NovoCure (NVCR) risk factors, FY2024 10-K

Risks relating to our business and our Products

1. 01To date, we have generated only occasional and intermittent operating profits, and we have a history of incurring substantial operating losses
2. 02Our clinical studies could be delayed or otherwise adversely affected by many factors, including difficulties in enrolling patients
3. 03If 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
4. 04marketing capabilities may be disproportionate to the revenues we may be able to generate on sales of our Products
5. 05The success of our business may be dependent on the actions of our collaborative partners
6. 06We 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
7. 07Failure to secure and maintain adequate coverage and reimbursement from third-party payers could adversely affect acceptance of our Products and reduce our revenues
8. 08to hospitals or other entities providing our Products or which may in the future provide our device candidates to patients
9. 09We 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
10. 10There is no assurance that Medicare or the Medicare Administrative Contractors will provide, or continue to provide, coverage or adequate payment rates for our Products
11. 11We depend on single-source suppliers for some of our components. The loss of these suppliers could prevent or delay shipments of our Products, delay our clinical studies or otherwise adversely affect our business
12. 12If the third parties on which we rely to conduct our preclinical and clinical studies 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
13. 13Continued testing of our Products may not yield successful results and could reveal currently unknown aspects or safety hazards associated with our Products
14. 14We 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
15. 15As we expand, we may experience difficulties managing our growth
16. 16Product liability suits, whether or not meritorious, could be brought against us due to alleged defective devices 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
17. 17Other future litigation and regulatory actions could have a material adverse impact on the Company
18. 18Global economic, political, industry and environmental conditions constantly change and unfavorable conditions may have a material adverse effect on our business and results of operations
19. 19We are increasingly dependent on information technology systems and subject to privacy and security laws. Our Products and our systems and infrastructure face certain risks, including from cyber security breaches and data leakage

Risks relating to the regulation of our business

1. 20Our device 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 devices
2. 21We may choose to, or may be required to, suspend, repeat or terminate our clinical studies if they are not conducted in accordance with regulatory requirements, the results are negative or inconclusive or the studies are not well designed
3. 22Legislative 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
4. 23other jurisdictions as we increase our efforts to market and sell Optune Gio or Optune Lua and future Products outside of the U.S
5. 24The 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
6. 25surveillance, vigilance, and registration of economic operators and of devices. However, if such medical devices undergo a significant change in their design or intended use, we would need to obtain a new CE Certificate under the MDR for these devices
7. 26In 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
8. 27Similar laws exist in the EU, individual EU member states and other countries. These laws are complemented by EU or national professional codes of practices
9. 28If 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
10. 29Our Products may in the future be subject to recalls that could harm our reputation, business and financial results
11. 30If our Products cause or contribute to a death or a serious injury, or malfunction in certain ways, we will be subject to medical device reporting regulations, which can result in voluntary corrective actions or agency enforcement actions
12. 31We may be subject to fines, penalties or injunctions if we are determined to be promoting the use of our Products for unapproved or off-label uses
13. 32We are affected by and subject to environmental laws and regulations that could be costly to comply with or that may result in costly liabilities
14. 33Safety issues concerning lithium-ion batteries could have a material adverse impact on our business

Risks relating to intellectual property

1. 34If we fail to maintain, develop, protect, defend or enforce our intellectual property rights, including to our proprietary technology, trade secrets or know how, competitors may be able to develop competing therapies
2. 35coverage and others having narrow coverage, for example being limited to certain intensities and frequencies. Our patent position is generally uncertain and involves complex legal and factual questions
3. 36management’s attention from our business and result in adverse publicity, the disruption of research and 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
4. 37Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our devices

Risks relating to our ordinary shares and capital structure

1. 38The market price for our ordinary shares may be volatile, which could result in substantial losses
2. 39Our ordinary shares are issued under the laws of Jersey, which may not provide the level of legal certainty and transparency afforded by incorporation in a U.S. state
3. 40U.S. shareholders may not be able to enforce civil liabilities against us
4. 41We 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 and make changes to our business
5. 42$100.0 million under the Facility, and we are required to draw down an additional $100.0 million no later than September 30, 2025
6. 43Our existing indebtedness and any additional indebtedness we may incur otherwise could require us to divert funds identified for other purposes for debt service and impair our liquidity position
7. 44Transactions relating to our Convertible Notes may dilute the ownership interest of existing shareholders, or may otherwise depress the price of our ordinary shares