Financial Data and Key Metrics Changes - Worldwide revenue reached $48.7 million in Q3 2025, representing approximately 21% growth year-over-year [4][19] - U.S. revenue grew over 21% to $46.4 million, driven by a procedure volume growth of over 22% [4][19] - Positive adjusted EBITDA of $2.3 million for the quarter, translating to an adjusted EBITDA margin of approximately 5% [6][22] - Gross profit was $38.8 million, an increase of 21.8% year-over-year, with a gross margin of 79.8% [20][21] Business Line Data and Key Metrics Changes - The launch of iFuse TORQUE contributed to notable international revenue growth, with international revenue at $2.3 million, representing 10.2% growth [19] - Double-digit volume growth was observed across all modalities, with a record number of physicians added in the quarter [5][6] - The number of physicians performing procedures using the company's solutions increased by 27% year-over-year, with 1,530 active physicians [14][70] Market Data and Key Metrics Changes - The company anticipates that the finalized 17% increase in reimbursement for office-based SI joint procedures will benefit its interventional business [8] - The new technology add-on payment (NTAP) of over $4,100 represents up to a 30% increase in hospital reimbursement for pelvic fracture fixation in Medicare patients [12][88] Company Strategy and Development Direction - The company is focused on innovation, physician engagement, commercial execution, and operational excellence as key priorities [7][17] - Plans to launch new products in 2026, including a next-generation technology aimed at optimizing physician workflow [9][11] - The company aims to expand its addressable market by developing solutions for compromised bone, leveraging its expertise in sacro-pelvic anatomy [14][76] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in sustaining strong top-line growth and expanding margins, driven by substantial adoption of current products and a promising pipeline [25][41] - The company is optimistic about achieving positive free cash flow in 2026, supported by improved profitability and cash flow from operating activities [23][46] 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 [22][23] - The company has a significant pipeline of novel technologies under development, with expectations to launch several solutions over the next five years [14][78] Q&A Session Summary Question: Discussion on physician density and operating leverage - Management highlighted the importance of physician density and the opportunity to increase procedure types among existing surgeons, with a focus on leveraging the expanded product platform [29][30][32] Question: Guidance update and momentum in Q4 - Management raised the full-year revenue guidance to $198 million-$200 million, citing strong performance and physician growth trends as indicators of continued momentum [38][42][44] Question: Cash burn expectations for the rest of the year - Management indicated expectations of some cash usage in Q4 due to investments in surgical capacity and new product preparations, but expressed confidence in achieving free cash flow in 2026 [46][47] Question: Trends in gross margins and ASP - Management noted that gross margins are expected to stabilize around 78%-78.5%, with ASP remaining stable despite some modest impacts from procedure mix [55][56] Question: TNT and NTAP adoption trends - Management expressed excitement about the NTAP's potential to drive TNT adoption, with ongoing interest from national distributors to expand access to the technology [88][90]

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]