Glaukos (GKOS) Conference Transcript

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.