Summary of Glaukos (GKOS) 2025 Conference Call Company Overview - **Company**: Glaukos Corporation (GKOS) - **Event**: 2025 Conference Call held on May 27, 2025 Key Points on iDose Reimbursement and Performance - **Reimbursement Status**: Progress is being made with Medicare administrators, including Noridian, Novitas, and First Coast, with increasing payments for the drug and facility fees [2][3][10] - **Professional Fee Adjudication**: Ongoing efforts to streamline professional fee payments, with some Medicare Administrative Contractors (MACs) showing signs of improvement [3][5] - **Volume Generation**: The timing of reimbursement progress is tied to generating procedural volumes, which is critical for establishing a systematic reimbursement process [4][5] - **ASP Comparison**: iDose's Average Selling Price (ASP) is competitive, with the product containing seven times the amount of drug compared to Darista, which has comprehensive coverage across payers [7][9][10] - **Coverage Status**: Approximately 50% of lives are covered under commercial plans and Medicare Advantage, with ongoing efforts to expand access [10][11] - **Market Dynamics**: iDose is positioned as a second or third-line therapy initially, with plans to drive it closer to first-line therapy over time [12] Financial Performance and Projections - **Q1 2025 Performance**: The company reported exceptional progress in the market, with Noridian fully operational and increasing payments from Novitas and First Coast [14][19] - **Sales Guidance**: For 2025, the guidance for iDose sales is projected between $120 million to $125 million, with expectations for a stronger second half of the year due to seasonality and backlog building [23][24] - **Gradual Launch**: The launch of iDose is expected to be gradual and methodical, with a focus on education and operationalizing reimbursement processes [37][39] Long-term Outlook - **Peak Sales Estimates**: Peak sales expectations for iDose have not changed significantly but have increased on a risk-adjusted basis due to positive real-world performance [45] - **Market Potential**: The company is optimistic about the long-term market opportunity, with a focus on expanding access and operational efficiency in physician offices [42][44] U.S. Stent Business Insights - **Recent Performance**: The U.S. stent business experienced mid-single-digit growth in early 2024 but faced challenges due to Local Coverage Determinations (LCDs) impacting procedures [47][48] - **Guidance Adjustments**: Guidance for 2025 has been adjusted to reflect the impact of LCDs, with expectations for recovery as awareness and adaptation to these changes improve [52][54] Profitability Goals - **Cash Flow Breakeven**: The company aims to achieve free cash flow breakeven in the near term while continuing to make necessary investments [56] Additional Notes - **Investor Enthusiasm**: There is strong enthusiasm from investors regarding the product's clinical performance, but the launch pace is primarily influenced by reimbursement dynamics [31][35] - **Education and Support**: The company emphasizes the importance of educating physicians and their staff on the procedural aspects and reimbursement processes to ensure successful adoption [29][30]

Core Viewpoint - Glaukos Corporation is positioned for growth due to favorable clinical trial results and a strong product pipeline, despite facing significant competition [1] Company Overview - Glaukos has a market capitalization of $5.48 billion and is recognized as a leading ophthalmic medical technology and pharmaceutical company, with a trailing four-quarter average earnings surprise of 21.62% [2] Key Catalysts - Strong product demand is primarily driven by the success of the flagship product, iStent, which has led to a robust performance in 2024 and a positive business outlook [3] - The adoption of iStent Infinite for glaucoma patients is increasing, supported by enhanced clinical education and improved market access, with five out of seven Medicare Administrative Contractors releasing draft local coverage determinations [4] Financial Performance - Glaukos' revenues exceeded estimates in Q1 2025, improving by 24.6% year over year, with expectations for full-year 2025 revenues between $475 million and $485 million, reflecting a projected sales growth of 25.5% and earnings growth of 53.4% [5] Product Portfolio Expansion - The first quarter's top line was significantly boosted by the strong adoption of the iDose TR product, with the U.S. glaucoma segment experiencing 41% year-over-year growth [6] - The FDA has accepted the NDA for Epioxa, a next-generation therapy for keratoconus, with a PDUFA date set for October 2025 [7] International Growth - Glaukos is expanding its international presence, reporting record sales of $29 million in its international glaucoma franchise for Q1, reflecting an 18.7% year-over-year operational growth [10] Challenges - The company relies on a limited number of third-party suppliers for components, which poses a risk if suppliers fail to deliver [11] - Restrictive Medicare Local Coverage Determinations have negatively impacted the U.S. stent business, leading to a mid-single-digit decline despite growth in iDose [12] Estimate Trends - The bottom-line estimate for Glaukos is a loss of 87 cents for 2025, which has narrowed by 8.4% in the past 30 days, with the Zacks Consensus Estimate for 2025 revenues at $480 million [13]

Core Insights - Glaukos reported $106.66 million in revenue for Q1 2025, a 24.6% year-over-year increase, with an EPS of -$0.22 compared to -$0.70 a year ago, exceeding the Zacks Consensus Estimate of $102.72 million by 3.84% [1] - The company achieved an EPS surprise of 33.33%, with the consensus EPS estimate being -$0.33 [1] Revenue Breakdown - U.S. revenues reached $75.07 million, surpassing the average estimate of $71.54 million, reflecting a 30.1% year-over-year increase [4] - International revenues totaled $31.59 million, slightly above the average estimate of $31.35 million, marking a 13.1% year-over-year increase [4] - Corneal Health revenues in the international market were $2.59 million, below the average estimate of $2.78 million, showing a decline of 4.1% year-over-year [4] - U.S. Corneal Health revenues were $15.94 million, exceeding the average estimate of $15.50 million, with a 1.5% year-over-year increase [4] - International Glaucoma revenues amounted to $29.01 million, surpassing the average estimate of $28.57 million, reflecting a 14.9% year-over-year increase [4] - U.S. Glaucoma revenues reached $59.13 million, exceeding the average estimate of $56.03 million, with a significant 40.8% year-over-year increase [4] - Total Corneal Health revenues were $18.53 million, slightly above the average estimate of $18.28 million, representing a 0.7% year-over-year increase [4] - Total Glaucoma revenues were $88.14 million, exceeding the average estimate of $84.60 million, reflecting a 31.1% year-over-year increase [4] Stock Performance - Glaukos shares have returned -5.8% over the past month, compared to the Zacks S&P 500 composite's -0.7% change, with a current Zacks Rank of 3 (Hold) indicating potential performance in line with the broader market [3]

Core Insights - Glaukos Corporation reported a narrower adjusted loss of 22 cents per share for Q1 2025, better than the Zacks Consensus Estimate of a loss of 33 cents, and improved from a loss of 70 cents per share in the same quarter last year [1] - The company achieved revenues of $106.7 million in Q1 2025, reflecting a year-over-year increase of 24.6% and surpassing the Zacks Consensus Estimate by 3.8% [2] Revenue Details - Net sales for the Glaucoma segment reached $88.1 million, marking a 31% increase year over year, while Corneal Health sales were $18.5 million [3] Margin Analysis - Gross profit rose by 25.9% year over year to $82.3 million, with an adjusted gross margin of 82%, slightly down from 83% in the previous year [4] - Selling, general and administrative expenses increased by 14% year over year to $70.7 million, while research and development expenses totaled $32.4 million, up 5.3% year over year [4] Operating Performance - The operating loss decreased to $20.7 million from $39.1 million in the prior year, with an adjusted operating loss of $15.2 million, an improvement from the loss of $32.8 million in the same quarter last year [5] Financial Update - At the end of Q1 2025, Glaukos had cash and cash equivalents and short-term investments totaling $303.4 million, down from $323.6 million at the end of Q4 2024 [6] 2025 Guidance - The company reiterated its revenue guidance for 2025, expecting net sales between $475 million and $485 million, with a consensus estimate of $480.9 million [7] Growth Drivers - The strong performance in Q1 was driven by the adoption of the iDose TR product, with the U.S. glaucoma segment experiencing a 41% year-over-year growth [9] - Management highlighted the strategic rollout of iDose TR, focusing on expanding surgeon training, payer access, and clinical validation [9] Product Development - Glaukos is advancing its product pipeline, including the FDA's acceptance of the NDA for Epioxa, targeting a PDUFA date in October 2025 [10] - The company is also progressing with the PRESERFLO MicroShunt study and other clinical trials, including the iStent infinite trial and GLK-401 for wet AMD [11] Challenges - Glaukos faces challenges from restrictive Medicare LCDs impacting the use of multiple glaucoma surgical devices, leading to a mid-single-digit decline in the U.S. stent business [12] Stock Performance - Following the Q1 results, shares of Glaukos fell by 6.6% in after-market trading, with a year-to-date decline of 37.1%, compared to the industry's decline of 9.1% [13]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-37463 GLAUKOS CORPORATION (Exact name of registrant as specified in its charter) (State or other jurisdiction of Delaware 33-0945406 (I.R.S. Em ...

Financial Data and Key Metrics Changes - Glycos Corporation reported record first quarter consolidated net sales of $106.7 million, up 25% on a reported basis and 26% on a constant currency basis compared to the same quarter last year [9] - The company reaffirmed its full year 2025 net sales guidance range of $475 million to $485 million [9] Business Line Data and Key Metrics Changes - The U.S. Glaucoma franchise achieved record first quarter net sales of $59.1 million, reflecting a year-over-year growth of 41%, driven by the adoption of iDoseTR [11] - The interventional glaucoma franchise delivered record net sales of $29 million, with a year-over-year growth of 15% on a reported basis and 19% on a constant currency basis [13] - The corneal health franchise reported net sales of $18.5 million, including $15.4 million from Vetrexa, impacted by the company's entry into the Medicare drug rebate program [15] Market Data and Key Metrics Changes - The U.S. glaucoma business experienced over 40% year-over-year growth and a 5% sequential growth in the first quarter [24] - International glaucoma sales showed strong growth, with expectations of high single-digit to low double-digit growth year-over-year [35] Company Strategy and Development Direction - The company is focused on pioneering the Interventional Glaucoma marketplace with new therapies aimed at slowing disease progression and reducing drug burden [10] - Glycos is actively expanding its global infrastructure and market access for its interventional glaucoma products, anticipating new product approvals in the coming years [13][14] - The company is also preparing for the commercial launch of Epioxa, a next-generation corneal cross-linking therapy, with an FDA review expected by October 20, 2025 [16] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strong foundation built for iDoseTR and the transformative potential of this technology in glaucoma management [12] - The company acknowledged potential headwinds from new competitive products in major international markets as it progresses through 2025 [14] - Management emphasized the importance of navigating macroeconomic uncertainties while maintaining a strong capital position with over $3 billion in cash and no debt [18] Other Important Information - The company is actively pursuing collaborations to enhance its capabilities in glaucoma diagnosis and care networks [19] - Glycos expects minimal direct exposure to recent tariff-related policies due to its primary manufacturing and sourcing within the United States [19] Q&A Session Summary Question: Can you provide U.S. spend growth in the quarter? - The U.S. glaucoma business reported over 40% year-over-year growth and a 5% sequential growth, driven by iDoseTR adoption, despite some impact from LCD restrictions [24] Question: Have you seen any acceleration in reimbursement in the Noridian region? - Noridian has shown solid and expanding growth, serving as a case study for other MACs as they come online [29] Question: What are the components of guidance for the remainder of the year? - The guidance remains unchanged, with expectations for flat to low single-digit growth in the corneal health business and mid single-digit declines for non-iDose revenues in 2025 [35][36] Question: How exposed is the company to an economic slowdown? - The company believes ophthalmology is somewhat insulated from economic downturns, but acknowledges potential impacts on surgery centers and customer offices [52] Question: What is the status of iDose reimplantation with the FDA? - The post-approval NDA supplement for iDose has been submitted to the FDA, with results expected by year-end [65] Question: How broad is the commercial coverage for iDose? - Coverage policies extend over more than 50% of the potential patient population, with early successes in claims processing with major payers [58] Question: What is the expectation for operational expenses growth? - The company continues to expect about 15% year-over-year growth in operational expenses off the adjusted 2024 base [93]

Financial Data and Key Metrics Changes - Glycos Corporation reported record first quarter consolidated net sales of $106.7 million, up 25% on a reported basis and 26% on a constant currency basis compared to the same quarter last year [7] - The company reaffirmed its full year 2025 net sales guidance range of $475 million to $485 million [7] Business Line Data and Key Metrics Changes - The U.S. glaucoma franchise achieved record first quarter net sales of $59.1 million, reflecting a strong year-over-year growth of 41%, primarily driven by the adoption of iDoseTR [10] - The interventional glaucoma franchise delivered record net sales of $29 million, with a year-over-year growth of 15% on a reported basis and 19% on a constant currency basis [12] - The corneal health franchise reported net sales of $18.5 million, including Vetrexa net sales of $15.4 million, impacted by the company's entry into the Medicare drug rebate program [13] Market Data and Key Metrics Changes - The U.S. glaucoma business experienced over 40% year-over-year growth and 5% sequential growth, driven by iDoseTR expansion, despite some decline in the stent franchise due to LCD restrictions [20] - International glaucoma sales showed strong growth as the company continues to scale its infrastructure and drive MIGS forward as the standard of care [12] Company Strategy and Development Direction - The company is focused on pioneering the Interventional Glaucoma marketplace with new therapies aimed at slowing disease progression and reducing drug burden [9] - Glycos is actively working on expanding its product portfolio and market access globally, anticipating new product approvals in the coming years [12][14] - The company has a strong capital position with cash and equivalents exceeding $3 million and no debt, allowing for continued investment in growth initiatives [16] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strong foundation built for iDoseTR and the transformative potential of this technology in glaucoma management [11] - The company acknowledged potential headwinds from competitive products and macroeconomic uncertainties but remains committed to its growth trajectory [12][33] - Management emphasized the importance of generating clinical evidence to support the use of combination therapies in glaucoma treatment [76] Other Important Information - The FDA accepted the NDA for Epioxa, a next-generation corneal cross-linking therapy, with a PDUFA date set for October 20, 2025 [14] - The company is also advancing several clinical trials, including pivotal studies for various therapies aimed at treating glaucoma and other eye diseases [15] Q&A Session Summary Question: Can you provide U.S. spend growth in the quarter? - The U.S. glaucoma business reported over 40% year-over-year growth and a 5% sequential growth, driven by iDoseTR, despite a mid-single-digit decline in the stent franchise due to LCD restrictions [20] Question: How is the reimbursement situation for iDose in the Noridian region? - Noridian has shown solid growth, and while some customers are achieving high volumes, others are still in the early adoption phase [95] Question: What are the expectations for iDose revenue growth? - The company expects continued progress in iDose revenue, with a modest increase in expectations for the remainder of 2025 [34] Question: How is the company addressing the impact of LCD restrictions? - The company is navigating the impact of LCD restrictions and expects to see a mid-single-digit decline in non-iDose revenues in 2025 [33] Question: What is the company's strategy regarding commercial coverage? - The company is methodically rolling out access to commercial Medicare Advantage and expects to see coverage policies extend over more than 50% of the potential patient population [56] Question: What are the expectations for operational expenses? - The company continues to expect about 15% year-over-year growth in operational expenses off the adjusted 2024 base [91]

APRIL 30, 2025 GLAUKOS CORPORATION (NYSE: GKOS) FIRST QUARTER 2025 IN REVIEW Important Information This document is intended to be read by investors in advance of regularly scheduled quarterly conference calls and was designed to provide a review of Glaukos Corporation's recent financial and operational performance and general business outlook. Please see "Forward-Looking Statements" and "Statement Regarding Use of Non-GAAP Financial Measures" in the "Additional Information" section of this document. | Conf ...

Glaukos Corporation (GKOS) reported record fourth-quarter 2024 revenues of $105.5 million, reflecting a 28% year-over-year increase. This growth was driven by strong demand for its innovative glaucoma and corneal health solutions. The company’s success in expanding its iDose TR adoption and international footprint further bolstered its financial performance. As GKOS continues to expand its footprint in the ophthalmology sector, key elements should shape its trajectory this year.The increasing prevalence of ...

Financial Performance - Net sales for 2024 reached $383.481 million, a 21.9% increase from $314.711 million in 2023[354]. - Gross profit for 2024 was $289.454 million, up from $239.136 million in 2023, reflecting a gross margin improvement[354]. - Total operating expenses increased to $411.820 million in 2024, compared to $367.836 million in 2023, primarily driven by higher selling, general and administrative expenses[354]. - The net loss for 2024 was $146.372 million, slightly higher than the net loss of $134.661 million in 2023[354]. - Cash and cash equivalents increased to $169.626 million in 2024, up from $93.467 million in 2023, indicating improved liquidity[353]. - Total assets grew to $974.756 million in 2024, compared to $940.414 million in 2023, reflecting a strong balance sheet[353]. - Stockholders' equity increased significantly to $766.931 million in 2024, up from $461.766 million in 2023, driven by additional paid-in capital[353]. - The company reported a net operating loss (NOL) of $147.8 million for the year ended December 31, 2024, compared to $138.2 million in 2023 and $101.3 million in 2022[512]. Revenue and Sales - The company’s revenue is derived from product sales in the U.S. and internationally, with revenue adjustments for volume-based rebates and other incentives[348]. - Total revenue for glaucoma products increased from $237.0 million in 2023 to $303.3 million in 2024, representing a growth of 27.9%[464]. - The company has faced challenges in auditing net sales, particularly in evaluating discounts and incentives related to customer programs[350]. Cash and Liquidity - The company has significant amounts of cash and cash equivalents at U.S. financial institutions that exceed federally insured limits, posing credit risk[337]. - Cash, cash equivalents, and restricted cash at the end of the period increased to $174.4 million from $99.3 million at the beginning of the period[362]. - The company maintains cash balances exceeding federally insured amounts, indicating a strong liquidity position[376]. Expenses and Costs - Research and development expenses were $136.425 million in 2024, slightly down from $138.768 million in 2023, indicating a focus on cost management[354]. - The company recorded advertising costs of approximately $3.6 million, $3.4 million, and $2.5 million for the years ended December 31, 2024, 2023, and 2022, respectively[413]. - Depreciation and amortization expense related to property and equipment rose to $10.1 million in 2024, up from $7.3 million in 2023, marking an increase of approximately 38.4%[438]. Risks and Challenges - The company reported a significant risk related to the commercial success of its iDose TR product, which could materially impact its business[19]. - The company faces potential supply and manufacturing disruptions that could reduce gross margins and negatively affect operating results[19]. - The company has not yet achieved sustained profitability and may fail to generate sufficient sales of its commercialized products[19]. - The company is exposed to foreign currency exchange risks, particularly as international operations grow, which could increase operational costs[338]. Foreign Currency and Hedging - A hypothetical 10% fluctuation in foreign exchange rates would have an immaterial impact on the company's net loss as of December 31, 2024[340]. - The company has not entered into foreign currency hedging contracts but may consider doing so in the future[339]. Stock and Equity - The weighted-average shares outstanding used to compute basic and diluted net loss per share increased to 52.755 million in 2024 from 48.433 million in 2023[354]. - The company has 5,000,000 authorized preferred stock issuable, with no preferred stock outstanding as of December 31, 2024, and December 31, 2023[428]. - The total stock-based compensation cost for the year ended December 31, 2024, was $50.2 million, an increase of 15.4% from $43.5 million in 2023[510]. Tax and Deferred Assets - Deferred tax assets increased to $269.6 million as of December 31, 2024, from $224.0 million in 2023, primarily due to an increase in net operating loss carryforwards[513]. - The valuation allowance for deferred tax assets increased by $50.7 million in 2024, indicating management's expectation that a portion of these assets may not be realized[514]. - The company had approximately $527.5 million in federal NOL carryforwards as of December 31, 2024, with $322.8 million subject to an 80% limitation on future taxable income[515]. Acquisitions and Investments - The company acquired a clinical stage biopharma company for $5.0 million in stock and $5.1 million in cash, with potential future payments of up to $201.0 million based on development and sales milestones[370]. - The company’s investment portfolio is primarily in marketable securities, with all investments stated at fair value[377]. Lease and Liabilities - Operating lease liabilities increased from $30.4 million in 2023 to $33.9 million in 2024, an increase of approximately 11.5%[455]. - The total lease liabilities rose from $103.2 million in 2023 to $105.9 million in 2024, indicating an increase of approximately 2.6%[455]. - The contingent consideration liability increased from $1.4 million to $1.6 million during 2024, reflecting a change in fair value due to updated assumptions[447].