Record Revenue and Year‑Over‑Year Growth
Full‑year net revenue of $655 million and fourth quarter net revenue of $174 million, each representing 8% year‑over‑year growth versus 2024.
Strong Active Patient Growth in Key International Markets
Notable active patient growth ex‑U.S.: Germany +10% YoY, France +19% YoY, Japan +29% YoY; U.S. active patients grew +4% YoY.
FDA Approval of Optune Pax with Rapid Review
Optune Pax approved Feb 11 for locally advanced pancreatic cancer (first‑line with nab‑paclitaxel + gemcitabine); FDA review completed at the 180‑day mark (faster than typical 9–12 month PMA timeline). U.S. launch has commenced and filings submitted in EU and Japan.
Pipeline and Clinical Catalysts Upcoming
Presented final data from two large randomized trials and published in major journals; PMA submissions for pancreatic cancer and brain metastases in place. Top‑line readouts expected: PANOVA‑4 next month, TRIDENT in Q2, and KEYNOTE‑58 Phase III enrollment expected complete by year‑end.
Growing Non‑GBM Revenue Trajectory
Optune Lua revenue totaled $10.4 million for 2025 (including $5.8 million from NSCLC); Q4 Optune Lua recognition $3.5 million (including $2.4 million for NSCLC). Company expects non‑GBM contributions of $15 million–$25 million in 2026 vs $10 million in 2025.
Solid Liquidity and Debt Reduction
Cash and investments of $448 million at year‑end and repayment of $561 million of convertible notes in Q4. Only $200 million drawn on the credit facility and management does not plan additional draws, providing runway while new revenue streams ramp.
First Formal Guidance and Path to Profitability
Issued 2026 revenue guidance of $675 million–$705 million (3%–8% YoY growth at constant FX) and adjusted EBITDA guidance of negative $20 million to breakeven, signaling a clear objective to reach adjusted EBITDA breakeven in 2026.
Cost Discipline and Operating Efficiency Signals
Full‑year sales & marketing expense flat at $240 million YoY and Q4 G&A down 41% (Q4 $43 million) with full‑year G&A down 6% to $178 million, driven by lower share‑based compensation in the period.