Financial Data and Key Metrics Changes - The company generated a record $655 million in net revenues for 2025, an 8% increase from 2024 [5][17] - Fourth quarter net revenue was $174 million, also reflecting an 8% year-over-year growth [17] - Gross margin for Q4 was 76% and 75% for the full year, down from 79% and 77% in 2024, primarily due to decreased prior period collections in the US and increased costs [19] - The net loss for Q4 was $24 million, with a loss per share of $0.22, and a full-year net loss of $136 million, or $1.22 per share [21] Business Line Data and Key Metrics Changes - Optune Lua revenue for the full year was $10.4 million, including $5.8 million from non-small cell lung cancer patients [17] - The company recognized $3.5 million from Optune Lua claims in Q4, including $2.4 million from non-small cell lung cancer [17] - Research and development costs increased by 19% in Q4 to $61 million, driven by costs related to phase 3 trials [20] Market Data and Key Metrics Changes - Active patient growth in major markets included 10% in Germany, 19% in France, and 29% in Japan, while the US saw a 4% growth [11] - The company expects growth rates to stabilize in the low to mid-single digits as markets mature [11] Company Strategy and Development Direction - The company aims to drive profitable growth and achieve adjusted EBITDA breakeven in 2026 [22] - New product launches are planned for Optune Gio in Spain, Czechia, and British Columbia, and Optune Lua in Japan [8][12] - The approval of Optune Pax for locally advanced pancreatic cancer is expected to significantly contribute to long-term growth [6][13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming regulatory, clinical, and commercial milestones for 2026, including the approval of Optune Pax and anticipated data readouts from ongoing trials [6][54] - The company is focused on establishing coverage policies for new indications and believes that the market opportunity for pancreatic cancer is significant [39][49] Other Important Information - The Chief Medical Officer resigned, and the company combined its scientific and clinical organizations to enhance R&D execution [9] - The company resolved a Medicare billing issue with CMS, ensuring no negative impact on revenue recognition [18] Q&A Session Summary Question: Guidance for 2026 - Management indicated that providing guidance now reflects a commitment to returning to steady growth and achieving adjusted EBITDA breakeven [26][27] Question: Optune Gio Revenue Growth - Management clarified that the guidance for low to mid-single digit growth is not a signal of market moderation but reflects the potential for increased patient prescriptions [34] Question: Optune Pax Prescription Strategy - Management emphasized the importance of targeting a highly motivated patient population for Optune Pax and leveraging existing sales teams for the launch [39][44] Question: Sales Force Allocation for Optune Pax - The existing sales team trained for Optune Lua will lead the Optune Pax launch without adding new headcount [44] Question: Revenue Contributions from Optune Pax - Management noted that revenue from Optune Pax will initially lag as coverage policies are established, with expectations for routine coverage taking 1-2 years [49][50]