Core Viewpoint - Glaukos (GKOS) has received FDA approval for its repeat dosing label for iDose, aligning with Wells Fargo's expectations, which is seen as supportive of the long-term iDose annuity model [1] Group 1 - The FDA approval for iDose includes some corneal-safety limits, indicating a broad label [1] - Wells Fargo maintains an Overweight rating on Glaukos shares with a price target set at $122 [1]

Core Insights - Alger Weatherbie Specialized Fund focuses on investing in a portfolio of 50 small and mid-cap companies with promising growth potential [1] - The US equity market ended Q4 2025 positively, with the S&P increasing by 2.7%, driven by better-than-expected corporate earnings and a supportive macroeconomic environment [1] - The fund's Class A shares underperformed the Russell 2500 Growth Index in Q4 2025, with Real Estate and Consumer Staples contributing positively while Information Technology and Health Care sectors detracted from performance [1] Company Highlights - Glaukos Corporation (NYSE:GKOS) is highlighted as a key stock, focusing on novel therapies for glaucoma and other eye disorders [2][3] - Glaukos experienced a one-month return of -7.131% but a 52-week gain of 22.99%, with a market capitalization of $7.131 billion as of January 21, 2026 [2] - The company reported a revenue growth of approximately 37% year-over-year, driven by its flagship glaucoma product, iDose, and received FDA approval for its next-generation corneal health product, Epioxa, which is expected to drive further growth [3]

Core Insights - Innovation is central to the company's strategy, driving its leadership in the ophthalmology market [1] - The company has pioneered the global MIGS (Minimally Invasive Glaucoma Surgery) marketplace and continues to lead in this area [1] - The introduction of iDose is aimed at creating a new market for procedural pharmaceuticals [1] - The company is expanding into the rare disease market and developing new procedures for corneal cross-linking to treat keratoconus [1] - There is an initiative to explore transdermal creams with active pharmaceutical ingredients (APIs) for anterior segment disease treatment, marking a novel approach in the industry [1]

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.

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]

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.