Guardant Health(US:GH)2023-02-24 03:35Financial Data and Key Metrics Changes - Total revenue for Q4 2022 was $126.9 million, up 17% from $108.1 million in the prior year quarter [51] - Full year revenue reached $449.5 million, representing a 20% increase from $373.7 million in the previous year [23] - Gross profit for Q4 2022 was $79.8 million, compared to $74.7 million in the same period of the prior year, with a gross margin of 63% [22] - Operating expenses for Q4 2022 were $225.9 million, an increase of 31% compared to $172.9 million in Q4 2021 [23] - Net loss for Q4 2022 was $139.9 million, or $1.36 per share, compared to a net loss of $90.9 million, or $0.89 per share, in Q4 2021 [23] Business Line Data and Key Metrics Changes - Precision oncology revenue from clinical tests was $83.7 million, up 13% from $64.2 million for the prior year quarter [5] - Clinical test volume for the year grew to 124,800, up 42% year-over-year from 87,600 tests [25] - Biopharma testing revenue in Q4 totaled $30.1 million, up 23% from $24.5 million in the prior year quarter [20] - Development services and other revenue in Q4 totaled $13.1 million, down 33% from the prior year quarter [21] Market Data and Key Metrics Changes - Guardant360 ASP was in the range of $2,600 to $2,700, consistent with the last few quarters [19] - Blended clinical ASP for 2022 was approximately $2,400, lower than the $2,700 in 2021 [25] - Biopharma ASP in the full year was approximately $3,610, slightly down from $3,650 in the prior year [26] Company Strategy and Development Direction - The company aims to reduce operating expenses below 2022 levels and improve free cash outflow to $350 million in 2023 [32] - Focus on maximizing opportunities in precision oncology while managing costs and expanding market penetration for new products [33] - The company plans to continue investing in clinical data development for reimbursement and technical development for lung and other cancers [33] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future of the Shield screening test and its potential to improve compliance and save lives [4][3] - The company expects full year 2023 revenue to be in the range of $525 million to $540 million, representing growth of approximately 17% to 20% compared to 2022 [34] - Management highlighted the importance of operational efficiencies and infrastructure to support growth in oncology diagnostics [32] Other Important Information - The company has initiated a prospective study, U-Screen, to examine whether Shield improves overall CRC screening in medically underserved populations [49] - The company ended 2022 with approximately $1 billion in cash, reflecting a free cash outflow of $387 million [31] Q&A Session Summary Question: Insights on Reveal assumptions for 2023 revenue guidance - Management indicated optimism about Reveal's growth, projecting low double-digit millions in revenue for 2023, driven by increasing traction in key tumor types [10] Question: Dynamics in the biopharma market and competitive landscape - Management acknowledged headwinds from the Inflation Reduction Act but maintained a strong pipeline and order book for 2023 [84][103] Question: Expected timeline for FDA approval and publication of ECLIPSE data - Management expects PMA submission to the FDA by the end of the quarter and anticipates approval in early 2024 [71][105] Question: Importance of U-Screen study for guideline inclusion - Management emphasized that U-Screen is part of a broader strategy to generate evidence supporting guideline inclusion and commercial adoption of the Shield test [112]