Sight Sciences (SGHT) risk factors, FY2025 10-K

Risks Related to Our Business

1. 01We are an early-stage company with a history of significant losses, we expect to incur losses in the future, and we may not be able to achieve or sustain profitability, which may make it difficult to evaluate the success of our business to date and to assess prospects for our future viability28% rewritten
2. 02We are highly dependent on revenue from the sales of our products, and our inability to successfully execute our growth strategy could negatively affect our results of operations and financial condition30% rewritten
3. 03Our business is dependent upon the broad adoption and continued use of our products by eyecare professionals and patients
4. 04Perceptions regarding the time commitment and skill development that may be required to gain familiarity and proficiency with our Interventional Glaucoma and Interventional Dry Eye products41% rewritten
5. 05customer and patient expectations and any resulting negative perceptions or publicity could harm our reputation and future sales and therefore adversely affect our business, financial condition and results of operationsNew
6. 06Established sales, marketing and worldwide distribution networks55% rewritten
7. 07Adoption of our products depends upon appropriate physician training, practice and patient selection55% rewritten
8. 08or harm our ability to meet the demand for our products in a timely manner, either of which could have a material adverse effect on our business, financial condition and results of operationsNew
9. 09Uncertainty in current global economic and political conditions could adversely affect our ability to predict product demand and costs and impact our financial results, and makes it more likely that our results will differ materially from expectations
10. 10We may provide inadequate training, fail to maintain effective sales and marketing capabilities or fail to develop broad brand awareness in a cost-effective manner
11. 11We have limited experience in training ECPs on, and marketing and selling, our TearCare products, which could adversely affect customer perceptions and adoption of our TearCare products43% rewritten
12. 12Our results of operations could be materially harmed if we are unable to accurately forecast customer demand for our products and manage our inventory
13. 13Develop an effective and dedicated sales and marketing team63% rewritten
14. 14development programs. Our failure or inability to devote adequate research and development resources or compete effectively with the research and development programs of our competitors could harm our businessNew
15. 15Our quarterly and annual results may fluctuate significantly and may not fully reflect the underlying performance of our business
16. 16Future accounting pronouncements or changes in our accounting policies
17. 17We may be unable to manage the anticipated growth of our business, including anticipated growth in our Interventional Dry Eye business42% rewritten
18. 18Performance issues, service interruptions or price increases by our shipping carriers and distributors could negatively affect our business, financial condition and results of operations and harm our reputation and the relationship between us and the ECPs we work with
19. 19Our products may become obsolete in the future
20. 20We may need additional funding to finance our planned operations, and may not be able to raise capital on acceptable terms, if at all, which could force us to delay, reduce or eliminate our product development programs and commercialization efforts27% rewritten
21. 21The performance of our international businessNew
22. 22We bear the risk of potential warranty claims on our products
23. 23We may enter into collaborations, in-licensing arrangements, joint ventures, strategic alliances or partnerships with third parties that may not result in the development of commercially viable products or product improvements or the generation of significant future revenue
24. 24We depend on our senior management team and the loss of one or more key employees or an inability to attract and retain highly skilled employees will negatively affect our business, financial condition and results of operations
25. 25The use, misuse or off-label use of our products may result in injuries that lead to product liability suits, which could be expensive, divert management’s attention and harm our reputation and business. We may not be able to maintain adequate product liability insurance
26. 26We have a significant amount of debt, which may affect our ability to operate our business and secure additional financing in the future
27. 27We may seek to grow our business through acquisitions of or investments in new or complementary businesses, products or technologies, and the failure to manage acquisitions or investments, or the failure to integrate them with our existing business, could have a material adverse effect on us
28. 28increased legal and accounting compliance costs, as well as potential litigation costs, arising out of the acquisition or investment
29. 29Security breaches, loss of data and other disruptions could compromise sensitive information related to our business or our customer’s patients, or prevent us from accessing critical information and expose us to liability, which could adversely affect our business and our reputation30% rewritten
30. 30Our international business operations expose us to market, legal, regulatory, political, operational, financial and economic risks associated with doing business outside of the United States
31. 31Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited
32. 32Uncertainties in the interpretation and application of existing, new and proposed tax laws and regulations could materially affect our tax obligations and effective tax rate31% rewritten
33. 33including further changes or enhancements to our procedures, policies, and controls, as well as potential personnel changes and disciplinary actionsNew
34. 34Epidemic diseases, or the perception of their effects, have and may have an adverse effect on our business, financial condition, results of operations, and cash flows

Risks Related to Our Intellectual Property

1. 35Our success will depend on our, and our licensors’, ability to obtain, maintain and protect our intellectual property rights
2. 36Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our existing and future products
3. 37We are party to, and may in the future become a party to intellectual property litigation or administrative proceedings that can be costly, time-consuming, unsuccessful, and could interfere with our ability to sell and market our products25% rewritten
4. 38If we are unable to protect the confidentiality of our other proprietary information, our business and competitive position may be harmed
5. 39We may be subject to claims that we or our employees have misappropriated the intellectual property of a third party, including trade secrets or know-how, or are in breach of non-competition or non-solicitation agreements with our competitors
6. 40We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property
7. 41If our trademarks and tradenames are not adequately protected, then we may not be able to build name recognition in our markets and our business may be adversely affected29% rewritten

Risks Related to Government Regulation

1. 42Our products, business practices, and operations are subject to extensive government regulation and oversight in the United States and elsewhere
2. 43We may not receive, or may be delayed in receiving, necessary clearances, certifications or approvals for our future products or modifications to our current products, and failure to timely obtain or retain such clearances, certifications or approvals would adversely affect our ability to grow our business
3. 44The potential for approval policies or regulations of the FDA to change significantly in a manner rendering our clinical data or regulatory filings insufficient for clearance or approval
4. 45We may incur significant liability if it is determined that we are promoting off-label uses of our products in violation of federal and state regulations in the United States or elsewhere
5. 46Failure to comply with post-marketing regulatory requirements could subject us to enforcement actions, including substantial penalties, and might require us to recall or withdraw a product from the market27% rewritten
6. 47A recall or suspension of our products, or the discovery of serious safety issues with our products, could have a significant negative impact on us
7. 48We have received ISO 13485:2016 certification for our quality management system. ISO certification generally includes recertification audits every third year, scheduled annual surveillance audits and periodic unannounced audits
8. 49If we do not obtain and maintain applicable regulatory registrations, clearances, certifications or approvals for our products, we will be unable to market and sell our products outside of the U.S
9. 50In addition, we may not continue to meet the quality and safety standards required to maintain the authorizations that we have received. If we are unable to maintain our authorizations in a particular country, we will no longer be able to sell the applicable product in that country38% rewritten
10. 51If we are found to have violated laws concerning the privacy and security of patient health information or other personal information, we could be subject to civil or criminal penalties, which could increase our liabilities or harm our reputation or business
11. 52Our employees, consultants, and other commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements
12. 53Compliance with environmental laws and regulations could be expensive, and the failure to comply with these laws and regulations could subject us to significant liability

Risks Related to Our Common Stock

1. 54Developments in our industry29% rewritten
2. 55If we fail to maintain effective internal control over financial reporting and effective disclosure controls and procedures, we may not be able to accurately report our financial results in a timely manner or prevent fraud, which may adversely affect investor confidence in our company34% rewritten
3. 56Provisions in our corporate charter documents and under Delaware law could make an acquisition of our company, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management