NOVOCURE LTD Management’s Discussion and Analysis of Financial Condition and Results of Operations (form 10-Q)

Management's Discussion and Analysis of Financial Condition and Results of
Operations ("MD&A") is intended to provide information to assist you in better
understanding and evaluating our financial condition and results of operations.
We encourage you to read this MD&A in conjunction with our unaudited
consolidated financial statements and the notes thereto for the period ended
September 30, 2022 included in Part I, Item 1 of this Quarterly Report on
Form 10-Q. This discussion contains forward-looking statements that involve
risks and uncertainties. Please refer to the information under the heading
"Cautionary Note Regarding Forward-Looking Statements" elsewhere in this report.
References to the words "we," "our," "us," and the "Company" in this report
refer to NovoCure Limited, including its consolidated subsidiaries.

Critical Accounting Policies and Estimates


In accordance with U.S. generally accepted accounting principles ("GAAP"), in
preparing our financial statements, we must make estimates and assumptions that
affect the reported amounts of assets and liabilities, the disclosure of
contingent assets and liabilities as of the date of the financial statements and
the reported amounts of net revenues and expenses during the reporting period.
We develop and periodically change these estimates and assumptions based on
historical experience and on various other factors that we believe are
reasonable under the circumstances. Actual results may differ from these
estimates.

The critical accounting policies requiring estimates, assumptions and judgments
that we believe have the most significant impact on our consolidated financial
statements can be found in our 2021 10-K. For additional information, see Note 1
to our unaudited consolidated financial statements in Part I, Item 1 of this
Quarterly Report. There were no other material changes to our critical
accounting policies and estimates as compared to the critical accounting
policies and estimates described in our 2021 10-K.

overview


We are a global oncology company with a proprietary platform technology called
Tumor Treating Fields ("TTFields"), which are electric fields that exert
physical forces to kill cancer cells via a variety of mechanisms. Our key
priorities are to drive commercial adoption of Optune and Optune Lua, our
commercial TTFields devices, and to advance clinical and product development
programs intended to extend overall survival in some of the most aggressive
forms of cancer.

Optune is approved by the U.S. Food and Drug Administration ("FDA") under the
Premarket Approval ("PMA") pathway for the treatment of adult patients with
newly diagnosed glioblastoma ("GBM") together with temozolomide, a chemotherapy
drug, and for adult patients with GBM following confirmed recurrence after
chemotherapy as monotherapy treatment. We also have a CE certificate to market
Optune for the treatment of GBM in the European Union ("EU"), as well as
approval or local registration in the United Kingdom ("UK"), Japan and certain
other countries. Optune Lua is approved by the FDA under the Humanitarian Device
Exemption ("HDE") pathway for the treatment of adult patients with malignant
pleural mesothelioma ("MPM") together with standard chemotherapies. We have also
received CE certification in the EU and approval or local registration to market
Optune Lua in certain other countries. We market Optune and Optune Lua in
multiple countries around the globe with the majority of our revenues coming
from the use of Optune in the U.S., Germany and Japan. We are actively
evaluating opportunities to expand our international footprint.

As a highly versatile first-in-class modality, TTFields therapy has significant
potential for broad applicability across solid tumor types and lines of therapy.
Currently, we are conducting phase 3 pivotal studies evaluating the use of
TTFields in non-small cell lung cancer ("NSCLC"), ovarian cancer, brain
metastases from NSCLC, and pancreatic cancer. Additionally, we have multiple
ongoing or recently completed phase 2 pilot studies evaluating the use of
TTFields. These studies are in gastric cancer and stage 3 NSCLC, as well as
testing the potential incremental survival benefit of TTFields delivered using
high-intensity arrays versus standard arrays. We are also currently conducting a
global phase 4 post-marketing study testing the potential survival benefit of
initiating Optune concurrent with radiation therapy versus following radiation
therapy in patients with newly diagnosed GBM. We anticipate expanding our
clinical pipeline over time to study the safety and efficacy of TTFields for
additional solid tumor indications and combinations with other cancer treatment
modalities.

We have completed recruitment of the pivotal Phase 3 LUNAR study in November 2021, which started the last patient’s 12-month follow-up period. Our clinical operations and data collection efforts remain on track and we expect to report top-line results early in Q1 2023.

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In March 2022, we announced that an independent data monitoring committee
("DMC") conducted a pre-specified interim analysis for the phase 3 pivotal
INNOVATE-3 study for the treatment of platinum-resistant ovarian cancer. As part
of the interim analysis, the DMC reviewed the safety data for all enrolled
patients and completed an analysis of overall survival on the first 540 patients
randomized in the study. The interim analysis did not indicate a need to
increase the patient sample size and the DMC recommended that the study should
continue to final analysis as planned. The INNOVATE-3 study accrued 540 patients
as of October 2021 and data will be reviewed in 2023, following an 18 month
follow-up period.

in the May 2022we have entered into a clinical trial collaboration agreement with MSD, a trading name of Merck & Co., Inc., (“MSD”) to conduct a double-blind, placebo-controlled study of TTFields concomitantly with pembrolizumab and temozolomide as maintenance therapy of newly diagnosed GBM.


In June 2022, we announced results of the phase 2 pilot EF-31 study evaluating
the use of TTFields together with standard-of-care (chemotherapy alone or in
combination with trastuzumab for HER2-positive patients) as first-line treatment
for gastric cancer. Initial analysis was conducted with a median follow-up
period of 8.6 months. The primary endpoint, confirmed objective response rate,
was 50%. Median progression-free survival was 7.8 months. Duration of response
was 10.3 months. Median overall survival had not yet been reached with a
one-year survival rate of 72%. We look forward to further exploration of these
potential benefits as we look ahead to a randomized phase 3 clinical study.

In June 2022, we announced the first patient has been enrolled in the phase 2
pilot KEYNOTE B36 study, conducted in collaboration with MSD. KEYNOTE B36 is
designed to evaluate the safety and effectiveness of TTFields together with
pembrolizumab for the treatment of locally advanced or metastatic intrathoracic
NSCLC that expresses PD-L1.

Today, we announced data from the EF-33 pilot study evaluating the safety and
preliminary efficacy of a higher intensity array design in 25 patients diagnosed
with recurrent GBM. Among those patients who used Optune as directed with higher
intensity arrays for at least one month, median progression-free survival was
4.5 months. This compares to 2.2 months from our pivotal EF-11 study in
recurrent GBM. Further, alongside the increased dosage, EF-33 patients reported
no TTFields-related toxicity.

We now expect to complete enrollment in our phase 3 pivotal METIS study for the
treatment of brain metastases from NSCLC in the first quarter of 2023. This will
begin the final patient's 12-month follow-up period and we anticipate top-line
data in the first quarter of 2024.

The table below shows the current status of the ongoing clinical trials in our oncology pipeline and the expected timing of data read-out.

[[Image Removed: nvcr-20220930_g1.jpg]]


Our therapy is delivered through a medical device and we continue to advance our
Products with the intention to extend survival and maintain quality of life for
patients. We have several product development programs underway that are
designed to optimize TTFields delivery to the target tumor and enhance patient
ease of use. Our intellectual
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property portfolio contains hundreds of issued patents and numerous patent
applications pending worldwide. We believe we possess global commercialization
rights to our Products in oncology and are well-positioned to extend those
rights into the future as we continue to find innovative ways to improve our
Products.

In 2018, we granted Zai Lab (Shanghai) Co., Ltd. ("Zai") a license to
commercialize Optune in China, Hong Kong, Macau and Taiwan ("Greater China")
under a License and Collaboration Agreement (the "Zai Agreement"). The Zai
Agreement also establishes a development partnership intended to accelerate the
development of TTFields in multiple solid tumor cancer indications. For
additional information, see Note 12 to the Consolidated Financial Statements in
the Company's Annual Report on Form 10-K for the fiscal year ended December 31,
2021 (the "2021 10-K").

We view our operations and manage our business in one operating segment. For the
three and nine months ended September 30, 2022, our net revenues were $131.0
million and $409.4 million, respectively. Our net loss for the three and nine
months ended September 30, 2022 were $26.6 million and $55.2 million,
respectively. As of September 30, 2022, we had an accumulated deficit of $741.2
million. Our net loss resulted primarily from net revenue growth which was more
than offset by increasing investments in research, development and clinical
trial initiatives and sales and marketing initiatives that support our ongoing
exploration of the benefits of TTFields across numerous cancer indications, as
well as geographic expansion and pre-commercial activities associated with
potential future indication launches.

Effects of COVID-19


In March 2020, the World Health Organization ("WHO") declared COVID-19 a global
pandemic. Since the pandemic began, we have been following the guidance of the
WHO, the U.S. Centers for Disease Control and Prevention, and local health
authorities in all of our active markets and we have adjusted the way we conduct
business to adapt to the evolving situation. The COVID-19 pandemic did not have
a material impact on our financial results through the third quarter of 2022.
The pandemic has had and is having an impact on our day-to-day operations, which
varies by region based on factors such as geographical spread, stage of
containment and recurrence of the pandemic in each region. We believe the
prolonged disruption caused by COVID-19 is resulting in increased volatility
across global health care systems, such as fluctuations in patient volumes and
changes in patterns of care in certain regions, which is currently impacting and
might continue to impact our business and clinical studies in the future. For
example, outside the U.S., localized lockdowns are causing disruptions in the
ability to monitor clinical studies. TTFields is an emerging modality in cancer
care and requires significant educational effort to drive awareness and
acceptance of our therapy. We have relied heavily on virtual engagement to
manage these educational efforts since the onset of the pandemic, which poses
challenges to our ability to effectively communicate and engage with our
customers and partners around the world.

Given the aggressive nature of the cancers that we treat, we believe that the
fundamental value proposition of the TTFields platform remains unchanged. We
continue to evaluate and plan for the potential effects of COVID-19 on our
business moving forward. The extent to which the COVID-19 pandemic may impact
our business and clinical studies in the future will depend on further
developments, which are highly uncertain and cannot be predicted with
confidence. The COVID-19 pandemic may also have the effect of heightening many
of the other risks described in our risk factors disclosed in our 2021 10-K.

Effects of the implementation of the Medical Devices Ordinance


As a result of the implementation of the Medical Device Regulation ("MDR"), our
notified body (as well as many other notified bodies throughout the European
Economic Area ("EEA") has suffered a significant backlog in issuing CE
Certificate renewals. That may affect our ability to obtain a renewal of our CE
Certificate for Optune before the current CE Certificate expires in October
2022. In the event of a gap between expiration of the current CE Certificate and
issuance of the renewal, we are able to continue to sell and market CE marked
Optune from current inventories in the EEA and Switzerland under the expired CE
Certificate. We have been assured in writing from the notified body that our
renewal application has passed technical review and no issues are expected while
the certification team completes the renewal. We are proactively procuring an
adequate supply of Optune to ensure the avoidance of any material disruption in
the event that there is a gap between expiration of the current CE Certificate
and issuance of the renewal.
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Commentary on the earnings situation


Net revenues. Our revenues are primarily derived from patients using our
Products in our active markets. We charge for treatment with our Products on a
monthly basis. Our potential net revenues per patient are determined by our
ability to secure payment, the monthly fee we collect and the number of months
that the patient remains on therapy.

We also receive revenue under the Zai Accord. Please see Note 12 to the Consolidated Financial Statements in our 2021 10-K for more information on the Zai Agreement.

cost of revenue. We use third parties to manufacture our products. Our cost of sales essentially breaks down as follows:

•disposable arrays;

• Depreciation costs for field equipment, including the electric field generator used by patients; and

•Personnel and overhead costs such as facilities, freight and depreciation of property, plant and equipment associated with the management of our inventory, warehousing and order processing functions.


Operating expenses. Our operating expenses consist of research, development and
clinical studies, sales and marketing and general and administrative expenses.
Personnel costs are a significant component for each category of operating
expenses and consist of wages, benefits and bonuses. Personnel costs also
include share-based compensation.

Financial expenses, net. Financial expenses, net primarily consists of debt
issuance costs, interest income from cash balances and short-term investments
and gains (losses) from foreign currency transactions. Our reporting currency is
the U.S. dollar. We have historically held substantially all of our cash
balances in U.S. dollar denominated accounts to minimize the risk of
translational currency exposure.

operating results


The following discussion provides an analysis of our results of operations and
reasons for material changes therein for the three and nine months ended
September 30, 2022 as compared to the three and nine months ended September 30,
2021. The tables contained in this section report U.S. dollars in thousands
(except share, patient, and prescription data).

The table below shows our consolidated income statement data:

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                                                    Three months ended September 30,                  Nine months ended September 30,
                                                       2022                     2021                    2022                     2021
                                                                Unaudited                                        Unaudited
Net revenues                                   $         130,998          $     133,606          $        409,411          $     401,818
Cost of revenues                                          29,749                 30,206                    85,979                 85,190
Gross profit                                             101,249                103,400                   323,432                316,628

Operating costs and expenses:
Research, development and clinical studies                51,956                 48,141                   151,265                144,372
Sales and marketing                                       41,395                 32,580                   124,029                 98,075
General and administrative                                32,509                 31,231                    94,683                 95,116
Total operating costs and expenses                       125,860                111,952                   369,977                337,563

Operating income (loss)                                  (24,611)                (8,552)                  (46,545)               (20,935)
Financial expenses (income), net                          (1,194)                 1,981                     2,743                  5,567

Income (loss) before income taxes                        (23,417)               (10,533)                  (49,288)               (26,502)
Income taxes                                               3,159                  2,591                     5,943                  5,391
Net income (loss)                              $         (26,576)         $     (13,124)         $        (55,231)         $     (31,893)

Basic net income (loss) per ordinary share     $           (0.25)         $       (0.13)         $          (0.53)         $       (0.31)
Weighted average number of ordinary shares
used in computing basic net income (loss) per
share                                                104,884,583            103,731,147               104,552,803            103,281,380
Diluted net income (loss) per ordinary share   $           (0.25)         $       (0.13)         $          (0.53)         $       (0.31)
Weighted average number of ordinary shares
used in computing diluted net income (loss)
per share                                            104,884,583            103,731,147               104,552,803            103,281,380


The following table shows the stock-based compensation expense included in costs and expenses:

                                                Three months ended September         Nine months ended September
                                                            30,                                  30,
                                                   2022              2021               2022              2021
                                                         Unaudited                            Unaudited
Cost of revenues                               $   1,013          $    808          $   2,994          $  2,368
Research, development and clinical studies         7,430             7,761             21,855            21,390
Sales and marketing                                7,686             5,806             21,143            16,706
General and administrative                        10,176            11,383             31,181            32,038

Total expense for stock-based compensation $26,305 $25,758

$77,173 $72,502

performance metrics


We believe certain commercial operating statistics are useful to investors in
evaluating our commercial business as they help our management team and
investors evaluate and compare the adoption of our Products from period to
period. The number of active patients on therapy is our principal revenue
driver. An "active patient" is a patient who is receiving treatment under a
commercial prescription order as of the measurement date, including patients who
may be on a temporary break from treatment and who plan to resume treatment in
less than 60 days. Prescriptions
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are a leading indicator of demand. A "prescription received" is a commercial
order for Optune or Optune Lua that is received from a physician certified to
treat patients with our Products for a patient not previously on Optune or
Optune Lua. Orders to renew or extend treatment are not included in this total.

The following table contains certain commercial operating statistics for and at the end of the periods presented.

                                        September 30,
Operating statistics                2022               2021
Active patients at period end
North America (1)                 2,181               2,223
EMEA:
Germany                             468                 562
Other EMEA                          417                 425
Japan                               354                 292
Total                             3,420               3,502


                                                           Three months ended September 30,                         Nine months ended September 30,
                                                         2022                              2021                   2022                            2021
Prescriptions received in period
North America (1)                                           978                                931                2,867                            2,815
EMEA:
Germany                                                     214                                220                  650                              705
Other EMEA                                                  118                                119                  363                              391
Japan                                                        79                                110                  276                              321
Total                                                     1,389                              1,380                4,156                            4,232


(1) North America includes data for the United States and Canada for the second
half of 2021 and all of 2022, and the United States only for the first half of
2021.

To date, 12 active MPM patients have been on therapy 09/30/2022 and 8 MPM prescriptions were received in the past three months 09/30/2022.

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Three and nine months ended 09/30/2022 compared to three and nine months ended September 30, 2021


                                          Three months ended September 30,                             Nine months ended September 30,
                                   2022                2021              % Change               2022                2021              % Change
Net revenues                   $  130,998          $ 133,606                    (2) %       $  409,411          $ 401,818                     2  %


Net revenues. Net revenues decreased 2% to $131.0 million for the three month
period ending September 30, 2022 from $133.6 million for the same period in
2021, and increased 2% to $409.4 million for the nine month period ended
September 30, 2022 from $401.8 million for the same period in 2021. For the
three month period ending September 30, 2022, the decrease resulted primarily
from a reduction in German approval rates as a result of updated coverage
criteria and the impact of foreign exchange rate fluctuations. For the nine
month period ending September 30, 2022, the increase in net revenues resulted
primarily from an increase in collections from previously denied and appealed
claims in the U.S. offset by a reduction in current period German net revenues
and prior period accounts receivable to reflect updated coverage criteria.

We continue to actively appeal and pursue previously denied claims, but the
cadence and size of these collections are impossible to predict. We believe the
claims which are most accessible will largely be exhausted this year and the
remaining outstanding claims will take a greater level of time and effort to
collect in the future.


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                                             Three months ended September 30,                           Nine months ended September 30,
                                       2022              2021              % Change               2022              2021              % Change
Cost of revenues                   $  29,749          $ 30,206                    (2) %       $  85,979          $ 85,190                     1  %


Cost of revenues. Our cost of revenues for the three month period ended
September 30, 2022 decreased 2% to $29.7 million, from $30.2 million for the
same period in 2021. Cost of revenues for the nine months ended September 30,
2022 increased by 1% to $86.0 million from $85.2 million for the same period in
2021. For the three month period ended September 30, 2022, the decrease in cost
of revenues was primarily driven by decreased shipments to Zai. For the nine
month period ended September 30, 2022, the increase in cost of revenues was
primarily a result of increased shipments to Zai. We continue to focus on
opportunities to increase efficiencies and scale within our supply chain. This
includes evaluating new materials, manufacturers, and processes that could lead
to lower costs.

Gross margin was 77% for the three months ended September 30, 2022 compared to
77% for the three months ended September 30, 2021. Gross margin was 79% for the
nine months ended September 30, 2022 and 79% for the nine months ended
September 30, 2021. Excluding sales to Zai, cost of revenues per active patient
per month was $2,543 for the three months ended September 30, 2022, an increase
of 2% from $2,485 for the same period in 2021, due to increased investments
intended to expand capacity in advance of future potential launches in new
indications. Cost of revenues per active patient is calculated by dividing the
cost of revenues for the quarter less equipment sales to Zai for the quarter by
the average of the active patients at the end of the prior quarter and the
ending active patients in the current quarter. This quarterly figure is then
divided by three to estimate the monthly cost of revenues per active patient.
Sales to Zai are deducted because they are sold at cost and in anticipation of
future royalties from Zai, and Zai patient counts are not included in our active
patient population. Product sales to Zai totaled $3.5 million and $8.8 million
for the three and nine months ended September 30, 2022 compared to $4.2 million
and $8.0 million for the three and nine months ended September 30, 2021.

Operating Expenses.

                                           Three months ended September 30,                             Nine months ended September 30,
                                    2022                2021              % Change               2022                2021              % Change
Research, development and
clinical studies                $   51,956          $  48,141                     8  %       $  151,265          $ 144,372                     5  %
Sales and marketing                 41,395             32,580                    27  %          124,029             98,075                    26  %
General and administrative          32,509             31,231                     4  %           94,683             95,116                     -  %
Total operating expenses        $  125,860          $ 111,952                    12  %       $  369,977          $ 337,563                    10  %


Research, development and clinical study expenses. Research, development and
clinical study expenses increased 8% to $52.0 million for the three month period
ended September 30, 2022 from $48.1 million for the same period in 2021, and
increased 5% to $151.3 million for the nine month period ended September 30,
2022 from $144.4 million in the same period in 2021. For both the three and nine
month periods, the change was primarily driven by an increase in direct clinical
study costs, preclinical costs associated with the design of future trials, and
costs associated with regulatory affairs.

Sales and marketing expenses. Sales and marketing expenses increased 27% to
$41.4 million for the three months ended September 30, 2022 from $32.6 million
for the same period in 2021, and increased 26% to $124.0 million for the nine
month period ended September 30, 2022 from $98.1 million for the same period in
2021. For the three and nine month period ended September 30, 2022, the change
was primarily due to an increase in market research and strategic planning
activities intended to enhance our commercial capabilities in anticipation of
potential future approvals in new indications, including NSCLC and ovarian
cancer. Additionally, we are investing in market access capabilities in order to
evaluate opportunities, identify optimal access pathways, and successfully gain
reimbursement in new geographies.

General and administrative expenses. General and administrative expenses
increased 4% to $32.5 million for the three months ended September 30, 2022 from
$31.2 million for the same period in 2021, and totaled $94.7 million for the
nine month period ended September 30, 2022, virtually unchanged from $95.1
million for the same period in 2021. For the three month period, the change was
primarily due to an increase in information technology and
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Investing in the supply chain to improve operational capabilities ahead of potential future launches in new indications.


                                       Three months ended September 30,                            Nine months ended September 30,
                                 2022              2021              % Change               2022               2021              % Change
Financial expenses (income),
net                          $  (1,194)         $  1,981                  (160) %       $    2,743          $  5,567                   (51) %


Financial expenses, net. Financial expenses decreased 160% to financial income
of $1.2 million for the three months ended September 30, 2022 from $2.0 million
for the same period in 2021, and decreased 51% to $2.7 for the nine months ended
September 30, 2022 from $5.6 for the same period in 2021. For the three and nine
month periods, the decrease was primarily due to increased interest income
partially offset by increased foreign exchange rate fluctuations. Foreign
exchange rate expenses increased to $2.5 million for the three months ended
September 30, 2022 from $0.9 million expenses for the same period in 2021, and
increased 272% to $7.7 million for the nine months ended September 30, 2022 from
$2.8 million for the same period in 2021.

                                         Three months ended September 30,                             Nine months ended September 30,
                                   2022               2021              % Change               2022               2021              % Change
Income taxes                   $    3,159          $  2,591                    22  %       $    5,943          $  5,391                    10  %


Income taxes. Income taxes increased 22% to $3.2 million for the three months
ended September 30, 2022 from $2.6 million for the same period in 2021, and was
increased by 10% to $5.9 million from $5.4 million for the nine months ended
September 30, 2022 compared to the same period in 2021. For the three and nine
months ended September 30, 2022 the increase reflects a change in the mix of
applicable statutory tax rates in active jurisdictions.

Non-GAAP Financial Measures


We also measure our performance using a non-GAAP measurement of earnings before
interest, taxes, depreciation, amortization and shared-based compensation
("Adjusted EBITDA"). We believe Adjusted EBITDA is useful to investors in
evaluating our operating performance because it helps investors evaluate and
compare the results of our operations from period to period by removing the
impact of earnings attributable to our capital structure, tax rate and material
non-cash items, specifically share-based compensation.

We calculate Adjusted EBITDA as operating income before financial expenses and
income taxes, net of depreciation, amortization and share-based compensation.
The following table reconciles net income (loss), which is the most directly
comparable GAAP operating performance measure, to Adjusted EBITDA.

                                          Three months ended September 30,                             Nine months ended September 30,
                                   2022                2021              % Change               2022                2021              % Change
Net income (loss)              $  (26,576)         $ (13,124)                  102  %       $  (55,231)         $ (31,893)                   73  %
Add: Income tax                     3,159              2,591                    22  %            5,943              5,391                    10  %
Add: Financial expenses
(income), net                      (1,194)             1,981                  (160) %            2,743              5,567                   (51) %
Add: Depreciation and
amortization                        2,659              2,734                    (3) %            7,924              7,584                     4  %
EBITDA                         $  (21,952)         $  (5,818)                  277  %       $  (38,621)         $ (13,351)                  189  %
Add: Share-based compensation      26,305             25,758                     2  %           77,173             72,502                     6  %
Adjusted EBITDA                $    4,353          $  19,940                   (78) %       $   38,552          $  59,151                   (35) %


Adjusted EBITDA decreased by 78% to $4.4 million for the three months ended
September 30, 2022 from $19.9 million for the same period in 2021, and decreased
by 35% to $38.6 million for the nine months ended September 30, 2022 from $59.2
million for the same period in 2021. The changes in both periods were primarily
due to a decrease in net income driven by increased investment in research,
development and clinical studies and sales and marketing intended to maximize
future growth opportunities.

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liquidity and capital resources

Since our inception in 2000, we have suffered significant losses and accumulated negative cash flows from operations 09/30/2022we had an accumulated deficit of $741.2 million. To date, we have funded our operations primarily through the issuance and sale of equity and the proceeds of long-term loans.


At September 30, 2022, we had $970.3 million in cash, cash equivalents and
short-term investments, an increase of $32.6 million compared to $937.7 million
at December 31, 2021. We believe our cash, cash equivalents and short-term
investments as of September 30, 2022 are sufficient for our operations for at
least the next 12 months based on our existing business plan and our ability to
control the timing of significant expense commitments. We expect that our
research, development and clinical study expenses, sales and marketing expenses
and general and administrative expenses will continue to increase over the next
several years and may outpace our gross profit. As a result, we may need to
raise additional capital to fund our operations.

The following summary of our cash flows for the periods shown is derived from our unaudited consolidated financial statements included elsewhere in this quarterly report:


                                             Nine months ended September 

30,

                                                 2022               2021              Change               % Change
Net cash provided by (used in) operating
activities                                   $  34,495          $  68,352          $  (33,857)                    (50) %
Net cash provided by (used in) investing
activities                                     (11,897)           354,256            (366,153)                   (103) %
Net cash provided by financing activities       12,081             22,050              (9,969)                    (45) %
Effect of exchange rate changes on cash and
cash equivalents                                  (252)              (139)               (113)                     81  %
Net increase (decrease) in cash, cash
equivalents and restricted cash              $  34,427          $ 444,519          $ (410,092)                    (92) %


operational activities. Net cash used or provided for operating activities represents our net income (loss) for the periods presented, stock-based compensation, and depreciation and amortization. Operating cash flow is also affected by changes in working capital.


Net cash provided by operating activities decreased by $33.9 million from $68.4
million net cash provided by operating activities for the nine months ended
September 30, 2021 to $34.5 million net cash provided by operating activities
for the nine months ended September 30, 2022. This decrease was a result of net
income decreasing by $23.3 million compared to the same period in 2021 and a
$12.2 million decrease in net cash provided by working capital, including a
$14.3 million decrease in accounts payables and accrued expenses, a $6.2 million
increase in inventories and a $4.2 million decrease in accounts receivables,
partially offset by a $1.6 million change in the mix from cash to non-cash based
expenses.

investment activity. Our investing activities consist primarily of investing in and redeeming our short-term investments and investing in property, plant and equipment.


Net cash used in investing activities was $11.9 million for the nine months
ended September 30, 2022, compared to $354.3 million provided by investing
activities for the nine months ended September 30, 2021. The net cash used in
investing activities for the nine months ended September 30, 2022 was primarily
attributable to $3.0 million of net proceeds from maturity of short-term
investments, offset by the purchase of $14.9 million of property and equipment.
The net cash provided by investing activities for the nine months ended
September 30, 2021 was primarily attributable to $364.2 million of net proceeds
from maturity of short-term investments, partially offset by the purchase of
$9.9 million of property and equipment.

Financing activities. To date, our primary financing activities have been the
sale of equity and the proceeds from long-term loans. Net cash provided by
financing activities was $12.1 million for the nine months ended September 30,
2022, as compared to $22.1 million provided by financing activities for the nine
months ended September 30, 2021. The net cash provided by financing activities
for the nine months ended September 30, 2022 and September 30, 2021 included
proceeds from the issuance of shares as well as proceeds from the exercise of
options under the Company's employee stock purchase plan and stock option plan.
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Table of Contents

Convertible Notes


On November 5, 2020, we issued $575.0 million aggregate principal amount of 0%
Convertible Senior Notes due 2025 (the "Notes"). The Notes are senior unsecured
obligations. The Notes do not bear regular interest, and the principal amount of
the Notes will not accrete. The Notes are convertible at an initial conversion
rate of 5.9439 ordinary shares per $1,000 principal amount of the Notes, which
is equivalent to an initial conversion price of approximately $168.24 per
ordinary share. The Notes are convertible at the option of the holders upon the
satisfaction of certain other conditions and during certain periods, and if the
Company exercises its right to redeem the Notes as permitted or required by the
indenture. On or after August 1, 2025 until the close of the business on the
business day immediately preceding the maturity date, holders may convert all or
any portion of their Notes at the conversion rate at any time irrespective of
the foregoing conditions.

In January 2021, we irrevocably elected to settle all conversions of Notes by a
combination of cash and our ordinary shares and that the cash portion per $1,000
principal amount of Notes for all conversion settlements shall be $1,000.
Accordingly, from and after the date of the election, upon conversion of any
Notes, holders of Notes will receive, with respect to each $1,000 principal
amount of Notes converted, cash in an amount up to $1,000 and the balance of the
conversion value, if any, in our ordinary shares

See Note 10a for more information. to the consolidated financial statements 2021 10-K.


Term loan credit facility

On November 6, 2020, we entered into a new three-year $150.0 million senior
secured revolving credit facility with a syndicate of relationship banks (the
"2020 Credit Facility"). We may, subject to certain conditions and limitations,
increase the revolving credit commitments outstanding under the 2020 Credit
Facility or incur new incremental term loans in an aggregate principal amount
not to exceed an additional $100.0 million.

The commitments under the 2020 Credit Facility are guaranteed by certain of our
subsidiaries and secured by a first lien on our and certain of our subsidiaries'
assets. Outstanding loans bear interest per annum at a sliding scale based on
the our secured leverage ratio from 2.75% to 3.25% above the applicable
interbank borrowing reference rate for the currency in which the loan is
denominated. Additionally, the 2020 Credit Facility contains a fee for the
unused revolving credit commitments at a sliding scale based on our secured
leverage ratio from 0.35% to 0.45%. The 2020 Credit Facility contains financial
covenants requiring maintenance of a minimum fixed charge coverage ratio and
specifying a maximum senior secured net leverage ratio, as well as customary
events of default which include a change of control. As of September 30, 2022,
we were in compliance with such covenants.

away 09/30/2022we had no outstanding amount borrowed under the 2020 Credit Facility.

Contractual Obligations and Commitments

There were no material changes from the information published in our 2021 10-K.

Off-Balance Sheet Arrangements


We did not have during the periods presented, and we do not currently have, any
off-balance sheet arrangements as defined under U.S. Securities and Exchange
Commission ("SEC") rules.

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