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]