# EDGAR Filing Document

**Accession Number:** 0001645113
**File Stem:** 0001645113-23-000006
**Filing Date:** 2023-1
**Character Count:** 14447
**Document Hash:** a15359c1a8d517e1587dfd1261d8e25b
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001645113-23-000006.hdr.sgml**: 20230109

**ACCESSION NUMBER**: 0001645113-23-000006

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 13

**CONFORMED PERIOD OF REPORT**: 20230109

**ITEM INFORMATION**: Results of Operations and Financial Condition

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230109

**DATE AS OF CHANGE**: 20230109

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** NovoCure Ltd
- **CENTRAL INDEX KEY:** 0001645113
- **STANDARD INDUSTRIAL CLASSIFICATION:** SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841]
- **IRS NUMBER:** 000000000
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-37565
- **FILM NUMBER:** 23516511

**BUSINESS ADDRESS:**
- **STREET 1:** NO. 4 THE FORUM
- **STREET 2:** GRENVILLE STREET
- **CITY:** ST. HELIER
- **STATE:** Y9
- **ZIP:** JE2 4UF
- **BUSINESS PHONE:** 44 (0)15 3475 6700

**MAIL ADDRESS:**
- **STREET 1:** NO. 4 THE FORUM
- **STREET 2:** GRENVILLE STREET
- **CITY:** ST. HELIER
- **STATE:** Y9
- **ZIP:** JE2 4UF

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Novocure Ltd
- **DATE OF NAME CHANGE:** 20150615

?xml version="1.0" ? nvcr-20230109

**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**

January 9, 2023

Date of Report (date of earliest event reported)

**NovoCure Limited** 

**(Exact name of registrant as specified in its charter)**

---

| | | | |
|:---|:---|:---|:---|
| **Jersey** | **001-37565** | **001-37565** | **98-1057807** |
| (State or other jurisdiction of incorporation or organization) | (Commission File Number) | (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) | (Address of Principal Executive Offices) | (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 <br> <u>Ordinary Shares, no par value</u> <u>NVCR</u> <u>The Nasdaq Stock Market LLC</u>

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.

□

------

**Item 2.02 &nbsp;&nbsp;&nbsp;&nbsp;Results of Operations and Financial Condition.**

On January 9, 2023, the Company issued a press release announcing certain preliminary financial results and providing certain other information for the quarter and year ended December 31, 2022. A copy of the press release is attached hereto as Exhibit 99.1 (the "Press Release").

The financial data contained therein are unaudited, preliminary, based upon the Company's good faith estimates and subject to completion of the Company's financial closing procedures. While the Company expects that its final financial results for the quarter and year ended December 31, 2022, following the completion of its financial closing procedures, will generally be consistent with the information provided in the Press Release, the Company's actual results may differ materially from these estimates as a result of the completion of its financial closing procedures for the quarter and year ended December 31, 2022, as well as final adjustments and other developments that may arise between now and the time that its financial results for the quarter and year ended December 31, 2022 are finalized.

The information contained in this Current Report shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

**Item 9.01&nbsp;&nbsp;&nbsp;&nbsp;Financial Statements and Exhibits.**

*(d)&nbsp;&nbsp;&nbsp;&nbsp;Exhibits*

---

| | |
|:---|:---|
| <u>Exhibit No.</u> | <u>Description</u> |
| 99.1 | <u>[Press Release of NovoCure Limited, dated January 9, 2023](pressreleaseprelim2022resu.htm)</u> |
| 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: January 9, 2023

By: <u>/s/ Ashley Cordova</u> 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Name: Ashley Cordova

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Title: Chief Financial Officer

## Exhibit 99.1

Exhibit 99.1

Novocure Announces Preliminary Full Year and Fourth Quarter 2022 Net Revenues and Provides Company Update

*Preliminary full year 2022 net revenues of $538 million and fourth quarter net revenues of $128 million*

*The LUNAR study met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in overall survival*

*Novocure announces first patients treated with new arrays* 

*Novocure to present at the 41*<sup>st</sup> *Annual J.P. Morgan Healthcare Conference at 7:30 a.m. PST on Tuesday, Jan. 10, 2023*

**ROOT, Switzerland** – Novocure (NASDAQ: NVCR) today reported preliminary unaudited financial results and operational updates for the quarter and full year ended December 31, 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).

"2022 was a year of meaningful milestones and consistent execution towards our mission of extending survival in some of the most aggressive forms of cancer," said William Doyle, Novocure's Executive Chairman. "The successful LUNAR study marks the beginning of a transformational period where we anticipate final data from multiple pivotal trials. We are eager to reach these clinical milestones and energized by the prospect of treating tens of thousands of patients who could benefit from Tumor Treating Fields."

**Financial updates for the year and quarter ended December 31, 2022:**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;a.Total preliminary net revenues for the year ended December 31, 2022, were $537.8 million, an increase of 1% compared the prior year.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;b.Total preliminary net revenues for the fourth quarter 2022 were $128.4 million.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;i.The United States, EMEA, and Japan contributed $98.6 million, $17.0 million, and $7.9 million in quarterly net revenues, respectively.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;ii.Revenue in Greater China from Novocure's partnership with Zai Lab totaled $4.9 million.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;c.Cash, cash equivalents and short-term investments were $969.4 million as of December 31, 2022.

**Operational updates for the year and quarter ended December 31, 2022:**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;a.As of December 31, 2022, there were 3,430 active patients on therapy. Active patients from North America, EMEA and Japan contributed 2,191, 870, and 369, respectively.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;b.1,373 prescriptions were received in the quarter. Prescriptions from North America, EMEA and Japan contributed 956, 312, and 105, respectively.

------

Exhibit 99.1

**Quarterly updates and achievements:** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;a.In January 2023, Novocure announced the topline results of the pivotal LUNAR study in non-small cell lung cancer. The LUNAR study met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in overall survival. The LUNAR study showed a statistically significant and clinically meaningful improvement in overall survival when patients were treated with TTFields and immune checkpoint inhibitors (ICI), as compared to those treated with immune checkpoint inhibitors alone, and a positive trend in overall survival when patients were treated with TTFields and docetaxel versus docetaxel alone. TTFields therapy was well tolerated by patients enrolled in the experimental arm of the study.

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;b.Following receipt of CE Mark for its new array in November 2022, Novocure successfully began treating patients through the company's European limited market release. The new thinner and lighter arrays are designed for more efficient TTFields delivery and greater comfort for patients with glioblastoma (GBM).

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;c.In November 2022, Health Canada approved Optune<sup>®</sup> for the treatment of newly diagnosed and recurrent GBM. Novocure is actively working to secure reimbursement of Optune<sup>®</sup> for the treatment of patients in Canada.

**Fourth quarter and full year 2022 financial results conference call**

Novocure will host a conference call and webcast to discuss fourth quarter and full year 2022 financial results at 8:00 a.m. EST on Thursday, February 23, 2023. Analysts and investors can participate in the conference call by using the following registration link, and dial-in details will be provided.

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.

The unaudited results in this press release are preliminary and subject to the completion of the Company's annual independent audit and, therefore, are subject to adjustment.

**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

------

Exhibit 99.1

research center in Haifa, Israel. For additional information about the company, please visit Novocure.com and follow @Novocure on LinkedIn and Twitter.

**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. 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.

**Investors:**

Ingrid Goldberg

investorinfo@novocure.com

610-723-7427

**Media:**

Leigh Labrie

media@novocure.com

610-723-7428

<br>