What the changes say
- Glaukos added risks regarding artificial intelligence adoption, 340B drug pricing rules, and recently approved Epioxa commercialization.
- Tax loss carryforwards and R&D credit figures increased across federal and state categories.
What changed since the prior 10-K
New
- NewRisks Related to Our Business
Volatility in credit or financial markets
Natural disasters or disruptions at the sole 120,000 square foot San Clemente manufacturing campus could halt production of the iStent, iDose, and Epioxa product lines.
- NewRisks Related to Our Business
costly and complex export requirements and restrictions, particularly relating to technology
Complex export requirements and foreign currency fluctuations could harm international sales and earnings from global operations.
- NewRisks Related to Our Business
We have incorporated and continue to further incorporate artificial intelligence into our internal operations. Implementation of artificial intelligence and machine learning technologies may result in legal and regulatory risks, reputational harm, or other adverse consequences to our business
Incorporating artificial intelligence and machine learning into R&D and internal processes creates potential regulatory, legal, reputational, and bias risks.
- NewRisks Related to Our Regulatory Environment
Services Administration, requires participating companies to agree to charge statutorily defined covered entities no more than the 340B “ceiling price” for covered outpatient drugs. The 340B program ceiling price is calculated using a statutory formula, which is based on pricing data calculated under the MDRP
The 340B drug pricing program and Inflation Reduction Act of 2022 impose mandatory manufacturer rebates and price constraints that could reduce net sales.
- NewRisks Related to Our Regulatory Environment
facility fee payment rates, which had an adverse impact on procedural iStent family product volumes and our revenues and net income
Unfavorable Medicare administrative contractor decisions regarding reimbursement codes and fee payment rates can directly suppress procedural volumes for iStent and iDose TR.
- NewRisks Related to Our Common Stock
require a supermajority vote of the stockholders and a majority vote of the board to amend certain of the above-mentioned provisions and our Bylaws
Supermajority voting requirements and Delaware General Corporation Law Section 203 hinder unsolicited takeovers or management replacement attempts by stockholders owning over 15 percent of stock.
- NewRisks Related to Our Common Stock
Court of the State of Delaware holding that such provisions are facially valid under Delaware law and means that suits brought by stockholders to enforce any duty or liability created under the Securities Act must be brought in federal court and cannot be brought in state court
Exclusive forum provisions mandate that federal Securities Act claims go to federal court and internal Delaware corporate claims go to Delaware Chancery Court, increasing litigation costs.
Dropped
- DroppedRisks Related to Our Business
If 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
- DroppedRisks Related to Indebtedness
If 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
- DroppedRisks Related to Our Regulatory Environment
additional 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
Reworded
- 65% rewrittenRisks Related to Our Regulatory Environment
Inadequate or inconsistent reimbursement for our products may adversely impact our business
Updated references from third party payors to third party payers throughout the reimbursement risk factor.
- 63% rewrittenRisks Related to Our Business
The commercial success of our iDose TR and Epioxa products is dependent upon multiple factors, the failure of any one of which could materially impact the prospects of these products and our business
Added the October 2025 FDA approval and planned 2026 commercialization of the Epioxa keratoconus therapy alongside iDose TR.
Was: The 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
- 62% rewrittenRisks Related to Our Common Stock
The 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
Retitled the exclusive forum risk factor to explicitly mention limits on stockholders bringing claims in favorable judicial forums.
- 57% rewrittenRisks Related to Our Regulatory Environment
Legislative or regulatory reform of the healthcare system could hinder or prevent our products’ commercial success
Expanded healthcare reform risks to explicitly warn that regulations could lower the prices the company can charge for products.
- 53% rewrittenRisks Related to Our Business
Unfavorable 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
Added specific mentions of U.S. trade policy changes and tariffs to the macro-level risk factors.
- 38% rewrittenRisks Related to Our Business
As 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
Reformatted international operations risk bullets into a continuous paragraph.
- 36% rewrittenRisks Related to Our Business
We cannot be certain that our net operating loss tax carryforwards will be available to offset future taxable income
Updated net operating loss and R&D tax credit carryforward figures for December 31, 2025, showing federal NOLs rising to $546.9 million.
- 36% rewrittenRisks Related to Our Business
Our 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
Integrated newly approved Epioxa therapies into the core description of the company's product development pipeline.
- 34% rewrittenRisks Related to Our Common Stock
Anti-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
- 25% rewrittenRisks Related to Our Regulatory Environment
Healthcare 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
- 22% rewrittenRisks Related to Our Business
Public health crises have adversely affected, and could in the future adversely affect, our business, results of operations, financial condition, liquidity, and cash flows
Was: Public 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
- 20% rewrittenRisks Related to Our Business
We have and may continue to enter into acquisitions, collaborations, in-licensing agreements, joint ventures, alliances or partnerships with third parties that could fail or result in litigation
Was: We have and may continue to enter into acquisitions, collaborations, in-licensing agreements, joint ventures, alliances or partnerships with third parties that could fail
All 28 risk factors
Headings as the filing states them, in filing order.
Risks Related to Our Business
- 01The commercial success of our iDose TR and Epioxa products is dependent upon multiple factors, the failure of any one of which could materially impact the prospects of these products and our business63% rewritten
- 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 flows53% rewritten
- 03Public health crises have adversely affected, and could in the future adversely affect, our business, results of operations, financial condition, liquidity, and cash flows22% rewritten
- 04Volatility in credit or financial marketsNew
- 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 accomplish36% rewritten
- 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 condition38% rewritten
- 07costly and complex export requirements and restrictions, particularly relating to technologyNew
- 08If 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
- 09Ophthalmic 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
- 10If 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
- 11If we are unable to retain or recruit qualified personnel for growth, our business results could suffer
- 12We have and may continue to enter into acquisitions, collaborations, in-licensing agreements, joint ventures, alliances or partnerships with third parties that could fail or result in litigation20% rewritten
- 13Failure to protect our information systems against cybersecurity threats, cybersecurity incidents, service interruptions, or data loss could materially disrupt our operations and adversely affect our business, operating results, or the effectiveness of our internal controls over financial reporting
- 14We have incorporated and continue to further incorporate artificial intelligence into our internal operations. Implementation of artificial intelligence and machine learning technologies may result in legal and regulatory risks, reputational harm, or other adverse consequences to our businessNew
- 15Failure to comply with data privacy and security laws could have a material adverse effect on our business
- 16We cannot be certain that our net operating loss tax carryforwards will be available to offset future taxable income36% rewritten
Risks Related to Financing Transactions
- 17The capped call transactions may affect the value of our common stock, and subject us to counterparty risk
Risks Related to Our Regulatory Environment
- 18Healthcare legislative reform measures and changes in U.S. and international trade policies may have a material adverse effect on our business and results of operations25% rewritten
- 19Legislative or regulatory reform of the healthcare system could hinder or prevent our products’ commercial success57% rewritten
- 20Services Administration, requires participating companies to agree to charge statutorily defined covered entities no more than the 340B “ceiling price” for covered outpatient drugs. The 340B program ceiling price is calculated using a statutory formula, which is based on pricing data calculated under the MDRPNew
- 21Inadequate or inconsistent reimbursement for our products may adversely impact our business65% rewritten
- 22facility fee payment rates, which had an adverse impact on procedural iStent family product volumes and our revenues and net incomeNew
Risks Related to Our Intellectual Property
- 23If 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
- 24We 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
- 25Anti-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 stock34% rewritten
- 26require a supermajority vote of the stockholders and a majority vote of the board to amend certain of the above-mentioned provisions and our BylawsNew
- 27The 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 employees62% rewritten
- 28Court of the State of Delaware holding that such provisions are facially valid under Delaware law and means that suits brought by stockholders to enforce any duty or liability created under the Securities Act must be brought in federal court and cannot be brought in state courtNew
Other Glaukos 10-Ks
- FY2024 10-K risk factors24 risks
Risk section is dominated by the commercialization and manufacturing risks of the newly launched iDose TR implant and iStent product lines. Heavy reliance on a single manufacturing facility in San Clemente, California creates substantial operational vulnerability. Extensive exposure to healthcare regulatory reforms, pricing pressures, and third-party reimbursement policies dictates financial viability.
Filed Feb 25, 2025
About this page
The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.