Glaukos (GKOS) risk factors, FY2024 10-K

Risks Related to Our Business

1. 01The commercial success of our iDose TR is dependent upon multiple factors, the failure of any one of which could materially impact the prospects of this product and our business
2. 02Unfavorable global and regional conditions have adversely affected, and could in the future materially and adversely affect, our business, results of operations, financial condition, liquidity, and cash flows
3. 03Public health crises, such as the COVID-19 pandemic, have adversely affected, and could in the future adversely affect, our business, results of operations, financial condition, liquidity, and cash flows
4. 04If the supply and/or manufacture of our principal revenue-producing products, the iStent family of products, our Photrexa therapies, or the iDose TR is materially disrupted, it may adversely affect our ability to manufacture products and could reduce our gross margins and negatively impact our operating results
5. 05Our success depends on our ability to continue to generate sales of our commercialized products and develop and commercialize additional products, which we may not be able to accomplish
6. 06As our growth strategy turns increasingly global, we are, and will continue to be, subject to a variety of risks associated with our international operations, which could adversely impact our results of operations and financial condition
7. 07If the quality or delivery of our products does not meet our customers’ expectations, our reputation could suffer and ultimately our sales and operating earnings could be negatively impacted
8. 08Ophthalmic surgeons may not use our products if they do not believe they are safe, efficient, effective and preferable alternatives to other treatment solutions in the market or may use our products without being adequately trained, which could result in inferior clinical outcomes
9. 09If we fail to manage our anticipated growth effectively, we may not be able to meet customer demand for our products and our business could suffer
10. 10If we are unable to retain or recruit qualified personnel for growth, our business results could suffer
11. 11We have and may continue to enter into acquisitions, collaborations, in-licensing agreements, joint ventures, alliances or partnerships with third parties that could fail
12. 12Failure to protect our information systems against cybersecurity threats, cybersecurity incidents, service interruptions, or data corruption could materially disrupt our operations and adversely affect our business, operating results, or the effectiveness of our internal controls over financial reporting
13. 13Failure to comply with data privacy and security laws could have a material adverse effect on our business
14. 14We cannot be certain that our net operating loss tax carryforwards will be available to offset future taxable income

Risks Related to Indebtedness

1. 15If we incur future indebtedness, our obligation to service the indebtedness could limit the cash flow available for our operations and have other consequences that could adversely affect our business, and we may not have sufficient cash flow from our business to pay our debt obligations
2. 16The capped call transactions may affect the value of our common stock, and subject us to counterparty risk

Risks Related to Our Regulatory Environment

1. 17Healthcare legislative reform measures and changes in U.S. and international trade policies may have a material adverse effect on our business and results of operations
2. 18Legislative or regulatory reform of the healthcare system could hinder or prevent our products’ commercial success
3. 19additional measures may be adopted or the impact of current and additional measures on the marketing, pricing and demand for our products, which could have a material adverse effect on our business, financial condition and results of operations
4. 20Inadequate or inconsistent reimbursement for our products may adversely impact our business

Risks Related to Our Intellectual Property

1. 21If we are unable to adequately protect our intellectual property, our competitors and other third parties could develop and commercialize products similar or identical to ours, which would substantially impair our ability to compete
2. 22We have been and may in the future become involved in patent and other intellectual property litigation or administrative proceedings relating to our intellectual property rights, which could be costly, time consuming and unsuccessful and could interfere with our ability to successfully commercialize our products

Risks Related to Our Common Stock

1. 23Anti-takeover provisions in our Charter and Bylaws and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management and limit the market price of our common stock
2. 24The exclusive forum provisions in our organizational documents could limit our stockholders’ ability to bring a claim in a judicial forum that it finds favorable for disputes with the Company or its directors, officers or other employees