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Item 1A. Risk Factors

2021-02-25 compared with 2020-02-27 · 285 added, 525 removed, 452 unchanged (64% of the section changed)

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Risks relating to our business and our Products

Our business and prospects depend heavily on Optune, which is currently approved only for the treatment of GBM, and NovoTTF-100L, which is approved for the treatment of MPM.

If we are unable to increase sales of our Products, obtain further regulatory approvals for and further commercialize our Products for the treatment of additional indications or are significantly delayed or limited in doing so, our business and prospects will be materially harmed.

Our business and prospects depend heavily on Optune, which is currently approved only for the treatment of GBM, and Optune Lua, which is currently approved only for the treatment of MPM.

If we are unable to increase sales of our Products, obtain further regulatory approvals and commercialize our Products for the treatment of additional indications, or are significantly delayed or limited in doing so, our business and prospects will be materially harmed.

To date we have received FDA regulatory approval under the PMA pathway and certain approvals in other jurisdictions for the use of Optune for the treatment of adult patients with newly diagnosed GBM in combination with temozolomide (a form of chemotherapy) and for the treatment of adult patients with recurrent GBM as monotherapy.

Optune has obtained a CE Certification, and affixed a CE mark, for the treatment of GBM in the EU.

We have also received FDA approval under the HDE pathway to market NovoTTF-100L for unresectable, locally advanced or metastatic, malignant pleural mesothelioma in combination with standard chemotherapies.

However, such approvals and the CE Certification, and affixing of a CE mark, of our Products, as applicable, do not guarantee future revenues for these indications.

Further, until we receive FDA and analogous approval in other jurisdictions for the use of our Products for other indications, almost all of our revenues will derive from sales and royalties from sales of Optune for the treatment of newly diagnosed and recurrent GBM and NovoTTF-100L for MPM.

The commercial

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success of our Products and our ability to generate and maintain revenues from the sale of our Products will depend on a number of factors, including:

• our ability to obtain additional regulatory approvals for and further commercialize our Products;

• our ability to develop, obtain regulatory approval for and appropriately commercialize our Products for additional indications;

Optune is CE Certified according to Council Directive 93/42/EEC concerning medical devices ("MDD"), and has a CE mark affixed for the treatment of GBM in the EU.

We have also received FDA approval under the HDE pathway to market Optune Lua for unresectable, locally advanced or metastatic, MPM in combination with standard chemotherapies.

Optune Lua is also CE Certified for the same indication in the EU and Switzerland under the name “ NovoTTF-100L” (references in this Annual Report to Optune Lua includes NovoTTF-100L in the appropriate EU and Swiss contexts).

However, such approvals and maintaining the CE Certificates of Conformity, and related CE marking, of our Products, as applicable, do not guarantee future revenues for these indications.

The commercial success of our Products and our ability to generate and maintain revenues from the sale of our Products will depend on a number of factors, including:

• our ability to develop and obtain additional regulatory approvals and further commercialize our Products for additional indications;

• the acceptance of our Products by patients and the healthcare community, including physicians and third-party payers (both private and governmental), as therapeutically effective and safe;

• the accomplishment of various scientific, engineering, clinical, regulatory and other goals, which we sometimes refer to as milestones, on our anticipated timeline;

• the relative cost, safety and efficacy of alternative therapies;

• our ability to obtain and maintain sufficient coverage or reimbursement by private and governmental third-party payers;

• our ability to obtain and maintain sufficient coverage or reimbursement by private and governmental third-party payers and to comply with applicable health care laws and regulations;

• the ability of our third-party manufacturers to manufacture our Products in sufficient quantities with acceptable quality;

• our ability to provide marketing, distribution and customer support for our Products;

• the presence of competitive products in our active indications;

• results of future clinical studies relating to our Products or other competitor products for similar indications;

• compliance with applicable health care and cybersecurity laws and regulations;

• compliance with applicable laws and regulatory requirements, in particular in the EU;

• the maintenance of our existing regulatory approvals;

• the consequences of any reportable adverse events involving our Products.

In addition, the promotion of our Products is limited to approved indications, which vary by geography, and the FDA label for Optune is limited in certain respects (for example, it is not approved for use in the brain stem, is not approved for use as monotherapy in newly diagnosed GBM and is limited for use by adults ages 22 and older), which may reduce the number of patients to whom it may be prescribed.

Similarly, the label for NovoTTF-100L also contains certain limitations which may adversely affect adoption, including the requirement to display on all marketing materials that the efficacy of the product has not been established, a limitation of use by adults ages 22 and older only, and the absence of Phase III clinical data.

Our ability to generate future revenues will also depend on achieving regulatory approval of, and eventual commercialization of, our Products for additional indications.

However, obtaining regulatory approval of our Products for additional indications is not guaranteed.

In addition, the promotion of our Products is limited to approved indications, which vary by geography, and the label for Optune is limited in certain respects (for example, it is not approved for use in the brain stem, is not approved for use as monotherapy in newly diagnosed GBM and is limited for use by adults ages 22 and older), which may reduce the number of patients to whom it may be prescribed.

Similarly, the label for Optune Lua also contains certain limitations that may adversely affect adoption, including the requirement in the United States to display on all marketing materials that the efficacy of the product has not been established, a limitation of use by adults ages 22 and older only, and the absence of Phase 3 clinical data.

Our ability to generate future revenues will also depend on achieving regulatory approval of, and eventual commercialization of, our Products for additional indications, which is not guaranteed.

Our near-term prospects are substantially dependent on our ability to obtain regulatory approvals on the timetable we have anticipated, and thereafter to further successfully commercialize our Products for additional indications.

Regulatory changes or actions in which we operate or propose to operate may further affect our ability to obtain regulatory approvals on the anticipated timetable.

If we are not able to receive such approvals or to further commercialize our Products, or are significantly delayed or limited in doing so, our business and prospects will be materially harmed and we may need to delay our initiatives or even significantly curtail operations.

To date, we have incurred substantial operating losses.

We were founded in 2000 and have incurred substantial operating losses to date.

In assessing our prospects, you must consider the risks and difficulties frequently encountered by companies in new and rapidly evolving markets, particularly companies engaged in the development and sales of oncology products.

These risks include our ability to:

• continue to develop and enhance our Products;

• obtain regulatory approval to commercialize our Products for additional indications and enhance or modify our Products;

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• increase our sales, marketing and distribution organization to commercialize our Products;

• perform preclinical and clinical research, engineering research and development and clinical trials on our Products and Tumor Treating Fields;

• establish and increase awareness and acceptance of our Products;

• implement and successfully execute our business and marketing strategy;

• respond effectively to competitive pressures and developments;

• maintain, protect and expand our intellectual property portfolio;

• operate in compliance with applicable health care and cybersecurity laws and regulations;

• expand our presence in our key markets;

• attract, retain and motivate qualified personnel;

• grow our organization to support our operations and our clinical pipeline and expand commercialization efforts.

Regulatory changes or actions in areas in which we operate or propose to operate may further affect our ability to obtain regulatory approvals on our anticipated timetable.

If we are not able to receive such approvals, meet other anticipated milestones, or further commercialize our Products, or are significantly delayed or limited in doing so, our business and prospects will be materially harmed and we may need to reduce expenses by delaying, reducing or curtailing the development of our Products and we may need to raise additional capital to fund our operations, which we may not be able to obtain on favorable terms, if at all.

To date, we have generated only limited operating profits, and we have a history of incurring substantial operating losses.

We were founded in 2000 and have only recently started generating limited operating profits.

We have otherwise had a history of incurring substantial operating losses.

We anticipate continuing to incur significant costs associated with commercializing our Products for approved indications including product sales, marketing, manufacturing, and distribution expenses.

We expect our research, development and clinical trials expenses to increase in connection with our ongoing activities and as additional indications enter late-stage clinical development.

Our expenses could increase beyond expectations if, for example, we are required by the FDA, or other regulatory agencies, to change manufacturing processes for our Products, or to perform clinical, nonclinical or other types of studies in addition to those that we currently anticipate.

We expect our research, development, and clinical trial expenses to increase in connection with our ongoing activities and as additional indications enter late-stage clinical development and as we advance our product development.

Our expenses could increase beyond expectations if, for example, we are required by the FDA, or other regulatory agencies or similar governing bodies, to change manufacturing processes for our Products or to perform clinical, nonclinical or other types of studies in addition to those that we currently anticipate.

Our revenues are dependent, in part, upon the size of the markets in the jurisdictions in which we receive regulatory approval, the accepted price for our Products and the ability to obtain reimbursement at the accepted applicable price.

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If we are not able to generate significant revenues, we may never be sustainably profitable.

If we do not achieve our projected research and development and commercialization goals in the timeframes we announce or expect, our results of operations would be adversely affected and we may need to raise additional capital to fund our operations.

We estimate the timing of the accomplishment of various scientific, engineering, clinical, regulatory and other goals, which we sometimes refer to as milestones.

These milestones may include the commencement or completion of scientific studies and clinical trials, the submission of regulatory filings in the U.S.

and other jurisdictions and the receipt of regulatory approvals in such jurisdictions.

From time to time, we may publicly announce the expected timing of some of these milestones.

All of these milestones are based on a variety of assumptions that may not turn out to be accurate or relevant in hindsight.

For example, our key milestones include clinical development and regulatory milestones for the use of our Products to treat brain metastases, non-small cell lung cancer, pancreatic cancer and ovarian cancer.

We can provide no assurance that we will achieve these milestones on our expected timetable, or at all.

The actual timing of the achievement of these milestones can vary dramatically from our estimates, in many cases for reasons beyond our control, depending on numerous factors, including:

• the rate of progress, costs and results of our research and development activities and clinical trials;

• our ability to identify and engage appropriate health care professionals to conduct our clinical trials;

• the extent of competing clinical trials for the same cohort of eligible patients;

• our ability to identify and enroll patients who meet clinical trial eligibility criteria;

• the extent of scheduling conflicts with participating clinicians and clinical institutions;

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• the occurrence of adverse events during clinical trials;

• the occurrence of adverse events due to a cybersecurity breach involving our Products;

• the receipt of approvals by our competitors of competing products and by us of additional indications for our Products;

• our ability to achieve coverage and reimbursement milestones with private and governmental third-party payers;

• our ability to access sufficient, reliable and cost-effective supplies of components used in the manufacture of our Products, including the batteries, transducer arrays and other materials;

• our ability to develop and maintain a compliant sales and marketing organization and/or enter into sales and marketing collaborations for our Products;

• changes in regulations and other actions by regulators.

If we do not achieve any of these milestones in the timeframes we expect and generate sufficient revenues, and/or if we are unable to obtain sufficient additional funds through financings, the proceeds from long-term loans, strategic collaborations or the license or sale of certain of our assets on a timely basis when necessary, we may be required to reduce expenses by delaying, reducing or curtailing the development of our Products and we may need to raise additional capital to fund our operations, which we may not be able to obtain on favorable terms, if at all.

If we fail to commence or complete, or experience delays in or are forced to curtail, our proposed clinical programs or otherwise fail to adhere to our projected development milestones in the timeframes we announce or expect (or within the timeframes expected by analysts or investors), or we fail to raise any required additional capital, any of such events could have a material adverse effect on our business, prospects, financial condition and results of operations and cause our stock price to decline.

We will need to generate significant revenues to be sustainably profitable, and we may never do so.

We may not be successful in our efforts to create a pipeline of future indications for our Products and successfully commercialize them.

We are pursuing clinical development of our Products to treat a variety of solid tumors.

For these future indications, we are at varying stages of development and we generally do not have relevant regulatory approvals to market our Products for these indications.

Further, we do not currently intend to pursue indications involving solid tumors of the throat or extremities, and we do not believe our Products would be efficacious for non-solid tumor cancers like lymphoma or other blood cancers.

Even if we are successful in continuing to build our pipeline, obtaining regulatory approvals and commercializing our Products for additional indications are susceptible to risks of failure, including the significant risk that the development of our Products for any potential indications will fail to demonstrate adequate efficacy or an acceptable safety profile, to gain regulatory approval and/or to become commercially viable.

We cannot provide any assurance that we will be able to advance any of these additional indications through the development and commercialization process.

Our research programs may initially show promise in addressing additional indications, yet fail to yield approvals or commercialization for many reasons, including the following:

• we may not be able to assemble sufficient resources to pursue clinical trials for additional indications;

• our Products may not succeed in preclinical or clinical testing for additional indications;

• our Products may, on further study be shown to have harmful side effects for other indications or other characteristics that indicate they are unlikely to be effective or otherwise do not meet applicable regulatory criteria for such indications;

• competitors may develop alternative treatments that render our Products obsolete or less attractive;

• the market for our Products may change so that the continued development of our pipeline as currently contemplated is no longer appropriate;

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• we may not be able to produce our Products for current and future indications in commercial quantities at an acceptable cost, or at all;

• our Products may not meet standards set by applicable regulatory authorities to obtain approval or clearance to market our Products for additional indications;

• our Products may not be accepted as safe, effective, convenient, cost-effective or otherwise desirable by patients, the medical community, regulatory authorities or third-party payers.

If any of these events occur, we may be forced to delay or abandon our development efforts for our anticipated pipeline, which would have a material adverse effect on our business and prospects and could potentially cause our stock price to decline and cause us to cease operations.

Moreover, any of these events regarding the use of our Products in any particular indication may have a negative effect on the approval process for other indications and/or result in losing or delaying approval of our Products for other indications, which may exacerbate the harm to our business and prospects.

If we encounter difficulties enrolling patients in our clinical trials, our clinical trials could be delayed or otherwise adversely affected.

Our clinical trials could be delayed or otherwise adversely affected by many factors, including difficulties in enrolling patients.

Clinical testing can be costly and take many years, and the outcome is uncertain and susceptible to varying interpretations.

Moreover, success in preclinical and early clinical trials does not ensure that large-scale trials will be successful or predict final results.

Acceptable results in early trials may not be replicable in later trials.

A number of companies in the oncology industry have suffered significant setbacks in advanced clinical trials, even after promising results in earlier trials.

Negative or inconclusive results or adverse events or incidents during a clinical trial could cause the clinical trial to be redone or terminated.

In addition, failure to construct appropriate clinical trial protocols could result in the test or control group experiencing a disproportionate number of adverse events or incidents and could cause a clinical trial to be suspended, redone or terminated.

The timely completion of clinical trials depends, among other things, on our ability to enroll a sufficient number of patients who remain in the trial until its conclusion.

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• the nature of the trial protocol, including the attractiveness of, or the discomforts and risks associated with, the treatments received by enrolled subjects;

• difficulties and delays in clinical trials that may occur as a result of the COVID-19 pandemic;

• the ability to obtain IRB approval at clinical trial locations;

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• the risk that patients enrolled in clinical trials will choose to withdraw from or otherwise not be able to complete a clinical trial.

Patients may be discouraged from enrolling and/or remaining enrolled in our clinical trials if the trial protocol requires them to undergo extensive follow-up to assess the safety and effectiveness of our Products, or if they

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determine that the treatments received under the trial protocols are not attractive or involve unacceptable risks or discomforts.

Patients may also not participate in our clinical trials if they choose to participate in contemporaneous clinical trials of competing products.

In addition, the inclusion of critically ill patients in our clinical trials may result in deaths or other adverse medical events for reasons that may not be related to our Products, or, in those trials where our Products are being tested in combination with one or more other therapies, for reasons that may be attributable to the other therapies, but which can nevertheless negatively affect clinical trial results.

If we have difficulty enrolling and retaining a sufficient number or diversity of patients to conduct our clinical trials as planned, we may need to delay or terminate ongoing or planned clinical trials, either of which would have an adverse effect on our business.

If we have difficulty enrolling and retaining a sufficient number or diversity of patients to conduct our clinical trials as planned, or encounter other difficulties, we may need to delay, terminate or modify ongoing or planned clinical trials, any of which would have an adverse effect on our business.

If we are unable to continue the development of an adequate sales and marketing organization or contract with third parties to assist us, we may not be able to successfully commercialize our Products for current and future indications.

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Developing and managing a sales and marketing organization is a difficult, expensive and time consuming process.

To be successful we must:

• recruit and retain adequate numbers of effective and experienced sales and marketing personnel;

• effectively train our sales personnel on the benefits and risks of our Products and healthcare compliance;

• establish and maintain successful and compliant sales, marketing and education programs that educate health care providers so they can appropriately inform their patients about our Products;

• manage geographically disbursed sales functions and marketing campaigns.

We may not be able to successfully develop adequate sales and marketing capabilities to achieve our growth objectives.

We will have to compete with other medical device, pharmaceutical and life sciences companies to recruit, hire, train and retain the sales and marketing personnel that we anticipate we will need, and the nature of our Products may make it more difficult to compete for sales and marketing personnel.

We compete with other medical device, pharmaceutical and life sciences companies to recruit, hire, train and retain the sales and marketing personnel that we anticipate we will need, and the nature of our Products may make it more difficult to compete for sales and marketing personnel.

In addition, because our current Products require, and we anticipate our future Products will require, physician training and education, our sales and marketing organization must grow substantially as we expand our approved indications and markets.

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If we are unable to establish adequate sales and marketing capabilities or successful sales and distribution relationships, we may fail to realize the full revenue potential of our Products for current and future indications, and we may not be able to achieve the necessary growth in a cost-effective manner or realize a positive return on our investment.

In our current and future sales and distribution agreements with other companies, we generally do not and may not have control over the resources or degree of effort that any of these third parties may devote to our Products, and if they fail to devote sufficient time and resources to the marketing of our Products, or if their performance is substandard, it will adversely affect our revenues.

The success of our business may be dependent on the actions of our collaborative partners.

Our global business strategy includes, in part, the consummation of collaborative arrangements with companies who will support the development and commercialization of our products and technology in return for royalties on commercial sales and milestone payments for progress in clinical development, regulatory approval and sales targets.

For example, we have exclusively licensed rights to commercialize our Products in the field of oncology in Greater China (the "Zai Territory") to Zai pursuant to an agreement that also establishes a development partnership for Tumor Treating Fields in multiple solid tumor indications.

Our global business strategy includes, in part, the consummation of collaborative arrangements with companies who will support the development and commercialization of our products and technology.

For example, we have exclusively licensed rights to commercialize our Products in the field of oncology in Greater China to Zai pursuant to an agreement that also establishes a development partnership for Tumor Treating Fields (“TTFields”) in multiple

solid tumor indications.

Zai is responsible for the development and commercialization of our Products in Greater China at its sole cost with certain assistance from us.

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In addition, our collaborative partners may have the right to abandon research or development projects and terminate applicable agreements, including payment obligations, prior to or upon the expiration of the agreed-upon terms.

We may not be successful in establishing or maintaining collaborative arrangements on acceptable terms or

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at all, collaborative partners may terminate funding before completion of projects, our Products may not achieve the criteria for milestone payments, our collaborative arrangements may not result in successful product commercialization, our Products may not receive acceptable pricing and we may not derive any revenue from such arrangements.

We may not be successful in establishing or maintaining collaborative arrangements on acceptable terms or at all, collaborative partners may terminate funding before completion of projects, our Products may not achieve the criteria for milestone payments, our collaborative arrangements may not result in successful product commercialization, our Products may not receive acceptable pricing and we may not derive any revenue from such arrangements.

Additionally, our collaborators may not perform their obligations as expected or in compliance with applicable laws and acts or omissions by collaborators may create liability for us in the jurisdictions in which we operate.

Any disagreements with collaborators, including disagreements over proprietary rights, contract interpretation or the preferred course of development or commercialization, might cause delays or termination of the research, development or commercialization of Products, might lead to additional responsibilities for us with respect to developing or commercializing Products, or might result in litigation or arbitration, any of which would be time-consuming and expensive.

To the extent that we are not able to develop and maintain collaborative arrangements, we would need to devote substantial capital to undertake development and commercialization activities on our own in order to further expand our global reach, and we may be forced to limit the territories in which we commercialize our Products.

Reliance on collaborative relationships poses a number of risks, including the following:

• our collaborators may not perform their obligations as expected or in compliance with applicable laws;

• the prioritization, amount and timing of resources dedicated by our collaborators to their respective collaborations with us is not under our control;

• some Products with respect to which we collaborate may be viewed by our collaborators as competitive with their own product candidates or products;

• our collaborators may elect not to proceed with the development of Products that we believe to be promising;

• disagreements with collaborators, including disagreements over proprietary rights, contract interpretation or the preferred course of development or commercialization, might cause delays or termination of the research, development or commercialization of Products, might lead to additional responsibilities for us with respect to Products, or might result in litigation or arbitration, any of which would be time-consuming and expensive;

• acts or omissions by collaborators may create liability for us in the jurisdictions in which we operate;

• some of our collaborators might develop independently, or with others, products that could compete with our Products;

• a delay in the development or regulatory approval timelines for our Products in a licensed territory would result in a potential delay or loss of milestone payments and future royalties (if any) from the partnership;

• if a collaboration is terminated for any reason, then we may need to establish a new development and commercialization partnership to further our Products in the relevant market.

There can be no assurance that we would be able to find such a partner.

We may not be successful in achieving market acceptance of our Products by healthcare professionals, patients and/or third-party payers in the timeframes we anticipate, or at all, which could have a material adverse effect on our business, prospects, financial condition and results of operations.

Our business model is predicated on achieving market acceptance of our Products as a monotherapy or in combination with well-established cancer treatment modalities like surgery, radiation and pharmacological therapies.

We may not achieve market acceptance of our Products for current or future indications in the amount of time that we have anticipated, or at all, for a number of different reasons, including the following factors:

We may not achieve market acceptance of our Products for current or future indications within the timeframes we have anticipated, or at all, for a number of different reasons, including the following factors:

• it may be difficult to gain broad acceptance of our Products because they are new technologies and involve a novel mechanism of action and, as such, physicians may be reluctant to prescribe our Products without prior experience or additional data or training;

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• physicians at large academic universities and medical centers may prefer to enroll patients into clinical trials instead of prescribing our Products;

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• it may be difficult to gain broad acceptance at community hospitals where the number of patients seeking cancer treatment may be more limited than at larger medical centers, and such community hospitals may not be willing to invest in the resources necessary for their physicians to become trained to use our Products, which could lead to reluctance to prescribe our Products;

• it may be difficult to gain broad acceptance at community hospitals where the number of patients seeking treatment may be more limited than at larger medical centers, and such community hospitals may not be willing to invest in the resources necessary for their physicians to become trained to use our Products, which could lead to reluctance to prescribe our Products;

• patients may be reluctant to elect to use our Products for various reasons, including a perception that the treatment is untested or difficult to use (for example, they will need to shave the areas on their bodies where the arrays are applied) or a perception that our software is not secure;

• our Products may have side effects (for example, dermatitis where the transducer arrays are placed) and our Products cannot be worn in all circumstances (for example, they cannot get wet and are difficult to wear in high temperatures);

• our Products may have side effects (for example, dermatitis where the arrays are placed) and our Products cannot be worn in all circumstances (for example, they cannot get wet and are difficult to wear in high temperatures);

• the price of our Products includes a monthly fee for use of the delivery system and therefore, as the duration of the treatment course increases, the overall price will increase correspondingly and, when used in combination with other treatments, the overall cost of treatment will be greater than using a single type of treatment.

In particular, our Products may not achieve market acceptance for current or future indications because of the following additional factors:

• achieving patient acceptance could be difficult because we are targeting devastating diseases with poor prognoses, and not all patients with potentially short lifespans are willing to comply with requirements of treatment with our Products, such as the need to use our Products for at least 18 hours per day, carrying around a device and shaving the area where the arrays are worn, and other patients may forego our Products for privacy, cosmetic, visibility or mobility reasons;

• achieving patient compliance is difficult because the recommended average daily use of our currently marketed Products is at least 18 hours a day, requiring patients to wear the delivery system nearly continuously, which to some extent restricts physical mobility because the battery must be frequently exchanged and recharged, and the patient or a caregiver must ensure that it remains continuously operable and this may also impact the pool of patients to whom physicians may be willing to prescribe our Products, as physicians may be reluctant to prescribe our Products;

• certain patients are contraindicated to using our Products due to a variety of factors, including, but not limited to, those who have an active implanted medical device, those who have a skull defect, and those who are sensitive to conductive hydrogels;

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additional adverse events reported in clinical trials by patients treated with our Products in combination with chemotherapies in addition to the above, were thrombocytopenia, nausea, constipation, vomiting, fatigue and other side effects consistent with treatment with chemotherapies.

In addition, even if we are successful in achieving market acceptance of our Products for GBM or MPM, we may be unsuccessful in achieving market acceptance of our Products as a treatment for other solid tumor cancers, such as brain metastases, NSCLC, pancreatic cancer, ovarian cancer and other solid tumor cancers, because certain radiation, chemotherapies and/or systemic medical therapies may become or remain the preferred standard of care for these indications.

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In addition, even if we are successful in achieving market acceptance of our Products for GBM or MPM, we may be unsuccessful in achieving market acceptance of our Products for other indications, such as brain metastases, NSCLC, pancreatic cancer, ovarian cancer and other solid tumor cancers, because certain radiation, chemotherapies and/or systemic medical therapies may become or remain the preferred standard of care for these indications.

There may be other factors that are presently unknown to us that also may negatively impact our ability to achieve market acceptance of our Products.

If we do not achieve market acceptance of our Products in the timeframes we anticipate, or are unable to achieve market acceptance at all, our business, prospects, financial condition and results of operations could be materially adversely affected, and our stock price could decline.

Failure to secure and maintain adequate coverage and reimbursement from third-party payers could adversely affect acceptance of our Products and reduce our revenues.

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In the U.S., private payers cover the largest segment of the population, with the remainder either uninsured or covered by governmental payers.

We anticipate that the majority of the third-party payers outside the U.S.

will be government agencies, government sponsored entities or other payers operating under significant regulatory requirements from national or regional governments.

Third-party payers may decline to reimburse for procedures, supplies or services not under coverage policies.

Additionally, some third-party payers may decline to reimburse us for a particular patient even with the existence of a coverage policy.

Additionally, private commercial and government payers may be permitted to consider the cost of a treatment in approving coverage or in setting payment for the treatment.

The majority of the third-party payers outside the U.S.

are government agencies, government sponsored entities or other payers operating under significant regulatory requirements from national or regional governments.

Third-party payers may decline to cover and reimburse certain procedures, supplies or services.

Additionally, some third-party payers may decline to cover and reimburse our Products for a particular patient even if the payer has a favorable coverage policy addressing our Products or previously approved reimbursement for our Products.

Additionally, private and government payers may consider the cost of a treatment in approving coverage or in setting reimbursement for the treatment.

Private and government payers around the world are increasingly challenging the prices charged for medical products and services.

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Adoption of additional price controls and cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could further limit our revenues and operating results.

If third-party payers do not consider our Products or the combination of our Products with additional treatments to be cost-justified under a required cost-testing model, they may not cover our Products for their populations or, if they do, the level of payment may not be sufficient to allow us to sell our Products on a profitable basis.

If third-party payers do not consider our Products or the combination of our Products with additional treatments to be cost-justified under a required cost-testing model, they may not cover our Products for their populations or, if they do, the level of reimbursement may not be sufficient to allow us to sell our Products on a profitable basis.

Reimbursement for the treatment of patients with medical devices around the world is governed by complex mechanisms established on a national or sub-national level in each country.

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We cannot guarantee that the use of our Products will receive reimbursement approvals and cannot guarantee that our existing reimbursement approvals will be maintained in any country.

We provide financial assistance to patients in certain markets who qualify based on established financial criteria.

Primarily, we provide financial assistance to patients where we have or are actively pursuing reimbursement.

We provide financial assistance to certain patients in certain markets who qualify based on established financial and other criteria.

Primarily, we provide financial assistance to patients where we have or are actively pursuing coverage and reimbursement.

This financial assistance is intended to defray out-of-pocket costs for our Products for patients who begin treatment but who are unable to pay for the costs of their treatment not covered by insurance.

Our costs associated with this program could increase if payers increase the cost-sharing burden of patients or we do not obtain reimbursement coverage and we elect to continue providing financial assistance in those markets.

Our costs associated with this program could increase if payers increase the cost-sharing burden of patients or we do not obtain coverage and reimbursement and we elect to continue providing financial assistance in those markets.

Additionally we provide charitable donations to foundations that can then provide financial assistance to those receiving health care coverage from federal or state funded programs.

Enforcement actions and changes to government regulations related to manufacturer-sponsored patient assistance programs that could reduce our ability to support patients financially in the future.

Enforcement actions and changes to government regulations related to manufacturer-sponsored and independent charitable patient assistance programs could reduce our ability to support patients financially in the future.

Our failure to secure or maintain adequate coverage or reimbursement for our Products by third-party payers in the U.S.

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We may not be successful in securing and maintaining reimbursement codes necessary to facilitate accurate and timely billing for our Products or physician services attendant to our Products.

Third-party payers, healthcare systems, government agencies or other groups often issue reimbursement codes to facilitate billing for products and physician services used in the delivery of medicine.

Within the U.S., the billing

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codes most directly related to our Products are contained in the Healthcare Common Procedure Coding System ("HCPCS code set").

Third-party payers, healthcare systems, government agencies or other groups often issue reimbursement codes to facilitate billing for products and physician services used in the delivery of healthcare.

Within the U.S., the billing codes most directly related to our Products are contained in the Healthcare Common Procedure Coding System ("HCPCS code set").

The HCPCS code set contains Level I codes that describe physician services, also known as Common Procedural Terminology codes ("CPT codes") and Level II codes that primarily describe products.

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to bill third-party payers.

Loss of these codes or any alteration in the payment attached to these codes would materially impact our operating results.

We do not have a unique HCPCS Level II code for NovoTTF-100L at this time.

Loss of these codes or any alteration in the reimbursement amounts attached to these codes would materially impact our operating results.

We do not have a unique HCPCS Level II code for Optune Lua at this time.

No CPT codes currently exist to describe physician services related to the delivery of therapy using our Products.

We may not be able to secure CPT codes for physician services related to our Products based on the relatively low incidence of GBM.

Our future revenues and results may be affected by the absence of CPT codes, as physicians may be less likely to prescribe the therapy when not adequately reimbursed for the time, effort, skill, practice expense and malpractice costs required to provide the therapy to patients.

Outside the U.S, we have not secured codes to describe our Products or to document physician services related to the delivery of therapy using our Products.

Our future revenues and results may be affected by the absence of CPT codes, as physicians may be less likely to prescribe the therapy when there is no certainty that adequate reimbursement will be available for the time, effort, skill, practice expense and malpractice costs required to provide the therapy to patients.

Outside the U.S., but excluding Germany, we have not secured codes to describe our Products or to document physician services related to the delivery of therapy using our Products.

The failure to obtain and maintain these codes could affect the future growth of our business.

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We anticipate that a significant portion of patients using our Products will be beneficiaries under the Medicare fee-for-service program.

Failure to secure or maintain coverage or maintain adequate payment from Medicare would reduce our revenues and may also affect the coverage and payment decisions of other third-party payers in the U.S.

Medicare classifies Optune and NovoTTF-100L as durable medical equipment ("DME").

Failure to secure or maintain coverage or maintain adequate reimbursement from Medicare

would reduce our revenues and may also affect the coverage and reimbursement decisions of other third-party payers in the U.S.

and elsewhere.

Medicare classifies Optune as durable medical equipment ("DME").

Medicare has the authority to issue national coverage determinations or to defer coverage decisions to its regional Medicare Administrative Contractors ("MACs").

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The absence of a positive coverage determination or a future restriction to existing coverage from Medicare or the DME MACs would materially affect our future revenues.

Additionally, Medicare has the authority to publish the price of DME products.

Medicare has published a price for Optune that falls below the median price that we have established with non-Medicare payers.

Medicare may in the future publish prices for our Products that do not reflect then-current prices for our Products or Medicare may decrease existing prices published for our Products.

Medicare price schedules are frequently referenced by private payers in the U.S.

Additionally, Medicare has the authority to publish the reimbursement amounts for DME products.

Medicare has published a reimbursement amount for Optune that falls below the median reimbursement that we have established with non-Medicare payers.

Medicare may in the future publish reimbursement amounts for our Products that do not reflect then-current prices for our Products or Medicare may decrease existing reimbursement amounts published for our Products.

Medicare fee schedules are frequently referenced by private payers in the U.S.

and around the world.

Medicare's publication of prices for our Products that are below established prices of our Products could materially reduce our revenues and operating results with respect to non-Medicare payers in the U.S.

Medicare's publication of reimbursement amounts for our Products that are below our Products’ established prices could materially reduce our revenues and operating results with respect to non-Medicare payers in the U.S.

and our other active markets.

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Claims for such items that did not receive prior authorization before they were furnished to a beneficiary will be automatically denied.

In the event Medicare adds one of our Products to the list of items requiring prior authorization that may reduce our ability to bill and secure payment for patients who would otherwise be covered to use our Product under the Medicare fee-for-service program.

Medicare issued guidance in 2018 that imposes a series of requirements on the MACs, including a requirement to form contractor advisory committees to review new LCDs and to subject almost all LCD revisions to a public comment period.

These requirements have slowed and could continue to slow the process for LCD revisions, and may delay coverage for our Products in future indications.

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In the event Medicare adds one of our Products to the list of items requiring prior authorization, our ability to bill and secure reimbursement for patients who would otherwise be covered to use our Product under the Medicare fee-for-service program may be reduced.

CMS has recently issued a new final rule (Medicare Coverage of Innovative Technology (CMS-3372-F) (“MCIT”) that further revises reimbursement coverage criteria for newly approved medical devices.

Under the MCIT rule, Medicare will require MACs to provide coverage for medical devices for four years after FDA approval, provided that the device has received an FDA “breakthrough” designation.

We are assessing the potential impact of this rule on our business and cannot provide any assurance that we can access this expanded coverage for our future products.

The Medicare fee-for-service program has denied coverage for all claims prior to the September 1, 2019 effective date for the DME MAC LCD, which provides coverage for Optune for the treatment of newly diagnosed GBM subject to certain conditions and restrictions.

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We appeal Medicare coverage denials through the Medicare appeals process:

redetermination by a MAC, reconsideration by a Qualified Independent Contractor, hearing before an ALJ at the Office of Medicare Hearings and Appeals, review by the Medicare Appeals Council, and judicial review in U.S.

redetermination by a MAC, reconsideration by a Qualified Independent Contractor, hearing before an Administrative Law Judge (“ALJ”) at the Office of Medicare Hearings and Appeals, review by the Medicare Appeals Council, and judicial review in U.S.

District Court.

Currently, there is a considerable backlog of appeals at the ALJ level and there are significant delays in the assignment of ALJ cases.

Thus, we anticipate that, even if we are successful in winning our appeals, we will experience a significant delay in securing payment for Medicare patients when Medicare’s DME MACs deny coverage for patients who start therapy.

We cannot provide any assurance that our outstanding ALJ appeals will be favorably decided.

Further, we anticipate that, even if we are successful in winning our appeals, we will experience a significant delay in securing reimbursement for Medicare patients when Medicare’s DME MACs deny coverage for patients who start therapy.

We depend on single-source suppliers for some of our components.

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If any one of these single-source suppliers were to fail to continue to provide components to us on a timely basis, or at all, our business and reputation could be harmed.

Our policy is to seek and maintain second-source suppliers, but we can provide no assurance we will secure or maintain such suppliers.

We are in the process of developing and obtaining regulatory approval for second sources for components in all jurisdictions.

Our policy is to seek and maintain second-source suppliers, but we can provide no assurance that we will secure or maintain such suppliers.

We have developed or are in the process of developing and obtaining regulatory approval for second sources for components in all jurisdictions.

Various steps must be taken before securing these suppliers, including qualifying these suppliers in accordance with regulatory requirements, but we may never receive such approvals.

Establishing additional or replacement suppliers for any components of our Products, and obtaining any additional regulatory approvals required to add or replace suppliers, will take a substantial amount of time and could result in increased costs and impair our ability to produce our Products, which would have a material adverse effect on our business, prospects, financial condition and results of operations.

We may have difficulty obtaining similar components from other suppliers that are acceptable to the FDA or other regulatory authorities, or to comply with requirements governing design and manufacturing in the EU.

The risks associated with the failure of our suppliers to comply with strictly enforced regulatory requirements as described below are exacerbated by our dependence on single-source suppliers.

Furthermore, since some of these suppliers are located outside of the U.S., we are subject to export laws in other jurisdictions and U.S.

import and customs regulations, which complicate and could delay shipments of components to us.

Changes in U.S.

social, political, regulatory and economic conditions or in laws and policies governing foreign trade, manufacturing, development and investment in the territories and countries where we may develop and sell products, and any negative sentiments towards the U.S.

as a result of such changes, could adversely affect our business.

If we experience any deficiency in the quality of, delay in or loss of availability of any components supplied to us by third-party suppliers, or if we have to switch to replacement suppliers, we may face additional regulatory delays and the manufacture and delivery of our Products would be interrupted for an extended period of time, which could materially adversely affect our business, prospects, financial condition and results of operations.

In addition, we may be required to obtain prior regulatory approval if we use different suppliers or components.

Such changes could affect our FDA regulatory approvals and the compliance of our Products with the Essential Requirements laid down in Annex I to the Medical Devices Directive and the validity of our current CE Certificates of Conformity.

If we are required to obtain prior regulatory approval from the FDA or regulatory authorities in other jurisdictions or to conduct a new conformity assessment procedure and obtain new CE Certificates of Conformity in the EU to use different suppliers or components for our Products, regulatory approval or the CE Certificates of Conformity for our Products may not be received on a timely basis, or at all, which would have a material adverse effect on our business, prospects, financial condition and results of operations.

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of our Products and, as a result, a material adverse effect on our business, prospects, financial condition and results of operations.

The risks associated with the failure of our suppliers to

comply with strictly enforced regulatory requirements as described below are exacerbated by our dependence on single-source suppliers.

If we experience any deficiency in the quality of, delay in or loss of availability of any components supplied to us by third-party suppliers, or if we switch suppliers or components, we may face additional regulatory delays and the manufacture and delivery of our Products would be interrupted for an extended period of time, which could materially adversely affect our business, prospects, financial condition and results of operations.

If we are required to obtain prior regulatory approval from the FDA or regulatory authorities or similar governing bodies in other jurisdictions or to conduct a new conformity assessment procedure and obtain new CE Certificates of Conformity in the EU to use different suppliers or components for our Products, regulatory approval or the CE Certificates of Conformity for our Products may not be received on a timely basis, or at all, which would have a material adverse effect on our business, prospects, financial condition and results of operations.

Quality control problems with respect to delivery systems and components supplied by third-party suppliers could have a material adverse effect on our reputation, our clinical trials or the commercialization of our Products and, as a result, a material adverse effect on our business, prospects, financial condition and results of operations .

Our Products, which are manufactured by third parties, are highly technical and are required to meet exacting specifications.

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The failure of our suppliers to comply with strictly enforced regulatory requirements could expose us to regulatory action, including warning letters, product recalls, suspension or termination of distribution, product seizures or civil penalties.

If we experience any delay or deficiency in the quality of products supplied to us by third-party suppliers, or if we have to switch to replacement suppliers, we may face additional regulatory delays and the manufacture and delivery of our Products would be interrupted for an extended period of time, which would materially adversely affect our business, prospects, financial condition and results of operations.

If the third parties on which we rely to conduct our clinical trials and to assist us with research and development do not perform as contractually required or expected, we may not be able to obtain regulatory approvals for or commercialize our Products.

We do not have the ability to independently conduct some of our preclinical and development activities and all of our clinical trials for our Products and we must rely on third parties, such as contract research organizations, medical institutions, clinical investigators, contract laboratories and collaborative partners, to conduct such trials.

If we experience any delay in the receipt or deficiency in the quality of products supplied to us by third-party suppliers, or if we have to switch to replacement suppliers, we may face additional regulatory delays and the manufacture and delivery of our Products would be interrupted for an extended period of time, which would materially adversely affect our business, prospects, financial condition and results of operations.

If the third parties on which we rely to conduct our preclinical and clinical trials and to assist us with research and development do not perform as contractually required or expected, we may not be able to obtain regulatory approvals for or commercialize our Products.

We do not have the ability to independently conduct certain of our preclinical and development activities or any of our clinical trials for our Products;

therefore, we must rely on third parties, such as contract research organizations, medical institutions, clinical investigators, contract laboratories and collaborative partners, to conduct such trials.

We and these third parties are required to comply with current good clinical practices ("cGCPs"), which are regulations and guidelines enforced by the FDA under the medical device Quality System Regulation ("QSR") and comparable regulatory authorities in other jurisdictions for clinical development.

We and these third parties are also required to comply with current good laboratory practices ("cGLPs"), which are regulations and guidelines enforced by the FDA and comparable regulatory authorities in other jurisdictions for nonclinical laboratory studies.

Regulatory authorities enforce these cGLPs and cGCPs through periodic inspections of trial sponsors, laboratories, principal investigators and trial sites.

If we or any of these third parties fail to comply with applicable cGLP and cGCP regulations, the data generated in our nonclinical studies and clinical trials may be deemed unreliable and the FDA or regulatory authorities in other jurisdictions may require us to perform additional nonclinical or clinical trials before approving our approved applications.

We cannot be certain that, upon inspection or review of our data, such regulatory authorities will determine that any of our nonclinical studies or clinical trials comply with the applicable cGLP or cGCP regulations.

Any third parties conducting our preclinical, clinical and other development programs are not and will not be our employees and, except for remedies available to us under our agreements with such third parties, we cannot control whether or not they devote sufficient time and resources to our ongoing preclinical, clinical and nonclinical programs.

These third parties may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting nonclinical studies, clinical studies or other development activities, which could affect their performance on our behalf.

Additionally, any third parties conducting our preclinical, clinical and other development programs are not and will not be our employees and, except for remedies available to us under our agreements with such third parties, we cannot control whether or not they devote sufficient time and resources to our ongoing preclinical, clinical and other development programs.

If these third parties do not successfully carry out their contractual duties or regulatory obligations or meet expected deadlines, if these third parties need to be replaced or if the quality or accuracy of the data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory requirements or for other reasons, our development activities or clinical trials may be extended, delayed, suspended or terminated, and we may not be able to obtain regulatory approval for our Products or successfully commercialize our Products on a timely basis, if at all, and our business, prospects and results of operations may be adversely affected.

Continued testing of our Products may not yield successful results and could reveal currently unknown safety hazards associated with our Products.

Our research and development programs are designed to test the safety and efficacy of our Products and Tumor Treating Fields through extensive preclinical and clinical testing.

Even if our ongoing and future clinical trials are completed as planned, we cannot be certain that their results will support our claims or that the FDA and other regulatory authorities will agree with our conclusions.

Our research and development programs are designed to test the safety and efficacy of our Products and TTFields through extensive preclinical and clinical testing.

Even if our ongoing and future preclinical and clinical trials are completed as planned, we cannot be certain that their results will support our claims or that the FDA and other regulatory authorities will agree with our conclusions.

Success in preclinical studies and early clinical trials does not ensure that later clinical trials will be successful, and we cannot be sure that the later trials will replicate the results of prior trials and preclinical studies.

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It is also possible that patients enrolled in clinical trials will experience adverse side effects that have not been previously observed.

In addition, our preclinical studies and

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clinical trials for our delivery system candidates involve a relatively small patient population and, as a result, these studies and trials may not be indicative of future results.

In addition, our preclinical studies and clinical trials for our delivery system candidates involve a relatively small patient population and, as a result, these studies and trials may not be indicative of future results.

We may experience numerous unforeseen events during, or as a result of, the testing process that could delay or prevent further commercialization of our Products, including the following:

• safety and efficacy results for our Products obtained in our preclinical and clinical testing may be inconclusive or may not be predictive of results obtained in future clinical trials, following long-term use or in much larger populations;

• unanticipated adverse events may occur during our clinical trials;

• the data collected from our clinical trials may not reach statistical significance due to limited sample size or otherwise not be sufficient to support FDA or other regulatory approval;

• our Products may not produce the desired effect or may result in adverse health effects or other effects that are not currently known that may preclude additional regulatory approval or result in additional limitations to commercial use if approved.

To date, patients treated with our Products in our clinical trials have experienced treatment-related side effects, including dermatitis (including mild to moderate skin irritation) where the transducer arrays are placed, headaches, weakness, falls, fatigue, muscle twitching and skin ulcers, along with traditional side-effects associated with the chemotherapeutic agents often co-administered with our Products.

There may be additional side effects observed in future clinical trials and/or through real-world experience with patients using our Products.

Undesirable side effects caused by our Products could cause us or regulatory authorities to interrupt, delay or terminate clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or other regulatory authorities.

Results of our clinical trials could reveal a high and unacceptable severity and prevalence of side effects.

• Preclinical and clinical testing for our Products may not produce the desired effect, may be inconclusive or may not be predictive of safety or efficacy results obtained in future clinical trials, following long-term use or in much larger populations;

• unanticipated adverse events or other side effects that are not currently known may occur during our clinical trials that may preclude additional regulatory approval or result in additional limitations to commercial use if approved;

• the data collected from our clinical trials may not reach statistical significance or otherwise not be sufficient to support FDA or other regulatory approval.

If unacceptable side effects arise in the development of our Products for future indications, we could suspend or terminate our clinical trials or the FDA or other regulatory authorities could order us to cease clinical trials or deny approval of our delivery system candidates for any or all targeted indications, narrow the approved indications for use or otherwise require restrictive product labeling or marketing or require further clinical trials, which may be time-consuming and expensive and may not produce results supporting FDA or other regulatory approval of our Products in a specific indication.

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In addition, these side effects may not be appropriately recognized or managed by the treating medical staff.

We expect to have to train medical personnel using our delivery system candidates to understand the side effect profiles for our clinical trials and upon any commercialization of our Products for future indications.

We expect to have a need to train medical personnel using our delivery system candidates to understand the side effect profiles for our clinical trials and upon any commercialization of our Products for future indications.

Inadequate training in recognizing or managing the potential side effects of our Products could result in patient injury or death.

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Any of these events could have a material adverse effect on our business, prospects, financial condition and results of operations and cause our stock price to decline.

We face competition from numerous competitors, most of whom have far greater resources than we have, which may make it more difficult for us to achieve significant market penetration and which may allow our competitors to develop additional oncology treatments to compete with our Products.

We face competition from numerous competitors, which may make it more difficult for us to achieve significant market penetration and which may allow our competitors to develop additional oncology treatments to compete with our Products.

The oncology market is intensely competitive, subject to rapid change and significantly affected by new product introductions and other market activities of industry participants.

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Many of our competitors are large, well-capitalized companies with significantly greater market share and resources than we have.

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consequence, they are able to spend more aggressively on product development, marketing, sales and other initiatives than we can.

As a consequence, they are able to spend more aggressively on product development, marketing, sales and other initiatives than we can.

Many of these competitors could have:

• significantly greater name recognition and experience;

• established relationships with government agencies, healthcare professionals, patients and third-party payers;

• established distribution networks;

• established distribution networks and/or relationships with government agencies, healthcare professionals, patients and third-party payers;

• additional product lines, and the ability to offer rebates or bundle products to offer higher discounts or more competitive pricing or other incentives to gain a competitive advantage;

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Although we believe our Products represent a treatment modality that can be used in combination with other cancer treatment modalities, our current and future competitors may at any time develop additional drugs or devices for the treatment of GBM, MPM, or other solid tumors that could be more effective from a therapeutic or cost-basis perspective than using our Products.

In our currently-approved indications, if current or future competitors develops a product that proves to be superior or comparable to our Products, our revenues may decline.

In our currently-approved indications, if current or future competitors develop a product that proves to be superior or comparable to our Products, our revenues may decline.

In addition, some of our competitors may compete by lowering the price of their cancer treatments.

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For future indications, other companies could view us as a competitor and attempt to block our market entry or otherwise hinder our Product growth in a market.

We are aware of a few third parties in the United States and China developing devices and filing for intellectual property protection related to TTFields.

Competitors could also pursue alternative technologies for the application of TTFields into a patient that we did not foresee or protect.

As we expand, we may experience difficulties managing our growth.

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Any failure by us to manage our growth effectively could have an adverse effect on our ability to achieve our development and commercialization goals.

Because of the specialized nature of our business, the termination of relationships with our key employees, consultants and advisors may prevent us from developing our Products, conducting clinical trials, commercializing our Products and obtaining any necessary financing.

Further, the inability to recruit and retain additional personnel may have an adverse effect on our ability to successfully operate our business.

Because of the specialized nature of our business, the termination of relationships with our key employees, consultants and advisors may prevent us from successfully operating our business, including developing our Products, conducting clinical trials, commercializing our Products and obtaining any necessary financing.

We are highly dependent on the members of our executive team, the loss of whose services may adversely impact the achievement of our objectives.

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The loss of the services of one or more of our current employees might impede the achievement of our business objectives.

The competition for qualified personnel in the oncology field is intense, and we rely heavily on our ability to attract and retain qualified scientific, technical and managerial personnel.

The competition for qualified personnel in the oncology and medical device fields is intense, and we rely heavily on our ability to attract and retain qualified scientific, technical and managerial personnel.

Our future success depends upon our ability to attract, retain and motivate highly skilled employees.

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Failure to do so could materially harm our business.

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Changes in tax or other laws, regulations or treaties, changes in our status under U.S.

laws or adverse determinations by taxing or other governmental authorities could increase our tax burden or otherwise affect our financial condition or results of operations, as well as subject our shareholders to additional taxes.

The amount of taxes we pay is subject to a variety of tax laws in the various jurisdictions in which we and our subsidiaries are organized and operate.

Our domestic and international tax liabilities are dependent on the location of earnings among these various jurisdictions.

Such tax liabilities could be affected by changes in tax or other laws, treaties and regulations, as well as the interpretation or enforcement thereof by tax or other governmental entities in any relevant jurisdiction.

The amount we pay in tax to any particular jurisdiction depends, in part, on the correct interpretation of the tax laws in such jurisdiction, and we have made a number of determinations as to the effect of such tax laws in our particular circumstances.

In some cases, the determinations we have made as to the effect of the tax laws in a particular jurisdiction depend on the continuing effectiveness of administrative rulings we have received from the tax authorities in that jurisdiction, while in other cases, our determinations are based on the reasoned judgment of our tax advisors.

Although we believe that we are in compliance with the administrative rulings we have received, that the assumptions made by our tax advisors in rendering their advice remain correct, and that as a result we are in compliance with applicable tax laws in the jurisdictions where we and our subsidiaries are organized and operate, a taxing authority in any such jurisdiction may challenge our interpretation of those laws and assess us or any of our subsidiaries with additional taxes.

Additionally, from time to time, proposals can be made and legislation can be introduced to change the tax laws, regulations or interpretations thereof (possibly with retroactive effect) of various jurisdictions or limit tax treaty benefits that, if enacted, could materially increase our tax burden, increase our effective tax rate or otherwise have a material adverse impact on our financial condition and results of operations.

It is possible that these changes could adversely affect our business.

While we monitor proposals and other developments that would materially impact our tax burden and effective tax rate and investigate our options accordingly, we could still be subject to increased taxation on a going forward and retroactive basis no matter what action we undertake if certain legislative proposals or regulatory changes are enacted, certain tax treaties are amended and/or our interpretation of applicable tax or other laws is challenged and determined to be incorrect.

Any alternative interpretations of applicable tax laws asserted by a tax authority or changes in tax laws, regulations or accounting principles that limit our ability to take advantage of tax treaties between jurisdictions, modify or eliminate the deductibility of various currently deductible payments, increase the tax burden of operating or being resident in a particular country, result in transfer pricing adjustments or otherwise require the payment of additional taxes, may have a material adverse effect on our cash flows, financial condition and results of operations

The termination or revision of any of our tax rulings or indirect tax exemptions that we have or may have in the future may have a material adverse effect on our cash flows, financial condition and results of operations.

Product liability suits, whether or not meritorious, could be brought against us due to alleged defective delivery systems or for the misuse of our Products.

These suits could result in expensive and time-consuming litigation, payment of substantial damages and an increase in our insurance rates.

If our current or future delivery systems are defectively designed or manufactured, contain defective components or are misused, or if someone claims any of the foregoing, whether or not meritorious, we may become subject to substantial and costly litigation.

For example, we may be sued if our Products causes or are perceived to cause injury or are found to be otherwise unsuitable during clinical testing, manufacturing, marketing or sale.

Product liability suits, whether or not meritorious, could be brought against us due to alleged defective delivery systems or for the misuse of our Products, which could result in expensive and time-consuming litigation, payment of substantial damages and/or expenses and an increase in our insurance rates.

substantial and costly litigation.

For example, we may be sued if our Products cause or are perceived to cause injury or are found to be otherwise unsuitable during clinical testing, manufacturing, marketing or sale.

This may occur if our Products are misused or damaged, have a sudden failure or malfunction (including with respect to safety features) or are otherwise impaired due to wear and tear.

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• decreased demand for our Products;

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• injury to our reputation;

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• initiation of investigations by regulators;

• costs to defend the related litigation;

• costs to prepare for and defend the related litigation;

• a diversion of management’s time and our resources;

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Global economic, political and industry conditions constantly change and unfavorable conditions may have a material adverse effect on our business and results of operations.

We are a global oncology company with worldwide operations.

Volatile economic, political and market conditions, such as political or economic instability, majority hostilities or acts of terrorism, in the regions in which we operate may have a negative impact on our operating results and our ability to achieve our business objectives.

We are a global company with worldwide operations.

Volatile economic, political and market conditions, such as political or economic instability, civil unrest, majority hostilities or acts of terrorism in the regions in which we operate may have a negative impact on our operating results and our ability to achieve our business objectives.

We may not have insight into economic and political trends that could emerge and negatively affect our business.

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addition, significant or volatile changes in exchange rates between the U.S.

In addition, significant or volatile changes in exchange rates between the U.S.

dollar and other currencies may have a material adverse impact upon our liquidity, revenues, costs and operating results.

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In addition, the political and security situation in Israel may result in parties with whom we have agreements involving performance in Israel claiming that they are not obligated to perform their commitments under those agreements pursuant to force majeure provisions in the agreements.

Additionally, natural disasters and pandemics, such as the COVID-19 coronavirus outbreak, could have a significant adverse effect on our business, including interruption of our commercial and clinical operations, supply chain disruption, endangerment of our personnel, fewer patient visits, increased patient drop-out rates, delays in recruitment of new patients, and other delays or losses of materials and results.

Additionally, natural disasters and public health emergencies, such as extreme weather events and the COVID-19 pandemic, could have a significant adverse effect on our business, including interruption of our commercial and clinical operations, supply chain disruption, endangerment of our personnel, fewer patient visits, increased patient drop-out rates, delays in recruitment of new patients, and other delays or losses of materials and results.

The COVID-19 pandemic could materially adversely impact our business, including our clinical trials.

As the COVID-19 pandemic continues around the globe, we have experienced and will likely continue to experience disruptions that could severely impact our business and clinical trials, which could include:

• delays and/or difficulties in onboarding active patients and enrolling patients in our clinical trials;

• delays and/or difficulties in clinical site initiation, including difficulties in recruiting clinical site investigators and clinical site staff;

• declines in prescriptions written due to a perception that our Products are difficult to administer remotely or if patients are unwilling to travel to treatment sites or receive in-home treatment assistance from us or other caregivers;

• reductions in third-party reimbursements, which could materially affect our revenue, as most of our patients rely on third-party payers to cover the cost of our Products and a material number of our patients could lose access to their private health insurance plan if they or someone in their family lose their job;

• diversion of healthcare resources away from conducting clinical trials, including the diversion of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of our clinical trials;

• interruption of key clinical trial activities, such as clinical trial site monitoring, due to limitations on travel imposed or recommended by federal or state governments, employers and others;

• delays in receiving approval from local regulatory authorities or IRBs to initiate our planned clinical trials;

• delays in clinical sites receiving the supplies and materials needed to conduct our clinical trials;

• interruption in global shipping that may affect the transport of active patient and clinical trial materials;

• changes in local regulations as part of a response to the COVID-19 outbreak that may require us to change the ways in which our clinical trials are conducted, which may result in unexpected costs, or to discontinue the clinical trials altogether;

• delays in necessary interactions with local regulators, ethics committees and other important agencies and contractors due to limitations in employee resources or forced furlough of government employees;

• disruption of our supply chain as our suppliers and common carriers are unable to meet our requirements to provide us the materials we need for clinical trial and active patient care needs;

• indirect consequences of the COVID-19 pandemic on the global economy in general, such as an increase in bankruptcies of our key suppliers, or the inability of our third-party payers to meet their obligations reimburse us in a timely fashion or at all;

• postponements and cancellations of key conferences and meetings and travel restrictions could interfere with our ability to interact with key thought leaders in the field, leading to a disruption in the rate of adoption of our technology;

• increases in expenditures for technology and other tools necessary to provide patient care in an environment where both patient and care-giver travel is restricted and access to in-person interaction is limited;

• refusal of the FDA to accept data from clinical trials in affected geographies outside the United States.

The global status of the COVID-19 pandemic continues to rapidly evolve.

The extent to which the pandemic may impact our business and clinical trials will depend on future developments, which are highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of the disease, the duration of the pandemic, travel restrictions and social distancing guidelines, business closures or business disruptions and the effectiveness of actions taken to contain and treat the disease.

The COVID-19 pandemic may also have the effect of heightening many of the other risks described herein.

We are increasingly dependent on information technology systems and subject to privacy and security laws.

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We could also experience a business interruption, information theft of confidential information, or reputational damage from industrial espionage attacks, malware or other cyber incidents, which may compromise our system infrastructure or lead to data leakage, either internally or at our third-party service providers or other business partners.

Additionally, we must comply with numerous laws and regulations governing the processing, collection, dissemination, access, use, sharing and security of PI.

In the U.S., HIPAA provides data privacy and security provisions for safeguarding medical information.

Additionally, states in the U.S.

are enacting local privacy laws (e.g., California).

In the EU, the GDPR harmonizes data privacy laws and rules on the processing of personal data, including patient and employee data, across the EU and repeals and replaces Directive 95/46/EC of the European Parliament and of the Council of October 24, 1995, and applicable national laws.

The GDPR has a number of strict data protection and security requirements for companies processing data of EU residents, including when such data is transferred outside of the EU.

Additionally, we need to comply with analogous privacy laws in other jurisdictions in which we operate.

While we have invested heavily in the protection of data and information technology and in related training, there can be no assurance that our efforts will prevent significant breakdowns, breaches in our systems or other cyber incidents or ensure compliance with all applicable security and privacy laws, regulations and standards, including with respect to third-party service providers that utilize sensitive personal information, including PI, on our behalf.

Any such breakdown, breach, incident or failure to comply could expose us to a risk of loss of information, litigation, penalties, remediation costs and potentially significant liability to customers, employees, business partners and regulatory authorities, including, for example, under HIPAA in the United States and the GDPR in the EU, and may ultimately have a material adverse effect upon our reputation, business, operations or financial condition.

Disruption of critical information systems or material security breaches in our products may adversely affect our business and customer relations.

Information technology helps us operate efficiently, develop and commercialize our products, interface with and support our customers, maintain financial accuracy and efficiency and produce our financial statements.

The size and complexity of our computer systems, and scope of our geographic reach, make us potentially vulnerable to IT system breakdowns, internal and external malicious intrusion, cyberattacks and computer viruses.

Because the techniques used to obtain unauthorized access, or to sabotage systems, change frequently and generally are not

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recognized until launched against a target, we may be unable to anticipate these techniques or to implement adequate preventative measures.

The size and complexity of our computer systems, and scope of our geographic reach, make us potentially vulnerable to information technology system breakdowns, internal and external malicious intrusion, cyberattacks and computer viruses.

Because the techniques used to obtain unauthorized access, or to sabotage systems, change frequently and generally are not recognized until launched against a target, we may be unable to anticipate these techniques or to implement adequate preventative measures.

If we do not allocate and effectively manage the resources necessary to build and sustain the proper technology infrastructure or properly manage third-party contractors who perform data management services on our behalf, then a security breach could subject us to, among other things, transaction errors, business process inefficiencies, the loss of customers, damage to our reputation, business disruptions or the loss of or damage to intellectual property.

Such security breaches could expose us to a risk of loss of information, litigation, penalties, remediation costs and potentially significant liability to customers, employees, business partners and regulatory authorities, including, for example, under the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) in the United States and Regulation 2016/679 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data under GDPR in the EU.

If our data management systems (including third party data management systems) do not effectively collect, secure, store, process and report relevant data for the operation of our business, whether due to equipment malfunction or constraints, software deficiencies, or human error, our ability to effectively plan, forecast and execute our business plan and comply with applicable laws and regulations will be impaired.

Any such impairment could materially and adversely affect our financial condition and results of operations.

We develop and commercialize hardware products that rely upon software to operate properly and software products that produce treatment data and confidential patient information.

Additionally, we process sensitive personal data, including patient health information, in the normal course of operating our business.

While we have implemented security measures to protect our hardware and software products and systems from unauthorized access, these measures may not be effective.

A security breach, whether of our products, systems or third-party hosting services we utilize, could disrupt treatments being provided by our products, disrupt access to our customers’ stored information, such as patient treatment data and health information, and could lead to the loss of, damage to or public disclosure of such data and information, including patient health information.

A security breach, whether of our Products, systems or third-party hosting services we utilize, could disrupt treatments being provided by our Products, disrupt access to our customers’ stored information, such as patient

treatment data and health information, and could lead to the loss of, damage to or public disclosure of such data and information, including patient health information.

Such an event could have serious negative consequences, including possible patient injury, regulatory action, fines, penalties and damages, reduced demand for our Products, an unwillingness of customers to use our Products, harm to our reputation and brand and time-consuming and expensive litigation, any of which could have a material adverse effect on our financial results.

If we were to experience a significant security breach of our information systems or data, the cost associated with the investigation, remediation and potential notification of the breach to customers, including patients, and counterparties could be material.

We carry a limited amount of insurance for cybersecurity liability, and our insurance coverage may be inadequate.

In the future, our insurance coverage may be expensive or not be available on acceptable terms or in sufficient amounts, if at all.

Changes in our technology could result in impairment charges in future periods.

generally accepted accounting principles ("GAAP") require annual (or more frequently if events or changes in circumstances warrant) impairment tests of goodwill, intangible assets and other long-lived assets.

Generally speaking, if the carrying value of the asset is in excess of the estimated fair value of the asset, the carrying value will be adjusted to fair value through an impairment charge.

Circumstances such as changes in technology or in the way an asset is being used may trigger an impairment review.

Any negative perception of such a deficit could have an adverse effect on the price of our ordinary shares and could impair our ability to obtain new financing or refinance existing indebtedness.

If any of our or our suppliers’ or manufacturers’ facilities are damaged or our clinical, research and development or other business processes interrupted, our business could be seriously harmed.

We conduct our business in a limited number of facilities around the world.

Damage or extended periods of interruption to our or our suppliers’ or manufacturers’ corporate, development or research facilities or delays in the transportation, import or export of finished goods or components due to fire, natural disaster, power loss, communications failure, unauthorized entry, terrorist attacks or other events could cause us to cease or delay development and/or delivery of our Products.

Our internal computer systems may fail or suffer security breaches, which could result in a material disruption of our business.

Our business may be seriously harmed by such delays and interruption.

Our research facilities are located in Israel, and certain key suppliers manufacture goods in physical locations in Israel.

Although our facilities have not sustained any damage from such attacks, this is a high conflict area and any future attacks and resulting damage could adversely affect our operations.

Our business insurance only covers certain specified events associated with war or terrorism in the Middle East, and may not cover all such events.

Any losses or damages incurred by us could have a material adverse effect on our business.

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We have significant debt service obligations and may incur additional indebtedness in the future, which could adversely affect our financial condition and results of operations and our ability to react to changes in our business.

We currently have $150.0 million of principal indebtedness outstanding under our Loan and Security Agreement dated as of February 7, 2018, between us, as borrower, and BioPharma Credit PLC, as lender ("2018 Credit Facility").

We may incur additional indebtedness in the future.

Our existing indebtedness and any additional indebtedness we may incur could require us to divert funds identified for other purposes for debt service and impair our liquidity position.

The fact that a substantial portion of our cash flow from operations could be needed to make payments on our indebtedness could have important consequences, including the following:

• increasing our vulnerability to general adverse economic and industry conditions or increased interests rates;

• reducing the availability of our cash flow for other purposes;

• limiting our flexibility in planning for or reacting to changes in our business and the markets in which we operate, which would place us at a competitive disadvantage compared to our competitors that may have less exposure to debt;

• limiting our ability to borrow additional funds for working capital, capital expenditures and other investments;

• failing to comply with the covenants in our debt agreements could result in all of our indebtedness becoming immediately due and payable.

Our ability to obtain necessary funds through borrowing, as well as our ability to service our indebtedness, will depend on our ability to generate cash flow from operations.

Our ability to generate cash is subject to general economic, financial, competitive, legislative, regulatory and other factors that are beyond our control.

If our business does not generate sufficient cash flow from operations or if future borrowings are not available to us under our 2018 Credit Facility or otherwise in amounts sufficient to enable us to fund our liquidity needs, our financial condition and results of operations may be adversely affected.

Our inability to make scheduled payments on our debt obligations in the future would require us to refinance all or a portion of our indebtedness on or before maturity, sell assets or seek additional equity investment.

We may not be able to take any of such actions on a timely basis, on terms satisfactory to us or at all.

Covenants in our debt agreements restrict our operational flexibility.

Our 2018 Credit Facility contains usual and customary restrictive covenants relating to the operation of our business, including restrictions on our ability:

• to incur or guarantee additional indebtedness;

• to incur or permit to exist certain liens;

• to enter into certain sale and lease-back transactions;

• to make certain investments, loans and advances;

• to effect certain mergers, consolidations, asset sales and acquisitions;

• to pay dividends on, or redeem or repurchase, capital stock, enter into transactions with affiliates or materially change our business;

• to repay or modify certain other agreements with respect to other material indebtedness or modify our organizational documents.

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The United Kingdom’s exit from the EU could adversely impact our business, results of operations and financial condition.

On January 31, 2020, the United Kingdom ("UK") officially withdrew from the EU ("Brexit").

Brexit is subject to a transition period until December 31, 2020, which could be extended up to two years under certain conditions (the "Brexit Transition Period").

During the Brexit Transition Period, EU legislation related to, inter alia , medical devices will continue to apply in the U.K.

There is uncertainty as to the scope, nature and terms of the relationship between the UK and the EU after the Brexit Transition Period.

This uncertainty could adversely impact customer and investor confidence, result in additional market volatility, including in the value of the British pound and European euro, legal uncertainty and divergent national laws and regulations.

At this time, we cannot predict the impact that Brexit, once the Brexit Transition Period ends, will have on our business generally and our UK and European activities more specifically, and no assurance can be given that our operating results, financial condition and prospects would not be adversely impacted by the result.

Risks relating to regulation

Risks relating to the regulation of our business

Our delivery system candidates must undergo rigorous preclinical and clinical testing and we must obtain regulatory approvals, which could be costly and time-consuming and subject us to unanticipated delays or prevent us from marketing any delivery systems.

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• the conduct of preclinical and clinical studies;

• product design, development, manufacturing and testing;

• product labeling;

• product storage and shipping;

• premarket clearance, approval and conformity assessment procedures;

• premarket clearance, approval and conformity assessment procedures for modifications introduced in marketed products;

• product design, development, manufacturing, testing, storage and shipping;

• product labeling, advertising and promotion;

• premarket clearance, approval and conformity assessment procedures, as well as for modifications introduced in marketed products;

• post-market surveillance and monitoring;

• reporting of adverse events or incidents and implementation of corrective actions, including product recalls;

• pricing and reimbursement;

• interactions with healthcare professionals;

• interactions with patients;

• information security;

• advertising and promotion;

• interactions with healthcare professionals and patients;

• product sales and distribution.

Clinical testing can be costly and take many years, and the outcome is uncertain and susceptible to varying interpretations.

Moreover, success in preclinical and early clinical trials does not ensure that large-scale trials will be successful or predict final results.

Acceptable results in early trials may not be replicable in later trials.

A number of companies in the oncology industry have suffered significant setbacks in advanced clinical trials, even after promising results in earlier trials.

Negative or inconclusive results or adverse events or incidents during a clinical

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trial could cause it to be redone or terminated.

We cannot be certain if or when the FDA, comparable regulatory agencies in other jurisdictions or our notified body might request additional studies, under what conditions such studies might be requested, or what the size or length of any such studies might be.

The clinical trials of our delivery system candidates may not be completed on schedule, the FDA, comparable agencies in other jurisdictions or our notified body may order us to stop or modify our research, or the FDA, comparable regulatory agencies in other jurisdictions or our notified body may not ultimately approve or issue a CE Certificate for any of our delivery system candidates for commercial sale.

We cannot be certain if or when the FDA, comparable regulatory agencies in other jurisdictions or our notified body might request additional or modified studies on our Products, under what conditions such studies might be requested, or the required size or length of any such studies.

The data collected from our clinical trials may not be sufficient to support regulatory approval in the U.S., Japan and other countries or to obtain a CE Certificate in the EU for our various future delivery system candidates.

Even if we believe the data collected from our clinical trials are sufficient, the FDA, comparable regulatory bodies in other jurisdictions and our notified body have substantial discretion in the assessment and approval or conformity assessment processes and may disagree with our interpretation of the data.

Our failure to adequately demonstrate the safety and efficacy of any of our delivery system candidates would delay or prevent regulatory approval in the U.S., Japan and other countries obtaining a CE Certificate (and therefore the CE marking) in the EU of our delivery system candidates, which could prevent us from being sustainably profitable.

Even if we believe the data collected from our clinical trials are sufficient, the FDA and comparable regulatory bodies in other jurisdictions have substantial discretion in the assessment and approval or conformity assessment processes and may disagree with our interpretation of the data.

Our failure to adequately demonstrate the safety and efficacy of any of our delivery system candidates would delay or prevent regulatory approval in the U.S., Japan and other countries or delay or prevent a CE Certificate in the EU (and therefore be unable to affix the CE mark) for our delivery system candidates, which could prevent us from being sustainably profitable.

In addition, any change in the laws or regulations that govern the clearance and approval processes relating to our current and future delivery systems could make it more difficult and costly to obtain clearance or approval for new delivery systems, or to produce, market and distribute our Products.

Significant delays in receiving clearance or approval, or the failure to receive clearance or approval for our new delivery systems would have an adverse effect on our ability to expand our business.

We currently market Optune in the U.S., the EU, Switzerland, Israel and Japan.

We currently market NovoTTF-100L in the U.S.

We currently market Optune Lua in the U.S.

We intend to market our Products in a number of additional international markets.

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Approval of a product by the FDA does not guarantee approval of the same product by the health authorities of other countries or CE marking of our Products in the EU and vice versa.

In addition, changes in regulatory policy in the U.S.

In addition, changes in

regulatory policy in the U.S.

or in other countries for the approval or CE marking of a medical device during the period of product development and regulatory agency review or notified body review of each submitted new application may cause delays or rejections.

The MDR, which will apply from May 26, 2020, will introduce significant changes to the regulatory framework for medical devices in the EU.

These changes may prevent or delay the CE Certification of our delivery system candidates or impact our ability to modify Optune on a timely basis.

In particular, the lack of MDR guidance documents at EU level and the limited availability of qualified notified bodies might affect our ability to timely comply and demonstrate such compliance with the new requirements or delay the MDR CE Certification of our delivery system candidates or Optune.

Regulation (EU) 2017/745 on medical devices (“MDR”), which will apply from May 26, 2021 and replace Council Directive 93/42/EEC concerning medical devices (“MDD”), will introduce significant changes to the regulatory framework for medical devices in the EU.

These changes may prevent or delay the CE Certification of our delivery system candidates or impact our ability to modify our Products on a timely basis.

In particular, the delay in the publication of key MDR guidance documents at EU level and the limited availability of qualified notified bodies might affect our ability to timely comply and demonstrate such compliance with the new requirements or delay the MDR CE Certification of our delivery system candidates.

We may choose to, or may be required to, suspend, repeat or terminate our clinical trials if they are not conducted in accordance with regulatory requirements, the results are negative or inconclusive or the trials are not well designed.

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The conduct of clinical trials may require large numbers of test patients.

Patient enrollment is a function of many factors, including the size of the patient population for the target indication, the proximity of patients to clinical sites, the eligibility criteria for the trial, the existence of competing clinical trials and the availability of alternative or new treatments.

Clinical trials may be suspended by the FDA or by a regulatory agency in another jurisdiction at any time if the FDA or the regulatory agency finds deficiencies in the conduct of these trials or it is believed that these trials expose patients to unacceptable health risks.

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We, the FDA or regulatory agencies in other jurisdictions might delay or terminate our clinical trials of a delivery system candidate for various reasons, including:

• the delivery system candidate may have unforeseen adverse side effects;

• the time required to determine whether the delivery system candidate is effective may be longer than expected;

The FDA or regulatory agencies in other jurisdictions might delay or terminate our clinical trials of a delivery system candidate for various reasons, including:

• the delivery system candidate may have unforeseen adverse side effects or may not appear to be more effective than current therapies;

• we may not agree with the FDA, a regulatory authority in another jurisdiction or an ethics committee regarding the protocol for the conduct of a clinical trial;

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• fatalities may occur during a clinical trial due to medical problems that may or may not be related to clinical trial treatments.

• the delivery system candidate may not appear to be more effective than current therapies;

• there may be insufficient patient enrollment in the clinical trials;

• we may not be able to produce sufficient quantities of the delivery system candidate to complete the trials.

Furthermore, the process of obtaining and maintaining regulatory approvals in the U.S.

and other jurisdictions and CE Certificates in the EU for new therapeutic products is lengthy, expensive and uncertain.

and other jurisdictions and CE Certification in the EU for new therapeutic products is lengthy, expensive and uncertain.

It can vary substantially, based on the type, complexity and novelty of the product involved.

Accordingly, any of our delivery system candidates could take a significantly longer time than we expect to, or may never, gain regulatory approval or obtain CE Certificates in the EU, which could have a material adverse effect on our business, prospects, financial condition and results of operations and cause our stock price to decline.

Healthcare reform and other legislative and regulatory changes in the U.S.

and in other countries may adversely affect our business and financial results.

In response to perceived increases in healthcare costs in recent years, there have been and continue to be proposals by the U.S.

federal government, state governments, regulators and third-party payers to control these costs and, more generally, to reform the U.S.

healthcare system.

In the U.S., the Patient Protection and Affordable Care Act (the "PPACA"), was enacted in 2010 with a goal of reducing the cost of healthcare and substantially changing the way healthcare is financed by both government and private insurers.

The current U.S.

Administration and members of the U.S.

Congress have stated that they will seek to modify, repeal, or otherwise invalidate all, or certain provisions of, the PPACA.

For example,in December 2017, the U.S.

President signed the Tax Cuts and Jobs Act, which, among numerous other actions, repealed the individual mandate of the PPACA, effective January 1, 2019.

In December 2018, a federal district court in Texas ruled the individual mandate was unconstitutional and could not be severed from the PPACA.

As a result, the court ruled the remaining provisions of the PPACA were also invalid, though the court declined to issue a preliminary injunction with respect to the PPACA.

This litigation is still ongoing, but places great uncertainty upon the longevity and nature of the PPACA moving forward.

Additionally, while the House and Senate attempted, but failed, to pass legislation to comprehensively repeal the PPACA, these efforts may be resumed.

Further legislative changes to and regulatory changes under the PPACA also remain possible.

There is uncertainty with respect to the impact the U.S.

Administration and any attempted legislation may have, if any, and any changes will likely take time to unfold and could have an impact on coverage and reimbursement for healthcare items and services, including our Products and our delivery system candidates.

For example, the PPACA requires that health insurance plans sold to individuals and small businesses provide coverage for "essential health benefits" ("EHBs"), which are defined according to state-specific benchmark plans.

The Department of Health and Human Services issued a final rule that provides states with greater flexibility in how they select their EHB-benchmark plan, including providing states with substantially more options in what they can select as an EHB-benchmark plan and allowing states to build their own set of benefits as part of their EHB-benchmark plan, subject

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to certain requirements.

Providing the states with this increased flexibility to define EHBs may have the effect of decreasing coverage for anti-cancer devices such as our Products.

In addition, other legislative changes have been proposed and adopted in the U.S.

since the PPACA was enacted.

The Budget Control Act of 2011, as amended requires Medicare payments for all items and services, including our Products and related services, to be reduced by up to 2.0% under sequestration ( i.e., automatic spending reductions, calculated each year by the Office of Management and Budget).

Subsequent legislation extended the 2.0% reduction, on average, to 2027 unless additional Congressional action is taken.

Additional sequestration orders could also be triggered, potentially resulting in up to a 4.0% reduction in Medicare payments.

To the extent Medicare makes a negative decision regarding the fees for our Products or declines to cover our Products, our business would be subject to material damage.

In 2017, CMS issued a final rule that aims to streamline the Medicare appeals process and includes changes such as permitting the designation of Medicare Appeals Council decisions as precedential, expanding the Office of Medicare Hearings and Appeals’ available adjudicator pool, and simplifying proceedings when CMS or CMS contractors are involved, among others.

The final rule became effective on March 20, 2017.

We are monitoring the implementation of this final rule and cannot predict to what extent CMS may or may not use this final rule in denying coverage for our Products.

The process governing Medicare appeals and the significant backlog of appeals at the ALJ level was the subject of multi-year litigation.

The litigation was adjudicated in November 2018 with the court ordering the Department of Health and Human Services to clear the backlog by 2022, and reach compliance with the 90-day timeline to decide ALJ cases by this time.

We cannot provide any assurance that our outstanding ALJ appeals will be favorably decided, or that the Department of Health and Human Services will meet this deadline.

We believe that substantial uncertainty remains regarding the net effect of the PPACA, or its repeal and potential replacement, on our business, including uncertainty over how benefit plans purchased on exchanges will cover our Products, how the expansion or contraction of the Medicaid program will affect access to our Products, the effect of risk-sharing payment models such as Accountable Care Organizations and other value-based purchasing programs on coverage for our Products, and the effect of the general increase or decrease in Federal oversight of healthcare payers.

The taxes imposed and the expansion in government’s role in the U.S.

healthcare industry under the PPACA, if unchanged, may result in decreased revenues, lower reimbursements by payers for our Products and reduced medical procedure volumes, all of which could have a material adverse effect on our business, prospects, financial condition and results of operations and cause our stock price to decline.

Finally, in the U.S., there is increased focus on drug pricing, and the U.S.

President, policy officials and lawmakers have expressed a clear interest in efforts to reduce prices for drugs and biologicals, further increase transparency around prices and price increases, lower out-of-pocket costs for consumers, and decrease spending on drugs by government programs.

We expect regulatory changes and continued Congressional investigations and negative media attention in the coming months with respect to drugs reimbursed by federal healthcare programs.

While the current focus is on pharmaceutical products, the scrutiny and concern with respect to rising healthcare costs could have a negative impact on our operations as well.

In the future, the U.S.

Congress could also pass additional healthcare laws and CMS could implement regulatory changes.

Further, various healthcare reform proposals have emerged at the state level.

These laws and regulations could potentially affect coverage and reimbursement for our Products and our delivery system candidates.

However, we cannot predict the ultimate content, timing or effect of any future federal or state healthcare initiatives or the impact any future legislation or regulation will have on us.

The national competent authorities in the EU member states, Switzerland, Israel, Japan, and other jurisdictions are increasingly active in their goal of reducing public spending on healthcare.

We cannot, therefore, guarantee that the treatment of patients with our Products would be reimbursed in any particular country or, if successfully included on reimbursement lists will remain thereon.

We are subject to extensive regulation by the FDA and comparable authorities in other jurisdictions, which could restrict the sales and marketing of our Products and could cause us to incur significant costs to

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maintain compliance.

In addition, we may become subject to additional regulation in other jurisdictions as we increase our efforts to market and sell Optune or NovoTTF-100L and future Products outside of the U.S.

Accordingly, any of our delivery system candidates could take a significantly longer time than we expect to, or may never, gain regulatory approval or obtain CE Certification in the EU, which could have a material adverse effect on our business, prospects, financial condition and results of operations and cause our stock price to decline.

Legislative and regulatory changes in the U.S.

and in other countries regarding healthcare insurance and government-sponsored reimbursement programs (such as Medicare in the United States) may adversely affect our business and financial results.

We rely to a material degree on highly regulated private and government-run health insurance programs for our revenue in most of the countries in which we operate.

The laws and regulations regarding health care programs, both public and private, are driven by public policy considerations that may be unrelated to the direct provision of patient care, such as lowering costs or requiring or limiting access to healthcare options.

These laws and regulations are very complicated and there are many requirements we must satisfy in order for our Products to become and remain eligible for reimbursement under these programs.

In many cases we may have limited negotiating power when negotiating reimbursement rates for our Products.

In the future, lawmakers and regulators could also pass additional healthcare laws and implement other regulatory changes at both the national and local levels.

These laws and regulations could potentially affect coverage and reimbursement for our Products.

However, we cannot predict the ultimate content, timing or effect of any future healthcare initiatives or the impact any future legislation or regulation will have on us.

With respect to countries outside the U.S., the national competent authorities in the EU member states, the UK, Switzerland, Israel, Japan, and other jurisdictions are also increasingly active in their goal of reducing public spending on healthcare.

We cannot, therefore, guarantee that the treatment of patients with our Products would be reimbursed in any particular country or, if successfully included on reimbursement lists, whether we will remain on such lists.

We are subject to extensive post-marketing regulation by the FDA and comparable authorities in other jurisdictions, which could impact the sales and marketing of our Products and could cause us to incur significant costs to maintain compliance.

In addition, we may become subject to additional regulation in other jurisdictions as we increase our efforts to market and sell Optune or Optune Lua and future Products outside of the U.S.

We market and sell our Products, and expect to market and sell future Products, subject to extensive regulation by the FDA and numerous other federal, state and governmental authorities in other jurisdictions.

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Although we have received FDA approval to market Optune in the U.S.

for the treatment of adult patients with newly diagnosed GBM (in combination with temozolomide) and recurrent GBM and approval to market NovoTTF-100L for adults patients with MPM, we will require additional FDA approval to market our Products for other indications.

for the treatment of adult patients with newly diagnosed GBM (in combination with temozolomide) and recurrent GBM and approval to market Optune Lua for adults patients with MPM, we will require additional FDA approval to market our Products for other indications.

We may be required to obtain approval of a new PMA, HDE or PMA supplement application for modifications made to our Products.

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New intended uses of CE marked medical devices falling outside the scope of the current CE Certificate require a completely new conformity assessment before the device can be CE marked and marketed in the EU for the new intended use.

These approval processes can be expensive, lengthy and entail significant fees.

The process required to gather necessary information and draw up documentation in order to obtain CE Certification of a medical device in the EU can be expensive and lengthy and its outcome can be uncertain.

We may make modifications to our Products in the future that we believe do not or will not require notifications to our notified body or new conformity assessments to permit the maintenance of our current CE Certificate.

If the competent authorities of the EU member states or our notified body disagree and require the conduct of a new conformity assessment, the modification of the existing CE Certificate or the issuance of a new CE Certificate, we may be required to recall or suspend the marketing of the modified versions of Optune.

In Japan, new medical devices or new therapeutic uses of medical devices falling outside the scope of the existing approval by the MHLW require a new assessment and approval for each such new device or use.

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and other jurisdictions, we also are subject to numerous post-marketing regulatory requirements, which include regulations under the QSR related to the manufacturing of our Products, labeling regulations and medical device reporting regulations, which require us to report to the FDA or comparable regulatory authorities in other jurisdictions and our notified body if our Products cause or contributes to a death or serious injury, or malfunction in a way that would likely cause or contribute to a death or serious injury.

In addition, these regulatory requirements may change in the future in a way that adversely affects us.

In addition, these regulatory requirements may in the future change in a way that adversely affects us.

If we fail to comply with present or future regulatory requirements that are applicable to us, we may be subject to enforcement action by the FDA or comparable regulatory authorities in other jurisdictions and notified bodies, which may include any of the following sanctions:

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• voluntary or mandatory recall, withdrawal or seizure of our current or future delivery systems;

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• administrative detention by the FDA or other regulatory authority in another jurisdiction of medical devices believed to be adulterated or misbranded;

• operating restrictions, suspension or shutdown of production;

• refusal or delay of our requests for PMA or analogous approval for new intended uses for or modifications to our Products;

• refusal or delay of our requests for PMA or analogous approval of new delivery systems;

• refusal or delay of our requests for PMA or analogous approval for new intended uses for or modifications to our Products or for approval of new delivery systems;

• refusal or delay in obtaining CE Certificates for new intended uses for or modifications to our Products;

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Responsibility for determination that a modification constitutes a substantial change lies with the manufacturer of the medical device.

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among other things, affect compliance with the Essential Requirements laid down in Annex I to the MDD/MDR or the devices’ intended use.

The notified body will then assess the changes and verify whether they affect the Product’s conformity with the Essential Requirements laid down in Annex I to the MDD/MDR or the conditions for the use of the device.

If the assessment is favorable, the notified body will issue a new CE Certificate or an addendum to the existing CE Certificate attesting compliance with the Essential Requirements laid down in Annex I to the MDD/MDR.

There is a risk that the competent authorities of the EU member states or our notified body may disagree with our assessment of the changes introduced to our Products.

We must inform the notified body that conducted the conformity assessment of the Products we market or sell in the EU of any planned substantial changes to our quality system or changes to our Products that could, among other things, affect compliance with the Essential Requirements laid down in Annex I to the MDD or the devices’ intended use.

The notified body will then assess the changes and verify whether they affect the Product’s conformity with the Essential Requirements laid down in Annex I to the MDD or the conditions for the use of the device.

There is a risk that the competent authorities of the EU member states or our notified body may disagree with our

assessment of the changes introduced to our Products.

The competent authorities of the EU member states or our notified body also may come to a different conclusion than the FDA on any given product modification.

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Delays in receipt or failure to receive approvals/certification, or the failure to comply with any other existing or future regulatory requirements, could reduce our sales, profitability and future growth prospects.

We will spend considerable time and money complying with federal, state and local rules, regulations and guidance in other jurisdictions in addition to FDA regulations, and, if we are unable to fully comply with such rules, regulations and guidance, we could face substantial penalties.

In addition to FDA requirements, we will spend considerable time and money complying with other federal, state, local and foreign rules, regulations and guidance and, if we are unable to fully comply with such rules, regulations and guidance, we could face substantial penalties.

We are subject to extensive regulation by the U.S.

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The laws that affect our ability to operate our business in addition to the Federal Food, Drug, and Cosmetic Act and FDA regulations include, but are not limited to, the following:

• the Federal Anti-Kickback Statute, which prohibits offering or providing remuneration of any kind with the intent to induce or reward referrals for items or services reimbursable by a federal healthcare program;

Federal False Claims Act and state false claims acts, which prohibit submitting false claims or causing the submission of false claims to the federal or a state government;

• Medicare laws and regulations that prescribe requirements for coverage and payment, including the conditions of participation for DME suppliers, and laws prohibiting false claims or unduly influencing selection of products for reimbursement under Medicare and Medicaid;

• the Federal Anti-Kickback Statute, an intent-based federal criminal statute which prohibits knowingly and willfully offering, providing, soliciting or receiving remuneration of any kind to induce or reward, or in return for, referrals or the purchase, lease, order or recommendation or arranging of any items or services reimbursable by a federal healthcare program;

• the Federal Civil False Claims Act, which imposes civil penalties, including through civil whistleblower or " qui tam" actions, for knowingly submitting or causing the submission of false or fraudulent claims of payment to the federal government, knowingly making, using or causing to be made or used a false statement or record material to payment of a false claim or avoiding, decreasing or concealing an obligation to pay money to the federal government;

• the Federal Criminal False Claims Act, which is similar to the Federal Civil False Claims Act and imposes criminal liability on those that make or present a false, fictitious or fraudulent claim to the federal government;

• Medicare laws and regulations that prescribe requirements for coverage and reimbursement, including the conditions of participation for DME suppliers, and laws prohibiting false claims or unduly influencing selection of products for reimbursement under Medicare and Medicaid;

• healthcare fraud statutes that prohibit false statements and improper claims to any third-party payer;

• the federal physician self-referral prohibition, commonly known as the Stark law, which, absent an applicable exception, prohibits physicians from referring Medicare patients to an entity for the provision of certain designated health services (including DME) if the physician (or a member of the physician’s immediate family) has an impermissible financial relationship with that entity and prohibits the DHS entity from billing for such improperly referred services;

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• the Federal Physician Self-Referral Law, commonly known as the Stark law, which, absent an applicable exception, prohibits physicians from referring Medicare and Medicaid patients to an entity for the provision of certain designated health services (“DHS”), including DME, if the physician (or a member of the physician’s immediate family) has an impermissible financial relationship with that entity and prohibits the DHS entity from billing for such improperly referred services;

• the Federal Beneficiary Anti-Inducement Statute, which prohibits the offering of any remuneration to a beneficiary of Medicare or Medicaid that is likely to influence that beneficiary’s choice of provider or supplier.

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There are established exceptions from liability, but we cannot guarantee that all of our practices will fall squarely within those exceptions;

• similar state anti-kickback, false claims, insurance fraud and self-referral laws, which may not be limited to government-reimbursed items, as well as state laws that require us to maintain permits or licenses to distribute durable medical equipment;

• federal and state accreditation and licensing requirements applicable to DME providers and equivalent requirements in other jurisdictions;

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• the Federal Trade Commission Act, the Lanham Act and similar federal and state laws regulating truthfulness in advertising and consumer protection;

• the federal Sunshine Act and similar state and foreign laws, which require periodic reporting of payments and other transfers of value made to U.S.-licensed physicians, teaching hospitals, and for reports submitted on or after January 1, 2022, physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, and certified nurse-midwives;

• HIPAA in the US, the GDPR in the EU and other regional data privacy rules that require certain levels of protection of individuals’ personal data.

• the Federal Physician Payments Sunshine Act, the French Sunshine Act and similar state and foreign laws, which require periodic reporting of payments and other transfers of value made to U.S.

and French-licensed physicians, teaching hospitals, and for reports submitted on or after January 1, 2022 in the U.S., physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, and certified nurse-midwives.

Similar laws exist in the EU, individual EU member states and other countries.

These laws are complemented by EU or national professional codes of practices.

HIPAA provides data privacy and security provisions for safeguarding medical information.

Additionally, states in the U.S.

are enacting local privacy laws (e.g., California).

In the EU, the GDPR harmonizes data privacy laws and rules on the processing of personal data, including patient and employee data, across the EU.

The GDPR has a number of strict data protection and security requirements for companies processing data of EU residents, including when such data is transferred outside of the EU.

Additionally, we need to comply with analogous privacy laws in other jurisdictions in which we operate, such as the Israeli Privacy Protection Law, the Asia Pacific Economic Cooperation Privacy Framework, and Japan’s Act on the Protection of Personal Information.

The laws and codes of practices applicable to us are subject to evolving interpretations.

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If we are required to obtain permits or licenses that we do not already possess, we also may become subject to substantial additional regulation or incur significant expense.

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To ensure compliance with Medicare, Medicaid and other regulations, federal and state governmental agencies and their agents, including DME MACs, may conduct audits of our operations to support our claims submitted for payment of items furnished to beneficiaries and health care providers.

For example, CMS contracts with Recovery Audit Contractors ("RACs") on a contingency fee basis to conduct post-payment reviews to detect and correct improper payments in the Medicare fee-for-service program.

The RAC program’s scope also includes managed Medicare plans and Medicaid claims.

RAC denials are appealable;

however, there currently are significant delays in the ALJ process, which could negatively impact our ability to appeal RAC payment denials.

In addition, CMS employs various other program integrity contractors to perform post-payment audits of claims and identify overpayments, and state Medicaid agencies and other contractors have increased their review activities.

Private and government-funded managed care payers may also conduct similar post-payment audits.

To ensure compliance with Medicare, Medicaid and other regulations, federal and state governmental agencies and their agents, including DME MACs, may conduct audits of our operations to support our claims submitted for reimbursement of items furnished to beneficiaries and health care providers.

Depending on the nature of the conduct found in such audits and whether the underlying conduct could be considered systemic, the resolution of these audits could adversely impact our revenue, financial condition and results of operations.

Further, in many instances, there can be a significant lack of clarity regarding the required documentation for the audit and audit methodology.

As such, the clarity and completeness of each patient medical file, some of which is the work product of physicians not employed by us, is essential to successfully challenging any payment denials.

For example, the DME MAC Supplier Manuals provide that clinical information from the "patient's medical record" is required to justify the initial and ongoing medical necessity for the provision of DME.

Some DME MACs, CMS staff and government subcontractors have taken the position, that the "patient's medical record" refers not to documentation maintained by the DME supplier but instead to documentation maintained by the patient's physician, healthcare facility or other clinician, and that clinical information created by the DME supplier's personnel and confirmed by the patient's physician is not sufficient to establish medical necessity.

If the physicians working with our patients do not adequately document, among other things, their diagnoses and plans of care, our risks related to audits and payment denials in general are greater.

If we, our collaborative partners, our contract manufacturers or our component suppliers fail to comply with the FDA’s QSR or equivalent regulations established in other countries, the manufacturing and distribution of our Products could be interrupted, and our Product sales and results of operations could suffer.

We, our collaborative partners, our contract manufacturers and our component suppliers are required to comply with the FDA’s QSR and the equivalent quality system requirements imposed by the laws and regulations in other jurisdictions, which are a complex regulatory framework that covers the procedures and documentation of the design, testing, production, control, quality assurance, labeling, packaging, sterilization, storage and shipping of our Products.

All aspects of our supply chain are subject to periodic inspections and audits by the FDA, notified bodies and other regulatory authorities to ensure continuing compliance.

We cannot assure you that our facilities or our contract manufacturers’ or component suppliers’ facilities would pass any future quality system inspection.

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The FDA requires that certain classifications of recalls be reported to the FDA within ten working days after the recall is initiated.

Requirements for the reporting of product recalls to the competent authorities are imposed in other

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jurisdictions in which our Products are or would be marketed in the future.

Requirements for the reporting of product recalls to the competent authorities are imposed in other jurisdictions in which our Products are or would be marketed in the future.

Companies are required to maintain certain records of recalls, even if they are not reportable to the FDA or to the competent authorities of other countries.

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If we fail to report these events to the FDA or to the equivalent authorities in other jurisdictions within the required time frames, or at all, the FDA or the equivalent authorities in other jurisdictions could take enforcement action against us.

Any such adverse event involving our Products also could result in future voluntary corrective actions, such as recalls or customer notifications, or agency action, such as inspection or enforcement action.

Any such adverse event

involving our Products also could result in future voluntary corrective actions, such as recalls or customer notifications, or agency action, such as inspection or enforcement action.

Any corrective action, whether voluntary or involuntary, as well as defending ourselves in a lawsuit, will require the dedication of our time and capital, distract management from operating our business, and may harm our reputation and financial results.

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Optune is also approved in Israel and in Australia for the treatment of recurrent GBM and newly diagnosed GBM (in combination with temozolomide).

The NovoTTF-100L System is only approved in the U.S.

for the treatment of unresectable, locally advanced or metastatic MPM.

The Optune Lua System is only approved in the U.S., the EU and Switzerland for the treatment of unresectable, locally advanced or metastatic MPM.

If the FDA or the competent authorities in other jurisdictions, including the EU member states, determine that our promotional materials or training constitutes promotion of an unapproved use, they could request that we modify our training or promotional materials or subject us to regulatory or enforcement actions, including the issuance of an untitled or warning letter, an injunction, seizure, civil fines and criminal penalties.

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In that event, our reputation could be damaged and the commercialization of our Products could be impaired.

legislative or FDA regulatory reforms may make it more difficult and costly for us to obtain regulatory approval of our delivery system candidates and to manufacture, market and distribute our Products after approval is obtained.

From time to time, legislation is drafted and introduced in the U.S.

Congress that could significantly change the statutory provisions governing the regulatory approval, manufacture and marketing of regulated products or the reimbursement thereof.

In addition, FDA regulations and guidance are often revised or reinterpreted by the FDA in ways that may significantly affect our business and our Products.

Any new regulations or revisions or reinterpretations of existing regulations may impose additional costs or lengthen review times of future delivery

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system candidates.

In addition, FDA regulations and guidance are often revised or reinterpreted by the agency in ways that may significantly affect our business and our Products.

It is impossible to predict whether legislative changes will be enacted or FDA regulations, guidance or interpretations changed, and what the impact of such changes, if any, may be.

Any change in the laws or regulations that govern the clearance and approval processes relating to our current and future delivery systems could make it more difficult and costly to obtain clearance or approval for new delivery systems, or to produce, market and distribute our Products.

Significant delays in receiving clearance or approval, or the failure to receive clearance or approval for our new delivery systems would have an adverse effect on our ability to expand our business in the U.S.

The United Kingdom’s exit from the EU could adversely impact our business, results of operations and financial condition.

On January 31, 2020, the United Kingdom ("UK") officially withdrew from the EU ("Brexit").

At this time, we do not market our Products in the UK;

however, Brexit has and will continue to have an effect on the economy of the EU and the rest of Europe.

We cannot predict the impact that Brexit will have on our business generally and European activities more specifically, and no assurance can be given that our operating results, financial condition and prospects would not be adversely impacted by the result.

Changes in tax or other laws, regulations or treaties, changes in our status under U.S.

The amount of taxes we pay is subject to a variety of tax laws in the various jurisdictions in which we and our subsidiaries are organized and operate.

Our domestic and international tax liabilities are dependent on the location of earnings among these various jurisdictions.

It is possible that these changes could

adversely affect our business.

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.

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In addition, we cannot predict the effect that additional or modified environmental laws and regulations may have on us, our third-party suppliers of equipment, batteries and our Products or our customers.

For example, we and our suppliers rely on an exemption from the European Directive 2011/65/EU relating to the restriction of the use of certain hazardous substances in electrical and electronic equipment relating to lead content in our transducer arrays.

To the extent this exemption is revoked, it may have a material impact on our business and results of operations.

For example, we and our suppliers rely on the exemption in European Directive 2011/65/EU relating to the restriction of the use of certain hazardous substances in electrical and electronic equipment, set out in Annex IV, relating to lead content in our arrays.

To the extent this exemption is revoked or amended, it may have a material impact on our business and results of operations.

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

Our Products use lithium-ion batteries.

On rare occasions, lithium-ion cells can rapidly release the energy they contain by venting smoke and flames in a manner that can ignite nearby materials as well as other lithium-ion cells.

On rare occasions, lithium-ion cells can rapidly release the energy they contain by venting smoke, heat, and flames in a manner that can ignite nearby materials as well as other lithium-ion cells.

A failure in the lithium-ion battery contained in a Product could occur, which could result in accidents, casualty or damages, and subject us to lawsuits, product recalls, or redesign efforts.

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Such damage or injury could lead to adverse publicity and potentially a safety recall.

Regulations on the transportation of lithium ion batteries may affect our business.

The transportation of lithium and lithium-ion batteries is regulated worldwide.

Laws regulating the transportation of batteries have been and may be enacted which could impose additional costs that could harm our ability to be profitable.

Under recommendations adopted by the International Air Transport Association ("IATA"), our batteries currently require a Class 9 designation for transportation.

Our larger first generation delivery system batteries must be properly packaged and labeled in order to be shipped by air transport as cargo.

Our smaller second generation delivery system batteries can be shipped without the class 9 sticker if shipped with the device but require the class 9 sticker if shipped by air separately.

The larger batteries are not allowed on passenger aircraft according to the IATA standards.

The smaller batteries are allowed as carry on only and cannot be checked as luggage.

Consequently, we offer to ship batteries for patients who are traveling by air.

If additional restrictions are put in place that limit our ability to ship our Products by air freight or on water borne cargo, it could have an adverse effect on our supply chain, our inventory management procedures and processes and our ability to fill prescriptions and service patients in a timely manner, which could have a material adverse effect on our business, prospects, financial condition and results of operations.

In addition, compliance with future worldwide or IATA approval process and regulations could require significant time and resources from our technical staff and, if redesign were necessary, could delay the introduction of new products.

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If additional restrictions are put in place that limit our ability to ship our Products by air freight or on water borne cargo, such restrictions could have an adverse effect on our supply chain, our inventory management procedures and processes and our ability to fill prescriptions and service patients in a timely manner, which could have a material adverse effect on our business, prospects, financial condition and results of operations.

In addition, compliance with future worldwide or International Air Transport Association approval process and regulations could require significant time and resources from our technical staff and, if redesign were necessary, could delay the introduction of new products.

Risks relating to intellectual property

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Patent and Trademark Office ("USPTO") and its counterparts in other jurisdictions use to grant patents are not always applied predictably or uniformly and can change.

Consequently, we cannot be certain as to whether pending patent applications will result in issued patents, and we cannot be certain as to the type and extent of patent claims that may be issued to us in the future.

Consequently, we cannot be certain as to whether pending patent applications will result in issued patents, and we cannot be certain as to the type and extent of patent claims

that may be issued to us in the future.

Any issued patents may not contain claims that will permit us to stop competitors from using similar technology.

Our current intellectual property portfolio consists of over 185 issued patents.

the patents have expected expiration dates between 2021 and 2037 .

As our patents expire we will be subject to additional risks.

The scope of some of our patents is limited to certain ranges.

For example, some of our patents protect low-intensity (1-3 V/cm) and intermediate frequency (100-300 kHz) alternating electric fields, but do not cover intensities and frequencies for electric fields that are outside of these ranges.

While intensities and frequencies of electric fields outside of these ranges have not yet proven to be effective treatment modalities, that may not be the case in the future.

Our patent position is generally uncertain and involves complex legal and factual questions.

In the U.S., our patents have expected expiration dates between 2021 and 2037.

Patent expiration could adversely affect our ability to protect future product development and our competitors may develop and market competing products.

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We may not be able to develop and successfully launch more advanced replacement products before these and other patents expire.

We have limited intellectual property rights outside of our key markets.

In some countries outside the U.S., we do not have any intellectual property rights, and our intellectual property rights in other countries outside the U.S.

have a different scope and strength compared to our intellectual property rights in the U.S.

Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the U.S.

Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and further, may export otherwise infringing products to territories where we have patent protection, but where enforcement rights are not as strong as those in the U.S.

These products may compete with our delivery systems, and our patents or other intellectual property rights may not be effective or adequate to prevent such competition.

For a variety of reasons, we may decide not to file for patent protection for certain of our intellectual property.

Our patent rights underlying TTFields and our Products may not be adequate, and our competitors or customers may design around our proprietary technologies or independently develop similar or alternative technologies or products that are equal or superior to ours without infringing on any of our patent rights.

In addition, the patents licensed or issued to us may not provide a competitive advantage, and may be insufficient to prevent others from commercializing products similar or identical to ours.

The occurrence of any of these events could have a material adverse effect on our business, prospects, financial condition and results of operations and cause our stock price to decline.

Our existing and future patent portfolio also may be vulnerable to legal challenges.

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There is therefore no guarantee that we will be able to obtain, maintain and enforce the intellectual property rights that may be necessary to protect and grow our business and to provide us with a meaningful competitive advantage, and our failure to do so could have a material adverse effect on our business, prospects, financial condition and results of operations and cause our stock price to decline.

The oncology industry is characterized by patent and other intellectual property litigation and disputes, and any litigation, dispute or claim against us may cause us to incur substantial costs, could place a significant strain on our financial resources, divert the attention of management from our business, harm our reputation and require us to remove certain delivery systems from the market.

The oncology and medical device industries are characterized by patent and other intellectual property litigation and disputes, and any litigation, dispute or claim against us may cause us to incur substantial costs, could place a significant strain on our financial resources, divert the attention of management from our business, harm our reputation and require us to remove certain delivery systems from the market.

Whether a product infringes a patent or violates other intellectual property rights involves complex legal and factual issues, the determination of which is often uncertain.

Any intellectual property dispute, even a meritless or unsuccessful one, would be time consuming and expensive to defend and could result in the diversion of our management’s attention from our business and result in adverse publicity, the disruption of research and

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development and marketing efforts, injury to our reputation and loss of revenues.

Any of these events could negatively affect our business, prospects, financial condition and results of operations.

Third parties may assert that Tumor Treating Fields, our Products, the methods employed in the use of our Products or other activities infringe on their patents.

Third parties may assert that TTFields, our Products, the methods employed in the use of our Products or other activities infringe on their patents.

Such claims may be made by competitors seeking to obtain a competitive advantage or by other parties, many of whom have significantly larger intellectual property portfolios than we have.

Additionally, in recent years, individuals and groups have begun purchasing intellectual property assets for the purpose of making claims of infringement and attempting to extract settlements from companies like ours.

The risk of infringement claims is exacerbated by the fact that there are numerous issued and pending patents relating to the treatment of cancer.

With respect to our current Products, the risk of infringement claims is exacerbated by the fact that there are numerous issued and pending patents relating to the treatment of cancer.

Because patent applications can take many years to issue, and in many cases remain unpublished for many months after filing, there may be applications now pending of which we are unaware that may later result in issued patents that our Products may infringe.

There could also be existing patents that one or more components of our Products may inadvertently infringe.

As the number of competitors in the market for the treatment of cancer grows, the possibility of inadvertent patent infringement by us or a patent infringement claim against us increases.

There could also be existing patents that one or more components of our Products or other delivery system candidates may inadvertently infringe.

As the number of competitors in the market or other delivery system candidates grows, the possibility of inadvertent patent infringement by us or a patent infringement claim against us increases.

To the extent we gain greater market visibility, our risk of being subject to such claims is also likely to increase.

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Any such litigation, dispute or claim could be costly to defend and could subject us to substantial damages, injunctions or other remedies, which could have a material adverse effect on our business, prospects, financial condition and results of operations and cause our stock price to decline.

The patent rights on which we rely to protect the intellectual property underlying our Products may not be adequate, which could enable third parties to use our technology or market competing products, which would harm our continued ability to compete in the market.

Our success will depend in part on our continued ability to develop or acquire commercially valuable patent rights and to protect these rights adequately.

The scope of some of our patents is limited to certain ranges.

While intensities and frequencies of electric fields outside of these ranges have not yet proven to be effective treatment modalities, that may not be the case in the future.

Our patent position is generally uncertain and involves complex legal and factual questions.

The risks and uncertainties that we face with respect to our patents and other related rights include the following:

• the pending patent applications we have filed may not result in issued patents or may take longer than we expect to result in issued patents;

• the pending patent applications and patents we own may be subject to interference proceedings or similar disputes over the priority of the inventions claimed;

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• the claims of any patents that are issued may not provide meaningful protection;

• we may not be able to develop additional proprietary technologies that are patentable;

• changes in patent laws or their interpretation in the U.S.

and other countries (including the recently enacted AIA) could diminish the value of our patents, narrow the scope of our patent protection or adversely affect our ability to obtain new patents;

• obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements;

• other parties may challenge patents, patent claims or patent applications licensed or issued to us, and such patents, patent claims or patent applications may be narrowed or found to be invalid or unenforceable;

• other companies may design around or expand upon technologies we have patented or developed.

We also may fail to apply for or be unable to obtain patent rights in some other countries.

In addition, the legal systems of certain countries may not protect our rights to the same extent as the laws of the U.S., which could affect our ability to enforce patent rights effectively in such other countries.

For a variety of reasons, we may decide not to file for patent protection for certain of our intellectual property.

Our patent rights underlying Tumor Treating Fields and our Products may not be adequate, and our competitors or customers may design around our proprietary technologies or independently develop similar or alternative technologies or products that are equal or superior to ours without infringing on any of our patent rights.

In addition, the patents licensed or issued to us may not provide a competitive advantage, and may be insufficient to prevent others from commercializing products similar or identical to ours.

The occurrence of any of these events could have a material adverse effect on our business, prospects, financial condition and results of operations and cause our stock price to decline.

We have limited intellectual property rights in other jurisdictions outside of our key markets and may not be able to protect our intellectual property rights throughout the world.

We have limited intellectual property rights outside of our key markets.

In some countries outside the U.S., we do not have any intellectual property rights, and our intellectual property rights in other countries outside the U.S.

have a different scope and strength compared to our intellectual property rights in the U.S.

Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the U.S.

These products may compete with our delivery systems, and our patents or other intellectual property rights may not be effective or adequate to prevent such competition.

Changes in U.S.

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Supreme Court rulings have narrowed the scope of patent protection available in certain circumstances and weakened the rights of patent owners in certain situations.

In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents once obtained.

In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of

patents once obtained.

Depending on decisions by the U.S.

Congress, the federal courts and the USPTO, the laws and regulations governing patents could change in unpredictable ways that could further negatively impact the value of our patents, narrow the scope of available patent protection or weaken the rights of patent owners.

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Risks relating to our ordinary shares

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.

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and (iii) the Jersey courts may refuse to allow unjust enrichment or to give effect to any provisions of an agreement (including provisions relating to contractual interest on a judgment debt) that it considers usurious.

Our annual and quarterly results may fluctuate due to a number of factors and, as a result, could fall below investor expectations or estimates by securities research analysts, which may cause the trading price of our ordinary shares to decline.

Our revenues and results of operations are difficult to predict, and potentially may vary significantly from period to period.

As a result of a number of factors, many of which are beyond our control, it is possible that results of operations for future periods may be below the expectations of public market analysts and investors, which could cause our stock price to decline.

Factors that may affect our quarterly results include, but are not limited to:

• failure to obtain regulatory approval for our delivery systems;

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• failure to effectively commercialize our delivery systems;

• competition;

• changes in the laws and regulations that affect our operations.

As a result, investors should not rely on year-to-year or quarter-to-quarter comparisons of results of operations as an indication of future performance.

Substantial future sales of our ordinary shares in the public market, or the perception that such sales may occur, could cause the price of our ordinary shares to decline.

Sales of a substantial number of shares of our ordinary shares in the public market could occur at any time.

These sales, or the perception in the market that holders of a large number of shares intend to sell shares, could reduce the market price of our ordinary shares stock.

Our outstanding shares, including shares issuable under our equity incentive plans, may be freely sold in the public market at any time to the extent permitted by Rules 144 and 701 under the Securities Act of 1933, as amended, or the Securities Act, or to the extent such shares have already been registered under the Securities Act and are held by non-affiliates of ours.

In addition, certain of our employees, executive officers, directors and affiliated stockholders have entered or may enter into Rule 10b5-1 plans providing for sales of shares of our ordinary shares from time to time.

Under a Rule 10b5-1 plan, a broker executes trades pursuant to parameters established by the employee, director or officer when entering into the plan, without further direction from the employee, officer, director or affiliated stockholder.

A Rule 10b5-1 plan may be amended or terminated in some circumstances.

Our employees, executive officers, directors and affiliated stockholders also may buy or sell additional shares outside of a Rule 10b5-1 plan when they are not in possession of material, nonpublic information.

Our memorandum and articles of association contain anti-takeover provisions that could adversely affect the rights of holders of our ordinary shares.

Our amended and restated memorandum and articles of association, referred to as the memorandum and articles of association, contain certain provisions that could limit the ability of third parties to acquire control of our company, including a provision that grants authority to our board of directors to issue from time to time one or more classes of preferred shares without action by our shareholders and to determine, with respect to any class of preferred shares, the terms and rights of that class.

The provisions could have the effect of depriving our shareholders of the opportunity to sell their ordinary shares at a premium over the prevailing market price by discouraging third parties from seeking to obtain control of our company in a tender offer or similar transactions.

If securities or industry analysts do not publish research or publish unfavorable or inaccurate research about our business, our share price and trading volume could decline.

The trading market for our ordinary shares will continue to depend, in part, on the research and reports that securities or industry analysts publish about us or our business.

We may be unable to sustain coverage by well-regarded securities and industry analysts.

If either none or only a limited number of securities or industry analysts maintain coverage of our company, or if these securities or industry analysts are not widely respected within the general investment community, the trading price for our ordinary shares would be negatively impacted.

In the event we obtain securities or industry analyst coverage, if one or more of the analysts who cover us downgrade our ordinary shares or publish inaccurate or unfavorable research about our business, the price of our ordinary shares would likely decline.

If one or more of these analysts cease coverage of our company or fail to publish reports on us regularly, demand for our ordinary shares could decrease, which might cause the price of our ordinary shares and trading volume to decline.

If we fail to maintain proper and effective internal controls, our ability to produce accurate and timely financial statements could be impaired and investors’ views of us could be harmed.

As a public company, we are required to maintain internal control over financial reporting and to report any material weaknesses in such internal controls.

If we or our independent registered public accounting firm identify deficiencies in our internal control over financial reporting that are deemed to be material weaknesses, the market price of our

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ordinary shares could decline and we could be subject to sanctions or investigations by the SEC or other regulatory authorities, which would require additional financial and management resources.

We have borrowed a significant amount of debt and have the ability to borrow additional debt in the future, which could adversely affect our financial condition and results of operations and our ability to react to changes in our business.

We currently have two significant debt facilities outstanding.

On November 5, 2020, we issued $575 million of 0% Convertible Senior Notes due 2025 (the “Convertible Notes”).

The Convertible Notes are senior unsecured obligations.

The Convertible Notes do not bear regular interest, and mature on November 1, 2025, unless earlier repurchased, redeemed or converted.

The Notes are not redeemable prior to November 6, 2023 and are convertible into a combination of cash and ordinary shares on or after August 1, 2025, or earlier upon certain events.

On November 6, 2020, we entered into a new $150.0 million senior secured revolving credit facility with J.P.

Morgan Chase Bank, N.A., as administrative agent, and a syndicate of relationship banks (the “Credit Facility”).

We may, subject to certain conditions and limitations, increase the revolving credit commitments outstanding under the Credit Facility in an aggregate principal amount not to exceed $250.0 million.

The commitments under the Credit Facility are guaranteed by certain of our subsidiaries and secured by a first-lien of our and certain of our subsidiary’s assets.

Outstanding loans will bear interest at a sliding scale between LIBOR plus 2.75% and LIBOR plus 3.25% per annum.

As of the date of this Annual Report, we had no outstanding balance borrowed under the Credit Facility.

Our existing indebtedness and any additional indebtedness we may incur under the Credit Facility or otherwise could require us to divert funds identified for other purposes for debt service and impair our liquidity position.

In addition, the Credit Facility contains usual and customary restrictive covenants relating to the operation of our business, including restrictions on our ability to incur or guarantee additional indebtedness, to incur or permit to exist certain liens, and other restrictions on corporate actions.

The fact that a substantial portion of our cash flow from operations could be needed to make payments on our indebtedness could have important consequences, including the following:

• increasing our vulnerability to general adverse economic and industry conditions or increased interests rates;

• limiting the availability of our cash flow for other purposes and our flexibility in planning for or reacting to changes in our business and the markets in which we operate, which would place us at a competitive disadvantage compared to our competitors that may have less exposure to debt;

• limiting our ability to borrow additional funds for working capital, capital expenditures and other investments;

• failing to comply with the covenants in our debt agreements could result in all of our indebtedness becoming immediately due and payable.

Our ability to obtain necessary funds through borrowing, as well as our ability to service our indebtedness, will depend on our ability to generate cash flow from operations.

Our ability to generate cash is subject to general economic, financial, competitive, legislative, regulatory and other factors that are beyond our control.

We may not be able to take any of such actions on a timely basis, on terms satisfactory to us or at all.

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

The conversion of some or all of our Convertible Notes would dilute the ownership interests of existing shareholders to the extent we deliver shares upon conversion of any of such notes.

Our Convertible Notes are convertible at the option of their holders prior to their scheduled terms under certain circumstances.

In connection with the conversion of our Convertible Notes, we may deliver to the holders of such notes a significant number of our ordinary shares.

Any sales in the public market of our ordinary shares issuable upon such conversion could adversely affect prevailing market prices of our ordinary shares.

In addition, the existence of our Convertible Notes may encourage short selling by market participants because the conversion of such notes could be used to satisfy short positions, or anticipated conversion of such notes into our ordinary shares could depress the price of our ordinary shares.

UNRESOLVED STAFF COMMENTS

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1A. Risk Factors