GeneDx — Third Quarter 2026 Earnings Summary

Financial Performance:

• Reported total revenue of $123.1 million for the third quarter of 2026, an increase of 5% year-over-year compared to $116.7 million in Q3 2025.
• Exome and genome test revenue reached $110.4 million, up 12% year-over-year from $98.9 million in Q3 2025.
• Exome and genome test volume grew 25% year-over-year to 32,134 tests, with accession growth of 28% year-over-year.
• Adjusted gross margin expanded to 72% in Q3 2026, up from 70% in Q2 2026 and down from 74% in Q3 2025; GAAP gross margin was 70%.
• Adjusted total operating expenses were $79.4 million, representing 65% of revenue; GAAP operating expenses were $96.5 million.
• Adjusted net income was $8.6 million, an increase of $8.2 million from Q2 2026 and a decrease from $16.1 million in Q3 2025.
• GAAP net loss was $12.3 million for the quarter, compared to a GAAP net loss of $7.6 million in Q3 2025.
• Cash, cash equivalents, marketable securities, and restricted cash totaled $171.1 million as of September 30, 2026.
• Long-term debt, net of current portion, increased to $146.2 million as of September 30, 2026, from $48.2 million as of December 31, 2025.

Guidance and Future Outlook:

• Reiterated full year 2026 revenue guidance of $475 million to $490 million, unchanged from previous guidance.
• Updated full year 2026 exome and genome volume guidance to at least 28% growth (previously at least 30% growth).
• Updated full year 2026 exome and genome revenue guidance to at least 17% growth (previously at least 20% growth).
• Updated full year 2026 adjusted gross margin guidance to approximately 71% (previously approximately 70%).
• Updated full year 2026 adjusted net income guidance to approximately $12 million (previously positive).
• Provided fourth quarter 2026 guidance: revenue of $135 million, exome and genome volume of 34,500 tests, exome and genome revenue of $121 million, adjusted gross margin of at least 71%, and adjusted net income of approximately $12 million.

Business Segments and Product Lines:

• Enhanced genome testing portfolio with the introduction of long-read whole genome sequencing.
• Launched new online offering for pediatric patients with global developmental delay, intellectual disability, or epilepsy to enable remote test initiation and provider connection.
• Introduced customer experience features including simplified test reports, easy ordering, and report guides.
• Collaborated with Mirum Pharmaceuticals to launch a sponsored testing program providing no-cost exome testing for patients with unexplained cholestasis, early onset cataracts, or PBD-ZSD.
• Partnered with Beren Therapeutics P.B.C. to launch the NPC GenomeComplete Sponsored Testing Program offering no-cost comprehensive genome sequencing for eligible pediatric patients with Niemann-Pick Disease Type C.
• Expanded Medicaid coverage for whole genome sequencing to 25 states with the addition of Arkansas and Utah.
• Appointed Nicole Maassen, J.D. as Chief Patient Access Officer to lead Market Access and Government Affairs.
• Published data with Seattle Children's demonstrating improved diagnostic rates and operational efficiency from first-tier rapid genome sequencing in inpatient pediatric units.
• Presented 27 scientific abstracts at the ASHG 2026 Annual Meeting covering AI-driven variant prioritization, exome/genome sequencing as standard of care for autism, and gene discovery.
• Partnered with the BRIDGES-NBS initiative to begin enrollment in Oregon for a multi-state genomic newborn screening study screening up to 30,000 newborns.

Market and Competitive Landscape:

• Positioned as the leader in rare disease diagnosis with the world's largest rare disease genomic dataset (GeneDx Infinity™).
• Tests ranked #1 by expert geneticists and granted FDA Breakthrough Device designation.
• Demonstrated feasibility and clinical value of genomic newborn screening across diverse populations with 72.3% parental participation in the GUARDIAN study (30,000 newborns enrolled).

Risks and Challenges:

• Forward-looking statements are subject to risks including the ability to implement business plans and identify opportunities.
• Risks include downturns and a changing regulatory landscape in the healthcare industry.
• Market size and growth uncertainty, future expansion of insurance coverage, and anticipated impacts of regulatory reimbursement changes.
• Actual results may differ materially from forward-looking statements due to these and other factors identified in SEC filings.

Management Commentary and Tone:

• CEO Katherine Stueland stated Q3 results reflect "profitable execution in a growing market" and the translation of rising demand into durable revenue growth.
• Management priorities identified as improving the economics of testing, expanding utilization, and delivering leading products at scale.
• Tone emphasizes uniting clinical expertise and differentiated capabilities to bring life-changing answers to more families.

Other Key Points:

• Reported a loss on extinguishment of debt of $6.6 million in the nine months ended September 30, 2026.
• Issued $146.0 million in long-term debt proceeds net of issuance costs in the nine months ended September 30, 2026.
• Repaid $54.0 million in long-term debt to Perceptive, including a prepayment penalty, during the nine months ended September 30, 2026.
• Reported an impairment loss of $31.3 million in the nine months ended September 30, 2026.
• Conference call held on November 9, 2026, at 4:30 p.m. ET.