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]

Financial Performance - Glaukos reported record third quarter net revenues of $133.5 million, up 38% reported and 37% on a constant currency basis compared to Q3 2024[5] - Third quarter 2025 non-GAAP revenue was $83.2 million, a 32% increase year-over-year from $63.3 million in Q3 2024[24] - Net sales for Q3 2025 reached $133.5 million, a 38.1% increase from $96.7 million in Q3 2024[36] - Total net sales for Q3 2025 reached $133.537 million, a 38.1% increase year-over-year compared to $96.670 million in Q3 2024[42] - Sequentially, total net sales increased by 7.6% from $124.120 million in Q2 2025[42] - Operational growth for total net sales was 37.3% year-over-year, excluding the effect of translational currency[42] - The currency impact on total net sales was minimal, contributing only 0.8% to the year-over-year growth[42] Revenue Breakdown - U.S. Glaucoma net revenues reached approximately $80.8 million, representing year-over-year growth of 57% driven by iDose TR sales of approximately $40 million[9] - International Glaucoma net revenues were approximately $29.4 million, reflecting a year-over-year growth of 20% reported and 17% on a constant currency basis[11] - Corneal Health net revenues were approximately $23.3 million, with U.S. Photrexa® net sales of $20.3 million, representing a 13% year-over-year growth[13] - Glaucoma product sales amounted to $29.443 million in Q3 2025, reflecting a 20.3% year-over-year growth from $24.467 million in Q3 2024[42] - Glaucoma product sales experienced a quarter-over-quarter decline of 5.8% from $31.251 million in Q2 2025[42] Guidance and Future Outlook - Full-year 2025 global consolidated net sales guidance raised to $490 - $495 million, up from previous guidance of $480 - $486 million[18] - Preliminary FY 2026 global consolidated revenue guidance expected to be $600 - $620 million[4] - Future outlook remains positive with expectations of continued growth driven by new product developments and market expansion strategies[42] Research and Development - Glaukos has invested over $800 million into R&D programs since 2018, supporting its pipeline of novel platforms[22] - The company has made significant investments in R&D, reflected in a 10% year-over-year increase in R&D expenses to $38.1 million in Q3 2025[24] - iDose TR is designed to continuously deliver glaucoma drug therapy for up to three years, with positive clinical outcomes reported[10] - Epioxa, a new treatment for keratoconus, received FDA approval and is expected to be commercially available in Q1 2026[22] - The iStent infinite product is currently undergoing an active PMA study and EU MDR certification expected in 2025[23] - iStent infinite received EU MDR certification, with commercial launch activities commencing in key European markets[22] Operating Expenses and Losses - Operating expenses for Q3 2025 were $277.5 million, a slight decrease of $1.1 million from $278.6 million in Q2 2025[24] - Operating expenses increased to $121.1 million in Q3 2025, compared to $98.7 million in Q3 2024, primarily driven by higher selling, general, and administrative expenses[36] - The company reported a net loss of $9.2 million in Q3 2025, improved from a net loss of $15.2 million in Q3 2024[24] - The net loss for Q3 2025 was $16.2 million, an improvement from a net loss of $21.4 million in Q3 2024[36] - Year-to-date net loss for 2025 was $54.0 million, improving from a net loss of $112.8 million for the same period in 2024[41] - Basic and diluted net loss per share for Q3 2025 was $0.28, compared to $0.39 in Q3 2024[36] Assets and Liabilities - Total assets as of September 30, 2025, were $999.4 million, an increase from $974.8 million at the end of 2024[37] - Cash and cash equivalents decreased to $98.2 million from $169.6 million at the end of 2024[37] - Total liabilities increased to $229.8 million as of September 30, 2025, compared to $207.8 million at the end of 2024[37] Operational Efficiency and Market Presence - The company continues to focus on expanding its international market presence, particularly in the glaucoma segment[42] - The company is committed to enhancing its operational efficiency to mitigate currency fluctuations' impact on sales[42] - The company is actively monitoring geopolitical and macroeconomic uncertainties that may impact operations[28] - The company expects minimal direct exposure to recent tariff-related policies due to its primary U.S. manufacturing and sourcing[28] Capital Expenditures and Facilities - Capital expenditures in Q3 2025 were $1.6 million, up from $1.4 million in Q3 2024[24] - The company celebrated the groundbreaking of a new research, development, and manufacturing facility in Huntsville, Alabama, aimed at supporting long-term growth[28] Non-GAAP Disclosures - Non-GAAP disclosures will be provided for further clarity on financial performance in upcoming reports[42]

Upgrades - Wells Fargo upgraded Glaukos (GKOS) to Overweight from Equal Weight with a price target of $120, up from $92, highlighting the potential of Epioxa as a significant growth driver [2] - RBC Capital upgraded Honeywell (HON) to Outperform from Sector Perform with a price target of $253, up from $235, citing a solid Q3 and the start of a breakup catalyst-rich phase [3] - Truist upgraded Booking Holdings (BKNG) to Buy from Hold with a price target of $5,750, up from $5,630, based on Asia's long-term travel outlook and steady global GDP growth [3] - JPMorgan upgraded Five Below (FIVE) to Overweight from Neutral with a price target of $186, up from $154, anticipating multi-year earnings growth supported by unit growth expansion [4] - Guggenheim upgraded Microsoft (MSFT) to Buy from Neutral with a price target of $586, believing the company will benefit from the artificial intelligence sector [5] Downgrades - Keefe Bruyette downgraded Berkshire Hathaway (BRK.A) to Underperform from Market Perform with a price target of $7,000, down from $735,000, due to concerns over Geico's underwriting margin and other economic pressures [5] - Morgan Stanley downgraded Harley-Davidson (HOG) to Underweight from Equal Weight with a price target of $25, down from $27, indicating a 10% downside potential [5] - RBC Capital downgraded Roper Technologies (ROP) to Sector Perform from Outperform with a price target of $539, down from $644, citing limited relative upside [5] - Jefferies downgraded Keysight Technologies (KEYS) to Hold from Buy with a price target of $180, down from $181, noting that the stock's valuation reflects its growth potential [5] - Williams Trading downgraded Wolverine World Wide (WWW) to Hold from Buy with a price target of $27, down from $30, expecting a deceleration in Saucony's sales growth [5]

Core Insights - The U.S. Food and Drug Administration has approved a new eye therapy from Glaukos Corp, providing patients with a less painful and more convenient treatment option for a progressive eye condition [1] Company Summary - Glaukos Corp has developed a new eye therapy that aims to improve patient comfort and convenience in treating a progressive eye condition [1] Industry Summary - The approval of this new therapy by the FDA highlights advancements in ophthalmic treatments, potentially impacting the market for eye care solutions [1]

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]

Core Viewpoint - Glaukos Corporation is set to release its third quarter 2025 financial results on October 29, 2025, after market close, indicating ongoing transparency and communication with investors [1] Financial Results Announcement - The financial results will be discussed during a conference call and simultaneous webcast scheduled for 1:30 p.m. PT (4:30 p.m. ET) on the same day [1]

Group 1 - Glaukos Corporation's shares increased after Goldman Sachs initiated coverage with a Buy recommendation [5] - The target price set by Goldman Sachs for Glaukos Corporation is $103 per share [5] - Analyst David Roman highlighted a compelling valuation setup as the reason for the positive outlook [5]

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]