GRAIL (GRAL) Canaccord Genuity's 46th Annual Growth Conference summary

Financial and operational performance

• Achieved 30% revenue growth and 42% test volume growth in the first half, with over 117,000 tests conducted.

• Expanded sales force, now fully trained and active, supporting growth in digital health and employer channels.

• Digital health channel volumes doubled year-over-year, with Function as a key partner; Hims & Hers partnership offers future upside.

• Average selling price (ASP) declined to $700 per test, trending toward $500 as Medicare reimbursement approaches.

• Highly automated lab infrastructure supports up to 1 million tests annually, providing significant fixed cost leverage.

Strategic partnerships and market access

• Quest Diagnostics and athenahealth integrations have streamlined test ordering; Epic integration expected by year-end to further reduce friction.

• Samsung partnership in Korea begins with distribution, with potential for broader expansion and local lab development post-FDA approval.

• Ongoing discussions with NHS in the UK about next steps, though progress may be slow due to external factors.

Regulatory and clinical milestones

• FDA Advisory Committee (AdCom) meeting for Galleri test scheduled for September 23, focusing on test performance and efficacy.

• PATHFINDER 2 study demonstrated consistent or improved performance in intended use populations, with PPV above 60%.

• NHS-Galleri study showed over 20% reduction in Stage IV cancers and doubled early-stage cancer detection, despite not meeting the primary endpoint.

• Additional 12-month follow-up for NHS-Galleri to read out in first half of 2027; nested mortality study expected in 2028.

• REACH study, important for Medicare coverage, is ongoing with final readout expected in 2030 or 2031, but interim data may be available earlier.