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) 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]

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]