UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-K
(Mark
One)
☒
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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
Commission
file number 333-188920
SCOUTCAM
INC.
(Exact
name of registrant as specified in its charter)
Nevada
47-4257143
State
or other jurisdiction of
incorporation or organization
(I.R.S.
Employer
Identification
No.)
Suite
7A and 3B , Industrial Park , P.O.
Box 3030
Omer ,
Israel 8496500
(Address
of principal executive offices) (Zip Code)
Tel:
+ 972 73 370-4691
Registrant’s
telephone number, including area code
Securities
registered pursuant to Section 12(b) of the Act: None
Title
of each class
Trading
Symbol(s)
Name
of each exchange on which registered
N/A
N/A
N/A
Securities
registered pursuant to Section 12(g) of the Act: None
N/A
(Title
of class)
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐
No ☒
Indicate
by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. 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 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, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer”,
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer
☐
Accelerated
filer
☐
Non-accelerated
filer
☒
Smaller
reporting company
☒
Emerging
growth company
☐
If
an emerging growth company, 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. ☐
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 whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒
The
aggregate market value of the voting and non-voting stock held by non-affiliates of the registrant as of June 30, 2021, based
on the price at which the common equity was last sold on the OTCQB Market on such date, was $ 25.89 million. For purposes
of this computation only, all officers, directors and 10% or greater stockholders of the registrant are deemed to be affiliates.
As
of March 28, 2022, there were 7,121,737 shares of the registrant’s common stock outstanding.
DOCUMENTS
INCORPORATED BY REFERENCE
None .
TABLE
OF CONTENTS
Forward-Looking Statements
3
Part I
Item
1.
Business
4
item
1a.
risk factors
13
Item
1b.
unresolved staff comments
27
Item
2.
properties
27
item
3.
legal proceedings
27
item
4.
mine safety disclosures.
27
PART II
item
5.
market for registrant’s common equity, related stockholder matters and issuer purchases
28
Item
6.
[ RESERVED ]
30
item
7.
management’s discussion and analysis of financial condition and results of operations
31
item
7a.
quantitative and qualitative disclosures about market risk
36
item
8.
financial statements and supplementary data
36
item
9.
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
36
item
9a.
controls and Procedures
37
Item
9b.
Other information
37
Item
9C.
BUSINESS DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
38
PART III
Item
10.
Directors, Executive Officers and corporate governance
38
item
11.
Executive Compensation
42
Item
12.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder matters
45
Item
13.
Certain relationships and related transactions, and director independence
46
Item
14.
Principal accounting fees and services
48
PART IV
Item
15.
exhibits, financial statement schedules
49
SIGNATURES
51
2
Forward-Looking
Statements
This
Annual Report on Form 10-K includes a number of forward-looking statements that reflect management ’ s current views with
respect to future events and financial performance. Forward-looking statements are projections in respect of future events or our future
financial performance. In some cases, you can identify forward-looking statements by terminology such as “may,” “should,”
“expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,”
“potential” or “continue” or the negative of these terms or other comparable terminology. Those statements include
statements regarding the intent, belief or current expectations of our Company and members of our management team as well as the assumptions
on which such statements are based. Prospective investors are cautioned that any such forward-looking statements are not guarantees of
future performance and involve risks and uncertainties, and that actual results may differ materially from those contemplated by such
forward-looking statements.
These
statements are only predictions and involve known and unknown risks, uncertainties and other factors including, but not limited to:
●
our
financial performance, including our history of operating losses;
●
our
ability to obtain additional funding to continue our operations;
●
our
ability to successfully develop and commercialize our products;
●
changes
in the regulatory environments of the United States and other countries in which we intend to operate;
●
our
ability to attract and retain key management and marketing personnel;
●
competition
from new market entrants; and
●
our
ability to identify and pursue development of additional products.
Readers
are urged to carefully review and consider the various disclosures made by us in this Annual Report and in our other reports filed with
the Securities and Exchange Commission. We undertake no obligation to update or revise forward-looking statements to reflect changed
assumptions, the occurrence of unanticipated events or changes in future operating results over time except as required by law. We believe
that our assumptions are based upon reasonable data derived from and known about our business and operations. No assurances are made
that actual results of operations or the results of our future activities will not differ materially from our assumptions.
As
used in this Annual Report and unless otherwise indicated, the terms “ScoutCam,” “we,” “us,” “our,”
or “our Company” refer to ScoutCam Inc. Unless otherwise specified, all dollar amounts are expressed in United States dollars.
On
August 9, 2021, we effected a one-for-nine reverse stock split of our common stock pursuant to which holders of our Common Stock received
one share of our common stock for every nine shares of common stock held. Unless the context expressly dictates otherwise, all references
to share and per share amounts referred in this Annual Report reflect the reverse stock split.
3
Part
I
Item
1. Business
Overview
We
are engaged in the development, production and marketing of innovative visual solutions composed of imaging equipment, cloud and software
based image processing (artificial intelligence (AI), machine learning (ML), and additional algorithm methodologies). Some of our products
that utilize our micro ScoutCam™ technology are used in medical procedures as well as various applications in other industries.
Our current business model is a business-to-business (B2B) approach in which we seek to identify target businesses interested in integrating
our micro ScoutCam™ technology, or commissioning individual projects using our technology. We derive a substantial portion of our
revenue from applications of our micro ScoutCam™ technology within the medical, defense and aerospace fields. We have recently
begun examining additional applications for our visual solutions portfolio (composed of image acquisition, data collection and storage
and image processing), including Predictive Maintenance (PdM) and Condition Based Monitoring (CBM), as well as additional industry sectors
such as aviation, automotive, industrial non-destructing-testing industries energy and maritime (we refer to these applications and sectors
as I4.0) We plan to further expand our activity in these non-medical spaces.
Pictured
above (from left to right) are the Company’s micro ScoutCam TM 1.0 Lum and micro ScoutCam™ 1.2.
The
Company’s eye-endoscope, which includes a camera at the distal tip, integrated illumination and embedded irrigation, which is only
1.2 mm in outer diameter.
Our
Corporate History and Background
We
were incorporated as a corporation under the laws of the State of Nevada on March 22, 2013 under the name Intellisense Solutions Inc.
We were initially engaged in the business of developing web portals to allow companies and individuals to engage in the purchase and
sale of vegetarian food products over the Internet. However, we were unable to execute our original business plan, develop significant
operations or achieve commercial sales.
We
received initial funding in March 2014 in the aggregate amount of $19,980 through the sale of common stock to two of our former officers
and directors, who purchased in the aggregate 1,998,000 shares of our common stock at $0.01 per share.
On
January 10, 2019, we formed Canna Patch Ltd., or Canna Patch, an Israeli corporation, of which 90% was initially owned by our Company,
and the remaining 10% owned by Rafael Ezra, Canna Patch’s Chief Technology Officer. Canna Patch did not have any operations and
on December 4, 2019, we sold 100% of our holdings in Canna Patch.
On
September 16, 2019, Intellisense and Medigus Ltd., an Israeli company traded on the Nasdaq Capital Market, entered into an Exchange Agreement
(as defined herein). For additional information about the Exchange Agreement, refer to – “ CERTAIN RELATIONSHIPS AND RELATED
TRANSACTIONS, AND DIRECTOR INDEPENDENCE” below.
4
On
December 30, 2019, we acquired ScoutCam Ltd. As a result of our acquisition of ScoutCam Ltd., we now own all of ScoutCam Ltd.’s
issued and outstanding share capital and have integrated and adopted ScoutCam Ltd.’s business into our Company as our primary business
activity.
ScoutCam
Ltd. was formed in the State of Israel on January 3, 2019 as a wholly-owned subsidiary of Medigus and commenced operations on March 1,
2019. ScoutCam Ltd. was incorporated as part of a reorganization of Medigus, which was designed to distinguish ScoutCam Ltd.’s
miniaturized imaging business, or the micro ScoutCam™ portfolio, from Medigus’ other operations and to enable Medigus to
form a separate business unit with dedicated resources focused on the promotion of such technology. On December 1, 2019, Medigus and
ScoutCam Ltd. consummated a certain Amended and Restated Asset Transfer Agreement, which transferred and assigned certain assets and
intellectual property rights related to its miniaturized imaging business. For additional information about the Amended and Restated
Asset Transfer Agreement, refer to – “CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE” below.
On May 18, 2020, in connection with the Arkin Transaction (as defined below), the Company and Medigus entered into a certain Side Letter
Agreement (the “Letter Agreement”), whereby the parties agreed to amend certain terms of the Amended and Restated Asset Transfer
Agreement and the License Agreement. For additional information about the Letter Agreement, refer to – “CERTAIN RELATIONSHIPS
AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE” below.
On
April 20, 2020, ScoutCam Ltd. entered into an Amended and Restated Intercompany Services Agreement with Medigus (the “Intercompany
Services Agreement”), which effectively amended and restated an intercompany services agreement dated May 30, 2019. For additional
information about the Intercompany Services Agreement, refer to – “CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR
INDEPENDENCE” below.
Sales
and Marketing
Our
vision is to improve the performance of organizations by offering prestigious tools that enhance the visual technological capabilities
and maximize AI analysis capabilities for companies across a variety of industries. Our mission is to become a global leader providing
innovative, off-the-shelf and custom-tailored visualization and analysis solutions to organizations across a variety of industries based
on highly resistant cameras and supplementary technologies. We are currently focused on custom-tailored solutions, and as a result have
a very limited offering of off-the-shelf products, which are used mainly as models for new uses of our technology and capabilities rather
than as a major source of revenue. Moreover, as we focus only on the visualization apparatus and supporting components, including for
example a small camera (that consists of a miniature Complementary Metal Oxide Semiconductor or CMOS video sensor, optics, filters, electronics,
housing and cables), illumination, cleaning methods (e.g., irrigation), and/or a mechanical structure based on the customer’s needs,
in most cases our products are components of the customer’s end-user products rather than independent end-user products.
Certain
illustrative examples of our component parts that have been previously integrated into our clients’ end-user products include:
5
The
Company’s micro ScoutCam™ 6.5 Lum, pictured above, was integrated into a NASA-commissioned project, and as a result it became
the first micro camera utilized in orbit when it was successfully operated outside the International Space Station in May 2015.
Pictured
above is a single-use visualization solution that was developed and sold to A.M. Surgical, which was designed to replace expensive and
bulky reusable endoscopes used in carpal tunnel surgery by their Stratos surgical device. We prepared both wired and wireless versions.
Our wireless device was cleared for marketing by the US Food and Drug Administration (FDA) and is compliant with FCC regulations.
Our
business model in the medical domain includes engaging companies seeking to add video visualization to their existing or new product(s)
or considering the development of new products that include micro video visualization. Accordingly, our customer base is exclusively
comprised of businesses, and therefore we are entirely removed from marketing, manufacturing, selling and distributing end-user products
to consumers. Our engagement with businesses is ordinarily conducted in two phases. During the first phase, we conduct the research and
development that is required in order to specify, design, develop, and produce the designated visualization apparatus, all for an agreed-upon
compensation amount (e.g., a non-recurrent engineering fee). During the second phase, we manufacture the apparatus and sell it to the
customer for an agreed-upon transfer price. In some cases, by customer request, we offer complete ‘turn-key’ contracts in
which we are responsible for most or all product phases, from the specifications phase to the provision of completed components or products
that are packaged and ready for sale. In such cases, we may conduct necessary regulatory tests and handle required regulatory approvals.
In addition, we may also be responsible, as necessary, for packaging, sterilization, labeling, and shipment.
In
the I4.0 domain, which target PdM and CBM applications, we intend to engage with companies who wish to increase the monitoring capabilities
of different elements of a device using our visual monitoring solutions (these include build of image acquisition, data collection and
storage, and image processing capabilities based on AI, ML and additional algorithm concepts). Based on our product portfolio with customized
solutions as needed, this will allow our customers to receive alerts on anomalies and failures as they are occur on the monitored component,
analyze and track trends and development of the anomaly and predict any impending failure of the component as a result of such anomaly
over time and usage.
As
a result, we expect customers to benefit from a reduction in downtime of their monitored equipment, using the prediction capabilities
of the platform to efficiently plan maintenance work on future faulty components. Another outcome we expect is more cost effective management
of resources, since components will only need to be replaced as a result of their actual condition rather than a strict maintenance schedule.
The
use of an image based platform in the fields of PdM and CBM provides richer and more informative data and insights not available with
traditional sensing methods. Together with the AI and ML models customized for the relevant use cases, we expect this will provide customers
with a clearer view of the status of their equipment, increasing revenues by saving on direct expenses and increasing the uptime of their
equipment.
Our
customers include technology-based companies and organizations, which are mainly large, well-established, international corporations.
Larger corporations provide financial stability, large purchased quantities, recurring revenue, and valid forecasts for extended durations.
In addition, we engage customers from various industries, such as biomedical, aerospace, energy, transportation, certain sensitive or
classified industries, security and defense, and research.
In
order to locate and secure new customers we employ both active and passive marketing strategies. As part of our active approach, we employ
three business development managers, in addition to other consultants, who analyze target industries and assess whether visualization
solutions may add value to companies operating in those industries. Once we have identified a potentially relevant industry, we approach
a variety of target companies and market the benefits of integrating our visualization solutions into their products. In addition, in
order to assist us in identifying such industries and target companies, we consult with subject matter experts from various industries.
6
In
addition to the active marketing strategy described above, we also employ a multitude of other marketing channels in order to increase
the exposure of our services to relevant industries. These marketing channels include advertising, participating in relevant tradeshows
and conferences, web-marketing, which includes a well maintained Company website, Search Engine Optimization (SEO), social media presence,
distribution of press-releases in target countries, as well as conventional marketing means, including brochures and presentations. Additionally,
we issue industry-specific marketing materials that are tailored to highlight the relevant features of our technology to a specific target
industry.
Our
marketing measures may include, but are not limited to, the following:
●
engaging
third party companies as territorial representatives in key markets;
●
initiating
business engagements based on leads received through our website, through active web based tools for lead generation, or via other
methods or means;
●
conducting
initial technical scopes and discussions together with such prospects in order to evaluate the feasibility of their contemplated
projects;
●
maintaining
an updated and detailed website presenting our core competency, solutions, use cases and proven track record;
●
promoting
our website in different search engines and other digital forums through SEO campaigning as well as other proactive digital marketing
measures;
●
employing
certain social media platforms for campaigning and advertising;
●
reconnecting
with our large database, which includes a multitude of past prospects;
●
developing
and refining marketing communications materials, including digital and printed brochures; and
●
participating
in major vision technology exhibitions as well as industry specific events.
In
addition to our business development efforts that are mainly based on currently existing or future customer needs, we aim to identify
new market opportunities. These efforts include systematical analysis of industrial fields as well as medical fields and procedures in
order to identify where visualization solutions, including image analysis, might benefit and attract value. When a potential opportunity
is identified, we protect our rights by establishing relevant intellectual property safeguards, develop various prototypes that may be
relevant for the specific application and engage key opinion leaders in that field to validate the feasibility of our solutions. In the
medical domain, given that we are not a business-to-consumer, or B2C, company, our business model does not include commercialization
of end-user products; nevertheless, we seek to partner with relevant companies to convert our innovative prototypes into market-ready
products, complete the required regulatory clearances, and commercialize them based on revenue share models. Regarding the I4.0 domain,
we are in the process of transforming our products and projects into market ready solutions, aiming to commercialize our platform as
part of a SaaS model offering with multi-year contracts which include required hardware, software, cloud service and ongoing support
and maintenance.
Regarding
project based solutions, we have certain internal procedures in place once a potential customer is identified which help provide a roadmap
for the ensuing working relationship. Prior to any formal engagement with a potential customer, two of our departments – business
development and R&D – work in parallel to define an understanding with the customer that will ordinarily incorporate two phases:
(a) an R&D phase, during which the R&D team develops a custom-tailored visualization component that synthesizes our technology
and skill with the customer’s stated requirements, specifications, and business constraints, and which phase generally includes
a formal agreement with respect to a Non-Recurrent Engineering (NRE) fee that is typically payable according to a pre-defined set of
milestones; and (b) a production phase, during which we manufacture and supply the component parts for an agreed upon transfer price.
7
Over
the years, we have offered and implemented tailor-made pricing schemes that allows us to separately price services rendered during the
previously described first phase. Pricing of this first phase is typically prepared by the engineering team, which provides an assessment
of the anticipated costs associated with the R&D of the project, which price will depend on a given customer’s specifications
and project vision. Such costs may include, inter alia, engineering labor, any contracts with sub-contractors, tooling, off-the-shelf
and newly designed components, materials, prototypes production, testing, management overhead, and travel costs. Once we have completed
our cost estimation for the R&D phase, we issue a quote for such services to the customer.
In
order to develop a transfer price in connection with the aforementioned second phase, the expected Bill-Of Material (BOM) and Cost-Of-Good
Sold (COGS) are established and we develop a quotation accordingly. Often times there are certain modifications to the original project
outlined and agreed upon in the R&D phase, which might necessitate an increase or decrease to the pricing of the overall project.
For that reason, we tend to include a certain margin of flexibility in the final target transfer price. In addition, we usually link
the end transfer price with both annual and per-order Minimum Order Quantities (MOQ), in order to reflect the actual production quantity
of the COGS as well as to commercially incentivize the customer to order larger quantities.
Both
the negotiation process and the contract drafting are usually done in collaboration with the customer, such that both sides can verify
throughout the process that the final agreement meets their technological and business expectations. Furthermore, we seek to maintain
close contact with the customer throughout the two phases of our engagement, including for example, by way of teleconferences, virtual
and actual meetings, document exchanges, on-site visits, and reporting of any completion of predefined milestones.
Regarding
our off the shelf products, the NRE phase in project based commercial interactions is not relevant, and the pricing model is set up front
based on the cost, margin and value that the product creates.
Our
Customers
Currently,
we have one major customer that is expected to generate most of our forecasted revenue in the near term: a large international bio-med
company that is developing a visualization component for its minimally-invasive surgical device. In addition to the foregoing
material customer, we are engaged in initial negotiations with multiple potential customers operating in a variety of sectors, including
biomedical, aerospace, aviation, automotive, energy, military and security, and others. In the I4.0 segment, aviation industries (both
manned and unmanned) are currently the source of our greatest level of interest, with recent growing interest coming from the transportation
(specifically railway) and energy (specifically wind turbine) sectors. We are pursuing these potential engagements with the goal of securing
proof of concepts and launching commercial pilots that may then materialize into multi-year production contracts. We are in various stages
of engagement with a variety of customers in all the above mentioned industries.
In
the biomedical space, for example, we generally seek to partner with medical device and pharmaceutical companies that develop endoscopes
with or without additional functionality. This variation allows the endoscope to be introduced into anatomical parts that were previously
(prior to adopting ScoutCam’s visualization solution) not accessible within the video-endoscope space either because of outer diameter
limitations and/or price. To this end, we focus on single-use products that accommodate the global trend to transition from expensive,
multi-use products that require a thorough cleaning protocol, but which cannot be sterilized, to single-use products.
Lastly,
we have recently mobilized efforts to market the possibility of employing our visualization technology and solutions for the purposes
of monitoring sensitive mechanical structures and elements in the aviation sector, engaging on a pilot basis with the Israeli Air Force
regarding their helicopters and unmanned aerial vehicles and with several defense companies. Such an application complements global market
trends associated with Industry 4.0 and Internet of Things, in which machines are programmed to test themselves and their production
output, which then automatically alerts the processor of any potential problems at the outset of an endeavor.
8
Competition
There
are currently several companies that offer small cameras, including, but not limited to, Opcom, Fujikura-Picoramedic, Awaiba, Fisba,
and Misumi. Unlike these competitors, we offer customized solutions, which include additional components as needed. Other companies,
such as IntraVu, Medit, and SPI Engineering, offer complete, small diameter, off-the shelf endoscopes/borescopes. Our focus, however,
is on customizing and integrating our solutions into a given customer’s device. Certain companies, such as Enable, Myriad Fiber
Imaging Tech., Inc., and Precision Optics, act as our direct competitors, since they offer similar services to those that we offer.
In
addition, there are currently many companies that develop and provide monitoring solutions for PdM and CBM. These monitoring solutions
can be the sensor itself, data collection and storage, AI processing, or a combination of these capabilities. The CBM and PdM solutions
are usually based on traditional sensing solutions such as vibration, temperature, and acoustic sensors. Based on our research and discussions
with customers, we believe these traditional sensing methods are limited in their ability to provide an in depth view of the condition
of the monitored components and usually alert on the occurrence of an anomaly when component failure has already occurred, which is too
late in some cases. From the AI perspective, there are several vendors providing off-the-shelf AI capabilities which then require customization
per market, use case, and/or data source. Our more holistic approach and reliance on image based solutions creates richer and more informative
data, leveraged by AI and ML algorithms, enabling our customers to deploy predictive maintenance programs.
Proprietary
Rights and Technology
As
we develop customized components and/or products per market needs or per specific customer requirements, our various projects are constantly
in different stages of development, including: planning, early R&D for a proof of concept, R&D for a prototype, final product/component
development, engineering necessary for a production-ready version, and production of initial batches.
We
currently own a total of six patent families which we consider material to our business and operating success. Our intellectual property
rights include patents and patent applications that were transferred to us by Medigus as part of the Addendum No. 1 to Amended and Restated
Asset Transfer Agreement (the “Addendum”), the License Agreement and the Letter Agreement, additional patent assets developed
by ScoutCam and an asset assigned to us from a third party. For additional information about the License Agreement refer to – “CERTAIN
RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE” below. Under the Addendum, and subject to certain limitations
as further set forth therein, Medigus transferred to us the following material patent families in exchange for a license in connection
with the marketing and sale of the Medigus Ultrasonic Surgical Endostapler:
●
Patent family related to Integrated Endoscope Irrigation: this patent family relates to our ability to develop visualization components
and endoscopes, which include irrigation with a smaller outer diameter by saving the space of the tube that is required to lead the fluids
in a conventional manner. This patent has been granted in Canada, Europe (validated in Germany, Spain, France, Great Britain and Italy),
Israel, Japan (original and divisional), and the United States, and has an allowed continuation patent application and an additional
pending continuation in the United States. The expiration date for this patent in the United States is December 3, 2033, and in each
of the other aforementioned jurisdictions is February 28, 2033;
●
Patent family related to Small Diameter Video Camera Heads and Medical Devices and Visualization Probes containing them: this patent
family relates to our ability to develop cameras, visualization components, and medical devices with a small diameter, thus enabling
the insertion of the camera into smaller cavities or leaving more space in the device for the use and application of other functions,
such as a working channel. This patent has been granted in Japan, Korea, Israel, the United States (2 patents, original and continuation
in part), and Europe (3 patents, original and 2 divisionals, currently under opposition proceedings, validated in Germany, France, Great
Britain, and Italy) and also has patent assets pending an opposition appeal in Europe. The expiration dates for these patents in the
United States are April 5, 2032 and March 10, 2031, and in each of the other aforementioned jurisdictions September 16, 2030.
As
a result of oppositional proceedings initiated by a third party in 2018, the Opposition Division of the EU Patent Office decided in 2019
to revoke two of the three European patents (EP 2.478.693 and EP 2.621.159) and in 2021 to maintain the third patent (EP 2.621.158).
Following appeals by Company and the third party of the 2019 and 2021 decisions, respectively, the Opposition Division of the EU Patent
Office is expected to hear and decide these matters in late 2022 or early 2023; and
●
Patent family related to Camera Head: this patent family relates to our ability to develop cameras, visualization components,
and endoscopes with a smaller total outer diameter, by reducing the outer diameter of the electronic board on which the sensor is mounted,
thus enabling the insertion of the camera into smaller cavities or leaving more space in the device for the use and application of other
functions, such as a working channel. This patent has been granted in Israel and the United States, and is pending approval in Canada,
Europe, Japan (original and divisional applications), and a continuation in part patent application in the United States. The expiration
date for this patent in Israel is June 11, 2035, and in each of the other aforementioned jurisdictions is June 9, 2036.
9
In
addition, our intellectual property rights further include the following material patent applications filed by ScoutCam:
●
Patent family related to Miniature Precision Medical Device: these pending patent applications relate to our ability to develop a
miniature precision medical device comprising an endoscope with at least one camera, where at least one sensor of one camera is
distally located at a tip of a shaft of the endoscope. Surrounding or next to the sensor, such shaft has sufficient space to
accommodate at least one accessory such as, for example, illumination source, irrigation tool, or suctioning tool. This patent
family has pending patent application in the United States and its expected expiry dates, if issued, will be in
2039-2040.
●
Patent family related to Medical Ophthalmic Device: this patent family is related to a tool comprising a hand piece
having a flattened cannulated tip that is adapted to receive flow from a pumping unit, in order to generate a jet of fluid suitable for
procedures such as “hydro-dissecting” cells in the eye. According to a representation of the invention, the tool comprises
a visualization probe with at least one camera, wherein the sensor of the camera is distally located at the tip of the tool to be inserted
into the eye for imaging from within the eye. This patent family is pending in China, Europe, Japan, Korea, and the United States. The
patent application’s expected expiry dates, if issued, will be in 2039-2040.
●
Patent family related to AI-Based and/or Electronic-Controlled Miniature Camera Sensor and Detector System this patent family
relates to sensor and detector systems for the development of very small size and resilient visualization capabilities. Such
systems can be used in extreme conditions and/or in conjunction with diagnostic software/hardware tools to display and analyze
changes in critical images that could not have been displayed or analyzed using existing systems. This patent family includes a
pending Patent Cooperation Treaty patent application. If ultimately issued by the United States Patent and Trademark Office, such
patent would be expected to expire in early 2042.
Employment
We
currently have approximately 35 full-time (or near full-time) employees. This number is expected to grow. We may recruit additional employees
to the R&D team.
Research
and Development
Our
R&D organization is responsible for the design, development, testing, and delivery of new technologies, features, products, and integrations
of our component parts. Research and development employees are located primarily in our principal corporate office on Omer, Israel. We
currently have approximately 14 employees in our research and development organization. We intend to continue to invest in our research
and development capabilities.
Regulation
Our
approach to regulation is generally determined based on a given project. In our engagements with customers operating in the biomedical
sector, we comply with the medical device standards in that corresponding territory, such as the FDA or International Organization for
Standardization (ISO), among others. Compliance with these regulations is achieved through our QA department and the support we receive
from highly experienced quality assurance and regulatory affairs consultants. In addition, we are being audited annually by MEDCERT GmbH,
a German Notified Body.
For
instance, ISO 13485:2016 is a regulatory benchmark that we comply with while working on our medical device projects. ISO 13845:2016 is
similar to ISO 9001 in terms of its quality management system (QMS) requirements, however, ISO 13485:2016 is generally considered more
rigorous and comprehensive.
10
Given
that we do not manufacture or distribute end-user products to the medical sector, and instead service businesses pursuant to a B2B model,
we are subject to far fewer regulatory standards commonly associated with medical device manufacturers or distributors. We develop and
manufacture components for other companies, and therefore our involvement in the regulatory submission demands comparatively less responsibility
This notwithstanding, we are careful to communicate with the business customer in order to identify certain regulatory dimensions inherent
to the project, to which we should pay additional attention. For example, when a component of ours is integrated into a business’s
end-user product, such as for the purpose of touching human tissue, we develop and manufacture our parts and components while taking
into account certain applicable regulatory standards. These standards might include, inter alia, relevant FDA regulations (e.g. CFR 21
part 820, the medical device reporting requirements (MDR), among others) as well as ISO regulations (e.g. ISO 14644-1, specifically in
connection with cleanrooms and associated controlled environments, among other items, or ISO 10993, in connection with the biological
evaluation of medical devices). Furthermore, we prioritize our team’s compliance with the Restriction of Hazardous Substances Directives
(RoHS) and REACH (EC 1907/2006).
Similarly,
if a component part of ours is incorporated into an electronic device for the purpose of being used inside a human body, we ensure compliance
with certain FDA requirements as well as IEC 60601 for safety and Electrostatic discharge, including the heating of parts at more than
42 degrees Celsius, as well as a variety of additional technical standards designed for the safety and essential performance of medical
electrical equipment. Moreover, we perform risk management assessments in accordance with EN ISO 14971:2019 and ISO/TR 24971:2020.
In
certain instances, our customers prefer that we conduct the testing of its products in internationally certified labs in order to further
guarantee our component parts satisfy the applicable regulatory standards. In this scenario, we perform the required tests as a service
to the customer and provide the customer with the official test results, specifically in accordance with ISO/IEC 17025:2017, which the
customer can later use in order to apply for the required marketing clearance of its end-user product.
Since
we are targeting to sell our products to customers in the aviation sector, we are in the process of implementing the AS9100D Standard
to comply with aerospace industry requirements. Once achieved, this standard will allow us to operate with an aerospace compatible quality
management system.
Israeli
Government Programs
As
a result of certain agreements between Medigus and ScoutCam Ltd. (for additional information about these agreements refer to –
“CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE” below) the Israel Innovation Authority, or the
IIA, approved a transfer of IIA know-how developed by Medigus in the framework of the Bio Medical Photonic Consortium, or the Medigus
Consortium, to ScoutCam Ltd.
Accordingly,
all rights and obligations with regard to the IIA under the Encouragement of Research, Development
and Technological Innovation in the Industry Law, 5744-1984, or the Innovation Law, in connection with such know-how now apply
to ScoutCam Ltd.
The
following are details regarding the rights and obligations within the framework of ScoutCam Ltd.’s activity in the Medigus Consortium,
which continue to apply to ScoutCam Ltd. notwithstanding the termination of the Medigus Consortium:
(i)
The
property rights to information which has been developed belongs to the Medigus Consortium member that developed it. However, the
developing entity is obligated to provide the other members in the Medigus Consortium a license for the use of the new information,
without consideration, provided that the other members do not transfer such information to any entity which is not a member of the
Medigus Consortium. The provision of a license or of the right to use the new information to a third party is subject to approval
by the administration of the MAGNET Program at the IIA;
(ii)
The
Medigus Consortium member is entitled to register a patent for the new information which has been developed by it within the framework
of its activity in the Medigus Consortium. The foregoing registration does not require approval from the administration of the MAGNET
Program at the IIA; and
(iii)
The
know-how and technology developed under the program is subject to the restrictions set forth under the Innovation Law, including
restrictions on the transfer of such know-how and any manufacturing rights with respect thereto, without first obtaining the approval
of the IIA. Such approval may entail additional payments to the IIA, as determined under the Innovation Law and regulations.
11
Obligations
relevant to us under the Innovation Law include the following:
●
Local
Manufacturing Obligation. The terms of the grants under the Innovation Law require that we
manufacture the products developed with these grants in Israel. Under the regulations promulgated
under the Innovation Law, the products may be manufactured outside Israel by us or by another
entity only if prior approval is received from the IIA (such approval is not required for
the transfer of less than 10% of the manufacturing capacity in the aggregate, in which case
a notice should be provided to the IIA). In general, due to manufacturing outside
Israel, with respect to royalties bearing grants we would be required to pay royalties at
an increased rate, usually 1% in addition to the standard rate and increased royalties cap
(between 120% and 300% of the grants, depending on the manufacturing volume that is performed
outside Israel).
●
Know-How
Transfer Limitation. The Innovation Law restricts the ability to transfer, in any manner, know-how funded directly or indirectly by the
IIA (sale of products is not prohibited), unless the IIA approves doing so and subject to the terms of the Innovation Law and of the
IIA’s approval.
Among other things, transfer
of IIA funded know-how outside of Israel requires prior approval of IIA and in certain circumstances is subject to certain payments
to the IIA, calculated according to a formula provided under the Innovation Law. If we wish to transfer IIA funded know-how
outside of Israel, the terms for approval will be determined according to the character of the transaction and the consideration
paid to us for such transfer. The IIA approval to transfer know-how created, in whole or in part, in connection with a IIA-funded project
to third party outside Israel where the transferring company remains an operating Israeli entity is subject to payment of a redemption
fee to the IIA calculated according to a formula provided under the Innovation Law that is based, in general, on the ratio between the
aggregate IIA grants to the company’s aggregate investments in the project that was funded by these IIA grants, multiplied by the
transaction consideration, considering statutory depreciation and less royalties already paid to the IIA. The transfer of such
know-how to a party outside Israel where the transferring company ceases to exist as an Israeli entity is subject to a redemption fee
formula that is based, in general, on the ratio between aggregate IIA grants received by the company and the company’s aggregate
research and development expenses, multiplied by the transaction consideration considering statutory depreciation and less royalties
already paid to the IIA. The regulations promulgated under the Innovation Law establish a maximum payment of the redemption fee paid
to the IIA under the above mentioned formulas and differentiates between two situations: (i) in the event that the company transfers
its IIA funded know-how, in whole or in part, or is sold as part of an M&A transaction, and subsequently ceases to conduct business
in Israel, the maximum redemption fee under the above mentioned formulas will be no more than six times the amount received (plus annual
interest) for the applicable know-how being transferred, or the entire amount received from the IIA, as applicable; (ii) in the event
that following the transactions described above (e.g. asset sale of IIA funded know-how or transfer as part of an M&A transaction)
the company continues to conduct its research and development activity in Israel (for at least three years following such transfer and
maintain staff of at least 75% of the number of research and development employees it had for the six months before the know-how was
transferred and keeps the same scope of employment for such research and development staff), then the company is eligible for a reduced
cap of the redemption fee of no more than three times the amounts received (plus annual interest) for the applicable know-how being transferred.
In addition, special rules and payment formulas apply for certain kinds of transfers of know-how outside of Israel, such as R&D
licenses. Transfer of IIA-funded know-how outside of Israel not according to the R&D Law may give rise to financial exposure as well
as criminal liability.
●
Approval
of the transfer of IIA funded technology to another Israeli company may be granted only if the recipient assumes and abides
by the provisions of the Innovation Law and related regulations, including the restrictions on the transfer of know-how and
manufacturing rights outside of Israel (in addition, there will be an obligation to pay royalties to the IIA from the income of such
sale transaction as part of the royalty payment obligation).
●
Approval
to manufacture products outside of Israel or consent to the transfer of technology, if requested, might not be granted. Furthermore,
the IIA may impose certain conditions on any arrangement under which it permits ScoutCam Ltd. to transfer technology or development
out of Israel.
12
Properties
We
do not own property and currently lease our principal corporate office, which is located at Suites 7A and 3B, Industrial Park, P.O. Box
3030, Omer, Israel 8496500. We believe our leased office sufficiently meets our current needs.
item
1a. risk factors
Risk
Factor Summary
Below
is a summary of the principal factors that make an investment in the Company speculative or risky. This summary does not address all
of the risks that we face. Additional discussion of the risks summarized in this risk factor summary, and other risks that we face, can
be found below, after this summary, and should be carefully considered.
Risks
Related to Our Business, Operations and Financial Condition
●
We
have had a limited operating history and may not be able to successfully operate our business or execute our business plan.
●
If
we are unable to establish sales, marketing and distribution capabilities or enter into successful relationships with business targets
and third parties to perform these services, we may not be successful in commercializing our products and technology.
●
We
may require substantial additional funding, which may not be available to us on acceptable terms, or at all.
●
Our
failure to effectively manage growth could impair our business.
●
Our
commercial success depends upon the degree of market acceptance by the medical community as well as by other prospective markets
and industries.
●
The
COVID-19 pandemic has adversely affected, and may continue to adversely affect, our business, financial condition, liquidity and
results of operations.
Risk
Related to Third Parties
●
Our
reliance on third-party suppliers for most of the components of our products, including miniature video sensors which are suitable
for our CMOS technology products mainly in the medical domain, could harm our ability to meet demand for our products in a timely
and cost-effective manner.
●
We
may not be able to manage our strategic partners effectively.
●
We
may not have sufficient manufacturing capabilities to satisfy any growing demand for our commissioned products. We may be unable
to control the availability or cost of producing such products.
Risks
Related to Competition
●
We
expect to face significant competition. If we cannot successfully compete with new or existing technologies or future developed products,
our marketing and sales will suffer and we may never be profitable.
●
Our
customers may develop the capabilities of our solution in-house, which would significantly reduce the demand for our products.
●
Failure
to comply with anti-bribery, anti-corruption and anti-money laundering laws could subject us to penalties and other adverse consequences.
Risks
Related to Intellectual Property
●
We
may not be able to obtain patents or other intellectual property rights necessary to protect our proprietary technology and business.
13
General
Risk Factors Related to Our Business
●
Our
business and operations would suffer in the event of computer system failures, cyber-attacks, or deficiencies in our cyber-security.
●
We
may be subject to product liability claims, product actions, including product recalls, and other field or regulatory actions that
could be expensive, divert management’s attention, and harm our business.
●
Testing
of our technologies potential applications for our products will be required and there is no assurance of regulatory approval.
●
We
rely on highly skilled personnel, and, if we are unable to attract, retain, or motivate qualified personnel, we may not be able to
operate our business effectively.
●
We
may be unable to keep pace with changes in technology as our business and market strategy evolves.
Risks
Related to this Offering and Our Common Stock
●
Although
we have filed an application to list our securities on Nasdaq, there can be no assurance that our securities will be so listed or,
if listed, that we will be able to comply with the continued listing standards.
●
Trading
on the OTC Markets is volatile, sporadic and often thin, which could depress the market price of our common stock and make it difficult
for our stockholders to resell their common stock.
●
Nevada
law and provisions in our amended and restated articles of incorporation and amended and restated bylaws could make a merger, tender
offer or proxy contest difficult, thereby depressing the market price of our common stock.
●
The
market price of our common stock may be highly volatile and such volatility could cause you to lose some or all of your investment.
●
Because
our common stock may be deemed a “penny stock,” it may be more difficult for investors to sell shares of our common stock,
and the market price of our common stock may be adversely affected.
●
Compliance
with the reporting requirements of federal securities laws can be expensive.
●
Our
investors’ ownership in the Company may be diluted in the future.
●
Directors,
executive officers, principal stockholders, and affiliated entities own a significant percentage of our capital stock, and they may
make decisions that our stockholders do not consider to be in their best interests.
●
We
do not anticipate paying any cash dividends in the foreseeable future.
Risks
Related to our Operations in Israel
●
Political,
economic and military instability in Israel may impede our ability to operate and harm our financial results.
●
It
may be difficult for investors in the United States to enforce any judgments obtained against us or some of our directors or officers.
●
Exchange
rate fluctuations between foreign currencies and the U.S. Dollar may negatively affect our earnings.
●
Certain
technology developed and used by us received Israeli government grants for certain research and development activities. The terms
of those grants require us to satisfy specified conditions in addition to repayment of the grants upon certain events.
●
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.
Certain
factors may have a material adverse effect on our business, financial condition, and results of operations. You should carefully consider
the following risks, together with all of the other information contained in this Annual Report on Form 10-K, including the sections
titled “Forward-Looking Statements” and “Management’s Discussion and Analysis of Financial Condition and Results
of Operations” and our financial statements and the related notes included elsewhere in this Annual Report on Form 10-K. Any of
the following risks could materially and adversely affect our business, strategies, prospects, financial condition, results of operations,
and cash flows. In such case, the market price of our common stock could decline. Our business, prospects, financial condition, or results
of operations could also be harmed by risks and uncertainties not currently known to us or that we currently do not believe are material.
14
Risks
Related to Our Business, Operations and Financial Condition
We
have had a limited operating history and may not be able to successfully operate our business or execute our business plan.
Given
our limited operating history, it is hard to evaluate our proposed business and prospects. Our proposed business operations will be subject
to numerous risks, uncertainties, expenses and difficulties associated with early-stage enterprises. Such risks include, but are not
limited to, the following:
●
the
absence of a lengthy operating history;
●
expected
continual losses for the foreseeable future;
●
operating
in multiple currencies;
●
our
ability to anticipate and adapt to a developing market(s);
●
acceptance
of our products by the medical and industrial (I4.0) markets (and the non-medical community) and consumers;
●
limited
marketing experience;
●
limited
experience in developing and implementing full platform solutions including AI and cloud;
●
insufficient
capital to fully realize our operating plan;
●
a
competitive environment characterized by well-established and well-capitalized competitors;
●
the
ability to identify, attract and retain qualified personnel; and
●
operating
in an environment that is highly regulated by a number of agencies.
Because
we are subject to these risks, evaluating our business may be difficult, our business strategy may be unsuccessful and we may be unable
to address such risks in a cost-effective manner, if at all. If we are unable to successfully address these risks our business could
be harmed.
If
we are unable to establish sales, marketing and distribution capabilities or enter into successful relationships with business targets
and third parties to perform these services, we may not be successful in commercializing our products and technology.
Given
that we are currently as a B2B company, our business is reliant on our ability to successfully attract potential business targets. Furthermore,
we have a limited sales and marketing infrastructure and have limited experience in the sale, marketing, or distribution of our technologies
beyond the B2B model. To achieve commercial success for our technologies or any future developed product, we will need to establish a
sales and marketing infrastructure or to out-license such future products.
In
the future, we may consider building a focused sales and marketing infrastructure to market any future developed products and potentially
other products in the United States or elsewhere in the world. There are risks involved with establishing our own sales, marketing, and
distribution capabilities. For example, recruiting and training a sales force could be expensive and time consuming and could delay any
product launch. This may be costly, and our investment would be lost if we cannot retain or reposition our sales and marketing personnel.
15
Factors
that may inhibit our efforts to commercialize any future products on our own include:
●
our
inability to recruit, train, and retain adequate numbers of effective sales and marketing personnel;
●
the
inability of sales personnel to obtain access to potential customers;
●
the
lack of complementary products to be offered by sales personnel or lack of product-market fit, which may put us at a competitive
disadvantage relative to companies with more extensive product lines; and
●
unforeseen
costs and expenses associated with creating an independent sales and marketing organization.
If
we are unable to establish our own sales, marketing, and distribution capabilities or enter into successful arrangements with third parties
to perform these services, our revenues and our profitability may be materially adversely affected.
In
addition, we may not be successful in entering into arrangements with third parties to sell, market, and distribute our products inside
or outside of the United States or may be unable to do so on terms that are favorable to us. We likely will have little control over
such third parties, and any of them may fail to devote the necessary resources and attention to sell and market our products effectively.
If we do not establish sales, marketing, and distribution capabilities successfully, either on our own or in collaboration with third
parties, we will not be successful in commercializing our technologies or any future products we may develop.
We
may require substantial additional funding, which may not be available to us on acceptable terms, or at all.
Our
cash and short-term deposit balance as of December 31, 2021 was $19.6 million. We may require additional funding to fund and grow our
operations and to develop certain products. There can be no assurance that financing will be available in amounts or on terms acceptable
to us, if at all. In the event we required additional capital, the inability to obtain such capital will restrict our ability to grow
and may reduce our ability to continue to conduct business operations. If we require and are unable to obtain additional financing, we
will likely be required to curtail our development plans. In that event, current stockholders would likely experience a loss of most
or all of their investment. Additional funding that we do obtain may be dilutive to the interests of existing stockholders.
Our
failure to effectively manage growth could impair our business.
Our
business strategy contemplates a period of rapid growth which may put a strain on our administrative and operational resources, and our
funding requirements. Our ability to effectively manage growth will require us to successfully expand the capabilities of our operational
and management systems, and to attract, train, manage, and retain qualified personnel. There can be no assurance that we will be able
to do so, particularly if losses continue and we are unable to obtain sufficient financing. If we are unable to appropriately manage
growth, our business, prospects, financial condition, and results of operations could be adversely affected.
Our
commercial success depends upon the degree of market acceptance by the medical community as well as by other prospective markets and
industries.
Our
current business model is that of a B2B approach in which we seek to identify target businesses interested in integrating our technology,
or commissioning individual projects using our technology. Any product that we commission or that is brought to the market may or may
not gain market acceptance by prospective customers. The commercial success of our technologies, commissioned products, and any future
product that we may develop depends in part on the medical community as well as other industries for various use cases, depending on
the acceptance by such industries of our commissioned products as a useful and cost-effective solution compared to current technologies.
During 2021, we commenced proactive market penetration into industries other than the biomedical sector. If our technology or any future
product that we may develop does not achieve an adequate level of acceptance, or does not garner significant commercial appeal, we may
not generate significant revenue and may not become profitable. The degree of market acceptance will depend on a number of factors, including:
●
the
cost, safety, efficacy/performance, perceived value and convenience of our technology and any commissioned product and any future
product that we may develop in relation to alternative products;
16
●
the
ability of third parties to enter into relationships with us without violating their existing agreements;
●
the
effectiveness of our sales and marketing efforts;
●
the
strength of marketing and distribution support for, and timing of market introduction of, competing technology and products; and
●
publicity
concerning our technology or commissioned products or competing technology and products.
Our
efforts to penetrate industries and educate the marketplace on the benefits of our technology, and reasons to seek the commissioning
of products based on our technology, may require significant resources and may never be successful. Such efforts to educate the marketplace
may require more resources than are required by conventional technologies.
The
COVID-19 pandemic has adversely affected, and may continue to adversely affect, our business, financial condition, liquidity and results
of operations.
To
date, the COVID-19 pandemic has not had a material effect on our operations. However, the measures adopted to contain and mitigate the
effects of the COVID-19 pandemic, including stay-at-home, business closure, social distancing, capsuled labor, and other restrictive
orders, and the resulting changes in consumer behaviors, have disrupted our normal operations and impacted our employees and suppliers.
We expect these disruptions and impacts to continue. In addition, certain of our suppliers experienced delays and shut-downs due to the
COVID-19 pandemic and we have experienced supply chain disruptions due to multiple factors, such as fulfillment center disruption and
limited shipping capacity. This has led to abnormally high transportation delays and shipping costs, which has increased our cost of
goods sold. Further, the continuation of the COVID-19 pandemic has led to increased operational and cybersecurity risks, including those
related to a number of our employees working remotely. These risks include, among others, increased demand on our information technology
resources and systems, the increased risk of phishing, and other cybersecurity attacks as cybercriminals try to exploit an increased
number of points of possible attack, such as laptops and mobile devices, both of which are now being used in increased numbers. Any failure
to effectively manage these increased operational and cybersecurity demands and risks, including to timely identify, appropriately respond
to, and remediate cybersecurity attacks and other security incidents, may materially adversely affect our results of operations and the
ability to conduct our business.
Given
the continued spread of COVID-19, including the emergence of COVID-19 variants, such as the recent Delta and Omicron variants, and the
resultant personal, economic and governmental reactions, we may have to take additional actions in the future that could adversely affect
our business, financial condition, and results of operations, including a return to a fully remote workforce.
These
changes could negatively impact our operations, sales, and marketing in particular, which could have longer-term effects on our sales
pipeline, or create operational or other challenges as our workforce remains predominantly remote, any of which could adversely affect
our business, financial condition, and results of operations. In addition, our management team has spent, and will likely continue to
spend, significant time, attention, and resources monitoring the COVID-19 pandemic and associated global economic uncertainty and seeking
to manage its effects on our business and workforce. The degree to which COVID-19 will affect our business, financial condition, and
results of operations will depend on future developments that are highly uncertain and cannot currently be predicted. These developments
include, but are not limited to, the duration, extent, impact and severity of the COVID-19 pandemic in different geographies, the effectiveness
of our transition from work-from-home arrangements to a gradual return to our offices, actions taken to contain the COVID-19 pandemic,
the long-term efficacy, global availability and acceptance of vaccines, related restrictions on economic activity and domestic and international
trade, and the extent of the impact of these and other factors on our employees, suppliers, and customers. The COVID-19 pandemic and
related restrictions could limit supplier and distributors’ ability to continue to operate (limiting their abilities to obtain
inventory, generate sales, ship and dispatch orders, or make timely payments to us). It could disrupt or delay the ability of employees
to work because they become sick or are required to care for those who become sick or for dependents for whom external care is not available.
In addition, the COVID-19 pandemic may also result in reduced consumer spending and adverse or uncertain economic conditions globally,
which in turn may impact our revenue.
17
Risk
Related to Third Parties
Our
reliance on third-party suppliers for most of the components of our products, including miniature video sensors which are suitable for
our CMOS technology products mainly in the medical domain, could harm our ability to meet demand for our products in a timely and cost-effective
manner.
We
rely on our third-party suppliers to obtain an adequate supply of quality components on a timely basis with favorable terms to manufacture
our commissioned products. Some of those components that we sell are provided to us by a limited number of suppliers. We will be subject
to disruptions in our operations if our sole or limited supply contract manufacturers decrease or stop production of components or do
not produce components and products of sufficient quantity or quality. Alternative sources for our components will not always be available.
Though
we attempt to ensure the availability of more than one supplier for each important component in any product that we commission, the number
of suppliers engaged in the provision of miniature video sensors which are suitable for our CMOS technology mainly in the medical domain
is very limited, and therefore in some cases we engage with a single supplier, which may result in our dependency on such supplier. This
is the case regarding sensors for the CMOS type technology that are produced by a single supplier in the United States. As we do not
have a contract in place with this supplier, there is no contractual commitment on the part of such supplier for any set quantity of
such sensors. The loss of our sole supplier in providing us with miniature sensors for our CMOS technology products mainly in the medical
domain, and our inability or delay in finding a suitable replacement supplier, could negatively affect our business, financial condition,
results of operations, and reputation.
We
are also subject to other risks inherent in the manufacturing of our products and their supply chain, including industrial accidents,
natural disasters (including as a result of climate change), environmental events, strikes, and other labor disputes, capacity constraints,
disruptions in material or packaging supplies, as well as global shortages, disruptions in supply chain or information technology, loss
or impairment of key manufacturing sites or suppliers, product quality control, safety, increase in commodity prices and energy costs,
licensing requirements and other regulatory issues, as well as other external factors over which we have no control. If such an event
were to occur, it could have an adverse effect on our business, financial condition, and results of operations. In addition, we may experience
interruptions with our suppliers and other supply chain disruptions as a result of the COVID-19 pandemic, or any other international
disorder. In recent months, global supply chain disruptions have slowed receipt of some of our supplies and delayed some of our deliveries,
although as yet not materially, and increased some of our product costs. Although such cost increases have been fully covered by our
customers to date, there is no assurance that this will continue in the future.
In
addition, if we cannot supply commissioned products or future potentially developed products due to a lack of components, or are unable
to utilize other components in a timely manner, our business will be significantly harmed. If inventory shortages occur, they could be
expected to have a material and adverse effect on our future revenues and ability to effectively project future sales and operating results.
We
may not be able to manage our strategic partners effectively.
We
have entered into, and we may continue to enter into, strategic alliances with third parties to gain access to new and innovative technologies
and markets. These parties are often large, established companies. Negotiating and performing under these arrangements involves significant
time and expense, and we may not have sufficient resources to devote to our strategic alliances, particularly those with companies that
have significantly greater financial and other resources than we do. The anticipated benefits of these arrangements may never materialize,
and performing under these arrangements may adversely affect our results of operations.
Failure
to manage our current partners effectively or enter into new strategic alliances may affect our success in executing our business plan
and may adversely affect our business, financial condition, and results of operation. We may not realize the anticipated benefits of
any or all partnerships, or may not realize them in the time frame expected.
18
We
may not have sufficient manufacturing capabilities to satisfy any growing demand for our commissioned products. We may be unable to control
the availability or cost of producing such products.
Our
current manufacturing capabilities may not reach the required production levels necessary in order to meet growing demands for any products
we may commission or future products we may develop. There can be no assurance that our commissioned products can be manufactured at
our desired commercial quantities, in compliance with our requirements, and at an acceptable cost. Any such failure could delay or prevent
us from shipping said products and marketing our technologies in accordance with our target growth strategies.
Risks
Related to Competition
We
expect to face significant competition. If we cannot successfully compete with new or existing technologies or future developed products,
our marketing and sales will suffer and we may never be profitable.
We
expect to compete against existing technologies and proven products in different industries. In addition, some of these competitors,
either alone or together with their collaborative partners, operate larger research and development programs than we do, and may have
substantially greater financial resources than we do, as well as significantly greater experience in obtaining regulatory approvals applicable
to the commercialization of relevant competitive technologies and future products.
Our
customers may develop the capabilities of our solution in-house, which would significantly reduce the demand for our products.
Our
customers may develop the capabilities to manufacture solutions in-house that are currently satisfied by our solutions. In the event
our customers, or future customers, develop such capacities, our potential for profitability may be significantly reduced.
Failure
to comply with anti-bribery, anti-corruption and anti-money laundering laws could subject us to penalties and other adverse consequences.
We
are subject to the U.S. Foreign Corrupt Practices Act, or the FCPA, Chapter 9 (sub-chapter 5) of the Israeli Penal Law, 5737-1977, and
the Israeli Prohibition on Money Laundering Law, 5760-2000, collectively, the Israeli Anti-Corruption Laws, and the UK Bribery Act 2010,
or UK Bribery Act, and other anticorruption, anti-bribery and anti-money laundering laws in the jurisdictions in which we do business,
both domestic and abroad. These laws generally prohibit us and our employees from improperly influencing government officials or commercial
parties in order to obtain or retain business, direct business to any person or gain any advantage. The FCPA, the Israeli Anti-Corruption
Laws, the UK Bribery Act, and other applicable anti-bribery and anti-corruption laws also may hold us liable for acts of corruption and
bribery committed by our third-party business partners, representatives and agents. In addition, we leverage third parties to sell our
products and conduct our business abroad. We and our third-party business partners, representatives and agents may have direct or indirect
interactions with officials and employees of government agencies or state-owned or affiliated entities and we may be held liable for
the corrupt or other illegal activities of these third-party business partners and intermediaries, our employees, representatives, contractors,
channel partners and agents, even if we do not explicitly authorize such activities. These laws also require that we keep accurate books
and records and maintain internal controls and compliance procedures designed to prevent any such actions. While we have policies and
procedures to address compliance with such laws, we cannot assure you that our employees and agents will not take actions in violation
of our policies or applicable law, for which we may be ultimately held responsible and our exposure for violating these laws increases
as our international presence is established and as we increase sales and operations in foreign jurisdictions. Any violation of the FCPA,
the Israeli Anti-Corruption Laws, the UK Bribery Act, or other applicable anti-bribery, anti-corruption laws and anti-money laundering
laws could result in whistleblower complaints, adverse media coverage, investigations, imposition of significant legal fees, loss of
export privileges, severe criminal or civil sanctions or suspension or debarment from U.S. government contracts, substantial diversion
of management’s attention, a decline in the market price of our common stock or overall adverse consequences to our reputation
and business, all of which may have an adverse effect on our results of operations and financial condition.
19
Risks
Related to Intellectual Property
We
may not be able to obtain patents or other intellectual property rights necessary to protect our proprietary technology and business.
We
may seek to patent concepts, components, processes, designs and methods, and other inventions and technologies that we consider to have
commercial value or that will likely give us a technological advantage. Despite devoting resources to the research and development of
proprietary technology, we may not be able to develop technology that is patentable or protectable. Patents may not be issued in connection
with pending patent applications, and claims allowed may not be sufficient to allow them to use the inventions that they create exclusively.
Furthermore, any patents issued could be challenged, re-examined, held invalid or unenforceable, or circumvented and may not provide
sufficient protection or a competitive advantage. In addition, despite efforts to protect and maintain patents, competitors and other
third parties may be able to design around their patents or develop products similar to our work products that are not within the scope
of their patents. Finally, patents provide certain statutory protection only for a limited period of time that varies depending on the
jurisdiction and type of patent.
Prosecution
and protection of the rights sought in patent applications and patents can be costly, lengthy, and uncertain, often involve complex legal
and factual issues, and consume significant time and resources. In addition, the breadth of claims allowed in our patents, their enforceability,
and our ability to protect and maintain them cannot be predicted with any certainty. The laws of certain countries may not protect intellectual
property rights to the same extent as the laws of the United States. Even if our patents are held to be valid and enforceable in a certain
jurisdiction, any legal proceedings that we may initiate against third parties to enforce such patents will likely be expensive, take
significant time, and divert management’s attention from other business matters. We cannot assure that any of our issued patents
or pending patent applications provide any protectable, maintainable, or enforceable rights or competitive advantages to us.
In
addition to patents, we will rely on a combination of copyrights, trademarks, trade secrets, and other related laws and confidentiality
procedures and contractual provisions to protect, maintain, and enforce our proprietary technology and intellectual property rights in
the United States and other countries. However, our ability to protect our brands by registering certain trademarks may be limited. In
addition, while we will generally enter into confidentiality and nondisclosure agreements with our employees, consultants, contract manufacturers,
distributors and resellers, and with others to attempt to limit access to and distribution of our proprietary and confidential information,
it is possible that:
●
misappropriation
of our proprietary and confidential information, including technology, will nevertheless occur;
●
our
confidentiality agreements will not be honored or may be rendered unenforceable;
●
third
parties will independently develop equivalent, superior, or competitive technology or products;
●
disputes
will arise with our current or future strategic licensees, customers, or others concerning the ownership, validity, enforceability,
use, patentability, or registrability of intellectual property; or
●
unauthorized
disclosure of our know-how, trade secrets, or other proprietary or confidential information will occur.
We
cannot assure that we will be successful in protecting, maintaining, or enforcing our intellectual property rights. If we are unsuccessful
in protecting, maintaining, or enforcing our intellectual property rights, then our business, operating results, and financial condition
could be materially adversely affected, which could:
●
adversely
affect our reputation with customers;
●
be
time-consuming and expensive to evaluate and defend;
●
cause
product shipment delays or stoppages;
20
●
divert
management’s attention and resources;
●
subject
us to significant liabilities and damages;
●
require
us to enter into royalty or licensing agreements; or
●
require
us to cease certain activities, including the sale of products.
If
it is determined that we have infringed, violated or are infringing or violating a patent or other intellectual property right of any
other person or if we are found liable in respect of any other related claim, then, in addition to being liable for potentially substantial
damages, we may be prohibited from developing, using, distributing, selling, or commercializing certain of our technologies unless we
obtain a license from the holder of the patent or other intellectual property right. We cannot assure that we will be able to obtain
any such license on a timely basis or on commercially favorable terms, or that any such licenses will be available, or that workarounds
will be feasible and cost-efficient. If we do not obtain such a license or find a cost-efficient workaround, our business, operating
results, and financial condition could be materially adversely affected.
General
Risk Factors Related to Our Business
Our
business and operations would suffer in the event of computer system failures, cyber-attacks, or deficiencies in our cyber-security.
Security
incidents involving our information technology systems and those of third parties on which we rely have occurred in the past, such as
phishing attacks, although none of these incidents have been material to our business. Such security incidents may occur in the future.
Despite the implementation of security measures, our internal computer systems, and those of third parties on which we rely, are vulnerable
to damage from computer viruses, malware, natural disasters, terrorism, war, telecommunication and electrical failures, cyber-attacks
or cyber-intrusions over the Internet, attachments to emails, persons inside our organization, or persons with access to systems inside
our organization. The risk of a security breach or disruption, particularly through cyber-attacks or cyber intrusion, including by computer
hackers, foreign governments, and cyber terrorists, has generally increased as the number, intensity and sophistication of attempted
attacks and intrusions from around the world have increased. If such an event were to occur and cause interruptions in our operations,
it could result in a material disruption of our product development programs. To the extent that any disruption or security breach was
to result in a loss of or damage to our data or applications, or inappropriate disclosure of confidential or proprietary information,
we could incur material legal claims and liability, and damage to our reputation, and the further development of our product candidates
could be delayed.
We
may be subject to product liability claims, product actions, including product recalls, and other field or regulatory actions that could
be expensive, divert management’s attention, and harm our business.
Our
business exposes us to potential liability risks, product actions, and other field or regulatory actions that are inherent in the manufacturing,
marketing and sale of medical device, or any other products that we may have commissioned for a target business. We may be held liable
if such products cause injury or death or are found otherwise unsuitable or defective during usage. Our products incorporate mechanical
and electrical parts, complex computer software, and other sophisticated components, any of which can contain errors or failures. Complex
computer software is particularly vulnerable to errors and failures, especially when first introduced. In addition, new products or enhancements
to our existing products may contain undetected errors or performance problems that, despite testing, are discovered only after installation.
If
any of our commissioned products are defective, whether due to design or manufacturing defects, improper use of the product, or other
reasons, we may voluntarily or involuntarily undertake an action to remove, repair, or replace the product at our expense. In some circumstances
we will be required to notify regulatory authorities of an action pursuant to a product failure.
21
Testing
of our technologies potential applications for our products will be required and there is no assurance of regulatory approval.
The
effect of government regulation and the need for compliance may delay marketing of our technologies and future potentially developed
products for a considerable period of time, impose costly procedures upon our activities, and provide an advantage to larger companies
that compete with us. There can be no assurance that we will be able to achieve regulatory compliance for any of our products. Any such
delay in achieving such regulatory compliance would materially and adversely affect the marketing of any contemplated products and the
ability to earn product revenue. Further, regulation of manufacturing facilities by state, local, and other authorities is subject to
change. Any additional regulation could result in limitations or restrictions on our ability to utilize any of our technologies, thereby
adversely affecting our operations. Various federal and foreign statutes and regulations also govern or influence the manufacturing,
safety, labeling, storage, record keeping, and marketing of our products. The process of compliance with relevant U.S. and foreign statutes
and regulations are time-consuming and require the expenditure of substantial resources. In addition, these requirements and processes
vary widely from country to country.
We
rely on highly skilled personnel, and, if we are unable to attract, retain, or motivate qualified personnel, we may not be able to operate
our business effectively.
Our
success depends in large part on continued employment of senior management and key personnel who can effectively operate our business,
as well as our ability to attract and retain skilled employees. Competition for highly skilled management, technical, research and development,
and other employees is intense and we may not be able to attract or retain highly qualified personnel in the future. In making employment
decisions, job candidates often consider the value of the equity awards they would receive in connection with their employment. Our long-term
incentive programs may not be attractive enough or perform sufficiently to attract or retain qualified personnel.
If
any of our employees leaves us, and we fail to effectively manage a transition to new personnel, or if we fail to attract and retain
qualified and experienced professionals on acceptable terms, our business, financial condition, and results of operations could be adversely
affected.
Our
success also depends on our having highly trained financial, technical, R&D, sales, and marketing personnel. We will need to continue
to hire additional personnel as our business grows. A shortage in the number of people with these skills or our failure to attract them
to our company could impede our ability to increase revenues from our existing technology and services, ensure full compliance with international
and federal regulations, or launch new product offerings and would have an adverse effect on our business and financial results.
We
may be unable to keep pace with changes in technology as our business and market strategy evolves.
We
will need to respond to technological advances in a cost-effective and timely manner in order to remain competitive. The need to respond
to technological changes may require us to make substantial, unanticipated expenditures. There can be no assurance that we will be able
to respond successfully to technological change.
Risks
Related to this Offering and Our Common Stock
Although
we have filed an application to list our securities on Nasdaq, there can be no assurance that our securities will be so listed or, if
listed, that we will be able to comply with the continued listing standards.
In
June 2021 we filed a comprehensive listing application package with The Nasdaq Stock Market, or Nasdaq, to request an uplisting of the
Company’s common stock. Nasdaq has not approved our application, and there can be no assurance that Nasdaq will approve us for
listing on The Nasdaq Capital Market and, even if our securities are listed, we cannot assure you that we will be able to maintain such
listing. In addition, if after listing, Nasdaq delists our securities from trading on its exchange for failure to meet the continued
listing standards, we and our shareholders could face significant material adverse consequences including a limited availability of market
quotations for our common stock, confirmation that our stock is “penny stock” and subject to increased regulations, and a
decreased ability to issue additional securities or obtain additional financing in the future.
22
Trading
on the OTC Markets is volatile, sporadic and often thin, which could depress the market price of our common stock and make it difficult
for our stockholders to resell their common stock.
Our
common stock is currently quoted on the OTCQB tier of the OTC Markets. Trading in securities quoted on the OTC Markets is often thin
and characterized by wide fluctuations in trading prices due to many factors, some of which may have little to do with our operations
or business prospects. This volatility could depress the market price of our common stock for reasons unrelated to operating performance.
Moreover, the OTC Markets is not a stock exchange, and trading of securities on the OTC Markets is often more sporadic than the trading
of securities listed on a stock exchange like NASDAQ or the NYSE. Our common stock has a history of thin trading. During the 52-week
period ended December 31, 2021, trades were only reported on 134 trading days. These factors may result in investors having difficulty
reselling any shares of our common stock .
Nevada
law and provisions in our amended and restated articles of incorporation and amended and restated bylaws could make a merger, tender
offer or proxy contest difficult, thereby depressing the market price of our common stock.
Some
provisions of Nevada law may prohibit or delay mergers or other takeover or change in control attempts and, accordingly, may discourage
attempts to acquire us even though such a transaction may offer our stockholders the opportunity to sell their stock at a price above
the prevailing market price. In addition, our amended and restated articles of incorporation and amended and restated bylaws contain
provisions that may make the acquisition of the Company more difficult, including the following:
●
our
board of directors is classified into three classes of directors with staggered three-year terms;
●
a
special meeting of our stockholders may only be called by either our chairman of the board or a majority of our board of directors;
and
●
advance
notice procedures apply for stockholders to nominate candidates for election as directors or to bring matters before an annual meeting
of stockholders.
These
provisions, alone or together, could discourage, delay or prevent a transaction involving a change in control of the Company. These provisions
could also discourage proxy contests and make it more difficult for stockholders to elect directors of their choosing and to cause us
to take other corporate actions they desire, any of which, under certain circumstances, could limit the opportunity for our stockholders
to receive a premium for their shares of our common stock, and could also affect the price that some investors are willing to pay for
our common stock.
The
market price of our common stock may be highly volatile and such volatility could cause you to lose some or all of your investment.
The
market price of our common stock may fluctuate significantly in response to numerous factors, some of which are beyond our control, such
as:
●
the
announcement of new products or product enhancements by us or our competitors;
●
developments
concerning intellectual property rights;
●
changes
in legal, regulatory, and enforcement frameworks impacting our technology or the application of our technology;
●
variations
in our and our competitors’ results of operations;
●
fluctuations
in earnings estimates or recommendations by securities analysts, if our common stock is covered by analysts;
●
the
results of product liability or intellectual property lawsuits;
●
future
issuances of common stock or other securities;
●
the
addition or departure of key personnel;
23
●
announcements
by us or our competitors of acquisitions, investments or strategic alliances;
●
current
or anticipated impact of military conflict, including the conflict between Russia and Ukraine, terrorism or other geopolitical events;
●
sanctions
imposed by the United States and other countries in response to such conflicts, including the one in Ukraine, may also adversely
impact the financial markets and the global economy, and any economic countermeasures by affected countries and others could exacerbate
market and economic instability; and
●
general
market conditions and other events or factors, many of which are beyond our control.
In
addition, the stock market has experienced significant volatility, particularly with respect to pharmaceutical, biotechnology and other
life sciences company stocks. The volatility of pharmaceutical, biotechnology and other life sciences company stocks often does not relate
to the operating performance of the companies represented by the stock. In the past, securities class action litigation has often been
initiated against companies following periods of volatility in their stock price. This type of litigation could result in substantial
costs and divert our management’s attention and resources, and could also require us to make substantial payments to satisfy judgments
or to settle litigation.
Because
our common stock may be deemed a “penny stock,” it may be more difficult for investors to sell shares of our common stock,
and the market price of our common stock may be adversely affected.
Our
common stock may be a “penny stock” if, among other things, the stock price is below $5.00 per share, it is not listed on
a national securities exchange, or it has not met certain net tangible asset or average revenue requirements. Broker-dealers who sell
penny stocks must provide purchasers of these stocks with a standardized risk-disclosure document prepared by the SEC. This risk-disclosure
document provides information about penny stocks and the nature and level of risks involved in investing in the penny-stock market. A
broker must also give a purchaser, orally or in writing, bid and offer quotations and information regarding broker and salesperson compensation,
make a written determination that the penny stock is a suitable investment for the purchaser and obtain the purchaser’s written
agreement to the purchase. Broker-dealers must also provide customers that hold penny stock in their accounts with such broker-dealer
a monthly statement containing price and market information relating to the penny stock. If a penny stock is sold to an investor in violation
of the penny stock rules, the investor may be able to cancel its purchase and get their money back.
If
applicable, the penny stock rules may make it difficult for stockholders to sell their shares of our common stock. Because of the rules
and restrictions applicable to a penny stock, there is less trading in penny stocks and the market price of our common stock may be adversely
affected. Also, many brokers choose not to participate in penny stock transactions. Accordingly, stockholders may not always be able
to resell their shares of our common stock publicly at times and prices that they feel are appropriate.
Compliance
with the reporting requirements of federal securities laws can be expensive.
We
are a public reporting company in the United States, and accordingly, subject to the information and reporting requirements of the Exchange
Act and other federal securities laws. The costs of preparing and filing annual and quarterly reports and other information with the
SEC and furnishing audited reports to stockholders are substantial. Failure to comply with the applicable securities laws could result
in private or governmental legal action against us or our officers and directors, which could have a detrimental impact on our business
and financials, the value of our stock, and the ability of stockholders to resell their stock.
24
Our
investors’ ownership in the Company may be diluted in the future.
In
the future, we may issue additional authorized but previously unissued equity securities, resulting in the dilution of ownership interests
of our present stockholders. For instance, pursuant to the Securities Exchange Agreement by and between Intellisense and Medigus, dated
September 16, 2019, if ScoutCam achieves $33.0 million in sales in the aggregate within the first three years following December 30,
2019, the consummation date of such agreement, we will issue shares of common stock to Medigus representing 10% of our issued and outstanding
share capital as of December 30, 2019. Similarly, we may issue a substantial number of shares of common stock or other securities convertible
into or exercisable for common stock in connection with capital raising activity, hiring or retaining employees, future acquisitions,
raising additional capital in the future to fund our operations, and other business purposes. We expect to authorize in the future a
substantial number of shares of our common stock for issuance under a stock option or similar plan, and may issue equity awards to management,
employees and other eligible persons. Additional shares of common stock issued by us in the future will dilute an investor’s investment
in the Company. In addition, we may seek stockholder approval to increase the amount of the Company’s authorized stock, which would
create the potential for further dilution of current investors.
Directors,
executive officers, principal stockholders, and affiliated entities own a significant percentage of our capital stock, and they may make
decisions that our stockholders do not consider to be in their best interests.
As
of March 28, 2022, our directors, executive officers, principal stockholders, and affiliated entities may be deemed to beneficially own,
in the aggregate, approximately 76.43% of our outstanding voting securities. As a result, if some or all of such parties
acted together, they would have the ability to exert substantial influence over the election of our board of directors and the outcome
of issues requiring approval by our stockholders. This concentration of ownership may also have the effect of delaying or preventing
a change in control of the Company that may be favored by other stockholders. This could prevent transactions in which stockholders might
otherwise recover a premium for their shares over current market prices. This concentration of ownership and influence in management
and board decision-making could also harm the price of our capital stock by, among other things, discouraging a potential acquirer from
seeking to acquire shares of our capital stock (whether by making a tender offer or otherwise) or otherwise attempting to obtain control
of our Company.
We
do not anticipate paying any cash dividends in the foreseeable future.
We
have never declared or paid cash dividends, and we do not anticipate paying cash dividends in the foreseeable future. Therefore, you
should not rely on an investment in our common stock as a source for any future dividend income. Our board of directors has complete
discretion as to whether to distribute dividends. Even if our board of directors decides to declare and pay dividends, the timing, amount,
and form of future dividends, if any, will depend on our future results of operations and cash flow, our capital requirements and surplus,
the amount of distributions, if any, received by us from our subsidiary, our financial condition, contractual restrictions, and other
factors deemed relevant by our board of directors.
Risks
Related to our Operations in Israel
Political,
economic and military instability in Israel may impede our ability to operate and harm our financial results.
Our
offices and management team are located in Israel. Accordingly, political, economic, and military conditions in Israel and the surrounding
region may directly affect our business and operations. In recent years, Israel has been engaged in sporadic armed conflicts with Hamas,
an Islamist terrorist group that controls the Gaza Strip, with Hezbollah, an Islamist terrorist group that controls large portions of
southern Lebanon, and with Iranian-backed military forces in Syria. In addition, Iran has threatened to attack Israel and may be developing
nuclear weapons. Some of these hostilities were accompanied by missiles being fired from the Gaza Strip against civilian targets in various
parts of Israel, including areas in which our employees and some of our consultants are located, and negatively affected business conditions
in Israel. Any hostilities involving Israel or the interruption or curtailment of trade between Israel and its trading partners could
adversely affect our operations and results of operations.
Our
commercial insurance does not cover losses that may occur as a result of events associated with war and terrorism. Although the Israeli
government currently covers the reinstatement value of direct damages that are caused by terrorist attacks or acts of war, we cannot
assure you that this government coverage will be maintained or that it will sufficiently cover our potential damages. Any losses or damages
incurred by us could have a material adverse effect on our business. Any armed conflicts or political instability in the region would
likely negatively affect business conditions and could harm our results of operations.
25
Further,
in the past, the State of Israel and Israeli companies have been subjected to economic boycotts. Several countries still restrict business
with the State of Israel and with Israeli companies. These restrictive laws and policies may have an adverse impact on our operating
results, financial condition, or the expansion of our business. A campaign of boycotts, divestment, and sanctions has been undertaken
against Israel, which could also adversely impact our business.
In
addition, many Israeli citizens are obligated to perform several days, and in some cases more, of annual military reserve duty each year
until they reach the age of 40 (or older, for reservists who are military officers or who have certain occupations) and, in the event
of a military conflict, may be called to active duty. In response to increases in terrorist activity, there have been periods of significant
call-ups of military reservists. It is possible that there will be military reserve duty call-ups in the future. Our operations could
be disrupted by such call-ups, which may include the call-up of members of our management. Such disruption could materially adversely
affect our business, prospects, financial condition, and results of operations.
It
may be difficult for investors in the United States to enforce any judgments obtained against us or some of our directors or officers.
It
may be difficult to acquire jurisdiction and enforce liabilities against any of our officers and directors who are based in Israel. It
may not be possible for United States investors to enforce their legal rights, to effect service of process upon our directors or officers
or to enforce judgments of United States courts predicated upon civil liabilities and criminal penalties of our directors and officers
under federal securities laws. Moreover, we have been advised that Israel does not have treaties providing for the reciprocal recognition
and enforcement of judgments of courts with the United States. Further, it is unclear if extradition treaties now in effect between the
United States and Israel would permit effective enforcement of criminal penalties of the federal securities laws. Even if an Israeli
court agrees to hear a claim, it may determine that the Israeli law, and not U.S. law, is applicable to the claim. Further, if U.S. law
is found to be applicable, certain 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 still be governed by the Israeli law. Consequently, you may be effectively prevented
from pursuing remedies under U.S. federal and state securities laws against us or any of our non-U.S. directors or officers.
Exchange
rate fluctuations between foreign currencies and the U.S. Dollar may negatively affect our earnings.
Our
reporting and functional currency is the U.S. dollar. Our revenues are currently primarily payable in U.S. dollars and we expect our
future revenues to be denominated primarily in U.S. dollars. However, some of our expenses are in NIS and as a result, we are exposed
to the currency fluctuation risks relating to the recording of our expenses in U.S. dollars. We may, in the future, decide to enter into
currency hedging transactions. These measures, however, may not adequately protect us from material adverse effects.
Certain
technology developed and used by us received Israeli government grants for certain research and development activities. The terms of
those grants require us to satisfy specified conditions in addition to repayment of the grants upon certain events.
The
research and development efforts that contributed to certain technology used by us was financed in part through grants from the IIA to
Medigus, which was subsequently transferred to ScoutCam Ltd. (for more information about such agreements, refer to – “CERTAIN
RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE” below”). The terms of such grants require ScoutCam Ltd.
to comply with the requirements of the Innovation Law. When a company develops know-how, technology or products using IIA grants, the
terms of these grants and the Innovation Law restrict the transfer outside of Israel of such know-how, and the manufacturing or manufacturing
rights of such products, technologies or know-how, without the prior approval of the IIA. Therefore, if aspects of our technologies are
deemed to have been developed with IIA funding, the discretionary approval of an IIA committee would be required for any transfer to
third parties outside of Israel of know-how or manufacturing or manufacturing rights related to those aspects of such technologies. We
may not receive those approvals. Furthermore, the IIA may impose certain conditions on any arrangement under which it permits us to transfer
technology or development out of Israel.
26
The
transfer of IIA-supported technology or know-how or manufacturing or manufacturing rights related to aspects of such technologies outside
of Israel may involve the payment of significant penalties and other amounts, depending upon the value of the transferred technology
or know-how, the amount of IIA support, the time of completion of the IIA-supported research project and other factors. These restrictions
and requirements for payment may impair our ability to sell our technology assets outside of Israel or to outsource or transfer development
or manufacturing activities with respect to any product or technology outside of Israel. Furthermore, the consideration available to
our shareholders in a transaction involving the transfer outside of Israel of technology or know-how developed with IIA funding (such
as a merger or similar transaction) may be reduced by any amounts that we are required to pay to the IIA.
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.
A
significant portion of ScoutCam’s intellectual property has been developed by ScoutCam’s employees in the course of their
employment for us. Under the Israeli Patent Law, 5727-1967, or the Patent Law, inventions conceived by an employee in the course and
as a result of or arising from his or her employment with a company 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 such agreement between an employer and an employee, the Israeli Compensation and Royalties Committee,
or the Committee, a body constituted under the Patent Law, will determine whether the employee is entitled to remuneration for his inventions.
Recent 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. 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 Patent Law). Although we generally enter into assignment-of-invention agreements with our employees pursuant to which such individuals
assign to us all rights to any inventions created in the scope of their employment or engagement with us, 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.
Item
1b. unresolved staff comments
Not
applicable.
Item
2. properties
We
do not own property and currently lease our principal corporate office, which is located at Omer Industrial Park, No. 7A and 3B, P.O.
Box 3030, Omer, Israel 8496500. We believe our leased office sufficiently meets our current needs.
item
3. legal proceedings
Three
of our European patents in our patent family related to Small Diameter Video Camera Heads and Medical Devices and Visualization Probes
are currently in oppositional proceedings before the Opposition Division of the EU Patent Office. For additional information about these
proceedings refer to – “PROPRIETARY RIGHTS AND TECHNOLOGY” above. Other than the above, we
are not aware of any pending legal proceedings to which we are a party, or to which any director, officer or affiliate of our Company,
or any owner of record or beneficially of more than 5% of any class of our voting securities, is a party adverse to us or has a material
interest adverse to us.
item
4. mine safety disclosures.
Not
applicable.
27
part
II
item
5. market for registrant’s common equity, related stockholder matters and issuer purchases
Market
Information
Our
common stock is quoted on the OTCQB under the symbol “SCTC”. Trading in stocks quoted on the OTCQB is often thin and is characterized
by wide fluctuations in trading prices due to many factors that may be unrelated to a company’s operations or business prospects.
We cannot assure you that there will be a market in the future for our common stock.
OTCQB
securities are not listed or traded on the floor of an organized national or regional stock exchange. Instead, OTCQB securities transactions
are conducted through a telephone and computer network connecting dealers in stocks. OTCQB issuers are traditionally smaller companies
that do not meet the financial and other listing requirements of a regional or national stock exchange.
Holders
On
August 9, 2021, we effected a one-for-nine reverse stock split of our common stock pursuant to which holders of our common stock received
one share of our common stock for every nine shares of common stock held. Unless the context expressly dictates otherwise, all references
to share and per share amounts referred in this Annual Report on Form 10-K reflect the reverse stock split.
As
of December 31, 2021, there were 40 stockholders of record of our common stock and 7,121,737 shares of our common stock outstanding.
The number of stockholders of record does not include beneficial owners of our common stock, whose shares are held in “street name”
in the names of various brokers, dealers, clearing agencies, banks, and other fiduciaries.
Dividends
We
have never declared or paid any cash dividends on our common stock. We currently intend to retain future earnings, if any, to increase
our working capital and do not anticipate paying any cash dividends in the foreseeable future.
Equity
Compensation Plan Information
2020
Share Incentive Plan
We
have adopted the 2020 Share Incentive Plan, or the 2020 Plan, under which we may grant equity-based incentive awards to attract, motivate,
and retain the talent for which we compete.
Authorized
Shares . The maximum number of ordinary shares available for issuance under the 2020 Plan is equal to the sum of 1,824,717 shares,
or such number as our board of directors may determine from time to time.
Administration.
Our board of directors, or a duly authorized committee of our board of directors, will administer the 2020 Plan. Under the 2020 Plan,
the administrator has the authority, subject to applicable law, to interpret the terms of the 2020 Plan and any award agreements or awards
granted thereunder, designate recipients of awards, determine and amend the terms of awards, including the exercise price of an option
award, the fair market value of an ordinary share, the time and vesting schedule applicable to an award or the method of payment for
an award, accelerate or amend the vesting schedule applicable to an award, prescribe the forms of agreement for use under the 2020 Plan,
and take all other actions and make all other determinations necessary for the administration of the 2020 Plan.
The
administrator also has the authority to amend and rescind rules and regulations relating to the 2020 Plan or terminate the 2020 Plan
at any time before the date of expiration of its ten year term.
Eligibility.
The 2020 Plan provides for granting awards under various tax regimes, including, without limitation, in compliance with Section 102
of the Israeli Income Tax Ordinance (New Version), 5721-1961 (the “Ordinance”), and Section 3(i) of the Ordinance and for
awards granted to our United States employees or service providers, including those who are deemed to be residents of the United States
for tax purposes, Section 422 of the Internal Revenue Code (the “Code”) and Section 409A of the Code.
28
Section
102 of the Ordinance allows employees, directors, and officers who are not controlling shareholders and are considered Israeli residents
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 section 3(i) of the Ordinance, which does not provide for similar tax benefits.
Grant.
All awards granted pursuant to the 2020 Plan will be evidenced by an award agreement, in a form approved, from time to time, by the
administrator in its sole discretion. The award agreement will set forth the terms and conditions of the award, including the type of
award, number of shares subject to such award, vesting schedule and conditions (including performance goals or measures), and the exercise
price, if applicable. Certain awards under the 2020 Plan may constitute or provide for a deferral of compensation, subject to Section
409A of the Code, which may impose additional requirements on the terms and conditions of such awards.
Each
award will expire seven years from the date of the grant thereof, unless such shorter term of expiration is otherwise designated by the
administrator.
Awards.
The 2020 Plan provides for the grant of stock options (including incentive stock options and nonqualified stock options), shares
of common stock, restricted shares, restricted share units, and other share-based awards.
Options
granted under the 2020 Plan to our employees who are U.S. residents may qualify as “incentive stock options” within the meaning
of Section 422 of the Code, or may be non-qualified stock options. The exercise price of a stock option may not be less than 100% of
the fair market value of the underlying share on the date of grant (or 110% in the case of ISOs granted to certain significant stockholders).
Exercise.
An award under the 2020 Plan may be exercised by providing the company with a written or electronic notice of exercise and full payment
of the exercise price for such shares underlying the award, if applicable, in such form and method as may be determined by the administrator
and permitted by applicable law. An award may not be exercised for a fraction of a share. With regard to tax withholding, exercise price,
and purchase price obligations arising in connection with awards under the 2020 Plan, the administrator may, in its discretion, accept
cash, provide for net withholding of shares in a cashless exercise mechanism, or direct a securities broker to sell shares and deliver
all or a part of the proceeds to the Company or the trustee.
Transferability.
Other than by will, the laws of descent and distribution, or as otherwise provided under the 2020 Plan, neither the options nor any
right in connection with such options are assignable or transferable.
Termination
of Employment. In the event of termination of a grantee’s employment or service with the company or any of its affiliates,
all vested and exercisable awards held by such grantee as of the date of termination may be exercised within three months after such
date of termination, unless otherwise determined by the administrator. After such three month period, all such unexercised awards will
terminate and the shares covered by such awards shall again be available for issuance under the 2020 Plan.
In
the event of termination of a grantee’s employment or service with the company or any of its affiliates due to such grantee’s
death, permanent disability, or retirement, all vested and exercisable awards held by such grantee as of the date of termination may
be exercised by the grantee or the grantee’s legal guardian, estate, or by a person who acquired the right to exercise the award
by bequest or inheritance, as applicable, within twelve months after such date of termination, unless otherwise provided by the administrator.
Any awards which are unvested as of the date of such termination or which are vested but not then exercised within the twelve month period
following such date, will terminate and the shares covered by such awards shall again be available for issuance under the 2020 Plan.
Notwithstanding
any of the foregoing, if a grantee’s employment or services with the company or any of its affiliates is terminated for “cause”
(as defined in the 2020 Plan), all outstanding awards held by such grantee (whether vested or unvested) will terminate on the date of
such termination and the shares covered by such awards shall again be available for issuance under the 2020 Plan.
29
Transactions.
In the event of a share split, reverse share split, share dividend, recapitalization, combination, or reclassification of our shares,
or any other increase or decrease in the number of issued shares effected without receipt of consideration by the company (but not including
the conversion of any convertible securities of the company), the administrator in its sole discretion shall make an appropriate adjustment
in the number of shares related to each outstanding award and to the number of shares reserved for issuance under the 2020 Plan, to the
class and kind of shares subject to the 2020 Plan, as well as the exercise price per share of each outstanding award, as applicable,
the terms and conditions concerning vesting and exercisability, and the term and duration of outstanding awards, or any other terms that
the administrator adjusts in its discretion, or the type or class of security, asset, or right underlying the award (which need not be
only that of the Company, and may be that of the surviving corporation or any affiliate thereof or such other entity party to any of
the above transactions); provided that any fractional shares resulting from such adjustment shall be rounded down to the nearest whole
share unless otherwise determined by the administrator. In the event of a distribution of a cash dividend to all shareholders, the administrator
may determine, without the consent of any holder of an award, that the exercise price of an outstanding and unexercised award shall be
reduced by an amount equal to the per share gross dividend amount distributed by the Company, subject to applicable law.
In
the event of a merger or consolidation of our company, or a sale of all, or substantially all, of the Company’s shares or assets,
or other transaction having a similar effect on the Company, or change in the composition of the board of directors, or liquidation or
dissolution, or such other transaction or circumstances that the board of directors determines to be a relevant transaction, then without
the consent of the grantee, the administrator may but is not required to (i) cause any outstanding award to be assumed or substituted
by such successor corporation, or (ii) regardless of whether or not the successor corporation assumes or substitutes the award (a) provide
the grantee with the option to exercise the award as to all or part of the shares, and may provide for an acceleration of vesting of
unvested awards, or (b) cancel the award and pay in cash, shares of the company, the acquirer, or other corporation which is a party
to such transaction, or other property as determined by the administrator as fair in the circumstances. Notwithstanding the foregoing,
the administrator may upon such event amend, modify, or terminate the terms of any award as it shall deem, in good faith, appropriate.
Recent
Sales of Unregistered Securities
On
March 29, 2021, the Company issued 2,469,156 units to certain investors in consideration of $20 million. Each such unit consisted of
(i) one share of the Company’s common stock and (ii) one warrant to purchase one share of common stock with an exercise price of
$10.35 per share (the “March Warrant” and the “Exercise Price”). Each March Warrant is exercisable until the
close of business on March 31, 2026. Pursuant to the terms of the March Warrants, following April 1, 2024, if the closing price of the
common stock equal or exceeds 135% of the Exercise Price (subject to appropriate adjustments for stock splits, stock dividends, stock
combinations and other similar transactions after the issue date of the March Warrants) for any thirty (30) consecutive trading days,
the Company may force the exercise of the March Warrants, in whole or in part, by delivering to these investors a notice of forced exercise.
Issuer
Purchases of Equity Securities
During
the period from January 1, 2021 to December 31, 2021, we did not purchase any of our equity securities.
Item
6. [Reserved]
30
item
7. management’s discussion and analysis of financial condition and results of operations
The
following discussion and analysis of our financial condition and results of operations should be read in conjunction with our financial
statements and the related notes appearing elsewhere in this Annual Report on Form 10-K. In addition to historical information, the following
discussion contains forward-looking statements that involve risks, uncertainties and assumptions. See “Forward-looking Statements”
for a discussion of the uncertainties and assumptions associated with these statements. Our actual results may differ materially from
those discussed below. Factors that could cause or contribute to such differences include, but are not limited to, those identified below,
and those discussed in the section titled “Risk Factors” included elsewhere in this Annual Report on Form 10-K.
Overview
We
were incorporated under the laws of the State of Nevada on March 22, 2013 under the name Intellisense Solutions Inc. We were initially
engaged in the business of developing web portals to allow companies and individuals to engage in the purchase and sale of vegetarian
food products over the Internet. However, were not able to execute our original business plan, develop significant operations, or achieve
commercial sales.
On
December 30, 2019, we acquired all of the issued and outstanding share capital of ScoutCam Ltd. (the “Closing Date”). Following
this transaction, we integrated and fully adopted ScoutCam Ltd.’s business into our Company as our primary business activity. On
December 31, 2019, we changed our name to ScoutCam Inc.
Through
ScoutCam Ltd., we are engaged in the development, production and marketing of innovative visual solutions composed of imaging equipment,
cloud and software based image processing (artificial intelligence (AI), Machine Learning (ML), and additional algorithm methodologies).
Some of our products that utilize our micro ScoutCam™ technology are used in medical procedures as well as various applications
in other industries. Our current business model is a business-to-business (B2B) approach in which we seek to identify target businesses
interested in integrating our micro ScoutCam™ technology, or commissioning individual projects using our technology. We derive
a substantial portion of our revenue from applications of our micro ScoutCam™ technology within the medical, defense and aerospace
fields. We have recently begun examining additional applications for our visual solutions portfolio (composed of image acquisition, data
collection and storage and image processing), including Predictive Maintenance (PdM) and Condition Based Monitoring (CBM), as well as
additional industries outside of the foregoing listed industries, including sectors such as aviation, automotive, industrial non-destructing-testing
industries, energy, maritime (we refer to these applications and sectors as I4.0) We plan to further expand our activity in these non-medical
spaces.
Impact
of COVID-19 Pandemic
The
COVID-19 pandemic has had a significant impact on global markets and the global economy, including countries in which the Company operates,
and we anticipate that it will have a continuing impact on global economies in the near and long-term future. In light of the below mentioned
factors, the COVID-19 pandemic had and most likely will continue to have some negative effect on the Company’s operations, and
the extent to which the COVID-19 pandemic will impact the Company’s operations will depend on certain developments, including the
duration and spread of the outbreak, future prevention and mitigation measures, as well as the potential for some of these measures to
be reinstituted in the event of repeat waves of the virus or future variants of the virus. In particular, COVID-19 has had and most likely
will continue to have some adverse impact on the Company’s operations and workforce, including its manufacturing activities, product
testing and market penetration and sales, as well as its ability to continue to raise capital. Travel restrictions had and most likely
will continue to have a negative impact on our penetration, sales and marketing and research and development efforts.
Critical
Accounting Policies and Estimates
Our
management’s discussion and analysis of our financial condition and results of operations is based on our financial statements,
which we have prepared in accordance with generally accepted accounting principles in the United States, or U.S. GAAP. The preparation
of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities
and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported revenues and
expenses during the reporting periods. We evaluate these estimates and judgments on an ongoing basis. We base our estimates on historical
experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for
making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Our actual results
may differ from these estimates under different assumptions or conditions.
31
While
our significant accounting policies are more fully described in Note 2 to our financial statements appearing elsewhere in this Form 10-K,
we believe that the following accounting policies are the most critical for fully understanding and evaluating our financial condition
and results of operations.
Development
Services Revenue and Contract Liabilities
We
determine at contract inception whether development services are distinct from the performance obligation to manufacture the product
under development. Revenues from development services that we determine as distinct from our performance obligation to manufacture the
product under development are recognized over the period of the applicable service contract. Revenues from development services that
we determine as not distinct from our performance obligation to manufacture the product under development are deferred until commencement
of manufacturing and are recognized over the manufacturing term. As a result, during the years ending 2020 and 2021, we have deferred
all service revenues billed by us (representing the contract liabilities balance of $2,420,000, as of December 31, 2021) and the respective
service costs (representing the contract fulfillment asset balance of $1,675,000 as of December 31, 2021).
Stock-Based
Compensation
We
apply the fair value recognition provisions of ASC 718, Compensation—Stock Compensation , or ASC 718, for stock-based awards
granted to employees, directors and other providers for their services. Determining the amount of stock-based compensation to be recorded
requires us to develop estimates of the fair value of stock options as of their grant date. We estimate the fair value of each stock
option grant using the Black-Scholes option-pricing model. Calculating the fair value of stock-based awards requires that we make subjective
assumptions.
Pursuant
to ASC 718, we measure stock-based awards granted to employees, members of the board of directors and other providers at fair value on
the date of grant and recognize the corresponding stock-based compensation expense of those awards on a straight-line basis over the
requisite service period.
The
Black-Scholes option-pricing model requires a number of assumptions, of which the most significant are the stock price volatility and
the expected option term. Our expected dividend rate is zero since we not currently pay cash dividends and does not anticipate doing
so in the foreseeable future. Each of the above factors requires our to use judgment and make estimates in determining the percentages
and time periods used for the calculation. If we were to use different percentages or time periods, the fair value of option awards could
be materially different. We recognizes stock-based compensation cost for option awards on a accelerated basis over the employee’s
requisite service period, net of estimated forfeitures.
Comparison
of the Year Ended December 31, 2021 and the Year Ended December 31, 2020
Overview
The
Company’s primary business activity during 2020 was R&D and preparation for production in connection with a customer-specific
project for a Fortune 500 multinational healthcare corporation.
The
Company’s primary business activities during 2021 were:
●
completion
of R&D and transition to the serial production in connection with a customer-specific project for a Fortune 500 multinational
healthcare corporation; and
●
enlarging
its focus on R&D activities in the domain of I4.0 (including PdM and CBM in sectors such
as the aviation, energy and automotive). The main effect of this activity was an increase in the number of employees to enable the
Company to manage the anticipated increased workload and solution development.
32
Other
major activities were the following:
-
Expanding
marketing activities, including the recruitment of VP Business Development for Industry 4.0, and launching a multi-platform digital
marketing campaign;
-
Extensive
activity in connection with the Company’s IP, including submissions of new patent applications as well as maintenance, defense,
and commercialization efforts of existing patents;
-
Increased
operation expenses in order to improve the current Company’s R&D capabilities;
-
Increase
in research and development activities, including the development of new products and the improvement of existing technology, and
the examination of additional applications for our visualization solutions, including in the domains of PdM and CBM, as well as additional
industries outside of the medical, defense, and aerospace fields, including sectors such as automotive, industrial non-destructing-testing
industries, automotive and energy; and
-
Investment
in capital expenses to provide the necessary facilities, IT, and lab tools for our newly recruited employees and to upgrade the Company’s
production and quality control capabilities.
The
following table summarizes our results of operations for the years ended December 31, 2021 and 2020, together with the changes in those
items in dollars and as a percentage:
2021
2020
% Change
Revenues
387,000
491,000
(21 )%
Cost of Revenues
1,108,000
994,000
11 %
Gross Loss
(721,000 )
(503,000 )
43 %
Research and development expenses
2,002,000
725,000
176 %
Sales and marketing expense
908,000
443,000
105 %
General and administrative expenses
5,481,000
3,035,000
81 %
Operating Loss
(9,112,000 )
(4,706,000 )
94 %
Revenues
As
a result of the nature of our target market and the current stage of our development, a substantial portion of our revenue comes from
a limited number of customers.
For
the year ended December 31, 2021, we generated revenues of $387,000, a decrease of $104,000, or 21%, from 2020 revenues. The
decrease in revenues was primarily due to sales of products to A.M. Surgical. Total sales to A.M. Surgical during year ended December
31, 2021 amounted to approximately $199,000, a decrease from approximately $383,000 in 2020. This decrease was partially offset by increase
in the sales of our products to other customers.
Remaining
performance obligations (“RPO”) represents contracted revenue that has not yet been recognized, which includes deferred revenue
and amounts that will be invoiced and recognized as revenue in future periods. As of December 31, 2021, the total RPO amounted to $3.2
million, which we expect to recognize over the expected manufacturing term of the product under development.
Cost
of Revenues
Cost
of revenue is primarily comprised of cost of personnel includes warehouse personnel costs, inventory write-downs, certain allocated facilities,
and expenses associated with logistics and quality control.
Cost
of revenues for the year ended December 31, 2021 were $1,108,000, an increase of $114,000, or 11%, compared to cost of revenues of $994,000
for the year ended December 31, 2020. The increase was primarily due to an increase in payroll
expenses (including stock-based compensation) as a result of hiring additional employees as part of the transition to the production
stage with respect to the contract with a Fortune 500 multinational healthcare corporation, partially offset by decrease in materials
as a result of a decrease in revenues.
33
Gross
Loss
Gross
loss for the year ended December 31, 2021 was $721,000, an increase of $218,000, or 43%, compared to a gross loss of $503,000 for the
year ended December 31, 2020. The increase was primarily due to a decrease in revenues and an increase
in cost of revenues as described above.
Research
and Development Expenses
Research
and development efforts are focused on new product development and on developing additional functionality for our existing products.
These expenses primarily consist of e mployee-related expenses, including salaries, benefits, and
stock-based compensation expense for personnel engaged in research and development functions , consulting
and professional fees related to research and development activities , prototype materials, facility
costs and other allocated expenses, which include expenses for rent and maintenance of our facility, utilities, depreciation, and other
supplies . We expense research and development costs as incurred.
Research
and development expenses for the year ended December 31, 2021 were $2,002,000, an increase of $1,277,000, or 176%, compared to $725,000
for the year ended December 31, 2020. The increase was primarily due to an increase in payroll expenses (including
stock-based compensation), materials and subcontractors, and because we have recently begun examining additional applications
for our micro ScoutCam™ portfolio outside of the medical, defense and aerospace fields, including in sectors such as automotive,
industrial non-destructing-testing industries, automotive, and energy.
In
addition, there was an increase in R&D payroll expenses in 2021 due to the fact that during 2020 a substantial part of the payroll
expenses was capitalized to contract fulfillment asset and was not recognized as expenses in profit and loss.
We
expect that our research and development expenses will increase as we continue to develop our products and service and recruit additional
research and development employees to the I4.0 domain.
Sales
and Marketing Expenses
Sales
and marketing expenses primarily consist of personnel costs, consulting services, promotional materials, demonstration equipment and
certain allocated facilities infrastructure costs.
Sales
and marketing expenses for the year ended December 31, 2021 were $908,000, an increase of $465,000, or 105%, compared to $443,000 for
the year ended December 31, 2020.
The
increase was primarily due to expanding marketing activity, including the recruitment of a VP Business Development in Industry 4.0, hiring
consultants and launching a multi-platform digital marketing campaign.
We
expect that our selling and marketing expenses will increase as we continue to increase our selling and marketing efforts.
General
and Administrative Expenses
General
and administrative expenses primarily consist of salaries and other related costs, including stock-based compensation, for personnel
in executive, finance, and administrative functions. General and administrative expenses also include direct and allocated facility-related
costs as well as professional fees for legal, patent, consulting, investor, and public relations, accounting, auditing, tax services,
and insurance costs.
General
and administrative expenses for the year ended December 31, 2021 were $5,481,000, an increase of $2,446,000, or 81%, compared to $3,035,000
for the year ended December 31, 2020.
34
The
increase was primarily due to:
●
an
increase of $675,000 in IP expenses due to maintenance, defense, and commercialization efforts of existing patents;
●
the
provision of $229,000 due to a VAT audit by the
Israeli Tax Authority ;
●
an
increase of $528,000 in share based compensation due to new option grants;
●
expenses
of approx. $206,000 related to our efforts to uplist to Nasdaq ;
●
an
increase in in payroll expenses due to the hiring of additional employees, including a new CEO and controller, and a shift in the
position of the CFO from part-time to full-time; and
●
an
increase in professional services expenses due to the hiring of a financial consultant, HR consultant, the appointment of new directors
and additional hires .
Operating
loss
We
incurred an operating loss of $9,112,000 for the year ended December 31, 2021, an increase of $4,406,000, or 94%,
compared to operating loss of $4,706,000 for the year ended December 31, 2020. The increase in operating loss was primarily due to increases
in expenses related to general and administrative, research and development, and sales and marketing, as described above.
Liquidity
and Capital Resources
As
of December 31, 2021, we had cash and cash equivalents of $8.6 million and $11 million of short-term deposits compared to cash and cash
equivalents $3.4 million and no short-term deposits as of December 31,2020. In addition, as of December 31, 2021 we incurred an accumulated
deficit of approximately $15.3 million compared to $6.3 million as of December 31, 2020.
Our
primary sources of liquidity to date have been from fund raising and warrant exercises. During 2021, we received $22.6 million from the
issuance of our shares and warrants in a private placement and from the exercise of outstanding warrants.
Additional
Cash Requirements
We
plan to continue to invest for long-term growth, and therefore we expect that our expenses will increase. We currently believe that our
existing cash and cash equivalents and short-term deposits will be sufficient to meet our anticipated cash needs for at least the next
12 months and beyond. We expect our expenses will increase in connection with our ongoing activities, particularly as we continue the
research and development and the scale up process of our I4.0 solutions. We expect to incur significant commercialization expenses related
to product sales, marketing, manufacturing, and distribution. Furthermore, we will continue to incur additional costs associated with
operating as a public company. Accordingly, we will need to obtain substantial additional funding in connection with our continuing operations.
We may raise these funds through equity financing, debt financing, or other sources, which may result in further dilution in the equity
ownership of our common stock. There is no assurance that we will be able to maintain operations at a level sufficient for investors
to obtain a return on their investment in our common stock, or that we will be able to raise sufficient capital required to implement
our business plan on acceptable terms, if at all. Even if we are successful in raising sufficient capital to implement our business plan,
we will, most likely, continue to be unprofitable for the foreseeable future. If we are unable to raise capital when needed or on attractive
terms, we would be forced to delay, reduce, or eliminate our research and development programs or future commercialization efforts.
Cash
Flows
The
following table sets forth the significant sources and uses of cash for the years ended December 31, 2021 and December 31, 2020 (in dollars):
2021
2020
Cash used in Operating Activities
(5,886,000 )
(4,187,000 )
Cash used in Investing Activities
(11,595,000 )
(276,000 )
Cash provided by Financing Activities
22,559,000
4,506,000
35
Operating
Activities
Our
primary uses of cash from operating activities have been for headcount-related expenditures, research and development costs, manufacturing
costs, marketing and promotional expenses, professional services cost and costs related to our facilities. Our cash flows from operating
activities will continue to be affected due to the expected increase of spending on our business and our working capital requirements.
During
the year ended December 31, 2021, cash used in operating activities was $5.9 million, consisting of net loss of $9 million, partially
offset by a non-cash benefit of $2 million and an favorable net change in operating assets and liabilities of $1.1 million. Our non-cash
benefit consisted primarily of non-cash charges of $2 million for stock-based compensation. The net change in our operating assets and
liabilities primarily reflects cash inflows from changes in contract liability of $1.6 million partially offset by cash outflows from
changes in contract fulfillment assets of $0.5 million.
During
the year ended December 31, 2020, cash used in operating activities was $4.2 million, consisting of net loss of $4.7 million, non-cash
charges of $1.1 million and a unfavorable net change in operating assets and liabilities of $0.6 million. Our non-cash charges consisted
primarily of stock-based compensation expense of $1.1 million. The net change in our operating assets and liabilities primarily reflects
cash outflows from the changes in contract fulfillment assets of $1.1 million, accrued expenses and other of $0.4 million and other assets
of $0.3 million, partially offset by cash inflows from changes in inventory of $0.7 million and change in contract liability of $0.3
million.
Investing
Activities
During
the year ended December 31, 2021, cash used in investing activities was $11.6 million, consisting of investment in short-term deposits
of $11 million and purchases of property and equipment of $0.6 million.
During
the year ended December 31, 200, cash used in investing activities was $0.3 million, consisting of purchases of property and equipment.
Financing
Activities
During
the year ended December 31, 2021, cash provided by financing activities was $22.6 million, consisting primarily of $19.1 million from
cash proceeds from issuance of shares and warrants in a private placement and $3.5 million proceeds from exercise of outstanding warrants.
During
the year ended December 31, 2020, cash provided by financing activities was $4.5 million, consisting primarily of $2.9 million from cash
proceeds from issuance of shares and warrants and $1.8 million proceeds from exercise of warrants.
item
7a. quantitative and qualitative disclosures about market risk
As
a smaller reporting company, we are not required to provide the information required by this Item.
item
8. financial statements and supplementary data
The
information called for by Item 8 is included following the “Index to Financial Statements” on page F-1 of this Annual Report.
item
9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
Not
applicable.
36
item
9a. controls and Procedures
Disclosure
Controls and Procedures
Disclosure
controls and procedures are controls and other procedures that are designed to ensure that information required to be disclosed in our
reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in
the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to
ensure that information required to be disclosed in our reports filed or submitted under the Exchange Act is accumulated and communicated
to management, including our Chief Executive Officer and Chief Financial Officer, or persons performing similar functions, as appropriate,
to allow timely decisions regarding required disclosure.
Management’s
Report on Internal Control over Financial Reporting
Our
management is responsible for establishing and maintaining adequate internal control over financial reporting. Our internal control over
financial reporting has been 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 in the United States of America.
Our
internal control over financial reporting includes policies and procedures that pertain to the maintenance of records that, in reasonable
detail, accurately and fairly reflect transactions and dispositions of our assets; provide reasonable assurance that transactions are
recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles in the
United States of America, and that receipts and expenditures are being made only in accordance with authorization of our management and
directors; and provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition
of our assets that could have a material effect on our financial statements.
Because
of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Therefore, even those
systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation.
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.
Management assessed the
effectiveness of our internal control over financial reporting on December 31, 2021. In making this assessment, management used the criteria
set forth by the Committee of Sponsoring Organizations of the Treadway Commission 2013 framework, in Internal Control—Integrated
Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”). Based on that assessment
under those criteria, management has determined that, as of December 31, 2021, our internal control over financial reporting was effective.
Attestation
Independent Report of the Registered Public Accounting Firm
This
annual report on Form 10-K does not include an attestation report of the Company’s independent registered public accounting firm
regarding internal control over financial reporting. Management’s report was not subject to attestation by the Company’s
registered public accounting firm pursuant to rules of the SEC that permit the Company to provide only management’s report in this
annual report on Form 10-K.
Changes
in Internal Control over Financial Reporting
There
were no changes in internal control over financial reporting during the year ended December 31, 2021 that have materially affected or
are reasonably likely to materially affect the Company’s internal control over financial reporting.
Item
9b. Other information
None.
37
ITEM
9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
Not
Applicable
part
iii
Item
10. Directors, Executive Officers and corporate governance
Directors,
Executive Officers, Promoters and Control Persons
The
following table sets forth the names and ages of our directors and executive officers:
Name
Age
Position
Prof.
Benad Goldwasser †
71
Chairman
of the Board
Shmuel
Donnerstein †
69
Director
Ronen
Rosenbloom
50
Director
Lior
Amit †
55
Director
Moshe
(Mori) Arkin
69
Director
Inbal
Kreiss†
55
Director
Zeev
Vurembrand †
70
Director
Yovav
Sameah
49
Chief
Executive Officer
Tanya
Yosef*
39
Chief
Financial Officer
Amir
Govrin*
55
Chief
Technology Officer
Katrin
Dlugach*
39
VP
of Research and Development
Roee
Peled*
43
VP
of Business Development
Arik
Priel*
47
Chief
SW Architect
*
Executive
Officer
†
Independent
Director
Directors
Prof.
Benad Goldwasser has served as chairman of our board of directors since December 26, 2019, and has served as chairman of ScoutCam
Ltd.’s board of directors since its inception. Prof. Goldwasser is a serial entrepreneur and retired urology medical doctor. In
2016, Prof. Goldwasser launched a venture capital fund partnered with SAIL, a Shanghai Government investment company. Prof. Goldwasser
has served as a member of the board of directors of Innoventric Ltd. since 2017 and Inspira Technologies Ltd. since January 2021. From
2013-2016 Prof. Goldwasser served as an external director of BioCanCell Ltd. (TASE: BICL). Prof. Goldwasser was the co-founder of Vidamed
Inc., Medinol Ltd., Rita Medical Inc., Optonol Ltd. and GI View Ltd. Prof. Goldwasser served as managing director of Biomedical Investments
Ltd., an Israeli Venture Capital firm. During his medical career, he served as Chairman of Urology at the Chaim Sheba Medical Center
and Professor of Surgery at Tel-Aviv University. Prof. Goldwasser holds an MD and MBA from Tel-Aviv University .
Shmuel
Donnerstein has served on our board of directors since December 26, 2019. Mr. Donnerstein has been an entrepreneur for over 40 years
and is an industry veteran. Mr. Donnerstein’s experience includes establishing businesses in multiple industries in Europe and
Israel. Most notably, in 2008 he established Rav Bariach 08 Industries Ltd (TASE: BRIH) after buying the assets of its predecessor in
receivership and led its turnaround to become a leading security door manufacturer worldwide. Mr. Donnerstein currently serves as the
Executive Chairman and majority shareholder of Rav Bariach. In addition, Mr. Donnerstein is the Chairman of Rail Vision Ltd and, in 2014,
received the Israeli Industry Award from Israel’s Minister of Economy and Industry for his lifelong contribution to the Israeli
Industrial sector.
Ronen
Rosenbloom has served as a member of our board since December 26, 2019. Mr. Rosenbloom is an independent lawyer working out of a
self-owned law firm specializing in white collar offences. Mr. Rosenbloom serves as chairman of the Israeli Money Laundering Prohibition
committee and the Prohibition of Money Laundering Committee of the Tel Aviv District, both of the Israel Bar Association. Mr. Rosenbloom
previously served as a police prosecutor in the Tel Aviv District. He has served as a member of the board of directors of Medigus Ltd.
since August 2018. Mr. Rosenbloom holds an LLB from the Ono Academic College, an Israeli branch of University of Manchester.
38
Lior
Amit has served on our board of directors since December 26, 2019. Since 2014, Mr. Amit has served as a financial consultant to multiple
companies on matters related to, inter alia, mergers and acquisitions. Mr. Amit currently serves as a member of the board of directors
for multiple Israeli public and private companies, including in the role of an external or independent director. He has served as a member
of the board of directors of Inspira Technologies Ltd. since June 2021. Mr. Amit holds both a BA in economics and accounting and an MBA
from Tel-Aviv University. Mr. Amit is a certified public accountant in Israel.
Moshe
(Mori) Arkin has served on our board of directors since February 15, 2021. Mr. Arkin is a leading life science and pharmaceutical
entrepreneur and serves as the chairman of Arkin Holdings, which he founded in 2009. Mr. Arkin has served as chairman of the board
of directors of Sol Gel Technologies Ltd. (NASDAQ: SLGL) since 2014 and sits on the board of directors of several private pharmaceutical
and medical device companies, including Digma Medical, a company developing systems to treat insulin resistance present in type 2 diabetes and other metabolic syndrome diseases,
and Valcare Medical, a company developing heart valve devices. From 2005 to 2008, Mr. Arkin served as the head of generics at Perrigo
Company, and from 2005 until 2011, as a member of its board of directors. Prior to joining Sol Gel Technologies Ltd., Mr. Arkin served
as a director of cCAM Biotherapeutics Ltd., a company focused on the discovery and development of novel immunotherapies to treat cancer
from 2012 until its acquisition in 2015 by Merck & Co., Inc. Mr. Arkin served as chairman of Agis Industries Ltd. from 1972 until
its acquisition by Perrigo Company in 2005. Mr. Arkin holds a B.A. in psychology from the Tel Aviv University, Israel.
Inbal
Kreiss has served on our board of directors since April 9, 2021. Ms. Kreiss is currently the Head of Innovation at the Systems, Missiles
and Space Division of the Israeli Aerospace Industries Ltd. (IAI) and Chairwoman of RAKIA, Israel’s 2nd Scientific and Technological
Mission to the International Space Station. Since 2013, Ms. Kreiss has served as Deputy Director of the Space Division at IAI, leading
the development, construction, launch and operation of observation and communication satellites for both Israeli and foreign users. Prior
to that, Ms. Kreiss held various leadership positions within IAI, including chief engineer of Israel’s Arrow 2 anti-ballistic missile
defense system from 2000 to 2006, and project manager of the Arrow 3 exo-atmospheric interceptor from 2007 to 2013. Ms. Kreiss holds
a B.Sc in chemical engineering from the Technion, Israeli Institute of Technology, an Executive Masters in Business Administration from
Tel Aviv University, and completed a visiting research fellowship at the Aeronautics & Astronautics Department of the Massachusetts
Institute of Technology (MIT).
Zeev
Vurembrand has served on our board of directors since May 13, 2021. Mr. Vurembrand is currently the Chief Executive Officer and
Owner of Vurembrand Management & Innovation Ltd. and a member of the board of directors of Isras Investment Company Ltd. (TASE:
ISRS) since 2016 and of Bezeq the Israeli Telecommunication Corp. Ltd. (TASE: BEZQ) since 2017. Mr. Vurembrand has also
served as chairman of the board of Lageen Ltd. since 2019. From 2013 until 2019, Mr. Vurembrand was the Chief Executive Officer
of Kupat Holim Meuhedet, Israel’s third largest health care organization. From 2008 until 2013, he was the Chief Executive
Officer of Alon Holding Blue Square – Israel Ltd., and prior to that, from 2007 until 2008, he was the Chief Executive Officer
of Phoenix Investments and Finance Ltd. Earlier in his career, from 2002 until 2007, Mr. Vurembrand was the Chief Executive Officer
of Clalit Health Services Group, Israel’s largest health care organization. Mr. Vurembrand has served on numerous boards of
directors, including Africa Israel Resedence LTD. (TASE: AFRE) from 2014 until 2016, Discount Bank (TASE:DSCT) 2006 until 2007,
U-Bank from 2005 until 2006, Blue Square Israel (TASE: BSI) from 2001 until 2006, and Dikla Medical Insurance Ltd. from 1995 until
2002. Mr. Vurembrand has also served on the board of trustees of Bar Ilan University since 2019. Mr. Vurembrand holds a B.Sc in
industrial engineering and management from the Technion, Israeli Institute of Technology.
Executive
Officers
Yovav
Sameah has served as Chief Executive Officer of the Company since April 15, 2021. Prior to his position with the Company, Mr. Sameah
was the Chief Executive Officer of Frontline PCB Solutions, a non-public worldwide leading provider of Pre-Production and Industry 4.0
SW solutions in the PCB industry, and the subsidiary of KLA-Tencor Corp. (Nasdaq: KLAC). From September 2013 until July of 2015, Mr.
Sameah was the Corporate Vice President and Chief Products Officer at Orbotech Ltd. (acquired by KLA-Tencor in February of 2019). Prior
to that, Mr. Sameah held a variety of roles at Orbotech, including Vice President of Electronic Components Manufacturers Business (PCB
Division) from September 2012 until September 2013, and Vice President AOI & Repair Product Line (PCB Division) from March 2008 until
March 2012. Mr. Sameah holds both a BSc in chemical engineering and an MBA from Ben-Gurion University, Israel.
39
Tanya
Yosef has served as our Chief Financial Officer since December 27, 2019. Ms. Yosef is a certified public accountant with many years
of experience, and held various positions with Medigus Ltd. (Nasdaq: MDGS) since December of 2009, including most recently as chief financial
officer and prior thereto as financial controller. During 2008-2009 Ms. Yosef worked in the audit department at Kesselman & Kesselman,
a member firm of PricewaterhouseCoopers International Limited. Ms. Yosef holds a BA in Economics and Accounting from the Ben-Gurion University,
Israel .
Amir
Govrin has served as our Chief Technology Officer since May 1, 2019. Prior to his position with ScoutCam, Mr. Govrin held various
positions at Medigus Ltd. (Nasdaq: MDGS) beginning in 2003, including VP R&D, R&D manager and GERD project manager. Prior to
his tenure at Medigus, Mr. Govrin was project manager at Aran R&D from 1997 until 2003, and an R&D engineer at Netafim Ltd. from
1992 until 1997. Mr. Govrin holds a B.Sc in mechanical engineering from Tel Aviv University, Israel .
Katrin
Dlugach has served as our VP of Research and Development since July 1, 2019. Prior to her position with ScoutCam, Ms. Dlugach was
a system engineer and project manager at Nanofabrica Ltd. from August 2018 to June 2019. Before that, Ms. Dlugach served in a number
of roles, including chief of development and chief executive officer, at Nitinotes Ltd. from 2014 until 2018. Earlier in her career,
Ms. Dlugach held a variety of R&D positions at Medigus Ltd. (Nasdaq: MDGS). Ms. Dlugach holds a B.Sc., M.Sc. and MBA from Ben-Gurion
University, Israel.
Roee
Peled has served as our VP of Business Development since October 17, 2021. Prior to joining ScoutCam and since 2017, Mr. Peled was
the VP Global Sales & Business Development at PointGrab. From 2016 until 2017, Mr. Peled was VP Business Development at imVision
Technologies. Prior to that, Mr. Peled held various managerial sales positions, including from 2012 until 2016 at Director of Global
Sales at Mantis Visio, and from 2010 until 2012 at Technical Sales Manager at Orckit Systems. Mr. Peled holds a B.Sc in Electrical and
Electronic Engineering from Tel Aviv University and an MBA from Bar-Ilan University.
Arik
Priel has served as our Chief SW Architect since November 1, 2021. Mr. Priel has over 20 years of experience in leading multidisciplinary
R&D and engineering teams in defining and navigating product development from concept to deployment, with a focus on cloud-based
architectures and AI-based technologies. Prior to joining ScoutCam, Mr. Priel held several senior technology positions, most recently
as CTO of Octopol from June 2019 to August 2021, where he combined state-of-the-art AI models together with cutting-edge software technology.
Prior to Octopol, Mr. Priel served as Director of Technology at Green & Gold Analytics from March 2017 to June 2019, where he established
partnerships with Microsoft and Amazon Web Services. Mr. Priel also previously served as VP R&D and established the Israeli Innovation
Center of Landesk (currently named Ivanti). Mr. Priel earned both his BSc in Computer Science and Economics and MBA from Bar-Ilan University.
Staggered
Board
Our
board of directors is divided into three classes. Ronen Rosenbloom and Zeev Vurembrand are our Class I directors, with their terms of
office to expire at our 2022 annual meeting of stockholders. Lior Amit, Shmuel Donnerstein and Inbal Kreiss are our Class II directors,
with their terms of office to expire at our 2023 annual meeting of stockholders. Professor Benad Goldwasser and Moshe (Mori) Arkin are
our Class III directors, with their terms of office to expire at our 2024 annual meeting of stockholders. At each annual meeting of stockholders,
directors elected to succeed those directors whose terms expire shall be elected for a term of office to expire at the third succeeding
annual meeting of stockholders after their election, with each director to hold office until his or her successor shall have been duly
elected and qualified.
Our
board of directors may consider a broad range of factors relating to the qualifications and background of nominees to serve as director,
which may include various diversity factors. We have no formal policy regarding board diversity.
40
Our
officers hold office until the earlier of their death, resignation or removal by our board of directors or until their successors have
been selected. They serve at the pleasure of our board of directors.
Family
Relationships
There
are no family relationships between or among any of our directors or executive officers.
Involvement
in Certain Legal Proceedings
To
our knowledge, our directors and executive officers have not been involved in any of the following events during the past ten years:
a)
any
bankruptcy petition filed by or against such person or any business of which such person was a general partner or executive officer
either at the time of the bankruptcy or within two years prior to that time;
b)
any
conviction in a criminal proceeding or being subject to a pending criminal proceeding (excluding traffic violations and other minor
offenses);
c)
being
subject to any order, judgment, or decree, not subsequently reversed, suspended or vacated, of any court of competent jurisdiction,
permanently or temporarily enjoining him from or otherwise limiting his involvement in any type of business, securities or banking
activities or to be associated with any person practicing in banking or securities activities;
d)
being
found by a court of competent jurisdiction in a civil action, the SEC or the Commodity Futures Trading Commission to have violated
a federal or state securities or commodities law, and the judgment has not been reversed, suspended, or vacated;
e)
being
subject of, or a party to, any federal or state judicial or administrative order, judgment decree, or finding, not subsequently reversed,
suspended or vacated, relating to an alleged violation of any federal or state securities or commodities law or regulation, any law
or regulation respecting financial institutions or insurance companies, or any law or regulation prohibiting mail or wire fraud or
fraud in connection with any business entity; or
f)
being
subject of or party to any sanction or order, not subsequently reversed, suspended, or vacated, of any self-regulatory organization,
any registered entity or any equivalent exchange, association, entity or organization that has disciplinary authority over its members
or persons associated with a member.
Compliance
with Section 16(a) of the Exchange Act
Our
common stock is not registered pursuant to Section 12 of the Exchange Act. Accordingly, our directors, officers and principal stockholders
are not subject to the beneficial ownership reporting requirements of Section 16(a) of the Exchange Act.
Code
of Ethics
We
currently do not have a code of ethics applicable to our principal executive officer, principal financial officer, principal accounting
officer or controller, or persons performing similar functions as required by the Sarbanes-Oxley Act of 2002 due to our small size and
limited resources and because management’s attention has been focused on matters pertaining to raising capital and the operation
of the business. However, we adopted a Conflict Minerals Policy that is available on our website at https://www.scoutcam.com/. Information
contained on, or that can be accessed through, our website does not constitute a part of this Annual Report.
41
Board
Committees
Currently,
our board of directors does not have any audit, nominating or compensation committees, or committees performing similar functions.
item
11. Executive Compensation
Summary
Compensation Table
The
following sets forth information about the compensation paid to or accrued by the company’s principal executive officer and its
two other most highly compensated persons serving as executive officers as of December 31, 2021. These executives are referred to as
the “named executive officers.”
Name
and Principal Position
Year
Base
Salary (*)
Bonus
Stock
Awards
Option
Awards (**)
All
Other Compensation
Total
$
in thousands
Dr.
Yaron Silberman,
2021
$ 73
$ -
$ -
$ (80 )
$ 7
$ -
Former Chief Executive Officer (1)
2020
$ 198
$ -
$ -
$ 167
$ 20
$ 385
Yovav Sameah,
Chief
Executive Officer (2)
2021
$ 232
$ 50 (***)
$ -
$ 616
$ 24
$ 922
Amir Govrin
2021
$ 184
$ -
$ -
$ 100
$ 22
$ 306
Chief Technology Officer (3)
2020
$ 168
$ -
$ -
$ 111
$ 21
$ 300
Katrin
Dlugach,
2021
$ 170
$ -
$ -
$ 93
$ -
$ 263
VP R&D (4)
2020
$ 156
$ -
$ -
$ 51
$ -
$ 207
(1)
Consists
of Dr. Silberman’s compensation earned in his capacity as the Chief Executive Officer of wholly-owned subsidiary, ScoutCam
Ltd. Dr. Silberman did not earn any compensation in his capacity as the Chief Executive Officer of ScoutCam Inc. Dr. Silberman’s
employment terminated on March 31, 2021.
(2)
Consists
of Mr. Sameah’s compensation earned in his capacity as the Chief Executive Officer of our wholly-owned subsidiary, ScoutCam
Ltd. Mr. Sameah did not earn any compensation in his capacity as the Chief Executive Officer of ScoutCam Inc. Mr. Sameah’s
employment commenced on April 15, 2021.
(3)
Consists
of Mr. Govrin’s compensation earned in his capacity as the Chief Technology Officer of our wholly-owned subsidiary, ScoutCam
Ltd. Mr. Govrin did not earn any compensation in his capacity as the Chief Technology Officer of ScoutCam Inc.
(4)
Consists
of Ms. Katrin Dlugach compensation earned in his capacity as the VP R&D of our wholly-owned subsidiary, ScoutCam Ltd. Ms. Dlugach
did not earn any compensation in her capacity as the VP R&D of ScoutCam Inc.
(*)
Base
salaries are intended to provide a level of compensation sufficient to attract and retain an effective management team, when considered
in combination with the other components of our executive compensation program. The relative levels of base salary for our named
executive officers are designed to reflect each named executive officer’s scope of responsibility and accountability. Base
salary amounts include management insurance (which includes pension, disability insurance and severance pay), payments towards such
employee’s education fund, Israeli social security and amounts paid for use of a Company car. Each named executive officer
also receives gross-up payments for the taxes on these benefits.
42
(**)
The
amounts shown in the “Option Awards” column represents
the equity-based compensation expenses recorded in the Company’s consolidated financial statements for the years ended December
31, 2021 and December 31, 2020, in accordance with ASC 718, not the actual amounts paid to
or realized by the named executive officer during fiscal 2021 and fiscal 2020 .
The
fair value of each stock option award is estimated as of the date of grant using the Black-Scholes valuation model. Additional information
regarding the assumptions used to estimate the fair value of all stock option awards is included in Note 9 to Consolidated Financial
Statements.
(***)
Represents
a signing bonus.
Employment
Agreements
We,
and through our Israeli subsidiary, have entered into written employment agreements with each of our executive officers. 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 law. In addition, we have entered into agreements
with each executive officer and director pursuant to which we have agreed to indemnify each of them to the fullest extent permitted by
law to the extent that these liabilities are not covered by directors and officers insurance.
Equity-based
compensation
Outstanding
Equity Awards
The
following table provides information concerning unexercised options for each of our named executive officers, as that term is defined
in Item 402(m)(2) of Regulation S-K as of our fiscal year end of December 31, 2021.
Name and Position
No.
of Securities Underlying Unexercised Options (#) Exercisable
No.
of Securities Underlying Unexercised Options (#) Unexercisable
Option
Exercise Price ($)
Vesting
Schedule
Option
Expiration Date
Dr. Yaron Silberman,
37,011
-
2.61
(*)
March 31, 2022
Former Chief Executive Officer
Yovav Sameah,
Chief Executive Officer
-
200,985
3.6
(**)
April 15, 2028
Amir Govrin
40,712
18,506
2.61
(*)
February 12, 2027
Chief Technology Officer
-
26,112
4.50
(**)
May 13, 2028
Katrin Dlugach
16,655
12,954
2.61
(*)
February 12, 2027
VP R&D
-
26,112
4.50
(**)
May 13, 2028
(*)
25% of the options granted will vest on the first anniversary, and 6.25% of the options will vest at the end of each subsequent three-month
period thereafter over the course of the following three (3) years; and (iii) an acceleration mechanism pursuant to which any outstanding
and unvested option shall immediately accelerate and vest upon the occurrence of certain events, including, inter alia, a merger or sale
of all assets of the Company.
43
(**)
33.33% of the options granted will vest on the first, and 8.33% of the options will vest at the end of each subsequent three-month period
thereafter over the course of the following two (2) years; and (iii) an acceleration mechanism pursuant to which any outstanding and
unvested option shall immediately accelerate and vest upon the occurrence of certain events, including, inter alia, a merger or sale
of all assets of the Company.
Retirement
or Similar Benefit Plans
We
do not have any arrangements or plans that provide for the payment of retirement or similar benefits to our directors or executive officers.
Resignation,
Retirement, Other Termination, or Change in Control Arrangements
We
have no contract, agreement, plan or arrangement, whether written or unwritten, that provides for payments to our directors or executive
officers at, following, or in connection with the resignation, retirement or other termination of our directors or executive officers,
or a change in control of our Company or a change in our directors’ or executive officers’ responsibilities following a change
in control.
Director
Compensation
The
following table sets out the compensation paid to directors for services rendered during the year ended December 31, 2021.
Name
Fees Earned or
Paid in Cash
Stock Awards
Option Awards (*)
All Other
Compensation
Total
$ in thousands
Prof. Benad Goldwasser
$ 120
$ -
$ 418
$ -
$ 538
Shmuel Donnerstein
$ 16
$ -
$ 69
$ -
$ 85
Ronen Rosenbloom
$ 16
$ -
$ 30
$ -
$ 46
Lior Amit
$ 16
$ -
$ 79
$ -
$ 95
Moshe (Mori) Arkin (1)
$ 14
$ -
$ 83
$ -
$ 97
Inbal Kreiss (2)
$ 12
$ -
$ 55
$ -
$ 67
Zeev Vurembrand (3)
$ 10
$ -
$ 33
$ -
$ 43
(1)
Appointed
as a director of ScoutCam Inc. on February 15, 2021.
(2)
Appointed
as a director of ScoutCam Inc. on April 9, 2021.
(3)
Appointed
as a director of ScoutCam Inc. on May 13, 2021.
(*)
Represents
the equity-based compensation expenses recorded in the Company’s consolidated financial statements for the year ended December
31, 2021, based on the option’s fair value, calculated in accordance with accounting guidance for equity-based compensation.
On
March 15, 2020, our board of directors approved a quarterly fee of $4,000 payable to each of our currently serving directors, excluding
Professor Benad Goldwasser. On each of April, 9, 2021 and August 12, 2021, our board of directors approved the same terms for directors
appointed subsequent to March 15, 2020.
44
Item
12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder matters
Security
Ownership of Certain Beneficial Owners and Management
The
table below provides information regarding the beneficial ownership of our common stock as of March 28, 2022, of (i) each of our current
directors, (ii) each of the Named Executive Officers, (iii) all of our current directors and officers as a group, and (iv) each person
or entity known to us who owns more than 5% of our common stock.
The
percentage of common stock beneficially owned is based on 7,121,737 shares of common stock outstanding as of March 28, 2022. The number
and percentage of shares beneficially owned by a person or entity also include shares of common stock issuable upon exercise of warrants
that are currently exercisable or will become exercisable within 60 days of March 28, 2022. However, these shares are not deemed to be
outstanding for the purpose of computing the percentage of shares beneficially owned of any other person or entity.
Unless
otherwise indicated below, the address for each beneficial owner listed in the table below is c/o ScoutCam Inc., Suite 7A and 3B, Industrial
Park, P.O. Box 3030, Omer, Israel 8496500.
Name and Address of Beneficial Owner
Amount and Nature
of Beneficial
Ownership (1)
Percent of Class
Prof. Benad Goldwasser (2)
360,839
4.85 %
Shmuel Donnerstein (3)
101,827
1.42 %
Ronen Rosenbloom (4)
12,534
*
Lior Amit (5)
20,546
*
Inbal Kreiss (6)
5,341
*
Moshe (Mori) Arkin (7)
1,600,815
20.49 %
Zeev Vurembrand
-
-
Yovav Sameah (8)
66,988
*
Tanya Yosef (9)
28,131
*
Amir Govrin (10)
53,116
*
Katrin Dlugach (11)
29,059
*
Roee Peled
-
-
Arik Priel
-
-
Directors and officers as a group (13 individuals)
2,279,196
27.21 %
Medigus Ltd.
1,923,575
27.01 %
The More Group (12)
940 ,318
12.39 %
The Phoenix Holdings (13)
1,358,026
17.41 %
The Meitav Dash Group (14)
891 ,500
11.78 %
Noked Long Limited Partnership
(15)
370,148
5.07 %
*
Less than 1%.
(1)
Beneficial
ownership is determined in accordance with the rules of the SEC and generally includes voting or investment power with respect to
securities. Each of the beneficial owners named in the table have, to our knowledge, direct ownership of and sole voting and investment
power with respect to the shares of common stock beneficially owned by them.
(2)
Includes
options to purchase 316,898 shares of common stock which are currently exercisable or will become exercisable within 60 days of March
28, 2022.
(3)
Includes
options to purchase 32,890 shares of common stock which are currently exercisable or will become exercisable within 60 days of March
28, 2022.
(4)
Includes
options to purchase 12,534 shares of common stock which are currently exercisable or will become exercisable within 60 days of March
28, 2022.
45
(5)
Includes
options to purchase 20,546 shares of common stock which are currently exercisable or will become exercisable within 60 days of March
28, 2022.
(6)
Includes
options to purchase 5,341 shares of common stock which are currently exercisable or will become exercisable within 60 days of March
28, 2022.
(7)
Mr.
Moshe Arkin is the sole shareholder and sole director of M. Arkin (1999) Ltd. and may therefore be deemed to be the indirect beneficial
owner of the shares of common stock and warrants to purchase shares of common stock owned directly by M. Arkin (1999) Ltd. Includes
warrants to purchase 681,360 shares of common stock and options to purchase 8,527 shares of common stock which are currently exercisable
or will become exercisable within 60 days of March 28, 2022.
(8)
Includes
options to purchase 66,988 shares of common stock which are currently exercisable or will become exercisable within 60 days of March
28, 2022
(9)
Includes
options to purchase 28,131 shares of common stock which are currently exercisable or will become exercisable within 60 days of March
28, 2022.
(10)
Includes
options to purchase 53,116 shares of common stock which are currently exercisable or will become exercisable within 60 days of March
28, 2022.
(11)
Includes
options to purchase 29,059 shares of common stock which are currently exercisable or will become exercisable within 60 days of March
28, 2022.
(12)
Based
on information provided to or available to the Company, consists of warrants to purchase 470,159 shares of common stock. The business
address of the More Group is BSR Tower 1, 2 Ben Gurion Street, Ramat Gan, Israel.
(13)
Based
on the Schedule 13G/A filed by The Phoenix Holdings with the SEC on February 7, 2022 and information provided to or available to
the Company, consists of 679,013 warrants to purchase shares of common stock, which are currently exercisable or will become exercisable
within 60 days of March 28, 2022. The business address of the Phoenix Holdings Ltd. is Derech Hashalom 53, Givataim 53454, Israel.
(14)
Based
on information provided to or available to the Company, consists of warrants to purchase 445,750 shares of common stock.
(15)
Based
on information provided to or available to the Company, consists of warrants to purchase shares 185,185 of common stock. The
business address of Noked Long Limited Partnership is 30 Haarbaa’a street, Tel Aviv, Israel
Item
13. Certain relationships and related transactions, and director independence
Related
Party Transactions
On
April 20, 2020, Medigus and ScoutCam Ltd. entered into an Intercompany Services Agreement, which amended and restated the intercompany
services agreement executed between the parties on May 30, 2019. The agreement has an initial term of one year, and renews automatically
for additional one-year periods, unless either party provides 60 (sixty) days written notice of non renewal. Either Medigus or ScoutCam
Ltd. may terminate the agreement for convenience upon providing 60 days prior written notice. The services to be provided by ScoutCam
Ltd. include the provision of office space, utilities, car services, insurance, and chief financial officer services. In consideration
for the foregoing services, ScoutCam Ltd. is entitled to arm’s length service fees based on the most recent transfer pricing analysis
as performed by an external expert, which may be adjusted from time to time. On March 22, 2022, ScoutCam Ltd. provided prior written
notice to Medigus of termination of the Intercompany Services Agreement effective May 21, 2022.
46
On
May 18, 2020, we entered into and consummated a securities purchase agreement with M. Arkin (1999) Ltd. (“Arkin Ltd.”) in
connection with the sale and issuance of 229,569 units (“Arkin Units”), at a purchase price of $8.712 per Arkin Unit, and
for an aggregate purchase price of $2,000,000 (the “Arkin Transaction”). Each Arkin Unit consists of: (i) two shares of common
stock and (ii) (a) one warrant to purchase one share of common stock with an exercise price of $5.355 (“Arkin Warrant A”)
and (b) two warrants, each to purchase one share of common stock with an exercise price of $8.037 (“Arkin Warrant B”, and
together with Arkin Warrant A, the “Arkin Warrants”). The shares of common stock and Arkin Warrants were issued to Arkin
Ltd. pursuant to Regulation S of the Securities Act of 1933, as amended.
Also
on May 18, 2020, and in connection with the Arkin Transaction, we, Medigus and Arkin Ltd. entered into a Voting Agreement, pursuant to
which Arkin Ltd. and Medigus each agreed to vote their respective shares of common stock in favor of the election of the opposite party’s
designated representative(s), as applicable, to our board of directors. Each of Arkin Ltd.’s and Medigus’ rights under the
Voting Agreement are contingent upon, inter alia, such party maintaining certain beneficial ownership thresholds in our company.
Also
on May 18, 2020, in connection with the Arkin Transaction, we, Medigus and Arkin, entered into the Letter Agreement, whereby, provided
that we obtain certain regulatory approvals described therein, we and Medigus agreed to amend certain terms of the Amended and Restated
Asset Transfer Agreement and the License Agreement, thereby transferring outright certain patent assets from Medigus to us; provided,
however, that in the event that we neglect the foregoing patent assets, we must transfer back ownership of the patent assets to Medigus
for no additional consideration and absent any additional contingencies. On July 27, 2020, Medigus and ScoutCam Ltd. entered into each
of the Addendum No. 1 to the Amended and Restated Asset Transfer Agreement, or the Addendum, and the Patent License Agreement Termination,
in order to reflect and effect the amendments agreed upon in the Letter Agreement.
On
June 23, 2020, we and Medigus entered into a Conversion Side Letter, pursuant to which Medigus converted $381,136 worth of outstanding
credit previously extended to us, including interest by Medigus, into (a) 87,497 shares of our common stock, (b) warrants to purchase
43,749 shares of common stock at an exercise price of $5.355, and (c) warrants to purchase 87,497 shares of our common stock at an exercise
price of $8.037.
In
November 2020, we and certain of our warrant holders, including Professor Benad Goldwasser and Arkin Ltd., executed an amendment in connection
with previously issued warrants to purchase shares of common stock, pursuant to which the parties agreed to remove the restrictions on
transferability originally imposed on such warrants. As of December 31, 2020, warrants to purchase 100,257 shares of common stock were
transferred in accordance with the foregoing amendment.
Beginning
on January 1, 2021 and as of the date hereof, our board of directors authorized the allotment of options and RSU to purchase 128,334
shares of common stock to Prof. Benad Goldwasser and an aggregate of 501,842 options to purchase shares of common stock to additional
directors and certain officers of our company.
On
March 29, 2021, we issued to certain investors, including M. Arkin (1999) Ltd., a major stockholder of our company, of which Mori Arkin,
a director of our company, is the owner, 2,469,156 units in exchange for an aggregate purchase price of $20 million. Each such unit consists
of (i) one share of common stock and (ii) one warrant to purchase one share of common stock with an exercise price of $10.35 per share.
Each such warrant is exercisable until the close of business on March 31, 2026. Pursuant
to the terms of the foregoing warrants, following April 1, 2024, if the closing price of our the common stock equal or exceeds 135% of
the aforementioned exercise price (subject to appropriate adjustments for stock splits, stock dividends, stock combinations and other
similar transactions after the issue date of the warrants) for any thirty (30) consecutive trading days, we may force the exercise of
the warrants, in whole or in part, by delivering to these investors a notice of forced exercise. The shares of common stock and the warrants
were issued to such investors pursuant to Regulation S of the Securities Act of 1933, as amended. The securities issued in connection
with the foregoing investment were registered by us for resale under a registration statement on Form S-1 declared effective on May 10,
2021.
47
Policies
and Procedures for Related Party Transactions
Our
board of directors is responsible for approving all related party transactions. Given our small size and limited financial resources,
we have not adopted formal policies and procedures for the review, approval, or ratification of transactions with our related persons.
We intend to establish formal policies and procedures in the future, once we have sufficient resources and have appointed additional
directors, so that such transactions will be subject to the review, approval, or ratification of our board of directors, or an appropriate
committee thereof.
Director
Independence
Our
board of directors has determined that Professor Benad Goldwasser, Mr. Shmuel Donnerstein, Ms. Inbal Kreiss, Mr. Lior Amit and Mr. Zeev
Vurembrand do not have a relationship that would interfere with the exercise of independent judgment in carrying out the responsibilities
of a director and that each of these directors is “independent”. We
are not currently subject to listing requirements of any national securities exchange, which generally stipulates certain requirements
that a majority of a company’s board of directors be classified as “independent”. As a result, we are not at this time
required to have our board of directors comprised of a majority of “independent directors”. Notwithstanding the foregoing,
we have voluntarily adopted the definition of “independent” as defined under Nasdaq Rule 5605(a)(2), and believe Professor
Goldwasser, Mr. Donnerstein, Ms. Kreiss, Mr. Amit and Mr. Vurembrand qualify accordingly.
Item
14. Principal accounting fees and services
Audit
and Accounting Fees
The
following table sets forth the fees billed to our Company for professional services rendered by Brightman Almagor Zohar & Co., a
firm in the Deloitte global network, and Kesselman & Kesselman, a member of PricwaterhouseCoopers International Limited,
for the fiscal years ended December 31, 2020 and December 31, 2021:
Services
Year Ended
December 31, 2021
Year Ended
December 31, 2020
$ in thousands
Audit fees (1)
$ 240 (3)
$ 170 (4)
Tax fees (2)
16
-
All other fees
-
-
Total fees
$ 256
$ 170
(1)
Audit
fees consist of audit and review services, consents and review of documents filed with the
SEC.
(2)
Tax
fees consist of services related to representing the Company before the Israel Tax Authority
in a VAT assessment.
(3)
Audit
Fees consists of $123,000 in connection with the services rendered by Brightman Almagor
Zohar & Co., a firm in the Deloitte global network, and $117,000 in connection
with the services rendered by Kesselman & Kesselman, a member of PricwaterhouseCoopers
International Limited
(4)
Audit Fees consists of $65,000 in connection with
the services rendered by Brightman Almagor Zohar & Co., a firm in the Deloitte global network, and $105,000 in
connection with the services rendered by Kesselman & Kesselman, a member of PricwaterhouseCoopers International Limited.
Audit
Committee Administration of Engagement
We
have not yet established an audit committee. Until then, there are no formal pre-approval policies and procedures with respect to the
engagement of an accountant for audit or non-audit services. Nonetheless, the auditors engaged for these services are required to provide
and uphold estimates for the cost of services to be rendered.
48
Part
IV
Item
15. exhibits, financial statement schedules
Exhibit
No.
Exhibit
Description
3.1.1
Amended and Restated Articles of Incorporation (incorporated by reference to Exhibit 3.1.4 to our Quarterly Report on Form 10-Q filed with the SEC on August 12, 2021)
3.2.1
Amended and Restated Bylaws (incorporated by reference to Exhibit 3.2.2 to our Quarterly Report on Form 10-Q filed with the SEC on August 12, 2021)
4.1
Description of the Registrant’s Securities (incorporated by reference to Exhibit 4.1 to our Annual Report on Form 10-K filed with the SEC on March 16, 2020)
10.1
Securities Exchange Agreement, dated September 16, 2019, by and between our Company and Medigus Ltd. (incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K filed with the SEC on September 17, 2019)
10.2
Amended and Restated Asset Transfer Agreement, by and between ScoutCam Ltd. and Medigus Ltd., dated December 1, 2019 (incorporated by reference to Exhibit 10.7 to our Current Report on Form 8-K filed with the SEC on December 31, 2019)
10.3+
Consulting Agreement by and between ScoutCam Ltd. and Prof. Benad Goldwasser, dated July 31, 2019 (incorporated by reference to Exhibit 10.8 to our Current Report on Form 8-K filed with the SEC on December 31, 2019)
10.4
2020 Share Incentive Plan (incorporated by reference to Exhibit 10.10 to our Annual Report on Form 10-K filed with the SEC on March 16, 2020)
10.5
Form of Notice of Option Grant and Option Agreement (incorporated by reference to Exhibit 10.11 to our Annual Report on Form 10-K filed with the SEC on March 16, 2020)
10.6
Amended and Restated Intercompany Services Agreement, by and between Medigus Ltd. and ScoutCam Ltd., dated April 20, 2020 (incorporated by reference to Exhibit 10.17 to our Form S-1 filed with the SEC on May 12, 2020)
10.7**
Patent License Agreement, by and between Medigus Ltd. and ScoutCam Ltd., dated December 1, 2019 (incorporated by reference to Exhibit 10.18 to our Form S-1 filed with the SEC on May 12, 2020)
10.8+
Employment Agreement, by and between ScoutCam Ltd. and Yaron Silberman, dated February 28, 2019 (incorporated by reference to Exhibit 10.19 to our Form S-1 filed with the SEC on May 12, 2020)
10.9+
Employment Agreement, by and between ScoutCam Ltd. and Amir Govrin, dated May 1, 2019 (incorporated by reference to Exhibit 10.20 to our Form S-1 filed with the SEC on May 12, 2020)
10.10+
Employment Agreement, by and between ScoutCam Ltd. and Tanya Yosef, dated January 14, 2021 (incorporated by reference to Exhibit 10.21 to our Annual Report on Form 10-K filed with the SEC on March 31, 2021)
10.11+
Employment Agreement, by and between ScoutCam Ltd. and Katrin Dlugach, dated July 1, 2019 (incorporated by reference to Exhibit 10.22 to our Annual Report on Form 10-K filed with the SEC on March 31, 2021)
10.12
Securities Purchase Agreement, dated May 18, 2020, by and between ScoutCam Inc. and M. Arkin (1999) Ltd. (incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K filed with the SEC on May 19, 2020)
10.13
Voting Agreement, dated May 18, 2020, by and among ScoutCam Inc. Medigus Ltd. and M. Arkin (1999) Ltd. (incorporated by reference to Exhibit 10.3 to our Current Report on Form 8-K filed with the SEC on May 19, 2020)
10.14
Letter Agreement, dated May 18, 2020, by and among ScoutCam Inc., ScoutCam Ltd., Medigus Ltd. and M. Arkin (1999) Ltd. (incorporated by reference to Exhibit 10.4 to our Current Report on Form 8-K filed with the SEC on May 19, 2020)
10.15
Form of Warrant B by and between ScoutCam Inc. and M. Arkin (1999) Ltd. (incorporated by reference to Exhibit 10.6 to our Current Report on Form 8-K filed with the SEC on May 19, 2020)
10.16**
Addendum No. 1 to the Amended and Restated Asset Transfer Agreement, dated July 27, 2020, by and between ScoutCam Ltd. and Medigus Ltd. (incorporated by reference to Exhibit 10.30 to our Registration Statement on Form S-1/A filed with the SEC on October 19, 2021)
10.17
Patent License Agreement Termination, dated July 27, 2020, by and between ScoutCam Ltd. and Medigus Ltd. (incorporated by reference to Exhibit 10.31 to our Registration Statement on Form S-1/A filed with the SEC on October 19, 2021)
49
10.18
Form of Amendment to Warrant to Purchase Shares of Common Stock (incorporated by reference to Exhibit 10.32 to our Annual Report on Form 10-K filed with the SEC on March 31, 2021)
10.19+
Employment Agreement, by and between Yovav Sameah and ScoutCam Ltd. (incorporated by reference to Exhibit 10.1 to our Current Report on Form 8-K filed with the SEC on March 8, 2021)
10.20
Purchase Order Form, between ScoutCam Inc. and the Investors in the March 2021 Private Placement (incorporated by reference to Exhibit 10.34 to our Registration Statement on Form S-1 filed with the SEC on May 4, 2021)
10.21
Form of Warrant (incorporated by reference to Exhibit 10.1 of our Current Report on Form 8-K filed with the SEC on March 24, 2021)
10.22+
Employment Agreement, dated August 31, 2021, by and between ScoutCam Ltd. and Roee Peled, (incorporated by reference to Exhibit 10.38 to our Registration Statement on Form S-1/A filed with the SEC on October 19, 2021)
10.23+*
Employment Agreement, dated October 26 , 2021, by and between ScoutCam Ltd. and Arik Priel
21.1
Subsidiaries of the Registrant (incorporated by reference to Exhibit 21.1 to our Current Report on Form 8-K filed with the SEC on December 31, 2019)
31.1*
Section 302 Certification under the Sarbanes-Oxley Act of 2002 of the Principal Executive Officer and Principal Financial Officer
32.1*
Section 906 Certification under the Sarbanes-Oxley Act of 2002 of the Principal Executive Officer and Principal Financial Officer
101.INS
Inline
XBRL Instance Document
101.SCH
Inline
XBRL Taxonomy Extension Schema Document
101.CAL
Inline
XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF
Inline
XBRL Taxonomy Extension Definition Linkbase Document
101.LAB
Inline
XBRL Taxonomy Extension Label Linkbase Document
101.PRE
Inline
XBRL Taxonomy Extension Presentation Linkbase Document
104
Cover
Page Interactive Data File (formatted in Inline XBRL and contained in Exhibit 101)
*
Filed
herewith
**
Certain
confidential information contained in this exhibit, marked by brackets, was omitted because it is both (i) not material and (ii)
would likely cause competitive harm to the Company if publicly disclosed. “[***]” indicates where the information has
been omitted from this exhibit
+
Management
contract or compensatory plan or arrangement
(b)
Financial
Statement Schedules. Schedules have been omitted because the information required to be set out therein is not applicable or is shown
in the financial statements or notes thereto.
50
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed
on its behalf by the undersigned, thereunto duly authorized.
SCOUTCAM
INC.
By:
/s/
Yovav Sameah
Name:
Yovav
Sameah
Title:
Chief
Executive Officer
Date:
March
30, 2022
Pursuant
to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the
registrant and in the capacities and on the dates indicated.
Signature
Title
Date
/s/
Yovav Sameah
Chief
Executive Officer
March
30, 2022
Yovav
Sameah
(Principal
Executive Officer)
/s/
Tanya Yosef
Chief
Financial Officer
March
30, 2022
Tanya
Yosef
(Principal
Financial Officer and Principal Accounting Officer)
/s/
Benad Goldwasser
Chairman
of the Board
March
30, 2022
Benad
Goldwasser
/s/
Shmuel Donnerstein
Director
March
30, 2022
Shmuel
Donnerstein
/s/
Ronen Rosenbloom
Director
March
30, 2022
Ronen
Rosenbloom
/s/
Lior Amit
Director
March
30, 2022
Lior
Amit
/s/
Mori Arkin
Director
March
30, 2022
Mori
Arkin
/s/
Inbal Kreiss
Director
March
30, 2022
Inbal
Kreiss
/s/
Zeev Vurembrand
Director
March
30, 2022
Zeev
Vurembrand
SCOUTCAM
INC.
TABLE
OF CONTENTS
Page
Consolidated
Financial Statements – in US Dollars (USD) in thousands
Report of Independent Registered Public Accounting Firm (PCAOB ID 1197 )
F-2
Consolidated Balance Sheets
F-3
Consolidated Statements of Operations
F-4
Consolidated Statements of Changes in Shareholders’ Equity
F-5
Consolidated Statements of Cash Flows
F-6
Notes to the Consolidated Financial Statements
F-8
F- 1
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To
the shareholders and the Board of Directors of Scoutcam Inc.
Opinion
on the Financial Statements
We
have audited the accompanying consolidated balance sheets of Scoutcam Inc. and its subsidiary (the “Company”) as of December
31, 2021 and 2020, and the related consolidated statements of operations, shareholders’ equity and cash flows for each of the two 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
as of December 31, 2021 and 2020, and the results of its operations and its cash flows for each of the two years in the period ended
December 31, 2021, in conformity with accounting principles generally accepted in the United States of America.
Basis
for Opinion
These
consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on
the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company
Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with
the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We
conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud.
The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part
of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing
an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our
audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether
due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence
regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles
used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements.
We believe that our audits provide a reasonable basis for our opinion.
Critical
Audit Matter
The
critical audit matter communicated below is a matter arising from the current-period audit of the consolidated financial statements that
was communicated or required to be communicated to the audit committee and that (1) relates to accounts or disclosures that are material
to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication
of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are
not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or
disclosures to which it relates.
Development
Services Revenue and Contract Liabilities – Refer to Note 2k. and Note 10 to the consolidated financial statements
Critical
Audit Matter Description
The
Company generates revenues from development services. The Company determines at contract inception whether development services are distinct
from the performance obligation to manufacture the product under development. Revenues from development services that are determined
as not distinct from the performance obligation to manufacture the product under development are deferred until commencement of manufacturing
and are recognized over the manufacturing term. During 2021, all development services revenues billed have been deferred and recorded
as contract liabilities (representing the contract liabilities balance of $2,420,000 as of December 31, 2021) and the respective service
costs have been deferred and recorded as contract fulfillment assets ($1,675,000 as of December 31, 2021), as the development services
were determined as not distinct from the performance obligation to manufacture the product under development.
We
identified the assessment of whether development services were a distinct performance obligation and the impact on the timing of revenue
recognition as a critical audit matter. Evaluating whether development services should be accounted for separately required judgment
and increased audit effort in comparison to our audit as a whole, because of the complexity of the technical accounting analysis and
due to the magnitude of the related contract liabilities as of December 31, 2021.
How
the Critical Audit Matter Was Addressed in the Audit
Our
audit procedures related to the Company’s determination of the performance obligations and the timing of revenue recognition for
development service contracts included the following, among others:
● We
read the agreements and analyzed the terms of the Company’s development service contracts.
● We
read communications between the Company and its clients relating to development services
contracts.
● We
inquired of Company research and development personnel to understand the commercial facts
and circumstances relating to development services contracts.
● We
evaluated the Company’s interpretation and application of the relevant requirements
of generally accepted accounting principles in relation to the development services contracts
and the related contract liabilities.
/s/
Brightman Almagor Zohar & Co.
Certified
Public Accountants
A
Firm in the Deloitte Global Network
Tel
Aviv, Israel
March
30, 2022
We
have served as the Company’s auditor since 2020.
F- 2
SCOUTCAM
INC.
CONSOLIDATED
BALANCE SHEETS
December
31,
2021
2020
USD
in thousands
Assets
Note
CURRENT
ASSETS:
Cash
and cash equivalents
8,581
3,373
Short
terms deposits
3
11,013
-
Accounts
receivable
8
17
Inventory
4
167
244
Medigus
receivable
8
-
47
Other
current assets
443
348
Total
current assets
20,212
4,029
NON-CURRENT
ASSETS:
Contract
fulfillment assets
10
1,675
1,130
Property
and equipment, net
5
781
269
Operating
lease right-of-use assets
12
482
107
Severance
pay asset
396
360
Total
non-current assets
3,334
1,866
TOTAL
ASSETS
23,546
5,895
Liabilities
and shareholders’ equity
CURRENT
LIABILITIES:
Accounts
payable
103
79
Contract
liabilities - short term
10
346
69
Operating
lease liabilities - short term
12
256
60
Accrued
compensation expenses
355
369
Medigus
payable
8
39
-
Other
accrued expenses
6
210
195
Total
current liabilities
1,309
772
NON-CURRENT
LIABILITIES:
Contract
liabilities - long term
10
2,074
779
Operating
lease liabilities - long term
12
203
47
Liability
for severance pay
344
333
Total
non-current liabilities
2,621
1,159
TOTAL
LIABILITIES
3,930
1,931
SHAREHOLDERS’
EQUITY:
9
Common stock, $ 0.001
par value; 300,000,000 and 75,000,000 shares authorized as of December 31, 2021 and December 31, 2020, 7,121,737 and 4,084,122 shares
issued and outstanding as of December 31, 2021 and December 31, 2020, respectively
7
4
Additional
paid-in capital
34,903
10,267
Accumulated
deficit
( 15,294 )
( 6,307 )
TOTAL
SHAREHOLDERS’ EQUITY
19,616
3,964
TOTAL
LIABILITIES AND SHAREHOLDERS’ EQUITY
23,546
5,895
The
accompanying notes are an integral part of these consolidated financial statements.
F- 3
SCOUTCAM
INC.
CONSOLIDATED
STATEMENTS OF OPERATIONS
Year
ended December 31,
Note
2021
2020
USD
in thousands
(except per share data)
REVENUES
11
387
491
COST
OF REVENUES
1,108
994
GROSS
LOSS
( 721 )
( 503 )
RESEARCH
AND DEVELOPMENT EXPENSES
2,002
725
SALES
AND MARKETING EXPENSES
908
443
GENERAL
AND ADMINISTRATIVE EXPENSES
5,481
3,035
OPERATING
LOSS
( 9,112 )
( 4,706 )
OTHER INCOME
8
-
FINANCING
INCOME (EXPENSES), NET
117
41
LOSS
BEFORE TAXES ON INCOME
( 8,987 )
( 4,665 )
TAXES
ON INCOME
-
( 2 )
NET
LOSS
( 8,987 )
( 4,667 )
Net
loss per share (basic and diluted, in USD)
( 1.44 )
( 1.32 )
Weighted
average common shares (basic and diluted, in thousands)
6,240
3,529
The
accompanying notes are an integral part of these consolidated financial statements.
F- 4
SCOUTCAM
INC.
CONSOLIDATED
STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY
Common
stock
Additional
paid-in capital
Accumulated
deficit
Total
Shareholders’ equity
Number
in
thousands
Amount
USD
in thousands
Balance
at January 1, 2021
4,084
$ 4
10,267
( 6,307 )
3,964
Issuance of shares
and warrants (see note 9)
2,469
$ 2
19,116
-
19,118
Exercise of warrants
(see note 9)
568
$ 1
3,490
-
3,491
Stock
based compensation (see note 9)
-
-
2,030
-
2,030
Round
up of shares due to reverse stock split (see note 9)
1
$ - *
- *
-
*
Conversion of a loan from Medigus
Conversion of a loan from Medigus, shares
Net
loss
-
-
-
( 8,987 )
( 8,987 )
Balance
at December 31, 2021
7,122
7
34,903
( 15,294 )
19,616
Common
stock
Additional
paid-in capital
Accumulated
deficit
Total
Shareholders’
equity
Number
in thousands
Amount
USD
in thousands
Balance
at January 1, 2020
2,987
$ 3
4,159
( 1,640 )
2,522
Balance
2,987
$ 3
4,159
( 1,640 )
2,522
Issuance of shares
and warrants (see note 9)
677
$ 1
2,857
-
2,858
Exercise of warrants
(see note 9)
333
$ - *
1,729
-
1,729
Stock
based compensation (see note 9)
-
-
1,141
-
1,141
Conversion
of loan from Medigus (see note 8)
87
$ - *
381
-
381
Net
loss
-
-
-
( 4,667 )
( 4,667 )
Balance at December
31, 2020
4,084
$ 4
10,267
( 6,307 )
3,964
Balance
4,084
$ 4
10,267
( 6,307 )
3,964
*
Represents
an amount less than $1 thousand
The
accompanying notes are an integral part of these consolidated financial statements.
F- 5
SCOUTCAM
INC.
CONSOLIDATED
STATEMENTS OF CASH FLOWS
Year
ended December 31,
2021
2020
USD
in thousands
CASH
FLOWS FROM OPERATING ACTIVITIES:
Net
loss
( 8,987 )
( 4,667 )
Adjustments
to reconcile net loss to net cash used in operating activities:
Depreciation
114
66
Share based compensation
2,030
1,107
Profit
from exchange differences on cash and cash equivalents
( 130 )
( 85 )
Severance pay asset and liability
( 25 )
4
Interest
income in respect of deposits
( 13 )
-
CHANGES
IN OPERATING ASSET AND LIABILITY:
Decrease
in accounts receivable
9
5
Decrease
in inventory
77
693
Increase in operating lease liability
20
-
Increase in ROU asset
( 43 )
-
Increase
in other current assets
( 126 )
( 270 )
Increase
in account payables
24
44
Increase
in contract fulfillment assets
( 545 )
( 1,130 )
Increase
in contract liabilities
1,572
346
Increase
(decrease) in accrued compensation expenses
( 14 )
72
Increase
(decrease) in Medigus receivable / payable
86
( 15 )
Increase
(decrease) in other accrued expenses
65
( 357 )
Net
cash flows used in operating activities
( 5,886 )
( 4,187 )
CASH
FLOWS FROM INVESTING ACTIVITIES:
Purchase
of property and equipment
( 595 )
( 276 )
Investment
in short terms deposits
( 11,000 )
-
Net
cash flows used in investing activities
( 11,595 )
( 276 )
CASH
FLOWS FROM FINANCING ACTIVITIES:
Proceeds
from issuance of shares and warrants
19,118
2,858
Proceeds from exercise
of warrants
3,491
1,729
Issuance expenses
( 50 )
-
Loan
repayment to Medigus
-
( 81 )
Net
cash flows provided by financing activities
22,559
4,506
INCREASE
IN CASH AND CASH EQUIVALENTS
5,078
43
BALANCE
OF CASH AND CASH EQUIVALENTS AT BEGINNING OF YEAR
3,373
3,245
PROFITS
FROM EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS
130
85
BALANCE
OF CASH AND CASH EQUIVALENTS AT END OF YEAR
8,581
3,373
F- 6
Non
cash activities -
Year
ended December 31,
2021
2020
USD
in thousands
Non
cash activities -
Right-of-use
assets obtained in exchange for operating lease liabilities
524
97
Increase
in property and equipment through a decrease in advances to suppliers
31
-
Loan
from Medigus settled against receivable from Medigus
-
41
Conversion
of loan from Medigus
-
381
The
accompanying notes are an integral part of these consolidated financial statements.
F- 7
SCOUTCAM
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE
1 – GENERAL :
a .
ScoutCam Inc. (the “Company”), formerly
known as Intellisense Solutions Inc., (“Intellisense”), was incorporated under the laws of the State of Nevada on March
22, 2013. Prior to the closing of the Exchange Agreement (as defined below), the Company was a non-operating “shell
company”.
The Company’s wholly owned subsidiary,
ScoutCam Ltd. (“ScoutCam”), was formed in the State of Israel on January 3, 2019, as a wholly-owned subsidiary
of Medigus Ltd. (“Medigus”), an Israeli company traded on the Nasdaq Capital Market, and commenced operations on March
1, 2019.
In December 2019, Medigus and ScoutCam consummated
an asset transfer agreement, under which Medigus transferred and assigned certain assets and intellectual property rights
related to its miniaturized imaging business to ScoutCam.
On December 30, 2019, Intellisense and
Medigus consummated a securities exchange agreement (the “Exchange Agreement”), pursuant to which
Medigus delivered 100% of its holdings in ScoutCam to Intellisense in exchange for shares of Intellisense’s common stock representing
60% of the issued and outstanding share capital of Intellisense immediately upon the consummation of the Exchange Agreement.
As of December 31, 2021, Medigus beneficially owned
27.01% of the Company’s outstanding common stock.
The Company, through ScoutCam, provides
image-based platforms. Through the use of its proprietary visualization technology, ScoutCam offers solutions across predictive
maintenance and condition-based monitoring markets, in sectors such as energy, automotive and aviation. ScoutCam’s
solutions are based on small and highly resilient cameras, specialized AI analysis and supplementary technologies.
F- 8
SCOUTCAM
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE
1 – GENERAL (continued) :
b.
On
August 9, 2021, the Company amended its Articles of Incorporation to effect a nine-to-one
reverse stock split of its outstanding Common Stock.
As
a result of the reverse stock split, every nine shares of the Company’s outstanding Common Stock was combined and reclassified
into one share of the Company’s Common Stock. No fractional shares were issued in connection with or following the reverse
split. The amount of authorized capital of the Company’s Common Stock and par value of such shares remained unchanged.
All
share, stock option and per share information in these consolidated financial statements have been adjusted to reflect the reverse
stock split on a retroactive basis.
.
c.
Since
incorporation of ScoutCam and through December 31, 2021, the Company accumulated
a deficit of approximately $ 15.3 million
and its activities have been funded mainly by its shareholders. The Company’s management
believes the Company’ cash and cash resources as of December 31, 2021 will enable
the Company to fund its operating plan for more than 12 months from the date of issuance
of these financial statements. The Company expects to continue to incur significant
research and development expenses and other costs related to its ongoing operations and,
as a result, will need to obtain additional funding in order to continue its future operations.
d.
In
early 2020, the World Health Organization declared the rapidly spreading coronavirus disease (COVID-19) outbreak a pandemic. This
pandemic has resulted in governments worldwide enacting emergency measures to combat the spread of the virus. The Company
considered the impact of COVID-19 on its operations and determined that there were no material adverse impacts on the Company’s
results of operations and financial position as of December 31, 2021. These estimates may change, as new events occur and additional
information is obtained.
F- 9
SCOUTCAM
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE
2 – SIGNIFICANT ACCOUNTING POLICIES :
a.
Basis of preparation :
The
consolidated financial statements reflect the Company’s financial position, results of operations, changes in shareholders equity
(capital deficiency) and cash flows in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”).
b.
Use of estimates
The
preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the
reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial
statements and the reported amounts of revenue and expenses during the reporting period. The Company evaluates its assumptions on an
ongoing basis, including those related to contingencies, deferred taxes and inventory impairment, as well as estimates used in applying
its revenue recognition policy. Actual results may differ from these estimates.
c.
Functional currency
A
majority of ScoutCam’s revenues are generated in U.S. dollars. The substantial majority of ScoutCam costs are incurred in U.S.
dollars and New Israeli Shekels (“NIS”). ScoutCam management believes that the U.S. dollar is the currency of the primary
economic environment in which ScoutCam operates. Thus, the functional currency of ScoutCam is the U.S. dollar.
Transactions
and balances originally denominated in U.S. dollars are presented at their original amounts. Balances in non U.S. dollar currencies are
translated into U.S. dollars using historical and current exchange rates for non-monetary and monetary balances, respectively. For non-U.S.
dollar transactions and other items in the statements of operations (indicated below), the following exchange rates are used: (i) for
transactions exchange rates at transaction dates and (ii) for other items (derived from non-monetary balance sheet items such as depreciation
and amortization) historical exchange rates. Currency transaction gains and losses are presented in financial income or expenses, as
appropriate.
d.
Cash and Cash Equivalents
The
Company considers as cash equivalents all short-term, highly liquid investments, which include short-term bank deposits with original
maturities of three months or less from the date of purchase that are not restricted as to withdrawal or use and are readily convertible
to known amounts of cash.
e.
Short-term bank deposits
Bank
deposits with maturities of more than three months but less than one year are included in short-term bank deposits. Such short-term bank
deposits are stated at cost which approximates fair market value.
F- 10
SCOUTCAM
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE
2 - SIGNIFICANT ACCOUNTING POLICIES (continued) :
f.
Accounts receivable
Accounts
receivable are presented in the Company’s consolidated balance sheets net of allowance for doubtful accounts. The Company estimates
the collectability of its accounts receivable balances and adjusts its allowance for doubtful accounts accordingly.
When
revenue recognition criteria are not met for a sale transaction that has been billed, the Company does not recognize deferred revenues
or the related account receivable.
As
of December 31, 2021 and 2020, no allowance for doubtful accounts was recorded.
g.
Property and equipment
Property
and equipment are stated at cost, net of accumulated depreciation and amortization. Depreciation is calculated on a straight-line basis
over the estimated useful lives.
The
annual depreciation rates are as follows:
SCHEDULE
OF PROPERTY AND EQUIPMENT ANNUAL DEPRECIATION RATES
%
Machinery
and laboratory equipment
10 %- 15 %
Office
furniture and equipment
10 %
Computers
and computer software
33 %
Leasehold
improvements
Over
the shorter of the lease term (including options if any) or useful life
h.
Severance pay
Israeli
labor law generally requires payment of severance pay upon dismissal of an employee or upon termination of employment in certain other
circumstances. Pursuant to Section 14 of the Severance Compensation Act, 1963 (“Section 14”), all of the ScoutCam’s
employees in Israel are entitled to a monthly contribution, at a rate of 8.33 %
of their monthly salary, made in their name with insurance companies. Contributions under Section 14 relieve the ScoutCam from any future
severance payment obligation with respect to those employees. The aforementioned contributions are not recorded as an asset on the Company’s
balance sheet, and there is no liability recorded as the Company does not have a future obligation to make any additional payments.
The
asset and the liability for severance pay presented in the balance sheets reflects employees that began employment prior to automatic
application of Section 14.
The
severance pay liability of ScoutCam to its employees that began employment prior to automatic application of Section 14 is based upon
the number of years of service and the latest monthly salary of such employees and is partly covered by regular deposits with recognized
pension funds and deposits with severance pay funds. Under labor laws, these deposits are in the employees’ names and, subject
to certain limitations, are the property of the employees. ScoutCam records the obligation as if it were payable at each balance sheet
date on an undiscounted basis.
F- 11
SCOUTCAM
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE
2 - SIGNIFICANT ACCOUNTING POLICIES (continued) :
i.
Stock-Based Compensation
The
Company measures and recognizes compensation expense for its equity classified stock-based awards granted under its plan based on estimated
fair values on the grant dates. The Company calculates the estimated fair value of option awards on the grant date using the Black-Scholes
option-pricing model. The Black-Scholes option-pricing model requires a number of assumptions, of which the most significant are the
stock price volatility and the expected option term. The Company’s expected dividend rate is zero since the Company does not currently
pay cash dividends on its stocks and does not anticipate doing so in the foreseeable future. Each of the above factors requires the Company
to use judgment and make estimates in determining the percentages and time periods used for the calculation. If the Company were to use
different percentages or time periods, the estimated fair value of option awards could be materially different. The Company recognizes
stock-based compensation cost for option awards on a accelerated basis over the employee’s requisite service period, net of estimated
forfeitures.
j.
Inventories
Inventories
include raw materials, inventory in process and finished products and are valued at the lower of cost or net realizable value.
The
cost is determined a “first in-first out” basis. Cost of purchased raw materials and inventory in process includes costs
of design, raw materials, direct labor, other direct costs and fixed production overheads. Materials and other supplies held for use
in the production of inventories are not written down if the finished products in which they will be incorporated are expected to be
sold at or above cost.
The
Company regularly evaluates its ability to realize the value of inventory based on a combination of factors including the following:
forecasted sales or usage and estimated current and future market values.
k.
Revenue recognition
a)
Revenue
measurement
The Company’s revenues are
measured according to the ASC 606, “Revenue from Contracts with Customers” (“ASC 606”). Under ASC 606, revenues
are measured according to the amount of consideration that the Company expects to be entitled in exchange for transferring promised goods
or services to a customer, excluding amounts collected on behalf of third parties, such as VAT taxes. Revenues are presented net of VAT.
b)
Revenue
recognition
The
Company recognizes revenue when a customer obtains control over promised goods or services. For each performance obligation, the Company
determines at contract inception whether it satisfies the performance obligation over time or satisfies the performance obligation at
a point in time.
Performance
obligations are satisfied over time if one of the following criteria is met:
F- 12
SCOUTCAM
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE
2 - SIGNIFICANT ACCOUNTING POLICIES (continued) :
(a)
the customer simultaneously receives and consumes the benefits provided by the Company’s performance; (b) the Company’s performance
creates or enhances an asset that the customer
controls
as the asset is created or enhanced; or (c) the Company’s performance does not create an asset with an alternative use to the Company
and the Company has an enforceable right to payment for performance completed to date.
If
a performance obligation is not satisfied over time, a Company satisfies the performance obligation at a point in time.
The
transaction price is allocated to each distinct performance obligations on a relative standalone selling price (“SSP”) basis
and revenue is recognized for each performance obligation when control has passed. In most cases, the Company is able to establish SSP
based on the observable prices of services sold separately in comparable circumstances to similar customers and for products based on
the Company’s best estimates of the price at which the Company would have sold the product regularly on a stand-alone basis. The
Company reassesses the SSP on a periodic basis or when facts and circumstances change.
Product
Revenue
Revenues
from product sales are recognized at a point in time when the customer obtains control of the Company’s product, typically upon
shipment to the customer. Indirect taxes collected from customers relating to product sales and remitted to governmental authorities
are excluded from revenues.
Service
Revenue
The
Company also generates revenues from development services. Revenue from development services is recognized over the period of the applicable
service contract. To the extent development services are not distinct from the performance obligation relating to the subsequent mass
production phase of the prototype under development, revenue from these services is deferred until commencement of the production phase
of the project.
F- 13
SCOUTCAM
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE
2 - SIGNIFICANT ACCOUNTING POLICIES (continued) :
l.
Cost of revenues
Cost
of revenue consists of products purchased from sub-contractors, raw materials for in-house assembly line, shipping and handling costs
to customers, salary, employee-related expenses, depreciation and overhead expenses.
Cost
of revenues are expensed commensurate with the recognition of the respective revenues. Costs deferred in respect of deferral of revenues
are recorded as contract fulfilment assets on the Company’s balance sheet and are written down to the extent the contract is expected
to incur losses.
m.
Research and development costs
Research
and development costs are expensed as incurred and includes salaries and employee-related expenses, overhead expenses, material and third-party
contractors’ charges.
n.
Income taxes
Income
taxes are accounted for using the asset and liability approach under ASC-740, “Income Taxes”. The asset and liability approach
require the recognition of taxes payable or refundable for the current year and deferred tax liabilities and assets for the future tax
consequences of events that have been recognized in the Company’s financial statements or tax returns.
The
measurement of current and deferred tax liabilities and assets is based on provisions of the relevant tax law. The measurement of deferred
tax assets is reduced, if necessary, by the amount of any tax benefits that, based on available evidence, are not expected to be realized.
Uncertain
tax positions are accounted for in accordance with the provisions of ASC 740-10, under which a company may recognize the tax benefit
from an uncertain tax position claimed or expected to be claimed on a tax return only if it is more likely than not that the tax position
will be sustained on examination by the taxation authorities, based on the technical merits of the position, at the largest benefit that
has a greater than fifty percent likelihood of being realized upon ultimate settlement. Interest and penalties, if any, related to unrecognized
tax benefits, are recognized in tax expense.
o.
Legal contingencies
From
time to time, the Company and its subsidiary become involved in legal proceedings or are subject to claims arising in their ordinary
course of business. Such matters are generally subject to many uncertainties and outcomes are not predictable with assurance. The Company
accrues for contingencies when the loss is probable and can reasonably estimate the amount of any such loss.
F- 14
SCOUTCAM
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE
2 — SIGNIFICANT ACCOUNTING POLICIES (continued):
p.
Basic and diluted net loss per common stock :
Basic
net loss per common stock is computed by dividing net loss, as adjusted to include the weighted average number of shares of common stock
outstanding during the year.
Diluted
net loss per common stock is computed by dividing net loss, as adjusted, by the weighted average number of shares of common stock outstanding
during the year, plus the number of shares of common stock that would have been outstanding if all potentially dilutive shares of common
stock had been issued, using the treasury stock method, in accordance with ASC 260-10 “Earnings per Share”.
All
outstanding stock options and warrants have been excluded from the calculation of the diluted loss per share for the years ended December
31, 2021 and December 31, 2020, since all such securities have an anti-dilutive effect.
q.
Leases
In accordance with ASC 842,
leases, at inception of an arrangement, the Company determines whether an arrangement is or contains a lease based on the
facts and circumstances present in the arrangement. An arrangement is or contains a lease if the arrangement conveys the right to control
the use of an identified asset for a period of time in exchange for consideration.
Arrangements that are determined to
be leases at inception are recognized in long-term right-of-use assets (“ROU”) assets and short and long-term lease liabilities
in the consolidated balance sheet at lease commencement. Operating lease ROU assets and operating lease liabilities are recognized based
on the present value of the future fixed lease payments over the lease term at commencement date. As most of the Company’s
leases do not provide an implicit rate, the Company applies its incremental borrowing rate based on the economic environment at commencement
date in determining the present value of future payments. Lease terms may include options to extend or terminate the lease when it is
reasonably certain that the Company will exercise that option. Lease expense for operating leases or payments are recognized on
a straight-line basis over the lease term.
The
Company has elected not to recognize on the balance sheet leases with terms of 12 months or less.
r.
Recent Accounting Standards:
Accounting
for Income Taxes
In
December 2019, the Financial Accounting Standards Board issued Accounting Standards Update No. ASU 2019-12, “Simplifying the Accounting
for Income Taxes”. This ASU amends Accounting Standards Codification (“ASC”) 740 by removing certain exceptions to
the general principles, clarifying and amending existing guidance. This guidance is effective for fiscal years, and interim periods within
those years, beginning after December 15, 2020. The Company adopted this standard in the first quarter of 2021. The adoption of this
ASU did not impact on the Company’s financial statements or the related disclosures.
F- 15
SCOUTCAM
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE
3 – SHORT-TERM DEPOSITS
Short
term investments as of December 31, 2021 include bank deposits bearing annual interest rates varying from 0.3 %
to 0.53 %,
with maturities of up to 12 months .
NOTE
4 - INVENTORY :
SCHEDULE OF INVENTORY
2021
2020
December
31,
2021
2020
USD
in thousands
Raw
materials and supplies
99
45
Work
in progress
2
-
Finished
goods
66
278
Inventory
write downs
-
( 79 )
Inventory
Net
167
244
During
the year ended 2021, no impairment occurred.
During
the year ended 2020, the Company recognized an inventory impairment of $ 79
thousands.
NOTE
5 - PROPERTY AND EQUIPMENT, NET :
Property,
plant and equipment, net consisted of the following:
SCHEDULE OF PROPERTY, PLANT AND EQUIPMENT NET
2021
2020
December
31,
2021
2020
USD
in thousands
Cost:
Machinery
and laboratory equipment
578
285
Leasehold
improvements, office furniture and equipment
316
36
Computers
and computer software
140
87
Total
property and equipment, gross
1,034
408
Less:
accumulated deprecation
( 253 )
( 139 )
Total
property and equipment, net
781
269
Depreciation
expenses were $ 114 thousand
and $ 66 thousand
for the years ended December 31, 2021 and 2020, respectively.
F- 16
SCOUTCAM
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE
6 – OTHER ACCRUED EXPENSES :
SCHEDULE OF OTHER ACCRUED EXPENSES
2021
2020
December
31,
2021
2020
USD
in thousands
IRS
(see note 7b)
40
73
Accrued
expenses
170
122
Total
other accrued expenses
210
195
NOTE
7 - INCOME TAXES :
a.
Basis
of taxation
The
Company and its subsidiary are taxed under the domestic tax laws of the jurisdiction of incorporation of each entity (United States and
Israel, respectively).
Income
from Israel was taxed at the corporate tax rate of 23 %.
The
Company was incorporated in the United States and is subject to the federal and state tax laws established in the United States.
On
December 22, 2017, the Tax Cuts and Jobs Act (the “Act”) was signed into law. The Act reduces the corporate tax rate to 21
percent from 35 percent, among other things .
b.
The
Company did not timely file its tax return for 2013-2014 and therefore the IRS imposed penalties in the amount of $ 60 thousand (approximately
$ 73 thousands including interest). As a result of a penalty abatement request by the Company, the IRS abated the penalty to approximately
to $ 40 thousand.
c.
Israel
tax loss carry forwards
As
of December 31, 2021, ScoutCam has accumulated losses for tax purposes that were generated in Israel. These losses may be carried forward
and offset against taxable income in the future for an indefinite period. A full valuation allowance was created against the ScoutCam’s
deferred tax assets generated in Israel. Management currently believes that it is more likely than not that the deferred taxes generated
in Israel will not be realized in the foreseeable future.
d.
On
December 31, 2021, following a VAT audit in Israel for years 2019-2021, ScoutCam owed
approximately NIS 740
thousand,
(which is approximately $ 229
thousand)
additional taxes to the Israeli Tax Authorities.
As such, the financial statements as of December 31, 2021, include a provision of $ 229
thousand
included in general and administrative expenses. On November 18, 2021, ScoutCam submitted
an appeal to the Israeli Tax Authority on the finding of this VAT audit.
F- 17
SCOUTCAM
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE
8 – RELATED PARTIES :
a.
On April 20, 2020, ScoutCam entered into an Amended
and Restated Intercompany Services Agreement with Medigus (the “Intercompany agreement”). The agreed upon services provided
under the amended and restated Intercompany Agreement include:
1)
lease of office space based on actual space utilized by Medigus and in shared spaces according to employee ratio; (2) utilities such
as electricity, water, information technology and communication services based on employee ratio; (3) car services, including car rental,
gas usage and payment for toll roads based on 100% of expense incurred from ScoutCam’s employee car; (5) directors and officers
insurance, Medigus shall pay $150,000 of the annual premium for; (6) CFO services at a sum of 50% of Medigus’ CFO employer cost;
(7) every direct expense of ScoutCam’s that is paid by Medigus in its entirety subject to approval of such direct expenses in advance;
and (7) any other mutual expense that is borne by the parties according to the respective portion of the mutual expense.
The
total net expenses for year ended December 31, 2020 amounted to $ 143 thousand.
The Company
didn’t recognize expenses for the year ended December 31, 2021 in connection with this agreement.
On March 22, 2022, ScoutCam
Ltd. provided 60 days prior written notice to Medigus of termination of the Intercompany Services Agreement.
b.
On
July 31, 2019, ScoutCam and Prof. Benad Goldwasser entered into a consulting agreement, whereby Prof. Goldwasser agreed to serve
as chairman of the Board of Directors of ScoutCam. Effective retroactively to March 1, 2019, services as chairman under the agreement
were provided in consideration for, inter alia , a monthly fee of $ 10,000 and options representing 5 % of Company’s fully-diluted
share capital as of the Closing Date.
c.
On
June 23, 2020, the Company and Medigus entered into a certain Conversion Side Letter, pursuant to which the Company converted $ 381,136
worth of outstanding credit previously extended by Medigus to the Company, which amount, as of the date thereof, included interest
accrued thereon. In accordance with the terms of the Conversion Side Letter, the Company issued to Medigus, at a purchase price of
$8.712, (a) 87,497 shares of common stock, (b) warrants to purchase 43,749 shares of common stock at an exercise price of $5.355,
and (c) warrants to purchase 87,497 shares of common stock at an exercise price of $8.037 .
d.
During
December 2019, the Company entered into a consulting agreement with Shrem Zilberman Group (the “Consultant”) in the amount
of $ 165
thousand (see also note 9a). A former
director of the Company is related to one of the Consultant’s shareholders.
F- 18
SCOUTCAM
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE
8 – RELATED PARTIES (continued):
e.
On March 15, 2020, the Company’s Board of Directors approved, among other things, a quarterly fee of $ 4,000 payable to each of the Company’s directors, excluding Professor Goldwasser.
f.
On May 18, 2020, the Company allocated in a private
issuance to M. Arkin (1999) Ltd. (“Arkin”) a total of 229,569 units (as described in note 9c) at a purchase price
of $ 8.712 per unit (“Arkin Transaction”).
In connection with the Arkin Transaction, the
Company, Medigus and Arkin, entered into the letter agreement, whereby, provided the Company obtains certain regulatory approvals
described therein, Medigus and the Company agreed to amend certain terms of the amended and restated asset transfer agreement
and the license agreement, thereby transferring outright certain patent assets from Medigus to the Company; provided,
however, that in the event the Company abandons the foregoing patent assets, the Company must transfer back ownership of the patent
assets to Medigus for no additional consideration and absent any additional contingencies.
In addition, on May 18, 2020, and in connection
with the Arkin Transaction, the Company, Medigus and Arkin entered into a voting agreement, pursuant to which Arkin and Medigus each
agreed to vote their respective shares of common stock in favor of the election of the opposite party’s designated representative(s),
as applicable, to the Board. Each of Arkin’s and Medigus’ rights under the Voting Agreement are contingent upon, inter
alia, such party maintaining a certain beneficial ownership threshold in the Company’ as follows:
(a) One person designated by Arkin is
to be elected, for as long as Arkin, continues to beneficially own at least eight percent of the issued and outstanding
capital stock of the Company.
(b) Three persons designated by Medigus
are to be elected, for as long as Medigus, continues to beneficially own at least thirty five percent of the issued
and outstanding capital stock of the Company.
(c) Two persons designated by Medigus
are to be elected for so long as Medigus, continues to beneficially own less than thirty five percent and more than twenty
percent of the issued and outstanding capital stock of the Company.
(d) One person designated by Medigus is
to be elected for as long as Medigus, continues to beneficially own less than twenty percent and more than eight percent of
the issued and outstanding capital stock of the Company.
g.
During 2020 the Company’s Board of Directors
authorized the grant of options to purchase 318,207 shares of common stock of the Company to Prof. Goldwasser, the Chairman of the Board,
options to purchase 131,048 shares of common stock of the Company to directors of the Company and options to purchase 227,356 shares of
common stock of the Company to certain officers of the Company.
h.
During 2021 the Company’s Board of Directors authorized the grant of options to purchase
83,334
shares of common stock of the Company to Prof. Goldwasser, the Chairman of the Board, options to purchase 75,855
shares of common stock of the Company to directors of the Company and options to purchase 335,987
shares of common stock of the Company to certain officers of the Company.
i.
During 2020 and 2021 the Company received development services from Smartec R&D Ltd., a company owned by the Company’s
CTO.
Total compensation for the fiscal years ended December 31, 2020 and December 31, 2021 was approximately $ 102 thousands and
$ 82 thousands, respectively.
j
During 2020 and 2021 the Company received financial consultant services from Anona De Finance
Ltd., a company owned by one of the Company’s directors.
Total compensation for the fiscal years ended December 31, 2020 and December 31, 2021 was approximately
$ 32 thousands and $ 37 thousands, respectively.
F- 19
SCOUTCAM
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE
9 - EQUITY :
Increase
of the authorized share capital
On
January 20, 2021, the Company’s Board of Directors approved an increase of the authorized share capital of the Company by an additional
225,000,000 shares of common stock par value $ 0.001 per share, such that the authorized share capital of the Company following such increase
shall be consisting of 300,000,000 shares of common stock.
Private
placement:
a.
In
December 2019, the Company allocated in a private placement, a total of 379,269
units at a purchase price of $ 8.712
per unit. Each
unit was comprised of two shares of common stock par value $0.001 per share, one Warrant A (as described below) and two Warrants
B (as described below). The immediate
proceeds (gross) from the issuance of the units amounted to approximately $ 3.3
million.
Each
Warrant A was exercisable into one share of common stock of the Company at an exercise price of $ 5.355 per share during the 12 month
period following the allocation. Each Warrant B is exercisable into one share of common stock of the Company at an exercise price of
$ 8.037 per share during the 18 month period following the allocation.
In
addition, Shrem Zilberman Group Ltd. (the “Consultant”) will be entitled to receive the amount representing 3 % of any exercise
price of each Warrant A or Warrant B that may be exercised in the future. In the event the total proceeds received as a result of exercise
of warrants will be less than $ 2 million at the time of their expiration, the Consultant will be required to invest $ 250,000 in the Company
in return for shares of common stock of Company. As of December 31, 2021, holders of the foregoing warrants have exercised in excess
of $ 2 million and, accordingly, the Consultant is not required to invest $250,000 in the Company.
During
2020, 332,551 Warrants A were exercised and 46,718 unexercised Warrants A expired on December 30, 2020 .
The Consultant received $ 53 thousand
following the exercise of 332,551 Warrants A.
During
the second quarter of 2021, 185,271 Warrants B were exercised and 573,256 unexercised Warrants B expired on June 30, 2021 .
The Consultant received $ 45 thousand
following the exercise of 185,274 Warrants A.
b.
On
March 3, 2020, the Company issued in a private placement a total of 108,880 units at a purchase price of $ 8.712 per unit.
Each
unit was comprised of two shares of common stock par value $0.001 per share, one Warrant A (as described below) and two Warrants
B (as described below) .
Each
Warrant A was exercisable into one share of common stock of the Company at an exercise price of $ 5.355 per share during the 12 month
period following the allocation.
Each
Warrant B is exercisable into one share of common stock of the Company at an exercise price of $ 8.037 per share during the 18 month period
following the allocation.
The
gross proceeds from the issuance of all securities offered amounted to approximately $ 948 thousands. After deducting issuance costs,
the Company received proceeds of approximately $ 909 thousand.
F- 20
SCOUTCAM
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE
9 – EQUITY (continued):
During
2021, 108,880 Warrants A were exercised.
217,760
unexercised Warrants B expired on September 3, 2021 .
c.
On
May 18, 2020, the Company allocated in a private placement to Arkin a total of 229,569 units at a purchase price of $ 8.712 per unit.
Each
unit was comprised of two shares of common stock par value $0.001 per share, one Warrant A (as described below) and two Warrants
B (as described below) .
Each
Warrant A was exercisable into one share of common stock of the Company at an exercise price of $ 5.355 per share during the 18 month
period following the allocation.
Each
Warrant B is exercisable into one share of common stock of the Company at an exercise price of $ 8.037 per share during the 24 month period
following the allocation.
The
gross proceeds from the issuance of all securities offered amounted to approximately $ 2 million. After deducting issuance costs, the
Company received proceeds of approximately $ 1.9 million.
During
February 2021, 37,349 Warrants A were exercised.
During November 2021, 192,220 Warrants A were exercised.
d.
On
June 23, 2020, (the “Conversion Date”), the Company entered into a side letter
agreement with Medigus whereby the parties agreed to convert, at a conversion price of $ 4.356
per
share, an outstanding line of credit previously extended by Medigus to ScoutCam, which as
of the Conversion Date had $ 381,136
outstanding,
into (a) 87,497
shares
of the Company’s common stock, (b) to 43,749
Warrant A (as described below), and (c) 87,497
Warrant B (as described below). As the conversion price represented
the same unit price as in the March 2020 and May 2020 private placements, no finance expenses
have been recorded in statement of operations as a result of the conversion.
Each
Warrant A is exercisable into one share of common stock of the Company at an exercise price of $ 5.355 per share during the 12 months
period following the allocation.
Each
Warrant B is exercisable into one share of common stock of the Company at an exercise price of $ 8.037 per share during the 18 months
period following the allocation.
During
June 2021, 43,749 Warrants A were exercised.
On
December 23, 2021, 87,497
unexercised Warrants B expired.
e.
On March 29, 2021, the Company issued to certain investors, including M. Arkin (1999) Ltd., a major
stockholder of the Company, of which Mori Arkin, a director of the company, is the owner, 2,469,156 units in exchange for an aggregate
purchase price of $ 20 million. Each such unit consists of (i) one share of common stock and (ii) one warrant to purchase one share
of common stock with an exercise price of $10.35 per share. Each such warrant is exercisable until the close of business on March 31,
2026 . Pursuant to the terms of the foregoing warrants, following April 1, 2024, if the closing price of Company common stock equal
or exceeds 135% of the aforementioned exercise price (subject to appropriate adjustments for stock splits, stock dividends, stock combinations
and other similar transactions after the issue date of the warrants) for any thirty (30) consecutive trading days, the Company may
force the exercise of the warrants, in whole or in part, by delivering to these investors a notice of forced exercise.
F- 21
SCOUTCAM
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE
9 – EQUITY (continued):
As
of December 31, 2021, the Company had the following outstanding warrants to purchase common stock:
SCHEDULE OF STOCK WARRANTS OUTSTANDING TO PURCHASE COMMON STOCK
Warrant
Issuance
Date
Expiration
Date
Exercise
Price
Per Share ($)
Number
of Shares
of common stock
Underlying
Warrants
Warrant
B
May 18,
2020
May 18,
2022
8.037
459,137
March 2021 Warrant
March
29, 2021
March
31, 2026
10.350
2,469,156
2,928,293
In
addition, if ScoutCam achieves an aggregate amount of $ 33
million in sales within the first three
years immediately after the Exchange Agreement,
the Company will issue to Medigus 298,722
shares of the Company’s common stock,
which represents 10 %
of the Company’s issued and outstanding share capital as of the Exchange Agreement.
Share-based
compensation to employees, directors and service providers:
In
February 2020, the Company’s Board of Directors approved the 2020 Share Incentive Plan (the “Plan”).
The
Plan initially included a pool of 580,890 shares of common stock for grant to Company employees, consultants, directors and other service
providers. On March 15, 2020, the Company’s Board of Directors approved an increase to the Company’s option pool pursuant
to the Plan by an additional 64,099 shares of common stock. On June 22, 2020, the Company’s Board of Directors approved an increase
to the Company’s option pool pursuant to the Plan by an additional 401,950 shares of common stock. During the second quarter of
2021, the Company’s Board of Directors approved an increase to the Company’s option pool pursuant to the Plan by an additional
777,778 shares of common stock.
The
Plan is designed to enable the Company to grant options to purchase shares of common stock and RSUs under various and different tax regimes
including, without limitation: (i) pursuant and subject to Section 102 of the Israeli Tax Ordinance or any provision which may amend
or replace it and any regulations, rules, orders or procedures promulgated thereunder and to designate them as either grants made through
a trustee or not through a trustee; and (ii) pursuant and subject to Section 3 (i) of the Israeli Tax Ordinance.
During
2020, the Company granted 737,049 options pursuant to the Plan.
During
2021, the Company granted 648,712 options pursuant to the Plan.
Options
granted generally have a contractual term of seven years and vest over a period of three to four years .
F- 22
SCOUTCAM
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE
9 – EQUITY (continued):
Stock
Option Activity
The
following summarizes stock option activity:
SCHEDULE
OF STOCK OPTION ACTIVITY
Amount
of options
Weighted
average exercise price
Weighted
Average Remaining Contractual Term (years)
Aggregate
Intrinsic Value (in thousands)
$
$
in thousands
Outstanding - December
31, 2019
-
-
-
-
Granted
737,049
2.61
-
-
Outstanding - December
31, 2020
737,049
2.61
6.23
2,446
Granted
648,712
4.09
-
-
Cancelled
( 132,207 )
3.34
-
-
Outstanding - December
31, 2021
1,253,554
3.31
5.65
5,884
Options Exercisable
- December 31, 2021
437,666
2.62
4.77
2,356
As
of December 31, 2021, the aggregate intrinsic value
of options granted is calculated as the difference between the exercise price and the closing price on the same date.
The
Company estimates the fair value of stock option awards on the grant date using the Black-Scholes option pricing model. The weighted-average
grant date fair value per option granted during the years ended December 31, 2021 was $ 6.73 . The fair value of each award is estimated
using Black-Scholes option-pricing model based on the following assumptions:
SCHEDULE
OF SHARE-BASED PAYMENT, STOCK OPTIONS, VALUATION ASSUMPTIONS
Year
ended
December
31, 2021
Year
ended
December
31, 2020
Underlying
value of shares ($)
7.65 - 10.35
4.014 - 7.2
Exercise
price ($)
2.61 - 7.2
2.61 - 3.15
Expected
volatility (%)
45.8 %- 49.00 %
43.35 %- 45.25 %
Term
of the options (years)
7
7
Risk-free
interest rate (%)
0.78 %- 1.51 %
0.54 %- 1.55 %
Volatility
is derived from the historical volatility of publicly traded set of peer companies. The risk-free interest rates used in the Black-Scholes
calculations are based on the prevailing U.S. Treasury yield as determined by the U.S. Federal Reserve. The Company has not paid dividends
and does not anticipate paying dividends in the foreseeable future. Accordingly, no dividend yield was assumed for purposes of estimating
the fair value of the
F- 23
SCOUTCAM
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE
9 – EQUITY (continued):
Company’s
share-based compensation. The weighted average expected life of options was estimated individually in respect of each grant.
The
unrecognized compensation expense calculated under the fair-value method for stock options expected to vest as of December 31, 2021 is
approximately $ 2.05 million and is expected to be recognized over a weighted-average period of 1.36 years.
F- 24
SCOUTCAM
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE
10 - REVENUES :
a.
Contract
fulfillment assets:
The
Company’s contract fulfillment assets:
SCHEDULE
OF CONTRACT FULFILLMENT ASSETS
December 31,
2021
2020
USD in thousands
The change in contract fulfillment assets:
Balance at beginning of year
1,130
-
Additions during the year
545
1,130
Balance at end of year
1,675
1,130
b.
Contract
liabilities:
The
Company’s contract liabilities were as follows:
SCHEDULE
OF CONTRACT LIABILITIES
2021
2020
December
31,
2021
2020
USD
in thousands
The
change in contract liabilities:
Balance
at beginning of year
848
502
Deferred
revenue relating to new sales
1,641
735
Revenue
recognition during the period
( 69 )
( 389 )
Balance
at end of year
2,420
848
Contract
liabilities include advance payments, which are primarily related to advanced billings for development services.
Revenue
recognized in 2021 that was included in deferred revenue balance as of December 31, 2020 was $ 69
thousand.
Revenue
recognized in 2020 that was included in deferred revenue balance as of December 31, 2019 was $ 389
thousand.
Remaining
Performance Obligations
Remaining
Performance Obligations (“RPO”) represents contracted revenue that has not yet been recognized, which includes contract liability
and amounts that will be invoiced and recognized as revenue in future periods. As of December 31, 2021, the total RPO amounted to $ 3.2
million, which the Company expects to recognize over the expected manufacturing term of the product under development.
F- 25
SCOUTCAM
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE
11 - ENTITY WIDE DISCLOSURES :
ASC 280, “Segment Reporting,”
establishes standards for reporting information about operating segments. The Company manages its business based on one operating
segment, as described in Note 1.
a.
Revenues
by geographical area (based on the location of customers)
The
following is a summary of revenues within geographic areas:
SCHEDULE
OF REVENUES WITHIN GEOGRAPHIC AREAS
2021
2020
Year
ended on
December 31,
2021
2020
USD
in thousands
United
States
273
418
United
Kingdom
48
41
Israel
19
5
Other
4 7
27
Revenue
387
491
b.
Major
customers
Set
forth below is a breakdown of Company’s revenue by major customers (major customer –revenues from these customers constituted
at least 10 % of total revenues in a certain year):
SCHEDULE
OF MAJOR CUSTOMER BREAKDOWN OF COMPANY’S REVENUE
Year
ended on
December
31,
2021
2020
USD
in thousands
Customer
A
199
383
Customers
B
48
41
F- 26
SCOUTCAM
INC.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE
12 - LEASES
The
Company’s leases relate to vehicles leases and to short term lease of Company’s offices.
The
components of lease expenses during the periods presented were as follows:
SCHEDULE
OF LEASE EXPENSES
2021
2020
Year
ended
December
31,
2021
2020
USD
in thousands
Operating
lease expenses
202
45
Short-term
lease expenses
-
88
Sublease income
( 8
)
-
Total
net lease expenses
194
133
Supplemental
cash flow information related to operating leases during the period presented was as follows:
SCHEDULE OF SUPPLEMENTAL CASH FLOW INFORMATION RELATED TO OPERATING LEASES
2021
2020
Year
ended December 31,
2021
2020
USD
in thousands
Cash paid for amounts
included in the measurement of lease liabilities:
Operating
cash flows from operating leases
202
45
Lease
term and discount rate related to operating leases as of the period presented were as follows:
SCHEDULE
OF LEASE TERM AND DISCOUNT RATE RELATED TO OPERATING LEASES
December
31,
2021
2020
USD
in thousands
Weighted-average
remaining lease term (in years)
0.76
1.85
Weighted-average
discount rate
6 %
10 %
The
maturities of lease liabilities under operating leases as of December 31, 2021 are as follows:
SCHEDULE
OF MATURITIES LEASE LIABILITIES UNDER OPERATING LEASES
USD
in thousands
2022
265
2023
203
2024
20
Total
undiscounted lease payments
488
Less:
Imputed interest
( 29 )
Total
lease liabilities
459
NOTE
13 - SUBSEQUENT EVENTS :
On
February 23, 2022, the Company’s Board of Directors authorized the grant of options to Prof. Goldwasser, the Chairman of the
Board, to purchase 45,000
shares of common stock of the Company and RSU to purchase 90,000
shares of common stock of the Company to certain
officers of the Company.
F- 27
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.