Financial Data and Key Metrics Changes - Worldwide revenue reached $48.7 million in Q3 2025, representing approximately 21% growth year-over-year [4][17] - U.S. revenue grew over 21% to $46.4 million, driven by increased adoption of solutions [4][17] - Positive adjusted EBITDA of $2.3 million for the quarter, translating to an adjusted EBITDA margin of approximately 5% [5][19] - Gross profit was $38.8 million, an increase of $6.9 million or 21.8%, with a gross margin of 79.8% [17][18] - Net loss narrowed to $4.6 million, or $0.11 per diluted share, compared to a net loss of $6.6 million, or $0.16 per diluted share [18][19] Business Line Data and Key Metrics Changes - The flagship solutions continue to perform well in a large, under-penetrated market, with double-digit volume growth across all modalities [5][6] - The interventional case volume doubled compared to Q3 2024, indicating strong adoption of clinically validated solutions [7] - The number of procedures using more than two Granite implants per case grew approximately 40% in the quarter [9] Market Data and Key Metrics Changes - International revenue in Q3 was $2.3 million, representing 10.2% growth, with expectations for acceleration in 2026 due to the launch of iFuse TORQUE [17][18] - The company added 330 physicians in the quarter, marking a 27% year-over-year increase in active physicians [12][48] Company Strategy and Development Direction - The company aims to expand its addressable market by adding new applications of technology and expertise, focusing on compromised bone [22][23] - Plans to launch several innovative solutions over the next five years to address poor bone quality [12][54] - The company is focused on operational excellence, with a disciplined pricing strategy and ongoing supply chain optimization initiatives [18][19] Management Comments on Operating Environment and Future Outlook - Management expressed confidence in sustaining strong top-line growth, expanding margins, and achieving positive free cash flow in 2026 [22][34] - The company anticipates continued physician engagement and adoption trends, with a significant opportunity to increase procedure density [12][15] - Management highlighted the importance of favorable reimbursement changes and the potential for new product launches to drive growth [37][61] Other Important Information - The company achieved its second consecutive quarter of net cash flow breakeven, ending the quarter with $145.7 million in cash and marketable securities [20][21] - The company is actively pursuing regulatory clearance to commercialize additional products across several international markets [17][56] Q&A Session Summary Question: Discussion on physician density and operating leverage - Management emphasized the importance of physician density and the opportunity to grow by increasing the use of technology across different procedure types [24][25] - Operating leverage is expected to range between 1.25-1.75 times, with a focus on delivering strong top-line growth [27][28] Question: Guidance update and momentum in Q4 - Management raised the full-year revenue guidance to $198 million-$200 million, reflecting continued outperformance and strong momentum heading into Q4 [30][32] Question: Trends in cash burn expectations - Management expects to use some cash in Q4 for building surgical capacity but remains confident in achieving free cash flow in 2026 [34] Question: Insights on TNT and NTAP adoption - Management expressed excitement about the NTAP, which represents a significant reimbursement improvement, and noted strong interest from national distributors for TNT [57][59] Question: Long-term profitability and operating leverage - Management highlighted the unique business model that allows for high ASP and operating leverage, with expectations for margin expansion as new products contribute to revenue [61][62]

Financial Data and Key Metrics Changes - Worldwide revenue for Q1 2025 reached $47.3 million, representing approximately 25% growth compared to the prior year [6][26] - U.S. revenue was $44.8 million, reflecting approximately 27% growth, driven by a 27.3% increase in procedure volume [7][26] - Gross profit was $37.7 million, an increase of $7.8 million or 26.2%, with a gross margin rate of 79.7% [27] - 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 [28] - Positive adjusted EBITDA of approximately $5 million compared to an adjusted EBITDA loss of $4 million in Q1 2024 [29] Business Line Data and Key Metrics Changes - The company experienced broad-based demand for existing technologies and rapid adoption of new solutions launched in 2024 [7][39] - The number of physicians performing procedures using the company's products grew by 27%, with over 1,400 U.S. physicians engaged [19] - The number of four implant Granite cases grew approximately 69% compared to the prior year period [13] Market Data and Key Metrics Changes - The total addressable market has increased to over $3.5 billion, with a cumulative procedure volume growth of 25% over the last three years [9][10] - The company is targeting nearly 100,000 degenerative procedures annually with its Granite product, which became eligible for transitional pass-through payment starting January 1, 2025 [13][14] Company Strategy and Development Direction - The company focuses on innovation, engagement, commercial execution, and operational excellence as key priorities [9] - The strategy includes diversifying the product platform with unique yet complementary technologies to expand the target modalities and physician footprint [9][10] - The company aims to reach 100 territories over the next 12 to 15 months, leveraging a hybrid commercial model combining territory managers and third-party agents [24][58] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to deliver strong results over the long term, supported by resilient business trends and favorable reimbursement conditions [8][9] - The updated full-year revenue guidance is between $193.5 million to $197.5 million, implying year-over-year growth of approximately 16% to 18% [32] - Management noted that the company is well-positioned to achieve free cash flow in 2026, with a focus on maintaining operational discipline [30][32] Other Important Information - The company has a strong pipeline of novel technologies under development, with plans to launch new products over the next 12 to 18 months [16][18] - The company does not anticipate any material impact on gross margins or supply chain from proposed tariffs, as most manufacturing is domestic [30][31] Q&A Session Summary Question: Contribution from new products and channels to growth - Management noted broad-based growth and strong demand for current solutions, with impressive adoption of new products launched in 2024 [39] Question: Drivers of gross margin and future expectations - Management highlighted better-than-expected average selling price (ASP) and efficiency initiatives as key drivers of gross margin improvement [42][44] Question: Long-term growth expectations - Management expressed confidence in sustained growth potential, driven by technology leadership and expanding physician engagement [53][56] Question: Expected cadence of new guidance and sequential growth - Management indicated that while they do not think about the business in quarters, they expect to manage seasonality effectively with new product rollouts [66] Question: Operating expenses guidance - Management explained that elevated R&D investments and higher commissions linked to revenue growth are driving the expected increase in operating expenses [70][72] Question: Update on surgeon base and engagement - Management reported a record increase in the physician base, with broad engagement across various specialties [76][78] Question: Updates on reimbursement proposals - Management provided insights on CMS proposals and the potential for increased reimbursement rates, which could accelerate adoption of products [80][81] Question: Traction and adoption of TNT product - Management noted that TNT is seeing rapid adoption and is expected to benefit from upcoming reimbursement changes [97]