Guardant Health (GH) investor relations material

Financial performance and guidance

• Achieved strong Q1 results, leading to a raised full-year guidance driven by oncology and Shield test volumes.

• Oncology growth is propelled by Guardant360 and the Smart Platform, with new Smart Apps expected to be catalysts throughout the year.

• Shield volume growth is supported by increased sales rep productivity, Quest collaboration, and direct-to-consumer campaigns, with significant impact expected in the second half of the year.

• Anticipated ACS guideline changes could further expand commercial opportunities, especially for patients under 65, with revenue impact expected more in 2027.

• ASP for Shield may temporarily decline as commercial volume grows, but is expected to recover within 12 months as commercial payers adopt reimbursement.

Strategic initiatives and market positioning

• Therapy selection and monitoring are key growth areas, with liquid biopsy adoption still in early stages and significant market expansion potential.

• The Smart Platform, launched in 2024, is driving accelerated growth and enabling new applications through AI and large-scale data analysis.

• AI integration has transformed operations, R&D, and regulatory processes, increasing efficiency and innovation velocity.

• Guardant360 Liquid and Reveal create a synergistic product ecosystem, enhancing share gains and supporting a unified approach to patient care.

• FDA approval for Guardant360 Liquid is expected to further strengthen market position and drive adoption.

Industry trends, risks, and regulatory environment

• ctDNA testing is increasingly recognized as the future of oncology, with broad support from key opinion leaders and regulatory bodies.

• The company is largely insulated from CLFS and PAMA reimbursement risks due to national CMS coverage and proactive compliance.

• Civil investigations are viewed as routine, with a strong compliance program in place and no material concerns identified.

• Diagnostics are gaining recognition for their value in clinical decision-making, with data-driven approaches expected to shift the value proposition further.