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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 September 30, 2024
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.) |
No. 4 The Forum
Grenville Street
St. Helier, Jersey JE2 4UF
(Address of principal executive 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 class | Trading Symbol(s) | Name of each exchange on which registered |
Ordinary Shares, no par value | NVCR | The 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 every Interactive Data File required to be submitted 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 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. | | | | | | | | | | | | | | |
Large accelerated filer | ☒ | | Accelerated filer | ☐ |
| | | |
Non-accelerated filer | ☐ | | 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 issuer’s classes of common stock, as of the latest practicable date. | | | | | | | | |
Class | | Outstanding as of October 25, 2024 |
Ordinary shares, no par value | | 108,201,434 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 research and development related to our Tumor Treating Fields ("TTFields") devices marketed under various brand names, including "Optune Gio" and "Optune Lua", and software, tools and other items to support and optimize the delivery of TTFields (collectively, the “Products”). In particular, these forward-looking statements include, among others, statements about:
•our research and development, clinical study and commercialization activities and projected expenditures;
•the further commercialization of our Products for current and future indications;
•our business strategies and the expansion of our sales and marketing efforts in the United States ("U.S.") and in other countries;
•the market acceptance of our Products for current and future indications by patients, physicians, third-party payers and others in the healthcare and scientific community;
•our plans to pursue the use of our Products for the treatment of indications other than glioblastoma (“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 the use of our Products in indications other than GBM and MPM;
•our ability to acquire from third-party suppliers the supplies needed to manufacture our Products;
•our ability to manufacture adequate supply of our Products;
•our ability to secure and maintain adequate coverage from third-party payers to reimburse us for our Products for current and future indications;
•our ability to receive payment from third-party payers for use of our Products for current and future indications;
•our ability to maintain, 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 COVID-19 (coronavirus), or international conflict or other disruptions outside of our control;
•our cash needs; 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” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 filed on February 22, 2024, as well as other risks and uncertainties set forth from time to time in the reports we file with the Securities and Exchange Commission (the "SEC"). In our prior filings, references to Optune now refer to Optune Gio® and NovoTTF-100L 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.
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.
NovoCure Limited
Quarterly Report on Form 10-Q
PART I—FINANCIAL INFORMATION
Item 1. Financial Statements
| | | | | | | | | | | |
NOVOCURE LIMITED AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS |
U.S. dollars in thousands (except share data) |
| September 30, 2024 | | December 31, 2023 |
| Unaudited | | Audited |
ASSETS | | | |
CURRENT ASSETS: | | | |
Cash and cash equivalents | $ | 185,422 | | | $ | 240,821 | |
Short-term investments | 774,476 | | | 669,795 | |
Restricted cash | 3,777 | | | 1,743 | |
Trade receivables, net | 67,060 | | | 61,221 | |
Receivables and prepaid expenses | 25,437 | | | 22,677 | |
Inventories | 39,096 | | | 38,152 | |
Total current assets | 1,095,268 | | | 1,034,409 | |
LONG-TERM ASSETS: | | | |
Property and equipment, net | 73,251 | | | 51,479 | |
Field equipment, net | 12,913 | | | 11,384 | |
Right-of-use assets | 28,330 | | | 34,835 | |
Other long-term assets | 12,224 | | | 14,022 | |
Total long-term assets | 126,718 | | | 111,720 | |
TOTAL ASSETS | $ | 1,221,986 | | | $ | 1,146,129 | |
| | | |
The accompanying notes are an integral part of these unaudited consolidated financial statements. |
| | | | | | | | | | | |
NOVOCURE LIMITED AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS |
U.S. dollars in thousands (except share data) |
| September 30, 2024 | | December 31, 2023 |
| Unaudited | | Audited |
LIABILITIES AND SHAREHOLDERS' EQUITY | | | |
CURRENT LIABILITIES: | | | |
Convertible note | $ | 557,333 | | | $ | — | |
Trade payables | 91,319 | | | 94,391 | |
Other payables, lease liabilities and accrued expenses | 86,350 | | | 84,724 | |
Total current liabilities | 735,002 | | | 179,115 | |
LONG-TERM LIABILITIES: | | | |
Convertible note | — | | | 568,822 | |
Senior secured credit facility, net | 97,149 | | | — | |
Long-term leases | 21,144 | | | 27,420 | |
Employee benefit liabilities | 7,892 | | | 8,258 | |
Other long-term liabilities | 18 | | | 18 | |
Total long-term liabilities | 126,203 | | | 604,518 | |
TOTAL LIABILITIES | 861,205 | | | 783,633 | |
COMMITMENTS AND CONTINGENCIES | | | |
| | | |
SHAREHOLDERS' EQUITY: | | | |
Share capital - | | | |
Ordinary shares no par value, unlimited shares authorized; issued and outstanding: 108,100,392 shares and 107,075,754 shares at September 30, 2024 (unaudited) and December 31, 2023, respectively | — | | | — | |
Additional paid-in capital | 1,454,367 | | | 1,353,468 | |
Accumulated other comprehensive income (loss) | (5,378) | | | (5,469) | |
Retained earnings (accumulated deficit) | (1,088,208) | | | (985,503) | |
TOTAL SHAREHOLDERS' EQUITY | 360,781 | | | 362,496 | |
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ | 1,221,986 | | | $ | 1,146,129 | |
The accompanying notes are an integral part of these unaudited consolidated financial statements.
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
NOVOCURE LIMITED AND SUBSIDIARIES CONSOLIDATED 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, |
| 2024 | | 2023 | | 2024 | | 2023 | | 2023 |
| Unaudited | | Unaudited | | Audited |
Net revenues | $ | 155,095 | | | $ | 127,321 | | | $ | 443,954 | | | $ | 375,554 | | | $ | 509,338 | |
Cost of revenues | 35,372 | | | 32,092 | | | 103,715 | | | 95,724 | | | 128,280 | |
Gross profit | 119,723 | | | 95,229 | | | 340,239 | | | 279,830 | | | 381,058 | |
| | | | | | | | | |
Operating costs and expenses: | | | | | | | | | |
Research, development and clinical studies | 51,882 | | | 53,623 | | | 158,435 | | | 168,754 | | | 223,062 | |
Sales and marketing | 59,830 | | | 57,964 | | | 171,652 | | | 167,621 | | | 226,809 | |
General and administrative | 40,103 | | | 41,887 | | | 117,344 | | | 124,609 | | | 164,057 | |
Total operating costs and expenses | 151,815 | | | 153,474 | | | 447,431 | | | 460,984 | | | 613,928 | |
| | | | | | | | | |
Operating income (loss) | (32,092) | | | (58,245) | | | (107,192) | | | (181,154) | | | (232,870) | |
Financial income (expenses), net | 10,507 | | | 10,023 | | | 31,236 | | | 27,948 | | | 41,130 | |
| | | | | | | | | |
Income (loss) before income tax | (21,585) | | | (48,222) | | | (75,956) | | | (153,206) | | | (191,740) | |
Income tax | 8,985 | | | 1,263 | | | 26,749 | | | 6,758 | | | 15,303 | |
Net income (loss) | $ | (30,570) | | | $ | (49,485) | | | $ | (102,705) | | | $ | (159,964) | | | $ | (207,043) | |
| | | | | | | | | |
Basic and diluted net income (loss) per ordinary share | $ | (0.28) | | | $ | (0.46) | | | $ | (0.95) | | | $ | (1.51) | | | $ | (1.95) | |
Weighted average number of ordinary shares used in computing basic and diluted net income (loss) per share | 108,247,716 | | | 106,772,814 | | | 107,679,501 | | | 106,219,194 | | | 106,391,178 | |
The accompanying notes are an integral part of these unaudited consolidated financial statements.
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
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, |
| 2024 | | 2023 | | 2024 | | 2023 | | 2023 |
| Unaudited | | Unaudited | | Audited |
Net income (loss) | $ | (30,570) | | | $ | (49,485) | | | $ | (102,705) | | | $ | (159,964) | | | $ | (207,043) | |
Other comprehensive income (loss), net of tax: | | | | | | | | | |
Change in foreign currency translation adjustments | 64 | | | 826 | | | (161) | | | 1,655 | | | 1,473 | |
Unrealized gain (loss) from debt securities | | | 15 | | | — | | | 440 | | | 445 | |
Pension benefit plan | (1,927) | | | (852) | | | 252 | | | (1,654) | | | (4,954) | |
Total comprehensive income (loss) | $ | (32,433) | | | $ | (49,496) | | | $ | (102,614) | | | $ | (159,523) | | | $ | (210,079) | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
NOVOCURE LIMITED AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY |
U.S. dollars in thousands (except share data) |
| Ordinary shares | | Additional paid-in capital | | Accumulated other comprehensive loss | | Retained earnings (accumulated deficit) | | Total shareholders' equity |
| | | |
Balance as of December 31, 2023 (audited) | 107,075,754 | | | $ | 1,353,468 | | | $ | (5,469) | | | $ | (985,503) | | | $ | 362,496 | |
| | | | | | | | | |
Share-based compensation to employees | — | | | 34,084 | | | — | | | — | | | 34,084 | |
Exercise of options and vested RSUs | 528,020 | | | 213 | | | — | | | — | | | 213 | |
Other comprehensive income (loss), net of tax benefit of $0 | — | | | — | | | 1,322 | | | — | | | 1,322 | |
Net income (loss) | — | | | — | | | — | | | (38,760) | | | (38,760) | |
Balance as of March 31, 2024 (Unaudited) | 107,603,774 | | | $ | 1,387,765 | | | $ | (4,147) | | | $ | (1,024,263) | | | $ | 359,355 | |
| | | | | | | | | |
Share-based compensation to employees | — | | | 31,830 | | | — | | | — | | | 31,830 | |
Proceeds from issuance of shares | 178,668 | | | 2,187 | | | — | | | — | | | 2,187 | |
Exercise of options and vested RSUs | 231,388 | | | 1,121 | | | | | — | | | 1,121 | |
Other comprehensive income (loss), net of tax benefit of $0 | — | | | — | | | 632 | | | — | | | 632 | |
Net income (loss) | — | | | — | | | — | | | (33,375) | | | (33,375) | |
Balance as of June 30, 2024 (Unaudited) | 108,013,830 | | | $ | 1,422,903 | | | $ | (3,515) | | | $ | (1,057,638) | | | $ | 361,750 | |
| | | | | | | | | |
Share-based compensation to employees | — | | | 31,364 | | | — | | | — | | | 31,364 | |
Exercise of options and vested RSUs | 86,562 | | | 100 | | | — | | | — | | | 100 | |
Other comprehensive income (loss), net of tax benefit of $0 | — | | | — | | | (1,863) | | | — | | | (1,863) | |
Net income (loss) | — | | | — | | | — | | | (30,570) | | | (30,570) | |
Balance as of September 30, 2024 (Unaudited) | 108,100,392 | | | $ | 1,454,367 | | | $ | (5,378) | | | $ | (1,088,208) | | | $ | 360,781 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|
|
| Ordinary shares | | Additional 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 RSUs | 1,137,751 | | | 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 shares | 81,730 | | | 2,883 | | | — | | | — | | | 2,883 | |
Exercise of options and vested RSUs | 336,439 | | | 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 | |
| | | | | | | | | |
Share-based compensation to employees | — | | | 26,346 | | | — | | | — | | | 26,346 | |
Exercise of options and vested RSUs | 142,939 | | | 1,171 | | | — | | | — | | | 1,171 | |
Other comprehensive income (loss), net of tax benefit of $0 | — | | | — | | | (11) | | | — | | | (11) | |
Net income (loss) | — | | | — | | | — | | | (49,485) | | | (49,485) | |
Balance as of September 30, 2023 (Unaudited) | 106,748,270 | | | $ | 1,334,120 | | | $ | (1,992) | | | $ | (938,424) | | | $ | 393,704 | |
The accompanying notes are an integral part of these unaudited consolidated financial statements.
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
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, |
| 2024 | | 2023 | | 2024 | | 2023 | | 2023 |
| Unaudited | | Unaudited | | Audited |
Cash flows from operating activities: | | | | | | | | | |
Net income (loss) | $ | (30,570) | | | $ | (49,485) | | | $ | (102,705) | | | $ | (159,964) | | | $ | (207,043) | |
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities: | | | | | | | | | |
Depreciation and amortization | 2,458 | | | 2,803 | | | 8,131 | | | 8,246 | | | 10,969 | |
Accrued Interest | (1,213) | | | 480 | | | 60 | | | 530 | | | (95) | |
Asset write-downs and impairment of field equipment | 450 | | | 112 | | | 784 | | | 374 | | | 493 | |
Share-based compensation | 31,364 | | | 26,346 | | | 97,278 | | | 98,170 | | | 115,608 | |
Foreign currency remeasurement loss (gain) | (503) | | | 1,398 | | | 763 | | | 2,185 | | | 161 | |
Decrease (increase) in accounts receivables and prepaid expenses | 5,411 | | | 2,642 | | | (8,983) | | | 24,094 | | | 29,414 | |
Amortization of discount (premium) | (6,737) | | | (6,691) | | | (18,972) | | | (15,822) | | | (23,084) | |
Decrease (increase) in inventories | 1,895 | | | (4,080) | | | (867) | | | (8,250) | | | (8,919) | |
Decrease (increase) in other long-term assets | 1,906 | | | 3,971 | | | 7,969 | | | 3,585 | | | 4,072 | |
Increase (decrease) in accounts payables and accrued expenses | 7,452 | | | 6,265 | | | (1,245) | | | (3,992) | | | 14,869 | |
Increase (decrease) in other long-term liabilities | (1,537) | | | (3,075) | | | (5,131) | | | (7,934) | | | (9,781) | |
Net cash provided by (used in) operating activities | $ | 10,376 | | | $ | (19,314) | | | (22,918) | | | (58,778) | | | (73,336) | |
| | | | | | | | | |
Cash flows from investing activities: | | | | | | | | | |
Purchase of property, equipment and field equipment | $ | (10,683) | | | $ | (7,253) | | | (33,913) | | | (20,272) | | | (27,093) | |
Proceeds from maturity of short-term investments | 190,000 | | | 275,549 | | | 608,000 | | | 916,433 | | | 1,214,982 | |
Purchase of short-term investments | (169,124) | | | (251,038) | | | (692,118) | | | (810,513) | | | (1,003,741) | |
Net cash provided by (used in) investing activities | $ | 10,193 | | | $ | 17,258 | | | (118,031) | | | 85,648 | | | 184,148 | |
| | | | | | | | | |
Cash flows from financing activities: | | | | | | | | | |
Proceeds from issuance of shares, net | $ | — | | | $ | — | | | 2,187 | | | 2,883 | | | 4,416 | |
Proceeds from senior secured credit facility, net | — | | | — | | | 96,922 | | | — | | | — | |
Repayment and redemption of long-term debt | — | | | — | | | (12,913) | | | (10) | | | (10) | |
Exercise of options | 100 | | | 1,171 | | | 1,434 | | | 11,004 | | | 11,381 | |
Net cash provided by (used in) financing activities | $ | 100 | | | $ | 1,171 | | | 87,630 | | | 13,877 | | | 15,787 | |
| | | | | | | | | |
Effect of exchange rate changes on cash, cash equivalents and restricted cash | $ | 87 | | | $ | (97) | | | (46) | | | (69) | | | 131 | |
| | | | | | | | | |
Increase (decrease) in cash, cash equivalents and restricted cash | 20,756 | | | (982) | | | (53,365) | | | 40,678 | | | 126,730 | |
Cash, cash equivalents and restricted cash at the beginning of the period | 168,443 | | | 157,494 | | | 242,564 | | | 115,834 | | | 115,834 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
NOVOCURE LIMITED AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF CASH FLOWS |
U.S. dollars in thousands |
| | | | | | | | | |
Cash, cash equivalents and restricted cash at the end of the period | $ | 189,199 | | | $ | 156,512 | | | $ | 189,199 | | | $ | 156,512 | | | $ | 242,564 | |
| | | | | | | | | |
| | | | | |
| | | | | | | | | |
| | | | | |
| | | | | | | | | |
Supplemental cash flow activities: | | | | | | | | | |
Cash paid during the period for: | | | | | | | | | |
Income taxes paid (refunded), net | $ | 6,637 | | | $ | 1,202 | | | $ | 17,053 | | | $ | 8,745 | | | $ | 13,665 | |
Interest paid | $ | 2,964 | | | $ | — | | | $ | 4,934 | | | $ | 1 | | | $ | 6 | |
Reconciliation of cash, cash equivalents and restricted cash: | | | | | | | | | |
Cash and cash equivalents | $ | 185,422 | | | $ | 154,860 | | | $ | 185,422 | | | $ | 154,860 | | | $ | 240,821 | |
Restricted cash | 3,777 | | | 1,652 | | | 3,777 | | | 1,652 | | | 1,743 | |
Total cash, cash equivalents and restricted cash | $ | 189,199 | | | $ | 156,512 | | | $ | 189,199 | | | $ | 156,512 | | | $ | 242,564 | |
Non-cash activities: | | | | | | | | | |
Right-of-use assets obtained (disposed) in exchange for lease liabilities | $ | 757 | | | $ | 4,693 | | | $ | (610) | | | $ | 10,477 | | | $ | 18,063 | |
Purchase of property incurred but unpaid at period end | $ | 201 | | | $ | — | | | $ | 201 | | | $ | — | | | $ | 1,714 | |
The accompanying notes are an integral part of these unaudited consolidated financial statements.
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") was incorporated in the Bailiwick of Jersey and is principally engaged in the development, manufacture and commercialization of Tumor Treating Fields ("TTFields") devices, including Optune Gio and Optune Lua (collectively, our "Products"), for the treatment of solid tumor cancers. The Company markets Optune Gio and Optune Lua in multiple countries around the globe with the majority of revenues coming from the use of Optune Gio in the U.S., Germany, France and Japan. The Company also has a License and Collaboration Agreement (the "Zai Agreement") with Zai Lab (Shanghai) Co., Ltd. ("Zai") to market Optune in China, Hong Kong, Macau and Taiwan ("Greater China").
Financial statement preparation. The accompanying unaudited consolidated financial statements include the accounts of the Company 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 for the periods presented. The preparation of these unaudited consolidated financial statements in conformity with U.S. generally accepted accounting principles ("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, 2023 (the "2023 10-K") filed with the Securities and Exchange Commission on February 22, 2024.
The significant accounting policies applied in the audited annual consolidated financial statements of the Company as disclosed in the 2023 10-K are applied consistently in these unaudited interim consolidated financial statements.
Concentration Risks. The Company's cash, cash equivalents, short-term investments and trade receivables are potentially subject to a concentration of risk. Cash, cash equivalents and short-term investments are invested at top tier financial institutions globally and the total value invested at any one institution is limited pursuant to the Company's investment policy. These investments may be in excess of insured limitations or not insured in certain jurisdictions. Generally, these investments may be redeemed upon demand according to the terms of the securities.
The Company's trade receivables are due from numerous governments and federal and state agencies that are paid from their respective budgets, and from hundreds of health insurance companies. The Company does not believe that there are significant default risks associated with these governments, agencies and health insurance companies based upon the Company's historical experience.
The Company has no off-balance sheet concentrations of credit risk such as foreign exchange contracts, option contracts or other foreign hedging arrangements.
Recently announced accounting pronouncements
In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which requires public entities to disclose information about their reportable segments’ significant expenses and other segment items on an interim and annual basis. Public entities with a single reportable segment are required to apply the disclosure requirements in ASU 2023-07, as well as all existing segment disclosures and reconciliation requirements in ASC 280 on an interim and annual basis. ASU 2023-07 is effective for fiscal years beginning after December 15, 2023, and for interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact of adopting ASU 2023-07.
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which requires public entities, on an annual basis, to provide disclosure of specific categories in the rate reconciliation, as well as disclosure of income taxes paid disaggregated by jurisdiction. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact of adopting ASU 2023-09.
NOTE 2: CASH, CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS
Cash equivalents include items almost as 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 September 30, 2024 and December 31, 2023, the Company’s cash and cash equivalents and short-term investments were composed of:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| September 30, 2024 |
| Unaudited |
| Fair value level | | Adjusted cost basis | | Unrealized gains | | Unrealized losses | | Fair market value | | Recorded basis | | Cash and cash equivalents | | Short-term investments (2) |
Cash | | | $ | 13,765 | | | $ | — | | | $ | — | | | $ | 13,765 | | | $ | 13,765 | | | $ | 13,765 | | | $ | — | |
Money market funds | Level 1 | | 171,657 | | | — | | | — | | | 171,657 | | | 171,657 | | | 171,657 | | | — | |
Certificate of deposits and term deposits | Level 2 | | 199,410 | | | — | | | — | | | 199,410 | | | 199,410 | | | | | 199,410 | |
HTM securities (1) | | | | | | | | | | | | | | | |
U.S. Treasury bills | Level 1 | | $ | 118,319 | | | $ | 194 | | | $ | — | | | 118,513 | | | 118,319 | | | $ | — | | | $ | 118,319 | |
| | | | | | | | | | | | | | | |
Corporate debt securities | Level 2 | | $ | 456,747 | | | $ | 1,942 | | | $ | (1) | | | 458,688 | | | 456,747 | | | $ | — | | | $ | 456,747 | |
| | | | | | | | | | | | | | | |
| | | $ | 575,066 | | | $ | 2,136 | | | $ | (1) | | | $ | 577,201 | | | $ | 575,066 | | | $ | — | | | $ | 575,066 | |
| | | | | | | | | | | | | | | |
Total | | | $ | 959,898 | | | $ | 2,136 | | | $ | (1) | | | $ | 962,033 | | | $ | 959,898 | | | $ | 185,422 | | | $ | 774,476 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| December 31, 2023 |
| Audited |
| Fair value level | | Adjusted cost basis | | Unrealized gains | | Unrealized losses | | Fair market value | | Recorded basis | | Cash and cash equivalents | | Short-term investments (2) |
Cash | | | $ | 9,955 | | | $ | — | | | $ | — | | | $ | 9,955 | | | $ | 9,955 | | | $ | 9,955 | | | $ | — | |
Money market funds | Level 1 | | 227,166 | | | — | | | — | | | 227,166 | | | 227,166 | | | 227,166 | | | — | |
Certificate of deposits and term deposits | Level 2 | | 153,169 | | | — | | | — | | | 153,169 | | | 153,169 | | | 3,700 | | | 149,469 | |
HTM securities (1) | | | | | | | | | | | | | | | |
U.S. Treasury bills | Level 1 | | $ | 78,844 | | | $ | 55 | | | $ | (110) | | | 78,789 | | | 78,844 | | | $ | — | | | $ | 78,844 | |
Government and governmental agencies | Level 2 | | $ | 24,940 | | | $ | 13 | | | $ | — | | | 24,953 | | | 24,940 | | | $ | — | | | $ | 24,940 | |
Corporate debt securities | Level 2 | | $ | 416,542 | | | $ | 486 | | | $ | (149) | | | 416,879 | | | 416,542 | | | $ | — | | | $ | 416,542 | |
| | | | | | | | | | | | | | | |
| | | $ | 520,326 | | | $ | 554 | | | $ | (259) | | | $ | 520,621 | | | $ | 520,326 | | | $ | — | | | $ | 520,326 | |
| | | | | | | | | | | | | | | |
Total | | | $ | 910,616 | | | $ | 554 | | | $ | (259) | | | $ | 910,911 | | | $ | 910,616 | | | $ | 240,821 | | | $ | 669,795 | |
(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.
(2) Pursuant to a bank guaranty agreement,$16,741 of short-term investments are pledged. See Note 4.
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 presented 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 September 30, 2024 and December 31, 2023, all investments mature in one year or less.
Unrealized losses from debt securities are primarily attributable to changes in interest rates. The Company does not believe any remaining unrealized losses represent impairments based on the evaluation of available evidence.
NOTE 3: INVENTORIES
Inventories are stated at the lower of cost or net realizable value. The weighted average methodology is applied to determine cost. As of September 30, 2024 and December 31, 2023, the Company’s inventories were composed of: | | | | | | | | | | | |
| September 30, 2024 | | December 31, 2023 |
| Unaudited | | Audited |
Raw materials | $ | 8,869 | | | $ | 10,265 | |
Work in progress | 10,342 | | | 9,796 | |
Finished products | 19,885 | | | 18,091 | |
Total | $ | 39,096 | | | $ | 38,152 | |
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 2044. The Company also leases motor vehicles under various operating leases, which expire on various dates, the latest of which is in 2027.
Pledged deposits and bank guarantees. As of September 30, 2024 and December 31, 2023, the Company pledged bank deposits of $2,350 and $2,848, respectively, to cover bank guarantees in respect of its leases of operating facilities and obtained bank guarantees for the fulfillment of the Company’s lease and other contractual commitments of $2,720 and $3,216, respectively. In addition, €15,000 ($16,741) of the Company's short term investments are pledged to a bank as guarantee for the Company's due execution of cash concentration agreements.
Legal Proceedings. In June 2023, a putative class action lawsuit was filed against the Company, its Executive Chairman and its Chief Executive Officer. The complaint, later amended to add our Chief Financial Officer as a defendant, which purports to be brought on behalf of a class of persons and/or entities who purchased or otherwise acquired ordinary shares of the Company from January 5, 2023 through June 5, 2023, alleges material misstatements and/or omissions in the Company’s public statements with respect to the results from its phase 3 LUNAR clinical trial. The Company believes that the action is without merit and plans to defend the lawsuit vigorously. As of September 30, 2024, the Company has not accrued any amounts in respect of this claim, as it believes liability is not probable and the amount of any potential liability cannot be reasonably estimated.
NOTE 5: LONG-TERM DEBT, NET
a.Convertible notes
On November 5, 2020, the Company issued $575,000 aggregate principal amount of 0% 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 Notes. As of September 30, 2024, the conditions allowing holders of the Notes to convert were not met.
In June 2024 the Company redeemed $14,055 of Notes in consideration of $12,913. The gain from redemption was reported as finance income in accordance with ASC 470 "Debt with Conversion and Other Options".
The net carrying amount of the liability of the Notes as of September 30, 2024 and December 31, 2023 are as follows:
| | | | | | | | | | | | | |
| September 30, 2024 | | | | December 31, 2023 |
| Unaudited | | | | Audited |
Liability component, net: | | | | | |
Principal amount | $ | 560,945 | | | | | $ | 575,000 | |
Unamortized issuance costs | (3,612) | | | | | (6,178) | |
Net carrying amount of liability component (1) | $ | 557,333 | | | | | $ | 568,822 | |
| | | | | |
Presented as: | | | | | |
Short-term liability (2) | $ | 557,333 | | | | | $ | — | |
Long-term liability | $ | — | | | | | $ | 568,822 | |
(1) An effective interest rate determines the fair value of the Notes, therefore they are categorized as Level 3 in accordance with ASC 820. The estimated fair value of the net carrying amount of liability component of the Notes as of September 30, 2024 and December 31, 2023 were $523,068 and $515,962, respectively.
The net carrying amount of the liability is represented by the principal amount of the Notes, less total issuance costs plus any amortization of issuance costs. The total issuance costs upon issuance of the Notes were $16,561 and are amortized to interest expense using the effective interest rate method over the contractual term of the Notes. Interest expense is recognized at an annual effective interest rate of 0.59% over the contractual term of the Notes.
(2) In January 2021, the Company elected to settle all conversions of Notes by a combination of cash and its ordinary shares and the cash portion per $1,000 principal amount of Notes for all conversion settlements shall be $1,000. Holders have the right to convert Notes beginning in August 2025. Since any conversion will result in the payment of cash as described above, the liability has been reclassified as current.
Finance expense related to the Notes was as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three months ended September 30, | | Nine months ended September 30, | | Year ended December 31, 2023 |
| 2024 | | 2023 | | 2024 | | 2023 | |
| Unaudited | | Unaudited | | Audited |
Gain from redemption of Notes | — | | | — | | | (1,142) | | | — | | | — | |
Amortization of debt issuance costs | 825 | | | 836 | | | 2,566 | | | 2,477 | | | 3,313 | |
Total finance expenses (income) recognized | $ | 825 | | | $ | 836 | | | $ | 1,424 | | | $ | 2,477 | | | $ | 3,313 | |
b. Senior secured credit facility, net
On May 1, 2024 Novocure Luxembourg S.a.r.l. ("Borrower"), a wholly-owned subsidiary of the Company, entered into a new five-year senior secured credit facility of up to $400.0 million (the "Facility") with BPCR Limited Partnership and BioPharma Credit Investments V (Master) LP (collectively, the "Lenders"), BioPharma Credit PLC, as collateral agent for the Lenders, and the guarantors party to such agreement (the "Loan Agreement"). The Facility may be drawn in up to four drawings. The Loan Agreement provides for an initial term loan in the principal amount of $100.0 million (the "Tranche A Loan"), which was funded to the Borrower on May 1, 2024 (the "Tranche A Funding Date"). Under the Loan Agreement, the Borrower is required to draw $100.0 million on the Facility on or before June 30, 2025 (the "Tranche B Loan"), subject to customary conditions precedent as set forth in the Loan Agreement. Not later than December 31, 2025, the Borrower has the option to draw an additional $100.0 million of the Facility (the "Tranche C Loan") if (i) (A) the Company has received positive results from its PANOVA-3 phase 3 clinical trial or (B) the Company's trailing net revenues for the most recently completed four quarters as reported by the Company in its financial statements filed with the U.S. Securities and Exchange Commission ("Trailing Four Quarters of Net Revenue") are greater than $575.0 million and (ii) the Notes are extinguished in full and are no longer outstanding. Not later than March 31, 2026, the Borrower has the option to draw an additional $100.0 million of the Facility (the "Tranche D Loan") if (i) the Company receives an approval or clearance from the U.S. Food and Drug Administration for the Company's Tumor Treating Fields device for a pancreatic cancer indication or (ii) Trailing
Four Quarters of Net Revenue is greater than $625.0 million. The obligations under the Loan Agreement are guaranteed by certain of the Company's subsidiaries and secured by a first lien on the Borrower's and certain of the Company's other subsidiaries’ assets. Outstanding term loans under the Loan Agreement will bear interest at an annual rate equal to 6.25% plus the three-month SOFR (subject to a 3.25% floor), payable quarterly in arrears and calculated on the basis of actual days elapsed in a 360-day year. The Borrower must pay 2.5% of additional consideration on each principal draw, with payment for the Tranche A Loan and the Tranche B Loan paid on the Tranche A Funding Date, and payments for the Tranche C Loan and the Tranche D Loan on their respective funding dates. Principal under the Facility will be repaid in eight equal quarterly repayments commencing with the third quarter of 2027 and continuing each quarter thereafter, with the final payment of outstanding principal due on the fifth anniversary of the Tranche A Funding Date. Voluntary prepayment of all, but not less than all, of the term loans outstanding is permitted at any time, subject to make-whole and prepayment premiums as set forth in the Loan Agreement. Prepayment of all term loans outstanding, subject to make-whole and prepayment premiums, is due and payable upon a change-in-control as defined in the Loan Agreement. Make-whole and prepayment premiums are due and payable for the Tranche B Loans for any voluntary prepayment of the term loans outstanding, upon a change-in-control (as defined in the Loan Agreement), and upon any acceleration of the maturity date, in each case regardless of whether the Tranche B Loan is drawn. The Loan Agreement contains a financial covenant only if the Tranche C Loan and/or Tranche D Loan are funded, in which case the Company is required to maintain at least Trailing Four Quarters of Net Revenue of at least $500.0 million, calculated on a trailing twelve-month basis as of the end of each fiscal quarter, beginning with the first quarter of 2027 based on year-end 2026 audited financial statements.
As of September 30, 2024 the Company had borrowed the Tranche A Loan in the principal amount of $100,000.
| | | | | | | | | | | | | |
| September 30, 2024 | | | | December 31, 2023 |
| Unaudited | | | | Audited |
Liability component, net: | | | | | |
Principal amount | $ | 100,000 | | | | | $ | — | |
Unamortized issuance costs | (2,851) | | | | | — | |
Net carrying amount of liability component (1) | $ | 97,149 | | | | | $ | — | |
(1) An effective interest rate determines the fair value of the Notes, therefore they are categorized as Level 3 in accordance with ASC 820. The estimated fair value of the net carrying amount of liability component of the Notes as of September 30, 2024 and December 31, 2023 were $115,011 and $0, respectively.
The net carrying amount of the liability is represented by the principal amount of the Notes, less total issuance costs plus any amortization of issuance costs. The total issuance costs upon issuance of the Notes were $3,078 and are amortized to interest expense using the effective interest rate method over the contractual term of the Notes. For purposes of calculating the net carrying amount, the annual effective interest rate is assumed to be 13.3% over the remaining contractual term of the Notes.
Finance expense related to the Facility was as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three months ended September 30, | | Nine months ended September 30, | | Year ended December 31, 2023 |
| 2024 | | 2023 | | 2024 | | 2023 | |
| Unaudited | | Unaudited | | Audited |
Interest | 2,960 | | | — | | | 4,922 | | | — | | | — | |
Amortization of debt issuance costs | 187 | | | — | | | 227 | | | — | | | — | |
Total finance expense recognized | $ | 3,147 | | | $ | — | | | $ | 5,149 | | | $ | — | | | $ | — | |
NOTE 6: REVENUE RECOGNITION
a. Net revenues
The Company’s net revenues by geographic region, based on the patient’s location are summarized as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three months ended September 30, | | Nine months ended September 30, | | Year ended December 31, |
| 2024 | 0 | 2023 | | 2024 | | 2023 | | 2023 |
United States | $ | 98,345 | | | $ | 86,243 | | | $ | 284,599 | | | $ | 258,429 | | | $ | 349,743 | |
International markets: | | | | | | | | | |
Germany | 16,990 | | | 14,683 | | | 47,834 | | | 45,547 | | | 60,210 | |
France | 15,243 | | | 4,157 | | | 39,998 | | | 4,157 | | | 11,736 | |
Japan | 8,581 | | | 7,588 | | | 24,062 | | | 24,118 | | | 31,668 | |
Other international markets | 11,311 | | | 7,894 | | | 32,053 | | | 24,481 | | | 32,757 | |
International markets - Total | 52,125 | | | 34,322 | | | 143,947 | | | 98,303 | | | 136,371 | |
| | | | | | | | | |
Greater China (1) | 4,625 | | | 6,756 | | | 15,408 | | | 18,822 | | | 23,224 | |
| | | | | | | | | |
Total net revenues | $ | 155,095 | | | $ | 127,321 | | | $ | 443,954 | | | $ | 375,554 | | | $ | 509,338 | |
(1) For additional information, see Notes 12 and 13 to the Consolidated Financial Statements in the 2023 10-K.
The Company's net revenues by performance period are as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three months ended September 30, | | Nine months ended September 30, | | Year ended December 31, |
| 2024 | 0 | 2023 | | 2024 | | 2023 | | 2023 |
Net revenues recognized in the reporting period from performance obligations satisfied in: | | | | | | | | | |
Reporting period | $ | 142,960 | | | $ | 125,704 | | | $ | 417,023 | | | $ | 362,636 | | | $ | 492,089 | |
Previous periods | 12,135 | | | 1,617 | | | 26,931 | | | 12,918 | | | 17,249 | |
Total net revenues | $ | 155,095 | | | $ | 127,321 | | | $ | 443,954 | | | $ | 375,554 | | | $ | 509,338 | |
b. Contract balances
The following table provides information about trade receivables, unbilled receivables and contract liabilities from contracts with customers:
| | | | | | | | | | | |
| September 30, 2024 | | December 31, 2023 |
| Unaudited | | Audited |
Trade receivables | $ | 61,316 | | | $ | 56,970 | |
Unbilled receivables | $ | 5,744 | | | $ | 4,251 | |
Deferred revenues (short-term contract liabilities) | (14,866) | | | (16,224) | |
During the nine months ended September 30, 2024 and 2023 and the year ended December 31, 2023 the Company recognized $16,224, $18,028 and $18,028, respectively, which were included in the deferred revenues (short-term contract liability) balance at January 1, 2024 and 2023.
NOTE 7: SHARE 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 share units (“RSUs”), performance-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 canceled or forfeited before expiration become available for future grants. RSUs granted under the 2015 Plan generally vest over a three-year period. PSUs granted under the 2015 Plan generally vest between a three- and six-year period as performance targets are attained. RSUs and PSUs granted under the 2015 Plan that are canceled before expiration become available for future grants.
As of September 30, 2024, no ordinary shares were available for grant under the 2015 Plan (see below).
In April 2024, the Company adopted the 2024 Omnibus Incentive Plan (the "2024 Plan"), which replaced the 2015 Plan, effective June 5, 2024 (the "Effective Date") following approval from the Company's shareholders. Under the 2024 Plan, the Company can issue various types of equity compensation awards such as share options, restricted shares, performance shares, restricted share units (“RSUs”), performance-based share units (“PSUs”), long-term cash awards and other share-based awards. The total number of shares of the Company’s ordinary shares that may be granted under the 2024 Plan consists of (i) up to 9,000,000 ordinary shares (reduced by 433,018 shares subject to awards granted under the 2015 Plan after April 2, 2024), all of which were available under the 2015 Plan and which ceased to be available for future awards under the 2015 Plan as of the Effective Date and (ii) the number of undelivered shares subject to outstanding awards under the 2015 Plan that become available for future awards under the 2024 Plan as provided for in the 2024 Plan.
Options granted under the 2024 Plan generally will have a two-year or four-year vesting period and expire ten years after the date of grant. Options granted under the 2015 Plan and 2024 Plan that are canceled or forfeited before expiration become available for future grants under the 2024 Plan. RSUs granted under the 2024 Plan generally will vest over a three-year period. PSUs granted under the 2024 Plan generally will vest between a three- and six-year period as performance targets are attained. RSUs and PSUs granted under the 2015 Plan and 2024 Plan that are canceled before expiration become available for future grants under the 2024 Plan.
As of September 30, 2024, 9,581,731 ordinary shares were available for grant under the 2024 Plan.
A summary of the status of the Company’s option plans as of September 30, 2024 and changes during the period then ended is presented below:
| | | | | | | | | | | |
| Nine months ended September 30, 2024 |
| Unaudited |
| Number of options | | Weighted average exercise price |
Outstanding at beginning of year | 8,539,507 | | | $ | 40.07 | |
Granted | 3,797,704 | | | 15.88 | |
Exercised | (184,633) | | | 7.77 | |
Forfeited and canceled | (719,823) | | | 50.14 | |
Outstanding as of September 30, 2024 | 11,432,755 | | | $ | 31.92 | |
| | | |
Exercisable options | 6,804,138 | | | $ | 35.14 | |
A summary of the status of the Company’s RSUs and PSUs as of September 30, 2024 and changes during the period then ended is presented below.
| | | | | | | | | | | |
| Nine months ended September 30, 2024 |
| Unaudited |
| Number of RSU/PSUs | | Weighted average grant date fair value |
Unvested at beginning of year | 5,813,066 | | | $ | 60.52 | |
Granted | 9,454,291 | | | 15.40 | |
Vested | (661,337) | | | 84.17 | |
Forfeited and cancelled | (1,252,395) | | | 39.97 | |
Unvested as of September 30, 2024 (1) | 13,353,625 | | | 29.33 | |
(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 September 30, 2024, in accordance with ASC 718 "Compensation — Stock Compensation" as follows:
| | | | | | | | | | | | | | | | | |
| September 30, 2024 |
| Number of PSUs | | Fair value at grant date per PSU | | Total fair value at grant date |
| 541,918 | | | $ | 16.30 | | | $ | 8,833 | |
| 37,893 | | | 19.44 | | | 737 | |
| 2,703,852 | | | 48.16 | | | 130,218 | |
| 161,422 | | | 76.97 | | | 12,425 | |
| 234,512 | | | 80.59 | | | 18,899 | |
| 15,210 | | | 87.66 | | | 1,333 | |
| 3,694,807 | | | | | $ | 172,445 | |
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 are construed in a manner consistent with the requirements of such section. As of September 30, 2024, 5,557,123 ordinary shares were available to be purchased by eligible employees under the ESPP.
The fair value of share-based awards was estimated using the Black-Scholes model for 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:
| | | | | | | | | | | | | | | | | |
| Nine months ended September 30, | | Year ended December 31, 2023 |
| 2024 | | 2023 | |
| Unaudited | | Audited |
Stock Option Plans | | | | | |
Expected term (years) | 5.50-5.73 | | 5.50-6.00 | | 5.50-6.00 |
Expected volatility | 71%-73% | | 63%-67% | | 63%-70% |
Risk-free interest rate | 3.88%-4.43% | | 3.48%-4.16% | | 3.48%-4.79% |
| | | | | |
| | | | | |
| | | | | |
Dividend yield | 0.00 | % | | 0.00 | % | | 0.00 | % |
ESPP | | | | | |
Expected term (years) | 0.50 | | 0.50 | | 0.50 |
| | | | | |
| | | | | |
Expected volatility | 73%-90% | | 56%-122% | | 56%-122% |
Risk-free interest rate | 5.13%-5.23% | | 4.76%-5.38% | | 4.76%-5.38% |
Dividend yield | 0.00 | % | | 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 nine months ended September 30, 2024 and 2023, and the year ended December 31, 2023 was:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three months ended September 30, | | Nine months ended September 30, | | Year ended December 31, 2023 |
| 2024 | | 2023 | | 2024 | | 2023 | |
| Unaudited | | Unaudited | | Audited |
Cost of revenues | $ | 1,834 | | | $ | 1,511 | | | $ | 5,280 | | | $ | 5,540 | | | $ | 6,587 | |
Research, development and clinical studies | 7,294 | | | 6,683 | | | 25,421 | | | 26,999 | | | 31,827 | |
Sales and marketing | 10,276 | | | 8,973 | | | 31,220 | | | 30,830 | | | 35,968 | |
General and administrative | 11,960 | | | 9,179 | | | 35,357 | | | 34,801 | | | 41,226 | |
Total share-based compensation expense | $ | 31,364 | | | $ | 26,346 | | | $ | 97,278 | | | $ | 98,170 | | | $ | 115,608 | |
NOTE 8: 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, Notes and the ESPP) considered outstanding during the period, in accordance with ASC 260-10 "Earnings Per Share", as determined under the treasury stock or if-converted method, as applicable.
The following table sets forth the computation of the Company’s basic and diluted net income (loss) per ordinary share: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three months ended September 30, | | Nine months ended September 30, | | Year ended December 31, 2023 |
| 2024 | | 2023 | | 2024 | | 2023 | |
| Unaudited | | Unaudited | | Audited |
Net income (loss) attributable to ordinary shares as reported used in computing basic and diluted net income (loss) per share | $ | (30,570) | | | $ | (49,485) | | | $ | (102,705) | | | $ | (159,964) | | | $ | (207,043) | |
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| | | | | | | | | |
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Weighted average number of ordinary shares used in computing diluted net income (loss) per share | 108,247,716 | | | 106,772,814 | | | 107,679,501 | | | 106,219,194 | | | 106,391,178 | |
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Potentially anti-dilutive shares that were excluded from the computation of basic net income (loss) per share: | | | | | | | | | |
Options | 9,887,237 | | | 6,250,189 | | | 9,392,376 | | | 6,354,627 | | | 6,950,781 | |
RSUs and PSUs | 4,651,689 | | | 2,590,322 | | | 3,880,895 | | | 1,470,542 | | | 1,423,377 | |
ESPP | 79,887 | | | 96,444 | | | 198,999 | | | 150,930 | | | 161,627 | |
Weighted anti-dilutive shares outstanding which were not included in the diluted calculation | 14,618,813 | | | 8,936,955 | | | 13,472,270 | | | 7,976,099 | | | 8,535,785 | |
| | | | | | | | | |
Basic and diluted net income (loss) per ordinary share | $ | (0.28) | | | $ | (0.46) | | | $ | (0.95) | | | $ | (1.51) | | | $ | (1.95) | |
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NOTE 9: SUPPLEMENTAL INFORMATION
The Company operates in a single reportable segment.
The following table presents long-lived assets by location:
| | | | | | | | | | | |
| September 30, 2024 | | December 31, 2023 |
| Unaudited | | Audited |
United States | $ | 53,533 | | | $ | 41,634 | |
Israel | 8,464 | | | 8,317 | |
Switzerland | 17,070 | | | 7,733 | |
| | | |
| | | |
Others | 7,097 | | | 5,179 | |
Total long lived assets | $ | 86,164 | | | $ | 62,863 | |
Restructuring
In November 2023, the Company announced a series of actions to strengthen and optimize its business operations to support near-term growth drivers and long-term value creation. The plan included a reduction in headcount of approximately 200 employees or 13% of the Company's then current workforce. The Company incurred restructuring costs (including severance pay, garden leave payments, etc.) for the three and nine months ended September 30, 2024 and the year ended December 31, 2023, as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Three months ended September 30, | | Nine months ended September 30, | | Year ended December 31, 2023 |
| 2024 | | 2023 | | 2024 | | 2023 | |
| Unaudited | | Unaudited | | Audited |
Cost of revenues | $ | — | | | $ | — | | | $ | 52 | | | $ | — | | | $ | 262 | |
Research, development and clinical studies | — | | | — | | | 275 | | | — | | | 2,070 | |
Sales and marketing | — | | | — | | | 1,512 | | | — | | | 2,404 | |
General and administrative | — | | | — | | | 164 | | | — | | | 1,495 | |
Total restructuring cost | $ | — | | | $ | — | | | $ | 2,003 | | | $ | — | | | $ | 6,231 | |
| | | | | | | | | |
Restructuring costs paid during the period | $ | — | | | $ | — | | | $ | 5,455 | | | $ | — | | | $ | 2,753 | |
These restructuring costs were offset by accrual reversals for the three and nine months ended September 30, 2024 and the year ended December 31, 2023 in the amount of $0, $369 and $3,041, respectively, which relate to the terminated employees' exits from the Company’s cash incentive plans. These restructuring costs were further offset by forfeited equity-based compensation expense reversals for the three and nine months ended September 30, 2024 and the year ended December 31, 2023 in the amount of $0, $1,991 and $9,313, respectively, which relate to the terminated employees' exits from the Company’s equity incentive plan.
NOTE 10: SUBSEQUENT EVENT
On October 15, 2024, the Company issued a press release announcing that that the U.S. Food and Drug Administration (FDA) has approved Optune Lua® for concurrent use with PD-1/PD-L1 inhibitors or docetaxel, for the treatment of adult patients with metastatic non-small cell lung cancer who have progressed on or after a platinum-based regimen. As a result of this approval, the Company expects to expense approximately $33,157 related to the vesting of PSUs granted to an executive officer. See Note 7 above.
Item 2. Management’s Discussion and Analysis of 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 September 30, 2024 included in Part I, Item 1 of this Quarterly Report on Form 10-Q. This discussion contains forward-looking statements that involve risks and uncertainties. Please refer to the information under the heading “Cautionary Note Regarding Forward-Looking Statements” elsewhere in this report. References to the words “we,” “our,” “us,” and the “Company” in this report refer to NovoCure Limited, including its consolidated subsidiaries.
Critical Accounting Policies and Estimates
In accordance with U.S. generally accepted accounting principles (“GAAP”), in preparing our financial statements, we must make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of net revenues and expenses during the reporting period. We develop and periodically change these estimates and assumptions based on historical experience and on various other factors that we believe are reasonable under the circumstances. Actual results may differ from these estimates.
The critical accounting policies requiring estimates, assumptions and judgments that we believe have the most significant impact on our consolidated financial statements can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 (the "2023 10-K"). For additional information, see Note 1 to our unaudited consolidated financial statements in Part I, Item 1 of this Quarterly Report. There were no other material changes to our critical accounting policies and estimates as compared to the critical accounting policies and estimates described in our 2023 10-K.
Overview
We are a global oncology company with a proprietary platform technology called Tumor Treating Fields ("TTFields"), which are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. Our key priorities are to drive commercial adoption of Optune Gio® and Optune Lua®, our commercial TTFields therapy devices, and to advance clinical and product development programs intended to extend overall survival in some of the most aggressive forms of cancer.
Optune Gio is approved by the U.S. Food and Drug Administration ("FDA") under the Premarket Approval ("PMA") pathway for the treatment of adult patients with newly diagnosed glioblastoma ("GBM") together with temozolomide, a chemotherapy drug, and for adult patients with GBM following confirmed recurrence after chemotherapy as monotherapy treatment. We also have a CE certificate to market Optune Gio for the treatment of GBM 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 approved by the FDA under the PMA pathway for the treatment of adult patients with metastatic non-small cell lung cancer ("NSCLC") concurrent with PD-1/PD-L1 inhibitors or docetaxel following progression on or after a platinum-based regimen and under the Humanitarian Device Exemption ("HDE") pathway to treat malignant pleural mesothelioma and pleural mesothelioma (together, "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 for the treatment of MPM. We market Optune Gio and Optune Lua in multiple countries around the globe with the majority of our revenues coming from the use of Optune Gio in the U.S., Germany, France and Japan. We are actively evaluating opportunities to expand our international footprint.
We believe the physical mechanisms of action behind TTFields therapy may be broadly applicable to solid tumor cancers. We are focusing our research and development activities in areas of greatest anticipated value creation. This includes NSCLC, brain cancers, and pancreatic cancer.
In October 2024, the U.S. FDA approved our PMA application for Optune Lua use concurrent use with PD-1/PD-L1 inhibitors or docetaxel for the treatment of adult patients with metastatic NSCLC who have progressed on or after a platinum-based regimen. This application was based on the results from the phase 3 LUNAR trial, which showed patients treated with TTFields therapy concomitant with PD-1/PD-L1 inhibitors or docetaxel exhibited a statistically significant and clinically meaningful improvement in median overall survival (OS) compared to patients treated with PD-1/PD-L1 inhibitors or docetaxel alone. The LUNAR trial included two pre-specified powered secondary endpoints. The first secondary endpoint, which met statistical significance, assessed median OS in patients treated with Optune Lua concurrently with a PD-1/PD-L1 inhibitor versus a PD-1/PD-L1 inhibitor alone. The second secondary endpoint, which showed a positive trend but did not meet statistical significance, assessed Optune Lua
concurrently with docetaxel versus docetaxel alone. We have also filed applications for use to the necessary regulatory bodies in Europe and Japan.
In June 2024, we presented positive results from the phase 3 METIS trial, evaluating the use of TTFields therapy and supportive care for the treatment of patients with 1-