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 ...

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]

Summary of Glaukos (GKOS) Conference Call - December 14, 2023 Company Overview - **Company**: Glaukos Corporation - **Product**: iDose TR, a micro-invasive injectable therapy for glaucoma Key Industry Insights - **FDA Approval**: iDose TR received FDA approval, marking a significant milestone for glaucoma treatment and Glaukos [6][10] - **Market Need**: High non-compliance rates (up to 90%) with traditional glaucoma medications create a strong demand for effective alternatives [12][16] Core Points and Arguments 1. **Product Description**: iDose TR is designed to lower intraocular pressure (IOP) for up to three years, addressing patient non-compliance and chronic side effects associated with topical medications [6][7] 2. **Clinical Efficacy**: - Phase 3 trials showed IOP reductions of 6.6 to 8.4 mmHg for iDose TR compared to 6.5 to 7.7 mmHg for topical Timolol [9] - 81% of iDose TR subjects were free of IOP-lowering topical medications at 12 months [13] - 93% of subjects remained well-controlled on the same or fewer medications after a single administration [14] 3. **Safety Profile**: iDose TR demonstrated excellent tolerability with no serious adverse events related to corneal endothelial cell loss or periorbital fat atrophy [10][15] 4. **Regulatory Pathway**: The FDA's conservative approach led to restrictions on repeat administration, which Glaukos plans to address in future discussions [11][36] 5. **Commercial Strategy**: - A controlled launch is planned for the first half of 2024, focusing on surgeon training and market access initiatives [20][22] - A temporary C code will be used until a permanent J code is established, expected in the second half of 2024 [22][50] 6. **Pricing**: The wholesale acquisition cost for iDose TR is set at $13,950 per dose, which is considered competitive given its long-duration therapy [25][72] Additional Important Information - **Manufacturing Capabilities**: Glaukos has developed a state-of-the-art nanotechnology manufacturing facility in California, which passed FDA inspection with no observations [18] - **Patient Access Initiatives**: Glaukos is committed to ensuring access for all eligible patients, including a philanthropic initiative to donate units for qualifying requests [26][27] - **Revenue Guidance**: The company reaffirmed 2023 revenue guidance of $307 to $310 million and introduced preliminary 2024 guidance of $350 to $360 million, factoring in iDose TR's launch [28][29] Conclusion - The approval of iDose TR represents a transformative opportunity for glaucoma management, with a strong focus on addressing patient non-compliance and improving treatment outcomes. Glaukos is well-positioned to capitalize on this market need through strategic commercialization efforts and robust clinical data supporting the product's efficacy and safety.