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]
Glaukos(GKOS) - 2025 Q1 - Earnings Call Transcript