What changed in this filing

/stocks — the workspaceLOADING

Item 1. Business

2023-02-23 compared with 2022-02-24 · 158 added, 142 removed, 455 unchanged (40% of the section changed)

We are a global oncology company with a proprietary platform technology called Tumor Treating Fields ("TTFields"), which are electric fields tuned to specific frequencies that disrupt cancer cell division.

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.

Our key priorities are to drive commercial adoption of Optune and Optune Lua, our commercial TTFields devices, and to advance clinical and product development programs intended to extend overall survival in some of the most aggressive forms of cancer.

1 unchanged sentence

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 also have a CE certificate to market Optune for the treatment of GBM in the European Union ("EU"), as well as approval or local registration in the United Kingdom ("UK"), Japan and certain other countries.

We also have a CE certificate to market Optune for the treatment of GBM in the European Union ("EU"), as well as approval or local registration in the United Kingdom ("UK"), Japan, Canada and certain other countries.

Optune Lua is approved by the FDA under the Humanitarian Device Exemption ("HDE") pathway to treatment malignant pleural mesothelioma ("MPM") together with standard chemotherapies.

1 unchanged sentence

We market Optune and Optune Lua in multiple countries around the globe with the majority of our revenues coming from the use of Optune in the U.S., Germany and Japan.

We are actively evaluating and executing upon opportunities to expand our international footprint.

We believe the physical mechanism of action behind TTFields therapy may be broadly applicable to solid tumor cancers.

Currently, we are conducting phase 3 pivotal studies evaluating the use of TTFields in non-small cell lung cancer ("NSCLC"), ovarian cancer, brain metastases from non-small cell lung cancer ("brain metastases") and pancreatic cancer.

In 2021, we completed patient enrollment in our phase 3 pivotal NSCLC and ovarian cancer studies with data anticipated in 2022 and 2023, respectively.

Additionally, we have multiple ongoing phase 2 pilot studies evaluating the use of TTFields in gastric cancer, for which patient enrollment is complete, and stage 3 NSCLC, as well as testing the potential incremental survival benefit of TTFields delivered using high-intensity arrays versus standard arrays.

We are designing several phase 2 pilot studies in partnership with oncology leaders to further explore the capabilities of TTFields.

We are also currently conducting a global phase 4 post-marketing study testing the potential survival benefit of initiating Optune concurrent with radiation therapy versus following radiation therapy in patients with newly diagnosed GBM.

In 2021, we presented data from our phase 2 pilot study studying the use of TTFields in liver cancer and are currently evaluating protocol design options for a large, randomized study in this indication.

We are actively evaluating opportunities to expand our international footprint.

We believe the physical mechanisms of action behind TTFields therapy may be broadly applicable to solid tumor cancers.

We recently completed patient follow-up and announced top line results from our pivotal LUNAR study evaluating the use of TTFields in the treatment of non-small cell lung cancer ("NSCLC") together with standard therapies.

Patients treated with TTFields and standard therapies demonstrated a statistically significant and clinically meaningful improvement in overall survival over standard therapies alone.

The LUNAR study also showed a statistically significant and clinically meaningful improvement in overall survival when patients were treated with TTFields and immune checkpoint inhibitors, as compared to those treated with immune checkpoint inhibitors alone, and a positive trend in overall survival when patients were treated with TTFields and docetaxel versus docetaxel alone.

We expect to present full results of the LUNAR study at a future medical conference.

In addition to the LUNAR study, we are conducting pivotal studies evaluating the use of TTFields in the treatment of ovarian cancer, brain metastases from NSCLC ("brain metastases") and pancreatic cancer.

We are also conducting a pivotal study testing the potential survival benefit of initiating Optune concurrent with radiation therapy versus following radiation therapy in patients with newly diagnosed GBM.

We have one ongoing pilot study evaluating the use of TTFields in the treatment of stage 3 NSCLC and are designing several additional pilot and pivotal studies in partnership with oncology leaders to further explore the capabilities of TTFields.

We anticipate expanding our clinical pipeline over time to study the safety and efficacy of TTFields for additional solid tumor indications and combinations with other cancer treatment modalities.

8 unchanged sentences

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.

Our principal operations are located in Switzerland, the U.S.

Daily management and control of the Company are located in Switzerland, with additional operating centers located around the world.

When cancer develops, rapid and uncontrolled division of unhealthy cells occurs.

Electrically charged proteins within the cell are critical for cell division, making the rapidly dividing cancer cells vulnerable to electrical

interference.

TTFields therapy is a treatment that uses electric fields tuned to specific frequencies to disrupt cancer cell division.

Electrically charged proteins within the cell are critical for cell division, making the rapidly dividing cancer cells vulnerable to electrical interference.

TTFields therapy is a treatment that uses electric fields which exert physical forces to kill cancer via a variety of mechanisms.

All cells are surrounded by a bilipid membrane, which separates the interior of the cell, or cytoplasm, from the space around it.

13 unchanged sentences

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.

Recent 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 inhibit DNA damage repair, induce autophagy, reduce cell migration and invasion, and increase anti-tumor immunity.

Recent 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.

20 unchanged sentences

Our product development initiatives include, but are not limited to:

next generation arrays that are more flexible and deliver higher intensities, next generation array layout planning software, development of a third generation device that optimizes the use of electric fields to treat tumors, and patient-centered software that enables scaled patient support as we prepare to treat larger patient populations across multiple indications.

ultimate goal is to optimize the energy delivered to patients' tumors, potentially improving efficacy.

next generation arrays that

are thinner, lighter and more flexible, next generation array layout mapping software, development of a third generation device that optimizes the use of electric fields to treat tumors, and patient-centered software that enables scaled patient support as we prepare to treat larger patient populations across multiple indications.

Our ultimate goal is to optimize the energy delivered to patients' tumors, potentially improving efficacy.

Any enhancements will be subject to applicable regulatory reviews and approvals.

5 unchanged sentences

In 2015, we received FDA approval to market Optune for the treatment of adult patients with newly diagnosed supratentorial GBM in combination with temozolomide.

The FDA approved Optune for newly diagnosed GBM based on the EF-14 study ("EF-14"), which was a randomized, phase 3 pivotal clinical study which compared, post radiation, Optune plus temozolomide versus temozolomide alone for the treatment of newly diagnosed GBM.

The FDA approved Optune for newly diagnosed GBM based on the EF-14 study ("EF-14"), which was a randomized pivotal clinical study which compared, post radiation, Optune plus temozolomide versus temozolomide alone for the treatment of newly diagnosed GBM.

The primary endpoint of the study was progression-free survival and a powered secondary endpoint was overall survival.

10 unchanged sentences

Physical, role, social, emotional and cognitive functioning for patients treated with Optune and temozolomide all remained stable and comparable with patients treated with temozolomide alone.

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) 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.

A post-hoc analysis of EF-14 showed that more time on Optune predicted increased survival in GBM patients.

6 unchanged sentences

n=119) had a median overall survival of 24.3 months compared to a median overall survival of 21.6 months for patients treated with Optune at lower intensities (less than 1.06 V/cm;

In these analyses, both time on therapy and higher levels of energy (power loss density) were associated with improved overall survival, independent of each other.

In addition, patients who used Optune at least 18 hours per day at higher energy levels (n=78) had a median overall survival of 25.1 months (95% CI 20.8-39.4).

In these analyses, both time on therapy and higher intensity were associated with improved overall survival, independent of each other.

In addition, patients who used Optune at least 18 hours per day at higher intensity levels (n=78) had a median overall survival of 25.1 months (95% CI 20.8-39.4).

Treatment of recurrent GBM

We initially received FDA approval for Optune in 2011 for use as a monotherapy treatment for adult patients with GBM, following confirmed recurrence after chemotherapy.

The FDA approved Optune based on the EF-11 study ("EF-11"), a randomized, phase 3 pivotal clinical study.

The FDA approved Optune based on the EF-11 study ("EF-11"), a randomized, pivotal clinical study.

EF-11 was a multi-center, active controlled clinical study of 237 adults with recurrent GBM.

14 unchanged sentences

The FDA approved Optune Lua for MPM based on the STELLAR study ("STELLAR").

STELLAR was a single-arm, open-label, multi-center study designed to test the safety and efficacy of Optune in combination with pemetrexed combined with cisplatin or carboplatin in patients with unresectable, previously untreated MPM.

STELLAR was a single-arm, open-label, multi-center study designed to test the safety and efficacy of Optune Lua in combination with pemetrexed combined with cisplatin or carboplatin in patients with unresectable, previously untreated MPM.

The study was powered to prospectively determine the overall survival in patients treated with Optune Lua plus chemotherapy.

3 unchanged sentences

The median overall survival was 21.2 months for patients with epithelioid MPM (n=53) and 12.1 months for patients with non-epithelioid MPM (n=27).

62% of patients enrolled in STELLAR who used Optune Lua plus chemotherapy were still alive at one year, with 42% of patients alive at two years.

62% of patients enrolled in STELLAR who used Optune Lua plus chemotherapy were still alive at one year, with 42% of patients alive at two

The disease control rate in patients with at least one follow-up CT scan performed (n=72) was 97%.

patients had a partial response, 57% had stable disease, and 3% had progressive disease.

40% of patients had a partial response, 57% had stable disease, and 3% had progressive disease.

The median progression-free survival was 7.6 months (95% CI, 6.7-8.6 months).

11 unchanged sentences

Of this population, we estimate that approximately 1,200 patients who are candidates for treatment with Optune based upon the rate of disease progression and medical eligibility will actively seek treatment.

In 2022, we estimate that approximately 3,000 people are diagnosed with malignant mesothelioma in the U.S.

In 2023, we estimate that approximately 3,000 people are diagnosed with malignant plural mesothelioma in the U.S.

Of this population, we estimate that approximately 1,600 patients are candidates for treatment with Optune Lua based upon the rate of disease progression and medical eligibility.

9 unchanged sentences

With respect to the treatment of MPM, our sales and marketing efforts are principally focused on certification training, supporting the required Institutional Review Board approval process in certain geographies, and driving awareness among radiation oncologists and thoracic oncologists.

We believe the benefit of our education efforts will extend beyond MPM to future indications treated by the same prescribers and that radiation oncologists will continue to play an increasingly important role in driving adoption of our Products in both current and future indications.

We believe the benefit of our education efforts will extend beyond MPM to future indications treated by the same prescribers.

We currently operate as a direct-to-patient distributor of our Products, except for Japan.

7 unchanged sentences

We provide our Products directly to patients following receipt of a prescription order and a signed patient service agreement (except in Japan as described above).

The number of active patients on therapy and the amount of net revenue recognized per active patient are our principal revenue drivers.

The number of active patients on therapy and the amount of net

revenue recognized per active patient are our principal revenue drivers.

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.

Median treatment duration differs based upon the patient's clinical diagnosis.

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 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.

Currently, the monthly list price for our therapy in the U.S.

is $21,000 and we have set list prices outside of the United States that are approximately equivalent to this price, subject to currency fluctuations.

We maintain a monthly list price for our therapy in the U.S.

and set list prices outside of the United States that are approximately equivalent to this price, subject to currency fluctuations.

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.

1 unchanged sentence

As of December 31, 2022, we have received national reimbursement for Optune in Austria, Germany, Israel, Japan, Sweden and Switzerland.

In February 2023, we finalized contract terms to establish national reimbursement in France for the treatment of adult patients with newly diagnosed GBM, pending official signatures and final publication in the Journal Officiel.

In the U.S., a substantial majority of Americans with private health insurance had coverage of Optune for newly diagnosed GBM and/or recurrent GBM as of December 31, 2022.

6 unchanged sentences

Our development pipeline

Based on the results of our preclinical research, we have developed a pipeline strategy to advance TTFields through phase 2 pilot, phase 3 pivotal studies and phase 4 post-marketing studies across multiple solid tumor types.

Based on the results of our preclinical research, we have developed a pipeline strategy to advance TTFields through pilot and pivotal studies across multiple solid tumor types.

We anticipate expanding our clinical pipeline over time to include additional solid tumor cancer indications.

Current Development Pipeline

The solid tumor cancers subject to our phase 2 pilot, phase 3 pivotal, and phase 4 post-marketing studies, as well as the studies themselves, are described in greater detail below.

We continue to conduct research in our approved indications to further advance the scientific evidence supporting the use of TTFields in GBM and to gather additional information about our therapy's optimal use.

2-THE-TOP phase 2 pilot study

In November 2021, Dr.

David Tran, Chief of the Division of Neuro-Oncology at the McKnight Brain Institute at the University of Florida, presented updated data from the phase 2 pilot 2-THE-TOP study testing the safety and efficacy of TTFields together with pembrolizumab and temozolomide for the treatment of adult patients with newly diagnosed GBM.

The solid tumor cancers subject to our pilot and pivotal studies, as well as the studies themselves, are described in greater detail below.

In addition to our studies in tumors of the head, thorax and abdomen, we continue to conduct

research in our approved indications to further advance the scientific evidence supporting the use of TTFields in GBM and to gather additional information about our therapy's optimal use.

GBM is the most common and aggressive form of primary brain cancer.

It is estimated that approximate 15,000 patients are diagnosed with GBM or tumors that typically progress to GBM each year in the U.S.

Following diagnosis, standard of care treatment includes surgical resection, followed by radiotherapy with concomitant chemotherapy, followed TTFields together with maintenance chemotherapy.

2-THE-TOP pilot study

David Tran, Chief of the Division of Neuro-Oncology at the University of Southern California Keck School of Medicine and co-Director of the USC Keck Brain Tumor Center, presented updated data from the pilot 2-THE-TOP study testing the safety and efficacy of TTFields together with pembrolizumab and temozolomide for the treatment of adult patients with newly diagnosed GBM.

As of May 24, 2021, 25 patients with a median age of 61 years were enrolled in the study, with a median follow-up of 14.7 months.

7 unchanged sentences

The most common adverse events were thrombosis (16%), seizure (12%), and metabolic disturbances (8%).

2-THE-TOP concluded that the triple combination of TTFields, temozolomide, and pembrolizumab is well tolerated and shows early evidence of efficacy in newly diagnosed GBM patients.

In March 2022, Dr.

Tran presented updated results from the 2-THE-TOP study.

These preliminary results, which are based on a median follow-up time of 16.8 months, compared outcomes for 26 patients in the ongoing 2-THE-TOP study versus a historical, matched-control group of 26 patients from the EF-14 study.

For patients in the 2-THE-TOP study, median progression-free survival was 12.1 months, compared with 7.9 months for the matched-control patients in EF-14 (hazard ratio=0.46, p=0.033).

Patients in 2-THE-TOP had a median overall survival of 25.2 months, compared with 15.9 months for the matched-control patients in EF-14 (hazard ratio=0.38, p=0.020).

Of the 15 patients in 2-THE-TOP with measurable target lesions, six (40%) achieved partial to complete response and eight (53%) had stable disease.

The 2-THE-TOP study concluded that the triple combination of TTFields, temozolomide, and pembrolizumab is well tolerated and shows early evidence of efficacy in newly diagnosed GBM patients.

Patients will continue follow-up with survival and molecular data to be updated.

EF-33 phase 2 pilot study

In 2020, we enrolled the first patient in our EF-33 study, an open-label, single-arm phase 2 pilot clinical study to study if Optune delivered at 200 kHz to the brain using high-intensity arrays in the treatment of recurrent GBM significantly improves the clinical outcomes of patients compared to using standard transducer arrays.

The primary endpoint is progression-free survival.

Secondary endpoints include overall survival, progression-free survival rate at six months, overall survival rate at one year and two years, overall radiological response, and severity and

frequency of adverse events.

All comparisons will be made against historical control data from the EF-11 study.

EF-33 is expected to enroll 25 patients and we anticipate data will be available in 2022.

TRIDENT phase 4 post-marketing study

In 2020, we enrolled the first patient in our TRIDENT study ("TRIDENT"), a phase 4 post-marketing study testing the potential survival benefit of initiating Optune concurrent with radiation therapy in patients with newly diagnosed GBM.

In 2022, we entered into a clinical collaboration agreement with MSD, a tradename of Merck & Co., Inc., ("MSD") to conduct the double-blind, placebo-controlled pivotal KEYNOTE D58 study of TTFields concomitant with pembrolizumab and maintenance temozolomide for the treatment of newly diagnosed GBM.

EF-33 pilot study

In October 2022, we announced preliminary data from our EF-33 pilot study, an open-label, single-arm study evaluating whether TTFields delivered at 200 kHz to the brain using high-intensity arrays in the treatment of recurrent GBM significantly improves the clinical outcomes of patients compared to using standard transducer arrays in 25 patients.

Among patients who used Optune as directed with for at least one month, median progression-free survival was 4.5 months compared to 2.2 months in the historical control, our pivotal EF-11 study.

Further, notwithstanding the increased dosage, EF-33 patients reported no TTFields-related toxicity.

TRIDENT pivotal study

In 2020, we enrolled the first patient in our TRIDENT study ("TRIDENT"), a pivotal study testing the potential survival benefit of initiating Optune concurrent with radiation therapy in patients with newly diagnosed GBM.

The primary endpoint is overall survival.

Secondary endpoints include 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.

TRIDENT is designed to accrue 950 patients with 24 months minimum follow-up after the last patient enrolled.

Secondary endpoints include 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.

TRIDENT is designed to accrue 950 patients with a 24-month minimum follow-up period after the last patient enrolled.

Non-small cell lung cancer

3 unchanged sentences

Surgery, which may be curative in a subset of patients, is usually used in early stages of the disease.

Since 1991, radiation with a combination of platinum-based chemotherapy drugs has been the first line standard of care for locally advanced or metastatic NSCLC.

Certain immune checkpoint inhibitors have recently been approved for the first line treatment of NSCLC and the standard of care in this setting appears to be evolving rapidly.

The standard of care for second line treatment is also evolving and may include platinum-based chemotherapy for patients who received immune checkpoint inhibitors as their first line regimen, pemetrexed, docetaxel or immune checkpoint inhibitors.

EF-15 phase 2 pilot study

In 2013, we published the results of our phase 2 pilot study, the EF-15 study ("EF-15"), evaluating the safety and efficacy of TTFields in the treatment of advanced NSCLC.

A combination of radiation, platinum-based chemotherapies, and immune checkpoint inhibitors, or targeted therapies, are the first line standard of care treatment for locally advanced or metastatic NSCLC.

Today, the standard of care for second line treatment is evolving and often includes immune checkpoint inhibitors, docetaxel, platinum-based chemotherapy or pemetrexed.

EF-15 pilot study

In 2013, we published the results of our pilot study, the EF-15 study ("EF-15"), evaluating the safety and efficacy of TTFields in the treatment of advanced NSCLC.

EF-15 focused on the effects of treatment with TTFields in combination with standard of care pemetrexed chemotherapy.

Results of the pemetrexed phase 3 pivotal FDA registration study were used as a historical control in this study.

Results of the pemetrexed pivotal FDA registration study were used as a historical control in this study.

A total of 42 patients were recruited to the study with a minimum follow-up of six months.

2 unchanged sentences

Adverse events reported in this combination study were comparable to those reported with pemetrexed alone, suggesting minimal added toxicities due to TTFields.

LUNAR phase 3 pivotal study

In 2017, we enrolled the first patient in our LUNAR study ("LUNAR"), a phase 3 pivotal study testing the effectiveness of TTFields in combination with immune checkpoint inhibitors or docetaxel versus immune checkpoint inhibitors or docetaxel alone for patients with stage 4 NSCLC who progressed during or after platinum-based therapy.

LUNAR pivotal study

In 2017, we enrolled the first patient in our LUNAR study ("LUNAR"), a pivotal study testing the effectiveness of TTFields in combination with immune checkpoint inhibitors or docetaxel versus immune checkpoint inhibitors or docetaxel alone for patients with stage 4 NSCLC who progressed during or after platinum-based therapy.

It is estimated that approximately 46,000 patients receive second-line treatment for stage 4 NSCLC each year in the U.S.

2 unchanged sentences

TTFields is intended principally for use in combination with other standard-of-care treatments, and LUNAR was designed to generate data that contemplates multiple outcomes, all of which we believe will be clinically meaningful.

In April 2021, we announced that an independent Data Monitoring Committee ("DMC") informed us that the pre-specified interim analysis for the LUNAR study was accelerated given the length of accrual and the number of events observed, to date.

In 2021, we announced that an independent Data Monitoring Committee ("DMC") informed us that the pre-specified interim analysis for the LUNAR study was accelerated given the length of accrual and the number of events observed, to date.

The interim analysis included data from 210 patients accrued through February 2021.

After review of the interim analysis, the DMC concluded that the LUNAR study should continue with no evidence of increased systemic toxicity.

The DMC went on to comment that the continued accrual to 534 patients as proposed in the original protocol, given the current rate of accrual and the interim data presented, is likely unnecessary and

possibly unethical for patients randomized to control.

The DMC went on to comment that the continued accrual to 534 patients as proposed in the original protocol, given the current rate of accrual and the interim data presented, is likely unnecessary and possibly unethical for patients randomized to control.

For this reason, the DMC recommended an adjustment of accrual to approximately 276 patients with a 12-month follow-up following the enrollment of the last patient.

1 unchanged sentence

In May 2021, the FDA approved our investigational device exemption supplement incorporating the recommended protocol changes and we enrolled our last LUNAR patient in November 2021.

We anticipate data in 2022.

KEYNOTE B36 phase 2 pilot study

In July 2020, we entered into a clinical study collaboration with MSD, a trade name of Merck & Co., Inc.

through a subsidiary, to study TTFields together with MSD’s anti-PD-1 therapy pembrolizumab for treatment of first-line NSCLC, expanding our research in the lung cancer space.

In April 2021, the FDA approved our IDE application to initiate the KEYNOTE B36 phase 2 pilot study to study TTFields with pembrolizumab in first-line NSCLC.

As of December 31, 2021 there were nine KEYNOTE B36 clinical study sites actively evaluating patients for enrollment.

In January 2023, we announced the LUNAR study met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in overall survival for patients treated with TTFields and standard therapies compared to those treated with standard therapies alone.

overall survival when patients were treated with TTFields and docetaxel versus docetaxel alone.

Patient enrollment was well balanced between the immune checkpoint inhibitor and docetaxel cohorts of the experimental and control arms, and the control arms performed in line with prior studies.

TTFields therapy was well tolerated by patients enrolled in the experimental arm of the study.

The publication of full data from the LUNAR study is anticipated in 2023.

KEYNOTE B36 pilot study

In June 2022, we enrolled the first patient in our KEYNOTE B36 study, a pilot study evaluating the safety and efficacy of TTFields together with the anti-PD-1 therapy pembrolizumab for the treatment of first-line NSCLC, expanding our research in the lung cancer space.

This study is the result of a clinical study collaboration with MSD.

Brain metastases

10 unchanged sentences

This 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.

METIS phase 3 pivotal study

In 2016, we enrolled the first patient in our METIS study ("METIS"), a phase 3 pivotal study testing the effectiveness of SRS plus TTFields compared to SRS alone in patients with brain metastases resulting from NSCLC.

METIS pivotal study

In 2016, we enrolled the first patient in our METIS study ("METIS"), a pivotal study testing the effectiveness of SRS plus TTFields compared to SRS alone in patients with brain metastases resulting from NSCLC.

It is estimated that between 20 to 40% of patients with NSCLC develop brain metastases, with an estimated 38,000 to 77,000 patients diagnosed each year in the U.S.

2 unchanged sentences

Secondary endpoints include, among others, time to neurocognitive failure, overall survival and radiological response rate following study treatments.

The study is designed to accrue 270 patients with data analyzed 12 months after the last patient in.

We anticipate data will be available in 2023.

Liver cancer is a leading cause of cancer deaths worldwide and is the sixth leading cause of cancer deaths annually in the U.S.

The incidence of liver cancer is approximately 42,000 new cases annually in the U.S.

The five-year survival rate with existing standards of care is less than 20%.

Hepatocellular carcinoma is the most widespread type of cancer that originates from the liver.

Advanced liver cancer has spread either to the lymph nodes or to other organs and, because these cancers are widespread, they cannot be treated with surgery.

The current common standard treatment for patients with advanced disease and those who progressed on loco-regional therapy is systemic therapy with sorafenib, lenvatinib, or atezolizumab plus bevacizumab.

In September 2021, we announced that the FDA granted breakthrough designation to the NovoTTF-200T System, a TTFields device intended for use together with atezolizumab and bevacizumab for the first-line treatment of patients with unresectable or metastatic liver cancer.

The designation offers us an opportunity to interact with FDA experts throughout the premarket review phase and allows for prioritized review of regulatory submissions.

HEPANOVA phase 2 pilot study

In 2018, we opened our HEPANOVA study, a single-arm, phase 2 pilot clinical study in liver cancer testing the safety and efficacy of TTFields in combination with sorafenib for the treatment of advanced hepatocellular cancer that are not eligible for standard local therapies or surgery.

The primary endpoint is overall response rate, and secondary endpoints include progression-free and overall survival at one year.

In July 2021, we announced the final results of the HEPANOVA study.

Historical control data showed a 4.5% objective response rate and a 43% disease control rate for patients treated with sorafenib alone.

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.

These results are even more encouraging when considering the poor prognosis of the study population.

52% of the patients in HEPANOVA were categorized as Child-Pugh Class B, compared to 5% in the historical control, indicating significant liver functional compromise.

Additionally, research conducted to date has shown that TTFields anti-mitotic effect requires extended exposure to the therapy for maximum impact.

This was a challenge given median patient treatment duration of only 10 weeks during the study.

Of the patients who received at least 12 weeks of therapy, the disease control rate reached 91% with an objective response rate of 18%.

These data demonstrate that TTFields have the potential to extend survival in advanced liver cancer.

Our team, along with study investigators, are actively designing a phase 3 pivotal study that contemplates TTFields therapy together with the current standard of care, including immunotherapy.

Gastric cancer

Gastric cancer is the third leading cause of cancer deaths worldwide and the third leading cause of cancer deaths in China.

The incidence of gastric cancer is approximately 478,500 new cases annually in China, and approximately 26,000 new cases annually in the U.S.

The five-year overall survival rate of gastric cancer is approximately 36%.

Current therapies include surgery, chemotherapy, radiotherapy and targeted therapy.

A commonly used chemotherapy regimen in treating gastric cancer is XELOX, a combination of oxaliplatin and capecitabine.

In patients diagnosed with advanced gastric cancer that is no longer operable, combination chemotherapy extends progression-free survival and overall survival to 3-6 months and 8-14 months, respectively.

EF-31 phase 2 pilot study

In 2020, we opened our EF-31 study, a single-arm, phase 2 pilot clinical study in gastric cancer in partnership with Zai testing the safety and efficacy of TTFields together with XELOX chemotherapy as first-line treatment for patients with unresectable gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.

The primary endpoint is investigator-assessed objective response rate, and secondary endpoints include progression-free and overall survival.

The protocol is designed to include 25 evaluable patients who receive at least one tumor assessment.

In October 2021, we announced the final patient was enrolled in the study and data is anticipated in 2022.

The study is designed to accrue 270 patients with a minimum 12-month follow-up period following the final patient enrollment.

We anticipate completing enrollment of the METIS study in the first quarter of 2023.

Ovarian cancer

6 unchanged sentences

Almost all patients with recurrent disease ultimately develop platinum resistance, and the prognosis for this population remains poor.

INNOVATE phase 2 pilot study

In 2018, we published the results of our phase 2 pilot study in recurrent ovarian cancer, the INNOVATE study ("INNOVATE"), examining TTFields in combination with standard of care chemotherapy.

INNOVATE pilot study

In 2018, we published the results of our pilot study in recurrent ovarian cancer, the INNOVATE study ("INNOVATE"), examining TTFields in combination with standard of care chemotherapy.

INNOVATE was a multi-center, non-randomized, open-label study designed to test the feasibility, safety and preliminary efficacy of TTFields in combination with weekly paclitaxel.

The paclitaxel control arm from the bevacizumab phase 3 pivotal FDA registration study was used as a historical control in this study.

The paclitaxel control arm from the bevacizumab pivotal FDA registration study was used as a historical control in this study.

A total of 31 patients were recruited to the study with a minimum follow-up of six months.

3 unchanged sentences

Efficacy results based on the 31 evaluable patients suggested more than doubling of the progression-free survival and an improvement in overall survival among patients who received TTFields therapy with paclitaxel compared to paclitaxel alone.

INNOVATE-3 phase 3 pivotal study

In 2019, we enrolled the first patient in our INNOVATE-3 study ("INNOVATE-3"), a phase 3 pivotal study testing the effectiveness of TTFields with paclitaxel in patients with platinum-resistant ovarian cancer.

INNOVATE-3 pivotal study

In 2019, we enrolled the first patient in our INNOVATE-3 study ("INNOVATE-3"), a pivotal study testing the effectiveness of TTFields with paclitaxel in patients with platinum-resistant ovarian cancer.

It is estimated that approximately 16,000 patients are diagnosed with platinum-resistant ovarian cancer each year in the U.S.

1 unchanged sentence

Secondary endpoints include progression-free survival, objective response rate, severity and frequency of adverse events, time to undisputable deterioration in health-related quality of life or death, and quality of life.

The study is designed to accrue 540 patients with data analyzed 18 months after the last patient in.

In October 2021, we announced that the final patient was enrolled in the pivotal INNOVATE-3 study.

A DMC will conduct the pre-specified interim analysis pursuant to the study protocol in 2022 and data is anticipated in 2023.The European Network for Gynaecological Oncological Trial groups ("ENGOT") and The GOG Foundation, Inc.

The study is designed to accrue 540 patients with 18-month follow-up after the last patient in.

In 2021, we announced that the final patient was enrolled in the pivotal INNOVATE-3 study.

In March 2022, we announced that an independent DMC conducted a pre-specified interim analysis for the study.

As part of the interim analysis, the DMC reviewed the safety data for all enrolled patients and completed an analysis of overall survival on the first 540 patients randomized in the study.

The interim analysis did not indicate a need to increase the patient sample size and the DMC recommended that the study should continue to final analysis as planned.

We anticipate that final data will be released in 2023, following completion of a minimum 18-month follow-up period.

The European Network for Gynaecological Oncological Trial groups ("ENGOT") and The GOG Foundation, Inc.

("GOG"), third-party clinical study networks, are collaborating with us on the study.

7 unchanged sentences

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.

PANOVA phase 2 pilot study

In 2018, we published the results of our phase 2 pilot study in advanced pancreatic adenocarcinoma, the PANOVA study ("PANOVA"), examining TTFields in combination with standard of care chemotherapy.

PANOVA pilot study

In 2018, we published the results of our pilot study in advanced pancreatic adenocarcinoma, the PANOVA study ("PANOVA"), examining TTFields in combination with standard of care chemotherapy.

PANOVA was a multicenter, non-randomized, open-label study.

4 unchanged sentences

In the first cohort, efficacy results showed that progression-free survival and overall survival of patients treated with TTFields combined with gemcitabine were more than double those of gemcitabine-treated historical controls.

Median progression-free survival in the TTFields-treated group was 8.3 months (compared to 3.7 months in the gemcitabine historical control), with locally advanced patients reaching a median progression-free survival of 10.3 months and patients with metastatic disease reaching a median progression-free survival of 5.7 months.

months and patients with metastatic disease reaching a median progression-free survival of 5.7 months.

The median overall survival for all patients was 14.9 months (compared to 6.7 months in the gemcitabine historical control).

1 unchanged sentence

Patients with metastatic disease experienced a median overall survival of 8.3 months.

survival was 55% (compared to 22% in the gemcitabine historical control).

One-year survival was 55% (compared to 22% in the gemcitabine historical control).

Of 11 patients with available CT scans, 5 (45%) had a partial response (compared to 7% with gemcitabine alone), 5 (45%) had stable disease, which means that the cancer is neither decreasing nor increasing in extent or severity, and 1 (10%) had progressive disease.

5 unchanged sentences

Patients reported no serious adverse events related to TTFields.

PANOVA-3 phase 3 pivotal study

In 2018, we enrolled the first patient in our PANOVA-3 study ("PANOVA-3"), a phase 3 pivotal study testing the effectiveness of TTFields with nab-paclitaxel and gemcitabine versus nab-paclitaxel and gemcitabine alone as a front-line treatment for unresectable locally advanced pancreatic cancer.

PANOVA-3 pivotal study

In 2018, we enrolled the first patient in our PANOVA-3 study ("PANOVA-3"), a pivotal study testing the effectiveness of TTFields with nab-paclitaxel and gemcitabine versus nab-paclitaxel and gemcitabine alone as a front-line treatment for unresectable locally advanced pancreatic cancer.

It is estimated that approximately 43,000 patients are diagnosed with unresectable pancreatic cancer each year in the U.S.

1 unchanged sentence

Secondary endpoints include progression-free survival, local progression-free survival, objective response rate, one-year survival rate, quality of life, pain-free survival, resectability rate and toxicity.

The study is designed to accrue 556 patients with data analyzed 18 months after the last patient in.

The study is designed to accrue 556 patients.

In February 2023, we announced that the final patient was enrolled in the pivotal PANOVA-3 study, beginning the minimum 18-month follow-up period.

A DMC will conduct a pre-specified interim analysis pursuant to the study protocol and final data is anticipated in 2024.

Liver cancer is a leading cause of cancer deaths worldwide and is the sixth leading cause of cancer deaths annually in the U.S.

The incidence of liver cancer is approximately 42,000 new cases annually in the U.S.

The five-year survival rate with existing standards of care is less than 20%.

Hepatocellular carcinoma is the most widespread type of cancer that originates from the liver.

Advanced liver cancer has spread either to the lymph nodes or to other organs and, because these cancers are widespread, they cannot be treated with surgery.

In 2021, we announced that the FDA granted breakthrough designation to the NovoTTF-200T System, a TTFields device intended for use together with atezolizumab and bevacizumab for the first-line treatment of patients with unresectable or metastatic liver cancer.

The designation offers us an opportunity to interact with FDA experts throughout the premarket review phase and allows for prioritized review of regulatory submissions.

HEPANOVA pilot study

In 2021, we announced the final results of our HEPANOVA study, a single-arm pilot study evaluating the safety and efficacy of TTFields in combination with sorafenib for the treatment of advanced hepatocellular cancer.

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.

These results are even more encouraging when considering the poor prognosis of the study population.

52% of the patients in HEPANOVA were categorized as Child-Pugh Class B, compared to 5% in the historical control, indicating significant liver functional compromise.

Additionally, research conducted to date has shown that TTFields anti-mitotic effect requires extended exposure to

the therapy for maximum impact.

This was a challenge given median patient treatment duration of only 10 weeks during the study.

Of the patients who received at least 12 weeks of therapy, the disease control rate reached 91% with an objective response rate of 18%.

These data demonstrate that TTFields have the potential to extend survival in advanced liver cancer.

Gastric cancer

Gastric cancer is the third leading cause of cancer deaths worldwide and the third leading cause of cancer deaths in China.

The incidence of gastric cancer is approximately 478,500 new cases annually in China, and approximately 26,000 new cases annually in the U.S.

The five-year overall survival rate of gastric cancer is approximately 36%.

Current therapies include surgery, chemotherapy, radiotherapy and targeted therapy.

A commonly used chemotherapy regimen in treating gastric cancer is XELOX, a combination of oxaliplatin and capecitabine.

EF-31 pilot study

In June 2022, we announced the results from our EF-31 pilot study, a single-arm study evaluating the safety and efficacy of TTFields 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.

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%.

Zai License and Collaboration Agreement

17 unchanged sentences

We have also filed several hundred additional patent applications worldwide, that, if issued, may protect aspects of our platform beyond the current last-to-expire patent in the relevant market.

pending applications cover innovations relating to our arrays, field generators and software platform, in addition to other topics related to TTFields.

These pending applications cover innovations relating to our arrays, field generators and software platform, in addition to other topics related to TTFields.

Our reliance on intellectual property involves certain risks, as described under the heading "Risk factors—Risks relating to intellectual property."

7 unchanged sentences

For additional information, see Note 12 to the Consolidated Financial Statements.

In 2015, we entered into a settlement agreement with the Technion Research and Development Foundation to resolve certain potential disputes regarding intellectual property developed by our founder and previously assigned to us.

In 2005, we granted an exclusive license to a third party, NovoBiotic LLC, to certain of our key intellectual property for use outside the field of oncology.

In December 2020, we entered into an agreement with Novobiotic LLC that terminated all pre-existing agreements between the parties, including any restrictions on our use of intellectual property outside the field of oncology.

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

13 unchanged sentences

In the U.S., our Products and our operations are subject to extensive regulation by the FDA under the Federal Food, Drug, and Cosmetic Act ("FDCA").

In the EU member states where we market our Products and operate, we are currently subject to, inter alia, the Medical Device Directive ("MDD") as implemented into national legislation by the EU member states.

On May 26, 2021, the MDD was replaced and repealed by the Medical Device Regulation ("MDR"), which applies directly in all EU member states.

In Switzerland, our Products and operations are subject to, inter alia, the Medical Devices Ordinance, which implements the MDD into Swiss law (See "Foreign approvals and CE mark" below).

In the EU member states where we market our Products and operate, we are currently subject to, inter alia, the Medical Device Regulation ("MDR") as implemented into national legislation by the EU member states, and as amended from time to time, as well as local applicable law.

The MDR replaced the Medical Device Directive ("MDD") on May 26, 2021.

In Switzerland, our Products and operations are subject to, inter alia, the Medical Devices Ordinance, which implements the MDR into Swiss law (See "Foreign approvals and CE mark" below).

In Japan, our Products and operations are subject to regulation by the Pharmaceuticals and Medical Device Agency ("PMDA") under the Pharmaceuticals and Medical Devices Act ("PMD Act").

In addition, our Products must meet the requirements of a large and growing body of national, regional and international standards that govern the preclinical and clinical testing, manufacturing, labeling, certification, storage, recordkeeping, advertising, promotion, export and marketing and distribution, among other things, of our Products for current and future indications.

In the UK, our Products and operations 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.

certification, storage, recordkeeping, advertising, promotion, export and marketing and distribution, among other things, of our Products for current and future indications.

In the U.S., advertising and promotion of medical devices, in addition to being regulated by the FDA, is also regulated by the Federal Trade Commission and by state regulatory and enforcement authorities.

In the EU, advertising and promotion is subject to not only the general provisions of the MDD or MDR, but also general EU advertising rules on misleading and comparative advertising and unfair commercial practices, as implemented at the EU member state level, such as the Heilmittelwerbegesetz in Germany.

In the EU, advertising and promotion is subject to not only the general provisions of the MDR, but also general EU advertising rules on misleading and comparative advertising and unfair commercial practices, as implemented at the EU member state level, such as the Heilmittelwerbegesetz in Germany.

In the UK, advertising and promotion is subject to the UK Regulations, general guidance and enforcement of the Medicines and Healthcare products Regulatory Agency (MHRA), and adherence to the Association of British HealthTech Industries (ABHI) Code of Ethical Business Practices.

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.

19 unchanged sentences

Unless an exemption applies, before we can commercially distribute medical devices in the U.S., we must obtain, depending on the type of device, either prior 510(k) clearance or premarket approval ("PMA") from the FDA.

FDA classifies medical devices into one of three classes.

The FDA classifies medical devices into one of three classes.

Devices deemed to pose lower risks are placed in either class I or II, which typically requires the manufacturer to submit to the FDA a premarket notification requesting permission to commercially distribute the device.

20 unchanged sentences

For class III devices intended to treat disease affecting 8,000 individuals or less per year in the U.S., called Humanitarian Use Devices ("HUD"), the FDA has a separate marketing authorization pathway called the HDE.

Approval basis for an HDE is a "reasonable assurance of safety" and that the probable benefit to health outweighs risk of injury from its use, which means a traditional phase 3 pivotal study usually is not required to support approval.

Approval basis for an HDE is a "reasonable assurance of safety" and that the probable benefit to health outweighs risk of injury from its use, which means a traditional pivotal study usually is not required to support approval.

In 2019, the FDA approved Optune Lua (then known as "NovoTTF-100L") for the treatment of MPM under the HDE pathway.

7 unchanged sentences

Clinical studies are subject to extensive monitoring, recordkeeping and reporting requirements.

Clinical studies must be

conducted under the oversight of an IRB for the relevant clinical study sites and must comply with FDA regulations, including those relating to current Good Clinical Practices ("cGCPs").

Clinical studies must be conducted under the oversight of an IRB for the relevant clinical study sites and must comply with FDA regulations, including those relating to current Good Clinical Practices ("cGCPs").

To conduct a clinical study, we also are required to obtain the patients’ informed consent in form and substance that complies with both FDA requirements and state and federal privacy and human subject protection regulations.

4 unchanged sentences

The FDA required a post-approval registry study as a condition of approval for Optune 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.

As with IDE studies, IND studies are subject to extensive monitoring, recordkeeping and reporting requirements, must be conducted under the oversight of an IRB, must comply with FDA drug or biologic regulations, and are required to obtain informed consent that complies with FDA requirements and state and federal privacy and human subject protection regulations.

IND clinical studies can be suspended at any time by us, the FDA or an IRB for various reasons, including a belief that the risks to study subjects outweigh the anticipated benefits.

Even if an IND study is completed, the results of clinical testing may not be sufficient to obtain FDA approval to market the product.

Foreign approvals and CE mark

2 unchanged sentences

In the European Economic Area (“EEA”), for Novocure’s devices these include the requirement to obtain a CE Certificate and to affix a CE mark to our Products.

In the EEA, whether or not we have obtained FDA approval, our devices must be subject to conformity assessment procedure involving an EEA notified body, a private organization accredited by an EEA member state to conduct conformity assessment procedures under the MDD/MDR.

Apart from low risk medical devices (Class I with no measuring function and which are not sterile), a conformity assessment procedure requires the intervention of a notified body.

The notified body typically audits and examines the device’s technical documentation, including the clinical evaluation, and the quality system for the manufacture, design and final inspection of our devices before issuing a CE Certificate demonstrating compliance with the relevant requirements or the quality system requirements laid down in the relevant Annexes to the MDD/MDR.

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.

1 unchanged sentence

authorities may be longer or shorter than that required for FDA approval.

Moreover, the MDR, which became applicable on May 26, 2021, imposed new, stricter requirements that we must comply with in order to renew the CE Certificates for our Products when these expire, or May 25, 2025, whichever comes first.

Moreover, the MDR, which became applicable on May 26, 2021, with transitional provisions for "legacy" devices under the MDD, imposed new, stricter requirements that we must comply with in order to obtain CE Certificates for new devices, and to renew the CE Certificates for our MDD-Products when these expire, or at the latest, December 31, 2027 or 2028, depending on the device, whichever comes first.

In addition, as of May 25, 2021, in the absence of a new MRA, Switzerland is now considered a non-EU “third country” with respect to medical devices, meaning that movement of our Products bearing a CE mark from the EEA to Switzerland is subject to additional requirements.

In the UK, we may continue to market and sell our Products under the CE mark until June 2023.

Thereafter, our Products will be regulated under the UK Regulations.

In the EEA, before carrying out a clinical investigation with a non-CE marked device to assess its safety or performance when in accordance with its intended use, the study sponsor must receive a positive opinion from the local ethics committee and approval from the national competent authority in the relevant EEA member states in which the clinical investigation will be conducted.

32 unchanged sentences

Department of Justice or other enforcement authorities outside of the U.S.

To date, our facility and those of our critical suppliers have been inspected by the FDA in order to obtain FDA approval of our Products.

No inspectional observations were identified and no FDA Form 483s were issued following these inspections.

DME accreditation and licensing and other requirements

In the U.S., we are subject to accreditation and licensing requirements as a DME supplier in most states and must meet the supplier standards of Medicare, Medicaid and other federal healthcare programs.

To date, our facilities and those of our critical suppliers have been inspected by several relevant regulatory authorities in order to obtain regulatory approval of our Products.

No inspectional observations were identified were issued following these inspections.

Durable medical equipment accreditation and licensing and other requirements

In the U.S., we are subject to accreditation and licensing requirements as a durable medical equipment ("DME") supplier in most states and must meet the supplier standards of Medicare, Medicaid and other federal healthcare programs.

Certain states require that DME providers maintain an in-state location.

18 unchanged sentences

The majority of states also have statutes or regulations similar to the federal Anti-Kickback Statute, Stark Law and False Claims Act laws, which apply to items and services reimbursed under Medicaid and other state programs, or, in several states, that apply regardless of the payer (e.g., including private/commercial payors or cash-pay scenarios).

Numerous federal and state laws and regulations, including 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"), govern the collection, dissemination, use, security and privacy of individually identifiable health information.

health information.

We believe we are in substantial compliance with such applicable laws and regulations, including HIPAA.

HIPAA also includes a number of federal criminal provisions, including for healthcare fraud and for false statements relating to healthcare matters.

The healthcare fraud provision prohibits knowingly and willfully executing a scheme

to defraud any healthcare benefit program, including private third-party payers.

The healthcare fraud provision prohibits knowingly and willfully executing a scheme to defraud any healthcare benefit program, including private third-party payers.

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.

39 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business