GeneDx Holdings Corp. Q3 FY2025 earnings call

• Record growth with continued commitment to profitability, raising 2025 revenue guidance to $425 million to $428 million.
• FDA granted breakthrough device designation to ExomeDx and GenomeDx tests, validating industry-leading technology.
• Strategy includes driving high profitable growth, offering best-in-class diagnostics, and building a network effect via GeneDx Infinity.
• Focus on expanding sales force, with plans to nearly double the sales force in coming quarters; work in NICU with 8 Epic Aura integrations live and on track for 12 by year-end.
• Newborn screening initiatives like GUARDIAN study, NIH Beacon program, and Sunshine Genetics Network, demonstrating clinical impact and potential for scale.
• International expansion with Fabric genomics platform to serve global markets.

In the third quarter of 2025, GeneDx reported revenues of $116.7 million, a 52% year-over-year increase. Exome and genome revenue was $98.9 million, up 66% from the same quarter the previous year, with 25,702 exome and genome tests conducted. The hereditary cancer offerings contributed minimally, with $1.2 million in revenue for the third quarter of 2025 compared to $3.3 million in the same quarter of 2024, and expected to be near $0 in the fourth quarter. Exome and genome revenue contribution was significant, driving the overall growth.

• Raised top-line total revenue guidance for 2025 to $425 million to $428 million.
• Exome and genome revenue guidance raised to $358 million to $361 million, expecting 53%-55% growth for full year 2025.
• Expect at least 30% exome and genome volume growth for 2025, with fourth quarter exit of at least 34%.
• Raised full year 2025 adjusted gross margin guidance to 70%-71% and reaffirmed profitability.

• Potential impact of lower initial payment rates from new call points and indications, which may temporarily affect average reimbursement rates.
• Dependence on successful execution of growth strategies, including sales force expansion and market penetration in new segments.
• Regulatory and payer-related uncertainties that could affect reimbursement and market adoption of products.

Q: With emphasis at AAP for clinicians to take a stepwise approach to ordering beginning with chromosomal microarray, have you seen an uptick in volume there? And if so, how does that change your strategy, if at all, to sunset some of these legacy products?

A: Katherine Stueland stated there was no meaningful uptake in orders from pediatricians for chromosomal microarray, but feedback from engagement with pediatricians was positive about ordering testing from GeneDx. Education and workflow improvements are key, not a change in sunsetting legacy products.

Q: The guide implies ASPs to go down sequentially. Is that just conservatism? Or are there any seasonal dynamics to call out? Even the margin guide implies COGS to increase sequentially? Any color you could provide.

A: Kevin Feeley explained the guide builds in conservatism due to new call points and target indication expansion where initial rates may be lower, and true-ups throughout the year are minimal with no extraordinary impact.