Summary of Glaukos Conference Call Company Overview - **Company**: Glaukos Corporation - **Industry**: Medical Technology, specifically focused on glaucoma treatment and corneal health Key Financial Highlights - **Q3 Revenue**: $133.5 million, a record quarter for Glaukos - **US Glaucoma Revenue**: $81 million, representing a 57% year-over-year growth [4][5] - **International Glaucoma Revenue**: $29 million, a 20% growth rate (17% on a constant currency basis) [4] - **Corneal Health Revenue**: $23 million, a 13% year-over-year growth [4] - **Gross Margin**: Reached almost 84%, driven by the high-margin product iDose [5][57] - **Cash Balance**: $277.5 million, slightly down from the previous quarter [6] Product Performance - **iDose**: - Contributed significantly to revenue growth, with 80% of volumes coming from three MACs (Noridian, Novitas, First Coast) [7][8] - Anticipated growth as more MACs establish pro fees, with NGS added recently [8][9] - Expected to drive utilization growth as operationalization takes time [9][10] - **Epiox**: - Announced pricing at $78,500 per eye, with expected net ASP between $65,000-$70,000 after discounts [31][33] - Targeting a mix of buy-and-bill and specialty pharmacy distribution models [34][35] - Anticipated to launch in early next year, with a focus on establishing a site of care network [36][37] Market Dynamics - **Commercial Coverage**: Approximately 50% of commercial plans currently cover iDose, with a significant portion of silent coverage [18][19] - **Patient Demographics**: The patient mix for iDose trials was approximately 50% Medicare-aged and 50% commercial-aged, indicating a potential shift in commercial usage over time [19] - **Utilization Trends**: Currently focused on glaucoma patients, with potential for treating ocular hypertension patients in the future [23] Strategic Insights - **Surgeon Training**: Surgeons are being trained at a healthy pace, with no significant barriers to adoption noted [16][17] - **Market Growth**: Anticipated recovery in the core MIGS market as LCD headwinds are overcome, with a focus on iDose as a primary growth driver [50][51] - **Cannibalization Concerns**: Some cannibalization of iStent by iDose is expected, but both products are seen as complementary [53] Future Outlook - **2026 Revenue Guidance**: Preliminary guidance of $600 million-$620 million, driven by multiple revenue streams including iDose and Epiox [55][56] - **Margin Expectations**: Continued improvement in gross margins expected as iDose and Epiox become a larger part of the business [57][58] - **Investment in R&D**: Plans to maintain a robust R&D pipeline while balancing operating expenses to achieve cash flow breakeven in the near term [59] Additional Considerations - **Educational Efforts**: Ongoing education for MACs and physicians regarding the clinical evidence supporting iDose is crucial for broader adoption [24][28] - **Patient Access**: Strategies in place to ensure patient access to Epiox, including trade-in programs for existing equipment [41][44] This summary encapsulates the key points discussed during the Glaukos conference call, highlighting financial performance, product insights, market dynamics, and future strategies.

Summary of Glaukos Conference Call Company Overview - **Company**: Glaukos Corporation - **Products Discussed**: Epioxa and iDose - **Industry**: MedTech, specifically focused on ophthalmic therapies Key Points Epioxa Pricing and Market Dynamics - Epioxa pricing was established after extensive research and consideration of value for patients, providers, and the payer system [5][6] - The company aims to maximize patient awareness and provider education, which is costly but essential for accessing therapies [7][8] - There are approximately 5 million cataract procedures annually in the U.S., but only about 10,000 patients are currently treated with FOTREXA, indicating a significant opportunity for Epioxa [6][9] - The gross-to-net dynamics for Epioxa include: - A 23% statutory discount for Medicaid patients [11] - A similar discount for sales to 340B public hospital systems [11] - Coverage of out-of-pocket costs for commercial patients to ensure access [12][13] Physician Reactions and Market Access - Initial physician feedback on Epioxa pricing has been mixed, with some expressing shock and unrest [15] - The company emphasizes that pricing decisions were made with patient access as a priority, and they are prepared to engage with physicians to explain their rationale [15][16] - The reimbursement landscape for Epioxa is expected to be non-linear, differing from the iDose experience due to the patient demographics and the number of insurance plans involved [19][20] Patient Volume and Market Potential - The U.S. market for Epioxa is estimated to have around 10,000 patients, with potential to reach 20,000 eyes at peak [23] - The company believes there are significantly more undiagnosed patients with keratoconus, indicating a larger market opportunity [25][26] - The goal is to not only return to previous treatment levels but to expand significantly beyond that [25][26] Comparison with iDose - The peak sales opportunity for iDose is viewed as larger than Epioxa due to a larger patient population (21 million potential ocular hypertensive and glaucomatous eyes) [27][28] - iDose is expected to benefit from a more established market and clearer treatment guidelines compared to Epioxa, which is in a rare disease category [21][22] Reimbursement and Market Access Challenges - The company is confident in the long-term access for iDose despite potential hurdles from the CAC (Coverage Advisory Committee) discussions [29][30] - The reimbursement process is complex, with a need for extensive data to support market access [30][31] - The company is optimistic about the potential for Medicare Advantage plans to cover iDose, which could expand access significantly [34][36] Future Outlook - The company is focused on driving incremental utilization in both commercial and Medicare Advantage populations [56][57] - There is a belief that the dynamics of patient access will improve over time as the company continues to engage with payers and physicians [35][36] Additional Insights - The company acknowledges the challenges of competing for operating room time during peak cataract surgery seasons, which may impact iDose sales [44][45] - The management is cautious about setting revenue expectations, considering various scenarios for both Epioxa and iDose [50][52] This summary encapsulates the key discussions and insights from the Glaukos conference call, highlighting the company's strategic focus on pricing, market access, and future growth opportunities in the ophthalmic therapy space.

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 - 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) 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.

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]

Summary of Glaukos (GKOS) 2025 Conference Call Company Overview - **Company**: Glaukos Corporation (GKOS) - **Event**: 2025 Conference Call held on May 27, 2025 Key Points on iDose Reimbursement and Performance - **Reimbursement Status**: Progress is being made with Medicare administrators, including Noridian, Novitas, and First Coast, with increasing payments for the drug and facility fees [2][3][10] - **Professional Fee Adjudication**: Ongoing efforts to streamline professional fee payments, with some Medicare Administrative Contractors (MACs) showing signs of improvement [3][5] - **Volume Generation**: The timing of reimbursement progress is tied to generating procedural volumes, which is critical for establishing a systematic reimbursement process [4][5] - **ASP Comparison**: iDose's Average Selling Price (ASP) is competitive, with the product containing seven times the amount of drug compared to Darista, which has comprehensive coverage across payers [7][9][10] - **Coverage Status**: Approximately 50% of lives are covered under commercial plans and Medicare Advantage, with ongoing efforts to expand access [10][11] - **Market Dynamics**: iDose is positioned as a second or third-line therapy initially, with plans to drive it closer to first-line therapy over time [12] Financial Performance and Projections - **Q1 2025 Performance**: The company reported exceptional progress in the market, with Noridian fully operational and increasing payments from Novitas and First Coast [14][19] - **Sales Guidance**: For 2025, the guidance for iDose sales is projected between $120 million to $125 million, with expectations for a stronger second half of the year due to seasonality and backlog building [23][24] - **Gradual Launch**: The launch of iDose is expected to be gradual and methodical, with a focus on education and operationalizing reimbursement processes [37][39] Long-term Outlook - **Peak Sales Estimates**: Peak sales expectations for iDose have not changed significantly but have increased on a risk-adjusted basis due to positive real-world performance [45] - **Market Potential**: The company is optimistic about the long-term market opportunity, with a focus on expanding access and operational efficiency in physician offices [42][44] U.S. Stent Business Insights - **Recent Performance**: The U.S. stent business experienced mid-single-digit growth in early 2024 but faced challenges due to Local Coverage Determinations (LCDs) impacting procedures [47][48] - **Guidance Adjustments**: Guidance for 2025 has been adjusted to reflect the impact of LCDs, with expectations for recovery as awareness and adaptation to these changes improve [52][54] Profitability Goals - **Cash Flow Breakeven**: The company aims to achieve free cash flow breakeven in the near term while continuing to make necessary investments [56] Additional Notes - **Investor Enthusiasm**: There is strong enthusiasm from investors regarding the product's clinical performance, but the launch pace is primarily influenced by reimbursement dynamics [31][35] - **Education and Support**: The company emphasizes the importance of educating physicians and their staff on the procedural aspects and reimbursement processes to ensure successful adoption [29][30]