Glaukos Corporation (GKOS) SEC Filings & Earnings Calls

Standard biotech risks; no new material risks.

“Forward-looking statements with standard risk factors.”

Commercial success of iDose TR and Epioxa uncertain

“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.” · word for word

Medicare coverage restrictions on MIGS procedures

“certain local coverage determinations (LCDs) finalized by five of the seven MACs in November 2024 that confirm non-coverage for surgical MIGS procedures in combination with other surgical MIGS procedures disrupted traditional customer ordering patterns and may have adversely impacted U.S. Glaucoma sales in 2024 and 2025” · word for word

Supply chain concentration risk

“Our sole manufacturing location for our iStent and iDose products is an approximately 120,000 square foot campus located in San Clemente, California” · word for word

Significant accumulated deficit and ongoing losses

“As of June 30, 2026, we had an accumulated deficit of approximately $971.3 million” · word for word

Dependence on iDose TR adoption and Epioxa launch for growth; competitive and regulatory risks in ophthalmic market.

“Growth driven by iDose TR and Epioxa; early stage of commercialization.”

Dependence on iDose TR for Growth

“This increase is primarily due to higher sales volume of iDose TR , which has a higher net sales price than our other products, combined with modest growth in the net sales of our non- iDose products.” · word for word

Extended Payment Terms for iDose TR

“an increase in accounts receivable of $12.5 million primarily due to increased iDose TR sales during the three months ended March 31, 2026 given iDose TR sales have extended terms” · word for word

Operating Losses and Cash Burn

“Loss from operations (19,856 ) (20,678 ) (4 )%” · word for word

No material risks identified; strong growth and guidance raise.

“All metrics positive, no adverse commentary.”

Commercial execution risk for iDose TR and Epioxa

“Our ability to successfully commercialize our iDose TR and Epioxa therapies.” · word for word

Supply and manufacturing disruptions

“Supply and/or manufacturing disruptions, including those impacting our principal revenue-producing products.” · word for word

Reimbursement and market access risk

“Risks related to securing or maintaining adequate coverage or reimbursement by government or third-party payors.” · word for word

Clinical trial and regulatory uncertainty

“The lengthy and expensive clinical trial process and the uncertainty of timing and outcomes from any particular clinical trial or regulatory approval processes.” · word for word

Competitive pressure

“The increasing number of competitive products and procedures facing our glaucoma business.” · word for word

iDose TR commercial adoption risk

“Failure to achieve commercial success of iDose TR or Epioxa could materially impact our business.” · word for word

Reimbursement uncertainty for iDose TR

“Throughout 2025, we have been continuously working with the MACs to streamline and obtain consistent reimbursement payments for iDose TR related to the permanent J-code, the facility fee, and the physician fee.” · word for word

Supply chain and manufacturing concentration

“Supply and/or manufacturing disruptions impacting our principal revenue-producing products could reduce our gross margins and negatively impact our operating results.” · word for word

Medicaid Drug Rebate Program (MDRP) impact on Photrexa realized revenues.

“these fourth quarter results reflect the continued impact to Photrexa realized revenues as a result of our entry as a company into the Medicaid Drug Rebate Program (MDRP).” · word for word

Foreign exchange exposure on international revenues.

“Constant currency adjustments highlight FX sensitivity.”

Preliminary results subject to change; reliance on third-party suppliers; regulatory and reimbursement risks.

“Forward-looking statements highlight risks including supply chain, regulatory approvals, and reimbursement.”

iStent franchise decline due to LCD restrictions

“lower volumes sold of our iStent family of products primarily due to the MIGS restrictions associated with the final LCDs issued by the five MACs” · word for word

Epioxa launch disruption to Corneal Health franchise

“we anticipate some potential disruption within our U.S. Corneal Health franchise as the market transitions from Photrexa to Epioxa following its approval” · word for word

iDose TR reimbursement uncertainty

“the physician fee payment rates for the procedures using our iDose TR product will be determined by the MACs, several of which have not yet published this rate” · word for word

U.S. government shutdown impact on FDA

“the U.S. government shutdown that started on October 1, 2025 and continues as of the date of this report has impacted certain regulatory agencies, such as the U.S. FDA” · word for word

Tariff exposure on supply chain

“these tariffs, or the introduction of new or higher tariffs in other countries, could pose a risk to our business, or the businesses of our customers, that could affect our net sales and cost of sourcing materials” · word for word

Potential competitive headwinds in international markets from new products trialing.

“Expect trialing of new competitive products in some of our major international markets may become an increasing headwind as we progress through 2025.”

Medicaid Drug Rebate Program (MDRP) impact on Photrexa realized revenues.

“Third quarter results reflect the continued impact to Photrexa realized revenues as a result of our entry as a company into the Medicaid Drug Rebate Program (MDRP).” · word for word