Lumos Diagnostics (ASX:LDX) Announces Q4 FY25 Financial Results and Major Distribution Agreement
Financial Performance
Lumos Diagnostics reported FY25 unaudited revenue of US$12.4 million, marking a 12% increase from FY24. However, Q4 revenue declined by 26% to US$2.6 million compared to the previous quarter, primarily due to the end of the U.S. flu season. Product revenue rose 7%, while services revenue decreased 43%.
Major Distribution Agreement
Post-reporting, Lumos signed an exclusive six-year distribution agreement with PHASE Scientific for FebriDx® in the U.S., valued at up to US$317 million (A$487 million). An initial payment of US$2.0 million was made, with further payments contingent on the submission of the CLIA waiver application to the FDA.
Operational Developments
The FebriDx CLIA Waiver Study is nearing completion with 105 of the targeted 120 positive bacterial patients enrolled. Lumos also secured Medicare payor coverage for FebriDx®, covering 20%-24% of the U.S. reimbursement payor mix. The Hologic fFN project also advanced to Phase 3 with an extended timeline to March 2026.
Financial Position
As of 30 June 2025, Lumos held a cash balance of US$2.0 million, with an operating cash outflow of US$1.7 million in Q4. The company also secured a binding term sheet for a discretionary A$5.0 million loan facility to support working capital needs.
Executive Comments
CEO Doug Ward stated, “The past few months have been critical for Lumos and for FebriDx®, marked by a series of very significant milestones that are not only advancing our U.S. regulatory pathway but also laying the foundation for FebriDx® as a true platform diagnostic. The distribution partnership with PHASE Scientific represents the culmination of years of hard work by our exceptional team. I remain deeply confident in the tangible benefits of FebriDx® and the meaningful impact it can have on patient care, clinical decision-making, and broader healthcare system efficiencies.”
“Our CLIA Waiver study for FebriDx® continues to progress well, with study completion expected around August 2025, with our FDA CLIA waiver application expected to be submitted within approximately one month of completion. Encouragingly, we’ve seen strong early support from U.S. public payors, which we believe will be the catalyst for broader adoption by private payors in due course.”
“I’m sincerely grateful for the continued backing of our two largest shareholders, Tenmile and Ryder Capital. The non-dilutive funding facility, along with contracted FebriDx® distribution fees and future milestone payments from our partners, positions Lumos well to meet working capital needs as we advance towards the anticipated granting of CLIA waiver.”
“Looking ahead, we remain firmly focused on our strategic priorities and committed to building a strong, sustainable business that delivers long-term value for patients, partners, and shareholders alike.”
Motley Fool contributor Lauren Surplice has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.
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