Cerus (CERS) risk factors, FY2025 10-K

Cerus's FY2025 10-K, filed Mar 02, 2026, lists 43 risk factors in 8 groups. Against the prior year's 44: 7 new, 8 dropped, 10 substantially reworded.

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Risk factors listed
438 groups
New this year
7vs 44 last year
Dropped
8since the prior 10-K
Substantially reworded
10of those kept
Section length
39k wordsItem 1A

What the changes say

  • Regulatory setbacks hit European approval for the red blood cell system via CBG application closure.

What changed since the prior 10-K

New

  • NewRisks Related to Our Business and Industry

    reduced cryoprecipitate poor plasma, we will continue to incur costs to discard the byproduct or be required to offset the economic impact to blood centers, which will continue to negatively impact our operating results

    Competition, regulatory disadvantages, and incompatibility with certain collection devices or methods could limit the marketability of our platelet and plasma products.

  • NewRisks Related to Our Business and Industry

    our red blood cell product’s reputation and may force us to suspend or terminate development activities related to the red blood cell system in the U.S

    The Dutch CBG concluded our red blood cell system MDR application data was insufficient, forcing us to close the application and restart with TÜV-SÜD.

  • NewRisks Related to Regulatory Approval, CE Certificates of Conformity, and Oversight, and Other Legal Compliance Matters

    We are also subject to domestic and foreign laws and regulations covering data privacy and the protection of health-related and other personal information. Domestic privacy and data security laws are complex and changing rapidly

    We face complex and rapidly changing domestic and foreign data privacy and security laws regarding health-related and personal information.

  • NewRisks Related to Regulatory Approval, CE Certificates of Conformity, and Oversight, and Other Legal Compliance Matters

    courts and data protection authorities may have different interpretations of applicable law, leading to potential inconsistencies in application of these laws. In addition to data privacy and security laws, we have contractual obligations related to privacy and security

    Inconsistent interpretations of data privacy laws and potential third-party failures may lead to costly compliance, enforcement actions, or bans on processing personal data.

  • NewRisks Related to Regulatory Approval, CE Certificates of Conformity, and Oversight, and Other Legal Compliance Matters

    reducing federal funding, and limiting provider taxes used to fund the program. Congress is considering proposed legislation intended to further reduce healthcare costs with alternatives to replace the expired ACA subsidies

    Government healthcare cost-control policies, reduced federal funding, and potential replacement of ACA subsidies create regulatory uncertainty for our business.

  • NewRisks Related to Our Reliance on Third Parties

    unforeseen potential disruption to manufacturing which could consume our cash resources faster than we anticipate and may cause our supply chain to be less efficient

    Middle East conflicts, shipping route disruptions, and plasma supply constraints could increase freight costs and limit production of our INTERCEPT Blood System for Cryoprecipitation.

  • NewRisks Related to Managing Our Growth and Other Business Risks

    Additionally, future or past business transactions (such as acquisitions or integrations) could expose us to additional cybersecurity risks and vulnerabilities, as our systems could be negatively affected by vulnerabilities present in acquired or integrated entities’ systems and technologies

    Third-party supplier ransomware attacks and vulnerabilities from business acquisitions introduce additional cybersecurity risks and potential operational disruptions.

Dropped

  • DroppedRisks Related to Our Business and Industry

    candidates in preclinical studies and clinical trials and products emerging from any successful trial may not reach the market for several years

  • DroppedRisks Related to Regulatory Approval, CE Certificates of Conformity, and Oversight, and Other Legal Compliance Matters

    In addition, voluntary EU and national industry Codes of Conduct provide guidelines on the advertising and promotion of our products to the general public and may impose limitations on our promotional activities with healthcare professionals

  • DroppedRisks Related to Regulatory Approval, CE Certificates of Conformity, and Oversight, and Other Legal Compliance Matters

    performance and results of operations, as well as our stock price. In addition, we incurred significant costs in connection with the CID, and we could incur significant costs in connection with potential future similar investigations, which could harm our ability to achieve our financial performance objectives

  • DroppedRisks Related to Regulatory Approval, CE Certificates of Conformity, and Oversight, and Other Legal Compliance Matters

    and/or credit reporting agencies of certain security breaches affecting personal information. These laws are not consistent, and compliance with them in the event of a widespread data breach is complex and costly

  • DroppedRisks Related to Regulatory Approval, CE Certificates of Conformity, and Oversight, and Other Legal Compliance Matters

    implemented payment system reforms including a national pilot program on payment bundling to encourage hospitals, physicians and other providers to improve the coordination, quality and efficiency of certain healthcare services through bundled payment models

  • DroppedRisks Related to Regulatory Approval, CE Certificates of Conformity, and Oversight, and Other Legal Compliance Matters

    significant changes to the health care system, which could have a material adverse effect on our business, results of operations, financial condition and growth prospects

    Narrow enrollment criteria for certain clinical trials.

  • DroppedRisks Related to Our Reliance on Third Parties

    cost to the hospital, we may need to keep additional inventory or manufacture IFC above levels generating an economic return, which could adversely affect our results of operations and financial condition

  • DroppedRisks Related to Managing Our Growth and Other Business Risks

    employees and management. Such disruptions may have an adverse impact on our operations, our ability to service existing markets and customers, or our ability to comply with regulations and laws

Reworded

  • 63% rewrittenRisks Related to Managing Our Growth and Other Business Risks

    cultural differences in the conduct of business

    No substantive changes were made to the text regarding foreign currency exposure and Euro-denominated transactions.

  • 61% rewrittenRisks Related to Regulatory Approval, CE Certificates of Conformity, and Oversight, and Other Legal Compliance Matters

    Legislative, regulatory, or other healthcare reforms may make it more difficult and costly for us to obtain regulatory approval or CE Certificates of Conformity for our products and to produce, market and distribute our products after approval or certification is obtained

    Removed specific references to U.S. healthcare overhaul legislation and framed price controls more generally.

  • 58% rewrittenRisks Related to Managing Our Growth and Other Business Risks

    Disruptions or other compromises of information technology systems or actual or perceived breaches of data security could adversely affect our business

    Added explicit mention of processing personal data and other sensitive information in the ordinary course of business.

    Was: Significant disruptions of information technology systems or actual or alleged breaches of data security could adversely affect our business

  • 51% rewrittenRisks Related to Regulatory Approval, CE Certificates of Conformity, and Oversight, and Other Legal Compliance Matters

    the Federal Trade Commission Act and similar laws regulating advertisement and consumer protections; and

    No substantive changes were made to the text regarding federal and state anti-kickback and false claims laws.

  • 51% rewrittenRisks Related to Managing Our Growth and Other Business Risks

    If we fail to attract, retain and motivate key personnel or to retain the members of our executive management team, our operations and our future growth may be adversely affected

    No substantive changes were made to the text regarding executive management and key personnel dependency.

  • 51% rewrittenRisks Related to Regulatory Approval, CE Certificates of Conformity, and Oversight, and Other Legal Compliance Matters

    Our company, our products, and blood products treated with the INTERCEPT Blood System are subject to extensive regulation by domestic authorities, foreign authorities and Notified Bodies

    No substantive changes were made to the text regarding extensive regulation by domestic and foreign authorities.

  • 51% rewrittenRisks Related to Our Business and Industry

    We may be unable to develop and maintain an effective and qualified U.S.-based commercial organization or educate blood centers, clinicians and hospital personnel. As a result, we may not be able to successfully educate the market on the value of pathogen reduction or commercialize our products in the U.S

    Updated phrasing to reflect that commercializing our products in the U.S. has taken a significant amount of time.

  • 48% rewrittenRisks Related to Our Business and Industry

    The red blood cell system is currently in development and may never receive any marketing approvals or CE Certificates of Conformity

    Updated details regarding the October 2024 CBG review and closure of our MDR application for the red blood cell system.

  • 42% rewrittenRisks Related to Managing Our Growth and Other Business Risks

    Adverse market and economic conditions may exacerbate certain risks affecting our business

  • 21% rewrittenRisks Related to Our Reliance on Third Parties

    Our manufacturing supply chain exposes us to significant risks

All 43 risk factors

Headings as the filing states them, in filing order.

Risks Related to Our Business and Industry

  1. 01comply with other U.S. healthcare regulatory requirements
  2. 02The INTERCEPT Blood System may not achieve or be able to sustain broad market adoption
  3. 03our products may never receive approval for storage of platelets beyond five days
  4. 04We are exposed to risks associated with the highly concentrated market for the INTERCEPT Blood System
  5. 05We may be unable to develop and maintain an effective and qualified U.S.-based commercial organization or educate blood centers, clinicians and hospital personnel. As a result, we may not be able to successfully educate the market on the value of pathogen reduction or commercialize our products in the U.S51% rewritten
  6. 06reduced cryoprecipitate poor plasma, we will continue to incur costs to discard the byproduct or be required to offset the economic impact to blood centers, which will continue to negatively impact our operating resultsNew
  7. 07The red blood cell system is currently in development and may never receive any marketing approvals or CE Certificates of Conformity48% rewritten
  8. 08our red blood cell product’s reputation and may force us to suspend or terminate development activities related to the red blood cell system in the U.SNew

Risks Related to Regulatory Approval, CE Certificates of Conformity, and Oversight, and Other Legal Compliance Matters

  1. 09Our company, our products, and blood products treated with the INTERCEPT Blood System are subject to extensive regulation by domestic authorities, foreign authorities and Notified Bodies51% rewritten
  2. 10Any of these actions, in combination or alone, could prevent us from selling our products and harm our business. In addition, any government investigation of alleged violations of law could require us to expend significant time and resources in response and could generate negative publicity
  3. 11If we or our third-party suppliers fail to comply with the FDA’s or other regulatory authorities’ or foreign regulatory authorities’ good manufacturing practice regulations, it could impair our ability to market our products in a cost-effective and timely manner
  4. 12If we modify our FDA-approved or CE Marked products, we may need to seek additional approvals, or certification, which, if not granted, would prevent us from selling our modified products
  5. 13We are subject to federal, state and foreign laws governing our business practices which, if violated, could result in substantial penalties and harm our reputation and business
  6. 14the Federal Trade Commission Act and similar laws regulating advertisement and consumer protections; and51% rewritten
  7. 15Our research, development and clinical programs, as well as our manufacturing and marketing operations, are subject to extensive regulation in countries outside of the U.S
  8. 16We are also subject to domestic and foreign laws and regulations covering data privacy and the protection of health-related and other personal information. Domestic privacy and data security laws are complex and changing rapidlyNew
  9. 17courts and data protection authorities may have different interpretations of applicable law, leading to potential inconsistencies in application of these laws. In addition to data privacy and security laws, we have contractual obligations related to privacy and securityNew
  10. 18Legislative, regulatory, or other healthcare reforms may make it more difficult and costly for us to obtain regulatory approval or CE Certificates of Conformity for our products and to produce, market and distribute our products after approval or certification is obtained61% rewritten
  11. 19reducing federal funding, and limiting provider taxes used to fund the program. Congress is considering proposed legislation intended to further reduce healthcare costs with alternatives to replace the expired ACA subsidiesNew

Risks Related to Government Contracts

  1. 20Unfavorable provisions in government contracts, including in our contracts with BARDA and DoD, may harm our business, financial condition and operating results
  2. 21change certain terms and conditions in our BARDA agreements
  3. 22If we fail to maintain compliance with these requirements, we may be subject to potential liability and to the termination of our government contracts
  4. 23Laws and regulations affecting government contracts, including our agreements with BARDA and DoD, make it more costly and difficult for us to successfully conduct our business. Failure to comply with laws and regulations could result in significant civil and criminal penalties and adversely affect our business
  5. 24laws, regulations and executive orders restricting the exportation of certain products and technical data

Risks Related to Our Reliance on Third Parties

  1. 25We rely on third parties to market, sell, distribute and maintain our products and to maintain customer relationships in certain countries
  2. 26Our manufacturing supply chain exposes us to significant risks21% rewritten
  3. 27unforeseen potential disruption to manufacturing which could consume our cash resources faster than we anticipate and may cause our supply chain to be less efficientNew

Risks Related to Our Financial Condition and Capital Requirements

  1. 28We expect to continue to generate losses and we may never achieve a profitable level of operations
  2. 29If we fail to obtain the capital necessary to fund our future operations or if we are unable to generate sufficient positive cash flows from our operations, we will need to curtail planned development or sales and commercialization activities

Risks Related to Managing Our Growth and Other Business Risks

  1. 30Adverse market and economic conditions may exacerbate certain risks affecting our business42% rewritten
  2. 31Risks associated with our operations outside of the United States could adversely affect our business
  3. 32cultural differences in the conduct of business63% rewritten
  4. 33If we fail to attract, retain and motivate key personnel or to retain the members of our executive management team, our operations and our future growth may be adversely affected51% rewritten
  5. 34Disruptions or other compromises of information technology systems or actual or perceived breaches of data security could adversely affect our business58% rewritten
  6. 35Additionally, future or past business transactions (such as acquisitions or integrations) could expose us to additional cybersecurity risks and vulnerabilities, as our systems could be negatively affected by vulnerabilities present in acquired or integrated entities’ systems and technologiesNew
  7. 36Uncertainties in the interpretation and application of existing, new and proposed tax laws and regulations could materially affect our tax obligations and effective tax rate
  8. 37Our ability to use our net operating loss carryforwards and certain other tax attributes is uncertain and may be limited

Risks Related to Our Intellectual Property

  1. 38We may not be able to protect our intellectual property or operate our business without infringing intellectual property rights of others
  2. 39prevent others from infringing on our proprietary rights

Risks Related to Our Common Stock

  1. 40Our stock price is volatile and your investment may suffer a decline in value
  2. 41any claim or cause of action against us or any of our current or former directors, officers or other employees, or our stockholders, governed by the internal affairs doctrine or otherwise related to our internal affairs
  3. 42Because we do not anticipate paying any cash dividends on our common stock in the foreseeable future, capital appreciation, if any, will be your sole source of gain
  4. 43Provisions of our charter documents, our compensatory arrangements and Delaware law could make it more difficult for a third-party to acquire us, even if the offer may be considered beneficial by our stockholders

Other Cerus 10-Ks

  • FY2024 10-K risk factors
    44 risks

    Cerus is commercializing the INTERCEPT Blood System amid concentration risks and stringent global healthcare regulations. The company relies heavily on third-party manufacturers, government contracts like BARDA, and achieving broader market adoption. Sustaining profitability and financing ongoing clinical developments remain central financial challenges.

    Filed Feb 26, 2025

About this page

The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.