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What changed in NovoCure Ltd's 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of NovoCure Ltd's 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+320 added−323 removedSource: 10-K (2026-02-26) vs 10-K (2025-02-27)

Top changes in NovoCure Ltd's 2025 10-K

320 paragraphs added · 323 removed · 255 edited across 8 sections

Item 1. Business

Business — how the company describes what it does

98 edited+23 added−20 removed122 unchanged
Biggest changeThis practice results in a window of unmet need after localized surgery and SRS are used and before whole brain radiation therapy is administered to delay or prevent the additional spread of brain metastases. 6 METIS Phase 3 trial In 2024, we presented data from the Phase 3 METIS trial, which evaluated the safety and efficacy of TTFields therapy and best supportive care ("BSC") compared to BSC alone in the treatment of adult patients with brain metastases resulting from NSCLC following stereotactic radiosurgery.
Biggest changeThis practice results in a window of unmet need after localized surgery and stereotactic radiation are used and before whole brain radiation therapy is administered to delay or prevent the additional spread of brain metastases.
The trial met its primary endpoint of progression-free survival and a powered secondary endpoint was overall survival. Patients treated with Optune Gio and temozolomide exhibited 6.7 and 20.9 months of median progression-free and overall survival, respectively, compared to 4.0 and and 16.0 months in patients treated with temozolomide alone.
The trial met its primary endpoint of progression-free survival and a powered secondary endpoint was overall survival. Patients treated with Optune Gio and temozolomide exhibited 6.7 and 20.9 months of median progression-free and overall survival, respectively, compared to 4.0 and 16.0 months in patients treated with temozolomide alone.
KEYNOTE D58 is evaluating the use of TTFields therapy together with temozolomide and pembrolizumab for the treatment of adult patients with newly diagnosed GBM. KEYNOTE D58 was designed to accrue 741 patients with a 24-month minimum follow-up period after the last patient is enrolled. The primary endpoint is overall survival.
KEYNOTE D58 is evaluating the use of TTFields therapy together with temozolomide and pembrolizumab for the treatment of adult patients diagnosed with newly diagnosed GBM. KEYNOTE D58 was designed to accrue 741 patients with a 24-month minimum follow-up period after the last patient is enrolled. The primary endpoint is overall survival.
In 26 evaluable patients, the primary endpoint, confirmed objective response rate, was 50%, median progression-free survival was 7.8 months, duration of response was 10.3 months and median overall survival had not yet been reached with a one-year survival rate of 72%.
In 26 evaluable patients, confirmed objective response rate, the primary endpoint, was 50%, median progression-free survival was 7.8 months, duration of response was 10.3 months and median overall survival had not yet been reached with a one-year survival rate of 72%.
In 21 evaluable patients, HEPANOVA showed a 9.5% objective response rate and 76% disease control rate, as well as 5.8 months of progression free survival, compared to historical control data showing a 4.5% objective response rate and 43% disease control rate for patients treated with sorafenib alone.
In 21 evaluable patients, HEPANOVA showed a 9.5% objective response rate and 8 76% disease control rate, as well as 5.8 months of progression free survival, compared to historical control data showing a 4.5% objective response rate and 43% disease control rate for patients treated with sorafenib alone.
These may include: • product listing and establishment registration, which helps facilitate FDA inspections and other regulatory action; • the QSR, which requires manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all aspects of the manufacturing process for products marketed in the U.S.; • labeling regulations and FDA and equivalent competent authority in other jurisdictions requiring promotion be truthful and non-misleading and prohibiting the promotion of products for uncleared, unapproved or off-label uses; • approval of product modifications that affect the safety or effectiveness of one of our devices that has been approved or is the subject of a CE Certificate; • Medical Device Reporting regulations of the FDCA and medical device vigilance, which require that manufacturers comply with FDA or equivalent competent authority requirements in other jurisdictions to report if their device may have caused or contributed to a death or serious injury, or has malfunctioned in a way that would likely cause or contribute to a death or serious injury if the malfunction of the device or a similar device were to recur; • post-approval restrictions or conditions, including post-approval study commitments; • post-market surveillance regulations, which apply when necessary to protect the public health or to provide additional safety and effectiveness data for the device; • the FDA’s and equivalent competent authority’s recall authority, whereby they can ask, or under certain conditions order, device manufacturers to recall from the market a product that is in violation of governing laws and regulations; • regulations pertaining to voluntary recalls; and • notices of corrections or removals.
These may include: • product listing and establishment registration, which helps facilitate FDA inspections and other regulatory action; • the QSR, which requires manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all aspects of the manufacturing process for products marketed in the U.S.; • labeling regulations and FDA and equivalent competent authority in other jurisdictions requiring promotion be truthful and non-misleading and prohibiting the promotion of products for uncleared, unapproved or off-label uses; 13 • approval of product modifications that affect the safety or effectiveness of one of our devices that has been approved or is the subject of a CE Certificate; • Medical Device Reporting regulations of the FDCA and medical device vigilance, which require that manufacturers comply with FDA or equivalent competent authority requirements in other jurisdictions to report if their device may have caused or contributed to a death or serious injury, or has malfunctioned in a way that would likely cause or contribute to a death or serious injury if the malfunction of the device or a similar device were to recur; • post-approval restrictions or conditions, including post-approval study commitments; • post-market surveillance regulations, which apply when necessary to protect the public health or to provide additional safety and effectiveness data for the device; • the FDA’s and equivalent competent authority’s recall authority, whereby they can ask, or under certain conditions order, device manufacturers to recall from the market a product that is in violation of governing laws and regulations; • regulations pertaining to voluntary recalls; and • notices of corrections or removals.
The FDA required a post-approval registry study as a condition of approval for Optune Gio for recurrent GBM, which we completed. Clinical studies involving pharmacological/immunological therapy candidates may be regulated under FDA’s drug regulations, Unless exempt, such studies require authorization from FDA of an Investigational New Drug Application ("IND") for a specified number of patients and study sites.
The FDA required a post-approval registry study as a condition of approval for Optune Gio for recurrent GBM, which we completed. 12 Clinical studies involving pharmacological/immunological therapy candidates may be regulated under FDA’s drug regulations, Unless exempt, such studies require authorization from FDA of an Investigational New Drug Application ("IND") for a specified number of patients and study sites.
The National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology ® (NCCN Guidelines ® ) for Central Nervous Systems Cancers were updated to include alternating electric fields therapy (Optune Gio) in combination with temozolomide following standard brain radiation therapy with concurrent temozolomide as a Category 1 recommended postoperative adjuvant treatment option for patients with newly diagnosed supratentorial GBM.
The National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology ® (NCCN Guidelines ® ) for Central Nervous Systems Cancers were updated to include alternating electric fields therapy (Optune Gio) with temozolomide following standard brain radiation therapy with concurrent temozolomide as a Category 1 recommended postoperative adjuvant treatment option for patients with newly diagnosed supratentorial GBM.
Promotional activities for FDA-regulated products of other companies have been the subject of government enforcement actions brought under healthcare laws and consumer protection statutes. In addition, we are required to meet analogous regulatory requirements in countries outside the U.S., which can change rapidly with relatively short notice.
Promotional activities for FDA-regulated products of other companies have been the subject of 10 government enforcement actions brought under healthcare laws and consumer protection statutes. In addition, we are required to meet analogous regulatory requirements in countries outside the U.S., which can change rapidly with relatively short notice.
The collaboration agreement grants Zai a license to commercialize our Products in Greater China and establishes a development partnership intended to accelerate the development of TTFields therapy in multiple solid tumor cancer indications. Zai has launched Optune Gio for the 9 treatment of newly diagnosed GBM in Hong Kong and mainland China, is seeking marketing authorization for GBM in Taiwan.
The collaboration agreement grants Zai a license to commercialize our Products in Greater China and establishes a development partnership intended to accelerate the development of TTFields therapy in multiple solid tumor cancer indications. Zai has launched Optune Gio for the treatment of newly diagnosed GBM in Hong Kong and mainland China, is seeking marketing authorization for GBM in Taiwan.
These agreements also generally provide that we own, or the individual is required to assign to us, all inventions conceived by the individual in the course of rendering services to us. Despite measures taken to protect our intellectual property, unauthorized parties may copy certain aspects of our products or obtain and use information that we believe is proprietary.
These agreements also generally provide that we own, or the individual is required to assign to us, all inventions conceived by the individual in the course of rendering services to us. Despite measures taken to protect our intellectual 9 property, unauthorized parties may copy certain aspects of our products or obtain and use information that we believe is proprietary.
The false statements provision prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services. Many states have similar healthcare fraud laws or insurance fraud laws that apply to claims for healthcare reimbursement.
The false statements provision 15 prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services. Many states have similar healthcare fraud laws or insurance fraud laws that apply to claims for healthcare reimbursement.
Patients randomized to receive Optune Gio monotherapy demonstrated 6.6 months of median overall survival, compared to 6.0 months in patients treated with physician's choice chemotherapy. Chemotherapies chosen for the active control arm included mainly bevacizumab, nitrosoureas and temozolomide. The study demonstrated that Optune Gio provided clinically comparable survival with an overall better quality of life.
Patients randomized to receive Optune Gio monotherapy demonstrated 6.6 months of median overall survival, compared to 6.0 months in patients treated with physician's choice chemotherapy. Chemotherapies chosen for the 3 active control arm included mainly bevacizumab, nitrosoureas and temozolomide. The study demonstrated that Optune Gio provided clinically comparable survival with an overall better quality of life.
The FDA governs the following activities that we perform or that are performed on our behalf: 11 • product design, development and manufacture; • product safety, testing, labeling and storage; • record keeping procedures; • product marketing, sales and distribution; and • post-marketing surveillance, complaint handling, medical device reporting, reporting of deaths, serious injuries or device malfunctions and repair or recall of products.
The FDA governs the following activities that we perform or that are performed on our behalf: • product design, development and manufacture; • product safety, testing, labeling and storage; • record keeping procedures; • product marketing, sales and distribution; and • post-marketing surveillance, complaint handling, medical device reporting, reporting of deaths, serious injuries or device malfunctions and repair or recall of products.
We expect that we will be required to obtain PMA approval for the use of our Products for future indications. A PMA must be supported by extensive data, including from technical tests, preclinical studies and clinical studies, manufacturing information and intended labeling to demonstrate, to the FDA’s satisfaction, the safety and effectiveness of a medical device for its intended use.
We expect that we will be required to obtain PMA approval for the use of our Products for future indications. 11 A PMA must be supported by extensive data, including from technical tests, preclinical studies and clinical studies, manufacturing information and intended labeling to demonstrate, to the FDA’s satisfaction, the safety and effectiveness of a medical device for its intended use.
Treatment of newly diagnosed GBM In 2015, we received FDA approval to market Optune Gio (then known as Optune) for the treatment of adult patients with newly diagnosed supratentorial GBM in combination with temozolomide based on the randomized Phase 3 EF-14 trial ("EF-14"), which compared Optune Gio plus temozolomide versus temozolomide alone for the treatment of newly diagnosed GBM post radiation.
Treatment of newly diagnosed GBM In 2015, we received FDA approval to market Optune Gio (then known as Optune) for the treatment of adult patients with newly diagnosed supratentorial GBM with temozolomide based on the randomized Phase 3 EF-14 trial ("EF-14"), which compared Optune Gio plus temozolomide versus temozolomide alone for the treatment of newly diagnosed GBM post radiation.
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 therapy. 10 Beginning in 2021, several of our early patents covering technology included in our Products began expiring in the U.S. and elsewhere.
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 therapy. Beginning in 2021, several of our early patents covering technology included in our Products began expiring in the U.S. and elsewhere.
However, our failure to adhere to these requirements could materially adversely 16 impact our business and financial results. Additionally, a number of states have transparency reporting requirements similar to (and in some cases broader than) the Sunshine Act, and regulations similar to the Sunshine Act have been adopted in foreign countries including a number of EU member states.
However, our failure to adhere to these requirements could materially adversely impact our business and financial results. Additionally, a number of states have transparency reporting requirements similar to (and in some cases broader than) the Sunshine Act, and regulations similar to the Sunshine Act have been adopted in foreign countries including a number of EU member states.
We were also required to obtain PMA approval for Optune Lua for use concurrent with PD-1/PD-L1 inhibitors or docetaxel in adult patients with metastatic NSCLC who have progressed on or after a platinum-based regimen, which the FDA granted in October 2024.
We were also required to obtain PMA approval for Optune Lua for use concurrent with PD-1/PD-L1 inhibitors or docetaxel in adult patients with metastatic NSCLC who have progressed on or after a platinum-based regimen, which the FDA granted in 2024.
The EF-19 study studied Optune Gio as a monotherapy for the treatment of recurrent GBM in 192 patients compared to the 117 recurrent GBM patients who received best standard of care chemotherapy in Novocure’s EF-11 registration study. Optune Gio as monotherapy reduced the risk of death with 3 fewer adverse events compared to best standard of care chemotherapy.
The EF-19 study studied Optune Gio as a monotherapy for the treatment of recurrent GBM in 192 patients compared to the 117 recurrent GBM patients who received best standard of care chemotherapy in Novocure’s EF-11 registration study. Optune Gio as monotherapy reduced the risk of death with fewer adverse events compared to best standard of care chemotherapy.
As healthy cells differ from cancer cells in their division rate, geometry and electric properties, the frequency of TTFields can be tuned to specifically affect the cancer cells while leaving healthy cells mostly unaffected. Whether cells are healthy or cancerous, cell division, or mitosis, is the same.
The frequency of TTFields can be tuned to specifically affect cancer cells while leaving healthy cells mostly unaffected, as healthy cells differ from cancer cells in their division rate, geometry and electric properties. Whether cells are healthy or cancerous, the process of cell division, or mitosis, is the same.
Moreover, the FDA and other 14 applicable regulatory authorities can order a mandatory recall if there is a reasonable probability that our device would cause serious adverse health consequences or death. The FDA has broad post-market and regulatory enforcement powers.
Moreover, the FDA and other applicable regulatory authorities can order a mandatory recall if there is a reasonable probability that our device would cause serious adverse health consequences or death. The FDA has broad post-market and regulatory enforcement powers.
The exact incidence of brain metastases is unknown because no national cancer registry documents brain metastases, and estimates from scientific literature vary greatly based on the study methodology applied. Brain metastases are commonly treated with a combination of surgery and radiation.
The exact incidence of brain metastases from NSCLC is unknown because no national cancer registry documents brain metastases, and estimates from scientific literature vary greatly based on the study methodology applied. Brain metastases from NSCLC are commonly treated with a combination of surgery and radiation.
Our track record of fundamental scientific research extends across more than two decades and, in all of our preclinical research to date, the application of TTFields has demonstrated a consistent anti-mitotic effect.
Our track record of fundamental scientific research extends across more than two decades and, in all of our preclinical research conducted to date, the application of TTFields has demonstrated a consistent anti-mitotic effect.
Future modifications may be considered by us as the need arises, some of 12 which we may deem to require a PMA supplement application and others to require reporting in our PMA Annual Report.
Future modifications may be considered by us as the need arises, some of which we may deem to require a PMA supplement application and others to require reporting in our PMA Annual Report.
In some cases, our practices may not meet 15 all of the technical elements for protection under a federal Anti-Kickback Statute exception or safe harbor.
In some cases, our practices may not meet all of the technical elements for protection under a federal Anti-Kickback Statute exception or safe harbor.
Premarket approval (PMA) and Humanitarian Device Exemption (HDE) pathways Optune Gio and Optune Lua are classified as Class III devices as they are deemed to be life-sustaining devices.
Premarket approval (PMA) and Humanitarian Device Exemption (HDE) pathways Optune Gio, Optune Lua and Optune Pax are classified as Class III devices as they are deemed to be life-sustaining devices.
In 2023, the data from the LUNAR study were published in The Lancet Oncology , and additional data detailing the LUNAR study have since been presented at multiple medical congresses.
In 2023, the data from the LUNAR trial were published in The Lancet Oncology , and additional data detailing the LUNAR study have since been presented at multiple medical congresses.
An active patient is a patient who is receiving treatment under a commercial prescription order as of the measurement date, including patients who may be on a temporary break from treatment and who plan to resume treatment in less than 60 days. Growth in the number of active patients is a factor of both new patient starts and treatment duration.
An active patient is a patient who is receiving treatment under a commercial prescription order as of the measurement date, including patients who may be on a temporary break from treatment and who plan to resume treatment in less than 60 days. Growth in the number of active patients is a function of both new patient starts and treatment duration.
In the U.S., a substantial majority of Americans with private health insurance had coverage of Optune Gio for newly diagnosed GBM and/or recurrent GBM as of December 31, 2024. Americans who are beneficiaries of the Medicare fee-for-service program also have coverage of Optune Gio for newly diagnosed GBM.
In the U.S., a substantial majority of Americans with private health insurance had coverage of Optune Gio for newly diagnosed GBM and/or recurrent GBM as of December 31, 2025. Americans who are beneficiaries of the Medicare fee-for-service program also have coverage of Optune Gio for newly diagnosed GBM.
We typically negotiate discounts from our list price with healthcare payers, and in certain cases we accept government-mandated discounts from our list prices in order to secure reimbursement for our Products. We continue to work with payers to expand access to Optune Gio for patients with GBM.
We typically negotiate discounts from our list price with healthcare payers, and in certain cases we accept government-mandated discounts from our list prices in order to secure reimbursement for our Products. We continue to work with payers to expand access to Optune Gio for patients with newly diagnosed GBM.
Gastric cancer EF-31 Phase 2 trial In 2022, we announced the final results from our EF-31 Phase 2 study, a single-arm study evaluating the safety and efficacy of TTFields therapy together with XELOX chemotherapy (and trastuzumab for HER2-positive patients) as first-line treatment for patients with unresectable gastric adenocarcinoma or gastroesophageal junction adenocarcinoma in partnership with Zai.
Gastric cancer EF-31 Phase 2 trial In 2022, we announced the final results from our EF-31 Phase 2 study, a single-arm study evaluating the safety and efficacy of TTFields therapy use together with XELOX chemotherapy (and trastuzumab for HER2-positive patients) as first-line treatment for adult patients diagnosed with unresectable gastric adenocarcinoma or gastroesophageal junction adenocarcinoma in partnership with Zai.
Our development pipeline Based on the results of our preclinical and clinical research, we have developed a pipeline strategy to advance TTFields therapy through phase 2 and phase 3 studies across multiple solid tumor types where TTFields has shown efficacy, including GBM, NSCLC and pancreatic cancer.
Our development pipeline Based on the results of our preclinical and clinical research, we have developed a pipeline strategy to advance TTFields therapy through Phase 2 and Phase 3 studies across multiple solid tumor types where TTFields has shown efficacy, including GBM, NSCLC, brain metastases from NSCLC and pancreatic cancer.
Secondary endpoints include, but are not limited to, progression-free survival, one and two-year survival rates, quality life and safety. KEYNOTE D58 was designed and is being conducted as part of a clinical collaboration between Novocure and MSD, a tradename of Merck & Co., Inc. KEYNOTE D58 is currently open and enrolling.
Secondary endpoints include, but are not limited to, progression-free survival, one and two-year survival rates, quality life and safety. KEYNOTE D58 was designed and is being conducted as part of a clinical collaboration between Novocure and MSD, a tradename of Merck & Co., Inc.
Systemic therapies are often utilized to treat the primary tumor, but many systemic therapies do not cross the blood brain barrier and are thus ineffective in the treatment of brain metastases. When brain metastases appear, they are either surgically removed or treated with radiation using stereotactic radiosurgery ("SRS") when possible.
Systemic therapies are often utilized to treat the primary tumor, but many systemic therapies do not cross the blood brain barrier and are thus ineffective in the treatment of brain metastases. When brain metastases appear, they are either surgically removed or treated with stereotactic radiosurgery when possible.
TRIDENT Phase 3 trial In January 2024, the final patient was enrolled in our TRIDENT trial ("TRIDENT"), a Phase 3 study testing the potential survival benefit of initiating Optune Gio concurrent with radiation therapy and maintenance temozolomide in patients with newly diagnosed GBM. The primary endpoint is overall survival.
TRIDENT Phase 3 trial In 2024, the final patient was enrolled in our TRIDENT trial ("TRIDENT"), a Phase 3 study testing the potential survival benefit of initiating Optune Gio use concurrent with radiation therapy and maintenance temozolomide in adult patients diagnosed with newly diagnosed GBM. The primary endpoint is overall survival.
Ovarian cancer INNOVATE-3 Phase 3 trial In 2024 , we presented results from the Phase 3 INNOVATE-3 trial ("INNOVATE-3"), studying the effectiveness of TTFields therapy with paclitaxel in patients with platinum-resistant ovarian cancer. INNOVATE-3 did not meet its primary endpoint of overall survival at the final analysis.
Ovarian cancer INNOVATE-3 Phase 3 trial In 2024 , we presented results from the Phase 3 INNOVATE-3 trial ("INNOVATE-3"), studying the effectiveness of TTFields therapy use with paclitaxel in adult patients diagnosed with platinum-resistant ovarian cancer. INNOVATE-3 did not meet its primary endpoint of overall survival at the final analysis.
Final data from the PANOVA-4 trial is anticipated in 2026. Non-small cell lung cancer Lung cancer is the most common cause of cancer-related death worldwide, and NSCLC accounts for approximately 85% of all lung cancers. Physicians use different combinations of surgery, radiation and pharmacological therapies to treat NSCLC, depending on the stage of the disease.
Topline data from the PANOVA-4 trial is anticipated in the first quarter of 2026. Non-small cell lung cancer Lung cancer is the most common cause of cancer-related death worldwide, and NSCLC accounts for approximately 85% of all lung cancers. Physicians use different combinations of surgery, radiation and pharmacological therapies to treat NSCLC, depending on the stage of the disease.
Presently, the traditional biotechnology, pharmaceutical and medical technology industries expend significant resources in developing novel and proprietary therapies for the treatment of solid tumors, including GBM, MPM and other indications that we are currently investigating.
Presently, the traditional biotechnology, pharmaceutical and medical technology industries expend significant resources in developing novel and proprietary therapies for the treatment of solid tumors, including GBM, NSCLC, pancreatic cancer, MPM and other indications that we are currently investigating.
Legislation similar to the FCPA has been adopted in foreign countries, including a number of EU member states. Human Capital Resources As of December 31, 2024, we had 1,488 employees, compared to 1,453 employees as of December 31, 2023. We believe relations with our employees are good.
Legislation similar to the FCPA has been adopted in foreign countries, including a number of EU member states. Human Capital Resources As of December 31, 2025, we had 1,605 employees, compared to 1,488 employees as of December 31, 2024. We believe relations with our employees are good.
PANOVA-4 Phase 2 trial In 2024, we completed enrollment in the Phase 2 PANOVA-4 trial ("PANOVA-4") evaluating the safety and efficacy of TTFields therapy together with atezolizumab, gemcitabine and nab-paclitaxel in the treatment of metastatic pancreatic cancer. The primary endpoint of PANOVA-4 is disease control rate.
PANOVA-4 Phase 2 trial In 2024, we completed enrollment in the Phase 2 PANOVA-4 trial ("PANOVA-4") evaluating the safety and efficacy of TTFields therapy use together with atezolizumab, gemcitabine and nab-paclitaxel in the treatment of adult patients diagnosed with metastatic pancreatic cancer. The primary endpoint of PANOVA-4 is disease control rate.
Liver cancer HEPANOVA Phase 2 trial In 2021, we announced the final results of our HEPANOVA Phase 2 trial, a single-arm study evaluating the safety and efficacy of TTFields therapy in combination with sorafenib for the treatment of advanced hepatocellular cancer.
Liver cancer HEPANOVA Phase 2 trial In 2021, we announced the final results of our HEPANOVA Phase 2 trial, a single-arm study evaluating the safety and efficacy of TTFields therapy use in combination with sorafenib for the treatment of adult patients diagnosed with advanced hepatocellular cancer.
We intend to pursue private 5 health insurance and Medicare coverage with CMS for Optune Lua for NSCLC. We cannot be certain when we will obtain such coverage or if we will be able to obtain such coverage at reasonable rates.
We intend to pursue private health insurance and Medicare coverage with CMS for Optune Lua for NSCLC and Optune Pax for pancreatic cancer. We cannot be certain when we will obtain such coverage or if we will be able to obtain such coverage at reasonable rates.
LUNAR-2 Phase 3 trial In July 2023, the FDA accepted the investigation device exemption for the LUNAR-2 clinical trial ("LUNAR-2"), a randomized, Phase 3 study evaluating the efficacy of TTFields therapy concomitant with pembrolizumab and platinum-based chemotherapy for the treatment of patients with metastatic NSCLC. The two primary endpoints of LUNAR-2 are overall survival and progression-free survival.
LUNAR-2 Phase 3 trial In July 2023, the FDA accepted the investigation device exemption for the LUNAR-2 clinical trial ("LUNAR-2"), a randomized, Phase 3 study evaluating the efficacy of TTFields therapy use concomitant with pembrolizumab and platinum-based chemotherapy as first-line treatment for adult patients diagnosed with metastatic NSCLC. The two primary endpoints of LUNAR-2 are overall survival and progression-free survival.
We distribute our Products through hospitals in Japan with the hospitals receiving reimbursement from the government-mandated insurance program and in turn contracting with us for the equipment, supplies and services necessary to treat patients with our Product. We maintain a monthly list price for our therapy.
We distribute 5 our Products through hospitals in those other markets, with the hospitals receiving reimbursement from the government-mandated insurance program and in turn contracting with us for the equipment, supplies and services necessary to treat patients with our Product. We maintain a monthly list price for our therapy.
LUNAR evaluated the safety and efficacy of TTFields therapy when used together with immune checkpoint inhibitors or docetaxel (collectively, "standard therapies") versus standard therapies alone for patients with stage 4 NSCLC who progressed during or after platinum-based therapy.
LUNAR evaluated the safety and efficacy of TTFields therapy when used together with immune checkpoint inhibitors or docetaxel (collectively, "standard therapies") versus standard therapies alone for patients with stage 4 NSCLC who progressed during or after platinum-based therapy. The LUNAR trial met its primary endpoint.
Optune Lua is approved by the FDA under the PMA pathway for the treatment of adult patients with metastatic non-small cell lung cancer ("NSCLC") concurrent with PD-1/PD-L1 inhibitors or docetaxel following progression on or after a platinum-based regimen.
Optune Lua is approved by the FDA under the PMA pathway for the treatment of adult patients with metastatic NSCLC concurrent with PD-1/PD-L1 inhibitors or docetaxel following progression on or after a platinum-based regimen.
As of December 31, 2024, we have received national reimbursement for Optune Gio in Austria, France, Germany, Israel, Japan, Sweden and Switzerland.
As of December 31, 2025, we have received national reimbursement for Optune Gio in Austria, Czechia, France, Germany, Israel, Japan, Spain, Sweden and Switzerland.
The LUNAR trial met its primary endpoint Patients treated with TTFields therapy and standard therapies demonstrated median overall survival of 13.2 months (95% CI, 10.3-15.5 months) compared to 9.9 months (95% CI, 8.2-12.2 months) in patients treated with standard therapies alone (p=0.042, HR=0.76).
Patients treated with TTFields therapy and standard therapies demonstrated median overall survival of 13.2 months (95% CI, 10.3-15.5 months) compared to 9.9 months (95% CI, 8.2-12.2 months) in patients treated with standard therapies alone (p=0.042, HR=0.76).
Secondary endpoints include, but are not limited to, overall survival, progression-free survival, one-year survival, objective response rate and frequency and severity of adverse events. PANOVA-4 was designed to accrue 76 patients with a 12-month follow-up period following enrollment of the last patient. PANOVA-4 was designed and is being conducted as part of a clinical collaboration between Novocure and Roche.
Secondary endpoints include, but are not limited to, overall survival, progression-free survival, one-year survival, objective response rate and frequency and severity of adverse events. 84 patients were enrolled in PANOVA-4 with a 12-month minimum follow-up period after the last patient enrolled. PANOVA-4 was designed and is being conducted as part of a clinical collaboration between Novocure and Roche.
As of December 31, 2024 we have not yet received national reimbursement for Optune Lua for NSCLC in any of our active markets, however, we are seeking to obtain national reimbursement (and private insurance coverage, where available) in multiple countries.
As of December 31, 2025 we have not yet received national reimbursement for Optune Lua for NSCLC or MPM or Optune Pax for pancreatic cancer in any of our active markets, however, we are seeking to obtain national reimbursement (and private insurance coverage, where available) in multiple countries.
Arrays are changed when hair growth or skin moisture reduces array adhesion to the skin. The therapy is designed to be delivered continuously throughout the day and night, and efficacy is strongly correlated to time on therapy. When the device is turned on, TTFields are continuously generated within the specific region of the body covered by the arrays.
Arrays are changed when hair growth or skin moisture reduces array adhesion to the skin. TTFields therapy is designed to be delivered continuously throughout the day and night. When the device is turned on, TTFields are continuously generated within the specific region of the body covered by the arrays. Healthy tissue remain unaffected by the therapy.
Food and Drug Administration ("FDA") under the Premarket Approval ("PMA") pathway for the treatment of adult patients with newly diagnosed glioblastoma ("GBM") together with temozolomide, a chemotherapy drug, and for adult patients with GBM following confirmed recurrence after chemotherapy as monotherapy treatment.
Optune Gio is approved by the U.S. Food and Drug Administration ("FDA") under the Premarket Approval ("PMA") pathway for the treatment of adult patients with newly diagnosed glioblastoma ("GBM") together with temozolomide, a chemotherapy drug, and for adult patients with GBM following confirmed recurrence after chemotherapy as monotherapy treatment.
We have several ongoing clinical trials which further explore the use of TTFields therapy in these solid tumor cancers, including the Phase 3 TRIDENT and KEYNOTE D58 trials in GBM, Phase 3 LUNAR-2 and Phase 2 LUNAR-4 trials in NSCLC, and Phase 2 PANOVA-4 trial in pancreatic cancer.
We have several ongoing and recently concluded clinical trials which further explore the use of TTFields therapy, including the Phase 3 TRIDENT 1 and KEYNOTE D58 trials in GBM, Phase 3 LUNAR-2 trial in NSCLC, and Phase 2 PANOVA-4 trial in pancreatic cancer.
We bill payers a single monthly fee for a month of therapy and we bear the financial risk of securing payment from third-party payers and patients in all markets except for Japan.
We bill payers a single monthly fee for a month of therapy and we bear the financial risk of securing payment from third-party payers and patients in all markets except for countries where we contract with hospitals.
Preclinical work suggests that the well-established impairment created by the physical effect of TTFields to tumor cells results in a series of changes to cell processes that downregulate DNA damage response, interfere with cell movement and migration, and increase anti-tumor immunity. Research is ongoing to further refine and build upon our understanding of TTFields' several mechanisms of action.
Preclinical work suggests that the well-established impairment created by the physical effect of TTFields to cancer cells results in a series of changes to cell processes that downregulate DNA damage response, and increase anti-tumor immunity. Research is ongoing to further refine and build upon our understanding of these downstream mechanisms.
("Zai") a license to commercialize our Products in China, Hong Kong, Macau and Taiwan ("Greater China") under a License and Collaboration Agreement (the "Zai Agreement"). The Zai Agreement also establishes a development partnership intended to accelerate the development of TTFields therapy in multiple solid tumor cancer indications.
("Zai") a license to commercialize our Products in China, Hong Kong, Macau and Taiwan ("Greater China") under a License and Collaboration Agreement (the "Zai Agreement"). The Zai Agreement also establishes a development partnership intended to accelerate the development of TTFields therapy in multiple solid tumor cancer indications. For additional information, see Note 12 to the Consolidated Financial Statements.
ITEM 1. BUSINESS Overview We are a global oncology company with a proprietary platform technology called Tumor Treating Fields ("TTFields"), which are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms.
ITEM 1. BUSINESS Overview We are a global oncology company with a proprietary platform technology called Tumor Treating Fields ("TTFields"), which are electric fields that exert physical forces to kill cancer cells. Our therapy is delivered through a medical device.
Because our current Products require, and we anticipate our future Products will require, physician training and education, we expect that our sales and marketing and patient support teams will continue to grow substantially as we expand our approved indications and markets.
Because our current Products require, and we anticipate our future Products will require, physician training and education, we expect that our sales and marketing and patient support teams will continue to grow as we expand our approved indications and markets. 16 Available information Our corporate website address is www.novocure.com .
Our intellectual property portfolio contains hundreds of issued patents and numerous patent applications pending worldwide. We believe we possess global commercialization rights to our Products in oncology and are well-positioned to extend those rights into the future as we continue to find innovative ways to improve our Products. In 2018, we granted Zai Lab (Shanghai) Co., Ltd.
We believe we possess global commercialization rights to our Products in oncology and are well-positioned to extend those rights into the future as we continue to find innovative ways to improve our Products. In 2018, we granted Zai Lab (Shanghai) Co., Ltd.
Optune Lua is also approved for use in the U.S. for the treatment of NSCLC.
Optune Lua is also approved for use in the U.S., EU and Japan for the treatment of NSCLC. Optune Pax is approved for use in the U.S. for the treatment of pancreatic cancer.
Available information Our corporate website address is www.novocure.com . Our website is an inactive textual reference and nothing on our website is incorporated by reference in this Annual Report.
Our website is an inactive textual reference and nothing on our website is incorporated by reference in this Annual Report.
More objective radiological responses were observed in the Optune Gio group than in the active control chemotherapy group (14 patients versus 7 patients). Three patients in the Optune Gio alone arm had a complete response versus no patients in the active chemotherapy arm.
More objective radiological responses were observed in the Optune Gio group than in the active control chemotherapy group (14 patients versus 7 patients). Three patients in the Optune Gio alone arm had a complete response versus no patients in the active chemotherapy arm. Final data from the EF-11 trial were published in the European Journal of Cancer in 2012.
Secondary endpoints include, but are not limited to, progression-free survival, survival rates at one and two years, overall radiological response, severity and frequency of adverse effects, pathological changes in resected GBM tumors post treatment, quality of life, and correlation of overall survival to TTFields dose.
Secondary endpoints include, but are not limited to, progression-free survival, survival rates at one and two years, overall radiological response, severity and frequency of adverse effects, pathological changes in resected GBM tumors post treatment, quality of life, and correlation of overall survival to TTFields dose. 981 patients were enrolled in TRIDENT with a 24-month minimum follow-up period after the last patient enrolled.
We employ a team of Device Support Specialists who provide technical training to the patient and any caregivers. Once treatment is initiated, we provide 24/7 technical support for patients and caregivers as well as assistance with insurance reimbursement. We also provide the healthcare provider and the patient with a usage report for monitoring patient time on therapy.
Once treatment is initiated, we provide technical support for patients and caregivers as well as assistance with commercial insurance reimbursement, when applicable. We also provide the healthcare provider and the patient with a usage report for monitoring patient time on therapy.
The complete devices, called Optune Gio and Optune Lua (for head and thoracic treatment, respectively), include a portable electric field generator, arrays, rechargeable batteries and accessories. Single-use arrays are placed directly on the skin in the region surrounding the tumor and connected to the electric field generator to deliver therapy.
The complete device, called Optune Gio (for the treatment of GBM), Optune Lua (for the treatment of NSCLC and MPM) and Optune Pax (for the treatment of pancreatic cancer), includes a portable electric field generator, arrays, rechargeable batteries and accessories. 2 Single-use arrays are placed directly on the skin in the region surrounding the tumor and connected to the electric field generator to deliver TTFields therapy.
We market Optune Gio and Optune Lua in multiple countries around the globe with the majority of our revenues coming from the use of Optune Gio in the U.S., Germany, France and Japan. We are actively evaluating opportunities to expand our international footprint.
We are pursuing regulatory approval to market Optune Pax in other countries. We market our Products in multiple countries around the globe with the majority of our revenues coming from the use of Optune Gio in the U.S., Germany, France and Japan.
Our key priorities are to drive commercial adoption of Optune Gio ® and Optune Lua ® , our commercial TTFields therapy devices, and to advance clinical and product development programs intended to extend overall survival in some of the most aggressive forms of cancer.
Our key priorities are to drive commercial adoption of Optune Gio ® , Optune Lua ® , and Optune Pax ® , our commercial TTFields therapy devices, obtain regulatory approval to market TTFields therapy devices in new indications, such as brain metastases from non-small cell lung cancer ("NSCLC"), and to advance clinical and product development programs intended to extend overall survival in some of the most aggressive forms of cancer.
In June 2024, we presented results from the Phase 3 METIS clinical trial evaluating the use of TTFields therapy and best supportive care for the treatment of adult patients with 1-10 brain metastases from NSCLC following stereotactic radiosurgery ("METIS").
In September 2025, we presented final data from the Phase 3 METIS clinical trial evaluating the use of TTFields therapy and best supportive care (BSC) for the treatment of adult patients (n=298) with 1-10 brain metastases from NSCLC following stereotactic radiosurgery at the 2025 American Society for Radiation Oncology Annual Meeting.
We plan to specifically target individual solid tumor types by optimizing field generator parameters such as frequency and power output. Our arrays have been developed and are in use, either commercially or clinically, for application on the head, thorax and abdomen. 2 Through engineering efforts, we plan to continue to advance our Products to optimize TTFields therapy.
Our arrays have been developed and are in use, either commercially or clinically, for application on the head, thorax and abdomen. Through engineering efforts, we plan to continue to advance our Products to optimize TTFields therapy.
Whole brain radiation therapy, although effective in delaying progression or recurrence of brain metastases when given either before or after SRS, is associated with neurotoxicity and a significant decline in cognitive functioning. Thus, whole brain radiation therapy is often delayed until later in the disease course and is often used as a last resort.
Whole brain radiation therapy, although effective in delaying progression or recurrence of brain metastases when given either before or after stereotactic radiation, is associated with neurotoxicity and a significant decline in cognitive functioning and is thus reserved as a 6 salvage treatment.
The time required to CE mark our 13 devices or to obtain approval from other non-U.S. authorities is not defined, and therefore may be longer or shorter than that required for FDA approval.
Following the issuance of this CE Certificate, we can draw up a declaration of conformity and affix the CE mark to the devices covered by this CE Certificate. The time required to CE mark our devices or to obtain approval from other non-U.S. authorities is not defined, and therefore may be longer or shorter than that required for FDA approval.
For additional information, see Note 12 to the Consolidated Financial Statements. 1 Our ordinary shares are quoted on the NASDAQ Global Select Market under the symbol "NVCR." We were incorporated in the Bailiwick of Jersey in 2000. Daily management and control of the Company are located in Switzerland, with additional operating centers located around the world.
Our ordinary shares are quoted on the NASDAQ Global Select Market under the symbol "NVCR." We were incorporated in the Bailiwick of Jersey in 2000. Daily management and control of the Company are located in Switzerland, with additional operating centers located around the world. Our therapy When cancer develops, rapid and uncontrolled division of cancerous cells occurs.
Annual diagnoses rates per capita are similar in our other European active markets. • 2,200 people will be diagnosed with GBM or tumors that typically progress to GBM in Japan. Of this population, approximately 1,200 patients are candidates for treatment with Optune Gio and will actively seek treatment. • 114,000 people will be diagnosed with metastatic NSCLC in the U.S.
In 2026, we estimate that annually approximately: • 15,000 people will be diagnosed with GBM or tumors that typically progress to GBM in the U.S. Of this population, approximately 8,200 patients are candidates for treatment with Optune Gio and will actively seek treatment. • 114,000 people will be diagnosed with metastatic NSCLC in the U.S.
For patients with locally advanced pancreatic cancer involving encasement of arteries but no extra-pancreatic disease, the standard of care is surgery followed by chemotherapy 7 with or without radiation. Unfortunately, the majority of locally advanced cases are diagnosed once the cancer is no longer operable, generally leaving chemotherapy with or without radiation as the only treatment option.
Unfortunately, the majority of locally advanced cases are diagnosed once the cancer is no longer operable, generally leaving chemotherapy with or without radiation as the only treatment option.
All cells are surrounded by a bilipid membrane, which separates the interior of the cell, or cytoplasm, from the space around it. This membrane prevents low frequency electric fields from entering the cell. TTFields, however, have a unique frequency range, between 100 to 500 kHz, enabling the electric fields to penetrate the cancer cell membrane.
This membrane prevents low frequency electric fields from entering the cell. TTFields, however, have a unique frequency range, between 100 to 500 kHz, enabling the electric fields to penetrate the cancer cell membrane.
Following diagnosis, standard of care treatment includes surgical resection, followed by radiotherapy with concomitant chemotherapy, followed by TTFields therapy together with maintenance chemotherapy.
Glioblastoma GBM is the most common and aggressive form of primary brain cancer. Following diagnosis, standard of care treatment includes surgical resection, followed by radiotherapy with concomitant chemotherapy, followed by TTFields therapy together with maintenance chemotherapy.
We believe the physical mechanisms of action behind TTFields therapy may be broadly applicable to solid tumor cancers.
We believe the physical mode of action behind TTFields therapy and resulting downstream cellular processes initiated by the damaged cells may be broadly applicable to solid tumor cancers.
Optune Lua is also approved under the Humanitarian Device Exemption ("HDE") pathway for the treatment of adult patients with malignant pleural mesothelioma or pleural mesothelioma (together, "MPM") together with standard chemotherapies. We have also received CE certification in the EU and approval or local registration to market Optune Lua in certain other countries for the treatment of MPM.
Optune Lua is also approved by the FDA under the Humanitarian Device Exemption ("HDE") pathway for the treatment of adult patients with malignant pleural mesothelioma or pleural mesothelioma (together, "MPM") together with standard chemotherapies.
In addition to our ongoing clinical trials, we continue to conduct research to further advance the scientific evidence supporting the use of TTFields therapy and to gather additional information about our therapy's optimal use. Central Nervous System Indications Brain metastases Metastatic cancer is cancer that has spread from the place where it first started to another place in the body.
In addition to our ongoing clinical trials, we continue to conduct research to further advance the scientific evidence supporting the use of TTFields therapy and to gather additional information about our therapy's optimal use.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeRegulations promulgated by the regulatory authorities in our applicable jurisdictions are wide-ranging and govern, among other things: • the conduct of preclinical and clinical studies; • 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; • interactions with healthcare professionals and patients; and • product sales and distribution. 30 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.
Biggest changeRegulations promulgated by the regulatory authorities in our applicable jurisdictions are wide-ranging and govern, among other things: • the conduct of preclinical and clinical studies; • product design, development, manufacturing, testing, storage and shipping; • product labeling, advertising and promotion; • regulatory jurisdiction, premarket clearance, approval and conformity assessment pathways and procedures for initial approvals, as well as for modifications introduced in marketed products; • post-market surveillance and monitoring; 30 • reporting of adverse events or incidents and implementation of corrective actions, including product recalls; • interactions with healthcare professionals and patients; and • product sales and distribution.
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; • our ability to expand into new markets and future 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 and to comply with applicable health care coverage 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 laws and regulatory requirements, in particular in the EU; • the maintenance of our existing regulatory approvals; and 18 • the consequences of any reportable adverse events involving our Products.
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; • our ability to expand into new markets and future 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 and to comply with applicable health care coverage 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; 18 • results of future clinical studies relating to our Products or other competitor products for similar indications; • compliance with applicable laws and regulatory requirements, in particular in the EU; • the maintenance of our existing regulatory approvals; and • the consequences of any reportable adverse events involving our Products.
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 or maintain 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; • physicians may be reluctant to prescribe our Products due to their perception that the supporting clinical study designs have limitations, as they are, for example, unblinded, or because reimbursement for physician time spent prescribing and assisting patients with our Products is low compared to other therapies; • physicians at large academic universities and medical centers may prefer to enroll patients into clinical studies instead of prescribing our Products; 21 • 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 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 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); and • the price of our Products includes a monthly fee for use of the device and therefore, as the duration of the treatment course increases, the overall price will increase correspondingly and, when used together with other treatments, the overall cost of treatment will be greater than using a single type of treatment.
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 or maintain 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; • physicians may be reluctant to prescribe our Products due to their perception that the supporting clinical study designs have limitations, as they are, for example, unblinded, or because reimbursement for 21 physician time spent prescribing and assisting patients with our Products is low compared to other therapies; • physicians at large academic universities and medical centers may prefer to enroll patients into clinical studies instead of prescribing 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 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 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); and • the price of our Products includes a monthly fee for use of the device and therefore, as the duration of the treatment course increases, the overall price will increase correspondingly and, when used together with other treatments, the overall cost of treatment will be greater than using a single type of treatment.
In addition, even if we are successful in achieving market acceptance of our Products for GBM, NSCLC or MPM, we may be unsuccessful in achieving market acceptance of our Products for other indications, such as brain metastases from NSCLC, pancreatic 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.
In addition, even if we are successful in achieving market acceptance of our Products for GBM, NSCLC, MPM or pancreatic cancer, we may be unsuccessful in achieving market acceptance of our Products for other indications, such as brain metastases from NSCLC 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.
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: • untitled letters, warning letters, fines, injunctions, consent decrees and civil penalties; • unanticipated expenditures to address or defend such actions; • patient notification, or orders for repair, replacement or refunds; • voluntary or mandatory recall, withdrawal or seizure of our current or future devices; • 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; 33 • 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 devices; • refusal or delay in obtaining CE Certificates for new intended uses for or modifications to our Products; • suspension, variation or withdrawal of the CE Certificates granted by our notified body in the EU; • prohibition or restriction of Products being placed on the market; • operating restrictions; • suspension or withdrawal of PMA or analogous approvals that have already been granted; • refusal to grant export approval for our Products or any device candidates; or • criminal prosecution.
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: • untitled letters, warning letters, fines, injunctions, consent decrees and civil penalties; • unanticipated expenditures to address or defend such actions; • patient notification, or orders for repair, replacement or refunds; • voluntary or mandatory recall, withdrawal or seizure of our current or future devices; • administrative detention by the FDA or other regulatory authority in another jurisdiction of medical devices believed to be adulterated or misbranded; 33 • 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 or for approval of new devices; • refusal or delay in obtaining CE Certificates for new intended uses for or modifications to our Products; • suspension, variation or withdrawal of the CE Certificates granted by our notified body in the EU; • prohibition or restriction of Products being placed on the market; • operating restrictions; • suspension or withdrawal of PMA or analogous approvals that have already been granted; • refusal to grant export approval for our Products or any device candidates; or • criminal prosecution.
In addition, "legacy" medical devices that have obtained a CE Certification under the MDD may in principle continue to be marketed under such CE Certificate until the CE Certificate expires but at the latest by December 31, 2027 or 2028, depending on device class, under transitional provisions as amended in February 2023, provided that the manufacturer complies with the MDR’s additional requirements related to post-marketing surveillance, market 34 surveillance, vigilance, and registration of economic operators and of devices.
In addition, "legacy" medical devices that have obtained a CE Certification under the MDD may in principle continue to be marketed under such CE Certificate until the CE Certificate expires but at the latest by December 31, 2027 or 2028, depending on device class, under transitional provisions as amended in February 2023, provided that the 34 manufacturer complies with the MDR’s additional requirements related to post-marketing surveillance, market surveillance, vigilance, and registration of economic operators and of devices.
The market price for our ordinary shares may be volatile and subject to wide fluctuations in response to factors such as publication of clinical studies relating to our Products, our system candidates or a competitor’s product, actual or 41 anticipated fluctuations in our quarterly results of operations, changes in financial estimates by securities research analysts, negative publicity, studies or reports, changes in the economic performance or market valuations of other companies that operate in our industry, changes in the availability of third-party reimbursement in the U.S. or other countries, changes in governmental regulations or in the status of our regulatory approvals or applications, announcements by us or our competitors of material acquisitions, strategic partnerships, joint ventures or capital commitments, intellectual property litigation, release of transfer restrictions on our outstanding ordinary shares, and economic or political conditions in the U.S. or elsewhere.
The market price for our ordinary shares may be volatile and subject to wide fluctuations in response to factors such as publication of clinical studies relating to our Products, our system candidates or a competitor’s product, actual or anticipated fluctuations in our quarterly results of operations, changes in financial estimates by securities research analysts, negative publicity, studies or reports, changes in the economic performance or market valuations of other companies that operate in our industry, changes in the availability of third-party reimbursement in the U.S. or other countries, changes in governmental regulations or in the status of our regulatory approvals or applications, announcements by us or our competitors of material acquisitions, strategic partnerships, joint ventures or capital 41 commitments, intellectual property litigation, release of transfer restrictions on our outstanding ordinary shares, and economic or political conditions in the U.S. or elsewhere.
Any alternative interpretations of applicable tax and other laws asserted by an authority or changes in tax and customs laws, regulations or accounting principles that limit our ability to take advantage of treaties between jurisdictions, modify or eliminate the deductibility of various currently deductible payments, increase the tax and tariff burden of operating 38 or being resident in a particular country, result in transfer pricing adjustments or otherwise require the payment of additional taxes or levies, may have a material adverse effect on our cash flows, financial condition and results of operations.
Any alternative interpretations of applicable tax and other laws asserted by an authority or changes in tax and customs laws, regulations or accounting principles that limit our ability to take advantage of treaties between jurisdictions, modify or eliminate the deductibility of various currently deductible payments, increase the tax and tariff burden of operating or being resident in a particular country, result in transfer pricing adjustments or otherwise require the payment of additional taxes or levies, may have a material adverse effect on our cash flows, financial condition and results of operations.
There can be no assurance that the UK Regulations will be interpreted by UK regulators in the same manner as the MDR from which the UK Regulations are based, which may prevent or delay the UK CE certification of our device candidates or impact our ability to modify our Products on a timely basis We may choose to, or may be required to, suspend, repeat or terminate our clinical studies if they are not conducted in accordance with regulatory requirements, the results are negative or inconclusive or the studies are not well designed.
There can be no assurance that the UK Regulations will be interpreted by UK regulators in the same manner as the MDR from which the UK Regulations are based, which may prevent or delay the UK CE certification of our device candidates or impact our ability to modify our Products on a timely basis. 31 We may choose to, or may be required to, suspend, repeat or terminate our clinical studies if they are not conducted in accordance with regulatory requirements, the results are negative or inconclusive or the studies are not well designed.
The 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; and • to repay or modify certain other agreements with respect to other material indebtedness or modify our organizational documents.
The 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; 42 • to pay dividends on, or redeem or repurchase, capital stock, enter into transactions with affiliates or materially change our business; and • to repay or modify certain other agreements with respect to other material indebtedness or modify our organizational documents.
Although we believe our Products represent a treatment modality that can be used together with other cancer treatment modalities, our current and future competitors may at any time develop additional drugs, biologics or devices for the treatment of GBM, NSCLC, MPM, or other solid tumors that could be more effective from a therapeutic or cost-basis perspective than using our Products.
Although we believe our Products represent a treatment modality that can be used together with other cancer treatment modalities, our current and future competitors may at any time develop additional drugs, biologics or devices for the treatment of GBM, NSCLC, MPM, pancreatic cancer or other solid tumors that could be more effective from a therapeutic or cost-basis perspective than using our Products.
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.
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. 40 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.
Our future revenues and results may be affected by the absence of specific 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.
Our future revenues and results may be affected by the 23 absence of specific 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.
Even if our agreements with our third-party manufacturers and suppliers entitle us to indemnification against losses, such indemnification may not be available or adequate should any claim arise. Other future litigation and regulatory actions could have a material adverse impact on the Company.
Even if our agreements with our third-party manufacturers and suppliers entitle us to indemnification against losses, such indemnification may not be available or adequate should any claim arise. 28 Other future litigation and regulatory actions could have a material adverse impact on the Company.
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 40 management’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 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 development and marketing efforts, injury to our reputation and loss of revenues.
The loss of the services of one or more of our current employees might impede the achievement of our business objectives. 27 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.
The loss of the services of one or more of our current employees might impede the achievement of our business objectives. 27 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, regulatory, technical and managerial personnel.
Our current intellectual property portfolio consists of hundreds of issued patents in multiple jurisdictions covering various aspects of our devices and related technology. The legal scope of our patents vary, with some having broad 39 coverage and others having narrow coverage, for example being limited to certain intensities and frequencies.
Our current intellectual property portfolio consists of hundreds of issued patents in multiple jurisdictions covering various aspects of our devices and related technology. The legal scope of our patents vary, with some having broad coverage and others having narrow coverage, for example being limited to certain intensities and frequencies.
Patent expiration could adversely affect our ability to protect our Products and future product development and our competitors may develop and market competing products. We have also filed additional patent applications in several countries that may never be issued. Consequently, our operating results and financial position could be materially adversely affected.
Patent expiration could adversely affect our ability to protect our Products and future product development and our competitors may develop and market competing products. We have also filed additional patent applications in several countries that 39 may never be issued. Consequently, our operating results and financial position could be materially adversely affected.
Coverage and payment relating to these codes is subject to discretion by each third-party payer. 23 Outside the U.S., Germany, France and Japan, we have not secured codes to describe our Products or to document physician services related to the delivery of therapy using our Products.
Coverage and payment relating to these codes is subject to discretion by each third-party payer. Outside the U.S., Germany, France and Japan, we have not secured codes to describe our Products or to document physician services related to the delivery of therapy using our Products.
From time to time, we may be subject to litigation and other legal and regulatory proceedings relating to our business or investigations or other actions by governmental agencies, including as described in Part I, Item 3 "Legal 28 Proceedings" of this Annual Report on Form 10-K.
From time to time, we may be subject to litigation and other legal and regulatory proceedings relating to our business or investigations or other actions by governmental agencies, including as described in Part I, Item 3 "Legal Proceedings" of this Annual Report on Form 10-K.
Clinical studies must be conducted in accordance with the FDA’s cGCPs and the equivalent laws and regulations applicable in other jurisdictions in which the clinical studies are conducted. The clinical studies are subject to 31 oversight by the FDA, regulatory agencies in other jurisdictions, ethics committees and institutional review boards at the medical institutions where the clinical studies are conducted.
Clinical studies must be conducted in accordance with the FDA’s cGCPs and the equivalent laws and regulations applicable in other jurisdictions in which the clinical studies are conducted. The clinical studies are subject to oversight by the FDA, regulatory agencies in other jurisdictions, ethics committees and institutional review boards at the medical institutions where the clinical studies are conducted.
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.
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 20 our Products may make it more difficult to compete for sales and marketing personnel.
Because the techniques used to obtain unauthorized access, or to sabotage systems, 29 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.
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.
As a consequence, our expenses associated with building up and maintaining our sales force and 20 marketing capabilities may be disproportionate to the revenues we may be able to generate on sales of our Products.
As a consequence, our expenses associated with building up and maintaining our sales force and marketing capabilities may be disproportionate to the revenues we may be able to generate on sales of our Products.
We may be unable to obtain reimbursement for our Products used in clinical trials where our Products are already part of the approved standard of care.
We may be unable to obtain reimbursement for our Products used in clinical trials 19 where our Products are already part of the approved standard of care.
Further, until we receive FDA and analogous approval in other jurisdictions for the use of our Products for other indications (including for NSCLC pending obtaining widespread reimbursement agreements), almost all of our revenues will derive from sales and royalties from sales of Optune Gio for the treatment of newly diagnosed and recurrent GBM.
Further, until we receive FDA and analogous approval in other jurisdictions for the use of our Products for other indications (including for NSCLC and pancratic cancer pending obtaining widespread reimbursement agreements), almost all of our revenues will derive from sales and royalties from sales of Optune Gio for the treatment of newly diagnosed and recurrent GBM.
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 study 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.
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 study expenses to remain significant in connection with our ongoing activities and as additional indications enter late-stage clinical development and as we advance our product development.
Our future success depends upon our ability to attract, retain and motivate highly skilled employees. In order to commercialize our Products successfully, we will be required to expand our workforce, particularly in the areas of research and development and clinical studies, sales and marketing and supply chain management.
Our future success depends upon our ability to attract, retain and motivate highly skilled employees. In order to commercialize our Products successfully, we will be required to expand our workforce, particularly in the areas of research and development and clinical studies, regulatory affairs, sales and marketing and supply chain management.
Our patent position is generally uncertain and involves complex legal and factual questions. In the U.S., our patents have expected expiration dates between 2024 and 2041. Starting in 2021, several patents covering technology included in our Products have expired in the U.S. and elsewhere.
Our patent position is generally uncertain and involves complex legal and factual questions. In the U.S., our patents have expected expiration dates between 2025 and 2041. Starting in 2021, several patents covering technology included in our Products have expired in the U.S. and elsewhere.
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 that we will secure or maintain such suppliers.
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 when economically feasible, but we can provide no assurance that we will secure or maintain such suppliers.
CPT codes for physician services specifically related to our Products may not be obtainable.
Other CPT codes for physician services specifically related to our Products may not be obtainable.
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.
We have developed or are in the process of developing and obtaining regulatory approval for second sources for components in all jurisdictions where economically feasible. 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.
We have also received FDA approval under the HDE pathway to market Optune Lua for unresectable, locally advanced or metastatic, MPM when used together with standard chemotherapies. Optune Lua is also CE Certified for the same indication in the EU and Switzerland.
We have also received FDA approval under the HDE pathway to market Optune Lua for unresectable, locally advanced or metastatic, MPM when used together with standard chemotherapies. Optune Lua is also CE Certified for NSCLC and MPM in the EU and Switzerland.
We are also party to a five-year senior secured credit facility of up to $400.0 million (the "Facility") among Novocure Luxembourg S.a.r.l., our wholly-owned subsidiary, and BPCR Limited Partnership and BioPharma Credit Investments V (Master) LP (collectively, the "Lenders"), BioPharma Credit PLC, as collateral agent for the Lenders, and other of our subsidiaries that are guarantors to such agreement.
We are party to a five-year senior secured credit facility (the "Facility") among Novocure Luxembourg S.a.r.l., our wholly-owned subsidiary, and BPCR Limited Partnership and BioPharma Credit Investments V (Master) LP (collectively, the "Lenders"), BioPharma Credit PLC, as collateral agent for the Lenders, and other of our subsidiaries that are guarantors to such agreement.
For example, our products contain per- and polyfluoroalkyl substances (PFAS), and we may be subject to reporting laws or regulations for products containing these substances, such as the Federal Toxic Substances Control Act (TCSA) of 1976 in the U.S.
For example, our products contain per- and polyfluoroalkyl substances (PFAS), and we may be subject to reporting laws or regulations for products containing these substances, such as the Federal Toxic Substances Control Act (TCSA) of 1976 in the U.S.,and/or similar laws at the State level.
Medicare has the authority to issue national coverage determinations or to defer coverage decisions to its regional Medicare Administrative Contractors ("MACs"). The fact that only two MACs administer the entire DME program may negatively affect our ability to petition individual medical policy decision-makers at the MACs for coverage.
Medicare classifies our Products 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"). The fact that only two MACs administer the entire DME program may negatively affect our ability to petition individual medical policy decision-makers at the MACs for coverage.
Optune Gio has a CE mark affixed for the treatment of GBM in the EU and Switzerland. Optune Lua is approved by the FDA under the PMA pathway for adults with metastatic NSCLC who have progressed on or after a platinum-based regimen, together with docetaxel or immune checkpoint inhibitors (ICI).
Optune Gio has a CE mark affixed for the treatment of GBM in the EU and Switzerland. Optune Lua is approved by the FDA under the PMA pathway for adults with metastatic NSCLC who have progressed on or after a platinum-based regimen, together with docetaxel or PD-1/PD-L1 inhibitors.
Similarly, the label for Optune Lua also contains certain limitations that may adversely affect adoption. For NSCLC it is approved specifically for concurrent use with PD-1/PDL-1 inhibitors or docetaxel for adult patients with metastatic NSCLC who have progressed on or after platinum-based therapies.
Similarly, the labeling for Optune Lua also contains certain limitations that may adversely affect adoption. For NSCLC it is approved specifically for concurrent use with PD-1/PDL-1 inhibitors or docetaxel for adult patients with metastatic NSCLC who have progressed on or after platinum-based therapies in most countries, but not docetaxel in Japan.
In the United Kingdom, our Products and operation are subject to, inter alia, the Medical Devices Regulations 2002 and the Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (the "UK Regulations"), which implements the MDR and MDR like provisions into UK law. We are regulated by comparable authorities in other countries.
In the United Kingdom, our Products and operation are subject to, inter alia, the Medical Devices Regulations 2002 and the Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 (the "UK Regulations"), which implements the MDR and MDR like provisions into UK law.
In addition, we may become subject to additional regulation in 32 other jurisdictions as we increase our efforts to market and sell Optune Gio or Optune Lua and future Products outside of the U.S.
In addition, we may become subject to additional regulation in other jurisdictions as we increase our efforts to market and sell current and future Products outside of the U.S.
Delays in receiving clearance or approval may result from these factors and others outside of our control, such as reductions in budgets to these agencies, staffing cuts and shifting priorities within these agencies.
Delays in receiving clearance or approval may result from these factors and others outside of our control, such as implementation of significant new or revised laws, regulations and policies, reductions in budgets to these agencies, staffing cuts and shifting priorities within these agencies.
While we have obtained Medicare coverage for our existing Products other than Optune Lua for NSCLC, we cannot provide any assurance that we can access transitional, expedited, or expanded Medicare coverage for our future Products, including Optune Lua for NSCLC.
While we have obtained Medicare coverage for Optune Gio, we cannot provide any assurance that we can access transitional, expedited, or expanded Medicare coverage for our future Products, including Optune Lua for NSCLC or Optune Pax for pancreatic cancer.
We expect that the vast majority of our revenues will come from third-party payers either directly to us in markets where we provide our Products or plan to provide our device candidates to patients or indirectly via payments made 22 to hospitals or other entities providing our Products or which may in the future provide our device candidates to patients.
Failure to secure and maintain adequate coverage and reimbursement from third-party payers could adversely affect acceptance of our Products and reduce our revenues. 22 We expect that the vast majority of our revenues will come from third-party payers either directly to us in markets where we provide our Products or plan to provide our device candidates to patients or indirectly via payments made to hospitals or other entities providing our Products or which may in the future provide our device candidates to patients.
Risks relating to our business and our Products Our business and prospects depend heavily on Optune Gio, which is currently approved only for the treatment of GBM, and Optune Lua, which is currently approved for the treatment of NSCLC in the United States and MPM.
Risks relating to our business and our Products Our business and prospects depend heavily on Optune Gio, which is currently approved only for the treatment of GBM, Optune Lua, which is currently approved for the treatment of NSCLC and MPM in certain countries and Optune Pax, which is currently approved for the treatment of pancreatic cancer in the U.S.
Medicare denied coverage for all claims prior to the September 1, 2019 effective date of DME MAC LCD L34823, which provides coverage for Optune Gio for the treatment of newly diagnosed GBM subject to certain conditions and restrictions.
Medicare denied coverage for all claims prior to the September 1, 2019 effective date of DME MAC LCD L34823, which provides coverage for Optune Gio for the treatment of newly diagnosed GBM subject to certain conditions and restrictions. We expect that Medicare will continue to deny essentially all claims that do not meet the coverage policy terms.
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 25 cannot control whether or not they devote sufficient time and resources to our ongoing preclinical, clinical and other development programs.
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 studies comply with the applicable cGLP or cGCP regulations. 25 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.
Loss of these codes or any alteration in the reimbursement amounts attached to these codes would materially impact our operating results. We do not expect to obtain different codes for new indications. No CPT codes specific to our therapy currently exist to describe physician services related to the delivery of therapy using our Products.
Loss of these codes or any alteration in the reimbursement amounts attached to these codes would materially impact our operating results. We do not expect to obtain different codes for new indications.
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.
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.
Our 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.
Our ability to service the Facility indebtedness and incur and service indebtedness in the future could be impacted by interest and currency rate fluctuations. Our 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.
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 and make changes to our business. On November 5, 2020, we issued $575 million of 0% Convertible Senior Notes due 2025 (the “Convertible Notes”).
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 and make changes to our business.
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.
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. 29 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.
The termination or revision of any of our rulings or indirect 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.
The termination or revision of any of our rulings or indirect 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. 38 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.
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 third parties in the United States and China developing devices and filing for intellectual property protection related to TTFields, which, if approved, may directly compete with our Products.
We are aware of third parties in the United States and China developing devices and filing for intellectual property protection related to TTFields and similar technologies, which, if approved, may directly compete with our Products.
Our failure or the failure of third-party participants in our studies to comply with their obligations to follow protocols and/or legal requirements may also result in our inability to use the affected data in our submissions to regulatory authorities. 19 The timely completion of clinical studies depends, among other things, on our ability to enroll a sufficient number of patients who remain in the study until its conclusion.
Our failure or the failure of third-party participants in our studies to comply with their obligations to follow protocols and/or legal requirements may also result in our inability to use the affected data in our submissions to regulatory authorities.
We expect that Medicare will continue to deny essentially all claims that do not meet the coverage policy terms, including for patients with recurrent GBM and NSCLC. Although we are actively appealing these coverage denials, we are prohibited from balance billing most of our existing Medicare fee-for-service patients for amounts not paid by Medicare.
Although we are actively appealing these coverage denials, we are prohibited from balance billing most of our existing Medicare fee-for-service patients for amounts not paid by Medicare. Therefore, we are absorbing and may continue to absorb the costs of treatment for amounts not paid by Medicare.
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 at a reasonable price.
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 at a reasonable price. 32 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.
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 Gio and Optune Lua as durable medical equipment ("DME").
We anticipate that a significant portion of patients using our Products will be beneficiaries under the Medicare program in the U.S. 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.
As of December 31, 2024, we have borrowed 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.
As of December 31, 2025, we have borrowed $200.0 million under the Facility. The maximum amount we could have borrowed under the Facility was $400.0 million; however, we did not exercise our option to draw down additional amounts under the Facility in 2025. Therefore we are not eligible to draw down any further amounts.
Although we have received FDA approval to market Optune Gio in the U.S. for the treatment of adult patients with newly diagnosed GBM (together with temozolomide) and recurrent GBM and approval to market Optune Lua for adults with metastatic NSCLC who have progressed on or after a platinum-based regimen, together with docetaxel or ICI, and in patients with MPM, we will require additional FDA approval to market our Products for other indications.
Although we have received FDA approval to market our Products for specific indications together with specific other therapies, such as temozolomide for GBM and PD-1/PD-L1 inhibitors for NSCLC, we will require additional FDA approval to market our Products for other indications.
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Failure to secure and maintain adequate coverage and reimbursement from third-party payers could adversely affect acceptance of our Products and reduce our revenues.
Added
In addition, we received regulatory approval for Optune Lua for the treatment of adult patients with unresectable advanced/recurrent NSCLC concurrent with PD-1/PD-L1 inhibitors following progression on or after a platinum-based regimen in Japan. Most recently, we have received FDA regulatory approval under the PMA pathway for the use of Optune Pax for the treatment of locally advanced pancreatic cancer.
Removed
We anticipate that a significant portion of patients using our Products will be beneficiaries under the Medicare program in the U.S, including a majority of our Optune Lua patients for NSCLC.
Added
The timely completion of clinical studies depends, among other things, on our ability to enroll a sufficient number of patients who remain in the study until its conclusion.
Removed
Therefore, we are absorbing and may continue to absorb the costs of treatment for amounts not paid by Medicare.
Added
Except for a Category III CPT code for TTFields therapy treatment planning services using our MAXPOINT mapping software, which does not include payment rates, no CPT codes specific to our therapy currently exist to describe physician services related to the delivery of therapy using our Products.
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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 studies comply with the applicable cGLP or cGCP regulations.
Added
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.
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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.
Added
In Japan, we must obtain approvals from the Ministry of Health, Labour, and Welfare ("MHLW") to market our devices. We are regulated by comparable authorities in other countries.
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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.
Added
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.
Removed
Currently, Optune Gio is approved for treatment of adult patients with newly diagnosed GBM (together with temozolomide) and recurrent GBM in the U.S. and is approved for treatment of adult patients with GBM in Japan.
Added
Currently, our Products are only approved in certain countries for specific types of cancer, together with specific types of other therapies, such as temozolomide for GBM and PD-1/PD-L1 inhibitors for NSCLC.
Removed
In the EU and Switzerland, we have CE marked Optune Gio for the treatment of newly diagnosed GBM (together with temozolomide), recurrent GBM, and advanced NSCLC (together with standard-of-care chemotherapy). Optune Gio is also approved in Israel and in Australia for the treatment of recurrent GBM and newly diagnosed GBM (together with temozolomide).
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We may not be able to take any of such actions on a timely basis, on terms satisfactory to us or at all. 43 ITEM 1B. UNRESOLVED STAFF COMMENTS None.
Removed
Optune Lua is approved in the U.S for adults with metastatic NSCLC who have progressed on or after a platinum-based regimen, together with docetaxel or ICI. Optune Lua is also approved in the U.S., the EU and Switzerland for the treatment of unresectable, locally advanced or metastatic MPM.
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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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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.
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The Convertible Notes are due in full in November 2025.
Removed
While the Convertible Notes do not accrue interest, our ability to service the Facility indebtedness and incur and service indebtedness in the future could be impacted by interest and currency rate fluctuations.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeWe have dedicated privacy and cybersecurity officers and committees with established processes to assess, identify, manage and investigate all potential privacy and cybersecurity risks and incidents. As a medical device manufacturer with a global presence, we are compliant with privacy laws and regulations in all jurisdictions where we conduct business.
Biggest changeAs a medical device manufacturer with a global presence, we are compliant with privacy laws and regulations in all jurisdictions where we conduct business.
In the U.S., the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act ("HITECH" and collectively "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 U.S., the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act ("HITECH" and collectively "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, Colorado).
We have not encountered any incidents from cybersecurity threats to date, including as a result of any previous cybersecurity incidents, that have materially affected, or are reasonably likely to materially affect, our business strategy, results of operations, or financial condition. 45
We have not encountered any incidents from cybersecurity threats to date, including as a result of any previous cybersecurity incidents, that have materially affected, or are reasonably likely to materially affect, our business strategy, results of operations, or financial condition. 44
On at least an annual basis, our information security management team engages in a thorough discussion and review of our cybersecurity practices and procedures that are designed to monitor the prevention, detection, mitigation, and remediation of cybersecurity incidents. Our information security management team is led jointly by our Vice President, IT Infrastructure and Cybersecurity and our Director of Privacy.
On at least an annual basis, our information security management team engages in a thorough discussion and review of our cybersecurity practices and procedures that are designed to monitor the prevention, detection, mitigation, and remediation of cybersecurity incidents.
Added
Our information security management team is led jointly by our Vice President, IT Infrastructure and Cybersecurity and our Head of Global Compliance and Privacy. We have dedicated privacy and cybersecurity officers and committees with established processes to assess, identify, manage and investigate all potential privacy and cybersecurity risks and incidents.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeThe Company believes that the action is without merit and plans to defend the lawsuit vigorously. In addition, from time to time, we are involved in various legal proceedings, claims, investigations and litigation that arise in the ordinary course of our business. Litigation is inherently uncertain. Accordingly, we cannot predict with certainty the outcome of these matters.
Biggest changeITEM 3. LEGAL PROCEEDINGS From time to time, we are involved in various legal proceedings, claims, investigations and litigation that arise in the ordinary course of our business. Litigation is inherently uncertain. Accordingly, we cannot predict with certainty the outcome of these matters.
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ITEM 3. LEGAL PROCEEDINGS In June 2023, a putative class action lawsuit was filed against the Company, its Executive Chairman and its former Chief Executive Officer.
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The complaint, later amended to add our former Chief Financial Officer as a defendant, purports to be brought on behalf of a class of persons and/or entities who purchased or otherwise acquired ordinary shares of the Company from January 5, 2023 through June 5, 2023, and alleges material misstatements and/or omissions in the Company’s public statements with respect to the results from its Phase 3 LUNAR clinical trial.

Item 4. Mine Safety Disclosures

Mine Safety Disclosures — required of mining issuers

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Biggest changeThe following table lists information about our executive officers: Name Age Position Ashley Cordova 46 Chief Executive Officer William Doyle 62 Executive Chairman and Director Barak Ben-Arye 49 General Counsel Christoph Brackmann 51 Chief Financial Officer Francis Leonard 45 Executive Vice President, President Novocure Oncology Nicolas Leupin 51 Chief Medical Officer Mukund Paravasthu 55 Chief Operating Officer Michael Puri 55 Chief Human Resources Officer Uri Weinberg 47 Chief Innovation Officer Ashley Cordova has been our Chief Executive Officer since January 1, 2025.
Biggest changeThe following table lists information about our executive officers: Name Age Position William Doyle 63 Executive Chairman and Director Frank Leonard 46 Chief Executive Officer Barak Ben-Arye 50 General Counsel Christoph Brackmann 52 Chief Financial Officer Mukund Paravasthu 56 Chief Operating Officer Michael Puri 56 Chief Human Resources Officer Uri Weinberg 48 Chief Medical Officer and Chief Innovation Officer William Doyle has served as our Executive Chairman since 2016, as Chairman of the Board since 2009 and as a member of our Board of Directors since 2004.
Doyle has been the managing director of WFD Ventures LLC, a private venture capital firm he co-founded, since 2002. Prior to 2002, Mr. Doyle was a member of Johnson & Johnson’s Medical Devices and Diagnostics Group Operating Committee and was Vice President, Licensing and 46 Acquisitions. While at Johnson & Johnson, Mr.
Mr. Doyle has been the managing director of WFD Ventures LLC, a private venture capital firm he co-founded, since 2002. Prior to 2002, Mr. Doyle was a member of Johnson & Johnson’s Medical Devices and Diagnostics Group Operating Committee and was Vice President, Licensing and Acquisitions. While at Johnson & Johnson, Mr.
Since joining Novocure in 2008, he has held several positions throughout his tenure with the Company and most recently held the position of Chief Science Officer since 2020. Dr. Weinberg holds an M.D. Ph.D. from the Technion – Israel Institute of Technology. 47 PART II
Since joining Novocure in 2008, he has held several positions throughout his tenure with the Company and most recently held the position of Chief Science Officer from 2020. Dr. Weinberg holds an M.D. Ph.D. from the Technion – Israel Institute of Technology. 46 PART II
Doyle holds an S.B. in materials science and engineering from the Massachusetts Institute of Technology and an M.B.A. from Harvard Business School. Mr. Doyle serves on Harvard Business School’s Board of Dean’s Advisors and MIT’s Institute of Medical Engineering & Science Visiting Committee.
Doyle holds an S.B. in materials science and engineering from the Massachusetts Institute of Technology and an M.B.A. from Harvard Business School. Mr. Doyle serves on Harvard Business School’s Board of Dean’s Advisors and MIT’s Institute of Medical Engineering & Science Visiting Committee. Frank Leonard was appointed Novocure’s Chief Executive Officer (CEO) in November 2025.
Michael Puri has served as our Chief Human Resources Officer since September 2023. Mr. Puri previously served as Vice President, HR Integration lead at CSL Limited, following the company’s acquisition of Vifor Pharma, where he served as Chief Human Resources Officer from 2015 to 2022.
Puri previously served as Vice President, HR Integration lead at CSL Limited, following the company’s acquisition of Vifor Pharma, where he served as Chief Human Resources Officer from 2015 to 2022. He also served as Chief Human Resources Officer at GrandVision, an international leader in optical retailing, from 2013 to 2015. Mr.
Barak Ben-Arye has been our General Counsel since April 2022 and prior to that was our Vice President, EMEA Counsel since June 2019 and our Senior Director, EMEA Counsel since joining us in 2018. Mr.
Leonard holds an A.B. from Harvard University and an M.A. from the London School of Economics and Political Science. Barak Ben-Arye has been our General Counsel since April 2022 and prior to that was our Vice President, EMEA Counsel since June 2019 and our Senior Director, EMEA Counsel since joining us in 2018. Mr.
Mr. Paravasthu joined us in May 2020 as Vice President of Product Development. Before joining Novocure, Mr. Paravasthu held several leadership roles at Johnson & Johnson’s orthopedic franchise, DePuy Synthes, from 2007. Mr. Paravasthu holds a Master’s degree in Electrical Engineering from the University of Oklahoma and a Bachelors in Electrical and Electronics Engineering from Annamalai University, India.
Mukund Paravasthu has been our Chief Operating Officer since October 2024. Mr. Paravasthu previously served as Novocure’s Senior Vice President of Product Development beginning in April 2022. Mr. Paravasthu joined us in May 2020 as Vice President of Product Development. Before joining Novocure, Mr. Paravasthu held several leadership roles at Johnson & Johnson’s orthopedic franchise, DePuy Synthes, from 2007. Mr.
He also served as Chief Human Resources Officer at GrandVision, an international leader in optical retailing, from 2013 to 2015. Mr. Puri has also held leadership positions at Staples, Inc. and UCB S.A., a global biopharma company.
Puri has also held leadership positions at Staples, Inc. and UCB S.A., a global biopharma company. He earned his bachelor’s degree in economics from the University of Nantes and his master’s degree in strategic marketing from the Grenoble Business School.
Frank Leonard has been our Executive Vice President, President Novocure Oncology since January 2024. Mr. Leonard joined Novocure in 2010, and most recently served as President, CNS Cancers U.S. Prior to joining Novocure, Mr. Leonard was a venture capital investor focused on high-impact medical technologies. Mr.
He joined Novocure in 2010 to prepare the company for a commercial launch and held various roles establishing Novocure’s finance, reimbursement, and business development functions. Prior to joining Novocure, Mr. Leonard was a venture capital investor focused on high-impact medical technology companies, including Novocure. He has served as a director of the Medical Device Manufacturers Association (MDMA) since 2023. Mr.
Removed
From September 2020 to December 2024, Ms. Cordova served as our Chief Financial Officer and from October 2018 to August 2020, she served as our Senior Vice President, Finance and Investor Relations. Ms. Cordova joined us in June 2014 as Director of Global Treasury.
Added
Before his appointment as CEO, Mr. Leonard was named the company’s President in June 2025. He was responsible for Novocure’s global business operations, which he led since January 2024, and was responsible for sales, marketing, field medical 45 affairs, patient experience, public affairs, market access, and product and portfolio strategy functions. Mr.
Removed
In March 2015, she became our Senior Director, Investor Relations and Global Treasury, and in July 2016, she became our Vice President, Finance and Investor Relations. Prior to joining us, Ms. Cordova served in various financial roles at Zoetis Inc. from 2012 to 2014 and Pfizer Inc. from 2005 to 2012. Ms.
Added
Leonard previously led our US business beginning October 2022. Mr. Leonard served as Chief Development Officer from September 2020 to September 2022, and was responsible for engineering, product development, business development and the overall strategic and operational leadership of Novocure’s innovation platforms.
Removed
Cordova graduated with a bachelor’s degree in Music and Business from Furman University, and earned her International Master of Business Administration from the University of South Carolina. William Doyle has served as our Executive Chairman since 2016, as Chairman of the Board since 2009 and as a member of our Board of Directors since 2004. Mr.
Added
Paravasthu holds a Master’s degree in Electrical Engineering from the University of Oklahoma and a Bachelors in Electrical and Electronics Engineering from Annamalai University, India. Michael Puri has served as our Chief Human Resources Officer since September 2023. Mr.
Removed
Leonard holds an A.B. from Harvard and an M.A. from the London School of Economics and Political Science. Nicolas Leupin, M.D., Ph.D., has served as our Chief Medical Officer since January 2024. Dr. Leupin previously served as Chief Medical Officer of Molecular Partners AG since August 2019. Prior to that Dr.
Added
Uri Weinberg, M.D., Ph.D.,has served as our Chief Innovation Officer since January 2023, leading our scientific and pre-clinical teams, and in February 2026 was also appointed to serve as our Chief Medical Officer and lead our clinical, safety, medical strategy, and biostatistics teams.
Removed
Leupin served as Chief Medical Officer of argenx from 2016. Dr. Leupin holds an M.D. from the University of Bern, an M.B.A. from Jones International University and a Ph.D. from the Université Bourgogne-Franche-Comté. Mukund Paravasthu has been our Chief Operating Officer since October 2024. Mr. Paravasthu previously served as Novocure’s Senior Vice President of Product Development beginning in April 2022.
Removed
He earned his bachelor’s degree in economics from the University of Nantes and his master’s degree in strategic marketing from the Grenoble Business School. Uri Weinberg, M.D., Ph.D. , has served as our Chief Innovation Officer since January 2023, where he is responsible for expanding the innovative potential of Tumor Treating Fields therapy.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

6 edited+0 added−0 removed3 unchanged
Biggest changeThe shareholder return shown on the graph below is not necessarily indicative of future performance, and we do not make or endorse any predictions as to future stockholder returns. 48 12/19 12/20 12/21 12/22 12/23 12/24 NovoCure Ltd 100.00 205.34 89.09 87.04 17.72 35.36 Russell 2000 100.00 119.96 137.74 109.59 128.14 142.93 NASDAQ Biotechnology 100.00 126.42 126.45 113.65 118.87 118.20 Recent Sales of Unregistered Securities Not applicable Issuer Purchases of Equity Securities Not applicable.
Biggest changeThe shareholder return shown on the graph below is not necessarily indicative of future performance, and we do not make or endorse any predictions as to future stockholder returns. 47 12/20 12/21 12/22 12/23 12/24 12/25 NovoCure Ltd 100.00 43.39 42.39 8.63 17.22 7.47 Russell 2000 100.00 114.82 91.35 106.82 119.14 134.40 NASDAQ Biotechnology 100.00 100.02 89.90 94.03 93.49 124.75 Recent Sales of Unregistered Securities Not applicable Issuer Purchases of Equity Securities Not applicable.
Securities Authorized for Issuance Under Equity Compensation Plans The following table gives information about our ordinary shares that may be issued upon the exercise of stock options and vesting of restricted stock units, as applicable, under all of our existing equity compensation plans as of December 31, 2024, including the 2003 Share Option Plan (the "2003 Plan"), the 2013 Share Option Plan (the "2013 Plan"), the 2015 Omnibus Incentive Plan (the "2015 Plan"), the 2024 Omnibus Incentive Plan and the Employee Share Purchase Plan (the "ESPP").
Securities Authorized for Issuance Under Equity Compensation Plans The following table gives information about our ordinary shares that may be issued upon the exercise of stock options and vesting of restricted stock units, as applicable, under all of our existing equity compensation plans as of December 31, 2025, including the 2003 Share Option Plan (the "2003 Plan"), the 2013 Share Option Plan (the "2013 Plan"), the 2015 Omnibus Incentive Plan (the "2015 Plan"), the 2024 Omnibus Incentive Plan and the Employee Share Purchase Plan (the "ESPP").
The graph below matches our cumulative 5-Year total shareholder return on our ordinary shares with the cumulative total returns of the Russell 2000 index and the Nasdaq Biotechnology index. The graph tracks the performance of a $100 investment in our ordinary shares and in each index (with the reinvestment of all dividends) from December 31, 2019 to December 31, 2024.
The graph below matches our cumulative 5-Year total shareholder return on our ordinary shares with the cumulative total returns of the Russell 2000 index and the Nasdaq Biotechnology index. The graph tracks the performance of a $100 investment in our ordinary shares and in each index (with the reinvestment of all dividends) from December 31, 2020 to December 31, 2025.
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Our ordinary shares are quoted on the NASDAQ Global Select Market under the symbol "NVCR." Holders of Ordinary Shares As of February 21, 2025, there were 17 holders of record of our ordinary shares.
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Our ordinary shares are quoted on the NASDAQ Global Select Market under the symbol "NVCR." Holders of Ordinary Shares As of February 20, 2026, there were 17 holders of record of our ordinary shares.
On February 21, 2025, the last reported sale price of our ordinary shares on the NASDAQ Global Select Market was $22.09 per share. Dividend Policy We have not paid any dividends on our ordinary shares since our inception and do not anticipate paying any dividends on our ordinary shares in the foreseeable future.
On February 20, 2026, the last reported sale price of our ordinary shares on the NASDAQ Global Select Market was $11.36 per share. Dividend Policy We have not paid any dividends on our ordinary shares since our inception and do not anticipate paying any dividends on our ordinary shares in the foreseeable future.
Equity Compensation Plan Information Plan Category (a) Number of Securities to be Issued Upon Exercise of Outstanding Options, Warrants and Rights (b) Weighted Average Exercise Price of Outstanding Options, Warrants and Rights (c) Number of Securities Remaining Available for Future Issuance (Excludes Securities Reflected in Column (a)) Equity compensation plans approved by shareholders 23,381,983 $ 15.20 17,210,661 Equity compensation plans not approved by shareholders — — — Total 23,381,983 $ 15.20 17,210,661 ITEM 6. [RESERVED] 49
Equity Compensation Plan Information Plan Category (a) Number of Securities to be Issued Upon Exercise of Outstanding Options, Warrants and Rights (b) Weighted Average Exercise Price of Outstanding Options, Warrants and Rights (c) Number of Securities Remaining Available for Future Issuance (Excludes Securities Reflected in Column (a)) Equity compensation plans approved by shareholders 23,962,007 $ 13.52 12,563,561 Equity compensation plans not approved by shareholders — — — Total 23,962,007 $ 13.52 12,563,561 ITEM 6. [RESERVED] 48

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

73 edited+29 added−23 removed41 unchanged
Biggest changeDecember 31, Operating statistics 2024 2023 2022 CNS Lung Total CNS Lung Total CNS Lung Total Active patients at period end (1) United States 2,161 31 2,192 2,145 17 2,162 2,158 6 2,164 International markets: Germany 564 11 575 520 520 5 525 466 1 467 France 426 — 426 262 — 262 — — — Japan 420 — 420 375 — 375 369 — 369 Other international 506 7 513 431 — 431 430 — 430 International markets - Total 1,916 18 1,934 1,588 5 1,593 1,265 1 1,266 4,077 49 4,126 3,733 22 3,755 3,423 7 3,430 Year ended December 31, 2024 2023 2022 CNS Lung Total CNS Lung Total CNS Lung Total Prescriptions received in period (2) United States 3,757 80 3,837 3,863 49 3,912 3,758 32 3,790 International markets: Germany 789 57 846 763 29 792 829 1 830 France 727 — 727 450 — 450 — — — Japan 407 — 407 354 — 354 381 — 381 Other international 640 15 655 575 — 575 528 — 528 International markets - Total 2,563 72 2,635 2,142 29 2,171 1,738 1 1,739 6,320 152 6,472 6,005 78 6,083 5,496 33 5,529 (1) Lung includes both active patients in NSCLC and MPM.
Biggest changeDecember 31, Operating statistics 2025 2024 2023 Optune Gio Optune Lua Total Optune Gio Optune Lua Total Optune Gio Optune Lua Total Active patients at period end (1) United States 2,251 110 2,361 2,161 31 2,192 2,145 17 2,162 International markets: Germany 623 43 666 564 11 575 520 5 525 France 509 — 509 426 — 426 262 — 262 Japan 542 — 542 420 — 420 375 — 375 Other international 539 3 542 506 7 513 431 — 431 International markets - Total 2,213 46 2,259 1,916 18 1,934 1,588 5 1,593 4,464 156 4,620 4,077 49 4,126 3,733 22 3,755 Year ended December 31, 2025 2024 2023 Optune Gio Optune Lua Total Optune Gio Optune Lua Total Optune Gio Optune Lua Total Prescriptions received in period (2) United States 3,775 408 4,183 3,757 80 3,837 3,863 49 3,912 International markets: Germany 802 127 929 789 57 846 763 29 792 France 774 1 775 727 — 727 450 — 450 Japan 488 — 488 407 — 407 354 — 354 Other international 651 9 660 640 15 655 575 — 575 International markets - Total 2,715 137 2,852 2,563 72 2,635 2,142 29 2,171 6,490 545 7,035 6,320 152 6,472 6,005 78 6,083 (1) Optune Lua includes both active patients in NSCLC and MPM.
("Borrower"), our wholly-owned subsidiary, entered into a new five-year senior secured credit facility of up to $400.0 million (the "Facility") with BPCR Limited Partnership and BioPharma Credit Investments V (Master) LP (collectively, the "Lenders"), BioPharma Credit PLC, as collateral 59 agent for the Lenders, and the guarantors party to such agreement (the "Loan Agreement").
("Borrower"), our wholly-owned subsidiary, entered into a new five-year senior secured credit facility of up to $400.0 million (the "Facility") with BPCR Limited Partnership and BioPharma Credit Investments V (Master) LP (collectively, the "Lenders"), BioPharma Credit PLC, as collateral agent for the Lenders, and the guarantors party to such agreement (the "Loan Agreement").
We intend to take actions that prioritize growth and maintain financial health as we position our company for future profitability. 57 Liquidity and capital resources We have incurred significant losses and cumulative negative cash flows from operations with only limited and intermittent operating profits since our founding in 2000.
We intend to take actions that prioritize growth and maintain financial health as we position our company for future profitability. Liquidity and capital resources We have incurred significant losses and cumulative negative cash flows from operations with only limited and intermittent operating profits since our founding in 2000.
We calculate Adjusted EBITDA as operating income before financial expenses and income taxes, net of depreciation, amortization and share-based compensation. The following table reconciles net loss (which is the most directly comparable U.S. GAAP operating performance measure) to Adjusted EBITDA.
We calculate Adjusted EBITDA as operating income before financial expenses and income taxes, net of depreciation, amortization and share-based compensation. The following table reconciles net loss (which is the 57 most directly comparable U.S. GAAP operating performance measure) to Adjusted EBITDA.
Not later than March 31, 2026, the Borrower has the option to draw an additional $100.0 million of the Facility (the "Tranche D Loan") if (i) we receive an approval or clearance from the U.S.
Not later than March 31, 2026, the Borrower has the option to draw an additional $100.0 million of the Facility (the 59 "Tranche D Loan") if (i) we receive an approval or clearance from the U.S.
Not later than December 31, 2025, the Borrower has the option to draw an additional $100.0 million of the Facility (the "Tranche C Loan") if (i) (A) we have received positive results from our PANOVA-3 Phase 3 clinical trial (which we received) or (B) our trailing net revenues for the most recently completed four quarters as reported in our financial statements filed with the U.S.
Not later than December 31, 2025, the Borrower had the option to draw an additional $100.0 million of the Facility (the "Tranche C Loan") if (i) (A) we received positive results from our PANOVA-3 Phase 3 clinical trial (which we received) or (B) our trailing net revenues for the most recently completed four quarters as reported in our financial statements filed with the U.S.
We believe our cash, cash equivalents and short-term investments as of December 31, 2024 are sufficient for our operations for at least the next 12 months based on our existing business plan and our ability to control the timing of significant expense commitments.
We believe our cash, cash equivalents and short-term investments as of December 31, 2025 are sufficient for our operations for at least the next 12 months based on our existing business plan and our ability to control the timing of significant expense commitments.
We have historically held substantially all of our cash balances in U.S. dollar denominated accounts to minimize the risk of translational currency exposure. Critical accounting policies and estimates In accordance with U.S.
Our reporting currency is the U.S. dollar. We have historically held substantially all of our cash balances in U.S. dollar denominated accounts to minimize the risk of translational currency exposure. Critical accounting policies and estimates In accordance with U.S.
For additional information, see Note 14 to the Consolidated Financial Statements. Results of operations The following discussion provides an analysis of our results of operations and reasons for material changes therein for 2024 as compared to 2023.
For additional information, see Note 14 to the Consolidated Financial Statements. Results of operations The following discussion provides an analysis of our results of operations and reasons for material changes therein for 2025 as compared to 2024.
Under the Loan Agreement, the Borrower is required to draw $100.0 million on the Facility on or before September 30, 2025 (the "Tranche B Loan"), subject to customary conditions precedent as set forth in the Loan Agreement.
Under the Loan Agreement, the Borrower was required to draw $100.0 million on the Facility on or before September 30, 2025 (the "Tranche B Loan"), subject to customary conditions precedent as set forth in the Loan Agreement.
Securities and Exchange Commission ("Trailing Four Quarters of Net Revenue") are greater than $575.0 million and (ii) the Notes are extinguished in full and are no longer outstanding.
Securities and Exchange Commission ("Trailing Four Quarters of Net Revenue") were greater than $575.0 million and (ii) the Notes were extinguished in full and no longer outstanding.
The following tables include certain commercial operating statistics for and as of the end of the periods presented. 54 The following table includes certain commercial operating statistics for and as of the end of the periods presented.
The following tables include certain commercial operating statistics for and as of the end of the periods presented. 53 The following table includes certain commercial operating statistics for and as of the end of the periods presented.
So long as our ordinary shares are publicly traded in a liquid market, we will rely on the daily trading price of our ordinary shares when we estimate the fair value of options granted. We incurred share-based compensation expense of $160.0 million, $115.6 million and $107.0 million during the years ended December 31, 2024, 2023 and 2022, respectively.
So long as our ordinary shares are publicly traded in a liquid market, we will rely on the daily trading price of our ordinary shares when we estimate the fair value of options granted. 51 We incurred share-based compensation expense of $104.8 million, $160.0 million and $115.6 million during the years ended December 31, 2025, 2024 and 2023, respectively.
We will continue to prioritize launch readiness, including field-based commercial and field-based medical team hiring, for the anticipated approval of TTFields therapy for the treatment of metastatic non-small cell lung cancer outside the United States and for future new indications around the world. General and administrative General and administrative expenses consist primarily of personnel, professional fees and facilities costs.
We will continue to prioritize launch readiness, including field-based commercial and field-based medical team hiring, for the anticipated approval of TTFields therapy for the treatment of pancreatic cancer outside the United States and for future new indications around the world. General and administrative General and administrative expenses consist primarily of personnel, professional fees and facilities costs.
Optune Lua is approved by the FDA under the PMA pathway for the treatment of adult patients with metastatic non-small cell lung cancer ("NSCLC") concurrent with PD-1/PD-L1 inhibitors or docetaxel following progression on or after a platinum-based regimen.
Optune Lua is approved by the FDA under the PMA pathway for the treatment of adult patients with metastatic NSCLC concurrent with PD-1/PD-L1 inhibitors or docetaxel following progression on or after a platinum-based regimen.
Product's cost sold to Zai totaled $9.7 million for the year ended December 31, 2024 compared to $12.0 million for the year ended December 31, 2023. Gross margin was 77% for the year ended December 31, 2024 and 75% for the year ended December 31, 2023.
Product's cost sold to Zai totaled $12.8 million for the year ended December 31, 2025 compared to $9.7 million for the year ended December 31, 2024. Gross margin was 75% for the year ended December 31, 2025 and 77% for the year ended December 31, 2024.
We are committed to investing strategically to maximize the growth potential of the TTFields therapy platform. As such, we are prioritizing clinical programs which have the greatest value potential in solid tumors where TTFields therapy has established efficacy, including glioblastoma, non-small cell lung cancer and pancreatic cancer.
We are committed to investing strategically to maximize the growth potential of the TTFields therapy platform. As such, we are prioritizing clinical programs which have the greatest value potential in solid tumors where TTFields therapy has established efficacy and an unmet clinical need for biophysical treatment exists, including glioblastoma, pancreatic cancer and non-small cell lung cancer.
The table below summarizes the assumptions that were used to estimate the fair value of the options granted to employees during the periods presented: Year ended December 31, 2024 2023 2022 Expected term (years) 5.50-5.73 5.50-6.00 5.33-5.83 Expected volatility 71%-73% 63%-70% 60%-62% Risk-free interest rate 3.88%-4.43% 3.48%-4.79% 1.58%-4.23% Dividend yield 0.00% 0.00% 0.00% If any of the assumptions used in the Black-Scholes option pricing model change significantly, share-based compensation for future awards may differ materially from the awards granted previously.
The table below summarizes the assumptions that were used to estimate the fair value of the options granted to employees during the periods presented: Year ended December 31, 2025 2024 2023 Expected term (years) 5.50-5.79 5.50-5.73 5.50-6.00 Expected volatility 75%-77% 71%-73% 63%-70% Risk-free interest rate 4.01%-4.02% 3.88%-4.43% 3.48%-4.79% Dividend yield 0.00 % 0.00 % 0.00 % If any of the assumptions used in the Black-Scholes option pricing model change significantly, share-based compensation for future awards may differ materially from the awards granted previously.
We have several ongoing clinical trials which further explore the use of TTFields therapy in these solid tumor cancers, including the Phase 3 TRIDENT and KEYNOTE D58 trials in GBM, Phase 3 LUNAR-2 and Phase 2 LUNAR-4 trials in NSCLC, and Phase 2 PANOVA-4 trial in pancreatic cancer.
We have several ongoing and recently concluded clinical trials which further explore the use of TTFields therapy, including the Phase 3 TRIDENT and KEYNOTE D58 trials in GBM, Phase 3 LUNAR-2 trial in NSCLC, and Phase 2 PANOVA-4 trial in pancreatic cancer.
Upcoming use of cash in operations will include payments in the normal course of business of $47.1 million in purchase obligations with certain of our suppliers, primarily for the purchase of Product components along with other commitments to purchase goods or services. These amounts include approximately $33.1 million of commitments with three major suppliers.
Upcoming use of cash in operations will include payments in the normal course of business of $49.1 million in purchase obligations with certain of our suppliers, primarily for the purchase of Product components along with other commitments to purchase goods or services. These amounts include approximately $41.9 million of commitments with four major suppliers.
General and administrative personnel costs include our executive, finance, human resources, information technology and legal functions. These costs also include our contributions to support industry and patient groups. Our professional fees consist primarily of accounting, information technology, legal and other consulting costs. We expect that general and administrative expenses will increase to support our growth.
General and administrative personnel costs include our executive, finance, human resources, information technology and legal functions. These costs also include our contributions to support industry and patient groups. Our professional fees consist primarily of accounting, information technology, legal and other consulting costs.
Food and Drug Administration ("FDA") under the Premarket Approval ("PMA") pathway for the treatment of adult patients with newly diagnosed glioblastoma ("GBM") together with temozolomide, a chemotherapy drug, and for adult patients with GBM following confirmed recurrence after chemotherapy as monotherapy treatment.
Optune Gio is approved by the U.S. Food and Drug Administration ("FDA") under the Premarket Approval ("PMA") pathway for the treatment of adult patients with newly diagnosed glioblastoma ("GBM") together with temozolomide, a chemotherapy drug, and for adult patients with GBM following confirmed recurrence after chemotherapy as monotherapy treatment.
Research, development and clinical studies costs, including direct and allocated expenses, are expensed as incurred and consist primarily of the following: • personnel costs for those employees involved in our preclinical and basic research, clinical development programs, clinical affairs, product development and regulatory activities; • costs to conduct research, product development and clinical study activity through agreements with contract research organizations and other third parties; • manufacturing expenses associated with our Products, including durable components and disposable arrays, utilized in clinical studies and other research; • costs associated with publications, presentations and investigator-sponsored trials; • professional fees related to regulatory approvals and conformity assessment procedures; and • facilities, depreciation and other allocated expenses, which include direct and allocated expenses for rent and maintenance of facilities, depreciation of leasehold improvements and equipment and laboratory and other supplies. 50 The following table summarizes our research, development and clinical study expenses by program for the years ended December 31, 2024, 2023 and 2022: Year ended December 31, U.S. dollars in thousands 2024 2023 2022 Preclinical and basic research $ 18,827 $ 18,936 $ 16,922 Clinical development programs: LUNAR 1,842 6,846 6,905 LUNAR - 2 14,645 2,999 — INNOVATE - 3 184 7,810 9,494 METIS 5,399 5,758 8,480 PANOVA - 3 9,535 18,243 22,185 KEYNOTE D58 5,651 241 — TRIDENT 18,369 20,348 12,162 Other clinical studies 13,375 6,960 5,524 Clinical administration 19,858 25,363 22,690 Product development 18,519 18,219 15,323 Clinical affairs 7,023 15,935 19,891 Other research and development costs (1) 43,702 43,577 35,719 Share based compensation 32,716 31,827 30,790 Research, development and clinical studies $ 209,645 $ 223,062 $ 206,085 (1) Other research, development and clinical study costs include regulatory affairs, quality assurance, intellectual property, product safety, allocated facilities and other overhead costs.
Research, development and clinical studies costs, including direct and allocated expenses, are expensed as incurred and consist primarily of the following: • personnel costs for those employees involved in our preclinical and basic research, clinical development programs, clinical affairs, product development and regulatory activities; • costs to conduct research, product development and clinical study activity through agreements with contract research organizations and other third parties; • manufacturing expenses associated with our Products, including durable components and disposable arrays, utilized in clinical studies and other research; • costs associated with publications, presentations and investigator-sponsored trials; • professional fees related to regulatory approvals and conformity assessment procedures; and • facilities, depreciation and other allocated expenses, which include direct and allocated expenses for rent and maintenance of facilities, depreciation of leasehold improvements and equipment and laboratory and other supplies. 49 The following table summarizes our research, development and clinical study expenses by program for the years ended December 31, 2025, 2024 and 2023: Year ended December 31, U.S. dollars in thousands 2025 2024 2023 Preclinical and basic research $ 19,990 $ 18,827 $ 18,936 Clinical development programs: LUNAR 480 1,842 6,846 LUNAR - 2 23,117 14,645 2,999 INNOVATE - 3 8 184 7,810 METIS 1,565 5,399 5,758 PANOVA - 3 4,518 9,535 18,243 KEYNOTE D58 16,807 5,651 241 TRIDENT 13,021 18,369 20,348 Other clinical studies 12,056 13,375 6,960 Clinical administration 20,271 19,858 25,363 Product development 25,621 18,519 18,219 Clinical affairs 6,336 7,023 15,935 Other research and development costs (1) 55,216 43,702 43,577 Share based compensation 25,538 32,716 31,827 Research, development and clinical studies $ 224,544 $ 209,645 $ 223,062 (1) Other research, development and clinical study costs include regulatory affairs, quality assurance, intellectual property, product safety, allocated facilities and other overhead costs.
The following summary of our cash flows for the periods indicated has been derived from our consolidated financial statements, which are included elsewhere in this Annual Report: Year ended December 31, U.S. dollars in thousands 2024 2023 2022 Net cash provided by (used in) operating activities $ (26,369) $ (73,336) $ 30,788 Net cash provided by (used in) investing activities (140,242) 184,148 (139,957) Net cash provided by (used in) financing activities 90,315 15,787 15,491 Effect of exchange rate changes on cash and cash equivalents (174) 131 (97) Net increase (decrease) in cash, cash equivalents and restricted cash $ (76,470) $ 126,730 $ (93,775) Operating activities Net cash used in operating activities primarily represents our net loss for the periods presented.
The following summary of our cash flows for the periods indicated has been derived from our consolidated financial statements, which are included elsewhere in this Annual Report: Year ended December 31, U.S. dollars in thousands 2025 2024 2023 Net cash provided by (used in) operating activities $ (49,031) $ (26,369) $ (73,336) Net cash provided by (used in) investing activities 437,276 (140,242) 184,148 Net cash provided by (used in) financing activities (451,343) 90,315 15,787 Effect of exchange rate changes on cash and cash equivalents 394 (174) 131 Increase (decrease) in cash, cash equivalents and restricted cash $ (62,704) $ (76,470) $ 126,730 Operating activities Net cash used in operating activities primarily represents our net loss for the periods presented.
Net cash used in investing activities was $140.2 million for the year ended December 31, 2024 compared to net cash provided by investing activities of $184.1 million for the year ended December 31, 2023.
Net cash provided by investing activities was $437.3 million for the year ended December 31, 2025 compared to net cash used in investing activities of $140.2 million for the year ended December 31, 2024.
("Zai") a license to commercialize our Products in China, Hong Kong, Macau and Taiwan ("Greater China") under a License and Collaboration Agreement (the "Zai Agreement"). The Zai Agreement also establishes a development partnership intended to accelerate the development of TTFields therapy in multiple solid tumor cancer indications. For additional information, see Note 12 to the Consolidated Financial Statements.
("Zai") a license to commercialize our Products in China, Hong Kong, Macau and Taiwan ("Greater China") under a License and Collaboration Agreement (the "Zai Agreement"). The Zai Agreement also establishes a development partnership intended to accelerate the development of TTFields therapy in multiple solid tumor cancer indications.
The fair value of share options is estimated at the date of grant using the Black-Scholes option pricing model and for market condition awards we also use the Monte-Carlo simulation model. Both models requires management to apply judgment and make estimates, which include the following. The computation of expected volatility is based on the historical volatility of our shares.
The fair value of share options is estimated at the date of grant using the Black-Scholes option pricing model and for market condition awards we also use the Monte-Carlo simulation model. Both models requires management to apply judgment and make estimates, which include models of volatility, term, dividends and interest rates.
We make estimates of the useful life of our field equipment, based on similar assets purchased in the past and our historical experience with such similar assets, in order to determine the depreciation expense to be recorded for each reporting period.
Depreciation is calculated using the straight-line method over the estimated useful life of the relevant asset. We make estimates of the useful life of our field equipment, based on similar assets purchased in the past and our historical experience with such similar assets, in order to determine the depreciation expense to be recorded for each reporting period.
As of December 31, 2024, we had an accumulated deficit of $1,154.1 million. To date, we primarily have financed our operations through the issuance and sale of equity and the proceeds from long-term loans. At December 31, 2024, we had $163.8 million in cash and cash equivalents and $796.1 million in short-term investments.
As of December 31, 2025, we had an accumulated deficit of $1,290.4 million. To date, we primarily have financed our operations through the issuance and sale of equity and the proceeds from long-term loans. At December 31, 2025, we had $93.5 million in cash and cash equivalents and $354.1 million in short-term investments.
For information about our ESPP, see Note 15 to the Consolidated Financial Statements. We recognize share-based compensation costs only for those shares expected to vest over the requisite vesting period of the award, which is generally the option vesting term of four years, using the accelerated method.
We recognize share-based compensation costs only for those shares expected to vest over the requisite vesting period of the award, which is generally the option vesting term of four years, using the accelerated method.
Our net revenues were $605.2 million for the year ended December 31, 2024, $509.3 million for the year ended December 31, 2023 and $537.8 million for the year ended December 31, 2022.
Our net revenues were $655.4 million for the year ended December 31, 2025, $605.2 million for the year ended December 31, 2024 and $509.3 million for the year ended December 31, 2023.
The expected term of options granted is calculated using our historical and future exercise behavior. Historically, we have not paid dividends and have no foreseeable plans to pay dividends. Therefore, we use an expected dividend yield of zero in the option pricing model. The risk-free interest rate is based on the yield of U.S. treasury bonds with equivalent terms.
The computation of expected volatility is based on the historical volatility of our shares. The expected term of options granted is calculated using our historical and future exercise behavior. Historically, we have not paid dividends and have no foreseeable plans to pay dividends. Therefore, we use an expected dividend yield of zero in the option pricing model.
Worldwide, there were 29, 22 and 7 active MPM patients on therapy as of December 31, 2024, 2023 and 2022 and 20 active NSCLC patients on therapy as of December 31, 2024. (2) Lung includes both prescriptions for NSCLC and MPM.
Worldwide, there were 34, 29, and 22 active MPM patients on therapy as of December 31, 2025, 2024 and 2023, 122 and 20 active NSCLC patients on therapy as of December 31, 2025 and 2024. 54 (2) Optune Lua includes both prescriptions for NSCLC and MPM.
Our net loss was $168.6 million for the year ended December 31, 2024, net 61 loss was $207.0 million for the year ended December 31, 2023 and net loss was $92.5 million for the year ended December 31, 2022. As of December 31, 2024, we had an accumulated deficit of $1,154.1 million.
Our net loss was $136.2 million for the year ended December 31, 2025, net loss was $168.6 million for the year ended December 31, 2024 and net loss was $207.0 million for the year ended December 31, 2023. As of December 31, 2025, we had an accumulated deficit of $1,290.4 million.
See "Results of Operations" in Part II, Item 7, Management's Discussion and Analysis of Financial Condition and Results of Operations in the Company's 2023 Annual Report on Form 10-K, filed with the SEC on February 22, 2024, for an analysis of the 2023 results as compared to 2022. 53 The following table sets forth our consolidated statements of operations data: Year ended December 31, U.S. dollars in thousands, except share and per share data 2024 2023 2022 Net revenues $ 605,220 $ 509,338 $ 537,840 Cost of revenues 137,181 128,280 114,867 Gross profit 468,039 381,058 422,973 Operating costs and expenses: Research, development and clinical studies 209,645 223,062 206,085 Sales and marketing 239,063 226,809 173,658 General and administrative 189,827 164,057 132,753 Total operating costs and expenses 638,535 613,928 512,496 Operating income (loss) (170,496) (232,870) (89,523) Financial (expenses) income, net 39,334 41,130 7,677 Income (loss) before income tax (131,162) (191,740) (81,846) Income tax 37,465 15,303 10,688 Net income (loss) $ (168,627) $ (207,043) $ (92,534) Basic and diluted net income (loss) per ordinary share $ (1.56) $ (1.95) $ (0.88) Weighted average number of ordinary shares used in computing basic and diluted net income (loss) per share 107,834,368 106,391,178 104,660,476 The following table details the share-based compensation expense included in costs and expenses: Year ended December 31, U.S. dollars in thousands 2024 2023 2022 Cost of revenues $ 6,873 $ 6,587 $ 4,690 Research, development and clinical studies 32,716 31,827 30,790 Sales and marketing 43,097 35,968 28,826 General and administrative 77,349 41,226 42,649 Total share-based compensation expense $ 160,035 $ 115,608 $ 106,955 Key performance indicators We believe certain commercial operating statistics are useful to investors in evaluating our commercial business as they help investors evaluate and compare the adoption of our Products from period to period.
See "Results of Operations" in Part II, Item 7, Management's Discussion and Analysis of Financial Condition and Results of Operations in the Company's 2024 Annual Report on Form 10-K, filed with the SEC on February 27, 2025, for an analysis of the 2024 results as compared to 2023. 52 The following table sets forth our consolidated statements of operations data: Year ended December 31, U.S. dollars in thousands, except share and per share data 2025 2024 2023 Net revenues $ 655,353 $ 605,220 $ 509,338 Cost of revenues 166,879 137,181 128,280 Gross profit 488,474 468,039 381,058 Operating costs and expenses: Research, development and clinical studies 224,544 209,645 223,062 Sales and marketing 240,064 239,063 226,809 General and administrative 177,666 189,827 164,057 Total operating costs and expenses 642,274 638,535 613,928 Operating income (loss) (153,800) (170,496) (232,870) Financial (expenses) income, net 17,550 39,334 41,130 Income (loss) before income tax (136,250) (131,162) (191,740) Income tax (23) 37,465 15,303 Net income (loss) $ (136,227) $ (168,627) $ (207,043) Basic and diluted net income (loss) per ordinary share $ (1.22) $ (1.56) $ (1.95) Weighted average number of ordinary shares used in computing basic and diluted net income (loss) per share 111,471,991 107,834,368 106,391,178 The following table details the share-based compensation expense included in costs and expenses: Year ended December 31, U.S. dollars in thousands 2025 2024 2023 Cost of revenues $ 3,627 $ 6,873 $ 6,587 Research, development and clinical studies 25,538 32,716 31,827 Sales and marketing 27,121 43,097 35,968 General and administrative 48,546 77,349 41,226 Total share-based compensation expense $ 104,832 $ 160,035 $ 115,608 Key performance indicators We believe certain commercial operating statistics are useful to investors in evaluating our commercial business as they help investors evaluate and compare the adoption of our Products from period to period.
We believe we possess global commercialization rights to our Products in oncology and are well-positioned to extend those rights into the future as we continue to find innovative ways to improve our Products. In 2018, we granted Zai Lab (Shanghai) Co., Ltd.
Our intellectual property portfolio contains hundreds of issued patents and numerous patent applications pending worldwide. We believe we possess global commercialization rights to our Products in oncology and are well-positioned to extend those rights into the future as we continue to find innovative ways to improve our Products. In 2018, we granted Zai Lab (Shanghai) Co., Ltd.
Overview We are a global oncology company with a proprietary platform technology called Tumor Treating Fields ("TTFields"), which are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms.
Overview We are a global oncology company with a proprietary platform technology called Tumor Treating Fields ("TTFields"), which are electric fields that exert physical forces to kill cancer cells. Our therapy is delivered through a medical device.
We market Optune Gio and Optune Lua in multiple countries around the globe with the majority of our revenues coming from the use of Optune Gio in the U.S., Germany, France and Japan. We are actively evaluating opportunities to expand our international footprint.
We are pursuing regulatory approval to market Optune Pax in other countries. We market our Products in multiple countries around the globe with the majority of our revenues coming from the use of Optune Gio in the U.S., Germany, France and Japan.
Sales and marketing expenses increased by $12.3 million, or 5%, to $239.1 million for the year ended December 31, 2024 from $226.8 million for the year ended December 31, 2023.
Sales and marketing expenses increased by $1.0 million, or 0.4%, to $240.1 million for the year ended December 31, 2025 from $239.1 million for the year ended December 31, 2024.
Our key priorities are to drive commercial adoption of Optune Gio ® and Optune Lua ® , our commercial TTFields therapy devices, and to advance clinical and product development programs intended to extend overall survival in some of the most aggressive forms of cancer.
Our key priorities are to drive commercial adoption of Optune Gio ® , Optune Lua ® , and Optune Pax ® , our commercial TTFields therapy devices, obtain regulatory approval to market TTFields therapy devices in new indications, such as brain metastases from non-small cell lung cancer ("NSCLC"), and to advance clinical and product development programs intended to extend overall survival in some of the most aggressive forms of cancer.
In June 2024, we presented results from the Phase 3 METIS clinical trial evaluating the use of TTFields therapy and best supportive care for the treatment of adult patients with 1-10 brain metastases from NSCLC following stereotactic radiosurgery ("METIS").
In September 2025, we presented final data from the Phase 3 METIS clinical trial evaluating the use of TTFields therapy and best supportive care (BSC) for the treatment of adult patients (n=298) with 1-10 brain metastases from NSCLC following stereotactic radiosurgery at the 2025 American Society for Radiation Oncology Annual Meeting.
Year ended December 31, 2024 2023 2022 Net income (loss) $ (168,627) $ (207,043) $ (92,534) Add: Income tax 37,465 15,303 10,688 Add: Financial expenses (income), net (39,334) (41,130) (7,677) Add: Depreciation and amortization 11,235 10,969 10,624 EBITDA $ (159,261) $ (221,901) $ (78,899) Add: Share-based compensation 160,035 115,608 106,955 Adjusted EBITDA $ 774 $ (106,293) $ 28,056 Adjusted EBITDA increased by $107.1 million, or 101%, to $0.8 million for the year ended December 31, 2024 from $(106.3) million for the year ended December 31, 2023.
Year ended December 31, 2025 2024 2023 Net income (loss) $ (136,227) $ (168,627) $ (207,043) Add: Income tax (23) 37,465 15,303 Add: Financial expenses (income), net (17,550) (39,334) (41,130) Add: Depreciation and amortization 14,650 11,235 10,969 EBITDA $ (139,150) $ (159,261) $ (221,901) Add: Share-based compensation 104,832 160,035 115,608 Adjusted EBITDA $ (34,318) $ 774 $ (106,293) Adjusted EBITDA decreased by $35.1 million to $(34.3) million for the year ended December 31, 2025 from $0.8 million for the year ended December 31, 2024.
Worldwide, 98, 78 and 33 MPM prescriptions were received in the years ended December 31, 2024, 2023 and 2022 and 54 NSCLC prescriptions were received in the year ended December 31, 2024. 55 Year ended December 31, 2024 compared to year ended December 31, 2023 Year ended December 31, 2024 2023 Change % Change Net revenues $ 605,220 $ 509,338 $ 95,882 19 % Net revenues.
Worldwide, 105, 98 and 78 MPM prescriptions were received in the years ended December 31, 2025, 2024 and 2023, 440 and 54 NSCLC prescriptions were received in the years ended December 31, 2025, 2024. 55 Year ended December 31, 2025 compared to year ended December 31, 2024 Year ended December 31, 2025 2024 Change % Change Net revenues $ 655,353 $ 605,220 $ 50,133 8 % Net revenues.
Net cash used in operating activities was $26.4 million for the year ended December 31, 2024 compared to $73.3 million used in operating activities for the year ended December 31, 2023 a decrease of net cash used in operating activities by $47.0 million.
Net cash used in operating activities was $49.0 million for the year ended December 31, 2025 compared to $26.4 million used in operating activities for the year ended December 31, 2024 an increase of net cash used in operating 58 activities by $22.1 million.
In addition, we incur significant legal and accounting costs related to compliance with SEC rules and regulations, including the costs of achieving and maintaining compliance with Section 404 of the Sarbanes-Oxley Act of 2002 and compliance with rules of the NASDAQ Stock Market, as well as insurance, investor relations and other costs associated with being a public company.
In addition, we incur significant legal and accounting costs related to compliance with SEC rules and regulations, including the costs of achieving and maintaining compliance with Section 404 of the Sarbanes-Oxley Act of 2002 and compliance with rules of the NASDAQ Stock Market, as well as insurance, investor relations and other costs associated with being a public company. 50 Financial expenses, net Financial expenses, net, primarily consists of bank fees, credit facility interest expense and related debt issuance costs, interest income from cash balances and short-term investments and gains (losses) from foreign currency transactions.
Year ended December 31, 2024 2023 Change % Change Income tax $ 37,465 $ 15,303 $ 22,162 145 % Income taxes. Income tax expenses increased by $22.2 million, or 145%, resulting in a tax expense of $37.5 million for the year ended December 31, 2024 compared to a tax expense of $15.3 million for the year ended December 31, 2023.
Year ended December 31, 2025 2024 Change % Change Income tax $ (23) $ 37,465 $ (37,488) (100) % Income taxes. Income tax expenses decreased by $37.5 million, or 100%, resulting in a tax benefit of $0.0 million for the year ended December 31, 2025 compared to a tax expense of $37.5 million for the year ended December 31, 2024.
The net cash provided by financing activities for 2024 was primarily attributable to net proceeds of $96.9 million from the senior secured term loan credit facility offset by $12.9 million of early repayment of the convertible notes and $2.2 million in proceeds from the exercise of options and $4.1 million in proceeds from the issuance of shares pursuant to the ESPP.
The net cash provided by financing activities for 2024 was primarily attributable to proceeds of $96.9 million from the Tranche A Loan of the senior secured term loan credit facility, offset by a repurchase of the convertible note of $12.9 million.
We believe the physical mechanisms of action behind TTFields therapy may be broadly applicable to solid tumor cancers.
We believe the physical mode of action behind TTFields therapy and resulting downstream cellular processes initiated by the damaged cells may be broadly applicable to solid tumor cancers.
The Notes mature on November 1, 2025, unless earlier repurchased, redeemed or converted. In June 2024, we redeemed $14.1 million of Notes for cash consideration in financing activities of $12.9 million.
In June 2024, we redeemed $14.1 million of Notes for cash consideration in financing activities of $12.9 million. In November 2025, we repaid the remaining $560.9 million of the outstanding Notes at maturity.
In the course of normal business operations, we also have agreements with contract service providers to assist in the performance of our research and development (including clinical studies) and manufacturing activities.
In the course of normal business operations, we also have agreements with contract service providers to assist in the performance of our research and development (including clinical studies) and manufacturing activities. We could also enter into additional collaborative research, contract research, manufacturing and supplier agreements in the future, which may require up-front payments and even long-term commitments of cash.
The net cash used in investing activities for 2024 was primarily attributable to net purchase of $97.4 million from short-term investments, offset by $42.9 million invested in property and equipment. The net cash provided by investing activities for 2023 was primary attributable to $27.1 million in property and equipment and the net proceeds of $211.2 million in short-term investments.
The net cash provided by investing activities for 2025 was primarily attributable to net proceeds of short-term investments of $ 463.9 million, offset by $26.6 million invested in property and equipment.
Net revenues increased by $95.9 million, or 19%, to $605.2 million for the year ended December 31, 2024 from $509.3 million for the year ended December 31, 2023.
Net revenues increased by $50.1 million, or 8%, to $655.4 million for the year ended December 31, 2025 from $605.2 million for the year ended December 31, 2024.
General and administrative expenses increased by $25.8 million, or 16%, to $189.8 million for the year ended December 31, 2024 from $164.1 million for the year ended December 31, 2023.
General and administrative expenses. General and administrative expenses decreased by $12.2 million, or 6%, to $177.7 million for the year ended December 31, 2025 from $189.8 million for the year ended December 31, 2024.
Optune Lua is also approved under the Humanitarian Device Exemption ("HDE") pathway for the treatment of adult patients with malignant pleural mesothelioma or pleural mesothelioma (together, "MPM") together with standard chemotherapies. We have also received CE certification in the EU and approval or local registration to market Optune Lua in certain other countries for the treatment of MPM.
Optune Lua is also approved by the FDA under the Humanitarian Device Exemption ("HDE") pathway for the treatment of adult patients with malignant pleural mesothelioma or pleural mesothelioma (together, "MPM") together 60 with standard chemotherapies.
The decrease was primarily driven by interest expenses of $7.7 million related to the senior secured credit facility, an increase in interest income of $4.9 million from our investments and a gain from the purchase of convertible notes by $1.0 million.
The decrease was primarily driven by a decrease in interest income of $11.3 million primarily driven by lower U.S. interest rates and a reduction in our short term investments due to repayment of the convertible note, an increase of $5.7 million in interest expenses from our senior secured term loan credit facility, and an increase of $3.6 million in foreign exchange expenses, offset by a gain from the purchase of convertible notes of $1.1 million.
Financial income, net, decreased by $1.8 million, or 4%, to $39.3 million income for the year ended December 31, 2024 from $41.1 million income for the year ended December 31, 2023.
Year ended December 31, 2025 2024 Change % Change Financial (expenses) income, net $ 17,550 $ 39,334 $ (21,784) (55) % Financial (expenses) income, net. Financial income, net, decreased by $21.8 million, or 55%, to $17.5 million income for the year ended December 31, 2025 from $39.3 million income for the year ended December 31, 2024.
GAAP measurement of earnings before interest, taxes, depreciation, amortization and shared-based compensation ("Adjusted EBITDA").
Non-GAAP financial measures We also measure our performance based upon a non-U.S. GAAP measurement of earnings before interest, taxes, depreciation, amortization and shared-based compensation ("Adjusted EBITDA").
The change was 56 primarily due to an increase of $22.0 million in costs related to a sales force expansion for NSCLC, partially offset by a $10.1 million reduction in marketing expenses. General and administrative expenses.
The change was primarily due to an increase of $8.1 million in costs related to a sales force expansion, a $4.0 million increase in marketing expenses related to the NSCLC launch and new indication preparations, a $2.8 million increase in market access costs related to securing reimbursements in new indications and new geographies, and a $2.1 million increase in other expenses, partially offset by a $16.0 million reduction in share-based compensation.
Impact of Current Events On October 7, 2023, the State of Israel was attacked by and subsequently declared war on Hamas. As of the date of this filing, we believe that there is no immediate risk to our business facilities or operations.
For additional information, see Note 12 to the Consolidated Financial Statements. 61 Impact of Current Events Conflict in Israel Since October 2023, the State of Israel has been in a state of war. As of the date of this filing, we believe that there is no immediate risk to our business facilities or operations.
Excluding sales to Zai, cost of revenues per active patient per month were $2,683 for the year ended December 31, 2024 compared to $2,714 for the year ended December 31, 2023.
In addition, the Company recognized a $3.2 million expense in 2025 related to an inventory obsolescence provision for Optune Lua arrays. Excluding sales to Zai, cost of revenues per active patient per month were $2,950 for the year ended December 31, 2025 compared to $2,683 for the year ended December 31, 2024.
Our cost of revenues were $137.2 million for the year ended December 31, 2024, an increase of $8.9 million, or 7%, from $128.3 million for the year ended December 31, 2023, primarily due to 10% growth in active patients and partially offset by lower shipments to Zai.
Our cost of revenues were $166.9 million for the year ended December 31, 2025, an increase of $29.7 million, or 22%, from $137.2 million for the year ended December 31, 2024, primarily due to 9% growth in Optune Gio active patients, $3.4 million higher array costs driven by the new array roll-out, $3.6 million attributed to the NSCLC launch, $5.2 million in higher tariffs, and $3.1 million more in sales to Zai.
In addition the decrease in net cash used in operating activities was driven by an increase in tax expenses of $ 22.2 million, an increase in working capital of $40.0 million, driven by an increase in accounts receivable of $55.7 million offset by a decrease in inventories of $11.5 million, and an increase in share based compensation of $44.4 million.
In addition, the increase in net cash used in operating activities is driven by an increase in working capital of $21.0 million, which was primarily driven by an increase in accounts receivable of $12.6 million and an increase of $8.2 million in inventories.
Financing activities To date, our primary financing activities have been the sale of equity and the proceeds from long-term loans. Net cash provided by financing activities was $90.3 million for the year ended December 31, 2024 compared to $15.8 million for the year ended December 31, 2023.
Net cash used in financing activities was $451.3 million for the year ended December 31, 2025 compared to net cash provided by of $90.3 million for the year ended December 31, 2024.
Our supply chain teams are working to increase stock levels to mitigate distribution and service risks from our suppliers in Israel. We view our operations and manage our business in one operating segment.
Our supply chain teams have increased stock levels to mitigate distribution and service risks from our suppliers in Israel, some of whom are single-source suppliers.
We have several product development programs underway that are designed to optimize the delivery of TTFields to the target tumor and enhance patient ease of use. Our intellectual property portfolio contains hundreds of issued patents and numerous patent applications pending worldwide.
The table below presents the current status of the ongoing clinical trials in our pipeline and anticipated timing of data. We have several product development programs underway that are designed to optimize the delivery of TTFields to the target tumor and enhance patient ease of use.
Research, development and clinical studies expenses decreased by $13.4 million, or 6%, to $209.6 million for the year ended December 31, 2024 from $223.1 million for the year ended December 31, 2023. The change was primarily due to a decrease in personnel expenses.
Research, development and clinical studies expenses increased by $14.9 million, or 7%, to $224.5 million for the year ended December 31, 2025 from $209.6 million for the year ended December 31, 2024.
As of December 31, 2024, we have unrecognized compensation expense of $119.6 million, which is expected to be recognized over a weighted average period of 52 approximately 1.59 years. We expect to continue to grant equity awards in the future, and to the extent that we do, our recognized share-based compensation expense will likely increase.
As of December 31, 2025, we have unrecognized compensation expense of $73.8 million, which is expected to be recognized over a weighted average period of approximately 1.45 years years.
We could also enter into additional collaborative research, contract research, manufacturing and supplier agreements in the future, which may require up-front payments and even long-term commitments of cash. 58 Investing activities Our investing activities primarily consist of capital expenditures to purchase property and equipment and field equipment, as well as investments in and redemptions of our short-term investments.
Investing activities Our investing activities primarily consist of investments in and redemptions of short-term investments, as well as capital expenditures to purchase property and equipment and field equipment.
At December 31, 2024, our cash, cash equivalents and short-term investments totaled $959.9 million, an increase of $49.3 million compared to $910.6 million at December 31, 2023. The increase was primarily due to net cash provided by financing activities.
At December 31, 2025, our cash, cash equivalents and short-term investments totaled $447.7 million, a decrease of $512.2 million compared to $959.9 million at December 31, 2024.
Year ended December 31, 2024 2023 Change % Change Operating expenses: Research, development and clinical studies $ 209,645 $ 223,062 $ (13,417) (6) % Sales and marketing 239,063 226,809 12,254 5 % General and administrative 189,827 164,057 25,770 16 % Total operating expenses $ 638,535 $ 613,928 $ 24,607 4 % Research, development and clinical studies expenses.
Year ended December 31, 2025 2024 Change % Change Operating expenses: Research, development and clinical studies $ 224,544 $ 209,645 $ 14,899 7 % Sales and marketing 240,064 239,063 1,001 — % General and administrative 177,666 189,827 (12,161) (6) % Total operating expenses $ 642,274 $ 638,535 $ 3,739 1 % Research, development and clinical studies expenses.
The net cash provided by financing activities for 2023 was primarily attributable to $11.4 million in proceeds from the exercise of options and $4.4 million in proceeds from the issuance of shares pursuant to the ESPP. Convertible Notes On November 5, 2020, we issued $575.0 million aggregate principal amount of 0% Convertible Senior Notes due 2025 (the “Notes”).
As a result, we no longer have the ability to borrow the Tranche C or Tranche D Loans. Convertible Notes On November 5, 2020, we issued $575.0 million aggregate principal amount of 0% Convertible Senior Notes due 2025 (the “Notes”). The net proceeds from the offering were approximately $558.4 million.
We expect that our gross margins will be impacted by current and future product enhancements, such as the launch of our new arrays in the U.S., our launch of NSCLC and changes in the tariff environment.
We expect that our gross margins will continue to be impacted by our launch of Optune Pax while we seek broad reimbursement, offset by expected decreases in array costs as we attempt to optimize our supply chain. In addition, changes in the tariff environment could impact our future gross margins.
For additional information, see Note 15 to the Consolidated Financial Statements. Long-lived assets Field equipment is stated at cost, net of accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful life of the relevant asset.
We expect to continue to grant equity awards in the future, and to the extent that we do, our recognized share-based compensation expense will fluctuate as a significant portion of our awards are tied to our performance. For additional information, see Note 15 to the Consolidated Financial Statements. Long-lived assets Field equipment is stated at cost, net of accumulated depreciation.
Removed
Financial expenses, net Financial expenses, net, primarily consists of bank fees, credit facility interest expense and related debt issuance costs, interest income from cash balances and short-term investments and gains (losses) from foreign currency 51 transactions. Our reporting currency is the U.S. dollar.
Added
We believe we have largely built out the structure to support a global multi-indication oncology company and will look to moderate general and administrative expense growth to achieve profitability.
Removed
The growth in net revenues was primarily driven by an increase of $44.0 million from our successful launch in France and an increase of $42.1 million of net revenues in the U.S. due to improved approval rates.
Added
The risk-free interest rate is based on the yield of U.S. treasury bonds with equivalent terms. For information about our ESPP, see Note 15 to the Consolidated Financial Statements.
Removed
The improved approval rates in the U.S. includes $22.3 million of increased net revenue from prior period claims during the year, primarily from 2023. Year ended December 31, 2024 2023 Change % Change Cost of revenues $ 137,181 $ 128,280 $ 8,901 7 % Cost of revenues.
Added
The growth in net revenues primarily resulted from a $20.5 million increase from continued growth in France, a $14.1 million increase in Germany from active patient growth and reimbursement improvements, and a $21.7 million increase from the remaining international markets driven by active patient growth and reimbursement improvements in certain markets.
Removed
The improvement in gross margin is due to the increase in net revenue per patient primarily attributed to our improved approval rates in the U.S. and successful launch in France.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

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Biggest changeThe effect of a hypothetical 10% change in foreign currency exchange rates applicable to our business would not have a material impact on our historical consolidated financial statements. We do not currently hedge our foreign currency exchange risk; however we may engage in hedging transactions in the future. 62
Biggest changeThe effect of a hypothetical 10% change in foreign currency exchange rates applicable to our business would not have a material impact on our historical consolidated financial statements. We do partially hedge our transaction related Euro foreign currency exchange risk and may engage in other currency hedging transactions in the future. 63
Our consolidated results of operations and cash flows are, therefore, subject to fluctuations due to changes in foreign currency exchange rates and may be adversely affected in the future due to changes in foreign exchange rates.
Our consolidated results of operations and cash flows are, 62 therefore, subject to fluctuations due to changes in foreign currency exchange rates and may be adversely affected in the future due to changes in foreign exchange rates.
Our market risk exposure is primarily a result of fluctuations in interest rates and foreign currency exchange rates. We do not hold or issue financial instruments for trading purposes. There were no material quantitative changes in our market risk exposures between the year ended December 31, 2024 and the year ended December 31, 2023.
Our market risk exposure is primarily a result of fluctuations in interest rates and foreign currency exchange rates. We do not hold or issue financial instruments for trading purposes. There were no material quantitative changes in our market risk exposures between the year ended December 31, 2025 and the year ended December 31, 2024.
Our expenses are generally denominated in the currencies in which our operations are located, which is primarily in the United States, Switzerland, Germany, Israel and Japan.
Our expenses are generally denominated in the currencies in which our operations are located, which is primarily in the United States, Switzerland, Germany, France, Israel and Japan.
Interest rate sensitivity Our exposure to market risk for changes in interest rates relates primarily to our investment portfolio. Our cash, cash equivalents and short-term investment accounts as of December 31, 2024 totaled $959.9 million and consist of cash, cash equivalents and short-term investments with maturities of less than one year from the date of purchase.
Interest rate sensitivity Our exposure to market risk for changes in interest rates relates primarily to our investment portfolio. Our cash, cash equivalents and short-term investment accounts as of December 31, 2025 totaled $447.7 million and consist of cash, cash equivalents and short-term investments with maturities of less than one year from the date of purchase.

Other NVCR 10-K year-over-year comparisons