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CDNA

CareDx, Inc.
NASDAQ · HEALTH CARE · SERVICES-MEDICAL LABORATORIES
69.21
+0.05 +0.07%
USD · close Oct 23
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MKT CAP $3.6BP/E 33.4DIV YIELD —FCF YIELD —REV TTM $458.1M +34.4%NET INCOME $111M +90.9%NET CASH $373.6M52W 14.28 – 70.74SEC XBRL · TTM TO Invalid Date

How CDNA rewrote its risk factors

10-K ITEM 1A · FY2024 → FY2025
Text kept
65%
of sentences unchanged
Added
210
new sentences
Dropped
129
sentences removed
Length
+2,691
words, now 29,839

New in FY2025

  • If we are unable to develop solutions to keep pace with rapid medical and scientific change, our operating results could be harmed. • If clinicians, hospital administrators, medical centers and laboratories do not adopt our diagnostic solutions, we will not achieve future sales growth. • Our quarterly operating results may fluctuate significantly or may fall below the expectations of investors or securities analysts, each of which may cause our stock price to fluctuate or decline. • Transplant centers may not adopt AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare, AlloSure Lung, or our other solutions due to historical practices or due to more favorable reimbursement policies associated with other means of monitoring transplants. • If we cannot maintain existing clinical collaborations and enter into new ones, our efforts to commercialize and develop products could be delayed. • If we are unable to successfully manage our growth and support demand for our tests, our business may suffer. • Our past revenue growth rates may not be indicative of future growth, and we may not grow at all, and revenue may decline. • If our laboratory facility in the U.S. becomes inoperable, we will be unable to perform AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare, AlloSure Lung and future testing solutions, if any, and our business will be harmed. • Investors’ expectations of our performance relating to environmental, social and governance factors may impose additional costs and expose us to new risks. • Performance issues, service interruptions or price increases by our shipping carriers could adversely affect our business and harm our reputation and ability to provide our services on a timely basis. • If we seek to and are unable to raise additional capital on acceptable terms in the future, it may limit our ability to develop and commercialize new diagnostic solutions and technologies, and we may have to curtail or cease operations. • The loss of key members of our senior management team or our inability to attract and retain highly skilled scientists, clinicians and laboratory and field personnel could adversely affect our business. • Recent and future acquisitions and investments could disrupt our business, harm our financial condition and operating results, dilute your ownership of us and increase our debt or cause us to incur significant expense. • We rely extensively on third-party service providers.
  • Failure of these parties to perform as expected, or interruptions in our relationship with these providers or their provision of services or supplies to us, could interfere with our ability to provide test results for our testing services business and kits for our products business. • Security breaches, loss of data, or other disruptions could compromise sensitive information, prevent access to critical information, expose us to liability, and adversely affect our business and our reputation. • We are subject to changing laws, regulations, standards, and contractual obligations related to privacy, data protection and data security.
  • The actual or perceived failure to comply with such obligations could lead to government enforcement actions, fines, sanctions, private litigation, and/or adverse publicity and could negatively affect our operating results and business. • International expansion of our business exposes us to business, regulatory, political, operational, financial and economic risks associated with doing business outside of the United States. • Our operating results may be adversely affected by unfavorable economic and market conditions. • Billing complexities associated with obtaining payment or reimbursement for our current and future solutions may negatively affect our revenue, cash flows and profitability. • Healthcare reform measures could hinder or prevent the commercial success of AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare and AlloSure Lung. • To operate our laboratory, we have to comply with the CLIA and federal and state laws and regulations governing clinical laboratories and laboratory-developed tests, including FDA regulations. • We are subject to numerous fraud and abuse and other laws and regulations pertaining to our business, the violation of any one of which could harm our business. • Our competitive position depends on maintaining intellectual property protection. • Our business is dependent on licenses from third parties. • Our operating results may fluctuate, which could cause our stock price to decrease. • The market price of our common stock has been and will likely continue to be volatile, and you could lose all or part of your investment.
  • 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.
  • We expect to continue to incur significant operating expenses and anticipate that our expenses will increase due to costs relating to, among other things: • researching, developing, validating and commercializing potential new testing services, products and patient and digital solutions, including additional expenses in connection with our continuing development and commercialization of our testing services and product portfolio, and other future solutions; • developing, presenting and publishing additional clinical and economic utility data intended to increase payer coverage and clinician adoption of our current and future solutions; • expansion of our operating capabilities; • maintenance, expansion and protection of our intellectual property portfolio and trade secrets; • the process of fully integrating acquired companies and operations and the associated potential disruptions to our business; • future clinical trials; • expansion of the size and geographic reach of our sales force and our marketing capabilities to commercialize our existing and future solutions; • employment of additional clinical, quality control, scientific, customer service, laboratory, billing and reimbursement and management personnel; • compliance with existing and changing laws, regulations and standards, including those relating to corporate governance and public disclosure and regulations implemented by the Securities and Exchange Commission, or the SEC, and The Nasdaq Stock Market LLC; • ongoing litigation; • employment of operational, financial, accounting and information systems personnel, consistent with expanding our operations; and • failure to achieve expected operating results may cause a future impairment of goodwill or other assets.
  • For the year ended December 31, 2025, revenue from Medicare for AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare and AlloSure Lung represented 46% of testing services revenue.
  • For example, on December 30, 2024, we received a CPT code for our AlloSure Kidney, AlloSure Heart and AlloSure Lung tests (PLA Code 0540U), which subjects such tests to a repricing process.
  • 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 the pricing for AlloSure Heart and AlloSure Lung tests.
  • On February 3, 2026, the “Consolidated Appropriations Act, 2026” was passed amending the PAMA law.
  • The legislation requires us, and other laboratories, to report private payor rates paid between January 1, 2025 and June 30, 2025 to CMS with a reporting period from May through July 2026.
  • The volume-weighted median of the rates reported for each test would set the Medicare Clinical Laboratory Fee Schedule rate for certain of our tests in calendar years 2027 to 2029.
  • We do not anticipate that the reporting will have a material impact on our current Medicare pricing.
  • 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 for certain CareDx testing, which could lead to lower rates of reimbursement.
  • MolDX and Noridian have 365 days from the date of issuance to finalize the Proposed LCD.
  • We cannot predict the ultimate outcome of the LCD process, including as it relates to the Proposed LCD, and whether it will produce changes in coverage, reimbursement practices, utilization limitations, or payment amounts, any of which could adversely affect our business, operating results and prospects.
  • If future reimbursement price or coverage levels are lower than the current prices or coverage level, our revenues and our ability to achieve profitability could be impaired, and the market price of our common stock could decline.
  • Our current Medicare coverage through Noridian provides for reimbursement for tests performed for qualifying Medicare patients throughout the United States so long as the tests are performed in our California laboratory.
  • If we are unable to increase sales of our testing services or products or successfully develop and commercialize other solutions, tests or enhancements, or if we do not continue our Medicare reimbursement submissions for AlloSure Kidney at the same levels, our revenues and ability to achieve profitability would be impaired, and the market price of our common stock could decline.
  • For example, 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 pursuant to the provisions under the contract.
  • We ar e also subject to claims reviews and/or audits by third-party payers, including governmental audits of our Medicare claims, and have in the past been required to repay these payers in certain circumstances where a preliminary finding was made that we were incorrectly reimbursed.
  • See Note 8, Commitments and Contingencies , to the consolidated financial statements included elsewhere in this Annual Report on Form 10-K under the caption “Litigation and Indemnification Obligations”, which is incorporated herein by reference.
  • Such matters may cause us to incur costly litigation and/or substantial settlement charges, divert management attention, result in adverse judgments, fines, penalties, injunctions or other relief, and may result in loss of customer or investor confidence regardless of their merit or ultimate outcome.
  • The acceptance of our services, products and patient and digital solutions will depend upon our ability to demonstrate the safety and efficacy, advantages, short and long-term clinical performance and cost-effectiveness of our services, products and patient and digital solutions.
  • Additional competition for kidney surveillance diagnostics currently comes from general, non-specific clinical chemistry tests such as serum creatinine, urine protein, immunosuppression drug levels, donor specific antibodies and others that are widely ordered by physician offices and routinely performed in clinical reference labs and hospital labs.
  • 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.
  • Competition for our AlloSure Heart, AlloMap Heart, and HeartCare solutions for heart transplant recipients comes largely from biopsies in the first few years, which generally involves evaluating biopsy samples to determine the presence or absence of rejection.
  • Beyond the first year or two, competition for heart transplant surveillance diagnostics includes echocardiography.
  • Throughout, biopsy and echocardiography are supplemented by general, non-specific clinical chemistry tests such as, immunosuppression drug levels, donor specific antibodies and others that are widely ordered by physician offices and routinely performed in clinical reference labs and hospital labs.
  • In the field of post-transplant surveillance, Natera and Eurofins has commercially available molecular diagnostics tests.
  • Competition for our AlloSure Lung solution for lung transplant recipients comes largely from spirometry to assess lung function and biopsy to diagnose rejection in the first few years.
  • These tests are supplemented by general, non-specific clinical chemistry tests such as, immunosuppression drug levels, donor specific antibodies and others that are widely ordered by physician offices and routinely performed in clinical reference labs and hospital labs.
  • In the field of post-transplant surveillance, Natera, has commercially available molecular diagnostics tests.
  • Competition for our patient and digital solutions includes various companies that develop application software and operate in the healthcare field.

and 170 more.

Gone since FY2024

  • If we are unable to develop solutions to keep pace with rapid medical and scientific change, our operating results could be harmed. • If clinicians, hospital administrators, medical centers and laboratories do not adopt our diagnostic solutions, we will not achieve future sales growth. • We have identified a material weakness in our internal control over financial reporting as of December 31, 2022, which was not remediated at December 31, 2024.
  • If we are unable to remediate this material weakness and maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results in a timely manner. • Our quarterly operating results may fluctuate significantly or may fall below the expectations of investors or securities analysts, each of which may cause our stock price to fluctuate or decline. • Transplant centers may not adopt AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare, AlloSure Lung, or our other solutions due to historical practices or due to more favorable reimbursement policies associated with other means of monitoring transplants. • If we cannot maintain existing clinical collaborations and enter into new ones, our efforts to commercialize and develop products could be delayed. • If we are unable to successfully manage our growth and support demand for our tests, our business may suffer. • Our past revenue growth rates may not be indicative of future growth, and we may not grow at all, and revenue may decline. • If our laboratory facility in the U.S. becomes inoperable, we will be unable to perform AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare, AlloSure Lung and future testing solutions, if any, and our business will be harmed. • Investors’ expectations of our performance relating to environmental, social and governance factors may impose additional costs and expose us to new risks. • Performance issues, service interruptions or price increases by our shipping carriers could adversely affect our business and harm our reputation and ability to provide our services on a timely basis. • If we seek to and are unable to raise additional capital on acceptable terms in the future, it may limit our ability to develop and commercialize new diagnostic solutions and technologies, and we may have to curtail or cease operations. • The loss of key members of our senior management team or our inability to attract and retain highly skilled scientists, clinicians and laboratory and field personnel could adversely affect our business. • Recent and future acquisitions and investments could disrupt our business, harm our financial condition and operating results, dilute your ownership of us and increase our debt or cause us to incur significant expense. • We rely extensively on third-party service providers.
  • Failure of these parties to perform as expected, or interruptions in our relationship with these providers or their provision of services or supplies to us, could interfere with our ability to provide test results for our testing services business and kits for our products business. • We face four primary risks relative to protecting critical information: loss of access risk, inappropriate disclosure risk, inappropriate modification risk and the risk of our being unable to identify and audit our controls over the first three risks.
  • In addition, an application, data security or network incident may allow unauthorized access to our systems or data or our customers’ data, disable access to our service, harm our reputation, create additional liability and adversely impact our financial results. • International expansion of our business exposes us to business, regulatory, political, operational, financial and economic risks associated with doing business outside of the United States. • Our operating results may be adversely affected by unfavorable economic and market conditions. • Billing complexities associated with obtaining payment or reimbursement for our current and future solutions may negatively affect our revenue, cash flows and profitability. • Healthcare reform measures could hinder or prevent the commercial success of AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare and AlloSure Lung. • To operate our laboratory, we have to comply with the CLIA and federal and state laws and regulations governing clinical laboratories and laboratory-developed tests, including FDA regulations. • We are subject to numerous fraud and abuse and other laws and regulations pertaining to our business, the violation of any one of which could harm our business. • Our competitive position depends on maintaining intellectual property protection. • Our business is dependent on licenses from third parties. • Our operating results may fluctuate, which could cause our stock price to decrease. • The market price of our common stock has been and will likely continue to be volatile, and you could lose all or part of your investment.
  • For the year ended December 31, 2024, our net income was $52.5 million and, for the year ended December 31, 2023, our net loss was $190.3 million.
  • As of December 31, 2024, we had an accumulated deficit of $626.2 million.
  • We expect to continue to incur significant operating expenses and anticipate that our expenses will increase due to costs relating to, among other things: • researching, developing, validating and commercializing potential new testing services, products and patient and digital solutions, including additional expenses in connection with our continuing development and commercialization of KidneyCare, HeartCare, AlloSeq, AiTraC and other future solutions; • developing, presenting and publishing additional clinical and economic utility data intended to increase payer coverage and clinician adoption of our current and future solutions; • expansion of our operating capabilities; • maintenance, expansion and protection of our intellectual property portfolio and trade secrets; • the process of fully integrating acquired companies and operations and the associated potential disruptions to our business; • future clinical trials; • expansion of the size and geographic reach of our sales force and our marketing capabilities to commercialize our existing and future solutions; • employment of additional clinical, quality control, scientific, customer service, laboratory, billing and reimbursement and management personnel; • compliance with existing and changing laws, regulations and standards, including those relating to corporate governance and public disclosure and regulations implemented by the Securities and Exchange Commission, or the SEC, and The Nasdaq Stock Market LLC; • ongoing litigation; • employment of operational, financial, accounting and information systems personnel, consistent with expanding our operations and our status as a public company; and • failure to achieve expected operating results may cause a future impairment of goodwill or other assets.
  • For the year ended December 31, 2024, revenue from Medicare for AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare and AlloSure Lung represented 50% of testing services revenue.
  • If future reimbursement price levels are less than the current price, our revenues and our ability to achieve profitability could be impaired, and the market price of our common stock could decline.
  • Our current Medicare coverage through Noridian provides for reimbursement for tests performed for qualifying Medicare patients throughout the U.S. so long as the tests are performed in our California laboratory.
  • If we are unable to increase sales of our testing services or products or successfully develop and commercialize other solutions, tests or enhancements, or if we do not continue our Medicare reimbursement submissions for AlloSure Kidney at the same levels in place prior to the Billing Articles issued by Palmetto MolDX in 2023 (the “Billing Articles”), our revenues and ability to achieve profitability would be impaired, and the market price of our common stock could decline.
  • We are also subject to claims reviews and/or audits by such payers, including governmental audits of our Medicare claims, and have in the past been required to repay these payers in certain circumstances where a preliminary finding was made that we were incorrectly reimbursed.
  • See Note 9, Commitments and Contingencies , to the consolidated financial statements included elsewhere in this Annual Report on Form 10-K under the caption “Litigation and Indemnification Obligations”, which is incorporated herein by reference.
  • Additional competition for kidney surveillance diagnostics currently comes from general, non-specific clinical chemistry tests such as serum creatinine, urine protein, donor specific antibodies, complete blood count, lipid profile and others that are widely ordered by physician offices and routinely performed in clinical reference labs and hospital labs.
  • In the field of post-transplant surveillance, Natera, Eurofins, and Oncocyte 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 Oncocyte.
  • Competition for our AlloMap Heart solution for heart transplant recipients also comes from biopsies, which generally involve evaluating biopsy samples to determine the presence or absence of rejection.
  • Competition for our patient and digital solutions include various companies that develop application software and operate in the healthcare field.
  • If we are not able to acquire or negotiate access to new and archived donor and recipient data and tissue and blood samples with source institutions, or if other laboratories or our competitors secure access to these samples before us, our ability to research, develop and commercialize future solutions such as AlloSure Kidney will be limited or delayed.
  • From 2023 to 2024, our revenue increased from $280.3 million to $333.8 million, which represents an annual increase of 19%.
  • If our laboratory facility in the U.S. becomes inoperable, we will be unable to perform AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare, AlloSure Lung and future testing solutions, if any, and our business will be harmed.
  • We perform all of our testing services for the U.S. in our laboratory located in Brisbane, California.
  • Additionally, any new clinical laboratory facility opened by us in the U.S. would be required to be certified under the Clinical Laboratory Improvement Amendments of 1988, or CLIA, a federal law that regulates clinical laboratories that perform testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention or treatment of disease.
  • Any failure or perceived failure by us in this regard could have a material adverse effect on our reputation and on our business, share price, financial condition or results of operations, including the sustainability of our business over time.
  • Our business will suffer if these service providers do not support AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare, AlloSure Lung or the other solutions that we may develop.
  • As of December 31, 2024, we had cash, cash equivalents and marketable securities of $260.7 million and an accumulated deficit of $626.2 million.
  • Specifically, we may need to raise additional capital to, among other things: • develop other solutions for clinical surveillance in transplantation; • increase our selling and marketing efforts to drive market adoption and address competitive developments; • expand our clinical laboratory operations; • fund our clinical validation study activities; • expand our research and development activities; • sustain or achieve broader commercialization of AlloSure Kidney, KidneyCare, AlloMap Heart, AlloSure Heart, HeartCare, AlloSure Lung, our products and patient and digital solutions or enhancements to those tests, products and patient and digital solutions; • acquire or license products or technologies including through acquisitions; and • finance our capital expenditures and general and administrative expenses.
  • As part of our longer-term growth strategy, we intend to target select international markets to grow our presence outside of the U.S.
  • In addition, conducting international operations subjects us to risks that, generally, we have not faced in the U.S., including: • uncertain or changing regulatory registration and approval processes; • failure by us to obtain regulatory approvals or adequate reimbursement for the use of our current and future solutions in various countries; • competition from companies located in the countries in which we offer our products that may put us at a competitive disadvantage; • financial risks, such as longer accounts receivable payment cycles and difficulties in collecting accounts receivable; • risks related to our operations in Russia and Iran, including restrictions on our access to banking services, changes in the U.S., EU or other sanctions laws that limit financial transactions or increase or compliance burden and potential legal exposure and counterparty risk; • logistics and regulations associated with shipping recipient samples, including infrastructure conditions and transportation delays; • limits in our ability to penetrate international markets if we are not able to process solutions locally; • difficulties in managing and staffing international operations and assuring compliance with foreign corrupt practices laws; • potentially adverse tax consequences, including the complexities of foreign value added tax systems, tax inefficiencies related to our corporate structure and restrictions on the repatriation of earnings; • increased financial accounting and reporting burdens and complexities; • multiple, conflicting and changing laws and regulations such as healthcare regulatory requirements and other governmental approvals, permits and licenses; • the imposition of trade barriers such as tariffs, quotas, trade wars, preferential bidding or import or export licensing requirements; • political and economic instability, including interruptions in international relations, wars, terrorism and political unrest, general security concerns, outbreak of disease, boycotts, curtailment of trade and other business restrictions, including the ongoing conflict between Ukraine and Russia, the global impact of restrictions and sanctions imposed on Russia and the Israel-Hamas war; • fluctuations in currency exchange rates; • regulatory and compliance risks that relate to maintaining accurate information and control over activities that may fall within the purview of the Foreign Corrupt Practices Act of 1977, its books and records provisions or its anti-bribery provisions, as well as risks associated with other anti-bribery and anti-corruption laws; and • reduced or varied protection for intellectual property rights in some countries.
  • Our expanding international operations could be affected by changes in laws, trade regulations, labor and employment regulations, and procedures and actions affecting approval, production, pricing, reimbursement and marketing of our current and future products and solutions, as well as by inter-governmental disputes.
  • Many of the countries in which we operate, including the U.S. and several of the members of the European Union, or EU, have experienced and continue to experience uncertain economic conditions resulting from global as well as local factors.
  • Our business or financial results may be adversely impacted by these uncertain economic conditions, including: adverse changes in interest rates, foreign currency exchange rates, tax laws or tax rates; prolonged periods of increased inflation globally and in the U.S. in particular; liquidity concerns at financial institutions; a potential economic recession; contraction in the availability of credit in the marketplace due to legislation or other economic conditions, which may potentially impair our ability to access the capital markets on terms acceptable to us or at all; and the effects of government initiatives to manage economic conditions.
  • If elevated levels of inflation were to persist or if the rate of inflation were to accelerate, the purchasing power of our cash and cash equivalents may be further diminished, our expenses could increase faster than anticipated or payers may be unwilling or unable to increase reimbursement rates to compensate for inflationary impacts, and we may utilize our capital resources sooner than expected.
  • In addition, we have recorded gross unrecognized tax benefits in our financial statements that, if recognized, would impact our effective tax rate.
  • Our current or future restructuring plans may not optimize costs and simplify our organizational and corporate structure and may materially impair our business operations.
  • We have previously announced restructuring plans intended to optimize costs and simplify our organizational and corporate structure, and we most recently implemented such plans in January, May and December 2023, and November and December 2024.
  • Any additional restructuring efforts may divert management’s attention, increase expenses on a short-term basis and lead to potential issues with employees, customers or suppliers.
  • If we do not complete these activities in a timely manner; do not realize anticipated cost savings, synergies and efficiencies or business disruption occurs during or following such activities; or incur unanticipated charges, our business, financial condition, operating results and cash flows may be materially impaired.
  • We may not be able to achieve the anticipated strategic benefits from our acquisition of Ottr, XynManagement, TransChart, MedActionPlan, TTP, HLA Data Systems, MediGO, or any other businesses or assets that we may acquire.
  • In addition, we may not be able to fully realize the anticipated strategic benefits of any such combination or integration and any other businesses or assets we have or may acquire, which includes, with respect to Ottr, the complementary Ottr software, with respect to XynManagement, XynQAPI, TransChart and MedActionPlan, as well as TTP, HLA Data Systems, and MediGO's services and technologies, and in each case the benefits of any significant cross-selling opportunities.

and 89 more.

Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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