Financial Data and Key Metrics Changes - Glaukos reported record fourth quarter consolidated net sales of $143.1 million, up 36% on a reported basis and 34% on a constant currency basis compared to the year-ago quarter [7] - For the full year of 2025, consolidated record net sales reached $507.4 million, growing 32% versus 2024 [7] - The company reaffirmed its full year 2026 net sales guidance range of $600 million to $620 million, implying over 20% year-over-year growth at the midpoint [7] Business Line Data and Key Metrics Changes - The U.S. glaucoma franchise achieved record fourth quarter net sales of $86.4 million, reflecting a strong year-over-year growth of 53%, driven by iDose TR, which generated approximately $45 million in sales during the fourth quarter [9] - The international glaucoma franchise delivered net sales of $32.8 million, with year-over-year growth of 18% on a reported basis and 13% on a constant currency basis [11] - The corneal health franchise reported net sales of $24 million, with year-over-year growth of 12%, including $21.4 million from Photrexa [12] Market Data and Key Metrics Changes - The company noted strong physician adoption of iDose TR, with sales of approximately $136 million in 2025, indicating positive clinical outcomes and growing contributions [9] - The international market is expected to face competitive product trialing headwinds in major markets, partially offset by contributions from iStent infinite following its EU MDR certification [11] Company Strategy and Development Direction - Glaukos aims to advance the interventional glaucoma treatment paradigm with iDose TR and launch Epioxa, targeting new markets in interventional keratoconus and rare diseases [8] - The company is focused on capital allocation, emphasizing ROI-driven investments and cash flow while advancing a robust industry-leading pipeline [9] - The FDA approval of Epioxa is seen as a pivotal moment, allowing the company to redefine its go-to-market approach and expand patient care access [15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in sustaining strong growth momentum into 2026, driven by the advancements in iDose TR and the launch of Epioxa [8] - The company acknowledged potential challenges in the transition from Photrexa to Epioxa, particularly in Q2 and Q3, but expects stronger results in Q4 as the J-code becomes effective [37] - Management highlighted the importance of clinical education and payer engagement to ensure successful adoption of Epioxa [25] Other Important Information - Glaukos has invested over $1 billion in R&D since inception, focusing on chronic and rare ophthalmic diseases [21] - The company is committed to pioneering new marketplaces within ophthalmology, emphasizing innovation as a core value [22] Q&A Session Summary Question: Can you elaborate on the early positive coverage determinations for Epioxa? - Management noted that early positive outcomes have been observed with a handful of Medicaid societies and one of the larger Blue plans, with no formal pushback on pricing dynamics [25] Question: What drove the sequential deceleration in iDose revenue in Q4? - Management indicated that the mix shift towards Medicare Advantage and specific dynamics related to glaucoma procedures impacted revenue, but they expect continued growth in Q1 [29] Question: Can you provide more detail on the components of the FY 2026 guidance? - Management expects high single-digit growth internationally, with U.S. glaucoma growth driven entirely by iDose TR, while corneal health is expected to grow modestly with some volatility [35][37] Question: How do you view the interplay between iDose and TREX? - Management emphasized the goal of providing multiple treatment options for patients, with expectations for different surgeons to choose between iDose TR and TREX based on clinical profiles [49] Question: What are the expectations for operating expenses in 2026? - Management anticipates mid-teen year-over-year growth in operating expenses, aiming for around $555 million to $560 million, while maintaining operating leverage [54]

Summary of Glaukos Conference Call Company Overview - **Company**: Glaukos - **Industry**: Medical Supplies and Devices, specifically in ophthalmology - **Core Focus**: Innovation in ophthalmic treatments, particularly in minimally invasive glaucoma surgery (MIGS) and procedural pharmaceuticals [4][5] Key Points and Arguments Innovation and Market Leadership - Glaukos has pioneered the global MIGS marketplace and is creating new markets in procedural pharmaceuticals with products like iDose [4][5] - The company has invested approximately $800 million in R&D since 2018, resulting in 12 commercially available products and 13 in various development phases [7] Market Growth and Financial Performance - Achieved over 30% market growth in the past year, with a sustained CAGR of over 20% for the last decade [7] - Reported a record quarter with revenues of $507 million for 2025, projecting a 20% CAGR over the next 10 years [36] Product Development and Pipeline - Focus on changing treatment paradigms for glaucoma and keratoconus, with significant advancements in products like iDose TR and Epioxa [8][28] - iDose TR shows promising results, with 81% of patients off all medications after one year and 70% well-controlled after three years [12][13] - Epioxa is a new treatment for keratoconus, targeting a younger patient demographic and aiming to increase patient access [30][31] Market Dynamics and Challenges - The current treatment paradigm for glaucoma is inefficient, with 90% of patients non-adherent to medication regimens [10] - Glaukos aims to shift clinicians towards interventional approaches that provide continuous treatment [10][11] - The company faces challenges in reimbursement processes for Epioxa, which differ significantly from those for iDose due to the complexity of commercial payers [46][48] Future Vision and Strategy - Glaukos envisions a future where interventional glaucoma procedures could match the volume of cataract surgeries, projecting significant growth in this area by 2035 [27] - Plans to create a new cadre of interventional glaucoma surgeons who will integrate iDose and iStent Infinite into their practices [26][27] - Commitment to building a comprehensive product portfolio that addresses all stages of glaucoma treatment [28] Additional Important Insights - The company is expanding its manufacturing capabilities with new facilities in San Clemente and Huntsville, Alabama [37] - Glaukos is diversifying its operations internationally, now present in 17 countries with over 300 employees [36] - The management emphasizes the importance of educating physicians and patients about the benefits of new therapies to drive adoption [55][56] Conclusion Glaukos is positioned as a leader in ophthalmic innovation, with a strong focus on developing new treatment paradigms for glaucoma and keratoconus. The company is navigating challenges in market access and reimbursement while maintaining a robust growth trajectory and a commitment to expanding its product offerings.

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 million-$495 million from the previous range of $480 million-$486 million [7][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 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 Photrexa net sales 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 major markets worldwide [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] - The FDA approval of Epioxa marks a significant milestone, introducing a new standard of care for keratoconus patients and practitioners [12] - The company plans to increase investments in patient awareness and access to address the challenges of underdiagnosis and under-treatment in keratoconus [18][19] 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 [22] - 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 [24] - A preliminary revenue guidance range of $600 million-$620 million for 2026 was introduced, reflecting expectations for continued growth from iDose TR and the launch of Epioxa [26][27] Other Important Information - Glaukos has invested over $1 billion in R&D to develop a robust pipeline focused on chronic and rare ophthalmic diseases [21] - The company is transitioning from Photrexa to Epioxa, with plans to discontinue Photrexa's commercial availability in 2026 while ensuring continuity of care for existing patients [25] Q&A Session Summary Question: Discussion on iDose and CAC meeting - Management discussed the rationale behind the CAC meeting, emphasizing the need to educate MACs on the unmet need that iDose addresses and the robust data supporting its utilization [30][31] Question: Confidence in Epioxa pricing and 2026 outlook - Management expressed confidence in executing the pricing strategy for Epioxa, highlighting the importance of educating payers on the therapy's benefits and the cost implications of untreated keratoconus [36][37] Question: iDose performance and future growth - Management provided insights into iDose's performance, noting broad-based growth and the importance of establishing reimbursement structures to support future adoption [44][46] Question: Epioxa's market development and education efforts - Management outlined targeted awareness and education campaigns to identify and reach keratoconus patients earlier in their disease journey, emphasizing the need for a comprehensive approach [77]

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]