Orasure Technologies (OSUR) risk factors, FY2024 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 Offerings
3. 03The Company Expects Revenue Levels From its InteliSwab® COVID-19 Rapid Test to Continue to Decline
4. 04Marketing 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
5. 05If Acceptance and Adoption of Oral Fluid Testing and Collection Products Does Not Continue, the Company's Future Results May Suffer
6. 06The Company Expects to Face Increasing Competition From Other Providers of Diagnostic Tests and Sample Collection Products
7. 07The 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
8. 08The Company's Inability To Expand International Sales Could Adversely Affect its Business and Results of Operations
9. 09The Company's International Presence May Increase Its Risks and Expose Its Business to Regulatory, Cultural or Other Restraints
10. 10The Company's U.S. Government Contracts Require Compliance With Numerous Laws and Increases Its Risk and Liability
11. 11The Company's Inability to Manufacture Products in Accordance with Applicable Specifications, Performance Standards or Quality Requirements Could Adversely Affect Its Business
12. 12The 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
13. 13The Company's Business Results Depend on Its Ability to Manage Disruptions in Its Domestic and Global Supply Chains and Distribution Channels
14. 14including the potential increase to the federal minimum wage in the United States that has been recently proposed by the current administration
15. 15Certain 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
16. 16The Company's U.S. Government Contracts May Affect Its Intellectual Property Rights
17. 17The Company's U.S. Government Contracts and Related Administrative Processes Are Subject to Audits and Cost Adjustments by the Federal Government

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 Business
4. 21The Company is Subject to Risks Related to Government Funding and Customer Ordering
5. 22Acquisitions 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
6. 23the Company's inability to successfully assimilate differences in foreign business practices or overcome language or cultural barriers and other inherent risks of operating in unfamiliar legal and regulatory environments
7. 24We May Fail to Realize the Anticipated Benefits of the Acquisition of Sherlock
8. 25The Company's Revenues Could be Affected by Third-Party Reimbursement Policies and Potential Cost Constraints
9. 26Changes in Healthcare Regulation Could Affect the Company's Revenues, Costs and Financial Condition
10. 27New or Changed Testing Guidelines Could Affect Sales of the Company's Diagnostic Products
11. 28Reductions 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. 29The Company's Failure to Maintain Existing Distribution Channels, or Develop New Distribution Channels, May Result in Lower Revenues
2. 30The 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. 31The Company May Need Strategic Partners to Assist in Developing and Commercializing Some of Its Products

Risks Relating to Intellectual Property

1. 32The Company's Success Depends on Its Ability to Protect Its Proprietary Technology
2. 33The 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. 34The Need to Obtain Regulatory Approvals, Clearances, Authorizations or Certifications Could Increase the Company's Costs and Adversely Affect Its Financial Performance
2. 35Failure 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 Revenues
3. 36The Company's Inability to Respond to Changes in Regulatory Requirements Could Adversely Affect Its Business
4. 37The Company Is Subject to Numerous Government Regulations in Addition to FDA Requirements, Which Could Increase the Company's Costs and Affect Its Operations
5. 38Failure to Comply With Privacy, Security and Breach Notification Regulations May Increase the Company's Costs
6. 39Failure to Comply With Data Protection Requirements or Privacy Laws Could Increase the Company's Costs
7. 40The 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 Data
8. 41FDA Regulation of Laboratory-Developed Tests and Genetic Testing Could Affect Demand For the Company's Products
9. 42On April 29, 2024, the FDA published a final rule on LDTs, in which FDA outlines its plan to end enforcement discretion for many LDTs in five stages over a four-year period
10. 43The 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. 44The Company Has Experienced Losses in the Past and May Not Be Able to Again Achieve and Maintain Profitable Operations
2. 45Increasing Geopolitical and Economic Risk and Tariffs Could Negatively Affect Our Ability to Maintain Sales at Existing Levels
3. 46An Impairment of Goodwill and Intangible Assets Could Reduce the Company's Earnings
4. 47Changes in Foreign Currency Exchange Rates Could Negatively Affect the Company's Operating Results

Risks Relating to the Company's Common Stock

1. 48The Company's Stock Price Could Continue to be Volatile
2. 49Future 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
3. 50Because 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
4. 51Certain Provisions in the Company's Certificate of Incorporation and Bylaws and Under Delaware Law Could Make a Third-Party Acquisition of the Company Difficult
5. 52The Company May Face Product Liability Claims for Injuries Resulting From the Use of Its Products
6. 53Performance of the Company's Products May Affect Its Revenues, Stock Price and Reputation
7. 54The Company's Ability to Sell Products Could be Adversely Affected by Competition From New and Existing Products and Services
8. 55Failure to Achieve the Company's Financial and Strategic Objectives Could Have a Material Adverse Impact on Its Business Prospects
9. 56If 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
10. 57If the Company Loses Key Personnel or Is Unable to Attract and Retain Qualified Personnel as Necessary, Its Business Could be Harmed
11. 58Increases 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
12. 59The 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
13. 60Cybersecurity Incidents and Other Disruptions Could Compromise the Company's Information, Expose It to Liability and Harm Its Reputation and Business
14. 61Federal and State Laws Pertaining to Healthcare Fraud and Abuse Could Adversely Affect the Company's Business, Financial Condition and Results of Operations
15. 62The Company May Experience Fluctuations in Its Financial Results or Fail to Meet Its Financial Projections
16. 63The Company May Require Future Additional Capital
17. 64Conditions 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 Results
18. 65Economic Volatility and Disruption Resulting from the COVID-19 Pandemic and any Future Pandemic and Health Crises Could Adversely Affect the Company’s Business, Financial Performance, Results of Operations, Cash Flow and Financial Condition or Those of Its Customers and Suppliers
19. 66Terrorist Attacks, Natural Disasters, Public Health Crises, Political Unrest or Other Catastrophic Events Outside of the Company's Control May Adversely Affect Its Business
20. 67The Increasing Prevalence of AI-based Software Presents New Risks and Could Adversely Affect Our Business and Reputation
21. 68Future 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