Summary of Glaukos Conference Call Company Overview - **Company**: Glaukos Corporation - **Industry**: Medical Technology (MedTech), specifically focused on ophthalmology and glaucoma treatment Key Financial Highlights - **Q3 Results**: Achieved record glaucoma revenues and total revenues, reporting $40 million from iDose for the quarter, a sequential increase from Q2 [7][40] - **Guidance Update**: Raised annual revenue guidance from $490 million to $495 million, indicating strong business growth as the year closes [7][40] Product Insights iDose - **Market Potential**: iDose is positioned to expand the total addressable market (TAM) for glaucoma treatments, with an estimated 22 million eyes affected by ocular hypertension and glaucoma, of which 12 million are currently treated [44][45] - **Clinical Evidence**: iDose has undergone two phase 3 trials with over 1,150 patients, demonstrating efficacy and safety [20][21] - **Future Growth**: Expected to exit 2025 with a run rate of approximately $180 million, with projections for 2026 around $220 million [42][40] EPIAXA - **New Approval**: EPIAXA is a new treatment for keratoconus that does not require corneal debridement, improving patient experience [115][121] - **Market Opportunity**: Currently, only 10,000 patients are treated annually, but there is potential for 50,000 patients who are not receiving treatment [117][119] - **Investment Focus**: Significant investments will be made to educate and identify patients, with a focus on establishing market access and reimbursement [123][129] Market Dynamics - **Interventional Glaucoma (IG)**: The company is focused on promoting interventional glaucoma treatments, which aim to address noncompliance with topical medications [49][78] - **Surgeon Adoption**: The adoption of IG practices is still in early stages, with a need for education and support for surgeons to implement these treatments effectively [186][190] Regulatory and Reimbursement Landscape - **MACs and J Code**: All seven Medicare Administrative Contractors (MACs) are now paying for the J code, with ongoing efforts to establish pro fees for remaining MACs [93][100] - **Future Reimbursement**: The establishment of a J code is expected to enhance commercial plan adoption and streamline reimbursement processes [135][139] R&D and Innovation - **Pipeline Development**: Glaukos has 14 publicly disclosed pipeline programs, including next-generation iDose and iLution for blepharitis [167][169] - **Focus on Innovation**: The company aims to build a world-class ophthalmology company through continuous innovation and product development [166][167] International Market Outlook - **Growth Drivers**: The approval of iStent infinite in Europe is expected to drive growth, with strong demand observed at recent conferences [193][195] - **Market Access Challenges**: Each international market presents unique challenges, but there is significant room for growth in unlocking potential [203][205] Conclusion - **Strategic Focus**: Glaukos is committed to addressing unmet patient needs through innovative products and expanding market access, with a clear path towards profitability and growth in the interventional glaucoma market [209][210]

Financial Data and Key Metrics Changes - Glaukos Corporation reported record third quarter consolidated net sales of $133.5 million, up 38% on a reported basis or 37% on a constant currency basis compared to the same quarter last year [7] - The company raised its full year 2025 net sales guidance range to $490 to $495 million from a previous range of $480 to $486 million [7][24] Business Line Data and Key Metrics Changes - The U.S. glaucoma franchise achieved record third quarter net sales of $80.8 million, reflecting a strong year-over-year growth of 57%, driven by iDose TR, which generated approximately $40 million in sales [8] - The international glaucoma franchise delivered net sales of $29.4 million, representing a year-over-year growth of 20% on a reported basis and 17% on a constant currency basis [9] - The corneal health franchise reported net sales of $23.3 million, with Votrexa contributing $20.3 million, reflecting a year-over-year growth of 13% [10] Market Data and Key Metrics Changes - Surgeons showed high initial interest in iStent Infinite during its commercial launch activities in key European markets, indicating strong potential for growth in the international market [9] - The company continues to scale its international infrastructure to drive growth as a standard of care in various regions [9] Company Strategy and Development Direction - Glaukos aims to evolve into a diversified ophthalmic leader with transformational growth drivers across multiple geographies and disease states, focusing on glaucoma and rare diseases [11] - The FDA approval of Epioxa marks a significant milestone, introducing a new standard of care for keratoconus patients with a unique incision-free treatment [12][17] - The company plans to increase investments in patient awareness and access to address the challenges of underdiagnosis and under-treatment in keratoconus [17][18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of Epioxa to deliver exceptional value to patients and the healthcare system, emphasizing the importance of education and awareness in driving patient access [20][21] - The company anticipates Epioxa will be commercially available in the first quarter of 2026, with a focus on establishing a site of care network and addressing payer adoption challenges [22][24] Other Important Information - Glaukos has invested over $1 billion in R&D to develop a robust pipeline focused on chronic and rare ophthalmic diseases [19] - The company is constructing a new 200,000-square-foot research, development, and manufacturing facility in Huntsville, Alabama, to support long-term growth and innovation [19] Q&A Session Summary Question: Can you discuss the rationale behind the CAC meeting and potential outcomes? - Management highlighted the importance of educating MACs on the unmet need that iDose addresses and the robust FDA data supporting its utilization [30][31] Question: What is the confidence level regarding payer coverage for Epioxa? - Management indicated that education at the payer level is crucial, and they are optimistic about engaging in conversations to establish coverage [36] Question: Can you provide more granularity on the 2026 revenue guidance? - Management stated that the preliminary guidance reflects expectations for Epioxa's rollout and the transition from Votrexa, with more detailed insights to be provided in future calls [41][42] Question: How is iDose performing in terms of utilization? - Management reported strong sales growth for iDose, with contributions from various MAC regions and a growing trend in combination with cataract surgeries [45][46] Question: What are the expectations for patient access to Epioxa? - Management acknowledged that while there may be initial headwinds, they aim to significantly expand patient access over time through education and awareness initiatives [55]

Financial Data and Key Metrics Changes - Glaukos Corporation reported record third quarter consolidated net sales of $133.5 million, up 38% on a reported basis or 37% on a constant currency basis compared to the same quarter last year [6][7] - The company raised its full year 2025 net sales guidance range to $490 to $495 million from a previous range of $480 to $486 million [6][26] Business Line Data and Key Metrics Changes - The U.S. glaucoma franchise achieved record third quarter net sales of $80.8 million, reflecting a year-over-year growth of 57%, driven by contributions from iDose TR, which generated approximately $40 million in sales [7][8] - The international glaucoma franchise delivered net sales of $29.4 million, representing a year-over-year growth of 20% on a reported basis and 17% on a constant currency basis [9] - The corneal health franchise reported net sales of $23.3 million, with Votrexa contributing $20.3 million, reflecting a year-over-year growth of 13% [10][11] Market Data and Key Metrics Changes - The company noted strong growth in both U.S. and international markets, with the U.S. glaucoma franchise being a significant contributor to overall sales growth [7][9] - Surgeons showed high initial interest in iStent Infinite during its commercial launch activities in Europe, indicating a positive market reception [9] Company Strategy and Development Direction - Glaukos is focused on advancing its strategic priorities, evolving into a diversified ophthalmic leader with growth drivers across multiple geographies and disease states [11][26] - The company plans to increase investments in patient awareness and access for Epioxa, aiming to address the challenges of underdiagnosis and under-treatment in keratoconus [18][19] - A new 200,000-square-foot research, development, and manufacturing facility is being established in Huntsville, Alabama, to support long-term growth and innovation [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of Epioxa to transform keratoconus treatment and emphasized the importance of education and awareness in expanding patient access [21][56] - The company anticipates a slow and methodical rollout for Epioxa in 2026, with initial patient access being gated by site of care network deployment and payer adoption [24][40] - Preliminary revenue guidance for 2026 is set at $600 million to $620 million, reflecting expectations for continued growth from iDose TR and the launch of Epioxa [26][27] Other Important Information - The FDA approval of Epioxa marks a significant milestone, being the first and only FDA-approved topical drug therapy for keratoconus that does not require removal of the corneal epithelium [12][13] - The company has invested over $1 billion in R&D to develop a robust pipeline focused on chronic and rare ophthalmic diseases [20] Q&A Session Summary Question: Can you discuss the rationale of the CAC meeting and potential outcomes? - Management highlighted the importance of educating MACs on the unmet need that iDose addresses and the robust data supporting its utilization [32][34] Question: What are your views on payer coverage and reimbursement for Epioxa? - Management indicated that gaining access for Epioxa will involve educating payers about the benefits and costs associated with keratoconus progression [38][56] Question: Can you provide more granularity on the 2026 revenue guidance? - Management stated that the preliminary guidance reflects expectations from various franchises and will provide more detailed views in the fourth quarter call [44][45] Question: How is iDose performing and what is the mix of standalone versus combination procedures? - Management reported strong sales growth for iDose, with a mix of utilization in both standalone and combination procedures, though specific tracking is not available [47][50] Question: What investments are being made for Epioxa's market development? - Management emphasized targeted awareness and education efforts, particularly within the optometric community, to drive early diagnosis and treatment [81]

Company Overview - Glaukos Corporation (NYSE:GKOS) is a leader in ophthalmic pharmaceutical and surgical therapies, focusing on glaucoma, corneal disorders, and retinal diseases through innovative "dropless" treatment platforms [2] - The company has developed the FDA-approved iDose sustained-release implant, which delivers continuous glaucoma therapy directly inside the eye, enhancing patient adherence and outcomes [2] Financial Performance - In Q2 2025, Glaukos reported a 30% year-over-year increase in net sales, reaching $124.1 million [3] - U.S. glaucoma treatment sales for the quarter amounted to $72.3 million, leading the company to raise its full-year guidance to a range of $480-$486 million [3] - The growth is attributed to strong adoption of the iDose TR implant and increasing market penetration [3] Product Pipeline and Innovations - Glaukos is advancing its pipeline with next-generation therapies, including the iDose TREX implant, which is currently in Phase 2b/3 trials aimed at extending treatment duration and improving compliance [3] - Ongoing trials for iStent Infinite and PRESERFLO devices are expected to broaden the company's long-term growth potential [3] Regulatory Developments - The company's Epioxa, a non-invasive epi-on corneal cross-linking therapy for keratoconus, has received FDA acceptance for review, with a PDUFA date set for October 20, 2025 [4] - If approved, Epioxa would be the first therapy of its kind that does not require corneal epithelium removal, promising shorter recovery times and enhanced patient comfort [4]

Core Insights - Glaukos Corporation (GKOS) is experiencing significant growth, with first-half 2025 revenues reaching $230.8 million, a 27.3% year-over-year increase, primarily driven by the adoption of the iDose TR implant [1][8] - The company has raised its full-year revenue guidance to $480-$486 million, indicating strong commercial momentum [1][8] Near-Term Growth Drivers - The iDose TR launch is gaining traction, generating approximately $31 million in second-quarter sales, with over 80% of volume coming from regions with established reimbursement schedules [3][8] - International glaucoma revenues increased by 20% year-over-year to $31.3 million, supported by the EU MDR clearance for iStent Infinite, which enhances Glaukos' interventional glaucoma strategy [4][8] Long-Term Growth Catalysts - Glaukos is advancing a diversified pipeline across five therapeutic platforms, with pivotal trials for iStent Infinite and PRESERFLO MicroShunt underway, and Epioxa awaiting FDA approval by October 2025 [9][10] - The company is positioning itself in a new stand-alone interventional glaucoma market, with expectations of millions of procedures annually over the next decade [10][11] Challenges and Watchpoints - Reimbursement complexities, including MAC LCD restrictions, pose challenges, although iDose TR reimbursement is expanding [12][14] - Execution risk exists in scaling iDose TR, particularly in regions with slower adoption rates [13][14] - Corneal health sales showed only a 4% year-over-year increase, with anticipated revenue softness during the transition to Epioxa [15][16] Competitive Landscape - The iDose TR launch positions Glaukos favorably against competitors like Alcon, Johnson & Johnson, and Sight Sciences, although Glaukos shares have underperformed compared to these rivals [17][18][21]

Financial Data and Key Metrics Changes - Glaukos reported record second quarter consolidated net sales of $124.1 million, up 30% on a reported basis or 29% on a constant currency basis compared to the same quarter last year [8] - The company raised its full year 2025 net sales guidance range to $480 million to $486 million, compared to the previous range of $475 million to $485 million [8] Business Line Data and Key Metrics Changes - The U.S. Glaucoma franchise achieved record second quarter net sales of $72.3 million, reflecting a strong year-over-year growth of 45%, driven by contributions from iDoseTR, which generated approximately $31 million in sales [10] - The international glaucoma franchise delivered record net sales of $31.3 million, with year-over-year growth of 20% on a reported basis and 15% on a constant currency basis [13] - The corneal health franchise reported net sales of $20.6 million, with a year-on-year growth of 4%, including Photrexa net sales of $17.9 million [15] Market Data and Key Metrics Changes - The U.S. market faced turbulence due to five MAC LCDs implemented in 2024, affecting the MIGS market, which is expected to continue into 2025 [11] - CMS proposed rules for 2026 largely maintained 2025 APC assignments and modestly increased facility fee rates, but proposed reductions in physician fee reimbursement for several category one CPT codes across ophthalmology [12] Company Strategy and Development Direction - The company is focused on driving new standalone intervention therapies designed to slow disease progression and reduce drug burden, particularly through the adoption of iDoseTR [9] - Glaukos plans to commence commercial launch activities for iStent Infinite in key European markets at the upcoming ESCRS Annual Meeting in September [15] - The company is advancing several important clinical programs across its five novel therapeutic platforms, including iDose and ILUTION [19] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the increasing clinical interest in interventional glaucoma therapies and the potential to reshape glaucoma management [10] - The transition from Photrexa to Epioxa is expected to create a material disruption headwind in Q4, as patients may defer procedures until Epioxa is available [27] - Management emphasized the importance of educating CMS on the proposed methodology shift regarding physician fees [12] Other Important Information - The company completed a small acquisition of Mobius Therapeutics, which solidifies its supply chain and supports broader glaucoma tertiary care efforts [20] - The company’s operational cash and equivalents grew by more than $4 million in the second quarter, excluding one-time investments [21] Q&A Session Summary Question: Clarification on 2025 sales guidance - Management acknowledged the exceptional second quarter performance but noted that guidance was raised conservatively due to less visibility in the second half, particularly in corneal health and U.S. glaucoma segments [24][25] Question: State of interventional glaucoma efforts - Management highlighted significant progress in building the standalone market opportunity for interventional glaucoma, with increasing traction and adoption of iDoseTR and iStent Infinite [28][30] Question: Comparison of geographic MAC coverage for iDose - Management indicated that growth was faster in MAC regions with established professional fees, and they are optimistic about progress in lagging MACs [35][36] Question: Impact of proposed reimbursement changes - Management expressed that the proposed facility fee increases are generally positive, but the overall impact on Glaukos is expected to be neutral to slightly positive [48] Question: SG&A growth expectations - Management noted a step-up in SG&A due to a one-time stock compensation expense, but overall operational expenses are expected to grow in the mid-teens [50][52] Question: iDose reimplantation decision timeline - Management clarified that the FDA has set a PDUFA date of January 28, 2026, for the iDose reimplantation petition, which reflects a change in timing [77] Question: Epioxa rollout strategy - Management indicated that the rollout of Epioxa will involve transitioning from Photrexa, with expectations of patient education and demand increasing post-approval [67][72]

Financial Data and Key Metrics Changes - Glaukos reported record second quarter consolidated net sales of $124.1 million, up 30% on a reported basis or 29% on a constant currency basis compared to the same quarter last year [6] - The company raised its full year 2025 net sales guidance range to $480 million to $486 million, up from the previous range of $475 million to $485 million [6] Business Line Data and Key Metrics Changes - The U.S. Glaucoma franchise achieved record second quarter net sales of $72.3 million, reflecting a strong year-over-year growth of 45%, driven by contributions from iDoseTR, which generated approximately $31 million in sales [9] - The international glaucoma franchise delivered record net sales of $31.3 million, with year-over-year growth of 20% on a reported basis and 15% on a constant currency basis [12] - The corneal health franchise reported net sales of $20.6 million, with a year-on-year growth of 4%, including Photrexa net sales of $17.9 million [13] Market Data and Key Metrics Changes - The U.S. market faced turbulence due to five MAC LCDs implemented in 2024, affecting the MIGS market, which is expected to continue into 2025 [10] - CMS proposed rules for 2026 largely maintained 2025 APC assignments and modestly increased facility fee rates, while proposing reductions in physician fee reimbursement for several ophthalmology codes [11] Company Strategy and Development Direction - The company is focused on driving new standalone intervention therapies designed to slow disease progression and reduce drug burden [7] - Glaukos aims to maintain and grow its presence in Europe with the recent EU MDR clearance for iStent Infinite, which is indicated for all stages of open-angle glaucoma [13] - The company completed a small acquisition of Mobius Therapeutics to solidify its supply chain and support its glaucoma tertiary care efforts [19] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the increasing clinical interest in interventional glaucoma therapies and the potential to reshape glaucoma management [8] - The company anticipates some transient disruption in the U.S. corneal health franchise as it transitions from Photrexa to Epioxa following targeted approval [16] - Management highlighted the importance of educating CMS on proposed methodology shifts affecting reimbursement [11] Other Important Information - The company is advancing several clinical programs across its therapeutic platforms, including iDose and ILUTION, with various trials and regulatory reviews ongoing [17][18] - The company expects to launch Epioxa in 2026, which will provide a new treatment option for keratoconus patients [15] Q&A Session Summary Question: Can you discuss the components of this year's revenue guidance? - Management noted that the guidance was raised due to exceptional second quarter performance, particularly driven by iDose, with expectations for low double-digit growth in international glaucoma and flat to low single-digit growth in corneal health [22][25] Question: What is the state of interventional glaucoma and the long-term opportunity? - Management highlighted a significant shift towards interventional approaches in glaucoma care, with increasing traction for iDoseTR and iStent Infinite, indicating a bright future for the company [26][30] Question: How are professional fees impacting the legacy MIGS business? - Management discussed the relativity of professional fees and the shift towards standalone glaucoma therapy as a viable pathway for practices facing reduced cataract surgery fees [38][41] Question: What are the implications of the proposed reimbursement changes? - Management expressed that the proposed facility fee increases are generally positive, while the impact on physician fees is more neutral [46] Question: What is the expected growth for SG&A expenses? - Management indicated that total OpEx would grow in the mid-teens, with a notable one-time stock comp expense affecting the quarter's results [48][50] Question: How will the rollout of Epioxa be managed post-approval? - Management stated that the transition from Photrexa to Epioxa will impact sales, with expectations for a significant portion of patients to defer to the new treatment [66][72]

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.

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]