Secured Major U.S. Distribution Agreement (PHASE)
Signed a 6-year exclusive U.S. distribution agreement for FebriDx with PHASE Scientific that guarantees a minimum of USD 317 million in sales to Lumos over the term; PHASE also paid a USD 1.0 million exclusivity fee recognized in H1 revenue.
CLIA Waiver Study Completed and Submitted
Completed the CLIA waiver study in August and submitted to the U.S. FDA; management is optimistic a CLIA waiver grant will be announced imminently (targeted for March), which would materially expand addressable market and in-office use.
Reimbursement Secured
Secured Medicare/Medicaid reimbursement set by CMS at USD 41.38 per test with seven MACs agreeing to pay full reimbursement, improving the economics and adoption potential for FebriDx in physician offices.
Revenue and Product Revenue Growth
Reported first half revenue of USD 6.1 million; product revenue was USD 1.7 million vs USD 0.8 million in prior corresponding period, representing approximately a +112.5% increase year-over-year (driven largely by FebriDx).
Strong Gross Profit and Margin Improvement
Gross profit of USD 4.2 million and a gross margin of 68%, up 1 percentage point on the prior corresponding period and up 13 percentage points versus two years ago; FebriDx product margin indicated north of 60%.
Improved Cash Flow and Nondilutive Funding
Operating cash flow turned positive at USD 0.1 million in H1 versus an outflow of USD 6.8 million in the prior corresponding period; received USD 2.8 million in BARDA funding during H1 and secured ~USD 6.2 million to fund the pediatric trial. Management emphasized nondilutive financing actions (BARDA, IP arrangements, sale-leaseback, investor loan facility).
Reduction in Losses vs Prior Years
Adjusted EBITDA loss improved to USD 1.4 million in H1 (slightly worse than the immediate prior period but a significant improvement from FY24 H1 loss of USD 4.2 million), indicating progress toward profitability.
Services Business Performing and Backfilled Revenue
Services revenue of USD 4.4 million with ongoing project work (~14 projects recently), cash-flow positive services segment and new contract wins (e.g., Aptatek) that help offset reduced IP revenue recognition.
Pediatric Study Funding and Label Expansion
Secured funding (~USD 6.2 million) to run a pediatric trial to extend FebriDx label to ages 2–12; trial expected to complete by end of the calendar year and expand market by an estimated ~20%.