)
10.50+
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)
10.51+
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)
10.52
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)
10.53
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)).
10.54
Form of Pre-Funded Warrant (incorporated by reference to Exhibit 4.4 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)).
10.55
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)).
10.56+
General Release and Severance Agreement, dated December 9, 2019, by and between the Company and James J. Barry, Ph.D. (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed on December 10, 2019)
10.57+
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).
10.58+
First Amendment to General Release and Severance Agreement, dated December 31, 2019, by and between the Company and James J. Barry, Ph.D. (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed on January 6, 2020).
10.59+
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).
10.60+
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)
10.61+
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)
- 83 -
10.62
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)).
10.63
Form of Pre-Funded 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))
10.64
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))
10.65
Sales Agreement, dated July 28, 2020 (incorporated by reference to Exhibit 1.1 to the Company’s Current Report on Form 8-K, filed with the SEC on July 28, 2020)
10.66
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))
10.67
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))
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, 2019, formatted
in 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
*
Filed herewith.
+
Management contract or compensatory plan or arrangement.
- 84 -
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 8, 2021
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
8, 2021
Marvin
Slosman
(principal
executive officer)
/s/
Craig Shore
Chief
Financial Officer, Chief Administrative Officer,
Secretary and Treasurer
March
8, 2021
Craig
Shore
(principal
financial and accounting officer)
/s/
Paul Stuka
Chairman
of the Board of Directors
March
8, 2021
Paul
Stuka
/s/
Michael Berman
Director
March
8, 2021
Michael
Berman
/s/
Thomas J. Kester
Director
March
8, 2021
Thomas
J. Kester
/s/
Campbell Rogers, M.D.
Director
March
8, 2021
Campbell
Rogers, M.D.
/s/
Gary Roubin
Director
March
8, 2021
Gary
Roubin
INSPIREMD,
INC.
CONSOLIDATED
FINANCIAL STATEMENTS
AS
OF AND FOR THE YEAR ENDED DECEMBER 31, 2020
F- 1
INSPIREMD,
INC.
CONSOLIDATED
FINANCIAL STATEMENTS
AS
OF AND FOR THE YEAR ENDED DECEMBER 31, 2020
TABLE
OF CONTENTS
Page
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
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, 2020 and 2019, 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, 2020 and 2019, 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.
Change
in Accounting Principle
As
discussed in Note 2(g) to the consolidated financial statements, the Company changed the manner in which it accounts for leases
in 2019.
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
8, 2021
We
have served as the Company’s auditor since 2010.
F- 3
INSPIREMD,
INC.
CONSOLIDATED
BALANCE SHEETS
(U.S.
dollars in thousands)
December 31,
2020
2019
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$ 12,645
$ 5,514
Accounts receivable:
Trade, net
476
823
Other
146
150
Prepaid expenses
334
87
Inventory
1,415
1,236
Receivable for sale of Shares
323
-
TOTAL CURRENT ASSETS
15,339
7,810
NON-CURRENT ASSETS:
Property, plant and equipment, net
448
547
Operating lease right of use assets
1,265
937
Fund in respect of employee rights upon retirement
725
586
TOTAL NON-CURRENT ASSETS
2,438
2,070
TOTAL ASSETS
$ 17,777
$ 9,880
December 31,
2020
2019
LIABILITIES AND EQUITY
CURRENT LIABILITIES:
Accounts payable and accruals:
Trade
236
646
Other
3,469
2,469
TOTAL CURRENT LIABILITIES
3,705
3,115
LONG-TERM LIABILITIES:
Operating lease liabilities
999
653
Liability for employee rights upon retirement
910
729
TOTAL LONG-TERM LIABILITIES
1,909
1,382
COMMITMENTS AND CONTINGENT LIABILITIES (Note 6)
TOTAL LIABILITIES
5,614
4,497
EQUITY:
Common stock, par value $0.0001 per share; 150,000,000 shares authorized at December 31, 2020 and 2019; 49,264,830 and 3,916,134 shares issued and outstanding at December 31, 2020 and 2019, respectively
5
-
Preferred B shares, par value $0.0001 per share;
500,000 shares authorized at December 31, 2020 and 2019; 17,303 shares issued and outstanding at December 31, 2020 and 2019, respectively
-
-
Preferred C shares, par value $0.0001 per share;
1,172,000 shares authorized at December 31, 2020 and 2019; 2,343 and 34,370 shares issued and outstanding at December 31, 2020 and 2019, respectively
-
-
Additional paid-in capital
180,334
163,015
Accumulated deficit
(168,176 )
(157,632 )
Total equity
12,163
5,383
Total liabilities and equity
$ 17,777
$ 9,880
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)
Year Ended December 31,
2020
2019
REVENUES (2020 - net of settlement payment of $580, see note 6)
$ 2,485
$ 3,721
COST OF REVENUES
2,402
2,965
GROSS PROFIT
83
756
OPERATING EXPENSES:
Research and development
2,233
2,954
Selling and marketing
2,103
2,396
General and administrative
6,127
5,222
Total operating expenses
10,463
10,572
LOSS FROM OPERATIONS
(10,380 )
(9,816 )
FINANCIAL EXPENSES
(160 )
(200 )
LOSS BEFORE TAX EXPENSES
(10,540 )
(10,016 )
TAX EXPENSES
4
24
NET LOSS
$ (10,544 )
$ (10,040 )
NET LOSS PER SHARE - basic and diluted
(0.46 )
(4.80 )
WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES USED IN COMPUTING NET LOSS PER SHARE - basic and diluted
22,686,590
2,089,964
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)
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, 2018
768,615
*
17,303
*
61,423
*
$ 156,355
$ (147,592 )
$ 8,763
Net loss
(10,040 )
(10,040 )
Issuance of common shares, warrants, pre-funded warrants and exercise of pre-funded warrants, net of $1,177 issuance costs
3,039,161
*
6,335
6,335
Conversion of Series C Convertible Preferred Stock to common shares
38,614
*
(27,053 )
*
*
-
Share-based compensation related to restricted stock , restricted stock units and stock options award, net of forfeitures of 838 shares
69,744
*
325
325
BALANCE as of December 31, 2019
3,916,134
*
17,303
*
34,370
*
$ 163,015
$ (157,632 )
$ 5,383
*
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, 2019
3,916,134
*
17,303
*
34,370
*
$ 163,015
$ (157,632 )
$ 5,383
Net loss
(10,544 )
(10,544 )
Exercise of pre-funded warrants
14,856,400
2
16
18
Settlement of restricted stock units in shares of common stock
165,000
*
*
Issuance of common shares, including at the market offering net of $1,110 issuance costs
24,108,771
3
15,197
15,200
Exercise of Warrants F
2,866,600
*
1,418
1,418
Exercise of Unit Purchase Option
253,587
*
82
82
Conversion of Series C Convertible Preferred Stock to common shares
372,173
*
(32,027 )
*
*
Share-based compensation related to restricted stock, restricted stock units and stock options award, net of forfeitures of 55,755 shares
2,726,165
*
606
606
BALANCE as of December 31, 2020
49,264,830
5
17,303
*
2,343
*
$ 180,334
$ (168,176 )
$ 12,163
*
Represents an amount less than $1
F- 7
INSPIREMD,
INC.
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(U.S.
dollars in thousands)
Year ended December 31,
2020
2019
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss
$ (10,544 )
$ (10,040 )
Adjustments required to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
151
158
Loss from sale of property, plant and equipment
14
-
Change in liability for employees rights upon retirement
181
124
Non cash financial expense (income)
(4 )
8
Net change in operating lease assets and liabilities
56
78
Share-based compensation expenses
606
325
Gains on amounts funded in respect of employee rights upon retirement, net
(18 )
(35 )
Changes in operating asset and liability items:
Increase in prepaid expenses
(247 )
(6 )
Decrease (increase) in trade receivables
347
(107 )
Decrease (increase) in other receivables
4
(46 )
Increase in inventory
(179 )
(102 )
Decrease in trade payables
(410 )
(283 )
Increase in other payables
962
116
Net cash used in operating activities
(9,081 )
(9,810 )
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of property, plant and equipment
(88 )
(284 )
Proceeds from sale of property, plant and equipment
22
-
Amounts withdrawn in respect of employee rights upon retirement, net
(121 )
(103 )
Net cash used in investing activities
(187 )
(387 )
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of shares and warrants and exercise of Pre-Funded
Warrants and unit purchase option, net of $1,110 and $1,177 issuance costs, respectively
16,395
6,335
Net cash provided by financing activities
16,395
6,335
EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS
4
(8 )
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
7,131
(3,870 )
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF YEAR
5,514
9,384
BALANCE OF CASH AND CASH EQUIVALENTS AT END OF YEAR
$ 12,645
$ 5,514
SUPPLEMENTAL NON-CASH INVESTING AND FINANCING ACTIVITIES:
Acquisition of right-of-use assets by means of lease liabilities
619
67
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).
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
During
the year ended December 31, 2020, in an effort to contain and mitigate the spread of
COVID-19, many countries have imposed unprecedented restrictions on travel, quarantines
and other public health safety measures. As of the beginning of the second quarter of
2020, we began to experience a significant COVID-19 related impact on our financial condition
and results of operations, which we primarily attribute to the postponement of CGuard
EPS procedures (non-emergency procedures), as hospitals shifted resources to patients
affected by COVID-19. To the best of our knowledge, most European countries in which
we operate are reinstating elective procedures, but we do not know when the hospitals
will resume to normal pre-pandemic levels with such procedures in light of recent increases
in COVID-19 cases in the territories we sell into. We anticipate that the continuation
of the pandemic and related restrictions and safety measures would likely result in a
continued fluctuations in sales of our products 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, assessing the likelihood of exercise of options to extend the lease term and legal contingencies.
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.
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”.
f.
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.
The fair value of the Company’s financial instruments
approximates their carrying values.”
g.
Leases
In
February 2016, the FASB established ASC Topic 842, Leases (Topic 842), by issuing ASU No. 2016-02, which requires lessees
to recognize leases on-balance sheet and disclose key information about leasing arrangements. The new standard establishes
a right-of-use (ROU) model that requires a lessee to recognize a ROU asset and lease liability on the balance sheet. Leases
will be classified as finance or operating, with classification affecting the pattern and classification of expense recognition
in the statement of operations. We adopted the new standard on January 1, 2019 using the modified retrospective transition
method and we did not restate comparative periods. The new standard provides a number of optional practical expedients in
transition. We have elected the ‘package of practical expedients’, which permit it not to reassess under the new
standard its prior conclusions about lease identification, lease classification and initial direct costs for leases entered
into prior to adoption of Topic 842.
Additionally,
the Company did not separate lease and non-lease components for all of our leases. The Company elected the short-term lease
recognition exemption for all leases that qualify. This means, for those leases that qualify, the Company will not recognize
ROU assets or lease liabilities, and this includes not recognizing ROU assets or lease liabilities for existing short-term
leases of those assets in transition. Instead, we will continue to recognize the lease payments for those leases in profit
or loss on a straight-line basis over the lease term.
The
new standard had a material effect on the Company’s financial statements. The most significant effects of adoption relate
to (1) the recognition of new operating lease ROU assets and operating lease liabilities on its balance sheet for real estate
operating leases; and (2) providing significant new disclosures about its leasing activities.
Upon
adoption, we recognized additional operating lease liabilities, of approximately $1.2 million based on the present value of
the remaining lease payments under current leasing standards for existing operating leases. The Company also recognized
corresponding ROU assets of approximately $1.2 million. Lease terms may include options to extend or terminate the lease when
the Company is reasonably certain that the extension option will be exercised or termination option will not be exercised.
For Operating Lease expense is recognized on a straight-line basis over the lease term. Our leases may include variable
payments based on measures that include changes in price index which are expensed as incurred and presented as
operating expense on the condensed consolidated statements of operations in the same line item as expense arising from fixed
lease payments.
The
new standard also provides practical expedients for an entity’s ongoing accounting. See Note 5.
h.
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.
i.
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):
j.
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).
k.
Research
and development costs
Research
and development costs are charged to the statement of operations as incurred.
l.
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.
m.
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”.
n.
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):
o.
Advertising
Costs
related to advertising and promotion of products are charged to sales and marketing expense as incurred. Advertising expenses
were approximately $163,000 and $262,000 for the years ended December 31, 2020 and 2019, respectively.
p.
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 922,720 and 151,884 weighted average shares of common stock
issuable to holders of Series B Convertible Preferred Stock for the years
ended December 31, 2020 and 2019, respectively, (since they are convertible based on
passage of time) and 72,493 weighted average shares of common stock issuable to holders
of unexercised Pre-Funded Warrants for the year ended December 31, 2019.
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 32,493,268 and 4,707,230 for the years ended December 31, 2020 and 2019, respectively.
q.
Segment
reporting
The
Company has one operating and reportable segment.
r.
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.
F- 13
INSPIREMD,
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE
2 - SIGNIFICANT ACCOUNTING POLICIES (continued):
s.
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.
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:
December 31,
2020
2019
($ in thousands)
Cost:
Computer equipment
$ 289
$ 287
Office furniture and equipment
95
95
Machinery and equipment
1,427
1,414
Leasehold improvements
211
206
2,022
2,002
Less - accumulated depreciation and amortization
(1,574 )
(1,455 )
Net carrying amount
$ 448
$ 547
b.
Depreciation
and amortization expenses totaled approximately $151,000 and $158,000 for the years ended December 31, 2020 and 2019, 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 $276,000 and $197,000
for the years ended December 31, 2020 and 2019, respectively.
Defined
contribution plan expenses were approximately $339,000 and $294,000 for the years ended December 31, 2020 and 2019, respectively.
The
Company expects contribution plan expenses in 2021 to be approximately $346,000.
F- 15
INSPIREMD,
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE
5 – LEASE AGREEMENTS
1)
The
Company’s Israeli subsidiary has a lease agreement for a facility in Israel, which expires on December 31, 2020 with
an option to extend the agreement for two additional years until December 31, 2022 under the terms stipulated in the agreement.
The company exercised the Option Period as estimated. In addition, the Company amended the agreement mentioned above which
include a new option period for two additional years until December 31, 2024 under the terms stipulated in the agreement,
the Option Period was taken in consideration when calculating the operating lease right of use assets and liabilities.
In addition, the Company entered into another amendment to the lease agreement for a lease of additional space in the facility,
the additional space amendment was taken in consideration when calculating the operating lease right of use assets and
liabilities.
2)
The
Company leases its motor vehicles under operating lease agreements.
3)
Operating
lease cost for the year ended December 31, 2020 was comprised of the following:
Twelve months ended
December 31
Twelve months ended
December 31
2020
2019
($ in
thousands)
($ in
thousands)
Operating lease expense
370
358
Short-term lease expense
-
8
370
366
Supplemental
information related to leases are as follows:
December 31
December 31
2020
2019
($ in
thousands)
($ in
thousands)
Operating lease right-of-use assets
1,265
937
Current Operating lease liabilities
(400 )
(362 )
Non-current operating lease liabilities
(999 )
(653 )
Other
information:
Operating cash flows from operating leases (cash paid in thousands)
(387 )
(366 )
Weighted Average Remaining Lease Term
1.73
1.33
Weighted Average Discount Rate
8.38 %
9.07 %
Maturities
of lease liabilities are as follows:
Amount
($ in thousands)
2021
421
2022
389
2023
400
2024
419
Total lease payments
1,629
Less imputed interest
(230 )
Total
1,399
F- 16
INSPIREMD,
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE
6 - COMMITMENTS AND CONTINGENT LIABILITIES :
Litigation:
In July 2016,
a service provider filed a suit seeking damages from the Company’s subsidiary amounting to $1,967,822. The Company’s
subsidiary and the plaintiff have entered into a confidential settlement agreement in the amount of $600,000, and on April 24,
2019, the parties filed a stipulation of dismissal, dismissing all claims in this action. On April 25, 2019, the court denied as
moot all pending motions. The related increase in provision of $354,000 was recorded to “Research and development expense”
within the Consolidated Statements of Operations for the year months ended December 31, 2019.
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.
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 $0.495,
the exercise price per share of warrants to purchase 274,029 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 $187.50 to $2.25 and a weighted average exercise price per share of $7.32.
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.
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.
NOTE
7 - EQUITY
a.
Share
capital
The
Company’s common stock are listed on the NYSE American.
On
March 27, 2019, 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-fifty reverse stock split of its common stock, par value $0.0001
per share, effective as of March 29, 2019, which decreased the number of issued and outstanding shares of common stock and restricted
stock as of December 31, 2018 from 38.4 million shares to 769 thousand shares.
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
April 8, 2019, the Company closed an underwritten public offering of 486,957 shares of the Company’s common stock at the
offering price to the public of $5.00 per share. The Company received net proceeds of approximately $2 million from the offering,
after deducting underwriter discounts and commissions and other fees and expenses payable by the Company. In connection with this
public offering, on April 12, 2019, the underwriter partially exercised its over-allotment option and purchased an additional
12,393 shares of our common stock at a price to the public of $5.00 per share. The Company received net proceeds of approximately
$47,000 from the exercise of the over-allotment option.
In
connection with the offering, the Company issued to the underwriter warrants to purchase up to 34,955 shares of common stock,
or 7% of the shares sold in the offering, including the shares issued pursuant to the over-allotment option (the “April
2019 Underwriter Warrants”). The April 2019 Underwriter Warrants are exercisable at any time and from time to time, in whole
or in part, following the date of issuance and ending on April 4, 2024, at an exercise price of $6.25 per share (125% of the offering
price to the public per share).
Upon
execution of the underwriting agreement, the respective conversion price of the outstanding shares of Series B Convertible Preferred
Stock and Series C Convertible Preferred Stock was reduced to $5.00 pursuant to the anti-dilution adjustment provisions of the
Series B Convertible Preferred Stock and of the Series C Convertible Preferred Stock, and the number of shares of common stock
issuable upon conversion of the Series B Convertible Preferred Stock and the Series C Convertible Preferred Stock had increased
as follows:
●
an
aggregate of 133,233 additional shares of common stock issuable upon conversion of the Series B Convertible Preferred Stock,
including the payment of the cumulative dividends accrued thereunder in common stock, based on 17,303 shares of Series B Convertible
Preferred Stock outstanding as of April 4, 2019.
●
an
aggregate of 50,708 additional shares of common stock issuable upon conversion of the Series C Convertible Preferred Stock,
based on 59,423 shares of Series C Convertible Preferred Stock outstanding as of April 4, 2019.
On
September 19, 2019, the Company entered into an underwriting agreement relating to an
underwritten public offering (the “September 2019 Offering”) of (i) 539,000
common units (“2019 Common Units”), with each 2019 Common Unit being comprised
of one share of the Company’s common stock and one Series E warrant (collectively,
the “Series E Warrants”) to purchase one share of common stock and (ii) 2,238,777
pre-funded units (“2019 Pre-Funded Units”), with each 2019 Pre-Funded Unit
being comprised of one pre-funded warrant (collectively, the “2019 Pre-Funded Warrants”)
to purchase one share of common stock and one Series E Warrant, which closed on September
24, 2019. The offering price to the public was $1.80 per 2019 Common Unit and $1.79 per
2019 Pre-Funded Unit. In connection with this public offering, on September 24, 2019,
the underwriter partially exercised its over-allotment option and purchased an additional
Series E Warrants to purchase 194,444 shares of common stock at a purchase price of $0.01
per Series E Warrant.
The
Series E Warrants included in the 2019 Common Units and the 2019 Pre-Funded Units are immediately exercisable at a price
of $1.80 per share of common stock, subject to adjustment in certain circumstances, and expire five years from the date
of issuance.
Each
2019 Pre-Funded Warrant contained in a 2019 Pre-Funded Unit is exercisable for one share
of our common stock at an exercise price of $0.01 per share. The 2019 Pre-Funded Warrants
are immediately exercisable and may be exercised at any time until all of the 2019 Pre-Funded
Warrants are exercised in full.
In
connection with the offering, the Company issued to the underwriter warrants to purchase up to 194,444 shares of common
stock, or 7% of the shares sold in the offering, including the number of shares of common stock issuable upon exercise
of the 2019 Pre-Funded Warrants sold in the offering (the “September 2019 Underwriter Warrants”). The September
2019 Underwriter Warrants are exercisable at any time and from time to time, in whole or in part, following the date of
issuance and ending on September 19, 2024, at an exercise price of $2.25 per share (125% of the offering price to the
public per 2019 Common Unit).
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 $1.80 per share, effective as of
the date of the underwriting agreement entered for the September 2019 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 355,288 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 September 19, 2019.
●
an
aggregate of 84,253 additional shares of common stock upon conversion of the Series C Preferred Stock, based on 37,025 shares
of Series C Preferred Stock outstanding as of September 19, 2019.
F- 18
INSPIREMD,
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE
7 – EQUITY (continued):
The
Company received gross proceeds of $5.0 million from the offering, before deducting underwriter
discounts and commissions and other fees and expenses payable by the Company.
On
June 5, 2020, the Company closed an underwritten public offering of (i) 7,635,800 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) 14,586,400 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 3,333,300 shares of common stock and 3,333,300
Series F Warrants. The offering price to the public was $0.45 per Unit and $0.449 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 $0.001 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 $0.495
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, 2,866,600 Series F Warrants were converted into 2,866,600 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 $0.45 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 1,665,414 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 283,285 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.
During
the year ended December 31, 2020, the Company issued a total of 14,586,400 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 270,000
shares of its common stock in connection with the exercise of 270,000 Pre-Funded Warrants issued in September 2019. As
of December 31, 2020, there are no outstanding Pre-Funded Warrants.
During
the year ended December 31, 2019, the Company issued a total of 2,000,811 shares of its common stock in connection with
the exercise of an aggregate of 2,000,811 Pre-Funded Warrants and 2019 Pre-Funded Warrants. The Company received aggregate
cash proceeds equal to approximately $35,705 in connection with such exercises.
F- 19
ATM
Offering
During
the year ended December 31, 2020, the Company sold 12,917,448 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
thousand.
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 $0.321 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 892,371 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 13,392 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.
As
of December 31, 2020, the Number of Preferred shares the amount each class is convertible into is below:
Number
of Preferred Stock
Number
of underlying Common stock
Series
B Convertible Preferred Stock*
17,303
3,112,923 **
Series
C Convertible Preferred Stock
2,343
46,714 ***
Total
3,159,637
*
See “Note 11 - Subsequent events” regarding conversion of all remaining Series B Convertible Preferred Stock into
common stock.
**
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 $33.00 which currently converted into 3,112,923 reflecting a conversion price equal to $ 0.321. 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 $6.40 which currently converted into 46,714 reflecting a conversion price equal to $ 0.321.
As
of December 31, 2020, the Company has outstanding warrants to purchase an aggregate of 26,705,502 shares of common stock as follows:
Number of
underlying
Common stock
Weighted
average
exercise price
Series A Warrants
1,107
$ 8,750.00
Series B Warrants
2,448
$ 3,500.00
Series D Warrants
766,698
$ 15.00
Series E Warrants
2,972,221
$ 1.80
Series F Warrants
22,688,900
$ 0.50
Underwriter Warrants
274,029
$ 0.50
Other warrants
99
$ 21,993.00
Total Warrants
26,705,502
$ 1.82
As
of December 31, 2020, 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 B Convertible Preferred Stock and 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 year ended December 31, 2020, the Company granted stock options to the CEO, employees and directors to purchase a total
of 1,379,856 shares of the Company’s common stock. The options have exercise prices ranging from $0.33-$1.10 per share,
respectively, which were the fair market value of the company’s common stock on the date of each respective grant. As
of December 31, 2020, the fair value of the above options, using the Black-Scholes pricing models, was approximately $509,000.
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, 2020 and 2019, the Company granted to the then CEO, employees and directors 2,781,920 and 70,582
restricted stock, respectively. The fair value of these restricted stock was approximately $1,051,604 and $668,000, 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, 2020 and 2019, the Company granted CEO and former CEO 1,357,668 and 165,000 Restricted Stock
Units, respectively. The fair value of these restricted stock units was approximately $658,981 and $141,900, respectively.
The restricted stock units granted during the years ended December 31, 2020 are subject to a three-year vesting period, with
one-third of such awards vesting each year. The restricted stock units granted during the year ended December 31, 2019 were
fully vested upon grant.
5)
The
following table summarizes information about stock options granted to employees:
Year ended December 31
2020
2019
Number of options
Weighted
average
exercise price
Number of options
Weighted
average
exercise price
Outstanding - beginning of period
160
$ 189,161.99
164
$ 184,656
Granted
1,379,856
0.41
-
-
Forfeited
(4,751 )
343.51
(4 )
4,423
Outstanding -end of period
1,375,265
$ 21.24
160
$ 189,162
Exercisable at the end of the period
115
$ 249,006
160
$ 189,162
F- 21
INSPIREMD,
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE
7 – EQUITY (continued):
6)
The
following table summarizes information about stock options granted to non-employees:
Year ended December 31
2020
2019
Number of options
Weighted average exercise price
Number of options
Weighted average exercise price
Outstanding - beginning of period
16
$ 1,711,975
20
$ 1,693,174
Granted
-
-
-
-
Forfeited
(1 )
2,156,208
(4 )
1,617,338
Exercised
-
-
-
-
Outstanding - end of period
15
1,682,385
16
1,711,975
Exercisable at the end of the period
15
1,682,385
16
1,711,975
7)
The
following table summarizes information about restricted stock granted to employees:
Year ended December 31
2020
2019
Number of restricted stock
Outstanding - beginning of period
69,631
19
Reverse Split Adjustments
-
(127 )
Granted
2,781,920
70,582
Forfeited
(55,755 )
(838 )
Vested
(9,915 )
(5 )
Outstanding - end of period
2,785,881
69,631
8)
The
following table summarizes information about Restricted Stock Unit granted to employees:
Year ended December 31
2020
2019
Number of restricted stock
Outstanding - beginning of period
165,000
-
Granted
1,357,668
165,000
Forfeited
-
-
Vested
(165,000 )
-
Outstanding - end of period
1,357,668
165,000
9)
The
following table provides additional information about all options outstanding and exercisable:
Outstanding as of December 31, 2020
Exercise
price
Options outstanding
Weighted average remaining contractual life (years)
Options
exercisable
$0.175
2
1.39
2
$0.33-0.39
1,314,356
9.69
-
$1.10
60,794
9.01
-
$175 and above
128
4.71
128
1,375,280
9.66
130
The
weighted average of the remaining contractual life of total vested and exercisable options as of December 31, 2020 was 4.66 years.
The
aggregate intrinsic value of the total exercisable options as of December 31, 2020 was approximately $1.
F- 22
INSPIREMD,
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE
7 – EQUITY (continued):
The
weighted average fair value of options granted was $0.37 for the year ended December 31, 2020. The weighted average fair value
of options granted was estimated using the Black-Scholes option-pricing model.
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, 2020:
Year ended December 31
2020
Expected life
5.5-6.5 years
Risk-free interest rates
0.32%-0.42 %
Volatility
124.53%-136.66 %
Dividend yield
0 %
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, 2020, the total unrecognized compensation cost on employee and non-employee stock options and restricted stock,
related to unvested stock-based compensation, amounted to approximately $1.7 million. This cost is expected to be recognized
over a weighted-average period of approximately 0.95 years. This expected cost does not include the impact of any future stock-based
compensation awards.
12)
The
following table summarizes the allocation of total share-based compensation expense in the consolidated statements of operations:
Year ended December 31
2020
2019
($ in thousands)
Cost of revenues
$ 22
$ 14
Research and development
29
10
Sales and marketing
32
29
General and administrative
523
272
$ 606
$ 325
F- 23
INSPIREMD,
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE
8 - 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 2020 is 21%. State tax may also apply .
Taxation
in Israel
The
corporate tax rate was 23% in 2020 and will be 23% thereafter.
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- 24
INSPIREMD,
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE
8 - 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, 2020, the Company had a net carry forward tax loss of approximately $44 million, of which approximately $35 million
(arising before January 1, 2018), expires until 2037, and approximately $9 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, 2020, InspireMD Ltd., an Israeli subsidiary, had a net carry forward tax loss of approximately $98 million. Under
Israeli tax laws, the carry forward tax losses can be utilized indefinitely.
d.
Loss
before income taxes
The
components of loss before income taxes are as follows:
Year ended December 31
2020
2019
($ in thousands)
Loss before taxes on income:
InspireMD, Inc.
$ (3,897 )
$ (3,687 )
Subsidiaries
(6,643 )
(6,329 )
$ (10,540 )
$ (10,016 )
F- 25
INSPIREMD,
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE
8 - TAXES ON INCOME (continued):
e.
Current
taxes on income
The
main reconciling items between the statutory tax rate of the Company and the effective tax rate are the change in subsidiary tax
rates and 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 and changes in tax rates following the 2017 Act.
The
changes in the valuation allowance for the year ended December 31, 2020 and 2019 were as follows:
Year ended December 31
2020
2019
($ in thousands)
Balance at the beginning of the year
$ 31,181
$ 27,640
Changes during the year:
Losses during the year (including foreign exchange rate effect)
3,964
3,541
Balance at the end of the year
$ 35,145
$ 31,181
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, 2020
and 2019 were as follows:
Year ended December 31,
2020
2019
($ in thousands)
Balance at beginning of period
$ 44
$ 28
Increase in uncertain tax positions because of tax positions taken during the year
8
16
Balance at end of period
$ 52
$ 44
A
summary of open tax years by major jurisdiction is presented below:
Jurisdiction
Years
U.S.
2017-2020
Israel
2015-2020
Germany
2017-2020
United Kingdom
2014-2015
F- 26
INSPIREMD,
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE
8 - TAXES ON INCOME (continued):
g.
Deferred
income tax:
December 31,
2020
2019
($ in thousands)
Long-term:
Allowance for bonus
2
57
Provision for vacation and recreation pay
63
35
R&D expenses
578
589
Operating lease right of use assets
(291 )
(215 )
Operating lease liabilities
322
233
Share-based compensation
2,669
2,596
Carry forward tax losses
31,759
27,854
Accrued severance pay, net
43
32
35,145
31,181
Less-valuation allowance
(35,145 )
(31,181 )
-
-
NOTE
9 - SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION:
Balance
sheets:
Inventory:
December 31,
2020
2019
($ in thousands)
Finished goods
$ 350
$ 173
Work in process
376
81
Raw materials and supplies
689
982
$ 1,415
$ 1,236
F- 27
INSPIREMD,
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS (continued)
NOTE
9 - SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION (continued):
a.
Accounts
payable and accruals-other:
December 31,
2020
2019
($ in thousands)
Employees and employee institutions
$ 1,236
$ 1,238
Accrued vacation and recreation pay
278
188
Accrued expenses
886
604
Accrual for settlement payment (see note 6)
580
-
Current Operating lease liabilities
400
362
Other
89
77
$ 3,469
$ 2,469
NOTE
10 – 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:
Year ended December 31,
2020
2019
($ in thousands)
Germany
$ 708
$ 727
Italy
596
686
Poland
219
370
Other (2020 - net of settlement payment of $580, see note 6)
962
1,938
$ 2,485
$ 3,721
By
product:
Year ended December 31,
2020
2019
($ in thousands)
CGuard™ EPS
$ 2,764
$ 3,265
MGuard Prime™ EPS (2020 - net of settlement payment of $580, see note 6)
(279 )
456
$ 2,485
$ 3,721
By
principal customers (2020 - before of settlement payment of $580 see note 6):
Year ended December 31,
2020
2019
Customer A
21 %
18 %
Customer B
11 %
8 %
Customer C
8 %
10 %
Customer D
7 %
10 %
All
tangible long lived assets are located in Israel.
NOTE
11 - SUBSEQUENT EVENTS:
Subsequent to December 31, 2020 the Company had several stock transactions
as follows (U.S. dollars in thousands, except share data):
Common Stock
Gross amount
BALANCE as of December 31, 2020
49,264,830
Issuance of shares to Chinese distributor
1,341,682
900 (a)
ATM sales
12,277,844
5,659 (b)
February 2021 public offering
33,387,096
20,700 (c)
Series F and Series G warrants exercise
18,381,177
9,469 (d)
Conversion of Series B Convertible Preferred Stock to common shares
3,112,923
- (e)
a.
On February 3, 2021, the Company entered into a 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, 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, or the SPA, pursuant to which investor agreed to invest $900,000
in exchange for shares of the Company’s common stock at a purchase price of $0.6708 per share.
F- 28
b. Subsequent to year-end, the Company sold an aggregate of 12,277,844
shares of common stock for aggregate gross proceeds of $5,659,000 under the ATM Sales Agreement. In addition, in January 2021 we
received $323,000 for shares of common stock sold on December 2020 and recorded to "Receivable for sale of Shares" in
current assets of the Consolidated Balance Sheet as of December 31, 2020.
c.
On February 3, 2021, the Company entered into an underwriting agreement with A.G.P./Alliance Global Partners, relating to an underwritten
public offering (the “Offering”) of 29,032,258 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 to purchase one-half of one share
of Common Stock. The offering price to the public was $0.62 per Unit. The Series G Warrants are immediately exercisable at a price
of $0.682 per share, subject to adjustment in certain circumstances, and expire five years from the date of issuance. The Offering
closed on February 8, 2021.
The
Company granted the Underwriter a 45-day option to purchase up to an additional 4,354,838 Units consisting of 4,354,838 shares
of Common Stock and Series G Warrants to purchase 2,177,419 shares of common stock in the Offering, which the Underwriter exercised
in full on February 4, 2021.
The
Company granted the Underwriter a compensation warrant to purchase up to 1,669,355 shares of Common Stock. The Underwriter Warrants
have an exercise price of $0.682 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 estimated expenses
associated with the Offering, but excluding the proceeds, if any, from the exercise of Series G Warrants sold in the Offering.
d. Subsequent
to year-end, Series F and Series G warrants
to purchase shares of common stock were exercised by investors at an exercise price of $0.495 and $0.682 per share, resulting in
the issuance of 18,381,177 shares of common stock for proceeds of approximately $9,469,000.
e.
On February 3, 2021, 17,303 shares of Series B Convertible Preferred Stock were converted into 3,112,923 shares of common stock.
F- 29
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.