What changed in this filing

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Item 2. Management’s Discussion and Analysis

2026-07-23 compared with 2026-04-30 · 100 added, 82 removed, 221 unchanged (45% 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 March 31, 2026 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 June 30, 2026 included in Part I, Item 1 of this Quarterly Report on Form 10-Q.

This discussion contains forward-looking statements that involve risks and uncertainties.

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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.

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.

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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 have submitted regulatory applications required to market Optune Pax in the EU and Japan.

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 gemcitabine and nab-paclitaxel in accordance with guideline recommendations.

We have submitted the regulatory application required to market Optune Pax in Japan.

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

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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 Optune Lua and Optune Pax and in the meantime we will bill and seek reimbursement from payers on an individual case basis, as applicable.

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.

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TTFields therapy was well-tolerated and device related safety was consistent with prior clinical studies.

In June, we announced topline results from the Phase 3 TRIDENT trial ("TRIDENT"), evaluating the initiation of TTFields therapy at the start of chemoradiation ("Early Start Arm") compared to initiation of TTFields therapy during the maintenance phase of treatment ("Maintenance Start Arm"), following completion of chemoradiation, for the treatment of newly diagnosed GBM.

TRIDENT did not show a statistically significant improvement in the primary endpoint of overall survival.

Patients randomized to the Early Start Arm demonstrated a median overall survival of 17.7 months compared to 17.5 months in the Maintenance Start Arm (HR 0.953;

Survival results in both study arms were durable over a long-term period.

One-, two-, and three-year survivals rates in the Early Start Arm were 70.9%, 33.9%, and 22.5%, respectively, and 72.0%, 31.6%, and 18.4%, respectively, in the Maintenance Start Arm.

TTFields therapy was well-tolerated and device related safety was consistent with prior clinical studies.

Full results from the TRIDENT trial have been accepted for presentation at the American Society for Radiation Oncology 2026 Annual Meeting.

In June, we announced that we received a CE certificate to market Optune Pax for the first-line treatment of locally advanced pancreatic cancer of exocrine origin, concomitant with gemcitabine and nab-paclitaxel (gem/nab-pac) in accordance with guideline recommendations.

The CE Mark is supported by data from the Phase 3 PANOVA-3 trial ("PANOVA-3"), which demonstrated a statistically significant improvement in median OS for patients treated with Optune Pax and gem/nab-pac, compared to patients who received gem/nab-pac alone, while also significantly extending time to pain progression.

Because the use of gem/nab-pac may vary by market, the approved CE certificate intended purpose for Optune Pax includes a reference to guideline recommendations to account for local differences.

We began certifying prescribing physicians for Optune Pax in Germany in July.

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

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

We have several ongoing clinical trials which further explore the use of TTFields therapy in these solid tumor cancers, including our Phase 3 KEYNOTE D58 trial in GBM, which we expect to complete enrollment by the end of 2026, and our Phase 3 LUNAR-2 trial in NSCLC.

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

The table below presents the current status of the ongoing clinical trials in our pipeline and anticipated timing of data.

We are exploring options to modify our LUNAR-2 trial design with the goals of compressing the timeline to completion and significantly reducing costs.

We anticipate engaging with regulators regarding potential protocol revisions in the coming months.

We anticipate engaging with regulators in the coming months regarding potential protocol revisions to streamline the trial’s primary endpoints with the goal of reducing the patient sample size.

We have several product development programs underway that are designed to optimize the delivery of TTFields to the target tumor and enhance patient ease of use.

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("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.

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 months ended March 31, 2026, our net revenues were $174.1 million.

Our net loss for the three months ended March 31, 2026 was $71.1 million.

As of March 31, 2026, we had an accumulated deficit of $1,361.5 million.

For the three and six months ended June 30, 2026, our net revenues were $183.6 million and $357.6 million, respectively.

Our net loss for the three and six months ended June 30, 2026 was $15.7 million and $86.8 million.

As of June 30, 2026, we had an accumulated deficit of $1,377.2 million.

Impact of Current Events

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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.

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.

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 pancratic cancer claims will be recognized in the period of cash collection.

We also recognize revenues pursuant to the Zai Agreement.

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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 are a significant component for each category of operating expenses and consist of wages, benefits and bonuses.

Personnel costs also include share-based compensation.

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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 months ended March 31, 2026 as compared to the three months ended March 31, 2025.

The following discussion provides an analysis of our results of operations and reasons for material changes therein for the three and six months ended June 30, 2026 as compared to the three and six months ended June 30, 2025.

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 March 31,

Three months ended June 30, Six months ended June 30,

2026 2025 2026 2025

Unaudited Unaudited

Net revenues $ 183,584 $ 158,805 $ 357,639 $ 313,799

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Weighted average number of ordinary shares used in computing basic and diluted net income (loss) per share 116,012,397 111,572,191 115,106,850 110,930,576

As a result of FDA approval of Optune Pax during the quarter, we incurred a non-cash general and administrative expense of approximately $43,406 related to 901,284 PSUs granted in March 2020 to an executive officer that were

expensed for U.S.

As a result of FDA approval of Optune Pax during the first quarter, we incurred a non-cash general and administrative expense of approximately $43,406 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.

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

Three months ended March 31,

Three months ended June 30, Six months ended June 30,

2026 2025 2026 2025

Unaudited Unaudited

Cost of revenues $ 537 $ 973 $ 1,136 $ 2,075

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The number of active patients on therapy is our principal revenue driver.

An "active patient" is a patient who is receiving treatment under a commercial prescription order as of the measurement date, including patients who may be on a temporary break from treatment and who plan to resume treatment in less than 60 days.

An "active patient" is a patient who

is receiving treatment under a commercial prescription order as of the measurement date, including patients who may be on a temporary break from treatment and who plan to resume treatment in less than 60 days.

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

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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).

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 March 31,

Three months ended Six months ended

June 30, 2026

Prescriptions received in period (1)

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Orders to renew or extend treatment are not included in this total.

Three months ended March 31, 2026 compared to three months ended March 31, 2025

Three months ended March 31,

2026 2025 % Change

Three and six months ended June 30, 2026 compared to three and six months ended June 30, 2025

Three months ended June 30, Six months ended June 30,

2026 2025 % Change 2026 2025 % Change

Net revenues $ 183,584 $ 158,805 16 % $ 357,639 $ 313,799 14 %

Net revenues.

Net revenues increased 12% to $174.1 million for the three months ending March 31, 2026 from $155.0 million for the same period in 2025.

For the three months ended March 31, 2026 the net revenue increase primarily resulted from $16.3 million in growth from international markets, driven by a $5.8 million increase in Germany from active patient growth and reimbursement improvements, a $5.0 million increase from continued growth in France, and a $3.7 million increase in other international markets due to active patient growth and the Optune Gio launch in Spain.

In the quarter, there were $3.5 million in one-time revenue benefits included in the aforementioned international market increase consisting of $2.5 million from Germany related to approval rate increases and aged collections and $1.0 million in France related to performance improvements.

Net revenues increased 16% to $183.6 million for the three months ending June 30, 2026 from $158.8 million for the same period in 2025.

For the three months ended June 30, 2026 the net revenue increase primarily resulted from $16.1 million in growth from international markets and $8.7 million from the United States, collectively driven primarily by 18% active patient growth globally.

In the quarter, there were $2.8 million in one-time revenue benefits included in the aforementioned market increases, consisting of $1.3 million from Germany related to approval rate increases and aged collections, $0.9 million from the United States from a lower annual deductible impact, and $0.6 million in France related to performance improvements.

Recognized revenue from Optune Lua and Optune Pax in the quarter was $5.4 million and $1.6 million respectively, versus $2.4 million and $0.0 million in the same period last year.

For the six months ended June 30, 2026, the increase primarily resulted from $32.3 million in growth from international markets due to 17% active patient growth and reimbursement improvements and $11.5 million from the United States due to 20% active patient growth.

The overall increase includes $6.1 million of exchange rate benefits.

In addition, net revenue in the United States grew by $2.8 million due to active patient growth in both Optune Gio and Optune Lua.

Recognized revenue from Optune Lua in the quarter was $3.0 million versus $1.5 million in the same period last year.

Three months ended March 31,

2026 2025 % Change

Three months ended June 30, Six months ended June 30,

2026 2025 % Change 2026 2025 % Change

Cost of revenues $ 41,106 $ 41,472 (1) % $ 80,035 $ 79,993 — %

Cost of revenues.

For the three months ended March 31, 2026, the increase in cost of revenues was primarily due to 12% growth in active patients mostly offset by $4.2 million lower costs of arrays mainly resulting from improved array utilization and lower supplier prices.

Excluding sales to Zai, cost of revenues per active patient per month was $2,530 for the three months ended March 31, 2026, a decrease of 9% from $2,794 for the same period in 2025, primarily due to the lower cost of arrays.

For the three months ended June 30, 2026, the decrease in cost of revenues was primarily due to a $4.9 million tariff refund and $2.8 million of lower array costs, mainly resulting from improved array utilization and manufacturing efficiencies, mostly offset by 18% growth in active patients.

For the six months ended June 30, 2026, the cost of revenues were flat versus prior year primarily due to the aforementioned tariff refund and $6.9 million lower costs of arrays mainly resulting from improved array utilization and manufacturing efficiencies, fully offset by the active patient growth.

Excluding sales to Zai, cost of revenues per active patient per month was $2,483 for the three months ended June 30, 2026, a decrease of 16% from $2,970 for the same period in 2025, primarily due to the tariff refund, 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.

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 $3.2 million for the three months ended March 31, 2026 compared to $3.3 million for the three months ended March 31, 2025.

Gross margin was 78% for the three months ended March 31, 2026 compared to 75% for the three months ended March 31, 2025.

The improvement in gross margin is primarily due to 12% active patient growth while limiting the increase in cost of revenues to only 1%.

Cost of products sold to Zai totaled $4.2 million and $7.4 million for the three and six months ended June 30, 2026 compared to $3.2 million and $6.5 million for the three and six months ended June 30, 2025.

Gross margin was 78% for the three months ended June 30, 2026 compared to 74% for the three months ended June 30, 2025.

The improvement in gross margin is primarily due to 18% active patient growth while decreasing the cost of revenues by 1%.

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.

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Operating Expenses.

Three months ended March 31,

2026 2025 % Change

Three months ended June 30, Six months ended June 30,

2026 2025 % Change 2026 2025 % Change

Research, development and clinical studies $ 51,448 $ 55,833 (8) % $ 109,784 $ 109,610 — %

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Research, development and clinical study expenses.

Research, development and clinical study expenses increased 8% to $58.3 million for the three months ended March 31, 2026 from $53.8 million for the same period in 2025.

For the three months ended March 31, 2026, the change was primarily due to a $2.0 million increase in engineering costs mostly related to payroll increases, a $1.3 million increase in direct clinical expenses mostly related to the ramp up of our KEYNOTE D58 trial partially offset by the completion of other clinical trials, and a $0.8 million increase in regulatory affairs expenses.

The increase was partially offset by a $2.2 million decrease in share based compensation expenses.

Research, development and clinical study expenses decreased 8% to $51.4 million for the three months ended June 30, 2026 from $55.8 million for the same period in 2025.

For the three months ended June 30, 2026, the change was primarily due to a $5.5 million decrease in direct clinical trial expenses from the completion of older clinical studies more than offsetting cost increases in newer studies, such as KEYNOTE D58, and a $1.8 million decrease in share-based compensation, partially offset by a $0.9 million increase in engineering expenses and a $0.7 million increase in preclinical expenses.

For the six months ended June 30, 2026, research, development and clinical expenses were flat versus prior year primarily due to a $4.2 million decrease in direct clinical trial expenses and a $3.9 million decrease in share-based compensation expenses, offset primarily by a $2.9 million increase in engineering expenses, a $1.2 million increase in preclinical expenses and a $1.2 million increase in regulatory 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 increased 5% to $58.4 million for the three months ended March 31, 2026 from $55.8 million for the same period in 2025.

For the three months ended March 31, 2026, the change was mainly driven by $5.4 million in sale and marketing efforts related to the Optune Pax launch in the United States and Optune Lua launch in Japan, partially offset by $4.2 million in lower share-based compensation expenses.

Sales and marketing expenses increased 8% to $61.7 million for the three months ended June 30, 2026 from $57.1 million for the same period in 2025.

For the three and six months ended June 30, 2026, the change was mainly driven by a $5.5 million and a $9.5 million increase, in sales and marketing efforts related to the Optune Pax launch in the United States and Optune Lua launch in Japan, respectively, partially offset by $1.4 million and $5.6 million, respectively, lower share-based compensation expenses.

General and administrative expenses.

General and administrative expenses increased 92% to $85.9 million for the three-month period ended March 31, 2026 from $44.8 million for the same period in 2025.

For the three months ended March 31, 2026, these changes were primarily due to $40.4 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.

General and administrative expenses decreased 9% to $39.9 million for the three-month period ended June 30, 2026 from $44.0 million for the same period in 2025.

For the three months ended June 30, 2026, these changes were primarily due to $5.6 million lower share-based compensation expenses partially offset by $1.6 million of higher personnel and professional expenses to support business growth.

For the six months ended June 30, 2026, the changes were primarily due to $34.8 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 $0.7 million increase in general and administrative expenses resulting from a $3.0 million increase in personnel expenses to support multiple launches partly offset by a one-time expense of $2.3 million recognized in the same period last year for the retirement of a production line.

Three months ended March 31,

2026 2025 % Change

Additionally, excluding share based compensation expenses, there was a $2.3 million increase in general and administrative expenses resulting from a $4.6 million increase in personnel and professional service expenses to support multiple launches, partly offset by a one-time expense of $2.3 million recognized in the same period last year for the retirement of a production line.

Three months ended June 30, Six months ended June 30,

2026 2025 % Change 2026 2025 % Change

Financial income (expenses), net $ (1,890) $ 4,542 (142) % $ (3,728) $ 12,112 (131) %

Financial income (expenses), net.

Financial income decreased by $ 9.4 million or 124% from $7.6 million in income for the three months ended March 31, 2025 to an expense of $1.8 million for the same period in 2026, primarily due to a $7.1 million decrease in interest income on our investments driven by the repayment upon maturity in November 2025 of our 0% coupon convertible notes, $2.3 million of higher interest expenses related to

our senior secured credit facility driven by our borrowing of Tranche B in September 2025 and $0.5 million of higher foreign currency exchange expenses, offset by $0.5 million of lower amortization expenses on our senior secured credit facility.

Three months ended March 31,

2026 2025 % Change

Financial income decreased by $6.4 million or 142% from $4.5 million in income for the three months ended June 30, 2025 to an expense of $1.9 million for the same period in 2026, primarily due to a $6.4 million decrease in interest income on our investments driven by the repayment upon maturity in November 2025 of our 0% coupon convertible notes, $2.4 million of higher interest expenses related to our senior secured credit facility driven by our borrowing of Tranche B in September 2025, offset by a $1.7 million decrease in foreign currency exchange expenses.

For the six months ended June 30, 2026, financial income decreased by $15.8 million or 131% from $12.1 million in income for the six months ended June 30, 2025 to an expense of $3.7 million for the same period in 2026, primarily.

due to a $13.5 million decrease in interest income on our investments and, $4.7 million of higher interest expenses related to our senior secured credit facility, offset by a $1.2 million decrease in foreign exchange currency loss and a $1.1 million decrease in amortization expenses related to debt.

Three months ended June 30, Six months ended June 30,

2026 2025 % Change 2026 2025 % Change

Income taxes $ 3,206 $ 5,160 (38) % $ 5,086 $ 9,184 (45) %

Income taxes .

Income taxes decreased 53% to $1.9 million for the three months ended March 31, 2026 from $4.0 million for the same period in 2025.

The change is driven primarily by a $1.2 million reduction due to intercompany interest income in Switzerland and Luxembourg and a $1.6 million increase in tax benefits from share-based compensation deductions in the period.

Income taxes decreased 38% to $3.2 million for the three months ended June 30, 2026 from $5.2 million for the same period in 2025 and decreased 45% to $5.1 million for the six months ended June 30, 2026 from $9.2 million for the same period in 2025.

For the three months ended June 30, 2026, the decrease was primarily attributable a $0.9 million reduction in tax expense associated with intercompany interest income and a $0.8 million increase in current tax benefits related to share-based compensation.

For the six months ended June 30, 2026, the decrease was primarily attributable to a $2.0 million reduction in tax expense associated with intercompany interest income and a $1.7 million decrease related to prior-period reserves, partially offset by a $0.6 million decrease in current tax benefits related to share-based compensation.

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 March 31,

2026 2025 % Change

Three months ended June 30, Six months ended June 30,

2026 2025 % Change 2026 2025 % Change

Net income (loss) $ (15,658) $ (40,139) (61) % $ (86,796) $ (74,458) 17 %

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Adjusted EBITDA $ 10,757 $ (9,934) (208) % $ 10,470 $ (14,922) (170) %

Adjusted EBITDA increased to a loss of $0.3 million for the three months ended March 31, 2026 from a loss of $5.0 million for the same period in 2025.

For three months ended March 31, 2026, the change in adjusted EBITDA was primarily driven by revenue growth partially offset by increasing costs for new indications.

Adjusted EBITDA increased to a gain of $10.8 million for the three months ended June 30, 2026 from a loss of $9.9 million for the same period in 2025.

For three months ended June 30, 2026, the change in adjusted EBITDA was primarily driven by revenue growth, cost of revenue efficiency improvements and tariff refunds, partially offset by increasing costs for new indications.

The revenue increase drove a $25.1 million increase in gross profit.

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

As of March 31, 2026, we had an accumulated deficit of $1,361.5 million.

As of June 30, 2026, we had an accumulated deficit of $1,377.2 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, 2026, we had $432.0 million in cash, cash equivalents and short-term investments, a decrease of $15.7 million compared to $447.7 million at December 31, 2025, primarily attributable to net cash used in operations.

We believe our cash, cash equivalents and short-term investments as of March 31, 2026 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.

At June 30, 2026, we had $440.6 million in cash, cash equivalents and short-term investments, a decrease of $7.1 million compared to $447.7 million at December 31, 2025, primarily attributable to net cash used in operations.

We believe our cash, cash equivalents and short-term investments as of June 30, 2026 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.

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:

Three months ended March 31,

Six months ended June 30,

2026 2025 Change % Change

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Net cash used in or provided by operating activities represents our net income (loss) for the periods presented.

Adjustments to net income (loss) for non-cash items include share-based compensation and depreciation, amortization and asset write-downs.

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

Net cash used in operating activities decreased by $22.1 million from $35.7 million net cash used in operating activities for the three months ended March 31, 2025 to $13.5 million net cash used in operating activities for the three months ended March 31, 2026.

This was primarily the result of an $11.3 million increase in accounts payable and accrued expenses, and a decrease of $9.4 million in accounts receivable and prepaid expenses.

Adjustments to net income (loss) for non-cash items include share-based compensation and accrued interest, depreciation, amortization and asset write-downs.

Operating cash flows are also impacted by changes in working capital as a result of changes in inventories, collections from trade receivables and payments of accounts payables and by changes in other long term assets and liabilities.

Net cash used in operating activities decreased by $46.2 million from $51.6 million net cash used in operating activities for the six months ended June 30, 2025 to $5.4 million net cash used in operating activities for the six months ended June 30, 2026.

This was primarily the result of a $24.3 million increase in share based compensation, a $20.3 million decrease in accounts receivable and prepaid expenses, and a $12.0 million increase in accounts payables and accrued expenses, offset by a $5.4 million decrease 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 provided by investing activities was $7.7 million for the three months ended March 31, 2026, compared to $6.5 million used in investing activities for the three months ended March 31, 2025.

The $7.7 million net cash provided by investing activities for the three months ended March 31, 2026 was primarily attributable to $12.9 million of net proceeds of short term investments offset by the purchase of $5.2 million of property and equipment.

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 offset by the purchase of $10.6 million of property and equipment.

Net cash provided by investing activities was $1.4 million for the six months ended June 30, 2026, compared to $29.5 million net cash provided by investing activities for the six months ended June 30, 2025.

The $1.4 million net cash provided by investing activities for the six months ended June 30, 2026 was primarily attributable to $13.4 million of net proceeds of short term investments offset by the purchase of $12.1 million of property and equipment.

The $29.5 million net cash used in investing activities for the six months ended June 30, 2025 was primarily attributable to $45.6.

million of net proceeds of short-term investments offset by the purchase of $16.1 million of property and equipment.

Financing activities.

Net cash used in financing activities was $0.2 million for the three months ended March 31, 2026, as compared to $5.2 million provided by financing activities for the three months ended March 31, 2025.

The $0.2 million net cash used in financing activities for the three months ended March 31, 2026 was primarily attributable to $0.6 million of tax payments related to net settlements on equity awards offset by exercise of options.

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

Net cash provided by financing activities was $4.4 million for the six months ended June 30, 2026, as compared to $7.6 million provided by financing activities for the six months ended June 30, 2025.

The $4.4 million net cash provided by financing activities for the six months ended June 30, 2026 was primarily attributable to the proceeds from the issuance of shares and the exercise of options.

The $7.6 million provided by financing activities for the six months ended June 30, 2026 was primarily attributable to the exercise of options under the Company's share option plan.

Senior Secured Term Loan Credit Facility

1 unchanged sentence

("Borrower"), our wholly-owned subsidiary, entered into a 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 could be drawn in up to four drawings.

The Facility could 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").

2 unchanged sentences

In addition, not later than March 31, 2026, the Borrower had the option to to draw an additional $100.0 million of the Facility (the "Tranche D Loan").

As of March 31, 2026, we have borrowed the Tranche A Loan and the Tranche B Loan in the aggregate principal amount

of $200.0 million.

As of June 30, 2026, we have 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.

15 unchanged sentences

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

What changed 10-Q

Item 2. Management’s Discussion and Analysis