Lumos Diagnostics Holdings Ltd (ASX:LDX, OTC:LDXHF) has released its quarterly activity statement for the fourth quarter (Q4) of financial year 2025, revealing a solid 12% year-on-year revenue increase but a dip in Q4 figures primarily attributed to the seasonal decline in US flu cases.
Despite the quarterly revenue dip, the company made significant progress in its regulatory and commercial initiatives, including a milestone exclusive distribution deal for its FebriDx® point-of-care diagnostic product.
Revenue and operational highlights
For the quarter ending June 30, 2025, Lumos posted unaudited revenue of US$2.6 million, a 26% drop compared with the previous quarter. While this decrease is largely due to the conclusion of the US flu season, the company remains on track with key product and service revenue streams.
For the full financial year, Lumos generated US$12.4 million in revenue, a 12% increase from the 2024 financial year (FY24), driven by growth in product sales, notably from FebriDx®.
The service segment, which includes revenue from diagnostic test development, contract manufacturing and licensing agreements, accounted for the majority of Q4 revenue at US$2.3 million. This reflected a 43% decrease from the same period in FY24, and a 17% decline from the prior quarter, primarily due to a reduced monthly revenue recognition rate from the Hologic development agreement and an extended timeline for the associated project milestones.
In the product segment, Lumos reported US$300,000 in sales for the quarter, down from US$700,000 in Q3 FY25. This decrease is tied to the end of the US flu season, which reduced demand for the ViraDx® test. However, the adoption of FebriDx® continues to show promise, with a notable 522% increase in sales over the same quarter in FY24.
Lumos also announced a significant achievement post-reporting period — a US$317 million exclusive distribution agreement for FebriDx® with PHASE Scientific in the US, one of the largest distribution deals ever signed by an Australian point-of-care diagnostics company. This deal positions Lumos to scale its operations in the US market, where FebriDx® has shown strong growth potential.
Strategic partnerships and regulatory progress
Lumos continues to make strides with its pivotal FebriDx® CLIA waiver study, which aims to secure US Food and Drug Administration (FDA) approval for the test. The study is progressing ahead of schedule, with 105 out of the targeted 120 bacterial positive patients already enrolled. The company anticipates completing the study in August 2025 and submitting its CLIA waiver application to the FDA shortly thereafter.
Additionally, Lumos has achieved a key milestone with the US Medicare program. The company now has payor coverage for FebriDx® through six of the seven Medicare Administrative Contractors (MACs), representing 85% of the US Medicare payor mix. This progress is crucial for ensuring reimbursement, which is expected to drive wider adoption of FebriDx® in clinical settings.
On the Hologic fFN project, Lumos completed Phase 2 work, with an additional Statement of Works (SOW) requested by Hologic for further work on the project. Phase 3 work, however, has been delayed, extending the project timeline to March 2026.
This program remains a key part of Lumos’ services revenue stream, with total milestone payments from Hologic expected to range from US$5.3 million to US$5.5 million.
Cash flow and funding update
Lumos ended Q4 with a cash balance of US$2 million. The company reported a net operating cash outflow of US$1.7 million, largely due to increased development costs and the ongoing CLIA waiver study.
Despite this, Lumos secured a binding term sheet for a discretionary A$5 million loan facility post-quarter, aimed at providing additional working capital support as it advances its clinical and regulatory milestones.
“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 US regulatory pathway but also laying the foundation for FebriDx® as a true platform diagnostic,” said CEO Doug Ward said.
“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.”
Key priorities and investor briefing
Looking ahead, Lumos’ key priorities include completing the CLIA waiver study, submitting the FDA application and expanding FebriDx® distribution under the PHASE Scientific agreement. The company is also preparing to initiate a BARDA-sponsored paediatric study and continue work on the Hologic fFN project.
Lumos has invited investors and analysts to attend an online briefing on July 25 to discuss the company’s Q4 results and recent progress. Participants can pre-register here.