GRAIL (GRAL) investor relations material

Commercial and digital channel expansion

• Digital health channels continue to grow, with integrations like Epic planned by year-end and ongoing momentum from Quest and athenahealth partnerships.

• Self-pay market is robust, with 70% of tests paid out-of-pocket, driven by brick-and-mortar physicians and digital health platforms such as Function Health and Hims & Hers.

• Over 1,300 physicians added last quarter, with increased retest rates above 30%, indicating strong physician and patient engagement.

• Market awareness is expanding through medical education, social media, and peer-to-peer physician groups.

• Investment in commercial expansion and digital tools is expected to contribute to growth in the second half of the year.

Clinical data, regulatory, and reimbursement updates

• ASCO data release at the end of the month is highly anticipated, with randomized controlled trial results from 140,000 participants over three years.

• FDA review is underway, with a 180-day timeline if no Ad Comm, or 320 days if there is one; package was submitted in January.

• NHS trial discussions will continue over the next 12 months, balancing politics, budget, and data, with key endpoints already met.

• REACH study with CMS and FDA is ongoing, with final readout expected around 2031 and interim data to support coverage decisions.

• MCED legislation sets reimbursement at just over $500 per test, supporting margins of 50%-60% at current scale.

Competitive landscape and market positioning

• Only player with interventional and prospective data in the MCED space, with FDA submission completed; competitors help build awareness.

• Focus remains on multi-cancer screening, with MRD and therapy selection capabilities available for future investment.

• Market education is a key barrier, as the technology is paradigm-shifting and requires significant physician and payer understanding.

• Other players entering the market are seen as beneficial for expanding awareness and credibility.

• The technology aims to detect more than 14% of cancers with a low false positive rate, offering a significant improvement over standard care.