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- **Revenue Growth**: Q3 revenue up 52% YoY to $116.7 million, with exome/genome revenue surging 66%.
- **Strategic Expansion**: Doubling sales force to target 60,000 pediatricians, with first reps hired.
- **FDA Milestone**: Breakthrough designation for ExomeDx and GenomeDx, reinforcing gold-standard status.
- **Profitability**: 74% gross margin, $14.7 million net income, and $0.51 EPS despite $71 million in strategic investments.
- **Newborn Screening**: Florida and NIH initiatives aim to diagnose 3% of newborns with actionable conditions.

**【CEO Summary Section】**
- GeneDx reported Q3 2025 revenue of $116.7 million, up 52% YoY, with exome/genome revenue growing 66% to $98.9 million.
- Raised full-year revenue guidance to $425-428 million, with exome/genome revenue expected to grow 53-55%.
- Expanded into pediatricians with a doubling of the sales force over the next quarters, targeting 60,000 U.S. pediatricians.
- FDA granted breakthrough device designation for ExomeDx and GenomeDx, validating their gold-standard status.
- Launched newborn screening initiatives in Florida and NIH's BEACONS program, aiming to proactively diagnose rare diseases at birth.

**【CFO Financial Commentary】**
- Adjusted gross margin expanded to 74%, driven by improved reimbursement rates ($3,800/test) and lower COGS through automation.
- Operating expenses rose to $71 million (61% of revenue), reflecting investments in sales teams, international markets, and customer experience.
- Generated $14.7 million in adjusted net income and $0.51 EPS, with $9 million in free cash flow.
- Raised gross margin guidance to 70-71% for 2025, maintaining profitability amid reinvestment.

**【Q&A Highlights】**
- **Medicaid Expansion**: California's Medi-Cal will cover whole genome testing, adding ~2,000 new tests/month and boosting reimbursement rates to ~80%.
- **Sales Force Growth**: Hiring regional sales directors and ~80 new reps to target pediatricians, with full rollout expected by mid-2026.
- **NICU Penetration**: 12+ Epic Aura integrations in NICUs, driving 33% Q3 volume growth and plans for broader inpatient adoption.
- **AI & COGS**: AI tools like GeneRanker reduce COGS by 30%, enabling 74% gross margin despite lower initial reimbursement rates in new markets.
- **Newborn Screening**: GUARDIAN study showed 3% actionable conditions at birth, supporting Florida's Sunshine Genetics Act and NIH's BEACONS program.


GeneDx Holdings Corp. (WGS) Q3 2025 Earnings Call Transcript

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