NovoCure Limited filed SEC Form 8-K: Regulation FD Disclosure, Financial Statements and Exhibits
$NVCR
Medical/Dental Instruments
Health Care
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
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Item 7.01 Regulation FD Disclosure.
On January 30, 2026 , the registrant's U.S. subsidiary, Novocure Inc. (the "Company") received a letter dated January 29, 2026 from the Centers for Medicare & Medicaid Services ("CMS") that the Company's billing privileges for its products were revoked retroactive to December 17, 2025. The Company was cited for an administrative process issue relating to the Company's triannual re-validation and not due to a substantive failure on the Company's part to qualify for re-validation.
The Company has filed a Corrective Action Plan with CMS and expects billing privileges to be reinstated; however, the Company is currently unable to predict with reasonable certainty when this will occur. While the reinstatement process is pending, the Company is continuing to provide services to existing patients and accept new patients. Until the Company reestablishes billing privileges, the Company is not permitted to bill Medicare, Medicare Advantage and other CMS-related programs ("CMS Payors") payors for services rendered from the date of revocation.
Based on historical patterns, the Company estimates it will not be able to recognize revenue of approximately $13 million per month from CMS Payors until billing privileges are reinstated. Once reinstated, the Company will attempt to bill CMS Payors for services rendered during the reinstatement process; however, it is unable to predict with reasonable certainty to what extent such amounts will be billable, if any. The ultimate outcome, timing of resolution and financial impact cannot be determined at this time.
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.
Forward-Looking Statements
In addition to historical facts or statements of current condition, this report 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 trial 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 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 27, 2025, 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.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
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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: February 5, 2026
By: /s/ Christoph Brackmann
Name: Christoph Brackmann
Title: Chief Financial Officer