Core Insights - NovoCure reported revenue of $158.81 million for the quarter ended June 2025, reflecting a year-over-year increase of 5.6% [1] - The company's EPS was -$0.36, a slight decline from -$0.31 in the same quarter last year [1] - Revenue exceeded the Zacks Consensus Estimate of $153.83 million by 3.24%, while EPS also surpassed expectations by 7.69% [1] Financial Performance - The reported revenue of $158.81 million indicates a positive trend compared to the previous year [1] - EPS of -$0.36 shows a deterioration in earnings performance compared to the prior year's -$0.31 [1] - The company achieved a revenue surprise of +3.24% and an EPS surprise of +7.69% against analyst estimates [1] Geographic Revenue Breakdown - Revenue from Greater China was $4.59 million, exceeding the average estimate of $3.7 million [4] - Revenue from Japan reached $9.48 million, surpassing the average estimate of $8.54 million [4] - Revenue from the United States was $94.26 million, slightly above the average estimate of $93.78 million [4] Stock Performance - NovoCure's shares have declined by 4.7% over the past month, contrasting with a 5.7% increase in the Zacks S&P 500 composite [3] - The stock currently holds a Zacks Rank 3 (Hold), suggesting it may perform in line with the broader market in the near term [3]

Core Viewpoint - Novocure's fiscal Q2 2025 results showed a 6% increase in revenue year-over-year, exceeding Wall Street expectations, while the company continues to develop noninvasive treatments for solid-tumor cancers [3][5]. Financial Performance - Revenue for Q2 2025 was $158.8 million, compared to $150.4 million in Q2 2024, marking a 6% increase [2]. - Earnings per share for Q2 2025 were -$0.36, slightly worse than -$0.31 in Q2 2024, but still beating expectations [2]. - Gross margin decreased to 74% from 77%, a decline of 300 basis points attributed to new product rollout costs [2][4]. - Total active patients increased from 3,963 in Q2 2024 to 4,331 in Q2 2025, a growth of 9% [2]. Product Development and Market Strategy - Revenue from the Optune Lua lung cancer treatment was $2.4 million, following its U.S. approval last fall [3]. - The company plans to seek FDA premarket approval for treatments targeting pancreatic and brain cancers by the end of the year, with trial data expected in the first half of 2026 [6]. Market Reaction - The market response to the results was muted, with Novocure's stock up about 2% in premarket trading, indicating that the results were largely in line with expectations [5]. Long-term Outlook - Despite the current progress, Novocure's stock has seen a significant decline of over 92% from its 2021 high due to previous disappointing trial results, highlighting the inherent risks in biotech investments [7].

Financial Data and Key Metrics Changes - The company reported net revenues of $159 million, an increase of 6% from the second quarter of the previous year, driven by a 7% year-over-year active patient growth in the GBM franchise [28][34] - Gross margin for the second quarter was 74%, down from 77% in the same quarter last year, primarily due to the rollout of the HIV rate and the continued launch of non-small cell lung cancer [30][34] - The net loss for the quarter was $40 million, with a loss per share of $0.36, and adjusted EBITDA was negative $10 million [34][35] Business Line Data and Key Metrics Changes - The company received 121 prescriptions for non-small cell lung cancer in the second quarter, with 106 in the U.S. and 15 in Germany, leading to $2.4 million in net revenues from OptuneLua [15][16] - The active patient count for Optune GEO reached 4,194, a 7% increase compared to the previous year, with all key markets experiencing double-digit growth [23][26] - The METIS trial demonstrated a 28% risk reduction in time to intracranial progression for patients treated with TT Fields therapy compared to supportive care alone [12] Market Data and Key Metrics Changes - The company is actively engaged in discussions with Japanese regulators for the launch of OptuneLua for non-small cell lung cancer, anticipating approval soon [21] - The company has seen promising feedback from peer-to-peer conversations with physicians, indicating a healthy mix of new and repeat prescribers for Tumor Treating Fields therapy [19][20] Company Strategy and Development Direction - The company aims to extend survival for patients with aggressive forms of cancer through the development of Tumor Treating Fields therapy, with ongoing efforts to gain approvals in new indications, particularly pancreatic cancer [5][11] - The company is focused on execution and has reached multiple milestones, including the launch of OptuneLua and the advancement of clinical trials for new indications [15][26] - The company plans to file PMA submissions for pancreatic cancer and brain metastases from non-small cell lung cancer in the near future, with potential approvals and launches expected in 2026 [13][35] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing launch of OptuneLua and the potential for significant growth in the coming years, particularly in the U.S. and Japan [21][35] - The management highlighted the importance of real-world evidence and peer-to-peer connections in driving adoption of Tumor Treating Fields therapy among physicians [19][20] - The company is committed to balancing investments in launches and future innovations while aiming for profitability, with a target revenue level of around $750 million to achieve adjusted EBITDA profitability [74] Other Important Information - The company is working on minimizing tariff exposure related to imports, with an estimated full-year P&L impact of up to $7 million [31] - The company has a cash and investment balance of $912 million, which is expected to support the retirement of convertible notes and bridge to new revenue streams [34][35] Q&A Session Summary Question: Why was the growth in non-small cell lung cancer prescriptions lower in Q2 compared to Q1? - Management indicated that the launch is progressing as expected, with a consistent ability to educate physicians and build volume [40][42] Question: How different were the METIS numbers disclosed compared to ASCO last year? - The management explained that the METIS trial's endpoint was progression, and the final data set confirmed statistical significance, which was a common practice in trials [46] Question: What is the path to profitability and timeframe? - The management stated that they are on track with expectations and aim for profitability at a revenue level of around $750 million, but did not provide a specific timeframe [74] Question: Are there plans to pursue combinations with other chemotherapy regimens for pancreatic cancer? - The management confirmed that they are actively discussing new combinations and will have data from the PANOVA-four trial in the first half of next year [75][76] Question: How does the NCCN guideline ranking influence commercial coverage? - Management noted that any improvement in ranking is helpful, and they are eager to see updated guidelines published later this fall [57] Question: Does the $94 million in U.S. sales include OptuneLua revenue? - Management confirmed that the $94 million includes all revenue from both Optune GO and Optune Lua [94]

Commercial Adoption - Novocure is driving global active patient growth in Non-Small Cell Lung Cancer (NSCLC) and pursuing reimbursement[1] - NSCLC CE Mark achieved, with launch underway in Germany[1] - NSCLC PMDA approval and launch in Japan[1] - In Q2, there were 121 global NSCLC prescriptions received[8] - 75 unique prescribers prescribed TTFields in Q2[8] - 55% of Q2 prescribers were new to TTFields therapy[8] - 93% of patients prescribed TTFields with ICI were previously treated with ICIs[8] - 76% of patients prescribed TTFields were for 2L or 3L use[8] Clinical Pipeline - PANOVA-3 data presented and published, submitted to FDA, CE Mark and PMDA[1, 13] - METIS submitted to FDA, clinical data published[1] - TRIDENT and PANOVA-4 patient follow up is ongoing, preparing for H1 2026 top-line data[1] Financial Performance - Net revenues for Q2 2025 were $158.8 million, compared to $150.4 million in Q2 2024[15] - Net loss for Q2 2025 was $40.1 million, compared to a net loss of $33.4 million in Q2 2024[15] - Cash, cash equivalents, and investments were $911.5 million[15] - Adjusted EBITDA for the three months ended June 30, 2025, was $(9.9) million, compared to $1.1 million for the same period in 2024[23]

[Second Quarter 2025 Financial and Operational Highlights](index=1&type=section&id=Second%20Quarter%202025%20Financial%20and%20Operational%20Highlights) Novocure achieved continued progress in Q2 2025 with net revenue up 6% to $159 million, 4,331 active patients, and positive Phase 3 PANOVA-3 trial results [Executive Summary](index=1&type=section&id=Executive%20Summary) Novocure achieved continued progress in Q2 2025 with net revenue up 6% to $159 million, 4,331 active patients, and positive Phase 3 PANOVA-3 trial results - Q2 2025 net revenue was **$159 million**, a **6% year-over-year increase**[1](index=1&type=chunk) - As of June 30, 2025, **4,331 active patients** were receiving treatment[1](index=1&type=chunk) - Phase 3 PANOVA-3 clinical trial results presented at the 2025 ASCO Annual Meeting and ESMO Gastrointestinal Cancer Congress, selected as 2025 ASCO Best of Study, and published in the Journal of Clinical Oncology[1](index=1&type=chunk) - CEO Ashley Cordova stated Novocure achieved growth in its glioblastoma and non-small cell lung cancer businesses and is committed to bringing TTFields therapy to more patient populations[2](index=2&type=chunk) [Key Financial Updates](index=1&type=section&id=Key%20Financial%20Updates) Q2 2025 net revenue grew 6% to $158.8 million, driven by active patient growth, while gross margin declined and operating expenses increased, leading to a net loss 2025 Q2 Net Revenue Breakdown | Revenue Source | Amount (million USD) | | :------------- | :------------------- | | Total Net Revenue | 158.8 | | United States | 94.3 | | Germany | 19.1 | | France | 18.4 | | Japan | 9.5 | | Other Active Markets | 13.0 | | Greater China (Zai Lab collaboration) | 4.6 | | Optune Lua Revenue | 2.4 | | - Non-Small Cell Lung Cancer (NSCLC) | 1.1 | | - Malignant Pleural Mesothelioma (MPM) | 1.3 | - Gross margin decreased from 77% in the prior year period to **74%**, primarily due to the launch of Head Flexible Electrode (HFE) transducer arrays, early NSCLC market entry without broad reimbursement, and increased tariffs[3](index=3&type=chunk) 2025 Q2 Key Expense Changes | Expense Category | Q2 2025 (million USD) | Q2 2024 (million USD) | YoY Growth Rate | | :--------------- | :-------------------- | :-------------------- | :-------------- | | Research and Development and Clinical Research | 55.8 | 54.9 | 2% | | Selling, General and Administrative | 57.1 | 56.6 | 1% | | General and Administrative | 44.0 | 37.7 | 17% | - Net loss for the quarter was **$40.1 million**, or **$0.36 per share**[6](index=6&type=chunk) - Adjusted EBITDA was **negative $9.9 million**[6](index=6&type=chunk) - Cash, cash equivalents, and short-term investments totaled **$911.5 million** as of June 30, 2025[6](index=6&type=chunk) [Key Operational Updates](index=2&type=section&id=Key%20Operational%20Updates) Global active patients reached 4,331, with Optune Gio growing 7%, Optune Lua receiving 143 prescriptions, and PANOVA-3 showing significant survival benefits in pancreatic cancer - As of June 30, 2025, **4,331 active patients** globally were receiving TTFields therapy[6](index=6&type=chunk) Optune Gio® and Optune Lua® Patient Data | Metric | Q2 2025 | Q2 2024 | YoY Change | | :----- | :------ | :------ | :--------- | | Optune Gio Prescriptions | 1,598 | 1,614 | -1% | | Optune Gio Active Patients | 4,194 | 3,937 | +7% | | Optune Lua Total Prescriptions | 143 | N/A | N/A | | - NSCLC Prescriptions | 121 | N/A | N/A | | - MPM Prescriptions | 22 | N/A | N/A | | Optune Lua Active Patients | 137 | 26 | +427% | | - NSCLC Active Patients | 94 | 1 | +9300% | | - MPM Active Patients | 43 | 25 | +72% | - Phase 3 PANOVA-3 clinical trial met its primary endpoint, demonstrating TTFields therapy combined with gemcitabine and nab-paclitaxel significantly extended overall survival in pancreatic cancer patients[6](index=6&type=chunk) - PANOVA-3 also showed TTFields therapy significantly extended pain-free survival and delayed the need for opioid analgesics, while delaying deterioration in multiple health status metrics, thereby better preserving patient quality of life[6](index=6&type=chunk)[7](index=7&type=chunk) [Detailed Financial Statements](index=5&type=section&id=Detailed%20Financial%20Statements) Novocure's Q2 2025 financial statements show increased net revenue but also expanded net loss due to rising operating costs, with total assets slightly up and shareholder equity down [Consolidated Statements of Operations](index=5&type=section&id=Consolidated%20Statements%20of%20Operations) Q2 2025 consolidated operations show net revenue of $158.8 million, a 6% increase, but a net loss of $40.1 million due to higher operating expenses Consolidated Statements of Operations (Three Months Ended June 30, 2025) | Metric (thousand USD) | 2025 | 2024 | | :-------------------- | :----- | :----- | | Net Revenue | 158,805 | 150,356 | | Cost of Sales | 41,472 | 34,654 | | Gross Profit | 117,333 | 115,702 | | Research and Development and Clinical Research Expenses | 55,833 | 54,955 | | Selling, General and Administrative Expenses | 57,066 | 56,616 | | General and Administrative Expenses | 43,955 | 37,711 | | Total Operating Costs and Expenses | 156,854 | 149,282 | | Operating Profit (Loss) | (39,521) | (33,580) | | Financial Income (Expense), Net | 4,542 | 10,851 | | Profit (Loss) Before Income Taxes | (34,979) | (22,729) | | Income Tax Expense | 5,160 | 10,646 | | Net Profit (Loss) | (40,139) | (33,375) | | Basic and Diluted Net Profit (Loss) Per Share | (0.36) | (0.31) | [Consolidated Balance Sheets](index=6&type=section&id=Consolidated%20Balance%20Sheets) As of June 30, 2025, total assets were $1.246 billion, total liabilities increased to $896.4 million, and total shareholder equity decreased to $349.4 million Consolidated Balance Sheets (As of June 30, 2025 and December 31, 2024) | Metric (thousand USD) | June 30, 2025 (Unaudited) | December 31, 2024 (Audited) | | :-------------------- | :------------------------ | :-------------------------- | | **Assets** | | | | Cash and Cash Equivalents | 149,624 | 163,767 | | Short-term Investments | 761,901 | 796,106 | | Trade Receivables, Net | 89,915 | 74,226 | | Inventories | 40,211 | 35,086 | | Total Current Assets | 1,083,299 | 1,106,575 | | Property and Equipment, Net | 80,333 | 77,660 | | Right-of-use Assets | 48,089 | 27,120 | | Total Non-current Assets | 162,576 | 134,209 | | **Total Assets** | **1,245,875** | **1,240,784** | | **Liabilities and Shareholders' Equity** | | | | Convertible Notes | 559,790 | 558,160 | | Trade Payables | 103,678 | 105,086 | | Total Current Liabilities | 749,634 | 756,376 | | Senior Secured Credit Facility, Net | 97,609 | 97,300 | | Long-term Leases | 42,853 | 19,971 | | Total Non-current Liabilities | 146,800 | 124,229 | | **Total Liabilities** | **896,434** | **880,605** | | Total Shareholders' Equity | 349,441 | 360,179 | | **Total Liabilities and Shareholders' Equity** | **1,245,875** | **1,240,784** | [Non-GAAP Financial Measures Reconciliation](index=8&type=section&id=Non-GAAP%20Financial%20Measures%20Reconciliation) Q2 2025 Adjusted EBITDA was negative $9.9 million, a significant decrease from Q2 2024, primarily due to increased net loss and reduced stock-based compensation adjustments Non-GAAP Financial Measures Reconciliation (Three Months Ended June 30, 2025) | Metric (thousand USD) | 2025 | 2024 | Percentage Change | | :-------------------- | :----- | :----- | :---------------- | | Net Profit (Loss) | (40,139) | (33,375) | 20% | | Add: Income Tax Expense | 5,160 | 10,646 | (52)% | | Add: Financial Expense (Income), Net | (4,542) | (10,851) | (58)% | | Add: Depreciation and Amortization | 3,444 | 2,858 | 21% | | EBITDA | (36,077) | (30,722) | 17% | | Add: Stock-based Compensation Expense | 26,143 | 31,830 | (18)% | | **Adjusted EBITDA** | **(9,934)** | **1,108** | **(997)%** | [Clinical and Regulatory Progress](index=2&type=section&id=Clinical%20and%20Regulatory%20Progress) Novocure's PANOVA-3 trial successfully met its primary endpoint, and the company plans two FDA PMA submissions in 2025, with more trial data expected in H1 2026 [PANOVA-3 Clinical Trial Results](index=2&type=section&id=PANOVA-3%20Clinical%20Trial%20Results) Phase 3 PANOVA-3 trial met its primary endpoint, demonstrating TTFields therapy combined with chemotherapy significantly extended overall survival in unresectable, locally advanced pancreatic cancer - PANOVA-3 clinical trial met its primary endpoint, demonstrating TTFields therapy combined with gemcitabine and nab-paclitaxel significantly extended overall survival in pancreatic cancer patients[6](index=6&type=chunk) - Patients receiving TTFields therapy showed significantly extended pain-free survival (secondary endpoint) and distant progression-free survival (post-hoc analysis)[6](index=6&type=chunk) - TTFields therapy significantly improved multiple pain metrics, delayed the need for opioid analgesics, and delayed deterioration in health status, preserving quality of life for unresectable, locally advanced pancreatic adenocarcinoma patients[7](index=7&type=chunk) [Anticipated Clinical and Regulatory Milestones](index=3&type=section&id=Anticipated%20Clinical%20and%20Regulatory%20Milestones) Novocure plans two FDA PMA submissions in Q3 and H2 2025 for pancreatic cancer and NSCLC brain metastases, with Phase 2/3 trial top-line data expected in H1 2026 - Planned submission of a Premarket Approval (PMA) application to the US FDA in **Q3 2025** based on Phase 3 PANOVA-3 clinical trial results for unresectable, locally advanced pancreatic cancer[12](index=12&type=chunk) - Planned submission of a PMA application to the FDA in **H2 2025** based on Phase 3 METIS clinical trial results for NSCLC brain metastases[12](index=12&type=chunk) - Top-line data from the Phase 2 PANOVA-4 metastatic pancreatic cancer clinical trial is expected in **H1 2026**[12](index=12&type=chunk) - Top-line data from the Phase 3 TRIDENT newly diagnosed glioblastoma clinical trial is expected in **H1 2026**[12](index=12&type=chunk) [Company Information](index=3&type=section&id=Company%20Information) Novocure is a global oncology company focused on extending survival for aggressive cancer patients through its innovative TTFields therapy, with commercial products approved for GBM, NSCLC, and MPM [About Novocure](index=3&type=section&id=About%20Novocure) Novocure is a global oncology company dedicated to extending survival for aggressive cancer patients through its innovative TTFields therapy, approved for GBM, NSCLC, and MPM - Novocure is a global oncology company dedicated to extending survival for aggressive cancer patients by developing and commercializing Tumor Treating Fields (TTFields) therapy[11](index=11&type=chunk) - Novocure's commercial products are approved in certain countries for adult glioblastoma, non-small cell lung cancer, and malignant pleural mesothelioma[11](index=11&type=chunk) - Company headquarters are in Baar, Switzerland, US headquarters in Portsmouth, New Hampshire, and R&D facilities in Haifa, Israel[12](index=12&type=chunk)[13](index=13&type=chunk) [Investor Relations and Media Contacts](index=3&type=section&id=Investor%20Relations%20and%20Media%20Contacts) Novocure provides investor and media contact information and details for its Q2 2025 earnings call and webcast, with materials available on its investor relations website - Novocure will host a conference call and webcast on **July 24, 2025**, to discuss Q2 2025 financial results[9](index=9&type=chunk) - Webcast, earnings slides, and corporate presentation are available on Novocure's investor relations website (www.novocure.com/investor-relations)[10](index=10&type=chunk) - Investor contact: Ingrid Goldberg (investorinfo@novocure.com); Media contact: Catherine Falcetti (media@novocure.com)[21](index=21&type=chunk) [Non-GAAP Financial Measurements Definition](index=4&type=section&id=Non-GAAP%20Financial%20Measurements%20Definition) Novocure uses "Adjusted EBITDA" as a non-GAAP metric to assess operational performance by excluding capital structure, tax rates, and non-cash items like stock-based compensation - Adjusted EBITDA is a non-GAAP measure representing earnings before interest, taxes, depreciation, amortization, and stock-based compensation[14](index=14&type=chunk) - The company believes Adjusted EBITDA helps investors evaluate and compare operational performance by excluding the impact of capital structure, tax rates, and significant non-cash items, particularly stock-based compensation[14](index=14&type=chunk) [Forward-Looking Statements](index=4&type=section&id=Forward-Looking%20Statements) This press release contains forward-looking statements regarding future events, clinical trials, regulatory approvals, and market outlook, subject to risks and uncertainties, with no obligation to update - This press release may contain forward-looking statements regarding anticipated scientific progress, clinical trial progress, potential product development, clinical outcome interpretation, regulatory approval prospects, manufacturing development and capabilities, product market prospects, third-party payer coverage, and collection[15](index=15&type=chunk) - Forward-looking statements can be identified by words such as "anticipate," "estimate," "expect," "project," "intend," "plan," and "believe"[15](index=15&type=chunk) - Novocure's performance and financial results may differ materially from forward-looking statements due to general financial, economic, environmental, regulatory, and political conditions, and other specific risks outlined in its 10-K annual report and subsequent SEC filings[15](index=15&type=chunk) - Novocure does not intend to publicly update any forward-looking statements unless required by law[15](index=15&type=chunk) [Product Safety Information](index=9&type=section&id=Product%20Safety%20Information) This section provides safety information for Optune Gio® and Optune Lua®, including indications, contraindications, and common side effects for their respective cancer treatments [Optune Gio® Safety Information](index=9&type=section&id=Optune%20Gio%C2%AE%20Safety%20Information) Optune Gio® is an FDA-approved wearable device for adult glioblastoma (GBM) patients aged 22+, used with temozolomide for newly diagnosed GBM or alone for recurrent GBM - Optune Gio® is an FDA-approved wearable, portable device for treating glioblastoma (GBM) in adults aged **22 years or older**[22](index=22&type=chunk) - For newly diagnosed GBM, it is used with temozolomide (TMZ); for recurrent GBM, it is used alone as an alternative to standard medical therapy[23](index=23&type=chunk) - Contraindications include: implanted medical devices (e.g., programmable shunts), skull defects, shrapnel, or known sensitivity to conductive hydrogels; not for pregnant or planning-to-be-pregnant individuals[23](index=23&type=chunk)[24](index=24&type=chunk) - Most common side effects when used with temozolomide include low platelet count, nausea, constipation, vomiting, fatigue, device-related scalp irritation, headache, seizures, and depression; when used alone, most common side effects are scalp irritation (redness and itching) and headache[27](index=27&type=chunk) [Optune Lua® Safety Information](index=10&type=section&id=Optune%20Lua%C2%AE%20Safety%20Information) Optune Lua® is an FDA-approved wearable device for metastatic NSCLC patients progressing after platinum-based therapy, used with PD-1/PD-L1 inhibitors or docetaxel - Optune Lua® is an FDA-approved wearable, portable device used with PD-1/PD-L1 inhibitors (immunotherapy) or docetaxel for adult patients with metastatic non-small cell lung cancer (mNSCLC) that has progressed after platinum-based therapy[28](index=28&type=chunk) - Contraindications include: electrical implants, known sensitivity to gels (e.g., those used with ECG patches or TENS electrodes); not for pregnant or planning-to-be-pregnant individuals[29](index=29&type=chunk) - Most common side effects when used with certain immunotherapies and chemotherapies include dermatitis, musculoskeletal pain, fatigue, anemia, alopecia, dyspnea, nausea, cough, diarrhea, anorexia, pruritus, leukopenia, pneumonia, respiratory tract infection, localized edema, rash, pain, constipation, skin ulcer, hypokalemia, hypoalbuminemia, hyponatremia, and dysphagia[31](index=31&type=chunk) - Other potential adverse reactions include treatment-related skin irritation, allergic reactions to adhesives or gels, array overheating causing pain and/or localized skin burns, infection at array contact sites, localized warmth and tingling sensation under arrays, medical device site reactions, muscle twitching, and skin breakdown/skin ulceration[32](index=32&type=chunk)

[Cautionary Note Regarding Forward-Looking Statements](index=3&type=section&id=Cautionary%20Note%20Regarding%20Forward%20Looking%20Statements) This report includes forward-looking statements about future developments and their impact, which are subject to risks and uncertainties that may cause actual results to differ materially - This report contains forward-looking statements based on current plans, expectations, hopes, beliefs, intentions, or strategies concerning future developments and their impact on the company. These statements are not historical facts and involve risks and uncertainties that may cause actual results to differ materially[8](index=8&type=chunk)[9](index=9&type=chunk) - Forward-looking statements cover areas such as research and development, clinical studies, commercialization activities, business strategies, market acceptance of products (Optune Gio, Optune Lua), regulatory approvals, supply chain, intellectual property, cash needs, and financial performance[8](index=8&type=chunk)[10](index=10&type=chunk) [Trademarks](index=4&type=section&id=Trademarks) This section acknowledges trademarks of NovoCure Limited and other entities included in the Quarterly Report on Form 10-Q - The Quarterly Report on Form 10-Q includes trademarks of NovoCure Limited and other persons, with all trademarks or trade names being the property of their respective owners[12](index=12&type=chunk) [PART I—FINANCIAL INFORMATION](index=6&type=section&id=PART%20I%E2%80%94FINANCIAL%20INFORMATION) This section provides NovoCure Limited's unaudited consolidated financial statements and management's discussion and analysis of financial condition and results of operations [Item 1. Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) This section presents NovoCure Limited's unaudited consolidated financial statements for the periods ended June 30, 2025, including balance sheets, statements of operations, comprehensive income, changes in shareholders' equity, and cash flows, along with detailed notes explaining accounting policies, financial instruments, debt, revenue recognition, and share-based compensation [Consolidated Balance Sheets](index=6&type=section&id=Consolidated%20Balance%20Sheets) This table presents the company's consolidated financial position, detailing assets, liabilities, and equity as of June 30, 2025, and December 31, 2024 | Metric | June 30, 2025 (Unaudited) | December 31, 2024 (Audited) | Change (k USD) | % Change | | :-------------------------- | :-------------------------- | :-------------------------- | :------------- | :------- | | **ASSETS** | | | | | | Cash and cash equivalents | $149,624 | $163,767 | $(14,143) | -8.6% | | Short-term investments | $761,901 | $796,106 | $(34,205) | -4.3% | | Total current assets | $1,083,299 | $1,106,575 | $(23,276) | -2.1% | | Total long-term assets | $162,576 | $134,209 | $28,367 | 21.1% | | **TOTAL ASSETS** | **$1,245,875** | **$1,240,784** | **$5,091** | **0.4%** | | **LIABILITIES & EQUITY** | | | | | | Convertible note (current) | $559,790 | $558,160 | $1,630 | 0.3% | | Total current liabilities | $749,634 | $756,376 | $(6,742) | -0.9% | | Total long-term liabilities | $146,800 | $124,229 | $22,571 | 18.2% | | **TOTAL LIABILITIES** | **$896,434** | **$880,605** | **$15,829** | **1.8%** | | Total shareholders' equity | $349,441 | $360,179 | $(10,738) | -3.0% | | **TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY** | **$1,245,875** | **$1,240,784** | **$5,091** | **0.4%** | [Consolidated Statements of Operations](index=8&type=section&id=Consolidated%20Statements%20of%20Operations) This section details the company's financial performance, including revenues, expenses, and net income (loss) for the three and six months ended June 30, 2025 | Metric (U.S. dollars in thousands) | Three months ended June 30, 2025 | Three months ended June 30, 2024 | % Change (YoY) | | :--------------------------------- | :------------------------------- | :------------------------------- | :------------- | | Net revenues | $158,805 | $150,356 | 5.6% | | Cost of revenues | $41,472 | $34,654 | 19.7% | | Gross profit | $117,333 | $115,702 | 1.4% | | Total operating costs and expenses | $156,854 | $149,282 | 5.1% | | Operating income (loss) | $(39,521) | $(33,580) | 17.7% | | Financial income (expenses), net | $4,542 | $10,851 | -58.1% | | Income (loss) before income tax | $(34,979) | $(22,729) | 53.0% | | Income tax | $5,160 | $10,646 | -51.5% | | Net income (loss) | $(40,139) | $(33,375) | 20.2% | | Basic and diluted net income (loss) per ordinary share | $(0.36) | $(0.31) | 16.1% | | Metric (U.S. dollars in thousands) | Six months ended June 30, 2025 | Six months ended June 30, 2024 | % Change (YoY) | | :--------------------------------- | :----------------------------- | :----------------------------- | :------------- | | Net revenues | $313,799 | $288,859 | 8.6% | | Cost of revenues | $79,993 | $68,343 | 17.0% | | Gross profit | $233,806 | $220,516 | 6.0% | | Total operating costs and expenses | $311,192 | $295,616 | 5.3% | | Operating income (loss) | $(77,386) | $(75,100) | 3.0% | | Financial income (expenses), net | $12,112 | $20,729 | -41.6% | | Income (loss) before income tax | $(65,274) | $(54,371) | 20.1% | | Income tax | $9,184 | $17,764 | -48.3% | | Net income (loss) | $(74,458) | $(72,135) | 3.2% | | Basic and diluted net income (loss) per ordinary share | $(0.67) | $(0.67) | 0.0% | [Consolidated Statements of Comprehensive Income (Loss)](index=9&type=section&id=Consolidated%20Statements%20of%20Comprehensive%20Income%20%28Loss%29) This table presents the company's net income (loss) and other comprehensive income (loss) components for the three and six months ended June 30, 2025 | Metric (U.S. dollars in thousands) | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :--------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net income (loss) | $(40,139) | $(33,375) | $(74,458) | $(72,135) | | Change in foreign currency translation adjustments | $(39) | $102 | $319 | $(225) | | Pension benefit plan | $(869) | $530 | $72 | $2,179 | | Total comprehensive income (loss) | $(41,047) | $(32,743) | $(74,067) | $(70,181) | [Consolidated Statements of Changes in Shareholders' Equity](index=9&type=section&id=Consolidated%20Statements%20of%20Changes%20in%20Shareholders%27%20Equity) This section outlines changes in the company's shareholders' equity, including ordinary shares, paid-in capital, and retained earnings, as of June 30, 2025 | Metric (U.S. dollars in thousands) | Balance as of Dec 31, 2024 | Balance as of June 30, 2025 | | :--------------------------------- | :------------------------- | :-------------------------- | | Ordinary shares (number) | 108,516,819 | 111,798,690 | | Additional paid-in capital | $1,519,809 | $1,583,138 | | Accumulated other comprehensive income (loss) | $(5,500) | $(5,109) | | Retained earnings (accumulated deficit) | $(1,154,130) | $(1,228,588) | | Total shareholders' equity | $360,179 | $349,441 | - Share-based compensation to employees contributed **$55,695k** to additional paid-in capital for the six months ended June 30, 2025[23](index=23&type=chunk) - Net loss for the six months ended June 30, 2025, was **$(74,458)k**, contributing to the accumulated deficit[23](index=23&type=chunk) [Consolidated Statements of Cash Flows](index=11&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) This table summarizes the company's cash inflows and outflows from operating, investing, and financing activities for the six months ended June 30, 2025 | Cash Flow Activity (U.S. dollars in thousands) | Six months ended June 30, 2025 | Six months ended June 30, 2024 | % Change (YoY) | | :--------------------------------------------- | :----------------------------- | :----------------------------- | :------------- | | Net cash provided by (used in) operating activities | $(51,601) | $(33,294) | 55.0% | | Net cash provided by (used in) investing activities | $29,514 | $(128,224) | 123.0% | | Net cash provided by (used in) financing activities | $7,634 | $87,530 | -91.3% | | Effect of exchange rate changes on cash, cash equivalents and restricted cash | $492 | $(133) | -470.0% | | Increase (decrease) in cash, cash equivalents and restricted cash | $(13,961) | $(74,121) | -81.2% | | Cash, cash equivalents and restricted cash at the end of the period | $152,133 | $168,443 | -9.7% | [Notes to Unaudited Consolidated Financial Statements](index=13&type=section&id=Notes%20to%20Unaudited%20Consolidated%20Financial%20Statements) This section provides detailed explanations of the accounting policies, significant estimates, and specific financial statement line items [NOTE 1: ORGANIZATION AND BASIS OF PRESENTATION](index=13&type=section&id=NOTE%201%3A%20ORGANIZATION%20AND%20BASIS%20OF%20PRESENTATION) This note describes NovoCure Limited's business, its focus on Tumor Treating Fields (TTFields) devices, and the basis of financial statement presentation - NovoCure Limited is a global oncology company focused on developing, manufacturing, and commercializing Tumor Treating Fields (TTFields) devices, including Optune Gio and Optune Lua, for solid tumor cancers[29](index=29&type=chunk) - The majority of revenues come from Optune Gio in the U.S., Germany, France, and Japan, with a License and Collaboration Agreement with Zai Lab for Greater China[29](index=29&type=chunk) - The company is evaluating the impact of ASU 2023-09 (Income Taxes) for adoption in fiscal year 2025 and ASU 2024-03 (Expense Disaggregation) for fiscal years beginning after December 15, 2026[35](index=35&type=chunk)[36](index=36&type=chunk) [NOTE 2: CASH, CASH EQUIVALENTS AND SHORT-TERM INVESTMENTS](index=14&type=section&id=NOTE%202%3A%20CASH%2C%20CASH%20EQUIVALENTS%20AND%20SHORT-TERM%20INVESTMENTS) This note details the composition and fair market value of the company's cash, cash equivalents, and short-term investments as of June 30, 2025 | Category | June 30, 2025 (Unaudited) | December 31, 2024 (Audited) | | :-------------------------- | :-------------------------- | :-------------------------- | | Cash | $13,475 | $11,848 | | Money market funds | $134,949 | $151,919 | | Certificate of deposits and term deposits | $72,673 | $170,120 | | U.S. Treasury bills | $118,634 | $118,710 | | Corporate debt securities | $571,757 | $508,169 | | **Total Fair Market Value** | **$911,488** | **$960,766** | | Cash and cash equivalents | $149,624 | $163,767 | | Short-term investments | $761,901 | $796,106 | - As of June 30, 2025, **$17,614k** of short-term investments are pledged pursuant to a bank guaranty agreement[38](index=38&type=chunk) [NOTE 3: INVENTORIES](index=15&type=section&id=NOTE%203%3A%20INVENTORIES) This note provides a breakdown of the company's inventory components, including raw materials, work in progress, and finished products | Inventory Component | June 30, 2025 (Unaudited) | December 31, 2024 (Audited) | | :------------------ | :-------------------------- | :-------------------------- | | Raw materials | $3,811 | $4,004 | | Work in progress | $3,986 | $7,969 | | Finished products | $32,414 | $23,113 | | **Total Inventories** | **$40,211** | **$35,086** | [NOTE 4: COMMITMENTS AND CONTINGENT LIABILITIES](index=15&type=section&id=NOTE%204%3A%20COMMITMENTS%20AND%20CONTINGENT%20LIABILITIES) This note discusses legal proceedings, including the dismissal of a class action lawsuit, and details bank deposits pledged for operating lease guarantees - The putative class action lawsuit filed in June 2023, alleging material misstatements regarding the LUNAR clinical trial, was dismissed by the court on March 18, 2025. The plaintiffs did not appeal, and the matter is now closed[44](index=44&type=chunk) - The company has pledged bank deposits of **$5,100k** (June 30, 2025) and **$4,909k** (December 31, 2024) to cover bank guarantees for operating leases[43](index=43&type=chunk) [NOTE 5: LONG-TERM DEBT, NET](index=15&type=section&id=NOTE%205%3A%20LONG-TERM%20DEBT%2C%20NET) This note details the company's convertible senior notes and a new senior secured credit facility, including terms, conversion rights, and drawdowns - The **$575,000k** aggregate principal amount of 0% Convertible Senior Notes due November 1, 2025, had a net carrying amount of **$559,790k** as of June 30, 2025. Holders have the right to convert beginning August 2025, with the company electing to settle conversions with **$1,000 cash per $1,000 principal** plus ordinary shares for the balance[45](index=45&type=chunk)[47](index=47&type=chunk)[49](index=49&type=chunk) - A new five-year senior secured credit facility of up to **$400,000k** was entered into on May 1, 2024. The initial Tranche A Loan of **$100,000k** was funded on May 1, 2024. Notice to draw the Tranche B Loan of **$100,000k** was given on June 30, 2025, with closing expected on September 26, 2025[50](index=50&type=chunk)[52](index=52&type=chunk) - The facility bears interest at an annual rate of **6.25%** plus the three-month SOFR (subject to a **3.25% floor**). Tranche C and D loans are conditional on positive PANOVA-3 results or revenue targets, and the extinguishment of the Convertible Notes[50](index=50&type=chunk)[51](index=51&type=chunk) [NOTE 6: REVENUE RECOGNITION](index=18&type=section&id=NOTE%206%3A%20REVENUE%20RECOGNITION) This note provides a geographical breakdown of net revenues and details contract balances, including trade receivables and deferred revenues | Geographic Region | Three months ended June 30, 2025 | Three months ended June 30, 2024 | % Change (YoY) | | :---------------- | :------------------------------- | :------------------------------- | :------------- | | United States | $94,261 | $95,711 | -1.5% | | Germany | $19,074 | $15,097 | 26.3% | | France | $18,416 | $14,267 | 29.1% | | Japan | $9,484 | $7,664 | 23.7% | | Other international markets | $12,979 | $11,771 | 10.3% | | Greater China | $4,591 | $5,846 | -21.5% | | **Total net revenues** | **$158,805** | **$150,356** | **5.6%** | | Contract Balance (U.S. dollars in thousands) | June 30, 2025 (Unaudited) | December 31, 2024 (Audited) | % Change | | :------------------------------------------- | :-------------------------- | :-------------------------- | :------- | | Trade receivables | $82,966 | $68,501 | 21.1% | | Unbilled receivables | $6,949 | $5,725 | 21.4% | | Deferred revenues (short-term contract liabilities) | $(15,354) | $(14,225) | 7.9% | [NOTE 7: SHARE OPTION PLANS AND ESPP](index=18&type=section&id=NOTE%207%3A%20SHARE%20OPTION%20PLANS%20AND%20ESPP) This note outlines the company's share option plans and Employee Share Purchase Plan (ESPP), including available shares and share-based compensation expense - The 2024 Omnibus Incentive Plan, adopted in April 2024, replaced the 2015 Plan, making **5,718,009** ordinary shares available for grant as of June 30, 2025[59](index=59&type=chunk)[60](index=60&type=chunk)[62](index=62&type=chunk) | Share-Based Compensation Expense (U.S. dollars in thousands) | Three months ended June 30, 2025 | Three months ended June 30, 2024 | % Change (YoY) | | :--------------------------------------------------------- | :------------------------------- | :------------------------------- | :------------- | | Cost of revenues | $973 | $1,698 | -42.7% | | Research, development and clinical studies | $5,787 | $9,517 | -39.2% | | Sales and marketing | $5,358 | $9,896 | -45.9% | | General and administrative | $14,025 | $10,719 | 30.8% | | **Total share-based compensation expense** | **$26,143** | **$31,830** | **-17.8%** | - The 2025 Novocure Employee Share Purchase Plan (ESPP) was adopted in February 2025, replacing the prior ESPP, with **6,366,651** ordinary shares available for purchase by eligible employees as of June 30, 2025[66](index=66&type=chunk) [NOTE 8: Basic and diluted net income (loss) per ordinary share](index=21&type=section&id=NOTE%208%3A%20Basic%20and%20diluted%20net%20income%20%28loss%29%20per%20ordinary%20share) This note presents the calculation of basic and diluted net income (loss) per ordinary share, including the impact of potentially anti-dilutive shares | Metric | Three months ended June 30, 2025 | Three months ended June 30, 2024 | | :-------------------------------------------------------------------------------- | :------------------------------- | :------------------------------- | | Net income (loss) attributable to ordinary shares (U.S. dollars in thousands) | $(40,139) | $(33,375) | | Weighted average number of ordinary shares used in computing diluted net income (loss) per share | 111,572,191 | 107,700,284 | | Basic and diluted net income (loss) per ordinary share | $(0.36) | $(0.31) | - Potentially anti-dilutive shares, including options, RSUs, PSUs, and ESPP shares, totaling **13,575,686** for the three months ended June 30, 2025, were excluded from the diluted EPS calculation due to the net loss[70](index=70&type=chunk) [NOTE 9: SUPPLEMENTAL INFORMATION](index=22&type=section&id=NOTE%209%3A%20SUPPLEMENTAL%20INFORMATION) This note confirms the company operates in a single reportable segment and provides a geographical breakdown of long-lived assets - The Company operates in a single reportable segment[71](index=71&type=chunk) | Location | June 30, 2025 (Unaudited) | December 31, 2024 (Audited) | | :--------- | :-------------------------- | :-------------------------- | | United States | $65,578 | $62,897 | | Switzerland | $49,552 | $27,014 | | Israel | $14,924 | $16,120 | | Others | $16,959 | $13,560 | | **Total long-lived assets** | **$147,013** | **$119,591** | [NOTE 10: SUBSEQUENT EVENT](index=22&type=section&id=NOTE%2010%3A%20SUBSEQUENT%20EVENT) This note describes a subsequent event in July 2025 regarding U.S. tax code amendments and their estimated impact on tax expense - In July 2025, amendments to the U.S. tax code, including permanent extension of certain business and international tax provisions, are estimated to decrease tax expense by approximately **$1.7 million** for the six months ended June 30, 2025[72](index=72&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on NovoCure Limited's financial condition and results of operations, discussing critical accounting policies, business overview, impact of current events, detailed analysis of revenue and expenses, key performance indicators, liquidity, and capital resources [Critical Accounting Policies and Estimates](index=23&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) This section confirms no material changes to the company's critical accounting policies and estimates since the 2024 Annual Report on Form 10-K - There were no material changes to the company's critical accounting policies and estimates compared to those described in its Annual Report on Form 10-K for the fiscal year ended December 31, 2024[75](index=75&type=chunk) [Overview](index=23&type=section&id=Overview) This section provides a business overview, highlighting the company's TTFields technology, key clinical trial results, and financial highlights for the period - NovoCure is a global oncology company utilizing Tumor Treating Fields (TTFields) technology to treat solid tumor cancers, with commercial devices Optune Gio (for GBM) and Optune Lua (for metastatic NSCLC and MPM)[76](index=76&type=chunk) - Positive results from the Phase 3 PANOVA-3 clinical trial for pancreatic adenocarcinoma were presented in May 2025, showing improved median overall survival (**16.2 months vs. 14.2 months**) and pain-free survival (**15.2 months vs. 9.1 months**). An FDA PMA application is expected in Q3 2025[78](index=78&type=chunk)[80](index=80&type=chunk) - The Phase 3 METIS clinical trial for brain metastases from NSCLC met its primary endpoint, demonstrating a statistically significant improvement in time to intracranial progression (median **15.0 months vs. 7.5 months control**). The full FDA PMA submission is expected by the end of 2025[79](index=79&type=chunk)[80](index=80&type=chunk) | Financial Highlight (U.S. dollars in millions) | Six months ended June 30, 2025 | | :--------------------------------------------- | :----------------------------- | | Net revenues | $313.8 | | Net loss | $(74.5) | | Accumulated deficit (as of June 30, 2025) | $(1,228.6) | [Impact of Current Events](index=25&type=section&id=Impact%20of%20Current%20Events) This section discusses the impact of the conflict in Israel on supply chain risks and potential increases in import duties due to changes in U.S. tariff rates - The conflict in Israel has led the company to increase stock levels and seek second-source suppliers outside Israel to mitigate supply chain risks, though no immediate risk to business facilities or operations is believed to exist[86](index=86&type=chunk) - Recent changes to U.S. tariff rates, including a **17% tariff on arrays from Israel** (previously 0%) and potential **30% tariffs on goods from Mexico and the EU**, could increase import duties by up to approximately **$7 million** in 2025. The company expensed an additional **$1.3 million** in duties for Q2 2025[88](index=88&type=chunk)[89](index=89&type=chunk) [Commentary on Results of Operations](index=25&type=section&id=Commentary%20on%20Results%20of%20Operations) This section provides a detailed analysis of the company's net revenues, cost of revenues, gross margin, operating expenses, and financial income for the period | Metric (U.S. dollars in thousands) | Three months ended June 30, 2025 | Three months ended June 30, 2024 | % Change (YoY) | | :--------------------------------- | :------------------------------- | :------------------------------- | :------------- | | Net revenues | $158,805 | $150,356 | 5.6% | | Cost of revenues | $41,472 | $34,654 | 19.7% | | Gross margin | 74% | 77% | -3.0 ppts | | Research, development and clinical studies | $55,833 | $54,955 | 1.6% | | Sales and marketing | $57,066 | $56,616 | 0.8% | | General and administrative | $43,955 | $37,711 | 16.6% | | Financial income (expenses), net | $4,542 | $10,851 | -58.1% | | Income taxes | $5,160 | $10,646 | -51.5% | - Net revenue growth was primarily driven by increases in France (**+$4.2M**), Germany (**+$4.0M**), and other international markets (**+$3.0M**), including **$3.8M** in exchange rate benefits, partially offset by a **$1.5M** reduction in U.S. revenue and a **$1.3M** decrease from Greater China[102](index=102&type=chunk) - Cost of revenues increased due to **9% active patient growth**, higher average array costs from new array roll-out and NSCLC launch, and increased tariffs. Cost of revenues per active patient per month increased **10% to $2,970**[104](index=104&type=chunk)[105](index=105&type=chunk) - Financial income decreased significantly due to a **$2.9M** decrease in interest income, a **$1.5M** increase in foreign exchange expenses, and a non-recurring **$1.1M** gain from convertible note redemption in the prior year[111](index=111&type=chunk) [Key Performance Indicators](index=27&type=section&id=Key%20performance%20indicators) This section presents key operational metrics, including active patients and prescriptions received for Optune Gio and Optune Lua | Metric | June 30, 2025 | June 30, 2024 | % Change (YoY) | | :-------------------------- | :------------ | :------------ | :------------- | | **Active patients at period end** | | | | | Optune Gio | 4,194 | 3,937 | 6.5% | | Optune Lua | 137 | 26 | 426.9% | | **Total Active Patients** | **4,331** | **3,963** | **9.3%** | | **Prescriptions received in Q2** | | | | | Optune Gio | 1,598 | 1,608 | -0.6% | | Optune Lua | 143 | 26 | 450.0% | | **Total Prescriptions Received** | **1,741** | **1,634** | **6.5%** | - Worldwide, active MPM patients increased from **25 to 43**, and active NSCLC patients increased from **1 to 94** as of June 30, 2025[100](index=100&type=chunk) - Worldwide, MPM prescriptions received in Q2 2025 were **22** (vs **24** in Q2 2024), and NSCLC prescriptions were **121** (vs **2** in Q2 2024)[101](index=101&type=chunk) [Non-GAAP Financial Measures (Adjusted EBITDA)](index=31&type=section&id=Non-GAAP%20financial%20measures) This section defines Adjusted EBITDA as a non-GAAP measure and presents its reconciliation to net income (loss), highlighting factors influencing its change - Adjusted EBITDA is a non-GAAP measure used to evaluate operating performance by removing the impact of capital structure, tax rate, and non-cash items like share-based compensation[114](index=114&type=chunk) | Metric (U.S. dollars in thousands) | Three months ended June 30, 2025 | Three months ended June 30, 2024 | % Change (YoY) | | :--------------------------------- | :------------------------------- | :------------------------------- | :------------- | | Net income (loss) | $(40,139) | $(33,375) | 20.2% | | Add: Income tax | $5,160 | $10,646 | -51.5% | | Add: Financial expenses (income), net | $(4,542) | $(10,851) | -58.1% | | Add: Depreciation and amortization | $3,444 | $2,858 | 20.5% | | EBITDA | $(36,077) | $(30,722) | 17.4% | | Add: Share-based compensation | $26,143 | $31,830 | -17.8% | | **Adjusted EBITDA** | **$(9,934)** | **$1,108** | **-996.6%** | - The decrease in Adjusted EBITDA to a loss of **$9.9 million** was primarily due to increased operating expenses related to the NSCLC launch and ramp-up of clinical trials, offsetting a **$1.6 million** increase in gross profit from revenue growth[117](index=117&type=chunk) [Liquidity and Capital Resources](index=32&type=section&id=Liquidity%20and%20Capital%20Resources) This section assesses the company's financial liquidity, including cash, investments, accumulated deficit, and cash flow from operating, investing, and financing activities - As of June 30, 2025, the company had an accumulated deficit of **$1,228.6 million** and **$911.5 million** in cash, cash equivalents, and short-term investments, a decrease of **$48.3 million** from December 31, 2024[118](index=118&type=chunk)[119](index=119&type=chunk) - Net cash used in operating activities increased by **$18.3 million** to **$51.6 million** for the six months ended June 30, 2025, primarily due to increased net loss, decreased share-based compensation, and increased working capital[120](index=120&type=chunk)[121](index=121&type=chunk) - Net cash provided by investing activities was **$29.5 million** for the six months ended June 30, 2025, a significant change from **$128.2 million** used in the prior year, mainly due to net proceeds from short-term investments[120](index=120&type=chunk)[123](index=123&type=chunk) - Net cash provided by financing activities decreased to **$7.6 million** for the six months ended June 30, 2025, from **$87.5 million** in the prior year, primarily due to the prior year's proceeds from the senior secured debt[120](index=120&type=chunk)[124](index=124&type=chunk) [Contractual Obligations and Commitments](index=34&type=section&id=Contractual%20Obligations%20and%20Commitments) This section states that there have been no material changes to the company's contractual obligations and commitments since its 2024 10-K filing - There have been no material changes to the company's contractual obligations and commitments from the information disclosed in its 2024 10-K[131](index=131&type=chunk) [Off-Balance Sheet Arrangements](index=34&type=section&id=Off-Balance%20Sheet%20Arrangements) This section confirms the company had no off-balance sheet arrangements during the periods presented, as defined under SEC rules - The company did not have, and does not currently have, any off-balance sheet arrangements as defined under SEC rules during the periods presented[132](index=132&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=34&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section states that there have been no material changes to the company's quantitative and qualitative disclosures about market risk since its 2024 10-K filing - There have been no material changes to the company's quantitative and qualitative disclosures about market risk from the information disclosed in its 2024 10-K[133](index=133&type=chunk) [Item 4. Controls and Procedures](index=34&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, with the participation of the CEO and CFO, evaluated the effectiveness of disclosure controls and procedures as of June 30, 2025, concluding they were effective at a reasonable assurance level. There were no material changes in internal control over financial reporting during the quarter - Management concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level as of June 30, 2025[134](index=134&type=chunk) - There has been no change in internal control over financial reporting during the quarter ended June 30, 2025, that has materially affected, or is reasonably likely to materially affect, internal control over financial reporting[135](index=135&type=chunk) [PART II—OTHER INFORMATION](index=35&type=section&id=PART%20II%E2%80%94OTHER%20INFORMATION) This section covers other information not included in the financial statements, such as legal proceedings, risk factors, equity sales, defaults, and exhibits [Item 1. Legal Proceedings](index=35&type=section&id=Item%201.%20Legal%20Proceedings) The putative class action lawsuit filed in June 2023 regarding the LUNAR clinical trial results was dismissed by the court on March 18, 2025, and is now closed as plaintiffs did not appeal. The company is involved in other routine legal matters, but management believes their ultimate disposition will not materially affect financial position or results - A putative class action lawsuit filed in June 2023, alleging material misstatements regarding the LUNAR clinical trial, was dismissed by the court on March 18, 2025. The plaintiffs did not appeal, and the matter is now closed[137](index=137&type=chunk) - Management believes that the ultimate disposition of other legal actions arising in the ordinary course of business will not materially affect the company's consolidated financial position or results of operations[138](index=138&type=chunk) [Item 1A. Risk Factors](index=35&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes to the risk factors disclosed in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2024 - There have been no material changes to the company's risk factors disclosed in Part I, Item 1A "Risk Factors" in the 2024 10-K[139](index=139&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=35&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities or use of proceeds occurred during the period - No unregistered sales of equity securities and use of proceeds occurred during the periods presented[140](index=140&type=chunk) [Item 3. Defaults Upon Senior Securities](index=35&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities during the period - There were no defaults upon senior securities during the periods presented[141](index=141&type=chunk) [Item 4. Mine Safety Disclosures](index=35&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Mine Safety Disclosures are not applicable to the company[142](index=142&type=chunk) [Item 5. Other Information](index=35&type=section&id=Item%205.%20Other%20Information) The company's Insider Trading Policy permits executive officers and directors to use Rule 10b5-1 trading plans. During the three months ended June 30, 2025, neither the company nor its executive officers or directors adopted or terminated any Rule 10b5-1 trading plans or non-Rule 10b5-1 trading arrangements - The company's Insider Trading Policy permits executive officers and directors to enter into trading plans designed to comply with Rule 10b5-1[143](index=143&type=chunk) - During the three-month period ended June 30, 2025, neither the company nor any executive officers or directors adopted or terminated any Rule 10b5-1 trading plans or non-Rule 10b5-1 trading arrangements[144](index=144&type=chunk) [Item 6. Exhibits](index=36&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed as part of the Form 10-Q, including certifications, XBRL documents, and the 2025 NovoCure Employee Share Purchase Plan - Key exhibits include certifications (31.1, 31.2, 32.1, 32.2), Inline XBRL documents (101.INS, SCH, CAL, DEF, LAB, PRE), and the 2025 NovoCure Employee Share Purchase Plan (10.1)[147](index=147&type=chunk) [Signatures](index=37&type=section&id=Signatures) This section confirms the report was signed on July 24, 2025, by Christoph Brackmann, Chief Financial Officer of NovoCure Limited - The report was signed on July 24, 2025, by Christoph Brackmann, Chief Financial Officer of NovoCure Limited[153](index=153&type=chunk)

Financial Performance & Market Position - Novocure reported 2024 net revenue of $605 million[13] - The company has over 4,000 global active patients on therapy[13] - Novocure has established a strong foundation and is building towards profitability[13] Clinical Pipeline & Development - Novocure has commercially launched in Non-Small Cell Lung Cancer (NSCLC)[15] - Positive Phase 3 data was reported in Brain Metastases from NSCLC and Locally Advanced Pancreatic Cancer[15] - Regulatory submissions for Brain Metastases from NSCLC (METIS) and Locally Advanced Pancreatic Cancer (PANOVA-3) are planned for H2 2025[17, 28] - The company is advancing label-expanding clinical trials and investing in its platform for future expansion opportunities[31] Clinical Trial Results - The PANOVA-3 Phase 3 clinical trial showed a statistically significant improvement in pain-free survival, with a median pain-free survival of 15.2 months in the TTFields + GnP group compared to 9.1 months in the GnP group (HR = 0.74)[24, 25] - The one-year pain-free survival rate in the TTFields + GnP group was 54.1%[25] Key Objectives - Novocure aims to drive global active patient growth in NSCLC and pursue reimbursement[30]

Company Overview - NovoCure (NVCR) shares increased by 5.3% to close at $18, supported by higher trading volume compared to normal sessions, following an 11.9% decline over the past four weeks [1][2] Product Development - The rise in stock price is linked to growing investor optimism regarding the development and commercialization of Tumor Treating Fields (TTFields) devices, specifically Optune Gio and Optune Lua, which are approved for treating solid tumor cancers [2] Financial Performance - NovoCure is expected to report a quarterly loss of $0.40 per share, reflecting a year-over-year decrease of 29%. Revenue is anticipated to be $152.48 million, representing a 1.4% increase from the same quarter last year [3] - The consensus EPS estimate for the upcoming quarter has remained unchanged over the last 30 days, indicating that stock price movements may not sustain without trends in earnings estimate revisions [4] Industry Context - NovoCure holds a Zacks Rank of 2 (Buy) and is part of the Zacks Medical - Biomedical and Genetics industry. In comparison, Kymera Therapeutics, another company in the same industry, saw a 3.5% decline in its stock price, despite a 51.1% return over the past month [5] - Kymera Therapeutics has experienced a 5.8% increase in its consensus EPS estimate over the past month, now projected at -$0.84, which is a 44.8% decrease from the previous year [6]

NovoCure (NVCR) could be a solid choice for investors given its recent upgrade to a Zacks Rank #2 (Buy). This upgrade is essentially a reflection of an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices.The sole determinant of the Zacks rating is a company's changing earnings picture. The Zacks Consensus Estimate -- the consensus of EPS estimates from the sell-side analysts covering the stock -- for the current and following years is tracked by the system.Individual ...

Core Insights - Novocure (NVCR) announced positive top-line results from its Phase 3 PANOVA-3 trial, showing a statistically significant improvement in overall survival for patients with unresectable, locally advanced pancreatic cancer when treated with Tumor Treating Fields (TTFields) therapy in combination with gemcitabine and nab-paclitaxel [1][10] - The trial demonstrated notable survival benefits at both the 12- and 24-month marks, indicating durable clinical efficacy and reinforcing TTFields' potential as a valuable addition to pancreatic cancer treatment options [2][4] Trial Details - The PANOVA-3 trial was a global, randomized, open-label Phase 3 study involving 571 patients, comparing TTFields therapy combined with chemotherapy against chemotherapy alone, with a primary endpoint of overall survival [8][9] - Results showed a median overall survival (mOS) of 16.2 months for the TTFields group compared to 14.2 months for the control group, reflecting a two-month survival benefit [10] - One-year survival rates were 68.1% for the TTFields group versus 60.2% for the chemotherapy-only group, marking a significant clinical advancement [10] Patient Outcomes - The trial highlighted improvements in patient-reported outcomes, particularly in pain management, with median pain-free survival of 15.2 months in the TTFields group compared to 9.1 months in the control arm, representing a statistically significant 6.1-month improvement [11] - Quality of life assessments indicated significant benefits in global health status, pain, and digestive symptoms for patients receiving TTFields therapy [11] Safety Profile - The overall safety profile of TTFields therapy was favorable, with no new safety signals reported and most device-related adverse events being mild-to-moderate skin reactions [12] Market Implications - The positive results from the PANOVA-3 trial could enhance Novocure's long-term business prospects by facilitating entry into the pancreatic cancer market, which has high unmet medical needs [4] - Regulatory approvals based on these findings could lead to TTFields therapy being adopted as a frontline treatment, driving revenue growth and improving reimbursement prospects globally [4][6]