Atomo Diagnostics (AT1) Q1 2025 earnings summary

Executive summary

• Strong demand for HIV self-test products in Australia and Europe, driven by government-funded programs, vending machine expansion, and new public health initiatives.

• Expansion into European markets with a new HIV test variant and growing retail pharmacy presence in the UK, Germany, Netherlands, and Eastern Europe.

• Secured a $2.44m CRC-P grant to develop a novel active syphilis biomarker test in partnership with the Burnet Institute, with initial funds expected in January.

• Progress on regulatory transition from IVDD to IVDR in Europe, with audits completed and dossier resubmission planned by May 2025.

• Ongoing partnerships and product development with Burnet Institute, including ALT biomarker for liver function and support for U.S. drug trials.

Financial highlights

• Q1 FY25 revenue was $876k (unaudited), mainly from HIV self-test sales in Australia and Europe, OEM Pascal sales, and development fees.

• Operating costs for the quarter were $1.6m, representing an 18-20% reduction year-over-year.

• Cash receipts for the quarter were $1.16m; quarter-end cash on hand was $2.61m, with no debt.

• Post-quarter, received an ATO rebate of $753k and expects additional government grant funding in January.

• Payments to directors during the quarter totaled $230k.

Outlook and guidance

• Anticipates continued growth in Australian HIV self-test business as government support and vending machine programs scale.

• On track to gain EU IVDR certification for HIV Self-Test by May 2025, with audits underway and dossier submission planned for Q3 FY25.

• Expects syphilis test to address a large, unmet clinical need and to perform well in both public health and pharmacy retail channels.

• OEM business expected to grow with new regulatory approvals and expansion into new European markets.

• Ongoing cost management and focus on capital efficiency.