GRAIL (GRAL) investor relations material

Key financial and operational highlights

• Achieved 50% volume growth and 37% revenue growth in the recent quarter, running over 500,000 commercial tests to date.

• Maintains 22%-32% revenue growth guidance for the year, with discounted pricing strategies impacting ASP but supporting volume trajectory.

• Epic integration expected by year-end to broaden physician access, though major impact awaits reimbursement; focus remains on expanding the physician ecosystem.

• Self-pay market is substantial and growing, but broad adoption hinges on future Medicare and commercial payer reimbursement, with MCED legislation enabling CMS coverage starting 2029.

• Lab capacity exceeds one million samples annually, supporting anticipated volume increases as reimbursement expands.

Clinical and regulatory developments

• NHS-Galleri study (140,000 participants) showed 40% of detected cancers at stages 1 and 2, and a 14% reduction in stage 4 cancers, rising to over 20% in later screening rounds.

• PATHFINDER 2 study found 71% of new cancers detected at stages 1-3, supporting early intervention and improved survival rates.

• FDA submission completed in January; active review ongoing, with a decision expected within a year, pending advisory committee determination.

• Additional 12-month follow-up data from NHS-Galleri expected in Q1/Q2 next year, with passive mortality follow-up planned.

Technology, R&D, and competitive positioning

• CSO (Cancer Signal Origin) accuracy consistently above 90%, enabling rapid diagnostic resolution (median 37-48 days) and reducing patient anxiety and resource use.

• High specificity (99.6%) prioritized to minimize false positives, differentiating from competitors with higher rates.

• Ongoing R&D focuses on assay improvement, leveraging a large proprietary data set and evaluating new biomarkers, though current targeted methylation panel remains most effective.

• AI and machine learning integrated into test development, workflow, and sales targeting, with further GenAI applications planned for scaling operations.

• Holds first-mover advantage with unmatched data in intended use populations and is the only company pursuing FDA approval for MCED, supported by over one million tests run.