Key Takeaways GKOS posted a narrower-than-expected Q2 loss and 29.7% revenue growth, beating the consensus estimate.Revenues were driven by strong uptake of iDose TR and solid performance from Photrexa in corneal health.The company raised 2025 revenue guidance but faces pressure from procedural bundling and coverage limits.Glaukos Corporation (GKOS) reported second-quarter 2025 adjusted loss of 24 cents per share, which was narrower than the Zacks Consensus Estimate of a loss of 26 cents. The figure also im ...

Financial Data and Key Metrics Changes - Glaukos reported record second quarter consolidated net sales of $124.1 million, up 30% on a reported basis or 29% on a constant currency basis compared to the same quarter last year [8] - The company raised its full year 2025 net sales guidance range to $480 million to $486 million, compared to the previous range of $475 million to $485 million [8] Business Line Data and Key Metrics Changes - The U.S. Glaucoma franchise achieved record second quarter net sales of $72.3 million, reflecting a strong year-over-year growth of 45%, driven by contributions from iDoseTR, which generated approximately $31 million in sales [10] - The international glaucoma franchise delivered record net sales of $31.3 million, with year-over-year growth of 20% on a reported basis and 15% on a constant currency basis [13] - The corneal health franchise reported net sales of $20.6 million, with a year-on-year growth of 4%, including Photrexa net sales of $17.9 million [15] Market Data and Key Metrics Changes - The U.S. market faced turbulence due to five MAC LCDs implemented in 2024, affecting the MIGS market, which is expected to continue into 2025 [11] - CMS proposed rules for 2026 largely maintained 2025 APC assignments and modestly increased facility fee rates, but proposed reductions in physician fee reimbursement for several category one CPT codes across ophthalmology [12] Company Strategy and Development Direction - The company is focused on driving new standalone intervention therapies designed to slow disease progression and reduce drug burden, particularly through the adoption of iDoseTR [9] - Glaukos plans to commence commercial launch activities for iStent Infinite in key European markets at the upcoming ESCRS Annual Meeting in September [15] - The company is advancing several important clinical programs across its five novel therapeutic platforms, including iDose and ILUTION [19] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the increasing clinical interest in interventional glaucoma therapies and the potential to reshape glaucoma management [10] - The transition from Photrexa to Epioxa is expected to create a material disruption headwind in Q4, as patients may defer procedures until Epioxa is available [27] - Management emphasized the importance of educating CMS on the proposed methodology shift regarding physician fees [12] Other Important Information - The company completed a small acquisition of Mobius Therapeutics, which solidifies its supply chain and supports broader glaucoma tertiary care efforts [20] - The company’s operational cash and equivalents grew by more than $4 million in the second quarter, excluding one-time investments [21] Q&A Session Summary Question: Clarification on 2025 sales guidance - Management acknowledged the exceptional second quarter performance but noted that guidance was raised conservatively due to less visibility in the second half, particularly in corneal health and U.S. glaucoma segments [24][25] Question: State of interventional glaucoma efforts - Management highlighted significant progress in building the standalone market opportunity for interventional glaucoma, with increasing traction and adoption of iDoseTR and iStent Infinite [28][30] Question: Comparison of geographic MAC coverage for iDose - Management indicated that growth was faster in MAC regions with established professional fees, and they are optimistic about progress in lagging MACs [35][36] Question: Impact of proposed reimbursement changes - Management expressed that the proposed facility fee increases are generally positive, but the overall impact on Glaukos is expected to be neutral to slightly positive [48] Question: SG&A growth expectations - Management noted a step-up in SG&A due to a one-time stock compensation expense, but overall operational expenses are expected to grow in the mid-teens [50][52] Question: iDose reimplantation decision timeline - Management clarified that the FDA has set a PDUFA date of January 28, 2026, for the iDose reimplantation petition, which reflects a change in timing [77] Question: Epioxa rollout strategy - Management indicated that the rollout of Epioxa will involve transitioning from Photrexa, with expectations of patient education and demand increasing post-approval [67][72]

Core Insights - Glaukos Corporation (GKOS) reported a record-breaking first-quarter 2025 performance with revenues of $106.7 million, a 25% year-over-year increase, primarily driven by the adoption of the iDose TR implant [1][8] - The company reaffirmed its full-year revenue guidance of $475-$485 million, indicating confidence in its commercial momentum [1] Near-Term Growth Drivers - The iDose TR launch is gaining traction, with U.S. glaucoma sales increasing by 41% year-over-year, contributing nearly $21 million in the first quarter, reflecting an $85 million annualized run rate [3] - Internationally, Glaukos achieved $29 million in interventional glaucoma sales, a 15% year-over-year increase, supported by the growing acceptance of minimally invasive glaucoma surgery (MIGS) [4] Long-Term Growth Catalysts - Glaukos has a robust R&D pipeline with key programs including Epioxa, iDose Trex, PRESERFLO MicroShunt, and GLK-401, which are expected to broaden the company's addressable market in the next three to five years [5][6] - The company is cultivating standalone use of MIGS devices like iStent infinite, anticipating long-term growth as more surgeons adopt interventional glaucoma practices [7] Challenges and Watchpoints - Reimbursement complexities and LCD restrictions are impacting legacy stent sales, which declined mid-single digits in the first quarter, with expectations of continued pressure through 2025 [8][9] - Sales of Photrexa remain muted due to the Medicaid Drug Rebate Program, with near-term growth in this segment expected to be flat to low-single digits [10] Competitive Landscape - The iDose TR launch positions Glaukos ahead in procedural glaucoma drug delivery, but competition from Alcon, Johnson & Johnson, and Sight Sciences remains significant [11] - Year-to-date, Glaukos shares have declined by 31.7%, underperforming its rivals in the MIGS space, while Alcon and J&J have seen increases [12]

Core Viewpoint - Glaukos Corporation is positioned for growth due to favorable clinical trial results and a strong product pipeline, despite facing significant competition [1] Company Overview - Glaukos has a market capitalization of $5.48 billion and is recognized as a leading ophthalmic medical technology and pharmaceutical company, with a trailing four-quarter average earnings surprise of 21.62% [2] Key Catalysts - Strong product demand is primarily driven by the success of the flagship product, iStent, which has led to a robust performance in 2024 and a positive business outlook [3] - The adoption of iStent Infinite for glaucoma patients is increasing, supported by enhanced clinical education and improved market access, with five out of seven Medicare Administrative Contractors releasing draft local coverage determinations [4] Financial Performance - Glaukos' revenues exceeded estimates in Q1 2025, improving by 24.6% year over year, with expectations for full-year 2025 revenues between $475 million and $485 million, reflecting a projected sales growth of 25.5% and earnings growth of 53.4% [5] Product Portfolio Expansion - The first quarter's top line was significantly boosted by the strong adoption of the iDose TR product, with the U.S. glaucoma segment experiencing 41% year-over-year growth [6] - The FDA has accepted the NDA for Epioxa, a next-generation therapy for keratoconus, with a PDUFA date set for October 2025 [7] International Growth - Glaukos is expanding its international presence, reporting record sales of $29 million in its international glaucoma franchise for Q1, reflecting an 18.7% year-over-year operational growth [10] Challenges - The company relies on a limited number of third-party suppliers for components, which poses a risk if suppliers fail to deliver [11] - Restrictive Medicare Local Coverage Determinations have negatively impacted the U.S. stent business, leading to a mid-single-digit decline despite growth in iDose [12] Estimate Trends - The bottom-line estimate for Glaukos is a loss of 87 cents for 2025, which has narrowed by 8.4% in the past 30 days, with the Zacks Consensus Estimate for 2025 revenues at $480 million [13]

Core Insights - Glaukos Corporation reported a narrower adjusted loss of 22 cents per share for Q1 2025, better than the Zacks Consensus Estimate of a loss of 33 cents, and improved from a loss of 70 cents per share in the same quarter last year [1] - The company achieved revenues of $106.7 million in Q1 2025, reflecting a year-over-year increase of 24.6% and surpassing the Zacks Consensus Estimate by 3.8% [2] Revenue Details - Net sales for the Glaucoma segment reached $88.1 million, marking a 31% increase year over year, while Corneal Health sales were $18.5 million [3] Margin Analysis - Gross profit rose by 25.9% year over year to $82.3 million, with an adjusted gross margin of 82%, slightly down from 83% in the previous year [4] - Selling, general and administrative expenses increased by 14% year over year to $70.7 million, while research and development expenses totaled $32.4 million, up 5.3% year over year [4] Operating Performance - The operating loss decreased to $20.7 million from $39.1 million in the prior year, with an adjusted operating loss of $15.2 million, an improvement from the loss of $32.8 million in the same quarter last year [5] Financial Update - At the end of Q1 2025, Glaukos had cash and cash equivalents and short-term investments totaling $303.4 million, down from $323.6 million at the end of Q4 2024 [6] 2025 Guidance - The company reiterated its revenue guidance for 2025, expecting net sales between $475 million and $485 million, with a consensus estimate of $480.9 million [7] Growth Drivers - The strong performance in Q1 was driven by the adoption of the iDose TR product, with the U.S. glaucoma segment experiencing a 41% year-over-year growth [9] - Management highlighted the strategic rollout of iDose TR, focusing on expanding surgeon training, payer access, and clinical validation [9] Product Development - Glaukos is advancing its product pipeline, including the FDA's acceptance of the NDA for Epioxa, targeting a PDUFA date in October 2025 [10] - The company is also progressing with the PRESERFLO MicroShunt study and other clinical trials, including the iStent infinite trial and GLK-401 for wet AMD [11] Challenges - Glaukos faces challenges from restrictive Medicare LCDs impacting the use of multiple glaucoma surgical devices, leading to a mid-single-digit decline in the U.S. stent business [12] Stock Performance - Following the Q1 results, shares of Glaukos fell by 6.6% in after-market trading, with a year-to-date decline of 37.1%, compared to the industry's decline of 9.1% [13]

Financial Data and Key Metrics Changes - Glycos Corporation reported record first quarter consolidated net sales of $106.7 million, up 25% on a reported basis and 26% on a constant currency basis compared to the same quarter last year [9] - The company reaffirmed its full year 2025 net sales guidance range of $475 million to $485 million [9] Business Line Data and Key Metrics Changes - The U.S. Glaucoma franchise achieved record first quarter net sales of $59.1 million, reflecting a year-over-year growth of 41%, driven by the adoption of iDoseTR [11] - The interventional glaucoma franchise delivered record net sales of $29 million, with a year-over-year growth of 15% on a reported basis and 19% on a constant currency basis [13] - The corneal health franchise reported net sales of $18.5 million, including $15.4 million from Vetrexa, impacted by the company's entry into the Medicare drug rebate program [15] Market Data and Key Metrics Changes - The U.S. glaucoma business experienced over 40% year-over-year growth and a 5% sequential growth in the first quarter [24] - International glaucoma sales showed strong growth, with expectations of high single-digit to low double-digit growth year-over-year [35] Company Strategy and Development Direction - The company is focused on pioneering the Interventional Glaucoma marketplace with new therapies aimed at slowing disease progression and reducing drug burden [10] - Glycos is actively expanding its global infrastructure and market access for its interventional glaucoma products, anticipating new product approvals in the coming years [13][14] - The company is also preparing for the commercial launch of Epioxa, a next-generation corneal cross-linking therapy, with an FDA review expected by October 20, 2025 [16] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strong foundation built for iDoseTR and the transformative potential of this technology in glaucoma management [12] - The company acknowledged potential headwinds from new competitive products in major international markets as it progresses through 2025 [14] - Management emphasized the importance of navigating macroeconomic uncertainties while maintaining a strong capital position with over $3 billion in cash and no debt [18] Other Important Information - The company is actively pursuing collaborations to enhance its capabilities in glaucoma diagnosis and care networks [19] - Glycos expects minimal direct exposure to recent tariff-related policies due to its primary manufacturing and sourcing within the United States [19] Q&A Session Summary Question: Can you provide U.S. spend growth in the quarter? - The U.S. glaucoma business reported over 40% year-over-year growth and a 5% sequential growth, driven by iDoseTR adoption, despite some impact from LCD restrictions [24] Question: Have you seen any acceleration in reimbursement in the Noridian region? - Noridian has shown solid and expanding growth, serving as a case study for other MACs as they come online [29] Question: What are the components of guidance for the remainder of the year? - The guidance remains unchanged, with expectations for flat to low single-digit growth in the corneal health business and mid single-digit declines for non-iDose revenues in 2025 [35][36] Question: How exposed is the company to an economic slowdown? - The company believes ophthalmology is somewhat insulated from economic downturns, but acknowledges potential impacts on surgery centers and customer offices [52] Question: What is the status of iDose reimplantation with the FDA? - The post-approval NDA supplement for iDose has been submitted to the FDA, with results expected by year-end [65] Question: How broad is the commercial coverage for iDose? - Coverage policies extend over more than 50% of the potential patient population, with early successes in claims processing with major payers [58] Question: What is the expectation for operational expenses growth? - The company continues to expect about 15% year-over-year growth in operational expenses off the adjusted 2024 base [93]

Financial Data and Key Metrics Changes - Glycos Corporation reported record first quarter consolidated net sales of $106.7 million, up 25% on a reported basis and 26% on a constant currency basis compared to the same quarter last year [7] - The company reaffirmed its full year 2025 net sales guidance range of $475 million to $485 million [7] Business Line Data and Key Metrics Changes - The U.S. glaucoma franchise achieved record first quarter net sales of $59.1 million, reflecting a strong year-over-year growth of 41%, primarily driven by the adoption of iDoseTR [10] - The interventional glaucoma franchise delivered record net sales of $29 million, with a year-over-year growth of 15% on a reported basis and 19% on a constant currency basis [12] - The corneal health franchise reported net sales of $18.5 million, including Vetrexa net sales of $15.4 million, impacted by the company's entry into the Medicare drug rebate program [13] Market Data and Key Metrics Changes - The U.S. glaucoma business experienced over 40% year-over-year growth and 5% sequential growth, driven by iDoseTR expansion, despite some decline in the stent franchise due to LCD restrictions [20] - International glaucoma sales showed strong growth as the company continues to scale its infrastructure and drive MIGS forward as the standard of care [12] Company Strategy and Development Direction - The company is focused on pioneering the Interventional Glaucoma marketplace with new therapies aimed at slowing disease progression and reducing drug burden [9] - Glycos is actively working on expanding its product portfolio and market access globally, anticipating new product approvals in the coming years [12][14] - The company has a strong capital position with cash and equivalents exceeding $3 million and no debt, allowing for continued investment in growth initiatives [16] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strong foundation built for iDoseTR and the transformative potential of this technology in glaucoma management [11] - The company acknowledged potential headwinds from competitive products and macroeconomic uncertainties but remains committed to its growth trajectory [12][33] - Management emphasized the importance of generating clinical evidence to support the use of combination therapies in glaucoma treatment [76] Other Important Information - The FDA accepted the NDA for Epioxa, a next-generation corneal cross-linking therapy, with a PDUFA date set for October 20, 2025 [14] - The company is also advancing several clinical trials, including pivotal studies for various therapies aimed at treating glaucoma and other eye diseases [15] Q&A Session Summary Question: Can you provide U.S. spend growth in the quarter? - The U.S. glaucoma business reported over 40% year-over-year growth and a 5% sequential growth, driven by iDoseTR, despite a mid-single-digit decline in the stent franchise due to LCD restrictions [20] Question: How is the reimbursement situation for iDose in the Noridian region? - Noridian has shown solid growth, and while some customers are achieving high volumes, others are still in the early adoption phase [95] Question: What are the expectations for iDose revenue growth? - The company expects continued progress in iDose revenue, with a modest increase in expectations for the remainder of 2025 [34] Question: How is the company addressing the impact of LCD restrictions? - The company is navigating the impact of LCD restrictions and expects to see a mid-single-digit decline in non-iDose revenues in 2025 [33] Question: What is the company's strategy regarding commercial coverage? - The company is methodically rolling out access to commercial Medicare Advantage and expects to see coverage policies extend over more than 50% of the potential patient population [56] Question: What are the expectations for operational expenses? - The company continues to expect about 15% year-over-year growth in operational expenses off the adjusted 2024 base [91]