UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended SeptemberJune 30, 2017

2023

or

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from                       to

Commission File Number 001-37565

NovoCure Limited

(Exact Name of Registrant as Specified in Its Charter)

Jersey

98-1057807

Jersey

98-1057807
(State or Other Jurisdiction of

(I.R.S. Employer

Incorporation or Organization)

Identification No.)

Le Masurier House

La Rue Le Masurier

No. 4 The Forum
Grenville Street
St. Helier, Jersey JE2 4YE

4UF

(Address of principal executive offices)

offices, including zip code)

+44 (0) 15 3475 6700

(Registrant’s Telephone Number, Including Area Code)

Not Applicable

(Former Name, Former Address and Former Fiscal Year, If Changed Since Last Report)

Securities registered pursuant to Section 12(b) of the Securities Exchange Act of 1934:
Title of each classTrading Symbol(s)Name of each exchange on which registered
Ordinary Shares, no par valueNVCRThe Nasdaq Stock Market LLC
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports) and (2) has been subject to such filing requirements for the past 90 days. Yes No .

☐.

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes     No  .

☐.

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act. (Check one):

Large accelerated filer

Accelerated filer

Non-accelerated filer

  (Do not check if a smaller reporting company)

Smaller reporting company

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  

☐    

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes      No  .

☒.

Indicate the number of shares outstanding of each of the registrant’sissuer’s classes of common stock, as of the latest practicable date.

Class

ClassOutstanding as of October 19, 2017

July 21, 2023

Ordinary shares, no par value

89,363,835106,615,874 Shares





CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

In addition to historical facts or statements of current condition, this report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements contained in this report are based on our current plans, expectations, hopes, beliefs, intentions or strategies concerning future developments and their impact on us. Forward-looking statements contained in this report constitute our expectations or forecasts of future events as of the date this report was filed with the Securities and Exchange Commission (the “SEC”) and are not statements of historical fact. You can identify these statements by the fact that they do not relate strictly to historical or current facts. Such statements may include words such as “anticipate,” “will,” “estimate,” “expect,” “project,” “intend,” “should,” “plan,” “believe,” “hope,”“hope” and other words and terms of similar meaning in connection with any discussion of, among other things, future operating or financial performance, strategic initiatives and business strategies, regulatory or competitive environments, our intellectual property and delivery system research and development.development related to our Tumor Treating Fields devices marketed under various brand names, including Optune and Optune Lua, and software and systems to support and optimize the delivery of Tumor Treating Fields (collectively, our “Products”). In particular, these forward-looking statements include, among others, statements about:

our research and development, clinical trialstudy and commercialization activities and projected expenditures;

the further commercialization of Optune®, our first Tumor Treating Fields (“TTFields”) delivery system,Products for current and our other TTFields delivery system candidates;

future indications;

our business strategies and the expansion of our sales and marketing efforts in the United States and in other countries;

efforts;

the market acceptance of Optuneour Products for current and our other TTFields delivery systemsfuture indications by patients, physicians, third-party payers and others in the healthcare and scientific community;

our plans to pursue the use of TTFieldsour Products for the treatment of other solid tumor cancers;

cancers other than glioblastoma multiforme (“GBM”) and malignant pleural mesothelioma (“MPM”);

our estimates regarding revenues, expenses, capital requirements and needs for additional financing;

our ability to obtain regulatory approvals for additionalthe use of our Products in indications other than GBM and any future TTFields delivery systems;

MPM;

our ability to acquire from third-party suppliers the supplies needed to manufacture our TTFields delivery systems from third-party suppliers;

Products;

our ability to manufacture adequate supply;

supply of our Products;

our ability to secure and maintain adequate coverage from third-party payers to reimburse us for Optune orour Products for current and future TTFields delivery systems;

indications;

our ability to receive payment from third-party payers for use of our Products for current and future indications;

our ability to obtain, maintain, and develop protect, defend or enforce our intellectual property position;

our ability to manage the risks associated with business disruptions caused by natural disasters, extreme weather events, pandemics such as the COVID-19 pandemic, including the emergence of variant strains, or international conflict and other disruptions outside of our control;

our cash needs;

and

our ongoing legal proceedings and tax audits; and

our prospects, financial condition and results of operations.

These forward-looking statements involve a number of risks and uncertainties (some of which are beyond our control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. Should one or more of these risks or uncertainties materialize, or should any of our assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-lookingforward-looking statements. Factors which may cause such differences to occur include those risks and uncertainties set forth under Part I, Item 1A., “Risk Factors” ofin our Annual Report on Form 10-K for the fiscal year ended December 31, 2016,2022 filed on February 23, 2023, as well as other risks and uncertainties set forth from time to time in the reports we file with the U.S. Securities and Exchange Commission.SEC. In our prior filings, references to NovoTTF-100L now refer to Optune Lua. We do not intend to update publicly any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

i


TRADEMARKS

This Quarterly Report on Form 10-Q includes trademarks of NovoCure Limited and other persons. All trademarks or trade names referred to herein are the property of their respective owners.

ii


NovoCure Limited

Quarterly Report on Form 10-Q

TABLE OF CONTENTS

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1 -


PART I—FINANCIALFINANCIAL INFORMATION

Item 1.  Financial Statements

NOVOCURE LIMITED AND SUBSIDIARIES

NOVOCURE LIMITED AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands (except share data)
June 30,
2023
December 31, 2022
UnauditedAudited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents$156,978 $115,326 
Short-term investments783,837 854,099 
Restricted cash516 508 
Trade receivables, net70,988 86,261 
Receivables and prepaid expenses20,148 25,959 
Inventories33,023 29,376 
Total current assets1,065,490 1,111,529 
LONG-TERM ASSETS:
Property and equipment, net41,156 32,678 
Field equipment, net11,519 12,684 
Right-of-use assets26,278 23,596 
Other long-term assets14,572 11,161 
Total long-term assets93,525 80,119 
TOTAL ASSETS$1,159,015 $1,191,648 
The accompanying notes are an integral part of these unaudited consolidated financial statements.
2

Table of ContentsCONSOLIDATED BALANCE SHEETS

U.S. dollars in thousands

 

 

September 30,

 

 

December 31,

 

 

 

2017

 

 

2016

 

 

 

Unaudited

 

 

Audited

 

ASSETS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CURRENT ASSETS:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

82,104

 

 

$

99,780

 

Short-term investments

 

 

104,453

 

 

 

119,854

 

Restricted cash

 

 

2,129

 

 

 

267

 

Trade receivables

 

 

23,000

 

 

 

6,339

 

Receivables and prepaid expenses

 

 

5,559

 

 

 

10,084

 

Inventories

 

 

24,642

 

 

 

25,549

 

Total current assets

 

 

241,887

 

 

 

261,873

 

 

 

 

 

 

 

 

 

 

LONG-TERM ASSETS:

 

 

 

 

 

 

 

 

Property and equipment, net

 

 

9,361

 

 

 

9,812

 

Field equipment, net

 

 

8,948

 

 

 

8,808

 

Severance pay fund

 

 

104

 

 

 

88

 

Other long-term assets

 

 

1,978

 

 

 

1,500

 

Total long-term assets

 

 

20,391

 

 

 

20,208

 

 

 

 

 

 

 

 

 

 

TOTAL ASSETS

 

$

262,278

 

 

$

282,081

 

NOVOCURE LIMITED AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands (except share data)
June 30,
2023
December 31, 2022
UnauditedAudited
LIABILITIES AND SHAREHOLDERS' EQUITY
CURRENT LIABILITIES:
Trade payables$82,536 $85,197 
Other payables, lease liabilities and accrued expenses67,551 73,580 
Total current liabilities150,087 158,777 
LONG-TERM LIABILITIES:
Long-term debt, net567,150 565,509 
Deferred revenues807 2,878 
Long-term leases20,329 18,762 
Employee benefit liabilities4,840 4,404 
Other long-term liabilities119 148 
Total long-term liabilities593,245 591,701 
TOTAL LIABILITIES743,332 750,478 
COMMITMENTS AND CONTINGENCIES
SHAREHOLDERS' EQUITY:
Share capital -
Ordinary shares no par value, unlimited shares authorized; issued and outstanding:
106,605,331 shares and 105,049,411 shares at June 30, 2023 (unaudited) and December 31, 2022, respectively
— — 
Additional paid-in capital1,306,603 1,222,063 
Accumulated other comprehensive income (loss)(1,981)(2,433)
Retained earnings (accumulated deficit)(888,939)(778,460)
TOTAL SHAREHOLDERS' EQUITY415,683 441,170 
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY$1,159,015 $1,191,648 

The accompanying notes are an integral part of these unaudited consolidated financial statements.

- 2 -

3

Table of ContentsNOVOCURE LIMITED AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

U.S. dollars in thousands (except share data)

 

 

September 30,

 

 

December 31,

 

 

 

2017

 

 

2016

 

 

 

Unaudited

 

 

Audited

 

LIABILITIES AND SHAREHOLDERS' EQUITY

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CURRENT LIABILITIES:

 

 

 

 

 

 

 

 

Trade payables

 

$

14,143

 

 

$

18,356

 

Other payables and accrued expenses

 

 

26,842

 

 

 

18,526

 

Total current liabilities

 

 

40,985

 

 

 

36,882

 

 

 

 

 

 

 

 

 

 

LONG-TERM LIABILITIES:

 

 

 

 

 

 

 

 

Long-term loan, net of discount and issuance costs

 

 

97,049

 

 

 

96,231

 

Employee benefit liabilities

 

 

2,489

 

 

 

2,590

 

Other long-term liabilities

 

 

5,070

 

 

 

4,033

 

Total long-term liabilities

 

 

104,608

 

 

 

102,854

 

 

 

 

 

 

 

 

 

 

TOTAL LIABILITIES

 

 

145,593

 

 

 

139,736

 

 

 

 

 

 

 

 

 

 

COMMITMENTS AND CONTINGENCIES

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SHAREHOLDERS' EQUITY:

 

 

 

 

 

 

 

 

Share capital -

 

 

-

 

 

 

-

 

Ordinary shares no par value, unlimited shares authorized; issued and outstanding:

   89,355,679 shares and 87,066,446 shares at September 30, 2017 (unaudited)  and

   December 31, 2016, respectively

 

 

 

 

 

 

 

 

Additional paid-in capital

 

 

689,460

 

 

 

664,154

 

Accumulated other comprehensive loss

 

 

(1,462

)

 

 

(1,883

)

Accumulated deficit

 

 

(571,313

)

 

 

(519,926

)

Total shareholders' equity

 

 

116,685

 

 

 

142,345

 

 

 

 

 

 

 

 

 

 

TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY

 

$

262,278

 

 

$

282,081

 

NOVOCURE LIMITED AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
U.S. dollars in thousands (except share and per share data)
Three months ended June 30,Six months ended June 30,Year ended December 31,
20232022202320222022
UnauditedUnauditedAudited
Net revenues$126,051 $140,866 $248,233 $278,413 $537,840 
Cost of revenues34,018 28,503 63,632 56,230 114,867 
Gross profit92,033 112,363 184,601 222,183 422,973 
Operating costs and expenses:
Research, development and clinical studies55,427 57,075 115,131 99,309 206,085 
Sales and marketing58,488 44,750 109,657 82,634 173,658 
General and administrative40,778 31,666 82,722 62,174 132,753 
Total operating costs and expenses154,693 133,491 307,510 244,117 512,496 
Operating income (loss)(62,660)(21,128)(122,909)(21,934)(89,523)
Financial income (expenses), net8,756 (2,228)17,925 (3,937)7,677 
Income (loss) before income tax(53,904)(23,356)(104,984)(25,871)(81,846)
Income tax3,514 652 5,495 2,784 10,688 
Net income (loss)$(57,418)$(24,008)$(110,479)$(28,655)$(92,534)
Basic and diluted net income (loss) per ordinary share$(0.54)$(0.23)$(1.04)$(0.27)$(0.88)
Weighted average number of ordinary shares used in computing basic and diluted net income (loss) per share106,289,073 104,627,789 105,979,791 104,408,164 104,660,476 

The accompanying notes are an integral part of these unaudited consolidated financial statements.

- 3 -

4

Table of ContentsNOVOCURE LIMITED AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
U.S. dollars in thousands
Three months ended June 30,Six months ended June 30,Year ended December 31,
20232022202320222022
UnauditedUnauditedAudited
Net income (loss)$(57,418)$(24,008)$(110,479)$(28,655)$(92,534)
Other comprehensive income (loss), net of tax:
Change in foreign currency translation adjustments529 680 829 1,010 1,425 
Unrealized gain (loss) from debt securities68 (769)425 (769)(445)
Pension benefit plan113 (678)(802)833 (244)
Total comprehensive income (loss)$(56,708)$(24,775)$(110,027)$(27,581)$(91,798)

NOVOCURE LIMITED AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY
U.S. dollars in thousands (except share data)
Ordinary sharesAdditional
paid-in
capital
Accumulated
other
comprehensive
loss
Retained earnings (accumulated
deficit)
Total shareholders'
equity
Balance as of December 31, 2022 (audited)105,049,411 $1,222,063 $(2,433)$(778,460)$441,170 
Share-based compensation to employees— 39,084 — — 39,084 
Exercise of options and vested RSUs1,137,751 5,211 — — 5,211 
Other comprehensive income (loss), net of tax benefit of $0— — (258)— (258)
Net income (loss)— — — (53,061)(53,061)
Balance as of March 31, 2023 (Unaudited)106,187,162 $1,266,358 $(2,691)$(831,521)$432,146 
Share-based compensation to employees— 32,740 — — 32,740 
Proceeds from issuance of shares81,730 2,883 — — 2,883 
Exercise of options and vested RSUs336,439 4,622 — 4,622 
Other comprehensive income (loss), net of tax benefit of $0— — 710 — 710 
Net income (loss)— — — (57,418)(57,418)
Balance as of June 30, 2023 (Unaudited)106,605,331 $1,306,603 $(1,981)$(888,939)$415,683 



5

Table of ContentsCONSOLIDATED STATEMENTS OF OPERATIONS

U.S. dollars in thousands (except share and per share data)

 

 

Three months ended September 30,

 

 

Nine months ended September 30,

 

 

Year ended

December 31,

 

 

 

2017

 

 

2016

 

 

2017

 

 

2016

 

 

2016

 

 

 

Unaudited

 

 

Unaudited

 

 

Audited

 

Net revenues

 

$

50,109

 

 

$

21,674

 

 

$

123,365

 

 

$

52,646

 

 

$

82,888

 

Cost of revenues

 

 

15,153

 

 

 

11,118

 

 

 

39,969

 

 

 

28,897

 

 

 

39,870

 

Impairment of field equipment

 

 

-

 

 

 

-

 

 

 

-

 

 

 

6,412

 

 

 

6,412

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Gross profit

 

 

34,956

 

 

 

10,556

 

 

 

83,396

 

 

 

17,337

 

 

 

36,606

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating costs and expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research, development and clinical trials

 

 

9,273

 

 

 

10,233

 

 

 

28,055

 

 

 

32,996

 

 

 

41,467

 

Sales and marketing

 

 

16,387

 

 

 

15,865

 

 

 

47,503

 

 

 

43,771

 

 

 

59,449

 

General and administrative

 

 

15,215

 

 

 

12,723

 

 

 

42,660

 

 

 

38,010

 

 

 

51,007

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total operating costs and expenses

 

 

40,875

 

 

 

38,821

 

 

 

118,218

 

 

 

114,777

 

 

 

151,923

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating loss

 

 

(5,919

)

 

 

(28,265

)

 

 

(34,822

)

 

 

(97,440

)

 

 

(115,317

)

Financial expenses, net

 

 

2,156

 

 

 

2,189

 

 

 

6,785

 

 

 

3,293

 

 

 

6,147

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss before income tax expense

 

 

(8,075

)

 

 

(30,454

)

 

 

(41,607

)

 

 

(100,733

)

 

 

(121,464

)

Income tax expense

 

 

3,423

 

 

 

3,174

 

 

 

9,110

 

 

 

8,944

 

 

 

10,381

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(11,498

)

 

$

(33,628

)

 

$

(50,717

)

 

$

(109,677

)

 

$

(131,845

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted net loss per ordinary share

 

$

(0.13

)

 

$

(0.39

)

 

$

(0.57

)

 

$

(1.29

)

 

$

(1.54

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average number of ordinary shares used in

   computing basic and diluted net loss per share

 

 

89,125,646

 

 

 

85,774,874

 

 

 

88,265,835

 

 

 

85,153,644

 

 

 

85,558,448

 

Ordinary sharesAdditional
paid-in
capital
Accumulated
other
comprehensive
loss
Retained earnings (accumulated
deficit)
Total shareholders'
equity
Balance as of December 31, 2021 (audited)103,971,263 $1,099,589 $(3,169)$(685,926)$410,494 
Share-based compensation to employees— 25,045 — — 25,045 
Exercise of options and vested RSUs587,825 3,148 — — 3,148 
Other comprehensive income (loss), net of tax benefit of $0— — 1,841 — 1,841 
Net income (loss)— — — (4,647)(4,647)
Balance as of March 31, 2022 (Unaudited)104,559,088 $1,127,782 $(1,328)$(690,573)$435,881 
Share-based compensation to employees— 25,823 — — 25,823 
Proceeds from issuance of shares46,709 2,759 — — 2,759 
Exercise of options and vested RSUs121,888 1,984 — — 1,984 
Other comprehensive income (loss), net of tax benefit of $0— (767)— (767)
Net income (loss)— — (24,008)(24,008)
Balance as of June 30, 2022 (Unaudited)104,727,685 $1,158,348 $(2,095)$(714,581)$441,672 

CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)

U.S. dollars in thousands

 

 

Three months ended September 30,

 

 

Nine months ended September 30,

 

 

Year ended

December 31,

 

 

 

2017

 

 

2016

 

 

2017

 

 

2016

 

 

2016

 

 

 

Unaudited

 

 

Unaudited

 

 

Audited

 

Net loss

 

$

(11,498

)

 

$

(33,628

)

 

$

(50,717

)

 

$

(109,677

)

 

$

(131,845

)

Other comprehensive income (loss), net of tax :

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Change in foreign currency translation adjustments

 

 

(2

)

 

 

8

 

 

 

8

 

 

 

64

 

 

 

10

 

Pension benefit plan

 

 

279

 

 

 

(409

)

 

 

413

 

 

 

(644

)

 

 

(388

)

Total comprehensive loss

 

$

(11,221

)

 

$

(34,029

)

 

$

(50,296

)

 

 

(110,257

)

 

$

(132,223

)


The accompanying notes are an integral part of these unaudited consolidated financial statements.

- 4 -

6

Table of ContentsNOVOCURE LIMITED AND SUBSIDIARIES

NOVOCURE LIMITED AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
U.S. dollars in thousands
 Three months ended June 30,Six months ended June 30,Year ended December 31,
20232022202320222022
UnauditedUnauditedAudited
Cash flows from operating activities:
Net income (loss)$(57,418)$(24,008)$(110,479)$(28,655)$(92,534)
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:
Depreciation and amortization2,721 2,654 5,443 5,264 10,624 
Accrued Interest1,170 (602)50 (823)(2,216)
Asset write-downs and impairment of field equipment136 216 262 351 955 
Share-based compensation32,740 25,823 71,824 50,868 106,955 
Foreign currency remeasurement loss (gain)914 943 787 1,192 (3,256)
Decrease (increase) in accounts receivables6,941 2,257 21,452 (5,204)2,547 
Amortization of discount (premium)(5,075)827 (9,131)1,511 (1,536)
Decrease (increase) in inventories(1,452)(209)(4,170)(5,013)(4,342)
Decrease (increase) in other long-term assets(1,920)2,356 (386)4,219 7,107 
Increase (decrease) in accounts payables and accrued expenses207 7,649 (10,257)(7,160)14,257 
Increase (decrease) in other long-term liabilities(1,701)(2,144)(4,859)(4,475)(7,773)
Net cash provided by (used in) operating activities$(22,737)$15,762 (39,464)12,075 30,788 
Cash flows from investing activities:
Purchase of property, equipment and field equipment$(6,931)$(4,131)(13,019)(9,224)(21,358)
Proceeds from maturity of short-term investments314,597 437,034 640,884 716,034 1,179,289 
Purchase of short-term investments(321,563)(277,146)(559,475)(568,463)(1,297,888)
Net cash provided by (used in) investing activities$(13,897)$155,757 68,390 138,347 (139,957)
Cash flows from financing activities:
Proceeds from issuance of shares, net$2,883 $2,759 2,883 2,759 5,224 
Repayment of long-term debt(3)(7)(10)(14)(28)
Exercise of options4,622 1,984 9,833 5,132 10,295 
Net cash provided by (used in) financing activities$7,502 $4,736 12,706 7,877 15,491 
Effect of exchange rate changes on cash, cash equivalents and restricted cash$(13)$(120)28 (145)(97)
Increase (decrease) in cash, cash equivalents and restricted cash(29,145)176,135 41,660 158,154 (93,775)
Cash, cash equivalents and restricted cash at the beginning of the period186,639 191,628 115,834 209,609 209,609 
Cash, cash equivalents and restricted cash at the end of the period$157,494 $367,763 $157,494 $367,763 $115,834 
7

Table of ContentsCONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY

U.S. dollars in thousands (except share data)

 

 

Ordinary shares

 

 

 

Additional

paid-in

 

 

Accumulated

other

comprehensive

 

 

Accumulated

 

 

Total shareholders'

 

 

 

Shares

 

 

 

capital

 

 

loss

 

 

deficit

 

 

equity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance as of December 31, 2015 (audited)

 

 

83,778,581

 

 

 

$

640,406

 

 

$

(1,505

)

 

$

(388,081

)

 

$

250,820

 

Share-based compensation to employees

 

 

-

 

 

 

 

21,441

 

 

 

-

 

 

 

-

 

 

 

21,441

 

Exercise of options and warrants

 

 

3,195,477

 

 

 

 

993

 

 

 

-

 

 

 

-

 

 

 

993

 

Issuance of shares in connection with employee stock

   purchase plan

 

 

92,388

 

 

 

 

616

 

 

 

-

 

 

 

-

 

 

 

616

 

Tax benefit from share-based award activity

 

 

-

 

 

 

 

698

 

 

 

-

 

 

 

-

 

 

 

698

 

Other comprehensive loss, net of tax benefit of $38

 

 

-

 

 

 

 

-

 

 

 

(378

)

 

 

-

 

 

 

(378

)

Net loss

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

(131,845

)

 

 

(131,845

)

Balance as of December 31, 2016 (audited)

 

 

87,066,446

 

 

 

$

664,154

 

 

$

(1,883

)

 

$

(519,926

)

 

$

142,345

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Share-based compensation to employees

 

 

-

 

 

 

 

20,760

 

 

 

-

 

 

 

-

 

 

 

20,760

 

Exercise of options and warrants

 

 

2,172,266

 

 

 

 

3,095

 

 

 

-

 

 

 

-

 

 

 

3,095

 

Cumulative effect adjustment resulting from ASU

   2016-09 adoption (see Note 1)

 

 

-

 

 

 

 

670

 

 

 

-

 

 

 

(670

)

 

 

-

 

Issuance of shares in connection with employee stock

   purchase plan

 

 

116,967

 

 

 

 

781

 

 

 

-

 

 

 

-

 

 

 

781

 

Other comprehensive income, net of tax benefit of $57

 

 

-

 

 

 

 

-

 

 

 

421

 

 

 

-

 

 

 

421

 

Net loss

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

(50,717

)

 

 

(50,717

)

Balance as of September 30, 2017 (unaudited)

 

 

89,355,679

 

 

 

$

689,460

 

 

$

(1,462

)

 

$

(571,313

)

 

$

116,685

 

NOVOCURE LIMITED AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
U.S. dollars in thousands
Supplemental cash flow activities:
Cash paid during the period for:
Income taxes paid (refunded), net$5,831 $1,854 $7,543 $3,027 $5,480 
Interest paid$— $$$$41 
Non-cash activities:
Right-of-use assets obtained in exchange for lease liabilities$2,333 $279 $5,784 $3,859 $12,117 

The accompanying notes are an integral part of these unaudited consolidated financial statements.

- 5 -

8

NOVOCURE LIMITED AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

U.S. dollars in thousands

 

 

Three months ended September 30,

 

 

Nine months ended September 30,

 

 

Year ended

December 31,

 

 

 

2017

 

 

2016

 

 

2017

 

 

2016

 

 

2016

 

 

 

Unaudited

 

 

Unaudited

 

 

Audited

 

Cash flows from operating activities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(11,498

)

 

$

(33,628

)

 

$

(50,717

)

 

$

(109,677

)

 

$

(131,845

)

Adjustments to reconcile net loss to net cash provided by

   (used in) operating activities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Depreciation and amortization

 

 

2,053

 

 

 

1,553

 

 

 

5,524

 

 

 

4,063

 

 

 

5,652

 

Asset write-downs and impairment of field equipment

 

 

72

 

 

 

10

 

 

 

206

 

 

 

6,440

 

 

 

6,446

 

Increase in accrued interest expense

 

 

-

 

 

 

222

 

 

 

-

 

 

 

222

 

 

 

-

 

Share-based compensation to employees

 

 

8,629

 

 

 

5,626

 

 

 

20,760

 

 

 

16,719

 

 

 

22,139

 

Excess tax benefits from share-based award activity

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(698

)

Increase in trade receivables

 

 

(9,112

)

 

 

-

 

 

 

(16,661

)

 

 

-

 

 

 

(6,339

)

Amortization of discount

 

 

17

 

 

 

81

 

 

 

226

 

 

 

25

 

 

 

155

 

Decrease (increase) in receivables and prepaid expenses

 

 

5,986

 

 

 

694

 

 

 

4,525

 

 

 

(1,514

)

 

 

243

 

Decrease (increase) in inventories

 

 

504

 

 

 

(2,757

)

 

 

907

 

 

 

(10,378

)

 

 

(11,955

)

Increase in other long-term assets

 

 

(238

)

 

 

(526

)

 

 

(532

)

 

 

(804

)

 

 

(692

)

Increase (decrease) in trade payables

 

 

983

 

 

 

(6,765

)

 

 

(4,213

)

 

 

(2,621

)

 

 

1,601

 

Increase in other payables and accrued expenses

 

 

4,830

 

 

 

1,651

 

 

 

8,308

 

 

 

2,407

 

 

 

6,647

 

Increase in employee benefit liabilities, net

 

 

113

 

 

 

80

 

 

 

352

 

 

 

350

 

 

 

97

 

Increase in other long-term liabilities

 

 

208

 

 

 

263

 

 

 

1,079

 

 

 

901

 

 

 

957

 

Net cash provided by (used in) operating activities

 

$

2,547

 

 

$

(33,496

)

 

$

(30,236

)

 

$

(93,867

)

 

$

(107,592

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash flows from investing activities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Purchase of property and equipment

 

$

(544

)

 

$

(1,715

)

 

$

(1,951

)

 

$

(5,055

)

 

$

(5,674

)

Purchase of field equipment

 

 

(1,208

)

 

 

(3,113

)

 

 

(3,469

)

 

 

(9,213

)

 

 

(11,990

)

Decrease (increase) in restricted cash

 

 

(592

)

 

 

27

 

 

 

(1,861

)

 

 

15

 

 

 

(180

)

Proceeds from maturity of short-term investments

 

 

-

 

 

 

120,000

 

 

 

120,000

 

 

 

270,000

 

 

 

270,000

 

Purchase of short-term investments

 

 

-

 

 

 

(119,613

)

 

 

(104,006

)

 

 

(239,341

)

 

 

(239,341

)

Net cash provided by (used in) investing activities

 

$

(2,344

)

 

$

(4,414

)

 

$

8,713

 

 

$

16,406

 

 

$

12,815

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash flows from financing activities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Proceeds from issuance of shares, net

 

$

-

 

 

$

-

 

 

$

781

 

 

$

-

 

 

$

616

 

Proceeds from long-term loan, net

 

 

-

 

 

 

72,870

 

 

 

19

 

 

 

72,887

 

 

 

72,887

 

Excess tax benefits from share-based award activity

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

698

 

Repayment of other long-term loan

 

 

(19

)

 

 

(17

)

 

 

(56

)

 

 

(52

)

 

 

(70

)

Exercise of options and warrants

 

 

1,732

 

 

 

-

 

 

 

3,095

 

 

 

961

 

 

 

993

 

Net cash provided by financing activities

 

$

1,713

 

 

$

72,853

 

 

$

3,839

 

 

$

73,796

 

 

$

75,124

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Effect of exchange rate changes on cash and cash equivalents

 

$

(2

)

 

$

8

 

 

$

8

 

 

$

64

 

 

$

10

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Increase (decrease) in cash and cash equivalents

 

 

1,914

 

 

 

34,951

 

 

 

(17,676

)

 

 

(3,601

)

 

 

(19,643

)

Cash and cash equivalents at the beginning of the period

 

 

80,190

 

 

 

80,871

 

 

 

99,780

 

 

 

119,423

 

 

 

119,423

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents at the end of the period

 

$

82,104

 

 

$

115,822

 

 

$

82,104

 

 

$

115,822

 

 

$

99,780

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Supplemental cash flow activities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash paid during the period for:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Income taxes

 

$

2,335

 

 

$

4,624

 

 

$

7,237

 

 

$

7,793

 

 

$

9,447

 

Interest

 

$

2,561

 

 

$

1,880

 

 

$

7,603

 

 

$

3,813

 

 

$

6,595

 

The accompanying notes are an integral part of these unaudited consolidated financial statements.

- 6 -


NOVOCURE LIMITED AND SUBSIDIARIES

NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS

U.S. dollars in thousands (except share data)

NOTE 1: ORGANIZATION AND BASIS OF PRESENTATION

Organization. NovoCure Limited (including its consolidated subsidiaries, the “Company”"Company") was incorporated in the Bailiwick of Jersey and is principally engaged in the development, manufacture and commercialization of Tumor Treating Fields (“TTFields”("TTFields") devices, including Optune and Optune Lua (collectively, our "Products"), for the treatment of solid tumors.tumor cancers. The Company markets Optune and Optune Lua in multiple countries around the globe with the majority of revenues coming from the use of Optune in the U.S., Germany and Japan. The Company also has regulatory approvalsa License and clearancesCollaboration Agreement (the "Zai Agreement") with Zai Lab (Shanghai) Co., Ltd. ("Zai") to market Optune in certain countries for Optune, its first TTFields delivery system, to treat adult patients with glioblastoma (“GBM”China, Hong Kong, Macau and Taiwan ("Greater China").

Financial statement preparation. The accompanying unaudited consolidated financial statements include the accounts of the Company and its consolidated subsidiaries, and intercompany accounts and transactions have been eliminated. In the opinion of the Company’s management, the unaudited consolidated financial statements reflect all adjustments, which are normal and recurring in nature, necessary for fair financial statement presentation.presentation for the periods presented. The preparation of these unaudited consolidated financial statements in conformity with U.S. generally accepted accounting principles (“GAAP”("GAAP") requires management to make estimates and assumptions that affect the amounts reported in these unaudited consolidated financial statements and accompanying notes. Actual results could differ materially from those estimates. These unaudited consolidated financial statements and accompanying notes should be read in conjunction with the Company’s annual consolidated financial statements and the notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 20162022 (the “2016 10-K”"2022 10-K") filed with the Securities and Exchange Commission (the “SEC”) on February 23, 2017.

2023.

The significant accounting policies applied in the audited annual consolidated financial statements of the Company as disclosed in the 20162022 10-K are applied consistently in these unaudited interim consolidated financial statements, exceptstatements.
9

NOTE 2: CASH, CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS
Cash equivalents include items almost as noted below:

Recently Adopted Accounting Pronouncements. liquid as cash, with maturity periods of three months or less when purchased, and short-term investments include items with maturity dates between three months and one year when purchased. As of June 30, 2023 and December 31, 2022, the Company’s cash and cash equivalents and short-term investments were composed of:

June 30, 2023
Unaudited
Fair value levelAdjusted cost basisUnrealized gainsUnrealized lossesFair market valueRecorded basisCash and cash equivalentsShort-term investments
Cash$9,995 $— $— $9,995 $9,995 $9,995 $— 
Money market fundsLevel 1139,983 — — 139,983 139,983 139,983 — 
Certificate of deposits and term depositsLevel 2251,090 — — 251,090 251,090 7,000 244,090 
HTM securities (1)
U.S. Treasury billsLevel 1$140,031 $12 $(136)139,907 140,031 $— $140,031 
Government and governmental agenciesLevel 2$25,282 $$(60)25,223 25,282 $— $25,282 
Corporate debt securitiesLevel 2$374,434 $43 $(665)373,812 374,434 $— $374,434 
$539,747 $56 $(861)$538,942 $539,747 $— $539,747 
Total$940,815 $56 $(861)$940,010 $940,815 $156,978 $783,837 

December 31, 2022
Audited
Fair value levelAdjusted cost basisUnrealized gainsUnrealized lossesFair market valueRecorded basisCash and cash equivalentsShort-term investments
Cash$9,697 $— $— $9,697 $9,697 $9,697 $— 
Money market fundsLevel 1105,629 — — 105,629 105,629 105,629 — 
Certificate of deposits and term depositsLevel 2316,946 — — 316,946 316,946 — 316,946 
HTM securities (1)
U.S. Treasury billsLevel 1$188,030 $$(540)187,498 188,030 $— $188,030 
Government and governmental agenciesLevel 2$44,357 $12 $(12)44,357 44,357 $— $44,357 
Corporate debt securitiesLevel 2$304,766 $1,066 $(587)305,245 304,766 $— $304,766 
$537,153 $1,086 $(1,139)$537,100 $537,153 $— $537,153 
Total$969,425 $1,086 $(1,139)$969,372 $969,425 $115,326 $854,099 
10

(1) Changes in fair value of held-to-maturity ("HTM") securities are presented for disclosure purposes as required by ASC 320 "Investments — Debt Securities" and are recorded as finance expenses only if the unrealized loss is identified as a credit loss.
In March 2016,November 2022, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-09, Compensation-Stock Compensation (Topic 718): ImprovementsCompany transferred all of its available-for-sale portfolio to Employee Share-Based Payment Accounting. The amendments in ASU 2016-09 affect all entities that issue share-based payment awards to their employees and involve multiple aspectsHTM as part of the accounting for share-based payment transactions, including income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows. ASU 2016-09 is effective for annual periods beginning after December 15, 2016, and interim periods within those annual periods.  The Company adopted ASU 2016-09 during the quarter ended March 31, 2017,Company's investment strategy. Such transfers are made at which time it changed its accounting policy to account for forfeitures as they occur. The change was applied on a modified retrospective basis with a cumulative effect adjustment to accumulated deficit of $670 as of January 1, 2017. In addition, excess tax benefits for share-based payments are now presented as an operating activity in the statements of cash flows rather than financing activity. The changes have been applied prospectively in accordance with the ASU and prior periods have not been adjusted.

Recent Accounting Pronouncements. In May 2014, FASB issued ASU 2014-09, Revenue from Contracts with Customers (Topic 606) (ASU 2014-09), which amends the existing accounting standards for revenue recognition. In August 2015, the FASB issued ASU No. 2015-14, Revenue from Contracts with Customers (Topic 606): Deferral of the Effective Date, which delays the effective date of ASU 2014-09 by one year. The Company is currently evaluating the requirements of the new standard to insure that it has processes, systems and internal controls in place to collect the necessary information to implement the standard, which will be effective as of January 1, 2018.  Currently, the Company anticipates using a portfolio approach to apply the standard to portfolios of contracts with similar characteristics and anticipates that it will apply the cumulative catch-up transition method which requires the application of the provisions of the new standard as offair value at the date of adoption withtransfer. The net unrealized loss on these securities at the cumulative effectdate of transfer was $911. These securities continue to be reported in accumulated comprehensive income (loss) and are amortized over the remaining lives of the retrospective application of the provisionssecurities as an adjustment through retained earnings. Whileto the yield. As of June 30, 2023 and December 31, 2022, the unamortized unrealized loss balances were $20 and $445, respectively, and are reported in accumulated other comprehensive income (loss).

In accordance with ASC 820, "Fair Value Measurements and Disclosures," the Company measures its money market funds at fair value. The fair value of the money market funds and HTM securities, which is stillpresented for disclosure purposes, is classified within Level 1 or Level 2. This is because these assets are valued using quoted market prices or alternative pricing sources and models utilizing market observable inputs.
As of June 30, 2023 and December 31, 2022, all investments mature in the process of completing its assessment on the impact this guidance will have on its consolidated financial statements and related disclosures, theone year or less.
Unrealized losses from debt securities are primarily attributable to changes in interest rates. The Company does not anticipate that the adoption of this standard will have a material impact on its financial position, results of operations or cash flows.

In April 2016, FASB issued ASU 2016-10, Revenue from Contracts with Customers (Topic 606): Identifying Performance Obligations and Licensing. ASU 2016-10 covers two specific topics: performance obligations and licensing. This amendment includes guidance on immaterial promised goods or services, shipping or handling activities, separately identifiable performance obligations, functional or symbolic intellectual property licenses, sales-based and usage-based royalties, license restrictions (time, use, geographical) and licensing renewals. In addition, in May 2016, FASB issued ASU No. 2016-12, Revenue from Contracts with Customers (Topic 606): Narrow-Scope Improvements and Practical Expedients, which is intended to not change the core principle of the guidance in Topic 606, but rather affect only the narrow aspects of Topic 606 by reducing the potential for diversity in practice at initial application and by reducing the cost and complexity of applying Topic 606 both at transition and on an ongoing basis. The Company is currently evaluating the impact of the adoption of both revenue standards on its consolidated financial statements.

In February 2016, FASB issued ASU 2016-02-Leases (ASC 842), which sets out the principles for the recognition, measurement, presentation and disclosure of leases for both parties to a contract (i.e. lessees and lessors). The new standard requires lessees to apply

- 7 -


a dual approach, classifying leases as either finance or operating leasesbelieve any remaining unrealized losses represent impairments based on the principleevaluation of whether or not the lease is effectively a financed purchase by the lessee. This classification will determine whether lease expense is recognized based on an effective interest method or on a straight line basis over the term of the lease, respectively. A lessee is also required to record a right-of-use asset and a lease liability for all leases with a term of greater than twelve months regardless of their classification. Leases with a term of twelve months or less will be accounted for similar to existing guidance for operating leases. The new standard requires lessors to account for leases using an approach that is substantially equivalent to existing guidance for sales-type leases, direct financing leases and operating leases. ASC 842 supersedes the previous leases standard, ASC 840. The standard is effective on January 1, 2019, with early adoption permitted. The Company currently anticipates adopting the new standard effective January 1, 2019 and is evaluating the impact of the adoption of this standard on its consolidated financial statements.

In May 2017, FASB issued ASU 2017-09, Compensation-Stock Compensation (Topic 718) Scope of Modification Accounting. ASU 2017-09 provides clarification on when modification accounting should be used for changes to the terms or conditions of a share-based payment award. This ASU does not change the accounting for modifications but clarifies that modification accounting guidance should only be applied if there is a change to the value, vesting conditions, or award classification and would not be required if the changes are considered non-substantive. The Company is evaluating the impact of ASU 2017-09.

NOTE 2: SHORT-TERM INVESTMENTS

The Company invests in marketable U.S. Treasury Bills (“T-bills”) that are classified as held-to-maturity securities. The amortized cost and recorded basis of the T-bills are presented as short-term investments in the amount of $104,453 and $119,854 as of September 30, 2017 and December 31, 2016, respectively, and their estimated fair value as of September 30, 2017 and December 31, 2016 was $104,419 and $119,825, respectively.

available evidence.


NOTE 3: INVENTORIES

Inventories are stated at the lower of cost or market.net realizable value. The weighted average methodology is applied to determine cost. As of SeptemberJune 30, 20172023 and December 31, 2016,2022, the Company’s inventories were composed of:

June 30,
2023
December 31,
2022
 UnauditedAudited
Raw materials$6,431 $4,314 
Work in progress10,803 9,321 
Finished products15,789 15,741 
Total$33,023 $29,376 

 

 

September 30,

 

 

December 31,

 

 

 

2017

 

 

2016

 

 

 

Unaudited

 

 

Audited

 

Raw materials

 

$

5,936

 

 

$

5,243

 

Work in progress

 

 

10,621

 

 

 

8,292

 

Finished products

 

 

8,085

 

 

 

12,014

 

Total

 

$

24,642

 

 

$

25,549

 


NOTE 4: COMMITMENTS AND CONTINGENT LIABILITIES

Operating Leases. The facilities of the Company are leased under various operating lease agreements for periods, including options for extensions, ending no later than 2024.2044. The Company also leases motor vehicles under various operating leases, which expire on various dates, the latest of which is in 2020.

2026.

Pledged deposits and bank guarantees. As of SeptemberJune 30, 20172023 and December 31, 2016,2022, the Company pledged bank deposits of $1,051 $2,346and $807,$2,296, respectively, to cover bank guarantees in respect of its leases of operating facilities and obtained bank guarantees by the bank for the fulfillment of the Company’s lease and other contractual commitments of $1,212 $2,700and $955, respectively.

$2,459, respectively.

Senior secured revolving credit facility. On November 6, 2020, the Company entered into a three-year $150,000 senior secured revolving credit facility ("2020 Credit Facility") with a syndicate of relationship banks. On February 17, 2023, the Company gave irrevocable notice to the administrative agent under the 2020 Credit Facility that the Company terminated all commitments, effective February 22, 2023. This effectively terminated the 2020 Credit Facility, as the Company's ability to borrow and the Company's obligations to comply with all covenants ended on such date. The liens and guaranties in favor of the lenders are released. There was no early termination fee payable and the Company had no outstanding balance borrowed under the 2020 Credit Facility.
The commitments under the 2020 Credit Facility were guaranteed by certain of the Company's subsidiaries and secured by a first lien on the Company's and certain of its subsidiaries’ assets. Outstanding loans bore interest per annum at a sliding scale based on the our secured leverage ratio from 2.75% to 3.25% above the applicable
11

interbank borrowing reference rate for the currency in which the loan is denominated. Additionally, the 2020 Credit Facility contained 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 contained 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, which are no longer applicable.
Legal Proceedings. In January 2017, twoJune 2023, a putative class action lawsuits werelawsuit was filed against the Company, its directorsExecutive Chairman and certain of its officers, as well as the underwriters in the Company’s October 2015 initial public offering.Chief Executive Officer. The complaints,complaint, which purportpurports to be brought on behalf of a class of persons and/or entities who purchased or otherwise acquired ordinary shares of the Company pursuant and/or traceable to the registration statement and prospectus issued in connection with the Company’s initial public offering,from January 5, 2023 through June 5, 2023, allege material misstatements and/or omissions in the Company’s initial public offering materials in alleged violation of the federal securities laws and seek compensatory damages, among other remedies.  The two actions have been consolidated and the plaintiffs filed a consolidated amended complaint on May 31, 2017.  The court granted the defendants’ motion to bifurcate the motion to dismiss into two stages: a threshold motion to dismiss for lack of personal jurisdiction, lack of subject matter jurisdiction, and insufficient process and service of process; and, if the matter is not dismissed following that threshold motion, a subsequent merits motion to dismiss regarding whether the allegations in the amended complaint state a claim under the securities laws. The defendants filed the threshold motion to dismiss on July 31, 2017, and the plaintiffs filed an oppositionstatements with respect to the threshold motion to dismiss on September 29, 2017.results from its phase 3 LUNAR clinical trial. The Company believes that the amended complaintaction is without merit and plans to defend the consolidated lawsuitslawsuit vigorously. TheAs of June 30, 2023, the Company has not

- 8 -


accrued any amounts in respect of these lawsuits,this claim, as ait believes liability is not probable and the amount of any potential liability cannot be reasonably estimated.

NOTE 5: SHARE CAPITAL

ForCONVERTIBLE NOTE

On November 5, 2020, the nine months ended September 30, 2017, warrants to purchase 1,418,711 ordinary shares with an exercise priceCompany issued $575,000 aggregate principal amount of $3.59 per share were cashlessly exercised, resulting0% Convertible Senior Notes due 2025 (the “Notes”).
The Notes mature on November 1, 2025, unless earlier repurchased, redeemed or converted as set forth in the issuanceNotes. As of 803,138 ordinary shares.  Also, warrantsJune 30, 2023, the conditions allowing holders of the Notes to purchase 6,498 ordinary sharesconvert were not met. The Notes are therefore not convertible as of June 30, 2023 and are classified as long-term liability.
The net carrying amount of the liability of the Notes as of June 30, 2023 and December 31, 2022 are as follows:
June 30,
2023
December 31,
2022
UnauditedAudited
Liability component, net:
Principal amount$575,000 $575,000 
Unamortized issuance costs(7,850)(9,491)
Net carrying amount of liability component (1)$567,150 $565,509 
(1) An effective interest rate determines the fair value of the Notes, therefore they are categorized as Level 3 in accordance with an exercise priceASC 820. The estimated fair value of $3.59 per sharethe net carrying amount of liability component of the Notes as of June 30, 2023 and December 31, 2022 were exercised for cash. For$473,001 and $455,091, respectively.
Finance expense related to the nine months ended September 30, 2017, options to purchase 1,370,810 ordinary shares were exercised, resulting in the issuance of 1,364,645 ordinary shares.  

Notes was as follows:

Three months ended June 30,Six months ended June 30,Year ended December 31,
2022
2023202220232022
UnauditedUnauditedAudited
Amortization of debt issuance costs826 820 1,641 1,630 3,293 
Total finance expense recognized$826 $820 $1,641 $1,630 $3,293 
NOTE 6: EQUITY INCENTIVESHARE OPTION PLANS

AND ESPP

In September 2015, the Company adopted the 2015 Omnibus Incentive Plan (the “2015 Plan”). Under the 2015 Plan, the Company can issue various types of equity compensation awards such as share options, restricted shares, performance shares, restricted stockshare units (“RSUs”), performanceperformance-based share units (“PSUs”), long-term cash awards and other share-based awards.

Options granted under the 2015 Plan generally have a two-year or four-year vesting period and expire ten years after the date of grant. Options granted under the 2015 Plan that are cancelledcanceled or forfeited before expiration become available for future grants. RSUs granted under the 2015 Plan generally vest in equal installments over a three-yearthree year period. PSUs granted under the 2015 Plan generally vest between a three- and six-year period as performance targets are
12

attained. RSUs and PSUs granted under the 2015 Plan that are canceled before expiration become available for future grants. As of SeptemberJune 30, 2017, 9,563,9852023, 18,945,024 ordinary shares were available for grant under the 2015 Plan.

A summary of the status of the Company’s option plans as of SeptemberJune 30, 20172023 and changes during the period then ended is presented below:

 

Nine months ended September 30, 2017

 

Six months ended June 30, 2023

 

Unaudited

 

Unaudited

 

Number

of options

 

 

Weighted

average

exercise

price

 

Number
of options
Weighted
average
exercise
price

Outstanding at beginning of year

 

 

11,377,354

 

 

$

9.76

 

Outstanding at beginning of year8,786,364 $37.27 

Granted

 

 

5,117,088

 

 

 

9.96

 

Granted779,388 74.07 

Exercised

 

 

(1,370,810

)

 

 

2.31

 

Exercised(704,027)13.93 

Forfeited and cancelled

 

 

(310,693

)

 

 

12.39

 

Outstanding as of September 30, 2017

 

 

14,812,939

 

 

 

10.46

 

Forfeited and canceledForfeited and canceled(239,866)75.47 
Outstanding as of June 30, 2023Outstanding as of June 30, 20238,621,859 $41.44 

 

 

 

 

 

 

 

 

Exercisable options

 

 

6,119,710

 

 

 

8.17

 

Exercisable options6,862,376 $30.57 

 

 

 

 

 

 

 

 

Vested and expected to vest

 

 

14,812,939

 

 

$

10.46

 

For the six months ended June 30, 2023, options to purchase 704,027 ordinary shares were exercised, resulting in the issuance of 704,027 ordinary shares.
A summary of the status of the Company’s RSUs and PSUs as of SeptemberJune 30, 20172023 and changes during the period then ended is presented below: 

below.

 

Nine months ended September 30, 2017

 

Six months ended June 30, 2023

 

Unaudited

 

Unaudited

 

Number

of RSUs

 

 

Weighted

average

grant date fair value

price

 

Number
of RSU/PSUs
Weighted
average
grant date fair value

Unvested at beginning of year

 

 

-

 

 

$

-

 

Unvested at beginning of year5,377,459 $66.87 

Granted

 

 

1,661,619

 

 

 

9.64

 

Granted1,267,758 76.04 

Vested

 

 

-

 

 

 

-

 

Vested(770,163)84.96 

Forfeited and cancelled

 

 

(10,400

)

 

 

7.15

 

Forfeited and cancelled(121,741)92.59 

Unvested as of September 30, 2017

 

 

1,651,219

 

 

$

9.66

 

Unvested as of June 30, 2023 (1)Unvested as of June 30, 2023 (1)5,753,313 65.95 

- 9 -


(1) Includes PSUs that have a mix of service, market and other milestone performance vesting conditions which are vested upon achievements of performance milestones that are not probable as of June 30, 2023, in accordance with ASC 718 "Compensation — Stock Compensation" as follows:
 June 30, 2023
Number of
PSUs
Fair value at grant date per PSUTotal fair value at grant date
2,703,852 $48.16 $130,218 
189,029 76.97 14,550 
124,701 80.59 10,050 
7,605 87.66 667 
10,532 94.94 1,000 
161,912 114.26 18,500 
3,197,631 $174,985 
13

These PSUs will be expensed over the performance period when the vesting conditions become probable in accordance with ASC 718.
In September 2015, the Company adopted an employee share purchase plan (“ESPP”) to encourage and enable eligible employees to acquire ownership of the Company’s ordinary shares purchased through accumulated payroll deductions on an after-tax basis. In the United States, the ESPP is intended to be an “employee stock purchase plan” within the meaning of Section 423 of the Internal Revenue Code and the provisions of the ESPP will beare construed in a manner consistent with the requirements of such section. The Company began its offerings under the ESPP on August 1, 2016. As of SeptemberJune 30, 2017, 2,328,1712023, 4,787,003 ordinary shares were available to be purchased by eligible employees under the ESPP and 209,355 shares had been issued under the ESPP.

The fair value of all equity-basedshare-based awards was estimated using the Black-Scholes option-pricing model withfor all equity grants. For market condition awards, the Company also applied the Monte-Carlo simulation model. The Company assessed fair value using the following underlying assumptions, excluding market condition awards for which fair value was estimated using the Monte Carlo option-pricing model: 

assumptions: 

 

Nine months ended September 30,

 

 

Year ended

December 31,

Six months ended June 30,Year ended December 31,
2022

 

2017

 

2016

 

 

2016

20232022

 

Unaudited

 

 

Audited

UnauditedAudited

Stock Option Plans

 

 

 

 

 

 

 

 

Stock Option Plans

Expected term (years)

 

5.5-6.25

 

6.25

 

 

6.25

Expected term (years)5.50-6.005.33-5.835.33-5.83

Expected volatility

 

56.74%-59.45%

 

59.80%-61.65%

 

 

58.40%-61.70%

Expected volatility63%-67%60%-62%60%-62%

Risk-free interest rate

 

1.97%-2.23%

 

1.23%-1.88%

 

 

1.23%-1.88%

Risk-free interest rate3.48%-4.10%1.58%-3.04%1.58%-4.23%

Dividend yield

 

0.00%

 

0.00%

 

 

0.00%

Dividend yield0.00 %0.00 %0.00 %

ESPP

 

 

 

 

 

 

 

 

ESPP

Expected term (years)

 

0.50

 

 

0.42

 

 

0.42

Expected term (years)0.500.500.50

Expected volatility

 

76.37%-82.00%

 

70.45%

 

 

70.45%

Expected volatility56 %51 %51%-77%

Risk-free interest rate

 

0.62%-1.13%

 

0.40%

 

 

0.40%

Risk-free interest rate4.76 %0.19 %0.19%-2.52%

Dividend yield

 

0.00%

 

0.00%

 

 

0.00%

Dividend yield0.00 %0.00 %0.00 %

The total non-cash share-based compensation expense related to all of the Company’s equity-based awards recognized for the three and ninesix months ended SeptemberJune 30, 20172023 and 20162022, and the year ended December 31, 20162022 was:

Three months ended June 30,Six months ended June 30,Year ended December 31,
2022
2023202220232022
UnauditedUnauditedAudited
Cost of revenues$2,023 $1,029 $4,029 $1,981 $4,690 
Research, development and clinical studies8,537 7,624 20,316 14,425 30,790 
Sales and marketing10,213 6,802 21,857 13,457 28,826 
General and administrative11,967 10,368 25,622 21,005 42,649 
Total share-based compensation expense$32,740 $25,823 $71,824 $50,868 $106,955 

 

 

Three months ended September 30,

 

 

Nine months ended September 30,

 

 

Year ended

December 31,

 

 

 

2017

 

 

2016

 

 

2017

 

 

2016

 

 

2016

 

 

 

Unaudited

 

 

Unaudited

 

 

Audited

 

Cost of revenues

 

$

79

 

 

$

160

 

 

$

353

 

 

$

471

 

 

$

623

 

Research, development and clinical trials

 

 

972

 

 

 

776

 

 

 

2,645

 

 

 

2,378

 

 

 

3,155

 

Sales and marketing

 

 

1,874

 

 

 

1,249

 

 

 

4,264

 

 

 

3,888

 

 

 

5,111

 

General and administrative

 

 

5,704

 

 

 

3,441

 

 

 

13,498

 

 

 

9,982

 

 

 

12,552

 

Total share-based compensation expense

 

$

8,629

 

 

$

5,626

 

 

$

20,760

 

 

$

16,719

 

 

$

21,441

 


NOTE 7: Basic and diluted net income (loss) per ordinary share
Basic net income (loss) per share is computed based on the weighted average number of ordinary shares outstanding during each period. Diluted net income per share is computed based on the weighted average number of ordinary shares outstanding during the period, plus potential dilutive shares (deriving from options, RSUs, PSUs, convertible notes and the ESPP) considered outstanding during the period, in accordance with ASC 260-10 "Earnings Per Share", as determined under the if-converted method.
14

The following table sets forth the computation of the Company’s basic and diluted net income (loss) per ordinary share:
 Three months ended June 30,Six months ended June 30,Year ended December 31,
2022
 2023202220232022
UnauditedUnauditedAudited
Net income (loss) attributable to ordinary shares as reported used in computing basic and diluted net income (loss) per share$(57,418)$(24,008)$(110,479)$(28,655)$(92,534)
Weighted average number of ordinary shares used in computing basic and diluted net income (loss) per share106,289,073 104,627,789 105,979,791 104,408,164 104,660,476 
Weighted anti-dilutive shares outstanding which were not included in the diluted calculation8,483,336 7,746,398 7,733,239 7,790,467 7,272,606 
Basic and diluted net income (loss) per ordinary share$(0.54)$(0.23)$(1.04)$(0.27)$(0.88)


15

NOTE 7:8: SUPPLEMENTAL INFORMATION

The Company operates in a single reportable segment.

The following table presents long-lived assets by location:

 

September 30,

 

 

December 31,

 

 

2017

 

 

2016

 

June 30,
2023
December 31,
2022

 

Unaudited

 

 

Audited

 

UnauditedAudited

United States

 

$

10,942

 

 

$

11,981

 

United States$35,229 $30,012 
IsraelIsrael7,678 7,180 

Switzerland

 

 

5,057

 

 

 

4,346

 

Switzerland6,106 5,084 

Israel

 

 

1,884

 

 

 

1,915

 

JapanJapan994 1,063 
GermanyGermany1,079 762 

Others

 

426

 

 

 

378

 

Others1,589 1,261 

Total

 

$

18,309

 

 

$

18,620

 

Total long lived assetsTotal long lived assets$52,675 $45,362 

- 10 -


The Company’s revenues by geographic region, based on the customer’s location, are summarized as follows:

 

 

Three months ended September 30,

 

 

Nine months ended September 30,

 

 

Year ended

December 31,

 

 

 

2017

 

 

2016

 

 

2017

 

 

2016

 

 

2016

 

 

 

Unaudited

 

 

Unaudited

 

 

Audited

 

United States

 

$

35,300

 

 

$

18,131

 

 

$

95,826

 

 

$

46,264

 

 

$

72,771

 

EMEA (*)

 

 

14,757

 

 

 

3,519

 

 

 

27,316

 

 

 

6,296

 

 

 

10,028

 

Japan

 

 

52

 

 

 

24

 

 

 

223

 

 

 

86

 

 

 

89

 

Total

 

$

50,109

 

 

$

21,674

 

 

$

123,365

 

 

$

52,646

 

 

$

82,888

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(*) including Germany

 

$

14,664

 

 

$

1,766

 

 

 

26,880

 

 

 

2,659

 

 

$

9,799

 

Three months ended June 30,Six months ended June 30,Year ended December 31,
2022
2023202220232022
UnauditedUnauditedAudited
United States$86,958 $108,203 $172,186 $205,619 $406,894 
Germany15,744 10,347 30,864 29,585 46,120 
Japan7,861 8,272 16,530 17,022 32,781 
Greater China (1)6,751 5,933 12,066 10,301 21,332 
Others8,737 8,111 16,587 15,886 30,713 
Total net revenues$126,051 $140,866 $248,233 $278,413 $537,840 

- 11 -

(1) For additional information, see Note 12 to the Consolidated Financial Statements in the 2022 10-K.

16

Table of Contents
Item 2.  Management’s Discussion and Analysis ofof Financial Condition and Results of Operations

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 SeptemberJune 30, 20172023 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. As a result of many factors, such as those set forthPlease refer to the information under Part I, Item 1A, “Risk Factors”, of our Annual Report on Form 10-K for the fiscal year ended December 31, 2016 (the “2016 10-K”), our actual results may differ materially from those anticipatedheading “Cautionary Note Regarding Forward-Looking Statements” elsewhere in these forward-looking statements.this report. References to the words “we,” “our,” “us,” and the “Company” in this report refer to NovoCure Limited, including its consolidated subsidiaries.

Overview

We are a commercial stage oncology company developing a profoundly different cancer treatment centered on a proprietary therapy called Tumor Treating Fields (“TTFields”), the use of electric fields tuned to specific frequencies to disrupt solid tumor cancer cell division.  Our key priorities are to accelerate commercial adoption of Optune, our first commercial TTFields delivery system, for the treatment of glioblastoma (“GBM”)

Critical Accounting Policies and to advance programs testing the efficacy and safety of TTFields in multiple solid tumor indications through our clinical pipeline.

We were founded in 2000 and operated as a development stage company through December 31, 2011. We initially received U.S. Food and Drug Administration (“FDA”) approval for Optune in 2011 for use as a monotherapy treatment for adult patients with GBM following confirmed recurrence after chemotherapy. In October 2015, we received FDA approval to market Optune for the treatment of adult patients with newly diagnosed GBM in combination with temozolomide, a chemotherapy drug. We have also received approval to market Optune in Germany, Austria, Switzerland, Israel, Japan and certain other countries.  To date, we have focused on commercializing Optune in the United States, Germany, Austria, Switzerland, Israel and Japan, which we refer to collectively as our currently active markets.

In April 2017, we announced final analyses of the full 695 patient dataset with a median follow-up of 40 months from our phase 3 pivotal trial of Optune in combination with temozolomide for patients with newly diagnosed GBM. For patients treated with Optune in combination with temozolomide versus patients treated with temozolomide alone, the two-year survival rate increased from 30 percent to 43 percent and the five-year survival rate increased from five percent to 13 percent. In September 2017, we announced results from health-related quality of life analyses from this same phase 3 pivotal trial. Patients treated with Optune in combination with temozolomide were able to maintain quality of life for longer compared to patients treated with temozolomide alone.  These data further support our belief that Optune plus temozolomide is an essential combination treatment for patients with newly diagnosed GBM.

We continue to work with payers to expand access to Optune for patients with newly diagnosed and recurrent GBM. As of September 30, 2017, more than 210 million Americans have available coverage for the use of Optune for newly diagnosed and/or recurrent GBM. Additionally, we have signed contracts to establish Optune as an in-network benefit for more than 178 million American lives. The percentage of our U.S. active patient population who are beneficiaries of the Medicare fee-for-service program, which has denied coverage for our claims to date, continues to range from 20 to 25 percent.

In Germany, we are able to bill healthcare payers for individual cases and each case is evaluated individually on its merits and under the payer’s specific rules for such cases. In the third quarter 2017, approximately half of German claims were approved for reimbursement. In September 2017, the German Federal Joint Committee, or G-BA, published its decision to support a clinical trial studying Optune for the treatment of newly diagnosed GBM. The proposed trial design will examine the benefit of starting Optune concurrent with radiation therapy and temozolomide prior to the initiation of maintenance temozolomide in accordance with Section 137e of the German Healthcare Provision Act. We anticipate that we will share the costs for the conduct of the clinical trial with the G-BA. The statutory health insurance funds will reimburse treatment costs, including the cost of Optune for clinical trial patients.  The G-BA decision is an important first step in the process to secure national reimbursement for Optune in Germany.

In August 2017, we signed a contract with the Federation of Austrian Social Insurance Institutions to grant reimbursement for Optune. All 18 Austrian insurance funds have agreed to participate in the contract, marking our first national reimbursement decision.  We are currently working to implement the contract and believe that our first payments for Austrian claims will begin in the fourth quarter 2017.

In April 2017, we submitted our applicate to the Federal Office of Public Health in Switzerland to secure a defined reimbursement rate for Optune based upon the long-term analysis of the EF-14 clinical trial data. We now believe a Swiss reimbursement decision will come no earlier than 2018. Until we secure a defined reimbursement rate, payment is not guaranteed.

- 12 -


In March 2017, we received Japanese Ministry of Health, Labour and Welfare (“MHLW”) approval for the second generation Optune. In March 2017, we filed an application to request a defined reimbursement rate for Optune based on the December 2016 regulatory approval of Optune to treat newly diagnosed GBM.  We are currently in active reimbursement discussions with the MHLW and believe that a reimbursement decision will come before the end of 2017.

We have researched the biological effects of TTFields extensively. Because TTFields are delivered regionally, act only on dividing cells (a biological process known as mitosis) and are frequency-tuned to target cells of a specific size, we believe there is minimal damage to healthy cells. We believe our pre-clinical and clinical research demonstrates that TTFields’ mechanism of action affects fundamental aspects of cell division and may have broad applicability across a variety of solid tumors. We have demonstrated in pre-clinical studies that TTFields can offer additive or synergistic benefits in combination with radiation, chemotherapy and immunotherapy, which may lead to greater efficacy than radiation, chemotherapy and immunotherapy alone, without significantly increasing the side effects when used in combination with other cancer treatments.

We are currently planning or conducting clinical trials evaluating the use of TTFields in brain metastases, non-small-cell lung cancer (“NSCLC”), pancreatic cancer, ovarian cancer and mesothelioma. We anticipate expanding our clinical pipeline over time to study the safety and efficacy of TTFields for additional solid tumor indications. The table below presents the current status of our clinical pipeline and our expected next milestone for each.

In May 2017, we received humanitarian use device (HUD) designation for the use of TTFields for the treatment of pleural mesothelioma.  The HUD designation is the first step in obtaining a Humanitarian Device Exemption (HDE) for the treatment of pleural mesothelioma with TTFields.  An approved HDE would allow us to market TTFields in combination with standard of care chemotherapy as a treatment for pleural mesothelioma in the United States.

In October 2016, we enrolled the first patient in our METIS trial, a phase 3 pivotal trial testing the effectiveness of stereotactic radiosurgery plus TTFields compared to stereotactic radiosurgery alone in patients with brain metastases resulting from NSCLC. In September 2017, the FDA approved an IDE supplement amending the protocol for the METIS trial.  The protocol amendment is designed to accelerate the pace of enrollment by expanding the eligible patient population. Among other updates, the protocol now allows for the enrollment of patients with infratentorial brain metastases, based upon new scientific information to support a specialized array layout to treat infratentorial tumors.

We own all commercialization rights to TTFields in oncology. Our robust global patent and intellectual property portfolio consists of over 120 issued patents, with numerous additional patent applications pending worldwide. The patents have expected expiration dates between 2021 and 2035. We have also filed approximately 50 additional patent applications that, if issued, may protect aspects of our platform beyond 2035. We believe we will maintain exclusive rights to market TTFields for all solid tumor indications in our key markets through the life of our patents.

We were incorporated in the Bailiwick of Jersey in 2000.  Our U.S. operations are located in Portsmouth, New Hampshire, Malvern, Pennsylvania, and New York City. Additionally, we have offices in Germany, Switzerland, Israel and Japan, and a research center in Israel.  We completed our initial public offering of our ordinary shares in October 2015.  Our ordinary shares are quoted on the NASDAQ Global Select Market under the symbol “NVCR.”

Financial Overview. We expect to continue to incur significant expenses and operating losses for at least the next several years. We expect our research, development and clinical trials expenses to increase in connection with our ongoing activities, and as additional indications enter late-stage clinical development. In addition, we expect to incur significant commercialization expenses for product sales, marketing, manufacturing and distribution. We may need additional funding to support the continuation of our operating activities. Until we can generate substantial revenues (which may not occur), we expect to finance our cash needs through our existing cash, cash equivalents, short-term investments, equity issuances or additional debt, and possibly also from collaborations, strategic alliances, licensing arrangements and other marketing and distribution arrangements. We will need to generate significant revenues to achieve profitability, and we may never do so.

- 13 -


Critical accounting policies and estimates

Estimates

In accordance with U.S. GAAP,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 20162022 10-K. For additional information, see Note 1 to our unaudited consolidated financial statements in Part I, Item 1 of this Quarterly Report. There have beenwere no other material changes to our critical accounting policies and estimates as compared to the critical accounting policies and estimates described in our 20162022 10-K.

Results

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 Operations

We account for revenue when all revenue recognition criteria have been met or when cash is collected. Revenue recognized in a given period may include a mixture of accrued revenue, cash collections from amounts billed in prior periods and cash collections from amounts billed in the current period. We report certain operating statisticsmechanisms. Our key priorities are to provide additional insight into thedrive commercial performanceadoption of Optune, our commercial TTFields device, and to advance clinical and product development programs intended to extend overall survival in our currently active markets.

The numbersome of active patients on the most aggressive forms of cancer.

Optune is our principal revenue driver. Growth inapproved by the numberU.S. Food and Drug Administration ("FDA") under the Premarket Approval ("PMA") pathway for the treatment of active patients is a factor of both treatment duration and new patient starts. Median treatment duration differs based upon the clinical diagnosis of the patient. For the three months ended September 30, 2017, more than 60% of prescriptions received were foradult patients with newly diagnosed GBM.  The conversionglioblastoma ("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 prescriptions to new patientsGBM in the European Union ("EU"), as well as approval or local registration in the United Kingdom ("UK"), Japan, Canada and certain other countries. Optune Lua is drivenapproved by the prescription fill rateFDA under the Humanitarian Device Exemption ("HDE") pathway to treatment 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.
In March 2023, we announced the reimbursement and availability of Optune together with temozolomide for the treatment of adult patients with newly diagnosed GBM in France. The order registering Optune on the List of Reimbursable Product and Services became effective March 15, 2023 and we are now treating patients.
We believe the physical mechanisms of action behind TTFields therapy may be broadly applicable to solid tumor cancers. In June 2023, we presented positive results from the phase 3 LUNAR study evaluating the use of TTFields together with standard therapies for the treatment of metastatic NSCLC following platinum-failure. The LUNAR study met its primary endpoint with a statistically significant and clinically meaningful 3-month improvement in median overall survival ("OS") with TTFields therapy added to standard therapies (HR=0.74, P=0.035). Patients randomized to receive TTFields together with standard therapies demonstrated median OS of 13.2 months compared to 9.9 months in patients treated with standard therapies alone. Patients randomized to receive TTFields and physician’s choice immune checkpoint inhibitor ("ICI") (n=66) demonstrated a median OS of 18.5 months, a profound extension compared to the median OS of 10.8 months demonstrated by patients that received ICI alone (n=68; HR=0.63; P=0.03). Patients randomized to receive TTFields and docetaxel (n=71) had a positive survival trend with a median OS of 11.1 months vs 8.7 months (n=71). TTFields therapy was well-tolerated with no added
17

Table of Contents
systemic toxicities and few grade 3 (no grade 4 or 5) device-related adverse events. These data are expected to serve as the basis for a PMA submission to the FDA in the second half of 2023.
We are planning to launch several additional trials intended to further explore the use of TTFields therapy in the treatment of NSCLC. In July 2023, the FDA accepted the investigation device exemption for the LUNAR-2 clinical trial ("LUNAR-2"), a randomized, phase 3 study testing the safety and effectiveness of TTFields concomitant with pembrolizumab and platinum-based chemotherapy in patients with metastatic NSCLC. The two primary endpoints of LUNAR-2 are overall survival and progression-free survival. LUNAR-2 is designed to accrue 734 patients with a 21-month follow-up following the enrollment of the last patient.
In addition to our NSCLC studies, we are conducting phase 3 studies evaluating the use of TTFields in the treatment of ovarian cancer, brain metastases from NSCLC ("brain metastases") and pancreatic cancer. We are also conducting a global phase 3 study testing the potential survival benefit of initiating Optune concurrent with radiation therapy versus following radiation therapy in patients with newly diagnosed GBM.
In July 2023, we announced that an independent data monitoring committee ("DMC") conducted a pre-specified interim analysis for the phase 3 PANOVA-3 study for the treatment of unresectable, locally advanced pancreatic cancer. As part of the interim analysis, the DMC reviewed the safety and efficacy data for all locally advanced pancreatic cancer patients enrolled in the study. The interim analysis resulted in a DMC recommendation that the study should continue to final analysis. The PANOVA-3 study accrued 556 patients as of February 2023 and data will be reviewed in 2024, following an 18-month follow-up period.
In March 2023, we announced the final patient enrolled in the pivotal METIS study evaluating the efficacy of TTFields therapy following stereotactic radiosurgery for the treatment of patients with brain metastases from NSCLC. Following the completion of enrollment, patients will be followed for a minimum of 12 months with final data anticipated in 2024.
We have one ongoing pilot study evaluating the use of TTFields in the treatment of stage 3 NSCLC and are designing several additional pilot and pivotal studies in partnership with oncology leaders to further explore the capabilities of TTFields. We anticipate expanding our clinical pipeline over time to fill. study the safety and efficacy of TTFields for additional solid tumor indications and combinations with other cancer treatment modalities.
The table below presents the current status of the ongoing clinical studies in our pipeline and anticipated timing of data.
Q2 2023 Clinical Trials Chart v1.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. One of these initiatives is the launch of new arrays, which are thinner, lighter and more flexible. We plan to submit for regulatory approval in the U.S. via PMA supplement in the second half of this year.
18

Table of Contents
Our intellectual 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 twelvedevelopment 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, 2022 (the "2022 10-K").
We view our operations and manage our business in one operating segment. For the three and six months ended SeptemberJune 30, 2017,2023, our prescription fill ratenet revenues were $126.1 million and $248.2 million, respectively. Our net loss for the three and six months ended June 30, 2023 was between 70-75%.

The following table includes certain$57.4 million and $110.5 million, respectively. As of June 30, 2023, we had an accumulated deficit of $888.9 million. Our net loss resulted primarily from increasing investments designed to support our commercial operating statistics forbusiness, geographic expansion and aspre-commercial activities associated with potential future indication launches.

Impact of COVID-19
On May 5, 2023, the World Health Organization (“WHO”) declared the end of the periods presented.

 

 

 

 

 

 

 

 

 

 

September 30,

 

Operating statistics

 

 

 

 

 

 

 

 

 

2017

 

 

2016

 

Active patients at period end (1)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

United States

 

 

 

 

 

 

 

 

 

 

1,234

 

 

 

783

 

EMEA (2) (*)

 

 

 

 

 

 

 

 

 

 

448

 

 

 

202

 

Japan (2)

 

 

 

 

 

 

 

 

 

 

1

 

 

 

-

 

 

 

 

 

 

 

 

 

 

 

 

1,683

 

 

 

985

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(*) including Germany

 

 

 

 

 

 

 

 

 

 

331

 

 

 

146

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three months ended September 30,

 

 

Nine months ended September 30,

 

 

 

2017

 

 

2016

 

 

2017

 

 

2016

 

Prescriptions received in period (3)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

United States

 

 

805

 

 

 

569

 

 

 

2,293

 

 

 

1,800

 

EMEA (2) (*)

 

 

270

 

 

 

120

 

 

 

731

 

 

 

301

 

Japan (2)

 

 

1

 

 

 

1

 

 

 

5

 

 

 

1

 

 

 

 

1,076

 

 

 

690

 

 

 

3,029

 

 

 

2,102

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(*) including Germany

 

 

202

 

 

 

87

 

 

 

553

 

 

 

221

 

(1)

An “active patient” is a patient who is on Optune 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 treatmentCOVID-19 pandemic as a public health emergency of international concern, however the WHO maintains that the virus remains a global health threat. Since the pandemic began, we have followed the guidance of the WHO, the U.S. Centers for Disease Control and Prevention, and local health authorities in less than 60 days.

(2)

As we enter each new market, our commercial activities focus initially on establishing the required in-market infrastructure, certifying physicians to prescribe Optune and obtaining a defined reimbursement pathway. Once established, our commercial efforts turn to increasing adoption.

(3)

A “prescription received” is a commercial order for Optune that is received from a physician certified to treat patients with Optune for a patient not previously on Optune. Orders to renew or extend treatment are not included in this total.

- 14 -


Net revenues. Substantially all of our active markets and will continue to do so. The COVID-19 pandemic did not have a material impact on our financial results through the second quarter of 2023. The pandemic is not having a direct impact on our day-to-day operations; however, we are still observing lingering impacts that might continue to impact our business and clinical studies in the future. For example, in many locations staffing levels at clinical trial sites have not returned to pre-pandemic levels, and our ability to conduct and monitor clinical studies may be impacted.

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 a possible COVID-19 resurgence 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 2022 10-K.
Commentary on Results of Operations
Net revenues. Our revenues are primarily derived from patients using our TTFields delivery system, marketed as OptuneProducts in our currently active markets. We charge patients or their third-party healthcare payers directlyfor treatment with our Products on a monthly basis and bear the financial risk of securing payment in the United States and Europe.

The following is a summary of gross billings and revenues recorded on an accrual basis and a cash basis by quarters (unaudited):

 

 

2017

 

 

2016

 

U.S. dollars in millions

 

Q3

 

 

Q2

 

 

Q1

 

 

Q4

 

 

Q3

 

 

Q2

 

 

Q1

 

Gross billings

 

$

101.9

 

 

$

87.2

 

 

$

73.2

 

 

$

63.8

 

 

$

57.5

 

 

$

54.0

 

 

$

45.5

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accrual basis revenue

 

$

35.7

 

 

$

19.1

 

 

$

14.7

 

 

$

8.5

 

 

$

0.0

 

 

$

0.0

 

 

$

0.0

 

Cash basis revenue for therapy provided in the period

 

 

3.1

 

 

 

5.7

 

 

 

5.9

 

 

 

6.3

 

 

 

8.9

 

 

 

7.6

 

 

 

5.6

 

Cash basis revenue for therapy provided in previous periods

 

 

11.3

 

 

 

13.6

 

 

 

14.3

 

 

 

15.5

 

 

 

12.7

 

 

 

10.3

 

 

 

7.4

 

Net revenues

 

$

50.1

 

 

$

38.4

 

 

$

34.9

 

 

$

30.2

 

 

$

21.7

 

 

$

17.9

 

 

$

13.1

 

We began recognizing a portion of ourbasis. 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 an accrual basis in the fourth quarter 2016. Priortherapy.

We also receive revenues pursuant to the third quarter 2017, all ofZai Agreement. For additional information regarding the net revenues recognized on an accrual basis represent chargesZai Agreement, see Note 12 to certain U.S.-based third-party payers. Beginningthe Consolidated Financial Statements in the third quarter 2017, net revenues recognized on an accrual basis represent charges to certain U.S.-based third-party payers and certain German payers. In the period of transition from cash-based to accrual-based revenue recognition, there is a one-time impact to net revenues as net revenues in the current period may also include revenues from gross billings from previous periods. In the table above, gross billings reflect the total charges for active patients on Optune without any deductions or adjustments for payer discounts, patient financial assistance, charitable care or other similar items.  The subsequent table line items detail the three sources of net revenue in the applicable reporting period.

our 2022 10-K.

Cost of revenues.We contract with third parties to manufacture our Products. Our cost of revenues is comprised primarily of (i) costcomprised of the following:

disposable transducer arrays purchased from third-party manufacturers, (ii) arrays;
depreciation expense for the field equipment, including the electric field generator used by patientspatients;
patient support and (iii)other personnel warrantycosts; and
overhead costs, such as facilities, freight and depreciation of property, plant and equipment associated with managing our inventory, warehousing and order fulfillment functions.

Operating Expenses. expenses. Our operating expenses consist of research, development and clinical trials,studies, sales and marketing and general and administrative expenses. Personnel costs are a significant component for each category
19

of operating expenses and consist of wages, benefits and bonuses. Personnel costs also include share-based compensation.

Financial expenses, net.income (expenses), net.Financial expenses,income (expenses), net primarily consists of interest expense and related debt issuance costs under our Term Loan Credit Facility (as defined below), interest income from cash balances and short-term investments, credit facility interest expense and related debt issuance costs, and gains (losses) from foreign currency transactions.

Our reporting currency is the U.S. dollar. We viewhave historically held substantially all of our cash balances in U.S. dollar denominated accounts to minimize the risk of translational currency exposure.


Results of Operations
The following discussion provides an analysis of our results of operations and managereasons for material changes therein for the three and six months ended June 30, 2023 as compared to the three and six months ended June 30, 2022. The tables contained in this section report U.S. dollars in thousands (except share, patient, and prescription data). The following table sets forth our consolidated statements of operations data:
Three months ended June 30,Six months ended June 30,
2023202220232022
UnauditedUnaudited
Net revenues$126,051 $140,866 $248,233 $278,413 
Cost of revenues34,018 28,503 63,632 56,230 
Gross profit92,033 112,363 184,601 222,183 
Operating costs and expenses:
Research, development and clinical studies55,427 57,075 115,131 99,309 
Sales and marketing58,488 44,750 109,657 82,634 
General and administrative40,778 31,666 82,722 62,174 
Total operating costs and expenses154,693 133,491 307,510 244,117 
Operating income (loss)(62,660)(21,128)(122,909)(21,934)
Financial income (expenses), net8,756 (2,228)17,925 (3,937)
Income (loss) before income taxes(53,904)(23,356)(104,984)(25,871)
Income taxes3,514 652 5,495 2,784 
Net income (loss)$(57,418)$(24,008)$(110,479)$(28,655)
Basic and diluted net income (loss) per ordinary share$(0.54)$(0.23)$(1.04)$(0.27)
Weighted average number of ordinary shares used in computing basic and diluted net income (loss) per share106,289,073 104,627,789 105,979,791 104,408,164 
20

Table of Contents
The following table details the share-based compensation expense included in costs and expenses:
Three months ended June 30,Six months ended June 30,
2023202220232022
UnauditedUnaudited
Cost of revenues$2,023 $1,029 $4,029 $1,981 
Research, development and clinical studies8,537 7,624 20,316 14,425 
Sales and marketing10,213 6,802 21,857 13,457 
General and administrative11,967 10,368 25,622 21,005 
Total share-based compensation expense$32,740 $25,823 $71,824 $50,868 

Key performance indicators
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 oneless than 60 days. Prescriptions 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 includes certain commercial operating segment.statistics for and as of the end of the periods presented.
June 30,
Operating statistics20232022
Active patients at period end
United States (1)2,200 2,229 
Germany499 458 
Japan352 346 
Others520 421 
Total3,571 3,454 
Three months ended June 30,Six months ended June 30,
 2023202220232022
Prescriptions received in period
United States (1)981 954 2,032 1,889 
Germany204 216 412 436 
Japan92 95 164 197 
Others279 118 444 245 
Total1,556 1,383 3,052 2,767 
(1) United States includes data for Canada for 2022. For 2023, Canada is included in "Others".
There were 16 active MPM patients on therapy as of June 30, 2023 and 25 MPM prescriptions were received in the three months ended June 30, 2023.
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Table of Contents
Three and six months ended June 30, 2023 compared to three and six months ended June 30, 2022
Three months ended June 30,Six months ended June 30,
20232022% Change20232022% Change
Net revenues$126,051 $140,866 (11)%$248,233 $278,413 (11)%
Net revenues. Net revenues decreased 11% to $126.1 million for the three months ending June 30, 2023 from $140.9 million for the same period in 2022, and decreased 11% to $248.2 million for the six-month period ended June 30, 2023 from $278.4 million for the same period in 2022. For the three and ninesix months ended SeptemberJune 30, 2017, our net revenues were $50.12023, the decrease resulted primarily from $13.4 million and $123.4$18.8 million, respectively, in reduced collections from previously denied or appealed claims in the U.S. Net revenues for the three-month period ended June 30, 2023 were also impacted by a reduction of $5.5 million resulting from variations in approval patterns in the U.S. compared to the same period in 2022, offset by a $5.4 million increase resulting from variations in approval rates in Germany as more patients are meeting coverage criteria in the market.
We believe the outstanding denied and ourappealed claims that were most accessible were largely exhausted in 2022 and the remaining outstanding claims will take time to collect. As a result, we expect future net lossrevenue to more closely reflect core drivers: number of active patients on therapy, duration of therapy, and net realized price per month. We continue to actively appeal and pursue the remaining previously denied claims, but the cadence and size of these collections are difficult to predict.
Three months ended June 30,Six months ended June 30,
20232022% Change20232022% Change
Cost of revenues$34,018 $28,503 19 %$63,632 $56,230 13 %
Cost of revenues. Our cost of revenues for the three months ended June 30, 2023 was $11.5$34.0 million, an increase of 19% from $28.5 million for the same period in 2022, and $63.6 million for the six months ended June 30, 2023, an increase of 13% from $56.2 million for the same period in 2022. For the three and six months ended June 30, 2023, the increase in cost of revenues was primarily due to increased costs of $3.5 million and $50.7$6.5 million, respectively. Our net lossrespectively, in patient support capacity in anticipation of treating larger patient populations in new cancer indications and new geographic regions.
Gross margin was 73% for the three months ended June 30, 2023 compared to 80% for the three months ended June 30, 2022. Gross margin was 74% for the six months ended June 30, 2023 and 80% for the six months ended June 30, 2022. Excluding sales to Zai, cost of revenues per active patient per month was $2,878 for the three months ended June 30, 2023, an increase of 20% from $2,391 for the same period in 2022, primarily due to increased patient support capacity. 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 $3.6 million and $6.3 million for the three and ninesix months ended SeptemberJune 30, 2017 includes $8.62023 compared to $3.4 million and $20.8$5.3 million respectively, in non-cash share-based compensation expense. As of September 30, 2017, we had an accumulated deficit of $571.3 million.

Threefor the three and six months ended SeptemberJune 30, 2017 compared2022. We expect that our gross margins will continue to three months ended September 30, 2016

(All dollar figures in tables are in thousands unless otherwise indicated)

 

 

Three months ended September 30,

 

 

 

 

 

 

 

 

 

 

 

2017

 

 

2016

 

 

Change

 

 

% Change

 

Net revenues

 

$

50,109

 

 

$

21,674

 

 

$

28,435

 

 

 

131

%

Net revenues.  Net revenues increased $28.4 million, or 131%,be impacted by current and future product enhancements, such as the ongoing launch of next generation arrays. We continue to $50.1focus 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.

22

Operating Expenses.
Three months ended June 30,Six months ended June 30,
20232022% Change20232022% Change
Research, development and clinical studies$55,427 $57,075 (3)%$115,131 $99,309 16 %
Sales and marketing58,488 44,750 31 %109,657 82,634 33 %
General and administrative40,778 31,666 29 %82,722 62,174 33 %
Total operating expenses$154,693 $133,491 16 %$307,510 $244,117 26 %
Research, development and clinical study expenses. Research, development and clinical study expenses decreased 3% to $55.4 million for the three months ended SeptemberJune 30, 20172023 from $21.7$57.1 million for the same period in 2022, and increased 16% to $115.1 million for the six-month period ended June 30, 2023 from $99.3 million in the same period in 2022. For the three months ended June 30, 2023, the change resulted primarily from reduced costs associated with recently completed clinical studies. For the six months ended June 30, 2023, the increase was primarily driven by an $6.9 million increase in engineering, regulatory affairs and preclinical costs, a $3.5 million increase in pre-launch activities related to new clinical trials, and an increase of $5.3 million in other personnel expenses. Total research and development expenses can fluctuate quarter-to-quarter dependent upon the amount of clinical research organization services delivered, clinical materials procured and the number of trials actively underway within a given quarter.
Sales and marketing expenses. Sales and marketing expenses increased 31% to $58.5 million for the three months ended SeptemberJune 30, 2016. This2023 from $44.7 million for the same period in 2022, and increased 33% to $109.7 million for the six-month period ended June 30, 2023 from $82.6 million for the same period in 2022. For the three and six months ended June 30, 2023, these changes were primarily due to increase of $7.0 million and $12.0 million, respectively, in costs associated with geographic expansion and pre-launch activities intended to increase awareness in TTFields in anticipation of future approvals in new indications, as well as increased personnel costs of $3.4 million and $8.4 million, respectively. 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 29% to $40.8 million for the three-month period ended June 30, 2023 from $31.7 million for the same period in 2022, and increased 33% to $82.7 million for the six months ended June 30, 2023 from $62.2 million for the same period in 2022. For the three and six months ended June 30, 2023, these changes were primarily due increases in personnel and project expenses to support potential new indication launches, new geographic launches, supply chain expansion and information technology enhancements of $9.1 million and $20.5 million, respectively.
Three months ended June 30,Six months ended June 30,
20232022% Change20232022% Change
Financial income (expenses), net$8,756 $(2,228)(493)%$17,925 $(3,937)(555)%
Financial income (expenses), net. Financial income increased 493% to $8.7 million in income for the three months ended June 30, 2023 from $2.2 million of expenses for the same period in 2022 and financial income increased 555% to $17.9 million in income for the six months ended June 30, 2023 from $3.9 million in expenses for the same period in 2022. For the three-month period ending June 30, 2023, the change from 2022 was primarily due to an increase of $17.2$8.6 million in commercial sales of Optune in the United Statesincreased interest income and an increase of $11.3$2.3 million in commercial sales of Optunereduced foreign exchange rate expenses. For the six-month period ending June 30, 2023, the change from 2022 was primarily due to $17.9 million in our other currently active markets, as well as the transition to accrual-based revenue recognition for a portion of our billings.

- 15 -


Cost of revenues.  Our cost of revenues increased by $4.0interest income and $3.8 million in reduced foreign exchange expenses.

Three months ended June 30,Six months ended June 30,
20232022% Change20232022% Change
Income taxes$3,514 $652 439 %$5,495 $2,784 97 %
Income taxes. Income taxes increased $2.9 million, or 36%,439% to $15.2$3.5 million for the three months ended SeptemberJune 30, 20172023 from $11.1$0.7 million for the threesame period in 2022, and income taxes increased $2.7 million, or 97% to $5.5 million
23

for the six months ended SeptemberJune 30, 2016.  The increase resulted primarily2023 from the cost of shipping transducer arrays to a higher volume of commercial patients, as well as an increase in field equipment depreciation.  Cost of revenues includes $0.1 million of non-cash share-based compensation.

Operating Expenses.  

 

 

Three months ended September 30,

 

 

 

 

 

 

 

 

 

 

 

2017

 

 

2016

 

 

Change

 

 

% Change

 

Research, development and clinical trials

 

$

9,273

 

 

$

10,233

 

 

$

(960

)

 

 

(9

%)

Sales and marketing

 

 

16,387

 

 

 

15,865

 

 

 

522

 

 

 

3

%

General and administrative

 

 

15,215

 

 

 

12,723

 

 

 

2,492

 

 

 

20

%

Total operating expenses

 

$

40,875

 

 

$

38,821

 

 

$

2,054

 

 

 

5

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-cash expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Share-based compensation expense

 

$

8,550

 

 

$

5,466

 

 

$

3,084

 

 

 

56

%

Other non-cash expenses

 

 

600

 

 

 

708

 

 

 

(108

)

 

 

(15

%)

Total non-cash expenses

 

$

9,150

 

 

$

6,174

 

 

$

2,976

 

 

 

48

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total operating expenses, net of non-cash expenses *

 

$

31,725

 

 

$

32,647

 

 

$

(922

)

 

 

(3

%)

*

This non-GAAP metric has been included because management believes that it provides for a more accurate year to year comparison of our operating expenses without the impact of non-cash items.

Research, development and clinical trials expenses.  Research, development and clinical trials expenses decreased $1.0 million, or 9%, to $9.3$2.8 million for the three months ended September 30, 2017 from $10.2 million for the three months ended September 30, 2016.same period in 2022. The change is primarily due to a decrease in clinical trial expenses resulting from the conclusion of our EF-14 phase 3 pivotal trial in newly diagnosed GBM, a decrease in expenses related to the approval of our second generation Optune and a decrease in medical grants driven principally by timing, partially offset by an increase in clinical trial expenses for our LUNAR and METIS trials. These expenses include $1.0 million of non-cash share-based compensation.

Sales and marketing expenses.  Sales and marketing expenses increased $0.5 million, or 3%, to $16.4 million for the three months ended September 30, 2017 from $15.9 million for the three months ended September 30, 2016. The change was primarily due to an increase of $1.7 million in personnel costs, including an increase of $0.7 million in non-cash share-based compensation, and an increase of $0.4 million in commercial shipping charges, reflecting our expanding commercial operations in the United States and Germany. This was partially offset by a decrease of $1.6 million in marketing expenses primarily related to advertising and professional services for the launch of our second generation Optune and the communication of our inclusion in the updated National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Central Nervous System Cancer (“NCCN Guidelines”).  These expenses include $1.9 million of non-cash share-based compensation.

General and administrative expenses.  General and administrative expenses increased $2.5 million, or 20%, to $15.2 million for the three months ended September 30, 2017 from $12.7 million for the three months ended September 30, 2016. The change was primarily due to an increase of $2.5 million in personnel costs, including an increase of $2.3 million in share based compensation. Personnel costs included $5.7 million of non-cash share-based compensation expense, including equity awards granted to our executive chairman and expenses related to our employee share purchase plan (“ESPP”).  

Financial expenses, net.  Financial expenses remained consistent at $2.2 million for both the three months ended September 30, 2017 and the three months ended September 30, 2016.  

 

 

Three months ended September 30,

 

 

 

 

 

 

 

 

 

 

 

2017

 

 

2016

 

 

Change

 

 

% Change

 

Income tax expenses

 

$

3,423

 

 

$

3,174

 

 

$

249

 

 

 

8

%

Income taxes.  Income taxes increased $0.2 million, or 8%, to $3.4 million for the three months ended September 30, 2017 from $3.2 million for the three months ended September 30, 2016. The increase was primarily a result ofincreases reflect a change in the mix of applicable statutory tax rates in certain non-USactive jurisdictions.

- 16 -


Nine months ended September 30, 2017 compared

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 nine months ended September 30, 2016

(All dollar figuresinvestors in tables are in thousands unless otherwise indicated)

 

 

Nine months ended September 30,

 

 

 

 

 

 

 

 

 

 

 

2017

 

 

2016

 

 

Change

 

 

% Change

 

Net revenues

 

$

123,365

 

 

$

52,646

 

 

$

70,719

 

 

 

134

%

Net revenues.  Net revenues increasedevaluating our operating performance because it helps investors evaluate and compare the results of our operations from period to period by $70.7removing 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 June 30,Six months ended June 30,
20232022% Change20232022% Change
Net income (loss)$(57,418)$(24,008)139 %$(110,479)$(28,655)286 %
Add: Income tax3,514 652 439 %5,495 2,784 97 %
Add: Financial expenses (income), net(8,756)2,228 (493)%(17,925)3,937 (555)%
Add: Depreciation and amortization2,721 2,654 %5,443 5,264 %
EBITDA$(59,939)$(18,474)224 %$(117,466)$(16,670)605 %
Add: Share-based compensation32,740 25,823 27 %71,824 50,868 41 %
Adjusted EBITDA$(27,199)$7,349 (470)%$(45,642)$34,198 (233)%
Adjusted EBITDA decreased by $34.5 million, or 134%470%, to $123.4a loss of $27.2 million for the ninethree months ended SeptemberJune 30, 20172023 from $52.6income of $7.3 million for the nine months ended September 30, 2016. This was primarily due to an increase of $49.6 millionsame period in commercial sales of Optune in the United States2022, and an increase of $21.2 million in commercial sales of Optune in our other currently active markets, as well as the transition to accrual-based revenue recognition for a portion of our billings.

Cost of revenues.  Our cost of revenues (excluding the impairment of field equipment described below) increaseddecreased by $11.1 million, or 38%233%, to $40.0a loss of $45.6 million for the ninesix months ended SeptemberJune 30, 20172023 from $28.9income of $34.2 million for the nine months ended September 30, 2016.  Thesame period in 2022. This decrease was primarily attributable to increased growth investments intended to expand our capacity to treat larger patient populations, to enhance commercial capabilities and to increase resulted primarily from the costawareness of shipping transducer arrays to a higher volumeTTFields in anticipation of commercial patients, as well as an increasepotential future approvals in field equipment depreciation.  Cost of revenues include $0.4 million of non-cash share-based compensation.

We received FDA approval on our PMA supplement application to market our second generation Optune in the United States in July 2016. In the second quarter 2016, we recorded an impairment loss with respect to the write-off of first generation Optune field equipment (finished goods and production stage) in the amount of $6.4 million that was not recoverable and was presented in cost of revenues. We do not expect the conversion to our second generation Optune to result in an additional material impairment charge in the future.

Operating Expenses.  

 

 

Nine months ended September 30,

 

 

 

 

 

 

 

 

 

 

 

2017

 

 

2016

 

 

Change

 

 

% Change

 

Research, development and clinical trials

 

$

28,055

 

 

$

32,996

 

 

$

(4,941

)

 

 

(15

%)

Sales and marketing

 

 

47,503

 

 

 

43,771

 

 

 

3,732

 

 

 

9

%

General and administrative

 

 

42,660

 

 

 

38,010

 

 

 

4,650

 

 

 

12

%

Total operating expenses

 

$

118,218

 

 

$

114,777

 

 

$

3,441

 

 

 

3

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-cash expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Share-based compensation expense

 

$

20,407

 

 

$

16,248

 

 

$

4,159

 

 

 

26

%

Other non-cash expenses

 

 

1,749

 

 

 

2,023

 

 

 

(274

)

 

 

(14

%)

Total non-cash expenses

 

$

22,156

 

 

$

18,271

 

 

$

3,885

 

 

 

21

%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total operating expenses, net of non-cash expenses

 

$

96,062

 

 

$

96,506

 

 

$

(444

)

 

 

(0

%)

*

This non-GAAP metric has been included because management believes that it provides for a more accurate year to year comparison of our operating expenses without the impact of non-cash items.

Research, development and clinical trials expenses.  Research, development and clinical trials expenses decreased $4.9 million, or 15%, to $28.1 million for the nine months ended September 30, 2017 from $33.0 million for the nine months ended September 30, 2016 . The change is primarily due to a decrease in clinical trial expenses resulting from the conclusion of our EF-14 phase 3 pivotal trial in newly diagnosed GBM, a decrease in expenses related to the approval of our second generation Optunenew indications, and a decreasereduction in medical grants driven principally by timing, partially offset by an increase in clinical trial expenses for our LUNAR and METIS trials. These expenses include $2.6 million of non-cash share-based compensation.

Sales and marketing expenses.  Sales and marketing expenses increased $3.7 million, or 9%, to $47.5 million for the nine months ended September 30, 2017 from $43.8 million for the nine months ended September 30, 2016. The change was primarily due to an increase of $6.1 million in personnel costs, including $0.4 million of non-cash share-based compensation, and an increase of $1.2 million in commercial shipping charges, reflecting our expanding commercial operations in the United States and Germany. This was partially offset by a decrease of $1.6 million in marketing expenses primarily related to advertising and professional services for the launch of our second generation Optune and the communication of our inclusion in the updated NCCN Guidelines.  These expenses include $4.3 million of non-cash share-based compensation.

- 17 -


General and administrative expenses.  General and administrative expenses increased $4.7 million, or 12%, to $42.7 million for the nine months ended September 30, 2017 from $38.0 million for the nine months ended September 30, 2016. The change was primarily due to an increase of $5.6 million in personnel costs, including $3.5 million in share based compensation, partially offset by a decrease of $0.9 million in professional services and other expenses. Personnel costs included $13.5 million of non-cash share-based compensation expense, including equity awards granted to our executive chairman and expenses related to our ESPP.  

Financial expenses, net.  Financial expenses, net increased by $3.5 million, or 106%, to $6.8 million for the nine months ended September 30, 2017 from $3.3 million for the nine months ended September 30, 2016. The change was primarily due to an increase in interest expense, including amortization expense of the discount and deferred issuance costs, related to our July 2016 withdrawal of the remaining $75 million in available funds under the term loan credit facility that we,revenue as borrower, entered into with BioPharma Secured Investments III Holdings Cayman LP, as lender, in January 2015, amended as of December 2016, February 2017 and September 2017 (collectively, the “Term Loan Credit Facility”).

described above.

 

 

Nine months ended September 30,

 

 

 

 

 

 

 

 

 

 

 

2017

 

 

2016

 

 

Change

 

 

% Change

 

Income tax expenses

 

$

9,110

 

 

$

8,944

 

 

$

166

 

 

 

2

%


Income taxes.  Income taxes increased by $0.2 million to $9.1 million for the nine months ended September 30, 2017 from $8.9 million for the nine months ended September 30, 2016. The increase was primarily a result of a change in the mix of applicable statutory tax rates in certain non-US jurisdictions.

Liquidity and Capital Resources

Sources

We have incurred significant losses and cumulative negative cash flows from operations since our founding in 2000. As of Liquidity

Since inception,June 30, 2023, we had an accumulated deficit of $888.9 million. To date, we have primarily financed our operations primarily through the issuance and sale of equity and the proceeds from long-term loans. As of September

At June 30, 2017,2023, we had received a total of $715.9$940.8 million from these activities. As of September 30, 2017, we had an accumulated deficit of $571.3 million since inception.

Our net losses were $50.7 million for the nine months ended September 30, 2017 and $131.8 million for the year ended December 31, 2016. Our net losses primarily resulted from costs incurred in connection with our pre-clinical and clinical trial programs, costs incurred in our commercial launch efforts, and general and administrative costs necessary to operate as a multi-national oncology business.

As of September 30, 2017, we had $82.1 million of cash, and cash equivalents and $104.5short-term investments, a decrease of $28.6 million of short-term investments.compared to $969.4 million at December 31, 2022. We believe our cash, and cash equivalents and short termshort-term investments as of SeptemberJune 30, 2017,2023 are sufficient for our operations for at least the next twelve12 months taking into considerationbased on our existing business plan and our ability to control the timing of significant expense commitments and our upcoming milestone payment obligation discussed below.

In the first quarter of 2018, we anticipate making a milestone payment of $5.5 million (the “Milestone Payment”) to the Technion Research and Development Foundation (“Technion”) pursuant to the settlement agreement dated February 10, 2015 (the “Settlement Agreement”).  Pursuant to the Settlement Agreement, we are obligated to pay the Milestone Payment to Technion in the quarter following the quarter in which we achieve $250.0 million of cumulative net sales (as defined in the Settlement Agreement) (the “Net Sales Milestone”).commitments. We anticipate achieving the Net Sales Milestone in the fourth quarter of 2017. We previously accrued for the anticipated Milestone Payment in the fourth quarter of 2016. 

We also expect that our research, development and clinical trials expenses, sales and marketing expenses and general and administrative operating expenses will continue to increase over the next several years.years and may outpace our gross profit as we prepare to expand into additional indications beyond GBM. As a result, we may need to raise additional capital in the future to fund our operations.

- 18 -

24

Table of Contents

 

 

Nine months ended September 30,

 

 

 

2017

 

 

2016

 

Net cash used in operating activities

 

$

(30,236

)

 

$

(93,867

)

Net cash provided by investing activities

 

 

8,713

 

 

 

16,406

 

Net cash provided by financing activities

 

 

3,839

 

 

 

73,796

 

Net decrease in cash and cash equivalents

 

 

(17,684

)

 

 

(3,665

)

Effect of exchange rates on cash and cash equivalents

 

 

8

 

 

 

64

 

Changes in short-term investments

 

 

(15,994

)

 

 

(30,277

)

Net decrease in cash, cash equivalents and short-term investments

 

$

(33,670

)

 

$

(33,878

)

The following summary of our cash flows for the periods indicated has been derived from our unaudited consolidated financial statements, which are included elsewhere in this Quarterly Report:

Six months ended June 30,
20232022Change% Change
Net cash provided by (used in) operating activities$(39,464)$12,075 $(51,539)(427)%
Net cash provided by (used in) investing activities68,390 138,347 (69,957)(51)%
Net cash provided by financing activities12,706 7,877 4,829 61 %
Effect of exchange rate changes on cash and cash equivalents28 (145)173 (119)%
Net increase (decrease) in cash, cash equivalents and restricted cash$41,660 $158,154 $(116,494)(74)%
Operating activities

activities. Net cash used in or provided by operating activities primarily represents our net lossincome (loss) for the periods presented. Adjustments to net loss for non-cash items includepresented, share-based compensation and depreciation and amortization, accrued interest and impairments.amortization. Operating cash flows are also impacted by changes in operating assets and liabilities, principally trade receivables, prepaid expenses, inventories, trade payables and accrued expenses.

working capital.

Net cash used in operating activities was $30.2increased by $51.5 million from $12.1 million net cash provided by operating activities for the ninesix months ended SeptemberJune 30, 2017, as compared2022 to $93.9$39.5 million net cash used in operating activities for the ninesix months ended SeptemberJune 30, 2016, reflecting2023. This increase was a net loss of $50.7 million and a change of $6.2 million in our net operating assets and liabilities, partially offset by non-cash charges of $26.7 million.

The change in our net operating assets and liabilities was primarily the result of an increase in other payables of $8.3 million, a decrease in other receivables of $4.5 million, an increase in other long-term liabilities and employee benefit liabilities, net of $1.4 million, and a decrease in inventories of $0.9income decreasing $81.8 million, offset by a $24.4 million decrease in working capital, an increase of $11.0 million in trade receivablescash to non-cash based expenses primarily consisting of $16.7 million, a decrease in trade payables of $4.2 million,shared-based compensation and an increase of $4.6 million in other long-term assetslong term assets. The decrease in working capital includes a $26.7 million decrease in accounts receivable offset by a decrease of $0.5 million. Non-cash charges included $20.8 million of share-based compensation, $5.7 million of depreciation and amortization and $0.2$3.1 million in impairments.

accounts payable.

Investing activities

activities. Our investing activities consist primarily of capital expenditures to purchase property and equipment and field equipment, as well as investments in and redemptions of our short-term investments.

investments as well as investments in property and equipment.

Net cash provided by investing activities was $8.7$68.4 million for the ninesix months ended SeptemberJune 30, 2017,2023, compared to $16.4$138.3 million provided by investing activities for the ninesix months ended SeptemberJune 30, 2016, reflecting an increase2022. The $68.4 million net cash provided by investing activities for the six months ended June 30, 2023 was primarily attributable to our receipt$81.4 million of $120.0 millionnet proceeds from the maturity of short-term investments partially offsetand the purchase of $13.0 million of property and equipment. The $138.3 million net cash provided by investing activities for the six months ended June 30, 2022 was primarily attributable to $147.6 million of net proceeds in short-term investments and by the purchase of $104.0 million of new short-term investments, purchases of $3.5 million of field equipment, purchases of $2.0$9.2 million of property and equipment, and a $1.9 million increase in restricted cash.  

equipment.

Financing activities

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 $3.8$12.7 million for the ninesix months ended SeptemberJune 30, 2017,2023, as compared to $73.8$7.9 million provided by financing activities for the ninesix months ended SeptemberJune 30, 2016, reflecting2022. The net cash provided by financing activities for the six months ended June 30, 2023 and June 30, 2022 included proceeds received from the exercise of warrants and options and our ESPP.

Our material outstanding indebtedness consists of our Term Loan Credit Facility.  As of September 30, 2017,under the Company's stock option plan.

Convertible Notes
On November 5, 2020, we issued $575.0 million aggregate principal balanceamount of amounts outstanding under0% Convertible Senior Notes due 2025 (the “Notes”). The Notes are senior unsecured obligations. The Notes do not bear regular interest, and the Term Loan Credit Facility was $100.0 million. Weprincipal 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 prepayconvert all or any portion of their Notes at the term loans, in whole,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 must prepayour 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
25

Table of Contents
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.
For more information, see Note 10a. to the Consolidated Financial Statements in the event2022 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 a change of control, in each case, subject to a pay-down fee, prepayment premium and/or make-whole payment. Interest on the outstanding loan is 10% annually, payable quarterly in arrears. The pay-down fee on all principal payments to be paid on the date such payments are made is 0.75% and the pre-payment fee ifrelationship banks (the "2020 Credit Facility"). On February 17, 2023, we prepay outstanding loan amounts priorgave irrevocable notice to the first, second or third year from the initial funding date is 3.0%, 2.0% or 1.0%, respectively.

- 19 -


All obligationsadministrative agent under the Term Loan2020 Credit Facility that we terminated all commitments, effective February 22, 2023. This effectively terminated the 2020 Credit Facility, as our ability to borrow and our obligations to comply with all covenants ended on such date. The liens and guaranties in favor of the lenders are released. There was no early termination fee payable.

The commitments under the 2020 Credit Facility were guaranteed by certain of our currentsubsidiaries and future domestic direct and indirect subsidiaries. In addition, the obligations under the Term Loan Credit Facility are secured by a first-priority securityfirst lien on our and certain of our subsidiaries’ assets. Outstanding loans bore 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 substantially allwhich the loan is denominated. Additionally, the 2020 Credit Facility contained 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 contained financial covenants requiring maintenance of the propertya minimum fixed charge coverage ratio and assets of,specifying a maximum senior secured net leverage ratio, as well as the equity interests owned by, us and the other guarantors.  On March 28, 2017, the Term Loan Credit Facility was amended ascustomary events of February 21, 2017 to increase to $1.5 million the limit in the Company’s pledges and deposits security liability for reimbursement or indemnification obligations in respectdefault which include a change of letters of credit or bank guarantees for the benefit of the Company’s landlords.  On September 29, 2017, the Term Loan Credit Facility was amended as of September 27, 2017 to increase the limit on the Company’s cash held at any financial institution to secure one or more letters of credit issued by such financial institution in respect of leased premises to $1.5 million, to increase the limit on the aggregate balance in certain of the Company’s operating accounts to $2.5 million, and to add certain provisions enabling the Company’s use of storage facilities to facilitate distribution of products to patients.

The Term Loan Credit Facility has a minimum liquidity covenant,control, which is tested quarterly. In addition, we must meet certain pro forma net sales requirements. The Term Loan Credit Facility also contains other customary covenants.

are no longer applicable.

Contractual Obligations and Commitments

There werehave been no material changes from the information disclosed in our commitments under contractual obligations during the three months ended September 30, 2017.

The total amount of unrecognized tax benefits for uncertain tax positions was $3.5 million and $2.4 million at September 30, 2017 and December 31, 2016, respectively. Payment of these obligations would result from settlements with taxing authorities. Discussions with the taxing authorities are ongoing and we cannot estimate with reasonable certainty the timing or amount of any such payments.

2022 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 SECU.S. Securities and Exchange Commission (“SEC”) rules.

Item 3.  Quantitative and Qualitative Disclosures About Market Risk

There have been no material changes from the information disclosed in our Annual Report on Form 10-K for the year ended December 31, 2016.

2022 10-K.

Item 4.  Controls and Procedures

Evaluation of Disclosure Controls and Procedures

As required by Rule 13a-15(b) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), our management, under the supervision and with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of the design and operation of our disclosure controls and procedures as of SeptemberJune 30, 2017.2023. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, as appropriate, to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of SeptemberJune 30, 2017,2023, our Chief Executive Officer and Chief Financial Officer have concluded that, as of SeptemberJune 30, 2017,2023, our disclosure controls and procedures were effective at the reasonable assurance level.

Changes in Internal Control over Financial Reporting

There has been no change in our internal control over financial reporting during the quarter ended SeptemberJune 30, 2017,2023 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

- 20 -

26

Table of Contents
PART II—OTHER INFORMATION

Item 1.  Legal Proceedings

In January 2017, twoJune 2023, a putative class action lawsuits werelawsuit was filed against the Company, its directorsExecutive Chairman and certain of its officers, as well as the underwriters in the Company’s October 2015 initial public offering.Chief Executive Officer. The complaints,complaint, which purportpurports to be brought on behalf of a class of persons and/or entities who purchased or otherwise acquired ordinary shares of the Company pursuant and/or traceable to the registration statement and prospectus issued in connection with the Company’s initial public offering,from January 5, 2023 through June 5, 2023, allege material misstatements and/or omissions in the Company’s initial public offering materials in alleged violation of the federal securities laws and seek compensatory damages, among other remedies.  The two actions have been consolidated and the plaintiffs filed a consolidated amended complaint on May 31, 2017.  The court granted the defendants’ motion to bifurcate the motion to dismiss into two stages: a threshold motion to dismiss for lack of personal jurisdiction, lack of subject matter jurisdiction, and insufficient process and service of process; and, if the matter is not dismissed following that threshold motion, a subsequent merits motion to dismiss regarding whether the allegations in the amended complaint state a claim under the securities laws. The defendants filed the threshold motion to dismiss on July 31, 2017, and the plaintiffs filed an oppositionstatements with respect to the threshold motion to dismiss on September 29, 2017.results from its phase 3 LUNAR clinical trial. The Company believes that the amended complaintaction is without merit and plans to defend the consolidated lawsuitslawsuit vigorously.  The Company has not accrued any amounts
In addition, from time to time, we are involved in respectvarious legal proceedings, claims, investigations and litigation that arise in the ordinary course of our business. Litigation is inherently uncertain. Accordingly, we cannot predict with certainty the outcome of these lawsuits, asmatters. After considering a liabilitynumber of factors, including (but not limited to) the views of legal counsel, the nature of contingencies to which the Company is subject and prior experience, management believes that the ultimate disposition of these legal actions will not probable and the amountmaterially affect its consolidated financial position or results of any potential liability cannot be reasonably estimated.

operations.

Item 1A.  Risk Factors

There have been no material changes to our risk factors disclosed in our Annual Report on Form 10-K forPart I, Item 1A “Risk Factors” in the year ended December 31, 2016.

2022 10-K.

Item 2.  Unregistered Sales of Equity Securities and Use of Proceeds

In July 2017, an investor in our 2007 Series E preferred shares offering exercised warrants to purchase 1,293 ordinary shares with an exercise price of $3.59 per share.  We believe that this issuance was exempt from registration under the Securities Act of 1933, as amended (the “Securities Act”), in reliance on Section 4(a)(2) of the Securities Act regarding transactions not involving a public offering.

None.

Item 3.  Defaults Upon Senior Securities

None.

Item 4.  Mine Safety Disclosures

Not applicable.

Item 5.  Other Information

None.

- 21 -

Securities Trading Plans of Executive Officers and Directors
Rule 10b5-1 under the Exchange Act provides an affirmative defense that enables prearranged transactions in securities in a manner that avoids concerns about initiating transactions at a future date while possibly in possession of material nonpublic information. Our Insider Trading Policy permits our executive officers and directors to enter into trading plans designed to comply with Rule 10b5-1.
The following table describes contracts, instructions or written plans for the purchase or sale of our securities that are intended to satisfy the affirmative defense conditions of Rule 10b5–1(c) promulgated under the Securities Exchange Act of 1934, as amended (each a "Rule 10b5-1 Plan") adopted by our executive officers and directors during the three month period ending June 30, 2023:
Name and TitleDate of AdoptionDuration of Rule 10b5-1 PlanAggregate Number of Securities to be Purchased Pursuant to the Rule 10b5-1 PlanAggregate Number of Securities to be Sold Pursuant to the Rule 10b5-1 Plan
Uri Weinberg, Chief Innovation OfficerJune 9, 20231/2/2024-12/31/202437,474 92,859 
Kinyip Gabriel Leung, DirectorJune 8, 20239/7/2023-8/31/202418,136 70,136 
During the three-month period ending June 30, 2023, none of our executive officers or directors terminated a Rule 10b5-1 trading plan or adopted or terminated a non-Rule 10b5-1 trading arrangement (as defined in Item 408(c) of Regulation S-K).
27

Table of Contents

Item 6.  Exhibits

EXHIBIT INDEX

Exhibit

 

 

 

Incorporated by Reference

 

Filed

Number

 

Exhibit Description

 

Form

 

Date

 

Number

 

Herewith

10.1

 

Third Amendment to Loan and Security Agreement, dated as of September 27, 2017, by and between the Company and BioPharma Secured Investments III Holdings Cayman LP

 

8-K

 

10/5/17

 

10.1

 

 

31.1

 

Certification of Principal Executive Officer Required Under Rule 13a-14(a) and 15d-14(a) of the Securities Exchange Act of 1934, as amended

  

 

 

 

 

 

 

X

31.2

 

Certification of Principal Financial Officer Required Under Rule 13a-14(a) and 15d-14(a) of the Securities Exchange Act of 1934, as amended

  

 

 

 

 

 

 

X

32.1*

 

Certification of Principal Executive Officer Required Under Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, and 18 U.S.C. §1350

  

 

 

 

 

 

 

X

32.2*

 

Certification of Principal Financial Officer Required Under Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, and 18 U.S.C. §1350

  

 

 

 

 

 

 

X

99.1

 

NovoCure Limited Policy on Recoupment of Incentive Compensation

 

8-K

 

8/1/17

 

99.1

 

 

101.INS

 

XBRL Instance Document

 

 

 

 

 

 

 

X

101.SCH

 

XBRL Taxonomy Extension Schema Document

 

 

 

 

 

 

 

X

101.CAL

 

XBRL Taxonomy Extension Calculation Linkbase Document

 

 

 

 

 

 

 

X

101.DEF

 

XBRL Taxonomy Extension Definition Linkbase Document

 

 

 

 

 

 

 

X

101.LAB

 

XBRL Taxonomy Extension Label Linkbase Document

 

 

 

 

 

 

 

X

101.PRE

 

XBRL Extension Presentation Linkbase Document

 

 

 

 

 

 

 

X

*

The certifications attached as Exhibits 32.1

Exhibit
Number
Incorporated by ReferenceFiled
Herewith
Exhibit DescriptionFormDateNumber
31.1X
31.2X
32.1*X
32.2*X
101.INSInline XBRL Instance DocumentX
101.SCHInline XBRL Taxonomy Extension Schema DocumentX
101.CALInline XBRL Taxonomy Extension Calculation Linkbase DocumentX
101.DEFInline XBRL Taxonomy Extension Definition Linkbase DocumentX
101.LABInline XBRL Taxonomy Extension Label Linkbase DocumentX
101.PREInline XBRL Extension Presentation Linkbase DocumentX
104Cover Page Interactive Date File (formatted as Inline XBRL and contained in such filing.

Exhibit 101)
X

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*    The certifications attached as Exhibits 32.1 and 32.2 that accompany this Quarterly Report on Form 10-Q are not deemed filed with the Securities and Exchange Commission and are not to be incorporated by reference into any filing of NovoCure Limited under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Form 10-Q, irrespective of any general incorporation language contained in such filing.




28

SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

NovoCure Limited

NovoCure Limited

Date: October 26, 2017

/s/ Wilco Groenhuysen

Date: July 27, 2023

Wilco Groenhuysen

/s/ Ashley Cordova

Ashley Cordova
Chief Financial Officer


(principal financial and accounting officer


and duly authorized officer)

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29