UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934

October 27, 2022
Date of Report (date of earliest event reported)

NovoCure Limited
(Exact name of registrant as specified in its charter)

Jersey	001-37565	98-1057807	
(State or other jurisdiction of incorporation or organization)	(Commission File Number)	(I.R.S. Employer Identification No.)	
		
No. 4 The Forum, Grenville Street	St. Helier	Jersey	JE2 4UF	
(Address of Principal Executive Offices)	(Zip Code)	
+44 (0) 15 3475 6700
Registrant's telephone number, including area code

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

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 is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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.
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Item 2.02     Results of Operations and Financial Condition.

On October 27, 2022, the Company issued a press release announcing certain financial results for the quarter ended
June 30, 2022. A copy of the press release is attached as Exhibit 99.1.

Item 9.01    Financial Statements and Exhibits.

(d)    Exhibits

Exhibit No.	Description	
		
99.1	Press Release of NovoCure Limited, dated October 27, 2022	
104	Cover Page Interactive Data File (embedded within the Inline XBRL document)	

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 hereunto duly authorized.

NovoCure Limited
(Registrant)

Date: October 27, 2022

By: /s/ Ashley Cordova  
Name: Ashley Cordova
Title: Chief Financial Officer

Exhibit 99.1
Novocure Reports Third Quarter 2022 Financial Results

Quarterly net revenues of $131 million with $52 million invested in research & development initiatives

Entering a transformational period with multiple pivotal trial readouts anticipated in coming quarters

Root, Switzerland – Novocure (NASDAQ: NVCR) today reported financial results for the quarter ended September 30, 2022. Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer by developing and commercializing its innovative therapy, Tumor Treating Fields (TTFields).

“In the third quarter, we showed consistent execution in service of our mission to extend survival in some of the most aggressive forms of cancer,” said William Doyle, Novocure’s Executive Chairman. “We are diligently working to reach additional patients in our current markets, expand into new markets, enhance our products and treat patients in new indications throughout the body. We are investing aggressively to prepare Novocure for the future and are eager to treat many more patients in the coming years.”

“Novocure is approaching a period that should be transformational for our company and patients,” said Asaf Danziger, Novocure’s Chief Executive Officer. “January marks the beginning of a two-year period of multiple data releases from our pivotal studies exploring the use of TTFields in a variety of solid tumor cancers and combinations. These data catalysts could enable us to treat tens of thousands more patients in the future, and we look forward to sharing these results with physicians, patients, and the investor community in the coming quarters.”

Financial updates for the third quarter ended September 30, 2022:
•Total net revenues for the quarter were $131.0 million, a decrease of 2% compared to the same period in 2021.
•The United States, EMEA and Japan contributed $102.7 million, $14.3 million, and $7.9 million in quarterly net revenues, respectively.
•Net revenues were impacted by the volume of cash collections from aged claims in the U.S., the ongoing impact of German coverage updates and foreign exchange pressure.
•Revenue in Greater China from Novocure’s partnership with Zai Lab totaled $6.2 million.
•Gross margin for the quarter was 77%.
•Research, development and clinical studies expenses for the quarter were $52.0 million, an increase of 8% from the same period in 2021.
•Sales and marketing expenses for the quarter were $41.4 million, an increase of 27% compared to the same period in 2021. This reflects increased investments in early commercial and market access capabilities.

Exhibit 99.1
•General and administrative expenses for the quarter were $32.5 million, an increase of 4% compared to the same period in 2021.
•Net loss for the quarter was $26.6 million with loss per share of $0.25.
•Adjusted EBITDA* for the quarter was $4.4 million.
•Cash, cash equivalents and short-term investments were $970.3 million as of September 30, 2022.
Operational updates for the third quarter ended September 30, 2022:
•As of September 30, 2022, there were 3,420 active patients on therapy. Active patients from North America, EMEA and Japan contributed 2,181, 885 and 354 active patients, respectively.
•1,389 prescriptions were received in the quarter. Prescriptions from North America, EMEA and Japan contributed 978, 332 and 79 prescriptions, respectively.

Quarterly updates and achievements:
•Today, we are announcing preliminary data from the phase 2 EF-33 pilot study evaluating the safety and efficacy of high density arrays in 25 patients with recurrent glioblastoma (GBM). Among those who used Optune® as directed for at least one month, median progression-free survival was 4.5 months compared to 2.2 months in the historical control, Novocure’s pivotal EF-11 study. Further, notwithstanding the increased TTFields intensity, EF-33 patients reported no TTFields-related toxicity.
•Our phase 3 pivotal METIS study for the treatment of brain metastases from non-small cell lung cancer (NSCLC) continues to enroll well, and we have visibility to final patient enrollment; however, we now expect to complete enrollment in the first quarter of 2023 versus the fourth quarter of 2022. This will begin the final patient’s 12-month follow-up period, and we anticipate top-line data in the first quarter of 2024.
•In September 2022, we announced the creation of our U.S. CNS (central nervous system) Cancers Franchise, intended to strengthen focus on growth in our U.S. GBM business by streamlining decision-making and improving coordination.

Anticipated clinical milestones:
•Top-line readout from phase 3 pivotal LUNAR study in NSCLC (Q1 2023)
•Data from phase 3 pivotal INNOVATE-3 study in recurrent ovarian cancer (2023)
•Data from phase 3 pivotal METIS study in brain metastases (2024)
•Data from phase 3 pivotal PANOVA-3 study in locally advanced pancreatic cancer (2024)

Conference call details
Novocure will host a conference call and webcast to discuss third quarter 2022 financial results at 8 a.m. EDT today, Thursday, October 27, 2022. Analysts and investors can participate in the conference call by using the following registration link, and dial-in details will be provided.

Exhibit 99.1
The webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website, as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

About Novocure
Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer through the development and commercialization of its innovative therapy, Tumor Treating Fields. Novocure’s commercialized products are approved in certain countries for the treatment of adult patients with glioblastoma and malignant pleural mesothelioma. Novocure has ongoing or completed clinical studies investigating Tumor Treating Fields in brain metastases, gastric cancer, glioblastoma, liver cancer, non-small cell lung cancer, pancreatic cancer and ovarian cancer.

Headquartered in Root, Switzerland and with a growing global footprint, Novocure has regional operating centers in Portsmouth, New Hampshire and Tokyo, as well as a research center in Haifa, Israel. For additional information about the company, please visit Novocure.com and follow @Novocure on LinkedIn and Twitter.

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

Forward-Looking Statements
In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, clinical study progress, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, coverage, collections from third-party payers and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning. Novocure’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, environmental, regulatory and political conditions as well as issues arising from the COVID-19 pandemic and other more specific risks and uncertainties facing Novocure such as those set forth in its Annual Report on Form 10-K filed on February 24, 2022, and subsequent filings with the U.S. Securities and Exchange Commission.

Exhibit 99.1
Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion.

Exhibit 99.1
Consolidated Statements of Operations
USD in thousands (except share and per share data)

	Three months ended September 30,		Nine months ended September 30,		Year ended December 31,	
	2022		2021		2022		2021		2021	
	Unaudited		Unaudited		Audited	
Net revenues	$	130,998 			$	133,606 			$	409,411 			$	401,818 			$	535,031 		
Cost of revenues	29,749 			30,206 			85,979 			85,190 			114,877 		
Gross profit	101,249 			103,400 			323,432 			316,628 			420,154 		
										
Operating costs and expenses:										
Research, development and clinical studies	51,956 			48,141 			151,265 			144,372 			201,303 		
Sales and marketing	41,395 			32,580 			124,029 			98,075 			137,057 		
General and administrative	32,509 			31,231 			94,683 			95,116 			126,127 		
Total operating costs and expenses	125,860 			111,952 			369,977 			337,563 			464,487 		
										
Operating income (loss)	(24,611)			(8,552)			(46,545)			(20,935)			(44,333)		
Financial expenses (income), net	(1,194)			1,981 			2,743 			5,567 			7,742 		
										
Income (loss) before income taxes	(23,417)			(10,533)			(49,288)			(26,502)			(52,075)		
Income taxes	3,159 			2,591 			5,943 			5,391 			6,276 		
Net income (loss)	$	(26,576)			$	(13,124)			$	(55,231)			$	(31,893)			$	(58,351)		
										
Basic net income (loss) per ordinary share	$	(0.25)			$	(0.13)			$	(0.53)			$	(0.31)			$	(0.56)		
Weighted average number of ordinary shares used in computing basic net income (loss) per share	104,884,583 			103,731,147 			104,552,803 			103,281,380 			103,433,274 		
Diluted net income (loss) per ordinary share	$	(0.25)			$	(0.13)			$	(0.53)			$	(0.31)			$	(0.56)		
Weighted average number of ordinary shares used in computing diluted net income (loss) per share	104,884,583 			103,731,147 			104,552,803 			103,281,380 			103,433,274 		

Exhibit 99.1
Consolidated Balance Sheets
USD in thousands (except share data)
												
	September 30,
2022		December 31, 2021	
	Unaudited		Audited	
ASSETS				
CURRENT ASSETS:				
Cash and cash equivalents	$	243,805 			$	208,802 		
Short-term investments	726,515 			728,898 		
Restricted cash	231 			807 		
Trade receivables, net	87,552 			93,567 		
Receivables and prepaid expenses	17,478 			17,025 		
Inventories	26,792 			24,427 		
Total current assets	1,102,373 			1,073,526 		
LONG-TERM ASSETS:				
Property and equipment, net	29,745 			22,693 		
Field equipment, net	11,985 			12,923 		
Right-of-use assets	19,405 			18,267 		
Other long-term assets	10,707 			12,086 		
Total long-term assets	71,842 			65,969 		
TOTAL ASSETS	$	1,174,215 			$	1,139,495 		

Exhibit 99.1
Consolidated Balance Sheets
USD in thousands (except share data)

												
	September 30,
2022		December 31, 2021	
	Unaudited		Audited	
LIABILITIES AND SHAREHOLDERS' EQUITY				
CURRENT LIABILITIES:				
Trade payables	$	77,026 			$	72,600 		
Other payables, lease liabilities and accrued expenses	64,050 			70,002 		
Total current liabilities	141,076 			142,602 		
LONG-TERM LIABILITIES:				
Long-term debt, net	564,677 			562,216 		
Deferred revenue	3,924 			6,477 		
Long-term leases	14,827 			12,997 		
Employee benefit liabilities	4,088 			4,543 		
Other long-term liabilities	222 			166 		
Total long-term liabilities	587,738 			586,399 		
TOTAL LIABILITIES	728,814 			729,001 		
				
COMMITMENTS AND CONTINGENCIES				
				
SHAREHOLDERS' EQUITY:				
Share capital -				
Ordinary shares no par value, unlimited shares authorized; issued and outstanding:
104,942,941 shares and 103,971,263 shares at September 30, 2022 (unaudited) and December 31, 2021, respectively	— 			— 		
Additional paid-in capital	1,188,864 			1,099,589 		
Accumulated other comprehensive income (loss)	(2,306)			(3,169)		
Retained earnings (accumulated deficit)	(741,157)			(685,926)		
TOTAL SHAREHOLDERS' EQUITY	445,401 			410,494 		
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY	$	1,174,215 			$	1,139,495 		

Exhibit 99.1
Non-U.S. GAAP financial measures reconciliation
USD in thousands

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

Investors:
Ingrid Goldberg
investorinfo@novocure.com
610-723-7427

Media:
Leigh Labrie
media@novocure.com
610-723-7428