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.

Core Insights - Glaukos Corporation reported a narrower adjusted loss of 16 cents per share for Q3 2025, better than the Zacks Consensus Estimate of a 27-cent loss and improved from a 28-cent loss in the same quarter last year [1] - The company achieved revenues of $133.5 million, reflecting a 38% year-over-year increase and surpassing the Zacks Consensus Estimate by 9.5% [2] Revenue Details - Net sales for Glaucoma reached $110.2 million, up 45% year over year, while Corneal Health sales totaled $23.3 million [3] Margin Analysis - Gross profit increased by 41.3% year over year to $104.7 million, with an adjusted gross margin of 84%, up from 82% in the previous year [4] - Selling, general, and administrative expenses rose by 30% year over year to $83 million, while research and development expenses increased by 10% to $38.1 million [4] Operating Performance - The operating loss decreased to $16.4 million from $24.7 million in the prior year, with an adjusted operating loss of $9.3 million, an improvement from the $18.4 million loss in the same quarter last year [5] Financial Update - At the end of Q3 2025, Glaukos had cash and cash equivalents and short-term investments totaling $277.5 million, slightly down from $278.6 million at the end of Q2 2025 [6] 2025 Guidance - The company raised its 2025 revenue guidance to a range of $490-$495 million, up from the previous estimate of $480-$486 million, with a loss per share estimate of 90 cents, indicating a 51.6% year-over-year improvement [7] Strategic Developments - The FDA approval of Epioxa represents a significant advancement, introducing a next-generation, incision-free therapy for keratoconus, enhancing Glaukos' rare disease portfolio [10] - The company is focused on disciplined capital allocation, robust R&D investment, and the upcoming Huntsville facility to support innovation and manufacturing scale, positioning itself for sustainable growth [11]

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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 [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 [7][24] 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 Votrexa 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 various regions [9] Company Strategy and Development Direction - Glaukos aims to evolve into a diversified ophthalmic leader with transformational growth drivers across multiple geographies and disease states, focusing on glaucoma and rare diseases [11] - The FDA approval of Epioxa marks a significant milestone, introducing a new standard of care for keratoconus patients with a unique incision-free treatment [12][17] - The company plans to increase investments in patient awareness and access to address the challenges of underdiagnosis and under-treatment in keratoconus [17][18] 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 [20][21] - 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 [22][24] Other Important Information - Glaukos has invested over $1 billion in R&D to develop a robust pipeline focused on chronic and rare ophthalmic diseases [19] - The company is constructing a new 200,000-square-foot research, development, and manufacturing facility in Huntsville, Alabama, to support long-term growth and innovation [19] Q&A Session Summary Question: Can you discuss the rationale behind the CAC meeting and potential outcomes? - Management highlighted the importance of educating MACs on the unmet need that iDose addresses and the robust FDA data supporting its utilization [30][31] Question: What is the confidence level regarding payer coverage for Epioxa? - Management indicated that education at the payer level is crucial, and they are optimistic about engaging in conversations to establish coverage [36] Question: Can you provide more granularity on the 2026 revenue guidance? - Management stated that the preliminary guidance reflects expectations for Epioxa's rollout and the transition from Votrexa, with more detailed insights to be provided in future calls [41][42] Question: How is iDose performing in terms of utilization? - Management reported strong sales growth for iDose, with contributions from various MAC regions and a growing trend in combination with cataract surgeries [45][46] Question: What are the expectations for patient access to Epioxa? - Management acknowledged that while there may be initial headwinds, they aim to significantly expand patient access over time through education and awareness initiatives [55]

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]

Core Insights - Glaukos Corporation (NYSE:GKOS) is positioned as a leading investment opportunity in the medical device sector, particularly with the upcoming PDUFA date for its Epioxa medication on October 20 [1] - Stifel has reaffirmed a Buy rating and a price target of $115 for Glaukos, supported by a survey indicating strong uptake and volume projections for Epioxa among ophthalmologists [1][2] Company Overview - Glaukos Corporation specializes in developing innovative treatments for eye diseases, including glaucoma and corneal issues, utilizing micro-invasive surgical instruments and drug delivery systems to improve patient outcomes [3] Market Potential - The findings from Stifel's survey suggest that Epioxa is expected to capture a significant share of the corneal cross-linking (CXL) operation volume, contributing to market growth [2] - The survey also indicates minimal patient warehousing prior to Epioxa's launch, which alleviates previously identified concerns by Glaukos management and supports an optimistic outlook for Corneal Health revenue in the latter half of 2025 and into 2026 [2]

Company Overview - Glaukos Corporation (NYSE:GKOS) is a leader in ophthalmic pharmaceutical and surgical therapies, focusing on glaucoma, corneal disorders, and retinal diseases through innovative "dropless" treatment platforms [2] - The company has developed the FDA-approved iDose sustained-release implant, which delivers continuous glaucoma therapy directly inside the eye, enhancing patient adherence and outcomes [2] Financial Performance - In Q2 2025, Glaukos reported a 30% year-over-year increase in net sales, reaching $124.1 million [3] - U.S. glaucoma treatment sales for the quarter amounted to $72.3 million, leading the company to raise its full-year guidance to a range of $480-$486 million [3] - The growth is attributed to strong adoption of the iDose TR implant and increasing market penetration [3] Product Pipeline and Innovations - Glaukos is advancing its pipeline with next-generation therapies, including the iDose TREX implant, which is currently in Phase 2b/3 trials aimed at extending treatment duration and improving compliance [3] - Ongoing trials for iStent Infinite and PRESERFLO devices are expected to broaden the company's long-term growth potential [3] Regulatory Developments - The company's Epioxa, a non-invasive epi-on corneal cross-linking therapy for keratoconus, has received FDA acceptance for review, with a PDUFA date set for October 20, 2025 [4] - If approved, Epioxa would be the first therapy of its kind that does not require corneal epithelium removal, promising shorter recovery times and enhanced patient comfort [4]

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]

Core Insights - Glaukos Corporation (GKOS) is experiencing significant growth, with first-half 2025 revenues reaching $230.8 million, a 27.3% year-over-year increase, primarily driven by the adoption of the iDose TR implant [1][8] - The company has raised its full-year revenue guidance to $480-$486 million, indicating strong commercial momentum [1][8] Near-Term Growth Drivers - The iDose TR launch is gaining traction, generating approximately $31 million in second-quarter sales, with over 80% of volume coming from regions with established reimbursement schedules [3][8] - International glaucoma revenues increased by 20% year-over-year to $31.3 million, supported by the EU MDR clearance for iStent Infinite, which enhances Glaukos' interventional glaucoma strategy [4][8] Long-Term Growth Catalysts - Glaukos is advancing a diversified pipeline across five therapeutic platforms, with pivotal trials for iStent Infinite and PRESERFLO MicroShunt underway, and Epioxa awaiting FDA approval by October 2025 [9][10] - The company is positioning itself in a new stand-alone interventional glaucoma market, with expectations of millions of procedures annually over the next decade [10][11] Challenges and Watchpoints - Reimbursement complexities, including MAC LCD restrictions, pose challenges, although iDose TR reimbursement is expanding [12][14] - Execution risk exists in scaling iDose TR, particularly in regions with slower adoption rates [13][14] - Corneal health sales showed only a 4% year-over-year increase, with anticipated revenue softness during the transition to Epioxa [15][16] Competitive Landscape - The iDose TR launch positions Glaukos favorably against competitors like Alcon, Johnson & Johnson, and Sight Sciences, although Glaukos shares have underperformed compared to these rivals [17][18][21]