AFT Pharmaceuticals Eyes $300M Revenue as FDA Clears Injectable Iron Phase III Trial
AFT Pharmaceuticals surged 22% to NZ$254.7 million revenue in FY26, surpassing profit guidance and securing FDA approval to advance a pivotal injectable iron Phase III trial targeting a $7.4 billion market. The company is poised for further global expansion and product launches in FY27.
- FY26 revenue up 22% to NZ$254.7 million
- Operating profit hits NZ$24.4 million, exceeding guidance
- FDA approves Phase III trial for injectable iron project
- Global sales reach 87 countries with strong international growth
- FY27 revenue target exceeds NZ$300 million with expanded R&D pipeline
Robust FY26 Performance Sets Stage for Ambitious Growth
AFT Pharmaceuticals (ASX:AFP; NZX:AFT) closed FY26 with a 22% jump in operating revenue to NZ$254.7 million, powered by double-digit sales growth across Australia, Asia, and international markets. Operating profit of NZ$24.4 million not only beat guidance but marked a 39% increase on the prior year, underpinning the company’s strategy of disciplined global expansion and R&D investment.
Sales growth was particularly strong internationally, surging 66% and broadening the company’s footprint to 87 countries, including new markets such as Taiwan and Egypt. The Australasian business remained solid with 19% growth, while Asia climbed 41%, reflecting AFT’s success in scaling its distribution partnerships and product launches worldwide.
FDA Clearance Accelerates Injectable Iron Clinical Program
A key highlight for AFT was the US Food and Drug Administration’s approval of its Investigational New Drug (IND) application, greenlighting a large-scale Phase III clinical trial for its injectable iron therapy. This pivotal study will enrol 1,366 patients across multiple regions including the US, China, India, Japan, Europe, and New Zealand, aiming to confirm the therapy’s safety and efficacy.
The injectable iron project targets a global market forecast to reach US$7.4 billion by 2033. Early Phase III data have been positive, showing negligible free iron release, the ability to administer large single doses, and a low incidence of adverse events, including no plasma phosphate decreases. The trial’s global regulatory plan also includes jurisdictions such as Armenia and the Eurasian Economic Union, positioning AFT for broad market access.
Diverse Pipeline and Licensing Deals Fuel Future Revenue
AFT’s R&D pipeline remains a core growth driver, with eight patented products and over two dozen off-patent injectables progressing towards commercialisation. The company has secured nine licensing agreements in FY26 alone, including partnerships for hospital injectables and novel formulations.
Notable projects include multiple Maxigesic formulations, an antibacterial cream (Crystaderm), and treatments for conditions ranging from bowel obstruction to neuropathic pain. The company is also advancing orphan drug candidates like Pascomer for facial angiofibromas and preparing dossier filings for Australian OTC projects with markets exceeding A$50 million.
FY27 Outlook Targets $300M+ Revenue with Continued Investment
Looking ahead, AFT is targeting over NZ$300 million in revenue for FY27, supported by ongoing international expansion, new product launches, and scaling contributions from emerging hubs in the UK and South Africa. Operating profit guidance sits between NZ$28 million and NZ$32 million, reflecting significant investment in R&D and regulatory milestones.
The company’s strategy includes active in-licensing and out-licensing programs to accelerate commercial traction and diversify revenue streams. This balanced approach aims to extend AFT’s two-decade record of uninterrupted growth by addressing unmet clinical needs with innovative therapies across multiple markets.
Bottom Line?
AFT Pharmaceuticals is leveraging strong FY26 momentum and FDA clearance to accelerate global growth, but execution of its ambitious clinical and commercial plans will be critical to reaching its $300 million revenue target.
Questions in the middle?
- How will AFT manage regulatory and operational risks across its expansive Phase III injectable iron trial?
- Can emerging international hubs like the UK and South Africa deliver meaningful earnings contributions in FY27?
- What impact will licensing deals and new product launches have on AFT’s margin profile amid rising R&D investment?
