Orasure Technologies Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Orasure Technologies Inc. has filed its annual 10-K report for the fiscal year 2023, detailing its financial performance and business operations.</b>

AI Summary

ORASURE TECHNOLOGIES INC (OSUR) filed a Annual Report (10-K) with the SEC on March 11, 2024. Orasure Technologies Inc. filed its 10-K report for the fiscal year ending December 31, 2023. The filing covers the period from January 1, 2023, to December 31, 2023. The company's principal business address is 220 E First St, Bethlehem, PA 18015. Orasure Technologies Inc. is classified under SIC code 3841 for Surgical & Medical Instruments & Apparatus. The report includes financial data for the fiscal years 2023, 2022, and 2021.

Why It Matters

For investors and stakeholders tracking ORASURE TECHNOLOGIES INC, this filing contains several important signals. This 10-K filing provides a comprehensive overview of Orasure's financial health and strategic direction for investors and stakeholders. The detailed financial statements and risk factors within the report are crucial for understanding the company's operational performance and future outlook.

Risk Assessment

Risk Level: — ORASURE TECHNOLOGIES INC shows moderate risk based on this filing. The company's financial performance and future prospects are subject to various market and operational risks inherent in the medical device industry, as detailed in the 10-K filing.

Analyst Insight

Review the detailed financial statements and risk factors in the 10-K filing to assess Orasure Technologies Inc.'s current financial health and future growth potential.

Key Numbers

• 2023-12-31 — Fiscal Year End (Conformed period of report)
• 2024-03-11 — Filing Date (As of date)
• 3841 — SIC Code (Standard Industrial Classification)

Key Players & Entities

• ORASURE TECHNOLOGIES INC (company) — Filer name
• 20231231 (date) — Fiscal year end
• 20240311 (date) — Filing date
• Bethlehem, PA (location) — Business address city and state
• 3841 (industry_code) — Standard Industrial Classification

FAQ

Industry Context

Orasure Technologies Inc. operates in the medical instruments and apparatus industry, focusing on diagnostic products and medical devices.

Regulatory Implications

The company is subject to standard SEC regulations for public companies, including the requirement to file annual reports (10-K) detailing financial performance and business operations.

What Investors Should Do

1. Analyze the revenue segments and growth rates for 'ProductAndServicesMember' and 'OtherRevenuesMember' for the past three fiscal years.
2. Examine the changes in 'CommonStockMember', 'AdditionalPaidInCapitalMember', 'AccumulatedOtherComprehensiveIncomeMember', and 'RetainedEarningsMember' from 2020 to 2023.
3. Investigate the details of 'AssetImpairmentCharges' and its impact on the company's financial statements.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K filing.
• 2024-03-11: Filing Date — Date the 10-K report was officially filed with the SEC.

Year-Over-Year Comparison

This filing is the 2023 Form 10-K, representing the annual report for the fiscal year ending December 31, 2023.

Key Financial Figures

• $0.000001 — ange on Which Registered Common Stock, $0.000001 par value per share OSUR The Nasdaq Sto
• $205 million — ch the DLA estimated to have a value of $205 million and which would provide InteliSwab test
• $13.6 million — tents which BARDA would provide up to $13.6 million in funding to obtain clearance of a pre
• $8.6 million — suant to which BARDA will provide up to $8.6 million in funding to the Company to develop a
• $6.8 million — ement was modified to add an additional $6.8 million in funding to be used to obtain the app

Filing Documents

• osur-20231231.htm (10-K) — 1859KB
• exhibit23_consent.htm (EX-23) — 2KB
• exhibit24powersofattorney.htm (EX-24) — 24KB
• osur-20231231xexx311.htm (EX-31.1) — 10KB
• osur-20231231xexx312.htm (EX-31.2) — 10KB
• osur-20231231xexx321.htm (EX-32.1) — 4KB
• osur-20231231xexx322.htm (EX-32.2) — 4KB
• exhibit971_compensationrec.htm (EX-97.1) — 36KB
• osur-20231231_g1.jpg (GRAPHIC) — 274KB
• 0001116463-24-000012.txt (&nbsp;) — 9944KB
• osur-20231231.xsd (EX-101.SCH) — 66KB
• osur-20231231_cal.xml (EX-101.CAL) — 114KB
• osur-20231231_def.xml (EX-101.DEF) — 276KB
• osur-20231231_lab.xml (EX-101.LAB) — 766KB
• osur-20231231_pre.xml (EX-101.PRE) — 560KB
• osur-20231231_htm.xml (XML) — 1220KB

Business

Business 2 ITEM 1A.

Risk Factors

Risk Factors 22 ITEM 1B. Unresolved Staff Comments 56 ITEM IC. Cybersecurity 56 ITEM 2.

Properties

Properties 57 ITEM 3.

Legal Proceedings

Legal Proceedings 58 ITEM 4. Mine Safety Disclosures 58 PART II ITEM 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 59 ITEM 6. Reserved 60 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 60 ITEM 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 66 ITEM 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 67 ITEM 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 67 ITEM 9A.

Controls and Procedures

Controls and Procedures 67 ITEM 9B. Other Information 69 ITEM 9C. Disclosure Regarding Foreign Jurisdictions That Prevent Inspections 69 PART III ITEM 10. Directors, Executive Officers and Corporate Governance 70 ITEM 11.

Executive Compensation

Executive Compensation 70 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 70 ITEM 13. Certain Relationships and Related Transactions, and Director Independence 70 ITEM 14. Principal Accountant Fees and Services 70 PART IV ITEM 15. Exhibits and Consolidated Financial Statement Schedules 71 ITEM 16. Form 10-K Summary 73

Signatures

Signatures 74 Table of Contents Use of Names References in this Annual Report on Form 10-K for the fiscal year ended December 31, 2023, (the "Annual Report") to "OraSure" mean OraSure Technologies, Inc. References in this Annual Report to "DNAG" mean DNA Genotek, Inc., references to "Diversigen" mean Diversigen, Inc., and references to "Novosanis" mean Novosanis NV. References in this Annual Report to "we", "us", "our", or the "Company" mean OraSure and its consolidated subsidiaries, DNAG, Diversigen, and Novosanis, unless otherwise indicated. Disclosure Regarding Forward Looking Statements This Annual Report contains certain "forward-looking statements," within the meaning of the Federal securities laws. These may include statements about the Company's expected revenues, earnings/losses per share, net income (loss), expenses, cash flow or other financial performance, or developments, clinical trial or development activities, expected regulatory filings and approvals, planned business transactions, views of future industry, competitive or market conditions, and other factors that could affect the Company's future operations, results of operations or financial position. These statements often include words, such as "believes," "expects," "anticipates," "intends," "plans," "estimates," "may," "will," "should," "could," or similar expressions. Forward-looking statements are not guarantees of future performance or results. Known and unknown factors that could cause actual performance or results to be materially different from those expressed or implied in these statements include, but are not limited to: Market acceptance of, and the Company's ability to market and sell, its products and services, whether through its internal, direct sales force or third parties; The Company's ability to fulfill its commitments under its contracts with the U.S. government for InteliSwab COVID-19 Rapid Tests; Failure of distributors or other customers to meet purchase foreca

Business

ITEM 1. Business. OraSure Technologies transforms health through actionable insight by powering the shift that connects people to healthcare wherever they are. In February 2023, the Company announced a corporate restructuring to combine the commercial and innovation teams across two segments, being the "Diagnostics" segment and the "Molecular Solutions" segment, into one business unit with sales, marketing, product development and research teams covering multiple product lines. This change is intended to accelerate innovation, enhance customer experience and result in operational synergies. As a result, all products and services reside under one reporting hierarchy. The Company's product portfolio is broadly divided into diagnostics products and sample management solutions. Products and Services The Company's business consists of the development, manufacture, marketing and sale of simple, easy to use diagnostic products and specimen collection devices using its proprietary technologies, as well as other diagnostic products including immunoassays and other in vitro diagnostic tests that are used on other specimen types. Our diagnostic products include tests for diseases including COVID-19, HIV and Hepatitis C that are performed on a rapid basis at the point of care, and tests for drugs of abuse that are processed in a laboratory. These products are sold in the United States and internationally to various clinical laboratories, hospitals, clinics, community-based organizations, and other public health organizations, distributors, government agencies, physicians' offices, and commercial and industrial entities. The Company's COVID-19 and HIV products are also sold in a consumer-friendly format in the over-the-counter ("OTC") market in the U.S. and, in the case of the HIV product, as a self-test to individuals in a number of other countries, including as an oral swab in-home test for HIV-1 and HIV-2 in Europe. The Company's business also includes molecular sample m

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