NovoCure Q3 Earnings Call Highlights

Key Points

• NovoCure reported strong Q3 growth: Revenue rose 16% year over year to $193 million, while adjusted EBITDA improved to $16 million from a $3 million loss. The company raised its 2026 revenue outlook to $736 million–$743 million and adjusted EBITDA guidance to $24 million–$34 million.
• Optune Gio and Optune Lua drove momentum, with active GBM patients reaching a record 4,729 and Japan emerging as a key growth market for Optune Lua. NovoCure also expects an FDA decision on Optune Mya for brain metastases by year-end, potentially supporting a 2027 launch.
• Optune Pax faces near-term U.S. commercial headwinds following the introduction of daraxonrasib, which has limited physician access and slowed momentum. NovoCure remains committed to pancreatic cancer and plans 2027 studies evaluating Optune Pax alongside KRAS inhibitors.

NovoCure NASDAQ: NVCR reported third-quarter 2026 net revenue of $193 million, up 16% from a year earlier, as growth in its Optune Gio business and an expanding launch of Optune Lua in Japan helped lift active patient counts to a record level. The company also raised its full-year revenue and adjusted EBITDA outlook while acknowledging commercial headwinds for its newer Optune Pax therapy in the United States.

Executive Chairman Bill Doyle said the quarter featured “solid execution,” including continued momentum in Optune Gio and a promising launch for Optune Lua in Japan. The company ended the quarter with 4,729 glioblastoma, or GBM, patients receiving Optune Gio therapy, an 11% increase year over year and the highest active GBM patient count in the company’s history.

Management said the Optune Gio business benefited from contributions across both established and newer markets. NovoCure is focusing country-level teams on outreach and efforts to connect with physicians and patients at points in their treatment journeys when treatment decisions are being made.

Clinical Programs and Potential New Indications

NovoCure said its Phase III KEYNOTE-D58 trial remains on track to complete enrollment by the end of 2026. The study is evaluating whether adding pembrolizumab to Optune Gio and low-dose chemotherapy can further improve survival for patients with newly diagnosed glioblastoma.

The company also expects an FDA decision by year-end on its premarket approval application for Optune Mya in brain metastases from non-small cell lung cancer. The application is based on data from the Phase III METIS trial, which NovoCure said showed a doubling in time to intracranial progression for patients receiving Tumor Treating Fields therapy compared with the control group.

If approved, management expects a potential Optune Mya launch in early 2027. NovoCure said it expects reimbursement for the therapy to be established within two years of launch.

Optune Pax Launch Faces U.S. Disruption

Optune Pax, the company’s therapy for pancreatic cancer, ended the third quarter with 276 active patients and generated $3.7 million in net revenue. CEO Frank Leonard said momentum slowed in the United States following the introduction of daraxonrasib, which has affected NovoCure’s ability to access physician practices and detail Optune Pax.

Leonard said practices have been managing patient demand for daraxonrasib, insurance appeals and skin irritation associated with the new treatment. He said NovoCure does not see substantial numbers of patients discontinuing Optune Pax to start daraxonrasib, nor does it see broad use of daraxonrasib in first-line treatment except among patients unable to tolerate standard chemotherapy.

“We still see strong recognition of the clinical value of Optune Pax as a first-line treatment in locally advanced pancreatic cancer,” Leonard said during the call. The company expects the initial disruption in physician practices to settle in coming quarters and said it remains committed to the indication.

NovoCure is awaiting the next update to National Comprehensive Cancer Network guidelines for pancreatic cancer, which management said could support further payer engagement. The company has submitted information for review and said it has one existing coverage policy with Elevance.

The company also outlined plans for two small safety and feasibility studies examining Optune Pax alongside KRAS inhibitors:

• PANOVA-5: A planned study of Optune Pax, gemcitabine, nab-paclitaxel and Verastem’s KRAS G12D inhibitor VS-7375 in locally advanced pancreatic cancer. NovoCure expects to initiate the approximately 25-patient trial in the first half of 2027.
• PANOVA-6: A planned study of Optune Pax with daraxonrasib in metastatic pancreatic adenocarcinoma, also expected to begin in the first half of 2027 with a similar number of patients.

Chief Innovation and Medical Officer Uri Weinberg said the studies are intended primarily to establish feasibility, tolerability and toxicity of using Optune Pax concurrently with KRAS inhibition. He added that preclinical research has suggested Tumor Treating Fields may affect downstream transcription factors related to KRAS.

Japan Becomes an Important Growth Market

Optune Lua generated $8 million in global net revenue during the quarter and reached 255 active patients. Japan accounted for 110 active patients and $4 million of Optune Lua revenue.

Leonard said the Japanese market is favorable because second-line immune checkpoint inhibitor use is standard care and overlaps with the company’s Optune Lua label and the strongest outcomes from the LUNAR trial. He also said the negotiated monthly Japanese price for Optune Lua is approximately in line with the global price for Optune Gio.

Japanese regulators approved Optune Pax earlier in 2026, and NovoCure expects reimbursement during the first half of 2027. Management said it believes Japan could eventually become the company’s second-largest market after the U.S., citing larger lung and pancreatic cancer patient populations than its existing GBM opportunity in the country.

Revenue Outlook Raised as Profitability Improves

CFO Christoph Brackmann said the 16% increase in quarterly revenue was driven primarily by a 19% rise in active patients, along with a $4 million one-time benefit from improved approval rates in the U.S. and Germany. Foreign exchange rates created a $2 million headwind in the quarter.

The company raised its 2026 revenue outlook to a range of $736 million to $743 million, representing growth of 12% to 13%. The forecast includes combined Optune Lua and Optune Pax revenue of $30 million to $34 million.

Third-quarter gross margin rose to 77% from 73% a year earlier, and NovoCure expects gross margin to remain in the mid- to high-70% range during the final quarter of 2026.

Research and development expense increased 8% year over year to $58 million, largely due to the KEYNOTE-D58 trial. Sales and marketing expense declined 9% to $53 million, while general and administrative expense fell 5% to $44 million, with both categories benefiting from lower share-based compensation.

NovoCure posted a net loss of $10 million, or $0.09 per share, compared with a $37 million loss in the prior-year quarter. Its adjusted EBITDA was positive $16 million, compared with a negative $3 million a year earlier. The company raised full-year adjusted EBITDA guidance to $24 million to $34 million.

Cash and investments totaled $463 million as of Sept. 30. Brackmann said the company views adjusted EBITDA breakeven as the first step in its profitability plan, followed by cash-flow breakeven and then net-income breakeven. He cautioned that quarterly results may fluctuate as the company prepares for future launches.

About NovoCure (NASDAQ:NVCR)

NovoCure Ltd. NASDAQ: NVCR is an oncology company that develops and commercializes therapies based on Tumor Treating Fields (TTFields), low-intensity electric fields designed to disrupt the division of cancer cells. Its treatments are delivered through portable, wearable devices used alongside other cancer therapies.

The company's principal products include Optune Gio for certain adults with glioblastoma and Optune Lua for adults with unresectable, locally advanced or metastatic pleural mesothelioma and certain forms of metastatic non-small cell lung cancer.

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