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| PART I: FINANCIAL INFORMATION | | 5 | |
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| Item 1. | Financial Statements | | 5 |
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| | Condensed Consolidated Balance Sheets | | 5 |
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| | Condensed Consolidated Statements of Operations | | 6 |
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| | Condensed Consolidated Statements of Comprehensive Loss | | 7 |
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| | Condensed Consolidated Statements of Stockholders’ Equity | | 8 |
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| | Condensed Consolidated Statements of Cash Flows | | 9 |
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| | Notes to Condensed Consolidated Financial Statements | | 10 |
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| Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | | 24 |
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| Item 3. | Quantitative and Qualitative Disclosures About Market Risk | | 33 |
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| Item 4. | Controls and Procedures | | 34 |
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| PART II: OTHER INFORMATION | | 35 | |
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| Item 1. | Legal Proceedings | | 35 |
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| Item1A. | Risk Factors | | 35 |
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| Item 6. | Exhibits | | 52 |
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| SIGNATURES | | 53 | |
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Note Regarding Forward-Looking Statements
This report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (Exchange Act) All statements other than statements of historical or current facts included in this report are forward-looking statements. In some cases, you can identify forward-looking statements by the following words: "may," "will," "could," "would," "should," "expect," "intend," "plan," "anticipate," "believe," "estimate," "predict," "project," "potential," "continue," "ongoing" or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Any statements in this Quarterly Report on Form 10-Q regardingfuture operations, including our expectations for future expenses, capital expenditures and income, our expectations regarding the impact of the macroeconomic environment, our strategy for growth, product development activities, the impact of the regulatory environment, including the timing and likelihood of regulatory approvals and the impact of new or changing regulations and pricing, and market positionare forward-looking statements. These forward-looking statements are based on management’s beliefs and assumptions based on the information available to management at the time of this report. Although we believe that we have a reasonable basis for each forward-looking statement contained in this report, we caution you that these forward-looking statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements.
You are urged to carefully review the disclosures we make concerning the risks we face and other factors that may affect the outcome of our forward-looking statements and our business and operating results, including the risks set forth in the “Risk Factors Summary” below and further described in the "Risk Factors" section of this report, which includes a discussion of important factors that may cause actual results to differ materially from those expressed or implied by the forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking statements in this report will prove to be accurate, and actual results may differ materially from those expressed or implied by the forward-looking statements. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. You are therefore cautioned not to place undue reliance on the forward-looking statements included in this report, which speak only as of the date of this document. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law**.**
We useGlaukos, our logo,iStent,iStent inject,iStent infinite,iPrism,iDose TR,*iPRIME, MIGS,*Avedro,Photrexa,iLink,KXL,Epioxa, iLution, PRESERFLO, Retina XRand other marks as trademarks. This report contains references to our trademarks and service marks and to those belonging to other entities. Solely for convenience, trademarks and trade names referred to in this report, including logos, artwork and other visual displays, may appear without the ® or ™ symbols, but such references are not intended to indicate in any way that we will not assert, to the fullest extent under applicable law, our rights or the rights of the applicable licensor to these trademarks and trade names. We do not intend our use or display of other entities’ trade names, trademarks or service marks to imply a relationship with, or endorsement or sponsorship of us by, any other entity.
References throughout this document to “we,” “us,” “our,” the “Company,” or “Glaukos” refer to Glaukos Corporation and its consolidated subsidiaries.
Risk Factors Summary
Investing in our securities involves a high degree of risk. The following is a summary of the principal factors that make an investment in our securities speculative or risky, all of which are further described below in the section titled “Risk Factors” in Part II, Item 1A of this report. This summary should be read in conjunction with the “Risk Factors” section and should not be relied upon as an exhaustive summary of the material risks facing our business. In addition to the following summary, you should consider the information set forth in the “Risk Factors” section and the other information contained in this report before investing in our securities.
Risks Related to Our Business
| ● | Failure to achieve commercial success of iDose TR could materially impact our business. |
| ● | Downturns or volatility in general economic conditions and public health crises could harm our business. |
| ● | Supply and/or manufacturing disruptions impacting our principal revenue-producing products could reduce our gross margins and negatively impact our operating results. |
| ● | We may not reach sustained profitability. |
| ● | We may fail to generate sufficient sales of our commercialized products or to develop and commercialize additional products. |
| ● | We are subject to a variety of risks associated with our international operations. |
| ● | We may not meet our customers’ expectations for the quality or delivery of our products, which could harm our reputation and sales. |
| ● | If ophthalmic surgeons do not use or if they misuse our products, our business could be harmed. |
| ● | We may fail to manage our anticipated growth effectively and may not be able to meet customer demand. |
| ● | We may be unable to retain or recruit qualified personnel for growth. |
| ● | We have and may continue to enter into acquisitions, collaborations, in-licensing agreements, joint ventures, alliances or partnerships with third parties that could fail. |
| ● | Cybersecurity incidents, service interruptions, or data corruption could materially disrupt our operations and adversely affect our business. |
| ● | Failure to comply with data privacy and security laws could have a material adverse effect on our business. |
| ● | Our net operating loss tax carryforwards may not be available, or may be subject to certain limitations, to offset future taxable income. |
Risks Related to Our Indebtedness
| ● | If we incur future indebtedness, our debt service obligations could limit our cash flow, and may adversely affect our financial condition and operating results. |
| ● | The capped call transactions may affect the value of our common stock, par value $0.001 per share (Common Stock) and subject us to counterparty risk. |
Risks 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. |
| ● | Compliance with applicable regulations can be costly and failure to comply with such regulations could harm our business, financial condition and operating results. |
| ● | Legislative or regulatory reform of the healthcare system could hinder or prevent our products’ commercial success. |
| ● | Inadequate or inconsistent reimbursement for our products may adversely impact our business. |
Risks Related to Our Intellectual Property
| ● | Failure to protect our intellectual property could substantially impair our ability to compete. |
| ● | Intellectual property claims or litigation could be costly, time-consuming and unsuccessful and could interfere with our ability to successfully commercialize our products. |
Risks Related to Our Common Stock
| ● | Provisions in our Certificate of Incorporation and Bylaws limit the ability of stockholders to take certain actions and could delay or discourage takeover attempts. |
| ● | Our Certificate of Incorporation designates the sole and exclusive forum for certain types of actions and proceedings, which could limit our stockholders’ ability to obtain a favorable judicial forum. |
