10-Q: CareDx Reports Q3 Profit Amid Strong Revenue Growth

Sentiment:

Quarterly Report 4 November 2025 4:13 PM

CareDx, Inc. announced a return to net income in Q3 2025 with significant revenue growth across its testing services, products, and digital solutions, despite ongoing legal challenges and an unaddressed material weakness in internal controls.

Capital raiseA universal shelf registration statement became effective on May 23, 2024, allowing the company to sell up to $250.0 million of various securities from time to time.The company completed a $50.0 million stock repurchase program (February 2025 Repurchase Program) during the three months ended June 30, 2025.A new $50.0 million share repurchase program (May 2025 Repurchase Program) was authorized, with $24.4 million remaining available as of September 30, 2025.

Better than expectedNet income of $1.7 million for Q3 2025, compared to a net loss of $10.6 million in Q3 2024, indicates a significant improvement in profitability.Total revenue growth of 21% year-over-year for Q3 2025 and 10% for the nine months ended September 30, 2025, demonstrates strong commercial performance.Reduction in net loss by 51% for the nine months ended September 30, 2025, compared to the prior year, shows progress towards overall profitability.

Summary

Total revenue for the three months ended September 30, 2025, increased by 21% year-over-year to $100.1 million.
Testing services revenue grew 19% to $72.2 million, driven by a 13% increase in testing volume.
Product revenue increased 22% to $12.5 million, primarily due to higher sales of NGS-based kitted solutions.
Patient and digital solutions revenue rose 30% to $15.4 million, attributed to expanded Ottr software customer base and higher pharmacy sales.
The company reported a net income of $1.7 million for Q3 2025, a significant improvement from a net loss of $10.6 million in Q3 2024.
For the nine months ended September 30, 2025, total revenue increased 10% to $271.4 million, and net loss decreased by 51% to $17.2 million from $35.1 million in the prior year.
Cash, cash equivalents, and marketable securities stood at $194.2 million as of September 30, 2025, with no outstanding debt.
The company completed a $50.0 million share repurchase program (February 2025) and initiated another $50.0 million program (May 2025), with $24.4 million remaining available as of September 30, 2025.
A material weakness in internal control over financial reporting, identified as of December 31, 2022, remains unremediated as of September 30, 2025.

Sentiment

Score: 7

Explanation: The company demonstrated strong revenue growth and a return to quarterly net income, indicating positive operational momentum. However, significant ongoing legal challenges, particularly the Natera patent appeals with potential $96.3 million liability, and the unremediated material weakness in internal controls, temper the overall positive sentiment. The share repurchase programs are a positive for shareholders.

Positives

Achieved net income of $1.7 million for the three months ended September 30, 2025, a substantial turnaround from a $10.6 million net loss in the prior year period.
Reported strong total revenue growth of 21% year-over-year for Q3 2025, reaching $100.1 million.
Testing services volume increased by 13% year-over-year, indicating growing adoption of core diagnostic solutions.
Product revenue and patient and digital solutions revenue showed robust growth of 22% and 30% respectively, diversifying revenue streams.
Net loss for the nine months ended September 30, 2025, significantly reduced by 51% to $17.2 million compared to the same period in 2024.
Maintained a strong liquidity position with $194.2 million in cash, cash equivalents, and marketable securities and no debt.
Successfully completed a $50.0 million share repurchase program and has $24.4 million remaining under a new $50.0 million program, demonstrating commitment to shareholder returns.
SEC investigation concluded with no enforcement action, and DOJ closed its investigation into the qui tam action with no finding of wrongdoing.

Negatives

Despite quarterly net income, the company still reported a net loss of $17.2 million for the nine months ended September 30, 2025.
Interest income, net, decreased by $1.0 million for Q3 2025 and $1.6 million for the nine months ended September 30, 2025, primarily due to a decrease in cash and marketable securities.
Litigation settlement expense increased by $5.7 million for the nine months ended September 30, 2025, mainly due to the settlement of the Securities Class Action lawsuit.
A material weakness in internal control over financial reporting, identified as of December 31, 2022, has not been remediated as of September 30, 2025, posing risks to financial reporting accuracy.

Risks

Continued history of losses and expectation to incur net losses for the next several years.
Substantial portion of revenue (48% of testing services revenue for Q3 2025) derived from Medicare, making the company vulnerable to changes in reimbursement policies or reductions.
PLA Code 0540U repricing process for AlloSure tests could lead to an $88 decrease in reimbursement for AlloSure Kidney, effective January 1, 2026.
A new draft proposed LCD (DL40058, DL40060) could introduce new coverage criteria, utilization limitations, and bundled payments, potentially lowering reimbursement rates.
Dependence on sales of AlloSure Kidney, AlloMap Heart, AlloSure Heart, HeartCare, and AlloSure Lung tests and products, with failure to increase sales or develop new solutions impairing profitability.
Third-party payers may revoke coverage or provide inadequate reimbursement, as evidenced by an ongoing dispute with a significant Medicare Advantage payer.
Ongoing legal proceedings, including patent infringement appeals with Natera, could be time-consuming, costly, and divert management attention, with potential liability up to $96.3 million plus interest.
New test and product development is a lengthy, complex, and risky process, with no guarantee of successful commercialization or market acceptance.
Rapid technological change in the diagnostic testing field could render existing solutions obsolete if the company fails to innovate.
Slow adoption of new diagnostic solutions by clinicians, hospital administrators, medical centers, and laboratories due to historical practices or perceived liability risks.
Significant competition from established and startup companies in the clinical surveillance of transplantation field, including Natera, Eurofins, Oncocyte, and Verici.
Reliance on a single laboratory facility in Brisbane, California, which is vulnerable to natural disasters like earthquakes, potentially disrupting operations.
International expansion exposes the company to business, regulatory, political, operational, financial, and economic risks, including trade barriers and currency fluctuations.
Incorporation of AI technologies into internal processes presents business, compliance, and reputational risks, including potential for inaccurate or biased outputs and increased regulatory scrutiny.
Disputes with labor unions in the Sweden facility could lead to work stoppages and adversely affect financial results.
Unfavorable economic and market conditions, such as inflation, recession, or government shutdowns, could adversely affect operating results and ability to raise capital.
Fluctuations in the effective tax rate and potential obligations in tax jurisdictions in excess of accrued amounts.
Potential for product liability or professional liability claims due to undetected errors or defects in products or inaccurate analysis.
Reliance on sole suppliers for critical laboratory instruments and reagents, with potential for supply interruptions or increased costs.
Limitations on the ability to utilize net operating loss carryforwards (NOLs) due to ownership changes, potentially increasing future tax liabilities.
The market price of common stock has been and will likely continue to be volatile, and techniques employed by short sellers may drive down the market price.

Future Outlook

The company expects to continue incurring significant operating expenses due to ongoing research and development, commercialization efforts for new diagnostic solutions, and integration of acquisitions. Future revenue growth depends on continued acceptance of current and future solutions, demand for services and products, maintaining Medicare reimbursement, and successful commercialization of new offerings. The final reimbursement rate for PLA Code 0540U for AlloSure tests is expected to be listed on the Clinical Laboratory Fee Schedule starting January 1, 2026, with a potential $88 decrease for AlloSure Kidney. The company believes its existing cash balance and expected cash from operations will be sufficient to meet anticipated cash requirements for the next 12 months.

Management Comments

Management is committed to maintaining a strong internal control environment and has taken actions to remediate the material weakness in internal control over financial reporting.
Management believes that the expectations reflected in the forward-looking statements are reasonable, but cannot guarantee future results, levels of activity, performance or events and circumstances.
Management has concluded that the condensed consolidated financial statements present fairly, in all material respects, the financial position, results of operations and cash flows for the periods disclosed in conformity with U.S. GAAP, despite the unremediated material weakness.

Industry Context

CareDx operates in the evolving field of diagnostic testing in transplantation, characterized by rapid technological development and innovation. The market for molecular diagnostics in post-transplant surveillance is competitive, with several established and emerging companies. The industry is also subject to significant regulatory scrutiny, particularly regarding reimbursement policies and the oversight of laboratory-developed tests (LDTs) by the FDA. Broader economic conditions, healthcare reform measures, and increasing focus on ESG factors also influence the industry landscape.

Comparison to Industry Standards

CareDx's AlloSure Kidney competes against existing diagnostic tests like biopsies and general clinical chemistry tests, as well as molecular diagnostic tests from competitors such as Natera, Eurofins, Oncocyte, and Verici.
AlloSure Heart, AlloMap Heart, and HeartCare solutions compete with biopsies and echocardiography for heart transplant recipients, supplemented by general clinical chemistry tests.
AlloSure Lung competes with spirometry and biopsies for lung transplant recipients, also supplemented by general clinical chemistry tests.
In pre-transplant typing, QTYPE competes with other quantitative PCR products from companies like Thermo Fisher, and alternatives like next-generation sequencing (NGS) typing products.
For patient and digital solutions, competitors include Phoenix (Epic's transplant application) for EMR solutions, and various hospital-affiliated and specialty pharmacies for patient solutions.
The company's revenue growth rates (21% for Q3 2025, 10% for nine months) indicate strong performance relative to the general market, but specific industry benchmarks for growth are not provided for direct comparison.
The ongoing legal disputes with Natera highlight intense competition and intellectual property challenges common in the diagnostics industry, where companies frequently assert and defend patent rights.

Management Changes

Role	Previous Person	New Person	Effective Date	Reason
Executive	Abhishek Jain	NA	August 6, 2025	Employment terminated; entered into a Release of Claims Agreement and Consulting Agreement.
General Counsel	NA	Jeffrey A. Novack	September 4, 2025	Adopted a Rule 10b5-1 trading plan (not a change in role, but a notable management action).

Corporate Governance

Change Type	Description	Effective Date	Impact Assessment
Internal Control Weakness	A material weakness in internal control over financial reporting, identified as of December 31, 2022, was not remediated as of September 30, 2025. This relates to the COSO framework components, including sufficiency of competent personnel, monitoring and risk assessment for complex transactions, and timely control activities.	Ongoing	Creates a reasonable possibility of material misstatement in consolidated financial statements not being prevented or detected timely. Remediation efforts are in progress.
Bylaw Amendment	Amended and restated bylaws designate the federal district courts of the United States of America as the exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act.	March 24, 2023	May limit stockholders' ability to choose a favorable judicial forum for disputes, potentially discouraging lawsuits or increasing costs for stockholders.

Legal Proceedings

**Natera False Advertising Suit**: The U.S. Court of Appeals for the Third Circuit affirmed the District Court's findings on both liability and damages on August 28, 2025. CareDx's petition for panel rehearing or rehearing en banc of the damages decision was denied on October 10, 2025. CareDx has not recorded a receivable or gain from the judgment.
**Natera Patent Infringement Suit**: The District Court overturned a jury verdict in February 2025, concluding Natera's U.S. Patents 11,111,544 and 10,655,180 were invalid for lack of written description. Natera has appealed this decision. CareDx derecognized the $96.3 million liability previously recorded. It is reasonably possible that CareDx may not prevail on appeal, with a potential loss up to $96.3 million plus interest.
**DOJ and SEC Investigations**: The SEC concluded its investigation with no enforcement action in September 2023. The DOJ closed its investigation into a qui tam action with no finding of wrongdoing in October 2024. However, the private plaintiff in the qui tam action filed an amended complaint on April 8, 2025, which CareDx intends to vigorously defend against.
**Securities Class Action**: An agreement-in-principle to settle for approximately $20.25 million was reached on April 22, 2025, and preliminarily approved on July 23, 2025. CareDx recorded a $20.25 million accrued litigation settlement expense and $14.9 million in expected insurance proceeds. A fairness and approval hearing is scheduled for December 2, 2025.
**Derivative Actions (Edelman and Burns)**: An agreement in principle to resolve both the Edelman and Burns Derivative Actions was reached on July 22, 2025, subject to attorney fee negotiation. A stipulation and agreement of compromise, settlement and release was entered on September 26, 2025, with a motion for preliminary approval filed. A hearing is scheduled for December 2, 2025. CareDx has not recorded any liabilities for these suits.
**Insurance Matter**: A lawsuit against D&O liability insurance carriers was dismissed following preliminary approval of the Securities Class Action settlement. The company was pursuing an appeal of a summary judgment granted to insurers, but the appeal was dismissed.

Stakeholder Impact

**Shareholders**: Positive impact from strong revenue growth and return to quarterly net income. Potential positive impact from ongoing share repurchase programs. Negative impact from potential stock price volatility due to legal proceedings and internal control issues. Potential dilution from future equity capital raises under the shelf registration statement.
**Employees**: Impacted by the termination of Abhishek Jain and the adoption of a Rule 10b5-1 trading plan by Jeffrey A. Novack. Ongoing remediation efforts for internal control weaknesses may affect financial reporting personnel. Potential for labor disputes in Sweden facility.
**Customers**: Continued availability and development of testing services, products, and digital solutions. Potential impact from changes in Medicare reimbursement policies or coverage criteria for AlloSure tests. Reliance on third-party service providers and sole suppliers could affect service delivery.
**Payers**: Ongoing disputes with Medicare Advantage payers and potential changes in reimbursement rates for AlloSure tests could affect payment amounts and coverage.
**Regulatory Bodies**: Continued scrutiny from federal and state agencies regarding compliance with healthcare laws, CLIA, and potential FDA oversight of LDTs. The company is cooperating with ongoing inquiries and investigations.

Next Steps

Continue efforts to remediate the material weakness in internal control over financial reporting.
Monitor the final reimbursement rate for PLA Code 0540U, expected to be listed on the Clinical Laboratory Fee Schedule starting January 1, 2026.
Defend against Natera's appeal of the patent invalidation ruling.
Continue to defend against the qui tam action and the Edelman Derivative Action.
Proceed with the fairness and approval hearing for the Securities Class Action settlement and the preliminary approval hearing for the derivative actions settlement on December 2, 2025.
Evaluate the potential impact of new FASB accounting standards (ASU 2023-09, ASU 2024-03, ASU 2025-06) on financial statements and disclosures.
Continue clinical studies to generate data on existing and planned future testing services.
Expand sales force and marketing capabilities to commercialize existing and future solutions.
Attract and retain highly skilled scientists, clinicians, and laboratory personnel.

Key Dates

Date	Description
December 31, 2022	Material weakness in internal control over financial reporting identified.
December 3, 2022	Board of Directors authorized a stock repurchase program of up to $50 million over two years.
December 2022	Company filed a lawsuit against its directors and officers liability insurance carriers.
March 2023	Company entered into a license and collaboration agreement for iBox software.
July 2023	Court upheld and reaffirmed the March 2022 jury verdict against Natera in the false advertising suit but did not uphold the monetary damages awarded by the jury.
August 2023	Court issued an injunction prohibiting Natera from making claims the jury found to be false advertising.
August 2023	Company entered into a license agreement with a university institution for royalty payments.
September 19, 2023	SEC notified the company that its investigation concluded with no enforcement action.
December 11, 2023	Court dismissed Natera's case alleging infringement of U.S. Patent 10,597,724.
December 31, 2023	FASB issued ASU No. 2023-09, 'Income Taxes (Topic 340): Improvements to Income Tax Disclosures'.
January 26, 2024	Jury concluded CareDx did not infringe Natera's U.S. Patent 10,655,180 but did infringe U.S. Patent 11,111,544, awarding Natera $96.3 million in damages.
March 13, 2024	Federal Circuit dismissed Natera's appeal of the dismissal of U.S. Patent 10,597,724.
March 20, 2024	Edward W. Burns IRA filed a stockholder derivative action (Burns Derivative Action).
April 11, 2024	Court entered an order staying the Burns Derivative Action.
May 23, 2024	SEC declared the universal shelf registration statement effective, allowing sale of up to $250.0 million of securities.
May 30, 2024	Natera filed a second notice of appeal of the dismissal of U.S. Patent 10,597,724.
June 4, 2024	Superior Court of California granted a motion for summary judgment by D&O insurers.
June 19, 2024	CareDx moved to dismiss Natera's appeal of the dismissal of U.S. Patent 10,597,724.
August 16, 2024	CMS issued a press release announcing that MACs decided not to finalize the proposed LCD (DL38568, DL38629).
September 11, 2024	Federal Circuit denied CareDx's motion to dismiss Natera's appeal of U.S. Patent 10,597,724 dismissal.
September 11, 2024	Natera informed the Court that it was abandoning claims of ongoing infringement related to U.S. Patent 11,111,544.
October 7, 2024	DOJ notified the U.S. District Court that it was declining to intervene in a qui tam action, closing its investigation with no finding of wrongdoing.
October 8, 2024	U.S. Court of Appeals for the Third Circuit remanded the Natera false advertising case to make additional findings.
November 2024	FASB issued ASU 2024-03, 'Income Statement Reporting Comprehensive Income Expense Disaggregation Disclosures'.
December 30, 2024	Company received a CPT code (PLA Code 0540U) for AlloSure Kidney, AlloSure Heart, and AlloSure Lung tests, subjecting them to a repricing process.
January 3, 2025	Court issued an order denying Natera's motion to set aside the jury's finding that CareDx did not infringe Natera's U.S. Patent 10,655,180.
February 14, 2025	PTO examiner issued a non-final Office action rejecting Claims 21, 26, and 27 of Natera's U.S. Patent 11,111,544.
February 20, 2025	Board of Directors approved the February 2025 Repurchase Program for up to $50.0 million in shares.
February 24, 2025	Court issued an order concluding that Natera's U.S. Patents 11,111,544 and 10,655,180 were invalid for lack of written description, overturning the jury verdict.
February 25, 2025	Court issued an order denying Natera's motion for an injunction as moot.
February 26, 2025	Edelman v. Bickerstaff derivative action initiated.
March 10, 2025	Amended stipulation and proposed order to continue the stay in the Burns Derivative Action was entered by the Court.
March 19, 2025	Administrative motion filed to consider whether the Edelman Derivative Action should be related to the Securities Class Action.
April 1, 2025	Court granted the motion to relate the Edelman Derivative Action to the Securities Class Action.
April 1, 2025	Mediation held for the Securities Class Action and the Edelman Derivative Action (no settlement for Edelman).
April 1, 2025	Mediation held for the Burns Derivative Action (no settlement).
April 8, 2025	The private plaintiff in the qui tam action filed an amended complaint on the public docket.
April 10, 2025	Initial Case Management Conference held in the Edelman Derivative Action, setting a trial date of July 19, 2027.
April 21, 2025	Plaintiffs in the Edelman Derivative Action submitted a letter motion to lift the discovery stay.
April 22, 2025	Parties in the Securities Class Action reached an agreement-in-principle to resolve the action for approximately $20.25 million.
April 23, 2025	CareDx submitted a brief in opposition to lifting the discovery stay in the Edelman Derivative Action.
May 16, 2025	Parties in the Securities Class Action reached a definitive stipulation of settlement.
May 23, 2025	Plaintiffs filed a motion for preliminary approval of the Securities Class Action settlement.
May 30, 2025	Board of Directors authorized a new share repurchase program (May 2025 Repurchase Program) of up to $50.0 million.
June 2025	CareDx recommended to CMS that AlloSure tests be priced consistent with PLA Code 0493U ($2,753).
June 9, 2025	Joint status report filed in Burns Derivative Action, informing the Court of the Securities Class Action settlement and ongoing derivative settlement discussions.
June 10, 2025	Hearing held on plaintiffs' letter motion to lift the discovery stay in the Edelman Derivative Action.
June 12, 2025	Court issued an order denying plaintiffs' letter motion to lift the PSLRA's discovery stay in the Edelman Derivative Action.
July 9, 2025	PTO issued a reexamination certificate finding Natera had overcome prior rejections for U.S. Patent 11,111,544.
July 16, 2025	District Court held a conference in the qui tam action, setting a briefing schedule for a motion to dismiss.
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).
July 22, 2025	Parties in the Burns Derivative Action reached an agreement in principle to resolve the case, subject to attorney fee negotiation.
July 23, 2025	District Court issued an order preliminarily approving the Securities Class Action settlement, triggering the company's obligation to fund its portion.
July 31, 2025	Parties in the Burns Derivative Action submitted a joint status report, notifying the Court of the selection of a JAMS mediator for attorney fee negotiation.
August 6, 2025	Abhishek Jain's employment with the company terminated.
August 6, 2025	Release of Claims Agreement and Consulting Agreement signed with Abhishek Jain.
August 28, 2025	U.S. Court of Appeals for the Third Circuit issued a decision affirming the District Court's findings on both liability and damages in the Natera false advertising case.
September 4, 2025	Jeffrey A. Novack, General Counsel, adopted a Rule 10b5-1 trading plan.
September 9, 2025	Mediation session to mediate attorneys' fees in the Burns Derivative Action was unsuccessful.
September 11, 2025	Parties in the Edelman Derivative Action submitted a joint status report notifying the Court of their intent to file a motion for preliminary approval of the derivative settlement.
September 25, 2025	CareDx filed a petition for panel rehearing or rehearing en banc of the Third Circuit's damages decision in the Natera false advertising case.
September 26, 2025	Parties entered into a stipulation and agreement of compromise, settlement and release resolving and settling, subject to court approval, both the Edelman and Burns Derivative Actions. Plaintiffs in the Edelman Derivative Action filed their unopposed motion for preliminary approval.
September 30, 2025	End of the current quarterly reporting period.
September 30, 2025	Plaintiffs in the Securities Class Action filed a motion for final approval and a motion for an award of attorneys' fees and expenses.
September 2025	FASB issued ASU 2025-06, 'Intangibles—Goodwill and Other—Internal-Use Software (Subtopic 350-40): Targeted Improvements to the Accounting for Internal-Use Software'.
October 1, 2025	Parties to the Burns Derivative Action filed a third amended stipulation and proposed order to continue the stay.
October 6, 2025	Court entered the stipulated order to continue the stay in the Burns Derivative Action.
October 10, 2025	Third Circuit denied CareDx's petition for panel rehearing or rehearing en banc of the damages decision in the Natera false advertising case.
October 10, 2025	Deadline to oppose the motion for preliminary approval in the Edelman Derivative Action (no opposition filed).
October 13, 2025	Plaintiffs in the Edelman Derivative Action filed a notice of non-opposition, requesting preliminary approval without oral argument.
October 17, 2025	Relator filed an opposition to CareDx's motion to dismiss in the qui tam action.
October 30, 2025	Latest practicable date for which shares outstanding were reported (51,432,639 shares).
October 31, 2025	CareDx filed its reply in further support of its motion to dismiss in the qui tam action.
November 4, 2025	Date of filing of the Quarterly Report on Form 10-Q.
November 27, 2026	Termination date for Jeffrey A. Novack's Rule 10b5-1 trading plan.
December 2, 2025	Fairness and approval hearing scheduled for the Securities Class Action and the Edelman Derivative Action.
January 1, 2026	Final reimbursement rate for PLA Code 0540U expected to be listed on the Clinical Laboratory Fee Schedule.
March 15, 2026	Latest date for payment of Abhishek Jain's Actual 2025 Bonus.
September 2026	Natera's U.S. Patent 11,111,544 expires.
December 31, 2025	FASB ASU No. 2023-09 effective for annual disclosures for the fiscal year ending this date.
December 31, 2027	FASB ASU 2024-03 effective for annual disclosures for the fiscal year ending this date.
December 15, 2027	FASB ASU 2025-06 effective for fiscal years beginning after this date.
July 19, 2027	Trial date for the Edelman Derivative Action.

Recommendation

hold

CareDx's Q3 2025 results show strong revenue growth and a return to net income, indicating operational improvements and market acceptance of its products. The company's liquidity position is solid, and its share repurchase programs are a positive signal for shareholders. However, significant legal uncertainties, particularly the Natera patent infringement appeals with a potential $96.3 million liability, and the unremediated material weakness in internal controls, present substantial risks. The potential for reduced Medicare reimbursement rates for AlloSure tests also adds a layer of uncertainty. While the company is making progress, these unresolved issues warrant a cautious approach. A seasoned investor would likely hold, awaiting clearer outcomes on the legal front and demonstrated remediation of internal control deficiencies before making a more aggressive move.

Keywords

CareDx, CDNA, SEC Filing, 10-Q, Quarterly Report, Financial Results, Transplant Diagnostics, AlloSure Kidney, AlloMap Heart, AlloSure Heart, AlloSure Lung, Precision Medicine, Genomics, Digital Health, Patient Solutions, Revenue Growth, Net Income, Litigation, Natera, Patent Infringement, False Advertising, Securities Class Action, Internal Controls, Material Weakness, Share Repurchase, Medicare Reimbursement, Risk Factors, Biopharma Partnerships, AlloCell, Organ Transplantation

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