Natera (NTRA) investor relations material

Growth and performance highlights

• Signatera has experienced significant volume growth, reaching 22,500 growth units last quarter and 225,000 units overall, with a recommended focus on trailing four quarters average to account for seasonality and compounding effects.

• Average selling price (ASP) for Signatera is currently $1,225, with potential to reach $2,000 as coverage expands and the test becomes standard of care, following trends seen in NIPT and Oncotype DX.

• Medicare broadly reimburses Signatera, while commercial payer coverage is still expanding, impacting realized ASP.

• Women's health business maintains over 40% market share in NIPT, with strong reimbursement and ongoing improvements in realized pricing.

• Operating expenses are projected to grow 9.5% this year, with SG&A roughly flat, reflecting operating leverage.

Clinical evidence and R&D priorities

• Continuous publication of compelling data across tumor types, with recent strong results in head and neck cancer at ASCO GU.

• Major R&D investment ($800 million, up 30% YoY) is focused on Signatera clinical trials, new product development in women's health, and early cancer detection, especially colorectal cancer.

• The FIND study for colorectal cancer screening is actively enrolling, representing a significant investment based on strong preliminary data.

• Foresight acquisition enhances Signatera's sensitivity through phased and structural variants, with analytic validity already demonstrated and clinical outcomes data to be integrated over time.

• Product development and clinical trial efforts span the portfolio, with Signatera as the central focus.

Regulatory and market expansion

• FDA approval for Signatera as a companion diagnostic (CDx) for atezolizumab in muscle-invasive bladder cancer is expected this year, following positive IMvigor011 phase III results.

• FDA approval could drive incremental demand and further establish Signatera as standard of care in MRD and recurrence monitoring.

• Hospital systems are beginning to implement IMvigor011 protocols, increasing adoption.

• Expansion into rare disease newborn testing leverages technological and commercial adjacencies from existing products.

• Early cancer detection in colorectal cancer is seen as a distinct, large market, with plasma-based tests addressing unmet needs for millions who avoid colonoscopy.