novocure(NVCR) - 2025 Q3 - Quarterly Results

Financial Performance - Quarterly net revenues were $167.2 million, an increase of 8% year-over-year, driven by active patient growth and $3.3 million in exchange rate benefits [2]. - Gross margin for the quarter was 73%, down from 77% in the prior year, primarily due to costs associated with new product rollouts and increased tariffs [2]. - Net loss for the quarter was $37.3 million, with a loss per share of $0.33 [5]. - Net loss for the three months ended September 30, 2025, was $37,270,000, a 22% increase compared to a net loss of $30,570,000 in the same period of 2024 [17]. - Adjusted EBITDA for the nine months ended September 30, 2025, was $(17,959,000), a significant improvement compared to $(1,783,000) in 2024, reflecting a 907% change [17]. Patient Statistics - As of September 30, 2025, there were 4,416 active patients on Tumor Treating Fields therapy globally [5]. - Optune Gio prescriptions increased by 7% to 1,675, with 4,277 active patients on therapy, a 5% increase year-over-year [5]. - Active patients on therapy as of September 30, 2025, totaled 4,416, an increase from 4,113 in 2024 [18]. - The number of active patients in the United States was 2,280, slightly down from 2,200 in the previous year [18]. - The company had 2,136 active patients in international markets as of September 30, 2025, compared to 1,913 in 2024, indicating growth in international adoption [18]. Expenses - Research, development, and clinical study expenses were $54.0 million, a 4% increase from the same period in 2024, driven by product development and regulatory expenses [2]. - Sales and marketing expenses decreased by 2% to $58.5 million, while general and administrative expenses increased by 15% to $45.9 million [5]. - The company reported a 49% increase in depreciation and amortization expenses for the three months ended September 30, 2025, totaling $3,663,000 compared to $2,458,000 in 2024 [17]. Assets and Liabilities - Cash, cash equivalents, and short-term investments totaled $1,033.5 million as of September 30, 2025 [5]. - As of September 30, 2025, total assets amounted to $1,361,194,000, an increase from $1,240,784,000 as of December 31, 2024 [16]. - Total current liabilities increased to $776,006,000 from $756,376,000 year-over-year [16]. - Total long-term liabilities rose to $243,855,000 from $124,229,000 year-over-year, primarily due to an increase in the senior secured credit facility [16]. - The total shareholders' equity decreased to $341,333,000 from $360,179,000 as of December 31, 2024 [16]. Regulatory and Clinical Developments - Novocure submitted a premarket approval application for Tumor Treating Fields therapy in pancreatic cancer, currently under review by the FDA [1]. - Anticipated clinical milestones include a PMA application for brain metastases from NSCLC in Q4 2025 and topline data from the Phase 2 PANOVA-4 trial expected in Q1 2026 [11]. Treatment Information - Optune Lua treatment may be affected by underlying serious skin conditions; consultation with a doctor is advised [28]. - Common side effects of Optune Lua include dermatitis, muscle pain, fatigue, and hair loss, with occurrences of anemia and respiratory infections [29]. - Additional adverse effects may include skin irritation, allergic reactions, and local infections at the array contact sites [30]. - For comprehensive information on the device's indications and precautions, users are directed to visit OptuneLua.com [31].