Cerus (CERS) risk factors, FY2024 10-K

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.S
6. 06candidates in preclinical studies and clinical trials and products emerging from any successful trial may not reach the market for several years
7. 07The red blood cell system is currently in development and may never receive any marketing approvals or CE Certificates of Conformity

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

1. 08Our 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
2. 09In 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
3. 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
4. 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
5. 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
6. 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
7. 14the Federal Trade Commission Act and similar laws regulating advertisement and consumer protections; and
8. 15performance 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
9. 16Our 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
10. 17and/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
11. 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 obtained
12. 19implemented 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
13. 20significant changes to the health care system, which could have a material adverse effect on our business, results of operations, financial condition and growth prospects

Risks Related to Government Contracts

1. 21Unfavorable provisions in government contracts, including in our contracts with BARDA, FDA and DoD, may harm our business, financial condition and operating results
2. 22change certain terms and conditions in our BARDA agreements
3. 23If we fail to maintain compliance with these requirements, we may be subject to potential liability and to the termination of our government contracts
4. 24Laws and regulations affecting government contracts, including our agreements with BARDA, FDA 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. 25laws, regulations and executive orders restricting the exportation of certain products and technical data

Risks Related to Our Reliance on Third Parties

1. 26We rely on third parties to market, sell, distribute and maintain our products and to maintain customer relationships in certain countries
2. 27Our manufacturing supply chain exposes us to significant risks
3. 28cost 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

Risks Related to Our Financial Condition and Capital Requirements

1. 29We expect to continue to generate losses and we may never achieve a profitable level of operations
2. 30If 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. 31Adverse market and economic conditions may exacerbate certain risks affecting our business
2. 32Risks associated with our operations outside of the United States could adversely affect our business
3. 33cultural differences in the conduct of business
4. 34If 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
5. 35employees 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
6. 36Significant disruptions of information technology systems or actual or alleged breaches of data security could adversely affect our business
7. 37Uncertainties 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. 38Our 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. 39We may not be able to protect our intellectual property or operate our business without infringing intellectual property rights of others
2. 40prevent others from infringing on our proprietary rights

Risks Related to Our Common Stock

1. 41Our stock price is volatile and your investment may suffer a decline in value
2. 42any 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. 43Because 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. 44Provisions 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