Group 1 - The firm Stephens raised the price target on Glaukos (GKOS) to $145 from $115 and maintains an Overweight rating on the shares [1] - The outlook for non-iDose U.S. glaucoma revenue was slightly moderated, while iDose revenue expectations were modestly increased [1] - Glaukos is viewed as "one of the best multi-year medtech growth stories" entering 2026, driven by expanding reimbursement, deeper utilization, a growing surgeon base, and a long runway of untreated and uncontrolled glaucoma patients [1]

Core Insights - The article emphasizes the importance of enabling Javascript and cookies in browsers to prevent access issues [1] Group 1 - The article suggests that users may face blocks if ad-blockers are enabled, indicating a need to disable them for proper access [1]

Financial Data and Key Metrics Changes - The company has transitioned from a cash-burning phase to a cash flow break-even profile, with the convertible debt retired and a focus on capital-light operations [31][32] - Revenue growth is expected to continue, with operating margins projected in the 30% to 35% range as the company progresses towards profitability [76][77] Business Line Data and Key Metrics Changes - The core MIGS market has seen double-digit growth over the past year but is projected to decline in the mid-single digits next year, with the stent business expected to stabilize [13][16] - iDose is becoming a significant driver of revenue, with a shift towards pharmaceutical revenue potentially surpassing device revenue [9][10] Market Data and Key Metrics Changes - The reimbursement landscape for concomitant MIGS is facing low double-digit decreases, impacting professional fees while facility economics remain stable [20] - The company is currently working with four of the seven MACs that are reimbursing for professional fees, representing about 70% of Medicare lives [44] Company Strategy and Development Direction - The company aims to establish itself in the interventional glaucoma market, focusing on innovative product solutions and expanding its pipeline to include rare disease treatments like Epioxa [9][62] - The strategy includes enhancing education and awareness for rare diseases, which requires a different approach compared to more prevalent conditions like glaucoma [60][62] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, highlighting the importance of clinical outcomes and physician enthusiasm for iDose, which is expected to drive growth [28][30] - The company is focused on executing its strategies and addressing reimbursement challenges to facilitate broader adoption of its products [84][85] Other Important Information - The next-generation iDose TREX is in development, designed to carry a larger drug payload and potentially allow for longer durations of effect [55][56] - The company is also exploring in-office procedures for iDose, which could expand its market reach [57] Q&A Session Summary Question: What are the expectations for the iDose launch? - Management noted that while there were initial challenges with reimbursement, the clinical performance of iDose has exceeded expectations, leading to increased physician interest [26][28] Question: How is the company approaching profitability? - The focus remains on achieving cash flow breakeven in the short term while balancing revenue growth with necessary investments in product launches and R&D [75] Question: What is the outlook for the reimbursement landscape? - Management indicated that continued education and clinical demand are essential for expanding reimbursement coverage, with a goal of reducing the focus on reimbursement issues over time [49][50]

Financial Data and Key Metrics Changes - The company has transitioned from a cash-burning phase to a cash flow break-even profile, with the convertible debt retired and a return to normal capital spending [31][32] - Operating expenses are growing, but the company is showing leverage in its financial model as revenues increase [32][33] Business Line Data and Key Metrics Changes - The core MIGS market has seen double-digit growth over the past year but is projected to decline in the mid-single digits next year [13][16] - The introduction of iDose is cannibalizing some of the stent business, but it is also expanding the overall market opportunity [15][19] Market Data and Key Metrics Changes - The reimbursement landscape for concomitant MIGS is expected to decline in low double digits for 2026, impacting professional fees [20] - Four out of seven MACs are now reimbursing for the professional fee associated with iDose, covering about 70% of Medicare lives [44] Company Strategy and Development Direction - The company is focused on creating differentiated product solutions in large market opportunities, with a shift towards pharmaceutical revenues [9][10] - The strategy includes a strong emphasis on education and awareness for rare diseases, particularly with the launch of Epioxa [62] Management's Comments on Operating Environment and Future Outlook - Management is optimistic about the future, citing strong physician enthusiasm and positive clinical outcomes for iDose [28][30] - The company aims to shift discussions from reimbursement issues to clinical adoption and standard of care improvements in the coming year [84] Other Important Information - The next-generation iDose TREX is in development, designed to carry a larger drug payload and potentially allow for longer duration effects [55][56] - The company recognizes the challenges in treating rare diseases and is committed to transforming its approach to market access and patient education [60][62] Q&A Session Summary Question: What are the expectations for the MIGS market? - The MIGS market has grown but is expected to stabilize next year, with iDose impacting the stent business [15][16] Question: How is the reimbursement landscape evolving? - Four of the seven MACs are now reimbursing for iDose, with ongoing efforts to educate and drive demand for the remaining MACs [44][45] Question: What is the company's path to profitability? - The focus remains on achieving cash flow breakeven in the short term while aiming for operating margins of 30%-35% in the medium to long term [75][76] Question: What are the key challenges in launching Epioxa? - The company is aware of the need for education and awareness in the rare disease space, which requires significant investment and effort [60][62] Question: What will the company be discussing next year? - Management hopes to focus on clinical adoption and the opportunities associated with iDose and Epioxa, moving past reimbursement-related discussions [84]

Financial Data and Key Metrics Changes - The company is transitioning towards generating more pharmaceutical revenue than device revenue, indicating a significant shift in its business model [10] - The convertible debt has been retired, and the company is returning to a normal capital spend, aiming for a cash flow break-even profile [30][31] - The company is experiencing leverage in its model, with revenues increasing while operating expenses grow, indicating improved financial health [31] Business Line Data and Key Metrics Changes - The core MIGS market has seen double-digit growth in the past year but is projected to decline in the coming year, with expectations of mid-single-digit growth [12][15] - The iDose product is cannibalizing some of the stent business, as physicians prefer it due to its clinical profile and outcomes [16][17] - The company is seeing more standalone MIGS procedures, benefiting from the expansion of procedure volumes across various technologies [20][21] Market Data and Key Metrics Changes - Reimbursement for concomitant MIGS is expected to decline in low double digits for 2026, impacting the professional fee side of the business [19] - The company has secured reimbursement from four of the seven MACs, covering about 70% of Medicare lives, with ongoing efforts to educate and push for reimbursement from the remaining MACs [42][43] Company Strategy and Development Direction - The company is focused on building a foundation for rare disease drugs, with Epioxa being the first product aimed at treating keratoconus, a rare disease [61][70] - The strategy includes expanding the iDose product line and developing next-generation products like iDose TREX, which aims to provide longer duration effects [53][54] - The company is committed to changing the standard of care in glaucoma treatment and is optimistic about future growth opportunities in the U.S. glaucoma market driven by iDose [28][80] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, highlighting the importance of clinical adoption and the potential for significant growth in the interventional glaucoma market [83][84] - The company aims to shift focus from reimbursement-related issues to clinical adoption and the opportunities associated with its products [83] - Management acknowledged the challenges in establishing proper access and coverage for new treatment modalities but remains committed to navigating these complexities [47][48] Other Important Information - The company is working on a next-generation iDose product that could allow for secondary procedures and potentially in-office procedures, enhancing its treatment offerings [55] - The company is investing in education and awareness for keratoconus to improve patient detection and treatment access [60][61] Q&A Session Summary Question: What has surprised you about the iDose launch in 2025? - Management was surprised by the ongoing challenges with MACs and professional fee schedules but remains optimistic about the product's clinical performance and physician enthusiasm [25][27] Question: How do you think about profitability and reaching it? - The focus remains on achieving cash flow breakeven in the short term while aiming for profitability in the medium to long term, leveraging high gross margins [72][74] Question: What do you think investors are missing? - Management believes investors should focus on the long-term growth potential and the breadth of the company's portfolio rather than short-term fluctuations [80]

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.

Group 1 - The article does not provide any relevant content regarding company or industry insights [1]

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]

Core Insights - Brown Capital Management sold 376,359 shares of Glaukos Corporation for an estimated $34.6 million in Q3, reducing its holding to 762,760 shares valued at $62.2 million [2][3] - The sale decreased Glaukos Corporation's weight in Brown Capital Management's portfolio to 2.6% of 13F assets [3][6] - Glaukos shares have declined approximately 34% over the past year, significantly underperforming the S&P 500, which is up nearly 15% [3] Company Overview - Glaukos Corporation specializes in ophthalmic medical technology, focusing on innovative micro-scale devices and pharmaceutical solutions for glaucoma and related eye disorders [5] - The company reported a total revenue of $433 million and a net income loss of $92.8 million for the trailing twelve months (TTM) [4] - As of the latest market close, Glaukos's stock price was $84.35, with a market capitalization of $4.8 billion [4] Recent Performance - The company's revenue grew by 28% year-over-year to $105.5 million, but it faced larger-than-expected losses and rising expenses, leading to a decline in stock price [7] - Management anticipates sales between $475 million and $485 million for 2025, while acknowledging challenges related to currency exchange and market entry [8] Strategic Positioning - Glaukos aims to expand its product portfolio and leverage proprietary technology platforms to meet unmet clinical needs in ophthalmology [5] - The company's competitive advantage lies in its focus on minimally invasive therapies and a robust pipeline targeting multiple ophthalmic indications [5][8]