Orasure Technologies (OSUR) risk factors, FY2025 10-K

Risks Relating to Products, Marketing and Sales

1. 01Changes in the Genomics Market May Adversely Affect the Company's Business
2. 02The Company's Future Success Depends Upon Market Acceptance of its Existing and Future Products and Service Offerings38% rewritten
3. 03If Acceptance and Adoption of Oral Fluid Testing and Collection Products Does Not Continue, the Company's Future Results May Suffer
4. 04The Company Expects to Face Increasing Competition From Other Providers of Diagnostic Tests and Sample Collection Products73% rewritten
5. 05ORAcollect® products. Additionally, there are a number of products for the detection of antigen to SARS-CoV-2 that compete with the Company's InteliSwab® COVID-19 diagnostic testNew
6. 06The Company's Product Sales Cycles Can be Lengthy, and May Depend on Public Funding, Which Can Cause Variability and Unpredictability in the Company's Operating Results
7. 07The Company's Inability To Expand International Sales Could Adversely Affect its Business and Results of Operations
8. 08The Company's International Presence May Increase Its Risks and Expose Its Business to Regulatory, Cultural or Other Restraints
9. 09The Company's U.S. Government Contracts Require Compliance With Numerous Laws and Increases Its Risk and Liability26% rewritten
10. 10The Company's Inability to Manufacture Products in Accordance with Applicable Specifications, Performance Standards or Quality Requirements Could Adversely Affect Its Business26% rewritten
11. 11The Company's Business Will Suffer if It Does Not Effectively Manage Challenges to Its Manufacturing Processes and It May be Unable to Successfully Scale-Up Manufacturing of Its Products in Sufficient Quality and Quantity to Meet Demand, Which Would Negatively Impact Revenue Expectations
12. 12The Company's Business Results Depend on Its Ability to Manage Disruptions in Its Domestic and Global Supply Chains and Distribution Channels38% rewritten
13. 13Certain of the Company's Products Depend on Components From a Sole-Source Supplier, the Loss of Which Would Cause the Company to be Unable to Deliver Such Products
14. 14The Company's U.S. Government Contracts May Affect Its Intellectual Property Rights
15. 15The Company's U.S. Government Contracts and Related Administrative Processes Are Subject to Audits and Cost Adjustments by the Federal Government
16. 16The Company Expects Revenue Levels From its InteliSwab® COVID-19 Rapid Test to Continue to Decline35% rewritten
17. 17Marketing of the Company's COVID-19 Tests and Collection Kits Under EUAs from the FDA Is Subject To Certain Limitations and the Company Is Required To Maintain Compliance with the Terms of the EUA, Among Other Things, and the Continuance of the EUAs Is Subject To Government Discretion

Risks Relating to the Company's Industry, Business and Strategy

1. 18Consolidation in the Healthcare Industry Could Adversely Affect the Company's Future Revenues and Operating Results
2. 19The Company's Research, Development and Commercialization Efforts May Not Succeed and Its Competitors May Develop and Commercialize More Effective or Successful Offerings
3. 20Customer Concentration Creates Risk for the Company's Business25% rewritten
4. 21The Company is Subject to Risks Related to Government Funding and Customer Ordering78% rewritten
5. 22life sciences procurement. Any reduction, delay, or uncertainty in the availability of such funding could adversely affect the purchasing patterns of these customers, impacting our business, financial condition, and results of operationsNew
6. 23Acquisitions or Investments May Not Generate the Expected Benefits and Could Disrupt the Company's Ongoing Business, Distract Its Management, Increase Its Expenses and Adversely Affect Its Business
7. 24The Company's Revenues Could be Affected by Third-Party Reimbursement Policies and Potential Cost Constraints
8. 25Changes in Healthcare Regulation Could Affect the Company's Revenues, Costs and Financial Condition
9. 26New or Changed Testing Guidelines Could Affect Sales of the Company's Diagnostic Products
10. 27Reductions in Government Funding and Research Budgets Could Adversely Affect the Company's Business and Financial Results

Risks Relating to the Company's Reliance on Third Parties

1. 28The Company's Failure to Maintain Existing Distribution Channels, or Develop New Distribution Channels, May Result in Lower Revenues
2. 29The Company has marketed many of its products by collaborating with laboratories, diagnostic companies and distributors. Its sales depend to a substantial degree on its ability to sell products to these customers and on the marketing and distribution abilities of the companies with which it collaborates
3. 30The Company May Need Strategic Partners to Assist in Developing and Commercializing Some of Its Products

Risks Relating to Intellectual Property

1. 31The Company's Success Depends on Its Ability to Protect Its Proprietary Technology
2. 32The Company May Become Involved in Intellectual Property Disputes, Which Could Increase Its Costs and Limit or Eliminate Its Ability to Sell Products, Provide Services or Use Certain Technologies

Regulatory Risks

1. 33The Need to Obtain Regulatory Approvals, Clearances, Authorizations or Certifications Could Increase the Company's Costs and Adversely Affect Its Financial Performance
2. 34Failure to Comply With FDA or Other Regulatory Requirements May Require the Company to Suspend Production or Sale of Its Products or Institute a Recall Which Could Result in Higher Costs and a Loss of Revenues45% rewritten
3. 35components or materials and of its distributors to sell its products could also be adversely affected if their operations are determined to be out of compliance. Such actions by the FDA and other regulatory bodies could adversely affect the Company's revenues, costs and results of operationsNew
4. 36The Company's Inability to Respond to Changes in Regulatory Requirements Could Adversely Affect Its Business
5. 37The Company Is Subject to Numerous Government Regulations in Addition to FDA Requirements, Which Could Increase the Company's Costs and Affect Its Operations
6. 38Disruptions at the FDA and Other Government Agencies, Including Staffing Constraints, and Funding Uncertainty, Could Delay or Prevent the Development, Review, Approval, or Commercialization of Our Products and Adversely Affect Our BusinessNew
7. 39Failure to Comply With Privacy, Security and Breach Notification Regulations May Increase the Company's Costs
8. 40Failure to Comply With Data Protection Requirements or Privacy Laws Could Increase the Company's Costs30% rewritten
9. 41Changes In Tax Laws Or In Their Implementation Or Interpretation May Adversely Affect Us Or Our InvestorsNew
10. 42The Use of New And Evolving Technologies, Such As Artificial Intelligence (“AI”), In Our Offerings May Present Risks And Challenges That Can Impact Our Business Including by Posing Security Risks to Our Confidential Information, Proprietary Information, and Personal Data62% rewritten
11. 43FDA Regulation of Laboratory-Developed Tests and Genetic Testing Could Affect Demand For the Company's Products61% rewritten
12. 44The Company's International Sales Create Potential Exposure Under Anti-Corruption Laws

Risks Relating to the Economy, the Company's Financial Results, Investments, and Need for Financing

1. 45The Company Has Experienced Losses in the Past and May Not Be Able to Again Achieve and Maintain Profitable Operations
2. 46Increasing Geopolitical and Economic Risk and Tariffs Could Negatively Affect Our Ability to Maintain Sales at Existing Levels52% rewritten
3. 47An Impairment of Goodwill and Intangible Assets Could Reduce the Company's Earnings
4. 48Changes in Foreign Currency Exchange Rates Could Negatively Affect the Company's Operating Results

Risks Relating to the Company's Common Stock

1. 49The Company's Stock Price Could Continue to be Volatile
2. 50Share Repurchases Could Increase the Volatility of the Trading Price of Our Common Stock and Diminish Our Cash Reserves, and We Cannot Guarantee That Our Stock Repurchase Program Will Enhance Long-Term Stockholder ValueNew
3. 51Future Sales of the Company's Common Stock by Existing Stockholders, Executive Officers or Directors Could Depress the Market Price of Its Common Stock and Make It More Difficult for the Company to Sell Stock in the Future
4. 52Because the Company Does Not Intend to Pay Cash Dividends on Its Common Stock, an Investor in the Company's Common Stock Will Benefit Only if the Its Common Stock Appreciates in Value
5. 53Certain Provisions in the Company's Certificate of Incorporation and Bylaws and Under Delaware Law Could Make a Third-Party Acquisition of the Company Difficult
6. 54Our Business Could be Negatively Affected as a Result of Actions of Activist StockholdersNew
7. 55The Company May Face Product Liability Claims for Injuries Resulting From the Use of Its Products
8. 56Performance of the Company's Products May Affect Its Revenues, Stock Price and Reputation
9. 57Failure to Achieve the Company's Financial and Strategic Objectives Could Have a Material Adverse Impact on Its Business Prospects
10. 58If the Company Fails To Establish and Maintain Proper And Effective Internal Control Over Financial Reporting, Its Operating Results and Its Ability to Operate Its Business Could Be Harmed
11. 59If the Company Loses Key Personnel or Is Unable to Attract and Retain Qualified Personnel as Necessary, Its Business Could be Harmed
12. 60Increases in Demand for the Company's Products and Services Could Require It to Expend Considerable Resources or Harm Its Customer Relationships if It Is Unable to Meet That Demand
13. 61The Company Relies on Information Technology in Its Operations and Any Material Failure, Inadequacy, Interruption or Security Breach of that Technology Could Harm Its Ability to Efficiently Operate Its Business
14. 62Cybersecurity Incidents and Other Disruptions Could Compromise the Company's Information, Expose It to Liability and Harm Its Reputation and Business
15. 63Federal and State Laws Pertaining to Healthcare Fraud and Abuse Could Adversely Affect the Company's Business, Financial Condition and Results of Operations
16. 64The Company May Experience Fluctuations in Its Financial Results or Fail to Meet Its Financial Projections33% rewritten
17. 65Company's sales from year-to-year. This can make it difficult to accurately forecast whether the Company will achieve its quarterly sales forecasts and can cause variability in its operating resultsNew
18. 66The Company May Require Future Additional Capital
19. 67Conditions in the Banking System and Financial Markets, Including the Failure of Banks and Financial Institutions, Could Have an Adverse Effect on the Company's Operations and Financial Results20% rewritten
20. 68Terrorist Attacks, Natural Disasters, Public Health Crises, Political Unrest or Other Catastrophic Events Outside of the Company's Control May Adversely Affect Its Business
21. 69Future Sales of Shares of the Company's Common Stock Could Adversely Affect the Trading Price of Its Common Stock and Its Ability to Raise Funds in New Equity Offerings