Financial Data and Key Metrics Changes - The company reported four consecutive quarters of over 20% growth, with a notable acceleration to 29% in constant currency during the second quarter [6][8] - The focus remains on cash flow breakeven rather than immediate profitability, with management indicating that profitability will be addressed in the future as growth continues [10][11] Business Line Data and Key Metrics Changes - iDose sales reached $31 million in the second quarter, an increase of approximately $10 million sequentially, indicating strong market acceptance [12] - The company anticipates continued growth in iDose sales, although seasonality may affect the third quarter [13][14] Market Data and Key Metrics Changes - The potential market for glaucoma procedures is estimated at 21-22 million eyes in the U.S., with 12-13 million currently diagnosed and treated, highlighting significant growth opportunities [8] - The company is actively working with various Medicare Administrative Contractors (MACs) to improve market access and reimbursement for its products [19][20] Company Strategy and Development Direction - The company aims to change the standard of care in combination cataract glaucoma surgery and is focused on unlocking larger market opportunities over the next decade [7][8] - Management emphasizes the importance of maintaining flexibility to invest in growth opportunities while gradually shifting focus towards profitability [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving sustained growth above 20% in the coming years, driven by ongoing investments and market expansion [7][8] - The company acknowledges potential headwinds from competitive dynamics but believes the overall market opportunity remains significant [59][60] Other Important Information - The company is preparing for the launch of Epioxa, which is expected to have a significant impact on the market, although initial disruptions are anticipated [41][42] - Management is focused on patient awareness and education to drive adoption of new therapies, particularly in the keratoconus market [45][47] Q&A Session Summary Question: What is the company's growth outlook? - The company has consistently achieved over 20% growth and expects to maintain this trajectory as it unlocks larger market opportunities [6][7] Question: How is the launch of iDose progressing? - iDose sales have shown strong growth, with management optimistic about future sales despite potential seasonal fluctuations [12][13] Question: What are the challenges with reimbursement? - The company is actively engaging with MACs to improve reimbursement processes, which is critical for the adoption of its products [19][20] Question: How does the company view competition? - Management respects competition but believes the focus should be on changing the standard of care rather than merely competing for market share [59][60] Question: What is the expected impact of Epioxa? - Epioxa is anticipated to disrupt the market initially, but management is confident in its long-term potential and is focused on driving patient access [41][42]

Financial Data and Key Metrics Changes - The company reported four consecutive quarters of over 20% growth, with a notable acceleration to 29% in constant currency during the second quarter [5][6] - Sales for iDose reached $31 million in the second quarter, an increase of approximately $10 million sequentially [11] Business Line Data and Key Metrics Changes - The iDose product is still in the early stages of market development, with significant sales driven by Noridian and Novitas, which cover about 50% of Medicare lives [12][13] - The company anticipates continued growth in iDose sales, although seasonality may affect trends in the third quarter [14][15] Market Data and Key Metrics Changes - The potential market for glaucoma procedures has expanded significantly, with estimates of 21 to 22 million eyes affected, compared to a previous estimate of 500,000 potential procedures in the U.S. [6][7] - The company is focusing on increasing market access and reimbursement to drive adoption of iDose and other products [12][25] Company Strategy and Development Direction - The company aims to change the standard of care in combination cataract and glaucoma surgery, with a focus on long-term growth opportunities [6][10] - Management emphasizes the importance of maintaining flexibility to invest in growth rather than prioritizing immediate profitability [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving sustained growth above market rates, with a focus on unlocking larger market opportunities over the next decade [6][7] - The company is preparing for potential challenges in 2026 related to commercial payer dynamics and the adoption of new products [50][66] Other Important Information - The company is actively working on advocacy and education efforts to facilitate the adoption of iDose among remaining MACs [23][24] - Management indicated that while there will be a transition period for Epioxa, they expect to see growth in the corneal health segment in 2026 [66] Q&A Session Summary Question: What is the company's growth outlook? - The company has posted four consecutive quarters of over 20% growth and expects to maintain this trajectory moving forward [5][6] Question: When will profitability become a focus? - The near-term focus remains on cash flow breakeven rather than immediate profitability, with management indicating that profitability will be addressed when appropriate [9][10] Question: How is the launch of iDose progressing? - The launch has been strong, with significant sales driven by key Medicare providers, and management expects continued growth despite seasonal fluctuations [11][14] Question: What are the competitive dynamics in the market? - Management believes that the industry is moving towards a larger opportunity in ophthalmology, focusing on changing the standard of care rather than competing for market share [58][59] Question: What challenges are anticipated in 2026? - The company expects normal commercial payer dynamics to create headwinds in 2026, but they are focused on driving advocacy to improve access to their products [50][66]

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.