Summary of Glaukos (GKOS) 2025 Conference Call Company Overview - **Company**: Glaukos Corporation (GKOS) - **Event**: 2025 Conference Call held on May 27, 2025 Key Points on iDose Reimbursement and Performance - **Reimbursement Status**: Progress is being made with Medicare administrators, including Noridian, Novitas, and First Coast, with increasing payments for the drug and facility fees [2][3][10] - **Professional Fee Adjudication**: Ongoing efforts to streamline professional fee payments, with some Medicare Administrative Contractors (MACs) showing signs of improvement [3][5] - **Volume Generation**: The timing of reimbursement progress is tied to generating procedural volumes, which is critical for establishing a systematic reimbursement process [4][5] - **ASP Comparison**: iDose's Average Selling Price (ASP) is competitive, with the product containing seven times the amount of drug compared to Darista, which has comprehensive coverage across payers [7][9][10] - **Coverage Status**: Approximately 50% of lives are covered under commercial plans and Medicare Advantage, with ongoing efforts to expand access [10][11] - **Market Dynamics**: iDose is positioned as a second or third-line therapy initially, with plans to drive it closer to first-line therapy over time [12] Financial Performance and Projections - **Q1 2025 Performance**: The company reported exceptional progress in the market, with Noridian fully operational and increasing payments from Novitas and First Coast [14][19] - **Sales Guidance**: For 2025, the guidance for iDose sales is projected between $120 million to $125 million, with expectations for a stronger second half of the year due to seasonality and backlog building [23][24] - **Gradual Launch**: The launch of iDose is expected to be gradual and methodical, with a focus on education and operationalizing reimbursement processes [37][39] Long-term Outlook - **Peak Sales Estimates**: Peak sales expectations for iDose have not changed significantly but have increased on a risk-adjusted basis due to positive real-world performance [45] - **Market Potential**: The company is optimistic about the long-term market opportunity, with a focus on expanding access and operational efficiency in physician offices [42][44] U.S. Stent Business Insights - **Recent Performance**: The U.S. stent business experienced mid-single-digit growth in early 2024 but faced challenges due to Local Coverage Determinations (LCDs) impacting procedures [47][48] - **Guidance Adjustments**: Guidance for 2025 has been adjusted to reflect the impact of LCDs, with expectations for recovery as awareness and adaptation to these changes improve [52][54] Profitability Goals - **Cash Flow Breakeven**: The company aims to achieve free cash flow breakeven in the near term while continuing to make necessary investments [56] Additional Notes - **Investor Enthusiasm**: There is strong enthusiasm from investors regarding the product's clinical performance, but the launch pace is primarily influenced by reimbursement dynamics [31][35] - **Education and Support**: The company emphasizes the importance of educating physicians and their staff on the procedural aspects and reimbursement processes to ensure successful adoption [29][30]

Financial Data and Key Metrics Changes - Revenue for the first quarter of 2025 was $726,000, a 1% increase from $719,000 in the first quarter of 2024, primarily driven by an increase in implants for surgical procedures, partially offset by a slight decrease in average selling price (ASP) due to account mix [14][15] - Gross profit for the first quarter of 2025 was $323,000, representing 44% of revenue, compared to $470,000 or 65% of revenue in the same quarter of the previous year [16] - Net loss for the first quarter of 2025 was $3,600,000, consistent with the loss in the same period of 2024 [17][18] Business Line Data and Key Metrics Changes - The upcoming full launch of the new Catamaran SE platform is expected to enhance the product offering for physicians preferring a smaller implant for SI joint fusion procedures [4][5] - The FDA clearance for the Catamaran SI Joint Fusion System for an extended indication to augment thoracolumbar fusion is anticipated to open new market opportunities [5][6] Market Data and Key Metrics Changes - The company received two European patents during the first quarter, enhancing its intellectual property portfolio, which now includes 12 issued patents and 31 pending applications [6] - The Catamaran technology is positioned to address a significant market segment lacking peer-reviewed data, which is crucial for gaining positive coverage from payers [11][12] Company Strategy and Development Direction - The company is focusing on sustainable revenue growth through a stable cost structure and plans to invest heavily in commercial operations, clinical research, and product refinement [12][19] - The strategy includes expanding the sales force and enhancing market access efforts to drive top-line growth [17][19] Management's Comments on Operating Environment and Future Outlook - Management anticipates improvements in the reimbursement environment, which has been a challenge due to coding confusion, and expects this to contribute to incremental growth [22][23] - The launch of the SE platform is viewed as an inflection point that will attract more physicians to adopt the technology [26][27] Other Important Information - The company completed equity financing of $7,100,000 in March 2025, contributing to a cash balance of $10,300,000 at the end of the quarter, with no outstanding debt [12][18] - The ongoing Main Sail study aims to evaluate clinical outcomes for patients treated with the Catamaran system, with interim results showing significant pain reduction and high patient satisfaction [9][10] Q&A Session Summary Question: Expectations for top line revenues trajectory through the year - Management expects incremental growth as reimbursement issues improve and the sales team expands [22][24] Question: Impact of SE launch on revenue - The SE launch is anticipated to be an inflection point, bringing more physicians into the adoption phase [26][27] Question: General and Administrative expenses trends - G&A expenses were lower in the first quarter, and this trend is expected to continue with some additional investments in sales initiatives [28] Question: Expansion of total addressable market due to new indication - The new indication for augmenting spinal fusion is expected to significantly increase the addressable market, particularly in complex spine surgeries [33][36] Question: Physician reaction to new approval and reimbursement considerations - Initial physician reactions are positive, with interest in the sacropelvic component of long constructs, and existing codes are anticipated to apply for the new procedures [37][38] Question: Targeting physicians for workshops - The company has improved its targeting capabilities and is now able to provide training more efficiently at physicians' clinics [40][41]

Financial Data and Key Metrics Changes - Worldwide revenue for the quarter reached $47.3 million, representing approximately 25% growth compared to the prior year [6][27] - U.S. revenue was $44.8 million, reflecting approximately 27% growth, driven by a 27.3% increase in procedure volume [7][28] - Gross profit was $37.7 million, an increase of $7.8 million or 26.2%, with a gross margin rate of 79.7%, improving by nearly 80 basis points [28] - Net loss narrowed to $6.5 million or $0.15 per diluted share, compared to a net loss of $10.9 million or $0.27 per diluted share in the prior year [29] Business Line Data and Key Metrics Changes - The company experienced broad-based demand for existing technologies and rapid adoption of new solutions launched last year [7][9] - The number of four implant Granite cases grew approximately 69% compared to the prior year period [14] - The introduction of iFuse Torque and iFuse Intra has expanded the market and accelerated procedure volume growth [11][12] Market Data and Key Metrics Changes - The total addressable market has increased to over $3.5 billion, with 25% cumulative procedure volume growth over the last three years [10][11] - The company is targeting nearly 100,000 degenerative procedures annually with the Granite product, which became eligible for transitional pass-through payment starting January 1, 2025 [14] - The pelvic trauma market, with nearly 60,000 potential target procedures annually, represents a $300 million market opportunity [18] Company Strategy and Development Direction - The company focuses on innovation, engagement, commercial execution, and operational excellence as key priorities [10] - A hybrid commercial model combining territory managers and clinical specialists with third-party agents is being utilized to enhance market reach [25] - The company plans to launch new products over the next twelve to eighteen months, including a new SI joint fusion solution and a breakthrough device targeting spine surgery [19][87] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the demand for solutions and the ability to maintain strong revenue growth despite macroeconomic uncertainties [32][56] - The company updated its full-year revenue guidance to a range of $193.5 million to $197.5 million, implying year-over-year growth of approximately 16% to 18% [33][34] - Management highlighted the importance of favorable reimbursement trends and the potential for continued growth in procedure volumes [15][56] Other Important Information - The company exited the quarter with $144.4 million in cash and marketable securities, with a total cash usage of $5.6 million, a 31.7% improvement over the prior year [30] - The company does not anticipate any material impact on gross margins or supply chain from proposed tariffs, as most manufacturing is domestic [31] Q&A Session Summary Question: Contribution from new products and channels to growth - Management noted broad-based growth across all modalities, with strong demand for new products launched in 2024 contributing to accelerating growth [39] Question: Drivers of strong gross margin and future expectations - Management attributed gross margin improvement to better-than-expected average selling prices and supply chain efficiencies, while remaining cautious about potential pressures [42][46] Question: Long-term growth potential and guidance - Management expressed confidence in sustained growth potential beyond 2025, driven by technology leadership and expanding physician engagement [55] Question: Sequential growth expectations and guidance update - Management indicated that while they expect to maintain strong growth, they are being prudent in their guidance due to macroeconomic conditions [64] Question: Operating expenses and growth expectations - Management highlighted that increased operating expenses are linked to R&D investments and sales commissions, but they expect to maintain healthy operating leverage [70]