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Item 7. Management’s Discussion and Analysis

2026-02-26 compared with 2025-02-27 · 112 added, 97 removed, 293 unchanged (42% of the section changed)

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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.

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

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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.

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

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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.

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.

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.

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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.

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.

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Expected term (years) 5.50-5.79

5.50-5.73 5.50-6.00

Expected volatility 75%-77%

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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, 2024, we have unrecognized compensation expense of $119.6 million, which is expected to be recognized over a weighted average period of

approximately 1.59 years.

We expect to continue to grant equity awards in the future, and to the extent that we do, our recognized share-based compensation expense will likely increase.

As of December 31, 2025, we have unrecognized compensation expense of $73.8 million, which is expected to be recognized over a weighted average period of approximately 1.45 years years.

We 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.

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Operating statistics 2025 2024 2023

CNS Lung Total CNS Lung Total CNS Lung Total

Optune Gio Optune Lua Total Optune Gio Optune Lua Total Optune Gio Optune Lua Total

Active patients at period end (1)

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2025 2024 2023

CNS Lung Total CNS Lung Total CNS Lung Total

Optune Gio Optune Lua Total Optune Gio Optune Lua Total Optune Gio Optune Lua Total

Prescriptions received in period (2)

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6,490 545 7,035 6,320 152 6,472 6,005 78 6,083

(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.

(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.

(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.

Year ended December 31, 2025 compared to year ended December 31, 2024

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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 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.

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,

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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.

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.

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Gross margin was 75% for the year ended December 31, 2025 and 77% for the year ended December 31, 2024.

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.

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.

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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.

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

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.

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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 $22.0 million in costs related to a sales force expansion for NSCLC, partially offset by a $10.1 million reduction in marketing expenses.

The change was primarily due to an increase of $8.1 million in costs related to a sales force expansion, a $4.0 million increase in marketing expenses related to the NSCLC launch and new indication preparations, a $2.8 million increase in market access costs related to securing reimbursements in new indications and new geographies, and a $2.1 million increase in other expenses, partially offset by a $16.0 million reduction in share-based compensation.

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.

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,

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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 interest expenses of $7.7 million related to the senior secured credit facility, an increase in interest income of $4.9 million from our investments and a gain from the purchase of convertible notes by $1.0 million.

The decrease was primarily driven by a decrease in interest income of $11.3 million primarily driven by lower U.S.

interest rates and a reduction in our short term investments due to repayment of the convertible note, an increase of $5.7 million in interest expenses from our senior secured term loan credit facility, and an increase of $3.6 million in foreign exchange expenses, offset by a gain from the purchase of convertible notes of $1.1 million.

Year ended December 31,

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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.

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

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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.

The following table reconciles net loss (which is the

most directly comparable U.S.

GAAP operating performance measure) to Adjusted EBITDA.

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Adjusted EBITDA $ (34,318) $ 774 $ (106,293)

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.

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.

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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, 2024, our cash, cash equivalents and short-term investments totaled $959.9 million, an increase of $49.3 million compared to $910.6 million at December 31, 2023.

The increase was primarily due to net cash provided by financing activities.

At December 31, 2025, our cash, cash equivalents and short-term investments totaled $447.7 million, a decrease of $512.2 million compared to $959.9 million at December 31, 2024.

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.

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Effect of exchange rate changes on cash and cash equivalents 394 (174) 131

Net increase (decrease) in cash, cash equivalents and restricted cash $ (76,470) $ 126,730 $ (93,775)

Increase (decrease) in cash, cash equivalents and restricted cash

$ (62,704) $ (76,470) $ 126,730

Operating activities

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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.

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

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 $33.1 million of commitments with three major suppliers.

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.

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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.

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 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.

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 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.

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

"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.

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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.

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.

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.

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.

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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

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.

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

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.

7 unchanged sentences

Impact of Current Events

On October 7, 2023, the State of Israel was attacked by and subsequently declared war on Hamas.

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 are working to increase stock levels to mitigate distribution and service risks from our suppliers in Israel.

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.

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 $168.6 million for the year ended December 31, 2024, net

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.

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.

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

What changed 10-K

Item 7. Management’s Discussion and Analysis