CareDx, Inc. (CDNA) SEC Filings & Earnings Calls

Divestiture of Lab Products reduces revenue diversification; future periods will no longer include that segment.

“Future periods will no longer include Lab Products segment results.” · word for word

Revenue includes $16M in prior period revenue, which may not recur.

“Average revenue per test of approximately $1,720, including $16 million in prior period revenue” · word for word

Medicare reimbursement dependency

“For the three months ended June 30, 2026, revenue from Medicare for AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare and AlloSure Lung represented 37% of our testing services revenue and 30% of our total revenue.” · word for word

Medicare pricing pressure

“On November 25, 2025, CMS issued a final determination to cross-walk AlloSure (0540U) to CPT code 0493U. As a result, PLA Code 0540U was listed on the Clinical Laboratory Fee Schedule effective January 1, 2026 at approximately $2,753. The new reimbursement rate represents an $88 decrease to the previous pricing for our AlloSure Kidney test.” · word for word

Payer dispute

“We are currently involved in a dispute with a significant Medicare Advantage payer concerning payment of claims. We are seeking recovery of claims amounts that we believe were improperly denied, underpaid or recouped. The payer has also asserted entitlement to recoup additional previously paid claims.” · word for word

Competition in transplant diagnostics

“In the field of post-transplant surveillance, Natera, Eurofins, iMDx, and Verici have commercially available molecular diagnostics tests. Other entrants with kitted products have indicated they are entering the market for post-transplant surveillance, including Thermo Fisher, Devyser, Bio-Rad, EuroBio, and iMDx.” · word for word

History of net losses

“We have a history of substantial net losses since our inception, and we may incur net losses in future periods.” · word for word

Patent litigation appeal risk

“Natera has appealed the Court's invalidation of the three patents it asserted against CareDx.” · word for word

Medicare reimbursement dependency

“approximately 27% ... of total revenue was derived from Medicare”

Derivative litigation ongoing

“The settlement remains subject to the final approval of the Court.” · word for word

Divestiture requires Swedish regulatory review; closing expected by end of Q3 2026

“The transaction, including the sale of CareDx’s Swedish entity, requires Swedish regulatory review. The parties anticipate the transaction to close by the end of CareDx’s third quarter, 2026.” · word for word

Preliminary financial results subject to adjustment; further guidance expected on April 28, 2026

“The preliminary financial information presented in this press release is based on CareDx’s current expectations and may be adjusted” · word for word

Medicare reimbursement reduction

“On November 25, 2025, CMS issued a final determination to cross-walk AlloSure (0540U) to CPT code 0493U. As a result, PLA Code 0540U was listed on the Clinical Laboratory Fee Schedule effective January 1, 2026 at approximately $2,753. The new reimbursement rate represents an $88 decrease to the previous pricing for our AlloSure Kidney test, and no change to ” · word for word

LCD revision risk

“On July 17, 2025, MolDX and Noridian released a new draft proposed revision to the existing foundational LCD (DL40058, DL40060) with a revised accompanying billing article (DA60146, DA60152), or the Proposed LCD. The Proposed LCD, which underwent public comment, may introduce new coverage criteria, utilization limitations, and a new bundled payment concept f” · word for word

Competitive pressure

“Our competitors also include companies that are focused on the development and commercialization of molecular diagnostic tests. In the field of post-transplant surveillance, Natera, Eurofins, iMDx, and Verici have commercially available molecular diagnostics tests. Other entrants with kitted products have indicated they are entering the market for post-trans” · word for word

History of losses

“We have incurred substantial net losses since our inception, and we may continue to incur additional losses for the next several years. For the year ended December 31, 2025, our net loss was $21.4 million, and for the year ended December 31, 2024, our net income was $52.5 million. As of December 31, 2025, we had an accumulated deficit of $735.4 million.” · word for word

Medicare LCD impact on 2026 revenue

“2026 guidance includes estimated 6-month impact of Medicare LCD of approximately $7.5 million”

Preliminary results subject to audit completion

“Preliminary unaudited results; subject to change upon audit”

Ongoing litigation risk; settlement not yet final.

“hearing date of June 30, 2026 to consider whether to grant final approval” · word for word

Dependence on transplant testing market; regulatory and reimbursement risks.

“Submitted comment letter intended to inform final draft of LCD policy.”

Medicare reimbursement reduction

“If CMS adopts this recommendation, the new reimbursement rate would represent an $88 decrease to the current pricing for our AlloSure Kidney test” · word for word

Proposed LCD coverage changes

“The Proposed LCD, which is subject to comment, may introduce new coverage criteria, utilization limitations, and a new bundled payment concept for certain CareDx testing, which could lead to lower rates of reimbursement.” · word for word

Payer dispute and recoupment risk

“We are currently involved in a dispute with a significant Medicare Advantage payer concerning payment of claims. We are seeking recovery of claims amounts that we believe were improperly denied, underpaid or recouped. The payer could also seek to recoup additional previously paid claims within an 18-month look-back period.” · word for word

Low risk; standard director appointment.

“No disputes or related party transactions reported.”