Key points
- Secured pivotal U.S. distribution agreement with PHASE Scientific for US$317m over six years
- Achieved U.S. FDA CLIA waiver for FebriDx®, expanding market to over US$1.0 billion
- Completed A$20.0 million capital raise for U.S. commercialization
- FY26 revenue of US$13.2 million, up 6% over the pcp
- FY26 gross profit of US$7.9 million, at a gross profit margin of 60.1%
Full summary
Lumos Diagnostics Holdings Ltd (ASX:LDX) announced its financial results for the year ended 30 June 2026, highlighting significant achievements that position the company for future growth. Key highlights include a six-year U.S. distribution agreement with PHASE Scientific valued at US$317 million, U.S. FDA CLIA waiver status for FebriDx®, and nationwide Medicare reimbursement recognition. These milestones expanded the U.S. market opportunity for FebriDx® to over US$1.0 billion annually. The company also achieved 100% Medicare reimbursement recognition across all seven U.S. Medicare Administrative Contractors (MACs), and commercialized FebriDx® in more than 170 healthcare locations across 24 states. FY26 revenue was US$13.2 million, up 6% over the previous corresponding period, with gross profit of US$7.9 million at a gross profit margin of 60.1%. The company completed a A$20.0 million capital raise to support U.S. commercialization activities.
Guidance
FY26 revenue: US$13.2 million, FY26 gross profit: US$7.9 million
Outlook
Lumos Diagnostics aims to convert FY26's regulatory and commercial milestones into sustained revenue growth in FY27, focusing on U.S. sales execution, expanding healthcare provider awareness, and advancing reimbursement coverage.