PolyNovo Limited reported a robust 28.9% increase in group sales to A$118.6 million for FY25, alongside a 151% surge in net profit after tax to A$13.2 million, driven by strong U.S. growth and key regulatory approvals.
- Group sales up 28.9% to A$118.6 million
- Net profit after tax rises 151.2% to A$13.2 million
- Strong U.S. sales growth of 28.7% to A$88.4 million
- FDA clearances expanded for NovoSorb BTM and MTX products
- New manufacturing facility on track for completion by December 2025
Strong Financial Performance
PolyNovo Limited has delivered a standout financial year for FY25, reporting group sales of A$118.6 million, a 28.9% increase over the previous year’s A$92.0 million. This growth was underpinned by a particularly strong performance in the United States, where sales rose 28.7% to A$88.4 million. The company’s net profit after tax more than doubled, surging 151.2% to A$13.2 million, reflecting improved operational efficiencies and expanding market penetration.
These results mark a significant milestone for PolyNovo, which continues to leverage its proprietary NovoSorb technology in the medical device sector, particularly in wound management and surgical applications.
Regulatory and Product Advances
FY25 saw important regulatory achievements, including expanded FDA clearances for both NovoSorb BTM and MTX products. NovoSorb BTM received 510(k) clearance for up to 6 mm thickness in the U.S., while NovoSorb MTX also gained clearance for models up to 6 mm thick with additional indications for complex wound types. These approvals broaden the clinical applications and commercial potential of PolyNovo’s product portfolio.
The company also successfully launched NovoSorb MTX in the U.S. market in late FY24, with sales reaching A$6.7 million in FY25. Internationally, PolyNovo expanded its footprint to 46 countries, including first-time sales in markets such as Macau, Malta, Malaysia, Portugal, and Peru, supported by new distributor partnerships and recurring orders.
Operational Expansion and Innovation
PolyNovo invested heavily in its infrastructure during FY25, opening a new R&D Innovation Centre in Port Melbourne and progressing construction of a third manufacturing facility, also in Port Melbourne, which remains on budget and is expected to be practically complete by December 2025. These facilities are critical to supporting the company’s growth trajectory and product development pipeline.
Research and development efforts continue to advance, with preclinical prototypes for hernia repair and plastic and reconstructive mesh products progressing, alongside ongoing clinical trials such as the BARDA pivotal trial for full thickness burns. The company is also exploring novel applications of its technology in cell therapy delivery through collaboration with Beta Cell Technologies.
Leadership and Financial Position
Leadership changes included the appointment of Dr Robyn Elliott as Acting CEO in March 2025, bringing extensive experience in strategic portfolio management and operational scaling. The company ended FY25 with a strong cash position of A$33.5 million after capital expenditures and debt repayments, positioning it well for continued investment in growth initiatives.
Chairman David Williams highlighted the nearing completion of major capital expenditure projects and anticipated improvements in cash flow from operations, signaling a focus on profitability and shareholder returns in FY26.
Bottom Line?
PolyNovo’s FY25 results set a strong foundation for regulatory milestones and commercial expansion, but investors will watch closely as the company navigates FDA PMA submissions and market adoption.
Questions in the middle?
- When will the FDA premarket approval (PMA) submission for NovoSorb BTM be finalized and approved?
- How will the new manufacturing facility impact production capacity and cost structure in FY26?
- What are the commercial prospects and timelines for the hernia repair and plastic reconstructive device products?