NovoCure Limited
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PART I
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Financial statements
data from SEC XBRL filings. Values are as-reported; restatements supersede originals. Values reported in .
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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 September 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. Optune Lua is also approved in Japan 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 ("gem/nab-pac"). We also have a CE certificate to market Optune Pax for the treatment of adult patients with locally advanced pancreatic cancer of exocrine origin, concomitant with gem/nab-pac in accordance with guideline recommendations. Optune Pax is also
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approved in Japan for the treatment of adult patients with unresectable locally advanced pancreatic cancer concurrent with gem/nab-pac.
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 gem/nab-pac 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 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 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.
In October, we announced that we received approval from Japan's Ministry of Health, Labour, and Welfare (MHLW) for Optune Pax for the treatment of adult patients diagnosed with unresectable locally advanced pancreatic cancer, concomitant with gem/nab-pac. The approval is supported by data from 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.
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 newly diagnosed 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.
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 have engaged with regulators regarding potential protocol revisions to streamline the trial’s primary endpoints with the goal of reducing the patient sample size.
In October, we entered into a Collaboration Agreement with Verastem Oncology ("Verastem") to explore the concomitant use of TTFields therapy together with VS-7375, an oral KRAS G12D inhibitor, and chemotherapy in
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locally advanced pancreatic cancer. We plan to initiate a clinical trial to evaluate safety and tolerability in approximately 25 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 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 nine months ended September 30, 2026, our net revenues were $193.4 million and $551.0 million, respectively. Our net loss for the three and nine months ended September 30, 2026 was $10.4 million and $97.2 million. As of September 30, 2026, we had an accumulated deficit of $1,387.6 million.
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. We do not believe the current escalation of hostilities with Iran will have an incremental impact.
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 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 are also actively pursuing refunds of tariffs we paid under the International Emergency Economic Powers Act ("IEEPA") following the February 2026 U.S. Supreme Court ruling that IEEPA does not authorize tariffs. We believe that we are entitled to recovery of amounts paid; however we cannot be assured that we will be able to collect the full amount or when any recoveries will occur.
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.
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. In the case of a new indication launch such as Optune Pax, it can take time for us to generate the claims history needed for a reasonable estimate of collections that will enable us to recognize revenues upon billing without waiting for a final collection of the claim. Until that time, our revenue from pancreatic cancer claims will be recognized in the period of cash collection.
We also recognize revenues pursuant to the Zai Agreement. For additional information regarding the Zai Agreement, see Note 13 to the Annual Consolidated Financial Statements in our 2025 10-K.
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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;
•patient support and other personnel costs; 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.
Financial income (expenses), net. Financial income (expenses), net primarily consists of interest income from cash balances and short-term investments, credit facility interest expense and related debt issuance costs, 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.
Results of Operations
The following discussion provides an analysis of our results of operations and reasons for material changes therein for the three and nine months ended September 30, 2026 as compared to the three and nine months ended September 30, 2025. The tables contained in this section report U.S. dollars in thousands (except share, patient, and prescription data). The following table sets forth our consolidated statements of operations data:
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| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||||||||
| Unaudited | Unaudited | |||||||||||||||||||||
| Net revenues | $ | 193,399 | $ | 167,204 | $ | 551,038 | $ | 481,003 | ||||||||||||||
| Cost of revenues | 44,529 | 44,729 | 124,564 | 124,722 | ||||||||||||||||||
| Gross profit | 148,870 | 122,475 | 426,474 | 356,281 | ||||||||||||||||||
| Operating costs and expenses: | ||||||||||||||||||||||
| Research, development and clinical studies | 58,099 | 54,029 | 167,883 | 163,639 | ||||||||||||||||||
| Sales and marketing | 53,297 | 58,546 | 173,338 | 171,404 | ||||||||||||||||||
| General and administrative | 43,645 | 45,921 | 169,406 | 134,645 | ||||||||||||||||||
| Total operating costs and expenses | 155,041 | 158,496 | 510,627 | 469,688 | ||||||||||||||||||
| Operating income (loss) | (6,171) | (36,021) | (84,153) | (113,407) | ||||||||||||||||||
| Financial income (expenses), net | (1,709) | 5,999 | (5,437) | 18,111 | ||||||||||||||||||
| Income (loss) before income taxes | (7,880) | (30,022) | (89,590) | (95,296) | ||||||||||||||||||
| Income taxes | 2,555 | 7,248 | 7,641 | 16,432 | ||||||||||||||||||
| Net income (loss) | $ | (10,435) | $ | (37,270) | $ | (97,231) | $ | (111,728) | ||||||||||||||
| Basic and diluted net income (loss) per ordinary share | $ | (0.09) | $ | (0.33) | $ | (0.84) | $ | (1.00) | ||||||||||||||
| Weighted average number of ordinary shares used in computing basic and diluted net income (loss) per share | 116,785,198 | 111,908,252 | 115,685,559 | 111,259,532 | ||||||||||||||||||
As a result of FDA approval of Optune Pax during the first quarter of 2026, we incurred a non-cash general and administrative expense of approximately $43.4 million related to 901,284 PSUs granted in March 2020 to an executive officer that were expensed for U.S. GAAP purposes, but not actually converted to Ordinary Shares and distributed to the executive officer. These PSUs are now cancelled.
The following table details the share-based compensation expense included in costs and expenses:
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||||||||
| Unaudited | Unaudited | |||||||||||||||||||||
| Cost of revenues | $ | 561 | $ | 929 | $ | 1,697 | $ | 3,004 | ||||||||||||||
| Research, development and clinical studies | 4,102 | 6,166 | 12,160 | 18,154 | ||||||||||||||||||
| Sales and marketing | 3,152 | 7,663 | 11,436 | 21,538 | ||||||||||||||||||
| General and administrative | 9,668 | 14,563 | 72,211 | 42,320 | ||||||||||||||||||
| Total share-based compensation expense | $ | 17,483 | $ | 29,321 | $ | 97,504 | $ | 85,016 | ||||||||||||||
Key performance indicators
We believe certain commercial operating statistics are useful to investors in evaluating our commercial business as they help our management team and 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
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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.
The following table includes certain commercial operating statistics for and as of the end of the periods presented.
| September 30, | |||||||||||||||||||||||||||||||||||||||||||||||
| 2026 | 2025 | ||||||||||||||||||||||||||||||||||||||||||||||
| Optune Gio | Optune Lua | Optune Pax | Total | Optune Gio | Optune Lua | Optune Pax | Total | ||||||||||||||||||||||||||||||||||||||||
| Active patients at period end | |||||||||||||||||||||||||||||||||||||||||||||||
| United States | 2,324 | 97 | 266 | 2,687 | 2,176 | 104 | — | 2,280 | |||||||||||||||||||||||||||||||||||||||
| International markets: | |||||||||||||||||||||||||||||||||||||||||||||||
| Germany | 656 | 42 | 10 | 708 | 595 | 31 | — | 626 | |||||||||||||||||||||||||||||||||||||||
| France | 493 | 1 | — | 494 | 499 | — | — | 499 | |||||||||||||||||||||||||||||||||||||||
| Japan | 592 | 110 | — | 702 | 474 | — | — | 474 | |||||||||||||||||||||||||||||||||||||||
| Other international | 664 | 5 | — | 669 | 533 | 4 | — | 537 | |||||||||||||||||||||||||||||||||||||||
| International markets - Total | 2,405 | 158 | 10 | 2,573 | 2,101 | 35 | — | 2,136 | |||||||||||||||||||||||||||||||||||||||
| 4,729 | 255 | 276 | 5,260 | 4,277 | 139 | — | 4,416 | ||||||||||||||||||||||||||||||||||||||||
Prescriptions are an indicator of new indication adoption during the first year of product launch. As such, we are no longer reporting new prescriptions received in indications which have been commercially available for more than one year (GBM, NSCLC, MPM). Prescriptions received for the treatment of pancreatic cancer will be provided for a one-year period following launch.
| Three months ended | Nine months ended | ||||||||||||||||||||||||||||||||||||||
| September 30, 2026 | |||||||||||||||||||||||||||||||||||||||
| Prescriptions received in period (1) | |||||||||||||||||||||||||||||||||||||||
| United States | 209 | 795 | |||||||||||||||||||||||||||||||||||||
| International markets: | |||||||||||||||||||||||||||||||||||||||
| Germany | 29 | 30 | |||||||||||||||||||||||||||||||||||||
| France | — | — | |||||||||||||||||||||||||||||||||||||
| Japan | — | — | |||||||||||||||||||||||||||||||||||||
| Other international | — | — | |||||||||||||||||||||||||||||||||||||
| International markets - Total | 29 | 30 | |||||||||||||||||||||||||||||||||||||
| 238 | 825 | ||||||||||||||||||||||||||||||||||||||
(1) A "prescription received" is a commercial order for Optune Pax that is received from a physician certified to treat patients with our Products for a patient not previously on Optune Pax. Orders to renew or extend treatment are not included in this total.
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Three and nine months ended September 30, 2026 compared to three and nine months ended September 30, 2025
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||||||||||||||||||||
| 2026 | 2025 | % Change | 2026 | 2025 | % Change | |||||||||||||||||||||||||||||
| Net revenues | $ | 193,399 | $ | 167,204 | 16 | % | $ | 551,038 | $ | 481,003 | 15 | % | ||||||||||||||||||||||
Net revenues. Net revenues increased 16% to $193.4 million for the three months ending September 30, 2026 from $167.2 million for the same period in 2025. For the three months ended September 30, 2026 the net revenue increase primarily resulted from $15.3 million in growth from the United States and $10.9 million in growth from international markets, collectively driven primarily by 19% active patient growth globally. In the quarter, there were $4.4 million in one-time revenue benefits included in the aforementioned market increases, consisting of $2.2 million from Germany and $2.2 million from the United States related to approval rate increases. Recognized revenue from Optune Lua and Optune Pax in the quarter was $8.2 million and $3.7 million respectively, versus $3.1 million and $0.0 million in the same period last year. The overall increase was offset by $2.0 million of exchange rate effects.
For the nine months ended September 30, 2026, the increase primarily resulted from $43.2 million in growth from international markets due to 20% active patient growth and reimbursement improvements and $26.8 million from the United States due to 18% active patient growth. The overall increase includes $3.9 million of exchange rate benefits.
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||||||||||||||||||||
| 2026 | 2025 | % Change | 2026 | 2025 | % Change | |||||||||||||||||||||||||||||
| Cost of revenues | $ | 44,529 | $ | 44,729 | — | % | $ | 124,564 | $ | 124,722 | — | % | ||||||||||||||||||||||
Cost of revenues. For the three months ended September 30, 2026, the cost of revenues were flat versus prior year primarily due to $4.5 million of lower array costs, mainly resulting from improved array utilization and manufacturing efficiencies in the current period and the absence of a $2.9 million inventory provision recognized in the prior year, mostly offset by 19% growth in active patients.
For the nine months ended September 30, 2026, the cost of revenues were flat versus prior year primarily due to a $4.9 million tariff refund and $12.3 million lower costs of arrays mainly resulting from improved array utilization and manufacturing efficiencies, mostly offset by the active patient growth.
Excluding sales to Zai, cost of revenues per active patient per month was $2,661 for the three months ended September 30, 2026, a decrease of 16% from $3,159 for the same period in 2025, primarily due to lower array utilization and manufacturing efficiencies. Cost of revenues per active patient is calculated by dividing the cost of revenues for the quarter less equipment sales to Zai for the quarter by the average of the active patients at the end of the prior quarter and the ending active patients in the current quarter. This quarterly figure is then divided by three to estimate the monthly cost of revenues per active patient. Sales to Zai are deducted because they are sold at cost and in anticipation of future royalties from Zai, and Zai patient counts are not included in our active patient population. Cost of products sold to Zai totaled $3.1 million and $10.4 million for the three and nine months ended September 30, 2026 compared to $3.3 million and $9.8 million for the three and nine months ended September 30, 2025.
Gross margin was 77% for the three months ended September 30, 2026 compared to 73% for the three months ended September 30, 2025. The improvement in gross margin is primarily due to 19% active patient growth while keeping the cost of revenues flat. We expect that our gross margins will continue to be impacted by our launches in NSCLC and pancreatic cancer, as well as by the changing tariff landscape. 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 costs.
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Operating Expenses.
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||||||||||||||||||||
| 2026 | 2025 | % Change | 2026 | 2025 | % Change | |||||||||||||||||||||||||||||
| Research, development and clinical studies | $ | 58,099 | $ | 54,029 | 8 | % | $ | 167,883 | $ | 163,639 | 3 | % | ||||||||||||||||||||||
| Sales and marketing | 53,297 | 58,546 | (9) | % | 173,338 | 171,404 | 1 | % | ||||||||||||||||||||||||||
| General and administrative | 43,645 | 45,921 | (5) | % | 169,406 | 134,645 | 26 | % | ||||||||||||||||||||||||||
| Total operating expenses | $ | 155,041 | $ | 158,496 | (2) | % | $ | 510,627 | $ | 469,688 | 9 | % | ||||||||||||||||||||||
Research, development and clinical study expenses. Research, development and clinical study expenses increased 8% to $58.1 million for the three months ended September 30, 2026 from $54.0 million for the same period in 2025. For the three months ended September 30, 2026, the change was primarily due to a $7.3 million increase in direct clinical trial expenses mostly attributable to KEYNOTE D58, partially offset by a $2.1 million decrease in share-based compensation and a $1.6 million decrease in regulatory expenses.
For the nine months ended September 30, 2026, research, development and clinical expenses the changes were primarily due to a $3.1 million increase in direct clinical trial expenses from the acceleration of KEYNOTE D58 enrollments partially offset by the completion of older clinical studies, a $3.6 million increase in engineering expenses, a $1.9 million increase in preclinical expenses and a $1.5 million increase in quality expenses, partially offset by a $6.0 million decrease in share-based compensation expenses.
Total research and development expenses can fluctuate quarter-to-quarter dependent upon the amount of clinical research organization services delivered, clinical materials procured and the number of trials actively underway within a given quarter.
Sales and marketing expenses. Sales and marketing expenses decreased 9% to $53.3 million for the three months ended September 30, 2026 from $58.5 million for the same period in 2025. For the three months ended September 30, 2026, the change was mainly driven by $4.5 million lower share-based compensation expenses and $2.0 million lower marketing expenses, partially offset by $0.9 in higher sales personnel expenses.
For the nine months ended September 30, 2026 the changes were primarily due to a $8.4 million increase in sales and marketing efforts and $2.2 million of reimbursement personnel expenses related to the Optune Pax launch in the United States and Optune Lua launch in Japan, partially offset by $10.1 million lower share-based compensation expenses.
General and administrative expenses. General and administrative expenses decreased 5% to $43.6 million for the three-month period ended September 30, 2026 from $45.9 million for the same period in 2025. For the three months ended September 30, 2026, these changes were primarily due to $4.9 million lower share-based compensation expenses partially offset by a $2.2 million retirement of production line equipment as a result of process efficiencies.
For the nine months ended September 30, 2026, the changes were primarily due to $29.9 million higher share-based compensation expenses, resulting primarily from approximately $43.4 million related to PSUs granted in March 2020 to an executive officer that were expensed according to U.S. GAAP as a result of the FDA approval of Optune Pax, but not distributed. Additionally, excluding share based compensation expenses, there was a $4.9 million increase in general and administrative expenses resulting from personnel and professional service expenses to support multiple launches.
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||||||||||||||||||||
| 2026 | 2025 | % Change | 2026 | 2025 | % Change | |||||||||||||||||||||||||||||
| Financial income (expenses), net | $ | (1,709) | $ | 5,999 | (128) | % | $ | (5,437) | $ | 18,111 | (130) | % | ||||||||||||||||||||||
Financial income (expenses), net. Financial income decreased by $7.7 million or 128% from $6.0 million in income for the three months ended September 30, 2025 to an expense of $1.7 million for the same period in 2026, primarily due to a $5.8 million decrease in interest income on our investments driven by the repayment upon
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maturity in November 2025 of our 0% coupon convertible notes and $2.3 million of higher interest expenses related to our senior secured credit facility driven by our borrowing of Tranche B at the end of September 2025.
For the nine months ended September 30, 2026, financial income decreased by $23.5 million or 130% from $18.1 million in income for the nine months ended September 30, 2025 to an expense of $5.4 million for the same period in 2026, primarily. due to a $19.3 million decrease in interest income on our investments, $6.9 million of higher interest expenses related to our senior secured credit facility, offset by a $1.1 million decrease in foreign exchange currency loss and a $1.6 million decrease in amortization expenses related to debt.
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||||||||||||||||||||
Next expected filings
- ~2027-02-25 10-K expected by 2027-03-02 (in 119 days)
- ~2027-04-29 10-Q expected by 2027-05-11 (in 182 days)
- ~2027-07-22 10-Q expected by 2027-08-03 (in 266 days)
- ~2027-10-28 10-Q expected by 2027-11-09 (in 364 days)
Predicted from historical filing cadence; not an SEC commitment.
Recent SEC filings
- 2026-10-29 8-K Earnings Release; Financial Statements and Exhibits
- 2026-10-29 10-Q Quarterly Report
- 2026-10-29 S-8 Employee Benefit Plan Registration
- 2026-09-09 8-K Officer/Director Change; Financial Statements and Exhibits
- 2026-09-01 8-K Other Events; Financial Statements and Exhibits
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