Atomo Diagnostics Reports 40% Revenue Surge to $5.3 Million in FY26 Driven by HIV and OEM Sales Expansion

Strong Revenue Growth Driven by HIV and OEM Segments in FY26

Atomo Diagnostics reported FY26 revenue of $5.3 million, a 40% increase from FY25's $3.8 million. The Q4 contribution was $2.3 million, underscoring sustained momentum in core revenue streams. HIV self-testing sales in Q4 generated approximately $1.6 million, while OEM sales reached $670,000. The OEM growth was propelled by expanded orders for the Pascal platform serving existing clients like FebriDx, alongside completion of orders for two new OEM customers, expected to underpin long-term supply agreements anticipated in Q1 FY27.

During Q4, Atomo secured sales orders exceeding $1.5 million, providing visibility into upcoming revenue. Cash receipts totaled $3.8 million, comprising $1.0 million from customer payments, $165,000 from the Syphilis CRC-P grant, and about $2.7 million from placement proceeds net of transaction costs. An additional $1.0 million in cash receipts was recorded in July 2026. This robust cash flow supports operational flexibility and investments in product development and market expansion.

Debt-Free Financial Position and Cost Discipline Propel Profitability Path

Atomo maintains a strong financial footing with $3.7 million cash on hand as of June 30, 2026, and no debt. Operating expenses for Q4 were $1.4 million, with management prioritizing revenue growth initiatives. Incorporating income from the Syphilis CRC-P grant and government R&D rebates improves the bottom line by over 15%. This non-dilutive funding, alongside selective asset licensing, has facilitated new diagnostic test development while sustaining fiscal discipline.

EBITDA trends indicate progress toward breakeven, with losses narrowing from H1 FY24 through H2 FY26. Growth in HIV testing and Pascal OEM sales, coupled with product portfolio expansion, contributed to this improvement. Atomo is validating a second-generation blister machine and high-cavity mould tooling to boost capacity, economies of scale, and margins, positioning the company for enhanced profitability as revenues grow.

Australian Pharmacy Network Expands 33% in Q4; Six-Year Goal to Multiply by Sixfold

Atomo’s HIV self-testing distribution through Australian pharmacies surged in Q4 FY26, increasing the network by 33% from 147 to 196 locations with 49 new pharmacies added. Further growth is expected in FY27. This expansion is central to Atomo’s strategy to increase HIV testing accessibility via convenient retail outlets. The company aims to grow its Australian pharmacy presence sixfold over three years, targeting over 1,000 locations.

In New Zealand, Atomo activated 70 pharmacies since FY25 launch, targeting an eightfold expansion over three years. Q4 saw the start of ordering from CDC, a major New Zealand pharmacy wholesaler, accelerating distribution and onboarding. Additionally, a rollover order from Australian government programs signals ongoing public sector demand. Demand from NAPWHA, representing people with HIV, rose 275% over 24 months, highlighting growing awareness and uptake of Atomo’s HIV self-testing.

International HIV Market Expansion Delivers Robust Year-on-Year Growth

Atomo’s HIV business is expanding significantly in Europe and low- and middle-income countries (LMICs) through partners like Viatris. Revenue in LMIC markets rose 69% year-on-year, while European operations grew 74%, reflecting strong global demand and effective partner distribution. These international markets offer substantial long-term growth potential, addressing limited HIV testing access and aligning with public health priorities.

The company’s diversified strategy, combining international partnerships with direct pharmacy networks in Australia and New Zealand, reduces dependency on any single market and positions Atomo to capitalize on the global rapid diagnostic testing market. The international business growth, alongside domestic network expansion, ensures HIV testing remains a key revenue driver.

Syphilis Test Development Advances Toward Mid-FY27 Clinical Trials

Atomo is progressing an active syphilis diagnostic test designed to distinguish active from prior infections—a capability unmatched by current rapid tests—and optimized for reliable self-testing. Development and initial verification are complete, with sensitivity exceeding 85% for active syphilis detection, attracting strong clinical and commercial interest.

Technology transfer for manufacturing began in Q4 FY26 and will continue into Q1 FY27, supporting clinical trials and regulatory submissions. Initial regulatory engagement was successful. Clinical trials are planned for mid-FY27, with commercialisation efforts underway. The syphilis test benefits from existing HIV testing channels, enabling efficient market entry and reduced development costs supported by the CRC-P grant. Engagement with clinical leaders through DILI and pharmaceutical conferences supports market development.

Liver Function Test Focuses on Pharmaceutical Monitoring Applications

Atomo is advancing business planning for a liver function test targeting patients on at-risk drugs. The company is evaluating commercial pathways, clinical trial use cases, and at-home liver monitoring prescribed by doctors. Q4 saw engagement with clinical key opinion leaders focused on drug-induced liver injury (DILI) and pharmaceutical uses, with expanded engagement planned for FY27 involving pharmaceutical companies, CROs, and commercial partners.

Additionally, Atomo is exploring a liver function screening test for fatty liver disease, a significant global public health issue attracting government interest. Engagement with Australian clinical leaders and public health authorities is underway to assess screening viability and funding opportunities, potentially leveraging preventive screening initiatives. This multi-pathway approach allows near-term pharmaceutical monitoring revenue while developing a larger public health screening opportunity.

Manufacturing Scale-Up with Second-Generation Blister Machine and Tooling

In Q4 FY26, Atomo completed setup and qualification of a second-generation blister machine at its Sydney facility, enhancing production capacity for diagnostic products. Validation of high-cavity mould tooling is underway to further increase capacity, improve economies of scale, and boost margins. These investments underpin revenue growth targets and product profitability improvements.

Qualification activities supporting product dossiers and Quality Management System upgrades have commenced, ensuring regulatory compliance and enabling new test introductions. The transition to scaled manufacturing capabilities marks a key milestone in Atomo’s growth, supporting multi-product commercialisation and international distribution.

Expanding Diagnostic Portfolio Targets Diverse Clinical Needs

Beyond HIV, syphilis, and liver function tests, Atomo is evaluating additional diagnostics including prostate-specific antigen (PSA) for prostate cancer screening, stroke acute neurological triage, coeliac gluten sensitivity detection, and a fourth-generation HIV test (HIV Gen 4), among others pending commercial assessment. This pipeline reflects Atomo’s strategy to develop innovative point-of-care rapid diagnostic tests addressing varied clinical conditions globally.

Portfolio expansion decisions prioritize commercial viability, clinical need, regulatory clarity, and market opportunity. Leveraging existing manufacturing, quality systems, and distribution channels across multiple products will enhance efficiency and profitability. This diversified strategy reduces reliance on any single product and offers long-term growth optionality.

Pascal OEM Business Drives Long-Term Supply Agreements and Revenue Diversification

Atomo’s OEM segment, supplying its Pascal diagnostic platform to manufacturers and partners, showed strong Q4 FY26 momentum with $670,000 in revenue. Growth was driven by increased orders for FebriDx and completion of orders for two new OEM customers, expected to lead to long-term supply agreements in Q1 FY27. This OEM business leverages Atomo’s technology and manufacturing to diversify revenue streams beyond branded products.

New OEM customers validate Atomo’s platform and manufacturing quality, providing stable, predictable revenue through long-term agreements. Expansion of the OEM customer base and rising orders from existing clients indicate broad commercial interest across markets. Combined with HIV self-testing and pipeline product growth, the OEM business supports a balanced and resilient revenue foundation.