NovoCure Ltd (NVCR)
SIC breadcrumb: Manufacturing > SIC Major Group 38 > SIC 3841 Surgical & Medical Instruments & Apparatus
SEC company page: https://www.sec.gov/edgar/browse/?CIK=1645113. Latest filing source: 0001645113-26-000017.
Informational only - descriptive public-record data, not investment advice.
Business
Read NVCR's verbatim Item 1 Business section from its latest 10-K: Business.
Risk Factors
Read NVCR's verbatim Item 1A Risk Factors from its latest 10-K: Risk Factors.
Selected Fundamentals
| Metric | Value | Unit | FY | Filed |
|---|---|---|---|---|
| Revenue | 655,353,000 | USD | 2025 | 2026-02-26 |
| Net income | -136,227,000 | USD | 2025 | 2026-02-26 |
| Assets | 804,326,000 | USD | 2025 | 2026-02-26 |
Financials
Annual standardized facts from SEC companyfacts as of latest extracted filing date 2026-02-26. Source: https://data.sec.gov/api/xbrl/companyfacts/CIK0001645113.json. Derived margins, ratios, and free cash flow are computed from the extracted annual SEC facts.
| Metric | 2016 | 2017 | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|---|---|---|---|---|---|
| Revenue | 82,888,000 | 177,026,000 | 248,069,000 | 351,318,000 | 494,366,000 | 535,031,000 | 537,840,000 | 509,338,000 | 605,220,000 | 655,353,000 |
| Net income | -131,845,000 | -61,662,000 | -63,559,000 | -7,230,000 | 19,808,000 | -58,351,000 | -92,534,000 | -207,043,000 | -168,627,000 | -136,227,000 |
| Operating income | -115,317,000 | -39,328,000 | -33,672,000 | -914,000 | 30,401,000 | -44,333,000 | -89,523,000 | -232,870,000 | -170,496,000 | -153,800,000 |
| Gross profit | 36,606,000 | 121,417,000 | 168,021,000 | 262,712,000 | 387,865,000 | 420,154,000 | 422,973,000 | 381,058,000 | 468,039,000 | 488,474,000 |
| Diluted EPS | -0.69 | -0.07 | 0.18 | -0.56 | -0.88 | -1.95 | -1.56 | -1.22 | ||
| Operating cash flow | -107,592,000 | -33,134,000 | -1,865,000 | 26,620,000 | 99,148,000 | 82,756,000 | 30,788,000 | -73,336,000 | -26,369,000 | -49,031,000 |
| Capital expenditures | 5,673,000 | 7,366,000 | 6,711,000 | 10,485,000 | 14,968,000 | 24,170,000 | 21,358,000 | 27,093,000 | 42,855,000 | 26,648,000 |
| Assets | 282,081,000 | 265,298,000 | 339,793,000 | 479,448,000 | 1,051,983,000 | 1,139,495,000 | 1,191,648,000 | 1,146,129,000 | 1,240,784,000 | 804,326,000 |
| Liabilities | 139,736,000 | 151,734,000 | 227,534,000 | 261,658,000 | 575,457,000 | 729,001,000 | 750,478,000 | 783,633,000 | 880,605,000 | 463,860,000 |
| Stockholders' equity | 142,345,000 | 113,564,000 | 112,259,000 | 217,790,000 | 476,526,000 | 410,494,000 | 441,170,000 | 362,496,000 | 360,179,000 | 340,466,000 |
| Cash and cash equivalents | 99,780,000 | 78,592,000 | 140,622,000 | 177,321,000 | 234,674,000 | 208,802,000 | 115,326,000 | 240,821,000 | 163,767,000 | 93,548,000 |
| Free cash flow | -113,265,000 | -40,500,000 | -8,576,000 | 16,135,000 | 84,180,000 | 58,586,000 | 9,430,000 | -100,429,000 | -69,224,000 | -75,679,000 |
Ratios
| Metric | 2016 | 2017 | 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|---|---|---|---|---|---|
| Net margin | -34.83% | -25.62% | -2.06% | 4.01% | -10.91% | -17.20% | -40.65% | -27.86% | -20.79% | |
| Operating margin | -139.12% | -22.22% | -13.57% | -0.26% | 6.15% | -8.29% | -16.64% | -45.72% | -28.17% | -23.47% |
| Return on equity | -92.62% | -54.30% | -56.62% | -3.32% | 4.16% | -14.21% | -20.97% | -57.12% | -46.82% | -40.01% |
| Return on assets | -46.74% | -23.24% | -18.71% | -1.51% | 1.88% | -5.12% | -7.77% | -18.06% | -13.59% | -16.94% |
| Liabilities / equity | 0.98 | 1.34 | 2.03 | 1.20 | 1.21 | 1.78 | 1.70 | 2.16 | 2.44 | 1.36 |
| Current ratio | 7.10 | 4.88 | 4.98 | 5.10 | 8.80 | 7.53 | 7.00 | 5.78 | 1.46 | 2.90 |
Industry Peer Context
Net margin peer context
Operating margin peer context
ROE peer context
ROA peer context
Financial Bridges
Income statement bridge from reported figures
Figure provenance: SEC companyfacts FY 2025. Revenue: accession 0001645113-26-000017; concept Revenues; source concepts us-gaap:Revenues | Gross profit: accession 0001645113-26-000017; concept GrossProfit; source concepts us-gaap:GrossProfit | Operating income: accession 0001645113-26-000017; concept OperatingIncomeLoss; source concepts us-gaap:OperatingIncomeLoss | Net income: accession 0001645113-26-000017; concept NetIncomeLoss; source concepts us-gaap:NetIncomeLoss
Free cash flow = operating cash flow - capital expenditures
Figure provenance: SEC companyfacts FY 2025. Operating cash flow: accession 0001645113-26-000017; concept NetCashProvidedByUsedInOperatingActivities; source concepts us-gaap:NetCashProvidedByUsedInOperatingActivities | Capital expenditures: accession 0001645113-26-000017; concept PaymentsToAcquirePropertyPlantAndEquipment; source concepts us-gaap:PaymentsToAcquirePropertyPlantAndEquipment | Free cash flow: accession 0001645113-26-000017; concept NetCashProvidedByUsedInOperatingActivities - PaymentsToAcquirePropertyPlantAndEquipment; source concepts us-gaap:NetCashProvidedByUsedInOperatingActivities; us-gaap:PaymentsToAcquirePropertyPlantAndEquipment
Financial Charts
Figure provenance: SEC companyfacts. Latest point: FY 2025 ended 2025-12-31; accession 0001645113-26-000017; filed 2026-02-26. Concept: Revenues. Source concepts: us-gaap:Revenues.
Figure provenance: SEC companyfacts. Latest point: FY 2025 ended 2025-12-31; accession 0001645113-26-000017; filed 2026-02-26. Concept: NetIncomeLoss. Source concepts: us-gaap:NetIncomeLoss.
Figure provenance: SEC companyfacts. Latest point: FY 2025 ended 2025-12-31; accession 0001645113-26-000017; filed 2026-02-26. Concept: OperatingIncomeLoss. Source concepts: us-gaap:OperatingIncomeLoss.
Figure provenance: SEC companyfacts. Latest point: FY 2025 ended 2025-12-31; accession 0001645113-26-000017; filed 2026-02-26. Concept: GrossProfit. Source concepts: us-gaap:GrossProfit.
Figure provenance: SEC companyfacts. Latest point: FY 2025 ended 2025-12-31; accession 0001645113-26-000017; filed 2026-02-26. Concept: EarningsPerShareDiluted. Source concepts: us-gaap:EarningsPerShareDiluted.
Figure provenance: SEC companyfacts. Latest point: FY 2025 ended 2025-12-31; accession 0001645113-26-000017; filed 2026-02-26. Concept: NetCashProvidedByUsedInOperatingActivities. Source concepts: us-gaap:NetCashProvidedByUsedInOperatingActivities.
Figure provenance: SEC companyfacts. Latest point: FY 2025 ended 2025-12-31; accession 0001645113-26-000017; filed 2026-02-26. Concept: PaymentsToAcquirePropertyPlantAndEquipment. Source concepts: us-gaap:PaymentsToAcquirePropertyPlantAndEquipment.
Figure provenance: SEC companyfacts. Latest point: FY 2025 ended 2025-12-31; accession 0001645113-26-000017; filed 2026-02-26. Concept: Assets. Source concepts: us-gaap:Assets.
Figure provenance: SEC companyfacts. Latest point: FY 2025 ended 2025-12-31; accession 0001645113-26-000017; filed 2026-02-26. Concept: Liabilities. Source concepts: us-gaap:Liabilities.
Figure provenance: SEC companyfacts. Latest point: FY 2025 ended 2025-12-31; accession 0001645113-26-000017; filed 2026-02-26. Concept: StockholdersEquity. Source concepts: us-gaap:StockholdersEquity.
Figure provenance: SEC companyfacts. Latest point: FY 2025 ended 2025-12-31; accession 0001645113-26-000017; filed 2026-02-26. Concept: CashAndCashEquivalentsAtCarryingValue. Source concepts: us-gaap:CashAndCashEquivalentsAtCarryingValue.
Figure provenance: SEC companyfacts. Latest point: FY 2025 ended 2025-12-31; accession 0001645113-26-000017; filed 2026-02-26. Concept: NetCashProvidedByUsedInOperatingActivities - PaymentsToAcquirePropertyPlantAndEquipment. Source concepts: us-gaap:NetCashProvidedByUsedInOperatingActivities; us-gaap:PaymentsToAcquirePropertyPlantAndEquipment.
Quarterly
Quarterly standardized facts from SEC companyfacts as of latest extracted filing date 2026-07-23. Source: https://data.sec.gov/api/xbrl/companyfacts/CIK0001645113.json.
| Quarter | End Date | Revenue | Net Income | Diluted EPS | Method |
|---|---|---|---|---|---|
| 2022-Q3 | 2022-09-30 | -0.25 | reported discrete quarter | ||
| 2023-Q1 | 2023-03-31 | -0.50 | reported discrete quarter | ||
| 2023-Q2 | 2023-06-30 | -0.54 | reported discrete quarter | ||
| 2023-Q3 | 2023-06-30 | -57,418,000 | reported discrete quarter | ||
| 2023-Q3 | 2023-09-30 | 127,321,000 | -0.46 | reported discrete quarter | |
| 2023-Q4 | 2023-12-31 | 133,784,000 | -47,079,000 | derived Q4 = FY annual - nine-month YTD | |
| 2024-Q1 | 2024-03-31 | 138,503,000 | -38,760,000 | -0.36 | reported discrete quarter |
| 2024-Q2 | 2024-03-31 | -38,760,000 | reported discrete quarter | ||
| 2024-Q2 | 2024-06-30 | 150,356,000 | -0.31 | reported discrete quarter | |
| 2024-Q3 | 2024-06-30 | -33,375,000 | reported discrete quarter | ||
| 2024-Q3 | 2024-09-30 | 155,095,000 | -0.28 | reported discrete quarter | |
| 2024-Q4 | 2024-12-31 | 161,266,000 | -65,922,000 | derived Q4 = FY annual - nine-month YTD | |
| 2025-Q1 | 2025-03-31 | 154,994,000 | -34,319,000 | -0.31 | reported discrete quarter |
| 2025-Q2 | 2025-03-31 | -34,319,000 | reported discrete quarter | ||
| 2025-Q2 | 2025-06-30 | 158,805,000 | -0.36 | reported discrete quarter | |
| 2025-Q3 | 2025-06-30 | -40,139,000 | reported discrete quarter | ||
| 2025-Q3 | 2025-09-30 | 167,204,000 | -0.33 | reported discrete quarter | |
| 2025-Q4 | 2025-12-31 | 174,350,000 | -24,499,000 | derived Q4 = FY annual - nine-month YTD | |
| 2026-Q1 | 2026-03-31 | 174,055,000 | -71,138,000 | -0.62 | reported discrete quarter |
| 2026-Q2 | 2026-03-31 | -71,138,000 | reported discrete quarter | ||
| 2026-Q2 | 2026-06-30 | 183,584,000 | -0.13 | reported discrete quarter |
Quarterly Charts
Figure provenance: SEC companyfacts. Latest point: FY 2026 ended 2026-06-30; accession 0001645113-26-000062; filed 2026-07-23. Concept: Revenues. Source concepts: us-gaap:Revenues.
Figure provenance: SEC companyfacts. Latest point: FY 2026 ended 2026-03-31; accession 0001645113-26-000042; filed 2026-04-30. Concept: NetIncomeLoss. Source concepts: us-gaap:NetIncomeLoss.
Figure provenance: SEC companyfacts. Latest point: FY 2026 ended 2026-06-30; accession 0001645113-26-000062; filed 2026-07-23. Concept: EarningsPerShareDiluted. Source concepts: us-gaap:EarningsPerShareDiluted.
Macro Cross-References
- CPIAUCSL - Consumer Price Index for All Urban Consumers: All Items in U.S. City Average
- UNRATE - Unemployment Rate
- FEDFUNDS - Federal Funds Effective Rate
- CES0500000003 - Average Hourly Earnings of All Employees, Total Private
- DFEDTARU - Federal Funds Target Range - Upper Limit
- DFEDTARL - Federal Funds Target Range - Lower Limit
- DGS3MO - Market Yield on U.S. Treasury Securities at 3-Month Constant Maturity
- DGS2 - Market Yield on U.S. Treasury Securities at 2-Year Constant Maturity
- DGS10 - Market Yield on U.S. Treasury Securities at 10-Year Constant Maturity
- DGS30 - Market Yield on U.S. Treasury Securities at 30-Year Constant Maturity
- T10Y2Y - 10-Year Treasury Constant Maturity Minus 2-Year Treasury Constant Maturity
- CPILFESL - Consumer Price Index for All Urban Consumers: All Items Less Food and Energy
- CPIUFDSL - Consumer Price Index for All Urban Consumers: Food
- CPIENGSL - Consumer Price Index for All Urban Consumers: Energy
- CUSR0000SAH1 - Consumer Price Index for All Urban Consumers: Shelter
- PCEPI - Personal Consumption Expenditures: Chain-type Price Index
- PCEPILFE - Personal Consumption Expenditures Excluding Food and Energy: Chain-type Price Index
- PPIACO - Producer Price Index by Commodity: All Commodities
- T10YIE - 10-Year Breakeven Inflation Rate
- U6RATE - Total Unemployed, Plus All Marginally Attached Workers Plus Total Employed Part Time for Economic Reasons
- PAYEMS - All Employees, Total Nonfarm
- CIVPART - Labor Force Participation Rate
- EMRATIO - Employment-Population Ratio
- UNEMPLOY - Unemployed
- CE16OV - Employment Level
- ICSA - Initial Claims
- JTSJOL - Job Openings: Total Nonfarm
- JTSQUR - Quits: Total Nonfarm
- GDPC1 - Real Gross Domestic Product
- A191RL1Q225SBEA - Real Gross Domestic Product: Percent Change from Preceding Period
- INDPRO - Industrial Production: Total Index
- TCU - Capacity Utilization: Total Index
- HOUST - New Privately-Owned Housing Units Started: Total Units
- PERMIT - New Privately-Owned Housing Units Authorized in Permit-Issuing Places: Total Units
- RSAFS - Advance Retail Sales: Retail Trade
- PCE - Personal Consumption Expenditures
- DSPIC96 - Real Disposable Personal Income
- PSAVERT - Personal Saving Rate
- M2SL - M2
- BOPGSTB - U.S. International Trade in Goods and Services: Balance
- MSPUS - Median Sales Price of Houses Sold for the United States
- HSN1F - New One Family Houses Sold: United States
- RHORUSQ156N - Homeownership Rate in the United States
- TTLCONS - Total Construction Spending: Total Construction in the United States
- RRVRUSQ156N - Rental Vacancy Rate in the United States
- TOTALSL - Total Consumer Credit Owned and Securitized
- REVOLSL - Revolving Consumer Credit Owned and Securitized
- DRCCLACBS - Delinquency Rate on Credit Card Loans, All Commercial Banks
- GDP - Gross Domestic Product
- GPDI - Gross Private Domestic Investment
- GCE - Government Consumption Expenditures and Gross Investment
- PCEC - Personal Consumption Expenditures
- NETEXP - Net Exports of Goods and Services
- GFDEBTN - Federal Debt: Total Public Debt
- GFDEGDQ188S - Federal Debt: Total Public Debt as Percent of Gross Domestic Product
- FYFSD - Federal Surplus or Deficit
- FGRECPT - Federal Government Current Receipts
- FGEXPND - Federal Government: Current Expenditures
- MANEMP - All Employees, Manufacturing
- USCONS - All Employees, Construction
- USTRADE - All Employees, Retail Trade
- USFIRE - All Employees, Financial Activities
- USGOVT - All Employees, Government
- AWHAETP - Average Weekly Hours of All Employees, Total Private
- DGORDER - Manufacturers' New Orders: Durable Goods
- NEWORDER - Manufacturers' New Orders: Nondefense Capital Goods Excluding Aircraft
- BUSINV - Total Business Inventories
- EXPGS - Exports of Goods and Services
- IMPGS - Imports of Goods and Services
- IR - Import Price Index (End Use): All Commodities
- PPIFIS - Producer Price Index by Commodity: Final Demand
Latest quarter (10-Q)
Latest 10-Q source: 0001645113-26-000062.
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Management’s Discussion and Analysis of Financial Condition and Results of Operations (“MD&A”) is intended to provide information to assist you in better understanding and evaluating our financial condition and results of operations. We encourage you to read this MD&A in conjunction with our unaudited consolidated financial statements and the notes thereto for the period ended June 30, 2026 included in Part I, Item 1 of this Quarterly Report on Form 10-Q. This discussion contains forward-looking statements that involve risks and uncertainties. Please refer to the information under the heading “Cautionary Note Regarding Forward-Looking Statements” elsewhere in this report. References to the words “we,” “our,” “us,” and the “Company” in this report refer to NovoCure Limited, including its consolidated subsidiaries.
Critical Accounting Policies and Estimates
In accordance with U.S. generally accepted accounting principles (“GAAP”), in preparing our financial statements, we must make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of net revenues and expenses during the reporting period. We develop and periodically change these estimates and assumptions based on historical experience and on various other factors that we believe are reasonable under the circumstances. Actual results may differ from these estimates.
The critical accounting policies requiring estimates, assumptions and judgments that we believe have the most significant impact on our consolidated financial statements can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025 (the "2025 10-K"). For additional information, see Note 1 to our unaudited consolidated financial statements in Part I, Item 1 of this Quarterly Report. There were no other material changes to our critical accounting policies and estimates as compared to the critical accounting policies and estimates described in our 2025 10-K.
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. Our key priorities are to drive commercial adoption of Optune Gio®, Optune Lua®, and Optune Pax® (collectively, our "Products"), 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.
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 also have a CE certificate to market Optune Gio 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 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. We also have a CE certificate to market Optune Lua concurrent with PD-1/PD-L1 inhibitors or docetaxel following progression on or after a platinum-based regimen for the treatment of metastatic NSCLC in the EU. In addition, we received regulatory approval in Japan for the use of 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.
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. We have also have a CE certificate in the EU and approval or local registration to market Optune Lua for the treatment of MPM in certain other countries.
Optune Pax is approved by the FDA under the PMA pathway for the treatment of adult patients with locally advanced pancreatic cancer concurrent with gemcitabine and nab-paclitaxel. We also have a CE certificate to market Optune Pax for the treatment of adult patients with locally advanced pancreatic cancer of exocrine origin,
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concomitant with gemcitabine and nab-paclitaxel in accordance with guideline recommendations. We have submitted the regulatory application required to market Optune Pax in Japan.
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. We are actively evaluating opportunities to expand access to Optune Gio, Optune Lua and Optune Pax in additional international markets.
We have established coverage policies with both public and private payers for the use of Optune Gio in our active markets. In March, we announced the approval of a national reimbursement coverage policy in Japan for the use of Optune Lua for the treatment of NSCLC. We are actively pursuing coverage policies with payers to expand access to our Products and in the meantime we will bill and seek reimbursement from payers on an individual case basis, as applicable.
In September 2025, we presented final data from the Phase 3 METIS clinical trial evaluating the use of TTFields therapy and best supportive care for the treatment of adult patients (n=298) with 1-10 brain metastases from NSCLC following stereotactic radiosurgery ("METIS") at the 2025 American Society for Radiation Oncology Annual Meeting. The METIS trial met its primary endpoint, demonstrating a statistically significant improvement in time to intracranial progression for patients treated with TTFields therapy and supportive care compared to patients treated with supportive care alone. In December 2025, we submitted the final module of our PMA application with the FDA seeking approval for the use of TTFields therapy for the treatment of brain metastases from NSCLC under the brand name Optune Mya®.
In March, we announced topline results from the Phase 2 PANOVA-4 clinical trial ("PANOVA-4") evaluating the use of TTFields therapy together with atezolizumab, gemcitabine and nab-paclitaxel (collectively, "systemic therapies") for the treatment of metastatic pancreatic cancer. PANOVA-4 met its pre-specified primary endpoint, achieving a statistically significant improvement in disease control rate (DCR) compared to the DCR reported in the Phase 3 MPACT study used as the historical control. Patients in PANOVA-4 achieved a DCR of 74% compared 48% in patients receiving gemcitabine and nab-paclitaxel alone (N=431) in the MPACT trial (difference = 26.4%, 1-sided p-value 0.001). Secondary endpoint analyses for overall survival (OS) and objective response rate (ORR) were also completed, with PANOVA-4 patients exhibiting a median OS of 9.7 months and ORR of 34.6% (95% CI, 24.2% - 46.2%). Median duration of treatment with TTFields therapy was 25.6 weeks and six cycles of systemic therapies. TTFields therapy was well-tolerated and device related safety was consistent with prior clinical studies.
In June, we announced topline results from the Phase 3 TRIDENT trial ("TRIDENT"), evaluating the initiation of TTFields therapy at the start of chemoradiation ("Early Start Arm") compared to initiation of TTFields therapy during the maintenance phase of treatment ("Maintenance Start Arm"), following completion of chemoradiation, for the treatment of newly diagnosed GBM. TRIDENT did not show a statistically significant improvement in the primary endpoint of overall survival. Patients randomized to the Early Start Arm demonstrated a median overall survival of 17.7 months compared to 17.5 months in the Maintenance Start Arm (HR 0.953; p=0.519). Survival results in both study arms were durable over a long-term period. One-, two-, and three-year survivals rates in the Early Start Arm were 70.9%, 33.9%, and 22.5%, respectively, and 72.0%, 31.6%, and 18.4%, respectively, in the Maintenance Start Arm. TTFields therapy was well-tolerated and device related safety was consistent with prior clinical studies. Full results from the TRIDENT trial have been accepted for presentation at the American Society for Radiation Oncology 2026 Annual Meeting.
In June, we announced that we received a CE certificate to market Optune Pax for the first-line treatment of locally advanced pancreatic cancer of exocrine origin, concomitant with gemcitabine and nab-paclitaxel (gem/nab-pac) in accordance with guideline recommendations. The CE Mark is supported by data from the Phase 3 PANOVA-3 trial ("PANOVA-3"), which demonstrated a statistically significant improvement in median OS for patients treated with Optune Pax and gem/nab-pac, compared to patients who received gem/nab-pac alone, while also significantly extending time to pain progression. Because the use of gem/nab-pac may vary by market, the approved CE certificate intended purpose for Optune Pax includes a reference to guideline recommendations to account for local differences. We began certifying prescribing physicians for Optune Pax in Germany in July.
We believe the physical mechanisms of action behind TTFields therapy may be broadly applicable to solid tumor cancers. We have several ongoing clinical trials which further explore the use of TTFields therapy in these solid tumor cancers, including our Phase 3 KEYNOTE D58 trial in GBM, which we expect to complete enrollment by the end of 2026, and our Phase 3 LUNAR-2 trial in NSCLC. We anticipate expanding our clinical pipeline over time to study the safety and efficacy of TTFields therapy for our existing and additional solid tumor indications and for use together with other cancer treatment modalities.
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We are exploring options to modify our LUNAR-2 trial design with the goals of compressing the timeline to completion and significantly reducing costs. We anticipate engaging with regulators in the coming months regarding potential protocol revisions to streamline the trial’s primary endpoints with the goal of reducing the patient sample size.
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. 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. ("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 13 to the Annual Consolidated Financial Statements.
We view our operations and manage our business in one operating segment. For the three and six months ended June 30, 2026, our net revenues were $183.6 million and $357.6 million, respectively. Our net loss for the three and six months ended Jun
[Excerpt truncated for page length; source filing is linked above.]
Latest 10-K MD&A
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Management’s Discussion and Analysis of Financial Condition and Results of Operations ("MD&A") is intended to provide information to assist you in better understanding and evaluating our financial condition and results of operations. We encourage you to read this MD&A in conjunction with our consolidated financial statements and the notes thereto included in Part II, Item 8 of this Annual Report on Form 10-K. This discussion contains forward-looking statements that involve risks and uncertainties. Please refer to the information under the heading "Cautionary Note Regarding Forward-Looking Statements" elsewhere in this report. References to the words "we," "our," "us," and the "Company" in this report refer to NovoCure Limited, including its consolidated subsidiaries.
Commentary on Results of Operations
Net revenues
Our revenues are primarily derived from patients using our Products in our active markets. We charge for treatment with our Products on a monthly basis. Our potential net revenues per patient are determined by our ability to secure payment, the monthly fee we collect and the number of months that the patient remains on therapy.
We also receive revenues pursuant to the Zai Agreement. For additional information regarding the Zai Agreement, see Note 12 to the Consolidated Financial Statements.
Cost of revenues
We contract with third parties to manufacture our Products. Our cost of revenues is primarily comprised of the following:
•disposable arrays;
•depreciation expense for the field equipment, including the electric field generator used by patients; and
•personnel and overhead costs such as facilities, freight and depreciation of property, plant and equipment associated with managing our inventory, warehousing and order fulfillment functions.
Operating expenses
Our operating expenses consist of research, development and clinical studies, sales and marketing and general and administrative expenses. Personnel costs are a significant component for each category of operating expenses and consist of wages, benefits and bonuses. Personnel costs also include share-based compensation.
Research, development and clinical studies
Our research, development and clinical studies activity is focused on advancing TTFields therapy through clinical studies across multiple solid tumor types and improving the efficacy and usability of our devices. 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.
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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.
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.
Sales and marketing
Sales and marketing expenses consist primarily of personnel costs, travel, marketing and promotional activities, medical education, market access, commercial shipping and facilities costs. Over the next few years, we expect to continue to make significant expenditures associated with selling and marketing our Products, primarily in connection with continued commercialization in North America, the EU and Japan for the treatment of our approved indications. 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. 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 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.
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.
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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. 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. GAAP, in preparing our financial statements we must make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of net revenues and expenses during the reporting period. We develop and periodically change these estimates and assumptions based on historical experience and on various other factors that we believe are reasonable under the circumstances. Actual results may differ from these estimates.
The critical accounting policies requiring estimates, assumptions and judgments that we believe have the most significant impact on our consolidated financial statements are described below.
Revenue recognition
The amount of revenue recognized reflects the consideration to which we expect to be entitled to receive in exchange for our Products. For additional information, see Note 2(m) to the Consolidated Financial Statements.
We also receive revenues pursuant to the Zai Agreement. For additional information regarding the Zai Agreement, see Note 12 to the Consolidated Financial Statements.
Share-based compensation
Under the FASB's ASC 718, Compensation-Stock Compensation, we measure and recognize compensation expense for share options granted to our employees and directors and for our ESPP based on the fair value of the awards on the date of grant. 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. 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. 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.
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 compensation costs for the value of performance stock units ("PSU") over the performance period when the vesting conditions become probable in accordance with ASC 718.
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.
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.
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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. 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 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. 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.
Our field equipment consists of equipment being utilized under rental agreements accounted for on a monthly basis as an operating lease, as well as service pool equipment. Service pool equipment is equipment owned and maintained by us that is swapped for equipment that needs repair or maintenance by us while being used by a patient. We record a provision for any excess, lost or damaged equipment when warranted based on an assessment of the equipment.
We assess impairment whenever events or changes in circumstances indicate that the carrying amount of the asset is impaired or the estimated useful life is no longer appropriate. Circumstances such as changes in technology or in the way an asset is being used may trigger an impairment review. For additional information, see Notes 2(i) and 2(j) to the Consolidated Financial Statements.
Inventories
Inventories are stated at the lower of cost or net realizable value. We regularly evaluate the ability to realize the value of inventory. If the inventories are deemed damaged, if actual demand for our devices declines, or if market conditions are less favorable than those projected, inventory write-offs may be required. For additional information, see Note 2(h) to the Consolidated Financial Statements.
Income taxes
As part of the process of preparing our consolidated financial statements, we are required to calculate our income taxes based on taxable income by jurisdiction. We make certain estimates and judgments in determining our income taxes, including assessment of our uncertain tax positions, for financial statement purposes. Significant changes to these estimates may result in an increase or decrease to our tax provision in the subsequent period when such a change in estimate occurs.
Uncertain tax positions are based on estimates and assumptions that have been deemed reasonable by management. Our estimates of unrecognized tax benefits and potential tax benefits may not be representative of actual outcomes.
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. 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.
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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. The number of active patients on therapy is our principal revenue driver. 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. Prescriptions are a leading indicator of demand. A "prescription received" is a commercial order for Optune Gio or Optune Lua that is received from a physician certified to treat patients with our Products for a patient not previously on Optune Gio or Optune Lua. Orders to renew or extend treatment are not included in this total. The following tables include certain commercial operating statistics for and as of the end of the periods presented.
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The following table includes certain commercial operating statistics for and as of the end of the periods presented.
| December 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. 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.
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(2) Optune Lua includes both prescriptions for NSCLC and MPM. 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.
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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 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. 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. The overall increase for the full year includes $10.9 million of exchange rate benefits. This increase was partially offset by $6.2 million less revenue in the United States related to a reduction in one-time benefits of prior period claims. Recognized revenue from Optune Lua in the year was $10.4 million, including $5.8 million from NSCLC, and $4.6 million from MPM.
| Year ended December 31, | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2025 | 2024 | Change | % Change | |||||||||||
| Cost of revenues | $ | 166,879 | $ | 137,181 | $ | 29,698 | 22 | % |
Cost of revenues. 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 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. Cost of revenues per active patient is calculated by dividing the cost of revenues for the year less product sales to Zai for the year by the average of the active patients at the end of the each quarter in the current year and the end of the year active patients from the prior year. This annual figure is then divided by twelve to estimate the monthly cost of revenues per active patient. Sales to Zai are deducted because they are made at burdened cost and in anticipation of future royalties from Zai, and Zai patient counts are not included in our active patient population. 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. The decrease in gross margin is due to the decrease of prior period claims in the U.S. and the aforementioned higher cost of revenues, mostly related to tariffs and a higher cost per array. 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. Our current analysis of the global tariff environment leads us to believe there should not be a material impact to margins in the short-term and we are actively working to mitigate any potential impacts in the medium to long-term. The tariff environment is changing rapidly, and we cannot be assured that we will not ultimately be negatively impacted by these changes. We continue to focus on opportunities to increase efficiencies and scale within our supply chain. This focus includes evaluating new materials, manufacturers, structures and processes that could lead to lower costs.
| 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. 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. The change was primarily due to a $7.1 million increase in product development costs, an $11.5 million increase in other research and development costs mainly from a $3.7 million
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increase in regulatory expenses and a $3.1 million increase in quality and safety expenses, and $2.6 million in direct clinical trial expenses related to the ramp up of the LUNAR-2 and KEYNOTE D58 trials, partially offset by $7.2 million lower share-based compensation.
Total research and development expenses can fluctuate period-to-period dependent upon the amount of clinical research organization services delivered, clinical materials procured and the number of trials actively underway within a given period.
Sales and marketing expenses. 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. 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.
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. The decrease primarily results from a $28.8 million decrease in share-based compensation, which was the result of non-recurring shared-based compensation mostly related to the indication approval for NSCLC in 2024, partially offset by $12.8 million higher personnel and professional service expenses to support the greater company build-out to support new indications, particularly in enterprise technology as we invest in our digital infrastructure to enable scale, a $1.6 million one-time expense of obsolete technology assets, and a $2.2 million one-time expense to retire a production line related to supply chain optimization efforts.
| 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. 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.
| 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 decrease primarily reflects a one-time $14.2 million reduction from a prior year return to provision related to a filing position for the tax treatment of share-based compensation, an $11.1 million increase in current year tax benefits from share-based compensation, a primarily one-time $8.9 million reduction due to favorable U.S. tax law changes, and a $4.3 million reduction due to intercompany interest income in Switzerland and Luxembourg.
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"). We believe Adjusted EBITDA is useful to investors in evaluating our operating performance because it helps investors evaluate and compare the results of our operations from period to period by removing the impact of earnings attributable to our capital structure, tax rate and material non-cash items, specifically share-based compensation.
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
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most directly comparable U.S. GAAP operating performance measure) to Adjusted EBITDA.
| 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. The change in Adjusted EBITDA was primarily due to revenue growth from Optune Gio being offset by increasing costs for new indications. Revenue increases drove a $20.4 million increase in gross profit. The gross profit increase was offset by increased operating expenses, primarily due to our launch in NSCLC and prelaunch activities for potential new indications. 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. 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. 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. The decrease was primarily due to net cash used in financing activities, primarily attributable to the repayment of the convertible note at maturity of $560.9 million offset by proceeds of $100 million from the Tranche B Loan of the senior secured term loan credit facility.
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 expect that our research, development and clinical expenses, sales and marketing expenses and general and administrative expenses will continue to increase over the next several years and may outpace our gross profit. As a result, we may need to raise additional capital to fund our operations.
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. Adjustments to net loss for non-cash items include share-based compensation, depreciation, amortization and asset write-downs. Operating cash flows are also impacted by changes in operating assets and liabilities, principally trade payables, deferred revenues, other payables, prepaid expenses, inventory and trade receivables.
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
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activities by $22.1 million. The increase in net cash used in operating activities was driven by a decrease of net loss of $32.4 million, offset by a decrease in cash to non-cash items of $38.6 million which is primarily driven by a decrease in shared-based compensation of $55.2 million, an increase in accrued interest of $ 5.6 million, an increase of $3.7 million in asset write-downs and impairment of field equipment and an increase of $3.4 million in depreciation and amortization. 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.
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. We make such commitments through a combination of purchase orders, supplier contracts, and open orders based on projected demand information. We also have employment agreements with certain employees that require the funding of a specific level of payments if certain events, such as a change in control or termination without cause, occur. 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.
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.
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. 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. The net cash used in investing activities for 2024 was primary attributable to $ 97.4 million in net purchases of short-term investments as well as $42.9 million in property and equipment.
Financing activities
To date, our primary financing activities have been the sale of equity and the proceeds from long-term loans.
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. The net cash used in financing activities for 2025 was primarily attributable to the repayment of the convertible note at maturity of $560.9 million offset by proceeds of $100 million from the Tranche B Loan of the senior secured term loan credit facility (described below) and $6.1 million in proceeds from the exercise of options and $3.7 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. In addition, net cash provided by financing activities in 2024 was attributable to proceeds from the issuance of shares of $4.2 million and the exercise of options by $2.2 million.
Senior Secured Term Loan Credit Facility
On May 1, 2024 Novocure Luxembourg S.a.r.l. ("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"). The Facility may be drawn in up to four drawings. The Loan Agreement provides for an initial term loan in the principal amount of $100.0 million (the "Tranche A Loan"), which was funded to the Borrower on May 1, 2024 (the "Tranche A Funding Date"). 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. 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. 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. Not later than March 31, 2026, the Borrower has the option to draw an additional $100.0 million of the Facility (the
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"Tranche D Loan") if (i) we receive an approval or clearance from the U.S. Food and Drug Administration for our Tumor Treating Fields device for a pancreatic cancer indication or (ii) Trailing Four Quarters of Net Revenue is greater than $625.0 million. The obligations under the Loan Agreement are guaranteed by certain of our subsidiaries and secured by a first lien on the Borrower's and certain of our other subsidiaries’ assets. Outstanding term loans under the Loan Agreement will bear interest at an annual rate equal to 6.25% plus the three-month SOFR (subject to a 3.25% floor), payable quarterly in arrears and calculated on the basis of actual days elapsed in a 360-day year. The Borrower must pay 2.5% of additional consideration on each principal draw, with payment for the Tranche A Loan and the Tranche B Loan paid on the Tranche A Funding Date, and payments for the Tranche C Loan and the Tranche D Loan on their respective funding dates. Principal under the Facility will be repaid in eight equal quarterly repayments commencing with the third quarter of 2027 and continuing each quarter thereafter, with the final payment of outstanding principal due on the fifth anniversary of the Tranche A Funding Date. Voluntary prepayment of all, but not less than all, of the term loans outstanding is permitted at any time, subject to make-whole and prepayment premiums as set forth in the Loan Agreement. Prepayment of all term loans outstanding, subject to make-whole and prepayment premiums, is due and payable upon a change-in-control as defined in the Loan Agreement. Make-whole and prepayment premiums are due and payable for the Tranche B Loans for any voluntary prepayment of the term loans outstanding, upon a change-in-control (as defined in the Loan Agreement), and upon any acceleration of the maturity date, in each case regardless of whether the Tranche B Loan is drawn. The Loan Agreement contains a financial covenant only if the Tranche C Loan and/or Tranche D Loan are funded, in which case we are required to maintain at least Trailing Four Quarters of Net Revenue of at least $500.0 million, calculated on a trailing twelve-month basis as of the end of each fiscal quarter, beginning with the first quarter of 2027 based on year-end 2026 audited financial statements.
The draw of the Tranche B Loan closed on September 26, 2025. As of December 31, 2025 we borrowed the Tranche A Loan and the Tranche B Loan in the aggregate principal amount of $200.0 million. We did not give notice of our intent to borrow the Tranche C Loan. 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. 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.
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. 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.
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 also have a CE certificate to market Optune Gio 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 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. We also have a CE certificate to market Optune Lua concurrent with PD-1/PD-L1 inhibitors or docetaxel following progression on or after a platinum-based regimen for the treatment of metastatic NSCLC in the EU. 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.
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
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with standard chemotherapies. We have also have a CE certificate in the EU and approval or local registration to market Optune Lua for the treatment of MPM in certain other countries.
Optune Pax is approved by the FDA under the PMA pathway for the treatment of adult patients with locally advanced pancreatic cancer concurrent with gemcitabine and nab-paclitaxel. 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. We are actively evaluating opportunities to expand access to Optune Gio, Optune Lua and Optune Pax in additional international markets.
We have established coverage policies with both public and private payers for the use of Optune Gio in our active markets. We are actively pursuing coverage policies with payers to expand access to Optune Lua and Optune Pax and in the meantime we will bill and seek reimbursement from payers on an individual case basis, as applicable.
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. The primary endpoint of the METIS trial was defined as the time to intracranial progression (TTIP), as measured from the date of first SRS treatment to intracranial progression or neurological death, whichever occurred first. When accounting for competing risks using the Fine–Gray method, patients treated with TTFields therapy and BSC experienced a 28% lower risk of intracranial progression compared to those receiving BSC alone (HR=0.72, p=0.044). The median time to intracranial progression was 15.0 months in patients treated with TTFields therapy and BSC compared to 7.5 months in patients treated with BSC alone.
In December 2025 we submitted the final module of the PMA, seeking approval under the proposed brand name Optune Mya®. The PMA has been accepted as filed by the FDA, and is under substantive review.
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. 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.
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. 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. ("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.
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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. 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. Pursuant to our policy to seek and maintain second-source suppliers wherever possible, we are in the process of obtaining second-source suppliers outside of Israel when feasible; however we can provide no assurance that we will secure or maintain such suppliers on a timely basis. Where second-sources suppliers are not reasonably available, we maintain increased inventories to reduce risk.
Recent Changes to U.S. Tariff Rates
Throughout 2025 and 2026, the U.S. has increased or threatened to increase tariff rates on imported goods from numerous countries. The manufacturing of our Products and associated accessories is fully outsourced to third parties across multiple countries. In recent years, in anticipation of active patient growth and new indication launches, we began onboarding additional suppliers and/or supply nodes to increase the resilience of our network. As an example, we are in the final steps of adding production capacity in Mexico and Ireland. This also helps us provide optionality around supply routes to optimize our cost structure, including the emerging tariff landscape. Our current analysis of the global tariff environment leads us to believe there should not be a material impact to gross margins in the short-term and we are actively working to mitigate any potential impacts in the medium to long-term.
We anticipate continued volatility in the global tariff environment through 2026 and we cannot be assured that we will not ultimately be negatively impacted further by these changes.
We view our operations and manage our business in one operating segment. 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. 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.
MD&A history
Prior-year 10-K MD&A spans are extracted from SEC filings with the same bounded parser used for the latest filing. The latest 10-K appears above; prior years are below.
FY 2024 10-K MD&A
SEC filing source: 0001645113-25-000002.
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Management’s Discussion and Analysis of Financial Condition and Results of Operations ("MD&A") is intended to provide information to assist you in better understanding and evaluating our financial condition and results of operations. We encourage you to read this MD&A in conjunction with our consolidated financial statements and the notes thereto included in Part II, Item 8 of this Annual Report on Form 10-K. This discussion contains forward-looking statements that involve risks and uncertainties. Please refer to the information under the heading "Cautionary Note Regarding Forward-Looking Statements" elsewhere in this report. References to the words "we," "our," "us," and the "Company" in this report refer to NovoCure Limited, including its consolidated subsidiaries.
Commentary on Results of Operations
Net revenues
Our revenues are primarily derived from patients using our Products in our active markets. We charge for treatment with our Products on a monthly basis. Our potential net revenues per patient are determined by our ability to secure payment, the monthly fee we collect and the number of months that the patient remains on therapy.
We also receive revenues pursuant to the Zai Agreement. For additional information regarding the Zai Agreement, see Note 12 to the Consolidated Financial Statements.
Cost of revenues
We contract with third parties to manufacture our Products. Our cost of revenues is primarily comprised of the following:
•disposable arrays;
•depreciation expense for the field equipment, including the electric field generator used by patients; and
•personnel and overhead costs such as facilities, freight and depreciation of property, plant and equipment associated with managing our inventory, warehousing and order fulfillment functions.
Operating expenses
Our operating expenses consist of research, development and clinical studies, sales and marketing and general and administrative expenses. Personnel costs are a significant component for each category of operating expenses and consist of wages, benefits and bonuses. Personnel costs also include share-based compensation.
Research, development and clinical studies
Our research, development and clinical studies activity is focused on advancing TTFields therapy through clinical studies across multiple solid tumor types and improving the efficacy and usability of our devices. 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.
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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.
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.
Sales and marketing
Sales and marketing expenses consist primarily of personnel costs, travel, marketing and promotional activities, medical education, market access, commercial shipping and facilities costs. Over the next few years, we expect to continue to make significant expenditures associated with selling and marketing our Products, primarily in connection with continued commercialization in North America, the EU and Japan for the treatment of our approved indications. 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. 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.
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.
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
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transactions. 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. GAAP, in preparing our financial statements we must make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of net revenues and expenses during the reporting period. We develop and periodically change these estimates and assumptions based on historical experience and on various other factors that we believe are reasonable under the circumstances. Actual results may differ from these estimates.
The critical accounting policies requiring estimates, assumptions and judgments that we believe have the most significant impact on our consolidated financial statements are described below.
Revenue recognition
The amount of revenue recognized reflects the consideration to which we expect to be entitled to receive in exchange for our Products. For additional information, see Note 2(m) to the Consolidated Financial Statements.
We also receive revenues pursuant to the Zai Agreement. For additional information regarding the Zai Agreement, see Note 12 to the Consolidated Financial Statements.
Share-based compensation
Under the FASB's ASC 718, Compensation-Stock Compensation, we measure and recognize compensation expense for share options granted to our employees and directors and for our ESPP based on the fair value of the awards on the date of grant. 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 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.
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 compensation costs for the value of performance stock units ("PSU") over the performance period when the vesting conditions become probable in accordance with ASC 718.
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.
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. 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
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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. 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 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.
Our field equipment consists of equipment being utilized under rental agreements accounted for on a monthly basis as an operating lease, as well as service pool equipment. Service pool equipment is equipment owned and maintained by us that is swapped for equipment that needs repair or maintenance by us while being used by a patient. We record a provision for any excess, lost or damaged equipment when warranted based on an assessment of the equipment.
We assess impairment whenever events or changes in circumstances indicate that the carrying amount of the asset is impaired or the estimated useful life is no longer appropriate. Circumstances such as changes in technology or in the way an asset is being used may trigger an impairment review. For additional information, see Notes 2(i) and 2(j) to the Consolidated Financial Statements.
Inventories
Inventories are stated at the lower of cost or net realizable value. We regularly evaluate the ability to realize the value of inventory. If the inventories are deemed damaged, if actual demand for our devices declines, or if market conditions are less favorable than those projected, inventory write-offs may be required. For additional information, see Note 2(h) to the Consolidated Financial Statements.
Income taxes
As part of the process of preparing our consolidated financial statements, we are required to calculate our income taxes based on taxable income by jurisdiction. We make certain estimates and judgments in determining our income taxes, including assessment of our uncertain tax positions, for financial statement purposes. Significant changes to these estimates may result in an increase or decrease to our tax provision in the subsequent period when such a change in estimate occurs.
Uncertain tax positions are based on estimates and assumptions that have been deemed reasonable by management. Our estimates of unrecognized tax benefits and potential tax benefits may not be representative of actual outcomes.
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. 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.
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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. The number of active patients on therapy is our principal revenue driver. 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. Prescriptions are a leading indicator of demand. A "prescription received" is a commercial order for Optune Gio or Optune Lua that is received from a physician certified to treat patients with our Products for a patient not previously on Optune Gio or Optune Lua. Orders to renew or extend treatment are not included in this total. The following tables include certain commercial operating statistics for and as of the end of the periods presented.
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The following table includes certain commercial operating statistics for and as of the end of the periods presented.
| December 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. 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, 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.
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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. 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. 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. 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. 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. 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.
Cost of revenues per active patient is calculated by dividing the cost of revenues for the year less product sales to Zai for the year by the average of the active patients at the end of the each quarter in the current year and the end of the year active patients from the prior year. This annual figure is then divided by twelve to estimate the monthly cost of revenues per active patient. Sales to Zai are deducted because they are made at burdened cost and in anticipation of future royalties from Zai, and Zai patient counts are not included in our active patient population. 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. 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. 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. Our current analysis of the global tariff environment leads us to believe there should not be a material impact to margins in the short-term and we are actively working to mitigate any potential impacts in the medium to long-term. The tariff environment is changing rapidly, and we cannot be assured that we will not ultimately be negatively impacted by these changes. We continue to focus on opportunities to increase efficiencies and scale within our supply chain. This focus includes evaluating new materials, manufacturers, structures and processes that could lead to lower costs.
| 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. 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.
Total research and development expenses can fluctuate period-to-period dependent upon the amount of clinical research organization services delivered, clinical materials procured and the number of trials actively underway within a given period.
Sales and marketing expenses. 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. The change was
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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. 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. The change was primarily due to a $36.1 million increase in shared-based compensation expenses mostly related to the indication approval for NSCLC, partially offset by $10.3 million lower personnel costs and professional services costs.
| Year ended December 31, | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2024 | 2023 | Change | % Change | |||||||||||
| Financial (expenses) income, net | $ | 39,334 | $ | 41,130 | $ | (1,796) | (4) | % |
Financial (expenses) income, net. 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. 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.
| 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. The change is primarily due to a $14.3 million decrease in tax benefits from share-based compensation, $10.6 million resulting from the utilization of tax credits in 2023 related to prior years and a change in the mix of applicable statutory tax rates.
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"). We believe Adjusted EBITDA is useful to investors in evaluating our operating performance because it helps investors evaluate and compare the results of our operations from period to period by removing the impact of earnings attributable to our capital structure, tax rate and material non-cash items, specifically share-based compensation.
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.
| 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. This increase was primarily driven by revenue growth from improved approval rates in the U.S. and a successful launch in France. The revenue increase drove a $87.0 million increase in gross profit. Actions taken during the November 2023 restructuring and a heightened focus on operational efficiencies reduced total operating expenses, excluding share-based compensation, by $19.5 million year-over-year. We intend to take actions that prioritize growth and maintain financial health as we position our company for future profitability.
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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. 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. 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.
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 expect that our research, development and clinical expenses, sales and marketing expenses and general and administrative expenses will continue to increase over the next several years and may outpace our gross profit. As a result, we may need to raise additional capital to fund our operations.
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. Adjustments to net loss for non-cash items include share-based compensation, depreciation, amortization and asset write-downs. Operating cash flows are also impacted by changes in operating assets and liabilities, principally trade payables, deferred revenues, other payables, prepaid expenses, inventory and trade receivables.
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. The decrease in net cash used in operating activities was driven by an increase in gross profits of $86.9 million driven by a revenue increase of $95.9 million offset by an increase in costs of revenue of $8.9 million. Furthermore, the benefit of a higher gross profit was partially offset by increased expenses, primarily driven by a $38.0 million increase in sales, marketing, general and administrative expenses to enhance our capabilities in anticipation of potential future approvals of new indications and entry into potential new markets, offset by a $13.4 million decrease in research and development expenses. 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.
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. We make such commitments through a combination of purchase orders, supplier contracts, and open orders based on projected demand information. We also have employment agreements with certain employees that require the funding of a specific level of payments if certain events, such as a change in control or termination without cause, occur. 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.
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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.
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. 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.
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. 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 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”). The net proceeds from the offering were approximately $558.4 million. We intend to use the net proceeds to further advance our clinical and product development programs and to invest in associated pre-commercial and commercial activities, as well as for general corporate purposes.
The Notes are senior unsecured obligations. The Notes do not bear regular interest, and the principal amount of the Notes will not accrete. Special interest, if any, payable in accordance with the terms of the Notes will be payable in cash semi-annually in arrears on May 1 and November 1 of each year, beginning on May 1, 2021. 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.
The Notes are convertible at an initial conversion rate of 5.9439 ordinary shares per $1,000 principal amount of the Notes, which is equivalent to an initial conversion price of approximately $168.24 per ordinary share. In January 2021, we irrevocably elected to settle all conversions of Notes by a combination of cash and our ordinary shares and that the cash portion per $1,000 principal amount of Notes for all conversion settlements shall be $1,000, Accordingly, from and after the date of the election, upon conversion of any Notes, holders of Notes will receive, with respect to each $1,000 principal amount of Notes converted, cash in an amount up to $1,000 and the balance of the conversion value, if any, in our ordinary shares
The Notes were not redeemable prior to November 6, 2023, except in the event of certain tax law changes. We may redeem for cash all or any portion of the Notes, at our option, on or after November 6, 2023 if the last reported sale price of our ordinary shares has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on, and including, the trading day immediately preceding the date on which we provide notice of redemption at a redemption price equal to 100% of the principal amount of the Notes to be redeemed, plus accrued and unpaid special interest, if any, to, but excluding, the redemption date. No sinking fund is provided for the Notes.
Prior to the close of business on the business day immediately preceding August 1, 2025, the Notes are convertible at the option of the holders only upon the satisfaction of certain conditions and during certain periods and if we exercise our right to redeem the Notes as permitted or required by the indenture. On or after August 1, 2025 until the close of the business on the business day immediately preceding the maturity date, holders may convert all or any portion of their Notes at the conversion rate at any time irrespective of the foregoing conditions.
Senior Secured Term Loan Credit Facility
On May 1, 2024 Novocure Luxembourg S.a.r.l. ("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
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agent for the Lenders, and the guarantors party to such agreement (the "Loan Agreement"). The Facility may be drawn in up to four drawings. The Loan Agreement provides for an initial term loan in the principal amount of $100.0 million (the "Tranche A Loan"), which was funded to the Borrower on May 1, 2024 (the "Tranche A Funding Date"). 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. 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. 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. 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. Food and Drug Administration for our Tumor Treating Fields device for a pancreatic cancer indication or (ii) Trailing Four Quarters of Net Revenue is greater than $625.0 million. The obligations under the Loan Agreement are guaranteed by certain of our subsidiaries and secured by a first lien on the Borrower's and certain of our other subsidiaries’ assets. Outstanding term loans under the Loan Agreement will bear interest at an annual rate equal to 6.25% plus the three-month SOFR (subject to a 3.25% floor), payable quarterly in arrears and calculated on the basis of actual days elapsed in a 360-day year. The Borrower must pay 2.5% of additional consideration on each principal draw, with payment for the Tranche A Loan and the Tranche B Loan paid on the Tranche A Funding Date, and payments for the Tranche C Loan and the Tranche D Loan on their respective funding dates. Principal under the Facility will be repaid in eight equal quarterly repayments commencing with the third quarter of 2027 and continuing each quarter thereafter, with the final payment of outstanding principal due on the fifth anniversary of the Tranche A Funding Date. Voluntary prepayment of all, but not less than all, of the term loans outstanding is permitted at any time, subject to make-whole and prepayment premiums as set forth in the Loan Agreement. Prepayment of all term loans outstanding, subject to make-whole and prepayment premiums, is due and payable upon a change-in-control as defined in the Loan Agreement. Make-whole and prepayment premiums are due and payable for the Tranche B Loans for any voluntary prepayment of the term loans outstanding, upon a change-in-control (as defined in the Loan Agreement), and upon any acceleration of the maturity date, in each case regardless of whether the Tranche B Loan is drawn. The Loan Agreement contains a financial covenant only if the Tranche C Loan and/or Tranche D Loan are funded, in which case we are required to maintain at least Trailing Four Quarters of Net Revenue of at least $500.0 million, calculated on a trailing twelve-month basis as of the end of each fiscal quarter, beginning with the first quarter of 2027 based on year-end 2026 audited financial statements.
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. 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 therapy is delivered through a medical device and we continue to advance our Products with the intention to extend survival and maintain quality of life for patients.
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 also have a CE certificate to market Optune Gio 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 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 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. 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.
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"). The METIS trial met its primary endpoint, demonstrating a statistically
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significant improvement in time to intracranial progression for patients treated with TTFields therapy and supportive care compared to patients treated with supportive care alone.
In December 2024, we announced the top-line results from the Phase 3 PANOVA-3 clinical trial evaluating the use of TTFields therapy together with gemcitabine and nab-paclitaxel for the treatment of adult patients with unresectable, locally advanced pancreatic cancer ("PANOVA-3"). The PANOVA-3 trial met its primary endpoint, demonstrating a statistically significant improvement in overall survival for patients treated with TTFields therapy, gemcitabine and nab-paclitaxel compared to patients treated with gemcitabine and nab-paclitaxel alone. We intend to submit marketing applications to regulators in our key markets based on the results of the METIS and PANOVA-3 trials.
We believe the physical mechanisms of action behind TTFields therapy may be broadly applicable to solid tumor cancers. 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. In December 2024, we discontinued our Phase 2 KEYNOTE B36 trial, which was to explore the use of TTFields therapy together with pembrolizumab for front-line treatment of locally advanced or metastatic NSCLC. We anticipate expanding our clinical pipeline over time to study the safety and efficacy of TTFields therapy for additional solid tumor indications and for use together with other cancer treatment modalities.
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. 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. ("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.
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. 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 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 loss was $168.6 million for the year ended December 31, 2024, net
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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.
FY 2023 10-K MD&A
SEC filing source: 0001645113-24-000006.
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Management’s Discussion and Analysis of Financial Condition and Results of Operations ("MD&A") is intended to provide information to assist you in better understanding and evaluating our financial condition and results of operations. We encourage you to read this MD&A in conjunction with our consolidated financial statements and the notes thereto included in Part II, Item 8 of this Annual Report on Form 10-K. This discussion contains forward-looking statements that involve risks and uncertainties. Please refer to the information under the heading "Cautionary Note Regarding Forward-Looking Statements" elsewhere in this report. References to the words "we," "our," "us," and the "Company" in this report refer to NovoCure Limited, including its consolidated subsidiaries.
Commentary on Results of Operations
Net revenues
Our revenues are primarily derived from patients using our Products in our active markets. We charge for treatment with our Products on a monthly basis. Our potential net revenues per patient are determined by our ability to secure payment, the monthly fee we collect and the number of months that the patient remains on therapy.
We also receive revenues pursuant to the Zai Agreement. For additional information regarding the Zai Agreement, see Note 12 to the Consolidated Financial Statements.
Cost of revenues
We contract with third parties to manufacture our Products. Our cost of revenues is primarily comprised of the following:
•disposable arrays;
•depreciation expense for the field equipment, including the electric field generator used by patients; and
•personnel and overhead costs such as facilities, freight and depreciation of property, plant and equipment associated with managing our inventory, warehousing and order fulfillment functions.
Operating expenses
Our operating expenses consist of research, development and clinical studies, sales and marketing and general and administrative expenses. Personnel costs are a significant component for each category of operating expenses and consist of wages, benefits and bonuses. Personnel costs also include share-based compensation.
Research, development and clinical studies
Our research, development and clinical studies activity is focused on advancing TTFields therapy through clinical studies across multiple solid tumor types and improving the efficacy and usability of our devices. 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.
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The following table summarizes our research, development and clinical study expenses by program for the years ended December 31, 2023, 2022 and 2021:
| Year ended December 31, | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| U.S. dollars in thousands | 2023 | 2022 | 2021 | ||||||||
| Preclinical and basic research | $ | 18,936 | $ | 16,922 | $ | 15,580 | |||||
| Clinical development programs: | |||||||||||
| LUNAR | 6,846 | 6,905 | 9,069 | ||||||||
| LUNAR - 2 | 2,999 | — | — | ||||||||
| INNOVATE - 3 | 7,810 | 9,494 | 17,708 | ||||||||
| METIS | 5,758 | 8,480 | 7,056 | ||||||||
| PANOVA - 3 | 18,243 | 22,185 | 15,026 | ||||||||
| TRIDENT | 20,348 | 12,162 | 12,588 | ||||||||
| Other clinical studies | 6,640 | 5,524 | 4,634 | ||||||||
| Clinical administration | 25,363 | 22,690 | 19,764 | ||||||||
| Product development | 18,219 | 15,323 | 15,248 | ||||||||
| Clinical affairs | 15,935 | 19,891 | 24,486 | ||||||||
| Other research and development costs (1) | 44,138 | 35,719 | 32,547 | ||||||||
| Share based compensation | 31,827 | 30,790 | 27,597 | ||||||||
| Research, development and clinical studies | $ | 223,062 | $ | 206,085 | $ | 201,303 |
(1) Other research, development and clinical study costs include regulatory affairs, quality assurance, intellectual property, product safety, allocated facilities and other overhead costs.
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.
Sales and marketing
Sales and marketing expenses consist primarily of personnel costs, travel, marketing and promotional activities, medical education, market access, commercial shipping and facilities costs. Over the next few years, we expect to continue to make significant expenditures associated with selling and marketing our Products, primarily in connection with continued commercialization in North America, the EU and Japan for the treatment of our approved indications. We are prioritizing 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 following progression on or after platinum-based therapies.
General and administrative
General and administrative expenses consist primarily of personnel, professional fees and facilities costs. 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.
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.
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
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transactions. 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. GAAP, in preparing our financial statements we must make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of net revenues and expenses during the reporting period. We develop and periodically change these estimates and assumptions based on historical experience and on various other factors that we believe are reasonable under the circumstances. Actual results may differ from these estimates.
The critical accounting policies requiring estimates, assumptions and judgments that we believe have the most significant impact on our consolidated financial statements are described below.
Revenue recognition
In May 2014, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") 2014-09, Revenue from Contracts with Customers (Topic 606) (ASU 2014-09), an updated standard on revenue recognition and issued subsequent amendments to the initial guidance in March 2016, April 2016, May 2016 and December 2016 within ASU 2016-08, 2016-10, 2016-12 and 2016-20, respectively. The Company adopted the standard effective January 1, 2018 using the modified retrospective method for all contracts. The reported results for 2018 and thereafter reflect the application of Accounting Standards Codification ("ASC") 606 guidance. The amount of revenue recognized reflects the consideration to which we expect to be entitled to receive in exchange for our Products. For additional information, see Note 2(m) to the Consolidated Financial Statements.
We also receive revenues pursuant to the Zai Agreement. For additional information regarding the Zai Agreement, see Note 12 to the Consolidated Financial Statements.
Share-based compensation
Under the FASB's ASC 718, Compensation-Stock Compensation, we measure and recognize compensation expense for share options granted to our employees and directors and for our ESPP based on the fair value of the awards on the date of grant. 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, including:
•beginning with the first quarter of 2022, the computation of expected volatility is based on the historical volatility the Company's shares, beginning with the first quarter of 2021 and prior to the first quarter of 2022, the computation of expected volatility is based on a combination of actual historical share price volatility of comparable publicly-traded companies and the historical volatility the Company's shares. Prior to the first quarter of 2021, due to the lack of sufficient historical information for the Company, the computation was based on actual historical volatility of comparable publicly-traded companies;
•beginning with the first quarter of 2021, the expected term of options granted is calculated using the Company's historical and future exercise behavior. Prior to the first quarter of 2021, it was calculated using the average between the vesting period and the contractual term to the expected term of the options in effect at the time of grant;
•the risk-free interest rate, which we base on the yield curve of U.S. Treasury securities with periods commensurate with the expected term of the options being valued; and
•the expected dividend yield, which we estimate to be zero based on the fact that we have never paid cash dividends and have no present intention to pay cash dividends.
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 compensation costs for the value of performance stock units ("PSU") over the performance period when the vesting conditions become probable in accordance with ASC 718.
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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, | ||||||
|---|---|---|---|---|---|---|
| 2023 | 2022 | 2021 | ||||
| Expected term (years) | 5.50-6.00 | 5.33-5.83 | 5.50-6.00 | |||
| Expected volatility | 63%-70% | 60%-62% | 60%-63% | |||
| Risk-free interest rate | 3.48%-4.79% | 1.58%-4.23% | 0.78%-1.27% | |||
| 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.
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 $115.6 million, $107.0 million and $94.9 million during the years ended December 31, 2023, 2022 and 2021, respectively. As of December 31, 2023, we have unrecognized compensation expense of $98.6 million, which is expected to be recognized over a weighted average period of approximately 1.64 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. For additional information, see Note 15 to the Consolidated Financial Statements.
Long-lived assets
Property and equipment and field equipment are 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 make estimates of the useful life of our property and equipment and 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.
Our field equipment consists of equipment being utilized under rental agreements accounted for on a monthly basis as an operating lease, as well as service pool equipment. Service pool equipment is equipment owned and maintained by us that is swapped for equipment that needs repair or maintenance by us while being used by a patient. We record a provision for any excess, lost or damaged equipment when warranted based on an assessment of the equipment.
We assess impairment whenever events or changes in circumstances indicate that the carrying amount of the asset is impaired or the estimated useful life is no longer appropriate. Circumstances such as changes in technology or in the way an asset is being used may trigger an impairment review. For additional information, see Notes 2(i) and 2(j) to the Consolidated Financial Statements.
Inventories
Inventories are stated at the lower of cost or net realizable value. We regularly evaluate the ability to realize the value of inventory. If the inventories are deemed damaged, if actual demand for our devices declines, or if market conditions are less favorable than those projected, inventory write-offs may be required. For additional information, see Note 2(h) to the Consolidated Financial Statements.
Income taxes
As part of the process of preparing our consolidated financial statements, we are required to calculate our income taxes based on taxable income by jurisdiction. We make certain estimates and judgments in determining our income taxes, including assessment of our uncertain tax positions, for financial statement purposes. Significant changes to these estimates may result in an increase or decrease to our tax provision in the subsequent period when such a change in estimate occurs.
Uncertain tax positions are based on estimates and assumptions that have been deemed reasonable by management. Our estimates of unrecognized tax benefits and potential tax benefits may not be representative of actual outcomes.
For additional information, see Note 14 to the Consolidated Financial Statements.
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Results of operations
The following discussion provides an analysis of our results of operations and reasons for material changes therein for 2023 as compared to 2022. 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 2022 Annual Report on Form 10-K, filed with the SEC on February 23, 2023, for an analysis of the 2022 results as compared to 2021.
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 | 2023 | 2022 | 2021 | ||||||||
| Net revenues | $ | 509,338 | $ | 537,840 | $ | 535,031 | |||||
| Cost of revenues | 128,280 | 114,867 | 114,877 | ||||||||
| Gross profit | 381,058 | 422,973 | 420,154 | ||||||||
| Operating costs and expenses: | |||||||||||
| Research, development and clinical studies | 223,062 | 206,085 | 201,303 | ||||||||
| Sales and marketing | 226,809 | 173,658 | 137,057 | ||||||||
| General and administrative | 164,057 | 132,753 | 126,127 | ||||||||
| Total operating costs and expenses | 613,928 | 512,496 | 464,487 | ||||||||
| Operating income (loss) | (232,870) | (89,523) | (44,333) | ||||||||
| Financial (expenses) income, net | 41,130 | 7,677 | (7,742) | ||||||||
| Income (loss) before income tax | (191,740) | (81,846) | (52,075) | ||||||||
| Income tax | 15,303 | 10,688 | 6,276 | ||||||||
| Net income (loss) | $ | (207,043) | $ | (92,534) | $ | (58,351) | |||||
| Basic and diluted net income (loss) per ordinary share | $ | (1.95) | $ | (0.88) | $ | (0.56) | |||||
| Weighted average number of ordinary shares used in computing basic and diluted net income (loss) per share | 106,391,178 | 104,660,476 | 103,433,274 |
The following table details the share-based compensation expense included in costs and expenses:
| Year ended December 31, | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| U.S. dollars in thousands | 2023 | 2022 | 2021 | ||||||||
| Cost of revenues | $ | 6,587 | $ | 4,690 | $ | 3,471 | |||||
| Research, development and clinical studies | 31,827 | 30,790 | 27,597 | ||||||||
| Sales and marketing | 35,968 | 28,826 | 22,673 | ||||||||
| General and administrative | 41,226 | 42,649 | 41,159 | ||||||||
| Total share-based compensation expense | $ | 115,608 | $ | 106,955 | $ | 94,900 |
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. The number of active patients on therapy is our principal revenue driver. 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. Prescriptions are a leading indicator of demand. A "prescription received" is a commercial order for Optune Gio or Optune Lua that is received from a physician certified to treat patients with our Products for a patient not previously on Optune Gio or Optune Lua. Orders to renew or extend treatment are not included in this total.
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The following table includes certain commercial operating statistics for and as of the end of the periods presented.
| December 31, | |||||||
|---|---|---|---|---|---|---|---|
| Operating statistics | 2023 | 2022 | 2021 | ||||
| Active patients at period end | |||||||
| United States | 2,162 | 2,164 | 2,259 | ||||
| International markets: | |||||||
| Germany | 525 | 467 | 563 | ||||
| Japan | 375 | 369 | 307 | ||||
| Other international | 693 | 430 | 458 | ||||
| International markets - Total | 1,593 | 1,266 | 1,328 | ||||
| Total | 3,755 | 3,430 | 3,587 |
| Year ended December 31, | |||||||
|---|---|---|---|---|---|---|---|
| 2023 | 2022 | 2021 | |||||
| Prescriptions received in period | |||||||
| United States | 3,912 | 3,790 | 3,770 | ||||
| International markets: | |||||||
| Germany | 792 | 830 | 924 | ||||
| Japan | 354 | 381 | 436 | ||||
| Other international | 1,025 | 528 | 532 | ||||
| International markets - Total | 2,171 | 1,739 | 1,892 | ||||
| Total | 6,083 | 5,529 | 5,662 |
Year ended December 31, 2023 compared to year ended December 31, 2022
| Year ended December 31, | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2023 | 2022 | Change | % Change | |||||||||||
| Net revenues | $ | 509,338 | $ | 537,840 | $ | (28,502) | (5) | % |
Net revenues. Net revenues decreased by $28.5 million, or 5%, to $509.3 million for the year ended December 31, 2023 from $537.8 million for the year ended December 31, 2022. The decrease resulted primarily from $48.4 million in reduced collections from denied or appealed claims in the U.S., partially offset by an increase of $14.1 million resulting from improved reimbursement approval rates in Germany and $11.7 million from our launch in France.
Following regulatory approval and prior to the establishment of coverage criteria, we have treated on-label patients in the U.S. at risk and appealed denied claims for commercial and Medicare fee-for-service beneficiaries on a case-by-case basis. For the year ended December 31, 2023, we recorded $5 million in revenue from the successful appeal of previously denied claims for Medicare fee-for-service beneficiaries billed prior to established coverage, a decrease of $27 million from $32 million recorded for the year ended December 31, 2022. We believe collections from these claims that were most accessible were largely exhausted in 2022 and the remaining outstanding claims will take time to collect. As a result, we expect future net revenue to more closely reflect core drivers of net revenue: number of active patients on therapy, duration of therapy, and net realized price per month.
| Year ended December 31, | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2023 | 2022 | Change | % Change | |||||||||||
| Cost of revenues | $ | 128,280 | $ | 114,867 | $ | 13,413 | 12 | % |
Cost of revenues. Our cost of revenues were $128.3 million for the year ended December 31, 2023, an increase of $13.4 million, or 12%, from $114.9 million for the year ended December 31, 2022. Excluding sales to Zai, cost of revenues per active patient per month were $2,714 for the year ended December 31, 2023 compared to $2,481 for the year ended December 31, 2022 driven by higher costs of arrays from our initial roll out of a next generation array and an increase in capacity of patient support services in anticipation of new indications.
Cost of revenues per active patient is calculated by dividing the cost of revenues for the year less product sales to Zai for the year by the average of the active patients at the end of the each quarter in the current year and the end
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of the year active patients from the prior year. This annual figure is then divided by twelve to estimate the monthly cost of revenues per active patient. Sales to Zai are deducted because they are made at burdened cost and in anticipation of future royalties from Zai, and Zai patient counts are not included in our active patient population. Product's cost sold to Zai totaled $12.0 million for the year ended December 31, 2023 compared to $11.1 million for the year ended December 31, 2022.
Gross margin was 75% for the year ended December 31, 2023 and 79% for the year ended December 31, 2022. We expect that our gross margins will continue to be impacted by current and future product enhancements, such as the ongoing launch of next generation arrays. We continue to focus on opportunities to increase efficiencies and scale within our supply chain. This includes evaluating new materials, manufacturers, and processes that could lead to lower cost.
| Year ended December 31, | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2023 | 2022 | Change | % Change | |||||||||||
| Operating expenses: | ||||||||||||||
| Research, development and clinical studies | $ | 223,062 | $ | 206,085 | $ | 16,977 | 8 | % | ||||||
| Sales and marketing | 226,809 | 173,658 | 53,151 | 31 | % | |||||||||
| General and administrative | 164,057 | 132,753 | 31,304 | 24 | % | |||||||||
| Total operating expenses | $ | 613,928 | $ | 512,496 | $ | 101,432 | 20 | % |
Research, development and clinical studies expenses. Research, development and clinical studies expenses increased by $17.0 million, or 8%, to $223.1 million for the year ended December 31, 2023 from $206.1 million for the year ended December 31, 2022. The change is primarily due to an increase of $11.0 million in costs incurred in support of ongoing and anticipated clinical trial launches and regulatory filings.
Total research and development expenses can fluctuate period-to-period dependent upon the amount of clinical research organization services delivered, clinical materials procured and the number of trials actively underway within a given period.
Sales and marketing expenses. Sales and marketing expenses increased by $53.2 million, or 31%, to $226.8 million for the year ended December 31, 2023 from $173.7 million for the year ended December 31, 2022. The change primarily was due to an increase of $37.6 million in costs associated with geographic expansion and pre-launch activities intended to increase awareness of TTFields therapy in anticipation of our launch in NSCLC, as well as an increase in non-cash personnel costs of $7.1 million.
General and administrative expenses. General and administrative expenses increased by $31.3 million, or 24%, to $164.1 million for the year ended December 31, 2023 from $132.8 million for the year ended December 31, 2022. The change was due to increases of $20.2 million in costs associated with increased personnel and services to support our anticipated launch in NSCLC and new geographies, as well as $11.1 million in costs associated with information technology services and personnel.
| Year ended December 31, | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2023 | 2022 | Change | % Change | |||||||||||
| Financial (expenses) income, net | $ | 41,130 | $ | 7,677 | $ | 33,453 | 436 | % |
Financial (expenses) income, net. Financial income, net, increased by $33.5 million, or 436%, to $41.1 million income for the year ended December 31, 2023 from $7.7 million income for the year ended December 31, 2022. The increase was primarily driven by an increase in interest income of $30.4 million and a decrease of foreign exchange expenses of $3.1 million.
| Year ended December 31, | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2023 | 2022 | Change | % Change | |||||||||||
| Income tax | $ | 15,303 | $ | 10,688 | $ | 4,615 | 43 | % |
Income taxes. Income tax expenses increased by $4.6 million, or 43%, resulting in a tax expense of $15.3 million for the year ended December 31, 2023 compared to a tax expense of $10.7 million for the year ended December 31, 2022. The increase reflects a change in the mix of applicable statutory tax rates in active jurisdictions.
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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"). We believe Adjusted EBITDA is useful to investors in evaluating our operating performance because it helps investors evaluate and compare the results of our operations from period to period by removing the impact of earnings attributable to our capital structure, tax rate and material non-cash items, specifically share-based compensation.
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.
| Year ended December 31, | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2023 | 2022 | 2021 | |||||||||
| Net income (loss) | $ | (207,043) | $ | (92,534) | $ | (58,351) | |||||
| Add: Income tax | 15,303 | 10,688 | 6,276 | ||||||||
| Add: Financial expenses (income), net | (41,130) | (7,677) | 7,742 | ||||||||
| Add: Depreciation and amortization | 10,969 | 10,624 | 10,251 | ||||||||
| EBITDA | $ | (221,901) | $ | (78,899) | $ | (34,082) | |||||
| Add: Share-based compensation | 115,608 | 106,955 | 94,900 | ||||||||
| Adjusted EBITDA | $ | (106,293) | $ | 28,056 | $ | 60,818 |
Adjusted EBITDA decreased by $134.3 million, or 479%, to $(106.3) million for the year ended December 31, 2023 from $28.1 million for the year ended December 31, 2022. This decrease was primarily attributable to increased growth investments intended to expand our capacity to treat larger patient populations, to enhance commercial capabilities and to increase awareness of TTFields in anticipation of potential future approvals in new indications, and a reduction in revenue as described above.
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. As of December 31, 2023, we had an accumulated deficit of $985.5 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, 2023, we had $240.8 million in cash and cash equivalents and $669.8 million in short-term investments. At December 31, 2023, our cash, cash equivalents and short-term investments totaled $910.6 million, a decrease of $58.8 million compared to $969.4 million at December 31, 2022. The decrease was primarily due to net cash used in operating activities partially offset by the net cash provided by the exercise of options.
We believe our cash, cash equivalents and short-term investments as of December 31, 2023 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 expect that our research, development and clinical expenses, sales and marketing expenses and general and administrative expenses will continue to increase over the next several years and may outpace our gross profit. As a result, we may need to raise additional capital to fund our operations.
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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 | 2023 | 2022 | 2021 | ||||||||
| Net cash provided by (used in) operating activities | $ | (73,336) | $ | 30,788 | $ | 82,756 | |||||
| Net cash provided by (used in) investing activities | 184,148 | (139,957) | (144,834) | ||||||||
| Net cash provided by (used in) financing activities | 15,787 | 15,491 | 25,702 | ||||||||
| Effect of exchange rate changes on cash and cash equivalents | 131 | (97) | (188) | ||||||||
| Net increase (decrease) in cash, cash equivalents and restricted cash | $ | 126,730 | $ | (93,775) | $ | (36,564) |
Operating activities
Net cash used in operating activities primarily represents our net loss for the periods presented. Adjustments to net loss for non-cash items include share-based compensation, depreciation, amortization and asset write-downs. Operating cash flows are also impacted by changes in operating assets and liabilities, principally trade payables, deferred revenues, other payables, prepaid expenses, inventory and trade receivables.
Net cash used in operating activities was $73.3 million for the year ended December 31, 2023 compared to $30.8 million provided by operating activities for the year ended December 31, 2022 a decrease of $ 104.1 million. The decrease in net cash from operating activities was driven by a decrease in gross profits of $41.9 million driven by a revenue decrease of $28.5 million and an increase in costs of revenue of $13.4 million. In addition, the decrease in net cash from operating activities was driven by increased expenses, primarily driven by a $84.5 million increase in sales, marketing, general and administrative expenses to enhance our capabilities in anticipation of potential future approvals of new indications and entry into potential new markets, and a $17.0 million increase in research and development expenses. In addition, finance income increased by $33.5 million driven by higher interest returns on our investments, tax expenses increased by $ 4.6 million and share based compensation increased by $8.7 million.
Upcoming use of cash in operations will include payments in the normal course of business of $43.1 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 $34.5 million of commitments with three major suppliers. We make such commitments through a combination of purchase orders, supplier contracts, and open orders based on projected demand information. We also have employment agreements with certain employees that require the funding of a specific level of payments if certain events, such as a change in control or termination without cause, occur. 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.
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.
Net cash provided by investing activities was $184.1 million for the year ended December 31, 2023 compared to net cash used in investing activities of $140.0 million for the year ended December 31, 2022. The net cash provided by investing activities for 2023 was primarily attributable to net proceeds of $211.2 million from short-term investments, offset by $27.1 million invested in property and equipment. The net cash used in investing activities for 2022 was primary attributable to $21.4 million in property and equipment and the net purchase of $118.6 million in short-term investments.
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 $15.8 million for the year ended December 31, 2023 compared to $15.5 million for the year ended December 31, 2022. 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. The net cash provided by financing activities for 2022 was primarily
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attributable to $10.3 million in proceeds from the exercise of options and $5.2 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”). The net proceeds from the offering were approximately $558.4 million. We intend to use the net proceeds to further advance our clinical and product development programs and to invest in associated pre-commercial and commercial activities, as well as for general corporate purposes.
The Notes are senior unsecured obligations. The Notes do not bear regular interest, and the principal amount of the Notes will not accrete. Special interest, if any, payable in accordance with the terms of the Notes will be payable in cash semi-annually in arrears on May 1 and November 1 of each year, beginning on May 1, 2021. The Notes mature on November 1, 2025, unless earlier repurchased, redeemed or converted.
The Notes are convertible at an initial conversion rate of 5.9439 ordinary shares per $1,000 principal amount of the Notes, which is equivalent to an initial conversion price of approximately $168.24 per ordinary share. In January 2021, we irrevocably elected to settle all conversions of Notes by a combination of cash and our ordinary shares and that the cash portion per $1,000 principal amount of Notes for all conversion settlements shall be $1,000, Accordingly, from and after the date of the election, upon conversion of any Notes, holders of Notes will receive, with respect to each $1,000 principal amount of Notes converted, cash in an amount up to $1,000 and the balance of the conversion value, if any, in our ordinary shares
The Notes were not redeemable prior to November 6, 2023, except in the event of certain tax law changes. We may redeem for cash all or any portion of the Notes, at our option, on or after November 6, 2023 if the last reported sale price of our ordinary shares has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on, and including, the trading day immediately preceding the date on which we provide notice of redemption at a redemption price equal to 100% of the principal amount of the Notes to be redeemed, plus accrued and unpaid special interest, if any, to, but excluding, the redemption date. No sinking fund is provided for the Notes.
Prior to the close of business on the business day immediately preceding August 1, 2025, the Notes are convertible at the option of the holders only upon the satisfaction of certain conditions and during certain periods and if we exercise our right to redeem the Notes as permitted or required by the indenture. On or after August 1, 2025 until the close of the business on the business day immediately preceding the maturity date, holders may convert all or any portion of their Notes at the conversion rate at any time irrespective of the foregoing conditions.
Term loan credit facility
On November 6, 2020, we entered into a new three-year $150.0 million senior secured revolving credit facility with a syndicate of relationship banks (the "2020 Credit Facility").
On February 17, 2023, we gave irrevocable notice to the administrative agent under the 2020 Credit Facility that we terminated all commitments, effective February 22, 2023. This effectively terminated the 2020 Credit Facility, as our ability to borrow and our obligations to comply with all covenants ended on such date. The liens and guaranties in favor of the lenders are released. There were no early termination fees payable and as of February 22, 2023 we had no outstanding balance borrowed under the 2020 Credit Facility. On November 6, 2023, the 2020 Credit Facility expired pursuant to its terms.
As of December 31, 2023, we had no outstanding balance borrowed or any other liability outstanding under the 2020 Credit Facility.
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. 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.
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 also have a CE certificate to market Optune Gio for the treatment of GBM in the
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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 treat malignant pleural mesothelioma and 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. 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 and Japan. 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 are focusing our research and development activities in areas of greatest anticipated value creation. This includes non-small cell lung cancer, brain cancers, and pancreatic cancer.
In 2023, we announced results from our phase 3 LUNAR study evaluating the use of TTFields together with standard therapies following platinum-based treatment failure in the treatment of patients with metastatic non-small cell lung cancer ("NSCLC"). Patients treated with TTFields therapy 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 therapy 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 therapy and docetaxel versus docetaxel alone. In December 2023, we filed a PMA application with the FDA seeking approval for the use of TTFields therapy together with standard systemic therapies for the treatment of NSCLC following progression on or after platinum-based therapy. In January 2024, we announced the FDA had accepted this submission for filing. We are investing in pre-commercial launch activities and anticipate a decision in the second half of 2024.
We have several ongoing or planned trials which will further explore the use of TTFields therapy in the treatment of NSCLC, including the phase 3 METIS and LUNAR-2 trials, as well as the phase 2 KEYNOTE B36 and LUNAR-4 trials. In addition to our trials in NSCLC, we have multiple ongoing or planned trials in our brain and pancreatic cancer programs, including the phase 3 TRIDENT, KEYNOTE D58 and PANOVA-3 trials, and the phase 2 PANOVA-4 trial. We anticipate expanding our clinical pipeline over time to study the safety and efficacy of TTFields therapy for additional solid tumor indications and combinations with other cancer treatment modalities.
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The table below presents the current status of the ongoing clinical trials in our pipeline and anticipated timing of data.
Our therapy is delivered through a medical device and we continue to advance our Products with the intention to extend survival and maintain quality of life for patients. 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
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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. ("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.
Impact of COVID-19
On May 5, 2023, the World Health Organization (“WHO”) declared the end of the COVID-19 pandemic as a public health emergency of international concern, however the WHO maintains that the virus remains a global health threat. Since the pandemic began, we have followed the guidance of the WHO, the U.S. Centers for Disease Control and Prevention, and local health authorities in all of our active markets and will continue to do so. The COVID-19 pandemic did not have a material impact on our financial results through the fourth quarter of 2023. The pandemic is not having a direct impact on our day-to-day operations; however, we are still observing lingering impacts that might continue to impact our business and clinical studies in the future. For example, in many locations staffing levels at clinical trial sites have not returned to pre-pandemic levels, and our ability to conduct and monitor clinical studies may be impacted.
Given the aggressive nature of the cancers that we treat, we believe that the fundamental value proposition of the TTFields platform remains unchanged. We continue to evaluate and plan for the potential effects of a possible COVID-19 resurgence or other similar outbreak on our business moving forward. The extent to which the COVID-19 pandemic or other outbreak may impact our business and clinical studies in the future will depend on further developments, which are highly uncertain and cannot be predicted with confidence.
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. Our supply chain teams are working to increase stock levels to mitigate distribution and service risks from our suppliers in Israel.
On January 19, 2024, President Biden signed into law a continuing resolution that allowed the U.S. government to continue to be funded and operating through March 1, 2024 (some government departments can continue operating through March 8, 2024). If full appropriations or continuing resolutions are not enacted, it is likely that some U.S. Food and Drug Administration functions would be required to stop working until they are funded. As a result, the review process for new products and clinical trials could be delayed.
We view our operations and manage our business in one operating segment. Our net revenues were $509.3 million for the year ended December 31, 2023, $537.8 million for the year ended December 31, 2022 and $535.0 million for the year ended December 31, 2021. Our net loss was $207.0 million for the year ended December 31, 2023, net loss was $92.5 million for the year ended December 31, 2022 and net loss was $58.4 million for the year ended December 31, 2021. As of December 31, 2023, we had an accumulated deficit of $985.5 million.
FY 2022 10-K MD&A
SEC filing source: 0001645113-23-000023.
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Management’s Discussion and Analysis of Financial Condition and Results of Operations ("MD&A") is intended to provide information to assist you in better understanding and evaluating our financial condition and results of operations. We encourage you to read this MD&A in conjunction with our consolidated financial statements and the notes thereto included in Part II, Item 8 of this Annual Report on Form 10-K. This discussion contains forward-looking statements that involve risks and uncertainties. Please refer to the information under the heading "Cautionary Note Regarding Forward-Looking Statements" elsewhere in this report. References to the words "we," "our," "us," and the "Company" in this report refer to NovoCure Limited, including its consolidated subsidiaries.
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. 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.
Optune 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 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. We have also received CE certification in the EU and approval or local registration to market Optune Lua in certain other countries. 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 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.
The table below presents the current status of the ongoing clinical studies in our pipeline and anticipated timing of data.
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Our therapy is delivered through a medical device and we continue to advance our Products with the intention to extend survival and maintain quality of life for patients. We have several product development programs underway that are designed to optimize TTFields delivery 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. 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. ("Zai") a license to commercialize Optune 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 in multiple solid tumor cancer indications. For additional information, see Note 12 to the Consolidated Financial Statements.
Impact of COVID-19
In March 2020, the World Health Organization (“WHO”) declared COVID-19 a global pandemic. Since the pandemic began, we have been following the guidance of the WHO, the U.S. Centers for Disease Control and Prevention, and local health authorities in all of our active markets and we have adjusted the way we conduct business to adapt to the evolving situation. The COVID-19 pandemic did not have a material impact on our financial results throughout 2022. The pandemic has had and is having an impact on our day-to-day operations, which varies by region based on factors such as geographical spread, stage of containment and recurrence of the pandemic in each region. We believe the prolonged disruption caused by COVID-19 is resulting in increased volatility across global health care systems, such as fluctuations in patient volumes and changes in patterns of care in certain regions, which is currently impacting and might continue to impact our business and clinical studies in the future. For example, outside the U.S., localized lockdowns are causing disruptions in the ability to monitor clinical studies. TTFields is an emerging modality in cancer care and requires significant educational effort to drive awareness and acceptance of our therapy. We have relied heavily on virtual engagement to manage these educational efforts since the onset of the pandemic, which poses challenges to our ability to effectively communicate and engage with our customers and partners around the world.
Given the aggressive nature of the cancers that we treat, we believe that the fundamental value proposition of the TTFields platform remains unchanged. We continue to evaluate and plan for the potential effects of COVID-19 on our business moving forward. The extent to which the COVID-19 pandemic may impact our business and clinical studies in the future will depend on further developments, which are highly uncertain and cannot be predicted with confidence. The COVID-19 pandemic may also heighten many of the other risks described in our risk factors disclosed in this Annual Report.
We view our operations and manage our business in one operating segment. Our net revenues were $537.8 million for the year ended December 31, 2022, $535.0 million for the year ended December 31, 2021 and $494.4 million for the year ended December 31, 2020. Our net loss was $92.5 million for the year ended December 31, 2022, net loss was $58.4 million for the year ended December 31, 2021 and net income was $19.8 million for the year ended December 31, 2020. As of December 31, 2022, we had an accumulated deficit of $778.5 million.
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Commentary on Results of Operations
Net revenues
Our revenues are primarily derived from patients using our Products in our active markets. We charge for treatment with our Products on a monthly basis. Our potential net revenues per patient are determined by our ability to secure payment, the monthly fee we collect and the number of months that the patient remains on therapy.
We also receive revenues pursuant to the Zai Agreement. For additional information regarding the Zai Agreement, see Note 12 to the Consolidated Financial Statements.
Cost of revenues
We contract with third parties to manufacture our Products. Our cost of revenues is primarily comprised of the following:
•disposable arrays;
•depreciation expense for the field equipment, including the electric field generator used by patients; and
•personnel and overhead costs such as facilities, freight and depreciation of property, plant and equipment associated with managing our inventory, warehousing and order fulfillment functions.
Operating expenses
Our operating expenses consist of research, development and clinical studies, sales and marketing and general and administrative expenses. Personnel costs are a significant component for each category of operating expenses and consist of wages, benefits and bonuses. Personnel costs also include share-based compensation.
Research, development and clinical studies
Our research, development and clinical studies activity is focused on advancing TTFields through clinical studies across multiple solid tumor types and improving the efficacy and usability of our devices. 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 medical grants, 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.
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The following table summarizes our research, development and clinical study expenses by program for the years ended December 31, 2022, 2021 and 2020:
| Year ended December 31, | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| U.S. dollars in thousands | 2022 | 2021 | 2020 | ||||||||
| Preclinical and basic research | $ | 16,922 | $ | 15,580 | $ | 12,079 | |||||
| Clinical development programs: | |||||||||||
| LUNAR | 6,905 | 9,069 | 8,261 | ||||||||
| INNOVATE - 3 | 9,494 | 17,708 | 14,190 | ||||||||
| METIS | 8,480 | 7,056 | 5,147 | ||||||||
| PANOVA - 3 | 22,185 | 15,026 | 7,033 | ||||||||
| TRIDENT | 12,162 | 12,588 | 3,709 | ||||||||
| Other clinical studies | 5,524 | 4,634 | 2,764 | ||||||||
| Clinical administration | 22,690 | 19,764 | 13,158 | ||||||||
| Product development | 15,323 | 15,248 | 9,710 | ||||||||
| Clinical affairs | 19,891 | 24,486 | 21,058 | ||||||||
| Other research and development costs (1) | 35,719 | 32,547 | 16,776 | ||||||||
| Share based compensation | 30,790 | 27,597 | 18,125 | ||||||||
| Research, development and clinical studies | $ | 206,085 | $ | 201,303 | $ | 132,010 |
(1) Other research, development and clinical study costs include regulatory affairs, quality assurance, intellectual property, product safety, allocated facilities and other overhead costs.
We are committed to investing strategically to maximize the growth potential of the TTFields platform. We expect growth in our research and development investments to continue into 2023 as we work to advance our pipeline programs and increase acceptance of Tumor Treating Fields across the global oncology community.
Sales and marketing
Sales and marketing expenses consist primarily of personnel costs, travel, marketing and promotional activities, medical education, commercial shipping and facilities costs. Over the next few years, we expect to continue to make significant expenditures associated with selling and marketing our Products, primarily in connection with continued commercialization in North America, the EU and Japan for the treatment of our approved indications.
General and administrative
General and administrative expenses consist primarily of personnel, professional fees and facilities costs. 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. 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.
Financial expenses, net
Financial expenses, net primarily consists of 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. 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.
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Critical accounting policies and estimates
In accordance with U.S. GAAP, in preparing our financial statements we must make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of net revenues and expenses during the reporting period. We develop and periodically change these estimates and assumptions based on historical experience and on various other factors that we believe are reasonable under the circumstances. Actual results may differ from these estimates.
The critical accounting policies requiring estimates, assumptions and judgments that we believe have the most significant impact on our consolidated financial statements are described below.
Revenue recognition
In May 2014, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") 2014-09, Revenue from Contracts with Customers (Topic 606) (ASU 2014-09), an updated standard on revenue recognition and issued subsequent amendments to the initial guidance in March 2016, April 2016, May 2016 and December 2016 within ASU 2016-08, 2016-10, 2016-12 and 2016-20, respectively. The Company adopted the standard effective January 1, 2018 using the modified retrospective method for all contracts. The reported results for 2018 and thereafter reflect the application of Accounting Standards Codification ("ASC") 606 guidance. The amount of revenue recognized reflects the consideration to which we expect to be entitled to receive in exchange for our Products. For additional information, see Note 2(m) to the Consolidated Financial Statements.
We also receive revenues pursuant to the Zai Agreement. For additional information regarding the Zai Agreement, see Note 12 to the Consolidated Financial Statements.
Share-based compensation
Under the FASB's ASC 718, Compensation-Stock Compensation, we measure and recognize compensation expense for share options granted to our employees and directors and for our ESPP based on the fair value of the awards on the date of grant. 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, including:
•beginning with the first quarter of 2022, the computation of expected volatility is based on the historical volatility the Company's shares, beginning with the first quarter of 2021 and prior to the first quarter of 2022, the computation of expected volatility is based on a combination of actual historical share price volatility of comparable publicly-traded companies and the historical volatility the Company's shares. Prior to the first quarter of 2021, due to the lack of sufficient historical information for the Company, the computation was based on actual historical volatility of comparable publicly-traded companies;
•beginning with the first quarter of 2021, the expected term of options granted is calculated using the Company's historical and future exercise behavior. Prior to the first quarter of 2021, it was calculated using the average between the vesting period and the contractual term to the expected term of the options in effect at the time of grant;
•the risk-free interest rate, which we base on the yield curve of U.S. Treasury securities with periods commensurate with the expected term of the options being valued; and
•the expected dividend yield, which we estimate to be zero based on the fact that we have never paid cash dividends and have no present intention to pay cash dividends.
For information about our ESPP, see Note 14 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 compensation costs for the value of performance stock units ("PSU") over the performance period when the vesting conditions become probable in accordance with ASC 718.
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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, | ||||||
|---|---|---|---|---|---|---|
| 2022 | 2021 | 2020 | ||||
| Expected term (years) | 5.33-5.83 | 5.50-6.00 | 5.50-6.00 | |||
| Expected volatility | 60%-62% | 60%-63% | 54%-56% | |||
| Risk-free interest rate | 1.58%-4.23% | 0.78%-1.27% | 0.30%-0.86% | |||
| 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.
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 $107.0 million, $94.9 million and $75.7 million during the years ended December 31, 2022, 2021 and 2020, respectively. As of December 31, 2022, we have unrecognized compensation expense of $125.6 million, which is expected to be recognized over a weighted average period of approximately 2.38 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. For additional information, see Note 14 to the Consolidated Financial Statements.
Long-lived assets
Property and equipment and field equipment are 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 make estimates of the useful life of our property and equipment and 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.
Our field equipment consists of equipment being utilized under rental agreements accounted for on a monthly basis as an operating lease, as well as service pool equipment. Service pool equipment is equipment owned and maintained by us that is swapped for equipment that needs repair or maintenance by us while being used by a patient. We record a provision for any excess, lost or damaged equipment when warranted based on an assessment of the equipment.
We assess impairment whenever events or changes in circumstances indicate that the carrying amount of the asset is impaired or the estimated useful life is no longer appropriate. Circumstances such as changes in technology or in the way an asset is being used may trigger an impairment review. For additional information, see Notes 2(i) and 2(j) to the Consolidated Financial Statements.
Inventories
Inventories are stated at the lower of cost or net realizable value. We regularly evaluate the ability to realize the value of inventory. If the inventories are deemed damaged, if actual demand for our devices declines, or if market conditions are less favorable than those projected, inventory write-offs may be required. For additional information, see Note 2(h) to the Consolidated Financial Statements.
Income taxes
As part of the process of preparing our consolidated financial statements, we are required to calculate our income taxes based on taxable income by jurisdiction. We make certain estimates and judgments in determining our income taxes, including assessment of our uncertain tax positions, for financial statement purposes. Significant changes to these estimates may result in an increase or decrease to our tax provision in the subsequent period when such a change in estimate occurs.
Uncertain tax positions are based on estimates and assumptions that have been deemed reasonable by management. Our estimates of unrecognized tax benefits and potential tax benefits may not be representative of actual outcomes.
For additional information, see Note 13 to the Consolidated Financial Statements.
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Results of operations
The following discussion provides an analysis of our results of operations and reasons for material changes therein for 2022 as compared to 2021. 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 2021 Annual Report on Form 10-K, filed with the SEC on February 24, 2022, for an analysis of the 2021 results as compared to 2020.
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 | 2022 | 2021 | 2020 | ||||||||
| Net revenues | $ | 537,840 | $ | 535,031 | $ | 494,366 | |||||
| Cost of revenues | 114,867 | 114,877 | 106,501 | ||||||||
| Gross profit | 422,973 | 420,154 | 387,865 | ||||||||
| Operating costs and expenses: | |||||||||||
| Research, development and clinical studies | 206,085 | 201,303 | 132,010 | ||||||||
| Sales and marketing | 173,658 | 137,057 | 118,017 | ||||||||
| General and administrative | 132,753 | 126,127 | 107,437 | ||||||||
| Total operating costs and expenses | 512,496 | 464,487 | 357,464 | ||||||||
| Operating income (loss) | (89,523) | (44,333) | 30,401 | ||||||||
| Financial (expenses) income, net | 7,677 | (7,742) | (12,299) | ||||||||
| Income (loss) before income tax | (81,846) | (52,075) | 18,102 | ||||||||
| Income tax | 10,688 | 6,276 | (1,706) | ||||||||
| Net income (loss) | $ | (92,534) | $ | (58,351) | $ | 19,808 | |||||
| Basic net income (loss) per ordinary share | $ | (0.88) | $ | (0.56) | $ | 0.20 | |||||
| Weighted average number of ordinary shares used in computing basic net income (loss) per share | 104,660,476 | 103,433,274 | 100,930,866 | ||||||||
| Diluted net income (loss) per ordinary share | $ | (0.88) | $ | (0.56) | $ | 0.18 | |||||
| Weighted average number of ordinary shares used in computing diluted net income (loss) per share | 104,660,476 | 103,433,274 | 108,877,648 |
The following table details the share-based compensation expense included in costs and expenses:
| Year ended December 31, | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| U.S. dollars in thousands | 2022 | 2021 | 2020 | ||||||||
| Cost of revenues | $ | 4,690 | $ | 3,471 | $ | 2,221 | |||||
| Research, development and clinical studies | 30,790 | 27,597 | 18,125 | ||||||||
| Sales and marketing | 28,826 | 22,673 | 17,672 | ||||||||
| General and administrative | 42,649 | 41,159 | 37,703 | ||||||||
| Total share-based compensation expense | $ | 106,955 | $ | 94,900 | $ | 75,721 |
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. The number of active patients on therapy is our principal revenue driver. 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. Prescriptions are a leading indicator of
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demand. A "prescription received" is a commercial order for Optune or Optune Lua that is received from a physician certified to treat patients with our Products for a patient not previously on Optune or Optune Lua. Orders to renew or extend treatment are not included in this total.
The following table includes certain commercial operating statistics for and as of the end of the periods presented.
| December 31, | |||||||
|---|---|---|---|---|---|---|---|
| Operating statistics | 2022 | 2021 | 2020 | ||||
| Active patients at period end | |||||||
| North America (1) | 2,191 | 2,272 | 2,193 | ||||
| EMEA: | |||||||
| Germany | 467 | 563 | 562 | ||||
| Other EMEA | 403 | 445 | 391 | ||||
| Japan | 369 | 307 | 265 | ||||
| Total | 3,430 | 3,587 | 3,411 |
| Year ended December 31, | |||||||
|---|---|---|---|---|---|---|---|
| 2022 | 2021 | 2020 | |||||
| Prescriptions received in period | |||||||
| North America (1) | 3,823 | 3,781 | 3,871 | ||||
| EMEA: | |||||||
| Germany | 830 | 924 | 910 | ||||
| Other EMEA | 495 | 521 | 467 | ||||
| Japan | 381 | 436 | 365 | ||||
| Total | 5,529 | 5,662 | 5,613 |
(1) North America includes data for the United States and Canada for the second half of 2021 and all of 2022, and the United States only for the first half of 2021 and 2020.
Worldwide, there were 7 active MPM patients on therapy as of December 31, 2022 and 33 MPM prescriptions were received in the year ended December 31, 2022.
Year ended December 31, 2022 compared to year ended December 31, 2021
| Year ended December 31, | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2022 | 2021 | Change | % Change | |||||||||||
| Net revenues | $ | 537,840 | $ | 535,031 | $ | 2,809 | 1 | % |
Net revenues. Net revenues increased by $2.8 million, or 1%, to $537.8 million for the year ended December 31, 2022 from $535.0 million for the year ended December 31, 2021. This was primarily due to an increase in collections from previously denied and appealed claims in the U.S. offset by a reduction in German approval rates as a result of updated coverage criteria, and the impact of foreign exchange rate fluctuations.
In 2022, we recorded $32 million in revenue from the successful appeal of previously denied claims for Medicare fee-for-service beneficiaries billed prior to established coverage. We continue to actively appeal and pursue previously denied claims for beneficiaries billed prior to established coverage, but the cadence and amount of these Medicare payments are impossible to predict. We believe collections from those claims which were most accessible were largely exhausted in 2022 and the remaining outstanding claims will take time to collect. As a result, we expect future net revenue to more closely reflect core drivers of net revenue: number of active patients on therapy, duration of therapy, and net realized price per month.
| Year ended December 31, | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2022 | 2021 | Change | % Change | |||||||||||
| Cost of revenues | $ | 114,867 | $ | 114,877 | $ | (10) | — | % |
Cost of revenues. Our cost of revenues were $114.9 million for the year ended December 31, 2022, virtually unchanged from $114.9 million for the year ended December 31, 2021. Excluding sales to Zai, cost of revenues per
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active patient per month were $2,481 for the year ended December 31, 2022 compared to $2,474 for the year ended December 31, 2021.
Cost of revenues per active patient is calculated by dividing the cost of revenues for the year less product sales to Zai for the year by the average of the active patients at the end of the each quarter in the current year and the end of the year active patients from the prior year. This annual figure is then divided by twelve to estimate the monthly cost of revenues per active patient. Sales to Zai are deducted because they are made at burdened cost and in anticipation of future royalties from Zai, and Zai patient counts are not included in our active patient population. Product's cost sold to Zai totaled $11.1 million for the year ended December 31, 2022 compared to $11.3 million for the year ended December 31, 2021.
Gross margin was 79% for the year ended December 31, 2022 and 79% for the year ended December 31, 2021. Our gross margins are affected by our ability to achieve efficiencies of scale, the number of active patients and array usage within a given period, product mix, and product modifications. Increased product sales to Zai have the effect of tempering gross margin, as those products are sold at cost.
| Year ended December 31, | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2022 | 2021 | Change | % Change | |||||||||||
| Operating expenses: | ||||||||||||||
| Research, development and clinical studies | $ | 206,085 | $ | 201,303 | $ | 4,782 | 2 | % | ||||||
| Sales and marketing | 173,658 | 137,057 | 36,601 | 27 | % | |||||||||
| General and administrative | 132,753 | 126,127 | 6,626 | 5 | % | |||||||||
| Total operating expenses | $ | 512,496 | $ | 464,487 | $ | 48,009 | 10 | % |
Research, development and clinical studies expenses. Research, development and clinical studies expenses increased by $4.8 million, or 2%, to $206.1 million for the year ended December 31, 2022 from $201.3 million for the year ended December 31, 2021. The change is driven by an increase of $4.8 million in product development and regulatory affairs expenses.
We expect growth in our research and development investments to continue into 2023 as we work to advance our pipeline programs and increase acceptance of TTFields across the global oncology community. We balance our investments in research and development with our organizational capacity to effectively execute our strategic initiatives.
Sales and marketing expenses. Sales and marketing expenses increased by $36.6 million, or 27%, to $173.7 million for the year ended December 31, 2022 from $137.1 million for the year ended December 31, 2021. The change primarily was due to increases of $22.7 million, $2.9 million and $2.9 million in marketing, health policy, and sales expenses, respectively, which are intended to increase awareness and acceptance of TTFields in our approved indications and enhance our commercial capabilities in anticipation of potential future approvals in new indications. Additionally, we are investing in market access capabilities in order to evaluate opportunities, identify optimal access pathways, and successfully gain reimbursement in new geographies.
General and administrative expenses. General and administrative expenses increased by $6.6 million, or 5%, to $132.8 million for the year ended December 31, 2022 from $126.1 million for the year ended December 31, 2021. The change primarily was due to increases of $5.0 million and $2.5 million in information technology infrastructure and supply chain optimization, respectively, and offset by a decrease in expenses associated with personnel costs and professional services.
| Year ended December 31, | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2022 | 2021 | Change | % Change | |||||||||||
| Financial (expenses) income, net | $ | 7,677 | $ | (7,742) | $ | 15,419 | (199) | % |
Financial (expenses) income, net. Financial expenses, net, decreased by $15.4 million, or 199%, to $7.7 million income for the year ended December 31, 2022 from $7.7 million expense for the year ended December 31, 2021. In 2022, financial income was primary driven by interest income and amortization of investment premiums on our cash, cash equivalents and short term investments. In 2021, financial expenses were primarily driven by foreign exchange expenses.
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| Year ended December 31, | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2022 | 2021 | Change | % Change | |||||||||||
| Income tax | $ | 10,688 | $ | 6,276 | $ | 4,412 | 70 | % |
Income taxes. Income tax expenses increased by $4.4 million, or 70%, resulting in a tax expense of $10.7 million for the year ended December 31, 2022 compared to a tax expense of $6.3 million for the year ended December 31, 2021. The increase was primarily due to an increase in income before taxes in the U.S.
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"). We believe Adjusted EBITDA is useful to investors in evaluating our operating performance because it helps investors evaluate and compare the results of our operations from period to period by removing the impact of earnings attributable to our capital structure, tax rate and material non-cash items, specifically share-based compensation.
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.
| Year ended December 31, | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2022 | 2021 | 2020 | |||||||||
| Net income (loss) | $ | (92,534) | $ | (58,351) | $ | 19,808 | |||||
| Add: Income tax | 10,688 | 6,276 | (1,706) | ||||||||
| Add: Financial expenses (income), net | (7,677) | 7,742 | 12,299 | ||||||||
| Add: Depreciation and amortization | 10,624 | 10,251 | 9,150 | ||||||||
| EBITDA | $ | (78,899) | $ | (34,082) | $ | 39,551 | |||||
| Add: Share-based compensation | 106,955 | 94,900 | 75,721 | ||||||||
| Adjusted EBITDA | $ | 28,056 | $ | 60,818 | $ | 115,272 |
Adjusted EBITDA decreased by $32.8 million, or 54%, to $28.1 million for the year ended December 31, 2022 from $60.8 million for the year ended December 31, 2021. This decrease was primarily driven by an increase in sales and marketing expenses intended to increase awareness and acceptance of TTFields in our approved indications, enhance our commercial capabilities in anticipation of potential future approvals in new indications, and expand our international footprint.
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. As of December 31, 2022, we had an accumulated deficit of $778.5 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, 2022, we had $115.3 million in cash and cash equivalents and $854.1 million in short-term investments. At December 31, 2022, our cash, cash equivalents and short-term investments totaled $969.4 million, an increase of $31.7 million compared to $937.7 million at December 31, 2021. The increase was primarily due to net cash generated by operating activities and the exercise of options.
We believe our cash, cash equivalents and short-term investments as of December 31, 2022 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 expect that our research, development and clinical expenses, sales and marketing expenses and general and administrative expenses will continue to increase over the next several years and may outpace our gross profit. As a result, we may need to raise additional capital to fund our operations.
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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 | 2022 | 2021 | 2020 | ||||||||
| Net cash provided by (used in) operating activities | $ | 30,788 | $ | 82,756 | $ | 99,148 | |||||
| Net cash provided by (used in) investing activities | (139,957) | (144,834) | (472,847) | ||||||||
| Net cash provided by (used in) financing activities | 15,491 | 25,702 | 440,209 | ||||||||
| Effect of exchange rate changes on cash and cash equivalents | (97) | (188) | 247 | ||||||||
| Net increase (decrease) in cash, cash equivalents and restricted cash | $ | (93,775) | $ | (36,564) | $ | 66,757 |
Operating activities
Net cash provided by operating activities primarily represents our net income for the periods presented. Adjustments to net income for non-cash items include share-based compensation, depreciation, amortization and asset write-downs. Operating cash flows are also impacted by changes in operating assets and liabilities, principally trade payables, deferred revenues, other payables, prepaid expenses, inventory and trade receivables.
Net cash provided by operating activities was $30.8 million for the year ended December 31, 2022 compared to $82.8 million for the year ended December 31, 2021 a decrease of $ 52.0 million. The decrease in net cash provided by operating activities was primarily driven by a $43.2 million increase in sales, marketing, general and administrative expenses to enhance our capabilities in anticipation of potential future approvals of new indications and entry into potential new markets, and a $4.8 million increase in research and development expenses. In addition, finance income increased by $15.4 million and tax expenses increased by $ 4.4 million, offsetting a $2.8 million increase in gross profit and a $17.0 million change in working capital.
Upcoming use of cash in operations will include payments in the normal course of business of $42.1 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 $30.6 million of commitments with three major suppliers. We make such commitments through a combination of purchase orders, supplier contracts, and open orders based on projected demand information. We also have employment agreements with certain employees that require the funding of a specific level of payments if certain events, such as a change in control or termination without cause, occur. 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.
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.
Net cash used in investing activities was $140.0 million for the year ended December 31, 2022 compared to net cash used in investing activities of $144.8 million for the year ended December 31, 2021. The net cash used in investing activities for 2022 was primarily attributable to $21.4 million in property and equipment and the net purchase of $118.6 million in short-term investments. The net cash used in investing activities for 2021 was primary attributable to $24.2 million in property and equipment and the net purchase of $120.7 million in short-term investments.
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 $15.5 million for the year ended December 31, 2022 compared to $25.7 million for the year ended December 31, 2021. The net cash provided by financing activities for 2022 was primarily attributable to $10.3 million in proceeds from the exercise of options and $5.2 million in proceeds from the issuance of shares pursuant to the ESPP. The net cash provided by financing activities for 2021 was primarily attributable to $21.2 million in proceeds from the exercise of options and $4.5 million in proceeds from the issuance of shares pursuant to the ESPP.
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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 intend to use the net proceeds to further advance our clinical and product development programs and to invest in associated pre-commercial and commercial activities, as well as for general corporate purposes.
The Notes are senior unsecured obligations. The Notes do not bear regular interest, and the principal amount of the Notes will not accrete. Special interest, if any, payable in accordance with the terms of the Notes will be payable in cash semi-annually in arrears on May 1 and November 1 of each year, beginning on May 1, 2021. The Notes mature on November 1, 2025, unless earlier repurchased, redeemed or converted.
The Notes are convertible at an initial conversion rate of 5.9439 ordinary shares per $1,000 principal amount of the Notes, which is equivalent to an initial conversion price of approximately $168.24 per ordinary share. In January 2021, we irrevocably elected to settle all conversions of Notes by a combination of cash and our ordinary shares and that the cash portion per $1,000 principal amount of Notes for all conversion settlements shall be $1,000, Accordingly, from and after the date of the election, upon conversion of any Notes, holders of Notes will receive, with respect to each $1,000 principal amount of Notes converted, cash in an amount up to $1,000 and the balance of the conversion value, if any, in our ordinary shares
The Notes are not redeemable prior to November 6, 2023, except in the event of certain tax law changes. We may redeem for cash all or any portion of the Notes, at our option, on or after November 6, 2023 if the last reported sale price of our ordinary shares has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on, and including, the trading day immediately preceding the date on which we provide notice of redemption at a redemption price equal to 100% of the principal amount of the Notes to be redeemed, plus accrued and unpaid special interest, if any, to, but excluding, the redemption date. No sinking fund is provided for the Notes.
Prior to the close of business on the business day immediately preceding August 1, 2025, the Notes are convertible at the option of the holders only upon the satisfaction of certain conditions and during certain periods and if we exercise our right to redeem the Notes as permitted or required by the indenture. On or after August 1, 2025 until the close of the business on the business day immediately preceding the maturity date, holders may convert all or any portion of their Notes at the conversion rate at any time irrespective of the foregoing conditions.
Term loan credit facility
On November 6, 2020, we entered into a new three-year $150.0 million senior secured revolving credit facility with a syndicate of relationship banks (the "2020 Credit Facility"). We may, subject to certain conditions and limitations, increase the revolving credit commitments outstanding under the 2020 Credit Facility or incur new incremental term loans in an aggregate principal amount not to exceed $250.0 million in total.
The commitments under the 2020 Credit Facility are guaranteed by certain of our subsidiaries and secured by a first lien on our and certain of our subsidiaries’ assets. Outstanding loans will bear interest per annum at a sliding scale based on the our secured leverage ratio from 2.75% to 3.25% above the applicable interbank borrowing reference rate for the currency in which the loan is denominated. Additionally, the 2020 Credit Facility contains a fee for the unused revolving credit commitments at a sliding scale based on our secured leverage ratio from 0.35% to 0.45%. The 2020 Credit Facility contains financial covenants requiring maintenance of a minimum fixed charge coverage ratio and specifying a maximum senior secured net leverage ratio, as well as customary events of default which include a change of control.
As of December 31, 2022, we had no outstanding balance borrowed under the 2020 Credit Facility.
On February 17, 2023, we gave irrevocable notice to the administrative agent under the 2020 Credit Facility that we terminated all commitments, effective February 22, 2023. This effectively terminated the 2020 Credit Facility, as our ability to borrow and our obligations to comply with all covenants ended on such date. The liens and guaranties in favor of the lenders are released. There are no early termination fees payable and as of February 22, 2023 we had no outstanding balance borrowed under the 2020 Credit Facility.
2020 Prepayment of 2018 term loan
In 2018, we entered into a Loan and Security Agreement ("2018 Loan Agreement") pursuant to which we borrowed a term loan in the aggregate principal amount of $150 million (the "2018 Credit Facility"). The term loan, which was drawn in full upon execution of the 2018 Loan Agreement, bore interest at 9.0% per annum, payable quarterly in arrears. In 2020, we terminated the 2018 Credit Facility and prepaid the principal amount in full. The prepayment
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included $150 million in principal repayment and $3.0 million in prepayment premium, plus accrued and unpaid interest and expenses payable through the payoff date.
FY 2021 10-K MD&A
SEC filing source: 0001645113-22-000011.
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Management’s Discussion and Analysis of Financial Condition and Results of Operations ("MD&A") is intended to provide information to assist you in better understanding and evaluating our financial condition and results of operations. We encourage you to read this MD&A in conjunction with our consolidated financial statements and the notes thereto included in Part II, Item 8 of this Annual Report on Form 10-K. This discussion contains forward-looking statements that involve risks and uncertainties. Please refer to the information under the heading "Cautionary Note Regarding Forward-Looking Statements" elsewhere in this report. References to the words "we," "our," "us," and the "Company" in this report refer to NovoCure Limited, including its consolidated subsidiaries.
Overview
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. Our key priorities are to drive commercial adoption of Optune and Optune Lua, our commercial devices, and to advance clinical and product development programs intended to extend overall survival in some of the most aggressive forms of cancer.
Optune 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 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. Optune Lua is approved by the FDA under the Humanitarian Device Exemption ("HDE") pathway to treatment malignant pleural mesothelioma ("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. 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 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 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.
The table below presents the current status of the ongoing clinical studies in our pipeline and anticipated timing of data.
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Our therapy is delivered through a medical device and we continue to advance our Products with the intention to extend survival and maintain quality of life for patients. We have several product development programs underway that are designed to optimize TTFields delivery 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. 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. ("Zai") a license to commercialize Optune 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 in multiple solid tumor cancer indications. For additional information, see Note 12 to the Consolidated Financial Statements.
Impact of COVID-19
In March 2020, the World Health Organization (“WHO”) declared COVID-19 a global pandemic. Since the pandemic began, we have been following the guidance of the WHO, the U.S. Centers for Disease Control and Prevention, and local health authorities in all of our active markets and we have adjusted the way we conduct business to adapt to the evolving situation. The COVID-19 pandemic did not have a material impact on our financial results throughout 2021. The pandemic has had and is having an impact on our day-to-day operations, which varies by region based on factors such as geographical spread, stage of containment and recurrence of the pandemic in each region. We believe the prolonged disruption caused by COVID-19 is resulting in increased volatility across global health care systems, such as fluctuations in patient volumes and changes in patterns of care in certain regions, which is currently impacting and might continue to impact our business and clinical studies in the future. For example, we continue to see fluctuations in the timing of surgeries and radiation therapy in certain regions, which has had some adverse influence on the eligible patient population for Optune. We have also have been impacted by staff disruptions and turnover internally and at treatment sites, clinical study sites and third-party providers, either directly as a result of illness or indirectly as a result of vaccine mandates and other changes in terms of employment. TTFields is an emerging modality in cancer care and requires significant educational effort to drive awareness and acceptance of our therapy. We have relied heavily on virtual engagement to manage these educational efforts since the onset of the pandemic, which poses challenges to our ability to effectively communicate and engage with our customers and partners around the world.
Given the aggressive nature of the cancers that we treat, we believe that the fundamental value proposition of the TTFields platform remains unchanged. We continue to evaluate and plan for the potential effects of COVID-19 on our business moving forward. The extent to which the COVID-19 pandemic may impact our business and clinical studies in the future will depend on further developments, which are highly uncertain and cannot be predicted with confidence. The COVID-19 pandemic may also heighten many of the other risks described in our risk factors disclosed in this Annual Report.
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We view our operations and manage our business in one operating segment. Our net revenues were $535.0 million for the year ended December 31, 2021, $494.4 million for the year ended December 31, 2020 and $351.3 million for the year ended December 31, 2019. Our net loss was $58.4 million for the year ended December 31, 2021, net income was $19.8 million for the year ended December 31, 2020 and net loss was $7.2 million for the year ended December 31, 2019. As of December 31, 2021, we had an accumulated deficit of $685.9 million.
Commentary on Results of Operations
Net revenues
Our revenues are primarily derived from patients using our Products in our active markets. We charge for treatment with our Products on a monthly basis. Our potential net revenues per patient are determined by our ability to secure payment, the monthly fee we collect and the number of months that the patient remains on therapy.
We also receive revenues pursuant to the Zai Agreement. For additional information regarding the Zai Agreement, see Note 12 to the Consolidated Financial Statements.
Cost of revenues
We contract with third parties to manufacture our Products. Our cost of revenues is primarily comprised of the following:
•disposable arrays;
•depreciation expense for the field equipment, including the electric field generator used by patients; and
•personnel and overhead costs such as facilities, freight and depreciation of property, plant and equipment associated with managing our inventory, warehousing and order fulfillment functions.
Operating expenses
Our operating expenses consist of research, development and clinical studies, sales and marketing and general and administrative expenses. Personnel costs are a significant component for each category of operating expenses and consist of wages, benefits and bonuses. Personnel costs also include share-based compensation.
Research, development and clinical studies
Our research, development and clinical studies activity is focused on advancing TTFields through clinical studies across multiple solid tumor types and improving the efficacy and usability of our devices. 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 medical grants, 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.
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The following table summarizes our research, development and clinical study expenses by program for the years ended December 31, 2021, 2020 and 2019:
| Year ended December 31, | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| U.S. dollars in thousands | 2021 | 2020 | 2019 | ||||||||
| Preclinical and basic research | $ | 15,580 | $ | 12,079 | $ | 6,874 | |||||
| Clinical development programs: | |||||||||||
| LUNAR | 9,069 | 8,261 | 7,243 | ||||||||
| INNOVATE - 3 | 17,708 | 14,190 | 4,822 | ||||||||
| METIS | 7,056 | 5,147 | 4,699 | ||||||||
| PANOVA - 3 | 15,026 | 7,033 | 5,368 | ||||||||
| TRIDENT | 12,588 | 3,709 | 424 | ||||||||
| Other clinical studies | 4,634 | 2,764 | 1,726 | ||||||||
| Clinical administration | 19,764 | 13,158 | 8,834 | ||||||||
| Product development | 15,248 | 9,710 | 4,944 | ||||||||
| Clinical affairs | 24,486 | 21,058 | 15,531 | ||||||||
| Other research and development costs (1) | 32,547 | 16,776 | 10,968 | ||||||||
| Share based compensation | 27,597 | 18,125 | 7,570 | ||||||||
| Research, development and clinical studies | $ | 201,303 | $ | 132,010 | $ | 79,003 |
(1) Other research, development and clinical study costs include regulatory affairs, quality assurance, intellectual property, product safety, allocated facilities and other overhead costs.
We are committed to investing strategically to maximize the growth potential of the TTFields platform. We expect growth in our research and development investments to continue into 2022 as we work to advance our pipeline programs and increase acceptance of Tumor Treating Fields across the global oncology community.
Sales and marketing
Sales and marketing expenses consist primarily of personnel costs, travel, marketing and promotional activities, commercial shipping and facilities costs. Over the next few years, we expect to continue to make significant expenditures associated with selling and marketing our Products, primarily in connection with continued commercialization in the United States, EU and Japan for the treatment of our approved indications.
General and administrative
General and administrative expenses consist primarily of personnel, professional fees and facilities costs. 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. 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.
Financial expenses, net
Financial expenses, net primarily consists of 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. 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.
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Critical accounting policies and estimates
In accordance with U.S. GAAP, in preparing our financial statements we must make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of net revenues and expenses during the reporting period. We develop and periodically change these estimates and assumptions based on historical experience and on various other factors that we believe are reasonable under the circumstances. Actual results may differ from these estimates.
The critical accounting policies requiring estimates, assumptions and judgments that we believe have the most significant impact on our consolidated financial statements are described below.
Revenue recognition
In May 2014, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") 2014-09, Revenue from Contracts with Customers (Topic 606) (ASU 2014-09), an updated standard on revenue recognition and issued subsequent amendments to the initial guidance in March 2016, April 2016, May 2016 and December 2016 within ASU 2016-08, 2016-10, 2016-12 and 2016-20, respectively. The Company adopted the standard effective January 1, 2018 using the modified retrospective method for all contracts. The reported results for 2018 and thereafter reflect the application of Accounting Standards Codification ("ASC") 606 guidance. The amount of revenue recognized reflects the consideration to which we expect to be entitled to receive in exchange for our Products. For additional information, see Note 2(m) to the Consolidated Financial Statements.
We also receive revenues pursuant to the Zai Agreement. For additional information regarding the Zai Agreement, see Note 12 to the Consolidated Financial Statements.
Share-based compensation
Under the FASB's ASC 718, Compensation-Stock Compensation, we measure and recognize compensation expense for share options granted to our employees and directors and for our ESPP based on the fair value of the awards on the date of grant. 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, including:
•the expected term of the stock option award, which we calculate using the simplified method, in accordance with ASC No.718-10-S99-1 (SAB No. 110) as we have insufficient historical information regarding our stock options to provide a basis for an estimate;
•the expected share price volatility of our underlying ordinary shares, which since the beginning of 2021, we estimate based on a combination of our own stock price and a representative group of publicly traded biopharmaceutical and medical technology companies with similar characteristics to us ("peer-based companies") for a period matching the expected term assumption when there is not sufficient historical information for our ordinary shares (prior to 2021 our estimation was based on the historical volatility of peer-based companies);
•the risk-free interest rate, which we base on the yield curve of U.S. Treasury securities with periods commensurate with the expected term of the options being valued; and
•the expected dividend yield, which we estimate to be zero based on the fact that we have never paid cash dividends and have no present intention to pay cash dividends.
For information about our ESPP, see Note 14 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.
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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, | ||||||
|---|---|---|---|---|---|---|
| 2021 | 2020 | 2019 | ||||
| Expected term (years) | 5.50-6.00 | 5.50-6.00 | 5.50-6.00 | |||
| Expected volatility | 60%-63% | 54%-56% | 55%-61% | |||
| Risk-free interest rate | 0.78%-1.27% | 0.30%-0.86% | 1.73%-2.40% | |||
| 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.
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 $94.9 million, $75.7 million and $52.4 million during the years ended December 31, 2021, 2020 and 2019, respectively. As of December 31, 2021, we have unrecognized compensation expense of $96.4 million, which is expected to be recognized over a weighted average period of approximately 2.63 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. For additional information, see Note 14 to the Consolidated Financial Statements.
Long-lived assets
Property and equipment and field equipment are 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 make estimates of the useful life of our property and equipment and 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.
Our field equipment consists of equipment being utilized under rental agreements accounted for on a monthly basis as an operating lease, as well as service pool equipment. Service pool equipment is equipment owned and maintained by us that is swapped for equipment that needs repair or maintenance by us while being used by a patient. We record a provision for any excess, lost or damaged equipment when warranted based on an assessment of the equipment.
We assess impairment whenever events or changes in circumstances indicate that the carrying amount of the asset is impaired or the estimated useful life is no longer appropriate. Circumstances such as changes in technology or in the way an asset is being used may trigger an impairment review. For additional information, see Notes 2(i) and 2(j) to the Consolidated Financial Statements.
Inventories
Inventories are stated at the lower of cost or net realizable value. We regularly evaluate the ability to realize the value of inventory. If the inventories are deemed damaged, if actual demand for our devices declines, or if market conditions are less favorable than those projected, inventory write-offs may be required. For additional information, see Note 2(h) to the Consolidated Financial Statements.
Income taxes
As part of the process of preparing our consolidated financial statements, we are required to calculate our income taxes based on taxable income by jurisdiction. We make certain estimates and judgments in determining our income taxes, including assessment of our uncertain tax positions, for financial statement purposes. Significant changes to these estimates may result in an increase or decrease to our tax provision in the subsequent period when such a change in estimate occurs.
Uncertain tax positions are based on estimates and assumptions that have been deemed reasonable by management. Our estimates of unrecognized tax benefits and potential tax benefits may not be representative of actual outcomes.
For additional information, see Note 13 to the Consolidated Financial Statements.
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Results of operations
The following discussion provides an analysis of our results of operations and reasons for material changes therein for 2021 as compared to 2020. 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 2020 Annual Report on Form 10-K, filed with the SEC on February 25, 2021, for an analysis of the 2020 results as compared to 2019.
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 | 2021 | 2020 | 2019 | ||||||||
| Net revenues | $ | 535,031 | $ | 494,366 | $ | 351,318 | |||||
| Cost of revenues | 114,877 | 106,501 | 88,606 | ||||||||
| Gross profit | 420,154 | 387,865 | 262,712 | ||||||||
| Operating costs and expenses: | |||||||||||
| Research, development and clinical studies | 201,303 | 132,010 | 79,003 | ||||||||
| Sales and marketing | 137,057 | 118,017 | 96,675 | ||||||||
| General and administrative | 126,127 | 107,437 | 87,948 | ||||||||
| Total operating costs and expenses | 464,487 | 357,464 | 263,626 | ||||||||
| Operating income (loss) | (44,333) | 30,401 | (914) | ||||||||
| Financial expenses (income), net | 7,742 | 12,299 | 7,910 | ||||||||
| Income (loss) before income tax | (52,075) | 18,102 | (8,824) | ||||||||
| Income tax | 6,276 | (1,706) | (1,594) | ||||||||
| Net income (loss) | $ | (58,351) | $ | 19,808 | $ | (7,230) | |||||
| Basic net income (loss) per ordinary share | $ | (0.56) | $ | 0.20 | $ | (0.07) | |||||
| Weighted average number of ordinary shares used in computing basic net income (loss) per share | 103,433,274 | 100,930,866 | 97,237,549 | ||||||||
| Diluted net income (loss) per ordinary share | $ | (0.56) | $ | 0.18 | $ | (0.07) | |||||
| Weighted average number of ordinary shares used in computing diluted net income (loss) per share | 103,433,274 | 108,877,648 | 97,237,549 |
The following table details the share-based compensation expense included in costs and expenses:
| Year ended December 31, | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| U.S. dollars in thousands | 2021 | 2020 | 2019 | ||||||||
| Cost of revenues | $ | 3,471 | $ | 2,221 | $ | 2,231 | |||||
| Research, development and clinical studies | 27,597 | 18,125 | 7,570 | ||||||||
| Sales and marketing | 22,673 | 17,672 | 11,897 | ||||||||
| General and administrative | 41,159 | 37,703 | 30,718 | ||||||||
| Total share-based compensation expense | $ | 94,900 | $ | 75,721 | $ | 52,416 |
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. The number of active patients on therapy is our principal revenue driver. 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. Prescriptions are a leading indicator of
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demand. A "prescription received" is a commercial order for Optune or Optune Lua that is received from a physician certified to treat patients with our Products for a patient not previously on Optune or Optune Lua. Orders to renew or extend treatment are not included in this total.
The following table includes certain commercial operating statistics for and as of the end of the periods presented.
| December 31, | |||||||
|---|---|---|---|---|---|---|---|
| Operating statistics | 2021 | 2020 | 2019 | ||||
| Active patients at period end | |||||||
| North America | 2,272 | 2,193 | 1,952 | ||||
| EMEA: | |||||||
| Germany | 563 | 562 | 493 | ||||
| Other EMEA | 445 | 391 | 272 | ||||
| Japan | 307 | 265 | 192 | ||||
| Total | 3,587 | 3,411 | 2,909 |
| Year ended December 31, | |||||||
|---|---|---|---|---|---|---|---|
| 2021 | 2020 | 2019 | |||||
| Prescriptions received in period | |||||||
| North America | 3,781 | 3,871 | 3,833 | ||||
| EMEA: | |||||||
| Germany | 924 | 910 | 872 | ||||
| Other EMEA | 521 | 467 | 360 | ||||
| Japan | 436 | 365 | 306 | ||||
| Total | 5,662 | 5,613 | 5,371 |
In the U.S., there were 11 active MPM patients on therapy as of December 31, 2021 and 48 MPM prescriptions were received in the year ended December 31, 2021.
Year ended December 31, 2021 compared to year ended December 31, 2020
| Year ended December 31, | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2021 | 2020 | Change | % Change | |||||||||||
| Net revenues | $ | 535,031 | $ | 494,366 | $ | 40,665 | 8 | % |
Net revenues. Net revenues increased by $40.7 million, or 8%, to $535.0 million for the year ended December 31, 2021 from $494.4 million for the year ended December 31, 2020. This primarily was due to an increase of 176 active patients, representing 5% growth and increased efficiency in our revenue operations, offset by a reduction in net revenue per active patient in Germany.
For the year ended December 31, 2021, we recorded $40.3 million in revenues from Medicare fee-for-service beneficiaries billed under the coverage policy compared to $36.1 million for the year ended December 31, 2020. We believe we have completed our administrative ramp-up for processing Medicare claims and efficiently pursuing appeals.
In 2021, we did not record material revenue from the successful appeal of previously denied claims for Medicare fee-for-service beneficiaries billed prior to established coverage, compared to approximately $19 million in incremental net revenues recorded in 2020. We continue to actively appeal and pursue previously denied claims for beneficiaries billed prior to established coverage, but the cadence and amount of these Medicare payments are impossible to predict.
| Year ended December 31, | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2021 | 2020 | Change | % Change | |||||||||||
| Cost of revenues | $ | 114,877 | $ | 106,501 | $ | 8,376 | 8 | % |
Cost of revenues. Our cost of revenues increased by $8.4 million, or 8%, to $114.9 million for the year ended December 31, 2021 from $106.5 million for the year ended December 31, 2020. The increase in cost of revenues primarily was due to increased array utilization and shipping costs to a higher volume of active patients, which
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increased 5% in the year ended December 31, 2021 compared to the year ended December 31, 2020. An increase of $5 million in product sales to Zai in the year ended December 31, 2021 compared to the year ended December 31, 2020 contributed to the increase in cost of revenues. Excluding sales to Zai, cost of revenues per active patient per month decreased 5% to $2,474 for the year ended December 31, 2021 from $2,602 for the year ended December 31, 2020 due to on-going efficiency initiatives and scale.
Cost of revenues per active patient is calculated by dividing the cost of revenues for the year less product sales to Zai for the year by the average of the active patients at the end of the each quarter in the current year and the end of the year active patients from the prior year. This annual figure is then divided by twelve to estimate the monthly cost of revenues per active patient. Sales to Zai are deducted because they are made at cost and in anticipation of future royalties from Zai, and Zai patient counts are not included in our active patient population. Product sales to Zai totaled $11.3 million for the year ended December 31, 2021 compared to $6.3 million for the year ended December 31, 2020.
Gross margin was 79% for the year ended December 31, 2021 and 78% for the year ended December 31, 2020. Gross margin continues to benefit from ongoing efficiency initiatives and increasing scale and is tempered by product sales to Zai.
| Year ended December 31, | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2021 | 2020 | Change | % Change | |||||||||||
| Operating expenses: | ||||||||||||||
| Research, development and clinical studies | $ | 201,303 | $ | 132,010 | $ | 69,293 | 52 | % | ||||||
| Sales and marketing | 137,057 | 118,017 | 19,040 | 16 | % | |||||||||
| General and administrative | 126,127 | 107,437 | 18,690 | 17 | % | |||||||||
| Total operating expenses | $ | 464,487 | $ | 357,464 | $ | 107,023 | 30 | % |
Research, development and clinical studies expenses. Research, development and clinical studies expenses increased by $69.3 million, or 52%, to $201.3 million for the year ended December 31, 2021 from $132.0 million for the year ended December 31, 2020. The change is primarily due to an incremental $31.6 million in clinical studies and clinical administration expenses, $5.5 million in product development expenses, $3.5 million in preclinical and basic research expenses, and $3.4 million in clinical affairs expenses.
We expect growth in our research and development investments to continue into 2022 as we work to advance our pipeline programs and increase acceptance of Tumor Treating Fields across the global oncology community. We balance our investments in research and development with our organizational capacity to effectively execute our strategic initiatives.
Sales and marketing expenses. Sales and marketing expenses increased by $19.0 million, or 16%, to $137.1 million for the year ended December 31, 2021 from $118.0 million for the year ended December 31, 2020. The change primarily was due to increases of $7.0 million, $4.0 million and $2.6 million in health policy, marketing and sales expenses, respectively, which are intended to support our growing commercial business and reimbursement efforts, including an incremental $5.7 million invested in pre-commercial activities associated with potential commercial launches in additional cancer indications and expansion into new markets in our approved indications.
General and administrative expenses. General and administrative expenses increased by $18.7 million, or 17%, to $126.1 million for the year ended December 31, 2021 from $107.4 million for the year ended December 31, 2020. The change primarily was due to increase of $10.1 million in expenses associated with personnel costs and professional services, as well as an increase of $4.6 in expenses associated with supply chain optimization.
| Year ended December 31, | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2021 | 2020 | Change | % Change | |||||||||||
| Financial expenses (income), net | $ | 7,742 | $ | 12,299 | $ | (4,557) | (37) | % |
Financial expenses, net. Financial expenses, net, decreased by $4.6 million, or 37%, to $7.7 million for the year ended December 31, 2021 from $12.3 million for the year ended December 31, 2020. The change primarily was due to a prepayment premium related to the 2018 Credit Facility, amortization costs related to the issuance of our convertible notes and expenses related to the senior secured revolving credit facility. See Note 10 to the Consolidated Financial Statements.
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| Year ended December 31, | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2021 | 2020 | Change | % Change | |||||||||||
| Income tax | $ | 6,276 | $ | (1,706) | $ | 7,982 | (468) | % |
Income taxes. Income tax expenses increased by $8.0 million, or 468%, resulting in a tax expense of $6.3 million for the year ended December 31, 2021 compared to a tax benefit of $1.7 million for the year ended December 31, 2020. The change was primary due to a net one-time tax benefit of $11.3 million which was recorded in the first quarter of 2020 in response to the changes in the U.S. tax code related to the economic impact of the COVID-19 pandemic. Without this one-time benefit in 2020, income taxes expenses decreased $3.3 million in 2021 driven by a change in the mix of applicable statutory tax rates in our active jurisdictions.
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"). We believe Adjusted EBITDA is useful to investors in evaluating our operating performance because it helps investors evaluate and compare the results of our operations from period to period by removing the impact of earnings attributable to our capital structure, tax rate and material non-cash items, specifically share-based compensation.
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.
| Year ended December 31, | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2021 | 2020 | 2019 | |||||||||
| Net income (loss) | $ | (58,351) | $ | 19,808 | $ | (7,230) | |||||
| Add: Income tax | 6,276 | (1,706) | (1,594) | ||||||||
| Add: Financial expenses (income), net | 7,742 | 12,299 | 7,910 | ||||||||
| Add: Depreciation and amortization | 10,251 | 9,150 | 8,460 | ||||||||
| EBITDA | $ | (34,082) | $ | 39,551 | $ | 7,546 | |||||
| Add: Share-based compensation | 94,900 | 75,721 | 52,416 | ||||||||
| Adjusted EBITDA | $ | 60,818 | $ | 115,272 | $ | 59,962 |
Adjusted EBITDA decreased by $54.5 million, or 47%, to $60.8 million for the year ended December 31, 2021 from $115.3 million for the year ended December 31, 2020. This decrease was in part due to a $59.8 million increase in investment in research, development and clinical studies expenses (net of share-based compensation expenses), intended to advance our pipeline programs and increase acceptance of TTFields across the global oncology community, as well as an incremental $5.7 million invested in pre-commercial activities associated with potential commercial launches in additional cancer indications and expansion into new markets in our approved indications.
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. As of December 31, 2021, we had an accumulated deficit of $685.9 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, 2021, we had $208.8 million in cash and cash equivalents and $728.9 million in short-term investments. At December 31, 2021, our cash, cash equivalents and short-term investments totaled $937.7 million, an increase of $95.1 million compared to $842.6 million at December 31, 2020. The increase was primarily due to net cash generated by operating activities and the exercise of options.
We believe our cash, cash equivalents and short-term investments as of December 31, 2021 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 expect that our research, development and clinical expenses, sales and marketing expenses and general and administrative expenses will continue to increase over the next several years and may outpace our gross profit. As a result, we may need to raise additional capital to fund our operations.
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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 | 2021 | 2020 | 2019 | ||||||||
| Net cash provided by (used in) operating activities | $ | 82,756 | $ | 99,148 | $ | 26,620 | |||||
| Net cash provided by (used in) investing activities | (144,834) | (472,847) | (51,667) | ||||||||
| Net cash provided by (used in) financing activities | 25,702 | 440,209 | 61,681 | ||||||||
| Effect of exchange rate changes on cash and cash equivalents | (188) | 247 | 26 | ||||||||
| Net increase (decrease) in cash, cash equivalents and restricted cash | $ | (36,564) | $ | 66,757 | $ | 36,660 |
Operating activities
Net cash provided by operating activities primarily represents our net income for the periods presented. Adjustments to net income for non-cash items include share-based compensation, depreciation, amortization and asset write-downs. Operating cash flows are also impacted by changes in operating assets and liabilities, principally trade payables, deferred revenues, other payables, prepaid expenses, inventory and trade receivables.
Net cash provided by operating activities was $82.8 million for the year ended December 31, 2021 compared to $99.1 million for the year ended December 31, 2020. Gross profit increased by $32.3 million in 2021 versus 2020, partially funding incremental investments of $69.3 million in research and development and $37.7 million in sales, marketing, general and administrative expenses. The year over year decrease in cash provided by operating activities was driven by lower cash earnings, offset by lower interest payments, as well as the timing of receipts and payments in the ordinary course of business.
Upcoming use of cash in operations will include payments in the normal course of business of $45.3 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 $34.4 million of commitments with three major suppliers. We make such commitments through a combination of purchase orders, supplier contracts, and open orders based on projected demand information. We also have employment agreements with certain employees that require the funding of a specific level of payments if certain events, such as a change in control or termination without cause, occur. 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.
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.
Net cash used in investing activities was $144.8 million for the year ended December 31, 2021 compared to net cash used in investing activities of $472.8 million for the year ended December 31, 2020. The net cash used in investing activities for 2021 was primarily attributable to $24.2 million in property and equipment and the net purchase of $120.7 million in short-term investments. The net cash used in investing activities for 2020 was primary attributable to $15.0 million in property and equipment and the net purchase of $457.9 million in short-term investments.
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 $25.7 million for the year ended December 31, 2021 compared to $440.2 million for the year ended December 31, 2020. The net cash provided by financing activities for 2021 was primary attributable to proceeds from exercise of options and issuance of shares pursuant to the ESPP. The net cash provided by financing activities for 2020 primarily was attributable to $558.4 million in proceeds from the convertible note issuance and $31.8 million in proceeds from exercise of options and shares related to the ESPP partially offset by $150.0 million in repayment of the 2018 Credit Facility (as described below).
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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 intend to use the net proceeds to further advance our clinical and product development programs and to invest in associated pre-commercial and commercial activities, as well as for general corporate purposes.
The Notes are senior unsecured obligations. The Notes do not bear regular interest, and the principal amount of the Notes will not accrete. Special interest, if any, payable in accordance with the terms of the Notes will be payable in cash semi-annually in arrears on May 1 and November 1 of each year, beginning on May 1, 2021. The Notes mature on November 1, 2025, unless earlier repurchased, redeemed or converted.
The Notes are convertible at an initial conversion rate of 5.9439 ordinary shares per $1,000 principal amount of the Notes, which is equivalent to an initial conversion price of approximately $168.24 per ordinary share. In January 2021, we irrevocably elected to settle all conversions of Notes by a combination of cash and our ordinary shares and that the cash portion per $1,000 principal amount of Notes for all conversion settlements shall be $1,000, Accordingly, from and after the date of the election, upon conversion of any Notes, holders of Notes will receive, with respect to each $1,000 principal amount of Notes converted, cash in an amount up to $1,000 and the balance of the conversion value, if any, in our ordinary shares
The Notes are not redeemable prior to November 6, 2023, except in the event of certain tax law changes. We may redeem for cash all or any portion of the Notes, at our option, on or after November 6, 2023 if the last reported sale price of our ordinary shares has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on, and including, the trading day immediately preceding the date on which we provide notice of redemption at a redemption price equal to 100% of the principal amount of the Notes to be redeemed, plus accrued and unpaid special interest, if any, to, but excluding, the redemption date. No sinking fund is provided for the Notes.
Prior to the close of business on the business day immediately preceding August 1, 2025, the Notes are convertible at the option of the holders only upon the satisfaction of certain conditions and during certain periods and if we exercise our right to redeem the Notes as permitted or required by the indenture. On or after August 1, 2025 until the close of the business on the business day immediately preceding the maturity date, holders may convert all or any portion of their Notes at the conversion rate at any time irrespective of the foregoing conditions.
Term loan credit facility
On November 6, 2020, we entered into a new three-year $150.0 million senior secured revolving credit facility with a syndicate of relationship banks (the "2020 Credit Facility"). We may, subject to certain conditions and limitations, increase the revolving credit commitments outstanding under the 2020 Credit Facility or incur new incremental term loans in an aggregate principal amount not to exceed $250.0 million in total.
The commitments under the 2020 Credit Facility are guaranteed by certain of our subsidiaries and secured by a first lien on our and certain of our subsidiaries’ assets. Outstanding loans will bear interest per annum at a sliding scale based on the our secured leverage ratio from 2.75% to 3.25% above the applicable interbank borrowing reference rate for the currency in which the loan is denominated. Additionally, the 2020 Credit Facility contains a fee for the unused revolving credit commitments at a sliding scale based on our secured leverage ratio from 0.35% to 0.45%. The 2020 Credit Facility contains financial covenants requiring maintenance of a minimum fixed charge coverage ratio and specifying a maximum senior secured net leverage ratio, as well as customary events of default which include a change of control. As of December 31, 2021, we were in compliance with such covenants.
As of December 31, 2021, we had no outstanding balance borrowed under the 2020 Credit Facility.
For additional information, see Note 12(c) to the Consolidated Financial Statements.
2020 Prepayment of 2018 term loan
In 2018, we entered into a Loan and Security Agreement ("2018 Loan Agreement") pursuant to which we borrowed a term loan in the aggregate principal amount of $150.0 million (the "2018 Credit Facility"). The term loan, which was drawn in full upon execution of the 2018 Loan Agreement, bore interest at 9.0% per annum, payable quarterly in arrears. In 2020, we terminated the 2018 Credit Facility and prepaid the principal amount in full. The prepayment included $150.0 million in principal repayment and $3.0 million in prepayment premium, plus accrued and unpaid interest and expenses payable through the payoff date.
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