NovoCure Ltd. Q4 FY2024 earnings call

• Achieved 2024 objectives: grew core GBM business, launched non-small cell lung cancer indication, and delivered on clinical pipeline.
• Received FDA PMA approval for non-small cell lung cancer, with 52 prescriptions and 20 active patients by year-end.
• Had positive Phase 3 results in METIS (brain mets from non-small cell lung cancer) and PANOVA-3 (locally advanced pancreatic cancer).
• Introduced HFE arrays, which are thinner, lighter, and more flexible, with positive feedback on rollout.

In 2024, NovoCure generated $605 million in net revenue. The core GBM business saw active patients grow by 10% to over 4,000. The newly launched non-small cell lung cancer indication had 52 prescriptions and 20 active patients by year-end. Revenue from the GBM segment contributes significantly, and the lung cancer segment is in the early stages of launch. The revenue from improved U.S. approval rates in 2024 was $42 million, with $22 million from prior periods.

• 2025 objectives include continuing lung cancer launch insights, pursuing clinical guidelines and reimbursement in U.S., and regulatory approvals in Europe and Japan.
• Expect to publish METIS and PANOVA trial results, engage with FDA for PMA submissions for brain mets and pancreatic cancer.
• Anticipate launches in brain mets and pancreatic cancer in 2026, with revenue ramping in 2026 as coverage expands for lung cancer.

• Forward-looking statements could differ materially from actual results, with risks described in SEC filings.
• Ongoing negotiations for reimbursement and payer coverage for lung cancer, which take time.
• Potential impact of global trade discussions on margins, though current estimates see no material short-term impact.

Q: Can you provide more granularity on when and where we might see the PANOVA full data presentation?

A: Ashley Cordova said they can't provide soon but are targeting spring conferences and will share more once converted acceptance. Nicolas Leupin added they are thrilled to present the data soon.

Q: What are targets on metrics for the lung launch this year and next?

A: Frank Leonard said they focus on getting the right physician-patient fit, building relationships with payers. Expect growth in volume as launch progresses. Payer coverage expected in 2025 with revenue ramping in 2026.

Q: How much did improved U.S. approval rates contribute to 2024 revenue? Any thoughts on 2025?

A: Christoph Brackmann said growth from improved approval rates in 2024 was $42 million, $22 million from prior periods. No similar impacts expected in 2025 as approval rates at a stable level.

Q: Should we expect METIS and PANOVA publication in 2025 or 2026?

A: Ashley Cordova said publication expected in 2025, in pre-submission discussions with FDA for PMA filings later this year. Breakthrough device designation aids the process.

Q: Q4 revenues declined sequentially in China. Was that timing?

A: Ashley Cordova said it was due to timing of royalty amortization and purchases, with Q4 as a baseline to look forward from.