Detailed Narrative
Spine Business Performance and Distributor Strategy
Global Spine Fixation net sales grew 10% on a constant currency basis, with U.S. spine fixation up 3%. The top 30 distributors, representing 80% of sales, performed well, but smaller distributors showed steeper declines. Management is actively evaluating these relationships to consolidate or exit those not delivering sustainable growth, prioritizing profitable growth and strong returns. Challenges with smaller distributors are expected to continue through the balance of the year.
Biologics Business Turnaround
Biologics net sales were approximately flat year-over-year, a significant improvement from double-digit contractions in 2025. This marks the second consecutive quarter of improved performance. The company is focusing on converting this constructive trajectory into durable growth through stronger account engagement, higher utilization, and targeted commercial focus on key products like Osteo bioactive synthetic bone graft. Investments are also being made in clinical evidence generation for Osteocove and Virtus, and a product registry for STEM.
Therapeutic Solutions Resilience and Reimbursement
Therapeutic Solutions delivered 3% year-over-year net sales growth despite temporary Medicare reimbursement pressure during part of Q2. The Centers for Medicare & Medicaid Services (CMS) restored medical reimbursement for bone growth stimulators to its prior level, retroactive to May 18, 2026, removing a meaningful headwind. The company plans to continue investing in elevating the patient and physician experience, including the launch of Access STIM 2.0, a redesigned bone growth therapy device.
Global Limb Reconstruction Momentum and Future Opportunities
Global Limb Reconstruction demonstrated solid performance, with net sales growing 11% on a constant currency basis, driven by strong international momentum and products like TrueLok Elevate and FITBONE. U.S. growth was below expectations due to commercial infrastructure needs. The company is improving distributor productivity and expanding market development. They also see opportunities in adjacent areas like diabetic foot ulcer, where an IDE has been submitted to the FDA to support potential expanded indications.
European MDR Strategy and Financial Impact
Orthofix has a strategic arrangement with a European distributor for spine products to preserve market access without pursuing full MDR compliance for the entire portfolio. This arrangement is expected to contribute approximately $15 million of incremental net sales in 2026, mostly in Q4, but will create an approximately $22 million net sales headwind in 2027 while MDR requirements are completed. This also creates a temporary free cash flow timing headwind in 2026.
Updated Full-Year Outlook and Strategic Priorities
The company updated its full-year 2026 net sales guidance to $845 million to $855 million and adjusted EBITDA guidance to $95 million to $98 million. This outlook reflects restored Medicare reimbursement, the European distributor arrangement, and stabilization in Biologics, offset by ongoing softness in smaller U.S. spine distributors. Management remains focused on improving commercial productivity, advancing differentiated innovation, and generating clinical evidence to drive durable, profitable growth and cash generation.