Forward Looking Statements
Certain information contained in this MD&A includes "forward-looking
statements." Statements which are not historical reflect our current
expectations and projections about our future results, performance, liquidity,
financial condition and results of operations, prospects and opportunities and
are based upon information currently available to us and our management and
their interpretation of what is believed to be significant factors affecting our
existing and proposed business, including many assumptions regarding future
events. Actual results, performance, liquidity, financial condition and results
of operations, prospects and opportunities could differ materially and perhaps
substantially from those expressed in, or implied by, these forward-looking
statements as a result of various risks, uncertainties and other factors,
including those risks described in detail in the section of this Annual Report
on Form 10-K entitled "Risk Factors" as well as elsewhere in this Annual Report.
Forward-looking statements, which involve assumptions and describe our future
plans, strategies, and expectations, are generally identifiable by use of the
words "may," "should," "would," "will," "could," "scheduled," "expect,"
"anticipate," "estimate," "believe," "intend," "seek," or "project" or the
negative of these words or other variations on these words or comparable
terminology.
In light of these risks and uncertainties, and especially given the nature of
our existing and proposed business, there can be no assurance that the
forward-looking statements contained in this section and elsewhere in this
Annual Report on Form 10-K will in fact occur. Potential investors should not
place undue reliance on any forward-looking statements. Except as expressly
required by the federal securities laws, there is no undertaking to publicly
update or revise any forward-looking statements, whether as a result of new
information, future events, changed circumstances or any other reason.
Overview
Microbot is a pre-clinical medical device company specializing in the research,
design and development of next generation robotic endoluminal surgery devices
targeting the minimally invasive surgery space. Microbot is primarily focused on
leveraging its micro-robotic technologies with the goal of redefining surgical
robotics while improving surgical outcomes for patients.
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Microbot's current technological platforms, ViRobTM, TipCATTM and LIBERTY®
(including certain CardioSert assets), are comprised of proprietary innovative
technologies. Using the ViRob platform, Microbot is currently developing the
Self-Cleaning Shunt for the treatment of hydrocephalus and Normal Pressure
Hydrocephalus, or NPH. Utilizing the LIBERTY and CardioSert platforms, Microbot
is developing the first ever fully disposable robot for various endovascular
interventional procedures. In addition, the Company is focused on the
development of a Multi Generation Pipeline Portfolio utilizing all of its
proprietary technologies.
Microbot has a patent portfolio of 47 issued/allowed patents and 29 patent
applications pending worldwide.
Technological Platforms
ViRob
The ViRob is an autonomous crawling micro-robot which can be controlled remotely
or within the body. Its miniature dimensions are expected to allow it to
navigate and crawl in different natural spaces within the human body, including
blood vessels, the digestive tract and the respiratory system as well as
artificial spaces such as shunts, catheters, ports, etc. Its unique structure is
expected to give it the ability to move in tight spaces and curved passages as
well as the ability to remain within the human body for prolonged time. The SCS
product was developed using the ViRob technology.
TipCAT
The TipCAT is a disposable self-propelled locomotive device that is specially
designed to advance in tubular anatomies. The TipCAT is a mechanism comprising a
series of interconnected balloons at the device's tip that provides the TipCAT
with its forward locomotion capability. The device can self-propel within
natural tubular lumens such as the blood vessels, respiratory and the urinary
and GI tracts. A single channel of air/fluid supply sequentially inflates and
deflates a series of balloons creating an inchworm like forward motion. The
TipCAT maintains a standard working channel for treatments. Unlike standard
access devices such as guidewires, catheters for vascular access and endoscopes,
the TipCAT does not need to be pushed into the patient's lumen using external
pressure; rather, it will gently advance itself through the organ's anatomy. As
a result, the TipCAT is designed to be able to reach every part of the lumen
under examination regardless of the topography, be less operator dependent, and
greatly reduce the likelihood of damage to lumen structure. The TipCAT thus
offers functionality features equivalent to modern tubular access devices, along
with advantages associated with its physiologically adapted self-propelling
mechanism, flexibility, and design.
One & DoneTM (CardioSert) Technology
On May 25, 2018, Microbot acquired a patent-protected technology from CardioSert
Ltd., a privately-held medical device company based in Israel that was part of a
technological incubator supported by the Israel Innovation Authorities. The
CardioSert technology contemplates a combination of a guidewire and
microcatheter, technologies that are broadly used for surgery within a tubular
organ or structure such as a blood vessel or duct. The CardioSert technology
features a unique guidewire delivery system with steering and stiffness control
capabilities which when developed is expected to give the physician the ability
to control the tip curvature, to adjust tip load to varying degrees of stiffness
in a gradually continuous manner. The CardioSert technology was originally
developed to support interventional cardiologists in crossing chronic total
occlusions (CTO) during percutaneous coronary intervention (PCI) procedures and
has the potential to be used in other spaces and applications, such as
peripheral intervention, and neurosurgery. The CardioSert tool is now
trademarked as "One & DoneTM."
LIBERTY
On January 13, 2020, Microbot unveiled what it believes is the world's first
fully disposable robotic system for use in Endovascular Interventional
procedures, such as cardiovascular, peripheral and neurovascular. The LIBERTY
robotic system features a unique compact design with the capability to be
operated remotely, reduce radiation exposure and physical strain to the
physician, as well as the potential to eliminate the use of multiple consumables
when used with its "One & Done" capabilities, based in part on the CardioSert
platform or possibly other guidewire/microcatheter technologies.
On August 17, 2020, Microbot announced the successful conclusion of its
feasibility animal study using the LIBERTY robotic system. The study met all of
its end points with no intraoperative adverse events, which supports Microbot's
objectives to allow physicians to conduct a catheter-based procedure from
outside the catheterization laboratory (cath-lab), avoiding radiation exposure,
physical strain and the risk of cross contamination. The study was performed by
two leading physicians in the neuro vascular and peripheral vascular
intervention spaces, and the results demonstrated robust navigation
capabilities, intuitive usability and accurate deployment of embolic agents,
most of which was conducted remotely from the cath-lab's control room.
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On December 22, 2021, we entered into a strategic collaboration agreement for
technology co-development with Stryker Corporation, acting through its
Neurovascular Division. Pursuant to the agreement, the collaborative development
program between Stryker and us aims to integrate certain of Stryker's
instruments with our LIBERTY Robotic System to address certain neurovascular
procedures. The activities contemplated by the Agreement shall be specified in
one or more development plans derived from the terms and conditions set forth in
the Agreement.
We are continuously exploring and evaluating additional innovative
guidewire/microcatheter technologies to be integrated and combined with the
LIBERTY robotic platform.
Financial Operations Overview
Research and Development Expenses
Research and development expenses consist primarily of salaries and related
expenses and overhead for Microbot's research, development and engineering
personnel, prototype materials and research studies, obtaining and maintaining
Microbot's patent portfolio. Microbot expenses its research and development
costs as incurred.
General and Administrative Expenses
General and administrative expenses consist primarily of the costs associated
with management salaries and benefits, professional fees for accounting,
auditing, consulting and legal services, and allocated overhead expenses.
Microbot expects that its general and administrative expenses will increase over
the long-term, even if a period-to-period comparison may show a decrease, as it
expands its operating activities, maintains and expands its patent portfolio,
and maintains compliance with exchange listing and SEC requirements. Microbot
expects these potential increases will likely include management costs, legal
fees, accounting fees, directors' and officers' liability insurance premiums and
expenses associated with investor relations.
Income Taxes
Microbot has incurred net losses and has not recorded any income tax benefits
for the losses. It is still in its development stage and has not yet generated
revenues, therefore, it is more likely than not that sufficient taxable income
will not be available for the tax losses to be fully utilized in the future.
Critical Accounting Policies and Significant Judgments and Estimates
Management's discussion and analysis of Microbot's financial condition and
results of operations are based on its consolidated financial statements, which
have been prepared in accordance with U.S. generally accepted accounting
principles, or GAAP. The preparation of these consolidated financial statements
requires Microbot to make estimates and judgments that affect the reported
amounts of assets, liabilities, and expenses and the disclosure of contingent
assets and liabilities at the date of the consolidated financial statements.
Microbot bases its estimates on historical experience, known trends and events,
and various other factors that are believed to be 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. Actual results may differ materially from these estimates under
different assumptions or conditions.
While Microbot's significant accounting policies are described in more detail in
the notes to its consolidated financial statements, Microbot believes the
following accounting policies are the most critical for fully understanding and
evaluating its consolidated financial condition and results of operations.
Contingencies
Management records and discloses legal contingencies in accordance with ASC
Topic 450 Contingencies. A provision is recorded when it is both probable that a
liability has been incurred and the amount of the loss can be reasonably
estimated. The Company monitors the stage of progress of its litigation matters
to determine if any adjustments are required.
Fair Value of Financial Instruments
The Company measures the fair value of certain of its financial instruments on a
recurring basis.
A fair value hierarchy is used to rank the quality and reliability of the
information used to determine fair values. Financial assets and liabilities
carried at fair value will be classified and disclosed in one of the following
three categories:
Level 1 - Quoted prices (unadjusted) in active markets for identical assets and
liabilities.
Level 2 - Inputs other than Level 1 that are observable, either directly or
indirectly, such as unadjusted quoted prices for similar assets and liabilities,
unadjusted quoted prices in the markets that are not active, or other inputs
that are observable or can be corroborated by observable market data for
substantially the full term of the assets or liabilities.
Level 3 - Unobservable inputs that are supported by little or no market activity
and that are significant to the fair value of the assets or liabilities.
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Results of Operations
Comparison of Years Ended December 31, 2021 and 2020
The following table sets forth the key components of Microbot's results of
operations for the years ended December 31, 2021 and 2020 (in thousands):
For the Years Ended
December 31,
2021 2020 Change
Research and development expenses $ (6,153 ) $ (3,396 ) $ (2,757 )
General and administrative expenses (5,204 ) (5,693 ) 489
Financing income (expenses), net
44 (80 ) 124
Research and Development Expenses. Microbot's research and development expenses
were approximately $6,153,000 for the year ended December 31, 2021, compared to
approximately $3,396,000 for the same period in 2020. The increase in research
and development expenses of approximately $2,757,000 in 2021 as compared to 2020
was primarily due to increased salaries and recruitment of employees,
professional services and material expenses relating to the LIBERTY project.
Microbot expects its research and development expenses to continue to increase
over time as Microbot advances its development programs and begins pre-clinical
and clinical trials for the SCS, LIBERTY and TipCAT research programs.
General and Administrative Expenses. General and administrative expenses were
approximately $5,204,000 for the year ended December 31, 2021, compared to
approximately $5,693,000 for the same period in 2020. The decrease in general
and administrative expenses of approximately $489,000 in 2021 as compared to
2020 was primarily due to decreased salaries, share-based compensation and
government fees of $885,000, partially offset by an increase of $396,000 in
insurance costs and professional services. Microbot believes its general and
administrative expenses may increase over time as it advances its programs,
requiring additional investments in headcount, facilities and other general and
administrative operating activities to support its growth, and as it continues
to incur expenses associated with public-company compliance.
Financing (income) Expenses. Financing income were approximately $44,000 for the
year ended December 31, 2021, consisting of the reversal of $131,000 of other
liability stemming from our 2016 merger with StemCells, offset by exchange rate
expenses of $87,000, compared to net financial expenses of approximately $80,000
for the same period in 2020, consisting of approximately $80,000 in interest
payments related to the appeal of our Sabby litigation as well as $70,000
exchange rate expenses and net interest, offset by $70,000 capital gain.
Liquidity and Capital Resources
Microbot has incurred losses since inception and negative cash flows from
operating activities for the years ended December 31, 2021 and 2020. As of
December 31, 2021 and 2020, respectively, Microbot had a net working capital of
approximately $13,895,000 and $23,908,000, consisting primarily of cash and cash
equivalents. Microbot anticipates that it will continue to incur net losses for
the foreseeable future as it continues research and development efforts of its
product candidates, hires additional staff, including clinical, scientific,
operational, financial and management personnel, and continues to incur costs
associated with being a public company.
Microbot has funded its operations through the issuance of capital stock, grants
from the Israeli Innovation Authority, and convertible debt. Since inception
(November 2010) through December 31, 2021, Microbot has raised net cash proceeds
of approximately $54,770,000, and incurred a total cumulative loss of
approximately $55,593,000. Microbot returned $3,375,000 (before interest) of
such proceeds to an investor as a result of an adverse outcome in a litigation
that concluded in the first quarter of 2020, and is now subject to an additional
lawsuit seeking the return of an additional $6,750,000 of such proceeds. This
litigation is in its early stages and we cannot project what the eventual
outcome will be, though management is vigorously defending its position that no
return of capital is warranted.
Microbot Israel obtained from the Israeli Innovation Authority ("IIA") grants
for participation in research and development for the years 2013 through
December 31, 2021 in the total amount of approximately $1,500,000 and, in
return, Microbot Israel is obligated to pay royalties amounting to 3%-3.5% of
its future sales up to the amount of the grant. The grant is linked to the
exchange rate of the dollar to the New Israeli Shekel and bears interest at an
annual rate of USD LIBOR. Under the terms of the grant and applicable law,
Microbot is restricted from transferring any technologies, know-how,
manufacturing or manufacturing rights developed using the grant outside of
Israel without the prior approval of the Israel Innovation Authority. Microbot
has no obligation to repay the grant, if the SCS project fails, is unsuccessful
or aborted before any sales are generated. The financial risk is assumed
completely by the IIA.
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To date, we have not generated revenues from our operations. As of December 31,
2021, we had unrestricted cash, cash equivalents and marketable securities of
approximately $15,492,000, excluding encumbered cash, which management believes
is sufficient to fund our operations for more than 12 months from the date of
this Annual Report on Form 10-K and sufficient to fund our operations necessary
to continue development activities of our current proposed products with
flexibility to adjust our costs to the cash needed for the next 12 months.
However, in the event we are unsuccessful in our current litigation discussed
above, pursuant to which certain investors are seeking the return of $6,750,000
in proceeds we received from them in a 2017 stock offering, we may have funds
for less than 12 months.
Microbot plans to continue to fund its research and development and other
operating expenses, other development activities relating to additional product
candidates, and the associated losses from operations, through its existing cash
and possibly additional grants from the Israeli Innovation Authority. Microbot
intends to also raise capital through future issuances of debt and/or equity
securities, including through its existing and as-yet-unused At-the-Market
offering or registered offerings under its existing Registration Statement on
Form S-3 for up to $75 million of securities, which it may draw down from time
to time. These issuances may be opportunistic and even if the Company has enough
funds at such time for operations for more than 12 months. The capital raises
from issuances of convertible debt and equity securities could result in
additional dilution to Microbot's shareholders. In addition, to the extent
Microbot determines to incur additional indebtedness, Microbot's incurrence of
additional debt could result in debt service obligations and operating and
financing covenants that would restrict its operations. Microbot can provide no
assurance that financing will be available in the amounts it needs or on terms
acceptable to it, if at all. If Microbot is not able to secure adequate
additional working capital when it becomes needed, it may be required to make
reductions in spending, extend payment terms with suppliers, liquidate assets
where possible and/or suspend or curtail planned research programs. Any of these
actions could materially harm Microbot's business.
Cash Flows
The following table provides a summary of the net cash flow activity for each of
the periods presented (in thousands):
For the Years Ended
December 31,
2021 2020
Net cash flows from operating activities $ (9,354 ) $ (7,252 )
Net cash flows from investing activities 3,200 (2,768 )
Net cash flows from financing activities
- (3,375 )
Net decrease in cash and cash equivalents $ (6,154 ) $ (13,395 )
Comparison of the Years Ended December 31, 2021 and 2020
Cash used in operating activities for the year ended December 31, 2021 was
approximately $9,354,000, compared to $7,252,000 in 2020. The increase was from
higher net losses in 2021, mostly related to increase in research and
development relating to LIBERTY.
Net cash flows from investing activities increased in 2021 compared to 2020
primarily from the net purchases of marketable securities.
Net cash flows from financing activities decreased in 2021 due primarily to a
2020 return of $3,375,000 of capital to investors as a result of the adverse
outcome of litigation discussed above.
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