Acrux Limited has reported a 109% increase in revenue and a return to profitability for the half-year ended 31 December 2025, driven by full commercialisation of four topical generic products and strategic portfolio adjustments.
- Revenue surges 109% to $3.573 million
- Net profit of $165,000 after prior period loss
- Divestment of underperforming Prilocaine/Lidocaine cream
- Expansion of licensing agreements, including Saudi Arabia
- Focus shifts to innovative transdermal delivery systems
Strong Revenue Growth from Commercialised Products
Acrux Limited, an Australian specialist in transdermal drug delivery, has posted a significant turnaround in its financial performance for the half-year ended 31 December 2025. Revenues more than doubled to $3.573 million, up 109% from the previous corresponding period. This growth was largely driven by the first full reporting period of sales from four FDA-approved topical generic pharmaceutical products marketed in the United States: Evamist® (an estradiol spray for hormone replacement therapy), Dapsone 5% and 7.5% gels for acne, and Nitroglycerin 0.4% ointment for chronic anal fissure pain.
Return to Profitability and Cost Discipline
After reporting a loss of $3.425 million in the prior period, Acrux recorded a net profit after tax of $165,000 for H1 FY26. This improvement reflects not only increased product licensing income but also a substantial reduction in operating expenses, which fell by over $2 million. Cost savings were achieved through a combination of headcount reductions, lower research and development expenditure following a strategic refocus, and the divestment of the non-performing Prilocaine 2.5% and Lidocaine 2.5% cream product.
Strategic Portfolio Realignment and Geographic Expansion
The divestment of the Prilocaine/Lidocaine cream in December 2025 for $0.829 million cash plus forgiveness of negative profit shares marks a clear shift in Acrux’s portfolio strategy. The company is moving away from generic products with diminishing returns due to increased market competition and price discounting. Instead, Acrux is focusing on leveraging its nearly 30 years of expertise in topical delivery and device innovation to develop next-generation transdermal drug delivery systems, particularly in the female hormone replacement therapy category.
Geographic expansion is also underway, with a new licensing agreement signed in July 2025 with Servacure Trading W.L.L. to distribute Dapsone 5% gel in Saudi Arabia, targeting a launch by the end of FY27. This deal exemplifies Acrux’s strategy to broaden the reach of its existing commercialised products beyond the US market.
New Revenue Streams from Laboratory and Development Services
In addition to product licensing, Acrux has begun offering specialised laboratory and product development services to external clients, including pharmaceutical, over-the-counter, veterinary, and cosmetic sectors. These fee-for-service activities generated $317,000 in revenue during the half-year and are expected to grow as the company secures new projects, such as ongoing work with Padagis and upcoming collaborations with Proteios Pty Ltd, a University of Sydney spinout.
Going Concern and Future Outlook
Despite the positive turnaround, Acrux’s directors caution that the company’s continued viability depends on sustaining revenue growth from existing products and successfully launching new ones in additional markets. The financial report highlights a material uncertainty regarding going concern, contingent on meeting revenue projections, securing R&D tax incentives, and accessing further funding if necessary. The company’s cash position remains modest at $946,000 as of 31 December 2025, underscoring the importance of executing its strategic plans effectively.
Bottom Line?
Acrux’s return to profit and strategic refocus set the stage for growth, but future success hinges on expanding markets and innovation execution.
Questions in the middle?
- How will Acrux navigate increasing competition and pricing pressures in the topical generics market?
- What is the timeline and commercial potential for the next-generation transdermal delivery products?
- Can Acrux secure additional funding or partnerships to support its growth ambitions beyond current cash reserves?