GeneDx Holdings Corp. Q3 FY2025 earnings call

Key Sections - Growth and Guidance: Katherine Stueland announced raising 2025 revenue guidance to $425 million to $428 million. - FDA Recognition: FDA granted breakthrough device designation to ExomeDx and GenomeDx tests, validating industry-leading technology. - Executive Hires: Lisa Gurry as Chief Business Officer and Dr. Mimi Lee as Chief Precision Medicine Officer hired to drive network effect. - Market Focuses: Emphasis on inpatient NICU (underpenetrated, with 8 Epic Aura integrations live and on track for 12 by year-end), newborn screening initiatives (GUARDIAN study, NIH Beacon program, Sunshine Genetics Network), and international expansion via Fabric genomics platform. - Technology and Innovation: Leveraging GeneDx Infinity (largest rare disease dataset) with AI tools like ML-powered GeneRanker Multiscore to enhance speed, accuracy, and utility of diagnostics; ongoing innovation in genomic technologies including medium and long-read sequencing. - Customer Experience: Simplifying ordering and result interpretation for clinicians, especially general pediatricians, to align with AAP guidelines.

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 last year, with 25,702 exome and genome tests performed. Growth in exome and genome tests has accelerated from 24% year-over-year in Q1 to 33% in Q3. Hereditary cancer offerings generated $1.2 million in Q3 2025, down from $3.3 million in Q3 2024, and will be near $0 in Q4 2025. Exome and genome revenue contribution was significant, driving overall growth.

Forward-Looking Statements - Raised top-line revenue guidance for 2025 to $425 million to $428 million. - Exome and genome revenue guidance raised to $358 million to $361 million, reflecting 53%-55% growth for 2025. - Adjusted gross margin guidance raised to 70%-71%. - Reaffirmed expectation of at least 30% exome and genome volume growth for 2025, with Q4 volume growth expected to be at least 34%.

Risks Identified - Potential lower initial payment rates in new market segments (e.g., general pediatricians) as new call points are opened, which may temporarily impact average reimbursement rates. - Need to build experience and demand with payers to ensure sustainable reimbursement levels in new markets. - Dependence on successful execution of commercial build-out, including sales force expansion and market access efforts to drive adoption in new segments.

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 no meaningful uptake in orders from pediatricians for chromosomal microarray, and the focus remains on education and improving ordering workflow for exome and genome testing.

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 that the guide builds in conservatism due to new call points and potential lower initial payment rates, with the average reimbursement rate in Q3 over $3,800, and minimal true-up impact in Q3.

Q: Maybe the first one, Kevin and Katherine, can you just speak to the NICU? I know you discussed, Katherine, in your prepared remarks, you guys are on track for the number of NICUs that are be enabled with EMR. But just kind of what did you see in Q3? How do we think about implicit in the volume guide for 4Q, what the NICU contribution is? And any color on just kind of what some of the early traction and kind of feedback has been?

A: Katherine Stueland and Kevin Feeley discussed NICU as a growing segment with nice volume growth, tracking to bring in incremental units in the second half, and positive feedback on Epic Aura integrations and clinical utility.