What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-04-24 compared with 2024-10-30 · 117 added, 136 removed, 188 unchanged (57% of the section changed)

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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, 2024 included in Part I, Item 1 of this Quarterly Report on Form 10-Q.

We encourage you to read this MD&A in conjunction with our unaudited consolidated financial statements and the notes thereto for the period ended March 31, 2025 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.

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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.

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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 and under the Humanitarian Device Exemption ("HDE") pathway to treat malignant pleural mesothelioma and pleural mesothelioma (together, "MPM") together with standard chemotherapies.

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 have also received CE certification for the use of Optune Lua for the treatment of adult patients with metastatic NSCLC concurrently with immune checkpoint inhibitors or docetaxel who have progressed on or after a platinum-based regimen.

We have initiated the local registration requirements for Optune Lua for NSCLC in Germany and are preparing for launch.

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

We are actively evaluating opportunities to expand our international footprint.

We are actively pursuing contracts with payers to expand access to Optune Lua for patients with NSCLC and MPM and in the meantime we will bill and seek reimbursement from payers on an individual case basis, as applicable.

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.

In April 2025, we announced that the results of the PANOVA-3 trial will be presented for the first time at the 2025 American Society of Clinical Oncology Annual Meeting in May 2025.

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 are focusing our research and development activities in areas of greatest anticipated value creation.

This includes NSCLC, brain cancers, and pancreatic cancer.

In October 2024, the U.S.

FDA approved our PMA application for Optune Lua use concurrent use with PD-1/PD-L1 inhibitors or docetaxel for the treatment of adult patients with metastatic NSCLC who have progressed on or after a platinum-based regimen.

This application was based on the results from the phase 3 LUNAR trial, which showed patients treated with TTFields therapy concomitant with PD-1/PD-L1 inhibitors or docetaxel exhibited a statistically significant and clinically meaningful improvement in median overall survival (OS) compared to patients treated with PD-1/PD-L1 inhibitors or docetaxel alone.

The LUNAR trial included two pre-specified powered secondary endpoints.

The first secondary endpoint, which met statistical significance, assessed median OS in patients treated with Optune Lua concurrently with a PD-1/PD-L1 inhibitor versus a PD-1/PD-L1 inhibitor alone.

The second secondary endpoint, which showed a positive trend but did not meet statistical significance, assessed Optune Lua

concurrently with docetaxel versus docetaxel alone.

We have also filed applications for use to the necessary regulatory bodies in Europe and Japan.

In June 2024, we presented positive results from the phase 3 METIS trial, evaluating the use of TTFields therapy and supportive care for the treatment of patients with 1-10 brain metastases from NSCLC following stereotactic radiosurgery (“METIS”) at the 2024 American Society of Clinical Oncology (ASCO) annual meeting.

The METIS trial met its primary endpoint, demonstrating a statistically significant improvement in time to intracranial progression for adult patients treated with TTFields therapy and supportive care compared to patients treated with supportive care alone.

Patients treated with TTFields therapy and supportive care exhibited a median time to intracranial progression of 21.9 months compared to 11.3 months in patients treated with supportive care alone for brain metastasis (n=298;

hazard ratio=0.67;

These data are expected to serve as the basis for regulatory submissions.

In October 2024, the FDA granted Breakthrough Device designation for the use of our NovoTTF-200M device and supportive care for the treatment brain metastases from NSCLC as used in the METIS protocol.

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

In June 2024, we presented top-line results from the prospective, non-interventional TIGER study at the 2024 ASCO annual meeting.

The TIGER study investigated the use of TTFields therapy in routine clinical use in the treatment of newly diagnosed GBM in Germany.

Of the 710 patients enrolled in the study between August 2017 to November 2019, 429 patients received TTFields therapy, across 81 participating centers.

Median overall survival for patients treated with TTFields therapy was 19.6 months (95% CI, 17.9-22.4) and median progression-free survival was 10.2 months (95% CI, 9.4-11.4).

TTFields therapy use was not associated with an increase in systemic toxicity and was well tolerated.

The outcomes observed in the TIGER study are consistent with the survival and safety results from our phase 3 EF-14 clinical trial.

In March 2024, an exploratory subgroup analysis of the phase 3 INNOVATE-3 clinical trial was presented at the European Society of Gynaecological Oncology 2024 Congress.

The randomized, phase 3 INNOVATE-3 trial evaluated the use of TTFields therapy together with paclitaxel in platinum-resistant ovarian cancer in patients with a maximum of five total prior lines of systemic therapy.

While the INNOVATE-3 trial did not meet its primary overall survival endpoint in the intent-to-treat population, the exploratory subgroup analysis found that pegylated liposomal doxorubicin (PLD) -naïve patients randomized to receive TTFields therapy and paclitaxel demonstrated significant improvement in median overall survival compared to PLD-naïve patients treated with paclitaxel alone.

These data provide valuable insights into the use of TTFields therapy in the treatment of solid tumors and will be informative in the design of future clinical trials.

Novocure and investigators will continue to analyze the data from the INNOVATE-3 trial.

We have several ongoing or planned trials which will further explore the use of TTFields therapy in the treatment of NSCLC, pancreatic cancer, and primary brain cancer.

Alongside the LUNAR and METIS phase 3 trials, our NSCLC program includes the phase 3 LUNAR-2 trial, which explores the use of TTFields therapy together with pembrolizumab and platinum-based chemotherapy as first-line treatment for metastatic NSCLC and the phase 2 LUNAR-4 trial, which evaluates the use of TTFields therapy together with an immune checkpoint inhibitor (ICI) following prior ICI treatment as a second-line treatment for metastatic NSCLC.

LUNAR-2 and LUNAR-4 are currently open and enrolling.

Finally, our phase 2 KEYNOTE B36 trial is exploring the use of TTFields therapy together with pembrolizumab for front-line treatment of locally advanced or metastatic NSCLC.

We are evaluating appropriate next steps for this trial given its pace of enrollment and our focus on LUNAR-2.

Our pancreatic cancer program is comprised of the phase 3 PANOVA-3 trial and the phase 2 PANOVA-4 trial.

The PANOVA-3 trial is exploring the use of TTFields therapy together with nab-paclitaxel and gemcitabine as front-line treatment for unresectable locally advanced pancreatic cancer and is fully enrolled with top-line data anticipated in the fourth quarter of 2024.

The PANOVA-4 trial is exploring the use of TTFields therapy together with atezolizumab, gemcitabine and nab-paclitaxel for the treatment of metastatic pancreatic cancer and has completed enrollment with data anticipated in 2026.

Our primary brain cancer clinical trial program includes the fully enrolled phase 3 TRIDENT trial and the phase 3 KEYNOTE D58 trial.

The TRIDENT trial is exploring the use of TTFields therapy concomitant with radiation and chemotherapy for the treatment of newly diagnosed GBM and data is anticipated in 2026.

The KEYNOTE D58 trial is evaluating the use of TTFields therapy together with temozolomide and pembrolizumab for the treatment of newly diagnosed GBM and we are initiating clinical sites.

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.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 TTFields delivery to the target tumor and enhance patient ease of use.

One of these initiatives is the launch of new arrays, which are thinner, lighter and more flexible.

We have obtained a CE Mark and rolled out our new arrays in multiple European countries.

We submitted the new arrays for regulatory approval in the U.S.

and Japan and are awaiting regulatory decisions.

We have several ongoing clinical trials which further explore the use of TTFields therapy in these solid tumor cancers, including the Phase 3 TRIDENT and KEYNOTE D58 trials in GBM, Phase 3 LUNAR-2 and Phase 2 LUNAR-4 trials in NSCLC, and Phase 2 PANOVA-4 trial in pancreatic cancer.

We 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.

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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 2023 10-K.

In September 2024, we announced that our Chief Executive Officer (CEO), Asaf Danziger, will retire at year-end 2024 and Novocure’s Chief Financial Officer (CFO), Ashley Cordova, will succeed him as the company’s next CEO.

Danziger, who has served as CEO since 2002, will serve as Senior Advisor through 2026, and will continue to serve on Novocure’s Board of Directors.

These changes will become effective on January 1, 2025.

In addition, Mukund Paravasthu transitioned into the role of Chief Operating Officer, effective October 1, 2024.

In October 2024, we announced the appointment of Christoph Brackmann as our CFO, effective January 1, 2025.

Brackmann joined in October 2024 as a Senior Finance Advisor and will continue in that role until his appointment as CFO takes effect.

For additional information, see Note 13 to the Consolidated Financial Statements.

Effective January 1, 2025, Ashley Cordova became our Chief Executive Officer (CEO), succeeding Asaf Danziger who retired at year-end 2024.

Prior to becoming our CEO, Ms.

Cordova served as our Chief Financial Officer (CFO) since 2020.

Danziger now serves as Senior Advisor through 2026, and continues to serve on Novocure’s Board of Directors.

Also effective January 1, 2025, Christoph Brackmann became our CFO.

Brackmann joined us in October 2024 as a Senior Finance Advisor.

Prior to joining Novocure, Mr.

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from October 2019 to June 2024.

During that time Mr.

Brackmann built out the finance team across FP&A, accounting, tax, treasury, procurement and business service centers to support Moderna’s scale-up.

Brackmann earned his Master of Business Administration from the SDA Bocconi School of Management in 2003 and holds a degree in Business and Economics from the University of Manheim.

We view our operations and manage our business in one operating segment.

For the three and nine months ended September 30, 2024, our net revenues were $155.1 million and $444.0 million, respectively.

Our net loss for the three and nine months ended September 30, 2024 was $30.6 million and $102.7 million, respectively.

As of September 30, 2024, we had an accumulated deficit of $1,088.2 million.

For the three months ended March 31, 2025, our net revenues were $155.0 million.

Our net loss for the three months ended March 31, 2025 was $34.3 million.

As of March 31, 2025, we had an accumulated deficit of $1,188.4 million.

Impact of Current Events

Conflict in Israel

On October 7, 2023, the State of Israel was attacked and is in a state of war.

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Our supply chain teams have increased stock levels to mitigate distribution and service risks from our suppliers in Israel.

Recent Changes to U.S.

The manufacturing of our Products and associated accessories are 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 process of adding production capacity in Mexico and Ireland.

This also helps us now to provide optionality around supply routes to optimize our cost structure, including the emerging tariff landscape.

In March and April 2025, the U.S.

increased tariff rates on imported goods from numerous countries.

At that time, our most significant tariff exposure resulted from the import of arrays into the U.S.

from Israel, which was subject to a 17% tariff rate.

This is compared to zero percent tariff rate prior to April 2025.

On April 9, the U.S.

temporarily delayed implementation of all new tariffs by 90 days, resulting in a 10% tariff for most countries.

If the tariffs return to the pre-April 9 rates after the pause expires, our current analysis of the global tariff environment leads us to estimate that import duties could increase by as much as $11 million in 2025.

If the pause continues through the end of 2025, we estimate an $8 million impact.

The global tariff environment is changing rapidly, and we cannot be assured that we will not ultimately be negatively impacted further by these changes.

We continue to focus on opportunities to mitigate negative impacts and increase efficiencies and scale within our supply chain.

Commentary on Results of Operations

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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 13 to the Consolidated Financial Statements in our 2023 10-K.

In the case of a new indication launch such as Optune Lua, 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 NSCLC 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 2024 10-K.

Cost of revenues.

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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.

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.

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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 the three and nine months ended September 30, 2024 as compared to the three and nine months ended September 30, 2023.

The following discussion provides an analysis of our results of operations and reasons for material changes therein for the three months ended March 31, 2025 as compared to the three months ended March 31, 2024.

The tables contained in this section report U.S.

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The following table sets forth our consolidated statements of operations data:

Three months ended September 30, Nine months ended September 30,

2024 2023 2024 2023

Unaudited Unaudited

Three months ended March 31,

Net revenues $ 154,994 $ 138,503

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The following table details the share-based compensation expense included in costs and expenses:

Three months ended September 30, Nine months ended September 30,

2024 2023 2024 2023

Unaudited Unaudited

Three months ended March 31,

Cost of revenues $ 1,102 $ 1,747

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The following table includes certain commercial operating statistics for and as of the end of the periods presented.

September 30,

Operating statistics 2024 2023

CNS Lung Total CNS Lung Total

Active patients at period end (1)

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International markets - Total 2,005 32 2,037 1,697 11 1,708

Total 4,113 3,639

Three months ended September 30, Nine months ended September 30,

4,162 106 4,268 3,819 26 3,845

Three months ended March 31,

CNS Lung Total CNS Lung Total

Prescriptions received in period (2)

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International markets - Total 700 33 733 639 14 653

Total 1,586 1,467 4,863 4,519

Three and nine months ended September 30, 2024 compared to three and nine months ended September 30, 2023

Three months ended September 30, Nine months ended September 30,

2024 2023 % Change 2024 2023 % Change

1,608 127 1,735 1,624 19 1,643

(1) Lung includes both active patients in NSCLC and MPM.

Worldwide, there were 44 and 26 active MPM patients on therapy as of as of March 31, 2025 and 2024 and 62 active NSCLC patients on therapy as of as of March 31, 2025.

(2) Lung includes both prescriptions for NSCLC and MPM.

Worldwide, 35 and 19 MPM prescriptions were received in the three months ended March 31, 2025 and 2024 and 92 NSCLC prescriptions were received in the three months ended March 31, 2025.

Three months ended March 31, 2025 compared to three months ended March 31, 2024

Three months ended March 31,

2025 2024 % Change

Net revenues $ 154,994 $ 138,503 12 %

Net revenues.

Net revenues increased 22% to $155.1 million for the three months ending September 30, 2024 from $127.3 million for the same period in 2023.

For the three and nine months ended September 30, 2024, the increase primarily resulted from $11.1 million and $35.8 million of net revenues from the successful launch in France and $12.1 million and $26.2 million of net revenues in the U.S.

due to improved approval rates.

The improved approval rates in the U.S.

resulted in $4.7 million and $14.0 million of increased net revenue from prior period claims during the three- and nine- month periods, primarily from 2023.

Three months ended September 30, Nine months ended September 30,

2024 2023 % Change 2024 2023 % Change

Net revenues increased 12% to $155.0 million for the three months ending March 31, 2025 from $138.5 million for the same period in 2024.

For the three months ended March 31, 2025, the increase resulted from active patient growth of 11% and reimbursement improvements across geographic markets.

In EMEA, the increase primarily resulted from $7.4 million from continued growth in France, a $3.0 million increase in Germany due to active patient and approval rate increases, and a $3.0 million increase from other European active markets due to active patient growth and receipt of aged collections.

In the U.S., net revenues for the period increased $2.6 million from the same period in 2024.

Recognized revenue from Optune Lua in the quarter was $1.5 million, including $0.8 million from MPM, and $0.7 million from NSCLC.

Three months ended March 31,

2025 2024 % Change

Cost of revenues $ 38,521 $ 33,689 14 %

Cost of revenues.

Our cost of revenues for the three months ended September 30, 2024 was $35.4 million, an increase of 10% from $32.1 million for the same period in 2023.

For the three and nine months ended September 30, 2024, the increase in cost of revenues was primarily due to 13% growth in active patients, partially offset by lower equipment sales to Zai in the amount of $1.5 million and $1.9 million, respectively.

Excluding sales to Zai, cost of revenues per active patient per month was $2,713 for the three months ended September 30, 2024, an increase of 4% from $2,599 for the same period in 2023, primarily due to an increase in

costs related to the rollout of our new arrays.

For the three months ended March 31, 2025, the increase in cost of revenues was primarily due to 11% growth in active patients and higher average array costs driven by the new array roll-out and the NSCLC launch.

Excluding sales to Zai, cost of revenues per active patient per month was $2,794 for the three months ended March 31, 2025, an increase of 3% from $2,715 for the same period in 2024, primarily due to higher average array costs driven by the new array roll-out and the NSCLC launch.

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.

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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.

Product sales to Zai totaled $2.5 million and $8.4 million for the three and nine months ended September 30, 2024 compared to $4.0 million and $10.3 million for the three and nine months ended September 30, 2023.

Gross margin was 77% for the three months ended September 30, 2024 compared to 75% for the three months ended September 30, 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 US 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.

and our launch in NSCLC.

Cost of products sold to Zai totaled $3.3 million for the three months ended March 31, 2025 compared to $2.7 million for the three months ended March 31, 2024.

Gross margin was 75% for the three months ended March 31, 2025 compared to 76% for the three months ended March 31, 2024.

The reduction in gross margin is due to the aforementioned cost of revenue increase and the completion of the Zai up front license and milestone fees recognition.

We expect that our gross margins will continue to be impacted by current and future product enhancements, such as the launch of our new arrays in the U.S.

and our launch in NSCLC, as well as by the changing tariff landscape.

We continue to focus on opportunities to increase efficiencies and scale within our supply chain.

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Operating Expenses.

Three months ended September 30, Nine months ended September 30,

2024 2023 % Change 2024 2023 % Change

Three months ended March 31,

2025 2024 % Change

Research, development and clinical studies $ 53,777 $ 51,598 4 %

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Research, development and clinical study expenses.

Research, development and clinical study expenses decreased 3% to $51.9 million for the three months ended September 30, 2024 from $53.6 million for the same period in 2023.

For the three and nine months ended September 30, 2024, the change was primarily due to a decrease in personnel expenses.

Research, development and clinical study expenses increased 4% to $53.8 million for the three months ended March 31, 2025 from $51.6 million for the same period in 2024.

For the three months ended March 31, 2025, the change was primarily due to a $2.5 million increase in direct clinical trial expenses related to the ramp up of the LUNAR-2, LUNAR-4, and KEYNOTE D58 trials.

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 increased 3% to $59.8 million for the three months ended September 30, 2024 from $58.0 million for the same period in 2023.

For the three months ended September 30, 2024, the change was primarily driven by an $7.8 million increase in costs related to a sales force expansion in anticipation of a potential launch in NSCLC, partially offset by a $6.2 million reduction in marketing spend.

For the nine months ended September 30, 2024, the increase was primarily driven by a $10.8 million increase related to the sales force expansion for NSCLC, partially offset by a $6.7 million reduction in marketing spend.

Sales and marketing expenses increased 1% to $55.8 million for the three months ended March 31, 2025 from $55.2 million for the same period in 2024.

For the three months ended March 31, 2025, the change was primarily driven by higher costs associated with the expansion of the sales force for NSCLC,

General and administrative expenses.

General and administrative expenses decreased 4% to $40.1 million for the three-month period ended September 30, 2024 from $41.9 million for the same period in 2023.

For the three and nine months ended September 30, 2024, these changes were primarily due to lower personnel and professional service expenses.

Three months ended September 30, Nine months ended September 30,

2024 2023 % Change 2024 2023 % Change

General and administrative expenses increased 13% to $44.8 million for the three-month period ended March 31, 2025 from $39.5 million for the same period in 2024.

For the three months ended March 31, 2025, these changes were primarily due to a $2.3 million one-time expense to retire a production line related to supply chain optimization efforts and higher personnel and professional service expenses to support the NSCLC launch and preparations for potential future indications.

Three months ended March 31,

2025 2024 % Change

Financial income (expenses), net $ 7,570 $ 9,878 (23) %

Financial income (expenses), net.

For the three months ended September 30, 2024, financial income increased $0.5 million or 5% to $10.5 million from $10.0 million for the same period in 2023, primarily due to $0.8 million higher interest income and $3.5 million in favorable foreign exchange adjustments, offset by $3.0 million in interest expenses related to the senior secured credit facility (see "Senior Secured Term Loan Credit Facility" below).

Financial income increased $3.3 million or 12%, to $31.2 million for the nine months ended September 30, 2024

from $27.9 million in income for the same period in 2023, primarily due to $5.0 million in higher interest income, $2.3 million in favorable foreign exchange impact and $1.1 million in gain from redemption of the Notes, offset by $4.9 million in interest expenses related to the senior secured credit facility.

Three months ended September 30, Nine months ended September 30,

2024 2023 % Change 2024 2023 % Change

Financial income decreased $2.3 million or 23%, to $7.6 million for the three months ended March 31, 2025 from $9.9 million in income for the same period in 2024, primarily due to $2.6 million in higher interest expenses related to our senior secured credit facility,

Three months ended March 31,

2025 2024 % Change

Income taxes $ 4,024 $ 7,118 (43) %

Income taxes .

Income taxes increased 611% to $9.0 million for the three months ended September 30, 2024 from $1.3 million for the same period in 2023 primarily due to $5.6 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 taxes increased 296% to $26.7 million for the nine months ended September 30, 2024 from $6.8 million for the same period in 2023 primarily due to a $7.3 million decrease in tax benefits from share-based compensation, $5.2 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 taxes decreased 43% to $4.0 million for the three months ended March 31, 2025 from $7.1 million for the same period in 2024.

The change is driven primarily by an increase in tax benefits from share-based compensation deductions in the period.

Non-GAAP financial measures

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The following table reconciles net income (loss), which is the most directly comparable GAAP operating performance measure, to Adjusted EBITDA.

Three months ended September 30, Nine months ended September 30,

2024 2023 % Change 2024 2023 % Change

Three months ended March 31,

2025 2024 % Change

Net income (loss) $ (34,319) $ (38,760) (11) %

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Adjusted EBITDA $ (4,988) $ (4,621) 8 %

Adjusted EBITDA increased by $30.8 million to $1.7 million for the three months ended September 30, 2024 from $(29.1) million for the same period in 2023.

This increase was primarily driven by revenue growth from improved approval rates in the U.S.

and a successful launch in France.

Adjusted EBITDA decreased by 8% to $(5.0) million for the three months ended March 31, 2025 from $(4.6) million for the same period in 2024.

For three months ended March 31, 2025, the change in adjusted EBITDA was primarily driven by revenue growth from increasing active patients and reimbursement improvements globally.

The revenue increase drove a $11.7 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 $6.3 million year-over-year.

The gross profit increase was offset by increased operating expenses, primarily due to our launch in NSCLC and ramp up of clinical trials.

We intend to take actions that prioritize growth and maintain financial health and flexibility as we position our company for future profitability.

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We have incurred significant losses and cumulative negative cash flows from operations since our founding in 2000.

As of September 30, 2024, we had an accumulated deficit of $1,088.2 million.

To date, we have primarily financed our operations through the issuance and sale of equity and the proceeds from long-term loans.

At September 30, 2024, we had $959.9 million in cash, cash equivalents and short-term investments, an increase of $49.3 million compared to $910.6 million at December 31, 2023, primarily as a result of the $100 million draw down of the first tranche of our senior secured credit facility in May 2024 (see "Senior Secured Term Loan Credit Facility" below), offset by net cash used in operations and used in investing activities.

We believe our cash, cash equivalents and short-term investments as of September 30, 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 operating expenses will continue to increase over the next several years and may outpace our gross profit as we prepare to expand into additional indications beyond GBM.

As of March 31, 2025, we had an accumulated deficit of $1,188.4 million.

To date, we have primarily financed our operations through the exercise of options, issuance and sale of equity and the proceeds from long-term loans.

At March 31, 2025, we had $929.1 million in cash, cash equivalents and short-term investments, a decrease of $30.7 million compared to $959.9 million at December 31, 2024, primarily caused by by net cash used in operations and used in investing activities.

We believe our cash, cash equivalents and short-term investments as of March 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 operating expenses will continue to increase over the next several years and may outpace our gross profit as we prepare to expand into additional indications beyond CNS and Lung.

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 unaudited consolidated financial statements, which are included elsewhere in this Quarterly Report:

Nine months ended September 30,

Three months ended March 31,

2025 2024 Change % Change

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Net cash used in or provided by operating activities represents our net income (loss) for the periods presented, share-based compensation and depreciation and amortization.

Operating cash flows are also impacted by changes in working capital.

Net cash used in operating activities decreased by $35.9 million from $58.8 million net cash used in operating activities for the nine months ended September 30, 2023 to $22.9 million net cash used in operating activities for the nine months ended September 30, 2024.

This was a result of a $57.3 million reduction in net loss, offset by a $22.9 million increase in working capital primarily driven by a $33.1 million increase in accounts receivable and a $7.4 million decrease of inventories, a decrease of $6.0 million in cash to non-cash based expenses primarily consisting of shared-based compensation, and a decrease of $4.4 million in other long term assets and an increase of $2.8 million in other long-term liabilities.

Operating cash flows are also impacted by changes in working capital as a result of collections from trade receivables and payments of accounts payables.

Net cash used in operating activities increased by $4.1 million from $31.6 million net cash used in operating activities for the three months ended March 31, 2024 to $35.7 million net cash used in operating activities for the three months ended March 31, 2025.

This was a result of a $4.4 million reduction in net loss, offset by an $8.0 million decrease in expenses consisting of $4.5 million of shared-based compensation and $3.9 million of accrued interest, a $2.8 million increase in working capital primarily driven by a $5.3 million increase in accounts receivable offset by an $1.8 million increase in accounts payable and accrued expenses, and a decrease of $1.4 million in other long term assets and an increase of $0.6 million in other long-term liabilities.

Investing activities.

Our investing activities consist primarily of investments in and redemptions of our short-term investments as well as investments in property and equipment.

Net cash used in investing activities was $118.0 million for the nine months ended September 30, 2024, compared to $85.6 million provided by investing activities for the nine months ended September 30, 2023.

The $118.0 million net cash used in investing activities for the nine months ended September 30, 2024 was primarily attributable to $84.1 million of the net purchase of short term investments and the purchase of $33.9 million of property and equipment.

The $85.6 million net cash provided by investing activities for the nine months ended September 30, 2023 was primarily attributable to $105.9 million of net proceeds from maturity of short term investments and by the purchase of $20.3 million of property and equipment.

Net cash used in investing activities was $6.5 million for the three months ended March 31, 2025, compared to $246.2 million provided by investing activities for the three months ended March 31, 2024.

The $6.5 million net cash used in investing activities for the three months ended March 31, 2025 was primarily attributable to $4.1 million of net proceeds of short term investments and the purchase of $10.6 million of property and equipment.

The $246.2 million net cash provided by investing activities for the three months ended March 31, 2024 was primarily attributable to $258.0 million of net proceeds from maturity of short term investments and by the purchase of $11.8 million of property and equipment.

Financing activities.

Net cash provided by financing activities was $87.6 million for the nine months ended September 30, 2024, as compared to $13.9 million provided by financing activities for the nine months ended September 30, 2023, primarily attributable to $96.9 million of net proceeds from the first tranche of our senior secured credit facility offset by $12.9 million used to partially repay Notes, In addition, the net cash provided by financing activities for the nine months ended September 30, 2024 and September 30, 2023 included proceeds from the exercise of options under the Company's share option plan.

Net cash provided by financing activities was $5.2 million for the three months ended March 31, 2025, as compared to $0.2 million provided by financing activities for the three months ended March 31, 2024, attributable to the exercise of options under the Company's share option plan.

Convertible Notes

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The Notes are convertible at the option of the holders upon the satisfaction of certain other conditions and during certain periods, and if the Company exercises its 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.

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.

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.

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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.

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.

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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-Q

Item 2. Management’s Discussion and Analysis