UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 20-F
☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934
☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
OR
For the fiscal year ended December 31, 2021
OR
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
OR
☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from _____ to ______
Date of event requiring this shell company report ________________
Commission file number 001-35165
BrainsWay Ltd.
(Exact name of Registrant as specified in its charter)
N/A
(Translation of Registrant’s name into English)
Israel
(Jurisdiction of incorporation or organization)
19 Hartum Street, Bynet Building, 3rd Floor, Har HaHotzvim, Jerusalem, 9777518, Israel
(Address of principal executive offices)
R. Scott Areglado, Senior Vice President, and Chief Financial Officer
1 Van de Graaff Drive, Burlington, MA 01803
Tel: +1-844-386-7001
(Name, Telephone, E-mail and/or Facsimi
le number and Address of Company Contact Person)
Securities registered or to be registered pursuant to Section 12(b) of the Act.
Title of class
American Depositary Shares, each representing two
Ordinary Shares (1)
Trading Symbol(s)
BWAY
Name of each exchange on which registered
NASDAQ Global Market
Ordinary Shares, par value NIS 0.04 per share
BWAY
Tel Aviv Stock Exchange
(1) Evidenced by American Depositary Receipts.
Securities registered or to be registered pursuant to Section 12(g) of the Act:
None
(Title of Class)
Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act:
None
(Title of Class)
Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by the
annual report: 32,911,134 Ordinary Shares.
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.
If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or
15(d) of the Securities Exchange Act of 1934.
Yes ☐ No ☒
Yes ☐ No ☒
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of
1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to
such filing requirements for the past 90 days.
Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to
submit such files).
Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or an emerging growth
company. See definition of “large accelerated filer," accelerated filer,” and "emerging growth company" in Rule 12b-2 of the Exchange Act.
Large Accelerated filer ☐
Accelerated filer ☐
Non-accelerated filer ☒
Emerging growth company ☒
If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has
elected not to use the extended transition period for complying with any new or revised financial accounting standards† provided pursuant to
Section 13(a) of the Exchange Act. ☐
† The term “new or revised financial accounting standard” refers to any update issued by the Financial Accounting Standards Board to its Accounting
Standards Codification after April 5, 2012.
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its
internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting
firm that prepared or issued its audit report. ☐
Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:
International Financial Reporting Standards as issued by the International Accounting Standards Board ☒
U.S. GAAP ☐
Other ☐
If “Other” has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected
to follow.
If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Item 17 ☐ Item 18 ☐
Yes ☐ No ☒
TABLE OF CONTENTS
IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS
ITEM 1.
OFFER STATISTICS AND EXPECTED TIMETABLE
ITEM 2.
KEY INFORMATION
ITEM 3.
INFORMATION ON THE COMPANY
ITEM 4.
UNRESOLVED STAFF COMMENTS
ITEM 4A.
OPERATING AND FINANCIAL REVIEW AND PROSPECTS
ITEM 5.
DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES
ITEM 6.
MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS
ITEM 7.
FINANCIAL INFORMATION
ITEM 8.
THE OFFER AND LISTING
ITEM 9.
ADDITIONAL INFORMATION
ITEM 10.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
ITEM 11.
DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES
ITEM 12.
DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES
ITEM 13.
MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS
ITEM 14.
CONTROLS AND PROCEDURES
ITEM 15.
[RESERVED]
ITEM 16.
AUDIT COMMITTEE FINANCIAL EXPERT
ITEM 16A.
CODE OF ETHICS
ITEM 16B.
PRINCIPAL ACCOUNTANT FEES AND SERVICES
ITEM 16C.
EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES.
ITEM 16D.
PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS
ITEM 16E.
CHANGE IN REGISTRANT’S CERTIFYING ACCOUNTANT
ITEM 16F.
ITEM 16G.
CORPORATE GOVERNANCE
ITEM 16H. MINE SAFETY DISCLOSURE
ITEM 16I.
ITEM 17.
ITEM 18.
ITEM 19.
GLOSSARY OF TERMS
EXHIBIT INDEX
DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
FINANCIAL STATEMENTS
FINANCIAL STATEMENTS
EXHIBITS
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98
118
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122
130
131
133
133
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134
134
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Unless the context otherwise requires, all references to “BrainsWay,” “we,” “us,” “our,” the “Company” and similar designations refer to BrainsWay Ltd., a
limited liability company incorporated under the laws of the State of Israel, and its consolidated subsidiaries. The term “including” means “including but
not limited to”, whether or not explicitly so stated. The term “NIS” refers to New Israeli Shekels, the lawful currency of the State of Israel, the terms
“dollar”, “US$”, “$” or “U.S.” refer to U.S. dollars, the lawful currency of the United States of America. Our functional and presentation currency is the
U.S. dollar. Unless otherwise indicated, U.S. dollar amounts herein (other than amounts originally receivable or payable in dollars) have been translated for
the convenience of the reader from the original NIS amounts at the representative rate of exchange as of December 31, 2021 ($1 = NIS 3.11). The dollar
amounts presented should not be construed as representing amounts that are receivable or payable in dollars or convertible into dollars, unless otherwise
indicated. Foreign currency transactions in currencies other than U.S. dollars are translated in this Annual Report into U.S. dollars using exchange rates in
effect at the date of the transactions.
The “BrainsWay” name and design logo are our registered trademarks. BrainsWay also asserts all rights, including but not limited to trademark, with
respect to the term “Deep TMS.” Solely for convenience, the trademarks, service marks, and trade names referred to in this Annual Report are without the
® and TM symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights
or the rights of the applicable licensors to these trademarks, service marks, and trade names. This Annual Report contains additional trademarks, service
marks, and trade names of others, which are the property of their respective owners. All trademarks, service marks, and trade names appearing in this
Annual Report are, to our knowledge, the property of their respective owners. We do not intend our use or display of other companies’ trademarks, service
marks or trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.
This Annual Report includes statistics and other data relating to markets, market sizes, and other industry data pertaining to our business that we have
obtained from industry publications, surveys, and other information available to us. Industry publications and surveys generally state that the information
contained therein has been obtained from sources believed to be reliable. Market data and statistics are inherently predictive, speculative and are not
necessarily reflective of actual market conditions. Such statistics are based on market research, which itself is based on sampling and subjective judgments
by both the researchers and the respondents, including judgments about what types of products and transactions should be included in the relevant market.
In addition, the value of comparisons of statistics for different markets is limited by many factors, including that (i) the markets are defined differently,
(ii) the underlying information was gathered by different methods, and (iii) different assumptions were applied in compiling the data. Likewise, market size
calculations and definitions are based on shifting and sometimes limited assumptions, including but not limited to relating to pricing models for our
products. Accordingly, the market statistics included in this Annual Report should be viewed with caution. We believe that information from these industry
publications included in this Annual Report is reliable.
ii
FORWARD-LOOKING STATEMENTS
Some of the statements under the sections entitled “Item 3. Key Information — Risk Factors,” “Item 4. Information on the Company,” “Item 5. Operating
and Financial Review and Prospects” and elsewhere in this Annual Report may include forward-looking statements. These statements involve known and
unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future
results, performance or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements
by terms including “anticipates,” “believes,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,”
“will,” “would,” and similar expressions intended to identify forward-looking statements. Forward-looking statements reflect our current views with
respect to future events and are based on assumptions and subject to risks and uncertainties. In addition, the sections of this Annual Report entitled “Item 4.
Information on the Company” contain information obtained from independent industry and other sources that we may not have independently validated.
You should not put undue reliance on any forward-looking statements. Unless we are required to do so under U.S. federal securities laws or other
applicable laws, we do not intend to update or revise any forward-looking statements.
Factors that could cause our actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not
limited to:
● market perception and acceptance of Deep Transcranial Magnetic Stimulation, or Deep TMS™, technology (“Deep TMS”);
● physician and patient satisfaction with the effectiveness, competitive advantages, and benefits of our Deep TMS system;
● availability of reimbursement from third-party payers, including insurance companies and Medicare;
● the adequacy of our existing capital to meet our future capital requirements;
● our ability to commercialize Deep TMS, including internationally, by ourselves or through third-party distributors;
● our ability to develop enhancements to our Deep TMS system through our research and development efforts;
● our reliance on third parties to conduct our clinical trials and manufacture our product candidates for clinical testing;
● our ability to complete and obtain favorable results from existing clinical trials, and to launch and successfully complete new clinical trials, for
Deep TMS indications;
● our ability to obtain regulatory approvals of Deep TMS and enhancements to our Deep TMS system on our anticipated time frames, or at all;
● our ability to comply with applicable regulatory approvals and requirements;
● our ability to obtain and maintain adequate protection of our intellectual property, including intellectual property licensed to us;
● our ability to operate within the changing market conditions caused by the COVID-19 global pandemic; and
● our ability to operate within a disrupted global supply chain, in particular given our reliance on third party suppliers of components and
manufacturing vendors.
iii
ITEM 1.
IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS
Not applicable.
ITEM 2.
OFFER STATISTICS AND EXPECTED TIMETABLE
Not applicable.
ITEM 3.
KEY INFORMATION
A.
B.
[Reserved]
Capitalization and Indebtedness
Not applicable.
C.
Reasons for the Offer and Use of Proceeds
Not applicable.
D.
Risk Factors
You should carefully consider the risks we describe below, in addition to the other information set forth elsewhere in this Annual Report, including our
financial statements and the related notes beginning on page F-1, before deciding to invest in our ordinary shares (the “Ordinary Shares”) or our
American Depositary Shares (“ADSs”). The risks and uncertainties described below in this annual report on Form 20-F for the year ended December 31,
2021 are not the only risks facing us. We may face additional risks and uncertainties not currently known to us or that we currently deem to be immaterial.
Any of the risks described below or incorporated by reference in this Form 20-F, and any such additional risks, could materially adversely affect our
reputation, business, financial condition or results of operations. In such case, you may lose all or part of your investment.
Summary of Risk Factors
The following is a summary of some of the principal risks we face. The list below is not exhaustive, and investors should read this “Risk factors” section in
full.
· We have a history of operating losses. We expect to incur additional losses in the future and may never be profitable.
· We cannot ensure that our existing capital will be sufficient to meet our capital requirements.
·
·
·
Raising additional capital may cause dilution to our existing shareholders, restrict our operations or require us to relinquish rights to our
technologies or product candidate(s).
Our success depends on Deep TMS as a safe treatment option for patients, as well as market perception and acceptance of TMS generally, and
patient satisfaction with the effectiveness of Deep TMS.
Our long-term growth depends on our ability to increase market penetration and further commercialize Deep TMS, as well as develop
enhancements and features to the Deep TMS system through our research and development efforts. If we fail to do so, we may be unable to
achieve future growth.
· We operate in a very competitive environment and if we are unable to compete successfully against our existing or potential competitors, our
revenues and operating results may be negatively affected.
·
If we are unable to adequately train physicians and other treatment providers and operators on the safe and appropriate use of our Deep TMS
systems, we may be unable to achieve our expected growth.
1
·
Failure to secure or maintain adequate coverage and reimbursement of our Deep TMS system for the currently authorized indications and other
indications for which we obtain FDA authorization in the future, if any, may make physicians reluctant to use or recommend Deep TMS and have
a material adverse effect on our sales, results of operations, and financial condition.
· We rely on third-party suppliers for some components used in manufacturing our Deep TMS products, and we may be unable to immediately
transition to alternative parties for these components.
· We rely, and in the future, expect to rely on a network of third-party distributors to market and distribute our products internationally, and if we are
unable to maintain and expand this network, we may be unable to generate anticipated revenues.
·
Clinical trials involve a lengthy and expensive process with an uncertain outcome, which may delay or cause us to abandon the development of
Deep TMS for additional indications.
· We rely in part on third parties to conduct our clinical trials. If these third parties fail to perform their duties on time or as expected, we may not be
able to obtain regulatory authorization for additional indications that we may seek for Deep TMS.
·
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·
·
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Our collaboration arrangements may not be successful, which could adversely affect our ability to develop and commercialize our products.
If product liability lawsuits are brought against us, our business may be harmed, and we may be required to pay damages that exceed our insurance
coverage.
Our insurance policies protect us only from some business risks, which will leave us exposed to significant uninsured liabilities.
Our operations could be affected in the event of further COVID-19 global pandemic outbreaks.
Our operations could be adversely affected by negative global trends, including supply chain disruptions and the “Great Resignation.”.
Performance issues, service interruptions, or price increases by our shipping carriers could adversely affect our business and harm our reputation
and ability to provide our services on a timely basis.
If we experience significant disruptions in our information technology systems, our business may be adversely affected.
· We rely on the use of technology and may become subject to cyber-terrorism or other compromises and shut-downs.
·
Security and privacy breaches may expose us to liability and harm our reputation and business.
· We may seek to grow our business through acquisitions or investments in new or complementary businesses, products or technologies, through the
licensing of products or technologies from third parties. The failure to manage acquisitions, investments, licenses or other strategic alliances, or
the failure to integrate them with our existing business, could harm our business.
·
Our products and operations are subject to extensive government regulation and oversight both in the United States and abroad, and our failure to
comply with applicable requirements could harm our business.
· We may not receive the necessary regulatory clearances or approvals to market our product for other proposed indications in the future, and failure
to timely obtain necessary clearances or approvals for such future indications would adversely affect our ability to grow our business.
· Modifications to our Deep TMS systems and treatments may require new 510(k) clearances, de novo classification or PMA, and may require us to
cease marketing or recall the modified products until authorizations are obtained.
·
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·
·
Our products must be manufactured in accordance with federal and state regulations, and we could be forced to recall our installed systems or
terminate production if we fail to comply with these regulations.
If treatment guidelines for the clinical conditions we are targeting change or the standard of care evolves, we may need to redesign and seek new
marketing authorization from the FDA for one or more of our products.
The misuse or off-label use of Deep TMS may harm our reputation in the marketplace, result in injuries that lead to product liability suits or result
in costly investigations, fines or sanctions by regulatory bodies, particularly if we are deemed to have engaged in the promotion of these uses, any
of which could be costly to our business.
Deep TMS may cause or contribute to adverse medical events that we are required to report to the FDA, and if we fail to do so, we would be
subject to sanctions that could harm our reputation, business, financial condition, and results of operations. The discovery of serious safety issues
with our products, or a recall of our products either voluntarily or at the direction of the FDA or another governmental authority, could have a
negative impact on us.
2
·
If we or our distributors do not obtain and maintain international regulatory registrations or approvals for Deep TMS, we will be unable to market
and sell our products outside of the United States.
· We are subject to certain federal, state, and foreign fraud and abuse laws, health information privacy and security laws, and transparency laws,
which, if violated, could subject us to substantial penalties. Additionally, any challenge to or investigation into our practices under these laws
could cause adverse publicity and be costly to respond to, and thus could harm our business.
·
Healthcare policy changes, including recently enacted legislation reforming the U.S. healthcare system, could harm our cash flows, financial
condition, and results of operations.
· We depend on our intellectual property, and our future success is dependent on our ability to protect our intellectual property and not infringe on
the rights of others.
·
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·
·
·
·
·
·
·
·
·
·
The lives of our patents may not be sufficient to effectively protect our products and business.
Our right to the essential intellectual property upon which the Deep TMS technology is based results from in-license agreements with government
agencies and research institutions, the termination of which would prevent us from commercializing Deep TMS.
Our license agreements for our critical patents and related intellectual property impose significant monetary obligations and other requirements
that may adversely affect our ability to successfully execute our business plan.
The key patents that underlie our Deep TMS technology are subject to the U.S. government’s royalty free usage rights on a worldwide basis for
any discovery based on such patents, which may have unexpected, adverse consequences upon the market for our product.
If we are unable to protect the confidentiality of our trade secrets or know-how, such proprietary information may be used by others to compete
against us.
Legal proceedings or third-party claims of intellectual property infringement and other challenges may require us to spend substantial time and
money and could prevent us from developing or commercializing Deep TMS.
The Israeli government grants that we have received require us to meet several conditions and may restrict our ability to manufacture our Deep
TMS systems and transfer relevant know-how outside of Israel and require us to pay royalties and satisfy specified conditions, including increased
royalties if we manufacture our Deep TMS systems outside of Israel or payment of a redemption fee if we transfer relevant know-how outside of
Israel.
International patent protection is particularly uncertain, and if we are involved in opposition proceedings in foreign countries, we may have to
expend substantial sums and management resources.
Our manufacturing, assembly and other significant functions are located in Israel and, therefore, our business and operations may be adversely
affected by political, economic and military conditions in Israel.
Exchange rate fluctuations between the U.S. dollar, the New Israeli Shekel and other foreign currencies may negatively affect our future revenues.
The price of the ADSs may be volatile and may fluctuate due to factors beyond our control.
The significant share ownership position of our officers, directors, and entities affiliated with certain of our directors may limit your ability to
influence corporate matters.
Risks Related to our Financial Condition and Capital Requirements
We have a history of operating losses. We expect to incur additional losses in the future and may never be profitable.
We have incurred net losses since our inception, largely reflecting research and development, general and administrative expenses, and sales and marketing
expenses. We have experienced net losses of $6.5 million and $5.4 million for the years ended December 31, 2021 and 2020, respectively. As a result of
ongoing losses, as of December 31, 2021, we had an accumulated deficit of $83.8 million. While we have sold and leased Deep TMS systems in various
markets over the last few years, primarily for Major Depressive Disorder (MDD) including anxious depression, and recently also for Obsessive-
Compulsive Disorder (OCD) and smoking addiction, we expect to continue to incur significant sales and marketing, product development, regulatory and
other expenses as we continue to expand our commercialization efforts to increase adoption of Deep TMS and expand existing relationships with our
customers, to obtain regulatory clearances or approvals for Deep TMS in additional countries and for additional indications, and to develop new
enhancements or features to our existing Deep TMS systems. The net losses we incur may fluctuate significantly from period to period. We will need to
generate additional revenues to achieve and sustain profitability, and even if we achieve profitability, we cannot be sure that we will remain profitable for
any substantial period of time. Our failure to achieve or maintain profitability could negatively impact the value of the ADSs.
3
We cannot ensure that our existing capital will be sufficient to meet our capital requirements.
We believe that our existing capital, other sources of liquidity will be sufficient to meet our capital requirements. To date we have funded our operations
primary through offerings of our securities, research and development grants from the Israel Innovation Authority and other sources, a loan under our credit
facility which has been repaid, and a Paycheck Protection Program loan through the Unites States Small Business Administration which has been forgiven.
We expect to generate revenues primarily through sales, lease and other potential income generated by the commercial distribution of Deep TMS systems
for approved indications.
The adequacy of our available funds to meet our operating and capital requirements will depend on many factors, including our ability to achieve revenue
growth and maintain favorable operating margins; our ability to increase the market share of Deep TMS and expand our operations and offerings, including
our sales and marketing efforts; the cost, progress and results of our future research, product development and clinical programs for additional
enhancements to Deep TMS and future indications for the system; the costs and timing of obtaining regulatory approvals for future indications of Deep
TMS; our ability to improve or maintain coverage and reimbursement arrangements with third-party and government payers; the terms and conditions of
commercial agreements for marketing and distribution of Deep TMS; the effect of competing technological and market developments; and costs incurred in
enforcing and defending certain of the patents and other intellectual property rights upon which our technologies are based, to the extent such rights are
challenged.
We cannot be certain that in the future alternative financing sources will be available to us at such times or in the amounts we need or whether we can
negotiate commercially reasonable terms or at all, or that our actual cash requirements will not be greater than anticipated. Any issuance of additional
equity or equity-linked securities could be dilutive to our existing shareholders, and any new equity securities could have rights, preferences, and privileges
superior to those of holders of the Ordinary Shares or ADSs. Additional debt financing, if available, may involve covenants restricting our operations or
our ability to incur additional debt, pay dividends, repurchase our shares, make investments and engage in merger, consolidation, or asset sale transactions.
If we are unable to obtain future financing through the methods we described above or through other means, our business may be materially impaired and
we may be unable to complete our business objectives and may be required to cease operations, curtail one or more product development or
commercialization programs, significantly reduce expenses, sell assets, seek a merger or joint venture partner, file for protection from creditors, or liquidate
all our assets.
Risks Related to our Business and Industry
Our success depends on Deep TMS as a safe treatment option for patients, as well as market perception and acceptance of TMS generally.
Our business currently depends entirely on the success of Deep TMS, our proprietary TMS solution. TMS is an emerging treatment option for patients. As
a result, physician and patient awareness of TMS therapy as a treatment option for applicable brain disorders, and experience with TMS therapies, is
limited. Because the market for TMS therapy is still developing and contains a limited number of market participants, sales of Deep TMS could be
negatively impacted by unfavorable market reactions to TMS generally, Deep TMS in particular, and/or negative developments in the industry. For
example, with respect to TMS generally, in June 2018 researchers in medical centers of the U.S. Veterans Affairs reported research findings that showed
that approximately 40% of the 81 patients with treatment-resistant major depression achieved remission in a randomized trial of a competitor’s TMS
device, but the rate was virtually the same with sham treatments versus active stimulation. As another example, with respect to Deep TMS in particular, in
February 2020, we announced that a multicenter study of our Deep TMS system for Post-Traumatic Stress Disorder (PTSD) was discontinued after interim
results showed subjects treated with the H-Coil that was involved in the study (i.e., the same as that used in our multicenter OCD study) did not
demonstrate sufficient efficacy relative to the sham group. If the use of our Deep TMS system or other TMS therapies results in serious adverse events
(e.g., seizures), or such products malfunction or are misused, patients and physicians may attribute such negative events to TMS and/or Deep TMS, which
may adversely affect market adoption of this form of therapy. For example, a paper entitled “Seizure risk with repetitive TMS: Survey results from over a
half-million treatment sessions” published in 2021 in Brain Stimulation claims that Deep TMS appears to be associated with a higher relative seizure risk
than with generic figure-8 coil TMS. While the authors of the paper themselves cite numerous reasons to view the results with caution (e.g., including but
not limited to sampling bias, inability to verify reported seizures, and the absence of information on patient-specific risk factors) and while the claims in the
paper were based on a small data set obtained from an informal survey which appear to be inconsistent with other more comprehensive studies, we may
nonetheless be unable to successfully educate the public about these often nuanced and technical deficiencies and thus the overall safety of our technology.
In addition, if patients undergoing treatment with any available TMS solutions perceive the benefits to be inadequate or the administration of TMS to be
too burdensome or inconvenient, and/or if adverse events and/or factors such as discomfort and noise with available TMS solutions are too numerous or
severe compared to the relevant rates of alternative therapies or pharmaceutical options, it will be difficult to demonstrate the value of Deep TMS to
patients and physicians. Additionally, psychiatrists may find it difficult to train existing employees and/or hire additional staff, allocate sufficient space or
operate our device given that psychiatry is a field not traditionally associated with medical equipment treatment options. As a result of any one or a
combination of these reasons, demand for and the use of Deep TMS may decline or may not increase at the pace or to the levels we expect. These reported
findings may have a negative effect on market perception of the effectiveness of the TMS therapy in general, and by extension Deep TMS.
4
Even if TMS therapy is widely accepted by physicians and patients, our success will depend in large part on our ability to educate and train physicians and
patients, and to successfully demonstrate the safety, tolerability, ease of use, efficacy, cost effectiveness and other advantages of Deep TMS. We have been
engaging in an active marketing campaign to raise awareness of Deep TMS and its benefits, but we cannot assure that these efforts will be successful or
that they will not prove to be too costly. Physicians may find patient set up and the subsequent procedures for future treatment sessions to be difficult or
complicated compared to competing treatment methods. Any of these factors could slow market adoption of Deep TMS.
Our long-term growth depends on our ability to increase market penetration and further commercialize Deep TMS, as well as develop enhancements
and features to the Deep TMS system through our research and development efforts. If we fail to do so, we may be unable to achieve future growth.
Our strategy depends on our ability to further commercialize and increase market penetration of Deep TMS for MDD (including reduction of comorbid
anxiety symptoms, commonly referred to as anxious depression), OCD, and smoking addiction, develop and seek regulatory approvals of Deep TMS for
new indications and add new enhancements or features for the Deep TMS system. These goals are also designed to respond to changing customer demands,
competitive pressures, and technologies. Our industry is characterized by intense competition, including from existing treatments (e.g., anti-depressant
medications), a growing number of Traditional TMS competitors, rapid technological changes, new product introductions and enhancements, price
competition, and evolving industry standards. It is important that we anticipate changes in technology and market demand, as well as physician practices to
successfully develop, obtain clearance or approval, if required, and successfully introduce new, enhanced, and competitive technologies to meet our
prospective customers’ needs on a timely and cost-effective basis.
We might be unable to further commercialize Deep TMS for approved indications or develop or obtain regulatory clearances or approvals to market Deep
TMS for new indications, or to develop and obtain regulatory approvals for enhancements or new features for the Deep TMS system. Additionally, Deep
TMS for MDD (including reduction of comorbid anxiety symptoms, commonly referred to as anxious depression), OCD, smoking addiction, and any
future indications, even if cleared, might not be sufficiently accepted by physicians or the third-party payers who reimburse for the procedures performed
with our products. We may be unable to devise pricing strategies that are attractive to customers. The success of any new indications, enhancements or
features for the Deep TMS system will depend on numerous additional factors, including our ability to:
● properly identify and anticipate clinician and patient needs;
5
● demonstrate the benefits associated with the use of Deep TMS when compared to the products and devices of our competitors;
● demonstrate the safety and efficacy of new indications, and obtain regulatory approvals of Deep TMS for such indications;
● adequately protect our intellectual property and avoid infringing upon the intellectual property rights of third parties; and
● develop and obtain the necessary regulatory clearances or approvals for enhancements or features for the Deep TMS system.
If we do not develop and obtain regulatory clearances or approvals for new indications, enhancements or features in time to meet market demand, or if
there is insufficient demand for these indications, enhancements or features, our results of operations will suffer. Our research and development efforts may
require a substantial investment of time and resources before we are adequately able to determine the commercial viability of a new indication for Deep
TMS, any enhancements to the Deep TMS system or any other innovation. In addition, even if we are able to develop enhancements or new features for
Deep TMS, these enhancements or features may not produce sales in excess of the costs of development and they may be quickly rendered obsolete by
changing customer preferences or the introduction by our competitors of products embodying new technologies or enhancements or features.
Furthermore, we must carefully manage our introduction of new indications. If potential customers believe such indications will be subject to additional
future enhancements or features or may become available at a more attractive price, they may delay purchases until such indications are available. We may
also have excess or obsolete inventory as we upgrade to newer models of our products and/or transition to new indications, and we have limited experience
in managing product transitions.
Our success also depends upon patient satisfaction with the effectiveness of Deep TMS.
In order to generate significant revenues from Deep TMS, patients must be satisfied with the effectiveness of Deep TMS. We train our physician customers
to properly diagnose patient candidates and select the appropriate patient candidates for treatment using the Deep TMS system, explain to their patients the
time-period over which the results from a treatment course can be expected to occur, and measure the success of treatments using medical guidelines.
However, our physician customers may not properly diagnose or select appropriate patient candidates for Deep TMS treatment and/or may utilize
unprescribed protocols, which may produce results that do not meet patients’ expectations. To the extent physicians do not make the proper measurements
for a specific patient, use the same procedures at each treatment session, and/or use proscribed protocols during treatment, it could result in variability of
the treatment efficacy and results for the patient. If patients are not satisfied with the results of Deep TMS, our reputation, and future results of operations
may be adversely affected.
We operate in a very competitive environment and if we are unable to compete successfully against our existing or potential competitors, our revenues
and operating results may be negatively affected.
Our Deep TMS systems for MDD (including reduction of comorbid anxiety symptoms, commonly referred to as anxious depression), OCD, smoking
addiction, and any future indications are or will be subject to intense competition. The industry in which we operate is subject to rapid change and is highly
sensitive to the introduction of new products or other market activities of current or new industry participants. Our ability to compete successfully will
depend on our ability to develop and obtain regulatory clearances of Deep TMS for indications that reach the market in a timely manner, to receive
adequate coverage and reimbursement from third-party payers, and to successfully demonstrate to physicians and patients the merits of Deep TMS
compared to the products of our competitors. If we are not successful in convincing others of the merits of Deep TMS or educating them on the use of the
Deep TMS system, they may not use our system or use them effectively and we may be unable to increase our revenues.
Deep TMS competes with several existing Traditional TMS competitors, including Neuronetics, Magventure, MAG & More, CloudTMS, Magstim, and
Nexstim. Competing TMS therapy companies have developed or may develop treatments that have improved efficacy when compared to our products or
that require a less significant investment of resources from physicians. Likewise, psychiatrists and other customers may not be able to easily compare Deep
TMS to our focal TMS competitors given limited data from head-to-head studies and marketing campaigns and tactics employed by competitors which
may have access to greater resources than we do.
6
We also face competition from pharmaceutical and other companies, many of which have greater resources than we do, that develop competitive products,
such as anti-depressant medications (including but not limited to a nasal spray utilizing the drug esketamine, which was recently approved by the FDA for
use in conjunction with an oral antidepressant) and to a lesser degree, ECT, home-use alternatives such as transcranial direct current stimulation (TDCS)
devices, prescription digital therapeutics (PDTs), and other neuromodulation treatment options. Our commercial opportunity could be reduced or eliminated
if these competitors develop and commercialize anti-depressant medications or other treatments that are safer or more effective than Deep TMS, or are
offered at more competitive prices, are more easily administered to patients or are otherwise more attractive to our customers and patients. At any time,
these and other potential market entrants may develop treatment alternatives that may make Deep TMS less competitive.
We also note that competition varies based on the indication, and some of the indications we are advancing may face marketability challenges based on
existing treatment options. For example, there are a variety of smoking cessation products currently available on the market, including nicotine patch
treatment. Electronic cigarettes, or e-cigarettes, are also widely available substitutes for tobacco smoking. Deep TMS for smoking cessation may not be a
marketable alternative to these existing options, particularly to the extent smokers need to pay out-of-pocket given the unavailability of reimbursement for
this indication.
In addition, our competitors may have more established distribution networks than we do (including but not limited to exclusivity or other arrangements
with large clinic networks), or may be acquired by enterprises that have more established distribution networks than we do. Our competitors may also
develop and patent processes or products earlier than we can or obtain domestic or international regulatory clearances or approvals for competing products
more rapidly than we can, which could impair our ability to develop and commercialize similar products. Furthermore, our educational efforts to
distinguish between Deep TMS and traditional TMS may be limited, and our competitors may thereby succeed in obtaining regulatory pathways for their
products based on our clinical data without having to invest in clinical trials themselves. In addition, we compete with our competitors to engage the
services of independent distributors outside the United States, both those presently working with us and those with whom we hope to work as we expand.
Furthermore, our competitors may be seeking predicate FDA approvals in other psychiatric and neurological indications, and TMS products of various
companies are frequently used off-label, and in certain circumstances, are marketed outside of the United States for other indications.
Moreover, the potential for both TMS competitors or other medical device or pharmaceutical companies to introduce new and disruptive products or forms
of therapy can significantly impact our financial performance and ability to compete.
If we are unable to adequately train physicians and other treatment providers and operators on the safe and appropriate use of our Deep TMS systems,
we may be unable to achieve our expected growth.
There is a learning process involved for treatment providers to become proficient in the use of our Deep TMS systems, which requires us to spend
considerable time and resources for training. It is critical to the success of our commercialization efforts to train a sufficient number of physicians and to
provide them with adequate, ongoing instruction and training in the use of our Deep TMS systems. This training process generally requires physicians to
review and study product materials and engage in hands-on training sessions. This training process may also take longer than expected or be more
complicated than the physicians or their personnel are comfortable with and may therefore affect our ability to increase sales. Convincing physicians to
dedicate the time and energy necessary for adequate training is challenging, and we may not be successful in these efforts.
The use of our Deep TMS system to treat OCD requires a special procedure to provoke the patient to exhibit symptoms of OCD while the patient is treated
with Deep TMS. This procedure requires special training and may make the treatment more difficult to apply than alternative treatments, as the treatment
must be tailored for the condition of each patient. As a result, this may lead to a variability of the overall results and between patients, which could
discourage use of Deep TMS for OCD. In addition, if the physicians and operators do not apply the treatment of OCD patients properly or experience
difficulties in the use of the system for OCD, this could reduce the level of satisfaction with this system for OCD, and adversely affect our revenues and our
operating results.
7
We may be unable to forecast our future growth accurately.
We may be unable to predict future growth related to Deep TMS for MDD (including reduction of comorbid anxiety symptoms, commonly referred to as
anxious depression), OCD, smoking addiction, and other psychiatric indications because some of these disorders are inherently difficult to diagnose and
there are frequent co-morbidities (overlap) in these disorders that complicate treatment methods. Diagnosis for psychiatric disorders, such as MDD and
OCD, is based on an individual’s reported experiences and mental status examination, and accordingly is subject to significant error. For example, it is
estimated that about half of the individuals in the United States who experience a major depressive episode annually are not diagnosed correctly. In
addition, there is a rising trend in which primary care providers, rather than mental health professionals, prescribe anti-depressant medications. Primary
care providers often prescribe anti-depressants without a psychiatric diagnosis of disease. In 73% of visits in which a primary care provider prescribed an
anti-depressant, patients did not have a psychiatric diagnosis. Without a psychiatric diagnosis, treatment cannot be tailored to the underlying condition.
Accordingly, a significant portion of MDD patients that are considered treatment-resistant may be unresponsive to first-line treatment as a result of
incorrect diagnosis, and any such patients may not respond to Deep TMS treatment. In addition, the H-Coils for our Deep TMS systems may prove to be
interchangeable and clinicians may be able to treat patients with multiple disorders in the same procedure. With respect to comorbidities, there is a high rate
of tobacco use amongst patients suffering from mental health conditions such as depression and anxiety. Approximately 3 of every 10 cigarettes smoked by
adults in the United States are smoked by persons with mental health conditions. As a result of the foregoing factors, the addressable market for Deep TMS
for MDD (including reduction of comorbid anxiety symptoms, commonly referred to as anxious depression), OCD, and smoking addiction, may be smaller
than we currently anticipate, and predictions for our future growth may prove to be inaccurate. This may have a materially adverse effect on our future
results of operations.
We may be unable to manage our anticipated growth effectively, which could make it difficult to execute our business strategy.
We have been growing rapidly and have a relatively short history of operating as a commercial-stage company. We intend to continue to grow our business
operations and may experience periods of rapid growth and expansion. This anticipated growth could create a strain on our organizational, administrative
and operational infrastructure, including our supply chain operations, quality control, technical support and customer service, sales force management and
general and financial administration. These risks increase as we expand into new countries, each requiring varied and often time-consuming regulatory
challenges. We may be unable to maintain the quality, regulatory infrastructure, or delivery timelines, of our products or customer service or satisfy
customer demand if our business grows too rapidly. Our ability to manage our growth properly will require us to continue to improve our operational,
financial and management controls, and our reporting systems and procedures. We may implement new enterprise software systems in a number of areas
affecting a broad range of business processes and functional areas. The time and resources required to implement these new systems is uncertain and failure
to complete this in a timely and efficient manner could harm our business.
As our commercial operations and sales volume grow, we will need to continue to increase our workflow capacity for our supply chain, regulatory
expansion, customer service, training and education personnel, billing, accounting reporting and general process improvements and expand our internal
quality assurance program, among other things. Our current work force may not be sufficient to handle our expanding growth and we will be required to
expand and train these personnel as we increase our sales efforts. We may not successfully implement these increases in scale or the expansion of our
personnel, which could harm our business.
If we are unable to successfully expand our sales and customer support team and adequately address our customers’ needs, it could negatively impact
revenues and market acceptance of Deep TMS and we may never generate sufficient revenues to achieve or sustain profitability.
8
As of December 31, 2021, we had 118 employees, including 49 employees in sales and marketing. Our operating results are directly dependent upon the
sales and marketing efforts of our sales and customer support team and, to a lesser extent, on our independent third party distributors outside of the United
States. If our employees or our independent distributors fail to adequately promote, market and sell or lease our Deep TMS systems, our revenues could
significantly decrease and/or fail to meet our targets.
In addition, our future revenues will largely depend on our ability to successfully execute our marketing efforts and adequately address our customers’
needs. We believe it is necessary to expand our sales force, including by hiring additional sales representatives or distributors with specific technical
backgrounds that can support our customers’ needs.
As we develop and seek regulatory clearances for new indications, enhancements and features and increase our marketing efforts, we will need to expand
the reach of our marketing and sales networks. Our future success will depend largely on our ability to continue to hire, train, retain and motivate skilled
employees, and distributors with significant technical knowledge in various areas. New hires require training and take time to achieve full productivity. If
we fail to train new hires adequately, or if we experience high turnover in our sales force in the future, new hires may not become as productive as may be
necessary to maintain or increase our sales. If we are unable to expand our sales and marketing capabilities domestically and internationally, we may be
unable to effectively commercialize our Deep TMS systems, which could harm our business.
Failure to secure or maintain adequate coverage and reimbursement of our Deep TMS system for the currently authorized indications and other
indications for which we obtain FDA authorization in the future, if any, may make physicians reluctant to use or recommend Deep TMS and have a
material adverse effect on our sales, results of operations, and financial condition.
Patients generally rely on third-party payers to reimburse all or part of the costs associated with outpatient treatment services. Patients may, thus, be
unwilling to undergo, and physicians may be unwilling to prescribe, a given course of treatment in the absence of adequate coverage and reimbursement.
Accordingly, our ability to successfully commercialize our Deep TMS system depends significantly on the extent to which treatment sessions using Deep
TMS are covered and reimbursed by government healthcare programs, such as Medicare and Medicaid (among others), commercial health insurers,
managed care organizations, and other third-party payers.
Third-party payers are increasingly examining the medical necessity and cost effectiveness of medical products and services, in addition to safety and
efficacy. Significant uncertainty exists as to the reimbursement status of any newly approved (or cleared) products or therapies, such as Deep TMS for
smoking addiction, which represent novel approaches to treatment of a disease, addiction, or condition. Even if a third-party payer covers a particular
treatment that uses Deep TMS, the resulting reimbursement rate may not be adequate to cover a provider’s cost to purchase or lease the Deep TMS system
or ensure such transaction is profitable for the provider. Reimbursement by a third-party payer may depend upon a number of factors, including the third-
party payer’s determination that a treatment is neither experimental nor investigational, safe, effective, and medically necessary, appropriate for the specific
patient, cost-effective, supported by peer-reviewed medical journals and included in clinical practice guidelines.
In the United States, there is no uniform policy of coverage and reimbursement among third-party payers, including private insurers. Therefore, coverage
and reimbursement for treatments can differ significantly from payer to payer. However, many third-party payers often rely upon Medicare coverage
policies and payment limitations in setting their own coverage and reimbursement policies and methodologies. Private insurance coverage for Deep TMS
as a treatment for MDD generally requires one to four failures of anti-depressant medications.
Medicare coverage for Deep TMS as a treatment for MDD generally requires that certain, specified clinical criteria relating to medical necessity are met
(and documented). In particular, subject to variations by payor and locale, under applicable payor policies, Deep TMS may be covered for MDD if: (i)
prescribed by a licensed physician, knowledgeable in the use of TMS (ii) as a treatment for an adult with a confirmed diagnosis of MDD and no
contraindications, (iii) where there is sufficient documentation of failure of between 1 and 4 previous medication trials (depending on the relevant Medicare
Administrative Contractor policy). Other relevant coverage factors considered under
treatment with
psychopharmacologic agents for depression, history of response to repetitive TMS, and whether the individual is a candidate for electroconvulsive therapy
(ECT) and TMS is less burdensome to the patient.
include resistance
these policies
to
9
Reimbursement for Deep TMS as an MDD treatment is also generally limited to 36 treatment sessions.
In 2021 there has been emerging reimbursement coverage for Deep TMS for the treatment of OCD. While the criteria for this emerging Deep TMS for
OCD coverage varies with each payer, generally, coverage requires the failure of a combination of between two and four medication trials of two different
classes, for specified periods, and may also require a trial of psychotherapy, before qualifying for reimbursement. Maintaining the reimbursement coverage
obtained during 2021 and obtaining coverage from additional payers may be difficult, and payers may condition coverage subject to satisfaction of varied
criteria.
Obtaining adequate reimbursement of Deep TMS for smoking addiction, or for any future indications, as applicable, may be difficult. Currently, there is no
third-party coverage of Deep TMS as a treatment for smoking addiction, as payors that have evaluated Deep TMS for smoking addiction coverage have not
yet concluded that it is a reasonable and necessary therapy for smoking addiction. We are working to gather and submit additional clinical data in order to
sufficiently demonstrate the efficacy of Deep TMS for the treatment of smoking addiction. These efforts may be expensive and time-consuming. Therefore,
it may take significant time to obtain sufficient reimbursement coverage of Deep TMS for smoking addiction. We may be required to conduct expensive
pharmacoeconomic studies to justify coverage and reimbursement or the level of reimbursement compared to existing approved biologics and other
therapies. There may be significant delays in obtaining coverage and reimbursement for newly approved therapies in the United States, and coverage may
be more limited than the indications for which the product is approved by the FDA or similar regulatory authorities outside the United States. Further, there
is no guarantee that Deep TMS will ever be adequately covered or reimbursed for smoking addiction, if at all, or any other future indication for which we
obtain authorization, if any. Nonetheless, the availability of reimbursement coverage in any given indication is not always the exclusive path to
commercialization, and we may pursue and/or develop cash-pay, corporate wellness programs, and/or other alternate models in order to monetize these
indications.
In addition, the U.S. federal government and state legislatures have continued to implement cost containment programs, including price controls and
restrictions on coverage and reimbursement. To contain costs, governmental healthcare programs and third-party payers are increasingly challenging the
price, scrutinizing the medical necessity, and reviewing the cost-effectiveness of medical treatments.
Outside of the United States, reimbursement systems vary significantly by country. Many foreign markets have government-managed healthcare systems
that govern reimbursement for psychiatric treatments and procedures and certain markets, including Japan, impose additional criteria that must be met
(such as the need for approval by sometimes insular medical societies) before coverage may be practically obtained even on approved procedures.
Additionally, some foreign reimbursement systems provide for limited payments in a given period and therefore result in extended payment periods. If
adequate levels of reimbursement from third-party payers outside of the United States, including Japan, are not obtained, international sales and lease
transactions for the Deep TMS system may not materialize or grow significantly.
The marketability of Deep TMS may suffer if the government and third-party payers fail to provide adequate coverage and reimbursement. Even if
favorable coverage and reimbursement status is attained, less favorable coverage policies and reimbursement rates may be implemented in the future.
We rely on third-party suppliers for some components used in manufacturing Deep TMS, and we may be unable to immediately transition to alternative
parties for these components.
We rely on suppliers for most of the components used in manufacturing Deep TMS, including the computer controlling the stimulator, the helmet, and the
arm of the helmet, and we may not have sufficient contractual assurances for the long-term supply of these components. We now assemble our proprietary
stimulator in our new-generation Deep TMS systems; however, we remain dependent on a single source third-party supplier for stimulators used in older
versions of our Deep TMS system, and accordingly we must still rely on third-party suppliers for those older versions. In addition, we rely on the
outsourcing company utilized for the manufacture of certain components in our newer systems, including our proprietary stimulator and various other
components. For us to be successful, our suppliers and contract manufacturer must be able to provide us with components in sufficient quantities, in
compliance with quality and regulatory requirements, in accordance with agreed upon specifications, at acceptable costs and on a timely basis. While these
suppliers have generally met our demand requirements on a timely basis in the past, their ability, and willingness to continue to do so going forward may be
limited for several reasons, including our lack of long-term agreements with those suppliers, our relative importance as a customer of those suppliers, or, as
applicable, their ability to produce the components for or provide assembly services to manufacture our Deep TMS systems. An interruption in our
commercial operations could occur if we encounter delays or difficulties in securing these components, if we cannot obtain an acceptable substitute. In
addition, we have experienced, and may continue to experience, more general supply chain issues, which are in part related to, or exacerbated by, the
COVID-19 pandemic. See “—Our operations could be adversely affected by the global supply chain disruptions.”
10
Any transition to a new supplier or contract manufacturer could be time-consuming and expensive, may result in interruptions in our operations and
product delivery, could affect the performance specifications of Deep TMS or could require that we modify its design. If we are required to change our
contract manufacturer, we will be required to verify that the new manufacturer maintains facilities, procedures, and operations that comply with our quality
and applicable regulatory requirements, which could further impede our ability to manufacture Deep TMS systems in a timely manner. If the change in
manufacturer results in a significant change to any product, a new 510(k) clearance from the FDA or similar non-U.S. regulatory authorization may be
necessary before we implement the change, which could cause a substantial delay. We cannot assure you that we will be able to identify and engage
alternative suppliers or contract manufacturers on similar terms or without delay. Furthermore, our contract manufacturer could require us to move to a
different production facility. The occurrence of any of these events could harm our ability to meet the demand for Deep TMS in a timely and cost-effective
manner.
We face risks associated with our international business.
We currently market and sell Deep TMS systems outside of the United States in various countries and/or intend to market and expand the
commercialization of Deep TMS in other markets, including Canada, Europe, Australia, and various Middle Eastern, Central/South American, and Asian
countries.
We are assessing the opportunity to expand into other international markets. However, our expansion plans may not be realized, or if realized, may not be
successful. We expect each market to have particular regulatory hurdles to overcome, and future developments in these markets, including the uncertainty
relating to governmental policies and regulations, could harm our business.
The sale, lease, and shipment of the Deep TMS system across international borders, as well as the purchase of components and products from international
sources, subjects us to extensive U.S. and other foreign governmental trade, import, export, regulatory, and customs regulations and laws. Compliance with
these regulations and laws is costly and exposes us to penalties for non-compliance. We expect our international activities will be dynamic over the
foreseeable future as we continue to pursue opportunities in international markets. Our international business operations are subject to a variety of risks,
including:
● difficulties in staffing and managing foreign and geographically dispersed operations, to the extent we establish non-U.S. operations;
● differing and multiple payer reimbursement regimes, government payers or patient self-pay systems;
● difficulties in determining and creating the proper sales pathway in new, international markets;
● compliance with various U.S. and international laws, including export control laws and the U.S. Foreign Corrupt Practices Act of 1977 (FCPA)
and similar international laws, and anti-money laundering laws;
● differing regulatory requirements for obtaining marketing authorizations for our products in non-U.S. jurisdictions;
● changes in, or uncertainties relating to, foreign rules and regulations that may impact our ability to sell our products, perform services or repatriate
profits to the United States;
11
● tariffs and trade barriers, export regulations, sanctions, and other regulatory and contractual limitations on our ability to sell our products in certain
foreign markets;
● potential adverse tax consequences, including imposition of limitations on or increase of withholding and other taxes on remittances and other
payments by foreign subsidiaries or joint ventures;
● imposition of differing labor laws and standards;
● armed conflicts or economic, political, and/or social instability in foreign countries and regions;
● fluctuations in foreign currency exchange rates;
● supply lags, inefficiencies, difficulty managing expenses in our local currency in the event that its value diverges from that of the currencies of the
jurisdictions where we earn income, and other risks created by any sourcing, manufacture, assembly and/or production of our
products/components outside of the U.S., while commercial activities are largely focused in the U.S.
● an inability, or reduced ability, to protect our intellectual property, including any effect of compulsory licensing imposed by government action;
and
● availability of government subsidies or other incentives that benefit competitors in their local markets that are not available to us.
We rely and in the future expect to rely on a network of third-party distributors to market and distribute our products internationally, and if we are
unable to maintain and expand this network, we may be unable to generate anticipated revenues.
We rely, and expect to rely in the future, on a network of third-party distributors to market and distribute our products in international markets. We are
assessing the opportunity to continue expanding into other international markets. We may face significant challenges and risks in managing a
geographically dispersed distribution network. We have limited ability to control any third-party distributors and agents. Our distributors and agents may be
unable to successfully market, lease, and sell our products and may not devote sufficient time and resources to support the marketing, sales, education, and
training efforts that we believe enable the products to develop, achieve or sustain market acceptance. Additionally, in some international jurisdictions, we
rely on our distributors to manage the regulatory process, while complying with all applicable rules and regulations, and we are dependent on their ability
to do so effectively. In addition, if a dispute arises with a distributor or if a distributor is terminated by us or goes out of business, it may take time to locate
an alternative distributor, to seek appropriate regulatory approvals with the new distributor and to train new personnel to market our products, and our
ability to sell those systems in the region formerly serviced by such terminated distributor could be harmed. Any of these factors could reduce our revenues
from affected markets, increase our costs in those markets or damage our reputation. In addition, if an independent distributor or agent were to depart and
be retained by one of our competitors, we may be unable to prevent that distributor or agent from helping competitors solicit business from our existing
customers, which could further adversely affect our sales. As a result of our reliance on third-party distributors and agents, we may be subject to disruptions
and increased costs due to factors beyond our control, including labor strikes, third-party error, and other issues. During the COVID-19 global pandemic,
our distributors have faced operational challenges, clinic closures due to governmental quarantine mandates and various other financial and operational
difficulties. We believe that these difficulties have limited our ability to penetrate these markets. If the services of any of these third-party distributors and
agents become unsatisfactory, we may experience delays in meeting our customers’ demands, and we may be unable to find a suitable replacement on a
timely basis or on commercially reasonable terms. Any failure to deliver products in a timely manner may damage our reputation and could cause us to lose
potential customers.
Clinical trials involve a lengthy and expensive process with an uncertain outcome, which may delay or cause us to abandon the development of Deep
TMS for additional indications.
12
We are currently at various stages of completed, ongoing or planned clinical trials of Deep TMS for new indications. Development of medical devices
includes pre-clinical studies and sometimes clinical trials, and is a long, expensive, and uncertain process, subject to delays and failure at any stage. Clinical
trials for Deep TMS involve certain specific risks, including factors related to trial design and patient enrollment. Additionally, if we are unable to recruit a
sufficient number of patients for our clinical trials, we may be unable to generate sufficient data to support marketing authorization. Moreover, our research
and development, pre-clinical and clinical trial activities are subject to extensive regulation and review by numerous governmental authorities. We cannot
predict whether we will encounter problems with any of our completed, ongoing or planned clinical trials, which would cause us or regulatory authorities to
delay or suspend clinical trials, or delay the analysis of data from completed or ongoing clinical trials. We estimate that clinical trials involving various
indications of Deep TMS will continue for several years; however, such trials may also take significantly longer to complete and may cost more money
than we have expected. Furthermore, the data obtained from the studies and trials may be inadequate to support regulatory authorizations or to enable
market acceptance of certain indications of Deep TMS. Failure can occur at any stage of testing, and we may experience numerous unforeseen events
during, or as a result of, the clinical trial process that could delay or prevent commercialization of the current, or a future, version of, Deep TMS, for any
particular indication, including but not limited to:
● delays in securing clinical investigators or trial sites for the clinical trials;
● delays in obtaining institutional review board and other regulatory approvals to commence a clinical trial;
● slower than anticipated patient recruitment and enrollment;
● negative or inconclusive results from clinical trials;
● unforeseen safety issues;
● an inability to monitor patients adequately during or after treatment;
● placement of a clinical trial on hold by the FDA, institutional review boards/ethics committees or other regulatory authorities;
● changes in governmental regulations or administrative actions, including governmental changes in permissible endpoints or other measures
utilized in clinical trials;
● problems with investigator or patient compliance with the trial protocols;
● the FDA or other regulators disagreeing as to the design, protocol or implementation of our clinical trials;
● exceeding budgeted costs due to difficulty in accurately predicting costs associated with clinical trials;
● the quality of the products falling below acceptable standards; and
● the inability to manufacture sufficient quantities of our products to commence or complete clinical trials.
Additionally, the FDA or other regulatory entities may disagree with our interpretation of the data from our pre-clinical studies and clinical trials, or may
find the clinical trial design, conduct or results inadequate to demonstrate safety or efficacy, and may require us to pursue additional pre-clinical studies or
clinical trials, which could further delay authorization of additional indications for Deep TMS. A number of companies in the medical device and
biotechnology industries, including those with greater resources and experience than us, have suffered significant setbacks in advanced clinical trials, even
after seeing promising results in earlier clinical trials. We do not know whether any clinical trials we or our clinical partners may conduct will demonstrate
adequate efficacy and safety to result in regulatory authorization to market new indications for Deep TMS. In addition, the results of our past clinical trials
of Deep TMS may not be predictive of future trial results. If later-stage clinical trials involving Deep TMS for new indications do not produce favorable
results, our ability to obtain regulatory authorization for such indications may be adversely impacted, which will have a material adverse effect on our
business, financial condition, and results of operations.
13
We rely in part on third parties to conduct our clinical trials. If these third parties fail to perform their duties on time or as expected, we may not be able
to obtain regulatory authorization for additional indications that we may seek for Deep TMS.
Our clinical trials are managed by our both own staff and personnel as well as certain third-parties, including clinical trial sites, medical institutions, clinical
research organizations, or CROs, and private practices, for, among other things, site monitoring, statistical work, and electronic data capture in our clinical
trials. Nevertheless, we are responsible for ensuring that each of our clinical trials is conducted in accordance with applicable protocols, and legal,
regulatory, and scientific standards, including current good clinical practices, or cGCPs, which are set forth in regulations and guidelines enforced by the
FDA and comparable foreign regulatory authorities for clinical trials. If we or any such third parties fail to comply with applicable cGCPs, the clinical data
generated in such trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require us to perform additional clinical
trials before granting a marketing authorization for any particular indication. In addition, if such third parties do not devote sufficient time and resources to
our clinical trials or otherwise carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or
accuracy of the clinical data they assist in obtaining is compromised due to the failure to adhere to our clinical protocols, regulatory requirements or for
other reasons, our clinical trials may be extended, delayed or terminated, and we may not be able to obtain regulatory authorization for or successfully
commercialize Deep TMS for a specified indication.
Our collaboration arrangements may not be successful, which could adversely affect our ability to develop and commercialize our products.
We are currently involved in a number of research and development collaborations with third parties relating to the development of new technology and
additional uses of Deep TMS. These and any future collaborations that we enter into may not be successful. The success of our collaboration arrangements
will depend heavily on the efforts and activities of our collaborators. Collaborations are subject to numerous risks, which may include that:
● collaborators have significant discretion in determining the efforts and resources that they will apply to collaborations;
● collaborators may not pursue development and commercialization of our products or may elect not to continue or renew development or
commercialization programs based on trial or test results or may change their strategic focus due to the acquisition of competitive products,
● availability of funding or other external factors, such as a business combination that diverts resources or creates competing priorities;
● collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our products or product
candidates;
● a collaborator with marketing, manufacturing, and distribution rights to one or more products may not commit sufficient resources to or otherwise
not perform satisfactorily in carrying out these activities;
● we could grant exclusive rights to our collaborators that would prevent us from collaborating with others;
● collaborators may not properly maintain or defend our intellectual property rights or may use our intellectual property or proprietary information
in a way that gives rise to actual or threatened litigation that could jeopardize or invalidate our intellectual property or proprietary information or
expose us to potential liability;
● disputes may arise between us and a collaborator that causes the delay or termination of the research, development, and/or commercialization of
our current or future products or that results in costly litigation or arbitration that diverts management attention and resources;
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● our collaborators may default on their obligations to us and we may be forced to terminate, litigate, and/or renegotiate such arrangements;
● our collaborators may have claims that we breached our obligations to them which may result in termination, renegotiation, litigation or delays in
performance of such arrangements;
● collaborations may be terminated, and, if terminated, may result in a need for additional capital to pursue further development or
commercialization of the applicable current or future products;
● collaborators may own or co-own intellectual property covering our products that results from our collaborating with them, and in such cases, we
would not have the exclusive right to develop or commercialize such intellectual property; and
● a collaborator’s sales and marketing activities or other operations may not be in compliance with applicable laws resulting in civil or criminal
proceedings.
If any of our collaboration arrangements are not successful, it could have a material adverse effect on our business, financial condition, and results of
operations.
If product liability lawsuits are brought against us, our business may be harmed, and we may be required to pay damages that exceed our insurance
coverage.
Our business exposes us to potential product liability claims that are inherent in the testing, manufacture, and sale of medical devices for the treatment of
MDD (including reduction of comorbid anxiety symptoms, commonly referred to as anxious depression), OCD, smoking addiction, and other potential
indications. Our treatments are designed for patients who suffer from significant psychiatric, neurological disorders, and addictions, and these patients are
more likely to experience significant adverse health outcomes, which could increase the risk of product liability lawsuits. Furthermore, if physicians and
other operators are not sufficiently trained in the use of our Deep TMS systems, they may misuse or ineffectively use our system, which may result in
unsatisfactory patient outcomes. We could become the subject of product liability lawsuits alleging that component failures, malfunctions, manufacturing
flaws, design defects or inadequate disclosure of product-related risks or product-related information resulted in an unsafe condition or injury to
Regardless of the merit or eventual outcome, product liability claims may result in:
● decreased demand for Deep TMS;
● injury to our reputation and brand;
● significant litigation costs;
● substantial monetary awards to or costly settlements with patients;
● product recalls;
● material defense costs;
● loss of revenues;
● the inability to commercialize new indications, enhancements, or features; and
● diversion of management attention from pursuing our business strategy.
Our existing product liability insurance coverage may be inadequate to protect us from any liabilities we might incur. If a product liability claim or series of
claims is brought against us for uninsured liabilities or in excess of our insurance coverage, our business could suffer. Any product liability claim brought
against us, with or without merit, could result in the increase of our product liability insurance rates or the inability to secure coverage in the future. In
addition, a recall of some of our products, whether or not related to a product liability claim, could result in significant costs and loss of customers.
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Our insurance policies protect us only from some business risks, which will leave us exposed to significant uninsured liabilities.
We do not carry insurance for all categories of risk that our business may encounter. Some of the policies we currently maintain include public liability,
employer's liability, property, third party liability, umbrella, workers’ compensation, products and clinical trial liability, and directors’ and officers’
insurance. We do not know, however, if these policies will provide us with adequate levels of coverage. Any significant uninsured liability may require us
to pay substantial amounts, which would adversely affect our cash position and results of operations.
We bear the risk of warranty claims on our products.
We bear the risk of warranty claims on the products we supply, often for the entire contract term for systems which are leased, and generally for one year
for Deep TMS systems we sell to customers. There can be no assurance that we will have sufficient funds, devices, components and/or personnel to cover
future warranty claims. We may not be successful in claiming recovery of relevant components from our suppliers or vendors in the event of a successful
warranty claim against us by a customer or that any recovery from such vendor or supplier would be adequate. In addition, warranty claims brought by our
customers related to third-party components may arise after our ability to bring corresponding warranty claims against such suppliers expires, which could
result in costs to us.
We could be negatively impacted by violations of applicable anti-corruption laws or violations of our internal policies designed to ensure ethical
business practices.
We operate in a number of countries throughout the world, and we may operate in countries that may not have as strong a commitment to anti-corruption
and ethical behavior that is required by U.S. laws or by our corporate policies. We are subject to the risk that we, our U.S. employees or any future
employees or consultants located in other jurisdictions or any third parties such as our distributors that we engage to do work on our behalf in foreign
countries may take action determined to be in violation of anti-corruption laws in any jurisdiction in which we conduct business, including the FCPA. The
FCPA generally prohibits covered entities and their intermediaries from engaging in bribery or making other prohibited payments, offers or promises to
foreign officials for the purpose of obtaining or retaining business or other advantages. In addition, the FCPA imposes recordkeeping and internal controls
requirements on publicly traded corporations and their foreign affiliates, which are intended to, among other things, prevent the diversion of corporate
funds to the payment of bribes and other improper payments, and to prevent the establishment of “off books” slush funds from which such improper
payments can be made.
We will face significant risks if we fail to comply with the FCPA and other laws that prohibit improper payments, offers or promises of payment to foreign
governments and their officials and political parties by us and other business entities for the purpose of obtaining or retaining business or other advantages.
In many foreign countries, particularly in countries with developing economies, it may be a local custom that businesses operating in such countries engage
in business practices that are prohibited by the FCPA or other laws and regulations. We have implemented or are in the process of implementing company
policies relating to compliance with the FCPA and similar laws. However, such policies may not be effective at preventing all potential FCPA or other
violations. Although our agreements with our international distributors state our expectations for our distributors’ compliance with U.S. laws, including the
FCPA, and provide us with various remedies upon any non-compliance, including the ability to terminate the agreement, our distributors may not comply
with U.S. laws, including the FCPA.
Any violation of the FCPA or any similar anti-corruption law or regulation could result in substantial fines, sanctions, civil and/or criminal penalties and
curtailment of operations in certain jurisdictions, and might harm our business, financial condition, or results of operations.
Our operations could be affected in the event of further COVID-19 global pandemic outbreaks.
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The COVID-19 global pandemic outbreaks have led governments and authorities around the globe to take various precautionary measures in order to limit
the spread of the virus, including government-imposed quarantines, lockdowns, and other public health safety measures, which have had major effects on
the global markets and its economy, including on the availability and pricing of materials, manufacturing and delivery efforts, sales to existing and potential
customers and leads, collections from accounts, and other aspects of the global economy. In 2021 these effects continued, albeit to a lesser extent than seen
during the initial onset of the pandemic in 2020, in areas impacted by outbreaks of the Delta and Omicron variants of the virus which resulted in less
commercial activity than could have otherwise been achieved. Additionally we continue to experience supply chain and shipping delays, shortages and
challenges forcing us to adapt our production line, forecasting and other logistical processes to address these challenges. Further outbreaks of the COVID-
19 global pandemic could exacerbate disruptions to production, cause additional delays in the supply and delivery of products used in our operations,
further divert the attention and efforts of the medical community to coping with the pandemic, impact our ability to recruit subjects for ongoing and
planned clinical trials, disrupt the marketplace in which we operate, and may have a material adverse effects on our operations, sales, revenues, collection
from accounts and ability to raise funds. Our third-party suppliers source certain components and materials of our Deep TMS systems from Asia and other
countries, and any continued spreading of the pandemic may adversely impact their development, manufacture, and supply processes. In addition, treatment
sessions conducted with our Deep TMS system, which are generally scheduled or non-emergency procedures, may be postponed to the extent hospitals and
healthcare centers shift resources to patients affected by any further outbreaks of the pandemic. The extent to which the COVID-19 global pandemic
impacts our results will depend on future developments, which are highly uncertain and cannot be predicted, including further outbreaks of existing or new
variant strains, new information which may emerge concerning the nature and effects of the pandemic, and/or any governmental mandates or other similar
actions instituted to contain the virus or treat its impact, among others. Moreover, the COVID-19 global pandemic has caused substantial adverse effects on
general commercial activity and the world economy, and our business and results of operations could be adversely affected to the extent that this or any
other epidemic causes further harms to the global economy.
Our operations could be adversely affected by the global supply chain disruptions
We have experienced, and may continue to experience, disruptions to the transportation channels used in our supply chain and distribution operations,
including increased airport and shipping port congestion, a lack of transportation capacity, increased fuel expenses, import or export controls or delays, and
labor disputes or shortages. Transport operators are exposed to various risks, such as extreme weather conditions, natural disasters, work stoppages,
personnel shortages, and operating hazards, as well as interstate and international transportation requirements. If we experience transportation problems, or
if there are other significant changes in the cost of these services, we may not be able to arrange efficient alternatives and timely means to obtain raw
materials or ship products to our customers. Disruptions in our container shipments may result in increased costs, including the additional use of air freight
to meet demand. Congestion to ports can affect previously negotiated contracts with shipping companies, resulting in unexpected increases in shipping
costs and reduction in our profitability. In particular, the COVID-19 global pandemic has resulted in several disruptions and delays, as well as quantity
limits and price increases, in our global transportation channels.
In the period following the onset of the pandemic, as part of the global supply chain crisis, we have seen a significant rise in the price of many of the
electronic components needed for our systems. These price increases are largely attributable to supply and demand factors, and, in some cases, shortages
relating to these parts across the globe. On a related point, the lead time for receiving electronic components shipped by suppliers has increased
significantly amid the worldwide supply chain crisis. This has compelled us to significantly increase buffer inventory levels to ensure that future demand
for our systems can be timely met. Within the broader context of electronic component supply issues, the third party we rely on for the outsourced
manufacture of our newer generation systems halted production in 2021 for a period due to the shortage in PC computers which are needed for these
systems. While we were able to adapt our standard manufacturing process to allow for the integration of these PC components at a later stage of the
production line once inventory levels were restocked, this is illustrative of the continuing risks and challenges posed by the worldwide supply chain crisis.
These risks may be further exacerbated in light of geopolitical events, including the recent outbreak of war in Ukraine in February 2022.
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Performance issues, service interruptions or price increases by our shipping carriers could adversely affect our business and harm our reputation and
ability to provide our services on a timely basis.
Expedited, reliable shipping is essential to our operations. We rely heavily on providers of transport services for reliable and secure point-to-point transport
of our products to our customers and for tracking of these shipments. Should a carrier encounter delivery performance issues such as loss, damage or
destruction of any systems, it would be costly to replace such systems in a timely manner, and such occurrences may damage our reputation and lead to
decreased demand for our products and increased cost and expense to our business. In addition, any significant increase in shipping rates could adversely
affect our operating margins and results of operations. Similarly, strikes, severe weather, natural disasters or other service interruptions affecting delivery
services we use would adversely affect our ability to process orders for our products on a timely basis.
The recent supply chain backlog has caused a dramatic rise in the cost of delivery of our systems, including sharp increases in air freight cost. The heavy
weight of our systems translates into a significant increase in the amount we spend on shipping our systems to customers, which also requires additional
labor on the part of our logistical staff to obtain multiple competitive shipping quotes from a variety of carriers in the industry. Any exacerbation or
continuation of these shipping cost pressures may cause corresponding pressures on the pricing of our products which can have an adverse impact on our
customers and their ability to purchase our systems.
Our operations are vulnerable to interruption or loss due to natural or other disasters, power loss, strikes and other events beyond our control.
A major earthquake, fire, or other disaster, such as a major flood, seasonal storms, military action or terrorist attack affecting our facilities, or those of our
third-party manufacturers or suppliers, could significantly disrupt our or their operations, and delay or prevent product shipment or installation during the
time required to repair, rebuild or replace our third-party manufacturers or suppliers’ damaged manufacturing facilities. These delays could be lengthy and
costly. If any of our manufacturers’, suppliers’ or customers’ facilities are negatively impacted by a disaster, shipments of our products could be delayed.
Additionally, customers may delay purchases of our products until operations return to normal. Even if we are able to quickly respond to a disaster, the
ongoing effects of the disaster could create some uncertainty in the operations of our business. Any shortages may increase our costs for power and energy
supplies or could result in blackouts, which could disrupt the operations of our affected facilities and harm our business. In addition, concerns about
terrorism, the effects of a terrorist attack, political turmoil or an outbreak of epidemic diseases could have a negative effect on our operations.
If we experience significant disruptions in our information technology systems, our business may be adversely affected.
We depend on our information technology systems for the efficient functioning of our business accounting, data storage, compliance, purchasing, and
inventory management. While we will attempt to mitigate interruptions, we may experience difficulties in implementing upgrades to our information
technology systems, which would impact our business operations, or experience difficulties in operating our business during the upgrade, either of which
could disrupt our operations, including our ability to timely ship and track product orders, project inventory requirements, manage our supply chain, and
otherwise adequately service our customers. In the event we experience significant disruptions as a result of the current implementation of our information
technology systems, we may be unable to repair our systems in an efficient and timely manner. Accordingly, such events may disrupt or reduce the
efficiency of our entire operation and have a material adverse effect on our results of operations and cash flows.
We are increasingly dependent on sophisticated information technology for our infrastructure. Our information systems require an ongoing commitment of
significant resources to maintain, protect, and enhance existing systems. Failure to maintain or protect our information systems and data integrity
effectively could have a materially adverse effect on our business.
We rely on the use of technology and may become subject to cyber-terrorism or other compromises and shut-downs.
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We rely heavily on our internal computer and information technology systems. Our information technology systems may be subject to cyber-terrorism or
other compromises and shut-downs, which may result in unauthorized access to our proprietary information, destruction of our data or disability,
degradation or sabotage of our systems, often through the introduction of computer viruses, cyber-attacks, and other means, and could originate from a
variety of sources, including internal or unknown third parties. We cannot predict what effects such cyber-attacks or compromises or shut-downs may have
on our business, and the consequences could be material. Cyber incidents may remain undetected for an extended period, which could exacerbate these
consequences. If our information systems or other technology are compromised, it could have a material adverse effect on our business.
Security and privacy breaches may expose us to liability and harm our reputation and business.
As part of our business we may receive and process information about our customers, partners and, potentially, their patients, including protected health
information (PHI), and we may configure our devices to collect, transmit or store or contract with third parties to collect, transmit or store our customers’
data, including PHI. PHI, a subset of “individually identifiable information,” is defined under the federal level by the Health Insurance Portability and
Accountability Act of 1996 (HIPAA), as amended by the Health Information and Technology for Economic and Clinical Health Act of 2009 (HITECH),
including applicable implementing regulations. HIPAA, along with various analogous laws at the state level, governs the protection and confidentiality of
PHI, and other sensitive information, as applicable (as more fully described below). To the extent we, or third parties we contract with, collect, store or
transfer PHI, we may be required to safeguard PHI in accordance with HIPAA. Furthermore, to the extent we qualify as a business associate under HIPAA,
we may be directly subject to HIPAA’s Privacy Rule.
While we implemented security measures relating to our operations, generally, those measures may not prevent security breaches that could harm our
business or expose us to liability under HIPAA and/or applicable state privacy laws. Advances in computer capabilities, inadequate technology or facility
security measures or other factors may result in a compromise or breach of our systems and any data we store and process. Our security measures may be
breached as a result of actions by third parties or employee error or malfeasance, among many other possibilities. A party who is able to circumvent our
security measures or exploit inadequacies in our security measures, could, among other things, misappropriate proprietary information, including
information about our customers and their patients, cause the loss or disclosure of some or all of this information, cause interruptions in our or our
customers’ operations or expose our customers to computer viruses or other disruptions or vulnerabilities. Any compromise of our systems or the data we
store or process could implicate reporting requirements, civil penalties, and other enforcement actions under applicable laws, result in a loss of confidence
in the security of our software, damage our reputation, disrupt our business, lead to legal liability, and adversely affect our results of operations. Moreover,
a compromise of our systems could remain undetected for an extended period of time, exacerbating the impact of that compromise. Actual or perceived
vulnerabilities may lead to claims against us by our customers, their patients or other third parties, including the federal and state governments. While our
customer agreements typically contain provisions that seek to limit our liability, there is no assurance these provisions will be enforceable and effective
under applicable law. In addition, the cost and operational consequences of implementing further data protection measures could be significant.
We may seek to grow our business through acquisitions or investments in new or complementary businesses, products or technologies, through the
licensing of products or technologies from third parties. The failure to manage acquisitions, investments, licenses or other strategic alliances, or the
failure to integrate them with our existing business, could harm our business.
Our success depends in part on our ability to continually enhance and broaden our product offerings in response to changing customer demands,
competitive pressures, technologies, and market pressures. Accordingly, from time to time, we may consider opportunities to acquire, make investments in
or license other technologies, products, and businesses that may enhance our capabilities, complement our current products, or expand the breadth of our
markets or customer base. Potential and completed acquisitions, strategic investments, licenses, and other alliances involve numerous risks, including:
● difficulty assimilating or integrating acquired or licensed technologies, products or business operations;
● issues maintaining uniform standards, procedures, controls, and policies;
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● unanticipated costs associated with acquisitions or strategic alliances, including the assumption of unknown or contingent liabilities and the
incurrence of debt or future write-offs of intangible assets or goodwill;
● diversion of management’s attention from our core business and disruption of ongoing operations;
● adverse effects on existing business relationships with suppliers, distributors, and customers;
● risks associated with entering new markets in which we have limited or no experience;
● potential losses related to investments in other companies;
● potential loss of key employees of the acquired businesses; and
● increased legal and accounting compliance costs.
We do not know if we will be able to identify acquisitions or strategic relationships we deem suitable, whether we will be able to successfully complete any
such transactions on favorable terms or at all or whether we will be able to successfully integrate any acquired business, product or technology into our
business or retain any key personnel, suppliers or distributors.
Foreign acquisitions involve unique risks in addition to those mentioned above, including those related to integration of operations across different cultures,
languages, legal, and regulatory environments, currency risks and the particular economic, political and regulatory risks associated with specific countries.
To finance any acquisitions, investments or strategic alliances, we may choose to issue Ordinary Shares, ADSs or other equity-linked securities as
consideration, which could dilute the ownership of our shareholders. Additional funds may not be available on terms that are favorable to us, or at all. If the
price of the Ordinary Shares or ADSs is low or volatile, we may be unable to consummate any acquisitions, investments or strategic alliances using our
shares as consideration.
Risks Related to Employee Matters
If we are not able to retain our key management, or attract and retain qualified scientific, technical, and business personnel, our ability to implement
our business plan may be adversely affected.
Our success largely depends on the skill, experience, and effort of our senior management. The loss of the service of any of these persons, including
Dr. David Zacut, the chairman of our board of directors, Christopher R. von Jako, our President and Chief Executive Officer, R. Scott Areglado, our Senior
Vice President and Chief Financial Officer, Hadar Levy, our Senior Vice President and General Manager of North America, and Dr. Yiftach Roth, our Chief
Scientist, would likely result in a significant loss in the knowledge and experience that we possess and could significantly delay or prevent successful
product development and other business objectives. Our ability to achieve our strategic growth plans depends in part on our ability to recruit and maintain a
talented sales and operations team members. New hires are often subject to a time intensive educational onboarding period before they can successfully
identify potential customer leads and close sales. This can lead to delays before we can ramp up our commercial initiatives and achieve sales targets. It can
also divert attention from our existing sales leadership and personnel who are needed to train these new hires. Additionally, we have experienced certain
challenges in hiring and/or maintaining employees that we believe are related to the "Great Resignation," also known colloquially as the "Big Quit," which
describes an economic trend characterized by employees voluntarily resigning from their jobs en masse, beginning in early 2021, primarily in the United
States. An article published in the Harvard Business Review on September 15, 2021 cited U.S. Bureau of Labor Statistics finding that 4 million
Americans quit their jobs in July 2021. It found differences in turnover rates between companies in different industries, with 3.6% more health care
employees quitting their jobs than in the previous year and, in technology, resignations increased by 4.5%. As we operate in both the health care and
technology fields, we have not been immune to this larger trend, and while our overall workforce increased over the past year, we also experienced
employee turnover, including in our salesforce, thus impacting our ability to ramp up our sales and marketing force as quickly as would have otherwise
been possible. There is intense competition between numerous medical device, pharmaceutical, and biotechnology companies, universities, governmental
entities, and other research institutions, all of whom are seeking to employ qualified individuals in the technical fields in which we operate, and we may not
be able to attract and retain the qualified personnel necessary for the successful development and commercialization of Deep TMS.
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Employment litigation and unfavorable publicity could negatively affect our future business.
Employees may, from time to time, bring lawsuits against us regarding injury, creating a hostile work place, discrimination, wage and hour, sexual
harassment, and other employment issues. In recent years there has been an increase in the number of discrimination and harassment claims generally.
Coupled with the expansion of social media platforms and similar devices that allow individuals access to a broad audience, these claims have had a
significant negative impact on some businesses. Companies that have faced employment or harassment related lawsuits have had to terminate management
or other key personnel, and have suffered reputational harm that has negatively impacted their sales. If we were to face any employment related claims, our
business could be negatively affected.
Under applicable employment laws, we may not be able to enforce covenants not to compete.
Our employment agreements generally include covenants not to compete. These agreements prohibit our employees, if they cease working for us, from
competing directly with us or working for our competitors for a limited period. We may be unable to enforce these agreements under the laws of the
jurisdictions in which our employees work. For example, Israeli courts have required employers seeking to enforce covenants not to compete to
demonstrate that the competitive activities of a former employee will harm one of a limited number of material interests of the employer, such as the
secrecy of a company’s confidential commercial information or the protection of its intellectual property. If we cannot demonstrate that such an interest will
be harmed, we may be unable to prevent our competitors from benefiting from the expertise of our former employees and our competitiveness may be
diminished.
Risks Related to Government Regulation
Our products and operations are subject to extensive government regulation and oversight both in the United States and abroad, and our failure to
comply with applicable requirements could harm our business.
We are subject to extensive regulation in the United States and elsewhere, including by the FDA, FTC, and their foreign counterparts. The FDA and foreign
regulatory agencies regulate, among other things, with respect to medical devices: design, development, and manufacturing; testing, labeling, content and
language of instructions for use and storage; clinical trials; product safety; marketing, sales and distribution; premarket clearance and approval; record
keeping procedures; advertising and promotion; recalls and field safety corrective actions; post-market surveillance, including reporting of deaths or serious
injuries and malfunctions that, if they were to recur, could lead to death or serious injury; post-market approval studies; and product import and export.
The regulations to which we are subject are complex and stringently enforced. Regulatory changes could result in restrictions on our ability to carry on or
expand our operations, higher than anticipated costs or lower than anticipated sales. The FDA enforces these regulatory requirements through, among other
means, periodic unannounced inspections. We do not know whether we will pass any future FDA inspections. Failure to comply with applicable regulations
could jeopardize our ability to sell our products and result in enforcement actions such as: warning letters; fines; injunctions; civil penalties; termination of
distribution; recalls or seizures of products; delays in the introduction of products into the market; total or partial suspension of production; refusal to grant
future clearances or approvals; withdrawals or suspensions of current clearances or approvals, resulting in prohibitions on sales of our products; and in the
most serious cases, criminal penalties.
We may not receive the necessary regulatory clearances or approvals to market our product for other proposed indications in the future, and failure to
timely obtain necessary clearances or approvals for such future indications would adversely affect our ability to grow our business.
An element of our strategy is to continue to upgrade our Deep TMS systems, add new enhancements and features, and expand clearance or approval of the
Deep TMS System to include new indications. In the United States, before we can market a new medical device, or claim new or expanded indications for
use or introduce a significant modification to an existing product, we must first receive either clearance under Section 510(k) of the Federal Food, Drug,
and Cosmetic Act, or the FDCA, de novo classification, or premarket approval application (PMA), from the FDA, unless an exemption applies. In the
510(k) clearance process, before a device may be marketed, the FDA must determine that a proposed device is “substantially equivalent” to a legally-
marketed “predicate” device, which includes a device that has been previously cleared through the 510(k) process, a device that was legally marketed prior
to May 28, 1976 (pre-amendments device), a device that was originally on the U.S. market pursuant to a PMA and later down-classified, or a 510(k)-
exempt device. To be “substantially equivalent,” the proposed device must have the same intended use as the predicate device, and either have the same
technological characteristics as the predicate device or have different technological characteristics and not raise different questions of safety or
effectiveness than the predicate device. Clinical data are sometimes required to support substantial equivalence. In the PMA process, the FDA must
determine that a proposed device is safe and effective for its intended use based, in part, on extensive data, including, but not limited to, technical, pre-
clinical, clinical trial, manufacturing, and labeling data. The PMA process is typically required for devices that are deemed to pose the greatest risk, such as
life-sustaining, life-supporting or implantable devices. However, some devices are automatically subject to the PMA pathway regardless of the level of risk
they pose because they have not previously been classified into a lower risk class by the FDA. Manufacturers of these devices may request that FDA
review such devices in accordance with the de novo classification procedure, which allows a manufacturer whose novel device would otherwise require a
PMA prior to marketing to request down-classification of the device on the basis that the device presents low or moderate risk. If the FDA grants the de
novo classification request, the applicant will then receive authorization to market the device. This device type can then be used as a predicate device for
future 510(k) submissions.
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We received marketing authorization of our MDD and smoking addition indications through the 510(k) clearance process and have made various
expansions to our MSS indication (including, in 2021, a clearance for a shortened three-minute depression protocol, and a labeling expansion for anxious
depression) through subsequent 510(k) clearances. We received marketing authorization of our OCD indication through the de novo classification process
but will be permitted to make changes to our system for the OCD indication through subsequent 510(k) clearances. A competitor has obtained 510(k)
clearance for its TMS device for an OCD indication, using our de novo classification as a predicate device in their submission, and others may follow suit.
The process of obtaining regulatory authorization to market a medical device can be costly and time consuming, and we may not be able to successfully
obtain authorizations on a timely basis, if at all.
The FDA can delay, limit or deny clearance or approval of a device for many reasons, including: we may be unable to demonstrate to the FDA’s satisfaction
that the product or modification is substantially equivalent to the proposed predicate device or is safe and effective for its intended use; the data from our
pre-clinical studies and clinical trials may be insufficient to support authorization, where required; and the manufacturing process or facilities we use may
not meet applicable requirements. The FDA may also, instead of accepting a 510(k) submission, require us to submit a PMA, which is typically a much
more complex, lengthy, and burdensome application than a 510(k) submission. To support a PMA, the FDA would likely require that we conduct one or
more clinical studies to demonstrate that the device is safe and effective. In some cases, such studies may be requested for a 510(k) as well. We may not be
able to meet the requirements to obtain 510(k) clearance or PMA approval (or a De Novo classification request), in which case the FDA may not grant any
necessary clearances or approvals. In addition, the FDA may place significant limitations upon the intended uses of our products as a condition to a 510(k)
clearance or PMA approval. Product applications can also be denied or withdrawn due to failure to comply with regulatory requirements or the occurrence
of unforeseen problems following clearance or approval. Any delays or failure to obtain FDA clearance or approval of new products we develop, any
limitations imposed by the FDA on new product use or the costs of obtaining FDA clearance or approvals could have a material adverse effect on our
business, financial condition, and results of operations.
Even if granted, a 510(k) clearance, de novo classification, or PMA imposes substantial restrictions on how our devices may be marketed or sold, and the
FDA continues to place considerable restrictions on our products and operations. For example, the manufacture of medical devices must comply with the
FDA’s Quality System Regulation (QSR). In addition, manufacturers must register their manufacturing facilities, list the products with the FDA, and
comply with requirements relating to labeling, marketing, complaint handling, adverse event and medical device reporting, reporting of corrections and
removals, and import and export restrictions. The FDA monitors compliance with the QSR and these other requirements through periodic inspections. If
our facilities or those of our suppliers are found to be in violation of applicable laws and regulations, or if we or suppliers fail to take satisfactory corrective
action in response to an adverse inspection, the regulatory authority could take enforcement action, including any of the following sanctions: untitled
letters, warning letters, fines, injunctions, consent decrees, and civil penalties; customer notifications or repair, replacement, refunds, recalls, detention or
seizure of our products; operating restrictions or partial suspension or total shutdown of production; refusing or delaying requests for 510(k) marketing
clearance or PMA approvals of new products or modified products; withdrawing 510(k) marketing clearances or PMA approvals that have already been
granted; refusing to provide Certificates for Foreign Government; refusing to grant export approval for our products; or pursuing criminal prosecution. Any
of these sanctions could impair our ability to produce or commercialize our products in a cost-effective and timely manner in order to meet our customers’
demands and could have a material adverse effect on our reputation, business, results of operations, and financial condition. We may also be required to
bear other regulatory compliance costs or take other actions that may have a negative impact on our sales and our ability to generate profits.
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In addition, the FDA may change its clearance and approval policies, adopt additional regulations or revise existing regulations, or take other actions,
which may prevent or delay authorization of our future products under development or impact our ability to modify our currently marketed products on a
timely basis. Such policy or regulatory changes could impose additional requirements upon us that could delay our ability to obtain new 510(k) clearances,
increase the costs of compliance or restrict our ability to maintain our current clearances. We also cannot predict the likelihood, nature or extent of
government regulation that may arise from future legislation or administrative or executive action in the United States, especially with a new administration
that may have different policy priorities than the previous one.
In order to sell our products in member countries of the EEA, or in countries that also rely on the CE Mark outside the EEA, our products must comply
with the essential requirements of the EU Medical Devices Directive (Council Directive 93/42/EEC), and with the Medical Device Regulation
(Regulation 2017/745). Compliance with these requirements is a prerequisite to be able to affix the CE Mark to our products, without which they cannot be
sold or marketed in the EEA. To demonstrate compliance with the essential requirements we must undergo a conformity assessment procedure, which
varies according to the type of medical device and its classification. Except for low-risk medical devices (Class I non-sterile, non-measuring devices),
where the manufacturer can issue an EC Declaration of Conformity based on a self-assessment of the conformity of its products with the essential
requirements of the EU Medical Devices Directive, a conformity assessment procedure requires the intervention of an organization accredited by a Member
State of the EEA to conduct conformity assessments, or a Notified Body. Depending on the relevant conformity assessment procedure, the Notified Body
would typically audit and examine the technical file and the quality system for the manufacture, design, and final inspection of our devices. The Notified
Body issues a certificate of conformity following successful completion of a conformity assessment procedure conducted in relation to the medical device
and its manufacturer and their conformity with the essential requirements. This certificate entitles the manufacturer to affix the CE Mark to its medical
devices after having prepared and signed a related EC Declaration of Conformity. If we fail to remain in compliance with applicable European laws and
directives, we would be unable to continue to affix the CE Mark to our device, which would prevent us from selling them within the EEA and may have an
impact on our marketing authorizations in other countries.
We or our distributors will also need to obtain, or retain, regulatory approval in other foreign jurisdictions in which we plan to or currently do market and
sell our products, and we or they may not obtain such approvals as necessary to commercialize our products in those territories. Regulatory marketing
authorizations in these foreign jurisdictions typically require device testing, conformance to classification requirements, pre-market requests to authorize
commercialization, and in some cases inspections.
Modifications to our Deep TMS systems and treatments may require new 510(k) clearances, de novo classification or PMA, and may require us to
cease marketing or recall the modified products until authorizations are obtained.
Any modification to a 510(k)-cleared product that could significantly affect its safety or effectiveness, or that would constitute a major change in its
intended use, design or manufacture, requires a new 510(k) clearance or de novo classification, or possibly, a PMA. Modifications to products that have
been approved through the PMA process generally require premarket FDA approval. Similarly, certain modifications made to products cleared through a
510(k) or authorized through the de novo classification process may require a new 510(k) clearance. Each of the PMA, de novo classification and the
510(k) clearance processes can be expensive, lengthy, and uncertain. The FDA’s 510(k) clearance process usually takes from three to 12 months, but can
last longer. The process of obtaining a PMA is much more costly and uncertain than the 510(k) clearance process and generally takes from one to three
years, or even longer, from the time the application is filed with the FDA. In addition, a PMA generally requires the performance of one or more clinical
trials.
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Despite the time, effort and cost, a device may not be approved or cleared by the FDA. Any delay or failure to obtain necessary regulatory authorizations
could harm our business. Furthermore, even if we are granted regulatory authorizations, they may include significant limitations on the indicated uses for
the device, which may limit the market for the device.
Any modifications to our existing products may require new 510(k) clearance; however, future modifications may be subject to the substantially more
costly, time-consuming, and uncertain PMA process. If the FDA requires us to go through a lengthier, more rigorous examination for future products or
modifications to existing products than we had expected, product introductions or modifications could be delayed or canceled, which could cause our sales
to decline.
The FDA requires every manufacturer to make this modification determination in the first instance, but the FDA may review any manufacturer’s decision.
The FDA may not agree with our decisions regarding whether new authorizations are necessary. We have made modifications to our products in the past
and have determined based on our review of the applicable FDA regulations and guidance that in certain instances new 510(k) clearances were not
required. We may make modifications or add additional enhancements or features in the future that we believe do not require a new 510(k) clearance, de
novo classification or a PMA. If the FDA disagrees with our determination and requires us to submit new 510(k) notifications, de novo classifications or
PMAs for modifications to our previously authorized products for which we have concluded that new authorizations are unnecessary, we may be required
to cease marketing or to recall the modified product until we obtain appropriate regulatory authorization, and we may be subject to significant regulatory
fines or penalties. In addition, the FDA may not authorize our products for the indications that are necessary or desirable for successful commercialization
or could require clinical trials to support any modifications. Any delay or failure in obtaining required regulatory authorizations would adversely affect our
ability to introduce new or enhanced products in a timely manner, which in turn would harm our future growth.
Our products must be manufactured in accordance with federal and state regulations, and we could be forced to recall our installed systems or
terminate production if we fail to comply with these regulations.
The methods used in, and the facilities used for, the manufacture of our products must comply with the FDA’s QSR, which is a complex regulatory scheme
that covers the procedures and documentation of the design, testing, production, process controls, quality assurance, labeling, packaging, handling, storage,
distribution, installation, servicing, and shipping of medical devices. Furthermore, we are required to verify that our suppliers maintain facilities,
procedures and operations that comply with our quality standards and applicable regulatory requirements. Compliance with the QSR is necessary to receive
FDA clearance or approval to market new products and is necessary for a manufacturer to be able to continue to market cleared or approved devices in the
United States. The FDA enforces the QSR through periodic announced or unannounced inspections of medical device manufacturing facilities, which may
include the facilities of subcontractors. Our products are also subject to similar state regulations and various laws and regulations of foreign countries
governing manufacturing. Foreign regulatory authorities also impose manufacturing quality requirements, that may differ from the FDA requirements, with
which we must comply.
We or our third-party suppliers may not take the necessary steps to comply with applicable regulations, which could cause delays in the delivery of our
products. In addition, failure to comply with applicable FDA or foreign jurisdiction requirements or later discovery of previously unknown problems with
our products or manufacturing processes could result in, among other things: warning letters or untitled letters; fines, injunctions or civil penalties;
suspension or withdrawal of approvals or clearances; seizures or recalls of our products; total or partial suspension of production or distribution;
administrative or judicially imposed sanctions; the FDA’s refusal to grant pending or future clearances or approvals of Deep TMS for additional
indications; clinical holds; refusal to permit the import or export of our products; and criminal prosecution of us or our employees. Any of these actions
could significantly and negatively impact supply of our Deep TMS systems. If any of these events occurs, our reputation could be harmed, we could be
exposed to product liability claims, and we could lose customers and suffer reduced revenues and increased costs.
If treatment guidelines for the clinical conditions we are targeting change or the standard of care evolves, we may need to redesign and seek new
marketing authorization from the FDA for one or more of our products.
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If treatment guidelines for the clinical conditions we are targeting or the standard of care for such conditions evolves, we may need to redesign our Deep
TMS systems and seek new marketing authorizations from the FDA. Our existing 510(k) and de novo clearances from the FDA are based on current
treatment guidelines. Additionally, if treatment guidelines change so that different treatments become desirable, the clinical utility of one or more of our
indications could be diminished and our business could suffer.
The misuse or off-label use of Deep TMS may harm our reputation in the marketplace, result in injuries that lead to product liability suits or result in
costly investigations, fines or sanctions by regulatory bodies, particularly if we are deemed to have engaged in the promotion of these uses, any of
which could be costly to our business.
Deep TMS system has been authorized for marketing by the FDA only for MDD (including reduction of comorbid anxiety symptoms, commonly referred
to as anxious depression), OCD, and smoking addiction indications. We train our commercial organization to not promote our products for uses outside of
the FDA-authorized indications for use, known as “off-label uses.” However, we cannot guarantee that all of our employees, representatives, and agents
will abide by our marketing policies. If the FDA determines that our promotional materials, training or other marketing activities constitute promotion of an
off-label or unapproved use, it could request that we modify our training or promotional materials or subject us to regulatory or enforcement actions,
including the issuance or imposition of an untitled letter, a warning letter, injunction, seizure, civil fine or criminal penalties. It is also possible that other
federal, state or foreign enforcement authorities might take action under other regulatory authority, such as laws prohibiting false claims for reimbursement.
Moreover, even if we, and all our employees, contractors, and agents, market our products in compliance with applicable FDA regulations, such regulations
do not apply to the practice of medicine, and we cannot prevent a physician from prescribing and/or using our products off-label when, in the physician’s
independent professional medical judgment, he or she deems it appropriate. Similarly, we cannot prevent patients from using our products off-label. There
may be increased risk of injury to patients if physicians attempt to prescribe, or patients attempt to use, Deep TMS off-label. Furthermore, the use of Deep
TMS for MDD (including reduction of comorbid anxiety symptoms, commonly referred to as anxious depression), OCD or smoking addiction other than as
stated on product labeling, or for indications other than those authorized by the FDA, may not be effective to treat such conditions, which could harm our
reputation in the marketplace among physicians and patients. There are similar risks if Deep TMS is used off-label with respect to non-U.S. regulatory
approvals.
Deep TMS may cause or contribute to adverse medical events that we are required to report to the FDA, and if we fail to do so, we would be subject to
sanctions that could harm our reputation, business, financial condition, and results of operations. The discovery of serious safety issues with our
products, or a recall of our products either voluntarily or at the direction of the FDA or another governmental authority, could have a negative impact
on us.
We are subject to the FDA’s medical device reporting regulations and similar foreign regulations, which require us to report to the FDA when we receive or
become aware of information that reasonably suggests that one or more of our products may have caused or contributed to a death or serious injury or
malfunctioned in a way that, if the malfunction were to recur, it could cause or contribute to a death or serious injury. The timing of our obligation to report
is triggered by the date we become aware of the adverse event as well as the nature of the event. We may fail to report adverse events of which we become
aware within the prescribed timeframe. We may also fail to recognize that we have become aware of a reportable adverse event, especially if it is not
reported to us as an adverse event or if it is an adverse event that is unexpected or removed in time from the use of the product. If we fail to comply with
our reporting obligations, the FDA could take action, including warning letters, untitled letters, administrative actions, criminal prosecution, imposition of
civil monetary penalties, revocation of our device clearance, seizure of our products or delay in clearance of future products.
The FDA and foreign regulatory bodies have the authority to require, and in the United States companies are expected to voluntarily, the recall of
commercialized products in the event of material deficiencies or defects in design or manufacture of a product or in the event that a product poses an
unacceptable risk to health. An FDA recall, whether mandatory or voluntary, may be based on a finding that there is reasonable probability that the device
could cause serious injury or death. A government mandated or voluntary recall by us could occur as a result of an unacceptable risk to health, component
failures, malfunctions, manufacturing defects, labeling or design deficiencies, packaging defects or other deficiencies or failures to comply with applicable
regulations. Product defects or other errors may occur in the future. If we initiate a correction or removal for one of our devices to reduce a risk to health
posed by the device, we would be required to submit a publicly available Correction and Removal report to the FDA and, in many cases, similar reports to
other regulatory agencies. This report could be classified by the FDA as a device recall which could lead to increased scrutiny by the FDA, other
international regulatory agencies, and our customers regarding the quality and safety of our devices. Furthermore, the submission of these reports could be
used by competitors against us in competitive situations and cause customers to delay purchase decisions or cancel orders and would harm our reputation.
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Depending on the corrective action we take to redress a product’s deficiencies or defects, the FDA may require, or we may decide, that we will need to
obtain new authorization for the device before we may market or distribute the corrected device. Seeking such authorization may delay our ability to
replace the recalled devices in a timely manner. Moreover, if we do not adequately address problems associated with our devices, we may face additional
regulatory enforcement action, including FDA warning letters, product seizure, injunctions, administrative penalties or civil or criminal fines.
Companies are required to maintain certain records of corrective actions, even if they are not reportable to the FDA. We may initiate voluntary corrective
actions for our products in the future that we determine do not require notification to the FDA. If the FDA disagrees with our determinations, it could
require us to report those actions as recalls, and we may be subject to enforcement action. A future recall announcement could harm our reputation with
customers, potentially lead to product liability claims against us and negatively affect our sales.
Any adverse event involving Deep TMS systems could result in voluntary corrective actions, such as recalls or customer notifications, or agency action,
such as inspection, mandatory recall or other enforcement action. Any corrective action, whether voluntary or involuntary, as well as exposing us to private
litigation, would require the dedication of our time and capital, distract management from operating our business, and may harm our reputation and
financial results.
If we or our distributors do not obtain and maintain international regulatory registrations or approvals for Deep TMS, we will be unable to market and
sell our products outside of the United States.
Sales of our Deep TMS systems outside of the United States are subject to foreign regulatory requirements that vary widely from country to country. While
the regulations of some countries may not impose barriers to marketing and selling Deep TMS systems or only require notification, others require that we
or our distributors obtain the approval of a specified regulatory body. Complying with foreign regulatory requirements, including obtaining registrations or
approvals, can be expensive and time-consuming, and we or our distributors may not receive regulatory approvals in each country in which we plan to
market Deep TMS or we may be unable to do so on a timely basis. The time required to obtain registrations or approvals, if required by other countries,
may be longer than that required for FDA authorization, and requirements for such registrations, clearances or approvals may significantly differ from FDA
requirements. If we modify our Deep TMS systems, we or our distributors may need to apply for additional regulatory approvals before we are permitted to
sell the modified product. In addition, we may not continue to meet the quality and safety standards required to maintain the authorizations that we or our
distributors have received. If we or our distributors are unable to maintain our authorizations in a particular country, we will no longer be able to sell the
applicable product in that country.
Regulatory authorization by the FDA and/or the permission to affix the CE Mark does not ensure clearance or approval by regulatory authorities in other
jurisdictions, and clearance or approval by one or more foreign regulatory authorities does not ensure clearance or approval by the FDA, the EU and/or the
regulatory authorities in other foreign countries. However, a failure or delay in obtaining regulatory clearance or approval in one country may have a
negative effect on the regulatory process in others.
We are subject to certain federal, state, and foreign fraud and abuse laws, health information privacy and security laws, and transparency laws, which,
if violated, could subject us to substantial penalties. Additionally, any challenge to or investigation into our practices under these laws could cause
adverse publicity and be costly to respond to, and thus could harm our business.
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There are numerous U.S. federal and state, as well as foreign, laws pertaining to healthcare fraud and abuse, including anti-kickback, false claims, and
physician transparency laws. Efforts to ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations
involve substantial costs. Our business practices and relationships with providers and patients are subject to scrutiny under these laws. We may also be
subject to patient information privacy and security regulation by both the federal government and the states and foreign jurisdictions in which we conduct
our business. The healthcare laws and regulations that may affect our ability to operate include:
● the federal healthcare Anti-Kickback Statute, which prohibits, among other things, persons, and entities from knowingly and willfully soliciting,
offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for,
or the purchase, lease, order, or arrange for or recommend a good or service, for which payment may be made, in whole or in part, under federal
healthcare programs, such as Medicare and Medicaid. The term “remuneration” has been broadly interpreted to include anything of value. The
government can establish a violation of the Anti-Kickback Statute without proving that a person or entity had actual knowledge of the law or a
specific intent to violate. Moreover, the government may assert that a claim including items or services resulting from a violation of the federal
healthcare Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act. Although there are a
number of statutory exceptions and regulatory safe harbors to the federal healthcare Anti-Kickback Statute protecting certain common business
arrangements and activities from prosecution or regulatory sanctions, the exceptions and safe harbors are drawn narrowly. Practices that involve
remuneration to those who prescribe, purchase, or recommend medical device products, including discounts, or engaging individuals as speakers,
consultants, or advisors, may be subject to scrutiny if they do not fit squarely within an exception or safe harbor. Our practices may not in all cases
meet all of the criteria for safe harbor protection from anti-kickback liability. Moreover, there are no safe harbors for many common practices,
such as reimbursement support programs, educational or research grants, or charitable donations;
●
the federal civil False Claims Act, which prohibits, among other things, individuals or entities from knowingly presenting, or causing to be
presented, false or fraudulent claims for payment of federal government funds, and knowingly making, using or causing to be made or used a false
record or statement material to a false or fraudulent claim to avoid, decrease or conceal an obligation to pay money to the federal government.
Private individuals, commonly known as “whistleblowers,” can bring civil False Claims Act qui tam actions, on behalf of the government and
such individuals and may share in amounts paid by the entity to the government in recovery or settlement. False Claims Act liability is potentially
significant in the healthcare industry because the statute provides for treble damages and mandatory penalties of $11,665 to $23,607 per false or
fraudulent claim or statement. The government may assert that a claim including items or services resulting from a violation of the federal Anti-
Kickback Statute constitutes a false or fraudulent claim under the federal civil False Claims Act. Many pharmaceutical and medical device
manufacturers have been investigated and have reached substantial settlements under the federal civil False Claims Act in connection with alleged
off-label promotion of their products and allegedly providing free products to customers with the expectation that the customers would bill federal
health care programs for the product. In addition, manufacturers can be held liable under the federal civil False Claims Act even when they do not
submit claims directly to government payers if they are deemed to “cause” the submission of false or fraudulent claims. There are also criminal
penalties, including imprisonment and criminal fines, for making or presenting false, fictitious or fraudulent claims to the federal government;
● HIPAA, which created additional federal criminal statutes that prohibit, among other things, knowingly and willfully executing or attempting to
execute a scheme to defraud any healthcare benefit program, including private third-party payers, knowingly and willfully embezzling or stealing
from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense, and knowingly and willfully falsifying,
concealing or covering up a material fact or making any materially false, fictitious or fraudulent statements or representations, or making or using
any false writing or document knowing the same to contain any materially false, fictitious or fraudulent statement or entry in connection with the
delivery of, or payment for, healthcare benefits, items or services. Similar to the federal healthcare Anti-Kickback Statute, a person or entity does
not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation;
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● the federal Physician Payments Sunshine Act under PPACA which requires certain manufacturers of drugs, devices, biologics and medical
supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report
annually to the United States Department of Health and Human Services, Centers for Medicare and Medicaid Services, information related to
payments and other transfers of value to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching
hospitals, and applicable manufacturers and group purchasing organizations, as well as ownership and investment interests held by physicians and
their immediate family members. Since January 2022, applicable manufacturers are also required to report information regarding payments and
transfers of value provided to physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, and certified nurse-
midwives;
● HIPAA, as amended by HITECH, and their respective implementing regulations, which imposes privacy, security, and breach reporting
obligations with respect to PHI, upon entities subject to the law, such as health plans, healthcare clearinghouses and certain healthcare providers,
and their respective business associates that perform services on their behalf that involve PHI. HITECH also created new tiers of civil monetary
penalties, amended HIPAA to make HIPAA compliance as well as civil and criminal penalties directly applicable to business associates, and gave
state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce the HIPAA laws and seek
attorneys’ fees and costs associated with pursuing federal civil actions; and
● analogous state and foreign law equivalents of each of the above federal laws, such as anti-kickback and false claims laws which may apply to
items or services reimbursed by any third-party payer, including commercial insurers or patients; state laws that require device companies to
comply with the industry’s voluntary compliance guidelines and the applicable compliance guidance promulgated by the federal government or
otherwise restrict payments that may be made to healthcare providers and other potential referral sources; state and local laws that require the
licensure of sales representatives; state laws that require device manufacturers to report information related to payments and other transfers of
value to physicians and other healthcare providers or marketing expenditures and pricing information; data privacy and security laws and
regulations in foreign jurisdictions that may be more stringent than those in the United States (such as the EU, which adopted the General Data
Protection Regulation, which became effective in May 2018); state laws governing the privacy and security of health information in certain
circumstances, many of which differ from each other in significant ways and may not have the same effect, thus complicating compliance efforts;
and state laws related to insurance fraud in the case of claims involving private insurers.
These laws and regulations, among other things, constrain our business, marketing, and other promotional activities by limiting the kinds of financial
arrangements, including sales programs, we may have with physicians or other potential purchasers of our products. We have also entered into consulting
agreements with physicians, which are subject to these laws. Further, while we do not submit claims and our customers will make the ultimate decision on
how to submit claims, we may provide reimbursement guidance and support regarding our products. Due to the breadth of these laws, the narrowness of
statutory exceptions and regulatory safe harbors available, and the range of interpretations to which they are subject, it is possible that some of our current
or future practices might be challenged under one or more of these laws.
To enforce compliance with healthcare regulatory laws, certain enforcement bodies have recently increased their scrutiny of interactions between
healthcare companies and healthcare providers, which has led to a number of investigations, prosecutions, convictions and settlements in the healthcare
industry. For example, U.S. federal and state regulatory and enforcement agencies continue to actively investigate violations of healthcare laws and
regulations, including pursuing novel theories of liability under these laws. These government agencies recently have increased regulatory scrutiny and
enforcement activity with respect to manufacturer reimbursement support activities and patient support programs, including bringing criminal charges or
civil enforcement actions under the federal healthcare Anti-Kickback statute, federal civil False Claims Act, the health care fraud statute, and HIPAA
privacy provisions. Responding to investigations can be time and resource consuming and can divert management’s attention from the business. Any such
investigation or settlement could increase our costs or otherwise have an adverse effect on our business. Even an unsuccessful challenge or investigation
into our practices could cause adverse publicity, and be costly to respond to.
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If our operations are found to be in violation of any of the healthcare laws or regulations described above or any other healthcare regulations that apply to
us, we may be subject to administrative, civil and criminal penalties, damages, fines, disgorgement, substantial monetary penalties, exclusion from
participation in government healthcare programs, such as Medicare and Medicaid, imprisonment, additional reporting obligations, and oversight if we
become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws, reputational harm, and the
curtailment or restructuring of our operations.
Healthcare policy changes, including recently enacted legislation reforming the U.S. healthcare system, could harm our cash flows, financial
condition, and results of operations.
From time to time, legislation is drafted and introduced in Congress that could significantly change the statutory provisions governing the regulation of
medical devices. In addition, FDA regulations and guidance are often revised or reinterpreted by the FDA in ways that may significantly affect our business
and our products. Any new statutes, regulations, revisions, or reinterpretations of existing regulations may impose additional costs, lengthen review times
of any future products, or make it more difficult to manufacture, market or distribute our products. We cannot determine what effect changes in regulations,
statutes, legal interpretation or policies, when and if promulgated, enacted or adopted may have on our business in the future.
For example, in March 2010, the Patient Protection and Affordable Care Act (PPACA) was enacted in the United States, which made a number of
substantial changes in the way healthcare is financed by both governmental and private insurers. Among other ways in which it may impact our business,
the PPACA:
● establishes a new Patient-Centered Outcomes Research Institute to oversee and identify priorities in comparative clinical effectiveness research in
an effort to coordinate and develop such research;
● implements payment system reforms including a national pilot program on payment bundling to encourage hospitals, physicians, and other
providers to improve the coordination, quality, and efficiency of certain healthcare services through bundled payment models; and
● expands the eligibility criteria for Medicaid programs.
Some of the provisions of the PPACA have yet to be implemented, and there have been judicial and Congressional challenges to modify, limit, or repeal
certain aspects of the PPACA since its enactment and have continued to evolve. During his presidency, President Trump has supported the repeal of all or
portions of the PPACA, and in January 2017, he signed Executive Orders designed to delay the implementation of certain provisions of the PPACA or
otherwise circumvent some of the requirements for health insurance mandated by the PPACA to the maximum extent permitted by law. Due to such efforts,
certain elements of the PPACA have been invalidated or suspended, which has, in turn, led to additional challenges against the law as a whole. For
example, the Tax Cuts and Jobs Act of 2017 included a provision repealing, effective January 1, 2019, the tax-based shared responsibility payment imposed
by the PPACA on certain individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly referred to as the “individual
mandate”. As a result, there is significant uncertainty regarding future healthcare reform and its impact on our operations. In December 2018, a district
court in Texas held that the individual mandate is unconstitutional and that the rest of the PPACA is, therefore, invalid. On appeal, the Fifth Circuit Court of
Appeals affirmed the holding on the individual mandate but remanded the case back to the lower court to reassess whether and how such holding affects the
validity of the rest of the PPACA. The Fifth Circuit’s decision on the individual mandate was appealed to the U.S. Supreme Court. On June 17, 2021, the
Supreme Court held that the plaintiffs (comprised of the state of Texas, as well as numerous other states and certain individuals) did not have standing to
challenge the constitutionality of the PPACA’s individual mandate and, accordingly, vacated the Fifth Circuit’s decision and instructed the district court to
dismiss the case. As a result, the PPACA will remain in-effect in its current form for the foreseeable future; however, we cannot predict what additional
challenges may arise in the future, the outcome thereof, or the impact any such actions may have on our business.
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The Biden administration also introduced various measures in 2021 focusing on healthcare and drug pricing, in particular. For example, on January 28,
2021, President Biden issued an executive order that initiated a special enrollment period for purposes of obtaining health insurance coverage through the
PPACA marketplace, which began on February 15, 2021, and remained open through August 15, 2021. The executive order also instructed certain
governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare, including among others, reexamining
Medicaid demonstration projects and waiver programs that include work requirements and policies that create unnecessary barriers to obtaining access to
health insurance coverage through Medicaid or the PPACA. On the legislative front, the American Rescue Plan Act of 2021 was signed into law on March
11, 2021, which, in relevant part, eliminates the statutory Medicaid drug rebate cap, currently set at 100% of a drug’s average manufacturer price, for single
source drugs and innovator multiple source drugs, beginning January 1, 2024. And, in July 2021, the Biden administration released an executive order
entitled, “Promoting Competition in the American Economy,” with multiple provisions aimed at prescription drugs. In response, on September 9, 2021,
HHS released a “Comprehensive Plan for Addressing High Drug Prices” that outlines principles for drug pricing reform and sets out a variety of potential
legislative policies that Congress could pursue as well as potential administrative actions HHS can take to advance these principles. And, in November
2021, President Biden announced the “Prescription Drug Pricing Plan” as part of the Build Back Better Act (H.R. 5376) passed by the House of
Representatives on November 19, 2021, which aims to lower prescription drug pricing by, among other things, allowing Medicare to negotiate prices for
certain high-cost prescription drugs covered under Medicare Part D and Part B after the drugs have been on the market for a certain number of years and
imposing tax penalties on drug manufacturers that refuse to negotiate pricing with Medicare or increase drug prices “faster than inflation.” If enacted, this
bill could have a substantial impact on our business. In the coming years, additional legislative and regulatory changes could be made to governmental
health programs that could significantly impact pharmaceutical companies and the success of our product candidates. At the state level, legislatures have
increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient
reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases,
designed to encourage importation from other countries and bulk purchasing.
There is uncertainty as to what healthcare programs and regulations may be implemented or changed at the federal and/or state level in the U.S. or the
effect of any future legislation or regulation. Furthermore, we cannot predict what actions the Biden administration will implement in connection with the
PPACA.
However, it is possible that such initiatives could have an adverse effect on our ability to obtain approval and/or successfully commercialize products in the
United States in the future. For example, any changes that reduce, or impede the ability to obtain, reimbursement for the type of products we intend to
commercialize in the United States (or our products more specifically, if approved) or reduce medical procedure volumes could adversely affect our
business plan to introduce our products in the United States.
Our employees, consultants, distributors, agents, and other commercial partners may engage in misconduct or other improper activities, including non-
compliance with regulatory standards and requirements.
We are exposed to the risk that our employees, consultants, distributors, agents, and other commercial partners may engage in inappropriate, fraudulent or
illegal activity. Misconduct by these parties could include intentional, reckless or negligent conduct or other unauthorized activities that violate the
regulations of the FDA and other U.S. healthcare regulators, as well as non-U.S. regulators, including by violating laws requiring the reporting of true,
complete and accurate information to such regulators, manufacturing standards, healthcare fraud and abuse laws and regulations in the United States and
abroad or laws that require the true, complete, and accurate reporting of financial information or data. In particular, sales, marketing, and business
arrangements in the healthcare industry, including the sale of medical devices, are subject to extensive laws and regulations intended to prevent fraud,
misconduct, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting,
marketing and promotion, sales commission, customer incentive programs, and other business arrangements. It is not always possible to identify and deter
misconduct by our employees, distributors, agents, and other third parties, and the precautions we take to detect and prevent this activity may not be
effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming
from a failure to comply with these laws or regulations. Efforts to ensure that the activities of these parties will comply with applicable healthcare laws and
regulations involve substantial costs. These risks may be more pronounced, and we may find that the processes and policies we have implemented are not
effective at preventing misconduct. If any actions are instituted against us and we are not successful in defending ourselves or asserting our rights, those
actions could result in the imposition of significant fines or other sanctions, including the imposition of civil, criminal and administrative penalties,
damages, monetary fines, individual imprisonment, disgorgement, possible exclusion from participation in government healthcare programs, additional
reporting obligations and oversight if we becomes subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance
with these laws, contractual damages, reputational harm, diminished profits and future earnings and the curtailment of our operations. Whether or not we
are successful in defending against such actions or investigations, we could incur substantial costs, including legal fees, and divert the attention of
management in defending ourselves against any of these claims or investigations.
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Risks Related to Our Intellectual Property
We depend on our intellectual property, and our future success is dependent on our ability to protect our intellectual property and not infringe on the
rights of others.
Our success depends, in part, on our ability to obtain sufficient patent protection and/or licensing rights for Deep TMS (including, but not limited to, the
various H-Coils utilized in our devices and various product features/capabilities), maintain the confidentiality of our trade secrets and know how, operate
without infringing on the proprietary rights of others, and prevent others from infringing our proprietary rights. Our success also depends, in part, on the
ability of the U.S. Public Health Service, or PHS, which refers collectively to the National Institutes of Health, or NIH, the Centers for Disease Control and
Prevention, and the FDA, as agencies of the PHS within the United States Department of Health and Human Services, or the DHHS, and Yeda Research
and Development Company Ltd., or Yeda, the technology transfer arm of the Weizmann Institute of Science, from whom we license essential intellectual
property upon which Deep TMS technology is based, to obtain sufficient patent protection for such intellectual property, maintain the confidentiality of
related trade secrets and know how, operate without infringing on or violating the proprietary rights of others, and prevent others from infringing or
violating the Company’s owned and/or in-licensed intellectual property.
We and our licensors try to protect our proprietary position by, among other things, filing U.S., European, and other patent applications related to Deep
TMS, as well as inventions and improvements that may be important to the continuing development of Deep TMS. While we generally apply for patents in
those countries where we intend to make, have made, use, sell, or import patented products, we may not accurately predict all of the countries where patent
protection will ultimately be desirable. If we fail to timely file a patent application in any such country, we may be precluded from doing so at a later date.
In addition, we cannot assure you that:
● any of our future processes or product indications will be patentable or enforceable even if patented;
● our processes or product indications will not infringe upon the patents of third parties; or
● we will have the resources to defend against charges of patent infringement or other violation or misappropriation of intellectual property by
third parties or to protect our own intellectual property rights against infringement, misappropriation or violation by third parties.
Because the patent position of medical device companies involves complex legal and factual questions, we cannot predict the validity and enforceability of
patents with certainty. Changes in either the patent laws or in interpretations of patent laws may diminish the value of our intellectual property.
Accordingly, we cannot predict the breadth of claims that may be allowable or enforceable in our patents (including patents owned by or licensed to us).
Our issued patents may not provide us with any competitive advantages, may be held invalid or unenforceable as a result of legal challenges by third parties
or could be circumvented. Our competitors may also independently develop formulations, processes and technologies or products similar to ours or design
around or otherwise circumvent patents issued to, or licensed by, us. Thus, any patents that we own or license from others may not provide any protection
against competitors. Our pending patent applications, those we may file in the future or those we may license from third parties may not result in patents
being issued. If these patents are issued, they may not be of sufficient scope to provide us with meaningful protection. The degree of future protection to be
afforded by our proprietary rights is uncertain because legal means afford relatively limited protection, and may not adequately protect our rights or permit
us to gain or keep our competitive advantage.
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Patent rights are territorial; thus, the patent protection we do have exists only in those countries in which we have issued patents. Even so, the laws of
certain countries do not protect our intellectual property rights to the same extent as do the laws of the United States and the European Union. Therefore,
we cannot assure you that the patents issued, if any, as a result of our foreign patent applications will have the same scope of coverage as our U.S. patents.
Competitors may successfully challenge our patents, produce similar products that do not infringe our patents, or produce products in countries where we
have not applied for patent protection or that do not respect our patents. Furthermore, it is not possible to know the scope of claims that will be allowed in
published applications and it is also not possible to know which claims of granted patents, if any, will be deemed enforceable in a court of law.
After the completion of development and registration of our patents, third parties may still act to manufacture and/or market products that infringe our
patent protected rights, and we may not have adequate resources to enforce our patents. Any such manufacturing and/or marketing of products that infringe
our patent rights may significantly harm our business, results of operations and prospects.
In addition, due to the extensive time needed to develop, test, and obtain regulatory approval for new indications of Deep TMS, any patents that protect
these indications may expire early during the commercialization process. This may reduce or eliminate any market advantages that such patents may give
us. Following patent expiration, we may face increased competition through the entry of competing products into the market and a subsequent decline in
market share and profits.
However, our business interests may change, or our licensors may disagree with the scope of our license grants. In such cases, litigation could result
impeding our ability to commercialize the technology, or such licensing arrangements may result in the development, manufacturing, marketing, and sale
by our licensors of products substantially similar to our products, causing us to face increased competition, which could reduce our market share and
significantly harm our business, results of operations and prospects.
The lives of our patents may not be sufficient to effectively protect our products and business.
Patents have a limited lifespan. In the United States, the natural expiration of a patent is generally 20 years after its first effective non-provisional filing
date. Although various extensions may be available, the life of a patent, and the protection it affords, is limited. Even if patents covering our technologies,
products, or product candidates are obtained, once the patent life has expired, we may be open to competition. Patents covering some of our core
technology have expired or will expire within the next five years. In particular, the earliest of our U.S. patents on Deep TMS is set to expire in 2024. See
“Business—Intellectual Property.” In addition, although upon issuance in the United States a patent’s life can be increased based on certain delays caused
by the United States Patent and Trademark Office (USPTO), this increase can be reduced or eliminated based on certain delays caused by the patent
applicant during patent prosecution. If we do not have sufficient patent life to protect our technologies, products, and product candidates, our business, and
results of operations will be adversely affected.
Our right to the essential intellectual property upon which the Deep TMS technology is based results from in-license agreements with government
agencies and research institutions, the termination of which would prevent us from commercializing Deep TMS.
We have in-licensing agreements with the PHS and Yeda. There is no assurance that the in-licenses or related rights on which we base our technology will
not be terminated or expire due to a material breach of the underlying agreements or some other failure to meet the terms of agreement, such as a failure on
our part to make certain progress milestone payments set forth in the terms of the licenses or to comply with manufacturing obligations under these
agreements. There is no assurance that we will be able to renew or renegotiate our license agreements on acceptable terms if and when such agreements
terminate. We cannot guarantee that any in-license is enforceable or will not be terminated in the future. The termination of any in-license or our inability to
practice such technology and/or to enforce our rights under any in-license would materially and adversely affect our ability to commercialize our Deep
TMS.
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Our license agreements for our critical patents and related intellectual property impose significant monetary obligations and other requirements that
may adversely affect our ability to successfully execute our business plan.
We depend upon license agreements with the PHS and Yeda for our intellectual property rights to Deep TMS technology. Deep TMS was developed by our
founders, among others, prior to our founding over the course of their work for the PHS. The key family of patents and patent applications upon which the
unique coil of Deep TMS technology is based is owned by the DHHS (based on an assignment of the related rights from the PHS) and is exclusively in-
licensed to us under a license agreement with the PHS. In addition, a second family of patent applications covering additional functions of Deep TMS
(including the multichannel stimulator that we are developing for use in a more advanced version of our system), which is jointly owned by us with the
NIH and Yeda, is also licensed to us under the PHS license agreement and our license agreement with Yeda.
Our license agreement with Yeda was made within the context of research we commissioned at the Weizmann Institute involving Deep TMS. This
agreement provides for in-licensed rights relating to our second and third families of patent applications, which cover additional characteristics of Deep
TMS (including several Deep TMS coils, multi-channel stimulation, and methods of use), as well as in-licensed rights to rotational field TMS, which
involves the perpendicular placement of two coils over the head operated with a phase lag which causes a rotating induced electric field that enables
stimulation of neurons in various orientations.
These agreements provide us an exclusive (subject to certain standard exceptions and such as described below), worldwide license, with a right to
sublicense, subject to the approval of PHS and Yeda, respectively, for the life of the relevant patents (in the case of Yeda, on a per country basis or, until the
15-year anniversary of the first commercial sale (per country) of a product developed on the basis of the agreement, if later) for the development, creation,
use, import, offer, and sale of any product or treatment that relates to Deep TMS technology and that is developed on the basis of such patents or (in the
case of the agreement with Yeda) such research. These agreements require us, as a condition to the maintenance of our license and other rights, to make
milestone and royalty payments and satisfy certain performance obligations, including with respect to manufacturing. If we were to receive a notice of non-
compliance under any of these agreements, we would need to either obtain appropriate waivers and/or cure such non-compliance, which may require us to
modify our operations.
All of the above-described obligations impose significant financial and logistical burdens upon our ability to carry out our business plan. Furthermore, if
we do not meet such obligations in a timely manner, we could lose the rights to our proprietary technology, which would have a material adverse effect on
our business, financial condition, and results of operations.
The key patents that underlie our Deep TMS technology are subject to the U.S. government’s royalty free usage rights on a worldwide basis for any
discovery based on such patents, which may have unexpected, adverse consequences upon the market for our product.
Under our PHS license agreement, the U.S. government possesses an irrevocable, nonexclusive, nontransferable royalty-free license for the practice of
inventions based on the inventions upon which our Deep TMS technology is based, for the benefit of the U.S. government, foreign governments, or
international organizations under any existing or future treaty or agreement applicable to the U.S. government at such time. Furthermore, the PHS may
grant, or may cause us to grant, nonexclusive research licenses, for the purpose of encouraging basic research at academic or corporate facilities (but, in the
case of any license to a commercial entity, subject to our right to object if we believe that such license would adversely impact the exclusivity of our rights
under the agreement). The PHS may also require us to grant sublicenses to responsible applicants if the public health and safety so require, subject to our
right to demonstrate that any such sublicense will not materially increase the availability to the public of our licensed rights or that such public health and
safety requirements may be otherwise met without any such sublicense.
No material limits have been placed on the license held by the U.S. government for its own (or for its treaty partners’ or agreement counter-parties’)
benefit, and it is possible that the U.S. government, a foreign government or an international organization could even commercialize a product on the basis
of this license and the related technology. We cannot provide assurance that these rights will not be exploited in a manner that infringes upon our otherwise
exclusive license to the PHS-owned patents, that does not develop or advance products that compete with our own, or that does not otherwise adversely
impact our business. Because our rights with respect to the PHS-owned patents are critical to Deep TMS-based technologies and systems, any unexpected
consequences from the U.S. government’s or other third party’s exploitation of such rights could have an adverse impact on the market for Deep TMS and,
hence, on our business, financial condition, and results of operations.
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If we are unable to protect the confidentiality of our trade secrets or know-how, such proprietary information may be used by others to compete against
us.
In addition to filing patent applications, we generally try to protect our trade secrets, know-how, technology, and other proprietary information by entering
into confidentiality or non-disclosure agreements with parties that have access to it, such as our development and/or commercialization partners,
employees, contractors, and consultants. We also enter into agreements that require the disclosure and assignment to us of the rights to the ideas,
developments, discoveries and inventions of our employees, advisors, research collaborators, contractors, and consultants while we employ or engage them.
However, we cannot assure you that these agreements will provide meaningful protection for our trade secrets, know-how or other proprietary information
in the event of any unauthorized use, misappropriation or disclosure of such trade secrets, know-how or other proprietary information because these
agreements can be difficult and costly to enforce or may not provide adequate remedies. Any of these parties may breach the confidentiality agreements
and willfully or unintentionally disclose our confidential information, or our competitors might learn of the information in some other way. The disclosure
to, or independent development by, a competitor of any trade secret, know-how or other technology not protected by a patent could materially adversely
affect any competitive advantage we may have over any such competitor.
To the extent that any of our employees, advisors, research collaborators, contractors or consultants independently develop, or use independently
developed, intellectual property in connection with any of our projects, disputes may arise as to the proprietary rights to this type of information. If a
dispute arises with respect to any proprietary right, enforcement of our rights can be costly and unpredictable, and a court may determine that the right
belongs to a third party.
Legal proceedings or third-party claims of intellectual property infringement and other challenges may require us to spend substantial time and money
and could prevent us from developing or commercializing Deep TMS.
The development, manufacture, use, offer for sale, sale or importation of Deep TMS may infringe on the claims of third-party patents or violate other
intellectual property rights. The nature of claims contained in unpublished patent filings around the world is unknown to us and it is not possible to know
which countries patent holders may choose for the extension of their filings under the Patent Cooperation Treaty, or other mechanisms. Therefore, there is a
risk that we could adopt a technology without knowledge of a pending patent application, which technology would infringe a third-party patent once that
patent is issued. The cost to us of any intellectual property litigation or other infringement proceeding, even if resolved in our favor, could be substantial.
Any claims of patent infringement, even those without merit, could be expensive and time consuming to defend; cause us to cease making, licensing or
using products that incorporate the challenged intellectual property; require us to redesign, reengineer or rebrand Deep TMS, if feasible; cause us to stop
from engaging in normal operations and activities, including developing and new indications for Deep TMS; and divert management’s attention and
resources. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively because of their substantially greater
financial resources. Uncertainties resulting from the initiation and continuation or defense of intellectual property litigation or other proceedings could have
a material adverse effect on our ability to compete in the marketplace. Intellectual property litigation and other proceedings may also absorb significant
management time. Consequently, we may not be able to manufacture, use, offer for sale, sell or import our Deep TMS systems in the event of an
infringement action.
Any claims we assert against perceived infringers could provoke these parties to assert counterclaims against us alleging that we infringe their patents. In
addition, in a patent infringement proceeding, a court may decide that a patent of ours is invalid or unenforceable, in whole or in part, construe the patent’s
claims narrowly or refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology in question.
An adverse result in any litigation proceeding could put one or more of our patents at risk of being invalidated or interpreted narrowly. Furthermore,
because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential
information could be compromised by disclosure during this type of litigation.
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In the event of patent infringement claims, or to avoid potential claims, we may choose or be required to seek a license from a third party and would most
likely be required to pay license fees or royalties or both. These licenses may not be available on acceptable terms, or at all. Even if we were able to obtain
a license, the rights may be nonexclusive, which could potentially limit our competitive advantage. Ultimately, we could be prevented from
commercializing a product or be forced to cease some aspect of our business operations if, as a result of actual or threatened patent infringement or other
claims, we are unable to enter into licenses on acceptable terms. This inability to enter into licenses could harm our business significantly.
In addition, because of our developmental stage, claims that Deep TMS infringes on the patent rights of others are more likely to be asserted after
commencement of commercial sales incorporating our technology.
In addition to infringement claims against us, we may become a party to other patent litigation or proceedings before regulatory agencies, including post-
grant review, inter parties review, interference or re-examination proceedings filed with the U.S. Patent and Trademark Office that challenge our patent
rights or the patent rights of our licensors. The costs of defending our patents or enforcing our proprietary rights in post-issuance administrative
proceedings can be substantial and the outcome can be uncertain. An adverse determination in these proceedings could weaken or invalidate the patent
claims that cover our technology and Deep TMS, which could harm our business significantly and dissuade companies from collaborating with us or permit
third parties to directly compete with the same technology.
We may be subject to claims that our employees, consultants, or independent contractors have wrongfully used or disclosed confidential information of
third parties or that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.
We employ individuals who were previously employed at universities or other medical device, biotechnology and/or pharmaceutical companies, including
our competitors or potential competitors. Although we try to ensure that our employees, consultants, and independent contractors do not use the proprietary
information or know-how of others in their work for us, we may be subject to claims that we or our employees, consultants, or independent contractors
have inadvertently or otherwise used or disclosed intellectual property, including trade secrets or other proprietary information, of any of our employees’
former employers or other third parties. Litigation may be necessary to defend against these claims. If we fail in defending any such claims, in addition to
paying monetary damages, we may lose valuable intellectual property rights or personnel, which could adversely impact our business. Even if we are
successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees.
International patent protection is particularly uncertain, and if we are involved in opposition proceedings in foreign countries, we may have to expend
substantial sums and management resources.
Patent law outside the United States may be different than in the United States. Further, the laws of some foreign countries may not protect our intellectual
property rights to the same extent as the laws of the United States, if at all. A failure to obtain sufficient intellectual property protection in any foreign
country could materially and adversely affect our business, results of operations, and future prospects. Moreover, we may participate in opposition
proceedings to determine the validity of our foreign patents or our competitors’ foreign patents, which could result in substantial costs and divert
management’s resources and attention. Additionally, due to uncertainty in patent protection law, we have not filed applications in many countries where
significant markets exist.
Risks Related to Our Functions in Israel
Our manufacturing, assembly and other significant functions are located in Israel and, therefore, our business and operations may be adversely
affected by political, economic and military conditions in Israel.
Aspects of our business are located in Israel. Accordingly, our business will be directly influenced by the political, economic, and military conditions
affecting Israel at any given time. Since the establishment of the State of Israel in 1948, a number of armed conflicts have occurred between Israel and its
neighboring countries. These conflicts involved missile strikes against civilian targets in various parts of Israel including most recently, central Israel, and
negatively affected business conditions in Israel. In addition, Israel faces threats from more distant neighbors, in particular, Iran. A change in the security
and political situation in Israel and in the economy could impede the raising of the funds required to finance our research and development plans and to
create joint ventures with third parties and could otherwise have a material adverse effect on our business, operating results, and financial condition.
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Our facilities are in range of rockets that may be fired from Lebanon, Syria or the Gaza Strip into Israel. In the event that our facilities are damaged as a
result of hostile action or hostilities otherwise disrupt the ongoing operation of our facilities, our research and development activities, and our ability to
deliver products to customers could be materially and adversely affected. Our commercial insurance does not cover losses that may occur as a result of an
event associated with the security situation in the Middle East. Although the Israeli government is currently committed to covering the reinstatement value
of direct damages that are caused by terrorist attacks or acts of war, there can be no assurance that this government coverage will be maintained, or if
maintained, will be sufficient to compensate us fully for damages incurred. Any losses or damages incurred by us could have a material adverse effect on
our business, financial condition, and results of operations.
In addition, popular uprisings in various countries in the Middle East and North Africa are affecting the political stability of those countries. Such
instability may lead to deterioration in the political and trade relationships that exist between the State of Israel and these countries. Furthermore, some
countries restrict doing business with Israel and Israeli companies, and additional countries may impose restrictions on doing business with Israel and
Israeli companies if hostilities involving Israeli or political instability in the region continue or intensify. Such restrictions may seriously limit our ability to
sell Deep TMS to customers in those countries. These restrictions may materially limit our ability to sell our products to customers in those countries. In
addition, there have been increased efforts by activists to cause companies and consumers to boycott Israeli products. Such efforts, particularly if they
become more widespread, may materially and adversely impact our ability to sell our products.
Any hostilities involving Israel or the interruption or curtailment of trade between Israel and its present trading partners, or significant downturns in the
economic or financial condition of could adversely affect our operations and product development, cause our revenues to decrease, and adversely affect the
share price of publicly traded companies having functions in Israel, such as us.
Exchange rate fluctuations between the U.S. dollar, the New Israeli Shekel and other foreign currencies may negatively affect our future revenues.
While a substantial portion of our revenues is and will continue to be generated in U.S. dollars, we incur a significant portion of our expenses in currencies
other than U.S. dollars, such as NIS. Likewise, our financial records are maintained in U.S. dollars, while many of our expenses are incurred in NIS. As a
result, our financial results have been and may continue to be affected by fluctuations in the applicable exchange rates of currencies in the U.S., Israel, and
other countries in which our products and services may be sold.
Our operations may be affected by negative labor conditions in Israel.
Strikes and work-stoppages occur relatively frequently in Israel. If Israeli trade unions threaten additional strikes or work-stoppages and such strikes or
work-stoppages occur, those may, if prolonged, have a material adverse effect on the Israeli economy and on our business, including our ability to deliver
products to our customers and to receive raw materials from our suppliers in a timely manner.
Our operations could be disrupted as a result of the obligation of our personnel to perform military service.
Members of our senior management and key employees reside in Israel, and although most of them are no longer required to perform reserve duty, some
may be required to perform annual military reserve duty, and may be called for active duty under emergency circumstances at any time. Our operations
could be disrupted by the absence for a significant period of time of one or more of these officers or key employees due to military service. Any such
disruption could adversely affect our business, results of operations, and financial condition.
The termination or reduction of tax and other incentives that the Israeli Government provides to domestic companies may increase the costs involved in
operating a company in Israel.
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The Israeli government currently provides tax and capital investment incentives to domestic companies, as well as grant and loan programs relating to
research and development, and marketing and export activities. In recent years, the Israeli Government has reduced the benefits available under these
programs and the Israeli Governmental authorities have indicated that the government may in the future further reduce or eliminate the benefits of those
programs. We may take advantage of these benefits and programs in the future, however, there is no assurance that such benefits and programs would
continue to be available in the future to us. If such benefits and programs were terminated or further reduced, it could have an adverse effect on our
business, operating results, and financial condition.
The Israeli government grants that we have received require us to meet several conditions and may restrict our ability to manufacture our Deep TMS
systems and transfer relevant know-how outside of Israel and require us to pay royalties and satisfy specified conditions, including increased royalties
if we manufacture our Deep TMS systems outside of Israel or payment of a redemption fee if we transfer relevant know-how outside of Israel.
We have received royalty-bearing grants from the government of Israel through the Israel Innovation Authority (IIA) formerly, the Office of the Chief
Scientist of the Ministry of Economy and Industry, for the financing of a portion of our research and development expenditures in Israel. We are required to
pay low single-digit royalties on the sale of those of our products developed with this funding, which payments shall not exceed, in the aggregate, the
amount of the grant received (in U.S. dollars), plus interest at an annual rate based on LIBOR. When know-how is developed using IIA grants, the
Encouragement of Research, Development and Technological Innovation in Industry Law 5744-1984, or the Innovation Law, the IIA’s rules and guidelines
as well as the terms of each of these grants, impose an obligation to pay royalties from any income deriving from a product developed, in whole or in part,
directly or indirectly, in the framework of a research and development program funded by the IIA, including any derivatives and related services, and
restrict our ability to manufacture our products and transfer know-how developed as a result of the IIA’s funded research and development outside of Israel.
In certain cases, transfer of the IIA funded know-how outside of Israel requires pre-approval by the IIA, which may also impose certain conditions,
including payment of a redemption fee calculated according to the formulas provided in the IIA’s rules and guidelines, or Redemption Fee, which
differentiate between certain situations (while in no event will the Redemption Fee be more than six (6) times the grants received from the IIA plus
interest). In addition, we may need to manufacture our products outside of Israel, in which case prior approval from the IIA is required (such approval is
not required for the transfer of less than 10% of the manufacturing capacity in the aggregate), and we would be required to pay royalties at an accelerated
rate and would be subject to payment of increased royalties, as defined under the IIA’s rules and regulations (up to, in the aggregate, 300% of the amount of
the grant received (dollar linked), plus interest at annual rate based on LIBOR, depending on the manufacturing volume that is performed outside Israel less
royalties already paid to the IIA). Accordingly, we may be limited in our ability to manufacture outside of Israel, and the manufacture of our products
outside of Israel could have a material adverse effect on our business and results of operations.
The IIA has also published rules and guidelines with respect to the grant to a foreign entity of the right to use know-how that was developed using the IIA’s
grants, or Funded Know-How, (in a manner that does not entirely prevent the IIA funded company from using the Funded Know-How) which is subject to
receipt of the IIA’s prior approval. This approval is subject to payment to the IIA in accordance with the formulas stipulated in these rules.
In addition, we may transfer Funded Know-How to another Israeli company, provided that the acquiring company assumes all of our responsibilities
toward the IIA (the transfer would still require IIA approval, and is subject to the obligation to pay royalties to the IIA from the income of such sale
transaction, but will not be subject to the payment of the Redemption Fee).
The obligation to comply with the IIA’s rules and guidelines and the Innovation Law (including with respect to the restriction of the transfer of Funded
Know-How and manufacturing rights outside of Israel) remains in effect even after full repayment of the amount of royalties payable pursuant to the grants.
Once a Redemption Fee is paid on a transfer of Funded Know-How outside Israel, all obligations towards the IIA (including the royalty obligation) cease.
We are also subject to reporting obligations towards the IIA including submitting during the R&D approved program period periodic reports pertaining to
the progress of research and development, reports on income derived from products developed using grants from the IIA and in certain circumstances,
reports regarding change in the holding and change in control. Furthermore, in the event of any change of control or any change in the holding of voting
rights or rights to appoint directors or the CEO a result of which any non-Israeli citizen or non-Israeli resident becomes an “Interested Party” in our
company, the non-Israeli citizen or non-Israeli resident shall comply with all the restrictions imposed on us and our obligations pursuant to Innovation Law
and the IIA’s rules and guidelines. See “Management—Internal Auditor” for definition of Interested Party. In addition, the government of State of Israel
may from time to time audit sales of products which it claims incorporate technology funded via IIA programs, and this may lead to additional royalties
being payable on additional product candidates. In addition, under certain circumstances, further offerings of our shares to the public in any stock exchange
whether in Israel or abroad, is subject to the approval of the IIA.
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These restrictions may impair our ability to enter into agreements for IIA Funded Know-how without the approval of the IIA, and we cannot be certain that
it will be obtained on terms that are acceptable to us, or at all. Furthermore, in the event that we undertake a transaction involving the transfer to a non-
Israeli entity of know-how developed with IIA funding pursuant to a merger or similar transaction, or in the event we undertake a transaction involving the
licensing of the IIA’s Funded Know-How, the consideration available to our shareholders may be reduced by the amounts we are required to pay to the IIA.
Any approval, if given, will generally be subject to additional financial obligations. Failure to comply with the requirements under the IIA’s rules and
guidelines and the Innovation Law may subject us to mandatory repayment of grants received by us (together with interest and penalties), as well as expose
us to criminal proceedings.
Enforcing a U.S. judgment against us and our current senior management and directors, or asserting U.S. securities law claims in Israel, may be
difficult.
We are incorporated in Israel. Directors and some members of our management reside in Israel (and most of our assets reside outside of the United States).
Therefore, a judgment obtained against us or any of these persons in the United States, including one based on the civil liability provisions of the
U.S. federal securities laws, may not be collectible in the United States, and may not be enforced by an Israeli court. It may also be difficult to effect
service of process on these persons in the United States or to assert U.S. securities law claims in original actions instituted in Israel.
Even if an Israeli court agrees to hear such a claim, it may determine that Israeli, and not U.S., law is applicable to the claim. Under Israeli law, if U.S. law
is found to be applicable to such a claim, the content of applicable U.S. law must be proved as a fact, which can be a time-consuming and costly process,
and certain matters of procedure would be governed by Israeli law. There is little binding case law in Israel addressing these matters. See “Enforceability of
Civil Liabilities” for additional information on your ability to enforce civil claim against us and our senior management and directors.
Provisions of our articles of association and Israeli law and tax considerations may delay, prevent or make difficult an acquisition of us, which could
prevent a change of control and negatively affect the price of the ADSs.
Israeli corporate law regulates mergers, requires tender offers for acquisitions of shares above specified thresholds, requires special approvals for certain
transactions involving directors, officers or significant shareholders and regulates other matters that may be relevant to these types of transactions. These
provisions of Israeli law may delay, prevent or make difficult an acquisition of us, which could prevent a change of control, and therefore would potentially
depress the price of the ADSs.
Furthermore, Israeli tax considerations may make potential transactions unappealing to us or to our shareholders, especially for those shareholders whose
country of residence does not have a tax treaty with Israel which exempts such shareholders from Israeli tax. For example, Israeli tax law does not
recognize tax-free stock exchanges to the same extent as U.S. tax law. With respect to mergers, Israeli tax law allows for tax deferral in certain
circumstances but makes the deferral contingent on the fulfillment of a number of conditions, including, in some cases, a holding period of two years from
the date of the transaction during which sales and dispositions of shares of the participating companies are subject to certain restrictions. Moreover, with
respect to certain share swap transactions, the tax deferral is limited in time, and when such time expires, the tax becomes payable even if no disposition of
the shares has occurred.
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We may become subject to claims for remuneration or royalties for assigned service invention rights by our employees, which could result in litigation
and adversely affect our business.
We have entered into assignment of invention agreements with our employees who engage in research and development for the company pursuant to which
such individuals agree to assign to us all rights to any inventions created during and as a result of their employment or engagement with us. A significant
portion of our intellectual property has been developed by our employees in the course and as a result of their employment for us. Under the Israeli Patent
Law, 5727-1967, or the Patent Law, inventions conceived by an employee during the scope of his or her employment with a company and as a result
thereof are regarded as “service inventions,” which belong to the employer, absent a specific agreement between the employee and employer giving the
employee service invention rights. The Patent Law also provides that if there is no agreement between an employer and an employee with respect to the
employee’s right to receive compensation for such “service inventions,” the Israeli Compensation and Royalties Committee, or the Committee, a body
constituted under the Patent Law, shall determine whether the employee is entitled to remuneration for his or her service inventions and the scope and
conditions for such remuneration. Israeli case law clarifies that the right to receive consideration for “service inventions” can be waived by the employee
and that in certain circumstances, such waiver does not necessarily have to be explicit. In order to determine the scope and validity of such wavier, the
Committee will examine, on a case-by-case basis, the general contractual framework between the parties, using interpretation rules of the general Israeli
contract laws. Further, the Committee has not yet determined one specific formula for calculating this remuneration (but rather uses the criteria specified in
the Patents Law). As such, and although our employees have agreed to assign to us service invention rights, we may face claims demanding remuneration
in consideration for assigned inventions. As a consequence of such claims, we could be required to pay additional remuneration or royalties to our current
and/or former employees, or be forced to litigate such claims, which could negatively affect our business.
The government tax benefits that we currently are entitled to receive require us to meet several conditions and may be terminated or reduced in the
future.
Some of our operations in Israel may entitle us to certain tax benefits under the Law for the Encouragement of Capital Investments, 5719-1959, or the
Investment Law, once we begin to generate taxable income. If we do not meet the requirements for maintaining these benefits, they may be reduced or
cancelled and the relevant operations would be subject to Israeli corporate tax at the standard rate, which is set at 23% in 2018 and thereafter. In addition to
being subject to the standard corporate tax rate, we could be required to refund any tax benefits that we may receive in the future, plus interest and penalties
thereon. Even if we continue to meet the relevant requirements, the tax benefits that our current “Technology Enterprise” is entitled to may not be
continued in the future at their current levels or at all. If these tax benefits were reduced or eliminated, the amount of taxes that we pay would likely
increase, as all of our operations would consequently be subject to corporate tax at the standard rate, which could adversely affect our results of operations.
Additionally, if we increase our activities outside of Israel, for example, by way of acquisitions, our increased activities may not be eligible for inclusion in
Israeli tax benefits programs. See “Material Tax Considerations—Israeli Tax Considerations and Government Programs—Tax Benefits Under the 2017
Amendment” for additional information concerning these tax benefits.
Your rights and responsibilities as a shareholder will be governed by Israeli law, which differs in some material respects from the rights and
responsibilities of shareholders of U.S. companies.
The rights and responsibilities of our shareholders are governed by our articles of association and by Israeli law. These rights and responsibilities differ in
some material respects from the rights and responsibilities of shareholders in U.S. corporations. For example, a shareholder of an Israeli company has a
duty to act in good faith and in a customary manner in exercising its rights and performing its obligations towards the company and other shareholders, and
to refrain from abusing its power in the company, including, among other things, voting at a general meeting of shareholders on matters such as
amendments to a company’s articles of association, increases in a company’s authorized share capital, mergers and acquisitions, and related party
transactions requiring shareholder approval. In addition, a shareholder who is aware that it possesses the power to determine the outcome of a shareholder
vote or to appoint or prevent the appointment of a director or executive officer in the company has a duty of fairness toward the company. There is limited
case law available to assist us in understanding the nature of these duties or the implications of these provisions. These provisions may be interpreted to
impose additional obligations and liabilities on our shareholders that are not typically imposed on shareholders of U.S. corporations.
39
Risks Related to our ADSs and Ordinary Shares
The price of the ADSs may be volatile and may fluctuate due to factors beyond our control.
The share price of publicly traded medical device companies has been highly volatile and is likely to remain highly volatile in the future. The market price
of the ADSs or Ordinary Shares on either The Nasdaq Global Market, or Nasdaq, or the Tel Aviv Stock Exchange, or TASE, respectively, may fluctuate
significantly due to a variety of factors, including:
● positive or negative results of testing and clinical trials by us, strategic partners, and competitors;
● delays in entering into strategic relationships with respect to development and/or commercialization of Deep TMS or entry into strategic
relationships on terms that are not deemed to be favorable to us;
● technological innovations or commercial product introductions by us or competitors;
● changes in government regulations;
● developments concerning proprietary rights, including patents and litigation matters;
● public concern relating to the commercial value or safety of Deep TMS;
●
financing or other corporate transactions;
● publication of research reports or comments by securities or industry analysts;
● general market conditions in the medical device industry or in the economy as a whole; or
● other events and factors, many of which are beyond our control.
These, and other market and industry factors, may cause the market price and demand for the ADSs to fluctuate substantially, regardless of our actual
operating performance, which may limit or prevent investors from readily selling their ADSs and may otherwise negatively affect the liquidity of the
ADSs. In addition, stock markets in general, and medical device companies in particular, have experienced extreme price and volume fluctuations that have
often been unrelated or disproportionate to the operating performance of these companies.
The significant share ownership position of our officers, directors, and entities affiliated with certain of our directors may limit your ability to influence
corporate matters.
Our officers, directors, and entities affiliated with certain of our directors beneficially own or control, directly or indirectly, approximately 19.0% of our
outstanding Ordinary Shares as of April 11, 2022. Accordingly, these persons are able to significantly influence, though not independently determine, the
outcome of matters required to be submitted to our shareholders for approval, including decisions relating to the election of our board of directors, and the
outcome of any proposed merger or consolidation of our company. These interests may not be consistent with those of our other shareholders. In addition,
these persons’ significant interest in us may discourage third parties from seeking to acquire control of us, which may adversely affect the market price of
our Ordinary Shares.
Holders of ADSs are not treated as holders of our Ordinary Shares.
Holders of ADSs are not treated as holders of our Ordinary Shares, unless they withdraw the Ordinary Shares underlying their ADSs in accordance with the
deposit agreement and applicable laws and regulations. The depositary is the holder of the Ordinary Shares underlying the ADSs. Holders of ADSs
therefore do not have any rights as holders of our Ordinary Shares, other than the rights that they have pursuant to the deposit agreement. See “Description
of American Depositary Shares.”
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Holders of ADSs may be subject to limitations on the transfer of their ADSs and the withdrawal of the underlying Ordinary Shares.
ADSs are transferable on the books of the depositary. However, the depositary may close its books at any time or from time to time when it deems
expedient in connection with the performance of its duties. The depositary may refuse to deliver, transfer or register transfers of ADSs generally when our
books or the books of the depositary are closed, or at any time if we or the depositary think it is advisable to do so because of any requirement of law,
government or governmental body, or under any provision of the deposit agreement, or for any other reason, subject to the right of ADS holders to cancel
their ADSs and withdraw the underlying Ordinary Shares. Temporary delays in the cancellation of the ADSs and withdrawal of the underlying Ordinary
Shares may arise because the depositary has closed its transfer books or we have closed our transfer books, the transfer of Ordinary Shares is blocked to
permit voting at a shareholders’ meeting or we are paying a dividend on our Ordinary Shares. In addition, ADS holders may not be able to cancel their
ADSs and withdraw the underlying Ordinary Shares when they owe money for fees, taxes, and similar charges, and when it is necessary to prohibit
withdrawals in order to comply with any laws or governmental regulations that apply to ADSs or to the withdrawal of Ordinary Shares or other deposited
securities. See “Description of American Depositary Shares.”
We and the depositary are entitled to amend the deposit agreement and to change the rights of ADS holders under the terms of such agreement, or to
terminate the deposit agreement, without the prior consent of the ADS holders.
We and the depositary are entitled to amend the deposit agreement and to change the rights of the ADS holders under the terms of such agreement, without
the prior consent of the ADS holders. We and the depositary may agree to amend the deposit agreement in any way we decide is necessary or advantageous
to us or to the depositary. Amendments may reflect, among other things, operational changes in the ADS program, legal developments affecting ADSs or
changes in the terms of our business relationship with the depositary. In the event that the terms of an amendment are materially disadvantageous to ADS
holders, ADS holders will only receive 30 days’ advance notice of the amendment, and no prior consent of the ADS holders is required under the deposit
agreement. Furthermore, we may decide to direct the depositary to terminate the ADS facility at any time for any reason. For example, terminations may
occur when we decide to list our Ordinary Shares on a non-U.S. securities exchange and determine not to continue to sponsor an ADS facility or when we
become the subject of a takeover or a going-private transaction. If the ADS facility will terminate, ADS holders will receive at least 90 days’ prior notice,
but no prior consent is required from them. Under the circumstances that we decide to make an amendment to the deposit agreement that is
disadvantageous to ADS holders or terminate the deposit agreement, the ADS holders may choose to sell their ADSs or surrender their ADSs and become
direct holders of the underlying Ordinary Shares, but will have no right to any compensation whatsoever.
ADS holders may not be entitled to a jury trial with respect to claims arising under the deposit agreement, which could result in less favorable outcomes
to the plaintiff(s) in any such action.
The deposit agreement governing the ADSs representing our Ordinary Shares provides that, to the fullest extent permitted by law, holders, and beneficial
owners of ADSs irrevocably waive the right to a jury trial of any claim they may have against us or the depositary arising out of or relating to the ADSs or
the deposit agreement.
If this jury trial waiver provision is not permitted by applicable law, an action could proceed under the terms of the deposit agreement with a jury trial. If
we or the depositary opposed a jury trial demand based on the waiver, the court would determine whether the waiver was enforceable based on the facts
and circumstances of that case in accordance with the applicable state and federal law. To our knowledge, the enforceability of a contractual pre-dispute
jury trial waiver in connection with claims arising under the federal securities laws has not been finally adjudicated by the United States Supreme Court.
However, we believe that a contractual pre-dispute jury trial waiver provision is generally enforceable, including under the laws of the State of New York,
which govern the deposit agreement, by a federal or state court in the City of New York, which has non-exclusive jurisdiction over matters arising under
the deposit agreement. In determining whether to enforce a contractual pre-dispute jury trial waiver provision, courts will generally consider whether a
party knowingly, intelligently, and voluntarily waived the right to a jury trial. We believe that this is the case with respect to the deposit agreement, and the
ADSs. It is advisable that you consult legal counsel regarding the jury waiver provision before entering into the deposit agreement.
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If you or any other holders or beneficial owners of ADSs bring a claim against us or the depositary in connection with matters arising under the deposit
agreement or the ADSs, including claims under federal securities laws, you or such other holder or beneficial owner may not be entitled to a jury trial with
respect to such claims, which may have the effect of limiting and discouraging lawsuits against us and / or the depositary. If a lawsuit is brought against us
and/or the depositary under the deposit agreement, it may be heard only by a judge or justice of the applicable trial court, which would be conducted
according to different civil procedures and may result in different outcomes than a trial by jury would have had, including results that could be less
favorable to the plaintiff(s) in any such action, depending on, among other things, the nature of the claims, the judge or justice hearing such claims, and the
venue of the hearing.
No condition, stipulation or provision of the deposit agreement or ADSs serves as a waiver by any holder or beneficial owner of ADSs or by us or the
depositary of compliance with any substantive provision of the U.S. federal securities laws, and the rules and regulations promulgated thereunder.
ADS holders will not have the same voting rights as the holders of our Ordinary Shares and may not receive voting materials in time to be able to
exercise their right to vote.
Holders of the ADSs will not be able to exercise voting rights attaching to the Ordinary Shares represented by the ADSs. Under the terms of the deposit
agreement, holders of the ADSs may instruct the depositary to vote the Ordinary Shares underlying their ADSs. Otherwise, holders of ADSs will not be
able to exercise their right to vote unless they withdraw the Ordinary Shares underlying their ADSs to vote them in person or by proxy in accordance with
applicable laws and regulations and our articles of association. Even so, ADS holders may not know about a meeting far enough in advance to withdraw
those Ordinary Shares. If we ask for the instructions of holders of the ADSs, the depositary, upon timely notice from us, will notify ADS holders of the
upcoming vote and arrange to deliver our voting materials to them. Upon our request, the depositary will mail to holders a shareholder meeting notice that
contains, among other things, a statement as to the manner in which voting instructions may be given. We cannot guarantee that ADS holders will receive
the voting materials in time to ensure that they can instruct the depositary to vote the Ordinary Shares underlying their ADSs. A shareholder is only entitled
to participate in, and vote at, the meeting of shareholders, provided that it holds our Ordinary Shares as of the record date set for such meeting and
otherwise complies with our articles of association. In addition, the depositary’s liability to ADS holders for failing to execute voting instructions or for the
manner of executing voting instructions is limited by the deposit agreement. As a result, holders of ADSs may not be able to exercise their right to give
voting instructions or to vote in person or by proxy, and they may not have any recourse against the depositary or us if their Ordinary Shares are not voted
as they have requested or if their shares cannot be voted.
Our Ordinary Shares and ADSs are traded on different markets and this may result in price variations.
Our Ordinary Shares have been traded on the TASE since January 4, 2007, and our ADSs have been traded on The Nasdaq Global Market since April 16,
2019. Trading in our securities on these markets takes place in different currencies (dollars on the Nasdaq and NIS on the TASE), and at different times
(resulting from different time zones, different trading days, and different public holidays in the United States and Israel). The trading prices of our securities
on these two markets may differ due to these and other factors. Any decrease in the price of our securities on one of these markets could cause a decrease in
the trading price of our securities on the other market.
We do not have any current plans to pay dividends in the near term
We do not have any current plans to pay any cash dividends in the near term. We currently intend to retain all available funds and any future earnings to
fund the development and growth of our business. As a result, capital appreciation, if any, of the ADSs will be the investors’ sole source of gain for at least
the next several years. In addition, Israeli law limits our ability to declare and pay dividends, and may subject us to certain Israeli taxes. For more
information, see “Dividend Policy.”
If equity research analysts do not publish research or reports about our business or if they issue unfavorable commentary or downgrade the ADSs, the
price of the ADSs could decline.
42
The trading market for the ADSs will rely in part on the research and reports that equity research analysts publish about us and our business. The price of
the ADSs could decline if one or more securities analysts downgrade the ADSs or if those analysts issue other unfavorable commentary or cease publishing
reports about us or our business.
We may be subject to securities litigation, which is expensive and could divert our management’s attention.
In the past, U.S.-listed companies that have experienced volatility in the market price of their securities, including many life sciences and biotechnology
companies, have been subject to securities class action litigation. We may be the target of this type of litigation in the future. Regardless of the merits or the
ultimate results of such litigation, securities litigation brought against us could result in substantial costs and divert our management’s attention from other
business concerns, which could have a material adverse effect on our results of operations.
As a foreign private issuer whose shares are listed on The Nasdaq Global Market, we follow certain home country corporate governance practices
instead of certain Nasdaq requirements.
As a foreign private issuer whose shares are listed on The Nasdaq Global Market, we are permitted to follow certain home country corporate governance
practices instead of certain requirements of the rules of The Nasdaq Global Market. Pursuant to the “foreign private issuer exemption”:
● we established a quorum requirement such that the quorum for any meeting of shareholders is two or more shareholders holding at least 331/3% of
our voting rights, which complies with Nasdaq requirements; however, if the meeting is adjourned for lack of quorum, the quorum for such
adjourned meeting will be two or more shareholders, having any percentage of our voting rights;
● we also follow Israeli corporate governance practice in lieu of Nasdaq Marketplace Rule 5635(c), which requires shareholder approval for certain
dilutive events (such as issuances that will result in a change of control, certain transactions other than a public offering involving issuances of a
20% or greater interest in us and certain acquisitions of the shares or assets of another company), and prior to an issuance of securities when a
stock option or purchase plan is to be established or materially amended or other equity compensation arrangement made or materially amended,
pursuant to which stock may be acquired by officers, directors, employees or consultants. By contrast, under the Israeli Companies Law,
shareholder approval is required (subject to certain limited exceptions) for, among other things: (a) transactions with directors concerning the
terms of their service (including indemnification, exemption, and insurance for their service or for any other position that they may hold at a
company); (b) extraordinary transactions with controlling shareholders of publicly held companies; (c) terms of office and employment or other
engagement of a controlling shareholder, if any, or such controlling shareholder’s relative; (d) approval of transactions with the company’s Chief
Executive Officer with respect to his or her compensation, whether in accordance with the approved compensation policy of the company or not,
or transactions with officers of the company not in accordance with the approved compensation policy; (e) approval of the compensation policy of
the company for office holders and (f) certain private placements involving the issuance of 20% or more of our total voting rights, or private
placements as a result of which a person will become a controlling shareholder of the company. In addition, under the Israeli Companies Law, a
merger requires approval of the shareholders of each of the merging companies; and
Otherwise, we comply with the rules generally applicable to U.S. domestic companies listed on The Nasdaq Global Market. However, we may in the future
decide to use the foreign private issuer exemption with respect to some or all of the other Nasdaq corporate governance rules. Following our home country
governance practices as opposed to the requirements that would otherwise apply to a U.S. company listed on The Nasdaq Global Market may provide less
protection than is accorded to investors of domestic issuers. See “Management—Foreign Private Issuer and Controlled Company Status.”
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In addition, as a foreign private issuer, we are exempt from the rules and regulations under the United States Securities Exchange Act of 1934, as amended,
or the Exchange Act, related to the furnishing and content of proxy statements (including disclosures with respect to executive compensation), and our
officers, directors, and principal shareholders are exempt from the reporting and short-swing profit recovery provisions contained in Section 16 of the
Exchange Act. In addition, we are not required under the Exchange Act to file annual, quarterly, and current reports, and financial statements with the SEC
as frequently or as promptly as domestic companies whose securities are registered under the Exchange Act.
We may lose our foreign private issuer status which would then require us to comply with the Exchange Act’s domestic reporting regime and cause us
to incur significant legal, accounting, and other expenses.
We are a foreign private issuer, and therefore we are not required to comply with all of the periodic disclosure and current reporting requirements of the
Exchange Act applicable to U.S. domestic issuers. In order to maintain our current status as a foreign private issuer, either (a) a majority of our Ordinary
Shares and ADSs (calculated together) must be either directly or indirectly owned of record by non-residents of the United States or (b)(i) a majority of our
senior management or directors may not be U.S. citizens or residents, (ii) more than 50 percent of our assets cannot be located in the United States and
(iii) our business must be administered principally outside the United States. If we were to lose this status, we would be required to comply with the
Exchange Act reporting and other requirements applicable to U.S. domestic issuers, which are more detailed and extensive than the requirements for
foreign private issuers. We may also be required to make changes in our corporate governance practices in accordance with various SEC and Nasdaq rules.
The regulatory and compliance costs to us under U.S. securities laws if we are required to comply with the reporting requirements applicable to a U.S.
domestic issuer may be significantly higher than the cost we would incur as a foreign private issuer. As a result, we expect that a loss of foreign private
issuer status would increase our legal and financial compliance costs and would make some activities highly time consuming and costly. We also expect
that if we were required to comply with the rules and regulations applicable to U.S. domestic issuers, it would make it more difficult and expensive for us
to obtain director and officer liability insurance, and we may be required to accept reduced coverage or incur substantially higher costs to obtain coverage.
These rules and regulations could also make it more difficult for us to attract and retain qualified members of our board of directors.
We may incur increased costs as a result of operating as a public company in the United States, and our management may be required to devote
substantial time to new compliance initiatives.
As a public company whose ADSs are listed in the United States, and particularly after we no longer qualify as an emerging growth company and/or lose
our foreign private issuer status, we may incur accounting, legal and other expenses that we did not incur prior to our listing on Nasdaq and registration
with the SEC, including costs associated with our reporting requirements under the Exchange Act. We also anticipate that we may incur costs associated
with corporate governance requirements, including requirements under Section 404 and other provisions of the Sarbanes-Oxley Act of 2002 (Sarbanes-
Oxley Act), as well as rules implemented by the SEC and The Nasdaq Global Market, and provisions of Israeli corporate law applicable to public
companies, and the rules of the TASE. These rules and regulations may increase our legal and financial compliance costs, introduce new costs such as
investor relations, increased insurance premiums and stock exchange listing fees, and may make some activities more time-consuming and costly. Our
board members and other personnel may need to devote a substantial amount of time to these initiatives. We are constantly evaluating and monitoring
developments with respect to these rules, and we cannot predict or estimate the amount of additional costs we may incur or the timing of such costs.
Any future changes in the laws and regulations affecting public companies in the United States and Israel, including Section 404 and other provisions of the
Sarbanes-Oxley Act, the rules and regulations adopted by the SEC, and the rules of the Nasdaq, will result in increased costs to us as we respond to such
changes.
As an “emerging growth company,” as defined in the JOBS Act, we take advantage of certain temporary exemptions from various reporting requirements,
including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act (and the rules
and regulations of the SEC thereunder). When these exemptions cease to apply, we expect to incur additional expenses and devote increased management
effort toward ensuring compliance with them. We cannot predict or estimate the amount of additional costs we may incur as a result of becoming a public
company or the timing of such costs.
Pursuant to Section 404 of the Sarbanes-Oxley Act and the related rules adopted by the SEC and the Public Company Accounting Oversight Board, starting
with the next annual report that we file with the SEC, our management will be required to report on the effectiveness of our internal control over financial
reporting. In addition, once we no longer qualify as an “emerging growth company” under the JOBS Act and lose the ability to rely on the exemptions
related thereto discussed above and depending on our status as per Rule 12b-2 of the Exchange Act, our independent registered public accounting firm may
also need to attest to the effectiveness of our internal control over financial reporting under Section 404. We have not yet commenced the process of
determining whether our existing internal controls over financial reporting systems are compliant with Section 404 and whether there are any material
weaknesses or significant deficiencies in our existing internal controls. This process will require the investment of substantial time and resources, including
by our chief financial officer and other members of our senior management. As a result, this process may divert internal resources and take a significant
amount of time and effort to complete. In addition, we cannot predict the outcome of this determination and whether we will need to implement remedial
actions in order to implement effective controls over financial reporting. The determination and any remedial actions required could result in us incurring
additional costs that we did not anticipate, including the hiring of outside consultants. Irrespective of compliance with Section 404 of the Sarbanes-Oxley
Act, any failure of our internal controls could have a material adverse effect on our stated results of operations and harm our reputation. As a result, we may
experience higher than anticipated operating expenses, as well as higher independent auditor fees during and after the implementation of these changes. If
we are unable to implement any of the required changes to our internal control over financial reporting effectively or efficiently or are required to do so
earlier than anticipated, it could adversely affect our operations, financial reporting and/or results of operations and could result in an adverse opinion on
internal controls from our independent auditors.
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Changes in the laws and regulations affecting public companies will result in increased costs to us as we respond to their requirements. These laws and
regulations could make it more difficult or more costly for us to obtain certain types of insurance, including director and officer liability insurance, and we
may be forced to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage. The impact of these
requirements could also make it more difficult for us to attract and retain qualified persons to serve on our board of directors, our board committees or as
senior management. We cannot predict or estimate the amount or timing of additional costs we may incur in order to comply with such requirements.
We are an “emerging growth company” and the reduced disclosure requirements applicable to emerging growth companies may make the ADSs less
attractive to investors.
We are an “emerging growth company,” as defined in the JOBS Act, and we may take advantage of certain exemptions from various requirements that are
applicable to other public companies that are not “emerging growth companies.” Most of such requirements relate to disclosures that we would only be
required to make if we also ceased to be a foreign private issuer in the future, for example, the requirement to hold shareholder advisory votes on executive
and severance compensation and executive compensation disclosure requirements for U.S. companies. However, as a foreign private issuer, we could still
be required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act. We are exempt from such requirement for as
long as we remain an emerging growth company, which may be up to five fiscal years after the date of our initial public offering on Nasdaq in April 2019.
We will remain an emerging growth company until the earliest of: (a) the last day of our fiscal year during which we have total annual gross revenues of at
least $1.07 billion; (b) December 31, 2024 (the last day of our fiscal year following the fifth anniversary of the closing of our initial public offering on
Nasdaq); (c) the date on which we have, during the previous three-year period, issued more than $1.0 billion in non-convertible debt; or (d) the date on
which we are deemed to be a “large accelerated filer” under the Exchange Act. We may choose to take advantage of some or all of the available
exemptions. When we are no longer deemed to be an emerging growth company, we will not be entitled to the exemptions provided in the JOBS Act
discussed above. We cannot predict if investors will find the ADSs less attractive as a result of our reliance on exemptions under the JOBS Act. If some
investors find the ADSs less attractive as a result, there may be a less active trading market for the ADSs, and our share price may be more volatile.
If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results or
prevent fraud. As a result, shareholders could lose confidence in our financial and other public reporting, which would harm our business and the
trading price of the ADSs and Ordinary Shares.
Effective internal controls over financial reporting are necessary for us to provide reliable financial reports and, together with adequate disclosure controls
and procedures, are designed to prevent fraud. Any failure to implement required new or improved controls, or difficulties encountered in their
implementation could cause us to fail to meet our reporting obligations. In addition, any testing by us conducted in connection with Section 404 of the
Sarbanes-Oxley Act, or any subsequent testing by our independent registered public accounting firm, may reveal deficiencies in our internal controls over
financial reporting that are deemed to be material weaknesses or that may require prospective or retroactive changes to our financial statements or identify
other areas for further attention or improvement. Inferior internal controls could also cause investors to lose confidence in our reported financial
information, which could have a negative effect on the trading price of the ADSs and Ordinary Shares.
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Our management will be required to assess the effectiveness of our internal controls and procedures and disclose changes in these controls on an annual
basis. However, for as long as we are an “emerging growth company” under the JOBS Act, our independent registered public accounting firm will not be
required to attest to the effectiveness of our internal controls over financial reporting pursuant to Section 404. We could be an “emerging growth company”
for up to five years. An independent assessment of the effectiveness of our internal controls could detect problems that our management’s assessment might
not. Undetected material weaknesses in our internal controls could lead to financial statement restatements and require us to incur the expense of
remediation.
Risks Related to Tax Matters
We may be a passive foreign investment company for U.S. federal income tax purposes, which generally would result in certain adverse U.S. federal
income tax consequences to our U.S. shareholders.
In general, a non-U.S. corporation is a “passive foreign investment company” (a PFIC) for any taxable year in which (i) 75% or more of its gross income
consists of passive income (the “income test”) or (ii) 50% or more of the average quarterly value of its assets consists of assets that produce, or are held for
the production of, passive income (the “asset test”). Generally, “passive income” includes interest, dividends, rents, royalties, certain gains, and cash is a
passive asset for PFIC purposes. We do not believe that we are currently a PFIC, and we do not anticipate becoming a PFIC in the foreseeable future.
Notwithstanding the foregoing, the determination of whether we are a PFIC depends on the particular facts and circumstances (such as the valuation of our
assets, including goodwill and other intangible assets), and may also be affected by the application of the PFIC rules, which are subject to differing
interpretations. The fair market value of our assets is expected to depend, in part, upon (i) the market price of the ADSs, which is likely to fluctuate, and
(ii) the composition of our income and assets, which will be affected by how, and how quickly, we spend any cash that is raised in any financing
transaction. If we were a PFIC for any taxable year during which a U.S. shareholder owned the ADSs, such U.S. shareholder generally will be subject to
certain adverse U.S. federal income tax consequences, including increased tax liability on gains from dispositions of the ADSs and certain distributions and
a requirement to file annual reports with the Internal Revenue Service. In light of the foregoing, no assurance can be provided that we are not currently a
PFIC or that we will not become a PFIC in any future taxable year. Prospective investors should consult their own tax advisers regarding our PFIC status.
See “Material Tax Considerations—Certain U.S. Federal Income Tax Considerations—Passive Foreign Investment Company Considerations.”
ITEM 4.
INFORMATION ON THE COMPANY
A.
History and Development of the Company
Our legal and commercial name is BrainsWay Ltd. We are a public company that was incorporated under the laws of the State of Israel in November 2006.
We completed our initial public offering on the TASE in January 2007, and in April 2019 we completed the listing of our ADSs on The Nasdaq Global
Market. Our Ordinary Shares are currently listed on the TASE under the symbol “BWAY”, and our ADSs are currently listed on The Nasdaq Global Market
under the symbol “BWAY”. Our Israel-based principal executive offices are located at 19 Hartum Street, Bynet Building, 3rd Floor, Har HaHotzvim,
Jerusalem 9777518, Israel, and our telephone number is +972-2-582-4030. We also have U.S. offices located in Boston and New Jersey. Our registered
agent in the United States is BrainsWay USA, Inc. The address of BrainsWay USA, Inc. is 1 Van de Graaf Drive, Burlington, MA 01803.
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The Securities and Exchange Commission, or SEC, maintains an Internet site that contains reports, proxy and information statements, and other
information regarding issuers that file electronically with the SEC at http://sec.gov.
Our Ordinary Shares have been traded on the TASE since January 4, 2007, and our ADSs have been traded on The Nasdaq Global Market since April 16,
2019.
Our web site address is http://www.brainsway.com. Information contained on, or that can be accessed through, our website does not constitute a part of this
Annual Report.
Our capital expenditures for the years ended December 31, 2021, 2020, and 2019 were approximately $2.2 million, $2.5 million and $3.3 million
respectively. Our current capital expenditures primarily involve purchase of equipment and system components in both Israel and the United States Our
research and development costs for the years ended December 31, 2021, 2020 and 2019 amounted to $6.3 million, $5.8 million and $7.9 million,
respectively. These research and development costs primarily consisted of expenses incurred in connection with the development of our existing and future
indication pipeline, and the development of our Deep TMS system. We expect our capital expenditures and research and development costs to remain
significant as we continue our research and development efforts and advance our existing and planned clinical pipeline, in the United States and other
strategic markets. We anticipate our capital expenditures and research and development costs in 2022 to be financed from our existing cash and cash
equivalents, including the proceeds from the follow-on underwritten public offering of ADSs closed on February 25, 2021. For the near future, our
investments will mainly remain in the United States and Israel, where our operations and research and development facilities are currently located.
B.
Business Overview
BrainsWay is a leader in advanced noninvasive neurostimulation treatments for mental health disorders. The Company is boldly advancing neuroscience
with its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology to improve health and transform lives. We are dedicated
to leading through superior science and building on our substantial body of clinical evidence. We are the first and only TMS company to obtain from the
U.S. Food and Drug Administration (FDA) three cleared indications backed by pivotal studies demonstrating clinically proven efficacy. Current indications
include MDD (including reduction of comorbid anxiety symptoms, commonly referred to as anxious depression), obsessive-compulsive disorder (OCD),
and smoking addiction.
We have also received CE Mark for a variety of psychiatric and neurological indications. We are focused on increasing global awareness of and broad
access to Deep TMS. Deep TMS uses magnetic pulses to stimulate neurons and consequently modulates the physiological activity of the brain. Our
technology can either increase brain activity in neuronal networks which are hypoactive, or alternatively decrease brain activity in neuronal networks which
are hyperactive. Our proprietary electromagnetic coils, which we refer to as H-Coils, are designed to safely stimulate deep and broad brain regions, which
we believe provides an advantage over other available TMS products, which we refer to collectively as Traditional TMS, that generally use a “figure 8”
design. In the United States, we sell our Deep TMS system for the treatment of MDD (including reduction of comorbid anxiety symptoms, commonly
referred to as anxious depression) and OCD and have recently began marketing our products for the treatment of smoking addiction in the United States.
We believe that our Deep TMS technology has the potential to be safe and effective for the treatment of a wide range of additional psychiatric,
neurological, and addiction disorders. Additional clinical trials of Deep TMS in various psychiatric, neurological, and addiction disorders are underway or
planned.
MDD is a common and debilitating mental disorder characterized by physiological symptoms, such as sleep disturbance and changes in appetite, emotional
symptoms, such as sadness, despair, emptiness, self-hate, and critique, and cognitive symptoms, such as difficulty concentrating, memory dysfunction,
suicidal thinking, and faulty judgment of reality. According to a 2018 study cited by the World Health Organization (WHO), depression affects
approximately 300 million people worldwide, with the rate of depression increasing in developed countries. The U.S. National Institute of Mental Health
(NIMH) estimates that 21.0 million individuals in the United States suffer from a major depressive episode in 2020. Based on 2006-2007 data from the
Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study, we estimate that approximately 7 million adult MDD patients in the United
States are considered treatment-resistant (i.e., do not achieve remission after four trials of anti-depressant medication), of which we estimate that
approximately 6.3 million or more are currently eligible to receive reimbursement for Deep TMS from either governmental or private insurers. Assuming a
course of treatment per patient of 33 treatment sessions and a price paid to us per treatment session of $70 (which is our benchmark price per treatment
session), we believe our total annual addressable market opportunity for MDD in the United States is approximately $14.6 billion.
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Comorbid anxiety symptoms are common in patients with major depressive disorder. Between 60-90% of patients with depression have moderate to severe
anxiety. In the United States, an estimated 21.0 million adults experienced at least one major depressive episode in 2020. Considering the rate of
comorbidity, we estimate that 12.6 to 18.9 million adults experience moderate to severe anxiety in addition to their primary diagnosis of depression.
Common anxiety symptoms include nervousness, feelings of panic, increased heart rate, rapid breathing, sweating, insomnia, trembling, and difficulty
focusing or thinking clearly. The economic burden in the United States for major depressive disorder totaled $326 billion per year between 2010 and 2018.
OCD is a common, chronic, and long-lasting disorder in which a person has uncontrollable, reoccurring thoughts (obsessions) and behaviors (compulsions)
that he or she feels the urge to repeat over and over in a manner that can interfere with all aspects of life, such as work, school, and personal relationships.
Based on data from the NIMH, we estimate that approximately 3.1 million adults in the United States suffer from OCD annually. We believe that
approximately half of the patients (1.5 million) that have sought help would be considered treatment-resistant (i.e., not having achieved ≥30% improvement
of their symptoms from medications and psychotherapy). Assuming our emerging OCD coverage ultimately reaches a target of 90% of covered lives (as
with MDD), and assuming a course of treatment per patient of 29 treatment sessions and a price paid to us per treatment session of $70 (which is our
benchmark price per treatment session), we believe our total addressable market opportunity for OCD in the United States is approximately $2.7 billion.
Smoking is one of the leading causes of death in developed countries. The addiction to nicotine, similar to the addiction to drugs and alcohol, involves
modulation of the brain reward system and causes uncontrollable desire to smoke. 480,000 U.S. adults die from smoking each year. Cigarette smoking has
been found to harm nearly every organ system in the body and is the leading cause of preventable death in the U.S. and of disease burden worldwide
(Rostron, BL, Chang CM, Pechacek TF. Estimation of cigarette smoking-attributable morbidity in the United States, JAMA Intern Med.
2014;174(12):1922-1928). Approximately 34 million U.S. adults smoke cigarettes, of which 68% state they want to quit and 55% actually attempted to quit
in 2018. Of those attempting to quit, 5.4 million made a serious attempt to quit (i.e., using medication). Only 15-20% of those making serious attempts to
quit via medication were successful, leaving approximately between 4.3 and 4.6 million adults who made serious attempts to quit via medication who were
unsuccessful. Reimbursement is not currently available for Deep TMS for smoking addiction, and it is therefore premature to assess the amount of money
our customers might be able to collect from potential payers, and willing to pay us, for this indication. That said, assuming a course of treatment per patient
of 18 treatment sessions, and even assuming an average price paid to us per treatment session of $50, we believe our total annual addressable market
opportunity for smoking addiction in the United States is approximately between $3.9 and $4.1 billion.
Our first commercial Deep TMS product received clearance from the FDA in 2013 for the treatment of MDD in adult patients who have failed to achieve
satisfactory improvement from anti-depressant medication in the current episode. Our pivotal trial for MDD demonstrated statistically significant response
and remission rates of 38.4% and 32.6%, respectively, in week five of Deep TMS treatment of 20 minutes per session, compared to 21.4% and 14.6%,
respectively, after sham treatment. Our Deep TMS system for MDD is currently marketed to and installed at psychiatrists’ offices and other facilities
principally in the United States and in certain other countries throughout the world.
Additionally, in April 2021, we received FDA clearance for a shorter 3-minute “Theta-Burst” protocol for our MDD treatment. In support of our successful
application to the FDA for this protocol, we submitted safety and efficacy data from 146 subjects who had received either the standard Deep TMS protocol
or Theta Burst Deep TMS. Clearance was obtained after it was demonstrated that subjects in both groups experienced a statistically and clinically
meaningful reduction in depression scores, and the results met the equivalence criteria needed for clearance of the shorter treatment. We believe that certain
patients and providers can benefit from these shorter treatment sessions and that this protocol has the potential to expand access to care by providing
patients with added flexibility in selecting courses of treatment that may fit better with their lifestyle.
We recently received an FDA-cleared expansion of our exiting MDD clearance to include the noninvasive treatment of anxiety symptoms among subjects
with MDD, commonly referred to as anxious depression. We received this clearance from the FDA in August 2021. In support of our application for this
labeling expansion, we demonstrated statistically significant results from three randomized controlled trials and open label studies which found favorable
outcomes with Deep TMS when compared to sham or medication as a standard of care. The data from the three randomized controlled trials studies of
Deep TMS demonstrated effect sizes ranging from 0.34 (when compared to sham) to 0.90 (when compared to medication), and an overall weighted, pooled
effect size of 0.55.
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In addition to our FDA clearance of Deep TMS for MDD, we were the first medical device company to offer an FDA-authorized noninvasive treatment for
OCD, the marketing authorization for which we received in August 2018 as an adjunct therapy for adult patients suffering from OCD. Our pivotal trial for
OCD demonstrated statistically significant response and partial response rates of 38.1% and 54.8%, respectively, after six weeks of daily active Deep TMS
treatment of 19 minutes per session, compared to 11.1% and 26.7%, respectively, after sham treatment.
We are the first and only TMS company to offer an FDA-cleared treatment for smoking addiction, which also represents the first FDA clearance for any
TMS device in the addiction space. We received this clearance from the FDA in August 2020 for use of our Deep TMS system as an aid in short-term
smoking cessation in adults. Our pivotal trial for smoking addiction demonstrated statistically significant results, with a 28.4% Continuous Quit Rate
(CQR) – defined as abstinence from smoking for any 4-week period during the study – achieved among patients who completed the full course of therapy,
compared with 11.7% of completers undergoing sham treatment.
We believe that Deep TMS represents a platform technology that provides for an opportunity to develop additional Deep TMS products for a variety of
psychiatric, neurological and addiction disorders. We are planning multicenter trials for other indications, including multiple sclerosis (MS), which would
be our first neurological indication, and potentially various other addiction disorders beyond smoking addiction.
Our current customers are principally doctors, hospitals, and medical centers in the field of psychiatry. Treatment with Deep TMS is typically performed as
an office-based procedure using our Deep TMS system, which consists of our proprietary H-Coil helmet, as well as several other components, including a
stimulator, cooling system, positioning arm and an operator interface. A course of treatment for MDD typically requires 20 treatment sessions five times a
week over a period of four weeks, and thereafter up to 24 additional maintenance-continuation sessions twice weekly over a period of up to 12 weeks. The
standard Deep TMS treatment protocol for OCD requires 29 treatment sessions over six weeks. A course of treatment for smoking addiction typically
requires 18 treatment sessions, comprised of treatment five times a week over a period of three weeks, followed by treatment once per week for an
additional three weeks. Each standard MDD, OCD or smoking addiction session lasts 20 minutes, 19 minutes, and 18 minutes, respectively. For Deep TMS
for MDD, the FDA also cleared a 3 minute “Theta Burst” treatment protocol. Patients may experience some discomfort during treatment and must use
earplugs to reduce exposure to the loud sounds produced by the device. The treatment requires no anesthesia, hospitalization or sedation, and no systemic
side effects are associated with the therapy.
We estimate that over 90% of the total private insurer adult covered lives in the United States have coverage for reimbursement of MDD treatment with
Deep TMS. In addition, our MDD treatment (including for reduction of anxiety symptoms, commonly referred to as anxious depression) with Deep TMS is
eligible for reimbursement from Medicare. Deep TMS treatment for MDD reimbursement coverage is generally available after between one and four failed
(inadequate response or intolerable) trials of anti-depressant medications. However, there is an increasing trend to reduce the number of prior failed
medication treatments required to qualify for coverage and thus to place Deep TMS for MDD earlier within the continuum of care. We are actively engaged
in efforts to work with payers to facilitate a continuation of this trend.
In 2021, for the first time, several payers issued policies and coverage determinations allowing for reimbursement coverage applicable to Deep TMS for
OCD, with approximately 60 million covered lives in the U.S. eligible for coverage as of March 2022. Positive coverage decisions for Deep TMS for OCD
have been issued by Centene Corporation (with 26 million covered lives), Health Care Service Corporation (HCSC) (with 17 million covered lives), and
TriCare (with 9.6 million covered lives). Additionally, in mid-2021, Palmetto GBA, one of the seven Medicare Administrative Contractors (MACs) in the
US, issued the first draft Local Coverage Determination (LCD) proposing coverage applicable to Deep TMS for OCD, and subsequently issued a final
LCD approving such coverage effective March 2022. While the criteria for this emerging Deep TMS for OCD coverage varies with each payer, generally,
coverage requires the failure of between two and four medication trials before qualifying for reimbursement. We are actively engaged in efforts to facilitate
increased coverage for OCD treatment by more payers, including both commercial and governmental.
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Reimbursement is not yet available for Deep TMS for smoking addiction; however, we are actively communicating our FDA clearance and evidence
outcomes to payors for future coverage consideration as our evidence and commercialization efforts for that indication progress, based on the novelty of the
technology, unmet clinical need, and the efficacy and safety profile of the treatment.
The United States is our primary and most strategic market, representing approximately 88%, 88%, and 89% of our revenues for the years ended
December 31, 2021, 2020 and 2019, respectively. We operate in the United States through our wholly owned subsidiary, BrainsWay USA Inc, as a direct
marketing and sales channel, where we currently have existing sales, marketing, and support infrastructure. We generate revenue from various flexible
pricing models that are designed to maximize market penetration. For the year ended December 31, 2021, we generated revenues in the United States of
$26.1 million, an increase of 35% as compared to $19.3 million for the year ended December 31, 2020.
On a consolidated basis, we generated revenue from leasing, one of our two categories of activity, of $13.5 million, $13.6 million and $13.2 million for the
years ended December 31, 2021, 2020 and 2019, respectively. Our revenue from sales, our other category of activity, of $16.2 million, $8.5 million and
$9.9 million for the years ended December 31, 2021, 2020 and 2019, respectively.
Our Deep TMS Platform
Our proprietary Deep TMS technology is intended for noninvasive treatment of psychiatric, neurological, and addiction disorders. The system includes an
H-Coil uniquely designed to transmit electric current flows at varying rates, creating an electromagnetic field that serves to depolarize cortical neurons and
activate neural networks in certain areas of the brain in accordance with the operating frequency, with the effect of treating the disorder associated with that
area of the brain. Our innovative technology is capable of stimulating deeper and broader regions of the brain than any other commercially available TMS
product.
We have developed a number of H-Coils with differing configurations, building upon our technology with important changes for each coil. For different
regions of the brain which are known to be associated with specific brain disorders, we offer different H-Coils that are designed to influence the
neurological networks of those regions. For example, we have one H-Coil that is used in our Deep TMS system for MDD (including for reduction of
anxiety symptoms, commonly referred to as anxious depression), another H-Coil for that is used for OCD, and another H-Coil used for smoking addiction.
Some of our H-Coils are also able to potentially treat more than one indication. The H-Coils transmit pulses which are generated by a power supply, known
as a stimulator. We developed our own proprietary stimulator that is more advanced than our previously used third-party stimulator and improves our
approved Deep TMS systems through its user-friendly software interface and other features. We expanded our FDA clearances in MDD, OCD, and
smoking addiction, which had previously applied to our older model systems with third-party stimulators, to now also include newer systems with our
proprietary stimulator. In addition, we are currently developing a next generation multichannel stimulator allowing for simultaneous modulation of different
areas of the brain with independent stimulation parameters, thus potentially enabling more flexible and effective treatment of various brain disorders, which
we believe would make our Deep TMS systems even more attractive to clinicians, researchers and patients. This innovation is potentially well-positioned
for use in neurology indications.
Our Deep TMS system is comprised of the various key components, as illustrated below. Each system can accommodate two helmets, and a third helmet
can be incorporated using a separate auxiliary stand (not pictured).
● Helmet, including proprietary H-Coil
● Stimulator, which provides the power supply and source of the Deep TMS electromagnetic field
● Graphic User Interface (GUI)
● One or More Arm(s)/Positioning Device(s)
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● Cooling System
● Movable Medical Cart
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We believe our Deep TMS platform has many advantages relative to other TMS . Our H-Coil is a flexible device encased in a helmet that fits securely
around the patient’s head. This, together with the proprietary structure of our H-Coil, means that a much larger surface area of the head is in contact with
the H-Coil. Furthermore, if the patient moves his or her head, the helmet—and thus the H-Coil—moves along with it, eliminating the need for features
which prevent the patient from moving his or her head during therapy. In contrast, all other currently available TMS products utilize what we refer to as
Traditional TMS, which generally utilizes a variation of the figure 8 coil that is placed adjacent to the scalp of the patient and needs to be specifically
positioned and attached to the head in order to deliver focal stimulation of the desired area of the brain. Whereas some figure 8 coils are handheld by the
operator, others are attached to an apparatus designed to minimize the ability of the patient to move the head away from the relevant portion of the coil
during therapy, and thus failing to achieve the required stimulation. These features either alert the operator in the event of a shift of the patient’s head away
from the coil, or actually fasten the coil next to the patient’s head. In either case, only a small surface area on the patient’s head comes into contact with the
figure 8 coil. Traditional TMS is limited to the relatively narrower and shallower areas of the brain which are stimulated, and the manual placing of the
figure 8 coil in Traditional TMS may cause inaccuracies in the region treated. Studies suggest that the figure 8 coil misses the target in 33% of patients.
A course of treatment for MDD typically requires 20 treatment sessions five times a week over a period of four weeks, and thereafter up to 24 additional
maintenance-continuation sessions twice weekly over a period of up to 12 weeks. The standard Deep TMS treatment protocol for OCD requires 29
treatment sessions over six weeks. The clearance for this indication is categorized as an adjunct therapy, which means that it should be administered in
conjunction with other first-line therapies and/or medications, as determined in the independent medical judgment of the treating healthcare professional on
a case-by-case basis. A course of treatment for smoking addiction typically requires 18 treatment sessions, comprised of treatment five times a week over a
period of three weeks, followed by treatment once per week for an additional three weeks. A standard MDD, OCD or smoking addiction session lasts 20,
19 and 18 minutes, respectively. For Deep TMS for MDD, the FDA also recently cleared a 3 minute “Theta Burst” treatment protocol. The protocols for
OCD and smoking addiction also require a short provocation procedure (i.e., triggering of OCD or smoking symptoms, as relevant), to ensure that Deep
TMS is calibrated to treat the particular needs of the patient, which is then followed by a Deep TMS session. The treatments are typically office-based
procedures performed in private clinics, hospitals, universities, and other medical centers. As with Traditional TMS, Deep TMS is contraindicated for
patients with metallic objects or implanted stimulator devices in or near the head, including cochlear implants, deep brain stimulators, other implanted
electrodes or stimulators, aneurysm clips or coils, stents, bullet fragments, jewelry, and hair barrettes. During treatment, the patient must use earplugs to
reduce exposure to the loud sounds produced by the device.
We believe that Deep TMS has additional advantages over Traditional TMS because it is capable of stimulating deeper and broader areas of the brain.
Studies have shown that while Traditional TMS devices create an electromagnetic field estimated to penetrate the cortical surface of the brain up to depths
in the range of 0.7 centimeters to 1.1 centimeters, Deep TMS creates a magnetic field with a slower and more gradual deterioration that reaches depths
from the cortical surface of approximately 1.8 centimeters for BrainsWay’s MDD coil, approximately 3.5 centimeters for BrainsWay’s OCD coil and
approximately 1.5 centimeters for BrainsWay’s smoking addiction coil. Studies have also shown that BrainsWay’s MDD coil has the capacity for total
stimulated brain volume of 17 cm3 compared to 3 cm3 for the figure 8 coil used in Traditional TMS. We believe this deeper and broader penetration of
Deep TMS provides an advantage over Traditional TMS because of its potential to address a wider variety of brain disorders, and for a given disorder, to
stimulate more relevant brain structures.
The training for operation of a Deep TMS system is relatively simple and generally requires a day of training which includes classroom lectures as well as a
number of hours of practice providing treatment. The OCD and smoking training protocols, respectively, also include tailored provocation procedures
tailored to provoke the specific obsessions, compulsions, or addictions, as relevant, of the subject.
Competitive Strengths
● Deep TMS technology has advantages over Traditional TMS.
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We believe that Deep TMS, with our proprietary H-Coil design, allows for deeper and broader penetration of regions of the brain compared to
Traditional TMS, permitting Deep TMS to address a wider variety of psychiatric, neurological, and addiction disorders. We believe that this
deeper and broader penetration provides us with the opportunity to address more indications with potentially greater clinical efficiency because
Deep TMS stimulates a larger portion of the brain and is less sensitive to coil orientation and position during treatment. In addition, Deep TMS is
administered at stimulation levels that we believe are as safe and tolerable as Traditional TMS.
● We have obtained FDA marketing authorizations of Deep TMS for MDD, OCD, and smoking addiction.
We are the only manufacturer of a TMS device to have been FDA-cleared for three indications based on clinically proven efficacy which was
demonstrated in pivotal studies conducted on the device: MDD, which was FDA-cleared in 2013 (expanded in August 2021 to include reduction
of comorbid anxiety symptoms, or anxious depression), OCD, which was classified by FDA as a Class II device in a de novo classification in
August 2018, and smoking addiction, which was cleared for short term treatment in August 2020. For MDD, we are one of only two TMS
companies that have performed clinical studies supporting the FDA clearance. For OCD, we are one of only two TMS companies to have devices
which are FDA-cleared for this indication, but we are the only company to have received such clearance based on clinical data from a pivotal
study on the device. For smoking addiction, we are the first and only TMS company to have received FDA clearance for the treatment of any
addiction.
● Our clinical data supports the efficacy and safety of Deep TMS.
We believe that our clinical data supports the efficacy and safety of Deep TMS that will accelerate its market acceptance by clinicians. Our pivotal
trial for MDD demonstrated statistically significant response and remission rates of 38.4% and 32.6%, respectively, in week five of Deep TMS
treatment of 20 minutes per session, compared to 21.4% and 14.6%, respectively, after sham treatment. Our pivotal trial for OCD demonstrated
statistically significant response and partial response rates of 38.1% and 54.8%, respectively, after six weeks of daily active Deep TMS treatment
of 19 minutes per session, compared to 11.1% and 26.7%, respectively, after sham treatment. Post-marketing data on Deep TMS for OCD
published in 2021 found that 58.4% of those who completed 29 sessions achieved response, and 73% of patients, including those who did and did
not complete the full course of therapy, demonstrated response at least once prior to the conclusion of treatment. Our pivotal trial for smoking
addiction demonstrated a statistically significant difference in reaching the Continuous Quit Rate (CQR), defined as 4-weeks of continuous
abstinence from smoking at any point during the study. Among the 168 participants in the study who completed three weeks of Deep TMS or
sham treatment, plus the mandatory additional three weeks of follow-up (reaching the six-week endpoint), the CQR was 28.4% in the treatment
group, compared to 11.7% in the sham group (p=0.007). Overall, Deep TMS treatment was safe and well-tolerated by patients in these trials.
With respect to our MDD labeling expansion which now includes anxious depression, data from 573 patients who had undergone Deep TMS
treatment in 11 studies, including both randomized controlled trials (RCT) and open-label studies, which was submitted by us in support of our
application to the FDA, demonstrated a treatment effect that was consistent, robust, and clinically meaningful for decreasing anxiety symptoms in
adult patients suffering from major depressive disorder. An analysis of our data found favorable outcomes with Deep TMS when compared to
sham or medication as standard of care. For example, using the Cohen’s d statistical method, data from the 3 RCT studies of Deep TMS
demonstrated effect sizes ranging from 0.34 (when compared to sham) to 0.90 (when compared to medication), and an overall weighted, pooled
effect size of 0.55. As a reference, published articles from approximately 16,000 subjects in over 70 studies of drug-based anxiety treatments –
including studies of standard-of-care medications frequently prescribed for patients suffering from anxious depression and general anxiety
disorder – report effect sizes ranging from 0.2 – 0.37.
● We have a commercial track record for MDD and OCD, and recently began marketing our products for smoking addiction
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We have an established commercial footprint in the United States for Deep TMS for MDD, including our own sales, marketing, and support
employees. We estimate that over 90% of total private insurer covered lives in the United States have coverage for reimbursement of MDD
treatment with Deep TMS. In addition, our MDD treatment with Deep TMS may be eligible for reimbursement from Medicare. We are also
currently selling Deep TMS for MDD in Canada, Europe, Asia, India, the United Arab Emirates, Australia, and certain other countries. We are
also increasing our commercialization efforts for Deep TMS for OCD. Our installed base of Deep TMS systems for MDD facilitates faster
expansion into OCD because clinicians who already have a Deep TMS system only need to lease or purchase an add-on arm and helmet to the
existing system. In 2021, for the first time, several payers issued policies and coverage determinations allowing for reimbursement coverage
applicable to Deep TMS for OCD, with over 60 million covered lives in the U.S. eligible for coverage. Additionally, in mid-2021, Palmetto GBA,
one of the seven Medicare Administrative Contractors (MACs) in the U.S., issued a draft Local Coverage Determination (LCD) providing
coverage applicable to Deep TMS for OCD, and subsequently issued a final LCD approving such coverage effective March 2022. We are actively
engaged in efforts to facilitate increased coverage for OCD treatment by more payers, including both commercial and governmental. We recently
began marketing our products for smoking addiction. Specifically, we completed controlled and limited market releases of our system for this
indication, and are currently embarking on a full commercial launch.
● Our flexible pricing models are designed to achieve market penetration.
We operate commercially utilizing two basic pricing models for our products: (i) a fixed-fee lease model enabling unlimited use; and (ii) a sales or
purchase model. We also have a pay per use leasing model with some of our existing customers. Warranty and support are either included (in
varying degrees and for varying periods) or may be purchased as part of all pricing models. Additional potential revenues may be derived from
extended warranty fees paid for the system for service coverage beyond the standard included warranty period, and from variable or usage fees
based on the number of treatments performed with the system. We are also able to leverage our platform technology, which includes the ability to
treat multiple indications using different H-coil helmets, to facilitate transactions utilizing combined pricing models often involving a single
system with one or more add-on helmets. We believe that our different pricing models offer flexibility and allow for increased market acceptance
among clinics and psychiatric professionals. Based on our commercial data, and depending on insurer reimbursement rates, we believe our
psychiatrist customers for MDD systems can generate up to approximately $10,000 of gross revenues per patient, and in some cases more, for a
course of treatment using our system. While OCD coverage is still emerging, we believe that our customers can generate up to approximately
$8,800 of gross revenues per OCD patient.
● Deep TMS has potential applicability to a range of psychiatric, neurological, and addiction disorders.
Deep TMS has the potential to serve as a platform technology that can address a potentially wide variety of other psychiatric, neurological, and
addiction disorders by using the appropriate H-Coil structure for the targeted brain region. We are the first and only TMS company to obtain from
the U.S. Food and Drug Administration (FDA) three cleared indications backed by pivotal studies demonstrating clinically proven efficacy.
Current indications include MDD (including reduction of comorbid anxiety symptoms, commonly referred to as anxious depression), obsessive-
compulsive disorder (OCD), and smoking addiction. Moreover, in August 2021, we received 510(k) clearance from the FDA expanding our MDD
indication to also include treatment of depressed patients for the reduction of comorbid anxiety symptoms (commonly referred to as anxious
depression), making us the only TMS company to have labeling which specifically addresses anxiety.
Beyond our existing indications, we are also planning further clinical trials in other areas, including for fatigue in MS, pain, and various other
addictions.
Our Strategy
We are currently focused on expanding the commercialization of Deep TMS with respect to MDD and OCD. We have also recently begun marketing our
products for smoking addiction in adults, and have already completed our controlled and limited market releases for this indication. We received in
September 2021 a 510(k) clearance from the FDA for expansion of our Deep TMS MDD treatment also to include treatment for reduction of anxiety
symptoms, commonly referred to as anxious depression. In addition, we are actively engaged in research for other potential applications for Deep TMS for
patients suffering from neurological conditions and addictions. For each potential indication, we assess and evaluate our technology’s efficacy, safety,
patent status, market potential, and development and regulatory pathways. Our systematic approach to evaluating and developing applications for Deep
TMS allows us to continually build upon our clinical pipeline, and advance those applications with the greatest clinical effect and revenue potential. We
also plan to advance other technological innovations in the neuromodulation space for the improvement of our products. For example, we are currently
developing a multichannel stimulator allowing for simultaneous modulation of different areas of the brain, as well as pursuing personalized treatment
solutions allowing for providers to customize ideal treatment approaches for each patient.
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Specific elements of our strategy include the following:
● Increase the full-scale commercialization of Deep TMS for MDD, and of Deep TMS for OCD and accelerate commercialization of Deep TMS
for smoking addiction.
We are continuing to scale up our commercialization of Deep TMS for MDD as we seek to further penetrate the MDD market, including since
September 2021 FDA-cleared treatment to anxious depression. We continue to focus our principal commercial activity on the U.S. market in light
of the market size and wide range of insurance coverage. In addition, we continue our full-scale commercialization of Deep TMS for OCD, which
is first noninvasive medical device FDA-authorized for the treatment of OCD, with reimbursement coverage for this indication obtained during
2021 and 2022 from payers covering approximately 60 million covered lives in the U.S., including by a Medicare Administrative Contractor
(MAC) which recently issued a final Local Coverage Determination (LCD) approving coverage applicable to our Deep TMS for OCD. In
addition, we are operating a controlled market release of Deep TMS for smoking addiction, which is currently the only noninvasive medical
device FDA-authorized for the treatment of smoking addiction.
● Pursue additional indications and technological innovations for Deep TMS.
We are working to expand the application to other areas as well including addictions, such as alcohol use disorder and cocaine and/or opioid
addictions, as well as neurological indications such as multiple sclerosis (“MS”). We intend to progress these plans ourselves and through our
relationships with third-party researchers and clinical institutions in conducting clinical trials for additional psychiatric, neurological, and
addiction disorders. With this approach, we address psychiatric, neurological, and addiction disorders that we believe present some of the most
promising market opportunities for Deep TMS.
● Expand reimbursement coverage for Deep TMS for OCD, smoking addiction and other approved indications in the future.
A key prerequisite to the successful market acceptance of Deep TMS is securing sufficient insurance/third-party payer coverage. The scope and
level of coverage are also key factors in our ability to penetrate the market and to expand further use of our Deep TMS system by healthcare
providers and facilities for the benefit of the larger patient population. Our MDD treatment with Deep TMS is widely eligible for reimbursement,
including from Medicare, subject to the satisfaction of certain clinical criteria. We aim to achieve similar levels of reimbursement for Deep TMS
for OCD (which is already underway) and smoking addiction, and we are also working to obtain reimbursement in other jurisdictions.
● Develop innovative enhancements and features for our Deep TMS systems.
We continue to develop innovative enhancements and features for our Deep TMS systems to expand the applicability of Deep TMS to additional
indications and improve the capabilities of the systems for approved indications. For example, in December 2021 we displayed a future version of
the platform that will serve as the basis for our next generation Deep TMS system, which incorporated a novel multichannel stimulator designed to
target multiple brain regions simultaneously with independent stimulation parameters, thus enabling more flexible and effective treatment of
various brain disorders. These developments include the novel technology of rotational field TMS which involves the operation of two orthogonal
coils to induce a rotating field in the brain. This method can stimulate neurons in various orientations, and we believe may potentially increase the
efficacy of our technology in various applications. We further believe these enhancements hold the potential to make Deep TMS even more
efficient for clinicians, researchers, and patients, and may serve to better position its use in neurology.
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● Increase our international commercial footprint.
We are working to expand our existing commercial footprint in Europe, Asia, Latin America, Australia, and Israel, and pursue commercialization
in additional markets. We currently have exclusive distribution agreements in various territories, including, notably, Japan, South Korea, Taiwan,
Thailand, the Philippines, and the United Arab Emirates. In Israel, we directly provide operations for our customers.
We obtained regulatory approval with the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, which is a precondition to receiving
reimbursement coverage under the Japanese National Health Insurance Plan. We are working through our Japanese distributor with the relevant
bodies in Japan to update the local society guidelines to include Deep TMS in order to obtain such coverage.
Deep TMS for MDD
Disease Overview
MDD is a common and debilitating mental disorder characterized by physiological symptoms, such as sleep disturbance and changes in appetite, emotional
symptoms, such as sadness, despair, emptiness, self-hate and critique, and cognitive symptoms, such as difficulty concentrating, memory dysfunction,
suicidal thinking, and faulty judgment of reality. MDD is expressed differently, and in different intensities, among patients, and significantly impacts the
functioning in all aspects of life. Patients are often not diagnosed due to low levels of awareness of the disease and its symptoms by the patient and the
family doctor involved, or due to prejudice related to psychotherapy. In order to be diagnosed with MDD, a patient must display symptoms that are present
most of the day, nearly every day, for at least two weeks. A diagnosis of MDD is established by clinical interview, and an assessment of whether a patient
reports a collection of the relevant symptoms.
MDD is a recurrent disease and follows a fluctuating course over an individual’s lifetime, with periods of remission and relapse. If an initial episode of
MDD is resolved, the return of depressive symptoms during the first nine months thereafter is referred to as a relapse of the illness and is generally
considered to be part of the same depressive episode. When depressive symptoms return more than 12 months after the initial episode of MDD is resolved,
it is considered to be a recurrence of the illness and is deemed a new and distinct episode. A response to treatment is commonly measured as a clinically
significant decrease in symptoms on a standardized rating scale from baseline scores. When a patient shows no or nearly no symptoms, the patient is
referred to as being in remission. Experiencing one episode of MDD places an individual at an estimated 50% risk of experiencing an additional episode of
MDD. Approximately 80% of those individuals who have experienced two episodes of MDD will experience an additional episode.
In people with MDD, the complex system of neuronal communication does not function properly. One of the most important discoveries in neuroscience
has been the recognition that improper regulation of one or more of the three major neurotransmitters, serotonin, norepinephrine, and dopamine, plays a key
role in a patient’s depression. This understanding has guided psychiatric drug development and the treatment of depression for more than three decades by
placing a major focus on targeting chemically-based mechanisms. The relatively recent introduction of TMS as a targeted, circuit-based treatment option
has reintroduced the importance of electrical mechanisms in restoring proper function to neuronal pathways to treat depression.
Market Information
According to the WHO, an estimated 280 million people worldwide including 21.0 million individuals in the United States develop a major depressive
episode within a given year. We estimate that there are 69 million depression patients in India, 71 million in China, 37 million in Europe, and 6 million in
Japan. MDD is one of the most prevalent mental illnesses across all demographics. According to the Clinical Psychology Review, MDD follows a chronic
course of repeated bouts of remission and recurrence in about 50% of people affected. The chronic nature of MDD makes it the leading cause of years lost
to disability in the world, and MDD patients are more likely to commit suicide. According to the American Journal of Psychiatry, roughly 2% of MDD
patients treated as outpatients, and 4% of those hospitalized because of their condition, commit suicide. In addition, studies suggest that some patients
exhibit a higher mortality rate even after controlling for suicide. Due to the prevalence and severity of MDD, the treatment of the disorder is a pressing
concern for mental health professionals.
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We focus on the population segment for whom conventional treatment (medicinal and/or psychotherapy) of MDD has not provided the required clinical
response, as patients who are treatment-resistant and are entitled to reimbursement for Deep TMS treatment. It is customary to assess that approximately
half of the sufferers from the illness do not respond to the first medicinal treatment, and that one-third do not find conventional solutions to their suffering
at all. In addition, even among patients who receive medicinal treatment that is found effective, many suffer from severe side effects that cause them to
abandon the treatment and be left with their depressive condition. We aim to meet the enormous need of these groups of treatment-resistant patients and
provide effective, non-medicinal treatment which is not accompanied by the systemic side effects of the medication on the one hand and the
electroconvulsive therapy (ECT) treatments on the other hand (such as damage to memory).
Treatment Options for MDD
Treatment for patients diagnosed with MDD varies by disease severity. For patients with mild to moderate depression, first line treatment is usually
psychotherapy (the treatment of mental disorders by psychological means), especially if the patient is able to identify particular stressors or sources of
depressive symptoms. For some of these patients, pharmacotherapy (anti-depressant medication) may be used to supplement psychotherapy. For patients
with moderate depression, pharmacotherapy with or without psychotherapy is the recommended initial treatment. TMS is a second line therapy for the
treatment of a patient who has failed to achieve satisfactory improvement from prior pharmacotherapy. For patients with severe depression and later stage
treatment, somatic treatments such as ECT may be an option.
The central group of anti-depressant medicines is the selective serotonin reuptake inhibitors (SSRI) and selective serotonin and norepinephrine reuptake
(SNR). Drug side effects play a decisive role in treatment selection and modification, as each class of drugs is associated with a host of side effects, some
more severe or more common than others. The most common side effects include gastrointestinal symptoms, sedation, insomnia, weight changes, sexual
dysfunction, nervousness, sleep disruption, nausea, headaches, and cardiovascular or neurological effects. Side effects may also cause patients not to adhere
to the treatment or to abandon it. On initiation of anti-depressant pharmacotherapy, close monitoring for response to treatment and development of side
effects is essential.
The limitations of anti-depressant medications in MDD treatment were demonstrated in the STAR*D study, a large clinical trial funded by the NIMH that
enrolled more than 4,000 adult MDD patients at 41 clinical sites to examine the outcomes to a sequenced series of anti-depressant medication attempts that
mimicked best practices. In the study, only 36.8% and 30.6% of patients achieved remission in their first and second medication attempts, respectively. In
addition, 30-40% of MDD patients did not experience a meaningful response to anti-depressant medication. An analysis conducted in 2020 which was
based on the STAR*D study further reinforced the limitations of anti-depressant medications in MDD treatment, finding that only 21% of patients achieve
remission with medication and that 58% achieved no meaningful benefit with a second step switch to a monoaminergic antidepressant. This means that
there is still a significant number of patients who could benefit from an alternative treatment such as Deep TMS.
Side effects are one of the most commonly cited reasons for patients terminating the use of anti-depressants. The most troubling side effects resulting from
long-term antidepressant use are insomnia, weight gain, gastrointestinal issues, and sexual dysfunction. In addition, correlation was discovered between
consumption of SSRI medications and actualization of suicidal thoughts in youth, and some SSRI group medicines require strict diets and medical
supervision.
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TMS has been used as an antidepressant therapy since 2008. Currently, TMS for MDD is generally recommended for treatment-resistant MDD patients.
Until recently payers typically required that patients fail three or more antidepressant medications prior to receiving TMS; however, there has been a recent
trend to reduce the number of required failures before qualifying for TMS. Based on research showing that TMS is effective in treating depressive
symptoms in patients earlier within the continuum of care, many payors have now reduced the number of prior failed medication trials needed to qualify for
Deep TMS for MDD. Specifically, about 90 million covered lives in the US with commercial coverage now qualify for Deep TMS for MDD after two to
three failed medication trials, and approximately 42 million lives in the US with Medicare reimbursement coverage qualify after just one to two failed
medication trials. For many patients, the side effects associated with pharmacological treatments for depression are a primary reason underlying low
compliance and, subsequently, low efficacy of treatment. For TMS, however, no significant side effects have been observed, other than mild headaches for
a short period of up to a few hours after the treatment, and rare instances of short seizures. The few side effects associated with TMS treatment is
considered one of its main advantages. The most common side effect of Deep TMS treatment is short-lasting mild pain or discomfort around the site of coil
application. This side effect usually only lasts during the first week of treatment. Other adverse reaction reactions such as jaw and face pain, muscle pain,
spasm or twitching, and neck pain were reported as mild or moderate and were also resolved shortly after treatment, as well as seizures in certain patients.
The less severe side effects associated with Deep TMS make it an attractive option for patients.
Alternatives to pharmacological and TMS-based treatments include ECT, vagal nerve stimulation (VNS), and deep brain stimulation (DBS). ECT, the main
psychotherapy alternative to TMS, is a therapy in which patients are administered brief electric currents through the brain. ECT is a noninvasive treatment
carried out by a doctor under full anesthesia and muscle relaxant medicines, and patients often undergo partial hospitalization with recovery time lasting
from hours to even days. While fewer treatment sessions are required (6-12 sessions) compared to TMS (20-30 sessions), each session lasts approximately
an hour compared to the Deep TMS sessions that are typically about 20 minutes each. While ECT has high proven efficacy (70-75%) for patients with
MDD, ECT’s potential for serious side effects, as well as negative stereotypes surrounding the treatment, often cause patients to be reluctant to undergo
ECT. ECT affects the entire brain, including parts which do not need treatment, and may cause permanent cognitive damage, including memory loss. ECT
may have significant and relatively severe side effects, the most common of which are cognitive and memory loss, changes in blood pressure, muscle pains,
nausea, changes in mood, headaches, and pain or discomfort. ECT is currently approved for treatment-resistant depression, severe mania, schizophrenia,
bipolar disorder, aggression or agitation in patients with dementia, and catatonia. It is provided usually in cases of severe MDD, where medicinal treatment
is ineffective or impossible and in instances where the depression constitutes a risk to the life of the patient.
VNS and DBS are invasive therapies that can have serious side effects. Both involve implanted devices, which require surgery. In DBS, two electrodes are
surgically implanted in the brain and a pulse generator is implanted into the patient’s chest. The electrodes produce electrical impulses that can regulate the
electrical activity of the brain. In VNS, a pulse generator is implanted on the upper left side of the chest to stimulate the vagus nerve. VNS and DBS
include surgical related risks, such as infection or local damage to the recurrent laryngeal nerve, which may lead to permanent voice alteration.
Prescription Digital Therapeutics, or PDTs, are a new therapeutic class of products designed to directly treat diseases with software. Certain PDTs are
prescribed by healthcare providers after evaluation by the FDA for safety and efficacy testing via randomized clinical trials. Digital therapeutic companies,
such as Pear Therapeutics, Inc., offer and/or are exploring products across a variety of therapeutic areas including substance abuse, insomnia, and
depression. These products can also include cognitive behavioral therapy (CBT) techniques designed to improve disease outcomes.
Deep TMS for MDD—Our Clinical Trials
Phase III Trial Measuring Efficacy and Safety of Deep TMS
We completed a Phase III trial at 20 different sites in the United States, Canada, Israel, and Germany to test the efficacy and safety of using Deep TMS to
treat MDD between 2009 and 2013. The therapeutic effect was clinically meaningful in both patients who failed one to two medications and patients who
failed three or more medications, indicating that Deep TMS is effective in an even more treatment-resistant population.
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Based on these results, we filed a 510(k) application to the FDA for Deep TMS using BrainsWay’s MDD coil. In 2013, the FDA cleared Deep TMS for the
treatment of MDD in adult patients who have failed to achieve satisfactory improvement from previous anti-depressant medication treatment in the current
episode.
(a) Trial Design
This randomized, double-blind, placebo-controlled, multicenter trial investigated the efficacy and safety of Deep TMS in 212 treatment-resistant adult
MDD patients. Enrolled subjects were randomized in a 1:1 ratio to undergo either monotherapy with active Deep TMS or with a sham. For active Deep
TMS treatment, BrainsWay’s MDD coil was used at 120% stimulation intensity and a frequency of 18 Hz.
The trial was designed with three phases. The first phase was a wash-out phase in which patients slowly stopped any anti-depressants, mood stabilizers, or
antipsychotics that they were previously taking. This phase lasted one to two weeks. The second phase was a four-week acute treatment phase in which
patients received daily treatment with Deep TMS or a sham. The treatments were administered in a five-day sequence each week during the second phase.
Measurements in respect of this phase were taken in week five. The final phase was a 12-week maintenance-continuation phase in which patients received
two treatments per week of Deep TMS or a sham. Measurements in respect of the final phase were taken in week 16.
The primary efficacy endpoint was a change in the 21-question Hamilton Depression Rating Scale (HDRS) at week five (following the end of the acute
treatment phase). The secondary efficacy endpoints were response and remission rates at week five. Response was defined as a reduction of at least 50%
from baseline HDRS score. Remission was defined as a total HDRS score of less than 10. Tertiary efficacy endpoints included a change in HDRS score
from baseline to week 16 and the response and remission rates at week 16. Safety was assessed at every treatment and additional safety evaluations
included auditory threshold tests and cognitive evaluations.
Inclusion and exclusion criteria required patients to meet the following criteria:
● Antidepressant medication-free (following washout period)
● Failure to respond to one to four antidepressant trials or not tolerant of at least two antidepressant treatments in the current episode
● Diagnosed with MDD with a single or recurrent episode
● Duration of current episode must be at least one month but less than seven years
● Score of at least four on the Clinical Global Impression Severity of Illness (CGI-S)
● Score of at least 20 on the HDRS
● No current (or within past year) diagnosis of other Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Axis I disorders (e.g., PTSD,
OCD, other mood disorders, eating disorders, psychotic disorders, or dissociative disorders)
● No history or increased risk of seizures
During analysis, the study results were analyzed in two separate groups: the intention-to-treat (ITT) and per-protocol (PP) analysis sets. The ITT group
included all subjects who met the eligibility criteria and received at least one Deep TMS treatment. Some of these patients, however, were not administered
the treatment at the specified stimulation intensity of 120%. The PP patients included all subjects from the ITT group who received the protocol-specified
treatment and stimulation intensity. Baseline demographic, clinical and safety assessments were performed on the ITT analysis set. Primary efficacy
analysis was performed only on the PP group.
(b) Trial Results
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The primary efficacy endpoint was a change in the HDRS total score from baseline through week five. The change was measured as the slope of a graph of
time point versus HDRS score. The estimated slope for the Deep TMS treatment group was −6.39 while the estimated slope for the sham treatment group
was −3.28. The difference between groups was statistically significant (p = 0.008) for the PP group.
The secondary efficacy endpoints were response and remission rates through week five. As shown in Figure 1, response rates were 38.4% at week five for
the Deep TMS group and 21.4% at the same time point for the sham group. Remission rates were 32.6% for the Deep TMS group and 14.6% for the sham
group. The difference between groups was statistically significant for both response and remission rates (p = 0.0138 and p = 0.0051, respectively).
The tertiary efficacy endpoints were changes in HDRS scores, response, and remission rates at week 16 compared to baseline (see Figure 1 below). The
difference in slope between Deep TMS and sham groups was 2.47, which was statistically significant (p = 0.0259). Additionally, the response rates at week
16 were 44.3% for the Deep TMS group and 25.6% for the sham group, which demonstrated a statistically significant difference between the groups (p =
0.0086). Remission rates at week 16 were 31.8% for the Deep TMS group and 22.2% for the sham group, which was a nonsignificant difference between
groups (p = 0.1492).
Figure 1. Response and Remission Rates for Deep TMS and Sham Groups at Week 5 and Week 16
Source: Levkovitz et al., 2015
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For the group of patients who failed one to two medications, remission rates were 36.6% in the Deep TMS group and 16.7% in the sham group. This was a
statistically significant difference (p = 0.032). For the group of patients who failed three or more medications, remission rates were 28.9% for the Deep
TMS group and 12.2% for the sham group. This difference was just outside of significance (p = 0.057). The data suggest that Deep TMS treatment can
achieve high rates of remission even in patients who have been more resistant to medications.
Figure 2. HDRS Score Change (Slope) and Remission Rates for Deep TMS and Sham Groups in Subpopulations of Patients Who Failed 1 to 2
Medications versus Patients Who Failed 3+ Medications
Source: Levkovitz et al., 2015
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I
Safety Results
Overall, Deep TMS treatment was safe and well-tolerated by patients. The most common reported side effects within the Deep TMS group are as follows:
26.7% of patients experienced headaches, 5.0% experienced application site pain, and 3.0% experienced application site discomfort. The most common
reported side effects within the sham group are as follows: 18.9% of patients experienced headaches, 3.6% experienced insomnia, and 2.7% of patients
experienced back pain. One subject experienced a seizure, following excessive consumption of alcohol on the night before treatment that was not reported
to the treating physician or operator at the time of treatment. This was considered device-related, albeit with the caveat that withdrawal from alcohol may
have led to a reduction of seizure threshold and consequently to this seizure during Deep TMS.
Longer-Term Remission and Response
As demonstrated by our pivotal multicenter study for MDD (as described above), and in another third-party study (Harel et al. (2014)), MDD patients who
achieved remission or response after an acute course of Deep TMS treatment of 20 sessions over four weeks were able to sustain the therapeutic effect by
continuing to undergo Deep TMS treatment beyond the treatment course. Additionally, our trial and the Harel study showed that among MDD patients who
did not achieve a response after an acute course of Deep TMS treatment, the longer such patients continued to undergo Deep TMS therapy, the more likely
they were to achieve remission or response. This result was also demonstrated in another study examining the results of our multicenter trial (Yip et al.
(2017)), which found that 72.7% of the patients who did not achieve response after an acute course of treatment achieved a response within the next 12
weeks (which involved twice weekly Deep TMS treatment), of which 60.6% achieved response within the first four weeks. These studies suggest that Deep
TMS may continue to be effective beyond the standard acute treatment course, potentially broadening its clinical applicability.
Deep TMS for OCD
Disease Overview
OCD is a common, chronic, and long-lasting disorder in which a person has uncontrollable, reoccurring thoughts (obsessions) and behaviors (compulsions)
that he or she feels the urge to repeat over and over in a manner that can interfere with all aspects of life, such as work, school, and personal relationships.
Individuals with OCD exhibit obsessions, compulsions, or both. Obsessions are reoccurring ideas, thoughts, or impulses that cause anxiety that individuals
experience excessively and without cause. Compulsions are defined as repetitive behaviors or thoughts that are performed on a strict schedule and appear to
have a purpose to the patient exhibiting the behavior or thought. Even if an individual is aware that the thoughts are inappropriate or irrelevant, he or she
still might not be able to suppress the thought or the corresponding action. Obsessions tend to be related to contamination, cleanliness, or orderliness, and
so compulsions frequently involve cleaning, washing, counting, arranging things in a particular way, or repeatedly checking on things. These symptoms can
interfere with all aspects of life, such as work, school, and personal relationships. While a wide spectrum of individuals may exhibit OCD-like symptoms,
in order to be diagnosed with OCD, he or she must exhibit symptoms that cause severe distress or disrupt a person’s functioning for more than one hour per
day.
OCD can severely disrupt an individual’s daily functioning, and many individuals suffering from OCD have a lower quality of life and significantly more
mental distress compared to unaffected individuals. A survey of OCD patients found that 73% of patients have weakened family relationships, 62% have
weakened friendships, and 40% are chronically underemployed or unemployed. Patients with both OCD and MDD, a frequent combination of disorders,
experience the most severely impacted quality-of-life. Additionally, individuals with OCD may feel embarrassment or shame regarding their obsessions
and compulsions, contributing to the low treatment-seeking rate of approximately 36%.
Market Information
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Despite variances in estimates of the incidence of the disorder, we believe that a majority of research reports that 2% of the global population suffer from
OCD sometime during their lifetime. According to the National Institute of Mental Health,approximately 1.2% of the adult population in the United States
suffers from OCD over their lifetime. Based on these data, we estimate that approximately 3.1 million adults in the United States suffer from OCD
annually, and approximately half (i.e., 1.5 million) are treatment resistant. Of the total OCD population, 50.6% of cases are characterized as having severe
impairment. Another 34.8% of adults with OCD had moderate impairment, and 14.6% had mild impairment. The average age of onset is 19 years old.
There is a significant overlap of patients experiencing MDD and those experiencing OCD. Researchers found that MDD was 10 times more prevalent in
OCD patients compared to the general population. Additionally, roughly 30% of OCD patients have concurrent OCD and MDD at the time of evaluation,
and 60 to 80% of OCD patients experience a depressive episode over the course of their lifetime. Frequently, depressive symptoms follow OCD, which
suggests that the depressive symptoms occur as a response to the distress caused by OCD.
Treatment Options for OCD
OCD is generally considered to be one of the most difficult psychiatric diseases to treat. The wide variability in the expression of the disease and the
frequent co-morbidity (simultaneous presence) with MDD and other anxiety disorders has complicated the development of an effective, targeted treatment
for OCD. The accepted treatment for OCD is medicinal treatment, psychotherapy or a combination of both. However, up to 40% of patients do not respond
to these treatments sufficiently.
While 60-70% of patients respond or partially respond to treatment with antidepressant medications such as SRIs or SSRIs, there is a high relapse rate of
approximately 60% when medications are stopped. The high relapse rate suggests that pharmacological treatments should be continued over an extended
period of time in order to have continued effect. In addition, when testing a new pharmacological treatment on a patient, it takes 10 to 12 weeks to
determine if the medication is bringing about clinically significant improvements in symptoms. Over half of patients experience a 25% to 35% decrease in
symptoms within 10 to 12 weeks, but symptoms rarely disappear entirely. In addition, 40-60% of OCD patients do not experience a meaningful response to
pharmacological treatment.
Deterrents to treatment include the often-severe side effects of medications. Tricyclic antidepressant medication, generally considered to be an effective
first-line OCD treatment, is known for its particularly strong side effect profile. The medication can cause heightened risk of seizures, weight gain,
sleepiness, tremor, dry mouth, nausea, constipation, visual changes, sweating, and sexual dysfunction. All other OCD medications may cause similar side
effects, which make it challenging for patients to retain a high quality of life while also working toward disease remission. Upon initiation of
pharmacological treatment for OCD, it is critical to closely monitor for development of any adverse effects.
Psychotherapy can be an effective treatment for adults and children with OCD. The treatment may involve controlled exposure to the source of the
obsession and practice of refraining from performance of the compulsion. Research shows that certain types of psychotherapy, including cognitive behavior
therapy (CBT) and other related therapies (e.g., habit reversal training) can be as effective as medication for many individuals. Research also shows that a
type of CBT called Exposure and Response Prevention (EX/RP) is effective in reducing compulsive behaviors in OCD, even in people who did not respond
well to antidepressant medication. For many patients EX/RP is the add-on treatment of choice when antidepressant medication does not effectively treat
OCD symptoms.
Deep TMS presents a novel, FDA-authorized treatment for OCD. In August 2018, the FDA classified and provided marketing authorization for Deep TMS
for OCD as an adjunct treatment (i.e., to be used in conjunction with first-line treatment, such as antidepressant medication or CBT) for adult patients
suffering from OCD. Deep TMS has the unique ability to simultaneously influence a network of specific regions in the brain related to OCD. In addition, it
offers a direct effect over deep regions in the brain associated with the disorder. The effects of the treatment begin within a relatively short time period and
the duration of the entire treatment plan is shorter compared to a medicinal treatment. Deep TMS therapy for OCD has not demonstrated any systemic side
effects, and we believe that Deep TMS presents an attractive alternative to existing treatment options for OCD because antidepressant medications, due to
their side effects, often lead to cessation of treatment by the patient and as a result, relapse of OCD symptoms.
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Positive data published in February 2022 in the Journal of Psychiatric Research demonstrated the relative cost-effectiveness of Deep TMS for refractory
OCD patients when compared with other treatments within the treatment continuum, which includes outpatient medication, CBT, as well as more intensive,
facility-based approaches. The data suggest that Deep TMS is a cost-effective alternative, and particularly indicate that it may serve as an incremental
strategy to employ when higher intensity strategies, such as facility-based approaches, are either unavailable, not financially feasible, or have extended
waits for admission.
In 2021, for the first time, several payers issued policies and coverage determinations allowing for reimbursement coverage applicable to Deep TMS for
OCD. While the criteria for this emerging Deep TMS coverage varies with each payer, generally, coverage requires the failure of between two and four
medication trials before qualifying for reimbursement.
The NIMH is supporting research into new treatment approaches for people whose OCD does not respond well to the usual therapies. These new
approaches include combination and add-on (augmentation) treatments, as well as novel techniques such as deep brain stimulation (DBS).
Deep TMS for OCD — Our Clinical Trials
Phase III Trial Measuring Efficacy and Safety
We completed a Phase III trial at 11 sites in the United States, Israel, and Canada to test the efficacy and safety of Deep TMS as a treatment for OCD,
which was conducted from 2014 through 2017. In this trial, Deep TMS met its safety and efficacy endpoints and based on these results, we filed a de novo
application to the FDA for the Deep TMS (using BrainsWay OCD) in this indication. In August 2018, the FDA classified and granted marketing
authorization for Deep TMS as an adjunct treatment for adult patients with OCD to be used together with other first-line therapies.
(a) Trial Design
This double blind, placebo-controlled trial tested the efficacy and safety of Deep TMS in the treatment of 94 treatment-resistant OCD patients. Enrolled
subjects were randomized to either treatment with active Deep TMS or a sham. Deep TMS for OCD was used for all treatment sessions, each of which
lasted 18.3 minutes. BrainsWay OCD is specifically used in OCD treatment because it targets the anterior cingulate cortex, a region believed to be affected
by OCD.
The trial consisted of three phases. The first phase, lasting one to two weeks, was the screening phase, during which antidepressant medications other than
SSRIs were tapered down and washed out (i.e., to make sure that patients take during the trial only medications that were approved by the protocol (such as
SSRIs), and that they remained stable on these medications). Following the screening phase, patients entered into a six-week treatment phase. During the
first five weeks of the treatment phase, patients received five consecutive sessions per week, followed by one week with four sessions (29 total treatment
sessions). The third phase was the follow-up, in which patients were assessed in week six after their final treatment.
The primary endpoint measure was the Yale-Brown Obsessive Compulsive Scale (YBOCS), which is a score ranging from 0 to 40, with higher scores
indicating greater severity of OCD symptoms. The secondary efficacy endpoint measures were response rate at weeks 6 and 10, partial response rate at
weeks 6 and 10, and remission rates at week 6. Secondary safety endpoint measures included the number of adverse events, physical and cognitive
evaluations, and vital signs.
Inclusion and exclusion criteria required patients to be diagnosed with OCD, have a YBOCS score of greater than 20, and not be diagnosed with any severe
personality disorders.
(b) Trial Results
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After six weeks of treatment, the Deep TMS treatment group had statistically significant improvement in YBOCS score compared to the sham treatment
group. The adjusted mean YBOCS score decreased by 6.04 points in the Deep TMS group and by 3.27 points in the sham control group. The difference
between the slopes of 2.78 points across six weeks between the treatment arms was statistically significant (p-value: 0.0127), and the effect size at week six
assessment was 0.69. As shown in Figure 3, 38.1% of the Deep TMS treatment group achieved a response compared to 11.1% of the sham treatment group.
Furthermore, 54.8% of the Deep TMS treatment group achieved a partial response, compared to 26.7% of the sham treatment group. The differences
between groups were statistically significant for both response rate (p = 0.0033) and partial response rate (p = 0.0076).
Figure 3. Response and Partial Response Rates for Deep TMS and Sham Treatment Groups
One month after the end of treatment (10 weeks after baseline), patients retained clinical improvement of symptoms, and these measures (YBOCS change
and response rate) were significantly better in the Deep TMS group compared to the sham group (p=0.03 for YBOCS change and p=0.0057 for response
rate).
Figure 4 highlights the continued decrease in unadjusted mean YBOCS score from baseline over the ten-week period.
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Figure 4. Total YBOCS Score Change from Baseline over 10-Weeks for Deep TMS and Sham Treatment Groups
Real world data further demonstrates the benefits of Deep TMS for OCD: In a post-marketing study, published as a peer-reviewed paper, the overall first
and sustained response rates were 72.6% and 52.4%, respectively. The response rate was 57.9% in patients who had YBOCS scores after the FDA-cleared
protocol of 29 Deep TMS sessions. First response was achieved in average after 18.5 sessions (SD = 9.4) or 31.6 days (SD = 25.2). Onset of sustained one-
month response was achieved in average after 20 sessions (SD = 9.8) or 32.1 days (SD = 20.5). Average YBOCS scores demonstrated continuous reduction
with increasing numbers of sessions. The results indicate that in real-world clinical practice, the majority of OCD patients benefitted from our therapy, and
the onset of improvement usually occurs within 20 sessions. Extending the treatment course beyond 29 sessions resulted in continued reduction of OCD
symptoms, raising the prospect of value for extended treatment protocols in non-responders.
A study published in November 2021 in the Brain Stimulation journal demonstrates the durability of Deep TMS for OCD and the significant reduction in
functional disability experienced by those who have undergone our therapy for this disorder. To evaluate durability, clinical sites from our pivotal trial, as
well as other clinical sites contributing post-marketing data, conducted follow up assessments with patients that had met response criteria following
treatment with our OCD coil. Durability was defined as the elapsed time from the end of the Deep TMS treatment course until there was a change in
ongoing treatment. Data revealed that of the 60 subjects evaluated from seven clinical sites, 52 demonstrated durability of one year or more (86.7%), 26 of
which showed two or more years of durability. The data also showed that patients exhibited a significant reduction in disability, with self-reported
unproductive days per week dropping from 5.5 days (±0.4) to 1.8 days (±0.4), and self-reported lost days per week dropping from 1.9 (±0.6) to 0.3 days
(±0.2).
Figure 5. OCD Durability and Reduction in Unproductivity
Deep TMS for Smoking Addiction
Disease Overview
Smoking is one of the leading causes of death in developed countries. The addiction to nicotine, similar to the addiction to drugs and alcohol, activates the
limbic system and causes uncontrollable desire to smoke. According to the World Health Organization (WHO), 1.3 billion people globally use tobacco,
primarily cigarette smoking. Globally, more than 8 million people die from smoking each year: 7 million from direct us and 1.2 million from second-hand
smoke. Approximately 34 million U.S. adults smoke cigarettes, and 480,000 die from smoking each year. Repeated nicotine use leads to tobacco use
disorder (TUD), characterized by craving and withdrawal, compulsive use despite negative consequences, repeated relapses, and is associated with multiple
health problems and failed attempts to cease. Smoking causes about 90% of all lung cancer deaths.
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Market Information
The global nicotine replacement therapy (NRT) market was estimated at $2.6 billion in 2019, and this market value is anticipated to increase as a result of
the increasing incidence of chronic, smoking-related diseases. Chantix (Varenicline), the leading smoking cessation pharmaceutical from Pfizer, had sales
of $1.1 billion worldwide in 2019, $899 million from the United States. Considering the U.S. market, there are 34 million cigarette smokers. Each year,
55% attempt to quit smoking (81% of which are motivated to quit.). Only 29% of adult smokers that attempt to quit report using medication (e.g. NRT,
Varenicline, Buproprion), and less than 10% of smokers quit within a given year with varied long-term success.
Treatment Options for Smoking Addiction
One of the most common smoking addiction options is nicotine replacement therapy (NRT), which is the affixing of patches to the body or the chewing of
gum which secrete decreasing concentrations of nicotine in a manner which may assist physical withdrawal. However, this method does not treat the
psychological-behavioral component of the addiction, and therefore there is a high probability that the patient will return to smoking if nicotine patch
treatment is discontinued. A study found that 93% of over-the-counter NRT users relapse and return to smoking within six months.
First line treatment options include antidepressants such as Zyban (bupropion) and Chantix (varenicline). Studies have found advantageous abstinence rates
compared to placebo. Yet, recent studies using objective measures found very low quit rates. A recent meta-analysis found that 20% of smokers treated
with medications remained abstinent for one year, compared to 12% with placebo. The medications may frequently be associated with undesirable adverse
events.
There are studies that indicate that combination of psychological support with pharmacotherapy may increase the chances to quit smoking.
Deep TMS for Smoking Addiction – Our Clinical Trials
Deep TMS presents a novel, FDA-authorized treatment for smoking addiction. In August 2020, the FDA classified and provided marketing authorization
for the use of Deep TMS as an aid in short-term smoking cessation in adults. Deep TMS has the unique ability to simultaneously influence a network of
specific regions in the brain associated with reward and craving. The effects of the treatment begin within a relatively short time period and the duration of
the entire treatment plan is shorter compared to a medicinal treatment. Deep TMS therapy for smoking cessation has not demonstrated any systemic side
effects, and we believe that Deep TMS presents an attractive alternative to existing treatment options for smoking cessation because antidepressant
medications, due to their side effects, often lead to cessation of treatment by the patient and as a result, relapse to smoking.
We concluded with positive results a pivotal multicenter trial assessing the safety and efficacy of Deep TMS as an aid in smoking cessation in adults
suffering from chronic smoking addiction.
The trial was a randomized, double-blind, multicenter study designed to evaluate the safety and efficacy of Deep TMS treatment as an aid in reducing
cigarette smoking in individuals suffering from chronic smoking addiction. It was conducted at 14 sites, primarily in the U.S., and enrolled 262 eligible
subjects randomized into two groups: an active treatment group treated with our proprietary H4 coil targeting addiction-related brain circuits, and a sham
(placebo) control group. The primary endpoint of the study was a comparison between the two groups of the four-week continuous quit rate (CQR),
representing abstinence during a consecutive four-week period. Weekly abstinence was defined as a subject’s self-report (in a diary) of no smoking,
confirmed by urine tests indicating abstinence from smoking. The participants in the study were highly addicted to smoking, with a history of smoking on
average for over 26 years and multiple failed attempts to quit. All of the subjects in the study had at least one prior unsuccessful attempt to quit smoking
before being enrolled in the trial. Over 68% of the subjects had undertaken at least three prior unsuccessful attempts, and over 25% had undertaken at least
five prior unsuccessful attempts.
Participants received three weeks of daily Deep TMS (or sham) treatment followed by one session per week for three more weeks (for a total of 18
treatments over six weeks). Assessment visits, including questionnaires and the collection of urine samples, were performed weekly from week two until
week six. In addition, subjects were asked to keep a record of their smoking behavior on a diary card. Patients reporting abstinence at 6 weeks were invited
for a long follow-up (L-UP) visit at 4 months.
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Of the 169 participants in the study who actually completed three weeks of Deep TMS or sham treatment, plus the mandatory additional three weeks of
follow-up (reaching the six-week endpoint), the CQR was 28.0% in the treatment group compared to 11.7% in the sham group (p=0.007). The primary
endpoint was defined based on the CQR among those subjects who received at least one Deep TMS (or sham) treatment session and had at least one post-
baseline assessment, even if not completing the treatment period. Within this cohort (ITT-E- which consisted of 234 participants and included dropouts)
the CQR was 19.4% in the treatment group and 8.7% in the sham group (p= 0.0174).
The Overall 4-week continuous quit rate (CQR) is shown in the figure below for the active dTMS and sham groups, within the ITT-E and completers (CO)
cohorts.
Figure 6. Overall 4-week Continuous Quit Rates for Deep TMS and Sham Treatment Groups
An important secondary endpoint was the reduction in the number of cigarettes smoked. At baseline, the average number of cigarettes smoked per
week was 123 for the active group and 139 for the sham group. After 3 weeks of treatment, the average number of cigarettes smoked per week was reduced
to 38 in the active group and 57 in the sham group (p= 0.0018, active vs. sham). By the sixth week of the study, the average number of cigarettes smoked
per week declined to 31 for the active group and 48 for the sham group (p=0.0125, active vs. sham).
The numbers of cigarettes per week, from baseline to the 6-week time-point, are shown in the figure below for the two groups. As can be seen, the
difference between the dTMS and sham group is significant starting from week 2.
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Figure 7. Number of Cigarettes Smoked for Deep TMS and Sham Treatment Groups
Sales and Marketing
United States
The United States is our primary and most strategic market, representing approximately 88% of our revenues for the year ended December 31, 2021. We
operate in the United States through our wholly owned subsidiary, BrainsWay USA Inc., as a direct marketing and sales channel, engaging in the
marketing, sales, support, and logistics independently in the United States. As of December 31, 2021, we had 52 U.S. employees, including 45 sales,
marketing and service/operations employees, 4 general and administrative employees, and 3 medical affairs employees.
In the United States, we sell or lease Deep TMS systems by one of the following two methods: (i) a fixed-fee lease model in which the Deep TMS system
is leased to a customer for a fixed annual fee, generally with a term of between 48 to 60 months, for unlimited use; and (ii) a sales or purchase model in
which the Deep TMS system is sold to the customer for a fixed purchase price. Additional potential revenues may be derived from extended warranty fees
paid for the system for service coverage beyond the standard included warranty period, and from variable or usage fees based on the number of treatments
performed with the system. We are also able to leverage our platform technology, which includes the ability to treat multiple indications using different H-
Coil helmets, to facilitate transactions utilizing combined pricing models often involving a single system with one or more add-on helmets. These flexible
offerings are designed to facilitate market penetration by addressing the differing clinical needs and risk tolerance among our customer base.
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As of December 31, 2021, approximately 43% of our global Deep TMS systems installed base for MDD utilized the fixed-fee lease model, and
approximately 47% utilized the sales model. We generally commercialize Deep TMS for OCD utilizing a leasing or purchase model, and often as part of a
combined offering with our MDD system.
We recently began marketing our products for smoking addiction. Specifically, we completed controlled and limited market releases of our system for this
indication, and are currently embarking on a full commercial launch.
The training for operation of our Deep TMS system is not complex and requires about a day of training which includes theoretical learning and a number of
practical hours of practice of placing the helmet on the head of the patient and providing treatment. Deep TMS for OCD requires additional training on
triggering the patient’s OCD symptoms prior to administration of the treatment. Similarly, Deep TMS for smoking addiction involves a provocation
procedure which triggers each individual smoker's craving for his or her preferred cigarette brand prior to the administration of therapy.
After installation of our system, we offer high quality service, technical support, and repair to customers. Customers leasing the device generally receive
support including maintenance and warranty for repairs and replacements during the full term of the lease. In contrast, customers purchasing the device
receive this support for the first year following purchase. Thereafter, the warranty and support can be extended on a yearly basis by paying a set fee.
Our marketing activities include, amongst other things, corporate presence in major commercial and professional conferences, press releases, advertising,
participation in open house and other similar events, social media, Search Engine Optimization (SEO), and other internet-based promotional campaigns,
and release of both direct and online marketing materials, which are all designed to increase the use of our systems for the authorized indications.
Outside of the United States
Approximately 12%, 13% and 12% of our revenues for the fiscal years ended December 31, 2021, 2020 and 2019, respectively, were generated outside of
the United States. A significant part of our sales outside the United States are made indirectly with local distributors and agents. Most of our sales outside
the United States are made only via the purchase model, although we lease some of our Deep TMS systems in France and Israel. Our primary focus is on
selling to hospitals, medical centers and clinics dealing with the treatment of psychiatric neurological and addiction illnesses and disorders.
Our non-U.S. sales are managed both by our internal team in Israel and by local agents in various countries. In Israel, we do not use a distributor and our
sales team distributes directly to our customers. We have exclusive distribution agreements in various territories, including, notably, in Japan, South Korea,
Thailand, Taiwan, the Philippines, and the United Arab Emirates, and are seeking new distribution partners for other strategic markets. Under our
distribution agreements, the distributor typically receives an exclusive right to commercialize the Deep TMS in the relevant territory. The exclusivity is
contingent upon fulfillment of certain quotas, or pre-defined minimum orders of a number of systems per period. We have the right to cancel the exclusivity
of the distributor if the distributor fails to fulfill the set targets. The distributor is required to pay us for each Deep TMS system installed in the territory.
The duration of these agreements varies between distributors and ranges between three and ten years. In territories in which we use a local distributor, the
distributor is generally responsible for obtaining and maintaining the regulatory approvals required for marketing of Deep TMS systems in the territory and
for the installation, training, and maintenance of the systems in the relevant territory. In Japan, we have obtained PMDA regulatory approval for our Deep
TMS system, which is a precondition to receiving reimbursement coverage under the Japanese National Health Insurance Plan. We are working through our
Japanese distributor with the relevant bodies in Japan in an effort to update the local society guidelines to include Deep TMS in order to obtain such
coverage.
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We aim to increase our marketing and sales outside the United States by means of cultivating and supporting our existing distributors, and by considering
other strategic opportunities in various markets. Success of penetration in each country is contingent on a variety of factors, including, among others, the
strength and capabilities of the distribution partner, the existence of regulatory approvals, the availability of reimbursement, the support of key opinion
leaders, and the ability of customers to adopt our technology.
Our Clinical Pipeline
Set forth below is a table presenting the status of our currently planned clinical pipeline:
Additional Potential Deep TMS Applications
Our primary focus for additional potential applications for Deep TMS are fatigue in multiple sclerosis (MS), addictions (for example, cocaine, opioid
and/or alcohol addiction), and potentially additional indications in neurology. The U.S. patient population for MS is approximately 1 million. We recently
announced pilot study results from a randomized, placebo-controlled, double-blind study on the safety and efficacy of Deep TMS in reducing alcohol
consumption and craving in adults with Alcohol Use Disorder (AUD). Analyzing data from 46 subjects, the study demonstrated that subjects in the active
group had an average of 2.9% heavy drinking days (defined as a day on which four or more drinks were consumed for women, or five or more drinks for
men) compared to 10.6% heavy drinking days in the sham group.
We have conducted clinical trials evaluating Deep TMS for a variety of neurological and psychiatric conditions and believe further investigation could pave
the way for marketing authorizations in new indications in the United States and expand the potential for treatment to a wider range of patients. Factors that
contribute to how we prioritize the pursuit of certain clinical studies include, but are not limited to, the strength of our feasibility clinical data, market
potential, required budget, and ease of conduct of the trial. However, there is no guarantee that we will ultimately be successful in obtaining marketing
clearance for the indications prioritized for further study.
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Competition
The industry for the treatment of mental health diseases, disorders, and other conditions is intensely competitive. Our currently marketed Deep TMS
System is, and any future indications we develop and commercialize will be, subject to intense competition. Our Deep TMS system for MDD competes
with existing antidepressant drugs, other TMS therapies and to a lesser degree, more invasive treatments such as ECT, VNS, and DBS. Our Deep TMS
system for OCD also competes with existing medications and other available treatments, although faces less direct competition as we are one of only two
FDA-cleared TMS products for this indication. The industry in which we operate is subject to rapid change and is highly sensitive to the introduction of
new products or other market activities of current or new industry participants. Certain competitors may be larger and have greater resources than us, and
may develop treatment options that receive faster regulatory approvals and/or are more rapidly adopted by clinicians and patients. Our competitors compete
with us on the basis of efficacy and safety, regulatory approvals, price and availability of reimbursement from third-party payers, ease of use/administration
of the treatment option, reputation, and market trends. Key competitive factors affecting the commercial success Deep TMS System are likely to be
efficacy, safety and tolerability, reliability, convenience and time frame of administration, market acceptance of our products relative to alternative
treatments, and reimbursement.
Competitors that sell other forms of TMS therapy for MDD include Neuronetics, MagVenture, Magstim, MAG & More, Cloud TMS, and Nexstim, that
compete directly with us. Their systems are typically based on traditional TMS utilizing a figure-8 coil and are generally FDA-cleared for MDD only,
although MagVenture has a non-clinical trials-based FDA clearance for OCD. By contrast, our unique Deep TMS H-Coils are designed to address a
number of different brain disorders. Other than MagVenture, none of our competitors in the MDD market is currently FDA-cleared for an OCD indication,
and BrainsWay is the only company currently with marketing authorizations for MDD, OCD, and the treatment of smoking addiction.
We also face competition from pharmaceutical and other companies that develop competitive products, such as antidepressant medications (including but
not limited to a nasal spray utilizing the drug esketamine which was recently approved by the FDA for use in conjunction with an oral antidepressant), with
certain competitive advantages such as widespread market acceptance, ease of patient use and well-established reimbursement. In addition, we may face
competition from ketamine, which is used as an anesthetic to treat a variety of brain disorders. Currently in clinical trials, there are a number of
psychedelics including lysergic acid diethyamide (LSD), psilosybin, DMT, and methylendioxymethamphetatmine (MDMA) showing early promise in the
treatment of mental health conditions like depression and PTSD. Our commercial opportunity could be reduced or eliminated if these competitors develop
and commercialize antidepressant medications or other treatments that are safer or more effective than Deep TMS. At any time, these and other potential
market entrants may develop treatment alternatives that may render our products uncompetitive or less competitive.
We are also subject to competition from invasive neuromodulation therapies such as ECT, VNS, and DBS. Major players in this space include Abbott,
Boston Scientific Corporation, LivaNova, and Medtronic. For example, the VNS system developed by Cyberonics (now LivaNova) is FDA-approved for
MDD.
For smoking addiction, there are a wide range of prescription and over-the-counter (OTC) short term aids in smoking cessation. Two prescription
medications that are synonymous with the market are Chantix® (varenicline) and Zyban (buproprion). OTC nicotine replacement therapies continue to
play a major role in a multi-modal approach to smoking cessation, with common forms ranging from chewing gums, to lozenges, to transdermal patches.
Digital therapeutics, including prescription digital therapeutics (PDTs), are also gaining popularity in the space of mental health treatments given the
availability and affordability of smart phones. For all of the conditions we address in the United States, there are numerous popular phone applications to
help reinforce the multi-modal treatment algorithms.
In addition, we may face competition in the future from other noninvasive treatments for MDD (including anxious depression), OCD, and smoking
addiction. Examples of noninvasive treatment options in early development include low-intensity and low-frequency ultrasound (LIFU), transcranial laser
therapy, and infrared therapy. We cannot predict whether any of these or any other treatment options will succeed in clinical trials or be commercially
marketable in the future.
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Intellectual Property
See “Item 5. Operating and Financial Review and Prospects – C. Research and Development, Patents and Licenses.”
Government Grants
As of December 31, 2021, we have received grants from the IIA in an aggregate amount of approximately $13.3 million. We are currently required to pay
3% royalties of sales of our Deep TMS products, which payment obligations do not currently exceed the amount of the grant received (in U.S. dollars), plus
interest at an annual rate equal to the LIBOR rate. As of December 31, 2021, we have paid royalties to the IIA in an aggregate amount of approximately
$3.4 million (including amounts in respect of accrued interest), with remaining outstanding royalties of up to $12.4 million.
In addition, we received from MAGNET approvals for grants in an aggregate amount of NIS 8.2 million (approximately $2.65 million based on the NIS to
USD exchange rate as of December 31, 2021). There is no requirement to repay the grants or pay royalties thereon.
Manufacturing and Supply
We manage all aspects of product supply through our Jerusalem and/or U.S.-based operations teams. We manufacture our proprietary H-Coils and
outsource the manufacture of certain components, including the stimulator, the computer controlling the stimulator, cooling system, the helmet, and the arm
of the helmet, which are produced and tested to our specifications. We assemble Deep TMS systems at our headquarters in Jerusalem, US warehouses
and/or installation sites. In some cases, we rely on third-party providers to provide components used in existing products and we expect to continue to do so
for future products. Our production activities also include manually assembling certain components of our devices for all required clinical and commercial
quantities, and the integration of all components into a functioning Deep TMS system.
We rely on suppliers for most of the components used in manufacturing Deep TMS, including the computer controlling the stimulator, the helmet, and the
arm of the helmet. In addition, we rely on the outsourcing company utilized for the manufacture of our newer systems, including our proprietary stimulator
and various other components. We manage our arrangements with our third-party manufacturers and suppliers to adjust delivery schedules and quantities of
components to match our changing manufacturing requirements. We forecast our component needs based on historical trends, current utilization patterns,
and sales forecasts of future demand. We establish our relationships with our third-party manufacturers and suppliers through supplier contracts and
purchase orders. In most cases, these supplier relationships may be terminated by either party upon short notice. The prices that we pay for sourced
components vary depending on various factors, including the cost of the raw materials required for those components, our required delivery times, and
shipping costs. Magstim (UK) has historically supplied us with stimulators, and it is anticipated that they will continue to be used a source for older
generation systems which do not include our newer FDA-cleared stimulator until such older generation systems remain in usage or are commercially
available.
In order to mitigate the risks related to a single-source of supply, we qualify alternative suppliers when possible, maximize the use of commercial, off the
shelf components and materials, minimize specialized or proprietary manufacturing processes, and develop contingency plans for responding to
disruptions, including maintaining adequate inventory of any critical components. For further discussion of the risks in this regard posed by the supply
chain crisis see “Risk Factors – Our operations could be adversely affected by the global supply chain disruptions”. To date, the supply of finished products
to our customers and clinicians has not been materially adversely affected as a result of component supply issues.
We are subject to extensive governmental regulation in connection with the manufacture of our devices. We must ensure that all of the processes, methods,
and equipment are compliant with the current Quality System Regulations (QSR) for devices on an ongoing basis, mandated by the FDA and other
regulatory authorities, and must conduct extensive audits of vendors, contract laboratories and suppliers. We comply with such regulatory requirements.
Certain of our foreign marketing authorizations requires compliance of said manufacturing process with the ISO 13485 standard, with which we are
compliant.
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Reimbursement
We estimate that over 90% of the total private insurer adult covered lives in the United States have coverage for reimbursement of MDD treatment with
Deep TMS, available after one to four failed (inadequate response or intolerable) trials of antidepressant medications. In addition, our MDD treatment with
Deep TMS is eligible for reimbursement from Medicare, and is expected to be available after one to four failed trials of psychopharmacologic agents (such
as antidepressant medications) and subject to the satisfaction of other clinical criteria. Typically, payors (including Medicare) will provide reimbursement
for up to 36 treatment sessions of Deep TMS for MDD, although the maximum number of covered sessions varies by insurer and/or location.
Over the past year there has been emerging reimbursement coverage for Deep TMS for the treatment of OCD, with approximately 60 million covered lives
eligible for coverage as of March 2022. In early 2021, Centene Corporation, the largest Medicaid managed care organization in the country with over 26
million members issued a positive coverage policy applicable to our Deep TMS therapy for OCD. In June 2021, Health Care Service Corporation (HCSC),
an independent licensee of Blue Cross Blue Shield Association, covering approximately 17 million members issued a positive coverage policy, applicable
to our Deep TMS therapy for OCD. In 2021, Tricare, which covers 9.6 million military family members across the US, also approved coverage of Deep
TMS for OCD. Additionally, in mid 2021, Palmetto GBA, one of the seven Medicare Administrative Contractors (MACs) in the US, issued the first draft
Local Coverage Determination (LCD) proposing coverage applicable to Deep TMS for OCD, and subsequently issued a final LCD approving such
coverage effective March 2022. In addition, there is currently an out-of-pocket market for our Deep TMS systems for OCD, and we are working to broaden
the scope of reimbursement coverage for Deep TMS for OCD treatment, both commercial and governmental, based on a demonstration of the
reasonableness and necessity of the treatment through clinical data. Deep TMS for smoking addiction is not currently eligible for reimbursement. We plan
to seek to obtain coverage as we progress in our commercialization for this indication.
The sale or lease of a medical device utilized for in-office medical treatments depend, in part, on the extent to which such treatments using that device will
be covered by third-party payers, such as government health care programs (e.g., Medicare), private insurance, and managed healthcare organizations. Even
if a third-party payer covers a particular treatment, the resulting reimbursement payment rates may not be adequate to cover a provider’s cost to purchase
such medical device or ensure that purchase or lease will be profitable for the provider. Additionally, patients who are treated in-office for a medical
condition generally rely on third-party payers to reimburse all or part of the costs associated with the treatment and may be unwilling to undergo such
treatment in the absence of coverage and adequate reimbursement.
Reimbursement by a third-party payer may depend upon a number of factors, including the third-party payer’s determination that a treatment is: neither
experimental nor investigational; safe, effective, and medically necessary; appropriate for the specific patient; cost-effective; supported by high quality
evidence published in peer reviewed medical journals; included in clinical practice guidelines; and supported by medical community acceptance and
demand.
Physician reimbursement under Medicare generally is based on a defined fee schedule, or the Physician Fee Schedule, through which payment amounts are
determined by the relative values of the service rendered in a physician office setting or by a physician in a facility setting. Medicare coverage for TMS
also has specific patient history requirements. Medicare coverage for Deep TMS generally requires one to four failed (inadequate response or intolerable)
trials of psychopharmacologic agents (such as antidepressant medications).
In the United States, there is no uniform policy of coverage and reimbursement among private third-party payers. Reimbursement rates from private payers
vary depending on the procedure performed, the commercial payer, contract terms, and other factors. Private third-party payers often rely upon Medicare
coverage policy and payment limitations in setting their own reimbursement policies, but also have their own methods and approval process apart from
Medicare coverage and reimbursement determinations. Private insurance coverage for Deep TMS has traditionally required three to four failures of
antidepressant medications. However, many payors have now reduced the number of prior failed medication trials needed to qualify for Deep TMS for
MDD. Specifically, about 90 million covered lives in the US with commercial coverage now qualify for Deep TMS for MDD after two to three failed
medication trials, and approximately 42 million lives in the US with Medicare reimbursement coverage qualify after just one to two failed medication
trials.
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Coverage and reimbursement for treatments can differ significantly from payer to payer. Decisions regarding the extent of coverage and amount of
reimbursement to be provided for an in-office treatment are made on a plan-by-plan basis. One payer’s determination to provide coverage for a specific
treatment does not assure that other payers will also provide coverage and adequate reimbursement.
In addition, the U.S. federal government and state legislatures have continued to implement cost containment programs, including price controls and
restrictions on coverage and reimbursement. Governmental and private insurers are increasingly challenging the price, examining the medical necessity,
and reviewing the cost-efficacy of medical services. Adoption of price controls and cost containment measures by any such payers, and adoption of more
restrictive policies in jurisdictions with existing controls and measures, could limit our market opportunity and reduce our revenues.
Private insurers currently cover treatments using our Deep TMS system for MDD, and there is now emerging coverage from various payers for Deep TMS
therapy for OCD. We are actively engaged in efforts to facilitate increased coverage for OCD treatment by more payers, including both commercial and
governmental. Reimbursement is not yet available for Deep TMS for smoking addiction or for therapies currently under development for other indications.
However, we are engaged in efforts to obtain coverage for Deep TMS for smoking addiction as our commercialization efforts for that indication progress,
based on the novelty of the technology, unmet clinical need and the efficacy and safety profile of the treatment.
Nonetheless, we can provide no assurances that we will be able to obtain a wide range reimbursement coverage for OCD nor any reimbursement coverage
for smoking addiction, and even if obtained, we can provide no assurance that the coverage will be at the same levels as we have for MDD.
We are also working to include Deep TMS in additional insurance coverages in the United States and in other jurisdictions in which we operate. In regions
where we have appointed a local distributor, where reasonable, it is typically required under our agreements that the distributor utilize efforts to obtain
reimbursement coverage for Deep TMS in the relevant territory on our behalf.
Government Regulation
United States
Our products and our operations are subject to extensive regulation by the FDA and other federal and state authorities in the United States, as well as
comparable authorities in foreign jurisdictions. Our products are subject to regulation as medical devices under the U.S. Federal Food, Drug and Cosmetic
Act (FDCA), as implemented and enforced by the FDA. The FDA regulates the development, design, non-clinical and clinical research, manufacturing,
safety, efficacy, labeling, packaging, storage, installation, servicing, recordkeeping, premarket clearance or approval, import, export, adverse event
reporting, advertising, promotion, marketing and distribution, and import and export of medical devices to ensure that medical devices distributed
domestically are safe and effective for their intended uses and otherwise meet the requirements of the FDCA.
In addition to U.S. regulations, we are subject to a variety of regulations in other jurisdictions governing clinical trials and commercial sales and
distribution of our products. Whether or not we obtain FDA clearance or approval for a product, we must obtain authorization before commencing clinical
trials or obtain marketing authorization or approval of our products under the comparable regulatory authorities of countries outside of the United States.
The marketing authorization process varies from country to country and the time may be longer or shorter than that required for FDA clearance or
approval.
FDA Premarket Clearance and Approval Requirements
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Unless an exemption applies, each medical device commercially distributed in the United States requires either FDA clearance of a 510(k) premarket
notification or premarket approval, or PMA. Under the FDCA, medical devices are classified into one of three classes—Class I, Class II or Class III—
depending on the degree of risk associated with each medical device and the extent of manufacturer and regulatory control needed to ensure its safety and
efficacy. Class I includes devices with the lowest risk to the patient and are those for which safety and efficacy can be assured by adherence to the FDA’s
general controls for medical devices, which include compliance with the applicable portions of the QSR facility registration and product listing, reporting
of adverse medical events, and truthful and non-misleading labeling, advertising, and promotional materials. Class II devices are subject to the FDA’s
general controls, and special controls as deemed necessary by the FDA to ensure the safety and efficacy of the device. These special controls can include
performance standards, post-market surveillance, patient registries, special labeling requirements, premarket data requirements and FDA guidance
documents. While most Class I devices are exempt from the 510(k) premarket notification requirement, manufacturers of most Class II devices are required
to submit to the FDA a premarket notification under Section 510(k) of the FDCA requesting permission to commercially distribute the device. The FDA’s
permission to commercially distribute a device subject to a 510(k) premarket notification is generally known as 510(k) clearance. Devices deemed by the
FDA to pose the greatest risks, such as life-sustaining, life-supporting or some implantable devices, or devices that have a new intended use, or use
advanced technology that is not substantially equivalent to that of a legally marketed device, are placed in Class III, requiring approval of a PMA.
Our Deep TMS system is classified as a Class II medical device. For MDD, smoking addiction, and subsequently granted applications relating to MDD
(including a 3-minute Theta Burst protocol and a labeling expansion to include reduction of comorbid anxiety symptoms among depressed patients), we
obtained FDA marketing authorization through the 510(k) clearance process. For OCD, we obtained FDA marketing authorization through the de novo
classification process. Subsequent changes made to our Deep TMS system will be made through one or more of the various existing FDA review pathways.
510(k) Marketing Clearance Pathway
To obtain 510(k) clearance, we must submit to the FDA a premarket notification submission demonstrating that the proposed device is “substantially
equivalent” to a predicate device already on the market. A predicate device is a legally marketed device that is not subject to premarket approval, i.e., a
device that was legally marketed prior to May 28, 1976 (pre-amendments device) and for which a PMA is not required, a device that has been reclassified
from Class III to Class II or I, or a device that was found substantially equivalent through the 510(k) process. The FDA’s 510(k) clearance process usually
takes nine to 12 months, but may take significantly longer. The FDA may require additional information, including clinical data, to make a determination
regarding substantial equivalence. If the FDA agrees that the device is substantially equivalent to a predicate device currently on the market, it will grant
510(k) clearance to commercially market the device. If the FDA determines that the device is “not substantially equivalent” to a previously cleared device,
the device is automatically designated as a Class III device. The device sponsor must then fulfill more rigorous PMA requirements, or can request a risk-
based classification determination for the device in accordance with the de novo classification process, which is a route to market for novel medical devices
that are low to moderate risk and are not substantially equivalent to a predicate device.
Premarket Approval Process
A PMA application must be submitted if the medical device is in Class III (although the FDA has the discretion to continue to allow certain pre-amendment
Class III devices to use the 510(k) process) or cannot be cleared through the 510(k) process. A PMA application must be supported by, among other things,
extensive technical, pre-clinical, clinical trials, manufacturing, and labeling data to demonstrate to the FDA’s satisfaction the safety and effectiveness of the
device.
After a PMA application is submitted and filed, the FDA begins an in-depth review of the submitted information, which typically takes between one and
three years, but may take significantly longer. During this review period, the FDA may request additional information or clarification of information
already provided. Also, during the review period, an advisory panel of experts from outside the FDA will usually be convened to review and evaluate the
application and provide recommendations to the FDA as to the approvability of the device. In addition, the FDA will conduct a pre-approval inspection of
the manufacturing facility to ensure compliance with the QSR, which imposes extensive design development, testing, control, documentation and other
quality assurance procedures in the design and manufacturing process. The FDA may approve a PMA application with post-approval conditions intended to
ensure the safety and effectiveness of the device including, among other things, restrictions on labeling, promotion, sale, distribution, and collection of
long-term follow-up data from patients in the clinical study that supported approval. Failure to comply with the conditions of approval can result in
materially adverse enforcement action, including the loss or withdrawal of the approval. New PMA applications or supplements are required for significant
modifications to the manufacturing process, labeling of the product and design of a device that is approved through the PMA process. PMA supplements
often require submission of the same type of information as an original PMA application, except that the supplement is limited to information needed to
support any changes from the device covered by the original PMA application, and may not require as extensive clinical data or the convening of an
advisory panel.
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De novo Classification Process
Medical device types that the FDA has not previously classified as Class I, II, or III are automatically classified as Class III regardless of the level of risk
they pose. The Food and Drug Administration Modernization Act of 1997 established a new route to market for low to moderate risk medical devices that
are automatically placed into Class III due to the absence of a substantially equivalent predicate device, called the “Request for Evaluation of Automatic
Class III Designation,” or the de novo classification process. This process allows a manufacturer whose novel device is automatically classified as Class III
to request down-classification of its medical device into Class I or Class II on the basis that the device presents low or moderate risk, rather than requiring
the submission and approval of a PMA application. Prior to the enactment of the Food and Drug Administration Safety and Innovation Act, or FDASIA, in
July 2012, a medical device could only be eligible for de novo classification if the manufacturer first submitted a 510(k) premarket notification and
received a determination from the FDA that the device was not substantially equivalent to a predicate device. FDASIA streamlined the de novo
classification pathway by permitting manufacturers to request de novo classification directly without first submitting a 510(k) premarket notification to the
FDA and receiving a not substantially equivalent determination. We obtained marketing authorization for the OCD indication for our system using the
direct de novo request classification process. We have used the 510(k) clearance process to obtain authorization from the FDA for changes to our marketed
Deep TMS system, including applications extending our clearances to our proprietary stimulator, and expansions to our MDD indication which now allow
us to market a shorter 3 minute depression protocol as well the ability to market our MDD therapy for the reduction of comorbid anxiety symptoms among
depressed patients.
Clinical Trials
A clinical trial is typically required to support a PMA application or de novo classification, and is sometimes required for a 510(k) premarket notification.
Clinical trials for significant risk devices generally require submission of an application for an Investigational Device Exemption, or IDE, to the FDA. The
IDE application must be supported by appropriate data, such as animal and laboratory testing results, showing that it is safe to test the device in humans
and that the investigational protocol is scientifically sound. The IDE application must be approved in advance by the FDA for a specified number of
patients, unless the product is deemed a non-significant risk device and eligible for more abbreviated IDE requirements. Clinical trials for a significant risk
device may begin once the IDE application is approved by the FDA as well as the appropriate institutional review boards (IRBs), at the clinical trial sites,
and the informed consent of the patients participating in the clinical trial is obtained. After a trial begins, the FDA may place it on hold or terminate it if,
among other reasons, it concludes that the clinical subjects are exposed to an unacceptable health risk. Any trials we conduct must be conducted in
accordance with FDA regulations as well as other federal regulations and state laws concerning human subject protection and privacy. Moreover, the results
of a clinical trial may not be sufficient to obtain clearance or approval of the product.
Changes to Marketed Devices
After a device receives 510(k) marketing clearance, or de novo classification, any modification that could significantly affect its safety or efficacy, or that
would constitute a major change or modification in its intended use, will require a new 510(k) marketing clearance or, depending on the modification, a de
novo classification or PMA. The FDA requires each manufacturer to determine whether the proposed change requires submission of a 510(k) or a PMA in
the first instance, but the FDA can review any such decision and disagree with a manufacturer’s determination. Many minor modifications today are
accomplished by a manufacturer documenting the change in an internal letter-to-file. The letter-to-file is in lieu of submitting a new 510(k) to obtain
clearance for every change. The FDA can always review these letters to file in an inspection. If the FDA disagrees with a manufacturer’s determination, the
FDA can require the manufacturer to cease marketing and/or request the recall of the modified device until 510(k) marketing clearance or PMA is obtained.
Also, in these circumstances, the manufacturer may be subject to significant regulatory fines or penalties.
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Post-market Regulation
After a device is cleared or approved for marketing, numerous and extensive regulatory requirements continue to apply. These include:
● establishment registration and device listing with the FDA;
● QSR requirements, which require manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation,
and other quality assurance procedures during all aspects of the design, manufacturing, and distribution process;
● labeling and marketing regulations, which require that promotion is truthful, not misleading, fairly balanced, and provide adequate directions for
use and that all claims are substantiated, and also prohibit the promotion of products for unapproved or “off-label” uses and impose other
restrictions on labeling;
● FDA guidance on off-label dissemination of information and responding to unsolicited requests for information;
● clearance or approval of product modifications to 510(k)-cleared devices that could significantly affect safety or efficacy or that would constitute a
major change in intended use of one of our cleared devices;
● medical device reporting regulations, which require that a manufacturer report to the FDA if a device it markets may have caused or contributed to
a death or serious injury, or has malfunctioned and the device or a similar device that it markets would be likely to cause or contribute to a death or
serious injury or serious adverse events, if the malfunction were to recur;
● correction, removal and recall reporting regulations, which require that manufacturers report to the FDA field corrections and product recalls or
removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health;
● complying with regulations requiring Unique Device Identifiers (UDI) on devices and also requiring the submission of certain information about
each device to the FDA’s Global Unique Device Identification Database (GUDID);
● the FDA’s recall authority, whereby the agency can order device manufacturers to recall from the market a product that is in violation of governing
laws and regulations; and
● post-market surveillance activities and regulations, which apply when deemed by the FDA to be necessary to protect the public health or to
provide additional safety and efficacy data for the device.
We may be subject to similar foreign laws that may include applicable post-marketing requirements such as safety surveillance and risk-benefit analysis.
Our manufacturing processes are required to comply with the applicable portions of the QSR, which cover the methods and the facilities and controls for
the design, manufacture, testing, production, processes, controls, quality assurance, labeling, packaging, distribution, installation, and servicing of finished
devices intended for human use. The QSR also requires, among other things, maintenance of a device master file, device history file, and complaint files.
As a manufacturer, we are subject to periodic scheduled or unscheduled inspections by the FDA. Our failure to maintain compliance with the QSR
requirements could result in the shut-down of, or restrictions on, our manufacturing operations, and the recall or seizure of our products. The discovery of
previously unknown problems with any of our products, including unanticipated adverse events or adverse events of increasing severity or frequency,
whether resulting from the use of the device within the scope of its clearance or off-label by a physician in the practice of medicine, could result in
restrictions on the device, including the removal of the product from the market or voluntary or mandatory device recalls.
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The FDA has broad regulatory compliance and enforcement powers. If the FDA determines that we failed to comply with applicable regulatory
requirements, it can take a variety of compliance or enforcement actions, which may result in any of the following sanctions:
● warning letters, untitled letters, fines, injunctions, consent decrees, and civil penalties;
● recalls, withdrawals, or administrative detention or seizure of our products;
● operating restrictions or partial suspension or total shutdown of production;
● refusing or delaying requests for 510(k) marketing clearance or PMA approvals of new products or modified products;
● withdrawing 510(k) clearances or PMA approvals that have already been granted;
● refusal to grant export or import approvals for our products; or
● criminal prosecution.
U.S. and Foreign Healthcare Laws and Compliance Requirements
Healthcare providers, physicians, and third-party payers play a primary role in the recommendation, prescription, and payment for medical treatments. A
medical device manufacturer’s arrangements with third-party payers, providers, and patients may expose it to broadly applicable fraud and abuse and other
healthcare laws and regulations that may affect its business or the financial arrangements and relationships through which it markets, sells and distributes
its products. Even if a medical device manufacturer does not control referrals of healthcare services or bill directly to Medicare, Medicaid or other third-
party payers, federal, and state healthcare laws and regulations are applicable to its business. In addition, portions of our business may be subject to the
Health Insurance Portability and Accountability Act of 1996 (HIPAA). To the extent we provide any covered entity customers with services that involve the
use or disclosure of protected health information (PHI) we may be required to enter into business associate agreements. Business associates are also
directly liable for compliance with HIPAA. The laws that may affect a medical device manufacturer’s ability to operate include, but are not limited to:
● the federal healthcare Anti-Kickback Statute, which prohibits, among other things, persons and entities from knowingly and willfully soliciting,
receiving, offering or providing remuneration (broadly interpreted to include anything of value), directly or indirectly, overtly or covertly, in cash
or in kind, to induce or reward either the referral of an individual for, or the purchase, lease, order, or arrange for or recommend a good or service
for which payment may be made, in whole or in part, under a federal healthcare program, such as Medicare and Medicaid. The government can
establish a violation of the Anti-Kickback Statute without proving that a person or entity had actual knowledge of the law or a specific intent to
violate. Moreover, the government may assert that a claim for reimbursement that includes items resulting from a violation of the federal
healthcare Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act. Although there are a
number of statutory exceptions and regulatory safe harbors to the federal healthcare Anti-Kickback Statute protecting certain common business
arrangements and activities from prosecution or regulatory sanctions, the exceptions and safe harbors are drawn narrowly. Practices that involve
remuneration to those who prescribe, purchase, or recommend medical device products, including discounts, or engaging individuals as speakers,
consultants, or advisors, may be subject to scrutiny if they do not fit squarely within an exception or safe harbor. Our practices may not in all cases
meet all of the criteria for safe harbor protection from anti-kickback liability. Moreover, there are no safe harbors for many common practices,
such as reimbursement support programs, educational or research grants, or charitable donations;
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● the federal civil False Claims Act (FCA), which prohibits, among other things, individuals or entities from knowingly presenting, or causing to be
presented, false or fraudulent claims for payment of federal government funds, and knowingly making, using or causing to be made or used a false
record or statement material to a false or fraudulent claim to avoid, decrease or conceal an obligation to pay money to the federal government.
Private individuals, commonly known as “whistleblowers,” can bring FCA qui tam actions, on behalf of the government and themselves, and may
share in amounts paid by the entity to the government in recovery or settlement. False Claims Act liability is potentially significant in the
healthcare industry because the statute provides for treble damages and mandatory penalties of $11,181 to $22,363 per false or fraudulent claim or
statement. Many pharmaceutical and medical device manufacturers have been investigated and have reached substantial settlements under the
FCA in connection with alleged off label promotion of their products and allegedly providing free products to customers with the expectation that
the customers would bill federal health care programs for the product. In addition, a claim including items or services resulting from a violation of
the federal healthcare Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the FCA. In addition, manufacturers can be
held liable under the FCA even when they do not submit claims directly to government payers if they are deemed to “cause” the submission of
false or fraudulent claims. There are also criminal penalties, including imprisonment and criminal fines, for making or presenting false, fictitious
or fraudulent claims to the federal government;
● HIPAA, which prohibits and imposes criminal liability for, among other things, knowingly and willfully executing or attempting to execute a
scheme to defraud any healthcare benefit program, including private third party payers, knowingly and willfully embezzling or stealing from a
healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense, and knowingly and willfully falsifying,
concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement or representation, or making or using
any false writing or document knowing the same to contain any materially false, fictitious or fraudulent statement or entry in connection with the
delivery of or payment for healthcare benefits, items or services. Similar to the federal healthcare Anti-Kickback Statute, a person or entity does
not need to have actual knowledge of the statute or specific intent to violate it to have committed a violation;
● HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (HITECH), and their implementing regulations,
which imposes privacy, security, transmission, and breach reporting obligations with respect to individually identifiable health information upon
entities subject to the law, including health plans, healthcare clearinghouses, and certain healthcare providers and their respective business
associates that perform services on their behalf that involve individually identifiable health information. HITECH also created new tiers of civil
monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and gave state attorneys
general new authority to file civil actions for damages or injunctions in federal courts to enforce the HIPAA laws and seek attorneys’ fees and
costs associated with pursuing federal civil actions;
● the federal Physician Payments Sunshine Act, created under the PPACA, which requires certain manufacturers of drugs, devices, biologics and
medical supplies reimbursed under Medicare, Medicaid, or the Children’s Health Insurance Program (with certain exceptions) to report annually to
the United States Department of Health and Human Services information related to payments or other transfers of value made to physicians
(defined to include doctors, dentists, optometrists, podiatrists, and chiropractors), and teaching hospitals, as well as ownership and investment
interests held by physicians and their immediate family members. Beginning in 2022, applicable manufacturers also will be required to report
information regarding payments and transfers of value provided to physician assistants, nurse practitioners, clinical nurse specialists, certified
nurse anesthetists, and certified nurse-midwives; and
● foreign and state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws, that may impose similar or more
prohibitive restrictions, and may apply to items or services reimbursed by any non-governmental third-party payers, including private insurers;
state laws that require device manufacturers to comply with the industry’s voluntary compliance guidelines and the applicable compliance
guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare providers and other potential
referral sources; state laws that require device manufacturers to report information related to payments and other transfers of value to physicians
and other healthcare providers or marketing expenditures and pricing information; and other federal and state laws that govern the privacy and
security of health information or personally identifiable information in certain circumstances, including state health information privacy and data
breach notification laws which govern the collection, use, disclosure, and protection of health-related and other personal information, many of
which differ from each other in significant ways and often are not preempted by HIPAA, thus requiring additional compliance efforts and data
privacy and security laws and regulations in foreign jurisdictions that may be more stringent than those in the United States (such as the European
Union, which adopted the General Data Protection Regulation, which became effective in May 2018).
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Because of the breadth of these laws and the narrowness of their statutory exceptions and regulatory safe harbors, it is possible that some of a medical
device manufacturer’s business activities could be subject to challenge under one or more of these laws. The scope and enforcement of each of these laws is
uncertain and subject to rapid change in the current environment of healthcare reform, especially in light of the lack of applicable precedent and regulations
on some issues. Federal and state enforcement bodies have recently increased their scrutiny of interactions between healthcare companies and healthcare
providers, which has led to a number of investigations, prosecutions, convictions and settlements in the healthcare industry.
Ensuring that business arrangements with third parties comply with applicable healthcare laws and regulations is costly and time consuming. If a medical
device manufacturer’s operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to it, it
may be subject to civil, criminal and administrative penalties, damages, fines, disgorgement, substantial monetary penalties, individual imprisonment,
exclusion from governmental funded healthcare programs, such as Medicare and Medicaid, additional reporting obligations and oversight if it becomes
subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws, reputational harm, diminished
profits and future earnings, and the curtailment or restructuring of operations, any of which could adversely affect the ability of a medical device
manufacturer to operate its business and the results of its operations.
United States Healthcare Reform
In the United States, a number of legislative and regulatory proposals have been considered or enacted to change the healthcare system in ways that could
affect a medical device manufacturer’s business. Among policy makers and governmental and private insurers in the United States, there is significant
interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality or expanding access. For
example, in 2010, the PPACA was enacted, which includes measures to significantly change the way health care is financed by both governmental and
private insurers, and significantly impacts the medical device industry. Among other ways in which it may impact a medical device manufacturer’s
business, the PPACA:
● establishes a new Patient-Centered Outcomes Research Institute to oversee and identify priorities in comparative clinical efficacy research in an
effort to coordinate and develop such research;
● implements payment system reforms including a national pilot program on payment bundling to encourage hospitals, physicians, and other
providers to improve the coordination, quality, and efficiency of certain healthcare services through bundled payment models; and
● expands the eligibility criteria for Medicaid programs.
Some of the provisions of the PPACA have yet to be implemented, and there have been judicial and Congressional challenges to modify, limit, or repeal
certain aspects of the PPACA since its enactment and have continued to evolve. During his presidency, President Trump has supported the repeal of all or
portions of the PPACA, and in January 2017, he signed Executive Orders designed to delay the implementation of certain provisions of the PPACA or
otherwise circumvent some of the requirements for health insurance mandated by the PPACA to the maximum extent permitted by law. Due to such efforts,
certain elements of the PPACA have been invalidated or suspended, which has, in turn, led to additional challenges against the law as a whole. For
example, the Tax Cuts and Jobs Act of 2017 included a provision repealing, effective January 1, 2019, the tax-based shared responsibility payment imposed
by the PPACA on certain individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly referred to as the “individual
mandate”. As a result, there is significant uncertainty regarding future healthcare reform and its impact on our operations. In December 2018, a district
court in Texas held that the individual mandate is unconstitutional and that the rest of the PPACA is, therefore, invalid. On appeal, the Fifth Circuit Court of
Appeals affirmed the holding on the individual mandate but remanded the case back to the lower court to reassess whether and how such holding affects the
validity of the rest of the PPACA. The Fifth Circuit’s decision on the individual mandate was appealed to the U.S. Supreme Court. On June 17, 2021, the
Supreme Court held that the plaintiffs (comprised of the state of Texas, as well as numerous other states and certain individuals) did not have standing to
challenge the constitutionality of the PPACA’s individual mandate and, accordingly, vacated the Fifth Circuit’s decision and instructed the district court to
dismiss the case. As a result, the PPACA will remain in-effect in its current form for the foreseeable future; however, we cannot predict what additional
challenges may arise in the future, the outcome thereof, or the impact any such actions may have on our business.
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The Biden administration also introduced various measures in 2021 focusing on healthcare and drug pricing, in particular. For example, on January 28,
2021, President Biden issued an executive order that initiated a special enrollment period for purposes of obtaining health insurance coverage through the
PPACA marketplace, which began on February 15, 2021, and remained open through August 15, 2021. The executive order also instructed certain
governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare, including among others, reexamining
Medicaid demonstration projects and waiver programs that include work requirements and policies that create unnecessary barriers to obtaining access to
health insurance coverage through Medicaid or the PPACA. On the legislative front, the American Rescue Plan Act of 2021 was signed into law on March
11, 2021, which, in relevant part, eliminates the statutory Medicaid drug rebate cap, currently set at 100% of a drug’s average manufacturer price, for single
source drugs and innovator multiple source drugs, beginning January 1, 2024. And, in July 2021, the Biden administration released an executive order
entitled, “Promoting Competition in the American Economy,” with multiple provisions aimed at prescription drugs. In response, on September 9, 2021,
HHS released a “Comprehensive Plan for Addressing High Drug Prices” that outlines principles for drug pricing reform and sets out a variety of potential
legislative policies that Congress could pursue as well as potential administrative actions HHS can take to advance these principles. And, in November
2021, President Biden announced the “Prescription Drug Pricing Plan” as part of the Build Back Better Act (H.R. 5376) passed by the House of
Representatives on November 19, 2021, which aims to lower prescription drug pricing by, among other things, allowing Medicare to negotiate prices for
certain high-cost prescription drugs covered under Medicare Part D and Part B after the drugs have been on the market for a certain number of years and
imposing tax penalties on drug manufacturers that refuse to negotiate pricing with Medicare or increase drug prices “faster than inflation.” If enacted, this
bill could have a substantial impact on our business. In the coming years, additional legislative and regulatory changes could be made to governmental
health programs that could significantly impact pharmaceutical companies and the success of our product candidates. At the state level, legislatures have
increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient
reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases,
designed to encourage importation from other countries and bulk purchasing.
There is uncertainty as to what healthcare programs and regulations may be implemented or changed at the federal and/or state level in the U.S. or the
effect of any future legislation or regulation. Furthermore, we cannot predict what actions the Biden administration will implement in connection with the
PPACA.
However, it is possible that such initiatives could have an adverse effect on our ability to obtain approval and/or successfully commercialize products in the
United States in the future. For example, any changes that reduce, or impede the ability to obtain, reimbursement for the type of products we intend to
commercialize in the United States (or our products more specifically, if approved) or reduce medical procedure volumes could adversely affect our
business plan to introduce our products in the United States.
Outside of the United States
We also have received European Conformity (CE) marking in the European Economic Area (EEA) and in Israel for MDD, OCD, and smoking addiction,
and 11 other indications in psychiatry, addiction treatment, and neurology. Additional regulatory approvals have also been obtained for Deep TMS in
various other existing and potential territories, including, for example, in Canada and India. Sales and marketing of medical devices outside of the United
States are subject to foreign regulatory requirements that vary widely from country to country. The time required to obtain appropriate marketing
authorizations from other foreign authorities may be longer or shorter than that required for FDA approval. Whether or not we have obtained FDA
approval, our Deep TMS systems may be subject to different regulatory requirements in other jurisdictions. The foreign regulatory approval process
includes all the risks associated with FDA regulation, as well as country-specific regulations.
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Employees
Our employees include professionals with extensive experience in medical device development and applications, neurology and psychopathology, pre-
clinical experimentation, clinical development, and business development. As of December 31, 2021, we had 118 employees, of which 52 were based in
the United States and 66 were based outside of the United States (in Israel). Our U.S. employee base includes 45 employees in sales, marketing, and
service/operations, 3 employees in medical affairs, and 4 general and administrative employees. Our Israeli employee base includes 49 employees in
clinical trials, research and development, production, and service/operations, 4 employees in sales and marketing, and 13 general and administrative
employees.
While none of our employees are party to any collective bargaining agreements, certain provisions of the collective bargaining agreements between the
Histadrut (General Federation of Labor in Israel) and the Coordination Bureau of Economic Organizations (including the Industrialists’ Associations) are
applicable to our employees by order of the Israel Ministry of Labor. Such orders are part of the employment related laws and regulations which apply to
our employees and set certain mandatory terms of employment. Such mandatory terms of employment primarily concern the length of the workday,
minimum daily wages, pension plan benefits for all employees, insurance for work-related accidents, procedures for dismissal of employees, severance pay
and other conditions of employment. We generally provide our employees with benefits and working conditions beyond the required minimums.
We have never experienced an employment-related work stoppage and we believe our relationship with our employees is good.
Environmental Matters
We are subject to various environmental, health and safety laws and regulations, including those governing noise emissions. We believe that our business,
operations, and facilities are being operated in compliance in all material respects with applicable environmental and health and safety laws and
regulations. Based on information currently available to us, we do not expect environmental costs and contingencies to have a material adverse effect on us.
Significant expenditures could be required in the future, however, if we are required to comply with new or more stringent environmental or health and
safety laws, regulations or requirements.
Legal Proceedings
We are not involved in any material legal proceedings.
C.
Organizational Structure
Our three subsidiaries, all of which wholly-owned are: BrainsWay, Inc., incorporated in Delaware on March 31, 2003, Brain Research and Development
Services Ltd., incorporated in Israel on August 13, 2003, and BrainsWay USA Inc., incorporated in Delaware on November 24, 2014.
D.
Property, Plants and Equipment
BrainsWay has offices in the United States and Israel.
In Israel, the Company has leased offices in Jerusalem, Israel, since November 2007, pursuant to a lease agreement that expires in September 2022. The
facility contains approximately 1,505 square meters of space, and lease payments and management fees are approximately $30,000 plus value added tax, or
VAT, per month, in the aggregate, and are paid in NIS. This facility houses various administrative functions, as well as research operations and our central
laboratory. Substantially all of our Israeli-based employees are based in this facility. We also lease a warehouse and storage area within the same building
as our Jerusalem offices pursuant to a lease addendum subject to a term (also expiring in September 2022) comprised of approximately 280 square meters,
and subject to monthly fees in the amount of approximately $2,500 plus VAT in the aggregate, paid in NIS.
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In the United States, the Company's corporate headquarters is located in Boston, MA, in a space comprised of 3,976 square feet leased at a rate of $8,118
per month, with a contractual lease term that expires in November 2024. We have also had corporate offices located in New Jersey since April 2016. Our
Cresskill, NJ offices occupy a space comprised of approximately 2,326 square feet leased at a rate of $4,815 per month, pursuant to a lease with a current
term expiring (unless extended) in June 2023.
ITEM 4A.
UNRESOLVED STAFF COMMENTS
Not applicable.
ITEM 5.
OPERATING AND FINANCIAL REVIEW AND PROSPECTS
You should read the following discussion of our financial condition and results of operations in conjunction with the financial statements and the notes
thereto included elsewhere in this Annual Report. The following discussion contains forward-looking statements that reflect our plans, estimates and
beliefs. Our actual results could differ materially from those discussed in the forward-looking statements. Factors that could cause or contribute to these
differences include those discussed below and elsewhere in this Annual Report, particularly those in “Item 3. Key Information – D. Risk Factors.”
Company Overview
BrainsWay is a leader in advanced noninvasive neurostimulation treatments for mental health disorders. The Company is boldly advancing neuroscience
with its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology to improve health and transform lives. We are dedicated
to leading through superior science and building on our substantial body of clinical evidence. We are the first and only TMS company to obtain from the
U.S. Food and Drug Administration (FDA) three cleared indications backed by pivotal studies demonstrating clinically proven efficacy. Current indications
include major depressive disorder (MDD), including reduction of comorbid anxiety symptoms, commonly referred to as anxious depression, obsessive-
compulsive disorder (OCD), and smoking addiction. We have also received CE Mark for a variety of psychiatric and neurological indications. We are
focused on increasing global awareness of and broad access to Deep TMS. Deep TMS uses magnetic pulses to stimulate neurons and consequently
modulates the physiological activity of the brain. Our technology can either increase brain activity in neuronal networks which are hypoactive, or
alternatively decrease brain activity in neuronal networks which are hyperactive. Our proprietary electromagnetic coils, which we refer to as H-Coils, are
designed to safely stimulate deep and broad brain regions, which we believe provides an advantage over other available TMS products, which we refer to
collectively as Traditional TMS, that generally use a “figure 8” design. In the United States, we sell our Deep TMS system for the treatment of MDD
(including reduction of comorbid anxiety symptoms, commonly referred to as anxious depression) and OCD and have recently began marketing our
products for the treatment of smoking addiction in the United States. We believe that our Deep TMS technology has the potential to be safe and effective
for the treatment of a wide range of additional psychiatric, neurological, and addiction disorders. Additional clinical trials of Deep TMS in various
psychiatric, neurological, and addiction disorders are underway or planned.
Our first commercial Deep TMS product received clearance from the FDA in 2013 for the treatment of MDD in adult patients who have failed to achieve
satisfactory improvement from anti-depressant medication in the current episode. Our Deep TMS system for MDD is currently marketed to and installed at
psychiatrists’ offices and other facilities principally in the United States and in certain other countries throughout the world. In addition, our second Deep
TMS system received FDA marketing authorization in August 2018 as an adjunct therapy for adult patients suffering from OCD, and we are currently
market and sell that indication. In addition, our third Deep TMS system received FDA marketing authorization in August 2020 as a short-term therapy for
smoking addiction. Moreover, in August 2021, we received 510(k) clearance from the FDA for our Deep TMS for its use for the reduction of comorbid
anxiety symptoms in adult patients with depression. Our sales and marketing efforts are currently focused in the United States, where we generated
approximately 88 % of our revenues in the year ended December 31, 2021.
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We believe that Deep TMS represents a platform technology that provides for an opportunity to develop additional Deep TMS products for a variety of
psychiatric, neurological, and addiction disorders. We are planning multicenter trials for other indications, including multiple sclerosis (MS), which would
be our first neurological indication, and potentially various other addiction disorders beyond smoking addiction.
Our current customers are principally doctors, hospitals, and medical centers in the field of psychiatry. Treatment with Deep TMS is typically performed as
an office-based procedure using our Deep TMS system, which consists of our proprietary H-Coil helmet, as well as several other components, including a
stimulator, cooling system, positioning arm and an operator interface. A course of treatment for MDD typically requires 20 treatment sessions five times a
week over a period of four weeks, and thereafter up to 24 additional maintenance-continuation sessions twice weekly over a period of up to 12 weeks. The
standard Deep TMS treatment protocol for OCD requires 29 treatment sessions over six weeks. A course of treatment for smoking addiction typically
requires 18 treatment sessions, comprised of treatment five times a week over a period of three weeks, followed by treatment once per week for an
additional three weeks. Each standard MDD, OCD or smoking addiction session lasts 20 minutes, 19 minutes, and 18 minutes, respectively. For Deep TMS
for MDD, the FDA also cleared a 3 minute “Theta Burst” treatment protocol. Patients may experience some discomfort during treatment and must use
earplugs to reduce exposure to the loud sounds produced by the device. The treatment requires no anesthesia, hospitalization or sedation and no systemic
side effects are associated with this therapy.
In the United States, we sell or lease Deep TMS systems by one of the following two methods: (i) a fixed-fee lease model in which the Deep TMS system
is leased to a customer for a fixed annual fee, generally with a term of between 48 and 60 months, for unlimited use; and (ii) a sales or purchase model in
which the Deep TMS system is sold to the customer for a fixed purchase price. Additional potential revenues may be derived from extended warranty fees
paid for the system for service coverage beyond the standard included warranty period, and from variable or usage fees based on the number of treatments
performed with the system. We are also able to leverage our platform technology, which includes the ability to treat multiple indications using different H-
Coil helmets, to facilitate transactions utilizing combined pricing models often involving a single system with one or more add-on helmets. These flexible
offerings are designed to facilitate market penetration by addressing the differing clinical needs and risk tolerance among our customer base. We
commercialize Deep TMS for OCD based generally on either the sale model, or as part of a fixed-fee lease model together with our MDD system. We
recently completed a controlled market release, and then a limited market release of Deep TMS for smoking addiction and are currently preparing for a full
market launch of our Deep TMS system for this indication.
As of December 31, 2021, we had an installed base of approximately 754 Deep TMS systems, whereby 396 systems were leased from us, and an additional
358 systems were sold by us prior to December 31, 2021. Our installed base increased by 125 systems during 2021. In addition, as of December 31, 2021,
we had shipped 302 OCD coils as additional coils attached to certain of our new and existing systems following our receipt in August 2018 of marketing
approval from the FDA for our OCD system.
For the year ended December 31, 2021, our revenues were $29.7 million compared to $22.1 million for the year ended December 31, 2020, representing an
increase of 34% over the revenues generated in 2020. We incurred net losses of $6.4 million for the year ended December 31, 2021.
As of December 31, 2021, we had an accumulated deficit of $83.8 million. Our primary sources of capital to date have been from public offerings in Israel
and in the United States, and private placements of our securities, grants from the Israel Innovation Authority (IIA), borrowings under our credit facilities,
and the lease and sale of our products.
We expect our research, development, and clinical trials expenses to increase in connection with our ongoing activities, particularly as we continue to
develop next generation technology (including in the areas of multichannel and rotational field TMS), rollout additional features on our current platform
(including beta testing of additional remote capabilities), pursue future confirmatory trials and data collection efforts for existing indications, and seek FDA
clearance for new indications such as fatigue in MS, addictions (including alcohol, cocaine and/or opioid addiction), and pain. In addition, we expect to
incur significant commercialization expenses for product sales, marketing, manufacturing, and distribution. On February 25, 2021 we closed a follow-on
underwritten public offering of ADSs with gross proceeds of approximately $45.2 million before deducting underwriting discount and commissions and
offering expenses. We believe that our existing cash resources will be sufficient to enable us to fund our operating expenses and capital expenditure
requirements for at least the next 24 months.
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Components of Our Results of Operations
Revenues
We derive our revenues from the lease and sale of our Deep TMS systems. We offer the following pricing models:
● Fixed-fee Lease Model: The customer leases the Deep TMS system and pays a fixed annual or monthly fee for the term of the lease (generally
between 48 and 60 months).
● Sale Model: The Deep TMS system is sold to the customer for a fixed purchase price.
Additional potential revenues may be derived from extended warranty fees paid for the system for service coverage beyond the standard included warranty
period, which is generally for one year, and from variable or usage fees based on the number of treatments performed with the system.
We are also able to leverage our platform technology, which includes the ability to treat multiple indications using different H-Coil helmets, to facilitate
transactions utilizing combined pricing models often involving a single system with one or more add-on helmets.
Our revenues from the operating leases of our Deep TMS systems are recognized on a straight-line method over the term of the lease. Usage based fees, if
applicable, are recognized as revenue when we are entitled to receive such revenue. Our revenues from sales are recognized when control of the system is
transferred to the customer, generally upon delivery of the system.
Cost of revenues and gross margin
Our cost of revenues includes a significant component of depreciation of the Deep TMS systems, due to the fact that we maintain ownership of those
systems placed under our fixed-fee lease model, in which we lease the system for use by our customers, rather than sell it outright. We expect to continue to
own those of our Deep TMS systems which have been placed under our fixed-fee lease model for the foreseeable future, which allows us to maintain our
relatively low cost of revenues for those systems.
In the case of the Deep TMS systems that we sell under our sales model, the entire cost of the Deep TMS system is recognized upon such sale. The cost of
revenues for systems that we sell primarily consists of the costs of raw materials, including components purchased from our third-party contract
manufacturers and manufacturing and assembly of the components that we perform ourselves. While we have previously used a third-party stimulator for
our Deep TMS systems, we developed and have received FDA clearance for our own proprietary stimulator for MDD (in May 2018), OCD (in
March 2019), and smoking addiction (in April 2021).
The cost of revenues for systems that we lease or sell also include costs related to personnel, royalties to PHS and Yeda, shipping, and our operations
department. We expect our cost of revenues to increase in absolute dollars to the extent our revenues increase.
Selling and marketing expenses
Selling and marketing expenses consist of marketing and commercial activities related to the sale and lease of our Deep TMS systems, as well as personnel
expenses, including salaries and related benefits, sales commissions, share-based compensation for employees, and facility costs. Other significant sales
and marketing costs include conferences, trade shows, and promotional and marketing activities, including direct and online marketing, SEO, earned
media, practice support programs, media campaigns and travel expenses.
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We anticipate an increase in the headcount of our commercial organization as we continue to expand our business in the United States and internationally,
and as we receive the relevant regulatory clearances for additional indications for our system. As a result, we expect our sales and marketing expenses to
continue to increase.
Research and development expenses, net
Research and development expenses, net, consist primarily of personnel expenses, including salaries and related benefits, share-based compensation for
employees, facility costs, laboratory materials, regulatory costs, patents, and travel expenses, as well as expenses associated with outsourced professional
scientific development services, and the costs of multi-center and other clinical trials.
We expect to continue to incur research and development expenses for the near future as we advance the development of our Deep TMS technology for the
treatment of new indications, which may include fatigue in MS, and other potential psychiatric, neurological, and addiction indications, as well as for
various hardware and software development projects related to the Deep TMS system. As a result, we expect our research and development expenses to
continue to increase.
A portion of our investment in research and development is funded by participation of the IIA through grants which are presented net of research and
development expenses.
General and administrative expenses
General and administrative expenses consist primarily of personnel expenses, including salaries and related benefits, share-based compensation, and travel
expenses for employees in executive, finance, information technology, legal, and human resource functions. General and administrative expenses also
include the cost of insurance, professional services, including legal and accounting fees as well as administrative costs, including corporate facility costs.
We anticipate that our general and administrative expenses will increase due to planned expansion of our activities. We anticipate higher corporate
infrastructure costs including, but not limited to, accounting, legal, human resources, consulting, investor relations, listing fees on The Nasdaq Global
Market, costs associated with reporting and compliance in the United States, as well as increased director and officer insurance premiums, as a result of
becoming a public company in the United States.
Finance expenses, net
Our finance expenses, net, consist primarily of expenses related to bank charges, and the amortization of deferred financing costs related to our finance
expense with respect to the fair value re-measurement related to our outstanding liability to the IIA on account of grants received for financing our research
and development activity, as well as interest income earned on our bank deposits and foreign currency exchange transactions.
Income taxes expense
Our income taxes expense is derived primarily from income generated from the sales and lease of our Deep TMS systems from our U.S. subsidiary. During
the year ended December 31, 2021, the Company recorded deferred tax assets in respect of temporary differences in the U.S. subsidiary.
Critical Accounting Policies and Estimates
The preparation of financial statements, in conformity with IFRS, requires companies to make estimates and assumptions that affect the reported amounts
of assets, liabilities, revenues and expenses, and disclosure of contingent assets and liabilities at and as of the date of the financial statements and the
reported amounts of revenues and expenses during the reporting period. These estimates and judgments are subject to an inherent degree of uncertainty, and
actual results may differ. Our significant accounting policies are more fully described in Note 2 to our financial statements included elsewhere in this
report. Critical accounting estimates and judgments are continually evaluated and are based on historical experience and other factors, including
expectations of future events that are believed to be reasonable under the circumstances, and are particularly important to the portrayal of our financial
position and results of operations. Our estimates are primarily guided by observing the following critical accounting policies:
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Revenue Recognition
We generate revenues from the sale and lease of our systems. We sell products mainly directly to end users, third party financing companies with
arrangements with end users, and to a lesser extent, to third-party distributors outside of the United States which typically do not include return rights. We
typically have post-sale obligations of training and installation of our systems and may provide an annual service warranty for the Deep TMS system after
the expiration of the standard warranty. Revenues for such services are deemed distinct performance obligations and are recognized when the services are
performed.
Revenue from sale of systems are recognized at the point in time when control of the system is transferred to the customer, generally upon delivery of the
system to the customer.
We generate lease revenue from a fixed-fee lease model in which the Deep TMS system is leased to a customer for a fixed annual fee, generally for a term
of between 48 to 60 months, allowing for unlimited use during the lease period. Leases in which substantially all the risks and rewards incidental to
ownership of the leased asset are not transferred to the lessee are classified as operating leases. Revenues from operating leases are recognized on a
straight-line basis over the lease term. Usage based fees are recognized as revenue when the Company is entitled to receive such revenue.
Allowance for doubtful accounts based on expected credit losses on trade receivables
We apply a simplified approach and measure the loss allowance in respect of our short -term financial assets, trade receivables, in an amount equal to the
lifetime expected credit losses.
The Company records an allowance for doubtful accounts based on expected credit losses for trade receivables. The allowance rates are based on days past
due for its various customers. The allowance is initially based on the Company’s historical observed default rates as well as forward-looking information.
At each reporting date, the historical observed default rates are updated and changes in the forward-looking estimates are analyzed. The amount of the
allowance is sensitive to changes in circumstances and forecasted economic conditions.
Royalty Bearing Governmental Grants
Government grants are recognized when there is reasonable assurance that the grants will be received, and the Company will comply with all attached
conditions. Government grants received from the IIA and repayable to the IIA through royalty-bearing sales are recognized upon receipt as a liability if
future economic benefits are expected to be derived through estimated future cash flows from the research project, resulting in royalty bearing sales due to
the IIA.
A liability for the grant is first measured at fair value using a discount rate that reflects a market rate of interest. The difference between the amount of the
grant received and the fair value of the liability is accounted for as a government grant and recognized as a reduction of research and development
expenses. After initial recognition, the liability is measured at amortized cost using the effective interest method. Royalty payments are recorded as a
reduction of the liability.
If no economic benefits are expected from the research activity, the grants received are recognized as a reduction of the related research and development
expenses. In that event, the royalty obligation is treated as a contingent liability.
On each reporting date, the Company evaluates whether there is reasonable assurance that the liability recognized, in whole or in part, will not be repaid
based on the best estimate of future sales and using the original effective interest method and, if so, the appropriate amount of the liability is derecognized
against a corresponding reduction in research and development expenses.
Grants received from the IIA prior to January 1, 2009, which are recognized as a liability, are accounted for as forgivable loans in accordance with IAS 20,
based on the original terms of the loan.
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Share-based compensation
Share-based compensation reflects the compensation expense of our stock option, and more recently, restricted share unit (RSU) programs granted to
employee and other service providers, in which the compensation expense is measured at the grant date fair value of the award. The grant date fair value of
share-based compensation is recognized as an expense over the requisite service period, net of estimated forfeitures. We recognize compensation expense
for awards conditioned only on continued service that have a graded vesting schedule using the accelerated method and classify these amounts in our
statement of comprehensive loss based on the department to which the related employee/service provider reports.
Traditionally, the preferred form of equity compensation to our employees, consultants and directors was in the form of options. On May 4, 2021, we
commenced a tender offer to exchange eligible options (“Eligible Options”) to purchase Ordinary Shares, par value NIS 0.04 per Ordinary Share, for
replacement options to purchase Ordinary Shares (“New Options”), with modified terms pursuant to the Offer to Exchange Eligible Options for New
Options, dated May 4, 2021 (the “Exchange Offer”). Following the Exchange Offer, to better align with the interests of prospective grantees, among other
factors, we principally shifted toward equity grants in the form of RSUs.
Share-Based Compensation Valuation
We selected the Binomial Lattice option-pricing model as the most appropriate method for determining the estimated fair value of options compensation.
For the purpose of the evaluation of the fair value, and the manner of the recognition of options compensation, our management is required to estimate,
among others, various subjective parameters that are included in the calculation of the fair value of the options compensation, as well as our results and the
amount of options that will vest. These parameters include the expected volatility of our share price over the expected term of the grant, the risk-free
interest rate assumption, forfeitures behaviors and expected dividends.
In 2021, we generally shifted from incentive equity grants in the form of options to grants in the form of restricted share units (RSUs). We evaluate the fair
value of RSUs based on the price of our ordinary shares at the time of grant and the quantity of RSUs granted.
Fair value of Ordinary Shares. Since our Ordinary Shares have traded on the TASE since 2007, and our ADSs have traded on The Nasdaq Global Market
since 2019, we have a market price per share of our Ordinary Shares and ADSs. Traditionally, the exercise price for options granted by the Company was
determined based on the average price per share over a calendar period of trading days preceding the grant date. Under the new compensation policy
approved by the Company’s shareholders on December 22, 2021, the exercise price for any newer options grants are to be based on the closing price of our
ADSs on the day prior to the grant. On June 2, 2021, we completed the Exchange Offer and the exercise price per Ordinary Share of the new options
granted pursuant to the exchange offer is $4.675 per Ordinary Share. See “Item 7. Major Shareholders and Related Party Transactions – Related Party
Transactions.”
Volatility. The expected volatility of the price of our Ordinary Shares reflects the assumption that the historical volatility of the share prices on the TASE is
reasonably indicative of expected future trends.
Risk-free interest rate. The risk-free interest rate is based on observed interest rates appropriate for the expected term of the options granted in dollar terms.
Expected term. The expected term of options granted is derived from the output of the option valuation model and represents the period of time the options
are expected to be outstanding.
Expected dividend yield. We have never declared or paid any cash dividends and we do not have current plans to pay cash dividends in the near term.
Recent Accounting Pronouncements
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The recent accounting pronouncements are set forth in Note 2 to our audited consolidated financial statements beginning on page F-1 of this Annual
Report.
A.
Operating Results
Quarterly Results of Operations
The following tables show our unaudited quarterly statements of operations for the periods indicated. We have prepared this quarterly information on a
basis consistent with our audited financial statements.
Three Months Ended
Statements of operations
Revenues
Cost of revenues
Gross profit
Research and development
March 31 June 30 Sep. 30 Dec. 31 March 31 June 30 Sep. 30 Dec. 31 March 31 June 30 Sep. 30 Dec. 31
2020
U.S. dollars in thousands
2019
2021
6,121
1,463
4,658
7,005 8,061 8,470 4,157
1,300 1,930 1,906 1,015
5,705 6,131 6,564 3,142
4,820 6,014 7,066 5,182
992 1,485 1,566 1,158
3,828 4,529 5,500 4,024
5,695 5,932 6,292
1,376 1,153 1,442
4,319 4,779 4,850
expenses, net
925
Selling and marketing expenses 3,129
General and administrative
expenses
1,405
5,459
Total operating expenses
801
Total operating loss
412
Finance expenses, net
1,213
Loss before income taxes
160
Income taxes (tax benefit)
Net loss and comprehensive loss 1,373
1,650 1,786 2,032 1,795
4,191 4,042 4,518 3,713
1,041 1,411 1,576 1,792
2,178 2,393 2,999 2,838
2,362 1,913 1,809
3,278 3,549 3,604
1,377 1,536 1,466 1,255
7,218 7,364 8,016 6,763
1,513 1,233 1,452 3,621
269
360
379
(309)
1,782 1,593 1,831 3,312
130
1,938 1,804 1,347 3,442
(484)
156
211
824 1,311 1,332 1,003
4,043 5,115 5,907 5,633
407 1,609
239
236
646 1,845
62
(240
406 1,907
215
179
394
177
571
586
210
796
170
966
1,380 1,492 1,428
7,020 6,954 6,841
2,701 2,175 1,991
178
3,373 2,519 2,169
147
3,473 2,632 2,316
100
672
344
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Our quarterly revenues and operating results have varied in the past and are expected to vary in the future due to numerous factors. We believe that period-
to-period comparisons of our operating results are not necessarily meaningful and should not be relied upon as indications of future performance.
Year ended December 31, 2021 compared to year ended December 31, 2020
Revenues
Our total revenues increased by $7.6 million, or 34%, from $22.1 million for the year ended December 31, 2020 to $29.7 million for the year ended
December 31, 2021. The increase in revenues was attributed mainly to increase in sales of our Deep TMS systems to customers. Revenues from leases
were 45% of the revenues for the year ended December 31, 2021, compared to 62% of the revenues for the year ended December 31, 2020.
Cost of revenues and gross margin
Our cost of revenues was $6.6 million for the year ended December 31, 2021 compared to $5.1 million for the year ended December 31, 2020. The increase
is primarily attributed to increase in sales volumes. There has been no material change in our gross margin as a percentage of revenue for the last three
years.
Research and development expenses, net
Our research and development expenses, net, were $6.4 million for the year ended December 31, 2021 compared to $5.8 million for the year ended
December 31, 2020. The increase of $0.6 million, or 10%, was mainly attributed to lower expenses in the corresponding period last year, in light of the
effect of the COVID-19 pandemic, as well as expenses incurred during the current year in connection with the options repricing program.
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Selling and marketing expenses
Our selling and marketing expenses were $15.9 million for the year ended December 31, 2021 compared to $11.3 million for the year ended December 31,
2020. The increase of $4.6 million, or 41%, was mainly attributed to the continued growth in our U.S. marketing activity, including recruitment of sales,
marketing and support personnel in the United States, as well as to lower operational expenses during the corresponding period last year, in light of the
effect of the COVID-19 pandemic.
General and administrative expenses
Our general and administrative expenses were $5.8 million for the year ended December 31, 2021 compared to $4.7 million for the year ended
December 31, 2020. The increase of $1.1 million, or 23% is attributed mainly to the Company’s continued growth, expenses relating to the completion of a
follow-on underwritten public offering in the first quarter of 2021 and expenses incurred in connection with the options repricing program.
Finance expenses, net
Our finance expenses, net, were $1.4 million for the year ended December 31, 2021 compared to $0.3 million for the year ended December 31, 2020. The
increase of $1.1 million was mainly attributed to exchange rate differences.
For information on the impact of currency fluctuations on the company, please see Item 11 “Quantitative and Qualitative Disclosures About Market Risk”
below.
Year ended December 31, 2020 compared to year ended December 31, 2019
For comparison of fiscal year 2020 to fiscal year 2019 please see “Management’s Discussion and Analysis of Financial Condition and Results of
Operations - Year ended December 31, 2020 compared to year ended December 31, 2019” section in our annual report on form 20-F filed with the SEC on
April 19, 2021.
B.
Liquidity and Capital Resources
Overview
As of December 31, 2021, we had cash, cash equivalents and short-term deposits of $57.3 million and an accumulated deficit of $83.7 million, compared to
cash equivalents and short-term deposits of $17.2 million, and an accumulated deficit of $77.3 million as of December 31, 2020. We incurred positive cash
flows from operating activities of $0.9 million and negative cash flows from operating activities of $1.4 million for the years ended December 31, 2021 and
2020, respectively. We have incurred operating losses since our inception, and we anticipate that our operating losses will continue in the near term as we
seek to expand our sales and marketing initiatives to support our growth in existing and new markets, and invest funds in additional research and
development activities. Our primary sources of capital to date have been from public offerings in the U.S. and Israel and private placements of our
securities, grants from the IIA, and leases and sales of our Deep TMS systems. From inception through December 31, 2021, we raised $129 million from
placements of our Ordinary Shares and exercise of options.
The Company’s primary contractual obligations consist of liabilities in respect of research and development grants, as well as lease liabilities in respect of
corporate facilities and vehicles. For information about the Company's contractual obligations, see Note 11 to our Audited Financial Statements.
We expect our revenues and expenses to increase in connection with our ongoing activities, particularly as we expand the marketing of our Deep TMS
system for MDD, OCD, and smoking addiction, and for other indications for which we may receive regulatory authorizations in the future. Based on our
current business plan, we believe that our cash and cash equivalents as of December 31, 2021 and the anticipated revenues from sales of our products will
be sufficient to fund our operating expenses and capital expenditure requirements through at least the next 24 months. However, if these sources are
insufficient to satisfy our liquidity requirements, we may seek to sell additional equity securities, seek to enter into a new credit facility, or seek financing
from third party collaborators. If we raise additional funds by issuing equity securities, our shareholders would experience dilution. Additional debt
financing, if available, may involve covenants restricting our operations or our ability to incur additional debt. We can provide no assurance that additional
equity or debt financing will be available on terms favorable to us, or at all. If we raise additional funds through collaborations with third parties, we may
be required to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or to grant licenses on terms
that may not be favorable to us. If we are unable to obtain adequate funds on reasonable terms, we will need to curtail operations significantly, including
possibly postponing anticipated clinical trials or entering into financing agreements with unfavorable terms.
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Cash flows
The table below summarizes our cash flow activities for the indicated periods:
(in thousands)
Net cash provided by (used in) operating activities
Net cash used in investing activities
Net cash provided by (used in) financing activities
Exchange rate differences on cash and cash equivalents
Increase (decrease) in cash and cash equivalents
Operating Activities
Year Ended
December 31,
2021
2020
$
$
884 $
(42,216)
41,516
(224)
(40) $
(1,436)
(2,465)
(1,030)
218
(4,713)
Net cash provided by operating activities was $0.9 million during the year ended December 31, 2021, compared to $1.4 million used during the year ended
December 31, 2020. The increase of $2.3 million was due primarily to changes in working capital as well as a decrease in cash used from operations.
Investing Activities
Net cash used in investing activities was $42.2 million during the year ended December 31, 2021, compared to $2.5 million during the year ended
December 31, 2020. The increase of $39.7 million was mainly attributed to the investment of funds raised during the year in long-term deposits.
Financing Activities
Net cash provided by financing activities was $41.5 million during the year ended December 31, 2021, compared to $1.0 million used in financing
activities during the year ended December 31, 2020. The change was due to the completion of a follow-on underwritten public offering of ADSs during the
year.
Government Grants
As of December 31, 2021, our wholly owned subsidiary, Brain Research and Development Services, Ltd., has received grants from the IIA in an aggregate
amount of approximately $13.3 million. Brain Research and Development Services, Ltd. is currently required to pay 3% royalties of sales of our Deep
TMS products, which payment obligations do not currently exceed the amount of the grant received (in U.S. dollars), plus interest at an annual rate equal to
the LIBOR rate. As of December 31, 2021, Brain Research and Development Services, Ltd. has paid royalties to the IIA in an aggregate amount of
approximately $3.4 million (including amounts in respect of accrued interest), with remaining outstanding royalties of up to $12.4 million.
Research and development grants received from the IIA are recognized upon receipt as a liability if future economic benefits are expected from the project
that will result in royalty-bearing sales. The amount of the liability for the loan is first measured at fair value using a discount rate that reflects a market rate
of interest that reflects, in turn, the appropriate degree of risks inherent in our business. If no economic benefits are expected from the research activity, the
grant receipts are recognized as a reduction of the related research and development expenses. In that event, the royalty obligation is treated as a contingent
liability in accordance with IAS 37, “Provisions, Contingent Liabilities, and Contingent Asset.”
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At the end of each reporting period, we evaluate whether there is a reasonable assurance that the received grants will not be repaid based on our best
estimate of future sales and, if so, no liability is recognized, and the grants are recorded against a corresponding reduction in research and development
expenses.
Research and development grants received from the European Union are recorded against a corresponding reduction in research and development expenses.
Additionally, in 2013, the MAGNET committee of the IIA (MAGNET) approved the activities of the consortium for the development plan of a brain
stimulator and monitor tool, which we refer to as the Consortium, of which we are one of the participants. As part of the Consortium, Brain Research and
Development Services, Ltd. received from MAGNET approvals for grants in an aggregate amount of NIS 8.2 million (approximately $2.65 million based
on the NIS to USD exchange rate as of December 31, 2021). There is no requirement to repay the grants or pay royalties thereon. Such non-royalty-bearing
grants from MAGNET program for funding approved research and development projects are recognized when there is reasonable assurance that the grants
will be received and we will comply with all attached conditions, on the basis of the costs incurred, and are presented as a deduction from research and
development expenses. In the event of failure of a project that was partly financed by the IIA, we would not be obligated to pay any royalties or repay the
amounts received.
C.
Research and Development, Patents, and Licenses
For descriptions of the company’s research and development policies for the years 2020 and 2019, please see the “Item 5.C Research and Development,
Patents, and Licenses” sections in our annual reports on Form 20-F filed with the SEC on April 19, 2021 and March 23, 2020, respectively.
Intellectual Property
The core technology of our Deep TMS based on H-Coils is covered by our patents.
Our intellectual property portfolio consists principally of patents and pending patent applications related to our Deep TMS technology that are either
exclusively licensed to us for commercialization on a worldwide basis from (1) agencies of the U.S. Public Health Service (PHS) within the U.S.
Department of Health and Human Services (DHHS), and (2) Yeda Research and Development Company Limited, or Yeda, the commercialization arm of
the Weizmann Institute for Science (Weizmann Institute) or are owned by us. These include a total of 33 issued U.S. patents, 3 pending U.S. patent
applications, 46 issued patents in other jurisdictions (treating Europe as one jurisdiction), and 20 pending patent applications in other jurisdictions.
Our strategy is to seek to protect our proprietary position by, among other methods, filing U.S. and foreign patent applications related to our proprietary
technology, inventions, and improvements that are important to the development of our business. Our intellectual property rights outside of the United
States are principally in Europe (France, Italy, Sweden, UK, and Germany), Canada, Australia, Japan, Hong Kong, and Israel. Patents related to our Deep
TMS technology may provide future competitive advantages with claims related to aspects of the structure of our coils and methods of administration of
treatment for applications of such technology. We also rely on our trade secrets, know-how and continuing technological innovation to develop and
maintain our proprietary position. We look to defend our Deep TMS technology by asserting our intellectual property rights, where it is determined to be
necessary, to preserve our rights and gain the benefit of our technological investments. We seek to obtain patents in connection with the technology that we
have developed as part of our strategy for protection of our intellectual property, including technology covered under our license agreements with the PHS
and Yeda.
The claiming strategy in each of our patent applications is based on the advice of our patent counsel and our business model and our business needs are
taken into consideration. We file patent applications containing claims seeking protection of our proprietary technologies and products, as well as all new
applications and/or uses we discover or develop for existing technologies and products, assuming these are strategically valuable. We continuously assess
the number and types of patent applications, as well as the pending and issued patent claims, to ensure that appropriate coverage and value are obtained for
our systems and methods, given the governing law and the corresponding patent office rules and regulations. In addition, claims may be modified during
patent prosecution or additional claims added to meet our intellectual property and business needs.
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Patents and Patent Applications
Our first group of patents (Patent Family A) relates to the H-Coil technology in general: This includes coverage for the H-Coil for MDD, the H-Coil for
OCD, the H-Coil for smoking addiction, and for future products we are developing. This group of patents has been exclusively licensed to us from the
PHS, and includes two issued U.S. patents and seven issued patents in other jurisdictions. The issued patents are set to expire in 2024 in the U.S. and expire
in 2021 outside the U.S. These coils are also covered by additional patents which extend until later dates as detailed further in this section.
Our second group of patents (Patent Family B) relates to additional design features of BrainsWay’s H-Coil for MDD, H-Coil for smoking addiction coil,
and also covers some future products we are developing. This group of patents has been licensed to us from the PHS and from Yeda, and includes six
issued U.S. patents, nine issued patents in other jurisdictions, and two pending patent applications in other jurisdictions. The issued patents in this group are
set to expire in 2025 in the U.S. and in 2026 in other countries, not taking into account any potential patent term adjustment or extension that may be
available in the future. These coils are also covered by additional patents which extend until later dates as detailed further in this section.
Our third group of patents (Patent Family C) relates to a family of central base coils including BrainsWay’s H-Coil for OCD, and also some future products
that we are developing. This group of patents is owned by us, and includes three issued U.S. patents, eight issued patents in other jurisdictions, and three
pending patent applications in other jurisdictions. The issued patents are set to expire in 2033 in the U.S., and in 2034 in other countries, not taking into
account any potential patent term adjustment or extension that may be available in the future.
Our fourth group of patents (Patent Family D) relates to a family of unilateral coils including some future products we are developing. Patent Family D is
owned by us, and includes one issued U.S. patent, and five issued patents in other jurisdictions. The issued patents are set to expire in 2033 in the U.S., and
in 2034 in other countries, not taking into account any potential patent term adjustment or extension that may be available in the future.
Our fifth group of patents (Patent Family E) consists of utility model patent applications which provide coverage of several H-Coils, including those used
in BrainsWay’s MDD and OCD systems. This group of patents (Patent Family E) is owned by us, and includes two issued Chinese Utility Model patent
applications: one for BrainsWay’s MDD coil, and another one for BrainsWay’s OCD coil, one issued patent application in the U.S. and five pending patent
applications in other jurisdictions incorporating both BrainsWay’s MDD and OCD systems. The issued patent is set to expire in 2039.
Our sixth group of patents (Patent Family F) relates to a family of circular coils including BrainsWay’s H-Coils for MDD and smoking, as well as some
other future products we are developing. This group of patents (Patent Family F) is owned by us, and includes two issued U.S. patents, six issued patents in
other jurisdictions and one pending patent applications in other jurisdictions. The issued patents are set to expire in 2033 in the U.S. and in 2034 in other
countries, not taking into account any potential patent term adjustment or extension that may be available in the future.
Our seventh group of patents (Patent Family G) relates to real-time closed-loop brain stimulation and includes one pending patent application in the U.S.
and three pending patent applications in other jurisdictions.
Our eighth group of patents (additional families of issued patents and pending patent applications) relates to a multichannel stimulator we are developing as
an enhancement to our Deep TMS system, which we see as the next generation of our products, several H-Coil designs which may be future products,
capabilities to address additional medical conditions such as the need to open the blood brain barrier, and biomarker research using Deep TMS with an
EEG that we are currently conducting. These include six issued U.S. patents, one pending U.S. patent application, nine issued patents in other jurisdictions,
and six pending patent applications in other jurisdictions. Patent applications in these families, if issued, are set to expire in 2029, 2031, 2033, and between
2037 and 2039, not taking into account any potential patent term adjustment or extension that may be available in the future.
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In addition to the list of patents noted above, an additional group of patents relates to multichannel stimulation and was acquired from TMS
Innovations, LLC. We believe these patents will enable us to broaden the scope of capabilities in the multichannel stimulator we are developing.. The
issued patents are set to expire between 2026 and 2035 in the U.S, not taking into account any potential patent term adjustment or extension that may be
available in the future.
In addition to the list of patents noted above, in January 2020 we exercised our option to exclusively license the rights to certain patents relating to
rotational field TMS from Yeda. This group of patents includes two issued U.S. patents and four issued patents in other jurisdictions. The issued patents are
set to expire in 2032 in the U.S. and in 2030 in other countries, not taking into account any potential patent term adjustment or extension that may be
available in the future.
The patent positions of companies like ours are generally uncertain and involve complex legal and factual questions that may vary from one jurisdiction to
another. Our ability to maintain and solidify our proprietary position for our technology will depend on our success in obtaining effective claims and
enforcing those claims once granted. We can provide no assurance that our patent applications or those patent applications that we in-license will result in
the issuance of any corresponding patents (other than any allowed patent applications, which normally result in the issuance of a patent after the applicant
has paid the required issue fee). The inability of any such patent applications to be allowed may harm our ability to protect our intellectual property, our
ability to compete in the neuromodulation market, and our results of operations. Our issued patents and those that may be issued in the future, or those
licensed to us, may be challenged, narrowed, circumvented or found to be invalid or unenforceable, which could limit our ability to stop competitors from
marketing related products. Neither we nor our licensors can be certain that we were the first to invent or first to file for the inventions claimed in our
owned or licensed patents or patent applications which may also affect our ability to assert the patents against others. In addition, our competitors may
design around our patents or any technology developed by us, and the rights granted under any issued patents may not provide us with any meaningful
competitive advantages against these competitors. Furthermore, because of the extensive time required for development, testing and regulatory review of a
potential product, it is possible that, before our future product can be commercialized, any related patent may expire or remain in force for only a short
period following commercialization, thereby reducing any advantage of the patent. See “Risk Factors—Risk Relating to Intellectual Property”.
License Agreements
The core technology for Deep TMS is exclusively licensed to us for commercialization on a worldwide basis from the PHS and Yeda.
PHS License Agreement
The initial discoveries of the Deep TMS technology and the feasibility studies for implementation of the technology were carried out in the framework of
research performed at NIH by the scientific founders of our Company prior to its formation. The rights for such discoveries are owned by the DHHS and
are now licensed to us by the PHS, an agency within the DHHS. Subsequent to these discoveries, applications were filed for registration of Patent Family A
and Patent Family B (described under “—Patents” above) covering the H-Coils developed in the course of this research.
In 2003, we entered into a license agreement with the PHS, pursuant to which we were granted (i) an exclusive license to develop, manufacture, use, import
and sell any product or treatment which is created or based on the patents and which deals with TMS and (ii) the right to enter into sublicense agreements,
subject to approval of the PHS. The U.S. government was granted an irrevocable, nonexclusive, nontransferable royalty-free license for use of any
invention in connection with the patents, throughout the world, for the benefit of the U.S. government, a foreign government and other international
organization under the provisions of a treaty or agreement applicable to the U.S. government at such time. In addition, the PHS is entitled to grant academic
or commercial bodies a nonexclusive license for use of the patents for advancement of basic research only, subject to our consent.
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We are required to pay royalties consisting of 2% of our net sales or payments received from sales or leases of our Deep TMS systems and/or portions
thereof using the licensed technology. In addition, we are required to pay a royalty of 8% from the net cash proceeds we receive from any sublicenses, so
long as the underlying intellectual property is valid and enforceable in the relevant territory.
The PHS is responsible for registration and defense of Patent Family A, subject to indemnification by us for registration expenses. We are responsible for
registration and defense of the Patent Family B and are required to bear all related expenses.
The PHS license agreement is valid up until the expiration of the last to expire of the licensed patent rights under the agreement. The PHS may cancel the
agreement in the event of, among others, (i) a fundamental breach by us, (ii) we enter into involuntary liquidation proceedings or shall become insolvent,
(iii) we have not achieved our milestones under the agreement (all of which have been achieved as of the date hereof), (iv) we have maliciously made a
false statement or has omitted a material fact in an application for a license or in any other report required under the agreement, (v) we do not make the
product based upon the patents accessible to the public after commencement of the commercial marketing of the product, (vi) we are unable to bring the
product to a level of safety which it must reach in order to license the product or (vii) we do not manufacture the licensed products substantially in the
United States without reasonable justification, in each case, subject to a 90-day cure period (other than in respect of clause (ii) above). We may cancel the
agreement at any time with 60 days’ notice, subject to payment of any outstanding royalties.
If the PHS license agreement is terminated as a result of the expiration of the first registered patent under the agreement (as described above), we may
continue to market and sell the products and processes in any country in which the patent is expired, without an obligation to pay royalties or any other
payment whatsoever to the PHS.
Yeda License Agreement
In 2005, we entered into a research and licensing agreement with Yeda, which, as amended from time to time, we refer to as the Yeda license agreement,
pursuant to which we licensed certain technologies developed at the Weizmann Institute in studies conducted by Prof. Avraham Zangen, the scientific
founder and neurobiological advisor of the Company, in the field of treatment of depression using TMS technology. Under the Yeda license agreement, all
of the rights, including the rights to registration of patents, rights and inventions, information and/or other results which shall arise from the research,
referred to as the “licensed technology”, remain exclusively owned by Yeda. The Yeda license agreement grants us an exclusive license to use the licensed
technology, throughout the world, for performance of research and development, manufacture, commercialization, and sale of systems for medical
treatment in the field of TMS treatment. The license is valid with regard to every product up to the expiration or revocation date of the latest patent
registered under the agreement in a particular country, provided that the date of expiry of the license shall be extended to a period of 15 years commencing
on the date of first commercial sale of the product in such country. Yeda reserves the right to make use of the information which shall be developed for
academic and research purposes only, including its publication, subject to various restrictions set forth in the agreement. We have agreed to lend to Yeda,
without consideration, one Deep TMS system, which it shall use for academic research purposes only. We have the right to grant sublicenses subject to the
fulfillment of conditions specified in the agreement.
In January 2020, we exercised our right to add the additional rotational field TMS innovation. To the extent products based on this technology are
commercialized we will have to pay Yeda royalties, either at increased rates ranging from an additional 1.6%-2% for “combined products” (which also
include innovations covered by previous agreements), or at a fixed rate of 5% for products based exclusively on the rotational field TMS.
In addition to customary termination rights of a party due to material breach by the other party, Yeda has the right to terminate the agreement in the event
that Yeda receives notice or a claim from the PHS that performance of the research constitutes breach of a patent of the PHS. We have agreed to indemnify
Yeda in respect of any such claim or demand from the PHS. To the best of our knowledge, the Yeda agreement and performance of the research thereunder
do not breach the terms of our license agreement with the PHS.
In any event of termination of the Yeda agreement, all of the rights in the licensed technology will be returned to Yeda, and we are required to grant Yeda a
nonexclusive license, without consideration, in perpetuity, throughout the world for all information developed by it or which shall arise from the
development of the products under the agreement, including any license or application for license submitted by us in connection with the products.
Following the expiry of the latest patent in such country with regard to such product, we would be entitled to continue to manufacture and sell such product
in such country without payment of royalties to Yeda.
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Trade Secrets and Know-How
We may rely, in some circumstances, on trade secrets and know-how to protect our technology. However, trade secrets can be difficult to protect. We seek
to protect our proprietary technology and processes, in part, through confidentiality agreements and assignment of inventions agreements with our
employees, consultants, scientific advisors, and contractors. We also seek to preserve the integrity and confidentiality of our data and trade secrets by
maintaining physical security of our premises and physical and electronic security of our information technology systems. While we have confidence in
these individuals, organizations and systems, such agreements or security measures may be breached, and we may not have adequate remedies for any
breach. In addition, our trade secrets may otherwise become known or be independently discovered by competitors.
D.
Trend Information
Trend information is included throughout the other sections of this Item 5. In addition, the COVID-19 global pandemic has led governments and authorities
around the globe, to take various precautionary measures in order to limit the spread of the COVID-19 global pandemic, including government-imposed
quarantines, lockdowns, and other public health safety measures, which have had and continues to have an adverse effect on the global markets and its
economy, including on the availability and pricing of materials, manufacturing and delivery efforts, sales to existing and potential customers and leads,
collections from accounts, and other aspects of the global economy. Therefore, the COVID-19 global pandemic could continue to disrupt production and
cause delays in the supply and delivery of products used in our operations, may further divert the attention and efforts of the medical community to coping
with the COVID-19 global pandemic, impact our ability to recruit subjects for ongoing and planned clinical trials and disrupt the marketplace in which we
operate and may have material adverse effects on our operations, sales, revenues, collection from accounts and ability to raise funds. In particular, certain of
our third-party suppliers may currently source certain components and materials of our Deep TMS systems from Asia and other affected countries, and the
continued outbreak and spreading of the COVID-19 global pandemic may adversely impact our third-party suppliers’ development, manufacture, and
supply of our Deep TMS systems. In addition, treatment sessions conducted with our Deep TMS system, which are generally scheduled or non-emergency
procedures, may be postponed as hospitals and healthcare centers shift resources to patients affected by the COVID-19 global pandemic. The extent to
which the COVID-19 global pandemic impacts our results will depend on future developments, which are highly uncertain and cannot be predicted,
including new information which may emerge concerning the severity of the COVID-19 global pandemic and the actions to contain the COVID-19 global
pandemic or treat its impact, among others. Moreover, the COVID-19 global pandemic has begun to have indeterminable adverse effects on general
commercial activity and the world economy, and our business and results of operations could be adversely affected to the extent that this COVID-19 global
pandemic or any other epidemic harms the global economy generally.
In the period following the onset of the pandemic, as part of the global supply chain crisis, we have seen a significant rise in the price of many of the
electronic components needed for our systems. These price increases are largely attributable to supply and demand factors, and in some cases, shortages,
relating to these parts across the globe. On a related point, the lead time for receiving electronic components shipped by suppliers has increased
significantly amid the worldwide supply chain crisis. This has compelled us to significantly increase inventory levels to ensure that future demand for our
systems can be timely met. Within the broader context of electronic component supply issues, the third party we rely on for the outsourced manufacture of
our newer generation systems halted production in 2021 for a period due to the shortage in PC computers which are needed for these systems. While we
were able to adapt our standard manufacturing process to allow for the integration of these PC components at a later stage of the production line once
inventory levels were restocked, this is illustrative of the continuing need to adapt to the realities and challenges posed by the worldwide supply chain
crisis.
The global shipping crisis and supply chain backlog have also caused a dramatic rise in the cost of delivery of our systems, including sharp increases in air
freight cost. The heavy weight of our systems translates into a significant increase in the amount we spend on shipping our systems to customers, which
also requires additional labor on the part of our logistical staff to obtain multiple competitive shipping quotes from a variety of carriers in the industry.
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Another trend affecting us is the so called "Great Resignation," also known as the "Big Quit," an economic trend in which employees voluntarily resigned
from their jobs en masse, beginning in early 2021, primarily in the United States. An article published in the Harvard Business Review on September 15,
2021 cited U.S. Bureau of Labor Statistics finding that 4 million Americans quit their jobs in July 2021. It found differences in turnover rates between
companies in different industries, with 3.6% more health care employees quitting their jobs than in the previous year, and in technology, resignations
increased by 4.5%. As we operate in both the health care and technology fields, we have not been immune to this larger trend, and while our overall
workforce increased over the past year, we also experienced employee turnover, including in our salesforce, thus impacting our ability to ramp up our sales
and marketing force as quickly as would have otherwise been possible and generally leading to increased base salaries for new hires.
Another trend relating to our business is the expansion and reliance on reimbursement by major insurers and government plans. Over the past year we have
experienced emerging reimbursement coverage for Deep TMS for the treatment of OCD, with approximately 60 million covered lives eligible for coverage
as of March 2022. In early 2021, Centene Corporation, the largest Medicaid managed care organization in the country with over 26 million members,
issued a positive coverage policy applicable to our Deep TMS therapy for OCD. In June 2021, Health Care Service Corporation (HCSC), an independent
licensee of Blue Cross Blue Shield Association, covering approximately 17 million members issued a positive coverage policy, applicable to our Deep
TMS therapy for OCD. In 2021, TriCare, which covers 9.6 million military family members across the US, also approved coverage of Deep TMS for OCD.
Additionally, in mid-2021, Palmetto GBA, one of the seven Medicare Administrative Contractors (MACs) in the US, issued the first draft Local Coverage
Determination (LCD) proposing coverage applicable to Deep TMS for OCD, and subsequently issued a final LCD approving such coverage effective
March 2022. If this trend continues, we anticipate that it can have a positive impact on our industry in general, and the demand for our Deep TMS therapy
in particular. This, in turn, could have a positive effect on our revenues, income from continuing operations, and profitability.
E.
Critical Accounting Estimates
Not applicable.
ITEM 6.
DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES
A.
Directors and Senior Management
The following table sets forth the name, age and position of each of our executive officers and directors as of the date of this Annual Report.
Name
Senior Management:
Christopher R. von Jako
R. Scott Areglado
Hadar Levy
Dr. Yiftach Roth
Directors:
Dr. David Zacut(3)
Avner Hagai(2)
Eti Mitrany(1)(2)
Karen Sarid(1)(2)(3)
Prof. Abraham Zangen
Yossi Ben Shalom(3)
Avner Lushi(1)
Age
53
58
48
52
70
66
52
71
52
65
55
Position
President and Chief Executive Officer
Senior Vice President and Chief Financial Officer
Senior Vice President and General Manager of North America
Chief Scientist
Chairman of the Board
Vice Chairman of the Board
Director
Director
Director
Director
Director
(1) Member of our audit committee that also serves on our financial statements committee.
(2) Member of our compensation committee.
(3) Member of our executive committee.
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Nasdaq’s Board Diversity Rule, which was approved by the SEC on August 6, 2021, is a disclosure standard designed to encourage a minimum board
diversity objective for companies and provide stakeholders with consistent, comparable disclosures concerning a company’s current board composition.
This rule requires companies listed on the Nasdaq exchange to: (1) publicly disclose board-level diversity statistics using a standardized template; and (2)
have or explain why they do not have at least two diverse directors. The rule also provides flexibility for Smaller Reporting Companies and Foreign
Issuers, which can meet the diversity objective by including two female directors. The rule establishes a transition period by which the diversity
requirements must be met; for example, for companies listed on Nasdaq prior to August 6, 2021, a board must include at least one diverse director by
August 7, 2023, and at least two diverse directors by either August 6, 2025 (if listed as a “Nasdaq Global Select or Global Markets” company) or August 6,
2026 (if listed as a “Nasdaq Capital Market” company). The required annual disclosure is made in the form of the “Board Diversity Matrix” established by
the Rule.
Our current board composition is reflected in the following matrix:
Board Diversity Matrix (As of April 12 2022)
Country of Principal Executive Offices:
Foreign Private Issuer
Disclosure Prohibited under Home Country Law
Total Number of Directors
Part I: Gender Identity
Directors
Part II: Demographic Background
Underrepresented Individual in Home Country Jurisdiction
LGBTQ
Did Not Disclose Demographic Background
Directors who are Jewish People
Directors with Disabilities
Israel
Yes
No
7
Female
2
0
0
0
7
0
Male
Non-binary
Did Not Disclose
Gender
5
0
0
As a Foreign Issuer subject to the added flexibility provided under Nasdaq’s Board Diversity Rule, we currently meet the diversity objectives promulgated
under this rule by having two female directors, as reflected in the above matrix.
Executive officers
Christopher R. von Jako, PhD serves as our president and chief executive officer since January 1, 2020. Most recently, Dr. von Jako served as CEO of
Dynatronics Corporation, a publicly-traded medical device company focusing on high-quality restorative products. Prior to Dynatronics, he served as
President and CEO of other companies including NinePoint Medical, Inc. and NeuroTherm, Inc. Earlier in his career, he held increasingly senior roles with
other leading medical device companies, including Integra LifeSciences, Covidien, Medtronic, and Radionics. Dr. von Jako holds a Ph.D. in Biomedical
Sciences from the University of Pécs, a M.S. degree in Radiological Sciences and technology from the department of Nuclear Engineering at the
Massachusetts Institute of Technology, and a double B.S. Degree in Physics and Mathematics from Bates College. He resides in Lynnfield, Massachusetts
and continues to serve as an independent director on the board nView medical Inc
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R. Scott Areglado has served as our Senior Vice President and Chief Financial Officer since May 2021. Prior to his service at the Company, Mr. Areglado
served as Chief Financial Officer of iCAD, Inc., a publicly traded global medical technologies provider of advanced image analysis, from May 2018, and
previously served as its Vice President and Corporate Controller (from 2011 to 2018). From 2005 to 2010, Mr. Areglado served as Vice President and
Controller at AMICAS, Inc., a Nasdaq-listed image and information management solutions company serving the healthcare industry. From 1991 to 2004,
he held various accounting and financial roles of increasing responsibility in the software, communications, and transportation and logistics industries. He
holds a Bachelor of Business Administration degree in Accounting from the University of Massachusetts, Amherst, and a Master of Business
Administration in Entrepreneurship from the Franklin W. Olin Graduate School of Business at Babson College.
Hadar Levy has served as our Senior Vice President and General Manager North America since May 2020. Prior to this, Mr. Levy served as our Chief
Financial Officer from September 2014 to May 2020. Prior to his service at the Company, from August 2011 to September 2014 Mr. Levy served as Chief
Financial Officer of the Latin American Division at Amdocs; and from 2008 to 2011, served as Chief Financial Officer & Vice President of Business
Development of Notalvision. Prior to this position, he served as Controller of GE Healthcare Israel. Mr. Levy holds a BA in Economics and Accounting
from Ruppin and an LLM from Bar Ilan University. Mr. Levy is a Certified Public Accountant.
Dr. Yiftach Roth is one of our scientific founders and key inventors of the Deep TMS technology. Dr. Roth has served as our Research and Development
Manager since May 2006. In 2010, Dr. Roth became our Chief Scientist. From 2003 through 2006, Dr. Roth worked in the Advanced Technology Center of
the Chaim Sheba Medical Center at Tel Hashomer as a researcher in the field of Magnetic Resonance Imaging (MRI). Dr. Roth holds B.Sc. and M.Sc.
degrees in Physics and a Ph.D. in Medical Physics from Tel Aviv University. Dr. Roth is the brother-in-law of Professor Zangen, a director and scientific
consultant for the Company.
Directors
Dr. David Zacut has served as our Chairman of the Board of Directors since our inception, is a member of our executive committee, and has been providing
consulting services to Brain Research and Development Services since May 2001. Since 1983, Dr. Zacut has been working as a senior practicing physician
at Hadassah Hospital, and from 1994 through 2003, he served as a managing director of several large medical centers. In addition, Dr. Zacut serves as a
director of several private companies, including Brain Research and Development Services. Dr. Zacut holds an M.D. degree from the Hebrew University of
Jerusalem.
Avner Hagai has served as our Vice Chairman of the Board of Directors since November 2006 and currently serves as a member of our compensation
committee. He serves as a director at several companies, including at Prisma F.S. Ltd., a building management company, where he has served since 2002.
Mr. Hagai established A.A. Glass Ltd., an automotive glass and services company, where he has served as a director since 1984.
Mr. Avner Lushi has served as our Director since January 2020 and currently serves as a member of our audit committee. He co-founded the Guangzhou
Sino-Israel Bio-industry Investment Fund (GIBF) which focuses on introducing Israeli and western life sciences companies to the Chinese market (and
related investments), where he also serves as a Managing Partner & CEO. Between 2004 and 2015 Mr. Lushi served as a Partner and Managing Director of
Israel Healthcare Ventures (IHCV), a life sciences venture capital fund. From 2001 to 2005, he co-founded and served as CEO of Life Sciences Transaction
Support Ltd. (LTS), a PwC subsidiary dealing with life sciences investment banking. Since 2005, Mr. Lushi has served as an independent board member at
nine public companies, the two last active ones being Ram-On Investments and Holdings (1999) Ltd and Allmed Solutions Ltd. In addition, he serves as a
board member of several private companies as part of his role at GIBF. From 1997 to 2001, prior to turning to the private sector, he held increasingly senior
roles within the Israeli Prime Minister’s Chamber and the Israeli Supreme Court. Mr. Lushi holds an LLM in Law from the Hebrew University of
Jerusalem, LLB in Law and a BA in Economics from the Haifa University.
Prof. Avraham Zangen has served as our Director since June 2019. Prof. Zangen is the Head of the Brain Stimulation and Behavior Lab and the Chair of
the PsychoBiology Brain Program at Ben-Gurion University in Israel. His research is directed at identifying and understanding altered neuroplasticity in
psychiatric disorders, primarily depression, addiction and ADHD, utilizing brain stimulation, and imaging techniques to explore mechanisms and potential
clinical applications. He co-developed, along with Dr. Yiftach Roth, the Deep TMS coil which serves as BrainsWay’s platform technology. Professor
Zangen has published over 150 peer reviewed articles, reviews, and book chapters. He has been awarded numerous prizes for his scientific achievements,
including the Medical Futures Innovation Award in London, the Sieratzki Prize for Advances in Neuroscience, and the Juludan Prize at the Technion. He
has also received several distinguished research grants, including from the National Institutes of Health, H2020 and the Israel Science Foundation.
Professor Zangen is the brother-in-law of Dr. Yiftach Roth, who serves as our Chief Scientific Officer and a co-developer of our Deep TMS technology.
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Eti Mitrany has served as our Director since June 2016, and currently serves as chairperson of our compensation committee and a member of our audit
committee. Ms. Mitrany Ms. Mitrany is an executive with over 25 years of global experience in the life sciences industry and since April 2021 serves as
CFO and Head of Corporate Strategy at CytoReason, a life sciences AI company developing a computational model of the human body. From 2012 until
January 2020, she served as Senior Vice President, Head of the Corporate Economic Department at Teva Pharmaceuticals, with global responsibility for
Teva’s business planning and analysis. Prior to that, Ms. Mitrany held various positions at Teva, including serving as CFO of its global specialty business
(commercial, R&D, and new ventures), head of Financial Planning & Analysis of the global branded business, and global CFO of Copaxone (a multiple
sclerosis treatment) and various other specialty products. Ms. Mitrany received her BA in Economics and an MBA in Finance, both from Tel-Aviv
University.
Karen Sarid has served as our Director since December 2017, currently serves as chairperson of our audit committee, and is a member of our compensation
committee and our executive committee. Between March 2014 and July 2017, Ms. Sarid served as VP Beauty and Dental and as Chairman of China
activities at Syneron Medical Ltd. Between January 2012 and August 2013 Ms. Sarid served as President of Alma Lasers Ltd. Ms. Sarid currently serves as
a director of Eva Visual Ltd. She holds a BA in Economics and Accounting from the University of Haifa.
Yossi Ben Shalom has served as our Director since December 2018 and is a member of our executive committee. Mr. Ben Shalom is a co-founder of
D.B.S.I, a private investment company specializing in investments in mature companies that are positioned globally for high growth or built for vast
expansion through M&As. As such, Mr. Ben Shalom serves as the Chairman of Pointer Telocation Ltd. (Nasdaq: PNTR), Rada (Nasdaq: RADA) and
Shagrir Group Car Services Ltd. (TASE: SHGR). He also serves as a director at Taldor Computer Systems (1986) Ltd. (TASE: TALD), Eldan Cargo Ltd.,
The 8 Note Production & Distribution Ltd., Car 2 Go Ltd., Matzman Et Merutz Milenum Ltd. and Kafrit Industries (1993) Ltd. Mr. Ben Shalom was
Executive Vice President and Chief Financial Officer of Koor Industries Ltd. from 1998 through to 2000. Before that, Mr. Ben-Shalom served as Chief
Financial Officer of Tadiran Ltd. between 1994 and 1998. Mr. Ben Shalom holds a BA in Economics and an MA in Business Administration both from Tel
Aviv University.
B.
Compensation
The aggregate compensation paid, and benefits-in-kind granted to or accrued on behalf of all of our directors and executive officers for their services, in all
capacities, to us during the year ended December 31, 2021, was approximately $3.7 million. Out of that amount, $2 million was paid as salary, $1.4 million
was attributed to the value of the equity-based awards granted to senior management during 2021, approximately $0.2 million was attributed to retirement
plans and approximately $0.1 million was attributed to all other compensation. No additional amounts have been set aside or accrued by us to provide
pension, retirement or similar benefits.
The compensation terms for our directors and officers are derived from their employment agreements, and comply with our Amended and Restated
Compensation Policy for Executive Officers and Directors recently approved by our shareholders on December 22, 2021 (the “Compensation Policy”).
The table and summary below outline the compensation granted to our five highest compensated directors and officers during the year ended December 31,
2021. The compensation detailed in the table below refers to actual compensation granted or paid to the director or officer during the year 2021.
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Name and position of director or officer
Christopher von Jako, President and CEO
Hadar Levy, SVP and General Manager North
America
Amit Ginou, VP, and Israel Site Manager
Christopher Boyer, VP Global Marketing
R. Scott Areglado, Senior Vice President and Chief
Financial Officer(5)
Base
Salary
or Other
Payments(1)
Value of
Social
benefits(2)
Value of
Equity Based
Compensation
Granted(3)
All Other
Compensation(4)
Total
640,000
51,964
445,150
—
1,136,844
442,500
178,043
245,667
42,699
46,434
37,310
338,365
96,692
43,962
—
13,188
—
823,564
334,358
326,940
194,208
33,593
77,706
—
305,508
(1) “Base Salary or Other Payments” means the aggregate yearly gross monthly salaries or other payments with respect to our senior management and
members of the board of directors which was actually paid during the year ended December 31, 2021.
(2) “Social Benefits” include payments to the National Insurance Institute, advanced education funds, managers’ insurance and pension funds; vacation
pay; and recuperation pay as mandated by Israeli law.
(3) Consists of the fair value of the equity-based compensation granted during the year ended December 31, 2021 in exchange for the directors' and
officers' services recognized as an expense in profit or loss and is carried to the accumulated deficit under equity. The total amount is recognized as an
expense over the vesting period of the options.
(4) “All Other Compensation” includes, among other things, bonuses, car-related expenses (including tax gross-up) and communication expenses.
(5) Mr. Areglado’s tenure with the Company commenced on May 5, 2021, and accordingly the table reflect compensation for the period from the
commencement date to the end of 2021.
In addition, all of our directors and executive officers are covered under our directors’ and executive officers’ liability insurance policies and were granted
letters of indemnification by us.
Employment Agreements
We have entered into written employment or service agreements with each member of our senior management. All of these agreements contain customary
provisions regarding noncompetition, confidentiality of information, and assignment of inventions. However, the enforceability of the noncompetition
provisions may be limited under applicable laws.
For information on exemption and indemnification letters granted to our directors and officers, please see “Item 6C. – Board Practices – Exemption,
Insurance and Indemnification of Directors and Officers.”
Director Compensation
As of the date of the filing of this annual report, we pay our non-executive directors (i.e., all directors other than Dr. Zacut and Prof. Zangen) an annual
cash fee of NIS 133,000 (approximately $41,612) Additionally, as of the date of the filing of this annual report, we pay a cash fee of NIS 2,480
(approximately $776) per meeting of the Board and any committee thereof, which is increased to (i) NIS 4,020 (approximately $1,258) in the case of a
committee chairperson; or (ii) NIS 4,390 (approximately $1,374) in the case of a director determined to be an expert.
According to the consultancy agreement between Dr. Zacut and the Company, as of May 30, 2016, Dr. Zacut is entitled to a monthly consulting fee of NIS
30,000, set based on a 40% capacity position. For more information, please see the proxy statement filed on December 9, 2019 and resulting resolution
approved by the shareholders on January 13, 2020. We also have a consultancy agreement with Prof. Zangen, a director and scientific founder of the
Company. For more information, please see “Item 7B. Related Party Transactions.”
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Compensation Policy
In general, under the Israeli Companies Law, a public company must have a compensation policy approved by the board of directors after receiving and
considering the recommendations of the compensation committee. In addition, the compensation policy requires the approval of the general meeting of the
shareholders. In public companies such as our Company, shareholder approval requires one of the following: (i) the majority of shareholder votes counted
at a general meeting including the majority of all of the votes of those shareholders who are non-controlling shareholders and do not have a personal
interest in the approval of the compensation policy, who vote at the meeting (excluding abstentions) or (ii) the total number of votes against the proposal
among the shareholders mentioned in paragraph (i) does exceed two percent (2%) of the voting rights in the company. Under special circumstances, the
board of directors may approve the compensation policy despite the objection of the shareholders on the condition that the compensation committee and
then the board of directors decide, on the basis of detailed arguments and after discussing again the compensation policy, that approval of the compensation
policy, despite the objection of the meeting of shareholders, is for the benefit of the company.
The compensation policy must be based on certain considerations, must include certain provisions, and needs to reference certain matters as set forth in the
Israeli Companies Law.
The compensation policy must serve as the basis for decisions concerning the financial terms of employment or engagement of office holders, including
exculpation, insurance, indemnification or any monetary payment or obligation of payment in respect of employment or engagement. The compensation
policy must relate to certain factors, including advancement of the company’s objectives, business plan, long-term strategy, and creation of appropriate
incentives for office holders. It must also consider, among other things, the company’s risk management, size, and the nature of its operations. The
compensation policy must furthermore consider the following additional factors:
● the education, skills, experience, expertise, and accomplishments of the relevant office holder;
● the office holder’s position, responsibilities, and prior compensation agreements with him or her;
● the ratio between the cost of the terms of employment of an office holder and the cost of the employment of other employees of the company,
including employees employed through contractors who provide services to the company, in particular the ratio between such cost, the average,
and median salary of the employees of the company, as well as the impact of such disparities on the work relationships in the company;
● if the terms of employment include variable components—the possibility of reducing variable components at the discretion of the board of
directors and the possibility of setting a limit on the value of variable equity-based components not settled in cash; and
● if the terms of employment include severance compensation—the term of employment or office of the office holder, the terms of his or her
compensation during such period, the company’s performance during such period, his or her individual contribution to the achievement of the
company goals and the maximization of its profits and the circumstances under which he or she is leaving the company.
The compensation policy must also include, among others:
● with regards to variable components in the terms of office and employment:
● with the exception of office holders who report directly to the chief executive officer, determining the variable components on long-term
performance basis and on measurable criteria; however, the company may determine that an immaterial part of the variable components of the
compensation package of an office holder’s shall be awarded based on non-measurable criteria, if such amount is not higher than three
monthly salaries per annum, while taking into account such office holder contribution to the company;
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● the ratio between variable and fixed components, as well as the limit of the values of variable components at the time of their payment.
However, with respect to variable equity-based components that are not settled in cash, the limit of their value at the time of grant.
● a condition under which the office holder will return to the company, according to conditions to be set forth in the compensation policy, any
amounts paid as part of his or her terms of employment, if such amounts were paid based on information later to be discovered to be wrong, and
such information was restated in the company’s financial statements;
● the minimum holding or vesting period of variable equity-based components to be set in the terms of office or employment, as applicable, while
taking into consideration long-term incentives; and
● a limit to retirement grants.
Our compensation policy is designed to promote retention and motivation of directors and senior management, incentivize superior individual excellence,
align the interests of our directors and senior management with our long-term performance and provide a risk management tool. To that end, a portion of an
executive officer compensation package is targeted to reflect our short and long-term goals, as well as the executive officer’s individual performance. On
the other hand, our compensation policy includes measures designed to reduce the executive officer’s incentives to take excessive risks that may harm us in
the long-term, such as limitations on the value of cash bonuses and equity-based compensation to a maximum number of monthly salaries, limitations on
the ratio between the variable and the total compensation of an executive officer and minimum vesting periods for equity-based compensation.
Our compensation policy also addresses our executive officer’s individual characteristics (such as his or her respective position, education, scope of
responsibilities and contribution to the attainment of our goals) as the basis for compensation variation among our senior management, and considers the
internal ratios between compensation of our senior management and directors and other employees. Pursuant to our compensation policy, the compensation
that may be granted to an executive officer may include: base salary, exemption indemnification and insurance, annual bonuses and other cash bonuses
(such as a signing bonus and special bonuses with respect to any special achievements, such as outstanding personal achievement, outstanding personal
effort or outstanding company performance), equity-based compensation, social benefits, retirement, and termination of service arrangements. All cash
bonuses to executive officers (“Annual Target Bonus”, “Overachievement Bonus and “Special Bonus”) are limited to a maximum amount linked to the
executive officer’s base salary. In addition, the total equity-based compensation components may not exceed 200% of each executive officer’s base salary
with respect to any given calendar year.
An annual cash bonus may be awarded to senior management upon the attainment of pre-set periodic objectives and individual targets. The annual cash
bonus that may be granted to our senior management will be based on performance objectives and a discretionary evaluation of the executive officer’s
overall performance by our compensation committee and board of directors and subject to minimum thresholds. The annual cash bonus that may be granted
to senior management may be based in a rate of up to 25% on a discretionary evaluation. Furthermore, our chief executive officer will be entitled to
recommend performance objectives, and such performance objectives will be approved by our compensation committee (and, if required by law, by our
board of directors).
The equity-based compensation under our compensation policy for our officers and directors is designed in a manner consistent with the underlying
objectives in determining the base salary and the annual cash bonus, with its main objectives being to enhance the alignment between the officers’ and
directors’ interests with our long-term interests and those of our shareholders, and to strengthen the retention and the motivation of senior management in
the long term. Our compensation policy provides for officers and directors compensation in the form of share options or other equity-based awards, such as
restricted shares and restricted share units (RSUs), in accordance with our Share Incentive Plan then in place. All equity-based incentives granted to
officers and directors shall be subject to vesting periods in order to promote long-term retention of the awarded officer or director. The equity-based
compensation shall be granted from time to time and be individually determined and awarded according to the performance, educational background, prior
business experience, qualifications, role, and the personal responsibilities of the officer or director.
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In addition, our compensation policy contains compensation recovery provisions which allows us under certain conditions to recover bonuses paid in
excess, enables our chief executive officer to approve an immaterial change in the terms of employment of an executive officer (provided that the changes
of the terms of employment are in accordance with our compensation policy) and allows us to exculpate, indemnify, and insure our senior management and
directors subject to certain limitations set forth thereto.
Our compensation policy also provides for compensation to the members of our board of directors (except for directors that are employed by, or provides
services, directly or through companies in their control, to the Company in another role) either (i) for external directors, if any, in accordance with the
amounts provided in the Companies Regulations (Rules Regarding the Compensation and Expenses of an External Director) of 2000, as amended by the
Companies Regulations (Relief for Public Companies Traded in Stock Exchange Outside of Israel) of 2000, as such regulations may be amended from time
to time, or (ii) for all other directors, in accordance with the amounts determined in our compensation policy.
Our amended and restated compensation policy was last approved by our shareholders on December 22, 2021 and is valid for a period of three years
according to the Israeli Companies Law.
C.
Board Practices
Appointment of Directors and Terms of Officers
Our board of directors consists of seven (7) directors, including five (5) directors who qualify as “independent” under applicable U.S. securities laws and
Nasdaq listing rules: Avner Hagai, Karen Sarid, Eti Mitrany, Yossi Ben Shalom, and Avner Lushi. The term of office of each director shall be until the next
general meeting of our shareholders.
Under our articles of association, the number of directors on our board of directors will be not less than four (4) but no more than nine (9) directors, not
including any external directors to the extent required to be appointed by the Israeli Companies Law, and not including up to two (2) additional directors
who may be appointed by our board of directors whose term of office would expire as of the first annual meeting of shareholders after their appointment, at
which they may be re-elected by such general meeting subject to the total number of directors not exceeding nine (9).
Under our articles of association, our board of directors may elect new directors if the number of directors is below the maximum provided in the articles of
association, and the term of office of such elected directors shall be until the next general meeting of our shareholders.
Under Israeli law, the chief executive officer of a public company may not serve as the chairman of the board of directors of the company unless approved
by a special majority of our shareholders as required under the Israeli Companies Law.
In addition, under the Israeli Companies Law, our board of directors must determine the minimum number of directors who are required to have financial
and accounting expertise. Under applicable regulations, a director with financial and accounting expertise is a director who, by reason of his or her
education, professional experience, and skills, has a high level of proficiency in and understanding of business accounting matters and financial statements.
He or she must be able to thoroughly comprehend the financial statements of the company and initiate debate regarding the manner in which financial
information is presented. In determining the number of directors required to have such expertise, the board of directors must consider, among other things,
the type and size of the company and the scope and complexity of its operations. Our board of directors has determined that we should have at least two
directors with the requisite financial and accounting expertise.
There are no arrangements or understandings between us, on the one hand, and any of our directors, on the other hand, providing for benefits upon
termination of their employment or service as directors of our Company.
Independent and External Directors - Israeli Companies Law Requirements
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Under the Israeli Companies Law, we would be required to include on our board of directors at least two members, each of whom qualifies as an external
director, and as to whom special qualifications, voting requirements and other provisions would be applicable. We would also be required to include one
such external director on each of our board committees.
Under regulations promulgated under the Israeli Companies Law, Israeli companies whose shares are traded on stock exchanges such as the Nasdaq that do
not have a controlling shareholder (as defined therein) and which comply with the requirements of the jurisdiction where the company’s shares are traded
with respect to the appointment of independent directors and the composition of an audit committee and compensation committee, may elect not to follow
the Israeli Companies Law requirements with respect to the composition of its audit committee and compensation committee and the appointment of
external directors. As we do not have a controlling shareholder, and as we comply with the requirements of the Nasdaq with respect to the composition of
our board and such committees, therefore we are exempt from the Israeli Companies Law requirements with respect thereto, including the appointment of
external directors.
Committees
Israeli Companies Law Requirements
Our board of directors has established four standing committees, the audit committee (which serves also as our financial statements committee), the
compensation committee, the nomination committee, and the executive committee.
Audit Committee
Israeli Companies Law Requirements
Under the Israeli Companies Law, the board of directors of any public company must also appoint an audit committee comprised of at least three directors,
including all of the external directors (if any). The audit committee may not include:
● the chairman of the board of directors;
● a controlling shareholder or a relative of a controlling shareholder;
● any director employed by us or by one of our controlling shareholders or by an entity controlled by our controlling shareholders (other than as a
member of the board of directors); or
● any director who regularly provides services to us, to one of our controlling shareholders or to an entity controlled by our controlling shareholders.
According to the Israeli Companies Law, the majority of the members of the audit committee, as well as the majority of members present at audit
committee meetings, will be required to be “independent” (as defined below), and the chairperson of the audit committee will be required to be an external
director. Any persons disqualified from serving as a member of the audit committee may not be present at the audit committee meetings, unless the
chairperson of the audit committee has determined that such person is required to be present at the meeting or if such person qualifies under one of the
exemptions of the Israeli Companies Law.
The term “independent director” is defined under the Israeli Companies Law as an external director or a director who meets the following conditions, and
who is appointed or classified as such according to the Israeli Companies Law: (1) the conditions for his or her appointment as an external director (as
described above) are satisfied, and the audit committee approves the director having met such conditions, and (2) he or she has not served as a director of
the company for over nine consecutive years with any interruption of up to two years of his or her service not being deemed a disruption to the continuity
of his or her service.
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Pursuant to regulations promulgated under the Israeli Companies Law, we comply with the requirements of Nasdaq with respect to the composition of our
audit committee and compensation committee, and do not follow the Israeli Companies Law requirements with respect to the composition of such
committees, such as those described above. See “Management—Our Board of Directors.”
Nasdaq Listing Requirements
Under the Nasdaq corporate governance rules, we are required to maintain an audit committee consisting of at least three independent directors, all of
whom are financially literate and one of whom has accounting or related financial management expertise.
Our audit committee consists of Karen Sarid, Eti Mitrany, and Avner Lushi. Karen Sarid serves as Chairperson of the committee. All members of our audit
committee meet the requirements for financial literacy under the applicable rules and regulations of the SEC and the Nasdaq corporate governance rules.
Our board of directors has determined that each of Karen Sarid, Eti Mitrany, and Avner Lushi is an audit committee financial expert as defined by SEC
rules, and has the requisite financial experience as defined by the Nasdaq listing rules.
Each of the members of the audit committee is “independent” as such term is defined in Rule 10A-3(b)(1) under the Exchange Act.
Approval of Transactions with Related Parties
The approval of the audit committee is required to effect specified actions and transactions with office holders and controlling shareholders and their
relatives, or in which they have a personal interest. See “Management—Fiduciary Duties and Approval of Specified Related Party Transactions and
Compensation under Israeli Law.” The audit committee may not approve an action or a transaction with a controlling shareholder or with an office holder
unless at the time of approval the audit committee meets the composition requirements under the Israeli Companies Law.
Audit Committee Charter
Our board of directors adopted an audit committee charter setting forth the responsibilities of the audit committee consistent with the rules of the SEC and
the Nasdaq corporate governance rules, which include:
● retaining and terminating our independent auditors, subject to board of directors and shareholder ratification;
● overseeing the independence, compensation, and performance of our independent auditors;
● the appointment, compensation, retention, and oversight of any accounting firm engaged for the purpose of preparing or issuing an audit report or
performing other audit services;
● pre-approval of audit and non-audit services to be provided by the independent auditors;
● reviewing with management and our independent directors our financial statements prior to their submission to the SEC; and
● approval of certain transactions with office holders and controlling shareholders, as described below, and other related party transactions.
Additionally, under the Israeli Companies Law, the role of the audit committee includes the identification of irregularities in our business management,
among other things, by consulting with the internal auditor or our independent auditors and suggesting an appropriate course of action to the board of
directors. In addition, the audit committee or the board of directors, as set forth in the articles of association of the company, is required to approve the
yearly or periodic work plan proposed by the internal auditor. The audit committee is required to assess the company’s internal audit system and the
performance of its internal auditor. The Israeli Companies Law also requires that the audit committee assess the scope of the work and compensation of the
company’s external auditor. In addition, the audit committee is required to determine whether certain related party actions and transactions are “material” or
“extraordinary” for the purpose of the requisite approval procedures under the Israeli Companies Law and whether certain transactions with a controlling
shareholder will be subject to a competitive procedure. The audit committee charter states that in fulfilling its role the committee is empowered to conduct
or authorize investigations into any matters within its scope of responsibilities. A company whose audit committee’s composition also meets the
requirements set for the composition of a compensation committee (as further detailed below) may have one committee acting as both audit and
compensation committees.
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Compensation Committee
Israeli Companies Law Requirements
Under the Israeli Companies Law, public companies are required to appoint a compensation committee in accordance with the guidelines set forth
thereunder.
The compensation committee must consist of at least three members. All of the external directors, if any, must serve on the committee and constitute a
majority of its members. The chairperson of the compensation committee must be an external director, if any. All external directors, if any, must be
members of the compensation committee, and the remaining members must be directors whose compensation is in accordance with the regulations for
compensation of external directors under the Israeli Companies Law. In addition, members of the compensation committee may not include directors who
are disqualified from serving as members of the audit committee (as described above).
The compensation committee, which consists of Eti Mitrany, Avner Hagai, and Karen Sarid, assists the board of directors in determining compensation for
our directors and officers. Eti Mitrany serves as Chairperson of the committee. Under SEC and Nasdaq rules, there are heightened independence standards
for members of the compensation committee, including a prohibition against the receipt of any compensation from us other than standard supervisory board
member fees. Although foreign private issuers are not required to meet this heightened standard, our board of directors has determined that all of our
expected compensation committee members meet this heightened standard.
In accordance with the Israeli Companies Law, the roles of the compensation committee are, among others, as follows:
(1) to recommend to the board of directors the compensation policy for directors and officers, and to recommend to the board of directors once every
three years whether the compensation policy that had been approved should be extended for a period of more than three years;
(2) to recommend to the board of directors updates to the compensation policy, from time to time, and examine its implementation;
(3) to decide whether to approve the terms of office, and employment of directors and officers that require approval of the compensation committee;
and
(4) to decide whether the compensation terms of the chief executive officer, which were determined pursuant to the compensation policy, will be
exempted from approval by the shareholders because such approval would harm the ability to engage the chief executive officer.
In addition to the roles mentioned above our compensation committee also makes recommendations to our board of directors regarding the awarding of
employee equity grants.
In addition to the above, our compensation committee is entitled to agree to prior notice periods for resignation or dismissal within the context of certain
acceleration events, and to agree to up to 12 months full payment of the compensation package and fringe benefits, upon termination by us of an
engagement with an officer or an employee.
Pursuant to regulations promulgated under the Israeli Companies Law, we comply with the requirements of the Nasdaq with respect to the composition of
our audit committee and compensation committee, and do not follow the Israeli Companies Law requirements with respect to the composition of such
committees, such as those described above. See “Management—Our Board of Directors.”
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Nasdaq Listing Requirements
Under the Nasdaq Listing Rules, we are required to maintain an audit committee consisting of at least three members, all of whom are independent and are
financially literate and one of whom has accounting or related financial management expertise.
The independence requirements of Rule 10A-3 of the Exchange Act implement two basic criteria for determining independence:
● audit committee members are barred from accepting directly or indirectly any consulting, advisory or other compensatory fee from the issuer or an
affiliate of the issuer, other than in the member’s capacity as a member of the board of directors and any board committee; and
● audit committee members may not be an “affiliated person” of the issuer or any subsidiary of the issuer apart from her or his capacity as a member
of the board of directors and any board committee.
The SEC has defined “affiliate” for non-investment companies as “a person that directly, or indirectly through one or more intermediaries, controls, or is
controlled by, or is under common control with, the person specified.” The term “control” is intended to be consistent with the other definitions of this term
under the Exchange Act, as “the possession, direct or indirect, of the power to direct or cause the direction of the management and policies of a person,
whether through the ownership of voting securities, by contract, or otherwise.” A safe harbor has been adopted by the SEC, under which a person who is
not an executive officer or 10% shareholder of the issuer would be deemed not to have control of the issuer.
In accordance with the Sarbanes-Oxley Act of 2002 and the Nasdaq Listing Rules, the audit committee is directly responsible for the appointment,
compensation, and performance of our independent auditors. In addition, the audit committee is responsible for assisting the board of directors in reviewing
our annual financial statements, the adequacy of our internal control and our compliance with legal and regulatory requirements. The audit committee also
oversees our major financial risk exposures and policies for managing such potential risks, discusses with management and our independent auditor
significant risks or exposure and assesses the steps management has taken to minimize such risk.
As noted above, the members of our audit committee include Karen Sarid, Eti Mitrany, and Avner Lushi, with Karen Sarid serving as chairperson. All
members of our audit committee meet the requirements for financial literacy under the Nasdaq Listing Rules. Our board of directors has determined that
each of Karen Sarid, Eti Mitrany, and Avner Lushi is an audit committee financial expert as defined by the SEC rules and all members of the audit
committee have the requisite financial experience as defined by the Nasdaq Listing Rules. Each of the members of the audit committee is “independent” as
such term is defined in Rule 10A-3(b)(1) under the Exchange Act.
Compensation Committee Charter
Our board of directors adopted a compensation committee charter setting forth the responsibilities of the compensation committee consistent with the rules
of the SEC and the Nasdaq corporate governance rules, which include:
● recommending to the Board of Directors for its approval (i) a compensation policy for officers and directors, (ii) once every three years, whether
to extend the compensation policy, subject to receipt of the required corporate approvals approval (either a new compensation policy or the
continuation of an existing compensation policy must in any case occur every three years); and (iii) periodic updates to the compensation policy.
In addition, the compensation committee is required to periodically review the implementation of the compensation policy;
● approving transactions relating to the terms of office and employment of office holders (within the meaning of the Companies Law), which require
the approval of the compensation committee pursuant to the Companies Law;
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● reviewing and approving the granting of options and other incentive awards to the extent such authority is delegated by our board of directors; and
● reviewing, evaluating and making recommendations regarding the compensation and benefits for our non-employee directors.
Nomination Committee
In March 2022, our Board of Directors appointed a nomination committee, comprised of Avner Lushi, Avner Hagai and Yossi Ben Shalom.
Our Nomination Committee assuming the responsibility for recommending to the Board nominees for election (including re-election) to the Company’s
Board of Directors, in lieu of the recommendation by our independent directors.
Consistent with the requirements of the Nasdaq Rules, our Nomination Committee is responsible for:
·
·
·
identifying potential new candidates for service on the Company’s Board of Directors, taking into account, inter alia, the candidate’s applicable
experience, expertise and/or familiarity with the Company’s field of business, as well as the candidate’s ethical character, independent judgment
and industry reputation;
conducting appropriate inquiries into the backgrounds and qualifications of potential candidates for service as directors; and
reviewing and resolving whether or not to approve arrangements with respect to such candidates.
Nasdaq Requirements
The Nasdaq Rules require that director nominees be selected or recommended for the board’s selection either by a nomination committee composed solely
of independent directors or by a majority of independent directors, in a vote in which only independent directors participate, subject to certain exceptions.
Executive Committee
In 2021, our Board of Directors appointed an executive committee, comprised of Dr. David Zacut, Karen Sarid and Yossi Ben Shalom.
The roles of the executive committee are
·
·
to oversee the implementation of the business strategy of our company, and
to exercise such other duties as the board may resolve from time to time.
Corporate Governance Practices
Internal Auditor
Under the Israeli Companies Law, the board of directors of a public company must appoint an internal auditor based on the recommendation of the audit
committee. The role of the internal auditor is, among other things, to examine whether a company’s actions comply with applicable law and orderly
business procedure. Under the Israeli Companies Law, the internal auditor may not be an interested party or an office holder or a relative of an interested
party or of an office holder, nor may the internal auditor be the company’s independent auditor or the representative of the same.
An “interested party” is defined in the Israeli Companies Law as (i) a holder of 5% or more of the issued share capital or voting power in a company,
(ii) any person or entity who has the right to designate one or more directors or to designate the chief executive officer of the company, or (iii) any person
who serves as a director or as a chief executive officer of the company.
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Mr. Yisrael Gewirtz of Fahn Kanne Control Management Ltd. (Grant Thornton Israel) serves as our internal auditor.
Duties of Directors and Officers and Approval of Specified Related Party Transactions under the Israeli Companies Law
Fiduciary Duties and Duty of Care of Office Holders
The Israeli Companies Law imposes a duty of care and a fiduciary duty on all office holders of a company. The duty of care of an office holder is based on
the duty of care set forth in connection with the tort of negligence under the Israeli Torts Ordinance (New Version) 5728-1968. This duty of care requires an
office holder to act with the degree of proficiency with which a reasonable office holder in the same position would have acted under the same
circumstances. The duty of care includes, among other things, a duty to use reasonable means, in light of the circumstances, to obtain:
● information on the business advisability of a given action brought for his or her approval or performed by virtue of his or her position; and
● all other important information pertaining to such action.
The fiduciary duty incumbent on an office holder requires him or her to act in good faith and for the benefit of the company, and includes, among other
things, the duty to:
● refrain from any act involving a conflict of interest between the performance of his or her duties in the company and his or her other duties or
personal affairs;
● refrain from any activity that is competitive with the business of the company;
● refrain from exploiting any business opportunity of the company for the purpose of gaining a personal advantage for himself or herself or others;
and
● disclose to the company any information or documents relating to the company’s affairs which the office holder received as a result of his or her
position as an office holder.
We may approve an act specified above which would otherwise constitute a breach of the office holder’s fiduciary duty, provided that the office holder
acted in good faith, the act or its approval does not harm the company, and the office holder discloses his or her personal interest, including any material
fact or document, a reasonable time before consideration of the approval of such act. Any such approval is subject to the terms of the Israeli Companies
Law, setting forth, among other things, the appropriate bodies of the company entitled to provide such approval, and the methods of obtaining such
approval.
Disclosure of Personal Interest of an Office Holder and Approval of Transactions
The Israeli Companies Law requires that an office holder disclose to the company without delay any personal interest that he or she may have and all
related material information or documents relating to any existing or proposed transaction by the company. An interested office holder’s disclosure must be
made without delay and in any event no later than the first meeting of the board of directors at which the transaction is considered. An office holder is not
obliged to disclose such information if the personal interest of the office holder derives solely from the personal interest of his or her relative in a
transaction that is not considered an extraordinary transaction.
Under the Israeli Companies Law, once an office holder has complied with the above disclosure requirement, a company may approve a transaction
between the company and the office holder or a third party in which the office holder has a personal interest. However, a company may not approve a
transaction or action that is not to the company’s benefit.
Under the Israeli Companies Law, unless the articles of association of a company provide otherwise, a transaction with an office holder or with a third party
in which the office holder has a personal interest, which is not an extraordinary transaction, requires approval by the board of directors. If the transaction
considered is an extraordinary transaction with an office holder or third party in which the office holder has a personal interest, then audit committee
approval is required prior to approval by the board of directors. For the approval of compensation arrangements with directors and senior management, see
“Management—Disclosure of Compensation of Directors and Senior Management.”
111
Any persons who have a personal interest in the approval of a transaction that is brought before a meeting of the board of directors or the audit committee,
except for a transaction with an office holder or with a third party in which the office holder has a personal interest, which is not an extraordinary
transaction, may not be present at the meeting or vote on the matter. However, if the chairman of the board of directors or the chairman of the audit
committee has determined that the presence of an office holder with a personal interest is required, such office holder may be present at the meeting for the
purpose of presenting the matter. Notwithstanding the foregoing, a director who has a personal interest may be present at the meeting, and vote on the
matter if a majority of the directors or members of the audit committee have a personal interest in the approval of such transaction. If a majority of the
directors at a board of directors meeting have a personal interest in the transaction, such transaction also requires approval of the shareholders of the
company.
A “personal interest” is defined under the Israeli Companies Law as the personal interest of a person in an action or in a transaction of the company,
including the personal interest of such person’s relative or the interest of any other corporate body in which the person and/or such person’s relative is a
director or general manager, a 5% shareholder or holds 5% or more of the voting rights, or has the right to appoint at least one director or the general
manager, but excluding a personal interest stemming solely from the fact of holding shares in the company. A personal interest also includes (1) a personal
interest of a person who votes according to a proxy of another person, including in the event that the other person has no personal interest, and (2) a
personal interest of a person who gave a proxy to another person to vote on his or her behalf regardless of whether or not the discretion of how to vote lies
with the person voting.
An “extraordinary transaction” is defined under the Israeli Companies Law as any of the following:
● a transaction other than in the ordinary course of business;
● a transaction that is not on market terms; or
● a transaction that may have a material impact on the company’s profitability, assets or liabilities.
Disclosure of a Personal Interest of a Controlling Shareholder and Approval of Transactions
The Israeli Companies Law also requires that a controlling shareholder disclose to the company without delay any personal interest that he or she may have
and all related material information or documents relating to any existing or proposed transaction by the company. A controlling shareholder’s disclosure
must be made without delay and in any event no later than the first meeting of the board of directors at which the transaction is considered. Extraordinary
transactions with a controlling shareholder or in which a controlling shareholder has a personal interest, including a private placement in which a
controlling shareholder has a personal interest, and the terms of engagement of the company, directly or indirectly, with a controlling shareholder or a
controlling shareholder’s relative (including through a corporation controlled by a controlling shareholder), regarding the company’s receipt of services
from the controlling shareholder, and if such controlling shareholder is also an office holder or employee of the company, regarding his or her terms of
employment, require the approval of each of (i) the audit committee or the compensation committee with respect to the terms of the engagement of the
company, (ii) the board of directors, and (iii) the shareholders, in that order. In addition, the shareholder approval must fulfill one of the following
requirements:
● a majority of the shares held by shareholders who have no personal interest in the transaction and are voting at the meeting must be voted in favor
of approving the transaction, excluding abstentions; or
● the shares voted by shareholders who have no personal interest in the transaction who vote against the transaction represent no more than two
percent (2%) of the voting rights in the company.
112
In addition, an extraordinary transaction with a controlling shareholder or in which a controlling shareholder has a personal interest, and an engagement of
the company, directly or indirectly, with a controlling shareholder or a controlling shareholder’s relative (including through a corporation controlled by a
controlling shareholder), regarding the company’s receipt of services from the controlling shareholder, and if such controlling shareholder is also an office
holder or employee of the company, regarding his or her terms of employment, in each case with a term of more than three years requires the
abovementioned approval every three years; however, transactions not involving the receipt of services or compensation can be approved for a longer term,
provided that the audit committee determines that such longer term is reasonable under the circumstances. In addition, transactions with a controlling
shareholder or a controlling shareholder’s relative who serves as an officer in a company, directly or indirectly (including through a corporation under his
control), involving the receipt of services by a company or their compensation can have a term of five years from the company’s initial public offering
under certain circumstances.
The Israeli Companies Law requires that every shareholder that participates, in person, by proxy or by voting instrument, in a vote regarding a transaction
with a controlling shareholder, must indicate in advance or in the proxy card whether or not that shareholder has a personal interest in the vote in question.
Failure to so indicate will result in the invalidation of that shareholder’s vote.
Duties of Shareholders
Under the Israeli Companies Law, a shareholder has a duty to act in good faith and in an acceptable manner in exercising its rights and performing its
obligations towards the company, and other shareholders and to refrain from abusing its power in the company, including, among other things, when voting
at meetings of shareholders on the following matters:
● an amendment to the articles of association;
● an increase in the company’s authorized share capital;
● a merger; and
● the approval of related party transactions and acts of office holders that require shareholder approval.
A shareholder also has a general duty to refrain from discriminating against other shareholders.
The remedies generally available upon a breach of contract will also apply to a breach of the shareholder duties mentioned above, and in the event of
discrimination against other shareholders, additional remedies may be available to the injured shareholder.
In addition, any controlling shareholder, any shareholder that knows that its vote can determine the outcome of a shareholder vote (including in a class
meeting), and any shareholder that, under a company’s articles of association, has the power to appoint or prevent the appointment of an office holder, or
any other power with respect to a company, is under a duty to act with fairness towards the company. The Israeli Companies Law does not describe the
substance of this duty except to state that the remedies generally available upon a breach of contract will also apply in the event of a breach of the duty to
act with fairness, taking the shareholder’s position in the company into account.
Approval of Private Placements
Under the Israeli Companies Law and the regulations promulgated thereunder, a private placement of securities does not require approval at a general
meeting of the shareholders of a company; provided however, that in special circumstances, such as a private placement which is intended to obviate the
need to conduct a special tender offer (see “Description of Share Capital—Acquisitions under Israeli Law”) or a private placement which qualifies as a
related party transaction (see “Management—Fiduciary Duties and Approval of Specified Related Party Transactions and Compensation under Israeli
Law”), approval at a general meeting of the shareholders of a company is required.
Exculpation, Insurance and Indemnification of Directors and Officers
113
Under the Israeli Companies Law, a company may not exculpate an office holder from liability for a breach of the fiduciary duty. An Israeli company may
exculpate an office holder in advance from liability to the company, in whole or in part, for damages caused to the company as a result of a breach of the
office holder’s duty of care but only if a provision authorizing such exculpation is included in its articles of association. Our articles of association include
such a provision. A company may not exculpate in advance a director from liability arising due to the breach of his or her duty of care in connection with
dividend or distribution to shareholders.
Under the Israeli Companies Law and the Israeli Securities Law, 5728-1968 (the “Israeli Securities Law”) a company may indemnify an office holder in
respect of the following liabilities, payments, and expenses incurred for acts performed by him or her as an office holder, either in advance of an event or
following an event, provided its articles of association include a provision authorizing such indemnification:
● a monetary liability incurred by or imposed on the office holder in favor of another person pursuant to a court judgment, including pursuant to a
settlement confirmed as judgment or arbitrator’s decision approved by a competent court. However, if an undertaking to indemnify an office
holder with respect to such liability is provided in advance, then such an undertaking must be limited to events which, in the opinion of the board
of directors, can be foreseen based on the company’s activities when the undertaking to indemnify is given, and to an amount or according to
criteria determined by the board of directors as reasonable under the circumstances, and such undertaking shall detail the abovementioned foreseen
events and amount or criteria;
● reasonable litigation expenses, including reasonable attorneys’ fees, which were incurred by the office holder as a result of an investigation or
proceeding filed against the office holder by an authority authorized to conduct such investigation or proceeding, provided that such investigation
or proceeding was either (i) concluded without the filing of an indictment against such office holder and without the imposition on him of any
monetary obligation in lieu of a criminal proceeding; (ii) concluded without the filing of an indictment against the office holder but with the
imposition of a monetary obligation on the office holder in lieu of criminal proceedings for an offense that does not require proof of criminal
intent; or (iii) in connection with a monetary sanction;
● a monetary liability imposed on the office holder in favor of a payment for a breach offended at an Administrative Procedure (as defined below) as
set forth in Section 52(54)(a)(1)(a) to the Israeli Securities Law;
● expenses expended by the office holder with respect to an Administrative Procedure under the Israeli Securities Law, including reasonable
litigation expenses and reasonable attorneys’ fees;
● reasonable litigation expenses, including attorneys’ fees, incurred by the office holder or which were imposed on the office holder by a court (i) in
a proceeding instituted against him or her by the company, on its behalf, or by a third party, (ii) in connection with criminal indictment of which
the office holder was acquitted, or (iii) in a criminal indictment which the office holder was convicted of an offense that does not require proof of
criminal intent; and
● any other obligation or expense in respect of which it is permitted or will be permitted under applicable law to indemnify an office holder,
including, without limitation, matters referenced in Section 56H(b)(1) of the Israeli Securities Law.
An “Administrative Procedure” is defined as a procedure pursuant to chapters H3 (Monetary Sanction by the Israeli Securities Authority), H4
(Administrative Enforcement Procedures of the Administrative Enforcement Committee) or I1 (Arrangement to prevent Procedures or Interruption of
procedures subject to conditions) to the Israeli Securities Law.
Under the Israeli Companies Law and the Israeli Securities Law, a company may insure an office holder against the following liabilities incurred for acts
performed by him or her as an office holder if and to the extent provided in the company’s articles of association:
114
● a breach of the fiduciary duty to the company, provided that the office holder acted in good faith and had a reasonable basis to believe that the act
would not harm the company;
● a breach of duty of care to the company or to a third party, to the extent such a breach arises out of the negligent conduct of the office holder;
● a monetary liability imposed on the office holder in favor of a third party;
● a monetary liability imposed on the office holder in favor of an injured party at an Administrative Procedure pursuant to Section 52(54)(a)(1)(a) of
the Israeli Securities Law; and
● expenses incurred by an office holder in connection with an Administrative Procedure, including reasonable litigation expenses and reasonable
attorneys’ fees.
Under the Israeli Companies Law, a company may not indemnify, exculpate or insure an office holder against any of the following:
● a breach of the fiduciary duty, except for indemnification and insurance for a breach of the fiduciary duty to the company to the extent that the
office holder acted in good faith and had a reasonable basis to believe that the act would not prejudice the company;
● a breach of duty of care committed intentionally or recklessly, excluding a breach solely arising out of the negligent conduct of the office holder;
● an act or omission committed with intent to derive illegal personal benefit; or
● a fine, civil fine, financial sanction or forfeit levied against the office holder.
Under the Israeli Companies Law, exculpation, indemnification, and insurance of office holders must be approved by the compensation committee and the
board of directors, and, with respect to directors or controlling shareholders, their relatives and third parties in which controlling shareholders have a
personal interest, also by the shareholders.
Our articles of association permit us to exculpate, indemnify, and insure our office holders to the fullest extent permitted or to be permitted by law. Our
office holders are currently covered by a directors’ and officers’ liability insurance policy. As of the date of this report, no claims for directors’ and officers’
liability insurance have been filed under this policy, and we are not aware of any pending or threatened litigation or proceeding involving any of our office
holders, including our directors, in which indemnification is sought.
D.
Employees
Our employees include professionals with extensive experience in medical device development and applications, neurology and psychopathology, pre-
clinical experimentation, clinical development, and business development.
As of December 31, 2021, we had 118 employees, of which 52 are based in the United States and 66 are based outside of the United States (in Israel). This
includes 30 employees in sales and marketing, and 35 employees in clinical trials and research and development.
Management, administration, and operations
Research and development
Sales and Marketing
115
2021
Company
Employees
As of December 31,
2020
Company
Employees
2019
Company
Employees
53
35
30
48
26
26
49
30
28
While none of our employees are party to any collective bargaining agreements, certain provisions of the collective bargaining agreements between the
Histadrut (General Federation of Labor in Israel) and the Coordination Bureau of Economic Organizations (including the Industrialists’ Associations) are
applicable to our employees by order of the Israel Ministry of Labor. Such orders are part of the employment related laws and regulations which apply to
our employees and set certain mandatory terms of employment. Such mandatory terms of employment primarily concern the length of the workday,
minimum daily wages, pension plan benefits for all employees, insurance for work-related accidents, procedures for dismissal of employees, severance pay
and other conditions of employment. We generally provide our employees with benefits and working conditions beyond the required minimums.
We have never experienced any employment-related work stoppages and believe our relationship with our employees is good.
E.
Share Ownership
For information regarding the share ownership of our directors and executive officers, please see “Item 7.A. Major Shareholders.”
Award Plans
On May 29, 2014, we adopted the Share Incentive Plan, as amended from time to time, or the Plan. The Plan is intended to afford an incentive to our and
any of our affiliate’s employees, directors, officers, consultants, advisors, and any other person or entity who provides services to the Company, its
subsidiaries and affiliates, to continue as service providers, to increase their efforts on our and our affiliates behalf and to promote our success, by providing
such persons with opportunities to acquire a proprietary interest in us.
On September 26, 2019 we adopted the BrainsWay Ltd. Amended and Restated 2019 Share Incentive Plan, which was approved by our shareholders on
January 13, 2020. The Plan provides for the granting of Ordinary Shares, ADSs, stock options under various tax regimes in Israel and the U.S., restricted
shares, restricted share units (RSUs), and other share-based awards to employees, officers, directors, and/or other service providers, including advisors of
the Company, and/or of its subsidiaries, and/or affiliated companies of the Company. The same number of our Ordinary Shares are available for issuance as
awards under the 2019 as were available under the 2014 plan as of the effective date of the 2019 plan, and the 2014 plan continues to govern the terms of
awards issued thereunder prior to the effective date of the 2019 plan.
Under the Plan, as amended and restated, we may issue options to purchase up to 3,626,200 of our Ordinary Shares. As of December 31, 2021, options to
purchase 1,460,983 Ordinary Shares, at a weighted average exercise price of $4.62 per share, and 559,530 unvested restricted share units (RSUs) were
outstanding. The equity pool under the Plan is subject to adjustment if particular capital changes affect our share capital or such other number as our board
of directors may determine from time to time. Ordinary shares subject to outstanding awards under the Plan that subsequently expire, are cancelled,
forfeited, repurchased or terminated for any reason before being exercised will be automatically, and without any further action, returned to the “pool” of
reserved shares and will again be available for grant under the Plan.
The equity pool under the Plan is subject to adjustment if particular capital changes affect our share capital or such other number as our board of directors
may determine from time to time. Ordinary shares subject to outstanding awards under the Plan that subsequently expire, are cancelled, forfeited,
repurchased or terminated for any reason before being exercised will be automatically, and without any further action, returned to the “pool” of reserved
shares and will again be available for grant under the Plan.
A stock option is the right to purchase a specified number of Ordinary Shares in the future at a specified exercise price and subject to the other terms and
conditions specified in the option agreement and the Plan. The exercise price of each stock option granted under the Plan will be determined in accordance
with the limitations set forth under the Plan. The exercise price of any stock options granted under the Plan may be paid in cash, through “cashless
exercise” mechanism or any other method that may be approved by our compensation committee, which may include procedures for cashless exercise.
116
Our compensation committee may also grant, or recommend that our board of directors' grant, other forms of equity incentive awards under the Plan, such
as restricted shares, restricted share units (RSUs), and other forms of share-based compensation.
Israeli participants in the Plan may be granted options subject to Section 102 of the Israeli Income Tax Ordinance (New Version), 1961, or the Israeli Tax
Ordinance. Section 102 of the Israeli Tax Ordinance allows employees, directors and officers who are not controlling shareholders (as defined for those
purposes under the Israeli Tax Ordinance) and are considered Israeli residents (and in certain cases also non-Israeli residents for the time they worked in
Israel) to receive favorable tax treatment for compensation in the form of shares or options. Our non-employee service providers and controlling
shareholders may only be granted options under another section of the Israeli Tax Ordinance, which does not provide for similar tax benefits. Section 102
includes two alternatives for tax treatment involving the issuance of options or shares to a trustee for the benefit of the grantees and also includes an
additional alternative for the issuance of options or shares directly to the grantee. Commonly, the most favorable tax treatment for the grantees is under
Section 102(b)(2) of the Israeli Tax Ordinance, the issuance to a trustee under the “capital gain track.” However, under this track we are not allowed to
deduct an expense with respect to the issuance of the options or shares. Any options granted under the Plan to participants in the United States will be
either “incentive stock options,” which may be eligible for special tax treatment under the Internal Revenue Code of 1986, or options other than incentive
stock options (referred to as “nonqualified stock options”), as determined by our compensation committee or our board of directors and stated in the option
agreement.
Our compensation committee administers the Plan, or if determined otherwise by our board of directors, the Plan will be administered by our board of
directors or other designated committee on its behalf. Even if the compensation committee or any other committee was appointed by our board of directors
in order to administrate the Plan, our board of directors may, subject to any legal limitations, exercise any powers or duties of the compensation committee
or any other committee concerning the Plan. The compensation committee will, among others, select which eligible persons will receive options or other
awards under the Plan and will determine, or recommend to our board of directors, the number of Ordinary Shares covered by those options or other
awards, the terms under which such options or other awards may be exercised (however, vested options generally may not be exercised later than ten years
from the grant date of an option and a lesser period if the grantee ceased to be employed by, or provide services to, the company) or may be settled or paid,
and the other terms and conditions of such options and other awards under the Plan. All awards granted under the Plan shall not be transferable other than
by will or by the laws of descent and distribution, unless otherwise determined by our compensation committee.
To the extent permitted under applicable law, our compensation committee will have the authority to accelerate the vesting of any outstanding awards at
such time and under such circumstances as it, in its sole discretion, deems appropriate. In the event of a change of control, as defined in the Plan, any award
then outstanding shall be assumed or an equivalent award shall be substituted by the successor corporation of the merger or sale or any parent or affiliate
thereof as determined by our board of directors. In the event that the awards are not assumed or substituted, our compensation committee may, in its
discretion, accelerate the vesting, exercisability of the outstanding award, or provide for the cancellation of such award and payment of cash, as determined
to be fair in the circumstances.
Subject to particular limitations specified in the Plan and under applicable law, our board of directors may amend or terminate the Plan, and the
compensation committee may amend awards outstanding under the Plan. In addition, an amendment to the Plan that requires shareholder approval under
applicable law will not be effective unless approved by the requisite vote of shareholders. In addition, in general, no suspension, termination, modification
or amendment of the Plan may adversely affect any award previously granted without the written consent of grantees holding a majority in interest of the
awards so affected. The Plan will continue in effect until all Ordinary Shares available under the Plan are delivered and all restrictions on those shares have
lapsed, unless the Plan is terminated earlier by our board of directors. No awards may be granted under the Plan on or after the tenth anniversary of the date
of adoption of the plan unless our board of directors chooses to extend the term.
Any equity award to an office holder, director or controlling shareholder, whether under the Plan or otherwise, may be subject to further approvals in
addition to the approval of the compensation committee as described above. See “Management—Fiduciary Duties and Approval of Specified Related Party
Transactions and Compensation under Israeli Law.”
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ITEM 7.
MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS
A.
Major Shareholders
The following table sets forth information with respect to the beneficial ownership of our Ordinary Shares as of April 11, 2022 by:
● each person or entity known by us to own beneficially 5% or more of our outstanding Ordinary Shares;
● our directors and members of senior management who are among our five highest compensated directors and officers, or our Named Directors and
Officers; and
● all of our directors and members of senior management as a group.
The beneficial ownership of our Ordinary Shares is determined in accordance with the rules of the SEC. Under these rules, 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. For purposes of the table below, we deem Ordinary
Shares issuable pursuant to options that are currently exercisable or exercisable within 60 days of April 12, 2022, if any, to be outstanding and to be
beneficially owned by the person holding the options for the purposes of computing the percentage ownership of that person, but we do not treat them as
outstanding for the purpose of computing the percentage ownership of any other person. The percentage of Ordinary Shares beneficially owned is based on
32,959,884 Ordinary Shares outstanding as of April 12, 2022.
Except where otherwise indicated, we believe, based on information furnished to us by such owners, that the beneficial owners of the ordinary shares listed
below have sole investment and voting power with respect to such shares.
None of our shareholders have different voting rights from other shareholders. We are not aware of any arrangement that may, at a subsequent date, result
in a change of control of our Company.
As of April 11, 2022, there was one shareholder of record of our Ordinary Shares. The number of record holders is not representative of the number of
beneficial holders of our Ordinary Shares, as the shares of all our shareholders who hold Ordinary Shares that are traded on the TASE are recorded in the
name of our Israeli share registrar, Registration Co. of United Mizrahi Bank Ltd. As of April 9, 2022, there were 74 U.S. persons that were holders of
record of our ADSs, representing approximately 50.73% of our outstanding Ordinary Shares. The number of record holders is not representative of the
number of beneficial holders of our ADSs, as the ADSs of all our shareholders who hold ADSs that are traded on NASDAQ are recorded in the name of
their respective brokers.
Unless otherwise noted below, the address for each beneficial owner is c/o BrainsWay Ltd., 19 Hartum Street, Bynet Building 3rd Floor, Har HaHotzvim,
Jerusalem, 9777518, Israel.
Name of Beneficial Owner
5% or Greater Shareholders
The Phoenix Provident Funds(1)
RTW Funds(2)
Cowen Financial Products, LLC(3)
Dr. David Zacut (4)
Masters Capital Management, LLC(5)
Avner Hagai(4)
Named Directors and Officers
Dr. Yiftach Roth
Prof. Avraham Zangen(6)
Christopher von Jako(7)
R. Scott Areglado(8)
Hadar Levy(9)
Christopher Boyer(10)
Amit Ginou(11)
Karen Sarid(12)
Yossi Ben Shalom(13)
Avner Lushi(14)
Eti Mitrany(15)
All directors and members of senior management as a group
*
Less than 1.0%
118
Shares Beneficially Owned
Number
Percentage
4,291,726
3,204,762
1,658,418
1,786,357
1,782,710
1,741,378
1,083,390
937,143
125,000
28,750
372,877
30,000
99,667
27,500
22,917
13,750
13,750
6,282,479
13.04%
9.7%
5.03%
5.4%
5.4%
5.3%
3.3%
2.8%
*
*
1.1%
*
*
*
*
*
*
19.0%
(1)
(2)
The shares are beneficially owned by various direct or indirect, majority or wholly-owned subsidiaries of the Phoenix Holding Ltd. (the “Phoenix
Provident Funds”). The Phoenix Provident Funds manage their own funds and/or the funds of others, including for holders of exchange-traded notes
or various insurance policies, members of pension or provident funds, unit holders of mutual funds, and portfolio management clients. Each of the
Phoenix Provident Funds operates under independent management and makes its own independent voting and investment decisions. The Phoenix
Holding Ltd. is a controlled subsidiary of Delek Group Ltd. The majority of Delek Group Ltd.’s outstanding share capital and voting rights are
owned, directly and indirectly, by Itshak Sharon (Tshuva) through private companies wholly-owned by him, and the remainder is held by the public.
The address of the Phoenix Provident Funds is HaShalom Road 53 Giv’atayim, 5345433, Israel.
The shares are held by RTW Master Fund, Ltd., one or more private funds (together the “Funds”) managed by RTW Investments, LP (the
“Adviser”), and Roderick Wong. The Adviser, in its capacity as the investment manager of the Funds, has the power to vote and the power to direct
the disposition of all Shares held by the Funds. Roderick Wong is the Managing Partner of the Adviser. The address of RTW Master Fund, Ltd. is
412 West 15th Street Floor 9, New York, New York 10011.
The address of Cowen Financial Products, LLC is 599 Lexington Ave. 21st fl, New York, NY 10022
(3)
(4) A director of the Company. This consists of shares held directly by the named beneficial owner as well as shares held by family members or affiliates
(5)
(6)
(7)
(8)
(9)
of the named beneficial owner.
The shares are held by Masters Capital Management, LLC and Michael Masters has beneficial ownership by virtue of his role as a control person of
Masters Capital Management, LLC. The address of Masters Capital Management, LLC is 3060 Peachtree Road, Suite 1425, Atlanta, Georgia 30305,
United States of America.
The address of Prof. Avraham Zangen is Mish’ol HaHadas 23, Jerusalem, Israel.
Consists of 125,000 Ordinary Shares.
Consists of 28,750 Ordinary Shares.
Consists of 21,210 Ordinary Shares and options to purchase 351,667 Ordinary Shares currently exercisable or exercisable within 60 days. The
exercise price of the options is $4.65, as 220,000 expires on December 8, 2025, 106,667 expires on November 12, 2026 and the remainder expires on
October 1, 2027.
(10) Consists of options to purchase 30,000 Ordinary Shares currently exercisable or exercisable within 60 days. The exercise price of the options is
$4.65. The options expire on June 1, 2028.
(11) Consists of options to purchase 99,667 Ordinary Shares currently exercisable or exercisable within 60 days. The exercise price of the options is NIS
15.26, as 8,000 expires on June 30, 2023, 50,000 expires on December 8, 2025 and the remainder expires on November 12, 2026.
(12) Consists of options to purchase 27,500 Ordinary Shares currently exercisable or exercisable within 60 days. The exercise price of the options is NIS
15.26. The options expire on December 3, 2027.
(13) Consists of options to purchase 22,917 Ordinary Shares currently exercisable or exercisable within 60 days. The exercise price of the options is NIS
15.26. The options expire on November 12, 2026.
(14) Consists of options to purchase 13,750 Ordinary Shares currently exercisable or exercisable within 60 days. The exercise price of the options is NIS
15.26. The options expire on January 13, 2028.
(15) Consists of options to purchase 13,750 Ordinary Shares currently exercisable or exercisable within 60 days. The exercise price of the options is NIS
15.26. The options expire on January 13, 2028.
119
The voting rights of our major shareholders do not differ from the voting rights of holders of our Ordinary Shares who are not major shareholders. Each of
the above listed securities entitles the holder to one vote at our Company’s shareholder meetings.
Changes in Percentage Ownership by Major Shareholders
Since January 1, 2020, there have been no significant changes in the percentage ownership held by any of our 5% or greater shareholders other than The
Phoenix Provident Funds which increased holdings from 9.7% to 13.4%, RTW Funds which increased holdings from 9.4% to 9.7%. Additionally, Cowen
Financial Products, LLC and Masters Capital Management, LLC, which now hold 5.03% and 5.4% respectively, were not previously listed as major
shareholders.
Control by Another Corporation, Foreign Government or Other Persons
To the best of our knowledge, the Company is not directly or indirectly owned or controlled by another corporation(s), by any foreign government or by
any other natural or legal person(s) severally or jointly.
B.
Related Party Transactions
Employment Agreements
We have entered into written employment agreements with each member of our senior management. These agreements provide for notice periods of
varying duration for termination of the agreement by us or by the relevant executive officer, during which time the executive officer will continue to
receive base salary and benefits. These agreements also contain customary provisions regarding noncompetition, confidentiality of information, and
assignment of inventions. However, the enforceability of the noncompetition provisions may be limited under applicable law. See “Risk Factors—Risks
Related to Employee Matters—Under applicable employment laws, we may not be able to enforce covenants not to compete.”
Consulting Agreement with Prof. Avraham Zangen
In April 2009, we entered into a consulting agreement, which was last amended in May 2014, with Prof. Avraham Zangen, our scientific founder and a
member of our Board, under which Prof. Zangen provides advisory services to us in the field of neurobiology. Prof. Zangen’s monthly consulting fee is NIS
19,375. This agreement provides for a notice period of 180 days for termination of the agreement by Prof. Zangen and 30 days for termination of the
agreement by us.
Sponsorship of an Obesity Study at BGU
In 2021, the Company entered into an addendum to a July 2012 agreement with Ben Gurion Negev Technology and Applications Ltd. which operates a lab
associated with Prof. Zangen, a director of the Company. Under the terms of the addendum, we agreed to sponsor a 40-patient obesity study involving Deep
TMS.
Option Grants
Each of our directors and members of senior management are participants in our Share Incentive Plan, pursuant to which they receive from time to time
grants of options to purchase our Ordinary Shares. For more information, see “Directors, Senior Management and Employees—Share Ownership—Award
Plans.”
Since January 1, 2019, we granted options to purchase 470,000 Ordinary Shares to employees and directors, with a weighted average exercise price,
following the completion of the Exchange Offer, of approximately $4.5 per share, or approximately NIS 14 per share (based on the exchange rate reported
by the Bank of Israel on December 31, 2021), and 609,730 restricted share units (RSUs).
Option Exchange
On May 4, 2021, we commenced the Exchange Offer, which expired on June 2, 2021.Pursuant to the Exchange Offer, the Company accepted for
cancellation Eligible Options to purchase an aggregate of 1,371,500 Ordinary Shares, representing approximately 93.06% of the total Ordinary Shares
underlying the Eligible Options. On June 2, 2021, following the expiration of the Exchange Offer, the Company granted New Options to purchase
1,371,500 Ordinary Shares, pursuant to the terms of the Exchange Offer and the Company’s 2014 Share Incentive Plan, as amended by our Amended and
Restated 2019 Share Incentive Plan (together, the “Plan”). The exercise price per Ordinary Share of the New Options granted pursuant to the Exchange
Offer is $4.675 (NIS15.26 based on January 25, 2021 US$/NIS exchange rate of 1/3.265) (being the closing price per ADS of the Company, as reported on
Nasdaq on January 25, 2021, the last day of trading prior to the approval of the Exchange Offer by our Board of Directors, divided by 2 to reflect the
exercise price per Ordinary Share). Each New Option has the same expiration date, vesting schedule and other terms (other than exercise price) as the
Eligible Option exchanged therefor.
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Directors and Officers Insurance Policy and Indemnification Agreements
Our articles of association permit us to exculpate, indemnify, and insure each of our directors and officers to the fullest extent permitted by the Israeli
Companies Law. We have obtained directors and officers insurance for each of our senior management and directors.
We have provided an undertaking to our directors and senior management to exculpate to the fullest extent permitted by law and to indemnify them for
certain liabilities, subject to limited exceptions, to the extent that these liabilities are not covered by insurance. This indemnification is limited, with respect
to any monetary liability imposed in favor of a third party, to events determined as foreseeable by the board of directors based on our activities. The
maximum aggregate amount of indemnification that we may pay to our directors and senior management based on such indemnification undertaking is the
greater of (i) 25% of our shareholders’ equity pursuant to our most recent audited financial statements at the time the indemnification is actually paid, and
(2) $20 million. Such indemnification amounts are in addition to any insurance amounts.
C.
Interests of Experts and Counsel
Not applicable.
ITEM 8.
FINANCIAL INFORMATION
A.
Financial Statements and Other Financial Information
The financial statements required by this item are found at the end of this Annual Report, beginning on page F-1.
Legal Proceedings
From time to time, we may become a party to legal proceedings and claims in the ordinary course of business. We are not currently a party to any
significant legal proceedings.
Export Sales
For geographical breakdown of the Company’s sales, see Note 17 to the financial statements.
Dividend Policy
We have never declared or paid cash dividends to our shareholders. We do not have current plans to pay cash dividends in the near term. We currently
intend to reinvest any future earnings, if any, in developing and expanding our business. Any future determination relating to our dividend policy will be at
the discretion of our board of directors and will depend on a number of factors, including future earnings, if any, our financial condition, operating results,
contractual restrictions, capital requirements, business prospects, applicable Israeli law and other factors our board of directors may deem relevant.
B.
Significant Changes
Except as otherwise disclosed in this Annual Report, no significant change has occurred since December 31, 2021.
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ITEM 9.
THE OFFER AND LISTING
A.
Offer and Listing Details
Our Ordinary Shares have been trading on the TASE under the symbol “BWAY” since January 2007. Our ADSs have been trading on The NASDAQ
Capital Market under the symbol “BWAY” since April 16, 2019.
B.
Plan of Distribution
Not applicable.
C.
Markets
Our Ordinary Shares are listed and traded on the TASE, and our ADSs, each representing two Ordinary Share and evidenced by an American depositary
receipt, or ADR, are traded on The Nasdaq Global Market under the symbol “BWAY.” The ADRs were issued pursuant to a Depositary Agreement entered
into with The Bank of New York.
D.
Selling Shareholders
Not applicable.
E.
Dilution
Not applicable.
F.
Expenses of the Issue
Not applicable.
ITEM 10.
ADDITIONAL INFORMATION
A.
Share Capital
Not applicable.
B.
Memorandum and Articles of Association
For a description of provisions of our articles of association relating to the power of directors; rights, preferences and restrictions attaching to each class of
the shares; changes in control of the company; and other information required under Item 10.B, please see Exhibit 2.3 “Description of Share Capital,”
which is incorporated herein by reference.
C.
Material Contracts
For a description of our material agreements, please see Item 5.C Research and Development, Patents, and Licenses.
D.
Exchange Controls
Israeli law and regulations do not impose any material foreign exchange restrictions on non-Israeli holders of our Ordinary Shares or on the Company with
respect to the import or export of capital. Dividends, if any, paid to holders of our Ordinary Shares, and any amounts payable upon our dissolution,
liquidation or winding up, as well as the proceeds of any sale in Israel of our Ordinary Shares to an Israeli resident, may be paid in non-Israeli currency or,
if paid in Israeli currency, may be converted into U.S. dollars at the rate of exchange prevailing at the time of conversion.
E.
Taxation
Israeli Tax Considerations
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General
The following is a summary of the material tax consequences under Israeli law concerning the purchase, ownership, and disposition of our Ordinary Shares
or ADSs (Shares).
This discussion does not purport to constitute a complete analysis of all potential tax consequences applicable to investors upon purchasing, owning or
disposing of our Shares. In particular, this discussion does not take into account the specific circumstances of any particular investor (such as tax-exempt
entities, financial institutions, certain financial companies, broker-dealers, investors that own, directly or indirectly, 10% or more of our outstanding voting
rights, all of whom are subject to special tax regimes not covered under this discussion). To the extent that issues discussed herein are based on legislation
which has yet to be subject to judicial or administrative interpretation, there can be no assurance that the views expressed herein will accord with any such
interpretation in the future.
Potential investors are urged to consult their own tax advisors as to the Israeli or other tax consequences of the purchase, ownership, and disposition of the
Shares, including, in particular, the effect of any foreign, state or local taxes.
General Corporate Tax Structure in Israel
Israeli companies are generally subject to corporate tax on their taxable income at the rate of 23% for the 2022 tax year.
Taxation of Shareholders
Capital Gains
Capital gains tax is imposed on the disposition of capital assets by an Israeli resident, and on the disposition of such assets by a non-Israeli resident if those
assets are either (i) located in Israel; (ii) are shares or a right to a share in an Israeli resident corporation, or (iii) represent, directly or indirectly, rights to
assets located in Israel, unless an exemption is available or unless an applicable double tax treaty between Israel and the seller’s country of residence
provides otherwise. The Israeli Income Tax Ordinance distinguishes between “Real Gain” and the “Inflationary Surplus.” Real Gain is the excess of the
total capital gain over Inflationary Surplus generally computed on the basis of the increase in the Israeli Consumer Price Index between the date of
purchase and the date of disposition. Inflationary Surplus is not subject to tax.
Real Gain accrued by individuals on the sale of the Shares will be taxed at the rate of 25%. However, if the individual shareholder is a “Controlling
Shareholder” (i.e., a person who holds, directly or indirectly, alone or together with another, 10% or more of one of the Israeli resident company’s means of
control) at the time of sale or at any time during the preceding 12-month period, such gain will be taxed at the rate of 30%.
Corporate and individual shareholders dealing in securities in Israel are taxed at the tax rates applicable to business income (23% in 2022), and a marginal
tax rate of up to 50% in 2022 for individuals, including an excess tax (as discussed below).
Notwithstanding the foregoing, capital gains generated from the sale of our Shares by a non-Israeli shareholder may be exempt from Israeli tax under the
Israeli Income Tax Ordinance provided that the following cumulative conditions are met: (i) the Shares were purchased upon or after the registration of the
Shares on the stock exchange (this condition will not apply to shares purchased on or after January 1, 2009), and (ii) the seller does not have a permanent
establishment in Israel to which the generated capital gain is attributed. However, non-Israeli resident corporations will not be entitled to the foregoing
exemption if Israeli residents: (i) have a 25% or more interest in such non-Israeli corporation or (ii) are the beneficiaries of, or are entitled to, 25% or more
of the income or profits of such non-Israeli corporation, whether directly or indirectly. In addition, such exemption would not be available to a person
whose gains from selling or otherwise disposing of the securities are deemed to be business income.
In addition, the sale of the Shares may be exempt from Israeli capital gains tax under the provisions of an applicable double tax treaty. For example, the
Convention between the Government of the U.S. and the Government of the State of Israel with respect to Taxes on Income (U.S.-Israel Double Tax
Treaty) exempts a U.S. resident (for purposes of the treaty) from Israeli capital gain tax in connection with the sale of the Shares, provided that: (i) the U.S.
resident owned, directly or indirectly, less than 10% of the voting power of the company at any time within the 12-month period preceding such sale; (ii)
the U.S. resident, being an individual, is present in Israel for a period or periods of less than 183 days during the taxable year; and (iii) the capital gain from
the sale was not derived through a permanent establishment of the U.S. resident in Israel; however, under the U.S-Israel Double Tax Treaty, the taxpayer
would be permitted to claim a credit for such taxes against the U.S. federal income tax imposed with respect to such sale, exchange or disposition, subject
to the limitations under U.S. law applicable to foreign tax credits. The U.S-Israel Double Tax Treaty does not relate to U.S. state or local taxes.
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Payers of consideration for the Shares, including the purchaser, the Israeli stockbroker or the financial institution through which the Shares are held, are
obligated, subject to certain exemptions, to withhold tax upon the sale of Shares at a rate of 25% of the consideration for individuals and corporations.
Upon the sale of traded securities, a detailed return, including a computation of the tax due, must be filed and an advanced payment must be paid to the
Israeli Tax Authority on January 31 and July 31 of every tax year in respect of sales of traded securities made within the previous six months. However, if
all tax due was withheld at source according to applicable provisions of the Israeli Income Tax Ordinance and regulations promulgated thereunder, such
return need not be filed, and no advance payment must be paid. Capital gains are also reportable on annual income tax returns.
Dividends
Dividends distributed by a company to a shareholder who is an Israeli resident individual will generally be subject to income tax at a rate of 25%. However,
a 30% tax rate will apply if the dividend recipient is a Controlling Shareholder, as defined above, at the time of distribution or at any time during the
preceding 12-month period. If the recipient of the dividend is an Israeli resident corporation, such dividend will generally be exempt from Israeli income
tax provided that the income from which such dividend is distributed, derived or accrued within Israel.
Dividends distributed by an Israeli resident company to a non-Israeli resident (either an individual or a corporation) are generally subject to Israeli
withholding tax on the receipt of such dividends at the rate of 25% (30% if the dividend recipient is a Controlling Shareholder at the time of distribution or
at any time during the preceding 12-month period). These rates may be reduced under the provisions of an applicable double tax treaty. For example, under
the U.S.-Israel Double Tax Treaty, the following tax rates will apply in respect of dividends distributed by an Israeli resident company to a U.S. resident: (i)
if the U.S. resident is a corporation which holds during that portion of the taxable year which precedes the date of payment of the dividend and during the
whole of its prior taxable year (if any), at least 10% of the outstanding shares of the voting stock of the Israeli resident paying corporation, and not more
than 25% of the gross income of the Israeli resident paying corporation for such prior taxable year (if any) consists of certain types of interest or dividends
the tax rate is 12.5%; (ii) if both the conditions mentioned in clause (i) above are met and the dividend is paid from an Israeli resident company’s income
which was entitled to a reduced tax rate under The Law for the Encouragement of Capital Investments, 1959, the tax rate is 15%; and (iii) in all other cases,
the tax rate is 25%. The aforementioned rates under the U.S.-Israel Double Tax Treaty will not apply if the dividend income is attributed to a permanent
establishment of the U.S. resident in Israel.
Excess Tax
Individual holders who are subject to tax in Israel (whether any such individual is an Israeli resident or non-Israeli resident), and who have taxable income
that exceeds a certain threshold in a tax year (NIS 663,240 for 2022, linked to the Israeli Consumer Price Index) will be subject to an additional tax at the
rate of 3% on his or her taxable income for such tax year that is in excess of such amount. For this purpose, taxable income includes taxable capital gains
from the sale of securities and taxable income from interest and dividends, subject to the provisions of an applicable double tax treaty.
Estate and Gift Tax
Israel does not currently impose estate or gift taxes.
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Foreign Exchange Regulations
Non-residents of Israel who hold our Shares are able to receive any dividends, and any amounts payable upon the dissolution, liquidation, and winding up
of our affairs, repayable in non-Israeli currency at the rate of exchange prevailing at the time of conversion. However, Israeli income tax is generally
required to have been paid or withheld on these amounts. In addition, the statutory framework for the potential imposition of currency exchange control has
not been eliminated and may be restored at any time by administrative action.
U.S. Federal Income Tax Considerations
The following is a summary of the material U.S. federal income tax consequences relating to the ownership and disposition of our Ordinary Shares and
ADSs by U.S. Holders, as defined below. This summary addresses solely U.S. Holders who hold Ordinary Shares or ADSs, as applicable, as capital assets
for tax purposes. This summary is based on current provisions of the Internal Revenue Code of 1986, as amended (Code), current and proposed Treasury
regulations promulgated thereunder, and administrative and judicial decisions as of the date hereof, all of which are subject to change, possibly on a
retroactive basis. In addition, this section is based in part upon representations of the depositary and the assumption that each obligation in the deposit
agreement and any related agreement will be performed in accordance with its terms. This summary does not address all U.S. federal income tax matters
that may be relevant to a particular holder or all tax considerations that may be relevant with respect to an investment in our Ordinary Shares or ADSs.
This summary does not address tax considerations applicable to a holder of our Ordinary Shares or ADSs that may be subject to special tax rules including,
without limitation, the following:
● dealers or traders in securities, currencies or notional principal contracts;
● financial institutions;
● insurance companies;
● real estate investment trusts;
● banks;
● persons subject to the alternative minimum tax;
● tax-exempt organizations;
● traders that have elected mark-to-market accounting;
● investors that hold Ordinary Shares or ADSs as part of a “straddle”, “hedge”, or “conversion transaction” with other investments;
● regulated investment companies;
● persons that actually or constructively own 10 percent or more of our voting shares;
● persons that are treated as partnerships or other pass-through entities for U.S. federal income purposes and persons who hold the Shares through
partnerships or other pass-through entities; and
● persons whose functional currency is not the U.S. dollars.
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This summary does not address the effect of any U.S. federal taxation other than U.S. federal income taxation. In addition, this summary does not include
any discussion of state, local, or foreign tax consequences to a holder of our Ordinary Shares or ADSs.
You are urged to consult your own tax advisor regarding the foreign and U.S. federal, state, local, and other tax consequences of an investment in
Ordinary Shares or ADSs.
For purposes of this summary, a “U.S. Holder” means a beneficial owner of an Ordinary Share or ADS that is for U.S. federal income tax purposes:
● an individual who is a citizen or resident of the U.S.;
● a corporation (or other entity taxable as a corporation for U.S. federal income tax purposes) created or organized in the U.S. or under the laws of
the U.S. or any political subdivision thereof;
● an estate, the income of which is subject to U.S. federal income tax regardless of its source; or
● a trust (1) if (a) a court within the U.S. is able to exercise primary supervision over the administration of the trust and (b) one or more U.S. persons
have the authority to control all substantial decisions of the trust or (2) that has a valid election in effect under applicable U.S. Treasury regulations
to be treated as a U.S. person.
If an entity that is classified as a partnership for U.S. federal tax purposes holds Ordinary Shares or ADSs, the U.S. federal tax treatment of its partners will
generally depend upon the status of the partners and the activities of the partnership. Entities that are classified as partnerships for U.S. federal tax purposes
and persons holding Ordinary Shares or ADSs through such entities should consult their own tax advisors.
In general, if you hold ADSs, you will be treated as the holder of the underlying Ordinary Shares represented by those ADSs for U.S. federal income tax
purposes. Accordingly, gain or loss generally will not be recognized if you exchange ADSs for the underlying Ordinary Shares represented by those ADSs.
Distributions
Subject to the discussion under “Item 10. Additional Information – E. Taxation – U.S. Federal Income Tax Considerations – Passive Foreign Investment
Companies” below, the gross amount of any distribution, including the amount of any Israeli taxes withheld from such distribution, see “Item 10.
Additional Information – E. Taxation – Israeli Tax Considerations”, actually or constructively received by a U.S. Holder with respect to our Ordinary
Shares (or, in the case of ADSs, received by the depositary) will be taxable to the U.S. Holder as foreign source dividend income to the extent of our
current and accumulated earnings and profits as determined under U.S. federal income tax principles. The U.S. Holder will not be eligible for any dividends
received deduction in respect of the dividends paid by us. Distributions in excess of earnings and profits will be non-taxable to the U.S. Holder to the extent
of the U.S. Holder’s adjusted tax basis in its Ordinary Shares or ADSs. Distributions in excess of such adjusted tax basis will generally be taxable to the
U.S. Holder as capital gain from the sale or exchange of property as described below under “Sale or Other Disposition of Ordinary Shares or ADSs.” If we
do not report to a U.S. Holder the portion of a distribution that exceeds earnings and profits, then the distribution will generally be taxable as a dividend.
The amount of any distribution of property other than cash will be the fair market value of that property on the date of distribution.
Under the Code, certain dividends received by non-corporate U.S. Holders will be subject to a maximum federal income tax rate of 20%. This reduced
income tax rate is only applicable to dividends paid by a “qualified foreign corporation” that is not a PFIC for the year in which the dividend is paid or for
the preceding taxable year, and only with respect to Ordinary Shares or ADSs held by a qualified U.S. Holder (i.e., a non-corporate holder) for a minimum
holding period (generally 61 days during the 121-day period beginning 60 days before the ex-dividend date). As discussed below, however, we believe we
may be a “passive foreign investment company” (see “Item 10. Additional Information – E. Taxation – U.S. Federal Income Tax Considerations – Passive
Foreign Investment Companies” below) for our current taxable year and future taxable years. Accordingly, dividends paid by us to individual U.S. Holders
may not be eligible for the reduced income tax rate applicable to qualified dividends. You should consult your own tax advisor regarding the availability of
this preferential tax rate under your particular circumstances.
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The amount of any distribution paid in a currency other than U.S. dollars (a “foreign currency”), including the amount of any withholding tax thereon, will
be included in the gross income of a U.S. Holder in an amount equal to the U.S. dollar value of the foreign currency calculated by reference to the exchange
rate in effect on the date of the U.S. Holder’s (or, in the case of ADSs, the depositary’s) receipt of the dividend, regardless of whether the foreign currency
is converted into U.S. dollars. If the foreign currency is converted into U.S. dollars on the date of receipt, a U.S. Holder generally should not be required to
recognize a foreign currency gain or loss in respect of the dividend. If the foreign currency received in the distribution is not converted into U.S. dollars on
the date of receipt, a U.S. Holder will have a basis in the foreign currency equal to its U.S. dollar value on the date of receipt. Any gain or loss on a
subsequent conversion or other disposition of the foreign currency will be treated as U.S. source ordinary income or loss.
Subject to certain conditions and limitations, any Israeli taxes withheld on dividends may be creditable against a U.S. Holder’s U.S. federal income tax
liability, subject to generally applicable limitations. The rules relating to foreign tax credits and the timing thereof are complex. U.S. Holders should consult
their own tax advisors regarding the availability of a foreign tax credit in their particular situation.
Sale or Other Disposition of Ordinary Shares or ADSs
Subject to the discussion under “Item 10. Additional Information – Taxation — U.S. Federal Income Tax Considerations – Passive Foreign Investment
Companies” below, if a U.S. Holder sells or otherwise disposes of its Ordinary Shares or ADSs, gain or loss will be recognized for U.S. federal income tax
purposes in an amount equal to the difference between the amount realized on the sale or other disposition and such holder’s adjusted basis in the Ordinary
Shares or ADSs. Such gain or loss generally will be a capital gain or loss, and will be a long-term capital gain or loss if the holder had held the Ordinary
Shares or ADSs for more than one year at the time of the sale or other disposition. Long-term capital gains realized by non-corporate U.S. Holders are
generally subject to a preferential U.S. federal income tax rate. In general, gain or loss recognized by a U.S. Holder on the sale or other disposition or our
Ordinary Shares or ADSs will be U.S. source gain or loss for purposes of the foreign tax credit limitation. As discussed below in “Item 10. Additional
Information – Taxation — U.S. Federal Income Tax Considerations – Passive Foreign Investment Companies,” however, we may be a PFIC for our current
taxable year and future taxable years. If we are a PFIC, any such gain will be subject to the PFIC rules, as discussed below, rather than being taxed as a
capital gain.
If a U.S. Holder receives foreign currency upon a sale or exchange of Ordinary Shares or ADSs, gain or loss will be recognized in the manner described
above under “Distributions.” However, if such foreign currency is converted into U.S. dollars on the date received by the U.S. Holder, the U.S. Holder
generally should not be required to recognize any foreign currency gain or loss on such conversion.
As discussed above under the heading “Item 10. Additional Information – E. Taxation – Israeli Tax Considerations – Taxation of Shareholders,” a U.S.
Holder who holds Ordinary Shares or ADSs through an Israeli broker or other Israeli intermediary may be subject to Israeli withholding tax on any capital
gains recognized on a sale or other disposition of the Ordinary Shares or ADSs if the U.S. Holder does not obtain approval of an exemption from the Israeli
Tax Authorities or claim any allowable refunds or reductions. U.S. Holders are advised that any Israeli tax paid under circumstances in which an exemption
from (or a refund of or a reduction in) such tax was available will not be creditable for U.S. federal income tax purposes. U.S. Holders are advised to
consult their Israeli broker or intermediary regarding the procedures for obtaining an exemption or reduction.
Medicare Tax on Unearned Income
Certain U.S. Holders that are individuals, estates or trusts are required to pay an additional 3.8% tax on their net investment income, which would include
dividends paid on the Ordinary Shares or ADSs and capital gains from the sale or other disposition of the Ordinary Shares or ADSs.
Passive Foreign Investment Companies
Although we do not believe that we are currently a PFIC and do not anticipate becoming a PFIC in the foreseeable future, it is possible that we may be
treated as a PFIC for U.S. federal income tax purposes for our current taxable year and future taxable years. A non-U.S. corporation is considered a PFIC
for any taxable year if either:
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● at least 75% of its gross income for such taxable year is passive income; or
● at least 50% of the value of its assets (based on an average of the quarterly values of the assets during a taxable year) is attributable to assets that
produce or are held for the production of passive income.
For purposes of the above calculations, if a non-U.S. corporation owns, directly or indirectly, 25% or more of the total value of the outstanding shares of
another corporation, it will be treated as if it (a) held a proportionate share of the assets of such other corporation, and (b) received a proportionate share of
the income of such other corporation directly. Passive income generally includes dividends, interest, rents, royalties, and capital gains, but generally
excludes rents and royalties which are derived in the active conduct of a trade or business, and which are received from a person other than a related
person.
A separate determination must be made each taxable year as to whether we are a PFIC (after the close of each such taxable year). Because the value of our
assets for purposes of the asset test will generally be determined by reference to the market price of the ADSs, our PFIC status will depend in large part on
the market price of the ADSs, which may fluctuate significantly. Based on our retention of a significant amount of cash and cash equivalents, and
depending on the market price of the ADSs, we may be a PFIC for the current taxable year and future taxable years.
If we are a PFIC for any year during which you hold the ADSs, we generally will continue to be treated as a PFIC with respect to you for all succeeding
years during which you hold the ADSs, unless we cease to be a PFIC and you make a “deemed sale” election with respect to the ADSs you hold. If such
election is made, you will be deemed to have sold the ADSs you hold at their fair market value on the last day of the last taxable year in which we qualified
as a PFIC, and any gain from such deemed sale would be subject to the consequences described below. After the deemed sale election, the ADSs with
respect to which the deemed sale election was made will not be treated as shares in a PFIC unless we subsequently become a PFIC.
For each taxable year we are treated as a PFIC with respect to you, you will be subject to special tax rules with respect to any “excess distribution” you
receive and any gain you realize from a sale or other disposition (including a pledge) of the ADSs, unless you make a “mark-to-market” election as
discussed below. Distributions you receive in a taxable year that are greater than 125% of the average annual distributions you received during the shorter
of the three preceding taxable years or your holding period for the ADSs will be treated as an excess distribution. Under these special tax rules, if you
receive any excess distribution or realize any gain from a sale or other disposition of the ADSs:
● the excess distribution or gain will be allocated ratably over your holding period for the ADSs;
● the amount of excess distribution or gain allocated to the current taxable year, and any taxable year before the first taxable year in which we were
a PFIC, must be included in gross income (as ordinary income) for the current tax year; and
● the amount allocated to each other year will be subject to the highest tax rate in effect for that year, and the interest charge generally applicable to
underpayments of tax will be imposed on the resulting tax attributable to.
The tax liability for amounts allocated to years before the year of disposition or “excess distribution” cannot be offset by any net operating losses for such
years, and gains (but not losses) realized on the sale of the ADSs cannot be treated as capital, even if you hold the ADSs as capital assets.
If we are treated as a PFIC with respect to you for any taxable year, to the extent any of our subsidiaries are also PFICs, you will be deemed to own your
proportionate share of any such lower-tier PFIC, and you may be subject to the rules described in the preceding two paragraphs with respect to the shares of
such lower-tier PFICs you would be deemed to own. As a result, you may incur liability for any “excess distribution” described above if we receive a
distribution from such lower-tier PFICs or if any shares in such lower-tier PFICs are disposed of (or deemed disposed of). You should consult your own tax
advisor regarding the application of the PFIC rules to any of our subsidiaries.
Alternatively, a U.S. Holder of “marketable stock” (as defined below) in a PFIC may make a mark-to-market election for such stock to elect out of the
general tax treatment for PFICs discussed above. If you make a mark-to-market election for the ADSs, you will include in income for each year we are a
PFIC an amount equal to the excess, if any, of the fair market value of the ADSs as of the close of your taxable year over your adjusted basis in such
Ordinary Shares. You are allowed a deduction for the excess, if any, of the adjusted basis of the ADSs over their fair market value as of the close of the
taxable year. However, deductions are allowable only to the extent of any net mark-to-market gains on the ADSs included in your income for prior taxable
years. Amounts included in your income under a mark-to-market election, as well as gain on the actual sale or other disposition of the ADSs, are treated as
ordinary income. Ordinary loss treatment also applies to the deductible portion of any mark-to-market loss on the ADSs, as well as to any loss realized on
the actual sale or disposition of the ADSs to the extent the amount of such loss does not exceed the net mark-to-market gains previously included for the
ADSs. Your basis in the ADSs will be adjusted to reflect any such income or loss amounts. If you make a valid mark-to-market election, the tax rules that
apply to distributions by corporations which are not PFICs would apply to distributions by us, except the lower applicable tax rate for qualified dividend
income would not apply. If we cease to be a PFIC when you have a mark-to-market election in effect, gain or loss realized by you on the sale of the ADSs
will be a capital gain or loss and taxed in the manner described above under “Sale or Other Disposition of Ordinary Shares or ADSs.”
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The mark-to-market election is available only for “marketable stock,” which is a stock that is traded in other than de minimis quantities on at least 15 days
during each calendar quarter, or regularly traded, on a qualified exchange or another market, as defined in applicable U.S. Treasury regulations. Any trades
that have as their principal purpose meeting this requirement will be disregarded. The ADSs are listed on the Nasdaq Global Market and, accordingly,
provided the ADSs are regularly traded, if you are a holder of ADSs, the mark-to-market election would be available to you if we are a PFIC. Once made,
the election cannot be revoked without the consent of the IRS unless the ADSs cease to be marketable stock. If we are a PFIC for any year in which the
U.S. Holder owns ADSs but before a mark-to-market election is made, the interest charge rules described above will apply to any mark-to-market gain
recognized in the year the election is made. If any of our subsidiaries are or become PFICs, the mark-to-market election will not be available with respect to
the shares of such subsidiaries that are treated as owned by you. Consequently, you could be subject to the PFIC rules with respect to income of the lower-
tier PFICs the value of which already had been taken into account indirectly via mark-to-market adjustments. A U.S. Holder should consult its own tax
advisors as to the availability and desirability of a mark-to-market election, as well as the impact of such election on interests in any lower-tier PFICs.
In certain circumstances, a U.S. Holder of stock in a PFIC can make a “qualified electing fund election” to mitigate some of the adverse tax consequences
of holding stock in a PFIC by including in income its share of the corporation’s income on a current basis. However, we do not currently intend to prepare
or provide the information that would enable you to make a qualified electing fund election.
Unless otherwise provided by the U.S. Treasury, each U.S. shareholder of a PFIC is required to file an annual report containing such information as the
U.S. Treasury may require. A U.S. Holder’s failure to file the annual report will cause the statute of limitations for such U.S. Holder’s U.S. federal income
tax return to remain open with regard to the items required to be included in such report until three years after the U.S. Holder files the annual report, and,
unless such failure is due to reasonable cause and not willful neglect, the statute of limitations for the U.S. Holder’s entire U.S. federal income tax return
will remain open during such period. U.S. Holders should consult their own tax advisors regarding the requirements of filing such information returns
under these rules, taking into account the uncertainty as to whether we are currently treated as or may become a PFIC.
YOU ARE STRONGLY URGED TO CONSULT YOUR OWN TAX ADVISOR REGARDING THE IMPACT OF OUR POTENTIAL PFIC
STATUS ON YOUR INVESTMENT IN THE ADSs AS WELL AS THE APPLICATION OF THE PFIC RULES TO YOUR INVESTMENT IN
THE ADSs.
Backup Withholding and Information Reporting
Payments of dividends with respect to Ordinary Shares or ADSs and the proceeds from the sale, retirement, or other disposition of Ordinary Shares or
ADSs made by a U.S. paying agent or other U.S. intermediary will be reported to the IRS and to the U.S. Holder as may be required under applicable U.S.
Treasury regulations. We, or an agent, a broker, or any paying agent, as the case may be, may be required to withhold tax (backup withholding), currently at
the rate of 24%, if a non-corporate U.S. Holder that is not otherwise exempt fails to provide an accurate taxpayer identification number and comply with
other IRS requirements concerning information reporting. Certain U.S. Holders (including, among others, corporations and tax-exempt organizations) are
not subject to backup withholding. Any amount of backup withholding withheld may be used as a credit against your U.S. federal income tax liability
provided that the required information is furnished to the IRS. U.S. Holders should consult their own tax advisors as to their qualification for exemption
from backup withholding and the procedure for obtaining an exemption.
129
U.S. Holders may be required to file certain U.S. information reporting returns with the IRS with respect to an investment in our Ordinary Shares or ADSs,
including, among others, IRS Form 8938 (Statement of Specified Foreign Financial Assets). As described above under “Item 10. Additional Information –
Taxation — U.S. Federal Income Tax Considerations – Passive Foreign Investment Companies,” each U.S. Holder who is a shareholder of a PFIC must file
an annual report containing certain information. Substantial penalties may be imposed upon a U.S. Holder that fails to comply with the required
information reporting.
U.S. Holders should consult their own tax advisors regarding the backup withholding tax and information reporting rules.
EACH PROSPECTIVE INVESTOR IS URGED TO CONSULT ITS OWN TAX ADVISOR REGARDING THE TAX CONSEQUENCES OF AN
INVESTMENT IN OUR ORDINARY SHARES OR ADSs IN LIGHT OF SUCH INVESTOR’S PARTICULAR CIRCUMSTANCES.
F.
Dividends and Paying Agents
Not applicable.
G.
Statement by Experts
Not applicable.
H.
Documents on Display
We are subject to the information reporting requirements of the Exchange Act, applicable to foreign private issuers, and under those requirements, we file
reports with the SEC. Those other reports or other information are available to the public through the SEC’s website at http://www.sec.gov.
As a foreign private issuer, we are exempt from the rules under the Exchange Act, related to the furnishing and content of proxy statements, and our
officers, directors, and principal shareholders are exempt from the reporting and short-swing profit recovery provisions contained in Section 16 of the
Exchange Act. In addition, we are not required under the Exchange Act, to file annual, quarterly, and current reports and financial statements with the SEC
as frequently or as promptly as U.S. companies whose securities are registered under the Exchange Act. However, we are required to comply with the
informational requirements of the Exchange Act, and, accordingly, file current reports on Form 6-K, annual reports on Form 20-F and other information
with the SEC.
In addition, since our Ordinary Shares are traded on the TASE, we have filed Hebrew language periodic, and immediate reports with, and furnish
information to, the TASE and the Israeli Securities Authority, as required under Chapter Six of the Israel Securities Law, 1968. Copies of our filings with
the Israeli Securities Authority can be retrieved electronically through the MAGNA distribution site of the Israeli Securities Authority
(www.magna.isa.gov.il) and the TASE website (www.maya.tase.co.il).
We maintain a corporate website at www.brainsway.com. Information contained on, or that can be accessed through, our website does not constitute a part
of this Annual Report.
I.
Subsidiary Information
Not applicable.
ITEM 11.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
130
Market risk is the risk of loss related to changes in market prices, including interest rates and foreign exchange rates, of financial instruments that may
adversely impact our financial position, results of operations or cash flows. Our overall risk management program focuses on the unpredictability of
financial markets and seeks to minimize potential adverse effects on our financial performance.
Risk of Interest Rate Fluctuation and Credit Exposure Risk
At present, our credit and interest risk arise from cash and cash equivalents, deposits with banks as well as accounts receivable. A substantial portion of our
liquid instruments is invested in short-term deposits.
We estimate that because the liquid instruments are invested mainly for the short-term, the credit, and interest risk associated with these balances is low.
The primary objective of our investment activities is to preserve principal while maximizing the income we receive from our investments without
significantly increasing risk and loss. Our investments are exposed to market risk due to fluctuations in interest rates, which may affect our interest income
and the fair market value of our investments. We manage this exposure by performing ongoing evaluations of our investments.
Foreign Currency Exchange Risk
The U.S. dollar is our functional and reporting currency. Although a substantial portion of our expenses (mainly salaries and related costs) are denominated
in NIS, accounting for approximately 37% of our expenses in the year ended December 31, 2021, all of our financing has been in U.S. dollars, and the
substantial majority of our liquid assets are held in U.S. dollars. Furthermore, while we anticipate that a portion of our expenses, principally salaries and
related personnel expenses in Israel will continue to be denominated in NIS, we expect to incur an increasing amount of expenses in U.S. dollars as we
increase our marketing and sales personnel, and enhance our clinical studies. Changes of 5% in the U.S. dollar/NIS exchange rate would have
increased/decreased operating expenses by approximately $679/$614 thousand during the year ended December 31, 2021. We also have expenses, although
to a much lesser extent, in other non-U.S. dollar currencies, in particular the Euro.
Moreover, for the next few years we expect that the substantial majority of our revenues from the sale or lease of our systems in the United States, if any,
will be denominated in U.S. dollars. Since a portion of our expenses is denominated in NIS and other non-U.S. currencies, we are exposed to risk
associated with exchange rate fluctuations vis-à-vis the non-U.S. currencies.
We do not hedge our foreign currency exchange risk. In the future, we may enter into formal currency hedging transactions to decrease the risk of financial
exposure from fluctuations in the exchange rates of our principal operating currencies. These measures, however, may not adequately protect us from the
material adverse effects of such fluctuations.
ITEM 12.
DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES
A.
Debt Securities
Not applicable.
B.
Warrants and Rights
Not applicable.
C.
Other Securities
Not applicable.
D.
American Depositary Shares
131
Each of the American Depositary Shares, or ADSs, represents 2 Ordinary Shares. The ADSs trade on The Nasdaq Global Market.
The form of the deposit agreement for the ADSs and the form of American Depositary Receipt (ADR) that represents an ADS have been incorporated by
reference as exhibits to this Annual Report on Form 20-F. Copies of the deposit agreement are available for inspection at the principal office of The Bank
of New York Mellon, located at 101 Barclay Street, New York, New York 10286, and at the principal office of our custodians in Israel, Bank Leumi Le-
Israel, 34 Yehuda Halevi St., Tel Aviv 65546, Israel.
Fees and Expenses
Persons depositing or withdrawing shares or
American Depositary Shareholders must pay:
$5.00 (or less) per 100 American Depositary Shares (or portion of 100
American Depositary Shares)
$.05 (or less) per American Depositary Share
A fee equivalent to the fee that would be payable if securities
distributed to you had been shares and the shares had been deposited
for issuance of American Depositary Shares
$.05 (or less) per American Depositary Shares per calendar year
Registration or transfer fees
Expenses of the depositary
Taxes and other governmental charges the depositary or the custodian
have to pay on any American Depositary Share or share underlying an
American Depositary Share, for example, stock transfer taxes, stamp
duty or withholding taxes
Any charges incurred by the depositary or its agents for servicing the
deposited securities
For:
●Issuance of American Depositary Shares, including issuances resulting from a
distribution of shares or rights or other property
●Cancellation of American Depositary Shares for the purpose of withdrawal,
including if the deposit agreement terminates
●Any cash distribution to American Depositary Shareholders
●Distribution of securities distributed to holders of deposited securities which are
distributed by the depositary to American Depositary Shareholders
●Depositary services
●Transfer and registration of shares on our share register to or from the name of
the depositary or its agent when you deposit or withdraw shares
●Cable, telex, and facsimile transmissions (when expressly provided in the
deposit agreement)
●Converting foreign currency to U.S. dollars
●As necessary
●As necessary
The depositary collects its fees for delivery and surrender of ADSs directly from investors depositing shares or surrendering ADSs for the purpose of
withdrawal or from intermediaries acting for them. The depositary collects fees for making distributions to investors by deducting those fees from the
amounts distributed or by selling a portion of distributable property to pay the fees. The depositary may collect its annual fee for depositary services by
deduction from cash distributions or by directly billing investors or by charging the book-entry system accounts of participants acting for them. The
depositary may collect any of its fees by deduction from any cash distribution payable (or by selling a portion of securities or other property distributable)
to ADS holders that are obligated to pay those fees. The depositary may generally refuse to provide fee-attracting services until its fees for those services
are paid.
From time to time, the depositary may make payments to us to reimburse us for costs and expenses generally arising out of establishment and maintenance
of the ADS program, waive fees and expenses for services provided to us by the depositary or share revenue from the fees collected from ADS holders. In
performing its duties under the deposit agreement, the depositary may use brokers, dealers, foreign currency dealers or other service providers that are
owned by or affiliated with the depositary and that may earn or share fees, spreads or commissions.
The depositary may convert currency itself or through any of its affiliates and, in those cases, acts as principal for its own account and not as agent, advisor,
broker or fiduciary on behalf of any other person and earns revenue, including, without limitation, transaction spreads, that it will retain for its own
account. The revenue is based on, among other things, the difference between the exchange rate assigned to the currency conversion made under the
deposit agreement and the rate that the depositary or its affiliate receives when buying or selling foreign currency for its own account. The depositary
makes no representation that the exchange rate used or obtained in any currency conversion under the deposit agreement will be the most favorable rate that
could be obtained at the time or that the method by which that rate will be determined will be the most favorable to ADS holders, subject to the depositary’s
obligations under the deposit agreement. The methodology used to determine exchange rates used in currency conversions is available upon request.
132
ITEM 13.
DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES
Not applicable.
ITEM 14.
MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS
Not applicable.
ITEM 15.
CONTROLS AND PROCEDURES
(a) Disclosure Controls and Procedures
We performed an evaluation of the effectiveness of our disclosure controls and procedures that are designed to ensure that information required to be
disclosed on Form 20-F and filed with the SEC is recorded, processed, summarized, and reported timely within the time period specified in the SEC’s rules
and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be
disclosed by us in the reports that we file or submit under the Exchange Act, is accumulated and communicated to our management, including our principal
executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.
There can be no assurance that our disclosure controls and procedures will detect or uncover all failures of persons within the company to disclose
information otherwise required to be set forth in our reports. Nevertheless, our disclosure controls and procedures are designed to provide reasonable
assurance of achieving the desired control objectives. Based on our evaluation, our management, including our Chief Executive Officer and Chief Financial
Officer, have concluded that our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act) as of the end of the
period covered by this report are effective at such reasonable assurance level.
(b) Management’s Annual Report on Internal Control over Financial Reporting
Our management, under the supervision of our Chief Executive Officer and Chief Financial Officer, is responsible for establishing and maintaining
adequate internal control over our financial reporting, as defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act of 1934, as amended. The
Company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and
the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. Internal control over financial
reporting includes policies and procedures that:
·
·
·
·
pertain to the maintenance of records that in reasonable detail accurately and fairly reflect our transactions and asset dispositions;
provide reasonable assurance that transactions are recorded as necessary to permit the preparation of our financial statements in accordance with
generally accepted accounting principles;
provide reasonable assurance that receipts and expenditures are made only in accordance with authorizations of our management and board of
directors (as appropriate); and
provide reasonable assurance regarding the prevention or timely detection of unauthorized acquisition, use or disposition of assets that could have
a material effect on our financial statements.
Due to its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. In addition, projections of any evaluation
of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of
compliance with the policies or procedures may deteriorate.
133
Under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, we assessed the
effectiveness of our internal control over financial reporting as of December 31, 2021, based on the framework for Internal Control-Integrated Framework
set forth by The Committee of Sponsoring Organizations of the Treadway Commission (COSO) (2013). Based on our assessment and this framework, our
management concluded that the Company’s internal control over financial reporting was effective as of December 31, 2021.
(c) Attestation Report of Registered Public Accounting Firm
This Annual Report does not include an attestation report of our independent registered public accounting firm regarding internal control over financial
reporting due to an exemption for emerging growth companies provided in the JOBS Act.
(d) Changes in Internal Control Over Financial Reporting
There were no changes in our internal control over financial reporting that occurred during the year ended December 31, 2021, that have materially affected
or are reasonably likely to materially affect our internal control over financial reporting.
ITEM 16.
[RESERVED]
ITEM 16A.
AUDIT COMMITTEE FINANCIAL EXPERT
Our board of directors has determined that Ms. Karen Sarid and Ms. Eti Mitrany are audit committee financial experts. Ms. Karen Sarid and Ms. Eti
Mitrany are independent directors for the purposes of The Nasdaq Listing Rules.
ITEM 16B.
CODE OF ETHICS
As of the date of this Annual Report, we have adopted a code of ethics that applies to our principal executive officer, principal financial officer, principal
accounting officer or controller, or persons performing
is posted on our website,
https://investors.brainsway.com/static-files/4f9e73f4-18d6-409a-b198-74984439a2e0.
This code of ethics
functions.
similar
ITEM 16C.
PRINCIPAL ACCOUNTANT FEES AND SERVICES
Fees Paid to Independent Registered Public Accounting Firm
The following table sets forth, for each of the years indicated, the aggregate fees billed by our independent registered public accounting firm for
professional services.
Services Rendered
Audit (1)
Audit-related fees (2)
Tax fees (3)
All other fees (4)
Total
Year Ended December 31,
2020
2021
(U.S. dollars in thousands)
205
-
74
50
329
237
-
63
-
300
(1) Audit fees consist of services that would normally be provided in connection with statutory and regulatory filings or engagements, including services
that generally only the independent accountant can reasonably provide.
134
(2) Audit-related fees for assurance and related services that were reasonably related to the performance of the audit not reported under “Audit Fees”.
(3) Tax fees relate to tax compliance, tax planning, and tax advice.
(4) Fees relating to F-3 registration statement and follow-on underwritten public offering of ADSs.
Audit Committee Pre-Approval Policies and Procedures
Our audit committee’s specific responsibilities in carrying out its oversight of the quality and integrity of the accounting, auditing, and reporting practices
of the Company include the approval of audit and non-audit services to be provided by the external auditor. The audit committee approves in advance the
particular services or categories of services to be provided to the Company during the following yearly period and also sets forth a specific budget for such
audit and non-audit services. Additional non-audit services may be pre-approved by the audit committee.
During 2021, all services provided to us by Ernst & Young were approved by our Audit Committee pursuant to paragraph (c)(7)(i) of Rule 2-01 of
Regulation S-X.
ITEM 16D.
EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES
Not applicable.
ITEM 16E.
PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS
Not applicable.
ITEM 16F.
CHANGE IN REGISTRANT’S CERTIFYING ACCOUNTANT
Not applicable.
ITEM 16G.
CORPORATE GOVERNANCE
Nasdaq Stock Listing Rules and Home Country Practices
As a foreign private issuer whose shares are listed on The Nasdaq Global Market, we are permitted to follow certain home country corporate governance
practices instead of certain requirements of the rules of The Nasdaq Global Market. Pursuant to the “foreign private issuer exemption”:
● we established a quorum requirement such that the quorum for any meeting of shareholders is two or more shareholders holding at least 331/3% of
our voting rights, which complies with Nasdaq requirements; however, if the meeting is adjourned for lack of quorum, the quorum for such
adjourned meeting will be any number of shareholders, instead of 331/3% of our voting rights;
● we also follow Israeli corporate governance practice in lieu of Nasdaq Marketplace Rule 5635(c), which requires shareholder approval for certain
dilutive events (such as issuances that will result in a change of control, certain transactions other than a public offering involving issuances of a
20% or greater interest in us and certain acquisitions of the shares or assets of another company) and prior to an issuance of securities when a
stock option or purchase plan is to be established or materially amended or other equity compensation arrangement made or materially amended,
pursuant to which stock may be acquired by officers, directors, employees or consultants. By contrast, under the Israeli Companies Law,
shareholder approval is required (subject to certain limited exceptions) for, among other things: (a) transactions with directors concerning the
terms of their service (including indemnification, exemption, and insurance for their service or for any other position that they may hold at a
company); (b) extraordinary transactions with controlling shareholders of publicly held companies; (c) terms of office, and employment or other
engagement of our controlling shareholder, if any, or such controlling shareholder’s relative; (d) approval of transactions with the company’s Chief
Executive Officer with respect to his or her compensation, whether in accordance with the approved compensation policy of the company or not,
or transactions with officers of the company not in accordance with the approved compensation policy; (e) approval of the compensation policy of
the company for office holders; and (f) certain private placements involving the issuance of 20% or more of our total voting rights, or private
placements as a result of which a person will become a controlling shareholder of the company. In addition, under the Israeli Companies Law, a
merger requires approval of the shareholders of each of the merging companies; and
135
Otherwise, we comply with the rules generally applicable to U.S. domestic companies listed on The Nasdaq Global Market. However, we may in the future
decide to use the foreign private issuer exemption with respect to some or all of the other Nasdaq corporate governance rules.
ITEM 16H.
MINE SAFETY DISCLOSURE
Not applicable.
ITEM 16I.
DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
Not applicable.
ITEM 17.
FINANCIAL STATEMENTS
Not applicable.
ITEM 18.
FINANCIAL STATEMENTS
The financial statements required by this item are found at the end of this Annual Report, beginning on page F-1.
ITEM 19.
EXHIBITS
See Exhibit Index on page 136.
BRAINSWAY LTD
EXHIBIT INDEX
1.1** Articles of Association of the Registrant, as amended (unofficial English translation).
2.1
Form of Deposit Agreement between BrainsWay Ltd., The Bank of New York Mellon as Depositary, and owners and holders from time to time of
ADSs issued thereunder (incorporated by reference to Exhibit 1 to the Registration Statement on Form F-6 filed by The Bank of New York
Mellon with the SEC on February 1, 2019).
2.2
Form of American Depositary Receipt (incorporated by reference to Exhibit 1 to the Registration Statement on Form F-6 filed by The Bank of
New York Mellon with the SEC on February 1, 2019).
2.3** Description of Share Capital.
4.1
Amended and Restated BrainsWay 2019 Share Incentive Plan (incorporated by reference to Exhibit 4.1 to the Company’s Annual Report on Form
20-F, filed with the Commission on April 19, 2021).
136
4.2
Form of Letter of Exculpation and Indemnification (incorporated by reference to Exhibit 10.2 to the Registration Statement on Form F-1 filed by
the Company with the SEC on January 14, 2019).
4.3** Compensation Policy for Executive Officers and Directors, dated December 22, 2021.
4.4
Employment Agreement, dated April 3, 2006, by and between Brain Research and Development Services Ltd. and Dr. Yiftach Roth, as amended
by First Amendment to Employment Agreement, dated May 9, 2006 (incorporated by reference to Exhibit 10.4 to the Registration Statement on
Form F-1 filed by the Company with the SEC on January 14, 2019).
4.5** Employment Agreement, dated November 24, 2019, between BrainsWay Ltd. and Christopher Von Jako (incorporated by reference to Exhibit 4.5
to the Company’s Annual Report on Form 20-F, filed with the Commission on March 23, 2020) and an amendment dated March 4, 2021.
4.6
Employment Agreement, dated July 25, 2019, between BrainsWay Inc. and Hadar Levy (incorporated by reference to Exhibit 4.6 to the
Company’s Annual Report on Form 20-F, filed with the Commission on March 23, 2020).
4.7** Employment Agreement, dated March 25th, 2021, between BrainsWay Inc. and R. Scott Areglado.
4.8
Patent License Agreement, dated July 7, 2003, by and between BrainsWay, Inc. and the United States Public Health Service (incorporated by
reference to Exhibit 10.7 to the Registration Statement on Form F-1 filed by the Company with the SEC on January 14, 2019).
4.9
Patent License Amendment, dated August 24, 2005, by and between BrainsWay, Inc. and the United States Public Health Service (incorporated by
reference to Exhibit 10.8 to the Registration Statement on Form F-1 filed by the Company with the SEC on January 14, 2019).
4.10
4.11
4.12
4.13
4.14
4.15
4.16
Second Amendment to Patent License Agreement, dated April 17, 2008, by and between BrainsWay, Inc. and the United States Public Health
Service (incorporated by reference to Exhibit 10.9 to the Registration Statement on Form F-1 filed by the Company with the SEC on January 14,
2019).
Research and License Agreement, dated June 2, 2005, by and between BrainsWay, Inc. and Yeda Research and Development Company Ltd.
(incorporated by reference to Exhibit 10.10 to the Registration Statement on Form F-1 filed by the Company with the SEC on January 14, 2019).
First Addendum Agreement, dated August 19, 2007, by and between BrainsWay, Inc. and Yeda Research and Development Company Ltd.
(incorporated by reference to Exhibit 10.11 to the Registration Statement on Form F-1 filed by the Company with the SEC on January 14, 2019).
Second Addendum Agreement, dated January 18, 2009, by and between BrainsWay, Inc. and Yeda Research and Development Company Ltd.
(incorporated by reference to Exhibit 10.12 to the Registration Statement on Form F-1 filed by the Company with the SEC on January 14, 2019).
Third Addendum Agreement, dated March 23, 2010, by and between BrainsWay, Inc. and Yeda Research and Development Company Ltd.
(incorporated by reference to Exhibit 10.13 to the Registration Statement on Form F-1 filed by the Company with the SEC on January 14, 2019).
Fourth Addendum Agreement, dated November 12, 2009, by and between BrainsWay, Inc. and Yeda Research and Development Company Ltd.
(incorporated by reference to Exhibit 10.14 to the Registration Statement on Form F-1 filed by the Company with the SEC on January 14, 2019).
First Amendment to Fourth Addendum Agreement, dated May 11, 2010, by and between BrainsWay, Inc. and Yeda Research and Development
Company Ltd. (incorporated by reference to Exhibit 10.15 to the Registration Statement on Form F-1 filed by the Company with the SEC on
January 14, 2019).
137
4.17
Fifth Addendum Agreement, dated February 22, 2018, by and between BrainsWay, Inc. and Yeda Research and Development Company Ltd.
(incorporated by reference to Exhibit 10.16 to the Registration Statement on Form F-1 filed by the Company with the SEC on January 14, 2019).
4.18
Underwriting Agreement, dated February 23, 2021, between the Company and Oppenheimer & Co. Inc. (incorporated by reference to Exhibit 1.1
to the Form 6-K filed by the Company with the SEC on February 25, 2021).
8.1
List of Subsidiaries (incorporated by reference to Exhibit 21.1 to the Registration Statement on Form F-1 filed by the Company with the SEC on
January 14, 2019).
12.1** Certification by Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
12.2** Certification by Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
13**
Certification by Chief Executive Officer and Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
15.1** Consent of Kost Forer Gabbay & Kasierer, Member Firm of Ernst & Young Global.
101
The following financial statements from the Company’s 20-F for the fiscal year ended December 31, 2021 formatted in Inline XBRL:
(i) Consolidated Statements of Comprehensive Loss, (ii) Consolidated Statements of Financial Position, (iii) Consolidated Statements of Changes
in Equity, (iv) Consolidated Statements of Cash Flows, and (v) Notes to the Consolidated Financial Statements.
104
Cover Page Interactive Data File.
** Filed herewith.
SIGNATUREs
The Registrant hereby certifies that it meets all of the requirements for filing on Form 20-F and that it has duly caused and authorized the undersigned to
sign this annual report on its behalf.
BRAINSWAY LTD.
By:/s/ Christopher R. von Jako, Ph.D.
Name: Christopher R. von Jako, Ph.D.
Title: Chief Executive Officer and President
By:/s/ R. Scott Areglado
Name: R. Scott Areglado
Title: Senior Vice President and
Chief Financial Officer
Date: April 12, 2022
138
BRAINSWAY LTD.
INDEX OF FINANCIAL STATEMENTS
Audited Consolidated Financial Statements as of and for the Years ended December 31, 2021, 2020 and 2019
Report of Independent Registered Public Accounting Firm (PCAOB ID 1281)
Consolidated Statements of Financial Position
Consolidated Statements of Comprehensive Loss
Consolidated Statements of Changes in Equity
Consolidated Statements of Cash Flows
Notes to Consolidated Financial Statements
F-2
F-3
F-4
F-5
F-6
F-7
F-8
AUDITED CONSOLIDATED FINANCIAL STATEMENTS AS OF DECEMBER 31, 2021 AND 2020 AND FOR THE YEARS ENDED
DECEMBER 31, 2021, 2020 AND 2019
BRAINSWAY LTD. AND ITS SUBSIDIARIES
F-2
Kost Forer Gabbay & Kasierer
144 Menachem Begin Road, Building A
Tel-Aviv 6492102, Israel
Tel: +972-3-6232525
Fax: +972-3-5622555
ey.com
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Shareholders and the Board of Directors of
BRAINSWAY LTD. and its subsidiaries
Opinion on the Financial Statements
We have audited the accompanying consolidated statements of the financial position of BrainsWay Ltd. and its subsidiaries (“the Company”) as of
December 31, 2021 and 2020, and the related consolidated statements of comprehensive loss, changes in equity and cash flows for each of the three years
in the period ended December 31, 2021, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the
consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2021 and 2020, and the
results of its operations and its cash flows for each of the three years in the period ended December 31, 2021, in conformity with International Financial
Reporting Standards (“IFRS”), as issued by the International Accounting Standards Board.
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 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 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 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 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 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 financial statements. We believe that our audits provide a reasonable basis for our opinion.
/S/ KOST FORER GABBAY & KASIERER
KOST FORER GABBAY & KASIERER
A Member of Ernst & Young Global
We have served as the Company’s auditor since 2003.
Tel-Aviv, Israel
April 12, 2022
F-3
BRAINSWAY LTD. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
U.S. dollars in thousands (except share and per share data)
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
Short-term deposits
Trade receivables, net
Other current assets
Total current assets
NON-CURRENT ASSETS:
System components
Leased systems, net
Other property and equipment, net
Other long-term assets
Total non-current assets
Total assets
LIABILITIES AND EQUITY
CURRENT LIABILITIES:
Trade payables
Deferred revenues
Liability in respect of research and development grants
Other accounts payable
Total current liabilities
NON-CURRENT LIABILITIES:
Deferred revenues and other liabilities
Liability in respect of research and development grants
Total non-current liabilities
EQUITY:
Share capital
Share premium
Share-based payment reserve
Currency Translation Adjustments
Accumulated deficit
Total equity
Total equity and liabilities
Note
2021
2020
December 31,
4
5
6
7
8
8
8
14a
9
10
14a
15
16
$
$
$
$
$
16,921 $
40,428
6,332
1,766
65,447
4,463 $
3,813
1,055
954
10,285
75,732 $
1,102 $
2,195
978
4,792
9,067
3,419
5,921
9,340
363
137,566
5,340
(2,188)
(83,756)
57,325
75,732 $
16,961
221
5,582
1,534
24,298
3,642
5,198
710
163
9,713
34,011
781
1,543
707
3,769
6,800
2,053
5,524
7,577
233
95,135
3,748
(2,188)
(77,294)
19,634
34,011
The accompanying notes are an integral part of the consolidated financial statements.
F-4
BRAINSWAY LTD. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
U.S. dollars in thousands (except share and per share data)
Revenues
Cost of revenues
Gross profit
Research and development expenses, net
Selling and marketing expenses
General and administrative expenses
Total operating expenses
Operating loss
Finance expense, net
Loss before income taxes
Income taxes
Net loss and total comprehensive loss
Basic and diluted net loss per share
Year ended
December 31,
2020
2019
29,657 $
6,599
23,058
6,393
15,880
5,784
28,057
4,999
1,420
6,419
43
6,462 $
(0.21) $
22,057 $
5,058
16,999
5,823
11,283
4,722
21,828
4,829
319
5,148
237
5,385 $
(0.24) $
23,101
5,129
17,972
7,876
13,269
5,303
26,448
8,476
1,430
9,906
422
10,328
(0.50)
2021
$
$
$
Note
17a
17b
17c
17d
17e
17f
13
18
The accompanying notes are an integral part of the consolidated financial statements.
F-5
BRAINSWAY LTD. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
U.S. dollars in thousands (except share and per share data)
$
Share
capital
Share
premium
Reserve for
share-based
payment
transactions
Currency
translation
adjustments
Accumulated
deficit
Total
equity
171
—
62
—
—
233
—
—
—
233
—
1
—
129
—
363
67,193
—
26,271
185
—
93,649
—
—
466
1,020
—
95,135
—
158
142
42,131
—
137,566
3,357
—
—
(185)
1,263
4,435
—
(187)
(466)
(1,020)
986
3,748
—
(159)
(142)
—
1,893
5,340
(2,188)
—
—
—
—
(2,188)
—
—
—
—
(2,188)
—
—
—
—
(2,188)
(61,581)
(10,328)
—
—
—
(71,909)
(5,385)
—
—
—
(77,294)
(6,462)
—
—
—
(83,756)
6,952
(10,328)
26,333
—
1,263
24,220
(5,385)
(187)
—
—
986
19,634
(6,462)
—
—
42,260
1,893
57,325
Balance at January 1, 2019
Net loss and total comprehensive loss
Issuance of shares, net (**)
Expiration of share options
Cost of share-based payment
Balance at December 31, 2019
Net loss and total comprehensive loss
Forfeiture of share options
Issuance of shares, net
Expiration of share options
Cost of share-based payment
Balance at December 31, 2020
Net loss and total comprehensive loss
Exercise of share options
Expiration of share options
Issuance of shares, net (***)
Cost of share-based payment
Balance at December 31, 2021
Lower than one thousand.
(*)
(**) Net of issuance expenses of $4,444 thousand.
(***) Net of issuance expenses of $2,940 thousand.
The accompanying notes are an integral part of the consolidated financial statements.
F-6
BRAINSWAY LTD. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
U.S. dollars in thousands (except share and per share data)
Cash flows from operating activities:
Total comprehensive loss
Adjustments to reconcile net loss to net cash used in operating activities:
Adjustments to profit or loss items:
Depreciation and amortization
Depreciation of leased systems
Impairment and disposals
Withdrawal of lease due to termination of contract
Finance expenses, net
Cost of share-based payment
Income taxes
Total adjustments to reconcile profit (loss)
Changes in asset and liability items:
Increase in trade receivables
Decrease (increase) in other accounts receivable
Increase (decrease) in trade payables
Increase (decrease) in other accounts payable
Increase in deferred revenues and other liabilities
Total changes in asset and liability
Cash paid and received during the year for:
Interest paid
Interest received
Income taxes paid
Total cash paid and received during the year
Net cash provided by (used in) operating activities
Cash flows from investing activities:
Purchase of property and equipment and system components, net
investment in short-term deposits, net
investment in long-term deposits, net
Net cash used in investing activities
Cash flows from financing activities:
Repayment of loan from bank, net
Receipt of government grants
Repayment of liability in respect of research and development grants
Repayment of lease liability
Issuance of share capital, net
Net cash provided by (used in) financing activities
Exchange rate differences on cash and cash equivalents
Increase (decrease) in cash and cash equivalents
Cash and cash equivalents at the beginning of the year
Cash and cash equivalents at the end of the year
Year ended
December 31,
2020
2021
2019
$
(6,462) $
(5,385) $
(10,328)
560
1,126
1,295
—
1,420
1,893
43
6,337
(849)
(1,226)
289
815
2,039
1,068
(62)
17
(14)
(59)
884
(2,238)
(40,000)
22
(42,216)
—
492
(761)
(475)
42,260
41,516
(224)
(40)
16,961
16,921 $
438
1,180
1,061
(5)
319
799
237
4,029
(7)
(97)
(552)
515
320
179
(71)
61
(249)
(259)
(1,436)
(2,470)
—
5
(2,465)
—
42
(655)
(417)
—
(1,030)
218
(4,713)
21,674
16,961 $
550
1,054
1,191
—
1,430
1,263
422
5,910
(2,634)
136
175
(385)
555
(2,153)
(296)
175
(552)
(673)
(7,244)
(3,311)
(120)
985
(2,446)
(3,000)
176
(601)
(434
26,333
22,474
(78)
12,706
8,968
21,674
$
F-7
BRAINSWAY LTD. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
U.S. dollars in thousands (except share and per share data)
(a) Significant non-cash transactions:
Purchase of property and equipment on credit
Recognition of new lease liability and right-of-use
Termination of lease liability and right of-use
$
$
— $
587
(64) $
23 $
48
(51) $
183
—
—
F-8
BRAINSWAY LTD. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
NOTE 1: GENERAL
a.
A general description of the Company and its activity:
BrainsWay is a leader in advanced noninvasive neurostimulation treatments for mental health disorders. The Company is advancing neuroscience
with its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology to improve health and transform lives. The
Company has obtained from the U.S. Food and Drug Administration (FDA) three cleared indications backed by pivotal studies demonstrating
clinically proven efficacy. Current indications include MDD (Major Depressive Disorder), obsessive-compulsive disorder (OCD), and smoking
addiction.
The Company received its first commercial Deep TMS product received clearance from the FDA in 2013, for the treatment of MDD in adult
patients who have failed to achieve satisfactory improvement from anti-depressant medication. In April 2021, the Company received FDA
clearance for a shorter innovative MDD treatment and in August 2021, the Company received an additional clearance from the FDA for expansion
of the existing MDD clearance to include the noninvasive treatment of anxiety symptoms.
The Company received a clearance from the FDA in August 2020, for use of its Deep TMS system as an aid in short-term smoking cessation in
adults.
BrainsWay Ltd. (the “Company”) and its wholly owned subsidiaries, BrainsWay, Inc. (“Inc”), Brain R&D Services Ltd. (“Brain R&D”),
BrainsWay USA Inc (“USA Inc”), collectively (the “Group”) derive revenues from the sale and lease of its systems.
b.
The COVID-19 global pandemic has led governments and authorities around the globe, to take various precautionary measures in order to limit
the spread of the COVID-19 global pandemic, including government-imposed quarantines, lockdowns, and other public health safety measures,
which have had and continues to have an adverse effect on the global markets and its economy, including on the availability and pricing of
materials, manufacturing and delivery efforts, sales to existing and potential customers and leads, collections from accounts, and other aspects of
the global economy.
Therefore, the COVID-19 global pandemic could continue to disrupt production and cause delays in the supply and delivery of products used in
the Company's operations, may further divert the attention and efforts of the medical community to coping with the COVID-19 global pandemic,
impact the Company's ability to recruit subjects for ongoing and planned clinical trials and disrupt the marketplace in which the Company operates
and may have material adverse effects on its operations, sales, revenues, collection from accounts and the ability to raise funds.
The extent to which the COVID-19 global pandemic impacts the Company's results will depend on future developments, which are highly
uncertain and cannot be predicted, including new information which may emerge concerning the severity of the COVID-19 global pandemic and
the actions to contain the COVID-19 global pandemic or treat its impact, among others.
F-9
BRAINSWAY LTD. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)
NOTE 1: GENERAL (Continued)
c.
d.
The Company has a positive cash flow from operating activities and an operating loss of $884 and $4,999 for the year ended December 31, 2021,
respectively. The Company’s management and board of directors believe that the Company has the current funding to finance its business activity
according to its plans in the foreseeable future
The financial statements of the Company as of December 31, 2021 and 2020 and for each of the three years in the period ended December 31,
2021 were authorized for issuance in accordance with a resolution of the board of directors on April 11, 2022.
NOTE 2: SIGNIFICANT ACCOUNTING POLICIES
The following accounting policies have been applied consistently in the financial statements for all periods presented, unless otherwise stated.
a.
Basis of presentation of the financial statements:
These financial statements have been prepared in accordance with International Financial Reporting Standards (“IFRS”) as issued by the
International Accounting Standards Board.
The Company’s financial statements have been prepared on a cost basis, except for certain financial instruments which are presented at fair value
through profit or loss.
The Company has elected to present the profit or loss items using the function of expense method.
b.
Consolidated financial statements:
The consolidated financial statements comprise the financial statements of companies that are controlled by the Company (subsidiaries). Control is
achieved when the Company is exposed, or has rights, to variable returns from its involvement with the investee and has the ability to affect those
returns through its power over the investee. Potential voting rights are considered when assessing whether an entity has control. The consolidation
of the financial statements commences on the date on which control is obtained and ends when such control ceases.
The consolidated financial statements of the Company and of the subsidiaries are prepared as of the same dates and periods. The consolidated
financial statements are prepared using uniform accounting policies by all companies in the Group. Significant intragroup balances and
transactions and gains or losses resulting from intragroup transactions are eliminated in full in the consolidated financial statements.
F-10
BRAINSWAY LTD. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
U.S. dollars in thousands (except share and per share data)
NOTE 2: SIGNIFICANT ACCOUNTING POLICIES (Continued)
c.
Functional currency, presentation currency and foreign currency:
1.
Functional currency and presentation currency:
The functional currency is the currency that best reflects the economic environment in which the Company operates and conducts its
transactions, is separately determined for each Group entity and is used to measure its financial position and operating results. The Group
determines the functional currency of each Group entity. The Company’s functional and presentation currency is the US Dollar for all
reported periods and subsidiaries
2.
Transactions, assets and liabilities in foreign currency:
Transactions denominated in foreign currency are recorded upon initial recognition at the exchange rate at the date of the transaction.
After initial recognition, monetary assets and liabilities denominated in foreign currency are translated at each reporting date into the
functional currency at the exchange rate at that date. Exchange rate differences, other than those capitalized to qualifying assets or
accounted for as hedging transactions in equity, are recognized in profit or loss. Non-monetary assets and liabilities denominated in
foreign currency and measured at cost are translated at the exchange rate at the date of the transaction. Non-monetary assets and liabilities
denominated in foreign currency and measured at fair value are translated into the functional currency using the exchange rate prevailing
at the date when the fair value was determined.
d.
Cash equivalents:
Cash equivalents are considered as highly liquid investments, including unrestricted short-term bank deposits with an original maturity of three
months or less from the date of investment or with a maturity of more than three months, but which are redeemable on demand without penalty
and which form part of the Group's cash management.
e.
Short-term deposits:
Short-term bank deposits are deposits with an original maturity of more than three months from the date of investment and which do not meet the
definition of cash equivalents. The deposits are presented according to their terms of deposit.
F-11
BRAINSWAY LTD. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
U.S. dollars in thousands (except share and per share data)
NOTE 2: SIGNIFICANT ACCOUNTING POLICIES (Continued)
f.
Revenue recognition:
Revenue from contracts with customers is recognized when the control over the goods or services is transferred to the customer. The transaction
price is the amount of the consideration that is expected to be received based on the contract terms, excluding amounts collected on behalf of third
parties (such as taxes).
In determining the amount of revenue from contracts with customers, the Company evaluates whether it is a principal or an agent in the
arrangement. The Company is a principal when the Company controls the promised goods or services before transferring them to the customer. In
these circumstances, the Company recognizes revenue for the gross amount of the consideration. When the Company is an agent, it recognizes
revenue for the net amount of the consideration, after deducting the amount due to the principal.
The Company primarily generates revenue from two major streams: (a) sale of systems and related services and (b) lease of systems.
Revenues from sale of systems and related services:
Revenue from sale of systems is recognized at the point in time when control of the system is transferred to the customer, generally upon shipment
of the system to the customer.
Revenue from rendering of extended warranty services is recognized over time, during the period the customer simultaneously receives and
consumes the benefits provided by the Company’s performance. The Company charges its customers based on payment terms agreed upon in
specific agreements. When payments are made before or after the service is performed, the Company recognizes the resulting contract asset or
liability.
Revenue from operating leases:
A lease in which substantially all the risks and rewards incidental to ownership of the leased asset have not been transferred to the lessee is
classified as an operating lease. Lease payments are recognized as income in profit or loss on a straight-line basis over the lease term. Initial direct
costs incurred in respect of the lease agreement are added to the carrying amount of the underlying asset and recognized as an expense over the
lease term on the same basis as the lease income.
Costs of obtaining a contract:
In order to obtain certain contracts with customers, the Company incurs incremental costs in obtaining the contract (such as sales commissions
which are contingent on making binding sales). Costs incurred in obtaining the contract with the customer which would not have been incurred if
the contract had not been obtained and which the Company expects to recover are recognized as an asset and amortized on a systematic basis that
is consistent with the provision of the services under the specific contract.
F-12
BRAINSWAY LTD. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
U.S. dollars in thousands (except share and per share data)
NOTE 2: SIGNIFICANT ACCOUNTING POLICIES (Continued)
An impairment loss in respect of capitalized costs of obtaining a contract is recognized in profit or loss when the carrying amount of the asset
exceeds the remaining amount of consideration that the Company expects to receive for the goods or services to which the asset relates less the
costs that relate directly to providing those goods or services and that have not been recognized as expenses.
The Company has elected to apply the practical expedient allowed by IFRS 15 according to which incremental costs of obtaining a contract are
recognized as an expense when incurred if the amortization period of the asset is one year or less.
Contract liabilities:
A contract liability, presented as deferred revenues, is the obligation to transfer goods or services to a customer for which the Company has
received consideration (or an amount of consideration is due) from the customer. Deferred revenue will be recognized as revenue in profit and loss
when the work is performed. The Company elected to apply the practical expedient in IFRS 15 and does not provide disclosure of the remaining
unsatisfied performance obligations with respect to contracts that have a term of up to one year.
Allocating the transaction price:
For contracts that consist of more than one performance obligation at contract inception, the Company allocates the contract transaction price to
each performance obligation identified in the contract on a relative stand-alone selling price basis. The stand-alone selling price is the price at
which the Company would sell the promised goods or services separately to a customer.
g.
Government grants:
Government grants are recognized when there is reasonable assurance that the grants will be received and the Company will comply with all
attached conditions.
Government grants received from the Israel Innovation Authority (“IIA”) are recognized upon receipt as a liability if future economic benefits are
expected from the research project, that will result in royalty-bearing sales.
A liability for the grant is first measured at fair value using a discount rate that reflects a market rate of interest. The difference between the
amount of the grant received and the fair value of the liability is accounted for as a government grant and recognized as a reduction of research
and development expenses. After initial recognition, the liability is measured at amortized cost using the effective interest method. Royalty
payments are treated as a reduction of the liability.
If no economic benefits are expected from the research activity, the grant received are recognized as a reduction of the related research and
development expenses. In that event, the royalty obligation is treated as a contingent liability in accordance with IAS 37.
Amounts paid as royalties are recognized as settlement of the liability.
F-13
BRAINSWAY LTD. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
U.S. dollars in thousands (except share and per share data)
NOTE 2: SIGNIFICANT ACCOUNTING POLICIES (Continued)
h.
Taxes on income:
Current or deferred taxes are recognized in profit or loss, except to the extent that they relate to items which are recognized in other
comprehensive income or equity.
1.
Current taxes:
The current tax liability is measured using the tax rates and tax laws that have been enacted or substantively enacted at the reporting date,
as well as adjustments required in connection with the tax liability in respect of previous years.
2.
Deferred taxes:
Deferred taxes are computed in respect of temporary differences between the carrying amounts in the financial statements and the
amounts attributed for tax purposes.
Deferred taxes are measured at the tax rate that is expected to apply when the asset is realized or the liability is settled, based on tax laws
that have been enacted or substantively enacted by the reporting date.
Deferred tax assets are reviewed at each reporting date and reduced to the extent that it is not probable that they will be utilized.
Temporary differences that can be deducted for which deferred tax assets had not been recognized are reviewed at each reporting date and
a respective deferred tax asset is recognized to the extent that utilization is probable.
Taxes that would apply in the event of the disposal of investments in subsidiaries have not been taken into account in computing deferred
taxes, as long as the disposal of the investments in subsidiaries is not probable in the foreseeable future. Also, deferred taxes that would
apply in the event of distribution of earnings by subsidiaries as dividends have not been taken into account in computing deferred taxes,
since the distribution of dividends does not involve an additional tax liability or since it is the Company’s policy not to initiate
distribution of dividends from a subsidiary that would trigger an additional tax liability.
Deferred taxes are offset if there is a legally enforceable right to offset a current tax asset against a current tax liability and the deferred
taxes relate to the same taxpayer and the same taxation authority.
F-14
BRAINSWAY LTD. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
U.S. dollars in thousands (except share and per share data)
NOTE 2: SIGNIFICANT ACCOUNTING POLICIES (Continued)
i.
Leases:
The Company accounts for a contract as a lease when the contract terms convey the right to control the use of an identified asset for a period of
time in exchange for consideration.
For leases in which the Company is the lessee, the Company recognizes on the commencement date of the lease a right-of-use asset and a lease
liability, excluding leases whose term is up to 12 months and leases for which the underlying asset is of low value. For these excluded leases, the
Company has elected to recognize the lease payments as an expense in profit or loss on a straight-line basis over the lease term. In measuring the
lease liability, the Company has elected to apply the practical expedient in the Standard and does not separate the lease components from the non-
lease components (such as management and maintenance services, etc.) included in a single contract.
On the commencement date, the lease liability includes all unpaid lease payments discounted at the interest rate implicit in the lease, if that rate
can be readily determined, or otherwise using the Company’s incremental borrowing rate. After the commencement date, the Company measures
the lease liability using the effective interest rate method.
On the commencement date, the right-of-use asset is recognized in an amount equal to the lease liability plus lease payments already made on or
before the commencement date and initial direct costs incurred. The right-of-use asset is measured applying the cost model and depreciated over
the shorter of its useful life and the lease term.
Following are the amortization periods of the right-of-use assets by class of underlying asset:
Lease facilities
Motor vehicles
2
Years
to
3
3
The Company tests for impairment of the right-of-use asset whenever there are indications of impairment pursuant to the provisions of IAS 36.
For leases in which the Company is the lessor, refer to revenue recognition in Note 2f.
j.
System components:
System components are measured at the lower of cost and net realizable value. The cost is determined on a weighted average basis. Net realizable
value is the estimated selling price in the ordinary course of business, which is primarily leasing to customers, less estimated costs of completion
and estimated costs necessary to make a sale or a lease. The Company periodically evaluates the intended use of the systems components, their
condition and age and records provisions for impairment accordingly.
F-15
BRAINSWAY LTD. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
U.S. dollars in thousands (except share and per share data)
NOTE 2: SIGNIFICANT ACCOUNTING POLICIES (Continued)
k.
Leased systems, net:
The cost of self-constructed systems (leased systems) includes the cost of materials, direct labor and share-based payment, as well as any costs
directly attributable to bringing the asset to the location and condition necessary for it to be capable of operating in the manner intended by
management, less accumulated depreciation and impairment losses.
The impairment and disposals of leased systems and system components recognized in cost of revenues was $1,295, $1,061 and $1,191 for the
years ended December 31, 2021, 2020 and 2019, respectively.
l.
Other property and equipment, net:
Other property and equipment are measured at cost, including directly attributable costs, less accumulated depreciation, accumulated impairment
losses and any related investment grants and excluding day-to-day servicing expenses. Cost includes spare parts and auxiliary equipment that are
used in connection with plant and equipment.
Depreciation is calculated on a straight-line basis over the useful life of the assets at annual rates as follows:
Leased systems
Laboratory equipment
Computers
Office furniture and equipment
Leasehold improvements
%
15
15
33
-
(*)
6
15
Leasehold improvements are depreciated on a straight-line basis over the shorter of the lease term (including the extension option held by the
Group and intended to be exercised) and the useful life of the improvement.
The useful life, depreciation method and residual value of an asset are reviewed at least each year-end and any changes are accounted for
prospectively as a change in accounting estimate. Depreciation of an asset ceases at the earlier of the date that the asset is classified as held for sale
and the date that the asset is derecognized.
F-16
BRAINSWAY LTD. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
U.S. dollars in thousands (except share and per share data)
NOTE 2: SIGNIFICANT ACCOUNTING POLICIES (Continued)
m.
Impairment of non-financial assets:
The Company evaluates the need to record an impairment of non-financial assets whenever events or changes in circumstances indicate that the
carrying amount is not recoverable. If the carrying amount of non-financial assets exceeds their recoverable amount, the assets are reduced to their
recoverable amount. The recoverable amount is the higher of fair value less costs of sale and value in use. In measuring value in use, the expected
cash flows are discounted using a pre-tax discount rate that reflects the risks specific to the asset. The recoverable amount of an asset that does not
generate independent cash flows is determined for the cash-generating unit to which the asset belongs. Impairment losses are recognized in profit
or loss.
An impairment loss of an asset is reversed only if there have been changes in the estimates used to determine the asset’s recoverable amount since
the last impairment loss was recognized. Reversal of an impairment loss, as above, shall not be increased above the lower of the carrying amount
that would have been determined (net of depreciation or amortization) had no impairment loss been recognized for the asset in prior years and its
recoverable amount. The reversal of impairment loss of an asset presented at cost is recognized in profit or loss.
n.
Financial instruments:
The Company has short-term financial assets, such as trade receivables, in respect of which the Company applies the simplified approach in IFRS
9 and measures the loss allowance in an amount equal to the lifetime expected credit losses.
o.
Fair value measurement:
Carrying amount of cash and cash equivalents, short-term deposits, trade receivables, other current assets, trade payables and other account
payables approximate their fair value due to the short-term maturities of the instruments.
p.
Provisions:
A provision in accordance with IAS 37 is recognized when the Group has a present obligation (legal or constructive) as a result of a past event, it
is probable that an outflow of resources embodying economic benefits will be required to settle the obligation and a reliable estimate can be made
of the amount of the obligation.
F-17
BRAINSWAY LTD. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
U.S. dollars in thousands (except share and per share data)
NOTE 2: SIGNIFICANT ACCOUNTING POLICIES (Continued)
q.
Employee benefit liabilities:
1.
Short-term employee benefits:
Short-term employee benefits are benefits that are expected to be settled wholly before twelve months after the end of the annual
reporting period in which the employees render the related services. These benefits include salaries, paid annual and sick leave, recreation
and social security contributions and are recognized as expenses as the services are rendered. A liability in respect of a cash bonus or a
profit-sharing plan is recognized when the Company has a legal or constructive obligation to make such payment as a result of past
service rendered by an employee and a reliable estimate of the amount can be made.
2.
Post-employment benefits:
The Group has defined contribution plans pursuant to Section 14 of the Severance Pay Law (“Section 14”) under which the Group pays
fixed contributions and has no legal or constructive obligation to pay further contributions if the fund does not hold sufficient amounts to
pay all employee benefits relating to employee service in the current and prior periods.
The Israeli Severance Pay Law, 1963 (“Severance Pay Law”), specifies that employees are entitled to severance payment following the
termination of their employment. Under the Severance Pay Law, the severance payment is calculated as one month salary for each year of
employment, or a portion thereof. The Company’s liability for severance pay is covered by the provisions of. Under Section 14,
employees are entitled to monthly deposits, at a rate of 8.33% of their monthly salary, made on behalf of the employee with insurance
companies. Payments in accordance with Section 14 release the Company from any future severance payments in respect of those
employees. Contributions to the defined contribution plan in respect of severance or retirement pay are recognized as an expense when
contributed concurrently with performance of the employee’s services and no additional provision is required in the financial statements.
F-18
BRAINSWAY LTD. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
U.S. dollars in thousands (except share and per share data)
NOTE 2: SIGNIFICANT ACCOUNTING POLICIES (Continued)
r.
Share-based payment transactions:
The Company’s employees and other service providers are granted remuneration in the form of equity-settled share-based payment (options and
restricted shares).
The cost of equity-settled transactions with employees is measured at the fair value of the equity instruments granted at grant date. The fair value
of an option granted is determined using the Binomial Lattice option-pricing model (“Binomial model”). The Binomial model takes into account
variables such as volatility, dividend yield rate, and risk-free interest rate and also allows for the use of dynamic assumptions and considers the
contractual term of the option, the probability that the option will be exercised prior to the end of its contractual life, and the probability of
termination or retirement of the option holder in computing the value of the option.
The fair value of the restricted shares granted is determined using the closing price of the Company's share, as quoted in the Tel-Aviv Stock
Exchange (TASE) on the day of the grant.
The cost of equity-settled transactions is recognized in profit or loss together with a corresponding increase in equity during the period which the
performance and/or service conditions are to be satisfied ending on the date on which the relevant employees become entitled to the award (“the
vesting period”). The cumulative expense recognized for equity-settled transactions at the end of each reporting date includes the Group’s best
estimate of the number of equity instruments that will ultimately vest.
No expense is recognized for awards that do not ultimately vest.
If the Company modifies the conditions on which equity-instruments were granted, an additional expense is recognized for any modification that
increases the total fair value of the share-based payment arrangement or is otherwise beneficial to the employee/other service provider at the
modification date.
s.
t.
Research and development expenditures:
Research expenses are recognized in profit or loss when incurred.
Loss per share:
Loss per share is calculated by dividing the net loss attributable to equity holders of the Company by the weighted number of ordinary shares
outstanding during the period. The Company does not have dilutive instruments since it generates loss in each of the three years in the period
ended December 31, 2021.
F-19
BRAINSWAY LTD. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
U.S. dollars in thousands (except share and per share data)
NOTE 2: SIGNIFICANT ACCOUNTING POLICIES (Continued)
u.
New standards in the period prior to their adoption
1. Amendment to IAS 16, "Property, Plant and Equipment":
In May 2020, the IASB issued an amendment to IAS 16, "Property, Plant and Equipment". The amendment prohibits a company from deducting
from the cost of property, plant and equipment ("PP&E") consideration received from the sales of items produced while the company is preparing
the asset for its intended use. Instead, the company should recognize such consideration and related costs in profit or loss.
The amendment is effective for annual reporting periods beginning on or after January 1, 2022, with earlier application permitted. The amendment
is to be applied retrospectively, but only to items of PP&E made available for use on or after the beginning of the earliest period presented in the
financial statements in which the company first applies the amendment. The company should recognize the cumulative effect of initially applying
the Amendment as an adjustment to the opening balance of retained earnings at the beginning of the earliest period presented.
The Company estimates that the application of the amendment is not expected to have a material impact on the financial statements.
2. Amendment to IAS 37, "Provisions, Contingent Liabilities and Contingent Assets":
In May 2020, the IASB issued an amendment to IAS 37, regarding which costs a company should include when assessing whether a contract is
onerous. According to the amendment, costs of fulfilling a contract include both the incremental costs (for example, raw materials and direct
labor) and an allocation of other costs that relate directly to fulfilling a contract (for example, depreciation of an item of property, plant and
equipment used in fulfilling the contract).
The amendment is effective for annual periods beginning on or after January 1, 2022 and applies to contracts for which all obligations in respect
thereof have not yet been fulfilled as of January 1, 2022. Early application is permitted.
The Company estimates that the application of the amendment is not expected to have a material impact on the financial statements.
3. Amendment to IAS 8, "Accounting Policies, Changes to Accounting Estimates and Errors":
In February 2021, the IASB issued an amendment to IAS 8, "Accounting Policies, Changes to Accounting Estimates and Errors", in which it
introduces a new definition of "accounting estimates".
Accounting estimates are defined as "monetary amounts in financial statements that are subject to measurement uncertainty". The amendment
clarifies the distinction between changes in accounting estimates and changes in accounting policies and the correction of errors.
F-20
BRAINSWAY LTD. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
U.S. dollars in thousands (except share and per share data)
NOTE 2: SIGNIFICANT ACCOUNTING POLICIES (Continued)
The amendment is to be applied prospectively for annual reporting periods beginning on or after January 1, 2023 and is applicable to changes in
accounting policies and changes in accounting estimates that occur on or after the start of that period. Early application is permitted.
The Company is evaluating the effects of the amendment on its financial statements.
F-21
BRAINSWAY LTD. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
U.S. dollars in thousands (except share and per share data)
NOTE 3: SIGNIFICANT ACCOUNTING JUDGMENTS, ESTIMATES AND ASSUMPTIONS USED IN THE PREPARATION OF THE
FINANCIAL STATEMENTS
In the process of applying the significant accounting policies in the financial statements, the Group has made the following judgments, estimates and
assumptions, which have the most significant effect on the amounts recognized in the financial statements:
a.
Judgments:
Classification of leases – the Company as a lessor:
In order to determine whether to classify a lease as a finance lease or an operating lease, the Company evaluates whether the lease transfers
substantially all the risks and rewards incidental to ownership of the asset.
Determining the fair value of share-based payment transactions:
The fair value of share-based payment transactions is determined upon initial recognition by the Binomial model. The Binomial model is based on
share price and exercise price and assumptions regarding expected volatility, term of share option, dividend yield and risk-free interest rate.
b.
Estimates and assumptions:
The preparation of the financial statements requires management to make estimates and assumptions that have an effect on the application of the
accounting policies and on the reported amounts of assets, liabilities, revenues and expenses. Changes in accounting estimates are reported in the
period of the change in estimate.
The key assumptions made in the financial statements concerning uncertainties at the reporting date and the critical estimates computed by the
Group that may result in a material adjustment to the carrying amounts of assets and liabilities within the next financial year are discussed below.
● Grants from the IIA:
Government grants received from the IIA are recognized as a liability if future economic benefits are expected from the research and
development activity that will result in royalty-bearing sales. There is uncertainty regarding the estimated future cash flows and discount
rate used to measure the amount of the liability.
● Legal claims:
In estimating the likelihood of outcome of legal claims filed against the Company and its investees, the companies rely on the opinion of
their legal counsel. These estimates are based on the legal counsel's best professional judgment, taking into account the stage of
proceedings and legal precedents in respect of the different issues. Since the outcome of the claims will be determined in courts, the
results could differ from these estimates.
F-22
BRAINSWAY LTD. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
U.S. dollars in thousands (except share and per share data)
NOTE 2: SIGNIFICANT ACCOUNTING JUDGMENTS, ESTIMATES AND ASSUMPTIONS USED IN THE PREPARATION OF THE
FINANCIAL STATEMENTS (Continued)
·
Deferred tax assets
Deferred tax assets are recognized for unused carryforward tax losses and deductible temporary differences to the extent that it is
probable that taxable profit will be available against which the losses can be utilized. Significant management judgment is required
to determine the amount of deferred tax assets that can be recognized, based upon the timing and level of future taxable profits, its
source and the tax planning strategy.
NOTE 4: CASH AND CASH EQUIVALENTS
Cash for immediate withdrawal
Cash equivalents—short-term deposits
Total
NOTE 5: SHORT-TERM DEPOSITS
Bank deposits
December 31,
2021
2020
$
$
15,471 $
1,450
16,921 $
15,457
1,504
16,961
December 31,
2021
2020
$
40,428 $
221
Short-term deposits at banks are for periods of up to one year. The deposits earn annual interest at the respective term of the deposits of
approximately 0.76%.
F-23
BRAINSWAY LTD. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
U.S. dollars in thousands (except share and per share data)
NOTE 6: TRADE RECEIVABLES, NET
a.
Trade receivables, net:
Open accounts (1)
Credit cards
Less—allowance for doubtful accounts
Trade receivables, net
December 31,
2021
2020
7,588 $
—
(1,256)
6,332 $
6,906
108
(1,432)
5,582
$
$
(1)
Trade receivables generally have 90-day credit terms. Certain customers payments are made through monthly credit card transactions.
b.
Movement in allowance for doubtful accounts:
Balance as of January 1, 2020
Provision for the year
Derecognition of bad debts
Balance as of December 31, 2020
Provision for the year
Derecognition of bad debts
Balance as of December 31, 2021
F-24
U.S. dollars in
thousands
$
$
930
1,058
(556)
1,432
323
(499)
1,256
BRAINSWAY LTD. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
U.S. dollars in thousands (except share and per share data)
NOTE 6: TRADE RECEIVABLES, NET (Continued)
Following is information about the credit risk exposure of the Company’s trade receivables:
December 31,
2021:
Not past
due
< 30
days
30 - 60
days
U.S. dollars in thousands
61 - 90
days
U.S. dollars in thousands
91 - 120
days
>120
days
Total
2,715 $
910 $
847 $
693 $
435 $
1,988 $
7,588
7 $
2,708
64 $
846
59 $
788
97 $
596
65 $
964 $
370
1,024 $
1,256
6,332
Not past
due
< 30
days
30 - 60
days
U.S. dollars in thousands
61 - 90
days
U.S. dollars in thousands
91 - 120
days
>120
days
Total
1,757 $
978 $
673 $
670 $
418 $
2,518 $
7,014
4 $
5 $
7 $
33 $
159 $
1,224 $
1,753
973
666
637
259
1,294 $
1,432
5,582
$
Gross carrying
amount
Allowance for
doubtful
accounts
Trade
receivables, net
$
December 31,
2020:
$
Gross carrying
amount
Allowance for
doubtful
accounts
Trade
receivables, net
$
NOTE 7: OTHER CURRENT ASSETS
Government authorities
Accrued income-IIA
Consumables
Prepaid expenses and other
Other current assets
December 31,
2021
2020
388 $
—
200
1,178
1,766 $
212
208
442
672
1,534
$
$
F-25
BRAINSWAY LTD. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
U.S. dollars in thousands (except share and per share data)
NOTE 8: PROPERTY AND EQUIPMENT, NET
December 31, 2021:
Cost:
Balance at January 1, 2021
Additions
Transfer to Leased systems
Reductions
Balance at December 31, 2021
Accumulated depreciation:
Balance at January 1, 2021
Additions
Reductions
Balance at December 31, 2021
System
Components
Leased
systems
Laboratory
equipment
and
Computers
Office
furniture
and
equipment
Right of
use assets
Leasehold
improvements
Total
$
$
3,642
5,448
(985)
$ 8,620
—
985
$
(3,642) (***)
4,463
(2,142) (**)
7,463
845 $ 1,335 $
587
325
—
—
(287)
—
1,635
1,170
96 $
39
—
—
135
—
—
—
—
$
$ 3,422
1,126
(898)
775 $
82
—
735 $
470
(224)
56 $
7
—
3,650
857
981
63
52
17
—
—
69
52
1
—
53
$ 14,590
6,416
—
(6,071)
14,935
$ 5,040
1,686
(1,122)
5,604
Depreciated cost at December 31, 2021
$
4,463
$ 3,813
$
313 $
654 $
72 $
16
$ 9,331
F-26
December 31, 2020:
Cost
Balance at January 1, 2020
Additions
Transfer to Leased systems
Reductions
Accumulated depreciation:
Balance at December 31, 2020
Balance at January 1, 2020
Additions
Reductions
Balance at December 31, 2020
System
Components
Leased
systems
Laboratory
equipment
and
Computers
Office
furniture
and
equipment
Right of
use assets
Leasehold
improvements
Total
$
3,117
3,989
(1,580)
(1,884) (***)
$ 8,151
—
1,580
(1,111) (**)
$
831 $ 1,414 $
48
14
—
—
(127)
—
3,642
—
—
—
—
8,620
2,660
1,180
(418)
845
694
81
—
1,335
460
351
(76)
3,422
775
735
56
90 $
6
—
—
96
50
6
—
52
—
—
—
52
52
—
—
52
$13,655
4,057
—
(3,122)
14,590
3,916
1,618
(494)
5,040
Depreciated cost at December 31, 2020
$
3,642
$ 5,198
$
70 $
600 $
40 $
—
(*) $9,550
(*)
Represents an amount lower than $ 1
(**) Derived mainly from returned systems as well as sale of leased systems.
(***) Mainly includes impairment and disposals charge of $1,295 and $1,161 and system components sold in the amount of $1,789 and $723 for the years
ended December 31, 2021 and 2020, respectively.
F-27
BRAINSWAY LTD. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
U.S. dollars in thousands (except share and per share data)
NOTE 9: OTHER ACCOUNTS PAYABLE
Employee and payroll accruals
Accrued expenses
Tax payable
Liabilities to related parties (1)
Lease liabilities
Other accounts payable
(1) A current non-interest bearing account.
NOTE 10: NON-CURRENT LIABILITIES
Composition:
Deferred revenues (a)
Lease liabilities (b)
Other liabilities
Total non-current liabilities
December 31,
2021
2020
$
1,139 $
2,899
18
236
500
$
4,792 $
972
2,266
—
102
429
3,769
December 31,
2021
2020
3,157
254
8
$
3,419 $
1,772
243
38
2,053
a.
Including an amount of $1,479 and $1,405 relating to deferred distribution fees received as of the years ended December 31 2021 and 2020,
respectively. For more information see note 14c.
F-28
BRAINSWAY LTD. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
U.S. dollars in thousands (except share and per share data)
NOTE 10: NON-CURRENT LIABILITIES (Continued)
b.
Lease liabilities:
Maturity analysis:
Less than one year
One to five years
Total lease commitments
Impact of discounting remaining lease payments
Lease liabilities as of December 31, 2021:
Current
Non-current
Total
Maturity analysis:
Less than one year
One to five years
Total lease commitments
Impact of discounting remaining lease payments
Total lease liabilities as of December 31, 2020
Current
Non-current
Total
F-29
U.S. dollars in
thousands
537
258
795
(41)
754
500
254
754
U.S. dollars in
thousands
463
312
775
(103)
672
429
243
672
$
$
BRAINSWAY LTD. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
U.S. dollars in thousands (except share and per share data)
NOTE 11: FINANCIAL INSTRUMENTS
a.
Financial risks factors:
The Company is exposed to foreign currency risk, interest risk, credit risk and liquidity risk. The Company’s senior management oversees the
management of these risks in accordance with the policies approved by the board of directors.
1.
Foreign currency risk:
The currency exposure arises from current accounts and deposits that are mainly managed in NIS and from liability in respect of
employee payroll accruals that are paid in NIS.
2.
Interest rate risk:
Interest rate risk is the risk that the fair value or future cash flows of a financial instrument will fluctuate because of changes in market
interest rates.
The Company's exposure to the risk of changes in market interest rates relates primarily to the Company's long-term liabilities in respect
of government grants received from IIA.
The repayment of grants received by the Company from 2018 have interest rate that reference LIBOR and are expected to be repaid after
2021.
In March 2021, the IBA released the LIBOR cessation statement, pursuant to which the IBA publicly announced that it intends to cease
publication of the USD LIBOR settings on June 30, 2023. In addition, the FCA provided that starting January 1, 2022, new use of USD
LIBOR is banned, subject to limited exceptions.
As of December 31, 2021, the carrying amount of the financial liabilities which is exposed to fluctuations of the LIBOR interest amounts
to $721 thousand. Since an alternative interest rate was not determined by the IIA yet, at this stage the Company is unable to determine
the effects, if any, that the discontinuance of IBORs will have on its financial instruments that reference the IBORs.
3.
Credit risk:
Credit risk is the risk that a counterparty will not meet its obligations as a customer or under a financial instrument leading to a loss to the
Group. The Group is exposed to credit risk from its operating activity (primarily trade receivables).
4.
Liquidity risk:
The Group monitors its risk of a shortage of cash using a quarterly budget.
F-30
BRAINSWAY LTD. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
U.S. dollars in thousands (except share and per share data)
NOTE 11: FINANCIAL INSTRUMENTS (Continued)
The table below presents the maturity profile of the Group’s financial liabilities based on contractual undiscounted payments:
December 31, 2021:
Trade payables $
Other accounts
payable
Liability in
respect of
research and
development
grants
Lease liability
Less than
one year
1 to 2
years
2 to 3
years
3 to 4
years
4 to 5
years
> 5
years
1,103 $
4,292
— $
—
— $
—
— $
—
— $
—
— $
—
Total
1,103
4,292
1,103
537
1,373
158
1,793
100
2,270
—
2,678
—
3,190
—
12,407
795
$
7,035 $
1,531 $
1,893 $
2,270 $
2,678 $
3,190 $
18,597
December 31, 2020:
Trade payables $
Other accounts
payable
Liability in
respect of
research and
development
grants
Lease liability
Less than
one year
1 to 2
years
2 to 3
years
3 to 4
years
4 to 5
years
> 5
years
781 $
3,340
— $
—
— $
—
— $
—
— $
—
— $
—
Total
781
3,340
388
463
713
299
893
13
1,261
—
1,793
—
8,108
—
13,156
775
$
4,972 $
1,012 $
906 $
1,261 $
1,793 $
8,108 $
18,052
F-31
BRAINSWAY LTD. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
U.S. dollars in thousands (except share and per share data)
NOTE 11: FINANCIAL INSTRUMENTS (Continued)
b.
Sensitivity tests relating to changes in foreign currency:
Sensitivity test to changes in the NIS exchange rate:
Gain (loss) from the change:
Increase of 5% in exchange rate
Decrease of 5% in exchange rate
December 31,
2021
2020
$
$
130 $
(130) $
(50)
50
As of December 31, 2021, the Company has excess of financial liabilities over financial assets in NIS in relation to US dollar of $ 2,601.
As of December 31, 2021, the Company has excess of financial assets over financial liabilities in Euro and Yen in relation to US dollar of $ 1,694
and $391, respectively. An increase or decrease of 5% of the US dollar relative to the Euro or Yen would not have a significant effect on the
Company.
Sensitivity tests and principal work assumptions:
The selected changes in the relevant risk variables were determined based on management’s estimate as to reasonable possible changes in these
risk variables.
The Company has performed sensitivity tests of principal market risk factors that are liable to affect its reported operating results or financial
position. The sensitivity tests present the profit or loss in respect of each financial instrument for the relevant risk variables chosen for that
instrument as of each reporting date. The test of risk factors was determined based on the materiality of the exposure of the operating results or
financial condition of each risk with reference to the functional currency and assuming that all the other variables are constant.
NOTE 12: EMPLOYEE BENEFITS AND LIABILITIES
Employee benefits consist of short-term and post-employment benefits.
Defined contribution plans:
Section 14 to the Severance Pay Law, 1963 applies to all of the Company’s employees pursuant to which the fixed contributions paid by the Group
into pension funds and/or policies of insurance companies release the Group from any additional liability to employees for whom said
contributions were made. These contributions benefits represent defined contribution plans.
Expense in respect of defined contribution plans was $329 and $258 for the years ended December 31, 2021 and 2020, respectively.
F-32
BRAINSWAY LTD. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
U.S. dollars in thousands (except share and per share data)
NOTE 13: TAXES ON INCOME
a.
Tax rates applicable to the Company and subsidiaries:
1.
Tax rate applicable to the Company and Brain R&D:
The Israeli corporate income tax rate was 23% in 2021, 2020 and 2019.
A company is taxable on its real capital gains at the corporate income tax rate in the year of sale.
2.
Tax rate applicable to US subsidiaries:
The subsidiaries are subject to U.S federal tax at the rate of 21%.
On December 22, 2017, the Tax Cuts and Jobs Act (the "Tax Act") was signed into law making significant changes to U.S. income tax
law. These changes include, but are not limited to, a corporate tax rate decrease from 35% to 21% effective for tax years 2018 onwards
and created new taxes on certain foreign-sourced earnings and certain related-party payments.
The Tax Act required the Company to pay U.S. income taxes on accumulated foreign subsidiaries earnings not previously subject to U.S.
income tax at a rate of 15.5% to the extent of foreign cash and certain other net current assets and 8% on the remaining earnings.
c.
Tax assessments:
The Company and the Israeli subsidiary received final tax assessments through tax year 2016.
The subsidiary, Inc, received final tax assessments through the 2017 tax year.
d.
Carryforward losses for tax purposes:
Carryforward losses for tax purposes as of December 31, 2021 amount to approximately $70 million in Brainsway Ltd. (on an Israeli consolidated
basis).
e.
Deferred taxes:
The Company did not record deferred tax assets with respect to net operating losses incurred by the Company and the Israeli subsidiary since it is
not probable that they will generate a taxable income in future years.
The Company recorded deferred tax assets in the amount of $458 as of December 31, 2021 in respect of temporary differences in the US
subsidiaries.
Tax reconciliation:
f.
For the years ended December 31, 2021 and 2020, the main differences between the statutory corporate tax benefits of $1,476 and $1,184, and the
tax expense (in respect of income generated by the US subsidiaries) in the amounts of $43 and $237 are mainly attributable to the carryforward
losses in Israel, for which no deferred taxes were recorded.
F-33
BRAINSWAY LTD. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
U.S. dollars in thousands (except share and per share data)
NOTE 14: CONTINGENT LIABILITIES, COMMITMENTS AND CHARGES
a.
Brain R&D received from the Israeli Government participation grants in research and development and, in return, it is currently obligated to pay
royalties amounting to 3% of sales of products from such grants up to 100% of total grants received.
The Company's provision for royalties payable to the IIA as of December 31, 2021 and 2020 amounts to $6,899 and $6,231, respectively.
As of December 31, 2021, the maximum royalties payable by the Company in the future in respect of active projects is $12,407, including interest
at the LIBOR rate. Through December 31, 2021, royalties paid were $3,403.
b.
The Company entered into a few distribution agreements with third parties regarding different territories around the world. According to these
distribution agreements, the third parties are generally granted the exclusive right to market, distribute, lease and/or sale, use and promote sales of
the systems in the relevant territories for a period defined in the agreement, generally ranging from 3 to 10 years. The Company supplies the
systems to the distributors, and they promote and provide various services (such as installation, training and maintenance) to local costumers.
These distributors are typically contractually committed to meet minimum order quantities, absent which may serve as grounds for termination.
F-34
BRAINSWAY LTD. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
U.S. dollars in thousands (except share and per share data)
NOTE 14: CONTINGENT LIABILITIES, COMMITMENTS AND CHARGES (Continued)
c.
In September 2013, the Company entered into a distribution agreement in Japan with Century Medical Inc., a member of the Itochu concern,
which specializes in the import and distribution of medical systems and equipment in Japan. According to the agreement, the distributor was
granted the exclusive right to market the Company’s system for the treatment of major depression in patients in Japan for a ten-year period which
begins after the required regulatory approvals for marketing the system in Japan and after either obtaining reimbursement or deployment of a
commercial product to a clinical site. If the distributor meets the minimum quantities which it has committed during the contractual term, the
agreement will be extended for an additional five year period. The distributor is granted a right of first offer to distribute the Company’s system in
Japan without further codification.
In consideration for the above, the distributor is obligated to pay the Company distribution fees of 190 million Yen (approximately $1.8 million),
whereby 100 million Yen paid in September 2013 and 90 million Yen paid in 2019.
In each year of the agreement in which the distributor meets the respective annual predetermined revenue target, 10% of the distribution fees are
returned to the distributor. The distribution fee which the Company expects to be entitled to is presented in deferred revenues and is recognized as
revenue during the estimated exclusivity term. The distributor will pay the Company for any treatment made with the Company’s system (pay-per-
use), but in no case less than the pre-determined annual amount. The agreement prescribes conditions in which the Company or the distributor can
cancel the agreement, including a requirement to conduct a clinical trial in order to obtain the PMDA approval and non-compliance with the
requirement to purchase minimum predetermined quantities.
The agreement sets a minimum payment threshold to the Company that is examined every few years throughout the contractual term. If the
distributor does not qualify for the minimum payment threshold at the end of each period, the Company will be entitled to terminate the
distribution agreement, unless the parties reach another agreement between them. The agreement further determines that the distributor will act on
its account to receive the regulatory approvals that are required to market the Company’s system for the treatment of depression in patients in
Japan and to receive reimbursement coverage at the price range established in the agreement.
On January 22, 2018, the distributor in Japan applied to the Pharmaceutical and Medical Devices Agency (“PMDA”), which is responsible for all
import and export licenses of pharmaceuticals and medical equipment to Japan, for approval of marketing and selling the Company’s systems in
Japan. On January 2019, approval of the PMDA was received.
The Company is currently working through its distributor in Japan with the relevant bodies in Japan to update the local society guidelines to
include Deep TMS in order to obtain reimbursement coverage under the Japanese National Health Insurance Plan.
F-35
BRAINSWAY LTD. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
U.S. dollars in thousands (except share and per share data)
NOTE 14: CONTINGENT LIABILITIES, COMMITMENTS AND CHARGES (Continued)
d.
In March 2014, the Company entered into an exclusive marketing and distribution agreement of the Company’s system with a third party in Israel
for a maximum period of 15 years, subject to meeting minimum sales targets as set in the agreement. In April 2014, the distributor paid the
Company a one-time exclusivity fee of NIS 1 million. Effective July 2019, the Company assumed direct operations for customers in Israel, after
terminating its distribution agreement with the third-party distributor, pursuant to which a portion of the exclusivity fee (up to NIS 600 thousand)
was determined to be refundable via annual payments, which depend on future sales. To date, the Company paid a total of NIS 200 thousand
(excluding VAT) of this amount.
e.
License agreements:
1.
2.
In July 2003, Inc signed a license agreement with the agencies of the U.S. Public Health Service within the U.S. Department of Health
and Human Services (“PHS”), according to which the Company was granted an exclusive license to develop, manufacture, make use of,
market, sell and import products and processes to be developed in the framework of the license agreement with respect to TMS and a
right to enter into sublicense agreements, subject to approval of the PHS. In return, Inc is committed to pay PHS royalties at fixed annual
amount of $2 from January 1, 2004 and royalties of 2% of net sales beyond this amount as defined in the agreement.
In addition, if Inc enters into a sub-license agreement, it is committed to pay royalties of 8% of the net consideration received for the
grant of the sub-license.
The agreement is valid until the expiration of the last to expire of the licensed patent rights under the agreement. PHS is entitled to cancel
the agreement if Inc does not comply with the conditions detailed in the agreement.
In June 2005 and March 2010, Inc signed a research and licensing agreement and addendum with Yeda Research and Development
Company Ltd. (“Yeda”), according to which Inc was granted an exclusive license to intellectual property that can be used for research,
development, marketing and manufacturing of products in the field of TMS treatment and may have the right to grant sublicenses subject
to conditions specified in the agreement in consideration of royalty payment as follows:
a)
b)
1% of net sales systems based upon certain patents (which include technology licensed from PHS);
3% for the first $10,000 of net sales, and 2% for net sales over $10,000, for all other Deep TMS products solely based on certain
patents licensed exclusively from Yeda provided however in the event that the products are sold to a sublicensee and are
thereafter sold by such sublicensee, the royalties paid to Yeda will be based on the higher of the net sales by the licensee or the
net sales of the sale by the sublicensee.
F-36
BRAINSWAY LTD. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
U.S. dollars in thousands (except share and per share data)
NOTE 14: CONTINGENT LIABILITIES, COMMITMENTS AND CHARGES (Continued)
c)
4%-8% of the net cash proceeds that the Company receives in respect of granting sublicenses or options for sublicenses
dependent on the patents licensed.
Royalties are payable at the later of 15 years after the first commercial sale or the patent life (20 years through October 2021).
The agreement expires at the later of: the expiration of the last patent, 15 years after Inc starts to sell products integrating the
patent and after a period of 20 years during which no sales are made.
The license agreement with Yeda may be subject to modifications in the event that the license agreement with PHS is modified
(see 1, above) and may be cancelled based on various conditions, including the cancellation of the PHS agreement.
On February 22, 2018, Inc and Yeda signed an additional addendum to the agreement (the "fifth addendum"), according to
which Inc received the right to examine an additional invention based upon the patent issued in connection with research in the
field of rotational electrical fields owned by Yeda. Under the fifth addendum, the Company has the right to include the
aforementioned invention and the intellectual property accompanying it under the Yeda license agreement.
In January 2020, the Company exercised the right granted to it under the fifth addendum, and accordingly royalties on net sales
of products which are based on the use of the invention and know-how subject to the fifth addendum will be paid to Yeda at
increased rates of 1.6%-2% in addition to the royalties described above and, in certain cases, at a flat rate of 2%. In respect of
products under the fifth addendum that are not based on patents or research results for which the license was granted according
to the original agreement (excluding the fifth addendum), royalties on net sales will be at the fixed rate of 5%.
F-37
BRAINSWAY LTD. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
U.S. dollars in thousands (except share and per share data)
NOTE 15: EQUITY
a.
Composition of share capital:
Ordinary shares of NIS 0.04 par value each
120,000,000
32,911,134
35,000,000
22,250,534
December 31, 2021
December 31, 2020
Authorized
Issued and
outstanding
Authorized
Issued and
outstanding
Number of shares
b.
Movement in share capital:
Issued and outstanding capital:
Balance as of January 1, 2021
Issuance of shares - public offering
Vesting of restricted shares
Balance as of December 31, 2021
c.
Rights attached to shares:
Number of
shares
22,250,534
10,630,600
30,000
NIS par
value
233,167
128,622
1,200
32,911,134
362,989
Ordinary shares confer their holders rights to receive dividends in cash and in Company’s shares, right to nominate the Company’s directors and
rights to participate in distribution of dividends upon liquidation in proportion to their holdings. Also, Ordinary shareholders have one vote at the
shareholders’ meeting such that each share confers one vote to its holder.
d.
In February 2021, the Company closed an underwritten public offering of 5,315,300 American Depositary Shares (“ADSs”) resulting in $45.2
million in gross proceeds to the Company, before deducting underwriting discounts and commissions and offering expenses. Each ADS
represents two ordinary shares.
F-38
BRAINSWAY LTD. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
U.S. dollars in thousands (except share and per share data)
NOTE 15: EQUITY (Continued)
e.
Capital management in the Company:
The Company’s capital management objectives are to preserve the Group’s ability to ensure business continuity thereby creating a return
for the shareholders, investors and other interested parties.
The Company is not under any minimal equity requirements nor is it required to attain a certain level of capital return.
F-39
BRAINSWAY LTD. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
U.S. dollars in thousands (except share and per share data)
NOTE 16: SHARE-BASED PAYMENT
a.
The expense recognized in the financial statements for services received is shown in the following table:
Year ended
December 31,
2020
2021
2019
Equity-settled share-based payment plans to employees, directors and consultants
$
1,893 $
799 $
1,263
b.
The share-based payment transactions that the Company granted to its employees, directors and consultants are shown in the following table:
Options outstanding
as of
December
31,
2021 (*)
Weighted Average
remaining contractual
Term
Weighted Average exercise
price ($)
Options exercisable
as of
December 31,
2021
1,482,383
70,000
4.92
9.00
4.71
3.41
1,053,417
17,500
Range of exercise prices
–
4.67
3.41
4.91
*)
**)
Options and restricted shares.
As of grant date.
c.
The fair value of the Company’s options granted for the years ended December 31, 2021, 2020 and 2019 was estimated using the Binomial model
with the following assumptions:
Dividend yield (%)
Expected volatility (%)
Risk-free interest rate (%)
Expected exercise factor
50.49
0.06
2021
—
–
–
2.8
F-40
Year ended December 31,
2020
—
–
–
2.8
64.44 48.00
0.14
1.59
76.78 40.06
1.61
0.62
2019
—
–
–
2.8
48.09
1.73
BRAINSWAY LTD. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
U.S. dollars in thousands (except share and per share data)
NOTE 16: SHARE-BASED PAYMENT (Continued)
d.
Movement of options during the year:
Year ended December 31,
2021
2020
Outstanding at January 1,
Granted
Exercised
Expired
Forfeited
Outstanding at December 31,
Exercisable at December 31,
Number of
options
1,522,975 $
135,000
—
(52,625)
(52,967)
Weighted
average
exercise
price(*)
$
Number of
options
Weighted
average
exercise
price(*)
$
7.5
4.7
—
5.9
6.8
2,213,812 $
285,008
(246,642)
(535,667)
(193,916)
1,552,383 $
4.6
1,522,975 $
1,070,917 $
4.7
839,418 $
7.1
5.4
5.8
7.4
6.7
7.5
9.5
(*)
The exercise price of all options denominated in NIS and was translated to USD in the table above using the exchange rate as of December 31,
2021 and 2020, respectively.
The contractual life of the options is ten years from the grant date. The weighted average remaining contractual life for the options outstanding as
of December 31, 2021 and 2020 was approximately five years and six years, respectively.
In the second quarter of 2021, the Company completed a repricing of outstanding options via an exchange offer pursuant to which the Company
exchanged previously granted options with new options. For those that chose to participate in the exchange, the repricing resulted in an updated
exercise price of $4.675 or NIS 15.26 per ordinary share, and is otherwise subject to the same expiration date, vesting schedule and other terms as
previously existed prior to the exchange offer. Several employees chose not to participate in the exchange because their options were subject to a
lower exercise price than that offered in the repricing. Accordingly, the exercise price range for options outstanding as of December 31, 2021 was
NIS 10.61-15.26.
F-41
BRAINSWAY LTD. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
U.S. dollars in thousands (except share and per share data)
NOTE 16: SHARE-BASED PAYMENT (Continued)
e.
Movement of restricted shares during the year:
Outstanding at January 1,
Granted
Vested
Forfeited
Outstanding at December 31,
2021
Number of
Restricted shares
2020
Number of
Restricted shares
45,000 $
549,730
(15,000)
(20,200)
559,530 $
—
60,000
(15,000)
—
45,000
F-42
BRAINSWAY LTD. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
U.S. dollars in thousands (except share and per share data)
NOTE 17: ADDITIONAL INFORMATION TO THE STATEMENTS OF COMPREHENSIVE LOSS
a.
Additional information on revenues:
Revenues reported in the financial statements for each group of similar products and services:
Revenues from lease
Revenues from sale
Revenue
Geographic information:
Year ended
December 31,
2020
2021
13,449 $
16,208
13,628 $
8,429
2019
13,218
9,883
29,657 $
22,057 $
23,101
$
$
Revenues reported in the financial statements derived from the Company’s country of domicile (Israel) and foreign countries based on the location
of the customers, are as follows:
2021
%
Year ended December 31,
%
2020
2019
%
U.S.
Europe
Israel
Other
$
26,094
2,031
149
1,383
88 $
7
1
4
19,330
1,847
150
730
88 $
8
1
3
20,636
1,353
267
845
$
29,657
100 $
22,057
100 $
23,101
89
6
1
4
100
b. Cost of revenues:
Cost of revenues - lease
Cost of revenues - sales
Cost of revenues
Year ended
December 31,
2020
2021
3,090 $
3,509
3,201 $
1,857
6,599 $
5,058 $
$
$
2019
2,656
2,473
5,129
F-43
BRAINSWAY LTD. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
U.S. dollars in thousands (except share and per share data)
NOTE 17: ADDITIONAL INFORMATION TO THE STATEMENTS OF COMPREHENSIVE LOSS (Continued)
c.
Research and development expenses, net:
Year ended
December 31,
2020
2021
2019
Salaries and related benefits
Subcontractors
Laboratory materials
Patents
Share-based payment
Travel
Depreciation
Other
Less—Government grants
$
3,580 $
961
665
204
411
28
107
538
(101)
3,289 $
1,530
275
288
182
2
87
383
(213)
Research and development expenses, net
$
6,393 $
5,823 $
d.
Selling and marketing expenses:
3,338
2,620
687
334
399
112
39
604
(257)
7,876
Salaries and related benefits
Agent commissions
Marketing
Travel
Share-based payment
Selling and marketing expenses
$
2021
8,887 $
392
4,782
1,121
698
Year ended
December 31,
2020
6,458 $
335
3,627
611
252
2019
6,419
221
5,239
1,176
214
$
15,880 $
11,283 $
13,269
F-44
e.
General and administrative expenses:
Salaries and related benefits
Professional fees and office expenses
Depreciation
Travel
Allowance for doubtful accounts
Share-based payment
$
2021
2,283 $
2,031
407
10
323
730
Year ended
December 31,
2020
2019
1,339 $
1,609
351
17
1,058
348
1,774
1,770
81
222
835
621
5,303
$
5,784 $
4,722 $
F-45
BRAINSWAY LTD. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
U.S. dollars in thousands (except share and per share data)
NOTE 17: ADDITIONAL INFORMATION TO THE STATEMENTS OF COMPREHENSIVE LOSS (Continued)
f.
Finance income and expense:
Finance income:
Interest-income revaluation of bank deposits
Revaluation of warrants
Exchange rate differences
Finance income
Finance expense:
Liability in respect of research and development grants
Interest expense and amortization of deferred costs- loan from bank
Bank commissions
Exchange rate differences
Interest expense of lease liability
Finance expense
NOTE 18: NET LOSS PER SHARE
Number of shares and loss used in the computation of net loss per share:
Year ended
December 31,
2020
2021
2019
$
$
$
225 $
30
—
255 $
1,171 $
—
81
363
60
$
1,675 $
61 $
40
448
549 $
762 $
—
40
—
66
868 $
175
62
—
237
969
283
108
192
115
1,667
2021
Loss
attributable to
equity holders
of the
Company
Weighted
number of
shares*)
Year ended December 31,
2020
Loss
attributable to
equity holders
of the
Company
Weighted
number of
shares*)
2019
Loss
attributable to
equity holders
of the
Company
Weighted
number of
shares*)
Used in the computation of basic
and diluted net loss
31,154,258 $
6,462
22,453,025 $
5,385
20,506,202 $
10,328
*)
Computation of diluted loss per share did not include potential ordinary shares that would result from conversion of outstanding options and
warrants, since their conversion has anti-dilutive effect.
F-46
BRAINSWAY LTD. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
U.S. dollars in thousands (except share and per share data)
NOTE 19: BALANCES AND TRANSACTIONS WITH RELATED PARTIES
a. Balances with interested and related parties:
Composition:
As of December 31, 2021
Other accounts payable
As of December 31, 2020
Other accounts payable
b.
Benefits to interested and related parties:
Salary to those employed by the Company or on its behalf
Directors’ fees to those not employed by the Company or on its behalf
Number of individuals to whom the salary and benefits relate:
Related and interested parties employed by the Company or on its behalf
Directors not employed by the Company
Benefits to interested and related parties
F-47
Key
management
personnel
Other
interested and
related
parties
$
192 $
45
Key
management
personnel
Other
interested and
related
parties
$
64 $
38
$
$
Year ended
December 31,
2020
2021
2019
885 $
148 $
3
5
8
769 $
60 $
2
6
8
945
90
3
8
11
BRAINSWAY LTD. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
U.S. dollars in thousands (except share and per share data)
NOTE 19: BALANCES AND TRANSACTIONS WITH RELATED PARTIES (Continued)
c.
Key management personnel:
Short-term benefits
Share-based payment to those employed by the Company or on its behalf
Share-based payment to those not employed by the Company or on its behalf
d.
Transactions with interested and related parties:
Year ended December 31, 2021
Year ended
December 31,
2020
2021
2019
— $
445 $
90 $
— $
182 $
150 $
3
190
147
$
$
$
Research and development expenses
General and administrative expenses
Year ended December 31, 2020
Research and development expenses
General and administrative expenses
Selling and marketing
F-48
Key
management
personnel*)
Other
interested and
related
parties
112 $
1,137
1,249 $
82
238
320
Key
management
personnel*)
Other
interested and
related
parties
236 $
619
150
1,005 $
—
201
—
201
$
$
$
$
BRAINSWAY LTD. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
U.S. dollars in thousands (except share and per share data)
NOTE 19: BALANCES AND TRANSACTIONS WITH RELATED PARTIES (Continued)
Year ended December 31, 2019
Research and development expenses
General and administrative expenses
Key
management
personnel*)
Other
interested and
related
parties
$
$
113 $
943
1,056 $
81
238
319
*) Some of the key management personnel are interested parties by virtue of holdings.
e.
Mr. Christopher R. von Jako, PhD commenced his role as the Company’s President and Chief Executive Officer (CEO) effective January 1, 2020.
Key employment terms include an annual gross base salary and an annual performance-based bonus of up to six months of his base salary and
equity grant of RSUs as further detailed in Note 16b.
f.
For information regarding the fair value of the options granted to directors, see Note 16b.
F-49
Exhibit 1.1
[UNOFFICIAL TRANSLATION INTO ENGLISH]
Amended and Restated Articles of Association
of
Brainsway Limited
[as amended by the shareholders on December 22, 2021]
Preamble
1.
1.1. In these Articles of Incorporation, save if the context requires otherwise -
“Man”, “Person” or “Persons”
Including a corporation
“In Writing”
“Registered Shareholder”
“Unregistered Shareholder”
“The Company”
Handwritten, printed, on a typewriter, on a photocopy, telex, fax or in any
other manner which is readable.
Shareholder as per the definition of Article 177 (2) of the Law.
Shareholder as per the definition of Article 177 (1) of the Law.
Brainsway Ltd.
“The Law” or “The Companies Law”
The Companies Law - 1999, as shall be from time to time and the
“The Securities Law”
Regulations issued thereunder.
The Securities Law - 1968, as shall be from time to time and the
Regulations thereunder, as issued from time to time.
“The Secretary”
The appointed Secretary of the Company.
“The Registry” or “The Registry of Shareholders”
The registry of shareholders of the company which must be maintained
according to the Law.
“The Office” or “The Registered Office”
The office of the Company, whose address shall be registered with the
Registrar of Companies, as shall be from time to time.
“The Ordinance” or “The Companies Ordinance”
The Companies Ordinance (new version) - 1983, as shall be from time to
“Special Majority”
“Ordinary Majority”
time, and regulations which shall be issued thereunder.
A majority of at least two-thirds of all the votes of the shareholders
present at the general meeting or in the class meeting, as the case may be,
entitled to vote and voted on their own or by proxy, without taking into
account abstentions.
Ordinary majority of all of the votes of the shareholders present in the
general meeting or in the class meeting, as the case may be,
“Year” or “Month”
“Corporation”
entitled to vote and having voted, without taking into account abstentions.
Of the Gregorian calendar.
Company, partnership, cooperative association, association and any other
incorporated or unincorporated group of persons.
“These Articles” or “The Articles”
The Articles of Incorporation in this document, as shall be amended from
time to time.
1.2. For every term in these Articles which has not been defined above, the significance shall be that which is known in The Companies
Law, save if this is contradictory to the matter which is written or its contents; the singular shall include the plural and vice versa and the masculine
shall include the feminine.
1.3. The headings in these Articles are intended for convenience only and may not be used for interpretation of these Articles.
1.4. In every place where these Articles determine that its provisions shall apply subject to the Ordinance and/or The Companies Law
and/or any Law, the intention is the provisions of the Ordinance and/or the provisions of The Companies Law and/or any Law, which may not be
stipulated upon, save if the context requires otherwise.
1.5. The provisions which maybe stipulated upon in The Companies Law shall apply to the Company save if determine otherwise in these
Articles and to such extent as there is no contradiction between them and the provisions of these Articles.
Name of the Company
2. The name of the Company is Brainsway Ltd.
Limitation of Liability
3. Limited liability
3.1. The liability of a shareholder for the debts of the Company is limited to the discharge of the amount (including premium) at which
shares were allotted to him but not less than of nominal value of the shares allotted to him, save if shares were allotted to him at law for a
consideration which is lower than their nominal value, in which case his liability is limited to the discharge of the consideration for which the share
was allotted to him.
3.2. The Company is not entitled to change the liability of a shareholder or to obligate a shareholder to purchase additional shares without
his consents.
Purposes of the Company
4. The purposes for which the Company was established:
4.1. Research, development, marketing and sales of medical devices for the treatment of the human brain.
4.2. To engage in any matter or issue or subject which is legally permissible, at the discretion of the directors and the business managers of
the Company.
Contributions
5. The Company is entitled to contribute reasonable amounts to worthy causes, even if the contribution is not in a framework of the
business considerations of the Company. The Board of Directors is authorized to determine, at its discretion, the amount of the contribution, the
purposes for which it is made, the identity of the recipient and every other condition in this context.
The Registered Office
6. The registered office of the Company shall be at the address determined by the Board of Directors, and shall change from time to time.
The Articles of Incorporation
7. The Company shall be entitled to change these Articles by resolution of the general meeting by ordinary majority.
8. A resolution passed by the general meeting with the majority required for changing of the Articles, as stated in Clause 7 above, which
changes any of the provisions of these Articles, shall be deemed a resolution for the alteration of these Articles, even if this was not indicated
expressly in the resolution.
9. Subject to provisions of The Companies Law, changes to these Articles shall be valid from the date of a passage of a resolution by the
Company or another date determined in the resolution.
Registered Share Capital
10. The registered share capital of the Company is NIS 4,800,000 divided into 120,000,000 ordinary shares, nominal value of NIS 0.04
each (hereinafter- the ordinary shares). The Company is entitled to change the registered share capital subject to the provisions of The Companies
Law and these Articles.
The Shares
11. Each ordinary share in the capital of the Company shall have equal rights, for all intents and purposes, to every other ordinary share,
including the rights to dividend, bonus shares
and participation in distribution of surplus assets of the Company upon liquidation, proportionally to the nominal value of each share, without taking
into account any premium paid thereupon, and all subject to the provisions of these Articles.
12. Each one of the ordinary shares entitles its owner to participate in the general meeting of the Company and to one vote.
13.
13.1. A shareholder in the Company is the party registered as the shareholder in the registry of shareholders or whomever a share is
registered in his favor with a stock exchange member, and such share is included in the registered shares in the registry of shareholders of the
Company in the name of a company for registration.
A shareholder who is a trustee will report thereupon to the Company, and the Company shall record him in the registry of shareholders, with
indication of his trust, and he shall be viewed for purposes of The Companies Law as a shareholder. Without detracting from that stated above, and
subject to the provisions of the Articles of the Company, the Company shall recognize a trustee as stated, as a shareholder for all intends and
purposes, and shall not recognize some other person, including the beneficiary, as the holder of any rights in the share. Without detracting from that
stated above, and subject to the provisions of the Articles of the Company, with the exception of shareholders of the Company as stated, no person
shall be recognized by the Company as having any rights in a share and the Company shall not be bound and shall not recognize any benefits under
the laws of equity or in the relations of trust or in a proper right, future or partial, in any share or benefit whatsoever in a fractional share or in any
other right with regards to a share, rather solely and exclusively the right of the shareholder as stated above, in the share in its entirety, and all save if
a competent court has directed otherwise.
13.2. Without detracting from that stated above, and subject to the provisions of these Articles, with the exception of shareholders of the
Company as stated in Clause 13.1 above, no person shall be recognized by the Company as having any right in a share and the Company shall not be
bound and shall not recognize any benefits under the laws of equity or the relations of trust or a proper right, future or partial, in any share or
benefits, in a fractional share or any other right with regard to a share, but rather solely and exclusively the right of the shareholder as stated in
Clause 13.1 above, in a share in its entirety and all save if a competent court has directed otherwise.
Share Certificates
14. The certificates testifying to the right of ownership in the shares shall bear the stamp of the Company and the signatures of one
director together with the CEO of the Company or together with the Secretary of the Company or the signatures of any two persons who were
appointed for this purpose by the Board of Directors.
The Board of Directors is entitled to decide that a signature or stamp as stated shall be carried out mechanically, as shall be determined by the Board
of Directors.
15. Unless the terms of the issue of shares determine otherwise:
15.1. Every registered shareholder is entitled to receive from the Company at his request within a period of two months after the allotment,
or registration of the transfer, as the case may be, one certificate testifying to his ownership in shares which are registered in his name or, at the
consent of the Company, a number of certificates as stated.
15.2. A registration Company is entitled to receive from the Company, at its request, within a period of two months after the allotment, or
the registration of the transfer, as the case may be, one certificate testifying to the number of shares and the type of shares registered in its name at
the registry of shareholders.
16. Subject to the provisions of The Companies Law, in each certificate shall be specified the number of shares in respect of which it was
issued, their serial numbers and their nominal value.
17. A certificate referring to a share registered in the name of two or more persons, shall be delivered to whomever shall appear first in the
registry of shareholders with regard to such share, save if all of the shareholders registered upon such share shall direct the Company in writing, to
deliver it to some other registered owner.
18. In the event that a share certificate shall be defaced, ruined, lost or harmed, the Board of Directors is entitled to direct its cancellation
and the issue of a new certificate in its stead. This, provided that the share certificate was produced to the Company and destroyed by it, or it was
proven to the satisfaction of the Board of Directors that the certificate was lost or destroyed and the Company received a guarantee to the satisfaction
of the Board of Directors in respect of any possible damage. A reasonable amount as shall be determined by the Board of Directors from time to
time shall be paid for every share certificate issued under this clause.
Payment for Shares
19. All of these shares in the issued capital of the Company, shall be shares which were discharged in full.
20. Canceled.
Transfer of Shares
21. Every transfer of shares which are registered in the registry of shareholders in the name of the registered shareholder, including a
transfer by a company for registration or to it, shall be in writing and provided that the Deed of Transfer shall be signed by hand only, by the
transferor and by the transferee, by themselves or by their legal representatives,
and by witnesses to their signature, and shall be delivered to the registered office or to any other place determined by the Board of Directors for this.
Subject to the provisions of The Companies Law, the transfer of shares shall not be recorded in the registry of shareholders save after a Deed of
Transfer has been delivered to the Company as stated above: The transferor shall continue to be deemed the owner of the transferred shares until the
registration of the transferee as the owner of the transferred shares in the registry of shareholders.
The registry of shareholders shall constitute prima facie evidence to the veracity of its content. In an instance of contradiction between that recorded
in the registry of shareholders and a share certificate, the evidentiary value of the Registry of Shareholders is superior to the evidentiary value of the
share certificate.
22. The Share Transfer Deed will be made in writing, in the form customary in Israel or in any other form approved by the Board of
Directors. To such extent as the transferor or the transferee is a corporation, a confirmation by an attorney or an accountant or some other person
whose identity is acceptable to the Board of Directors shall be given regarding the authority of the signatories in the name of the corporation to carry
out or to receive the transfer, as the case may be.
23. The Company is entitled to close the Registry of Shareholders for a period of time determined by the Board of Directors and provided
that it shall not exceed, in total, 30 days each year. When the registry is closed, transfer of shares shall not be recorded in the registry. Without the
detracting from that stated above, the Board of Directors is entitled to determine a determining date with regard to the right to vote in a general
meeting, or to receive payment of dividend or allotment of rights whatsoever or for any other legal purpose.
24. Subject to the provisions of these Articles or the terms of the issue of shares of any type, shared transfer shall be possible without the
need for Board of Directors approval.
25. Every transfer deed shall be submitted to the office or to any other place as shall be determined by the Board of Directors, for
registration, together with the certificates of the shares to be transferred, if these were issued, and all other proof required by the Board of Directors
regarding the right of ownership of the transferor or his right to transfer the shares. The transfer deeds which shall be recorded shall remain with the
Company; however, any transfer deed which the Board of Directors refused to record will be returned to the party who submitted it, at its request.
26. In the event that the Board of Directors refuses to approve the transfer of shares, it shall notify the transferor no later than one month
from the date of receiving of the transfer deed.
27. The Company shall be entitled to collect payment for recording of the transfer, in an amount determined by the Board of Directors,
from time to time, and which shall be reasonable in the circumstances of the matter.
28.
28.1 Subject to the provisions of The Companies Law and these Articles. If it was proven to the Company to the satisfaction of the Board
of Directors in a manner determined by it, that the conditions required at Law were fulfilled for the assignment of the rights in the shares which are
registered in the registry in the name of a registered shareholder, the Company shall recognize the assignee, and him alone, as the holder of the rights
in the shares as mentioned.
28.2 Notwithstanding that stated above, in an instance of the death of one or more of the registered joint owners of shares registered in their
name in the registry, the Company shall recognize the registered owners who remain alive, solely, as the holders of ownership rights in such shares.
29.
29.1 Subject to the provisions of these Articles, the Company shall change the registration of ownership in the shares in the Registry of
Shareholders upon receipt of an order of a court to amend the registry or if it was proven to the Company, to the satisfaction of the Board of
Directors and in a manner determined by it, that the conditions at Law for the assignment of the rights in the shares were fulfilled, and the Company
shall not recognize any right of a person in the shares, prior to the proof of his right, as stated above.
29.2 Without detracting from that stated above, the Board of Directors is entitled to refuse to perform the registration or to delay it, as it
shall be entitled to do, in the event that the registered owner himself shall have transferred the shares prior to the assignment of the right.
30. Subject to the provisions of The Companies Law and these Articles, a person who became entitled to a share as stated in Clause 28
above, shall be entitled to carry out a transfer of the shares similar to the right to do so of the registered owner, himself, prior to the assignment of the
right.
31. The Company is entitled to destroy a share transfer deed at the expiry of seven years from the date of the recording in the registry, and
to destroy Certificate of Shares which were canceled, at the expiry of seven years from the date of their cancellation, and a prima facie presumption
shall exist that any deed of transfer and certificates which was destroyed as mentioned, was fully valid and that the transfers, cancellations and
registrations as the case may be were carried out at Law.
Changes in the Capital
32. The Company is entitled, in a resolution passed by the general meeting, in an ordinary majority, to increase the registered share
capital of the Company and/or to create additional classes of shares in the capital of the Company, and all as it shall determine.
33. Subject to the provisions of The Companies Law, the Company is entitled, in a resolution passed by the general meeting in an ordinary
majority:
33.1 To merge its shares, in whole or in part, and to divide them to shares with higher nominal values than the nominal value of the existing
shares.
33.2 To divide its shares, in whole or in part, a secondary division, to shares with lower nominal values than the nominal value of the
existing shares.
33.3 To reduce the capital of the Company and any principal reserved for redemption of capital.
For purposes of performance of such resolution as stated, the Board of Directors is entitled to resolve, at its discretion, any difficulty which shall
arise in connection therewith.
34. Without detracting from the generality of the authorities of the Board of Directors as stated above, if as a result of the merger or
division as stated above, there shall remain fractional shares in the hands of shareholders, the Board of Directors is entitled at its discretion to act as
follows:
34.1 To determine that fractional shares which shall not accord the owners thereof an entire share, shall be sold by the Company and the
proceeds from the sale shall be paid to those entitled under terms and in a manner as determined.
34.2 To allot to each of the owners of the shares whose merger and/or division shall leave them with a fractional share, shares of a class of
shares which existed in the capital of the Company prior to the merger and/or division, in such number that the merger thereof with the fraction shall
create one whole share, and such allotment shall be deemed valid immediately prior to the merger or division, as the case may be.
34.3 To determine the manner of payment of the amounts which must be paid for the shares which were allotted as stated in Clause 34.2
above, including the manner in which the discharge of the amounts shall be possible on account of bonus shares.
34.4 To determine that the owners of the fractional shares shall not be entitled to receive a whole share in respect of the fraction of a share.
34.5 To determine that the owners of the shares shall not be entitled to receive a whole share in respect of a fraction of a whole share with a
certain or lower nominal value and shall be entitled to receive a whole share in respect of the fraction of a whole share with a nominal value which is
higher than the stated nominal value.
35. The Company is entitled by resolution of the general meeting by ordinary majority, to cancel registered share capital which has not yet
been allotted, and provided that the Company has not undertaken, including a conditional undertaking, to allot the shares.
Change in Rights
36. At any time, when the share capital shall be divided into different classes, the Company shall be entitled by resolution of the general
meeting by ordinary majority, save if the conditions of the issue of the shares of such class stipulate otherwise, to cancel, to convert, to expand, to
add, to reduce, to amend or to change in some other manner the rights of the class of shares of the Company, and provided that consent for this was
received in writing of all of the holders of the shares of such class or the resolution was passed in the general meeting of shareholders of such class
by ordinary majority, or in an instance where it was stipulated otherwise in the terms of the issue of the certain class of shares of the Company, as
was stipulated in the terms of the issue of such class.
37. The provisions determined in these Articles with regard to the general meeting shall apply mutatis mutandis, to every class meeting
and provided that the legal quorum in a class meeting will be present when there shall be present at the opening of the meeting, themselves or by
proxy, at least two shareholders who own at least 25% of the number of shares issued of such class. However, if there was not a legal quorum as
stated, the class meeting shall be postponed to a later date and in the postponed meeting, a legal quorum shall be fulfilled by any number of
participants, regardless of the number of shares they own.
38. The rights accorded to the shareholders or the owners of such class of shares which were issued in respect of ordinary rights and in
respect of preferred rights or some other special rights, shall not be deemed for purposes of Clause 36 above as though they were converted, reduced,
prejudiced or changed in some other manner by the creation and/or issue of additional shares of any class, whether they are equivalent to them or of
a different or preferred class, and shall not be deemed for purposes of the aforementioned clause as though they were converted, reduced, prejudiced
or otherwise changed, by a change in the rights attached to shares of any other class, and all save if stipulated otherwise explicitly in the terms of the
issue of such shares.
39. Issue of shares and other securities.
39.1. The Board of Directors is entitled to issue or allot shares and other securities, which are convertible or may be exercised into shares,
up to the limit of the registered share capital of the Company. For this matter, securities which are convertible or may be converted or exercised into
shares shall be viewed as though they were exercised or converted at the date of their issue. Without detracting from the generality of that stated
above, the Board of Directors shall be entitled to issue the shares and other securities as stated above, to grant rights of choice for their purchase,
including options, or to grant them in some other manner, and all to persons who were determined by it and at the time and the prices and terms as
determined by it, and to determine any other provision related to this, and
including provisions regarding the manner of distribution of the shares and securities which shall be issued by the Company, between the purchasers
thereof, including an instances of oversubscription, and all at the discretion of the Board of Directors.
39.2. The authorities of the Board of Directors as specified in Clause 39.1 above may be delegated as specified in the following paragraphs
(1) or (2):
(1) To a Board of Directors committee - in the issue or allotment of securities in the framework of an employee remuneration scheme or agreements
of employment or wage between the Company and its employees or between the Company and employees of an associated Company whose Board
of Directors has agreed to this in advance, and provided that the issue or allotment shall be in accordance with a program which includes specific
covenants which were issued and approved by the Board of Directors.
(2) A Board of Directors committee, the CEO or the holder of such position (in this clause - CEO) or some other person who the CEO has
recommended - in the issue of shares subsequent to exercise or conversion of securities of the Company.
40. Without detracting from the generality of that stated above and subject to the provisions of The Companies Law and these Articles,
the Board of Directors is entitled to determine that the consideration for the shares shall be paid in cash or in kind and including in securities or any
other manner, at its discretion, or that the shares shall be allotted as bonus shares or that the shares shall be allotted for consideration equal to their
nominal value or higher than it, whether individually or in series, and all under terms and dates as determined by the Board of Directors at its
discretion.
41. In a decision to increase the registered share capital of the Company, the general meeting may determine that the new shares included
in the amounts by which the registered share capital was increased as stated (here and after: “ the new shares ”) or any part thereof, will be offered
initially at their nominal value or for an added premium, to all of the shareholders holder who hold shares at such times, at a rate proportional to the
nominal value of their shares in the Company or to determine other provisions for the manner of the issue and allotment of the new shares.
However, in the event that the general meeting has not determined as stated in the decision to increase the registered share capital of the Company,
the Board of Directors may offer them as stated in Clause 39 above.
42. The Board of Directors is entitled to resolve to pay commissions or underwriting fees to any person in consideration for subscription
or agreement to subscription or the obtaining of subscriptions or the promise of subscriptions upon shares, or bonds or other securities of the
Company. The Board of Directors may also, in any event of the issue of securities of the Company, resolve to pay intermediary commissions, in
cash, in Company shares or other securities which were issued by the Company or in any other manner or partly in one manner and partly in another,
and all subject to the provisions of applicable Law.
Redeemable Securities
43. Subject to the provisions of The Companies Law, the Company is entitled to issue securities which may be redeemed at terms and in a
manner determined by the Board of Directors at its discretion.
Registries
44.
44.1 The Company shall conduct a registry of the shareholders and shall record in it the names of the owners of the shares and the
additional details required under The Companies Law, immediately after the issue of any shares of the Company. Subject to the provisions of the
Law, upon the registration in the registry, a registered shareholder shall be deemed the owner of the shares registered in his name, and even if share
certificates were not issued in respect of these shares.
44.2 The Company shall conduct a registry of substantial shareholders as required by The Companies Law.
45. The Company is entitled to conduct an additional registry of shareholders outside of Israel under terms as determined for this matter in
The Companies Law.
46. The Company shall conduct a registry of the holders of bonds and securities which may be converted into shares of the Company and
all of the provisions of these Articles in connection with shares shall apply also to these convertible securities with regard to the registration in the
registry, the issue of certificates, the replacement of certificates, transfer and assignment, mutatis mutandis as the case may be, and all subject to the
terms of the issue of the securities.
General Meeting
47. Resolutions of the Company in the following matters shall be passed by the general meeting:
47.1 Changes to the Articles of the Company or its Memorandum.
47.2 Implementation of the authorities of the Board of Directors by the general meeting if the Board of Directors is precluded from
implementing its authorities and the implementation of any of its authorities is crucial for the proper conduct of the Company, as stated in
Article 52(A) of The Companies Law.
47.3 The appointment of an auditing accountant for the Company and the cessation of his employment.
47.4 The appointment of directors for the Company and their dismissal.
47.5 Approval of actions and transactions requiring the approval of the general meeting under the provisions of Articles 255 and 268 to 275
of The Companies Law.
47.6 Increase of the registered share capital and its decrease in accordance with the provisions of Articles 286 and 287 of The Companies
Law and changes in the capital as stated in Clause 33 above.
47.7 Merger as stated in Article 320(A) of The Companies Law.
47.8 Any resolution which must be passed in accordance with these Articles, by the general meeting.
Subject to the provisions of The Companies Law, the general meeting is entitled to undertake authorities given to some other organ, and if the
general meeting has undertaken the authorities of the Board of Directors of the Company, the shareholders will be liable and responsible for the
liabilities and duties of the directors, as stated in Article 50(b) of The Companies Law.
48. The Company will conduct an annual general meeting every year and not later than the expiry of 15 months from the previous annual
meeting, at the date and time as determined by the Board of Directors.
49. The agenda of the annual general meeting shall include the following items:
49.1 Discussion of the financial reports of the Company and the Board of Directors report on the state of affairs of the Company which are
submitted to the general meeting.
49.2 Appointment of directors and determination of their wages.
49.3 Appointment of an auditing accountant.
49.4 Reporting by the Board of Directors upon the wage of the auditing accountant for the auditing activity and for the additional services,
if any.
49.5 In addition to that stated above, the agenda of the annual meeting may include any other matter which was determined in the agenda
as stated in Clause 52 below.
The general meeting as stated above shall be called “an annual meeting” and any other general meeting shall be called “a special meeting”.
50. The Board of Directors of the Company will convene a special meeting in accordance with its resolution and in accordance with the
demand of any of the following:
50.1 Two directors or one-quarter of the serving directors.
50.2 A shareholder, one or more, with at least 5% of the issued share capital and 1% of the voting rights in the Company, or one or more
shareholder with at least 5% of the voting rights in the Company.
In the event that the Board of Directors was required to convene a special meeting as stated above, it shall be convened within 21 days from the date
upon which the demand was submitted to it, at a date determined in the notice upon the special meeting as stated in Clause 54.1 below and provided
that the date of the meeting shall be not later than 35 days from the date of the publishing of the notice and all subject to the provisions of The
Companies Law and Clause 53.1 below.
51. In the event that the Board of Directors fails to summon a special meeting as requested under Clause 50 above, the requesting party is
entitled, and when one is speaking of shareholders-also part of them who have more than half of their voting rights, to convene the meeting itself,
and provided that it shall not take place more than three months from the date of submission of the request as stated, and shall be convened, to such
extent as possible, in the same manner as assemblies are convened by the Board of Directors.
52.
52.1 The agenda of the general meeting shall be determined by the Board of Directors and shall include the matters for which the
convening of the special meeting under Clause 50 above was requested as well as a subject requested as stated in Clause 52.2 below. The Board of
Directors may include election of directors in an agenda of a special meeting.
52.2 One or more shareholders with at least 1% of the voting rights in the general meeting may request the Board of Directors to include a
subject in the agenda of the general meeting which shall be convened in the future, and provided that the subject is appropriate for deliberation in the
general meeting.
52.3 A request as stated in Clause 52.2 above will be submitted to the Company in writing not less than 10 days from the date of notice of
the convening of the general meeting and a text of the resolution which is proposed by the shareholder shall be attached to it as well as the details of
his holdings in the Company (including indirect or derivative holdings), relationships and/or agreements between him and other shareholders in the
Company and insofar as such request is in connection with the appointment of a director - also details regarding the director nominee (including all
details required by law and reporting rules) and regarding relationships or agreements that the director nominee has with the shareholders of the
Company, and if the Company is listed for trading on the Nasdaq, whether he or she is eligible to be appointed as an independent director in
accordance with Nasdaq Listing Rules.
53.
53.1 Notice of the general meeting will be published in accordance with the requirements of the Law at least 14 days prior to the convening
of
the meeting with the exception of notice of a general meeting with an agenda which includes the items specified in Article 87 of The Companies
Law, which shall be published 35 days at least prior to its convening.
53.2 In addition to the notice upon the general meeting as stated in Clause 53.1 above, the Company will deliver notice upon the general
meeting only to shareholders who are registered in the registry whose address is in Israel.
54.
54.1 In the notice upon the general meeting there shall be specified the place, the date and the time at which the general meeting shall be
convened and it shall include the agenda, a synopsis of the proposed resolutions, the required majority for the resolutions, the date of determination
of the rights of all of the shareholders to vote in the general meeting and any other detail required at law. In the event that the Company shall
determine that a postponed meeting shall be held at a date which is later than that determined in Article 78(b) of the Law, it shall indicate the date as
mentioned in the notice.
54.2 In a decision regarding the convening of an meeting, the Board of Directors is entitled to determine the manner of the detailing of
these issues on the agenda for the meeting, which will be delivered to such shareholders entitled to participate in the meeting, and all at the
discretion of the Board of Directors and subject to the provisions of The Companies Law.
54.3 Without detracting from the authorities of the Board of Directors as stated in this Clause 54 above, and without detracting from a
generality of the provisions of these Articles with regard to the transfer of the authorities by the Board of Directors, the Board of Directors will be
entitled to transfer its authorities as stated in this Clause 54 above, to a Board of Directors committee and/or an officer in the Company, whether for
the purpose of a certain general meeting or for a period of time.
55. A good faith defect in the convening of a general meeting or its conduct, including a defect arising from non-fulfillment of a provision
or condition determined in the Law or in these Articles, including with regard to the manner of the convening of the general meeting or its conduct,
shall not invalidate any resolution passed in the general meeting and shall not prejudice the deliberations conducted therein, subject to the provisions
of any Law.
Deliberations in the General Meeting
56. No deliberations may be commenced at the general meeting unless a legal quorum is present at the opening of the meeting. A legal
quorum will be constituted when there are present, themselves or by proxy, a shareholder or shareholders who have at least one-third of the voting
rights, within one-half of an hour from the time determined for the opening of the meeting, save if determined otherwise in these Articles.
57. In the absence of a legal quorum at the general meeting at the expiry of half of an hour from a time determined for commencement of
the meeting (or the expiry of some other time as determined by the Chairman of the meeting, but in any event no more than one hour), the meeting
shall be postponed for seven days, for the same date at the same hour and in the same place, without the requirement to notify the shareholders
thereupon and subject to the provisions of The Companies Law, the Securities Law and the Regulations promulgated under these laws, or some later
date if indicated in the notice upon the meeting, or a date, hour and place which are different, as determined by the Board of Directors in the notice
to the shareholders.
58. A legal quorum for a postponed meeting shall be constituted when there are present, themselves or by proxy, one or more shareholders
who have at least one-third of the voting rights, within half of an hour from the time determined for the opening of the meeting. In the absence of a
legal quorum at the postponed meeting at the expiry of half of an hour from the time determined for commencement of the postponed meeting, any
two shareholders present at the postponed meeting, themselves or by proxy, shall constitute legal quorum at the postponed meeting.
59. The Chairman of the Board of Directors or, in his absence, any director appointed by the Board of Directors, will chair every general
meeting of the Company. In the absence of a chairman as stated or if at some meeting none of these are present after the passage of 15 minutes from
the time determined for commencement of the meeting or if they refuse to serve as Chairman of the meeting, the directors which are present may, by
majority between them, elect a chairman from amongst them or from any of the officers in the Company present at the meeting, and if they fail to do
so-the shareholders present will elect themselves or by proxy one of the directors or one of the officers present to chair the meeting. In the absence
of directors or officers or if all of the directors or officers refuse to chair the meeting, one of the shareholders or their proxy as stated shall be elected
to chair the meeting.
60. The Company shall maintain minutes of the proceedings in the general meeting which shall include the following details:
60.1 The names of the shareholders participating in the general meeting and the number of shares held by them.
60.2 The matters discussed at the general meeting and the resolution is passed.
61. Minutes which are signed by the chairman of the general meeting constitute prima facie evidence to their content.
Voting and the Passage of Resolutions at the General Meeting
62. A shareholder wishing to vote at the general meeting shall prove to the company his ownership in a share as required by The
Companies Law and the Companies Ordinance (proof of ownership of share for a purpose of voting at general meeting) — 2000. Without
the detracting from the generality of that stated above, the Board of Directors is entitled to determine provisions and procedures regarding the proof
of ownership of shares in the company.
63. A shareholder is entitled to vote in the general meeting or in a class meeting, himself or by proxy, all in accordance with the provisions
of these Articles and subject to the provisions of The Companies Law. A proxy for a vote is not required to be a shareholder in the company. Voting
in the general meeting of the Company by means of a voting deed, in accordance with the provisions of The Companies Law and the regulations
there under, will be possible solely and exclusively on issues specified in Articles 87A(1) — 87A(3) and 87A(5), of The Companies Law.
64. Subject to the provisions of applicable Law, in an instance of joint ownership in a share, any one of them may vote at any meeting,
whether himself or by proxy, in relation to such share, as though he was the sole party entitled to it. If more than one joint owner of a share
participates in an meeting, himself or by proxy, the vote will be made by the party whose name appears first in the registry of shareholders with
regard to the share or in the confirmation of the stock exchange member with regard to the ownership in the share (“confirmation of ownership”),
or some other document determined by the Board of Directors for such matter, as the case maybe. Individual legal guardians or individual executors
of estate over a registered shareholder who is deceased, shall be considered for purposes of this clause as joint owners in these shares. Without the
detracting from that stated above, in an instance where more than one shareholder is registered in the registry of shareholders of the Company as the
holder of a share, the Company shall view the first person registered in the registry of shareholders as the legal representative of the remaining
parties registered as holding the share, save if a document was delivered to the company, signed by the majority of the registered owners of the
share, or a court order, indicating the name of some other registered owner as the representative of the holders of the share.
65. Every party entitled to a share under clause 28 above, is entitled to vote by virtue thereof in any general meeting in the same manner
as though he was the registered owner of such shares and provided that he shall prove to the satisfaction of the Board of Directors his entitlement to
the share at least 48 hours prior to the date of the general meeting or the postponed meeting, as the case maybe, in which he intends to vote, save if
the Company has previously recognized his right to vote by virtue of the shares at such meeting.
66. A document appointing a proxy for a vote (“deed of appointment”) shall be made in writing and shall be signed by the appointing
party, and if the appointing party is a corporation, the deed of an appointment shall be made in writing and shall be signed in a manner binding the
corporation. The Board of Directors is entitled to require delivery to the Company prior to the convening of the meeting, of a confirmation in
writing, to the satisfaction of the Board of Directors, regarding the authority of the signatories to bind the corporation. The Board of Directors is
further entitled to determine provisions and procedures in everything related thereto.
66. A deed of appointment or a suitable copy thereof, to the satisfaction of the Board of Directors, will be deposited at the registered
office or some other place or places, in Israel or outside of Israel - as shall be determined by the Board of Directors from time to time, generally or
for a specific instance - at least 48 hours prior to commencement of the meeting or the postponed meeting, as the case maybe, in which the proxy
intends to vote in reliance upon such deed of appointment. Notwithstanding, that stated above, the chairman of the meeting may, at his discretion,
accept such deed of appointment also after the time as stated, if he deems this appropriate, at his discretion. If a deed of appointment shall not be
received as stated in this clause above, it shall not be valid in such meeting.
67. A proxy for a vote is entitled to participate in deliberations of the general meeting and to be elected as a chairman as was the
shareholder appointing him, and provided that it was not indicated otherwise in the deed of appointment.
67.1. A deed of appointment appointing a proxy for vote shall be in the format customary in Israel or in any other format approved by the
Board of Directors.
67.2. The deed of appointment will indicate the class and the number of shares in respect of which it was issued. In the absence of
indication in the deed of appointment of the number of shares in respect of which it was issued or an indication therein of a number of shares which
is higher than the number of shares registered in the name of the shareholder or which are indicated in the confirmation of ownership, as the case
maybe, the deed of appointment will be deemed to have been issued in respect of all of the shares of the shareholder.
67.3. In the event that the deed of appointment was issued in respect of a number of shares which is lower than the number of shares
registered in the name of the shareholder or indicated in the confirmation of ownership, as the case maybe, the shareholder will be deemed as
refraining from appearing at the vote in respect of the balance of the shares and the deed of appointment will be valid in respect of number of shares
indicated therein.
68. Without detracting from the provisions of these Articles with regard to the appointment of a proxy for a vote, a shareholder holding
more than one share will be entitled to appoint more than one proxy subject to the following provisions:
68.1. Each deed of appointment will indicate the class and the number of shares in respect of which it was issued.
68.2. In the event that the total number of shares of any class indicated in deeds of appointment issued by one shareholder shall exceed the
number of shares of such class registered in his name or indicated in the confirmation of ownership, as the case maybe, all the deeds of appointment
issued by such shareholder shall be invalidated.
69. A shareholder or a proxy is entitled to vote a part of the shares which are owned by him or for which he is a proxy, and is entitled to
vote part of the shares in one manner and part of the shares in another manner.
70. A vote made by virtue of a deed of appointment shall be valid even if prior to the vote the appointing party passed away or was
declared incompetent or the deed of appointment was canceled or the share was transferred in respect of which the deed of appointment was granted,
save if notice was received at the office prior to the meeting, in writing, with regard to the death, incapacity, cancellation or transfer, as the case may
be. Notwithstanding that stated above, the chairman of the meeting is entitled, at his discretion, to receive such notice as stated also during the
course of the meeting, if he deems this appropriate at his discretion.
71. A deed of appointment shall be valid also with regard to any postponed meeting or an meeting to which the deed of appointment
relates, and provided that it was not indicated otherwise in the deed of appointment.
72. Every ordinary share entitles its owner to participate in the general meeting of the Company and to one vote.
73. A resolution proposed for a vote in the general meeting shall be decided by a count of the participating votes. The manner of the
counting of the votes will be determined by the chairman of the Board of Directors, unless prior to the vote, a secret ballot was requested by a
shareholder or holders with at least 10% of the issued share capital of the Company. In a case of a dispute whether to accept or reject any individual
vote in the vote, the chairman of the meeting shall determine the matter and his good faith decision shall be final and decisive.
74. A declaration made by the chairman that a resolution was passed or rejected at the general meeting, unanimously or by some majority,
and the declaration was recorded in this matter in the minutes of the meeting, shall be prima facie evidence to that stated, and it shall not be
necessary to prove the number of votes (or their proportional share) which were made in favor or against such resolution.
75. Subject to the provisions of the Companies Law or the provisions of these Articles with regard to some other majority, decisions of the
general meeting shall be passed by an ordinary majority. The chairman of the meeting shall not have an additional vote or a decisive vote.
76. The chairman of the general meeting is entitled, at the consent of an meeting in which a legal quorum is present, to postpone it or to
postpone the deliberation or the passage of a resolution in some specific matter on the agenda, to a later time or a place which shall be determined,
and he is required to do so in accordance with the demand of the meeting. At such, postponed meeting as stated, no matter will be deliberated which
was not on the agenda and for which a resolution was not passed in the meeting at which the postponement was resolved upon. If the general
meeting was postponed for more than
21 days, notice will be issued upon the postponed meeting, as stated in Clauses 53 and 54 above. If the general meeting was postponed without
changing its agenda, for a date not exceeding 21 days, the notices and summons with regard to the new date will be issued as early as possible, and
not later than 72 hours prior to the general meeting. The notices and the summons as stated will be issued in accordance with Clauses 53 and 54
above, mutatis mutandis.
The Board of Directors
77. The number of directors shall not be less than four and shall not exceed nine (not including external directors, to the extent there is an
obligation to appoint them, and not including up to two additional directors appointed by the Board of Directors as described in Article 80.
78.
The annual general meeting of the Company shall appoint, by ordinary majority, the members of the Board of Directors. Each
appointed director shall serve as a member of the Board of Directors until the next annual general meeting. The term of a director shall terminate at
the next annual general meeting, unless extended by that annual general meeting, or terminated by the general meeting in accordance with Article
82. A director is not required to be a shareholder in the Company. The provisions of this clause with regard to the appointment of directors shall not
apply to external directors who will be appointed in the accordance with the provisions of the Companies Law, to the extent there is an obligation to
appoint them.
79. With the exception of directors who served in the Company up until the date of the annual meeting and/or parties upon whom the
Board of Directors of the Company recommended their appointment as director before the general meeting, no director will be appointed at the
annual meeting, unless a shareholder in the Company who holds at least 1% of the Company’s share capital, who is seeking to propose him as a
candidate, shall submit to the office at least 45 (forty-five) days prior to the convening of the annual meeting, a document in writing signed by the
shareholder notifying of the intent of the shareholder to propose the candidate for appointment as director, with the consent in writing of the
candidate attached to this document to serve as a director together with his resume, as stated in Article 52.3 above.
80. The Board of Directors shall appoint up to two (2) directors whose term of office will expire on the date of the next following annual
meeting, provided that they may be reappointed by the Board of Directors according to this Article for one additional term of office, provided that
they may be reappointed by the annual meeting (subject to Article 78 above).
81. The general meeting or the Board of Directors is entitled to determine that the service of a director appointed by them, as the case may
be, shall commence at a later date from the date of the resolution upon his appointment.
82. Notwithstanding that stated above, the general meeting is entitled at any time to remove a director from his position, with the
exception of an external director (regarding which there shall apply the provisions of the Companies Law) prior to the end of his period of service,
and provided that the director is granted a reasonable opportunity to present his position before the general meeting. Any general meeting may, by
ordinary majority, appoint in the stead of a director who was removed from his position as stated above, some other party as director, and provided
that the recommendation of a shareholder was given as stated in Clause 79 above.
The position of a director shall be vacated automatically in any one of the following instances:
82.1. Resignation.
82.2. Declaration of bankruptcy.
82.3. Conviction of a crime as stated in Article 232 of the Law.
82.4. If the director is a corporation which has resolved voluntary liquidation, or an order for liquidation has been issued against it.
82.5. Per a decision of the court as stated in Article 233 of the Law.
82.6. Declaration of legal incompetency.
82.7. If his term was automatically terminated in accordance with the law.
82.8. Death.
83. If the position of the director is vacated, the Board of Directors may continue to operate in every matter so long as the number of
directors is not less than the minimum number of directors determined in Clause 77 above.
For so long as the general meeting was not convened, the Board of Directors shall not be entitled to act upon manners which may be postponed, up
to the date of the convening of the general meeting for the appointment of the directors.
84. A director may resign by submission of notice to the Board of Directors, to the chairman of the Board of Directors or the Company, as
required in the Companies Law. The resignation shall be valid on the date of the delivery of the notice. Unless the notice determines a later date. A
director will provide the reasons for his resignation.
85. Subject to the provisions of the Companies Law, the Company is entitled to pay directors remuneration for fulfillment of their position
as directors.
86.
86.1. A director may appoint an alternate (hereinafter: “Alternate director’’). Notwithstanding that stated above, a party not eligible to be
appointed as a director will not be appointed nor serve as an alternate director, nor shall a serving director in the Company or a serving alternate
director.
A serving director may be appointed as an alternate director for a membership in a Board of Directors committee, and provided that at the date of
appointment as an alternate director to a member of a committee, he does not serve as a member of such Board of Directors committee and if he is
an alternate director to an external director, the candidate will be an external director with accounting and financial expertise or professional
competency, in accordance with the competency of the director being replaced.
86.2. An alternate director shall be equivalent to the director whom he replaces, and shall be entitled to be present at members of the Board
of Directors and/or committees of the Board of Directors, to participate and to vote therein as it was entitled to be director who appointed him.
Notwithstanding that stated, the Company shall not pay remuneration to an alternate director.
86.3. A director who appointed an alternate director may, subject to the provisions of the law, cancel the appointment at any time.
Additionally, the position of the alternate directors shall be vacated at any time when the position of the director who appointed the alternate director
shall be vacated in any manner.
86.4. Any appointment or cancellation of an alternate director as stated above, will be by notice in writing delivered to the alternate director
and to the Company, and will be valid after delivery of the deed of appointment, or deed of cancellation as stated or at the time
determined in the deed of appointment or deed of cancellation, the later of these, and if a period was not determined in the deed of appointment, the
period shall be congruent with the period of service of the appointing director.
External Directors
87. At least two external directors shall serve in the Company, to the extent there is an obligation to appoint them, and the provisions
determined in the Companies Law shall apply in this matter.
Authorities of the Directors and their Duties
88. The directors shall have all of the authorities and the powers granted to them in accordance with these Articles, in accordance with the
Companies Law and applicable law.
89. Without detracting from the provisions of these Articles, the Board of Directors shall direct the policies of the Company and shall
oversee performance of the positions of the CEO and his activities, and including:
89.1. Shall determine the action plans of the Company, principles for the financing thereof and priorities among them.
89.2. Shall examine the financial state of the Company, determine the credit framework which the Company may take.
89.3. Shall determine the organizational structure and the wage policy.
89.4. May decide upon the issue of a series of bonds.
89.5. Is responsible for preparation and approval of financial reports as stated in Article 171 of the Companies Law.
89.6. Will report to the annual meeting upon the state of affairs of the Company and its business results as stated in Article 173 of the
Companies Law.
89.7. Will appoint and dismiss the CEO.
89.8. Will decide upon actions and transactions requiring its approval under these Articles or the provisions of Articles 255 and 268 through
275 of the Companies Law.
89.9. May allot shares and securities convertible into shares up to the limit of the registered share capital of the Company.
89.10. May resolve upon distribution of dividend, interim dividend or distribution of bonus shares as the case may be.
89.11. May resolve upon a significant acquisition as per the definition of this term in Article 1 of the Companies Law, from all of the
shareholders of the Company or part thereof or any of them, at its discretion.
89.12. Will express its opinion upon a special purchase offer as stated in Article 328 of the Companies Law.
89.13. Will determine the minimum number of directors required in the Board of Directors, who must have financing and accounting
expertise, as per the definition thereof under Article 240 of the Companies Law. The Board of Directors will determine the minimum number as
stated taking into account, inter alia, the type of Company, its size, the scope of activity and complexity of operations, subject to the number of
directors determined under Clause 77 above.
The authorities of the Board of Directors under this clause may not be delegated to the CEO, save as specified in Clause 39.2(2).
90. The Board of Directors may exercise any authority of the Company not accorded by law or in these Articles to some other organ.
91.
91.1. The Board of Directors may resolve that authorities granted to the CEO will be transferred to its own authority, and all for a certain
purpose or certain period of time.
91.2. Without detracting from that stated above, the Board of Directors may direct the CEO how to operate with regard to a certain matter.
If the CEO shall fail to fulfill the instructions, the Board of Directors may exercise the authorities required for performance of the instruction in his
stead.
91.3. If the CEO was precluded from exercising his authorities, the Board of Directors may do so in his stead.
92. Subject to the provisions of the Companies Law, the Board of Directors may delegate any of the authorities of the CEO to an officer in
the Company or some other person. Delegation of authorities of the Board of Directors may be for a certain matter or a certain period of time, and
all at the discretion of the Board of Directors.
Receiving of Credit and Granting of Guarantees and Collateral
93. Without detracting from any of the authorities accorded to the Board of Directors under these Articles, the Board of Directors may
from time to time at its discretion resolve upon:
93.1 Receiving of credit by the Company in any amount and the securing of its discharge in the manner it shall deem proper:
93.2. The granting of a guarantee, collateral and any type of security.
93.3. The issue of a series of bonds, including capital notes or deeds of undertaking, including debentures, capital notes or deeds of
undertaking which are convertible or maybe exercised into shares, and to determine the terms thereof, to pledge its property, in whole or in part, in
the present or in the future, whether by floating charge or fixed charge. Bonds, capital notes, deeds of undertaking or other securities as stated above
may be issued at a discount or at a premium and in any other manner, with deferred rights or special rights and/or preferred rights and/or other rights
and all as determined by the Board of Directors at its discretion.
94. That stated in Clause 93 above does not negate the authorities of the CEO or any party appointed therefore to resolve upon the
receiving of credit by the Company and/or the issue of collateral by the Company within the limits of the credits and the collateral determined by the
Board of Directors.
Committees of the Board of Directors
95. Subject to the provisions of the Companies Law, the Board of Directors may as it deems proper, establish committees of two or more
members, appoint members from out of the members of the Board of Directors (hereinafter: “ Board of Directors committee”), and to delegate to
the Board of Directors committee its authorities, in whole or in part.
In a Board of Directors committee to which the Board of Directors has delegated any of its authorities, only members of the Board of Directors may
serve. In a Board of Directors committee whose function is to advise the Board of Directors or recommend only, parties who are not members of the
Board of Directors may serve.
Notwithstanding that stated above, in the following matters, the Board of Directors may not delegate any of its authorities to a Board of Directors
committee, but rather shall be entitled to establish committees for recommendation only:
95.1. Determination of general policies of the Company.
95.2. Distribution, save for the purchase of shares of the Company in accordance with a framework determined in advance by the Board of
Directors.
95.3. Determination of the position of the Board of Directors on a matter requiring approval of the general meeting or the issue of an
opinion on the profitability of a special purchase offer, as stated in Article 329 of the Companies Law.
95.4. Appointment of directors.
95.5. Issue or allotment of shares or of securities convertible into shares or which may be exercised into shares, or a series of bonds, save as
specified in Clause 39.2 above.
95.6. Approval of financial reports.
95.7. Approval of transactions and actions requiring approval of the Board of Directors under the provisions of Articles 255 and 268
through 275 of the Companies Law.
96. A resolution passed or an action carried out by a Board of Directors committee, is deemed a resolution passed or an action carried out
by the Board of Directors save if determined explicitly otherwise by the Board of Directors, for a certain matter or for a certain committee. The
Board of Directors may from time to time expand, reduce or cancel the delegation of authorities to a Board of Directors committee, but the reduction
or cancellation as stated shall not prejudice the validity of a resolution of the committee according to which the Company has acted as towards some
other person who was unaware of the cancellation.
97.
97.1. The legal quorum for the opening of a Board of Directors committee shall be two committee members who are serving at the time of
the meeting, or their alternates, unless determined otherwise by the Board of Directors.
97.2. The general provisions of these Articles with regard to the operation of the Board of Directors shall apply, mutatis mutandis, also upon
the Board of Directors committees so long as they have not been replaced by directives issued by the Board of Directors for such matter, and all
subject to the provisions of the Companies Law.
97.3. The Board of Directors committee shall report to the Board of Directors continuously upon its resolutions or recommendations.
98.
98.1. The Board of Directors will appoint an audit committee from amongst its members. The number of members of the audit committee
shall not be less than three and all of the external directors (to the extent there is an obligation to appoint them) shall be members therein. The
following shall not be members of the audit committee: The chairman of the Board of Directors, any director employed by the Company or
routinely providing services to it, and a controlling interest in the Company or his relation.
98.2. The functions of the audit committee shall be as determined in the Companies Law including any other function imposed upon it by
the Board of Directors.
Actions of the Board of Directors
99. Subject to the provisions of these Articles, the Board of Directors may convene for purposes of performance of its functions and
postpone its meetings and regulate its activities and deliberations as it shall deem fit.
100. The Board of Directors will appoint one of its members as chairman of the Board of Directors (hereinafter “Chairman of the Board
of Directors” ). The Board of Directors may appoint one or more of its members as deputy chairman of the Board of Directors who shall serve as
replacement chairman in his absence. The Board of Directors may determine the period for which the chairman and his deputies shall serve. In the
absence of such determination, the chairman of the Board of Directors and his deputies shall serve for so long as they serve as directors and no
resolution has been passed by the Board of Directors of the Company upon their replacement.
101. The chairman of the Board of Directors shall chair meetings of the Board of Directors and shall conduct them. If the chairman of the
Board of Directors is absent from a meeting of the Board of Directors, in accordance with a notice delivered in advance, or has failed to appear to a
meeting of the Board of Directors within 15 minutes from the date determined for the meeting (hereinafter: “absence” ), then the deputy chairman
of the Board of Directors shall chair the meeting (if one was appointed). In the absence of both the chairman of the Board of Directors and his
deputy from the meeting, members of the Board of Directors who are present will elect one of their members as chairman of the meeting.
102. The Board of Directors will convene as per the requirements of the Company, and at least once every three months.
103. The chairman of the Board of Directors may convene the Board of Directors at any time, and determine the place and the date for the
meeting of the Board of Directors.
104. Without detracting from that stated above, the chairman of the Board of Directors shall be required to convene the Board of Directors
upon the occurrence of one of the following:
104.1. Receiving a demand for convening of the Board of Directors from at least two directors, for deliberation upon a matter which shall be
specified in their demand, and if there are five directors in the Company (or less), a demand for convening of the Board of Directors from at least
one director shall suffice for conducting of a discussion on the matter specified in his demand.
104.2. Receiving notice or report of the CEO which requires an action of the Board of Directors.
104.3. Receiving notice from the auditing accountant of material defects in the accounting auditing of the Company.
105. Upon receipt of the notice or report as stated, the chairman of the Board of Directors shall convene the Board of Directors, without
delay, not later than the passage of 14 days from the date of the demand, report or notice, as the case may be.
105.1. Notice in advance of the convening of the Board of Directors shall be provided to each of the members of the Board of Directors three
days prior to the date of the meeting.
105.2. Notwithstanding that stated above, the Board of Directors may, at the consent of all of the directors, convene for a meeting without
notice.
106. The agenda of meetings of the Board of Directors will be determined by the chairman of the Board of Directors and shall include:
106.1. Matters determined by the chairman of the Board of Directors.
106.2. Matters determined as stated in Clause 104 above.
106.3. Any matter which a director or the CEO has requested of the chairman of the Board of Directors, a reasonable time prior to the
convening of the meeting of the Board of Directors, to be included in the agenda (hereinafter: “ the agenda ”).
107. The notice of the convening of the Board of Directors shall indicate the date of the meeting, its location and reasonable details of the
matters to be discussed at the meeting, in accordance with the agenda. The notice may be in writing and it may be oral.
108. Notice of a meeting of the Board of Directors, if the notice is delivered in writing, shall be delivered to the address which the director
provided to the Company in advance save if the director has requested that the notice be delivered to him at some other location or if he has
consented to its delivery at some other location.
109. The legal quorum for the opening of a meeting of the Board of Directors shall be a majority of the members of the Board of Directors
serving at the time of the meeting and entitled to participate therein, themselves or their alternates.
In the absence of a legal quorum upon the passage of half of an hour from the time determined for the meeting of the Board of Directors, the meeting
shall be postponed for 48 hours. At a postponed meeting as stated in the absence of a legal quorum within half of an hour from the convening, the
directors who are present and entitled to vote shall constitute the legal quorum.
110.1. In a vote in the Board of Directors, each director shall have one vote. Resolutions of the Board of Directors shall be passed by a
majority of the votes of the directors present at the meeting and voting therein, without taking into account abstentions. The chairman of the Board
of Directors shall not have a decisive vote in the event of a tie.
110.
110.2. In the event of tied votes, the proposed resolution upon which the members of the Board of Directors have voted shall be deemed
rejected.
111. The Board of Directors may conduct meetings by any means of communication and provided that all of the directors participating can
hear each other simultaneously. The Board of Directors may regulate the manner and the methods for the conduct of its meetings by means of
communication.
112. The Board of Directors may pass resolution even without actually convening, and provided that all of the directors entitled to
participate in the deliberation and to vote upon the matter presented for resolution, have consented to the resolution and have signed thereupon (or
on separate copies thereof, including by means of facsimile). A resolution passed in such manner shall be valid for all intents and purposes as
though it was passed at a meeting of the Board of Directors, which was convened and conducted lawfully.
Minutes
113. The Board of Directors shall ensure that minutes shall be held of the proceedings and the meetings of the Board of Directors. The
minutes shall be recorded in books prepared for such purpose and shall include, inter alia, the following details:
113.1. The names of the participating directors and other parties present of every meeting of the Board of Directors.
113.2. The matters discussed at the meeting of the Board of Directors and the resolutions passed.
Each minutes shall be signed by the chairman of the Board of Directors or by the chairman of the meeting, as the case may be. Minutes which are
signed and approved as stated shall serve as prima facie evidence to the content thereof.
114. The provisions of Clause 113 above shall apply also to the meetings of the Board of Directors committees and the passage of
resolutions of the Board of Directors without convening, as stated in Clause 112 above.
The CEO
115. The Board of Directors shall appoint from time to time a CEO for the Company, and is entitled to appoint more than one CEO (each
one of these shall hereinafter be called: CEO ). The Board of Directors is also entitled to dismiss the CEO or to replace him at any time it deems
proper.
116. The CEO is not required to be a shareholder in the Company nor must he be a director.
117. The CEO is responsible for the continuous management of the affairs of the Company, in the framework of the policy determined by
the Board of Directors and subject to its directives.
118. The CEO shall have all of the authorities of management and execution not granted at law or in these Articles or by virtue thereof to
some other organ of the Company with the exception of authorities as stated which shall be transferred from him to the Board of Directors in
accordance with the provisions of Clause 91.1 above, if they shall be transferred. The CEO shall be subordinate to the Board of Directors.
119. Subject to the provisions of the Companies Law and these Articles, the Board of Directors may from time to time deliver and grant to
the CEO authorities belonging to the Board of Directors under these Articles, as it shall deem fit, and it is entitled to grant any of these authorities
for such period, such purpose and under such terms and limitations as the Board of Directors shall deem appropriate, and the Board of Directors is
entitled to grant these authorities, both without relinquishing its authority in the matter or in their stead or subordinates to them, in whole or in part,
and is entitled from time to time to cancel, suspend and change these authorities, in whole or in part.
120. Without detracting from that stated in Article 127 and 129 below, the CEO is entitled, with the approval of the Board of Directors, to
delegate any of his authorities to other/s, subordinate to him. Approval of the Board of Directors as mentioned may be granted generally or for a
specific matter.
121. Without detracting from the provisions of the Companies Law and applicable law, the CEO will submit to the Board of Directors
reports on matters, at times and at a scope as determined by the Board of Directors, whether in a specific resolution or in the framework of the
procedures of the Board of Directors.
122. The wage of the CEO may be paid as a salary, or commission or participation in the profit or the granting of securities or the rights to
purchase these, or in any other manner.
Validity of Actions and Approval of Transactions
123. Subject to the provisions of applicable law, all of the actions taken by the Board of Directors or by a Board of Directors committee or
by any person acting as director or member of a Board of Directors committee or by an officer, as the case may be - shall be valid even if it evolves
thereafter that there was some defect in the appointment of the director, Board of Directors committee, director who is a member of the committee or
officer, as the case may be, or that any of the officers mentioned was prohibited from serving in such position.
124.1 Subject to the provisions of the Companies Law, the holding of shares in the Company and the service as an officer in the Company
whilst being a party at interest or an officer
124.
in any other corporation, including a corporation in which the Company is a party at interest or a shareholder in the Company, shall not preclude an
officer from being an officer in the Company. Additionally, an officer shall not be precluded from being an officer in the Company due to his
engagement or subsequent to the engagement of any corporation as stated above, in a contract with the Company in any matter or manner
whatsoever.
124.2 Subject to the provisions of the Companies Law, the service of a person as an officer in the Company shall not preclude him and/or his
relations and/or some other corporation in which he is a party at interest, from engaging with the Company in transactions in which the officer has a
personal interest in any manner whatsoever.
124.3 Subject to the provisions of the Companies Law, an officer shall be entitled to participate and to vote in deliberations with regard to
approval of transactions or actions in which he has a personal interest.
125. Subject to the provisions of the Companies Law, a transaction of the Company with some other person in whom the officer in the
Company has a personal interest, and which are not extraordinary transactions, will be approved as follows:
125.1 Engagement as stated above in a transaction which is not extraordinary shall be approved by the Board of Directors or by some other
party (including the audit committee of the Company) authorized therefor by the Board of Directors, whether in a specific resolution or in the
framework of the procedures of the Board of Directors, whether by general agreement or by agreement to a certain type of transactions or a specific
transaction.
125.2 Approval of transactions which are not extraordinary as stated above may be made by general approval for a certain type of
transaction or approval for a specific transaction.
126. Subject to the provisions of the Companies Law, general notice issued to the Board of Directors by an officer or a controlling interest
in the Company with regard to his personal interest in a certain body, with details of his personal interest, shall constitute disclosure by the officer or
the controlling interest, to the Company, with regard to his personal interest as stated for purposes of any engagement with the aforementioned body,
or an engagement in which the aforementioned body has a personal interest.
Signature on behalf of the Company
127. Subject to the provisions of the Companies Law and these Articles, the Board of Directors may authorize any party to act and to sign
on behalf of the Company, whether himself or some other person, generally or on certain matters.
128. The Company shall have a stamp bearing the name of the Company. A signature upon a document shall not bind the Company save if
it was signed by those authorized to sign on behalf of the Company together with the stamp of the Company or its printed name.
Appointment of Legal Representatives
129. Subject to the provisions of the Companies Law, the Board of Directors is entitled at any time to grant a power of attorney to any
person to legally represent the Company for such purposes and with such authorities and discretion and for such period of time and subject to such
terms and all as the Board of Directors shall deem fit.
The Board of Directors will be entitled to grant to such person, inter alia, authorities to transfer to some other, fully or partially, the authorities and
powers and discretion granted to him.
Exemption, Indemnification and Insurance
130. Subject to the provisions of the Companies Law, the Company is entitled to exempt an officer from liability, in whole or in part, due to
damage for breach of the duty of caution towards it. However, a Company may not exempt a director in advance from his liability towards it due to
breach of the duty of caution upon distribution.
131. Subject to the provisions of the Companies Law and the Securities Law, the Company may engage in a contract to insure the liability
of its officer, for liability imposed upon him due to an act carried out by virtue of his position as an officer, in any one of the following:
131.1. Breach of the duty of caution towards the Company or towards some other person.
131.2. Breach of the fiduciary duty towards the Company and provided that the officer acted in good faith and had reasonable cause to
assume that the actions shall not harm the welfare of the Company.
131.3. Monetary liabilities imposed upon him in favor of some other person including payments to the victim of the breach as stated in
Article 52nd (a)(1)(a) of this security’s law.
131.4. Any other event for which it is permitted and/or shall be permitted to insure the liability of an officer including for expenses made in
connection with proceedings conducted against him (as defined in Article 56h (a)(1) of the Securities Law) including reasonable litigation expenses
and including lawyers professional fees.
132. Subject to the provisions of the Companies Law and the Securities Law -
132.1. The Company is entitled to provide an undertaking in advance to indemnify its officers for liability or expense as stated in Clause 133
below, in any of the following (hereinafter: “ undertaking for indemnification ”):
(a) As specified in Clause 133.1 below and provided that the undertaking for indemnification will be limited to events which in
the opinion of the Board of Directors are anticipated in light of the activity of the Company in practice at the time of the issue
of the undertaking for indemnification and to an amount or a criteria which the Board of Directors has determined are reasonable in the
circumstances and that in the undertaking for indemnification, there shall be indicated the events which in the opinion of the Board of Directors are
anticipated in light of the activity of the Company in practice at the time of the issue of the undertaking and the amount or criteria which the Board
of Directors has determined are reasonable in the circumstances.
(b) As specified in Clause 133.2 or 133.3 below.
132.2. Without detracting from that stated in Clause 132.1 above, the Company is entitled to indemnify an officer therein retroactively, due to
a liability or an expense as stated in Clause 133 below which was imposed upon him due to an action taken as an officer in the Company.
133. An undertaking for indemnification or indemnification as stated in Clause 132 above, may be granted due to liability or expense as
specified in sub Clauses 133.1 to 133.4 below, which were imposed upon the officer or which he expended due to an action taken by virtue of being
an officer in the Company, as follows:
133.1. A monetary liability imposed upon him in favor of some other party by a judgment, including a judgment issued in a settlement or an
arbitrator’s judgment approved by a court, for payment to the injured party of a breach as stated in article 52ns (a)(1)(a) of the Security’s law.
133.2. Reasonable litigation expenses including attorney’s professional fees which the officer expended due to investigation or proceedings
conducted against him by an authority entitled to conduct an investigation or proceedings and which ended without submission of an indictment
against him and without monetary liabilities imposed upon him as an alternative to a criminal proceeding or which ended without submission of an
indictment against him or the imposition of monetary liability as an alternative to criminal proceedings for a crime which does not require the proof
of mens rea ; in this paragraph -
Termination of proceedings without submission of an indictment in the matter in which a criminal investigation was commenced - means the closing
of the case as per Article 62 of the Criminal Procedural Law (combined version) - 1982 (in this sub-clause - the Criminal Procedural Law) or a stay
of proceedings by the Attorney General under Article 231 of the Criminal Procedural Regulations.
“Monetary liability as an alternative to criminal proceedings” - monetary liability imposed at law as an alternative to a criminal proceeding,
including an administrative fine under the Administrative Crimes Law - 1985, a fine for a crime determined as a fine-crime under the provisions of
the Criminal Procedural Regulations, and administrative fine or ransom.
133.3. Reasonable litigation expenses, including lawyers professional fees, which the officer expended or was obligated by the court, in
proceedings commenced against him by the
Company or in its name or by some other person, or a criminal indictment from which he was acquitted or a criminal indictment in which he was
convicted of a crime which does not require the proof of mens rea.
133.4. Any other liability or expense for which indemnification of an officer is and/or shall be permitted.
133.5. An expense made in connection with proceedings under Section H3, H4 or I1 of the Securities Law, including reasonable litigation
expenses and lawyer’s professional fees.
134. Subject to the provisions of the Companies Law, nothing in the provisions of these Articles shall limit the Company in any manner in
connection with its engagement in an insurance contract or in connection with the granting of an exemption or indemnification:
134.1. In connection with an officer in the Company or a director in another Company, to such extent as the insurance, exemption or
indemnification are not prohibited under any law.
134.2. In connection with parties who are not officers in the Company or directors in another Company, including but without detracting
from the generality of that stated above, employees, contractors or advisers.
134A. The maximum amount of indemnification that the Company will pay to all officers who receive a letter of indemnity from the
Company (in addition to the amounts received from an insurance company, if received, under directors and officers liability insurance purchased by
the Company, if purchased), in the aggregate for one event or more, shall not exceed the greater of the following: (i) an amount that constitutes 25%
of the Company’s shareholders’ equity after excluding the minority interest, on the actual payment date of the indemnification; and (ii) US $10
million, and if the Company lists for trade on a stock exchange outside of Israel - US $20 million.
Dividends, Funds, and Amortization of Funds and Profits
135. The Board of Directors may, prior to resolving upon distribution of dividend, as stated in clause 137 above, allocate from the within
the profits, certain amounts as they shall deem fit and subject to any law, to a general fund or to a fund reserved for distribution of dividend, for
distribution of bonus shares or some other purpose, as shall be determined by the Board of Directors at its discretion. The Board of Directors of the
Company may, prior to resolving upon distribution of dividend, allot from within the profits certain amounts, as which shall be in fit, to a general
fund or to a fund reserved for any purpose, as the Board of Directors shall determine at its discretion. In accordance with the discretion of the Board
of Directors, profits of the Company which the Board of Directors has not resolved to distribute as dividend shall be transferred to the following
year.
136. Until use is made of the aforementioned funds, the Board of Directors may invest the amounts allotted as stated above and the funds,
in any investment, as it shall deem fit, and to handle such investments, to change them or to make any other use thereof, and is
entitled to distribute the reserved fund into special funds and to use each fund or part thereof for purposes of the business of the Company, without
maintaining it separate from the remainder of the assets of the Company, all according to the discretion of the Board of Directors and the terms it
shall determine.
137. Subject to the provisions of the Companies Law, the Board of Directors may resolve upon distribution of dividend. The Board of
Directors resolving upon distribution of dividend may resolve that the dividend shall be paid, in whole and in part, in cash or in kind, and including
this in securities or any other manner, at its discretion.
138.
138.1.
(A) Subject to the provisions of the Companies Law, the Board of Directors may resolve upon the allotment of bonus shares, and to
convert into share capital as per the definition thereof in Article 302(b) of the Companies Law, some of the profits of the Company derived from
shares or from a premium on shares or from any other source included in the shareholders capital, indicated in its last financial reports, in an amount
determined by the Board of Directors and which shall not be less than the nominal value of the bonus shares.
(B) A Board of Directors resolving upon the allotment of bonus shares, shall determine whether they shall be of one class only for all
shareholders without taking into account the class of shares held by them or for each shareholder as stated there shall be distributed bonus shares of
the same class in respect of each class of shares held by him.
(C) Bonus shares which shall be allotted under this clause shall be deemed as fully paid up.
138.2 A Board of Directors resolving upon allotment of bonus shares may resolve that the Company shall transfer to a special fund
designated for distribution of bonus shares in the future, such amounts that the conversion thereof into share capital shall suffice to allot to
whomever shall, at such time for any reason, be entitled to purchase shares in the Company (including rights which may be implemented only at a
later date), bonus shares which shall be due to him, had he exercised the right to purchase shares on the eve of the determining date for the right to
receive the bonus shares (in this clause - “ the determining date ”). In the event that after the determining date a holder of a right as stated shall
exercise his right to purchase shares or part thereof, the Company shall allot bonus shares to him with a nominal value and which are due to him had
he exercised the right to purchase shares which he actually purchased, on the eve of the determining date, and this by the conversion into share
capital of the special fund as mentioned. Bonus shares shall accord the owners thereof participation and distribution of dividends in cash or bonus
shares starting on the date determined by the Board of Directors. With regard to determination of the amount which shall be transferred to the
special fund as stated, any amounts transferred to such fund in respect of previous distributions of bonus shares shall
be viewed as already amortized and that shares have already allotted from it, which grant bonus shares to the holders of the right to purchase shares.
139. Subject to the rights ancillary to the classes of shares issued by the Company and the provisions of these Articles, a dividend or a
bonus share shall be distributed to the shareholders proportionally to the nominal value of each share, without taking into account any premium
which was paid thereupon.
140. In order to execute a resolution regarding distribution of dividend or allotment of bonus shares, the Board of Directors is entitled:
140.1 To resolve at its discretion any difficulty which shall arise in connection therewith and to adopt all of the steps it deems proper to
overcome such difficulty.
140.2 To resolve that fractions lower than a certain amount determined by the Board of Directors shall not be taken into account for
adjustment of the right of the shareholders or to sell fractions of shares and to pay the consideration for them (net) to those entitled to them.
140.3 To authorize to sign on behalf of the shareholders upon any contract or other documents required for the validity of the allotment and
or distribution, and particularly to authorize to sign and submit for registration a document in writing as stated in Article 291 of the Companies Law.
140.4 To determine the value of certain assets which shall be distributed and to decide that payments in cash will be paid to shareholders on
the basis of the value which was determined.
140.5 To grant cash or certain assets to trustees in favor of parties entitled thereto, as shall seem practical in view of the Board of Directors.
140.6 To make any arrangement or other arrangement which shall be required in the opinion of the Board of Directors to enable the
allotment or distribution, as the case may be.
141. Dividend or other benefit in respective shares shall not bear interest or linkage differences.
142. The Board of Directors may delay any dividend or bonus shares or other benefits in respect of a share for which the consideration
determined therefor, in whole or in part, was not paid to the Company, and to collect any amount as stated or consideration which shall be received
from the sale of any bonus shares or other benefits, on account of the debt or liability in respect of the aforementioned share, this, whether the
aforementioned share is owned exclusively by the shareholder in debt or jointly with other shareholders.
143. The Board of Directors may delay any dividend or bonus share or other benefit in respect of a share to which a person is entitled to be
registered as its owner in the registry or is
entitled to transfer it, under clauses 28 or 30 above, as the case may be, until such person shall be registered as the owner of the share or until he
shall transfer it at law, as the case may be.
144. The Board of Directors may determine from time to time the manner of the payment of the dividend or allotment of bonus shares or
their transfer to those entitled and instructions, procedures and arrangements in connection therewith, both with regard to the registered shareholders
and non-registered shareholders. Without detracting from the generality of that stated above, the Board of Directors is entitled to determine as
follows:
144.1.
(A) Subject to that stated in sub-clause (B) below, a dividend or funds which shall be distributed to registered shareholders shall be paid to
the registered shareholder by the dispatch of a check by post to his address as shall be registered in registry of shareholders, or in the instance of
jointly registered owners of the share, to the party whose name appears first in the registry of shareholders regarding such share. Every dispatch of a
check as stated shall be made at the risk of the registered shareholder. Without detracting from that stated above, the Board of Directors may
determine that a dividend amount less than a certain amounts determined by the Board of Directors shall not be sent by check as stated, and there
shall apply to it the provisions of sub-clause (B) below.
(B) The Board of Directors may determine that the payment of dividend or funds which are distributed to the registered shareholders, may
be made at the office or any other place determined by the Board of Directors.
144.2. Dividends distributed to non-registered shareholders shall be transferred to such shareholders by means of a company for registration
or any other means determined by the Board of Directors.
145. If two or more persons are jointly registered for a share in the registry of shareholders, each of them is entitled to issue a valid receipt
for any dividend, share or other security, or other funds or benefits due in respect of the share.
Documents of the Company
146.
146.1. Shareholders shall have a right to view documents of the Company specified in Articles 184 of the Companies Law, upon fulfillment
of the conditions determined therefor.
146.2. Shareholders shall not have a right to view documents of the Company or any part of them save if they were granted a right as stated,
under statute or under these Articles or if they were permitted so to do by the Board of Directors as stated in Clause 146.1 above.
147. Subject to the provisions of applicable law, any book, record or registry which the Company must maintain in accordance with the law
or these Articles, will be maintained using technical or other means as decided by the Board of Directors.
Financial Reports
148. The financial reports of the Company shall be signed by the party authorized therefor by the Board of Directors, as required at law.
Auditing Accountant
149. The auditing accountant or the auditing accountants shall be appointed at every annual meeting and shall serve in their position until
the end of the following annual meeting.
150.
150.1. The Board of Directors shall determine the wage for the audit activity of the auditing accountant appointed by the Company, at the
discretion of the Board of Directors.
150.2. The wage of the auditing accountant for additional services to the Company which are not auditing service, shall be determined by the
Board of Directors at its discretion.
Notices
151. The provision of notices or delivery of documents to shareholders and a company for registration, in accordance with the provisions of
the law or these Articles, shall be in such manners indicated below in this section.
152. Notice of a general meeting shall be delivered in accordance with Clause 53 above.
153.
153.1. Without detracting from that stated above, the Company is entitled to deliver notice or document to a shareholder by personal delivery
or by facsimile or by post or by electronic mail. Postal delivery shall be made to the address of the shareholder registered in the registry or in the
absence of such registered address, at the address delivered by him to the Company for the dispatch of notices to him. Notice delivered by means of
facsimile shall be sent to the shareholder in accordance with the facsimile number delivered by him to the Company. Notice delivered by email shall
be sent to the shareholder at the email address delivered by him to the Company.
(A) Notice or documents delivered to the shareholder shall be deemed delivered upon their time of their delivery to his possession.
153.2.
(B) Notice or documents sent by post shall be deemed properly delivered if delivered for postal dispatch when they bear the proper
address and are lawfully postaged. Delivery shall be deemed to have been performed at the time at which the letter was to be delivered in the
ordinary manner by the post, and not more than three days from the date in which the letter including the notice was delivered as stated at the post
office.
(C) Notice sent by facsimile or email shall be deemed delivered 24 hours after the dispatch.
154. Without detracting from that stated above, the Company is entitled to deliver notice to shareholders by publication of the notice once,
in two daily papers published in Israel in the Hebrew language, both in addition to and in the stead of notice as stated in clause 153 above. The date
of publication in the paper shall be deemed the date of receipt of the notice by the shareholders.
155. The Company is entitled to notify upon the delivery of a document at the office or in any other place determined by the Board of
Directors or in any other manner, including by means of the internet.
156. The Company is entitled to deliver to joint shareholders a notice or a document by dispatched to the shareholder whose name appears
first in the registry of shareholders for such share.
157. Every person to whom a right to any share was lawfully transferred, by transfer or any other manner, shall be bound by such notice
with regard to such share which was lawfully delivered to the person from whom his right derives to such share, prior to the recording of his details
in the registry.
158. Any document or notice delivered to a shareholder in the Company in accordance with the provisions of these Articles shall be
deemed as properly delivered notwithstanding his death, bankruptcy or the liquidation of such shareholder or the assignment of the right in the
shares, in accordance with the law (whether the Company knew thereof or not) for so long as some other party was not registered in his stead as a
shareholder, and the dispatch or delivery as stated shall be deemed for all purposes as sufficient with regard to any party interested in such shares
and/or entitled to them by virtue of assignment of the right, in accordance with the law, whether together with such shareholder or by virtue thereof
or in his stead.
159. Subject to the provisions of applicable law, a shareholder, director or any other party, who is entitled to receive notice in accordance
with these Articles or at law, may waive its receipt, whether an advance or in retrospect, whether in a special circumstance or in general, and having
done so, the notice will be deemed to have been lawfully provided and any proceedings or action in respect of which notice was to have been given,
shall be deemed valid and in force.
160. Confirmation in writing signed by a director or by the Secretary of the Company with regard to the dispatch of a document or a notice
in any one of the manners specified in these Articles, shall be deemed decisive proof of any detail included therein.
161. For so long as advance notice of a number of days must be granted or a notice is valid for a certain period, the date of delivery shall be
included in the count of the number of days or the period, save as indicated otherwise. If notice was given in more than one of the manners specified
above, it shall be deemed to have been received at the earliest dates at which it was considered received, as stated above.
Merger
162. Approval of a merger in accordance with the first chapter of the eighth section of the Companies Law, requires an ordinary majority in
the general meeting or a class meeting, as the case maybe, and all subject to the provisions of applicable law.
Liquidation
163. Subject to the provisions of applicable law, the liquidator is entitled, whether in voluntary or other liquidation, in accordance with the
resolution of the general meeting passed by ordinary majority, to distribute in kind between the shareholders, the surplus assets, in whole or in part,
and the liquidator is further entitled in accordance with a resolution of the general meeting passed by an ordinary majority to deposit any part of the
surplus assets in trust which shall be held in favor of the shareholders, as the liquidator shall deem appropriate. For the purpose of distribution of
surplus assets in kind, the liquidator may determine the proper value of the property available for distribution and to decide how to carry out the
distribution between the shareholders taking into account the ancillary rights from the different classes of shares in the Company which they own.
Bearer Shares
164. Subject to the provisions of applicable law, the Company is entitled to issue for a share which was paid up in full, a share certificate in
accordance with the provisions which shall be determined for this matter by the Board of Directors of the Company, and in such instance, the share
shall be registered as stated in Article 130(a)(2) of the Companies Law, and the name of the shareholder shall be erased from the registry of
shareholders.
Internal Auditor
165. The organizational supervisor of the internal auditor shall be the chairman of the Board of Directors, or if the Board of Directors shall
determine - the CEO of the Company.
166. Proposals for the annual work plan shall be submitted by the internal auditor for approval of the Board of Directors of the Company,
or if the Board of Directors has determined, for approval of the audit committee.
DESCRIPTION OF SHARE CAPITAL
Exhibit 2.3
The following description of the capital stock of BrainsWay is a summary of the rights of our ordinary shares and certain provisions of our articles of
association currently in effect. This summary does not purport to be complete and is qualified in its entirety by the provisions of our articles of association
previously filed with the Securities and Exchange Commission and incorporated by reference as an exhibit to the Annual Report on Form 20-F, as well as
to the applicable provisions of the Israeli Companies Law. We encourage you to read our articles of associations and applicable portions of the Israeli
Companies Law carefully.
Each of the American Depositary Shares, or ADSs, represents 2 Ordinary Shares. The ADSs trade on the NASDAQ Global Market.
The principal office of The Bank of New York Mellon, located at 101 Barclay Street, New York, New York 10286.
You may hold American Depositary Shares either (A) directly (i) by having an American Depositary Receipt, which is a certificate evidencing a specific
number of American Depositary Shares, registered in your name, or (ii) by having American Depositary Shares registered in your name in the Direct
Registration System, or (B) indirectly by holding a security entitlement in American Depositary Shares through your broker or other financial institution. If
you hold American Depositary Shares directly, you are a registered American Depositary Share holder. This description assumes you are an American
Depositary Share holder. If you hold the American Depositary Shares indirectly, you must rely on the procedures of your broker or other financial
institution to assert the rights of American Depositary Share holders described in this section. You should consult with your broker or financial institution
to find out what those procedures are.
The Direct Registration System, or DRS, is a system administered by The Depository Trust Company, also referred to as DTC, pursuant to which the
depositary may register the ownership of uncertificated American Depositary Shares, which ownership is confirmed by periodic statements sent by the
depositary to the registered holders of uncertificated American Depositary Shares.
As an American Depositary Share holder, we will not treat you as one of our shareholders and you will not have shareholder rights. Israeli law governs
shareholder rights. The depositary will be the holder of the ordinary shares underlying your American Depositary Shares. As a registered holder of
American Depositary Shares, you will have American Depositary Share holder rights. A deposit agreement among us, the depositary and you, as an
American Depositary Share holder, and all other persons indirectly holding American Depositary Shares sets out American Depositary Share holder rights
as well as the rights and obligations of the depositary. New York law governs the deposit agreement and the American Depositary Shares.
The following is a summary of the material provisions of the deposit agreement. For more complete information, you should read the entire deposit
agreement and the form of American Depositary Receipt, each of which has been filed as an exhibit to our Registration Statement on Form F-1 filed with
the Securities and Exchange Commission.
Dividends and Other Distributions
How will you receive dividends and other distributions on the shares?
The depositary has agreed to pay to American Depositary Share holders the cash dividends or other distributions it or the custodian receives on
shares or other deposited securities, after deducting its fees and expenses. You will receive these distributions in proportion to the number of shares your
American Depositary Shares represent.
·
Cash. The depositary will convert any cash dividend or other cash distribution we pay on the shares into U.S. dollars, if it can do so on a
reasonable basis and can transfer the U.S. dollars to the U.S. If that is not possible or if any government approval is needed and cannot be
obtained, the deposit agreement allows the depositary to distribute the foreign currency only to those American Depositary Share holders to whom
it is possible to do so. It will hold the foreign currency it cannot convert for the account of the American Depositary Share holders who have not
been paid. It will not invest the foreign currency and it will not be liable for any interest.
·
·
·
Before making a distribution, any withholding taxes, or other governmental charges that must be paid will be deducted. It will distribute only
whole U.S. dollars and cents and will round fractional cents to the nearest whole cent. If the exchange rates fluctuate during a time when the
depositary cannot convert the foreign currency, you may lose some or all of the value of the distribution.
Shares. The depositary may, and will if we so request, distribute additional American Depositary Shares representing any shares we distribute as a
dividend or free distribution. The depositary will only distribute whole American Depositary Shares. It will sell shares which would require it to
deliver a fractional American Depositary Share and distribute the net proceeds in the same way as it does with cash. If the depositary does not
distribute additional American Depositary Shares, the outstanding American Depositary Shares will also represent the new shares. The depositary
may sell a portion of the distributed shares sufficient to pay its fees and expenses in connection with that distribution.
Rights to purchase additional shares. If we offer holders of our securities any rights to subscribe for additional shares or any other rights, the
depositary may make these rights available to American Depositary Share holders. If the depositary decides it is not legal and practical to make
the rights available but that it is practical to sell the rights, the depositary will use reasonable efforts to sell the rights and distribute the proceeds in
the same way as it does with cash. The depositary will allow rights that are not distributed or sold to lapse. In that case, you will receive no value
for them.
If the depositary makes rights available to American Depositary Share holders, it will exercise the rights and purchase the shares on your behalf.
The depositary will then deposit the shares and deliver American Depositary Shares to the persons entitled to them. It will only exercise rights if
you pay it the exercise price and any other charges the rights require you to pay.
U.S. securities laws may restrict transfers and cancellation of the American Depositary Shares represented by shares purchased upon exercise of
rights. For example, you may not be able to trade these American Depositary Shares freely in the U.S. In this case, the depositary may deliver
restricted depositary shares that have the same terms as the American Depositary Shares described in this section except for changes needed to put
the necessary restrictions in place.
Other Distributions. The depositary will send to American Depositary Share holders anything else we distribute on deposited securities by any
means it thinks is legal, fair and practical. If it cannot make the distribution in that way, the depositary has a choice. After consultation with us to
the extent practicable, it may decide to sell what we distributed and distribute the net proceeds, in the same way as it does with cash. Or, it may
decide to hold what we distributed, in which case American Depositary Shares will also represent the newly distributed property. However, the
depositary is not required to distribute any securities (other than American Depositary Shares) to American Depositary Share holders unless it
receives satisfactory evidence from us that it is legal to make that distribution. The depositary may sell a portion of the distributed securities or
property sufficient to pay its fees and expenses in connection with that distribution.
The depositary is not responsible if it decides that it is unlawful or impractical to make a distribution available to any American Depositary Share
holders. We have no obligation to register American Depositary Shares, shares, rights or other securities under the Securities Act. We also have no
obligation to take any other action to permit the distribution of American Depositary Shares, shares, rights or anything else to American
Depositary Share holders. This means that you may not receive the distributions we make on our shares or any value for them if it is illegal or
impractical for us to make them available to you.
Deposit, Withdrawal and Cancellation
How are American Depositary Shares issued?
The depositary will deliver American Depositary Shares if you or your broker deposits shares or evidence of rights to receive shares with the custodian.
Upon payment of its fees and expenses and of any taxes or charges, such as stamp taxes or stock transfer taxes or fees, the depositary will register the
appropriate number of American Depositary Shares in the names you request and will deliver the American Depositary Shares to or upon the order of the
person or persons that made the deposit.
How can American Depositary Share holders withdraw the deposited securities?
You may surrender your American Depositary Shares at the depositary’s corporate trust office. Upon payment of its fees and expenses and of any taxes or
charges, such as stamp taxes or stock transfer taxes or fees, the depositary will deliver the shares and any other deposited securities underlying the
American Depositary Shares to the American Depositary Share holder or a person the American Depositary Share holder designates at the office of the
custodian. Or, at your request, risk and expense, the depositary will deliver the deposited securities at its corporate trust office, if feasible.
How do American Depositary Share holders interchange between certificated American Depositary Shares and uncertificated American Depositary
Shares?
You may surrender your American Depositary Receipt to the depositary for the purpose of exchanging your American Depositary Receipt for uncertificated
American Depositary Shares. The depositary will cancel that American Depositary Receipt and will send to the American Depositary Share holder a
statement confirming that the American Depositary Share holder is the registered holder of uncertificated American Depositary Shares. Alternatively, upon
receipt by the depositary of a proper instruction from a registered holder of uncertificated American Depositary Shares requesting the exchange of
uncertificated American Depositary Shares for certificated American Depositary Shares, the depositary will execute and deliver to the American Depositary
Share holder an American Depositary Receipt evidencing those American Depositary Shares.
Voting Rights
How do you vote?
American Depositary Share holders may instruct the depositary to vote the number of deposited shares their American Depositary Shares represent. The
depositary will notify American Depositary Share holders of shareholders’ meetings and arrange to deliver our proxy and voting materials to them if we
ask it to. Those materials will describe the matters to be voted on and explain how American Depositary Share holders may instruct the depositary how to
vote. For instructions to be valid, they must reach the depositary by a date set by the depositary. Otherwise, you won’t be able to exercise your right to vote
unless you withdraw the shares. However, you may not know about the meeting enough in advance to withdraw the shares.
The depositary will try, as far as practical, subject to the laws of Israel and of our articles of association or similar documents, to vote or to have its agents
vote the shares or other deposited securities as instructed by American Depositary Share holders. The depositary will only vote or attempt to vote as
instructed.
If the depositary solicited your voting instructions but does not receive instructions by the date specified, the depositary will consider you to have instructed
it to give a proxy to a person designated by us to vote the deposited shares, unless we notify the depositary that:
- we do not wish to receive a proxy;
- substantial opposition exists; or
- the matter would materially and adversely affect the rights of holders of our ordinary shares.
We cannot assure you that you will receive the voting materials in time to ensure that you can instruct the depositary to vote your shares. In addition, the
depositary and its agents are not responsible for failing to carry out voting instructions or for the manner of carrying out voting instructions. This means
that you
may not be able to exercise your right to vote and there may be nothing you can do if your shares are not voted as you requested.
In order to give you a reasonable opportunity to instruct the depositary as to the exercise of voting rights relating to deposited securities, if we request the
depositary to act, we agree to give the depositary notice of any such meeting and details concerning the matters to be voted upon at least 30 days in advance
of the meeting date.
Amendment and Termination
How may the deposit agreement be amended?
We may agree with the depositary to amend the deposit agreement and the American Depositary Receipts without your consent for any reason. If an
amendment adds or increases fees or charges, except for taxes and other governmental charges or expenses of the depositary for registration fees, facsimile
costs, delivery charges or similar items, or prejudices a substantial right of American Depositary Share holders, it will not become effective for outstanding
American Depositary Shares until 30 days after the depositary notifies American Depositary Share holders of the amendment. At the time an amendment
becomes effective, you are considered, by continuing to hold your American Depositary Shares, to agree to the amendment and to be bound by the
American Depositary Receipts and the deposit agreement as amended.
How may the deposit agreement be terminated?
The depositary will terminate the deposit agreement at our direction by mailing notice of termination to the American Depositary Share holders then
outstanding at least 30 days prior to the date fixed in such notice for such termination. The depositary may also terminate the deposit agreement by mailing
notice of termination to us and the American Depositary Share holders if 60 days have passed since the depositary told us it wants to resign but a successor
depositary has not been appointed and accepted its appointment.
After termination, the depositary and its agents will do the following under the deposit agreement but nothing else: collect distributions on the deposited
securities, sell rights and other property, and deliver shares and other deposited securities upon cancellation of American Depositary Shares. Four months
after termination, the depositary may sell any remaining deposited securities by public or private sale. After that, the depositary will hold the money it
received on the sale, as well as any other cash it is holding under the deposit agreement for the pro rata benefit of the American Depositary Share holders
that have not surrendered their American Depositary Shares. It will not invest the money and has no liability for interest. The depositary’s only obligations
will be to account for the money and other cash. After termination our only obligations will be to indemnify the depositary and to pay fees and expenses of
the depositary that we agreed to pay.
Limitations on Obligations and Liability
Limits on our Obligations and the Obligations of the Depositary; Limits on Liability to Holders of American Depositary Shares
The deposit agreement expressly limits our obligations and the obligations of the depositary. It also limits our liability and the liability of the depositary. We
and the depositary:
·
·
·
are only obligated to take the actions specifically set forth in the deposit agreement without negligence or bad faith;
are not liable if we are or it is prevented or delayed by law or circumstances beyond our control from performing our or its obligations under the
deposit agreement;
are not liable if we or it exercises discretion permitted under the deposit agreement;
·
·
are not liable for the inability of any holder of American Depositary Shares to benefit from any distribution on deposited securities that is not
made available to holders of American Depositary Shares under the terms of the deposit agreement, or for any special, consequential or punitive
damages for any breach of the terms of the deposit agreement;
have no obligation to become involved in a lawsuit or other proceeding related to the American Depositary Shares or the deposit agreement on
your behalf or on behalf of any other person; and
· may rely upon any documents we believe or it believes in good faith to be genuine and to have been signed or presented by the proper person.
In the deposit agreement, we and the depositary agree to indemnify each other under certain circumstances.
Requirements for Depositary Actions
Before the depositary will deliver or register a transfer of an American Depositary Share, make a distribution on an American Depositary Share, or permit
withdrawal of shares, the depositary may require:
·
·
·
payment of stock transfer or other taxes or other governmental charges and transfer or registration fees charged by third parties for the transfer of
any shares or other deposited securities;
satisfactory proof of the identity and genuineness of any signature or other information it deems necessary; and
compliance with regulations it may establish, from time to time, consistent with the deposit agreement, including presentation of transfer
documents.
The depositary may refuse to deliver American Depositary Shares or register transfers of American Depositary Shares generally when the transfer
books of the depositary or our transfer books are closed or at any time if the depositary or we think it advisable to do so.
Your Right to Receive the Shares Underlying your American Depositary Shares
American Depositary Share holders have the right to cancel their American Depositary Shares and withdraw the underlying shares at any time except:
·
·
·
when temporary delays arise because: (i) the depositary has closed its transfer books or we have closed our transfer books; (ii) the transfer of
shares is blocked to permit voting at a shareholders’ meeting; or (iii) we are paying a dividend on our shares;
when you owe money to pay fees, taxes and similar charges; or
when it is necessary to prohibit withdrawals in order to comply with any laws or governmental regulations that apply to American Depositary
Shares or to the withdrawal of shares or other deposited securities.
Securities Registers
The transfer agent and registrar for our ADSs is The Bank of New York Mellon, and its address is 101 Barclay Street, New York, NY.
Objects and Purposes
According to Section 4 of our articles of association, we shall engage in any legal business. Our number with the Israeli Registrar of Companies is 51-
389076-4.
Private Placements
Under the Israeli Companies Law, if (i) as a result of a private placement a person would become a controlling shareholder or (ii) a private placement will
entitle investors to receive 20% or more of the voting rights of a company as calculated before the private placement, and all or part of the private
placement consideration is not in cash or in public traded securities or is not in market terms and if as a result of the private placement the holdings of a
substantial shareholder will increase or as a result of it a person will become a substantial shareholder, then, in either case, the allotment must be approved
by the board of directors and by the shareholders of the company. A “substantial shareholder” is defined as a shareholder who holds five percent or more of
the company’s outstanding share capital, assuming the exercise of all of the securities convertible into shares held by that person. In order for the private
placement to be on “market terms” the board of directors has to determine, on the basis of detailed explanation, that the private placement is on market
terms, unless proven otherwise.
Board of Directors
Under our articles of association, resolutions by the board of directors are decided by a majority of votes of the directors present, or participating, in the
case of voting by media, and voting, each director having one vote.
In addition, the Israeli Companies Law requires that certain transactions, actions, and arrangements be approved as provided for in a company’s articles of
association and in certain circumstances by the compensation or audit committee and by the board of directors itself. Those transactions that require such
approval pursuant to a company’s articles of association must be approved by its board of directors. In certain circumstances, compensation or audit
committee and shareholder approval are also required. See “Item 6. Directors, Senior Management and Employees – C. Board Practices” in our annual
report on Form 20-F.
The Israeli Companies Law requires that a member of the board of directors or senior management of the company promptly and, in any event, not later
than the first board meeting at which the transaction is discussed, disclose any personal interest that he or she may have, either directly or by way of any
corporation in which he or she is, directly or indirectly, a 5% or greater shareholder, director or general manager or in which he or she has the right to
appoint at least one director or the general manager, as well as all related material information known to him or her, in connection with any existing or
proposed transaction by the company. In addition, if the transaction is an extraordinary transaction, (that is, a transaction other than in the ordinary course
of business, otherwise than on market terms, or is likely to have a material impact on the company’s profitability, assets or liabilities), the member of the
board of directors or senior management must also disclose any personal interest held by his or her spouse, siblings, parents, grandparents, descendants,
spouse’s descendants, siblings, and parents, and the spouses of any of the foregoing.
Once the member of the board of directors or senior management complies with the above disclosure requirement, a company may approve the transaction
in accordance with the provisions of its articles of association. Under the provisions of the Israeli Companies Law, whoever has a personal interest in a
matter, which is considered at a meeting of the board of directors or the audit committee, may not be present at this meeting or vote on this matter, unless it
is not an extraordinary transaction as defined in the Israeli Companies Law. However, if the chairman of the board of directors or the chairman of the audit
committee has determined that the presence of a director or an officer with a personal interest is required for the presentation of a matter, such officer
holder may be present at the meeting. Notwithstanding the foregoing, if the majority of the directors have a personal interest in a matter, they will be
allowed to participate and vote on this matter, but an approval of the transaction by the shareholders in the general meeting will be required.
Our articles of association provide that, subject to the Israeli Companies Law, all actions executed in good faith by the board of directors or by a committee
thereof or by any person acting as a director or a member of a committee of the board of directors, will be deemed to be valid even if, after their execution,
it is discovered that there was a flaw in the appointment of these persons or that any one of these persons was disqualified from serving in his or her office.
Our articles of association provide that, subject to the provisions of the Israeli Companies Law, the board of directors may appoint board of directors’
committees. The committees of the board of directors report to the board of directors their resolutions or recommendations on a regular basis, as prescribed
by the board of directors. The board of directors may cancel the resolution of a committee that has been appointed by it; however, such cancellation will not
affect the validity of any resolution of a committee, pursuant to which we acted, vis-à-vis another person, who was not aware of the cancellation thereof.
Decisions or recommendations of the committee of the board which require the approval of the board of directors will be brought to the directors’ attention
a reasonable time prior to the discussion at the board of directors.
According to the Israeli Companies Law, a contract of a company with its directors, regarding their conditions of service, including the grant to them of
exemption from liability from certain actions, insurance, and indemnification as well as the company’s contract with its directors on conditions of their
employment, in other capacities, require the approval of the compensation committee, the board of directors, and the shareholders by a Special Majority.
According to Israeli Companies Law, the board of directors may direct the chief executive officer how to act in a specific matter, and if the chief executive
officer does not so act, the board of directors is authorized to act in his/her stead.
According to our articles of association, subject to the provisions of the Israeli Companies Law, the board of directors is entitled at any time to grant a
power of attorney to any person to legally represent the Company for such purposes and with such authorities and discretion and for such period of time
and subject to such terms and all as the board of directors shall deem fit. The board of directors will be entitled to grant to such person, inter alia, authorities
to transfer to some other, fully or partially, the authorities and powers and discretion granted to him.
According to the Israeli Companies Law and our articles of association, the board of directors is entitled to transfer its authorities, to a board of directors
committee and/or an officer in the Company, whether for the purpose of a certain general meeting or for a period of time.
According to the Israeli Companies Law, an authority not granted under the law or the articles of association of a company to another, may be operated by
its board of directors.
Description of Securities
Ordinary Shares
Our authorized share capital currently consists of 120,000,000 Ordinary Shares, par value NIS 0.04 per share. As of December 31, 2021, there were
32,911,134 Ordinary Shares issued and outstanding.
All of our outstanding Ordinary Shares are and will be validly issued, fully paid and non-assessable. Our Ordinary Shares are not redeemable and do not
have any preemptive rights.
As of December 31, 2021, there were outstanding options to purchase an aggregate of 1,552,383 Ordinary Shares, with a weighted-average exercise price
of $4.62 per Ordinary Share. In addition, there are an additional 1,590,887 Ordinary Shares reserved for future issuance of equity under our Share Incentive
Plan. As of December 31, 2021, there were 559,530 outstanding RSUs.
Transfer of Shares. Fully paid Ordinary Shares are issued in registered form and may be freely transferred pursuant to our articles of association unless that
transfer is restricted or prohibited by another instrument. There are no Israeli law and regulations that impose limitations on the rights to own securities,
including the rights of non-resident or foreign shareholders to hold or exercise voting rights on the securities imposed by foreign law or by the charter or
other constituent document of the Company.
Shareholders Meetings. Under Israeli law, we are required to hold an annual general meeting of our shareholders once every calendar year that must be
held no later than 15 months after the date of the previous annual general meeting. All general meetings other than the annual meeting of shareholders are
referred to in our articles of association as special meetings. In accordance with our articles of association and the Israeli Companies Law, our board of
directors may call special meetings whenever it sees fit, at such time and place, within or outside of Israel, as it may determine. In addition, the Israeli
Companies Law provides that our board of directors is required to convene a special meeting upon the written request of (i) any two of our directors or one-
quarter of the members of our board of directors or (ii) one or more shareholders holding, in the aggregate, either (a) 5% or more of our outstanding issued
shares and 1% or more of our outstanding voting power or (b) 5% or more of our outstanding voting power. This is different from the Delaware General
Corporation Law, or the DGCL, which allows such right of shareholders to be denied by a provision in a company’s certificate of incorporation.
Under Israeli law, one or more shareholders holding at least 1% of the voting rights at the general meeting may request that the board of directors include a
matter in the agenda of a general meeting to be convened in the future, provided that it is appropriate to discuss such a matter at the general meeting.
Subject to the provisions of the Israeli Companies Law and the regulations promulgated thereunder, shareholders entitled to participate and vote at general
meetings are the shareholders of record on a date to be decided by the board of directors, which may be between four and forty days prior to the date of the
meeting. Furthermore, the Israeli Companies Law requires, inter alia, that resolutions regarding the following matters must be passed at a general meeting
of our shareholders:
● amendments to our articles of association;
● appointment or termination of our auditors;
● appointment of external directors (if applicable);
● approval of certain related party transactions;
● increases or reductions of our authorized share capital;
● mergers; and
● the exercise of our board of director’s powers by a general meeting, if our board of directors is unable to exercise its powers and the exercise of
any of its powers is required for our proper management.
The Company shall give notice of a general meeting only to the shareholders registered in the registry, whose address is in Israel. Our articles of
association, in accordance with the provisions of the Israeli Companies Law requires that a notice of any annual general meeting or special general meeting
be provided to shareholders at least 14 days prior to the meeting and if the agenda of the meeting includes the appointment or removal of directors, the
approval of transactions with office holders or interested or related parties, or an approval of a merger, or as otherwise required under applicable law, notice
must be provided at least 35 days prior to the meeting. Under the Israeli Companies Law, shareholders are not permitted to take action by written consent in
lieu of a meeting.
Election of Directors. Our Ordinary Shares do not have cumulative voting rights for the election of directors. As a result, the holders of a majority of the
voting power represented at a shareholders meeting have the power to elect all of our directors. Under our articles of association, our board of directors
must consist of not less than four (4) but no more than seven (7) directors, not including any external directors required to be appointed by the Israel
Companies Law and not including up to two (2) additional directors who may be appointed by our board of directors whose term of office would expire on
the next following annual meeting of shareholders after their appointment, provided that they may be reappointed by the Board of Directors
for one additional term of office. Each appointed director, other than external directors, if any, shall serve as a member of the Board of Directors until the
next annual general meeting. The term of a director shall terminate at the next annual general meeting, unless extended by that annual general meeting, or
terminated by the general meeting. Pursuant to our articles of association, the vote required to appoint a director is a simple majority vote of holders of our
voting shares participating and voting at the relevant meeting. For a more detailed description on the composition of our board of election procedures of our
directors, see “Item 6. Directors, Senior Management and Employees – C. Board Practices – Appointment of Directors and Terms of Office” in our annual
report on Form 20-F.
Dividend and Liquidation Rights. Our profits, in respect of which a resolution was passed to distribute them as a dividend or bonus shares, are to be paid
pro rata to the amount paid or credited as paid on account of the nominal value of shares held by the shareholders. In the event of our liquidation, the
liquidator may, with the general meeting’s approval, distribute parts of our property in specie pro rata to the amount paid or credited as paid on account of
the nominal value of shares held by the shareholders and he may, with similar approval, deposit any part of our property with trustees in favor of the
shareholders as the liquidator, with the approval mentioned above deems fit.
Voting, Shareholders’ Meetings, and Resolutions. Our articles of association provide that all resolutions of our shareholders require a simple majority vote,
unless otherwise required by the Israeli Companies Law. The Ordinary Shares all have equal voting rights.
Our articles of association provide that the following would require approval of at least 662/3% of the total voting power voted at a general meeting of
shareholders: (i) dismissing a director before the end of his or her term in office, and (ii) amending provisions in our articles of association relating to the
size of our board of directors, the right of our board of directors to elect new directors provided that the number of directors is less than the maximum
number of directors the right of a shareholder to recommend a board nominee for consideration by Company shareholders, the special majority required to
dismiss a director before the end of his or her term in office, the conditions under which the term of office of a director is terminated and the ability of the
board of directors to function until the next general meeting so long as the number of members of our board of directors is not less than the minimum
number of directors required under our articles of association.
Under the Israeli Companies Law, each of (i) the approval of an extraordinary transaction with a controlling shareholder, and (ii) the terms of employment
or other engagement of the controlling shareholder of the company or such controlling shareholder’s relative (even if not extraordinary) requires the
approval described above under “Management—Fiduciary Duties and Approval of Specified Related Party Transactions and Compensation under Israeli
Law—Disclosure of Personal Interests of a Controlling Shareholder and Approval of Transactions.” Certain transactions with respect to remuneration of
our office holders and directors require further approvals described above under “Management—Fiduciary Duties and Approval of Specified Related Party
Transactions and Compensation under Israeli Law—Compensation of Directors and Senior management.” Under our articles of association, any change to
the rights and privileges of the holders of any class of our shares requires a simple majority of the class so affected. Another exception to the simple
majority vote requirement is a resolution for the voluntary winding up, or an approval of a scheme of arrangement or reorganization, of the company
pursuant to Section 350 of the Israeli Companies Law, which requires the approval of holders of 75% of the voting rights represented at the meeting, in
person, by proxy or by voting deed and voting on the resolution.
Allotment of Shares. Our board of directors has the power to allot or to issue shares to any person, with restrictions and condition as it deems fit.
Acquisitions under Israeli Law
Full Tender Offer
A person wishing to acquire shares of an Israeli public company and who would as a result hold over 90% of the target company’s issued and outstanding
share capital is required by the Israeli Companies Law to make a tender offer to all of the company’s shareholders for the purchase of all of the issued and
outstanding shares of the company.
A person wishing to acquire shares of an Israeli public company and who would as a result hold over 90% of the issued and outstanding share capital of a
certain class of shares is required to make a tender offer to all of the shareholders who hold shares of the same class for the purchase of all of the issued and
outstanding shares of the same class.
If the shareholders who do not respond to or accept the offer hold less than 5% of the issued and outstanding share capital of the company or of the
applicable class of the shares, and more than half of the shareholders who do not have a personal interest in the offer accept the offer, all of the shares that
the acquirer offered to purchase will be transferred to the acquirer by operation of law. However, a tender offer will be accepted if the shareholders who do
not accept it hold less than 2% of the issued and outstanding share capital of the company or of the applicable class of the shares.
Upon a successful completion of such a full tender offer, any shareholder that was an offeree in such tender offer, whether such shareholder accepted the
tender offer or not, may, within six months from the date of acceptance of the tender offer, petition the Israeli court to determine whether the tender offer
was for less than fair value, and that the fair value should be paid as determined by the court. However, under certain conditions, the offeror may determine
in the terms of the tender offer that an offeree who accepted the offer will not be entitled to petition the Israeli court as described above.
If the shareholders who did not respond or accept the tender offer hold at least 5% of the issued and outstanding share capital of the company or of the
applicable class, the acquirer may not acquire shares of the company that will increase its holdings to more than 90% of the company’s issued and
outstanding share capital or of the applicable class from shareholders who accepted the tender offer.
The description above regarding a full tender offer will also apply, with necessary changes, when a full tender offer is accepted, and the offeror has also
offered to acquire all of the company’s securities.
Special Tender Offer
The Israeli Companies Law provides that an acquisition of shares of an Israeli public company must be made by means of a special tender offer if as a
result of the acquisition the purchaser would become a holder of at least 25% of the voting rights in the company. This rule does not apply if there is
already another holder of at least 25% of the voting rights in the company.
Similarly, the Israeli Companies Law provides that an acquisition of shares of a public company must be made by means of a special tender offer if as a
result of the acquisition the purchaser would become a holder of more than 45% of the voting rights in the company, if there is no other shareholder of the
company who holds more than 45% of the voting rights in the company.
These requirements do not apply if the acquisition (i) occurs in the context of a private offering, on the condition that the shareholders meeting approved
the acquisition as a private offering whose purpose is to give the acquirer at least 25% of the voting rights in the company if there is no person who holds at
least 25% of the voting rights in the company, or as a private offering whose purpose is to give the acquirer 45% of the voting rights in the company, if
there is no person who holds 45% of the voting rights in the company; (ii) was from a shareholder holding at least 25% of the voting rights in the company,
and resulted in the acquirer becoming a holder of at least 25% of the voting rights in the company; or (iii) was from a holder of more than 45% of the
voting rights in the company and resulted in the acquirer becoming a holder of more than 45% of the voting rights in the company.
The special tender offer may be consummated only if (i) at least 5% of the voting power attached to the company’s outstanding shares will be acquired by
the offeror, and (ii) the special tender offer is accepted by a majority of the votes of those offerees who gave notice of their position in respect of the offer;
in counting the votes of offerees, the votes of a holder in control of the offeror, a person who has personal interest in acceptance of the special tender offer,
a holder of at least 25% of the voting rights in the company, or any person acting on their or on the offeror’s behalf, including their relatives or companies
under their control, are not taken into account.
In the event that a special tender offer is made, a company’s board of directors is required to express its opinion on the advisability of the offer or must
abstain from expressing any opinion if it is unable to do so, provided that it gives the reasons for its abstention.
An officer in a target company who, in his or her capacity as an officer, performs an action the purpose of which is to cause the failure of an existing or
foreseeable special tender offer or is to impair the chances of its acceptance, is liable to the potential purchaser and shareholders for damages resulting from
his acts, unless such officer acted in good faith, and had reasonable grounds to believe he or she was acting for the benefit of the company. However,
officers of the target company may negotiate with the potential purchaser in order to improve the terms of the special tender offer, and may further
negotiate with third parties in order to obtain a competing offer.
If a special tender offer was accepted by a majority of the shareholders who announced their stand on such offer, then shareholders who did not respond to
the special offer or had objected to the special tender offer may accept the offer within four days of the last day set for the acceptance of the offer. In the
event that a special tender offer is accepted, then the purchaser or any person or entity controlling it and any corporation controlled by them must refrain
from making a subsequent tender offer for the purchase of shares of the target company and may not execute a merger with the target company for a period
of one year from the date of the offer, unless the purchaser or such person or entity undertook to effect such an offer or merger in the initial special tender
offer.
Merger
The Israeli Companies Law permits merger transactions if approved by each party’s board of directors and, unless certain requirements described under the
Israeli Companies Law are met, a majority of each party’s shareholders, by a majority of each party’s shares that are voted on the proposed merger at a
shareholders’ meeting.
The board of directors of a merging company is required pursuant to the Israeli Companies Law to discuss and determine whether in its opinion there exists
a reasonable concern that, as a result of a proposed merger, the surviving company will not be able to satisfy its obligations towards its creditors, taking into
account the financial condition of the merging companies. If the board of directors has determined that such a concern exists, it may not approve a
proposed merger. Following the approval of the board of directors of each of the merging companies, the boards of directors must jointly prepare a merger
proposal for submission to the Israeli Registrar of Companies.
For purposes of the shareholder vote, unless a court rules otherwise, the merger will not be deemed approved if a majority of the shares voting at the
shareholders meeting (excluding abstentions) that are held by parties other than the other party to the merger, any person who holds 25% or more of the
means of control (See “Management – Audit Committee – Approval of Transactions with Related Parties” in our annual report on Form 20-F for a
definition of means of control) of the other party to the merger or anyone on their behalf including their relatives (See “Management – External Directors –
Qualifications of External Directors” in our annual report on Form 20-F for a definition of relatives) or corporations controlled by any of them, vote against
the merger.
In addition, if the non-surviving entity of the merger has more than one class of shares, the merger must be approved by each class of shareholders. If the
transaction would have been approved but for the separate approval of each class of shares or the exclusion of the votes of certain shareholders as provided
above, a court may still rule that the company has approved the merger upon the request of holders of at least 25% of the voting rights of a company, if the
court holds that the merger is fair and reasonable, taking into account the appraisal of the merging companies’ value and the consideration offered to the
shareholders.
Under the Israeli Companies Law, each merging company must send a copy of the proposed merger plan to its secured creditors. Unsecured creditors are
entitled to receive notice of the merger, as provided by the regulations promulgated under the Israeli Companies Law. Upon the request of a creditor of
either party to the proposed merger, the court may delay or prevent the merger if it concludes that there exists a reasonable concern that, as a result of the
merger, the surviving company will be unable to satisfy the obligations of the target company. The court may also give instructions in order to secure the
rights of creditors.
In addition, a merger may not be completed unless at least 50 days have passed from the date that a proposal for approval of the merger was filed with the
Israeli Registrar of Companies and 30 days from the date that shareholder approval of both merging companies was obtained.
Anti-takeover Measures
The Israeli Companies Law allows us to create and issue shares having rights different from those attached to our Ordinary Shares, including shares
providing certain preferred or additional rights to voting, distributions or other matters and shares having preemptive rights. We do not have any authorized
or issued shares other than Ordinary Shares. In the future, if we do create and issue a class of shares other than Ordinary Shares, such class of shares,
depending on the specific rights that may be attached to them, may delay or prevent a takeover or otherwise prevent our shareholders from realizing a
potential premium over the market value of their Ordinary Shares. The authorization of a new class of shares will require an amendment to our articles of
association which requires the prior approval of a majority of our shares represented and voting at a general meeting. Shareholders voting at such a
meeting will be subject to the restrictions under the Israeli Companies Law described above in “– Voting, Shareholders’ Meetings, and Resolutions.”
Exhibit 4.3
BrainsWay Ltd.
(The "Company")
Compensation Policy
(the “Policy” or “Compensation Policy”)
As adopted by the Company's Shareholders on December 22, 2021.
- The Company's board of directors;
- The Company's compensation committee;
- BrainsWay Ltd.;
- The Companies Law, 1999, Israel;
- The members of the Board of the Company;
- The Securities Law, 1968, Israel;
- As defined under Section 1 of the Securities Law.
- Bonus, payment, compensation or any other benefit awarded to an officer with regard to conclusion
of their office with the Company;
- As defined in the Companies Law, excluding the Directors;
- Amended and Restated 2019 Share Incentive Plan, as it may be amended from time to time, or such
other equity incentive plan, including an employee stock purchase plan, adopted by the Company
from time to time;
- A fixed amount paid by the Company to its Officers in return for work performed. Base salary does
not include benefits, bonuses or any other potential compensation;
- Cost to the employing entity.
1. Definitions
“Board”
"Committee"
"Company"
"Companies Law"
"Director"
"Securities Law"
"Subsidiaries"
"Retirement Bonus"
"Officer"
"Stock Option Plan"
“Base Salary”
"Cost"
2. Overview
2.1. General
2.1.1. The Compensation Policy considers, inter alia, the Company's risk management parameters, size and nature of its operations and, with
regard to terms of office and employment which include variable components, the Officer's long-term contribution to achieving the
Company's objectives and to maximizing shareholders value, taking into account the scope and reach of the Officer's role.
2.1.2. The Compensation Policy was prepared with due consideration to the nature of the Company’s operations in the life-sciences sector,
territories where the Company operates, market capitalization on the applicable stock exchange or trading platforms on which the
Company's ordinary shares and American Depository Shares (“ADS”) are then listed or traded, as well as other criteria. The compensation
amounts and ratios are generally based on a survey conducted by Compvision Ltd. for the Company, which refers to the different
positions, both Israeli and international comparison group and reflect a market benchmark for the Company.
2.1.3. The compensation principles, targets and benchmarks are derived, inter alia, form the Company's annual work plan and from long-term
plans as determined by the Board from time to time.
1
2.1.4. For the avoidance of doubt, it is clarified that in case of any amendment made to provisions of the Companies Law and any other relevant
rules and regulations in a manner that will facilitate the Company with respect to its action with regard to Officer compensation, the
Company may be entitled to follow these provisions even if they contradict the principles of this Policy.
2.2. Overall Compensation - Ratio Between Fixed and Variable Compensation
2.2.1. This Policy aims to balance the mix of "fixed compensation", comprised of Base Salary and benefits (“Fixed Compensation") and
"variable compensation", comprised of cash bonuses and equity-based compensation (“Variable Compensation") in order to, among other
things, appropriately incentivize Officers and Directors to meet BrainsWay's short and long term goals while taking into consideration the
Company’s need to manage a variety of business risks.
2.2.2. The total Variable Compensation of each Officer shall not exceed 85% of the total compensation package of such an Officer on an annual
basis. The Board believes that such range expresses the appropriate compensation mix in the event that all performance objectives are
achieved and assumes that all compensation elements are granted with respect to a given year.
2.2.3.
It should be clarified, that the Fixed Compensation may constitute 100% of the total compensation package for an Officer in any year
(under circumstances in which a variable component will not be approved for that year and/or in the event of a failure to meet the set
goals, if and when determined).
2.3. Intra-Company Compensation Ratio
In the process of drafting this Policy, BrainsWay’s Board has examined the ratio between employer cost, as such term is defined in the Companies
Law, associated with the engagement of the Officers (the “Officers Cost") and the average and median employer cost associated with the
engagement of the other employees of BrainsWay (the “Other Employees Cost" and the “Ratio", respectively). The Board believes that the current
Ratio does not adversely impact the work environment in BrainsWay. The following are the ratios as of the date of the approval of this
Compensation Policy:
Position
CEO
Other Officers
Directors
Ratio to average Other Employees Cost
12.13
3.21
5.73
Ratio to the median Other Employees Cost
14.62
3.34
8.77
2.4. Compensation Components
Compensation components will include each of the following
a. Base Salary;
b. Benefits;
c. Cash bonuses;
d. Equity based compensation;
e. Retirement and termination; and
f.
Exemption, Indemnification and Insurance.
2.5. Compensation Currency
While the Company's employment agreements and/or consulting agreements may be in NIS, USD or any other currency, the Company's
compensation costs (including salaries, benefits and consulting) are reported in the Company's financial statements in USD. Thus, all
compensation components are presented in this policy in USD. Conversion from USD to the relevant currency for the purposes of complying with
this Policy shall be made when determining and approving a specific compensation component.
2
2.6. Interpretation
The language of this Compensation Policy uses the male pronoun only as a measure of comfort. This Policy applies to both male and female
Officers.
3. Officers' areas of responsibility, education and experience
The compensation package to the Officers and Directors is individually determined by the Committee and the Board (unless other approvals are
required under any applicable law) according to the educational background, prior vocational experience, qualifications, role, business responsibilities,
past performance and previous compensation arrangements of such Officer.
4. Base Salary
4.1. Position: Company CEO
The annual Base Salary for the Company CEO shall be up to USD $550,000 for a full-time position.1
4.2. Position: Officers (other than CEO)
The annual Base Salary for each Officer (other than CEO) shall not exceed an amount of US $425,0002.
4.3. Position: Directors
4.3.1. Chairman of the Board (the “Chairman”)
The monthly remuneration of the chairman of the Board of Directors in the Company shall not exceed an annual cash fee retainer of US
$280,000 (for full-time position). The monthly wage shall be reduced in a linear manner in the case of a reduction in the scope of the
position.
4.3.2. Other Directors
4.3.2.1. All BrainsWay's Board members, excluding the chairman of the Board, may be entitled to an annual cash fee retainer of up to
USD $50,000, BrainsWay committee membership annual cash fee retainer of up to USD $15,000, and committee chairperson
annual cash fee retainer of up to USD $20,000 (not to be paid both as committee member and chairperson).
4.3.2.2. In addition to the above, to the extent a Director is tasked to assist the Company's management on special and strategic projects or
matters requiring specialized expertise and/or significant additional time beyond the scope expected within a Director’s regular
responsibilities, such Director shall be entitled to a monthly amount of up to US $15,000 for each full month in which the Director
assisted with said project/matter.
4.3.3.
In spite of the above, the compensation of the Company’s external directors, if any, shall be in accordance with the Companies
Regulations (Rules Regarding the Compensation and Expenses of an External Director), 5760-2000, as amended by the
Companies Regulations (Relief for Public Companies Traded in Stock Exchange Outside of Israel), 5760-2000, as such
regulations may be amended from time to time.
1 This amount is not intended as a reflection of current market value for the indicated role; rather it is expressed as an upper limit to ensure appropriate
flexibility, including such as required to meet future needs of the Company.
2 This amount is not intended as a reflection of current market value for the indicated role; rather it is expressed as an upper limit to ensure appropriate
flexibility, including such as required to meet future needs of the Company.
3
4.3.4.
It is hereby clarified that the compensation (and limitations) stated under Section 4.3.2.1 will not apply to directors who serve as Officers
or consultants of the Company, and in such case the compensation shall be on the terms agreed upon between such director with the
Company and duly approved under applicable law.
4.4. Officers Benefits
4.4.1. The following benefits may be granted to Officers in order, among other things, to comply with legal requirements:
·
·
·
·
·
·
Vacation days in accordance with market practice and applicable law, including redemption thereof;
Sick days in accordance with market practice and applicable law;
Convalescence pay according to applicable law;
Monthly remuneration for a study fund, as allowed by applicable law and with reference to the Company's practice and common
market practice;
Contribution by the Company on behalf of the Officer to an insurance policy or a pension fund, as allowed by applicable law and
with reference to the Company's policies and procedures and common market practice; and
Contribution by the Company on behalf of the Officer towards work disability insurance, as allowed by applicable law and with
reference to the Company's policies and procedures and common market practice.
4.4.2. The Company may offer additional benefits to the Officers, including but not limited to: communication, company car and travel benefits,
insurances, other benefits (such as newspaper subscriptions, academic and professional studies, etc.) including their gross up.
4.5. Expenses Reimbursement
The Company CEO and all other Officers and Directors will be entitled to reimbursement of reasonable per diem (“ל"שא”) expenses incurred in
the course of discharging its office, including expenses with respect to attending meetings, travel and entertainment expenses, against provision of
receipts, Director declaration, and/or such other reasonable documentation as may be requested. The Company may pay such expenses by credit
card. Expense reimbursement for overseas travel will be in conformity with the Company's policy.
4.6. Non-Material Change
A change in the fixed compensation of the CEO, which was approved by the Committee and the Board, shall be considered to be non-material
according to section 272(d) so long as it does not exceed 10% of the fixed compensation, and all within the framework of the Policy.
According to section 1B3 to the Companies Regulations (Relief in Transactions with Related Parties), 2000, non-material changes in the terms of
employment of an officer who is subject to the CEO, will not require Committee approval, as stated in section 272(d) to the Companies Law. For
these purposes, a change shall be considered to be non-material so long as the change in the compensation does not exceed 10% of the fixed
compensation and has been approved by the CEO, and all within the framework of the Policy.
5. Cash Bonuses
5.1. Company-Wide Threshold Conditions for Annual Target Bonus Payment
4
The following cumulative conditions (the “Company-Wide Threshold Conditions”) must be fulfilled by the Company in order for Officers to
qualify for an Annual Target Bonus in any given year:
5.1.1. Adherence to at least 80% of the parameters of the Bonus Goals (as defined below); and
5.1.2. The Company does not have negative cash flow or other circumstances which would endanger its ability to meet its liabilities over the
course of the following 18 months (after payment of the proposed bonuses.)
5.2. Annual Target Bonus
5.2.1. Allocation Criteria. The Company may award (subject to the approvals of the Committee and the Board) an annual bonus to its Officers
due to their contribution to the Company. The annual bonus to the Company’s Officers (the “Annual Target Bonus”) shall be determined
substantially based on measurable criteria, and with respect to its less significant part may be determined at the discretion of the
Committee and the Board, in accordance with the following breakdown:
Position
CEO
Other Officers
Company/Individual Performance Measures
75%-100%
75%-100%
Company’s Discretion
0%-25%
0%-25%
5.2.2. The measurable criteria and their relative weight shall be determined by the Committee and the Board in respect of each calendar year.
These measurable criteria will be based on, inter alia, the Company’s financial results, the scope of the Company’s business activity, the
CEO’s opinion on the contribution of the Officer to the Company, the distribution of the annual bonus over the year, objectives relating to
compliance with the Company’s work plans and with various budget objectives, including, inter alia, compliance with objectives relating
to revenues, expenses, investments, etc., meeting various financial objectives, such as objectives relating to the annual profit (net profit,
pre-tax profit, etc.) and the Company’s EBITDA, objectives relating to the recruitment and development of professional personnel,
objectives relating to raising investments, debt, etc., objectives relating to the Company’s business operations and the Company’s
operations as a company traded on NASDAQ, objectives relating to the realization of the Company’s assets, the acquisition of new
activities and/or companies and objectives relating to an increase of the return on the Company’s assets (the “Bonus Goals”).
5.2.3. Maximum Amount. The maximum amount for the Annual Target Bonus that may be paid in any fiscal year shall not exceed six (6)
monthly Base Salaries (equivalent to 50% of the Base Salary on an annualized basis) to the CEO, and five (5) monthly Base Salaries
(equivalent to 41.66% of the Base Salary on an annualized basis) to any other Officer.
5.2.4. Minimum Personal Achievement Threshold for Annual Target Bonus. In addition to satisfaction by the Company of the above-mentioned
Company-Wide Threshold Conditions, in order for an individual Officer to qualify for any portion of the Annual Target Bonus in any
given year, the Officer must have achieved at least 50% of the bonus criteria that have been specified for such Officer by the Company in
such year.
5.2.5. Overachievement Bonus. In the event of overachievement (satisfaction of over 100%) of the bonus criteria by an Officer or CEO that have
been specified for such Officer by the Company in a given year, the Company may pay out an additional amount of up to four (4) monthly
Base Salaries (equivalent to 33.33% of the Base Salary on an annualized basis) to the CEO, and an additional amount of up to three (3)
monthly Base Salaries (equivalent to 25% of the Base Salary on an annualized basis) to any other Officer (the “Overachievement
Bonus”).
5.3. Special Bonus
5
5.3.1.
In addition to the Annual Target Bonus and the Overachievement Bonus , the Company (subject to the approvals of the Committee and the
Board)) shall have the authority to grant Officers, on a per event basis, a special bonus (a “Special Bonus”) as an award for the following:
(i) special contribution (outstanding personal achievement, outstanding personal effort, and/or outstanding Company performance, such as
related to mergers and acquisitions, offerings, or special recognition in case of retirement); (ii) relocation overseas (i.e. conditioned upon
continued employment with the Company, the Company may reimburse an Officer for his or her actual reasonable relocation expenses
when relocating to another country or state, and upon return), and/or; (iii) talent attraction purposes (e.g such as for a “hiring,” “sign-on”
or “inducement” bonus), all at the full discretion of the Committee and the Board (and with respect to the CEO, also the Company’s
general meeting of shareholders, as required).
5.3.2. Maximum Special Bonus Amount. The maximum amount for the Special Bonus that may be paid an in any fiscal year shall not exceed six
(6) monthly Base Salaries (equivalent to 50% of the Base Salary on an annualized basis) to the CEO, and five (5) monthly Base Salaries
(equivalent to 41.66% of the Base Salary on an annualized basis) to any other Officer.
5.3.3. Maximum Payout Cap. The aggregate amount of any Special Bonus, the Annual Target Bonus and the Overachievement Bonus awarded
to each Officer on an annualized basis[3], as calculated at grant date, shall not exceed 200% of Base Salary on an annual basis of such
Officer, as the case may be (the “Maximum Aggregate Cap”).
5.3.4. Form of Consideration. Any bonuses allowed under this policy may be paid out in any form of consideration that the Company deems
appropriate.
5.4. Bonus upon Termination during a Fiscal Year
Except in the event of termination for cause as that term as defined in the Company’s policies, procedures and/or agreements, should the
Company terminate the employment or service of an Officer prior to the end of a fiscal year, the Company may, but is not obligated to, pay the
Officer the pro rata share of that fiscal year’s annual bonus, based on the period such Officer was employed by the Company or has served in the
Company, and based on the Officer’s satisfaction of the applicable performance metrics.
5.5. Compensation Recovery (“Clawback”):
5.5.1.
In the event of an accounting restatement, the Company shall be entitled to recover from its Officers the bonus compensation in the
amount in which such bonus exceeded what would have been paid under the financial statements, as restated, provided that a claim is
made by the Company prior to the third anniversary of fiscal year end of the restated financial statements.
5.5.2. Notwithstanding the aforesaid, subject to compliance with applicable law, the compensation recovery will not be triggered in the
following events:
·
·
·
The financial restatement is required due to changes in the applicable financial reporting standards; or
The Committee has determined that Clawback proceedings in the specific case would be impossible, impractical or not
commercially or legally efficient; or
The amount to be paid under the Clawback proceedings is less than 10% of the relevant bonus received by the Officer.
3 Taking into consideration the vesting period of any grant.
6
5.5.3. Nothing in this Section limits the Company’s obligation to comply with any “Clawback” or similar provisions regarding disgorging of
profits imposed on Officers by virtue of applicable securities laws.
5.6. Committee and Board Discretion
The Company's Committee and Board may reduce the bonus awarded to an Officer at their discretion, including under the following
circumstances: material deterioration of the Company's position or such material deterioration anticipated by the Board, deterioration in the state
of the economy, deterioration in the performance of the Officer or inappropriate conduct by the Officer.
6. Equity-Based Compensation
6.1. The Committee and the Board shall review from time to time the overall equity-based grant for all Officers. When doing so, the Committee and
the Board shall take into consideration: (1) each Officer's (including Board members) contribution to the Company including expected
contribution; and (2) creating an effective long-term incentive to harness and motivate Officers.
6.2. The equity-based compensation offered by the Company may be in the form of share options, restricted shares and/or other equity-based awards,
such as RSUs, in accordance with the then-current Stock Option Plan.
6.3. Subject to any applicable law and at the Committee and the Board’s discretion, as applicable, the Company may determine the tax regime under
which equity-based compensation may be granted, including a tax regime which will maximize the benefit to the Officers.
6.4. The fair market value of equity-based compensation awarded to each Officer on an annual basis[4], as calculated at grant date, shall not exceed
200% of Base Salary on an annual basis of such Officer, as the case may be. Such quantity shall not include the annual implication of prior equity
allocations made in previous years.
6.5. The fair market value of equity-based compensation awarded to each non-management director (including the chairman) in a given year[5], as
calculated at grant date, shall not exceed 400% of the annual cash fee retainer of such director, as the case may be. Such quantity shall not include
the annual implication of prior equity allocations made in previous years.
6.6. In the case of a grant of options, the exercise price for each option shall be determined based on the closing price of the Company’s ADSs[6] on
the NASDAQ exchange on the day prior to the approval by the Board (or if authorized, the Committee), or by the shareholders meeting (if
required).
6.7. All equity-based incentives granted to Officers and Directors shall be subject to vesting periods in order to promote long-term retention of such
recipients. Generally, grants of equity under ordinary circumstances shall vest over a period of four (4) years, starting on the Officer or director's
grant date, as follows: (i) Twenty-five percent (25%) of the Options shall vest on the first year anniversary of the Vesting Commencement Date;
and (ii) The remainder portion of the Options shall vest in equal quarterly installments at the end of each quarter over the following thirty-six (36)
months, such that all the Options shall be fully vested on the four (4) year anniversary of the Vesting Commencement Date.
6.8. In extraordinary circumstances, equity grants to Officers (excluding Directors) may be subject to vesting period equal to shorter vesting periods of
at least two (2) years. Grants to directors shall vest over a period of at least one (1) year. Such grants may be vested on a quarterly, semi-annual or
an annual basis, or based on other time periods (which may not be necessarily equal), as determined by the Company (subject to the approvals of
the Committee and the Board, and with respect to the Company's directors and CEO- also the Company's general meeting of shareholders). The
Company (subject to the abovementioned required approvals) may, but is not required to, condition the vesting of part or all of the equity-based
incentives, for some or all of its Officers, upon the achievement of predetermined performance goals. The Company (subject to the
abovementioned required approvals) may also set terms relating to vesting in connection with an Officer leaving the Company (due to a dismissal,
resignation, death, or disability). All other terms of the equity awards shall be in accordance with the Stock Option Plan and other related practices
and policies.
4
5
6
Taking into consideration the vesting period of any grant.
Taking into consideration the vesting period of any grant.
As of the date of the drafting of this policy, one (1) ADS is equivalent to two (2) ordinary shares of the Company. Thus, for example, assuming this
ratio remains in place, a grant of options to purchase 1,000 ordinary shares would be subject to an exercise price of half the closing ADS price on the
NASDAQ exchange on the day prior to the required approval.
7
7. Retirement and Termination
7.1. Severance pay: in the case of termination (other than termination of an Officer for cause), the Officer will be eligible to receive severance pay in
accordance with any applicable law.
7.2. Notice period:
7.2.1. The Company may give an Officer a notice period of up to three (3) months, provided that the termination of employment of such officer
happened without cause.
7.2.2. The Company may waive the Officer's services to the Company during the notice period or any part thereto and may pay the amount
payable in lieu of notice, plus the value of benefits and bonuses, even in case of immediate termination.
7.3. Non-compete bonus: Subject to compliance with applicable laws, the Company may grant an Officer a bonus upon termination of employment in
return for a commitment by the Officer not to compete with Company business. The extent of the non-compete commitment would be determined
by the Company's Committee and Board. Such bonus shall be calculated according to a key of up to two (2) monthly Base Salaries for each three
(3) months of non-compete period and shall not exceed a total of twelve (12) monthly Base Salaries.
7.4. Retirement bonus: the Company may grant an Officer a retirement bonus upon termination without cause of employment. The retirement bonus
shall not exceed twelve (12) monthly Base Salaries for Officers that engaged with the Company for over twelve (12) months.
Such retirement bonus, if applicable, shall be awarded based on the Officer's tenure, the Company's achievements during the relevant period and
the Officer's contribution to such achievements, and the circumstances of such Officer's retirement from the Company.
7.5. Change of Control: the Company may grant an Officers a bonus if its office is terminated or deemed terminated by the Company within twelve
(12) months following a "change of control" (as defined in a Stock Option Plan approved by the Committee and the Board) upon such conditions
determined by the Committee and the Board. The bonus shall not exceed twelve (12) monthly Base Salaries for each Officer. It is clarified that a
sale of the majority of the assets of the Company shall not be deemed as a “Change of Control” if after such sale the remaining assets held by the
Company are not materially different than at the time the Officer was hired.
7.6. For the avoidance of doubt, all of the above bonuses (i.e. in this section 7) may be applied on an accumulative and not necessarily on an
independent basis, save for the non-competition, which if applies is to the exclusion of the other termination provisions (except for the notice
period).
8. Exemption, Insurance, and Indemnification
8.1. General: In addition to its compensation in accordance with the provisions of this Policy, each Officer shall be entitled to exemption, insurance
and indemnification subject to the limitation and the approvals under of any applicable law and the provisions of this Policy.
In this Section 8 “Officers” shall include “Directors”.
8.2. Exemption (Waiver of liability): the Company may waive the Officer's liability for any damage incurred by the Company, directly or indirectly,
due to any breach of the Officer's due care duty towards the Company and/or any affiliated entity by its action and pursuant to his position as an
Officer.
8
8.3. Officer Liability Insurance (claims made): the Company shall obtain a D&O liability insurance policy for its and its Subsidiaries Officers, from
time to time, subject to the following terms and conditions: (a) the total insurance coverage under the insurance policy shall not exceed US $100
million; and (b) the purchase of such policy shall be approved by the Committee which shall determine that such policy costs reflect the current
market conditions, and it shall not materially affect the Company's profitability, assets or liabilities.
8.4. Officer’s liability insurance (run-off): should the Company sell its operations (in whole or in part) and/or in case of merger, spin-off or any other
significant business combination involving the Company and/or part or all of its assets or any other occasion which terminates its D&O insurance,
the Company may obtain an Officer’s liability insurance policy (run-off/tail) with regard to the relevant operations, subject to the following terms
and conditions: (a) the insurance term shall not exceed 7 years; (b) the coverage amount shall not exceed US $100 million; and (c) the purchase of
such policy shall be approved by the Committee which shall determine that such policy reflects the current market conditions, and it shall not
materially affect the Company's profitability, assets or liabilities
8.5. Indemnification in advance: the Company may provide a commitment to indemnify in advance any Officer of the Company in the course of its
position as Officer of the Company and its Subsidiaries thereof, all subject to the terms of the letter of indemnification, as approved by the
Company' from time to time.
8.6. Retroactive indemnification: the Company may provide retroactive indemnification to any Officer to the extent allowed by the Companies Law.
8.7. The Officers shall be entitled to receive from the Company a note of exemption and indemnification in accordance with the than customary and
approved exemption and indemnification.
9. Engagement as a contractor or through a management company
The Company may engage an Officer as an independent contractor rather than as a salaried employee. In such a case, the maximum cost of
employment would be calculated based on the maximum cost for a salaried employee in a similar position, and guidelines of the Compensation Policy
would apply to such an officer, mutatis mutandis.
10. Miscellaneous
10.1.The Committee and the Board are responsible for the management of the compensation plan and its implementation and all of the actions required
therefor including the authority to interpret the provisions of the compensation policy in any event of doubt with regard to the implementation.
10.2.It is emphasized that nothing in that stated in this compensation policy shall prejudice existing agreements and/or binding practices (if any)
between the Company and the officers prior to approval of this compensation policy.
10.3.In the event of any change in the relevant law or any other relevant rules and regulations or the in interpretation therewith, which is more lenient
than the provisions of this compensation policy, the Committee and the Board shall be entitled to adopt the more lenient provisions to follow these
provisions even if they contradict the principles of this Policy, and this without requiring approval of the shareholders meeting of the Company in
connection therewith.
10.4.The Committee and the Board will examine from time to time the compensation policy and the need for its adjustment in the face of a material
change of the circumstances which had prevailed when it was determined or for other reasons.
10.5.The Company's Chief Executive Officer and Chief Financial Officer shall be responsible for the actual Implementation of this Policy and shall
report immediately regarding to any issues relating thereto to the Committee and the Board.
9
10.6.During the effectiveness period of this policy, an internal review over the Implementation of the policy by the Company.
10.7.The US Dollar-New Israeli Shekel exchange rate, or any other exchange rate, shall be calculated as the rate on the date of the engagement of the
beneficiary with the Company or the date upon which the actual grant is made/approved (the “Exchange Rate Date").
10.8.Changes may occur in the identity of Officers from year to year, and persons who served as Officers in one year and whose terms of employment
or office were subject to this Compensation Policy may not necessarily continue to serve as Officers in subsequent years, and thus, their terms of
employment or office would not be subject to this Compensation Policy, and vice versa. Moreover, the Company may revise the terms of
employment or office of any Officer at any time, and is under no obligation to apply the same terms of employment or office to any Officer
applied to them in previous years.
10.9.This Policy shall not confer any right on Officers to whom this Compensation Policy applies, nor on any other third party, to receive any
compensation whatsoever.
10.10.Note, for the sake of clarification, that the content of this policy does not detract from provisions of the Companies Law with regard to the
manner of approval of contracting between the Company and any Officer or Director with regard to its terms.
10.11.Any payment made to Officers pursuant to compensation plans, in addition to the fixed compensation component, is not and shall not be deemed
part of the Officer's regular pay for all intents and purposes, and shall not form basis for calculation and/or eligibility and/or accrual of any
benefits and will not, notwithstanding the foregoing, be a component included in payment of paid leave, severance pay, contributions to
provident funds, etc.
10.12.It is hereby clarified that the amounts and benefits described in this document apply across all geographic jurisdictions.
10.13.As part of the approval process of each annual plan, with its various components, changes to Company objectives, market conditions, the
Company's position, etc. would be reviewed annually by the Board. Consequently, the targets, benchmarks and compensation targets for each
plan would be reviewed annually, and their actual application would be subject to change based on decisions made by the Board from time to
time.
* * *
Amendment to
BrainsWay Employment Agreement
with
Christopher R. von Jako, PhD
Exhibit 4.5
This Amendment (the “Amendment”) is made as of March 4, 2021 between BrainsWay USA INC., a subsidiary of BrainsWay LTD. (collectively,
“BrainsWay” or the “Company”) and Christopher R. von Jako, PhD (“Executive”) with respect to the signed Employment Agreement between the
aforesaid parties originally entered into November 24, 2019 (the “Original Agreement”).
Pursuant to the approval of the Shareholders of the Company on March 4, 2021, the following change(s) to the Original Agreement are agreed upon
between the Parties:
1.
In lieu of the 180,000 Restricted Stick Units (“RSUs”) (i.e. representing 180,000 Ordinary Shares) which were originally contemplated to be
granted in three (3) separate tranches (i.e. 60,000 RSUs as “Tranche B” on March 31, 2021, 60,000 RSUs as “Tranche C” on March 31, 2022, and
60,000 RSUs as “Tranche D” on March 31, 2023) provided satisfaction of certain individual and corporate performance-based criteria set forth in
the Original Agreement, the parties have agreed for the Company to instead grant said 180,000 RSUs as part of a single tranche, which, except to
the extent otherwise provided herein shall not be subject to satisfaction of any additional conditions, as follows:
180,000 RSUs to be granted to Executive as of March 4, 2021 (the “Shareholder Approval Date”), to vest over a period of four years
beginning on the Shareholder Approval Date, with the first 25% said RSUs vesting 12 months after the Shareholder Approval Date, and
with the remaining 75% of the RSUs vesting in 12 equal portions – each upon the last day of every three month period thereafter until the
grant is fully vested, subject to Executive’s continued employment with the Company at the time of each such scheduled vesting, and
otherwise in accordance with the terms of the BrainsWay Amended and Restated 2019 Share Incentive Plan.
2. For the avoidance of doubt, nothing herein shall be construed as amending or modifying the 60,000 RSUs previously granted as of Executive’s
Employment Start Date as “Tranche A” under Section 3(c)(a.) of the Original Agreement. It is further acknowledged that the 60,000 RSUs granted
as Tranche A, and the 180,000 RSUs granted hereunder, collectively, represent the entire equity commitment of the Company toward Executive
and that no other equity has been promised as part of any oral or written understandings or agreements between the parties.
3. The parties shall cooperate in executing such documents and following such additional Company policies and procedures as are in effect and/or
deemed reasonably prudent with respect to equity grants by the Company, including but not limited to the signature of a BrainsWay Restricted
Stock Unit Agreement which shall be deemed to incorporated by reference into this Amendment and the Original Agreement.
Except as specifically set forth in this Amendment, the Original Agreement is unaffected and shall continue in full force and effect in accordance with
the terms set forth therein.
AGREED TO AND ACCEPTED,
By Company
Signature: /s/_David Zacut
Name: David Zacut
Title: Chairman
By Executive
Signature: /s/_Christopher R. von Jako
Name: Christopher R. von Jako, PhD
Title: President and CEO
Exhibit 4.7
March 25, 2021
R. SCOTT AREGLADO
22 Locksley Road
Lynnfield, MA 01940
M: (617) 771-2287
E: sareglado@yahoo.com
Dear Mr. Areglado,
Re: Employment Offer Letter
We are very pleased to present to you this offer letter (the “Employment Offer Letter”) for a position with BrainsWay USA, Inc. (the “Company” or
“BrainsWay”), as Senior Vice President and Chief Financial Officer for BrainsWay, reporting directly to the Company’s Chief Executive Officer. In this
full-time position, you will undertake and render services that are normally associated with this role in other companies in our industry. If you accept this
offer, your employment will commence on the “Start Date” which shall be defined as May 5, 2021 or such other date as mutually agreed to by you and the
Company.
1. Base Salary. In compensation for your work, the Company will pay you a base salary (“Base Salary”) at the annualized gross rate of
$295,000.00 (Two Hundred and Ninety Five Thousand U.S. Dollars). Your salary will be paid in equal installments, less applicable taxes and
withholdings, in accordance with the Company’s semi-monthly payroll schedule through our PEO TriNet/ADP. You confirm that you have had
the opportunity to consult with a tax expert regarding tax liabilities applicable to the payments and other consideration, if any, to which you are
entitled under this Agreement. Your Base Salary will be subject to periodic review and possible raises at the Company’s discretion (with your
Base Salary, as so adjusted, constituting “Base Salary” for all purposes thereafter).
a. Exempt Employee Status: Please note, that as an “exempt” employee under applicable U.S. law, you will not be entitled to overtime
compensation.
2. Bonus Compensation. You will be eligible to receive a performance bonus targeted at 40% of your Base Salary (the “Target Bonus”), pro-rated
in the first calendar year based on the Start Date. The actual bonus percentage and payment is discretionary and will be subject to assessment of
your performance, as well as business conditions at the Company as determined by the Company’s (and/or its parent company’s) board of
directors (the “Board”) or the Company’s (and/or its parent company’s) compensation committee (the “Compensation Committee”). You must
be employed on the date a bonus is paid to earn any part of that bonus.
3. Options Package. Pursuant to the approval by the board of directors of BrainsWay Ltd. (the “Parent”), which will be sought within thirty (30)
days of your Start Date, you will be granted an option (non-qualified) to purchase 115,000 ordinary shares of the Parent (the "Options"). The
approved grant will take place as of the “Vesting Commencement Date” which shall be defined as the Start Date. The Options will be subject to
the terms and conditions of the compensation plan and/or share incentive plan in effect for employees of the Company as amended and restated
from time to time (the “Plan”), your continued employment by the Company at each applicable vesting date, as well as any as any other terms
and conditions at the Company as determined by the Company’s (and/or the Parent’s) board of directors or the Company’s (and/or the Parent’s)
compensation committee (the “Compensation Committee”). The shares subject to the Options shall vest over a period of four years beginning
on the Vesting Commencement Date as follows: twenty-five percent (25%) of the shares on the first anniversary of the Vesting Commencement
Date, and six and one-quarter percent (6.25%) of the shares at the end of each subsequent three-month period thereafter until the end of the
four-year period. The exercise price of each ordinary share subject to the Options shall be the price equal to 110% of the average closing share
price of the Company in the 90 trading days preceding the Vesting Commencement Date.
4. Severance and Change of Control Rider: Your employment will be subject to certain additional terms and conditions set forth in the Severance
and Change of Control Rider attached hereto as Annex A.
BrainsWay
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5. Taxes; Section 409A
a. All forms of compensation referred to in this Agreement are subject to reduction to reflect applicable withholding and payroll taxes
and other deductions required by law. You hereby acknowledge that the Company does not have a duty to design its compensation
policies in a manner that minimizes your tax liabilities, and you will not make any claim against the Company or its board of directors
related to tax liabilities arising from your compensation.
b. To the extent applicable, this Agreement is intended to comply with the requirements of Section 409A of the Internal Revenue Code of
1986, as amended (“Section 409A”), and the parties hereby agree to amend this Agreement as and when necessary or desirable to
conform to or otherwise properly reflect any guidance issued under Section 409A after the date hereof without violating Section 409A.
In case Section 409A applies to any one or more provisions of this Agreement, but said provision(s) fail(s) to comply with the
provisions of Section 409A, the remaining provisions of this Agreement shall remain in effect, and this Agreement shall be
administered and applied as if the non-complying provision(s) were not part of this Agreement. The parties in that event shall endeavor
to agree upon a reasonable substitute for the non-complying provision(s), to the extent that a substituted provision would not cause this
Agreement to fail to comply with Section 409A, and, upon so agreeing, shall incorporate such substituted provisions into this
Agreement.
6. US Work eligibility: This offer letter is expressly conditioned upon your eligibility to work in the United States.
7. Background Check: This offer and your employment are expressly conditioned on the Company’s complete satisfaction
(at its sole discretion) with the results of a background check into your personal and employment history.
8. Overrides Prior Offers or Agreements: This offer letter overrides and supersedes any prior offers, communications, agreements or other
understandings between you and Company, whether made orally or in writing, concerning your employment at BrainsWay or the terms
pertaining thereto. No other terms governing your prospective employment and/or compensation shall apply.
9. Vacation; Sick Days; Holidays. You will be entitled to vacation days, sick days and/or holidays in accordance with the
Company’s policy. The accrual and carrying forward of such days may be changed from time to time.
10. Health Benefits. You will be eligible to participate in Company’s employee health benefits plan (i.e. medical, dental and vision), or as may
otherwise be adopted by the Company from time to time and in effect for employees of the Company in similar positions. Your participation
will be subject to the terms of the applicable plans and generally applicable Company policies. The provision of such benefits in no way
changes or impacts the at-will status of your employment.
11. Participation in Retirement or Deferred Compensation Plan: You will be eligible to participate in any Company 401k plan (unmatched), or
other similar retirement or deferred compensation program, as may generally be in place for the employees of the Company during the period
of your employment, which plan may change from time to time.
12. Expenses. The Company will pay or reimburse you for all reasonable pre-approved business expenses incurred or paid by you in the
performance of your duties and responsibilities, subject to any expense policy of the Company, which may change from time to time, and such
substantiation and documentation requirements as may be specified by the Company from time to time.
13. Employment At-Will. Your employment with the Company is at-will and for no specified period. As a result, you are free to resign at any time
for any reason or no reason. Similarly, the Company is free to conclude its employment relationship with you at any time effective immediately
without notice, for any reason or no reason. Nothing contained in this Offer Letter may be construed to guarantee employment for any length of
time or otherwise change the at-will status of your employment. This “at-will” employment relationship shall remain unchanged during your
tenure as an employee, and cannot be changed except in an express written agreement, signed by you and by an authorized Company officer.
14. Other Employment. During the term of your employment with the Company, you may not engage in any other employment, occupation,
consulting or other business without the written consent of Company, and you shall dedicate all of your working time in favor of your
employment with the Company unless otherwise agreed upon in writing with Company. You will provide reasonable advance notice to the
Company of planned activities which may possibly conflict with your obligations to the Company and/or reasonably trigger this section. You
will not engage in any other activities that conflict with your obligations to the Company. You agree to comply with all Company standard
policies in this regard, which may be amended from time to time.
BrainsWay
Page 2
15. Compliance. As a Company employee, you are required to act in conformity with the law at all times, without exception. You will also be
expected to abide by Company written rules and regulations and you may be required to agree to Company written rules of conduct and/or
terms contained in any employee handbook. You are required to sign and comply with the CONFIDENTIALITY, INVENTIONS NON-
COMPETITION AND NOT SOLICITATION AGREEMENT, attached hereto as Annex
B. You will be required to complete an I-9 Form (concerning work eligibility) and provide any of the accepted forms of identification specified
on the Form.
16. Representation. Your acceptance of employment for this position shall constitute your representation and acknowledgement that you are
permitted under law to accept this position, that (i) your employment for Company is not a breach of any other agreements or undertakings (ii)
you are not and will not use any confidential information of any other entity in carrying out your duties, and (iii) the existing or proposed
products and/or services developed, owned, commercialized, marketed or sold by entities which engaged you at any time during the six (6)
months period prior to the date first written above, do not directly compete with the products or services of the Company.
17. Governing Law; Disputes. The laws of the State of Massachusetts shall govern the interpretation, validity and performance of this Offer Letter,
regardless of the law that might be applied under principles of conflicts of law. Any disputes arising hereunder out of your employment shall be
resolved by non-binding mediation in Massachusetts, followed by binding arbitration in Massachusetts by a single arbitrator to be chosen
according to the Employment Rules of the American Arbitration Association.
18. Company Approval; Integration. This offer is ultimately contingent upon the review and approval by the Company and any of its affiliates with
respect to the subject matter hereof and supersedes any and all prior or contemporaneous oral or written representations, understandings,
agreements or communications between you, the Company and any of its affiliates. This letter, together with the CONFIDENTIALITY,
INVENTIONS NON-COMPETITION AND NOT SOLICITATION AGREEMENT, forms the complete and exclusive statement of the terms
of your employment with the Company. To the extent there is any conflict between the terms of this letter and any other Company document or
policy, the terms of this letter control
19. Amendment. This Agreement may not be amended without the written consent of you and the Company.
Please indicate your acceptance of the Company’s offer, by signing and dating this letter in the spaces provided below and returning it to us. This offer and
all the terms stated in this letter will expire if you have not returned signed copies of this letter to the Company on or prior to the close of business on the
day falling one calendar week from the date of this letter. The Company may withdraw this offer at any time before receiving your acceptance. We look
forward to a mutually successful working relationship.
Sincerely,
/S/ Christopher von Jako
Christopher von Jako, PhD
President and Chief Executive Officer
BrainsWay
I HEREBY ACCEPT EMPLOYMENT WITH BRAINSWAY ON THE TERMS STATED ABOVE:
Name: /S/ Scott Areglado
R. SCOTT AREGLADO
Dated: March 30, 2021
BrainsWay
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Annex A
SEVERENCE AND CHANGE OF CONTROL RIDER
Nothing contained in this Severance and Change of Control Rider may be construed as detracting from the at-will status of your employment and/or to
guarantee employment for any length of time:
1. Termination for Cause or Resignation. In the event the Company terminates your employment for Cause (as defined herein), or in the event that
you voluntarily resign your employment without Good Reason (as defined herein) or your employment otherwise terminates for any reason except
by termination by the Company without Cause or resignation for Good Reason, the obligations of the Company shall cease immediately and you
will not be entitled to any further payments or benefits of any kind, including any portion of the payments described in sections 1 through 3 of the
Employment Offer Letter other than earned Base Salary through the date of termination. The aforesaid cease of benefits shall not include any
retirement or disability benefits which have already vested under the express terms of the Company’s benefits plans, or any benefits which you
may be clearly entitled to as a matter of law irrespective of termination (including under COBRA). For purposes of this agreement, “Cause” shall
be defined as: (i) your (a) material failure to perform your duties or (b) gross negligence in the performance of your duties, provided that in the
case of either (a) or (b), the Company shall give written notice to you of at least thirty (30) days prior to such termination of the Company’s intent
to terminate under this provision, which notice shall set out the ways in detail in which you have failed to perform, and you shall have failed to
cure such failure prior to the expiration of such thirty (30) day period; (ii) your material breach of the terms of the Employment Offer Letter or the
Company’s policies, or a material breach of fiduciary duty causing the Company material harm; (iii) your willful violation of lawful directives
from the Company’s Board; (iv) dishonesty, willful misconduct causing the Company material harm or fraud in connection with your employment
by the Company, the performance of your duties, or in any way related to the business of the Company; (v) a reportable violation of banking,
securities or commodities laws, rules or regulations; or (vi) conviction or a plea of nolo contendere (or the equivalent) to a felony or any crime
involving moral turpitude.
2. Termination Without Cause and Resignation for Good Reason. Subject to the compliance of this section with the shareholder-approved
compensation plan in effect for the Company, in the event the Company terminates your employment without Cause, or you resign your
employment hereunder for Good Reason, provided you have been actively employed by BrainsWay for at least one year prior to such termination
without Cause or resignation for Good Reason, you shall be entitled to a total severance payment of an aggregate amount equal to 75% of your
then-current annualized gross Base Salary, payable in one lump sum less applicable taxes and withholdings within 30 days of your last day of
employment. Further, in the event that you have been awarded, but not yet paid, a bonus for the prior fiscal year, that bonus shall be paid to you on
the same date bonuses are paid.
3. For purposes of this agreement, “Good Reason” shall mean, without your prior written consent, any action or inaction by the Company that results
in the occurrence of any of the following: (i) a reduction in your Base Salary or target bonus; (ii) a material diminution in your responsibilities,
authority or duties, (iii) you having to report to someone other than the Company’s CEO; (iv) you having to work in a location more than seventy-
five miles from the office location you report to (v) discovery of a violation of compliance or regulatory obligations due to no fault on your part
that the Company has failed to cure upon notice by you, and which you in good faith believe you cannot continue your employment under such
circumstances; or (vi) any other action or inaction that constitutes a material breach by the Company of this agreement. Notwithstanding the
foregoing, no termination shall be deemed to be for Good Reason unless you follow the Good Reason Process. For purposes of this agreement,
“Good Reason Process” shall mean that 1) you reasonably determined in good faith that a “Good Reason” condition has occurred; 2) you notify
the Company in writing of the first occurrence of the Good Reason condition within 30 days of the first occurrence of such occurrence, with such
notice specifically identifying same as a “Good Reason condition” under this agreement, 3) you cooperate in good faith with the Company’s
efforts, for a period not less than 30 days following such notice (the “Cure Period”), to remedy the condition; 4) notwithstanding such efforts, the
Good Reason condition continues to exist; and 5) you terminate your employment within 30 days after the end of the Cure Period. If the Company
cures the Good Reason condition during the Cure Period, Good Reason shall be deemed not to have occurred. Except as provided in section 2 of
this Rider, you understand that you shall not be entitled to any further payments or benefits in the event of termination of your employment. You
agree that no payment shall be made to you pursuant to section 2 of this Rider unless you execute a release within thirty (30) days after your
termination date in a form satisfactory to the Company in favor of the Company and all affiliated and related entities and their current and former
officers, directors, employees and agents from any and all claims permitted to be released by applicable law.
BrainsWay
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4. Change of Control.
a.
In the event that a Change of Control (as defined herein) occurs and your employment is terminated by the Company without Cause or
by you for Good Reason within six months of such Change of Control, you will be entitled to the following:
i.
ii.
Severance: Receipt of the severance benefits set out in Section 2 herein, and
Equity Acceleration: with respect to any Options granted to you by the Company prior to the date of the Change of Control that,
as of the date of the Change of Control, have not yet vested, the vesting date of such unvested shares shall be accelerated to the
later of the day immediately prior to the Change of Control or your termination date.
b. Your receipt of the benefits set out in this Section 4 shall be subject to (i) your continued employment and performance of your
obligations through the termination of your employment, and (ii) your execution and non-revocation of a release in a form satisfactory
to the Company in favor of the Company and all affiliated and related entities and their current and former officers, directors,
employees and agents from any and all claims within thirty (30) days of your termination date.
c. For purposes of this agreement, “Change of Control” means (i) the acquisition following the Start Date, directly or indirectly, by any
person or entity, in one transaction or a series of related transactions, of securities of the Company representing in excess of fifty
percent (50%) or more of the combined voting power of the Company’s then outstanding securities, if such person/entity or his or its
affiliate(s) do not own in excess of 50% of such voting power on the date of this Agreement, or (ii) the future disposition by the
Company (whether direct or indirect, by sale of assets or stock, merger, consolidation or otherwise) of all or substantially all of their
business and/or assets in one transaction or series of related transactions (other than a merger effected exclusively for the purpose of
changing the domicile of the Company).
BrainsWay
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Annex B
CONFIDENTIALITY, INVENTIONS NON-COMPETITION AND NON-SOLICITATION AGREEMENT
This Confidentiality, Restrictive Covenant and Inventions Agreement (“Agreement”) is entered into by you, the undersigned employee and
Brainsway USA, Inc. (the "Company”). In consideration of your employment and of the salary, benefits, and other compensation hereafter to be paid to
you by or on behalf of the Company, as well as other consideration, the sufficiency of which is hereby acknowledged, and in acknowledging that the
Company is employing you in reliance on your full compliance with the Agreement, you promise and agree as follows:
I.
Confidential Information
1. Definition. During the course of your employment with the Company, you will receive confidential information of and/or be in the possession of
confidential information from BrainsWay, its parents, subsidiaries, and any affiliated companies (the Company and/or any or all of the above
detailed entities shall collectively hereinafter be referred to as “BrainsWay”), as well as similar information pertaining to BrainsWay’s clients or
customers, including, but not limited to, customer or client lists, services provided to such customers or clients, sources and leads for obtaining new
business, vendors or suppliers, trade secrets, images, slogans, logos, designs, sketches, mock-ups, samples, computer software, operations, systems,
services, financial affairs of BrainsWay, forms, contracts, agreements, literature or other documents designed, developed or written by, for, with or
on behalf of the Company, concepts, ideas, inventions, original works of authorship, discoveries, techniques, copyrights, patents, trademarks, and
any and all information and know-how now or in the future, whether or not such confidential information relates to any Work Product (as defined
herein) including without limitation, the underlying concept and production methodology of such Work Product (hereinafter, “Confidential
Information”). Confidential Information shall not include information which is or which comes into the public domain through no fault of yours, or
was known to you prior to any affiliation with the Company.
2. Exclusive Property. All Confidential Information is, and at all times shall remain, the exclusive property of BrainsWay. You recognize and
acknowledge that Confidential Information is valuable, special and unique to the business of BrainsWay, and that access to and knowledge thereof is
essential to the performance of your duties to the Company. During the time that you are an employee of the Company, and at all times thereafter,
you will keep secret and will not use or disclose any Confidential Information to any person or entity, in any fashion or for any purpose whatsoever,
except at the request of or with prior written consent of the Company (or as may be required by applicable law). If you have any questions about
whether any information is Confidential Information, as defined in this Agreement, you should consult with the Company before using or disclosing
such information. You agree to store and maintain all Confidential Information in a secure place. You further agree that any property situated on
BrainsWay’s premises and owned by BrainsWay, including electronic files and other digital, analog or hard copy storage media, filing cabinets,
lockers, desks or other work areas, is subject to inspection by BrainsWay personnel at any time with or without notice. At the time of termination of
your employment with the Company for any reason, you agree to promptly deliver to the Company and/or permanently delete (and will not keep in
your possession, or otherwise recreate or deliver to anyone else), in whatever medium recorded, any and all Confidential Information and all other
documents, materials, information, and property developed or obtained by you pursuant to your employment or otherwise belonging to the
Company.
II.
Intellectual Property
3. Ownership. You agree that the Company or any affiliate thereof shall own all right, title and interest throughout the world in and to any and all
inventions, original works of authorship, developments, concepts, know-how, improvements, and trade secrets, whether or not patentable or
registrable under copyright or similar laws, that you may solely or jointly conceive or develop or reduce to practice, or cause to be conceived or
developed or reduced to practice during your employment, whether or not during regular working hours, provided that they (i) relate at the time of
conception or development to the actual or demonstrably proposed business or research and development activities of BrainsWay, (ii) result from or
relate to any work performed for the Company, or (iii) are developed through the use of confidential information and/or resources of BrainsWay or
in consultation with any personnel of BrainsWay (collectively referred to as “Work Product”). You hereby assign
BrainsWay
Page 6
to BrainsWay and its affiliates all right, title, and interest in and to any and all Work Product, and agree to BrainsWay, at BrainsWay’s expense, to
further evidence, record, and perfect such assignments, and to perfect, obtain, maintain, enforce, and defend any rights specified to be so owned or
assigned. In addition to, and not in contravention of any of, the foregoing, you acknowledge that all original works of authorship that are made by
you (solely or jointly with others) within the scope of employment and that are protectable by copyright are “works made for hire,” as that term is
defined in the United States Copyright Act (17 U.S.C. § 101). To the extent allowed by law, this includes all rights of paternity, integrity, disclosure,
and withdrawal, and any other rights that may be known or referred to as “moral rights.” To the extent you retain any such moral rights under
applicable law, you hereby waive such moral rights and consent to any action consistent with the terms of this Agreement with respect to such moral
rights, in each case, to the full extent of such applicable law. You agree to confirm any such waivers and consents from time to time as requested by
BrainsWay.
III.
Restrictions on Activities
4. Competition and Interfering Activities. During your employment with the Company , and for the applicable Restricted Period (as such term is
hereinafter defined), you agree that you will neither Compete (as such term is hereinafter defined) with BrainsWay nor engage in any Interfering
Activities (as such term is hereinafter defined), nor will you take any steps in anticipation of Competing with BrainsWay or engaging in Interfering
Activities. For purposes of this Agreement:
(a) “Compete” or “Competing” means to, directly or indirectly, on your behalf or on behalf of any other person or
entity, in any way, whether as an individual proprietor, partner, stockholder, officer, employee, consultant, agent, director, joint venturer, investor, or in
any other capacity, own, operate, manage, control, engage in, participate in, invest in, permit your name to be used by, act as a consultant or advisor to,
render services for (alone or in association with any person, firm, corporation, or business organization), or otherwise assist any person or entity that
engages in or owns, invests in, operates, manages, controls, or is affiliated with any venture or enterprise that, anywhere in the United States, offers or
plans to offer competing products and services with those offered by BrainsWay.
(b) “Interfering Activities” means to, directly or indirectly, on behalf of yourself or any other person or entity, in
any way (i) solicit, induce, or encourage the resignation of any member, partner, employee, agent, or consultant of BrainsWay (ii) solicit, induce or
encourage any member, partner, employee, agent or consultant of BrainsWay to join or perform services for anyone else, in any capacity, (iii) interfere in
any way with the relationship between BrainsWay and any of its respective members, partners, employees, agents, or consultants, (iv) hire or attempt to
hire or reach any agreement (oral or written) with respect to the prospective hiring of any member, partner, employee, agent, or consultant of BrainsWay
or any person or entity that was a member, partner, employee, agent, or consultant within the six (6) month period immediately preceding the hire or
attempt to hire, (v) interfere, or attempt to interfere, with the relationship between BrainsWay and any of its actual or prospective clients or customers, or
(vi) solicit, or attempt to solicit, the business of, any actual or prospective client or customer of BrainsWay. You further acknowledge that this Section
C.1(b)(vi) shall apply to clients or customers you originated or serviced during your employment with the Company, or about whom you are aware of
Confidential Information, but only where BrainsWay continues to provide services in the geographical area where such client or customer does business.
This restriction is meant to protect the BrainsWay from losing such clients or customers to you, who by virtue of your employment with the Company,
maintained a relationship with the clients and customers, gained knowledge about them, and/or become familiar with the requirements of such clients
and customers.
(c) “Restricted Period” means (i) with respect to your covenant not to compete, the period commencing on the
termination of your employment for any reason and ending on the twelve (12) month anniversary of the date of such termination, and (ii) with respect to
your covenant as to Interfering Activities, the period commencing on the termination of your employment for any reason and ending on the twelve (12)
month anniversary of the date of such termination.
5. Tolling of Restricted Periods. If you shall violate any covenant contained herein with a stated duration, the duration of any such covenant so violated
shall automatically be extended with respect to you for a period equal to the period during which you shall have been in violation of such covenant.
6. Non-Disparagement/No Speaking with the Media. Both during your employment with the Company and at all times thereafter, you agree that,
except as required by applicable law or compelled by process of law, you will not, nor will you permit anyone acting on your behalf to disparage
BrainsWay’s products, services, customers or clients, whether to the press, via social media, or to any other third party.
7. Notice to Future Employers, Notice to BrainsWay of Future Employers. In the event that you leave the employ of the Company for any reason, you
hereby agree to notify your new employer of your obligations that are continuing under this Agreement after the termination hereof. To enable
BrainsWay to monitor your compliance with the obligations imposed by
BrainsWay
Page 7
this Agreement, you agree to inform the Company at the time you give notice of your termination of employment, of the identity of your new
employer and of your job title and responsibilities, and will continue to so inform the Company, in writing, at any time you change employment
during the twelve (12) months following termination of your employment with the Company for any reason.
8. Reasonableness of Covenants. You acknowledge and expressly agree that the covenants contained in this Annex B of this Agreement are reasonably
necessary to protect valuable business interests of BrainsWay, BrainsWay’s business, its officers, directors and employees. You represent that your
experience, capabilities and circumstances are such that these provisions will not prevent you from earning a livelihood. You further agree that you
have received valuable and adequate compensation in exchange for entering into the restrictions set out in this Agreement.
IV.
Enforcement
9.
Injunctive Relief. You and the Company acknowledge and agree that a remedy at law for any breach or threatened breach of this Agreement would
be inadequate, and therefore, agree that the non-breaching party shall be entitled to injunctive relief, without posting bond or other security, in
addition to any other available rights and remedies in cases of any such breach or threatened breach; provided, however, that nothing contained
herein shall be construed as prohibiting a party from pursuing any other rights and remedies available for any such breach or threatened breach. The
parties further agree that if suit is successfully brought to enforce this Agreement or to seek damages for its breach or threatened breach, the
prevailing party, in addition to any other damages caused to such party, will be paid all attorneys’ fees and costs incurred in seeking such relief.
10. Jurisdiction and Governing Law. You agree that any proceeding concerning the enforcement of this Agreement, including an entry of a temporary
and/or permanent restraining order which precludes the breach or continuing breach of this Agreement shall be brought in the United States District
Court for the Eastern District of Massachusetts or in the Superior Court of the Commonwealth of Massachusetts, and you consent to personal
jurisdiction therein. This Agreement shall be governed by, and construed in accordance with, the laws of the Commonwealth of Massachusetts,
without regard to conflict of law principles.
11. No Waiver. No failure or delay by a party in exercising any right, power or privilege under this Agreement shall operate as a waiver thereof or
preclude any other or further exercise thereof or the exercise of any other rights, power or privilege hereunder.
12. No Oral Modification. This Agreement may not be changed or modified except by a written agreement that has been signed by both you and a
director or officer of the Company.
13. Blue Penciling and Severability. It is the intention of you and the Company that the provisions of this Agreement shall be enforced to the fullest
extent permissible under the laws of Massachusetts. If any court of competent jurisdiction or arbitration panel determinates that any covenant or
provisions of this Agreement is unenforceable or unlawful, that covenant or provision shall not render unenforceable or impair the remaining
covenants and provisions of this Agreement. In addition, if any covenant or provision is held to be unenforceable because of the scope, duration or
area of its applicability, the court or tribunal making such determination shall have the power to modify such scope, duration or area, or all of them,
and such covenant or provision shall then be applicable in such modified form and every other provision of this Agreement shall remain in full force
and effect.
14. Successor and Assigns. The Company may assign this Agreement to any successors or assigns, and you shall be bound to any successor or assign of
the Company. The Company will assign this Agreement to any successor to the assets of the Company.
Agreed to and accepted:
By:
/S/ Scott Areglado
R. Scott Areglado
March 30, 2021
Date
BrainsWay
Page 8
CERTIFICATION BY CHIEF EXECUTIVE OFFICER PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
Exhibit 12.1
I, Christopher von Jako, certify that:
1.
I have reviewed this annual report on Form 20-F of BrainsWay Ltd.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this
report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the
financial condition, results of operations and cash flows of the company as of, and for, the periods presented in this report;
4. The company’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in
Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-
15(f)) for the company and have:
a. Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our
supervision, to ensure that material information relating to the company, including its consolidated subsidiaries, is made known to us by
others within those entities, particularly during the period in which this report is being prepared;
b. Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for
external purposes in accordance with generally accepted accounting principles;
c. Evaluated the effectiveness of the company’s disclosure controls and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d. Disclosed in this report any change in the company’s internal control over financial reporting that occurred during the period covered by
the annual report that has materially affected, or is reasonably likely to materially affect, the company’s internal control over financial
reporting; and
5. The company’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the
company’s auditors and the audit committee of the company’s board of directors (or persons performing the equivalent functions):
a. All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the company’s ability to record, process, summarize and report financial information; and
b. Any fraud, whether or not material, that involves management or other employees who have a significant role in the company’s internal
control over financial reporting.
Date: April 12, 2022
/s/ Christopher von Jako
Christopher von Jako
Chief Executive Officer
CERTIFICATION BY CHIEF FINANCIAL OFFICER PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
Exhibit 12.2
I, R. Scott Areglado, certify that:
1.
I have reviewed this annual report on Form 20-F of BrainsWay Ltd.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this
report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the
financial condition, results of operations and cash flows of the company as of, and for, the periods presented in this report;
4. The company’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in
Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-
15(f)) for the company and have:
a. Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our
supervision, to ensure that material information relating to the company, including its consolidated subsidiaries, is made known to us by
others within those entities, particularly during the period in which this report is being prepared;
b. Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for
external purposes in accordance with generally accepted accounting principles;
c. Evaluated the effectiveness of the company’s disclosure controls and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d. Disclosed in this report any change in the company’s internal control over financial reporting that occurred during the period covered by
the annual report that has materially affected, or is reasonably likely to materially affect, the company’s internal control over financial
reporting; and
5. The company’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the
company’s auditors and the audit committee of the company’s board of directors (or persons performing the equivalent functions):
a. All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the company’s ability to record, process, summarize and report financial information; and
b. Any fraud, whether or not material, that involves management or other employees who have a significant role in the company’s internal
control over financial reporting.
Date: April 12, 2022
/s/ R. Scott Areglado
R. Scott Areglado
Chief Financial Officer
CERTIFICATION BY CHIEF EXECUTIVE OFFICER AND CHIEF FINANCIAL OFFICER PURSUANT TO SECTION 906 OF THE
SARBANES-OXLEY ACT OF 2002
In connection with the Annual Report of BrainsWay Ltd. (the “Company”) on Form 20-F for the period ended December 31, 2021 as filed with the
Securities and Exchange Commission on the date hereof (the “Report”), each of the undersigned officers of the Company certifies, pursuant to 18 U.S.C.
§1350, as adopted pursuant to §906 of the Sarbanes-Oxley Act of 2002, that to such officer's knowledge:
(1)
(2)
The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Exhibit 13
Dated: April 12, 2022
/s/ Christopher von Jako
Christopher von Jako
Chief Executive Officer
/s/ R. Scott Areglado
R. Scott Areglado
Chief Financial Officer
Consent of Independent Registered Public Accounting Firm
We consent to the incorporation by reference in the Registration Statement (Form F-3 No. 333- 259610) of BrainsWay Ltd. and in
the related Prospectus of our report dated April 12, 2022, with respect to the consolidated financial statements of BrainsWay Ltd.
included in this Annual Report (Form 20-F) for the year ended December 31, 2021.
Exhibit 15.1
/s/ Kost Forer Gabbay & Kasierer
KOST FORER GABBAY & KASIERER
A Member of Ernst & Young Global
Tel-Aviv, Israel
April 12, 2022