Short answer
CareDx, Inc. (CDNA) filed its fiscal 2025 10-K annual report with the SEC on Feb 25, 2026. It reported revenue of $380M (+13.8% year over year) and net income of −$21M.
- Top risk flagged: MolDX/Noridian Proposed LCD revision may reduce reimbursement, impose utilization limits, and introduces bundled payment, with final decision due within 365 days from July 17, 2025
FY2025 key financial metrics · XBRL
- Revenue
- $380M
- +13.8% YoY
- Net income
- −$21M
- −140.6% YoY
- Operating margin
- -8.1%
- −20.3 pp YoY
- EPS (diluted)
- −$0.40
- −143.0% YoY
- ROE
- -7.0%
- −20.9 pp YoY
- Operating cash flow
- $42M
- +10.5% YoY
Source: XBRL data from the CareDx, Inc. (CDNA) FY2025 10-K on SEC EDGAR. USD.
CareDx, Inc. FY2025 10-K analysis
AI summary of each section, grounded in the filing text
Business Overview
- Core business model: Specialized molecular diagnostic testing and digital pharmacy solutions for transplant patients
- Expanded patient and digital solutions revenue by 31%, driven by pharmacy sales growth and wider Ottr software deployment
- Strategic share repurchase programs totaling $88 million in 2025, reflecting confidence despite net loss of $21 million
- Testing services volume increased 14% to approximately 200,000 tests, with overall revenue growth of 14% to $380 million
- Noteworthy litigation expense reversal in 2024 due to favorable patent ruling, partially offset by 2025 Securities Class Action settlement
Management Discussion & Analysis
- Revenue recognition includes testing services, product sales, patient and digital solutions; testing revenue reduced by $3.5M refund reserve in 2025
- No profitability or margin figures disclosed in the provided text
- Management sees no goodwill or intangible asset impairments as of Dec 31, 2025; foreign operations risks noted but no quantified impact or guidance
Risk Factors
- MolDX/Noridian Proposed LCD revision may reduce reimbursement, impose utilization limits, and introduces bundled payment, with final decision due within 365 days from July 17, 2025
- Medicare reimbursement risk: 46% of testing revenue from Medicare, with AlloSure Kidney 2026 fee reduced by $88 to $2,753 per test after CMS crosswalk decision
- Dependency on single California lab facility; if inoperable, inability to perform core tests AlloSure Kidney, AlloMap Heart, HeartCare, and AlloSure Lung
- Competitive risk from rapid technological evolution in transplantation diagnostics, could render CareDx’s AlloSure and AlloMap tests obsolete
- Concentration risk around Medicare Advantage payer dispute over denied and recouped claims, creating financial uncertainty and potential repayment obligations
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