RegulatoryMay 21, 2026, 08:07 AM
Orthofix Cuts 2026 Outlook to $838M-$848M Net Sales on CMS Changes
AI Summary
Orthofix Medical Inc. has updated its financial outlook following a U.S. Food and Drug Administration reclassification of non-invasive bone growth stimulators and subsequent Centers for Medicare & Medicaid Services (CMS) billing requirement updates. The company anticipates an approximate 10% decline in average Medicare reimbursement for certain codes, leading to a revised full-year 2026 net sales forecast of $838 million to $848 million and non-GAAP adjusted EBITDA of $90 million to $93 million. Orthofix no longer expects positive free cash flow for 2026 and has withdrawn its three-year financial targets.
Key Highlights
- FDA reclassified non-invasive bone growth stimulators from Class III to Class II devices on April 16, 2026.
- CMS updated billing requirements for non-invasive bone growth stimulators effective May 18, 2026.
- Orthofix expects average Medicare reimbursement for HCPCS codes E0747, E0748, E0760 to decline by approximately 10%.
- Revised full-year 2026 net sales outlook to a range of $838 million to $848 million.
- Revised full-year 2026 non-GAAP adjusted EBITDA outlook to a range of $90 million to $93 million.
- Company does not expect positive free cash flow for full-year 2026.
- Orthofix's three-year financial targets are no longer applicable.
Price Impact
More from OFIX