Financial Data and Key Metrics Changes - In Q3 2025, worldwide revenue was $61.2 million, a 12% increase compared to Q3 2024, driven by strong performance in Trauma and Deformity, Scoliosis, and OPSB, despite declines in 7D unit sales and LATSAM stocking and set sales [19][20] - U.S. revenue reached $48.7 million, a 14% increase year-over-year, representing 80% of total revenue [19] - Adjusted EBITDA improved by 56% to $6.2 million compared to $4.0 million in Q3 2024 [25] - Gross profit margin increased to 74% from 73% in the prior year, primarily due to a favorable product sales mix [21][22] Business Line Data and Key Metrics Changes - Trauma and Deformity global revenue grew by 17% to $44.1 million, driven by strong sales in cannulated screws, PMP femur, PMP tibia, DF2, and OPSB [21] - Scoliosis global revenue increased by 4% to $16.3 million, led by sales of RESPONSE 5560 and Firefly, offset by lower 7D unit sales [21][14] - OPSB growth exceeded 20%, with strong performance in both Trauma and Deformity and Scoliosis segments [6][11] Market Data and Key Metrics Changes - International revenue totaled $12.5 million, a 6% increase year-over-year, primarily driven by increased procedure volumes, despite lower stocking and set sales in LATSAM [20] - EMEA and APAC regions showed strong demand and surgical volume, while LATSAM faced headwinds, particularly in Brazil [16][17] Company Strategy and Development Direction - The company aims to close critical gaps in pediatric healthcare, focusing on expanding its core business segments, which generate higher margins and better free cash flow [5][8] - The 3P pediatric plating platform is expected to drive growth, with new systems launching annually, enhancing trauma and limb deformity revenue [10][11] - The company is strategically expanding its OPSB clinics, with a focus on targeted territory expansion and R&D efforts [12][13] Management Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving positive free cash flow in Q4 2025 and breakeven in 2026, despite adjusting top-line revenue expectations [8][18] - The exit of competitors from the pediatric space is seen as an opportunity for the company to capture market share [29] - Management acknowledged ongoing challenges in LATSAM but is implementing improvement plans to stabilize growth [14][17] Other Important Information - The company recorded restructuring and impairment charges totaling $4.6 million in Q3 2025, aimed at improving operational efficiency [22][23] - Free cash flow usage significantly improved to $3.4 million from $11.7 million in Q3 2024 [25] Q&A Session Summary Question: Competitors exiting the space - Management noted that major OEMs like Johnson & Johnson and Smith & Nephew are pulling pediatric-specific products, which presents an opportunity for the company [29] Question: Potential for accelerating OPSB clinic openings - Management confirmed high demand for clinics and expressed willingness to accelerate openings if feasible while balancing profitability [30][31] Question: Impact of 7D sales outlook on core spine business growth - Management indicated that delays in 7D placements would not significantly impact long-term growth rates for the implant business [53][54] Question: Confidence in 12% growth baseline - Management cited strong adoption rates and growth momentum in various business areas as the basis for the 12% growth outlook [42][43] Question: Strategy for Latin American growth - Management emphasized the importance of profitable revenue generation and improving cash flow rather than prioritizing revenue at all costs [80]

Financial Data and Key Metrics Changes - In Q3 2025, worldwide revenue was $61.2 million, a 12% increase compared to Q3 2024, driven by strong performance in Trauma and Deformity, Scoliosis, and OPSB, offset by declines in 7D unit sales and LATSAM stocking and set sales [19][20] - U.S. revenue reached $48.7 million, a 14% increase from the prior year, representing 80% of total revenue [19] - Adjusted EBITDA improved by 56% to $6.2 million compared to $4.0 million in Q3 2024 [24] - Gross profit margin increased to 74% from 73% year-over-year, primarily due to a favorable product sales mix [20][21] Business Line Data and Key Metrics Changes - Trauma and Deformity global revenue grew by 17% to $44.1 million, driven by strong growth in multiple product lines [20] - Scoliosis global revenue increased by 4% to $16.3 million, led by sales of RESPONSE 5560 and Firefly, despite a decline in 7D unit sales [20][14] - OPSB growth was robust, contributing significantly to overall revenue growth [6][12] Market Data and Key Metrics Changes - International revenue totaled $12.5 million, a 6% increase year-over-year, primarily driven by increased procedure volumes in EMEA and APAC, offset by lower sales in LATSAM [19][16] - The company experienced strong demand in EMEA for scoliosis products, while LATSAM faced ongoing headwinds [17][14] Company Strategy and Development Direction - The company aims to address unmet needs in pediatric healthcare, focusing on expanding its core business segments, including Trauma and Deformity and Scoliosis implants [5][12] - The 3P platform is expected to drive future growth, with new product launches planned for the coming years [11][68] - The company is strategically expanding its OPSB clinics, with a focus on high-demand markets and operational efficiency [13][12] Management's Comments on Operating Environment and Future Outlook - Management acknowledged challenges in 7D capital sales and LATSAM but expressed confidence in the core business's strength and profitability [6][9] - The company expects to generate positive free cash flow in Q4 2025 and aims for breakeven in 2026 [9][25] - Management highlighted the exit of competitors from the pediatric space as a potential opportunity for market share growth [27][28] Other Important Information - Total operating expenses increased by 19% to $54.7 million, driven by restructuring and impairment charges, as well as growth in OPSB clinics [21][22] - The company recorded a GAAP net loss per share of $0.50, compared to $0.34 in the prior year [23] Q&A Session Summary Question: Competitors exiting the space - Management noted that major OEMs like Johnson & Johnson and Smith & Nephew are pulling pediatric-specific products, which could benefit the company competitively [27][28] Question: Expansion of OPSB clinics - Management confirmed high demand for clinics and expressed willingness to accelerate openings if feasible, balancing profitability with growth [29][30] Question: Revenue and EBITDA guidance - Management clarified that product mix is the primary driver of changes in EBITDA guidance, with no significant concerns about the revenue range [34] Question: Impact of 7D sales on growth - Management indicated that delays in 7D placements would not significantly impact long-term growth rates for the implant business [51] Question: EU MDR approvals and staffing changes - Management confirmed that upcoming EU MDR approvals would enhance the Scoliosis portfolio in Europe, while staffing reductions are part of cost management efforts [60][62]

Financial Data and Key Metrics Changes - In Q2 2025, worldwide revenue reached $61.1 million, a 16% increase compared to 2024, driven by strong performance across Trauma and Deformity, Scoliosis, and OPSB [26][27] - US revenue was $48.1 million, a 17% increase from 2024, representing 79% of total revenue [26] - International revenue totaled $12.9 million, reflecting a 12% growth compared to 2024, accounting for 21% of total revenue [27] - Gross profit margin decreased to 72% from 77% in 2024, primarily due to higher 7D growth and increased international set sales [28] - Adjusted EBITDA improved to $4.1 million, a 50% increase from $2.6 million in 2024 [32] Business Line Data and Key Metrics Changes - Trauma and Deformity global revenue was $41.7 million, a 10% increase year-over-year, driven by PMP femur, PMP tibia, DF2, and OPSB [27] - Scoliosis global revenue reached $18.5 million, a 35% increase compared to the prior year, driven by increased sales of Response, ApiFix, and 7D Technology [27][28] - The OPSB business grew over 20%, surpassing initial guidance for 2025 territory expansion [14][20] Market Data and Key Metrics Changes - International sales were solid, particularly in Europe and the Middle East, with strong surgical demand [6][23] - The company achieved its first EU MDR approval through LP Canada, which is expected to catalyze future growth [24] Company Strategy and Development Direction - The company is focused on expanding its OPSB strategy through territory expansion, accelerated R&D, and scaling its sales force [14][20] - The 3P pediatric plating platform is expected to enhance market share in trauma and limb deformity, with multiple new systems planned for launch [13][89] - The company is committed to helping more children and significantly growing revenue while improving adjusted EBITDA and reducing cash burn [35] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving strong momentum throughout 2025, driven by successful scaling of OPSB and innovative product launches [8][9] - The company raised its revenue guidance for 2025 to a range of $237 million to $242 million, representing year-over-year growth of 16% to 18% [33] Other Important Information - The company hosted 182 unique training experiences for over 3,420 healthcare professionals in Q2 2025 [25] - The company ended Q2 2025 with $72.2 million in cash, short-term investments, and restricted cash [32] Q&A Session Summary Question: Can you discuss the clinic strategy and the performance of existing clinics? - Management noted that existing clinics are seeing growth due to investments made on the sales side, while new Greenfield clinics are contributing to revenue but not yet at maximum volume [39][40] Question: Can you provide insights on the Scoliosis and T&D business growth expectations for the second half of the year? - Management expects Scoliosis growth to remain strong, potentially exceeding overall company growth, while T&D growth may be lighter due to previous quarter comparisons [45] Question: What caused the selective case slowdown in the limb deformity segment? - Management indicated that the volume was lighter in the first part of Q2 but rebounded strongly in June, attributing the fluctuation to normal business ebbs and flows [49][50] Question: How is the international product expansion strategy structured? - Management stated that international growth is expected to outpace US growth, with new product launches planned on a quarterly basis following EU MDR approvals [64][66] Question: What are the expectations for the trauma portfolio and potential product gaps? - Management highlighted the introduction of the 3P system as a significant opportunity to fill gaps in the trauma and deformity market, with plans for multiple system launches over the next few years [88][89]