NovoCure Limited Q2 FY2025 earnings call

• Clinical Milestones: PANOVA-3 trial showed TTFields therapy with gemcitabine and nab-paclitaxel improved survival and pain in pancreatic cancer; METIS trial for brain metastases from non-small cell lung cancer met primary endpoint with improved time to intracranial progression.
• Regulatory Updates: Working on PMA submissions for PANOVA-3 (pancreatic cancer) with plans to file prior to year-end and for METIS (brain metastases from non-small cell lung cancer), having submitted first modules in April and on track for final submission later this year.
• Commercial Progress: Optune Lua launched in US and Germany, with 121 prescriptions in Q2; GBM had 7% active patient growth globally; real-world study from Mayo Clinic showed 2-year survival benefit for GBM patients on TTFields therapy.

Net revenues for the second quarter were $159 million, a 6% increase from Q2 2024. The growth was driven by 7% year-over-year active patient growth in the GBM franchise, including double-digit growth in international markets. Optune Lua generated $2.4 million in net revenues in the quarter, with $1.1 million from non-small cell lung cancer collections. GBM ended the quarter with 4,194 Optune Gio patients, a 7% increase year-over-year.

• Expect to file PMA for PANOVA-3 and METIS prior to year-end, with potential approvals and launches in 2026.
• Next clinical data readouts from TRIDENT (newly diagnosed GBM) and PANOVA-4 (metastatic pancreatic cancer) anticipated in first half of next year.
• Anticipate revenue growth from Optune Lua as reimbursement and adoption progress in non-small cell lung cancer.

• Tariff uncertainties with potential P&L impact up to $7 million due to import tariffs on arrays.
• Uncertainty in regulatory review timelines for PMA submissions, affecting approval and launch timelines.
• Dependence on clinical trial results and payer coverage decisions for commercial success of new indications.

Q: Larry Biegelsen asked about the slower sequential growth in non-small cell lung cancer prescriptions and patients in Q2 and ramp expectations.

A: Ashley Cordova and Frank Leonard stated the launch is on track, with repeat prescribers building volume and the launch progressing as expected.

Q: Jason Bednar asked about increasing adoption of Optune Lua and uptake progression.

A: Frank Leonard responded that there's high clinical unmet need in Stage IV non-small cell lung cancer, with physicians comfortable using the therapy and refining marketing messages to target patients off platinum therapy.

Q: Vijay Kumar asked about the reception of PANOVA-3 data at ASCO.

A: William F. Doyle and Ashley Cordova mentioned the positive reception, with a Dana-Farber physician concluding TTFields should be standard of care, and the presentation being highly anticipated.

Q: Jessica Fye asked about METIS PMA timing and revenue from prior period claims.

A: Ashley Cordova explained METIS has a modular submission with modules 1 and 2 submitted, and revenue from prior period claims is a recurring feature at 3-5% of revenue.

Q: Kevin DeGeeter asked about NCCN guidelines and payer feedback on Optune Lua.

A: Ashley Cordova and Christoph Brackmann stated higher NCCN category ratings are helpful, and payer feedback is positive with early successes in case-by-case reimbursements.

Q: Emily Bodnar asked about sales breakdown and Germany reimbursement.

A: Ashley Cordova said $94 million US sales include Optune Lua, and Germany is expected to have similar case-by-case reimbursement dynamics as the US.