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novocure(NVCR) - 2025 Q1 - Quarterly Results
novocurenovocure(US:NVCR)2025-04-24 11:02

Novocure First Quarter 2025 Financial Results Overview Financial Highlights Novocure reported $155 million in net revenue, a 12% increase, driven by active patient growth and improved reimbursement, reporting a $34.3 million net loss Key Financial Data for Q1 2025 | Metric | Q1 2025 (Million USD) | Q1 2024 (Million USD) | YoY Change | | :--- | :--- | :--- | :--- | | Net Revenue | 155.0 | 138.5 | +12% | | Gross Margin | 75% | 76% | -1% | | Net Loss | (34.3) | (38.8) | -11% | | Adjusted EBITDA | (5.0) | (4.6) | +8% | - Net revenue growth was primarily driven by active patient growth in key markets, followed by improved reimbursement. The U.S., Germany, France, and Japan contributed $93.2 million, $18.7 million, $17.9 million, and $8.7 million in revenue, respectively. Greater China, through collaboration with Zai Lab, contributed $4.6 million. Optune Lua generated $1.5 million in revenue, with $0.8 million from MPM and $0.7 million from NSCLC2 - The decrease in gross margin was primarily due to the rollout of HFE arrays and the launch of the NSCLC product, where the company is treating at-risk on-label patients before widespread reimbursement is established2 Operational and Clinical Highlights Global active TTFields patients reached 4,268, with increased operating expenses related to NSCLC launch and future indications, alongside key clinical trial advancements Operating Expenses for Q1 2025 | Expense Category | Q1 2025 (Million USD) | Q1 2024 (Million USD) | YoY Change | | :--- | :--- | :--- | :--- | | Research & Development and Clinical Studies | 53.8 | 51.6 | +4% | | Sales & Marketing | 55.8 | 55.2 | +1% | | General & Administrative | 44.8 | 39.5 | +13% | - As of March 31, 2025, there were 4,268 active TTFields therapy patients globally. Optune Gio prescriptions totaled 1,608, a 1% year-over-year decrease, with 4,162 active patients, up 9%. Optune Lua prescriptions were 127, including 92 for NSCLC and 35 for MPM, with 106 active patients6 - PANOVA-3 Phase III clinical trial results for pancreatic cancer were accepted as a late-breaking abstract for presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. Optune Lua received CE Mark approval for use in adult patients with metastatic NSCLC in combination with immune checkpoint inhibitors or docetaxel112 Company Information About Novocure Novocure is a global oncology company focused on extending survival for aggressive cancer patients through its innovative TTFields therapy - Novocure's mission is to extend the survival of patients with aggressive cancers through Tumor Treating Fields (TTFields) therapy9 - Commercialized products are approved for treating glioblastoma, non-small cell lung cancer, malignant pleural mesothelioma, and pleural mesothelioma9 - The company's headquarters are in Baar, Switzerland, U.S. headquarters in Portsmouth, New Hampshire, and research facilities in Haifa, Israel10 Detailed Financial Performance Consolidated Statements of Operations Novocure reported $155 million in net revenue, a 12% increase, but incurred an operating loss of $37.9 million and a net loss of $34.3 million due to increased operating expenses Consolidated Statements of Operations Summary for Q1 2025 | Metric (Thousand USD) | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net Revenue | 154,994 | 138,503 | | Cost of Sales | 38,521 | 33,689 | | Gross Profit | 116,473 | 104,814 | | Research & Development and Clinical Studies Expenses | 53,777 | 51,598 | | Sales & Marketing Expenses | 55,792 | 55,206 | | General & Administrative Expenses | 44,769 | 39,530 | | Operating Loss | (37,865) | (41,520) | | Net Loss | (34,319) | (38,760) | | Basic & Diluted Loss Per Share | (0.31) | (0.36) | Consolidated Balance Sheets As of March 31, 2025, Novocure's total assets were $1.249 billion, with a decrease in cash offset by an increase in short-term investments, and total liabilities at $887 million Consolidated Balance Sheets Summary | Metric (Thousand USD) | March 31, 2025 (Unaudited) | December 31, 2024 (Audited) | | :--- | :--- | :--- | | Cash & Cash Equivalents | 127,279 | 163,767 | | Short-Term Investments | 801,852 | 796,106 | | Accounts Receivable, Net | 84,507 | 74,226 | | Inventory | 39,468 | 35,086 | | Total Current Assets | 1,089,301 | 1,106,575 | | Total Assets | 1,248,809 | 1,240,784 | | Convertible Notes | 558,970 | 558,160 | | Total Current Liabilities | 743,305 | 756,376 | | Total Liabilities | 886,851 | 880,605 | | Total Stockholders' Equity | 361,958 | 360,179 | Non-GAAP Financial Measures Reconciliation Novocure's adjusted EBITDA for Q1 2025 was negative $5.0 million, an expanded loss compared to Q1 2024, reflecting operational performance excluding certain non-cash items Non-GAAP Financial Measures Reconciliation Summary | Metric (Thousand USD) | Q1 2025 | Q1 2024 | YoY Change | | :--- | :--- | :--- | :--- | | Net Loss | (34,319) | (38,760) | (11)% | | Add: Income Tax Expense | 4,024 | 7,118 | (43)% | | Add: Interest Expense (Income), Net | (7,570) | (9,878) | (23)% | | Add: Depreciation & Amortization | 3,325 | 2,815 | 18% | | EBITDA | (34,540) | (38,705) | (11)% | | Add: Share-Based Compensation | 29,552 | 34,084 | (13)% | | Adjusted EBITDA | (4,988) | (4,621) | 8% | - Adjusted EBITDA is considered a useful metric for evaluating the company's operating performance as it excludes the impact of capital structure, tax rates, and non-cash items, particularly share-based compensation13 Operational Metrics Key Operating Statistics Global active TTFields patients reached 4,268, with Optune Gio active patients increasing and Optune Lua showing continued growth, while the company plans to shift reporting focus to active patients by indication from Q1 2026 Key Operating Data for Optune Gio and Optune Lua | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Global Active TTFields Patients | 4,268 | 3,845 | | Optune Gio Prescriptions | 1,608 | 1,624 | | Optune Gio Active Patients | 4,162 | 3,819 | | Optune Lua Total Prescriptions | 127 | N/A | | Optune Lua NSCLC Prescriptions | 92 | N/A | | Optune Lua MPM Prescriptions | 35 | N/A | | Optune Lua Active Patients | 106 | 26 | - Starting Q1 2026, Novocure plans to discontinue reporting new prescriptions received during the period, instead focusing on active TTFields therapy patients segmented by indication and key market as key operating statistics6 Active Patients on Therapy As of March 31, 2025, global active TTFields patients totaled 4,268, with significant growth in lung cancer indications, reaching 106 patients Active Patients as of March 31, 2025 (by Region and Indication) | Region | CNS (2025) | Lung Cancer (2025) | Total (2025) | CNS (2024) | Lung Cancer (2024) | Total (2024) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | U.S. | 2,157 | 74 | 2,231 | 2,122 | 15 | 2,137 | | Germany | 573 | 21 | 594 | 531 | 9 | 540 | | France | 463 | — | 463 | 318 | — | 318 | | Japan | 445 | — | 445 | 379 | — | 379 | | Other International | 524 | 11 | 535 | 469 | 2 | 471 | | Global Total | 4,162 | 106 | 4,268 | 3,819 | 26 | 3,845 | - Lung cancer patients include NSCLC and MPM. As of March 31, 2025, there were 44 active MPM patients and 62 active NSCLC patients globally19 Clinical Development and Regulatory Status Recent Clinical and Regulatory Achievements Novocure achieved significant clinical and regulatory milestones, including PANOVA-3 trial results accepted by ASCO and Optune Lua receiving CE Mark approval for mNSCLC - PANOVA-3 Phase III clinical trial results for pancreatic cancer were accepted as a late-breaking abstract for presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting1 - Optune Lua received CE Mark approval for use in adult patients with metastatic NSCLC in combination with immune checkpoint inhibitors or docetaxel, following disease progression on platinum-based therapy1 Anticipated Clinical Milestones The company anticipates future data releases for key clinical trials, including PANOVA-4 for metastatic pancreatic cancer and TRIDENT for newly diagnosed glioblastoma - PANOVA-4 Phase II clinical trial data for metastatic pancreatic cancer is anticipated in the first half of 202612 - TRIDENT Phase III clinical trial data for newly diagnosed glioblastoma is anticipated in the first half of 202612 Risk Factors and Disclosures Tariff Environment Impact The evolving global tariff environment could lead to $8 million to $11 million in increased import duties for Novocure in 2025, depending on the duration of current tariff suspensions - On April 9, 2025, the U.S. temporarily postponed the implementation of new tariffs for 90 days, resulting in a 10% tariff applicable to most countries2 - If the current suspension is extended until year-end, Novocure could face up to $8 million in increased import tariffs in 20252 - If tariffs revert to pre-April 9 levels after the 90-day suspension, Novocure could face up to $11 million in increased import tariffs in 202523 Forward-Looking Statements This press release contains forward-looking statements regarding future events, subject to inherent risks and uncertainties that may cause actual results to differ materially - Forward-looking statements involve expectations or predictions about future events, including scientific progress, clinical trials, product development, regulatory approvals, manufacturing capabilities, and market outlook14 - The company'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 and uncertainties14 - The company undertakes no obligation to publicly update any forward-looking statements unless required by law14 Important Safety Information Optune Gio Safety Information Optune Gio is an FDA-approved wearable device for adult glioblastoma patients, used with or without temozolomide, with common side effects and contraindications for certain medical conditions - Optune Gio is approved for treating glioblastoma (GBM) in adult patients aged 22 and older21 - Contraindications include implanted medical devices, skull defects or shrapnel, and known sensitivity to conductive hydrogels. It should not be used by pregnant women or those planning to become pregnant2322 - Common side effects include low platelet count, nausea, constipation, vomiting, fatigue, scalp irritation, headache, seizures, and depression25 Optune Lua Safety Information Optune Lua is an FDA-approved wearable device for adult metastatic NSCLC patients, used in combination with PD-1/PD-L1 inhibitors or docetaxel, with specific contraindications and common side effects - Optune Lua is approved for use in adult patients with metastatic non-small cell lung cancer (mNSCLC) who have progressed on platinum-based therapy, in combination with PD-1/PD-L1 inhibitors or docetaxel26 - Contraindications include electrical implants and known sensitivity to the gel. It should not be used by pregnant women or those planning to become pregnant27 - Common side effects include dermatitis, musculoskeletal pain, fatigue, anemia, alopecia, dyspnea, nausea, cough, diarrhea, decreased appetite, pruritus, leukopenia, pneumonia, respiratory tract infection, localized edema, rash, pain, constipation, and skin ulceration28 Corporate Communications Conference Call and Webcast Details Novocure hosted a conference call and webcast on April 24, 2025, to discuss Q1 2025 financial results, with details available on the investor relations page - Novocure hosted a conference call and webcast on Wednesday, April 24, 2025, at 8:00 AM ET, to discuss its first-quarter 2025 financial results7 - The webcast, earnings slides, and company presentation are available on Novocure's investor relations page and will remain accessible for at least 14 days after the event8 Investor and Media Contacts This report provides detailed contact information for Novocure's investor relations and media inquiries to facilitate stakeholder communication - Investor Contact: Ingrid Goldberg, Email: investorinfo@novocure.com20 - Media Contact: Catherine Falcetti, Email: media@novocure.com20