Sight Sciences (SGHT) risk factors, FY2024 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 viability
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 condition
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 OMNI and TearCare products
5. 05Established sales, marketing and worldwide distribution networks
6. 06Adoption of our products depends upon appropriate physician training, practice and patient selection
7. 07Uncertainty 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
8. 08We may provide inadequate training, fail to maintain effective sales and marketing capabilities or fail to develop broad brand awareness in a cost-effective manner
9. 09We 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 products
10. 10Our results of operations could be materially harmed if we are unable to accurately forecast customer demand for our products and manage our inventory
11. 11Develop an effective and dedicated sales and marketing team
12. 12Our quarterly and annual results may fluctuate significantly and may not fully reflect the underlying performance of our business
13. 13Future accounting pronouncements or changes in our accounting policies
14. 14We may be unable to manage the anticipated growth of our business
15. 15Performance 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
16. 16Our products may become obsolete in the future
17. 17We 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 efforts
18. 18The rate at which we expand internationally
19. 19We bear the risk of potential warranty claims on our products
20. 20We 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
21. 21We 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
22. 22The 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
23. 23We have a significant amount of debt, which may affect our ability to operate our business and secure additional financing in the future
24. 24We 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
25. 25increased legal and accounting compliance costs, as well as potential litigation costs, arising out of the acquisition or investment
26. 26Security 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 reputation
27. 27Our international business operations expose us to market, legal, regulatory, political, operational, financial and economic risks associated with doing business outside of the United States
28. 28Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited
29. 29Uncertainties in the interpretation and application of existing, new and proposed tax laws and regulations could materially affect our tax obligations and effective tax rate
30. 30Epidemic 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. 31Our success will depend on our, and our licensors’, ability to obtain, maintain and protect our intellectual property rights
2. 32Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our existing and future products
3. 33We have been party to, and may in the future become a party to intellectual property litigation or administrative proceedings that could be costly, time-consuming, unsuccessful, and could interfere with our ability to sell and market our products
4. 34If we are unable to protect the confidentiality of our other proprietary information, our business and competitive position may be harmed
5. 35We 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. 36We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property
7. 37If 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 affected

Risks Related to Government Regulation

1. 38Our products, business practices, and operations are subject to extensive government regulation and oversight in the United States and elsewhere
2. 39We 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. 40The 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. 41We 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. 42Failure 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 market
6. 43A 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. 44We 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. 45If 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. 46In 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 country
10. 47available, and the range of interpretations to which they are subject, it is possible that some of our current or future practices might be challenged under one or more of these laws
11. 48If 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
12. 49Our employees, consultants, and other commercial partners may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements
13. 50Compliance 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. 51Developments in our industry
2. 52If 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 company
3. 53Material weaknesses in our internal control over financial reporting may cause us to fail to timely and accurately report our financial results or result in a material misstatement of our financial statements
4. 54Provisions 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