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Achieved record net revenue of $655 million in 2025, driven by substantial active patient growth in international markets like France and Japan.
Transitioned to a multi-indication platform company following the FDA approval of Optune Pax for locally advanced pancreatic cancer in a record 180-day review cycle.
Stabilized the core glioblastoma (GBM) business in mature markets, shifting focus toward high-return potential indications like pancreatic cancer over slower-growing lung cancer segments.
Restructured the leadership team by combining scientific and clinical organizations under a dual Chief Innovation and Medical Officer role to accelerate R&D-to-clinical cycles.
Leveraged an existing ‘torso’ sales force to launch Optune Pax, minimizing incremental commercial spend by utilizing established physician relationships in oncology.
Addressed a temporary Medicare billing administrative issue, securing retroactive reinstatement to ensure no negative impact on revenue recognition.
Projected 2026 revenue of $675 million to $705 million, assuming low to mid-single-digit growth in the core GBM business and $15 million to $25 million from new indications.
Accelerated the timeline for adjusted EBITDA breakeven, targeting a range of negative $20 million to breakeven for full-year 2026 through diligent expense management.
Anticipated clinical catalysts include Phase II PANOVA-4 top-line data in March and Phase III TRIDENT data in the second quarter of 2026.
Expects to complete enrollment for the Phase III KEYNOTE D58 trial in newly diagnosed GBM by the end of 2026.
Planned international expansion with product launches in Japan, Spain, Czechia, and British Columbia to diversify the global revenue base.
Anticipated a non-cash share-based compensation charge in Q1 2026 triggered by the regulatory approval of Optune Pax, similar to the 2024 Optune Lua milestone.
Acknowledged a 1-2 year lag in routine commercial insurance coverage for new indications, requiring an initial reliance on appeals and NCCN guideline inclusion.
Rightsized marketing spend for Optune Lua in the U.S. and Germany due to slower-than-projected adoption in the non-small cell lung cancer market.
Reported a decrease in gross margin to 75% for 2025, attributed to lower prior-period collections and increased costs from HIV rates and tariffs.
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