GRAIL (GRAL) Piper Sandler 36th Annual Healthcare Conference summary

Growth outlook and commercial strategy

• Projected Galleri test growth of 40%-50% in 2024, with 2025 growth expected to be lower as focus shifts to capital efficiency and cost-neutral U.S. commercial operations.

• Restructuring reduced commercial staff from 400 to 200, concentrating efforts in high-performing regions and leveraging physician champions and health system partnerships.

• Average selling price remains around $800, with expectations for price reduction as the test becomes more broadly accessible and reimbursed.

Regulatory and reimbursement progress

• Final FDA module submission, including Pathfinder 2 and NHS-Galleri data (175,000 participants), planned for first half of 2026, with anticipated one-year review period.

• Legislation to enable CMS coverage for multi-cancer early detection tests has bipartisan support; ideal passage would occur before FDA approval.

• Engagement with FDA focuses on demonstrating consistent test performance, safety, and ability to localize cancer origin.

Financial position and operational efficiency

• Cash balance projected at ~$700 million by year-end, with runway into 2028; major study costs subsiding as NHS Galleri and Pathfinder 2 complete.

• Launching a next-generation, lower-cost, high-throughput test version to improve gross margins and reduce variable costs.

• Targeting 60% gross margins at scale in the U.S., with long-term operating margins of 5%-10% over five years.