novocure(NVCR) - 2025 Q2 - Quarterly Results

Second Quarter 2025 Financial and Operational Highlights 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 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] - As of June 30, 2025, 4,331 active patients were receiving treatment[1] - 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] - 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] Key Financial Updates 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] 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] - Adjusted EBITDA was negative $9.9 million[6] - Cash, cash equivalents, and short-term investments totaled $911.5 million as of June 30, 2025[6] Key Operational Updates 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] 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] - 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][7] Detailed Financial Statements 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 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 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 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 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 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] - Patients receiving TTFields therapy showed significantly extended pain-free survival (secondary endpoint) and distant progression-free survival (post-hoc analysis)[6] - 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] Anticipated Clinical and Regulatory Milestones 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] - 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] - Top-line data from the Phase 2 PANOVA-4 metastatic pancreatic cancer clinical trial is expected in H1 2026[12] - Top-line data from the Phase 3 TRIDENT newly diagnosed glioblastoma clinical trial is expected in H1 2026[12] Company Information 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 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] - Novocure's commercial products are approved in certain countries for adult glioblastoma, non-small cell lung cancer, and malignant pleural mesothelioma[11] - Company headquarters are in Baar, Switzerland, US headquarters in Portsmouth, New Hampshire, and R&D facilities in Haifa, Israel[12][13] Investor Relations and Media Contacts 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] - 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] Non-GAAP Financial Measurements Definition 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] - 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] Forward-Looking Statements 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] - Forward-looking statements can be identified by words such as "anticipate," "estimate," "expect," "project," "intend," "plan," and "believe"[15] - 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] - Novocure does not intend to publicly update any forward-looking statements unless required by law[15] Product Safety Information 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 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] - 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] - 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][24] - 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] Optune Lua® Safety Information 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] - 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] - 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] - 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]