0001217234-26-000018
SEC filingCareDx repurchased $87.8M in stock in 2025, with $12.2M remaining under new $50M program; cash and marketable securities totaled $201.4M.
CareDx is a precision medicine company focused on improving outcomes for transplant patients and advancing organ health. The Company delivers integrated solutions including non-invasive molecular testing for heart, kidney, and lung transplants, laboratory products, digital health technologies, and patient solutions for pre- and post-transplant care. It identifies itself as the leading provider of genomics-based information for transplant patients. Headquartered in Brisbane, California, CareDx also has primary operations in Omaha, Nebraska and Stockholm, Sweden.
CareDx is organized and operates as a single reportable segment. The filing states, 'We are organized and operate as a single reportable segment.' Accordingly, no segment-level revenue or profit disclosure is provided in the Business section.
The Company's commercially available post-transplant testing services include AlloSure Kidney (dd-cfDNA for kidney), AlloMap Heart (gene expression profiling for heart), AlloSure Heart (dd-cfDNA for heart), HeartCare (combination of AlloMap and AlloSure Heart in one solution), and AlloSure Lung (dd-cfDNA for lung). Additionally, AlloHeme is an NGS-based test for relapse prediction after hematopoietic cell transplant, and AlloCell monitors cell therapy engraftment. In the laboratory products segment, CareDx offers distributed PCR kits (QTYPE, Olerup SSP) and NGS kits (AlloSeq Tx, AlloSeq cfDNA, AlloSeq HCT) for HLA typing and transplant monitoring. Patient and digital solutions include Ottr (workflow management), TxAccess (referral management), XynQAPI (quality tracking), MedActionPlan (medication adherence), AlloHome (remote patient monitoring), and the CareDx pharmacy.
CareDx's commercial approach is customer-centric with a regional U.S. structure. Each region includes territory account managers, digital specialists, laboratory product experts, and medical science liaisons. Outside the U.S., the Company uses country managers in Western Europe and distributors elsewhere. No specific customer concentration is disclosed; however, substantially all revenues come from the United States and Europe.
For testing services, principal competitors include Natera, Eurofins Transplant Genomics, Devyser, and Insight Molecular Diagnostics (iMDx). In the HLA typing market, Thermo Fisher through its One Lambda business is the market leader. The Company also faces competition from hospital and commercial reference laboratories developing in-house tests. CareDx believes competitive factors include clinical validation, technical performance, reimbursement, and inclusion in practice guidelines.
CareDx outlines four strategic priorities: (1) accelerate profitable growth through solutions-selling, integrated go-to-market, clinical evidence for reimbursement, and pipeline execution; (2) drive operational excellence via process improvement and investments in automation, AI, and data security; (3) define TRANSPLANT+ to expand into adjacent markets such as pre-transplant organ assessment, autoimmune diseases, and cell therapy; and (4) elevate performance culture by engaging and inspiring employees.
As of December 31, 2025, CareDx employed 765 individuals (761 full-time). By function: 145 in manufacturing operations and support, 186 in research and development, 252 in sales and marketing, and 182 in general and administrative positions. Geographically, 706 employees were in the U.S. and 59 outside the U.S. The filing emphasizes attracting and retaining talent, offering competitive compensation including base salary, short-term cash incentives, and long-term equity, as well as comprehensive benefits and training via LinkedIn Learning. The Company maintains a zero-tolerance policy for discrimination and has a Diversity, Equity, and Inclusion committee.
At December 31, 2025, CareDx held $65.4 million in cash and cash equivalents and $135.9 million in marketable securities (amortized cost), totaling $201.4 million in liquid assets. Inventory rose to $26.7 million from $19.5 million a year earlier, driven by raw materials and finished goods. Deferred revenue stood at $4.7 million. The company maintains a strong liquidity position with no outstanding debt (only operating lease liabilities of $26.2 million present value).
The Notes do not disclose material purchase commitments beyond operating leases ($29.8 million total lease payments) and royalty agreements (mid-single to low-double digits on product sales). Contingent consideration liabilities were $1.8 million at year-end, reflecting fair value estimates for prior acquisitions. Litigation contingencies include a recorded $96.3 million verdict that was subsequently overturned and derecognized in 2024; no liability remains.
Capital allocation activity centered on share repurchases. In 2025, the company executed two programs: a $50 million program (completed in Q2 2025) and a new $50 million program authorized on May 30, 2025. Total repurchases during the year were $87.8 million for 5.8 million shares, all retired. As of December 31, 2025, $12.2 million remained available under the May 2025 program. No dividends were paid. Capital expenditures (from cash flow statement, not in Notes) are not detailed in the Notes section.
CareDx operates as a single reportable segment. Geographic revenue breakdown for 2025: United States $359.9 million (95%), Rest of World $19.9 million (5%). Testing services revenue was $274.5 million, product revenue $48.4 million, and patient/digital solutions revenue $56.9 million. The CODM uses net income as the primary measure to assess performance and allocate resources.
The provided excerpt from the 10-K filing does not contain the actual cash flow statement. Only auditor reports and index pages were included. Therefore, no analysis can be performed.