Guardant Health (GH) Q1 FY26 earnings call: guidance and Q&A

What is the confidence level for April Shield volumes, and how much of the raised guidance is attributable to the Quest collaboration versus other drivers?

Management expressed high confidence in the new guidance, noting strong momentum in March driven by DTC campaigns, influencer campaigns, and the Quest launch. Early indications from Quest are positive and factored into the guide, but the company will continue to monitor its incremental contribution.

“Based on the trends that we've seen in March, and it's -- we don't want to get into Q2 commentary, but based on everything that we've seen, gives us a lot of good confidence of what we can deliver in this year.”

asked by Mark Massaro · answered by AmirAli Talasaz

Despite being on the market for over a decade, Guardant360 is growing 30% year-over-year. What is driving this outsized growth, and how much of the full-year guide raise is attributed to Guardant360?

Management attributed Guardant360's sustained growth to the capabilities of its 'smart liquid biopsy platform,' leading to share gains and increased adoption among physicians. They emphasized that the platform is still in its early innings, with significant potential for continued growth from Smart Apps and longitudinal testing.

“this is a fundamental step change in terms of the power of liquid biopsy and its capabilities, allowing us to see phenotype, allowing us to have all these different capabilities that were never possible with liquid biopsy before.”

asked by Subhalaxmi Nambi · answered by Helmy Eltoukhy

What are the key drivers behind Reveal's over 100% growth, and what are the upcoming catalyst sets for reimbursement, particularly regarding MolDx submissions?

Management highlighted strong growth in CRC, breast, and lung cancer surveillance, along with the successful addition of therapy monitoring. They noted that MolDx submissions for breast cancer surveillance, immuno-oncology monitoring, and chemotherapy monitoring are key reimbursement catalysts that, if favorable, would significantly improve Reveal's ASP.

“Part of the drivers are -- we're still continuing to see really good growth in CRC, breast and lung cancers and the surveillance setting. But therapy monitoring has also been a great addition to the portfolio, and we're seeing, I think, great traction there.”

asked by Patrick Donnelly · answered by Helmy Eltoukhy

Shield ASP appears to be holding up better than expected, with an implied full-year ASP north of $800. What percentage of Q1 Shield volume came from CMS, and how is that expected to evolve?

Management stated that Q1 ASP was strong due to a high proportion of Medicare/Medicare Advantage tests, consistent with late last year. They expect a 'tick down' in ASP for the remainder of the year as the company expands its reach to under-65 commercial patients, where reimbursement is not yet established.

“Q1 was pretty consistent with what we saw towards the back end of last year with a pretty high proportion of Shield tests being either Medicare -- fee-for-service or Medicare Advantage. And so that's what's been driving that strong ASP over the last few quarters.”

asked by Colleen Babington · answered by Michael Bell

How sustainable is the strong growth in Guardant360 Tissue, and what is the pathway to ASP upside from the whole transcriptome addition?

Management believes G360 Tissue's growth is sustainable, with future FDA approval of G360 Liquid expected to streamline the portfolio and further accelerate adoption. They anticipate that whole transcriptome RNA testing will go through its own regulatory pathway, potentially qualifying for ADLT status and substantially improving ASP.

“we think one of the things that will sort of further accelerate that growth is as we get FDA approval for our Guardant360 Liquid test. And we think that will really streamline the portfolio, allow simplified ordering between the 2 products and really help move everything on to the Smart platform.”

asked by Sebastian Sandler · answered by Helmy Eltoukhy

How can the average repeat use of G360 increase beyond 1.3, especially given the camizestrant AdCom's positive view on G360 and ctDNA use?

Management emphasized multiple 'shots on goal' for increasing repeat use, primarily through the combined use of Guardant360 Liquid and Reveal for adaptive and dynamic patient monitoring. They expressed confidence that ctDNA will be integral to future oncology therapy switching, regardless of the specific camizestrant outcome.

“And I think the primary one is going to be using really the 1, 2 punch of Guardant360 Liquid and Reveal for monitoring. And then as Reveal ebbs and flows, it will be a much simpler way to reflex patients to essentially a G360 test in those patients if and when those patients progress.”

asked by Puneet Souda · answered by Helmy Eltoukhy

In light of recent acquisitions in the AI diagnostics space, how is Guardant Health thinking about its AI strategy and offering AI-based companion diagnostics?

Management asserted Guardant's leadership in 'real AI' with actionable insights, leveraging its vast data treasury (aiming for an exabyte of data) and purpose-built architecture. They highlighted existing collaborations (e.g., Lunit) and InfinityAI's role in therapeutic discovery, promising more exciting AI developments in the coming quarters.

“I feel like we've been leading the pack, frankly, in terms of real AI that has that actionable insight. There's a lot of talk about AI in the space, but I think you can see physicians voting with their feet when they're using our products much more than others in the space right now.”

asked by Kyle Mikson · answered by Helmy Eltoukhy