Financial Data and Key Metrics Changes - Consolidated revenue for Q2 2025 was approximately $2.3 million, an increase of 25% compared to the same period in 2024, driven primarily by the dental segment [11][14] - Consolidated gross profit for Q2 2025 was approximately $1.6 million, an increase of approximately $206,000 compared to approximately $1.4 million for the same period in 2024 [14] - The loss from operations decreased to approximately $1.5 million in Q2 2025 from $1.8 million in Q2 2024, a decrease of approximately $296,000 [16] Business Line Data and Key Metrics Changes - Dental revenue for Q2 2025 was approximately $1.3 million, with international sales more than doubling [14] - Medical revenue increased to approximately $32,000 in Q2 2025 from $19,000 in Q2 2024, reflecting a growth of $13,000 [14] - For the six months ending June 30, 2025, medical revenue was approximately $83,000, an increase of $57,000 compared to the same period in 2024 [17] Market Data and Key Metrics Changes - International revenue for Q2 2025 was approximately $1.49 million, an increase of $511,000 compared to the same period in 2024 [14] - International sales accounted for 48% of total revenues in Q2 2025, driven by additional distributors and larger orders [32] Company Strategy and Development Direction - The company is focusing on accelerating penetration in existing markets, expanding internationally, and capturing greater share in the U.S. dental market through targeted marketing and direct engagement [12] - In the medical segment, the strategy includes building on the reimbursement foundation and pursuing new distribution partnerships both domestically and internationally [12] - The leadership team emphasizes disciplined execution and focused growth in both medical and dental sectors [19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the untapped potential of the company, highlighting the importance of disciplined execution and data collection for reimbursement processes [9][25] - The recent addition of key leadership members is expected to drive growth and improve operational efficiency [5][8] - Management acknowledged the challenges in the medical segment but is committed to focusing efforts on a few clinics to gather data and improve adoption rates [25][26] Other Important Information - The company has maintained a solid balance sheet with cash and cash equivalents of $1.3 million and working capital of approximately $3.9 million, with no long-term debt [18] - The company is actively managing expenses and evaluating where to allocate resources for future growth [76] Q&A Session Summary Question: Can you discuss the medical side and adoption of the CompuFlo system? - Management indicated that between five and ten clinics are currently using the product in the U.S. market and emphasized a focused approach to data collection and reimbursement [25][26] Question: Have there been other key hires besides Jason Papes? - Management confirmed that Jason brings a team with him and is evaluating additional hires based on current talent in the marketplace [28][29] Question: What percentage of revenues came from international sales this quarter? - International sales accounted for 48% of total revenues, with growth driven by additional distributors and larger orders [32] Question: What role do tariffs play in international sales? - Management stated that tariffs have been mitigated by shipping directly from their warehouse in China, ensuring that inventory levels remain unaffected [40][42] Question: What is the status of reimbursement with JMAC and private payers? - Management plans to focus on existing users of the CompuFlo system to understand reimbursement processes before expanding to new markets [43][46] Question: How bullish are clinicians on the technology? - Management acknowledged the need for focused efforts to gather insights from clinicians and emphasized the importance of understanding use cases before broader market expansion [55][56] Question: What is the status of the VA opportunities? - Management is actively engaged with VA facilities and plans to focus on one vision to create a successful model before expanding further [66][68] Question: What is the situation with Brazil? - Management indicated that Brazil remains a long-term potential market but is not a focus in the near term due to recent tariffs [70]

Financial Data and Key Metrics Changes - For the three months ended 03/31/2025, revenue was $725,000 compared to $743,000 for the same period in 2024, indicating a slight decrease [12] - Gross profit for the same period was $218,000, down from $269,000 year-over-year, with gross margin decreasing from 36% to 30% [12] - Total operating expenses were $3,880,000, slightly down from $3,920,000 in the previous year [12] - Net loss was $3,590,000 or $0.06 per share, compared to a net loss of $3,610,000 or $0.08 per share for the same period last year [12] - As of 03/31/2025, cash equivalents were approximately $6,000,000, increasing to about $6,200,000 by 05/27/2025, which includes a $2,000,000 unsecured bridge loan [12][11] Business Line Data and Key Metrics Changes - The revenue increase was primarily driven by sales in North America and Europe, while sales in Asia declined significantly [12] - The company continues to expect revenue and gross profit to fluctuate quarter to quarter as it builds out its commercial infrastructure [12] Market Data and Key Metrics Changes - In North America, revenue increased by approximately 11% year-over-year, while Europe saw a 60% increase [29] - Sales in Asia experienced a decline of about 60%, with other parts of Asia declining by approximately 40% [29] Company Strategy and Development Direction - The company is focused on obtaining FDA marketing authorization for ProSense, which is expected to be a first-in-class minimally invasive option for early-stage breast cancer treatment [5][8] - Following FDA approval, the company plans to commence commercial sales while running a post-market study, which could lead to additional reimbursement opportunities [7][9] - The company is also preparing for potential regulatory filings and approvals in Japan and Israel [9] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the FDA's review of the post-market study plan, viewing it as a positive signal for future marketing authorization [6][7] - The company anticipates that the post-market study will drive further interest in ProSense and accelerate adoption in the market [44] Other Important Information - The company raised $2,650,000 in net proceeds from the sale of ordinary shares under its at-the-market offering facility between 01/13/2025 and 05/27/2025 [14] - The company maintains a supportive relationship with its largest shareholder, who provided a $2,000,000 unsecured loan [10] Q&A Session Summary Question: Is the post-market study expected to involve a minimum of 400 patients over 25 sites? - Yes, the post-market study will require 400 patients in at least 25 sites, but the FDA cannot guarantee a specific response time for the submission [18][19] Question: How long is the post-market study expected to take? - The recruitment for the study is expected to be completed within three years [21][22] Question: Can you provide more details on the potential for expanded reimbursement? - The company believes it can increase reimbursement rates after obtaining more records and claims under the CPT3 code, and plans to apply for a CPT1 code post-authorization [23][24] Question: What is the size of the breast cancer patient population in Japan? - The total number of new breast cancer cases in Japan is between 100,000 and 105,000 annually, with a significant portion being low-risk early-stage cases [25][26] Question: What was the geographic breakdown of revenue this quarter? - North America saw an 11% increase in revenue, while Europe experienced a 60% increase; however, Asia saw a decline of about 60% [29][30] Question: Is ProSense subject to any new tariffs for U.S. markets? - Yes, the company is currently affected by tariffs imposed by the U.S. Administration, but the situation is still evolving [36][37] Question: Will the sales team expand after post-market approval? - Yes, the company plans to increase its sales team following marketing authorization [38] Question: What are the pricing and sales strategies for ProSense? - The company plans a mix of placement and outright sales, requiring commitments for probe usage over a period [40]

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]