NovoCure Ltd SEC Filings

NovoCure Limited is a global oncology company focused on Tumor Treating Fields (TTFields), a medical device–delivered electric field therapy designed to disrupt cancer cell division. Its main commercial products are Optune Gio for glioblastoma, Optune Lua for metastatic non-small cell lung cancer (NSCLC) and malignant pleural mesothelioma, and Optune Pax for locally advanced pancreatic cancer.

The company generates most revenue from Optune Gio use in the U.S., Germany, France and Japan, and is pursuing broader reimbursement and geographic expansion. NovoCure highlights positive late‑stage data, including the METIS brain metastases trial, and is advancing multiple Phase 2 and 3 studies in GBM, NSCLC and pancreatic cancer while emphasizing extensive regulatory, manufacturing, reimbursement and competition risks.

Novocure Limited reported modest growth in 2025 while advancing its cancer therapy portfolio. Full year net revenues reached $655.4 million, up 8%, with fourth quarter net revenues of $174.4 million, also up 8%, driven by more active patients on Tumor Treating Fields therapy.

Net loss improved to $136.2 million for 2025 and $24.5 million in the fourth quarter, with quarterly loss per share of $0.22. Adjusted EBITDA was $(16.4) million for the quarter and $(34.3) million for the year, reflecting high R&D and commercialization spending.

Novocure ended 2025 with $447.7 million in cash, cash equivalents and short-term investments and 4,620 active patients on therapy. In early 2026, the FDA approved Optune Pax for locally advanced pancreatic cancer, public payers in Czechia and British Columbia expanded Optune Gio coverage, and CMS reversed a temporary revocation of U.S. billing privileges. The company guided 2026 net revenues to $675–$705 million and Adjusted EBITDA between $(20) million and $0.

Novocure Limited reported that Medicare billing privileges for its U.S. subsidiary were temporarily revoked and then fully restored. CMS had revoked billing for the company’s products retroactive to December 17, 2025 due to an administrative issue with a triannual re-validation process, not a substantive qualification failure.

On February 24, 2026, CMS rescinded the revocation and reinstated Medicare billing privileges retroactive to December 17, 2025. Novocure states it continued serving existing and new patients throughout this period and believes there will ultimately be no impact on its ability to recognize revenue for those services.

Soleus Capital Master Fund, L.P. and affiliated entities filed an amended ownership report on NovoCure Limited. They report beneficial ownership of 8,530,665 ordinary shares, representing 7.6% of NovoCure’s ordinary shares, based on 111,981,981 shares outstanding as of October 24, 2025.

The group has shared voting and dispositive power over all reported shares and no sole voting or dispositive power. The filing is made on a passive basis, certifying that the securities were not acquired to change or influence control of NovoCure.

Novocure Limited announced that the U.S. FDA approved Optune Pax, a wearable Tumor Treating Fields device, for adult patients with locally advanced pancreatic cancer when used with gemcitabine and nab-paclitaxel. This is described as the first FDA‑approved treatment in nearly 30 years for this disease stage.

In the Phase 3 PANOVA‑3 trial (571 patients), Optune Pax plus chemotherapy improved median overall survival to 16.2 months versus 14.2 months in the intent‑to‑treat group and to 18.3 months versus 15.1 months in the modified per protocol group, with statistically significant hazard ratios. One‑year survival rates and time to pain progression also improved, while safety was mainly limited to expected skin reactions under the arrays and fatigue, with no device‑related deaths or unanticipated safety issues.

Novocure Limited reported that its U.S. subsidiary’s Centers for Medicare & Medicaid Services (CMS) billing privileges were revoked retroactive to December 17, 2025 due to an administrative issue with triannual re-validation, not a substantive qualification failure. The company has filed a Corrective Action Plan and expects billing to be reinstated but cannot predict the timing or final outcome. During the suspension, Novocure continues treating existing and new patients but cannot bill Medicare, Medicare Advantage and other CMS-related programs, and estimates it cannot recognize approximately $13 million per month in revenue from these payors. The company intends to bill for services provided once privileges are restored but cannot estimate how much, if any, will ultimately be recoverable.

NovoCure Ltd’s Chief Operating Officer, Paravasthu Mukund, reported an automatic share withholding related to equity compensation. On 01/11/2026, 2,133 ordinary shares were withheld by the company at a price of $14.35 per share to cover tax obligations arising from the vesting of Restricted Stock Units.

After this non-discretionary tax-withholding transaction, Mukund beneficially owns 78,306 ordinary shares directly. The withholding was approved as required under Rules 16b-3(e) and 16b-3(d)(1), and reflects routine tax handling of vested stock-based awards rather than an open-market sale.