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NovoCure Ltd

For the period ended Dec 31, 2024. Filed Feb 27, 2025.

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A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.

FY2024 · Filed Feb 27, 2025

NVCR$13.28-2.0%Stored close · as of Nov 6, 2026
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Contents

Cautionary Note Regarding Forward‑Looking Statementsii

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," "Optune Lua," and software, tools and other items to support and optimize the delivery of TTFields therapy (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"), non-small cell lung cancer ("NSCLC") 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, NSCLC 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 IA, Risk Factors, of this Annual Report on Form 10-K, as well as other risks and uncertainties set forth from time to time in the reports we file with the U.S. Securities and Exchange Commission the ("SEC"). 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.

ii

The following is a summary of some of the risks and uncertainties that could materially adversely affect our business, financial condition and results of operations. You should read this summary together with the more detailed description of each risk factor contained below.

Risks relating to the manufacturing, marketing and sales of our products

We currently have only two products approved for use for specific indications. Our ability to expand our product line and their uses requires regulatory approval, which is costly and requires significant time and effort to obtain.

To date, we have generated only occasional and intermittent operating profits, and we have a history of incurring substantial operating losses. As we expand, we may experience difficulties managing our growth.

To obtain approvals for new products and indications and to continue to market our existing products, we are required to conduct preclinical and clinical studies and other testing. Our clinical studies could be delayed or otherwise adversely affected by many factors, including difficulties in enrolling patients and problems with third-party providers. Continued testing of our products may not yield successful results and could reveal currently unknown safety hazards associated with our products. We may choose to, or may be required to, suspend, repeat or terminate our clinical studies if they are not conducted in accordance with regulatory requirements, the results are negative or inconclusive or the studies are not well designed.

Our products do not have a significant history in the marketplace, as a result we may have difficulty:

developing an adequate sales and marketing organization or contracting with third parties to assist us in doing so;

achieving market acceptance of our products by healthcare professionals, patients and/or third-party payers; and

securing and maintaining adequate coverage and reimbursement from third-party payers, including governmental agencies in the countries where we market our products.

We depend on single-source suppliers and manufacturers for some of our components, the loss of which could prevent or delay shipments of our products to customers or delay our clinical studies.

Quality control problems with respect to materials supplied by third-party suppliers could prevent or delay shipments of our products to customers or delay our clinical studies.

We face competition from numerous competitors.

Because of the specialized nature of our business, the termination of relationships with our key employees, consultants and advisors may be detrimental to our business.

Product liability suits, whether or not meritorious, could be brought against us and result in expensive and time-consuming litigation, payment of substantial damages and/or expenses and an increase in our insurance rates.

Other future litigation and regulatory actions could have a material adverse impact on the Company.

We are subject to fluctuations in global economic, political, environmental, and industry conditions, some of which may be unfavorable.

Our products and infrastructure face certain risks, including from cyber security breaches and data leakage. We are also subject to privacy and data security laws.

Risks relating to the regulation of our business

Legislative and regulatory changes in the U.S. and in other countries regarding healthcare and government-sponsored programs may adversely affect us.

We are subject to extensive post-marketing regulation by the U.S. Federal Drug Administration ("FDA") and comparable authorities in other jurisdictions, which could cause us to incur significant costs to maintain compliance.

Modifications to our products may require regulatory approvals and our regulators may not agree with our conclusions regarding whether new approvals are required. Regulatory authorities may require us to cease promoting or to recall the modified versions of our products until such approvals are obtained.

In addition to FDA requirements, we will spend considerable time and money complying with other federal, state, local and foreign rules, regulations and guidance.

If we, our collaborative partners, our contract manufacturers, or our component suppliers fail to comply with regulations, the manufacturing and distribution of our products could be interrupted.

Our products could be subject to recalls that could harm our reputation and financial results.

If our products cause or contribute to a death or a serious injury, or malfunction in certain ways, we will be subject to medical device reporting regulations, which can result in voluntary corrective actions or agency enforcement actions.

We are not permitted to promote the use of our products for unapproved or off-label uses.

We pay taxes and tariffs in multiple jurisdictions and adverse determinations by governmental authorities or changes in laws, rates or our status under which jurisdictions apply to us could increase our tax and tariff burden or subject our shareholders to additional taxes.

We are affected by and subject to environmental laws and regulations that could be costly to comply with or that may result in costly liabilities.

Safety issues concerning lithium-ion batteries could have a material adverse impact on our business.

Risks relating to intellectual property

If we fail to maintain, develop, protect, defend or enforce our intellectual property rights, competitors may be able to develop competing therapies.

Intellectual property litigation and disputes may cause us to incur substantial costs, divert attention from the management of our business, harm our reputation, or require us to remove certain products from the market.

Changes in U.S. patent law could impair our ability to protect our devices.

Risks relating to our ordinary shares and capital structure

The market price for our ordinary shares may be volatile, which could result in substantial losses.

Our ordinary shares are issued under the laws of Jersey, which may not provide the level of legal certainty and transparency afforded by incorporation in a U.S. state.

U.S. shareholders may not be able to enforce civil liabilities against us.

We have borrowed a significant amount of debt and have the ability to borrow additional debt in the future.

Transactions relating to our convertible notes may dilute the ownership interest of existing shareholders, or may otherwise depress the price of our ordinary shares.

iii

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