REWALK ROBOTICS LTD. - 10-Q - MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS - Insurance News | InsuranceNewsNet

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November 7, 2022 Newswires
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REWALK ROBOTICS LTD. – 10-Q – MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Edgar Glimpses
The following discussion and analysis of our financial condition and results of
operation should be read in conjunction with the unaudited condensed
consolidated financial statements and the related notes included elsewhere in
this quarterly report and with our audited consolidated financial statements
included in our Form 10-K for the year ended December 31, 2021 as filed with the
SEC on February 24, 2022 and amended on May 2, 2022 (the "2021 Form 10-K"). In
addition to historical condensed financial information, the following discussion
contains forward-looking statements that reflect our plans, estimates and
beliefs. Our actual results could differ materially from those discussed in the
forward-looking statements. For a discussion of factors that could cause or
contribute to these differences, see "Special Note Regarding Forward-Looking
Statements" above.

Overview

We are an innovative medical device company that is designing, developing, and
commercializing robotic exoskeletons that allow individuals with mobility
impairments or other medical conditions the ability to stand and walk once
again. We have developed and are continuing to commercialize our ReWalk Personal
and ReWalk Rehabilitation devices for individuals with spinal cord injury ("SCI
Products"), which are exoskeletons designed for individuals with paraplegia that
use our patented tilt-sensor technology and an on-board computer and motion
sensors to drive motorized legs that power movement.

In May 2021, the FDA granted breakthrough design designation to the ReWalk
Personal stairs feature. In June 2022, we submitted a 510(k) application to the
FDA for our ReWalk Personal exoskeleton system seeking clearance for the use of
ReWalk Personal units on stairs and curbs in the United States, which is
currently under review.

We have also developed and began commercializing our ReStore device in June
2019. ReStore is a powered, lightweight soft exo-suit intended for use in the
rehabilitation of individuals with lower limb disability due to stroke. During
the second quarter of 2020 we finalized and moved to implement two separate
agreements to distribute additional product lines in the U.S. market. We will be
the exclusive distributor of the MediTouch Tutor movement biofeedback systems in
the United States and will also have distribution rights for the MYOLYN MyoCycle
FES cycles to U.S. rehabilitation clinics and personal sales through U.S.
Department of Veteran Affairs ("VA") hospitals. These new products will improve
our product offering to clinics as well as patients within the VA as they both
have similar clinician and patient profile.

Our principal markets are the United States and Europe. In Europe, we have a
direct sales operation in Germany and the United Kingdom and work with
distribution partners in certain other major countries. We have offices in
Marlborough, Massachusetts, Berlin, Germany and Yokneam, Israel, where we
operate our business from.


We have in the past generated and expect to generate in the future revenues from
a combination of third-party payors, self-payors, including private and
government employers, and institutions. While a broad uniform policy of coverage
and reimbursement by third-party commercial payors currently does not exist in
the United States for electronic exoskeleton technologies such as the ReWalk
Personal, we are pursuing various paths of reimbursement and support fundraising
efforts by institutions and clinics. In December 2015, the VA issued a national
policy for the evaluation, training and procurement of ReWalk Personal
exoskeleton systems for all qualifying veterans across the United States. The VA
policy is the first national coverage policy in the United States for qualifying
individuals who have suffered spinal cord injury. As of September 30, 2022, we
had placed 33 units as part of the VA policy.

According to a 2017 report published by the Centers for Medicare and Medicaid
Services ("CMS"), approximately 55% of the spinal cord injury population which
are at least five years post their injury date are covered by CMS. In July 2020,
a code was issued for ReWalk Personal 6.0 (effective October 1, 2020), which
might later be followed by coverage policy of CMS. On June 8, 2022, CMS held its
First Biannual Healthcare Common Procedure Coding System ("HCPCS") public
meeting to discuss several preliminary benefit and payment decisions under the
new Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS)
rules. Included on the agenda was a discussion of the Medicare benefit category
and payment determination for the ReWalk Personal 6.0. No preliminary
determination was made during the meeting. On September 26, 2022, CMS affirmed
that Medicare Administrative Contractors have the discretion to cover and
reimburse for the ReWalk exoskeleton. Following this determination, the Company
submitted the first case for Medicare coverage in early November and will
continue to prepare further cases for submission for Medicare coverage and
reimbursement. CMS has stated that it plans to further deliberate on a benefit
category designation for the ReWalk exoskeleton and has said that it will
provide more information in the near future.


                                       24
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Additionally, to date, several private insurers in the United States and Europe
have provided reimbursement for ReWalk in certain cases. In Germany, we continue
to make progress toward achieving ReWalk coverage from the various government,
private and worker's compensation payors. In September 2017, each of German
insurer BARMER GEK ("Barmer") and national social accident insurance provider
Deutsche Gesetzliche Unfallversicherung ("DGUV"), indicated that they will
provide coverage to users who meet certain inclusion and exclusion criteria. In
February 2018, the head office of German statutory health insurance ("SHI"),
Spitzenverband ("GKV") confirmed their decision to list the ReWalk Personal 6.0
exoskeleton system in the German Medical Device Directory. This decision means
that ReWalk will be listed among all medical devices for compensation, which SHI
providers can procure for any approved beneficiary on a case-by-case basis.
During the year 2020 we announced several new agreements with German SHIs such
as TK and DAK Gesundheit and others as well as the first German Private Health
Insurer ("PHI") that have chosen to enter into an agreement that outlines the
process of obtaining a device for eligible insured patient. We are currently
working with several additional SHIs and PHIs on securing a formal operating
contract that will establish the process of obtaining a ReWalk Personal 6.0
device for their beneficiaries within their system.

Third Quarter 2022 and Subsequent Period Business Highlights

• Total revenue for the third quarter of 2022 was $0.9 million, compared to $2.0

    million in the third quarter of 2021;


  • Strong cash position with $74.0 million as of September 30, 2022;

• The Company's operating expenses were $5.7 million in the third quarter of

2022, compared to $3.8 million in the thirds quarter of 2021;

• ReWalk submitted its first case to a MAC in early November and will continue

    to prepare further cases for submission for Medicare coverage and
    reimbursement.



Evolving COVID-19 Pandemic

The impact of the COVID-19 pandemic has resulted in, and will likely continue to
result in, significant disruptions to the global economy and the capital
markets, as well as our business. A significant number of our global suppliers,
vendors, distributors and manufacturing facilities are located in regions that
have been affected by the pandemic. Those operations have been materially
adversely affected by restrictive government and private enterprise measures
implemented in response to the pandemic, which in turn, has negatively impacted
our operations. Despite the distribution of COVID-19 vaccines, new and
occasionally more virulent variants (including the BA.4 and BA.5 subvariants) of
the virus that causes COVID-19, including the Delta and Omicron variants, have
emerged, and there is significant uncertainty as to how the countries in which
we do business will continue to respond to such outbreaks, including whether
there will be future partial or total shutdowns, which would adversely affect
our business.

Although we have seen the U.S. and German markets start to fully open for the
first time since the pandemic started in early 2020, allowing us to restart
market development and access programs, the COVID-19 pandemic has continued to
affect our ability to engage with our SCI Products, ReStore and Distributed
Products existing customers, conduct trials of product candidates, deliver
ordered units or repair existing systems and provide training for our products
to new patients, who have largely remained at home due to local movement
restrictions, and to rehabilitation centers, which have temporarily shifted
priorities and responses to pandemic-related medical equipment. In addition,
staffing shortages within the healthcare system itself has resulted in a
diminished demand for our SCI Products as the attention of healthcare workers
and potential patients has turned elsewhere. As a result, our sales and results
of operations have been adversely impacted. We believe that these adverse
impacts may continue as long as the pandemic continues to impact our key
markets, which are Germany and the United States, especially as long as our
ability to conduct trials of product candidates is limited or if our existing
customers can't train with our SCI Products and as long as capital budgets for
rehabilitation devices such as the ReStore remain reduced or on-hold.
Additionally, some clinics, such as VA clinics, and many other healthcare
facilities, have historically been enforcing in-clinic restrictions, which have
to date affected our ability to demonstrate our devices to patients or start
training for qualified potential customers; although we are starting to see this
trend revert back to pre-pandemic levels. We continue to monitor our sales
pipeline on a day-to-day basis in order to assess the effect of these
limitations as some have short term effects and others affect our future
pipeline development. While our sole manufacturer, Sanmina Corporation, has not
shut down its facilities during the COVID-19 pandemic, supply chain delays,
component shortages have had a limited impact on our manufacturing and are also
leading to price increases of specific parts. Other adverse impacts on our
production capacity as a result of government directives or health protocols can
occur. Moreover, the current limitations on our sales activities has made it
difficult to effectively forecast our future requirements for systems. For more
information, see "Part I, Item 1A. Risk Factors." of our 2021 Form 10-K in
addition to the "Risk Factors" section included below.

In addition, our future results of operations and liquidity could be adversely
impacted by delays in payments of outstanding receivable amounts beyond normal
payment terms, supply chain disruptions and operational challenges faced by our
customers. The occurrence of new outbreaks of COVID-19 could result in a
widespread health crisis that could adversely affect the economies and financial
markets of many countries, resulting in an economic downturn or a global
recession that could cause significant volatility or decline in the trading
price of our securities, affect our ability to execute strategic business
activities such as business combination, affect demand for our products and
likely impact our operating results. These may further limit or restrict our
ability to access capital on favorable terms, or at all, lead to consolidation
that negatively impacts our business, weaken demand, increase competition, cause
us to reduce our capital spend further, or otherwise disrupt our business.

During the pandemic, we have implemented remote working procedures in the United
States, Germany and Israel and are establishing in-office measures to contain
the spread of COVID-19 according to local regulations. With the vaccination of
most of our employees, we gradually returned to in-office work arrangements
during 2021 and 2022, but we believe there remains the potential risk for future
disruptions with the continued spread of new variants. Despite this current
situation and the challenges it imposes, we have developed several methods to
continue to engage with our current and prospective customers with some partial
success through video conferencing, virtual training events, and online
education demos to offer our support and showcase the value of our products.

                                       25
--------------------------------------------------------------------------------

Results of Operations for the Three and Nine Months Ended September 30, 2022 and
September 30, 2021


Our operating results for the three and nine months ended September 30, 2022, as
compared to the same periods in 2021, are presented below (in thousands, except
share and per share data). The results set forth below are not necessarily
indicative of the results to be expected in future periods.

                                                Three Months Ended                 Nine Months Ended
                                                   September 30,                     September 30,
                                               2022             2021             2022             2021
Revenues                                   $        886     $      1,972     $      3,332     $      4,724
Cost of revenues                                    665              832            2,100            2,150

Gross profit                                        221            1,140            1,232            2,574

Operating expenses:
Research and development, net                     1,065              638            2,928            2,243
Sales and marketing                               2,588            1,821            7,119            5,105
General and administrative                        2,001            1,343            5,282            4,050

Total operating expenses                          5,654            3,802           15,329           11,398

Operating loss                                   (5,433 )         (2,662 )        (14,097 )         (8,824 )
Financial expenses, net                               1               27               69               14

Loss before income taxes                         (5,434 )         (2,689 )        (14,166 )         (8,838 )
Taxes on income (tax benefit)                        26              (14 )             90               40
Operating loss
Net loss                                   $     (5,460 )   $     (2,675 )   $    (14,256 )   $     (8,878 )

Net loss per ordinary share, basic and
diluted                                    $      (0.09 )   $      (0.06 )  

$ (0.23 ) $ (0.21 )


Weighted average number of shares used
in computing net loss per ordinary
share, basic and diluted                     62,793,847       46,570,130    

62,611,580 43,021,972

Three and Nine Months Ended September 30, 2022 Compared to Three and Nine Months
Ended September 30, 2021


Revenues

Our revenues for the three and nine months ended September 30, 2022, and 2021,
were as follows:

                                                      Three Months Ended                           Nine Months Ended
                                                         September 30,                               September 30,
                                                2022                      2021               2022                   2021
                                              (in thousands, except unit amounts)         (in thousands, except unit amounts)
Personal unit revenues                     $           822           $         1,357     $       2,837         $         3,818
Rehabilitation unit revenues                            64                       615               495                     906
Revenues                                   $           886           $         1,972     $       3,332         $         4,724


Personal unit revenues consist of ReWalk Personal 6.0 and Distributed Products
sale, rental, service and warranty revenue for home use.

                                       26
--------------------------------------------------------------------------------

Rehabilitation unit revenues consist of ReStore, Distributed Products and SCI
Products sale, rental, service and warranty revenue to clinics, hospitals for
treating patients with relevant medical conditions.

Revenues decreased by $1.1 million, or 55%, for the three months ended September
30, 2022, compared to the three months ended September 30, 2021. The decrease is
due to lower number of personal 6.0 units sold in Europe and a lower number of
personal 6.0 and rehabilitation units sold in the United States. The sales of
personal 6.0 units in the quarter were adversely affected by the timing of
coverage decisions by insurers and delays in the training timetables for some
candidates.

Revenues decreased by $1.4 million, or 29%, for the nine months ended September
30, 2022, compared to the nine months ended September 30, 2021. The decrease is
due to lower number of personal 6.0 units sold in Europe and a lower number of
personal 6.0 and rehabilitation units sold in the United States.

We expect that our future revenue growth to be driven by sales of our ReWalk
Personal device to third-party payors as we continue to focus our resources on
broader commercial coverage policies with third-party payors as well as sales of
the ReStore and other products to rehabilitation clinics and personal users.

Gross Profit

Our gross profit for the three and nine months ended September 30, 2022, and
2021 were as follows (in thousands):

                 Three Months Ended          Nine Months Ended
                    September 30,              September 30,
                 2022           2021          2022         2021
Gross profit   $    221       $  1,140     $    1,232     $ 2,574



Gross profit was 25% of revenue for the three months ended September 30, 2022,
compared to 58% for the three months ended September 30, 2021. Gross profit was
37% of revenue for the nine months ended September 30, 2022, compared to 54% for
the nine months ended September 30, 2021. The decrease in gross profit for the
three and nine months ended September 30, 2022, was mainly driven by the impact
of fixed production costs being covered by the margin from fewer sales of the
ReWalk Personal 6.0 devices, as well as rising production costs.

We expect our gross profit to improve, assuming we increase our sales volumes to
better leverage our operations infrastructure, which could also decrease the
product manufacturing costs. Improvements may be partially offset by the lower
margins we currently expect from ReStore and our Distributed Products as well as
due to an increase in the cost of product parts, especially as long as COVID-19
pandemic is affecting the market.

                                       27

--------------------------------------------------------------------------------

Research and Development Expenses, net

Our research and development expenses, net for the three and nine months ended
September 30, 2022, and 2021 were as follows (in thousands):

                                           Three Months Ended          Nine Months Ended
                                              September 30,              September 30,
                                            2022           2021        

2022 2021
Research and development expenses, net $ 1,065 $ 638 $ 2,928 $ 2,243




Research and development expenses, net increased $427 thousand, or 67%, for the
three months ended September 30, 2022, compared to the three months ended
September 30, 2021. Research and development expenses increased $685 thousand,
or 31%, for the nine months ended September 30, 2022, compared to the nine
months ended September 30, 2021. The increase is attributable to increased
personnel and personnel related expenses and subcontractors' expenses primarily
due to development projects offset partially with grant received from the IIA.

We intend to focus our research and development expenses mainly on our current
products maintenance and improvement as well as developing our "soft suit"
exoskeleton for additional indications affecting the ability to walk or a home
use design such as the ReBoot design.

Sales and Marketing Expenses

Our sales and marketing expenses for the three and nine months ended September
30, 2022
, and 2021 were as follows (in thousands):

                                 Three Months Ended          Nine Months Ended
                                    September 30,              September 30,
                                  2022          2021          2022         2021
Sales and marketing expenses   $    2,588      $ 1,821     $    7,119     $ 5,105



Sales and marketing expenses increased $767 thousand, or 42%, for the three
months ended September 30, 2022, compared to the three months ended September
30, 2021. Sales and marketing expenses increased $2.0 million, or 40%, for the
nine months ended September 30, 2022, compared to the nine months ended
September 30, 2021. The increase for the three and nine months ended September
30, 2022, was driven mainly by higher consulting expenses related to CMS
reimbursement progress , increase in tradeshow activities since Covid-19
restrictions are being lifted and personnel and personnel related expenses.

In the near term our sales and marketing expenses are expected to be driven by
our efforts expand our reimbursement coverage of our ReWalk Personal device and
to expand our current product commercialization.

General and Administrative Expenses

Our general and administrative expenses for the three and nine months ended
September 30, 2022, and 2021 were as follows (in thousands):

                                        Three Months Ended          Nine Months Ended
                                           September 30,              September 30,
                                         2022          2021          2022         2021

General and administrative expenses $ 2,001 $ 1,343 $ 5,282 $ 4,050




General and administrative expenses increased $658 thousand, or 49%, for the
three months ended September 30, 2022, compared to the three months ended
September 30, 2021. General and administrative expenses increased $1.2 million,
or 30%, for the nine months ended September 30, 2022, compared to the nine
months ended September 30, 2021. The increase in the three and nine months ended
September 30, 2022, was mainly driven by increased professional services
expenses related to the 2022 proxy process offset partially with a decrease in
insurance costs.

                                       28
--------------------------------------------------------------------------------

Financial Expenses, Net

Our financial expenses, net, for the three and nine months ended September 30,
2022
, and 2021 were as follows (in thousands):

                              Three Months Ended            Nine Months Ended
                                September 30,                 September 30,
                           2022              2021          2022            2021
Financial expenses, net   $     1         $       27     $      69         $  14



Financial expenses, net, decreased by $26 thousand, for the three months ended
September 30, 2022, compared to the three months ended September 30, 2021.
Financial expenses, net, increased by $55 thousand, for the nine months ended
September 30, 2022, compared to the nine months ended September 30, 2021. The
change was primarily due to exchange rate fluctuations.

Income Taxes

Our income taxes for the three and nine months ended September 30, 2022, and
2021 were as follows (in thousands):

                                  Three Months Ended           Nine Months Ended
                                     September 30,               September 30,
                                 2022           2021          2022            2021

Taxes on income (tax benefit) $ 26 $ (14 ) $ 90

$ 40




Taxes on income increased $40 thousand for the three months ended September 30,
2022, compared to the three months ended September 30, 2021. Taxes on income
increased $50 thousand or 125% for the nine months ended September 30, 2022,
compared to the nine months ended September 30, 2021. The increase in the three
and nine months ended September 30, 2022, was mainly due to deferred taxes and
timing differences in our subsidiaries.

Critical Accounting Policies and Estimates


Our condensed consolidated financial statements are prepared in accordance with
U.S. GAAP. The preparation of our condensed financial statements requires us to
make estimates, judgments and assumptions that can affect the reported amounts
of assets and liabilities, disclosure of contingent assets and liabilities at
the date of the financial statements and the reported amounts of revenues and
expenses during the reporting period. We base our estimates, judgments and
assumptions on historical experience and other factors that we believe to be
reasonable under the circumstances. Materially different results can occur as
circumstances change and additional information becomes known. Besides the
estimates identified above that are considered critical, we make many other
accounting estimates in preparing our condensed financial statements and related
disclosures. See Note 2 to our audited consolidated financial statements
included in our 2021 Form 10-K for a description of the significant accounting
policies that we used to prepare our consolidated financial statements.

There have been no material changes to our critical accounting policies or our
critical judgments from the information provided in "Part II, Item 7.
Management's Discussion and Analysis of Financial Condition and Results of
Operations - Critical Accounting Policies" of our 2021 Form 10-K, except for the
updates provided in Note 3 of our unaudited condensed consolidated financial
statements set forth in "Part I, Item 1. Financial Statements" of this quarterly
report.

Recent Accounting Pronouncements

See Note 3 to our unaudited condensed consolidated financial statements set
forth in "Part I, Item 1. Financial Statements" of this quarterly report for
information regarding new accounting pronouncements.

                                       29
--------------------------------------------------------------------------------

Liquidity and Capital Resources

Sources of Liquidity and Outlook


Since inception, we have funded our operations primarily through the sale of
certain of our equity securities and convertible notes to investors in private
placements, the sale of our ordinary shares in public offerings and the
incurrence of bank debt.

During the nine months ended September 30, 2022, we incurred a consolidated net
loss of $14.3 million and as of September 30, 2022, we had an accumulated
deficit of $208.4 million. Our cash and cash equivalents as of September 30,
2022, were $74.0 million and our negative operating cash flow for the nine
months ended September 30, 2022, was $14.0 million. We believe we have
sufficient funds to support our operations for more than 12 months following the
issuance date of our condensed consolidated unaudited financial statements for
the three and nine months ended September 30, 2022.

We expect to incur future net losses and our transition to profitability is
dependent upon, among other things, the successful development and
commercialization of our products and product candidates, the achievement of a
level of revenues adequate to support our cost structure. Until we achieve
profitability or generate positive cash flows, we will continue to need to raise
additional cash from time to time.

We intend to fund future operations through cash on hand, additional private
and/or public offerings of debt or equity securities, cash exercises of
outstanding warrants or a combination of the foregoing. In addition, we may seek
additional capital through arrangements with strategic partners or from other
sources and we will continue to address our cost structure. Notwithstanding,
there can be no assurance that we will be able to raise additional funds or
achieve or sustain profitability or positive cash flows from operations.

Our anticipated primary uses of cash are (i) sales, marketing and reimbursement
expenses related to market development activities of our ReStore and Personal
6.0 devices, broadening third-party payor and CMS coverage for our ReWalk
Personal device and commercializing our new product lines added through
distribution agreements; (ii) research and development of our lightweight
exo-suit technology for potential home personal health utilization for multiple
indications and future generation designs for our spinal cord injury device;
(iii) routine product updates; (iv) general corporate purposes, including
working capital needs; and (v) potential acquisitions of business. Our future
cash requirements will depend on many factors, including our rate of revenue
growth, the expansion of our sales and marketing activities, the timing and
extent of our spending on research and development efforts and international
expansion. If our current estimates of revenue, expenses or capital or liquidity
requirements change or are inaccurate, we may seek to sell additional equity or
debt securities, arrange for additional bank debt financing, or refinance our
indebtedness. There can be no assurance that we will be able to raise such funds
at all or on acceptable terms.

Further, on October 10, 2022, we received a deficiency letter from the Nasdaq
Stock Market LLC ("Nasdaq") notifying us that because the closing bid price of
our ordinary shares had been below the minimum $1.00 per share for 30
consecutive business days, we are out of compliance with the requirements for
continued listing on Nasdaq, and are subject to potential delisting. If we are
unable to re-achieve compliance with the Nasdaq listing requirements within 180
days, or April 10, 2023, after receipt of a delisting notice, and if we are
unable to obtain an extension therefore, we would be subject to delisting, which
likely would further impair the liquidity and value of our ordinary shares.

Equity Raises


Beginning with the filing of our Form 10-K on February 17, 2017, we were subject
to limitations under the applicable rules of Form S-3, which constrained our
ability to secure capital pursuant to our ATM Offering Program (as defined
below) or other public offerings pursuant to our effective Form S-3. These rules
limit the size of primary securities offerings conducted by issuers with a
public float of less than $75 million to no more than one-third of their public
float in any 12-month period. At the time of filing our annual report for the
year ended December 31, 2020, we were no longer subject to these limitations,
because our public float had reached at least $75 million in the 60 days
preceding the filing of that annual report. Likewise, because our public float
was at least $75 million within the 60 days preceding the date of our 2021
Annual Report, we are not currently subject to these limitations, and will
continue to not be subject to these limitations for the remainder of the 2022
fiscal year and until such time as we file our next annual report for the year
ended December 31, 2022, at which time we will be required to re-test our status
under these rules. If our public float subsequently drops below $75 million as
of the filing of our next annual report on Form 10-K, or at the time we file a
new Form S-3, we will become subject to these limitations again, until the date
that our public float again reaches $75 million. These limitations do not apply
to secondary offerings for the resale of our ordinary shares or other securities
by selling shareholders or to the issuance of ordinary shares upon conversion by
holders of convertible securities, such as warrants. We have registered up to
$100 million of ordinary shares warrants and/or debt securities and certain
other outstanding securities with registration rights on our new registration
statement on Form S-3, which was declared effective by the SEC in May 2022.

                                       30
--------------------------------------------------------------------------------

Equity Offerings and Warrant Exercises


On February 19, 2021, we entered into a purchase agreement with certain
institutional and other accredited investors for the issuance and sale of
10,921,502 ordinary shares, par value NIS 0.25 per share at $3.6625 per ordinary
share and warrants to purchase up to an aggregate of 5,460,751 ordinary shares
with an exercise price of $3.6 per share, exercisable from February 19, 2021,
until August 26, 2026. Additionally, we issued warrants to purchase up to
655,290 ordinary shares, with an exercise price of $4.578125 per share,
exercisable from February 19, 2021, until August 26, 2026, to certain
representatives of H.C. Wainwright as compensation for its role as the placement
agent in our February 2021 Offering.

On September 27, 2021, we signed a purchase agreement with certain institutional
investors for the issuance and sale of 15,403,014 ordinary shares, pre-funded
warrants to purchase up to an aggregate of 610,504 ordinary shares and ordinary
warrants to purchase up to an aggregate of 8,006,759 ordinary shares at an
exercise price of $2.00 per share. The pre-funded warrants have an exercise
price of $0.001 per ordinary share and are immediately exercisable and can be
exercised at any time after their original issuance until such pre-funded
warrants are exercised in full. Each ordinary share was sold at an offering
price of $2.035 and each pre-funded warrant was sold at an offering price of
$2.034 (equal to the purchase price per ordinary share minus the exercise price
of the pre-funded warrant). The offering of the ordinary shares, the pre-funded
warrants and the ordinary shares that are issuable from time to time upon
exercise of the pre-funded warrants was made pursuant to our shelf registration
statement on Form S-3 initially filed with the SEC on May 9, 2019, and declared
effective by the SEC on May 23, 2019, and the ordinary warrants were issued in a
concurrent private placement. The ordinary warrants are exercisable at any time
and from time to time, in whole or in part, following the date of issuance and
ending five and one-half years from the date of issuance. All of the pre-funded
warrants were exercised in full on September 27, 2021, and the offering closed
on September 29, 2021. Additionally, we issued warrants to purchase up to
960,811 ordinary shares, with an exercise price of $2.5438 per share,
exercisable from September 27, 2021, until September 27, 2026, to certain
representatives of H.C. Wainwright as compensation for its role as the placement
agent in our September 2021 private placement offering.

As of September 30, 2022, a total of 9,814,754 previously issued warrants with
exercise prices ranging from $1.25 to $1.79 have been exercised for total gross
proceeds of approximately $13.8 million.

ATM Offering Program


On May 10, 2016, we entered into our Equity Distribution Agreement with Piper
Jaffray, as amended on May 9, 2019, pursuant to which we may offer and sell,
from time to time, ordinary shares having an aggregate offering price of up to
$25.0 million through Piper Jaffray acting as our agent (the "ATM Offering
Program"). Subject to the terms and conditions of the Equity Distribution
Agreement, Piper Jaffray will use its commercially reasonable efforts to sell on
our behalf all of the ordinary shares requested to be sold by us, consistent
with its normal trading and sales practices. Piper Jaffray may also act as
principal in the sale of ordinary shares under the Equity Distribution
Agreement. Such sales may be made under our Form S-3 in what may be deemed
"at-the-market" equity offerings as defined in Rule 415 promulgated under the
Securities Act, directly on or through the Nasdaq Capital Market, to or through
a market maker other than on an exchange or otherwise, in negotiated
transactions at market prices prevailing at the time of sale or at prices
related to such prevailing market prices, and/or any other method permitted by
law, including in privately negotiated transactions.

Piper Jaffray is entitled to compensation at a fixed commission rate of 3% of
the gross sales price per share sold through it as agent under the Equity
Distribution Agreement. Where Piper Jaffray acts as principal in the sale of
ordinary shares under the Equity Distribution Agreement, such rate of
compensation will not apply, but in no event will the total compensation of
Piper Jaffray, when combined with the reimbursement of Piper Jaffray for the
out-of-pocket fees and disbursements of its legal counsel, exceed 8.0% of the
gross proceeds received from the sale of the ordinary shares.

                                       31
--------------------------------------------------------------------------------

We may instruct Piper Jaffray not to sell ordinary shares if the sales cannot be
effected at or above the price designated by us in any instruction. We or Piper
Jaffray may suspend an offering of ordinary shares under the ATM Offering
Program upon proper notice and subject to other conditions, as further described
in the Equity Distribution Agreement. Additionally, the ATM Offering Program
will terminate on the earlier of (i) the sale of all ordinary shares subject to
the Equity Distribution Agreement, (ii) the date that is three years after a new
registration statement on Form S-3 goes effective, (iii) our becoming ineligible
to use Form S-3 and (iv) termination of the Equity Distribution Agreement by the
parties. The Equity Distribution Agreement may be terminated by Piper Jaffray or
us at any time on the close of business on the date of receipt of written
notice, and by Piper Jaffray at any time in certain circumstances, including any
suspension or limitation on the trading of our ordinary shares on the Nasdaq
Capital Market, as further described in the Equity Distribution Agreement. We
temporarily suspended use of the ATM Offering Program on February 20, 2019 to
facilitate our February 2019 "best efforts" public offering. As of September 30,
2020, we had sold 302,092 ordinary shares under the ATM Offering Program for net
proceeds to us of $14.5 million (after commissions, fees, and expenses).
Additionally, as of that date, we had paid Piper Jaffray compensation of $471
thousand and had incurred total expenses (including such commissions) of
approximately $1.2 million in connection with the ATM Offering Program. No sales
were made under the ATM Offering Program during the year ended December 31, 2021
or during the nine months ended September 30, 2022.

We intend to continue using the at-the-market offering or similar continuous
offering programs opportunistically to raise additional funds, although we are
currently subject to restrictions on using the ATM Offering Program with Piper
Jaffray. Under our September 2021 purchase agreement with certain investors,
equity or debt securities convertible into, or exercisable or exchangeable for,
ordinary shares at a conversion price, exercise price or exchange price which
floats with the trading price of the ordinary shares or which may be adjusted
after issuance upon the occurrence of certain events or (ii) enter into any
agreement including an equity line of credit, whereby the Company may issue
securities at a future-determined price, other than an at-the-market facility
with the placement agent, H.C. Wainwright & Co, LLC, beginning on March 29,
2022. Such limitations may inhibit our ability to access capital efficiently.

Share Repurchase Program


In June 2022, we announced that our Board had approved a program to repurchase
up to $8.0 million of our ordinary shares, par value NIS 0.25 per share, subject
to receipt of Israeli court approval. In July 2022, we announced that we had
received approval from an Israeli court for the share repurchase program, valid
through January 20, 2023.

Under the program, share repurchases may be made from time to time using a
variety of methods, including open market transactions or in privately
negotiated transactions. Such repurchases will be made in accordance with all
applicable securities laws and regulations, including restrictions relating to
volume, price and timing under applicable law, including Rule 10b-18 under the
United States Securities Exchange Act of 1934, as amended (the "Exchange Act").
The timing and amount of shares repurchased will be determined by our
management, within guidelines to be established by the Board or a committee
thereof, based on its ongoing evaluation of our capital needs, market
conditions, the trading price of our ordinary shares, trading volume and other
factors, subject to applicable law. For all or a portion of the authorized
repurchase amount, we may enter into a plan compliant with Rule 10b5-1 under the
Exchange Act that is designed to facilitate these repurchases.

The repurchase program does not require us to acquire a specific number of
shares, and may be suspended or discontinued at any time. There can be no
assurance as to the timing or number of shares of any repurchases in the future,
and any such share repurchases will be funded from available working capital. As
of September 30, 2022, we have repurchased approximately $183,540 of our
ordinary shares under the repurchase program.


                                       32
--------------------------------------------------------------------------------

Cash Flows for the Nine Months Ended September 30, 2022 and September 30, 2021
(in thousands):

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