Glaukos(GKOS)2025-02-21 09:29Financial Data and Key Metrics Changes - Glaukos reported record fourth quarter consolidated net sales of 383.5 million, growing 22% compared to 2023 [10] - The company provided full-year 2025 net sales guidance in the range of 485 million [10] Business Line Data and Key Metrics Changes - U.S. glaucoma franchise achieved record fourth quarter net sales of 27.9 million, with year-over-year growth of 28% on a reported basis and 29% on a constant currency basis [21] - Corneal health franchise reported net sales of 18.8 million, benefiting from entry into the Medicaid Drug Rebate Program [23] Market Data and Key Metrics Changes - The U.S. market for glaucoma procedures includes over 20 million eyes with ocular hypertension or glaucoma, with approximately 10 million actively treated [55] - The international growth outlook for 2025 is expected to be high single-digit growth, impacted by foreign exchange headwinds and competitive product trials [82][84] Company Strategy and Development Direction - Glaukos aims to pioneer new marketplaces within ophthalmology, focusing on interventional glaucoma and innovative treatment options [11] - The company is expanding its clinical literature and training programs to support the adoption of iDose TR and enhance market access [14][15] - Plans to build a new research, development, and manufacturing facility in Huntsville, Alabama, to support future expansion [29] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued growth of iDose TR, with expectations for increasing adoption as reimbursement confidence improves [39] - The company anticipates that the headwinds from new LCD restrictions will peak in the first half of 2025, with a gradual improvement expected in the second half [51] - Management remains optimistic about the potential of Epioxa, a next-generation corneal cross-linking therapy, with an anticipated FDA approval decision by the end of 2025 [25][27] Other Important Information - The company ended 2024 with cash and equivalents of approximately 287.5 million in convertible senior notes [30] - Glaukos is advancing a Phase 2 clinical program for its third-generation iLink therapy and plans to commence a Phase 2 trial for iLution Blepharitis in 2025 [28] Q&A Session Summary Question: Can you elaborate on the trends seen with iDose in the quarter? - Management noted strong performance with iDose TR revenues doubling compared to the previous quarter, supported by positive clinical outcomes and expanding surgeon training [35][36] Question: Can you break down the components of the 2025 revenue guidance? - Management indicated that the guidance reflects healthy expectations for the iDose franchise, while non-iDose revenues may see flat to low single-digit growth due to LCD headwinds and the expiration of the Hydrus royalty [41][42] Question: How do you expect the impact of LCD headwinds to play out in 2025? - Management expects the headwinds to peak in the first half of the year, with some improvement anticipated in the second half [51][52] Question: What is the status of iDose's market share compared to DURYSTA? - Management characterized the growth as overall market expansion rather than direct share gains from DURYSTA, emphasizing the opportunity for multiple products to grow together [58][59] Question: What is the expected timeline for iDose TRIO? - Management expects to begin a small safety study for iDose TRIO mid-year, with a commercial launch anticipated in 2026 [92] Question: How is the uptake of iDose varying between larger and smaller facilities? - Management noted that smaller facilities tend to adopt iDose more readily, while larger systems face more bureaucratic hurdles [122]