Core Insights - OrthoPediatrics Corp. is focused on advancing pediatric orthopedics and will participate in three upcoming investor conferences [1][2] Group 1: Upcoming Events - The company will participate in the Stifel 2025 Healthcare Conference on November 13, 2025, at 1:20 pm ET in a fireside chat format [1] - OrthoPediatrics will present at the Jeffries Global Healthcare Conference in London on November 18, 2025, at 12:00 pm ET [1] - The company will also engage in a fireside chat at the Piper 37 Annual Healthcare Conference on December 4, 2025, at 9:30 am ET [1] Group 2: Company Overview - Founded in 2006, OrthoPediatrics specializes in pediatric orthopedics and has developed a comprehensive product offering to improve the lives of children with orthopedic conditions [2] - The company markets over 80 products across three major categories: trauma and deformity, scoliosis, and sports medicine/other procedures [2] - OrthoPediatrics has a global sales organization focused exclusively on pediatric orthopedics, distributing products in the United States and over 70 countries worldwide [2]

Financial Performance - Net revenue for Q3 2025 was $61,250,000, representing a 12.3% increase from $54,573,000 in Q3 2024[15] - Gross profit for Q3 2025 was $45,274,000, up from $40,060,000 in Q3 2024, indicating a gross margin improvement[15] - Operating loss for Q3 2025 was $(9,428,000), compared to $(5,566,000) in Q3 2024, reflecting increased operating expenses[15] - The company reported a net loss of $(11,773,000) for Q3 2025, compared to $(7,919,000) in Q3 2024[17] - For the nine months ended September 30, 2025, the net loss was $29,545,000, compared to a net loss of $21,753,000 for the same period in 2024, representing an increase in losses of approximately 35.5%[24] - Product sales for the three months ended September 30, 2025, totaled $61,250, an increase from $54,573 in 2024, representing a growth of 30.8%[103] - U.S. product sales for the nine months ended September 30, 2025, were $137,757, up from $118,269 in 2024, reflecting a growth of 16.5%[103] Assets and Liabilities - Total current assets increased to $245,852,000 as of September 30, 2025, from $237,173,000 at the end of 2024[13] - Total assets grew to $493,486,000 as of September 30, 2025, compared to $473,209,000 at December 31, 2024[13] - Total liabilities rose to $144,177,000 as of September 30, 2025, compared to $118,643,000 at December 31, 2024[13] - The accumulated deficit increased to $(265,109,000) as of September 30, 2025, from $(235,564,000) at the end of 2024[13] - The company’s cash position decreased to $16,826,000 as of September 30, 2025, from $43,820,000 at the end of 2024[13] Cash Flow - The company reported cash used in operating activities of $15,199,000 for the nine months ended September 30, 2025, a decrease from $23,061,000 in the same period of 2024[24] - Cash, cash equivalents, and restricted cash at the end of the period were $18,884,000, down from $45,777,000 at the beginning of the year[24] - Net cash used in investing activities increased to $36.4 million for the nine months ended September 30, 2025, compared to $10.8 million for the same period in 2024[151] - Net cash provided by financing activities was $24.4 million for the nine months ended September 30, 2025, compared to $53.7 million for the same period in 2024[152] Expenses - Research and development expenses for Q3 2025 were $2,333,000, down from $2,577,000 in Q3 2024[15] - Sales and marketing expenses increased by $1.9 million, or 11%, to $18.7 million for the three months ended September 30, 2025, and by $6.8 million, or 14%, to $54.3 million for the nine months ended September 30, 2025[140] - General and administrative expenses rose by $2.9 million, or 11%, to $29.2 million for the three months ended September 30, 2025, and by $11.5 million, or 15%, to $89.9 million for the nine months ended September 30, 2025[141] - The company incurred stock-based compensation expenses of $13,362,000 for the nine months ended September 30, 2025, compared to $9,660,000 for the same period in 2024, reflecting a 38.0% increase[24] Acquisitions and Goodwill - The Company acquired Medtech Concepts, LLC for approximately $15,274, consisting of $3,000 in cash, $2,274 in common stock, and future payments totaling $2,500 over four anniversaries[40] - The Company purchased Boston Brace International, Inc. for a total consideration of $21,535 in cash and $233 in common stock[46] - Goodwill increased from $93,844 at January 1, 2025, to $103,613 by September 30, 2025, after accounting for acquisitions and impairments[52] - The Company recorded an impairment charge of $1,874 for goodwill and $0.4 million for customer relationship intangible assets due to exiting the regulatory consulting business[55] Debt and Financing - As of September 30, 2025, total debt increased to $105,311 million from $77,483 million as of December 31, 2024, representing a 35.8% increase[65] - The Company issued $50,000 million in 4.75% Convertible Senior Notes due February 15, 2030, for an aggregate purchase price of $49,500 million[73] - The Company signed a $100 million term loan and private placement arrangement, consisting of a $50 million term loan and $50 million of convertible notes[153] - The term loan has an interest rate of SOFR + 6.50%, with payments being interest-only until maturity in August 2029[153] Market and Operational Insights - The company estimates the pediatric orthopedic market represents a $6.2 billion opportunity globally, including over $2.8 billion in the United States[122] - Revenue is typically higher in summer months and holiday periods due to increased pediatric surgeries[160] - The company operates approximately 40 orthotic and prosthetic clinics in the United States[123] - The company has expanded its international operations by establishing operating companies in the Netherlands and Germany in 2019 and 2022, respectively[126] Regulatory and Compliance - The company continues to evaluate the impact of recent accounting standards updates on its financial statements and disclosures[38] - Certifications of the Chief Executive Officer and Chief Financial Officer were filed in compliance with the Sarbanes-Oxley Act of 2002[193] - The company has committed to furnish omitted schedules from agreements to the SEC upon request[194]

Core Insights - Several biotech and healthcare stocks experienced significant after-hours trading gains due to clinical updates, strategic deals, and regulatory milestones [1] Company Summaries - **Genenta Science S.p.A. (GNTA)**: Shares closed at $2.40, down 27.71% during regular trading, but rebounded to $2.45, up 2.08% in after-hours. The volatility was driven by a $15 million registered direct offering and a strategic collaboration announcement [2] - **EDAP TMS S.A. (EDAP)**: Closed at $1.81, down 22.58%, but rose 8.29% to $1.96 in after-hours trading. The recovery appears technical, with no new news, and is supported by upcoming investor meetings at the UBS Global Healthcare Conference [3] - **BridgeBio Pharma Inc. (BBIO)**: Ended regular trading at $64.50, up 1.48%, and climbed 6.71% to $68.83 after hours. The increase reflects anticipation for Phase 3 CALIBRATE trial results for ADH1, with topline data expected on October 29 [4] - **OrthoPediatrics Corp. (KIDS)**: Closed at $16.91, down 0.29%, but surged 6.45% to $18.00 after releasing Q3 financial results, reporting a GAAP loss per share of $(0.50) despite 12% revenue growth [5][6] - The company raised its full-year 2025 revenue guidance to $233.5 million to $234.5 million, indicating projected growth of 14% to 15% compared to the prior year [7] - **Modular Medical Inc. (MODD)**: Dipped 1.30% to $0.5392 but rallied 5.38% to $0.5682 after hours following the successful completion of its Stage 1 ISO 13485:2016 audit, a key step toward CE Mark certification [8] - **Vivani Medical Inc. (VANI)**: Rose 3.09% to $1.67 and added 3.65% to $1.7310 after closing a $15.7 million capital raise, which included a registered direct offering and private placement, indicating insider confidence [9] - **Amarin Corp. plc (AMRN)**: Slipped 1.56% to $18.94 but rebounded 5.07% to $19.90 after the FDA revised fenofibrate drug labeling, which may favor Amarin's Vascepa in the lipid management space [10]

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Core Insights - OrthoPediatrics reported $61.25 million in revenue for Q3 2025, a 12.2% year-over-year increase, but fell short of the Zacks Consensus Estimate of $62.59 million by 2.14% [1] - The company posted an EPS of -$0.24, compared to -$0.18 a year ago, with a surprise of +7.69% against the consensus estimate of -$0.26 [1] Financial Performance - The stock has returned -7.4% over the past month, contrasting with the Zacks S&P 500 composite's +3.6% change [3] - OrthoPediatrics holds a Zacks Rank 3 (Hold), suggesting it may perform in line with the broader market in the near term [3] Product Sales Breakdown - Trauma and deformity product sales reached $44.14 million, slightly below the average estimate of $44.65 million, reflecting a year-over-year increase of 17.3% [4] - Sports medicine/other product sales were $0.85 million, significantly lower than the average estimate of $1.13 million, marking a year-over-year decline of 34.7% [4] - Scoliosis product sales totaled $16.26 million, slightly below the average estimate of $16.8 million, with a year-over-year change of +4% [4]

分组1 - OrthoPediatrics reported a quarterly loss of $0.24 per share, which was better than the Zacks Consensus Estimate of a loss of $0.26, representing an earnings surprise of +7.69% [1] - The company posted revenues of $61.25 million for the quarter ended September 2025, missing the Zacks Consensus Estimate by 2.14%, compared to $54.57 million in the same quarter last year [2] - The stock has underperformed the market, losing about 26.8% since the beginning of the year, while the S&P 500 gained 16.9% [3] 分组2 - The current consensus EPS estimate for the coming quarter is -$0.32 on revenues of $59.89 million, and for the current fiscal year, it is -$1.07 on revenues of $235.94 million [7] - The Zacks Industry Rank for Medical - Instruments is in the top 37% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8] - OrthoPediatrics has surpassed consensus EPS estimates two times over the last four quarters, while it has topped consensus revenue estimates just once [2]

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 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 [21] - Free cash flow usage decreased significantly to $3.4 million from $11.7 million in Q3 2024 [25] Business Line Data and Key Metrics Changes - Trauma and Deformity (T&D) global revenue grew by 17% to $44.1 million, driven by strong growth in multiple product lines [21] - Scoliosis global revenue increased by 4% to $16.3 million, primarily due to increased sales of RESPONSE products, offset by lower 7D unit sales [21][14] - OPSB growth was robust, exceeding 20%, contributing significantly to overall revenue growth [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 due to reduced stocking and set sales [16][17] Company Strategy and Development Direction - The company aims to address critical gaps in pediatric healthcare, focusing on expanding its core business in Trauma and Deformity and Scoliosis implants, as well as OPSB clinics [5][11] - The 3P Pediatric Plating Platform is expected to drive future growth, with new systems planned for launch each year [10][11] - The company is strategically limiting new stocking and set sales in LATSAM to improve cash metrics, focusing on profitability rather than revenue at all costs [17][80] Management's 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 revenue expectations [8][26] - The exit of competitors from the pediatric space is seen as an opportunity for the company to capture market share [29] - Management highlighted the importance of maintaining profitability and cash flow while pursuing growth opportunities [80] Other Important Information - The company recorded restructuring and impairment charges totaling $4.6 million in Q3 2025, impacting operating expenses [22][23] - The company has expanded its OPSB clinics from 26 to over 40 since acquiring Boston O&P in January 2024, with plans for further expansion [12][11] Q&A Session Summary Question: Competitors exiting the space - Management noted that major OEMs like J&J and Smith & Nephew are pulling pediatric products, which could benefit the company competitively [29] Question: Potential for accelerating OPSB expansions - Management confirmed high demand for clinics and expressed willingness to accelerate openings if financially viable [30] Question: Impact of 7D placements on core spine business growth - Management indicated that delays in 7D placements would not significantly affect long-term growth rates for the Scoliosis business [54] Question: EU MDR approvals and staffing reductions - Management confirmed that upcoming EU MDR approvals would enhance the Scoliosis portfolio in Europe, while staffing reductions are part of cost-saving measures [64] Question: Long-term growth outlook and profitability in LATSAM - Management emphasized that future strategies would prioritize profitable revenue growth over maximizing revenue at all costs in LATSAM [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, 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 Performance - OrthoPediatrics Corp. announced preliminary unaudited net revenue for Q3 2025, with specific figures to be confirmed after the audit process[4] - The company revised its financial guidance for the full year ending December 31, 2025, indicating potential changes in revenue expectations[4] - Management cautioned that actual results for Q3 2025 may differ materially from preliminary estimates due to various risks and uncertainties[6]