nvcr-10q_20170630.htm

 

 

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 June 30, 2017

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

(State or Other Jurisdiction of

 

(I.R.S. Employer

Incorporation or Organization)

 

Identification No.)

 

Le Masurier House

La Rue Le Masurier

St. Helier, Jersey JE2 4YE

(Address of principal executive offices)

+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)

 

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’s classes of common stock, as of the latest practicable date.

 

Class

 

Outstanding as of July 20, 2017

Ordinary shares, no par value

 

89,002,575 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 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,” 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. In particular, these forward-looking statements include, among others, statements about:

 

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

 

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

 

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

 

the market acceptance of Optune and our other TTFields delivery systems by patients, physicians, third-party payers and others in the healthcare and scientific community;

 

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

 

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

 

our ability to obtain regulatory approvals for additional indications and any future TTFields delivery systems;

 

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

 

our ability to manufacture adequate supply;

 

our ability to secure adequate coverage from third-party payers to reimburse us for Optune or future TTFields delivery systems;

 

our ability to maintain and develop our intellectual property position;

 

our cash needs;

 

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-looking statements. Factors which may cause such differences to occur include those risks and uncertainties set forth under Part I, Item 1A., “Risk Factors” of our Annual Report on Form 10-K for the fiscal year ended December 31, 2016, 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. 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.

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

 

 

 

 

 

Page

Cautionary Note Regarding Forward Looking Statements

 

ii

Trademarks

 

ii

 

PART I—FINANCIAL INFORMATION

 

Item 1.

 

Financial Statements

  

2

Item 2.

 

Management’s Discussion and Analysis of Financial Condition and Results of Operations

  

12

Item 4.

 

Controls and Procedures

  

20

 

PART II—OTHER INFORMATION

 

Item 1.

 

Legal Proceedings

  

21

Item 2.

 

Unregistered Sales of Equity Securities and Use of Proceeds

  

21

Item 6.

 

Exhibits

  

22

 

 

 

Signatures

 

23

 

 

- 1 -


 

PART I—FINANCIAL INFORMATION

Item 1.  Financial Statements

NOVOCURE LIMITED AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

U.S. dollars in thousands

 

 

 

June 30,

 

 

December 31,

 

 

 

2017

 

 

2016

 

 

 

Unaudited

 

 

Audited

 

ASSETS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CURRENT ASSETS:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

80,190

 

 

$

99,780

 

Short-term investments

 

 

104,186

 

 

 

119,854

 

Restricted cash

 

 

1,537

 

 

 

267

 

Trade receivables

 

 

13,888

 

 

 

6,339

 

Receivables and prepaid expenses

 

 

11,544

 

 

 

10,084

 

Inventories

 

 

25,147

 

 

 

25,549

 

Total current assets

 

 

236,492

 

 

 

261,873

 

 

 

 

 

 

 

 

 

 

LONG-TERM ASSETS:

 

 

 

 

 

 

 

 

Property and equipment, net

 

 

9,621

 

 

 

9,812

 

Field equipment, net

 

 

9,061

 

 

 

8,808

 

Severance pay fund

 

 

102

 

 

 

88

 

Other long-term assets

 

 

1,766

 

 

 

1,500

 

Total long-term assets

 

 

20,550

 

 

 

20,208

 

 

 

 

 

 

 

 

 

 

TOTAL ASSETS

 

$

257,042

 

 

$

282,081

 

 

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

- 2 -


 

NOVOCURE LIMITED AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

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

 

 

 

June 30,

 

 

December 31,

 

 

 

2017

 

 

2016

 

 

 

Unaudited

 

 

Audited

 

LIABILITIES AND SHAREHOLDERS' EQUITY

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CURRENT LIABILITIES:

 

 

 

 

 

 

 

 

Trade payables

 

$

13,161

 

 

$

18,356

 

Other payables and accrued expenses

 

 

22,010

 

 

 

18,526

 

Total current liabilities

 

 

35,171

 

 

 

36,882

 

 

 

 

 

 

 

 

 

 

LONG-TERM LIABILITIES:

 

 

 

 

 

 

 

 

Long-term loan, net of discount and issuance costs

 

 

96,765

 

 

 

96,231

 

Employee benefit liabilities

 

 

2,679

 

 

 

2,590

 

Other long-term liabilities

 

 

4,882

 

 

 

4,033

 

Total long-term liabilities

 

 

104,326

 

 

 

102,854

 

 

 

 

 

 

 

 

 

 

TOTAL LIABILITIES

 

 

139,497

 

 

 

139,736

 

 

 

 

 

 

 

 

 

 

COMMITMENTS AND CONTINGENCIES

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SHAREHOLDERS' EQUITY:

 

 

 

 

 

 

 

 

Share capital -

 

 

-

 

 

 

-

 

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

   88,630,205 shares and 87,066,446 shares at June 30, 2017 (unaudited)  and

   December 31, 2016, respectively

 

 

 

 

 

 

 

 

Additional paid-in capital

 

 

679,099

 

 

 

664,154

 

Accumulated other comprehensive loss

 

 

(1,739

)

 

 

(1,883

)

Accumulated deficit

 

 

(559,815

)

 

 

(519,926

)

Total shareholders' equity

 

 

117,545

 

 

 

142,345

 

 

 

 

 

 

 

 

 

 

TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY

 

$

257,042

 

 

$

282,081

 

 

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

 

 

- 3 -


 

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,

 

 

 

2017

 

 

2016

 

 

2017

 

 

2016

 

 

2016

 

 

 

Unaudited

 

 

Unaudited

 

 

Audited

 

Net revenues

 

$

38,376

 

 

$

17,919

 

 

$

73,256

 

 

$

30,972

 

 

$

82,888

 

Cost of revenues

 

 

13,152

 

 

 

9,797

 

 

 

24,816

 

 

 

17,779

 

 

 

39,870

 

Impairment of field equipment

 

 

-

 

 

 

6,412

 

 

 

-

 

 

 

6,412

 

 

 

6,412

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Gross profit

 

 

25,224

 

 

 

1,710

 

 

 

48,440

 

 

 

6,781

 

 

 

36,606

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating costs and expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research, development and clinical trials

 

 

9,371

 

 

 

11,318

 

 

 

18,782

 

 

 

22,763

 

 

 

41,467

 

Sales and marketing

 

 

16,360

 

 

 

14,598

 

 

 

31,116

 

 

 

27,906

 

 

 

59,449

 

General and administrative

 

 

15,023

 

 

 

13,031

 

 

 

27,445

 

 

 

25,287

 

 

 

51,007

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total operating costs and expenses

 

 

40,754

 

 

 

38,947

 

 

 

77,343

 

 

 

75,956

 

 

 

151,923

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating loss

 

 

(15,530

)

 

 

(37,237

)

 

 

(28,903

)

 

 

(69,175

)

 

 

(115,317

)

Financial expenses, net

 

 

(2,183

)

 

 

(555

)

 

 

(4,629

)

 

 

(1,104

)

 

 

(6,147

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss before income tax expense

 

 

(17,713

)

 

 

(37,792

)

 

 

(33,532

)

 

 

(70,279

)

 

 

(121,464

)

Income tax expense

 

 

3,461

 

 

 

2,820

 

 

 

5,687

 

 

 

5,770

 

 

 

10,381

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(21,174

)

 

$

(40,612

)

 

$

(39,219

)

 

$

(76,049

)

 

$

(131,845

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted net loss per ordinary share

 

$

(0.24

)

 

$

(0.48

)

 

$

(0.45

)

 

$

(0.90

)

 

$

(1.54

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average number of ordinary shares used in

   computing basic and diluted net loss per share

 

 

88,218,868

 

 

 

85,274,683

 

 

 

87,835,926

 

 

 

84,843,028

 

 

 

85,558,448

 

 

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,

 

 

 

2017

 

 

2016

 

 

2017

 

 

2016

 

 

2016

 

 

 

Unaudited

 

 

Unaudited

 

 

Audited

 

Net loss

 

$

(21,174

)

 

$

(40,612

)

 

$

(39,219

)

 

$

(76,049

)

 

$

(131,845

)

Other comprehensive income (loss), net of tax :

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Change in foreign currency translation adjustments

 

 

1

 

 

 

56

 

 

 

10

 

 

 

56

 

 

 

10

 

Pension benefit plan

 

 

183

 

 

 

235

 

 

 

134

 

 

 

(235

)

 

 

(388

)

Total comprehensive loss

 

$

(20,990

)

 

$

(40,321

)

 

$

(39,075

)

 

 

(76,228

)

 

$

(132,223

)

 

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

 

 

- 4 -


 

NOVOCURE LIMITED AND SUBSIDIARIES

CONSOLIDATED 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

 

 

-

 

 

 

 

12,131

 

 

 

-

 

 

 

-

 

 

 

12,131

 

Exercise of options and warrants

 

 

1,446,792

 

 

 

 

1,363

 

 

 

-

 

 

 

-

 

 

 

1,363

 

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 loss, net of tax benefit of $29

 

 

-

 

 

 

 

-

 

 

 

144

 

 

 

-

 

 

 

144

 

Net loss

 

 

-

 

 

 

 

-

 

 

 

-

 

 

 

(39,219

)

 

 

(39,219

)

Balance as of June 30, 2017 (unaudited)

 

 

88,630,205

 

 

 

$

679,099

 

 

$

(1,739

)

 

$

(559,815

)

 

$

117,545

 

  

 

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

 

 

- 5 -


 

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,

 

 

 

2017

 

 

2016

 

 

2017

 

 

2016

 

 

2016

 

 

 

Unaudited

 

 

Unaudited

 

 

Audited

 

Cash flows from operating activities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(21,174

)

 

$

(40,612

)

 

$

(39,219

)

 

$

(76,049

)

 

$

(131,845

)

Adjustments to reconcile net loss to net cash used in

   operating activities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Depreciation and amortization

 

 

1,811

 

 

 

1,407

 

 

 

3,471

 

 

 

2,510

 

 

 

5,652

 

Asset write-downs and impairment of field equipment

 

 

59

 

 

 

6,425

 

 

 

134

 

 

 

6,430

 

 

 

6,446

 

Increase in accrued interest expense

 

 

-

 

 

 

(637

)

 

 

-

 

 

 

-

 

 

 

-

 

Share-based compensation to employees

 

 

7,570

 

 

 

5,637

 

 

 

12,131

 

 

 

11,093

 

 

 

22,139

 

Excess tax benefits from share-based award activity

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

(698

)

Increase in trade receivables

 

 

(2,064

)

 

 

-

 

 

 

(7,550

)

 

 

-

 

 

 

(6,339

)

Amortization of discount (premium)

 

 

103

 

 

 

(39

)

 

 

209

 

 

 

(56

)

 

 

155

 

Decrease (increase) in receivables and prepaid expenses

 

 

3,354

 

 

 

(1,672

)

 

 

(1,461

)

 

 

(2,208

)

 

 

243

 

Decrease (Increase) in inventories

 

 

803

 

 

 

(4,769

)

 

 

403

 

 

 

(7,621

)

 

 

(11,955

)

Increase in other long-term assets

 

 

(38

)

 

 

(111

)

 

 

(294

)

 

 

(278

)

 

 

(692

)

Increase (decrease) in trade payables

 

 

(1,638

)

 

 

2,321

 

 

 

(5,195

)

 

 

4,144

 

 

 

1,601

 

Increase in other payables and accrued expenses

 

 

4,888

 

 

 

2,399

 

 

 

3,478

 

 

 

756

 

 

 

6,647

 

Increase in employee benefit liabilities, net

 

 

130

 

 

 

32

 

 

 

239

 

 

 

270

 

 

 

97

 

Increase in other long-term liabilities

 

 

321

 

 

 

225

 

 

 

871

 

 

 

638

 

 

 

957

 

Net cash used in operating activities

 

$

(5,875

)

 

$

(29,394

)

 

$

(32,783

)

 

$

(60,371

)

 

$

(107,592

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash flows from investing activities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Purchase of property and equipment

 

$

(376

)

 

$

(2,338

)

 

$

(1,407

)

 

$

(3,340

)

 

$

(5,674

)

Purchase of field equipment

 

 

(859

)

 

 

(4,274

)

 

 

(2,261

)

 

 

(6,100

)

 

 

(11,990

)

increase in restricted cash

 

 

(1

)

 

 

(13

)

 

 

(1,269

)

 

 

(12

)

 

 

(180

)

Proceeds from maturity of short-term investments

 

 

60,000

 

 

 

-

 

 

 

120,000

 

 

 

150,000

 

 

 

270,000

 

Purchase of short-term investments

 

 

(59,352

)

 

 

-

 

 

 

(104,006

)

 

 

(119,728

)

 

 

(239,341

)

Net cash provided by (used in) investing activities

 

$

(588

)

 

$

(6,625

)

 

$

11,057

 

 

$

20,820

 

 

$

12,815

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash flows from financing activities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Proceeds from issuance of shares, net

 

$

781

 

 

$

-

 

 

$

781

 

 

$

-

 

 

$

616

 

Proceeds from long-term loan, net

 

 

19

 

 

 

17

 

 

 

19

 

 

 

17

 

 

 

72,887

 

Excess tax benefits from share-based award activity

 

 

-

 

 

 

-

 

 

 

-

 

 

 

-

 

 

 

698

 

Repayment of other long-term loan

 

 

(19

)

 

 

(19

)

 

 

(37

)

 

 

(35

)

 

 

(70

)

Exercise of options and warrants

 

 

1,286

 

 

 

904

 

 

 

1,363

 

 

 

961

 

 

 

993

 

Net cash provided by financing activities

 

$

2,067

 

 

$

902

 

 

$

2,126

 

 

$

943

 

 

$

75,124

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Effect of exchange rate changes on cash and cash equivalents

 

$

(1

)

 

$

56

 

 

$

10

 

 

$

56

 

 

$

10

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Decrease in cash and cash equivalents

 

 

(4,397

)

 

 

(35,061

)

 

 

(19,590

)

 

 

(38,552

)

 

 

(19,643

)

Cash and cash equivalents at the beginning of the period

 

 

84,587

 

 

 

115,932

 

 

 

99,780

 

 

 

119,423

 

 

 

119,423

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents at the end of the period

 

$

80,190

 

 

$

80,871

 

 

$

80,190

 

 

$

80,871