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]

Financial Data and Key Metrics Changes - The company reported four consecutive quarters of over 20% growth, with a notable acceleration to 29% in constant currency during the second quarter [6][8] - The focus remains on cash flow breakeven rather than immediate profitability, with management indicating that profitability will be addressed in the future as growth continues [10][11] Business Line Data and Key Metrics Changes - iDose sales reached $31 million in the second quarter, an increase of approximately $10 million sequentially, indicating strong market acceptance [12] - The company anticipates continued growth in iDose sales, although seasonality may affect the third quarter [13][14] Market Data and Key Metrics Changes - The potential market for glaucoma procedures is estimated at 21-22 million eyes in the U.S., with 12-13 million currently diagnosed and treated, highlighting significant growth opportunities [8] - The company is actively working with various Medicare Administrative Contractors (MACs) to improve market access and reimbursement for its products [19][20] Company Strategy and Development Direction - The company aims to change the standard of care in combination cataract glaucoma surgery and is focused on unlocking larger market opportunities over the next decade [7][8] - Management emphasizes the importance of maintaining flexibility to invest in growth opportunities while gradually shifting focus towards profitability [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving sustained growth above 20% in the coming years, driven by ongoing investments and market expansion [7][8] - The company acknowledges potential headwinds from competitive dynamics but believes the overall market opportunity remains significant [59][60] Other Important Information - The company is preparing for the launch of Epioxa, which is expected to have a significant impact on the market, although initial disruptions are anticipated [41][42] - Management is focused on patient awareness and education to drive adoption of new therapies, particularly in the keratoconus market [45][47] Q&A Session Summary Question: What is the company's growth outlook? - The company has consistently achieved over 20% growth and expects to maintain this trajectory as it unlocks larger market opportunities [6][7] Question: How is the launch of iDose progressing? - iDose sales have shown strong growth, with management optimistic about future sales despite potential seasonal fluctuations [12][13] Question: What are the challenges with reimbursement? - The company is actively engaging with MACs to improve reimbursement processes, which is critical for the adoption of its products [19][20] Question: How does the company view competition? - Management respects competition but believes the focus should be on changing the standard of care rather than merely competing for market share [59][60] Question: What is the expected impact of Epioxa? - Epioxa is anticipated to disrupt the market initially, but management is confident in its long-term potential and is focused on driving patient access [41][42]

Financial Data and Key Metrics Changes - The company reported four consecutive quarters of over 20% growth, with a notable acceleration to 29% in constant currency during the second quarter [5][6] - Sales for iDose reached $31 million in the second quarter, an increase of approximately $10 million sequentially [11] Business Line Data and Key Metrics Changes - The iDose product is still in the early stages of market development, with significant sales driven by Noridian and Novitas, which cover about 50% of Medicare lives [12][13] - The company anticipates continued growth in iDose sales, although seasonality may affect trends in the third quarter [14][15] Market Data and Key Metrics Changes - The potential market for glaucoma procedures has expanded significantly, with estimates of 21 to 22 million eyes affected, compared to a previous estimate of 500,000 potential procedures in the U.S. [6][7] - The company is focusing on increasing market access and reimbursement to drive adoption of iDose and other products [12][25] Company Strategy and Development Direction - The company aims to change the standard of care in combination cataract and glaucoma surgery, with a focus on long-term growth opportunities [6][10] - Management emphasizes the importance of maintaining flexibility to invest in growth rather than prioritizing immediate profitability [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving sustained growth above market rates, with a focus on unlocking larger market opportunities over the next decade [6][7] - The company is preparing for potential challenges in 2026 related to commercial payer dynamics and the adoption of new products [50][66] Other Important Information - The company is actively working on advocacy and education efforts to facilitate the adoption of iDose among remaining MACs [23][24] - Management indicated that while there will be a transition period for Epioxa, they expect to see growth in the corneal health segment in 2026 [66] Q&A Session Summary Question: What is the company's growth outlook? - The company has posted four consecutive quarters of over 20% growth and expects to maintain this trajectory moving forward [5][6] Question: When will profitability become a focus? - The near-term focus remains on cash flow breakeven rather than immediate profitability, with management indicating that profitability will be addressed when appropriate [9][10] Question: How is the launch of iDose progressing? - The launch has been strong, with significant sales driven by key Medicare providers, and management expects continued growth despite seasonal fluctuations [11][14] Question: What are the competitive dynamics in the market? - Management believes that the industry is moving towards a larger opportunity in ophthalmology, focusing on changing the standard of care rather than competing for market share [58][59] Question: What challenges are anticipated in 2026? - The company expects normal commercial payer dynamics to create headwinds in 2026, but they are focused on driving advocacy to improve access to their products [50][66]

Summary of Glaukos (GKOS) Conference Call - December 14, 2023 Company Overview - **Company**: Glaukos Corporation - **Product**: iDose TR, a micro-invasive injectable therapy for glaucoma Key Industry Insights - **FDA Approval**: iDose TR received FDA approval, marking a significant milestone for glaucoma treatment and Glaukos [6][10] - **Market Need**: High non-compliance rates (up to 90%) with traditional glaucoma medications create a strong demand for effective alternatives [12][16] Core Points and Arguments 1. **Product Description**: iDose TR is designed to lower intraocular pressure (IOP) for up to three years, addressing patient non-compliance and chronic side effects associated with topical medications [6][7] 2. **Clinical Efficacy**: - Phase 3 trials showed IOP reductions of 6.6 to 8.4 mmHg for iDose TR compared to 6.5 to 7.7 mmHg for topical Timolol [9] - 81% of iDose TR subjects were free of IOP-lowering topical medications at 12 months [13] - 93% of subjects remained well-controlled on the same or fewer medications after a single administration [14] 3. **Safety Profile**: iDose TR demonstrated excellent tolerability with no serious adverse events related to corneal endothelial cell loss or periorbital fat atrophy [10][15] 4. **Regulatory Pathway**: The FDA's conservative approach led to restrictions on repeat administration, which Glaukos plans to address in future discussions [11][36] 5. **Commercial Strategy**: - A controlled launch is planned for the first half of 2024, focusing on surgeon training and market access initiatives [20][22] - A temporary C code will be used until a permanent J code is established, expected in the second half of 2024 [22][50] 6. **Pricing**: The wholesale acquisition cost for iDose TR is set at $13,950 per dose, which is considered competitive given its long-duration therapy [25][72] Additional Important Information - **Manufacturing Capabilities**: Glaukos has developed a state-of-the-art nanotechnology manufacturing facility in California, which passed FDA inspection with no observations [18] - **Patient Access Initiatives**: Glaukos is committed to ensuring access for all eligible patients, including a philanthropic initiative to donate units for qualifying requests [26][27] - **Revenue Guidance**: The company reaffirmed 2023 revenue guidance of $307 to $310 million and introduced preliminary 2024 guidance of $350 to $360 million, factoring in iDose TR's launch [28][29] Conclusion - The approval of iDose TR represents a transformative opportunity for glaucoma management, with a strong focus on addressing patient non-compliance and improving treatment outcomes. Glaukos is well-positioned to capitalize on this market need through strategic commercialization efforts and robust clinical data supporting the product's efficacy and safety.