Cerus Corp Files 2023 Annual Report on Form 10-K

TL;DR

<b>Cerus Corporation filed its 2023 10-K, detailing financial performance, business operations, and risk factors.</b>

AI Summary

CERUS CORP (CERS) filed a Annual Report (10-K) with the SEC on March 5, 2024. Cerus Corporation filed its annual report for the fiscal year ended December 31, 2023. The filing includes financial data and business operations for the period. Key financial statement items such as revenue, net income, and debt are detailed. The report covers the company's performance and strategic initiatives. Risk factors and forward-looking statements are also presented.

Why It Matters

For investors and stakeholders tracking CERUS CORP, this filing contains several important signals. This 10-K filing provides a comprehensive overview of Cerus Corp's financial health and operational status for the fiscal year 2023, crucial for investors to assess performance and future prospects. Understanding the disclosed risk factors and business segments is essential for evaluating potential challenges and opportunities facing Cerus Corp in the medical device industry.

Risk Assessment

Risk Level: medium — CERUS CORP shows moderate risk based on this filing. The company's financial performance and future outlook are subject to various risks, including market adoption of its products and competition, as detailed in the risk factors section.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to make informed investment decisions regarding Cerus Corp.

Key Numbers

• 20231231 — Fiscal Year End (Conformed period of report)
• 106 — Public Document Count (Number of documents in the filing)
• 20240305 — Filing Date (Date the report was filed)
• 3841 — SIC Code (Standard Industrial Classification)

Key Players & Entities

• CERUS CORP (company) — Filer name
• 20231231 (date) — Conformed period of report
• 20240305 (date) — Filed as of date
• 000-21937 (company) — SEC file number
• 9252886000 (phone) — Business phone
• CERUS TECHNOLOGIES INC (company) — Former company name
• 19960731 (date) — Date of name change
• American Red Cross (company) — Customer concentration risk

FAQ

Risk Factors

• Customer Concentration Risk [medium — market]: A significant portion of revenue may be derived from a limited number of customers, such as the American Red Cross, making the company vulnerable to changes in these relationships.

Industry Context

Cerus Corporation operates in the medical instruments and apparatus industry, focusing on blood safety technologies.

Regulatory Implications

The company's operations are subject to regulatory oversight typical for medical device manufacturers, including compliance with FDA regulations and international standards.

What Investors Should Do

1. Analyze the detailed financial statements for revenue trends, profitability, and cash flow.
2. Evaluate the risk factors, particularly customer concentration and market adoption, to understand potential business challenges.
3. Review management's discussion and analysis for insights into strategic priorities and future outlook.

Year-Over-Year Comparison

This filing is the annual 10-K report for the fiscal year ended December 31, 2023, providing updated financial and operational information compared to previous filings.

Key Financial Figures

• $0.001 — h Registered Common Stock , par value $0.001 per share CERS The Nasdaq Stock Mar
• $2.46 — (1) Based on a closing sale price of $2.46 per share on June 30, 2023. Excludes 29

Filing Documents

• cers-20231231.htm (10-K) — 3349KB
• cers-ex4_2.htm (EX-4.2) — 22KB
• cers-ex10_1.htm (EX-10.1) — 96KB
• cers-ex10_3.htm (EX-10.3) — 175KB
• cers-ex10_4.htm (EX-10.4) — 61KB
• cers-ex10_6.htm (EX-10.6) — 131KB
• cers-ex10_9.htm (EX-10.9) — 76KB
• cers-ex10_10.htm (EX-10.10) — 119KB
• cers-ex10_12.htm (EX-10.12) — 109KB
• cers-ex21_1.htm (EX-21.1) — 5KB
• cers-ex23_1.htm (EX-23.1) — 4KB
• cers-ex31_1.htm (EX-31.1) — 13KB
• cers-ex31_2.htm (EX-31.2) — 13KB
• cers-ex32_1.htm (EX-32.1) — 9KB
• img117975587_0.jpg (GRAPHIC) — 2KB
• img234657320_0.jpg (GRAPHIC) — 18KB
• 0000950170-24-026195.txt (&nbsp;) — 14669KB
• cers-20231231.xsd (EX-101.SCH) — 1616KB
• cers-20231231_htm.xml (XML) — 2861KB

Business

Business 5 Item 1A.

Risk Factors

Risk Factors 22 Item 1B. Unresolved Staff Comments 59 Item 1C. Cybersecurity 59 Item 2.

Properties

Properties 59 Item 3.

Legal Proceedings

Legal Proceedings 60 Item 4. Mine Safety Disclosures 60 PART II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 61 Item 6. Reserved 61 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 62 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 73 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 73 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 73 Item 9A.

Controls and Procedures

Controls and Procedures 74 Item 9B. Other Information 76 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 76 PART III Item 10. Directors, Executive Officers and Corporate Governance 77 Item 11.

Executive Compensation

Executive Compensation 77 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 77 Item 13. Certain Relationships and Related Transactions, and Director Independence 78 Item 14. Principal Accountant Fees and Services 78 PART IV Item 15. Exhibits and Financial Statement Schedules 79 Item 16. Form 10-K Summary 84

SIGNATURES

SIGNATURES 112 SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended, that involve risks and uncertainties. The forward-looking statements are contained principally in Item 1, "Business," Item 7, "Management's Discussion and Analysis of Financial Condition and Results of Operations," and in Item 1A, "Risk Factors." These statements relate to future events or to our future operating or financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These forward-looking statements may include, but are not limited to, statements about: the impact of macroeconomic developments, including the ongoing conflict between Ukraine and Russia and the state of war between Israel and Hamas and the risk of a larger regional conflict on our business and operations as well as the business or operations of our customers, manufacturers, research partners, and other third parties with whom we conduct business; future sales of and anticipated demand for, and our ability to effectively commercialize and achieve market acceptance of the INTERCEPT Blood System, including our ability to comply with applicable United States, or U.S., and foreign laws, regulations and regulatory requirements; our ability to successfully complete the development of, receive regulatory approvals for and commercialize the red blood cell system; our strategy and the potential therapeutic applications for the INTERCEPT Blood System; our ability to manage the growth of our business and attendant cost increases, including in connection with the commercialization of the

B usiness

Item 1. B usiness Overview We are a biomedical products company focused on developing and commercializing the INTERCEPT Blood System to enhance blood safety. The INTERCEPT Blood System, which is based on our proprietary technology for controlling biological replication, is designed to reduce blood-borne pathogens in donated blood components intended for transfusion. Our INTERCEPT Blood System is intended for use with blood components and certain of their derivatives: platelets, plasma, red blood cells and to produce INTERCEPT Fibrinogen Complex, or IFC, and pathogen reduced plasma, cryoprecipitate reduced. The INTERCEPT Blood System for platelets, or platelet system, and the INTERCEPT Blood System for plasma, or plasma system, have received a broad range of regulatory approvals and certification, including but not limited to FDA approval in the U.S., CE Certificates of Conformity delivered in accordance with the Medical Devices Directive 93/42/EEC, or MDD, and the Medical Devices Regulation 2017/745, or MDR, permitting us to affix the CE Mark to our products and place them on the market in the European Union and other jurisdictions that recognize the CE Mark, and are being marketed and sold in a number of countries around the world, including the U.S., certain countries in Europe, the Commonwealth of Independent States, or CIS, the Middle East, and Latin America and selected countries in other regions of the world. Additionally, we have received FDA approval for the INTERCEPT Blood System for Cryoprecipitation. The INTERCEPT Blood System for Cryoprecipitation uses our plasma system to produce IFC for the treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency. In addition, the INTERCEPT Blood System for Cryoprecipitation is used to produce pathogen reduced plasma, cryoprecipitate reduced. We currently sell the platelet and plasma systems using our direct sales force and through distributors and sell IFC or disposa

View Full Filing

View this 10-K filing on SEC EDGAR