NovoCure (NASDAQ:NVCR) reported record fourth-quarter and full-year 2025 revenue on its latest earnings call, while outlining regulatory, clinical and commercial milestones expected in 2026, including the recent FDA approval of Optune Pax for locally advanced pancreatic cancer.
2025 performance and key milestones
Executive Chairman Bill Doyle said 2025 was “a year of progress and change” for the company, highlighted by record net revenue of $655 million, up 8% from 2024. The company also presented final data from two large randomized trials in plenary sessions at major medical congresses and published the results in medical journals. During the year, NovoCure submitted premarket approval (PMA) applications to the FDA for Tumor Treating Fields (TTFields) therapy in pancreatic cancer and in brain metastases from non-small cell lung cancer.
Leadership and organizational update
Doyle said Chief Medical Officer Dr. Nicolas Leupin resigned effective Feb. 25. Following the departure, NovoCure decided to combine its scientific and clinical organizations “to accelerate our R&D execution.” Chief Innovation Officer Dr. Uri Weinberg will assume the Chief Medical Officer role in addition to his current responsibilities.
Commercial trends: GBM growth and new launches
CEO Frank Leonard, speaking in his new role, said 2025 was the company’s “most successful commercial year to date” and that management expects to carry momentum into 2026 as NovoCure evolves into a “multi-indication platform company.”
Leonard said the company’s glioblastoma (GBM) business remains core. In 2025, NovoCure saw active patient growth across major markets, driven primarily outside the U.S. He cited year-over-year active patient growth of 10% in Germany, 19% in France and 29% in Japan, along with 4% growth in the U.S., which he said had been flat in recent years. For 2026, management expects growth rates to stabilize in the “low to mid-single digit” range as markets mature, with modest first-year contributions expected from launches in Spain, Czechia and British Columbia.
On Optune Lua, Leonard said NovoCure is preparing to launch in Japan and expects final reimbursement approval “in the coming weeks,” enabling a launch with national coverage and pricing. However, he reiterated that Optune Lua has launched more slowly than expected in the U.S. and Germany, prompting the company to “right-size” marketing spending and prioritize investments in indications with “higher return potential,” including pancreatic cancer.
Optune Pax launch plans and market opportunity
Leonard highlighted the FDA’s review timeline for Optune Pax, noting the PMA was approved on Feb. 11 after a 180-day review, compared with an industry-standard 9–12 months for PMAs. He said NovoCure has begun the launch process, including certifying prescribers and receiving prescriptions, and is emphasizing digital prescriptions through its healthcare provider portal.
The approved label is for locally advanced pancreatic cancer in the first-line setting, used concurrently with nab-paclitaxel plus gemcitabine, which management described as a motivated patient population with limited treatment options.
On commercialization, Leonard said NovoCure is leveraging its existing “torso” sales force, which had been trained for the Optune Lua effort, and is not adding incremental sales headcount at this time. CFO Christoph Brackmann added that incremental spend for the pancreatic launch will be primarily on the marketing side and that some of that spend began in the fourth quarter.
Brackmann estimated the total addressable market for locally advanced pancreatic cancer in the U.S. at about 15,000 patients annually. Management also cautioned that early in the launch, revenue may not correlate directly with active patient counts due to the process of establishing payer coverage policies and potential appeals, as the company has experienced in prior launches. Leonard said NovoCure has submitted an application for inclusion in NCCN guidelines for locally advanced pancreatic cancer, calling it a key step toward broader coverage.
Financial results, Medicare billing update, and 2026 guidance
Brackmann reported fourth-quarter net revenue of $174 million and full-year net revenue of $655 million, both up 8% year over year. Growth was primarily driven by ex-U.S. expansion, with foreign exchange providing a tailwind of about $5 million in Q4 and $11 million for the full year versus 2024.
Optune Lua contributed $3.5 million of revenue in the quarter, including $2.4 million from non-small cell lung cancer. Full-year Optune Lua revenue was $10.4 million, including $5.8 million from non-small cell lung cancer patients.
Brackmann also addressed a recent Medicare billing issue. He said CMS temporarily halted NovoCure’s billing privileges due to an administrative issue during a DME supplier revalidation process, but CMS later rescinded the revocation and directed reinstatement retroactive to Dec. 17, 2025. As a result, the company does not expect a negative impact on revenue recognition.
Profitability metrics remained negative in 2025. Fourth-quarter gross margin was 76% and full-year gross margin was 75%, down from 79% and 77% in the comparable 2024 periods, which management attributed primarily to lower prior-period collections in the U.S. and higher costs tied to HFE arrays and tariffs. For 2026, NovoCure expects gross margin in the mid-70% range.
Expenses included R&D of $61 million in Q4 (up 19%) and $225 million for the year (up 7%), driven by trial and regulatory costs. Sales and marketing was $69 million in Q4 (up 2%) and $240 million for the year (flat). G&A was $43 million in Q4 (down 41%) and $178 million for the year (down 6%), primarily due to lower share-based compensation expenses related to 2020 PSUs; Brackmann noted a similar charge is expected in Q1 2026 triggered by Optune Pax approval.
NovoCure posted a Q4 net loss of $24 million (loss per share of $0.22) and a full-year net loss of $136 million (loss per share of $1.22). Adjusted EBITDA was negative $16 million for Q4 and negative $34 million for the year. Cash and investments ended the quarter at $448 million. Brackmann said the company repaid $561 million of convertible notes in cash during Q4 and does not plan to draw beyond the $200 million already taken from its credit facility.
For 2026, NovoCure issued net revenue guidance for the first time, projecting $675 million to $705 million at constant exchange rates, representing 3% to 8% growth. The outlook assumes low- to mid-single-digit growth for Optune Gio, modest contributions from newer GBM markets, and $15 million to $25 million of net revenue from non-GBM products (up from $10 million in 2025), including contributions from Optune Lua in Japan and Optune Pax. The company also guided to adjusted EBITDA of negative $20 million to break even for 2026, which management said reflects both revenue expectations and expense management as it targets a path toward profitable growth.
About NovoCure (NASDAQ:NVCR)
NovoCure is a global oncology company pioneering Tumor Treating Fields (TTFields), a novel anti-mitotic therapy for solid tumors. The company’s non-invasive treatment platforms deliver low-intensity, alternating electric fields designed to disrupt cancer cell division. NovoCure’s approach offers an alternative modality to complement existing therapies in oncology, with a focus on hard-to-treat malignancies.
Founded in 2000 and headquartered in Haifa, Israel, NovoCure maintains a second operational center in Portsmouth, New Hampshire.
