Summary of Glaukos (GKOS) 2025 Conference Call Company Overview - **Company**: Glaukos Corporation (GKOS) - **Industry**: Medical Supplies and Devices, specifically focused on glaucoma treatment Key Points and Arguments Interventional Glaucoma Paradigm Shift - The interventional glaucoma approach is gaining acceptance as a proactive method to manage glaucoma, moving away from traditional drop treatments which patients often neglect [3][4] - The company emphasizes the need for changing practice patterns and educating healthcare providers to adopt this new approach effectively [5][6] - The transition to an interventional approach is expected to take about ten years, with a focus on improving patient outcomes [6] Physician Adoption and Challenges - Physician receptiveness varies, but the main challenge lies in translating positive clinical feedback into actionable changes in practice [7][8] - The company is focused on addressing operational challenges within practices, such as educating referral networks and changing administrative processes [9] Market Dynamics and Treatment Modalities - The company acknowledges the competition from other treatment modalities like SLT and emphasizes the importance of interventional approaches in patient care [12][16] - The average patient remains in care for over 20 years, necessitating multiple interventions to manage their condition effectively [17] iDose Product Launch and Reimbursement - The iDose product has seen successful launch and is currently focused on securing reimbursement from various Medicare Administrative Contractors (MACs) [18][19] - The reimbursement landscape is segmented into three tiers, with varying levels of predictability and success in claims processing [19][20] - The company is actively working to streamline reimbursement processes and is optimistic about future growth in iDose contributions [26][27] Financial Performance and Cash Flow - The company aims to achieve cash flow breakeven in the near term, with expectations that iDose will contribute positively to gross margins over time [41][42] - Operating expenses are growing at a slower rate than revenue, indicating operational leverage is being achieved [45] Sales Strategy and Market Access - The sales force is deemed sufficient, with plans to fill geographic gaps as needed [47] - The company is focusing on supporting healthcare providers in navigating the complexities of commercial payer systems, which differ significantly from Medicare processes [36][37] Future Outlook and Growth Potential - The company anticipates continued growth in the MIGS market, with expectations of mid-single-digit growth rates in the long term [57][58] - The focus remains on increasing standalone utilization of iDose and other products, which may influence market dynamics and physician preferences [58] Additional Important Insights - The company is investing in educational initiatives and industry collaborations to promote best practices in interventional glaucoma [11] - The reimbursement process is described as a data collection effort by MACs to ensure medical necessity and appropriate payment calculations [23][24] - The company is also working on new product developments, including the Trio system, which aims to enhance in-office procedures [50][51] This summary encapsulates the key discussions and insights from the Glaukos conference call, highlighting the company's strategic focus on interventional glaucoma, product launches, and market dynamics.

Summary of Glaukos (GKOS) FY Conference June 03, 2025 Company Overview - Glaukos is focused on innovative treatments for glaucoma and other eye diseases, emphasizing dropless therapies and interventional glaucoma solutions [3][4][5] - The company has developed five novel platforms, including the iStent franchise and the latest product line, iDose [5][6] Key Products and Innovations - **iStent Franchise**: Established product line for treating glaucoma [5] - **iDose**: A new product that allows for continuous drug delivery, showing a 70% control rate of intraocular pressure over three years in trials [22][23] - **EyeLink**: A product targeting keratoconus, with an NDA submitted and a PDUFA date set for October 2025 [36] - **Ilucian**: A cream-based drug delivery system targeting Demodex blepharitis, with clinical trials starting this year [37] - **Retina Products**: Utilizing a small molecule approach for retinal diseases, with a phase one trial underway [39] Market Opportunity - The total addressable market for glaucoma treatment includes approximately 22 million eyes in the U.S., with 12 million actively treated [25] - The company aims to shift from a cataract surgery-focused market to a standalone glaucoma treatment market, which presents significant growth potential [25][26] Research and Development Investment - Over the past seven years, Glaukos has invested more than $700 million in R&D, resulting in 14 disclosed programs in the pipeline [7] - The company is committed to long-term innovation, with a focus on interventional glaucoma as a ten-year journey [28] Commercial Strategy - Emphasis on early intervention in glaucoma treatment to improve patient outcomes and reduce reliance on drops, which have low compliance rates [10][12] - The "forever patient" model allows for multiple treatment iterations over a patient's lifetime, enhancing both patient care and business opportunities for ophthalmologists [21][22] Financial Performance - Glaukos has achieved a ten-year compound annual growth rate (CAGR) of over 20% and maintains gross margins exceeding 80% [42] - The company has a strong balance sheet with over $300 million in cash and no debt [43] Future Milestones - Key milestones for 2025 include advancing clinical trials for new products and expanding market access for existing therapies [42] Conclusion - Glaukos is positioned as a leader in the ophthalmology market with a robust pipeline of innovative products aimed at improving patient care in glaucoma and other eye diseases, supported by strong financial health and a commitment to R&D [41][42]

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 ...