Glaukos(US:GKOS)2025-04-30 20:30Financial 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]