Orthofix Medical (NasdaqGS:OFIX) Q4 2025 Earnings call February 24, 2026 08:30 AM ET Company ParticipantsJulie Andrews - CFOJulie Dewey - Chief Investor Relations and Communications OfficerMassimo Calafiore - President and CEOMathew Blackman - Managing DirectorMichaela Smith - Equity Research AssociateTom Stephan - AVPConference Call ParticipantsMike Petusky - Managing Director and Senior Research AnalystOperatorThank you. I would now like to turn the call over to Julie Dewey.Julie DeweyThank you, operator, ...

Orthofix Medical (NasdaqGS:OFIX) Q4 2025 Earnings call February 24, 2026 08:30 AM ET Company ParticipantsJulie Andrews - CFOJulie Dewey - Chief Investor Relations and Communications OfficerMassimo Calafiore - President and CEOMathew Blackman - Managing DirectorMichaela Smith - Equity Research AssociateTom Stephan - AVPConference Call ParticipantsMike Petusky - Managing Director and Senior Research AnalystOperatorThank you. I would now like to turn the call over to Julie Dewey.Julie DeweyThank you, operator, ...

Financial Data and Key Metrics Changes - Total global net sales in Q4 reached $218.6 million, a 3% increase supported by strong performances in Bone Growth Therapies and U.S. limb reconstruction segments [12] - Pro forma non-GAAP adjusted gross margin was 71.4%, reflecting the impact of the M6 discontinuation and productivity improvements [15] - Fourth quarter pro forma non-GAAP adjusted EBITDA was $29.2 million, or 13.4% of net sales, with year-over-year margin expansion of approximately 230 basis points [15] - Free cash flow for Q4 was exceptionally strong at $16.8 million, demonstrating the strength and scalability of the business model [15] Business Line Data and Key Metrics Changes - Global spine fixation Q4 net sales grew 10% for the year and in Q4, with U.S. spine fixation net sales growing 6% for the year and 5% for the quarter [4] - Bone Growth Therapies (BGT) net sales were $68.3 million, up 7%, significantly outperforming the market [13] - U.S. limb reconstruction sales were $38 million in Q4, driven by 8% U.S. growth [14] Market Data and Key Metrics Changes - U.S. limb reconstruction grew 8% in Q4 and 16% for the full year, driven by successful product launches [7] - The spine commercial channel optimization efforts led to a 25% year-over-year growth in net sales from the top 30 U.S. distributor partners [5] Company Strategy and Development Direction - The company has rebranded its orthopedics business as limb reconstruction, focusing on four high-value clinical categories, representing an estimated $2.6 billion market opportunity [6] - The full market release of the VIRATA Spinal Fixation System is anticipated in the second half of 2026, expected to enhance surgical efficiency and serve as a multi-year growth catalyst [6] - The company is recalibrating its three-year financial targets to fully capture the anticipated benefits of its spine commercial channel optimization [9] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about entering 2026 with strong momentum and a solid foundation for growth, driven by new product launches and improved distributor performance [11] - The company expects to deliver durable top-line growth, expanding margins, and strong free cash flow in 2026 [9] - Management highlighted the importance of disciplined execution and targeted capital deployment to create sustainable long-term shareholder value [22] Other Important Information - The company expects full-year net sales of $850 million-$860 million for 2026, representing implied pro forma constant currency year-over-year growth of approximately 5.5% [16] - Adjusted growth margins for the full year are expected to be approximately 72.5% [19] Q&A Session Summary Question: Clarification on CMS impact on BGT - Management clarified that the CMS change will have about a 1% impact in Q1 specific to BGT revenue only [31] Question: Long-range plan (LRP) and margin improvement - Management indicated that the delay in the LRP reflects the extensive work done to strengthen the foundation and optimize the distributor transition [32][33] - They emphasized the focus on gross margin expansion and productivity improvements to achieve mid-teens EBITDA and positive free cash flow [35] Question: 2026 revenue guidance specifics - Management expects above-market growth for BGT and limb reconstruction, with U.S. limb reconstruction returning to double-digit growth in the second half of 2026 [40] Question: 7D placements and biologics portfolio - Management reported a 30% increase in 7D placements in 2025 and expressed confidence in the biologics portfolio's potential for recovery and growth [48][50] Question: Tariff impact and legal settlements - Management confirmed that the tariff impact is included in the 2026 guidance, expecting about $1 million-$2 million impact [54] - They acknowledged having taken an accrual for a legal settlement in Q3 [56]

Drive Profitable Growth Investor Presentation February 2026 Forward-Looking Statements This presentation contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended, relating to our business and financial outlook, which are based on our current beliefs, assumptions, intentions, plans, expectations, estimates, forecasts and projections. In some cases, you can identify forward-looking statem ...

Financial Performance - Orthofix's Global Spine segment accounted for 84% of total net sales in 2025, while Global Limb Reconstruction contributed 16%[26]. - The company completed a merger with SeaSpine Holdings Corporation in January 2023, converting each share of SeaSpine common stock into 0.4163 shares of Orthofix common stock[24]. - The company operates in two reporting segments: Global Spine (84% of total net sales) and Global Limb Reconstruction (16% of total net sales) for the year 2025[115]. - In 2025, 2024, and 2023, the company incurred research and development expenses of $65.8 million, $73.6 million, and $80.2 million, respectively[84]. Product Portfolio - The Global Spine segment includes Bone Growth Therapies and Spinal Implants, with significant growth initiatives focused on innovation and partnerships[30]. - Orthofix's Bone Growth Therapies include market-leading devices utilizing PEMF and LIPUS technologies, primarily sold in the U.S.[31]. - The company offers a comprehensive portfolio of spinal implants designed for various surgical procedures, including ALIF, PLIF, and ACDF[36]. - The company’s interbody portfolio includes various material types and integrated fixation options, catering to different surgical approaches and patient needs[50]. - The company’s comprehensive spinal fixation solutions cover the entire spine, offering modular options for various surgical needs[51]. - The company’s biologics portfolio includes bone graft substitutes and is distributed globally through a network of distributors and sales representatives[35]. - The company’s Biologics products are derived from human or bovine tissue, sourced from FDA-registered tissue banks, ensuring safety and compliance[132]. - The company offers a 3D printed Firebird SI system for sacroiliac joint disruptions, differentiating itself from competitors who lack SI fixation options[38]. - Trinity Elite and Virtuos Lyograft are leading products in the cellular allografts portfolio, with Trinity Elite maintaining market leadership for over a decade[58]. Technology and Innovation - The 7D FLASH Navigation System is a key enabling technology that enhances image-guided surgery, providing significant economic value and improved safety[34]. - The 7D FLASH Navigation System utilizes visible light technology for fast, efficient, and radiation-free spine surgery, enhancing surgical workflow[53]. - The 7D FLASH Navigation System's Spine Module will see enhancements and new features launched in 2026, including additional navigation tools and improved user interface[54]. - The STIM onTrack mobile app allows physicians to remotely monitor patient adherence to treatment protocols, enhancing patient engagement and outcomes[44][47]. - The company is exploring opportunities to integrate the 7D FLASH Navigation technology into various orthopedic applications[82]. Market Strategy - The company emphasizes ongoing clinical research to support its product portfolios and aims to attract and retain key talent for growth[33]. - Orthofix's strategy includes regular product launches and global sales channel optimization to enhance market presence[33]. - The company aims to continue the strong pace of new product launches and invest in technologies to support market opportunities[71]. - The company plans to continue investing in additional instrument sets and marketing efforts to support the expansion of its independent sales agent footprint[120]. - The company focuses on enhancing its competitive position through product features, value-added services, and training, rather than competing solely on price[128]. Regulatory Compliance - The company’s Spinal Implants and Global Limb Reconstruction products are primarily classified as Class II devices, while Bone Growth Therapies products are classified as Class III and approved through the PMA process[89]. - The company incurs significant costs to maintain compliance with the E.U. Medical Device Regulation, which imposes strict requirements for marketing and selling medical devices, with transition periods extending until December 2028 for certain products[90]. - The company’s products derived from human tissue must comply with both HCT/P requirements and additional regulations applicable to biologics, devices, or drugs, including 510(k) clearance or PMA approval[96]. - The company is AATB-accredited and licensed for tissue banking in multiple states, ensuring compliance with various state regulations[98]. - The company is subject to various U.S. laws regulating healthcare fraud and abuse, including the Anti-Kickback Statute and the Stark Law, which impact sales and marketing practices[106]. Competition and Market Challenges - The company’s Bone Growth Therapies product category competes with products from companies like EBI, Enovis, and Bioventus, while its Biologics and Spinal Implants markets face competition from major players like Medtronic and DePuy Synthes[127]. - The healthcare industry consolidation has led to increased pricing pressures, with Group Purchasing Organizations (GPOs) negotiating discounts that could adversely affect profitability[147]. - The company faces competition from larger device companies that leverage volume discounts and multi-year arrangements, potentially limiting access to key customers[149]. - The medical device industry is characterized by rapid technological change, with new products regularly introduced that may render existing products non-competitive[151]. - Supply chain disruptions, such as those experienced during the COVID-19 pandemic, have previously impacted operations and could affect future business results[152]. Operational Risks - The company relies on a limited number of suppliers, and interruptions in the supply chain could lead to significant delays and additional costs[153]. - The supply of allograft tissues is unpredictable, and any reclassification by the FDA could increase operational costs and regulatory burdens[157]. - The approval process for human-derived products in the E.U. is lengthy and unpredictable, with non-compliance potentially leading to product bans[159]. - The company faces significant risks in developing and introducing new products, which may not meet market expectations[161]. - Cyber-attacks and data breaches pose risks to the company's information systems, potentially leading to unauthorized access to sensitive data and significant operational disruptions[182]. Human Resources and Talent Management - Attracting and retaining qualified executives and key employees is crucial for the company, as competition for talent in the medical device industry is intense[201]. - The company relies on third parties for clinical studies and pre-clinical development, and any failure in their performance could delay regulatory approvals and commercialization[156]. Community Engagement - The company emphasizes community involvement through its "Orthofix Gives Back" initiative, focusing on health innovation and education to create a lasting impact[144].

Exhibit 99.1 News Release Orthofix Reports Fourth Quarter and Full-Year 2025 Financial Results and Provides 2026 Financial Guidance LEWISVILLE, Texas — February 24, 2026 — Orthofix Medical Inc. (NASDAQ:OFIX), a leading global medical technology company, today reported its financial results for the fourth quarter and full-year ended December 31, 2025, provided full- year 2026 financial guidance and updated its three-year financial targets. All pro forma measures contained within this release exclude the impa ...

"projects,†"intends,†"predicts,†"potential,†"positioned,†"deliver,†or "continue†or other comparable terminology. Forward-looking statements in this communication include the Company's expectations regarding net sales, adjusted EBITDA, and free cash flow for the year ended December 31, 2025. Forward-looking statements are not guarantees of our future performance, are based on our current expectations and assumptions regarding our business, the economy and other future conditions, and are subject to risks, ...

Summary of Orthofix Medical Q3 2025 Conference Call Company Overview - **Company**: Orthofix Medical (NasdaqGS: OFIX) - **Date**: November 12, 2025 - **Key Focus**: Discussion of Q3 2025 financial performance and future outlook Key Highlights Financial Performance - **Q3 Revenue**: Beat consensus by approximately $3 million, achieving a revenue growth of 6% [3][5] - **EBITDA Margin**: Experienced a 230 basis points expansion, marking the seventh consecutive quarter of EBITDA margin growth [3] - **Free Cash Flow**: Positive free cash flow of $2.5 million in Q3 [3] Market Dynamics - **U.S. Spine Growth**: Strong procedure growth at 10%, with expectations to continue growing above market rates [9][10] - **International Orders**: Q3 revenue beat primarily driven by earlier-than-expected international stocking orders [6][7] Product and Strategy Insights - **Distributor Transition**: Ongoing consolidation of a fragmented distributor network is expected to drive incremental growth [14][16] - **7D Placement Demand**: Positive trends noted in capital equipment demand, with a focus on earn-out agreements to reduce upfront costs for hospitals [18][21] - **Verada Launch**: The new product is designed to enhance user experience in the operating room, with a full launch expected in 2026 [25][30] Future Outlook - **2026 Expectations**: Anticipated positive growth driven by the Verada launch, full-year impact from distributor transitions, and new product introductions [34] - **BGT Revenue Impact**: CMS pilot program expected to have an immaterial annual impact on BGT revenue, with no change in physician prescribing behavior anticipated [38][39] Margin and Profitability Goals - **Gross Margin Expansion**: Targeting 300 basis points of gross margin expansion by 2027, driven by supplier consolidation and insourcing strategies [40][42] - **EBITDA Margin Goals**: Aiming for mid-teens EBITDA margins by 2027, with a focus on leveraging operational efficiencies [47][56] Orthopedics Business Outlook - **Growth Potential**: Positive outlook for the Orthopedics segment, particularly in trauma and diabetic foot treatment markets, with significant product differentiation [58][59] Underappreciated Aspects - **Company Transformation**: Notable improvements in free cash flow and consistent EBITDA performance are seen as underappreciated by the market [61][62] Additional Insights - **Pricing Strategy**: Long-term guidance assumes 1% to 2% price erosion, but current pricing has remained relatively flat [12] - **Market Positioning**: Orthofix aims to leverage its innovative product lines and strong distributor relationships to capture market share [10][16] This summary encapsulates the key points discussed during the conference call, highlighting the company's financial performance, market dynamics, product strategies, and future outlook.

Company Overview - Orthofix is a med tech company focused on the spine market, specifically in Bone Growth Therapy, Biologics, and Orthopedics [1] - The company has a competitive portfolio and has been on a journey for the past two years to leverage commercial synergies within its offerings [1] - The strategic focus is on achieving profitable growth and generating free cash flow while targeting specific segments within the broad market [1] Market Position - In the Spine vertical, Orthofix is currently considered subscale but possesses a strong portfolio [2]

Summary of Orthofix Medical Conference Call Company Overview - **Company**: Orthofix Medical (NasdaqGS: OFIX) - **Industry**: Medical Technology, specifically focused on spine and orthopedic markets - **Key Focus Areas**: Bone growth therapy, biologics, and limb reconstruction [4][5] Core Insights and Arguments - **Business Strategy**: Orthofix aims for profitable growth and free cash flow creation, leveraging commercial synergies within its portfolio [4][5] - **Financial Performance**: - Transitioned from a loss of over $109 million in free cash flow to being free cash flow positive [7][8] - Achieved seven consecutive quarters of positive EBITDA [8] - **Management Changes**: A new management team was established with expertise in relevant markets to drive execution and innovation [9][10] - **Market Position**: - The spine vertical is still considered subscale but has a strong portfolio and innovation strategy [4] - The company is focusing on specific subcategories in orthopedics, particularly limb reconstruction [5] Recent Performance Highlights - **Q3 Performance**: - Achieved growth above market expectations, attributed to optimized distribution and timing of international orders [11][12] - Top 30 U.S. distributor partners grew sales by 25% year-over-year [17] - International spine fixation sales grew by 86% in Q3, driven by strategic market focus [20] Product Innovations and Launches - **Upcoming Launches**: - Excitement around the launch of the Vorata platform in spine, which is expected to enhance operational efficiency and market competitiveness [15][16] - TRULOC Elevate and FITBONE nails are in the early stages of market adoption, with a focus on education and training for surgeons [27][31] - **Enabling Technologies**: - Investment in the 7D flash navigation system, which has shown significant commercial success and improved operational efficiencies [33][36] Market Dynamics and Competitive Landscape - **Competitive Landscape**: - Recent divestitures by larger competitors (e.g., J&J and Stryker) present opportunities for Orthofix to capture market share [53][54] - The company is positioned to benefit from a shift towards nimble companies that focus on surgeon needs [54][56] Financial Outlook and Growth Targets - **Long-term Targets**: - Projected net sales CAGR of 6.5% to 7.5% and mid-teens adjusted EBITDA by 2027 [51] - Anticipated catalysts include successful product launches and continued market penetration [51][52] - **Risks**: - Potential price pressure of 1% to 2% expected, but manageable through volume increases [26] - Market stability is anticipated, with no significant changes expected in payer policies [43] Capital Allocation Strategy - **Investment Focus**: - Prioritizing R&D, particularly in differentiated platforms like 7D [57][58] - Discontinued over 40 product lines to streamline focus and enhance capital allocation [59] Conclusion - **Investor Perception**: There is a perceived disconnect between investor expectations and the company's current trajectory, with Orthofix still in the early stages of its growth strategy [60][61]