PolyNovo’s wound platform gains momentum before key US filing

Commercial growth advances despite lower statutory profit

PolyNovo Limited (ASX:PNV) has entered FY27 with its commercial engine running faster, but the bottom line remains more complicated. Total revenue reached A$149.984 million in FY26, up 16.1%, while commercial product sales rose 16.7% to A$138.440 million. Operating cash flow was the standout financial measure, increasing to A$23.109 million from A$3.148 million.

The statutory result was less flattering: net profit after tax fell 44.5% to A$7.341 million. That comparison is distorted by a A$5.695 million tax benefit recorded in FY25, while FY26 included a A$4.717 million write-off after a fire damaged equipment and construction work at PolyNovo’s R&D Innovation Centre. EBITDA, an unaudited non-IFRS measure, still increased 8.1% to A$12.060 million.

U.S. burn submission moves towards year-end filing

The most consequential FY27 milestone is regulatory rather than accounting. PolyNovo says its U.S. pivotal randomised controlled trial’s Clinical Study Report has been finalised using 12-month follow-up data, supporting the company’s plan to submit a full Premarket Approval application for NovoSorb BTM in full-thickness burns before the end of calendar 2026. The submission is expected to incorporate 18-month follow-up data, but FDA approval remains a future regulatory decision.

The company’s U.S. commercial sales rose 15.6% in Australian-dollar terms to A$102.1 million, or 21.1% on a constant-currency basis. PolyNovo said a PMA could allow active marketing for full-thickness burns, support surgeon and hospital education, and open additional reimbursement opportunities. Those are potential benefits of approval, not outcomes secured by the planned filing.

MTX and outpatient care broaden the product runway

NovoSorb MTX is providing an early proof point for the company’s effort to move beyond its traditional burns base. Commercial MTX sales increased 92.7% on a constant-currency basis to A$12.2 million, compared with A$6.7 million in FY25. PolyNovo describes MTX as complementary to BTM, with applications across chronic, trauma and surgical wounds.

In the United States, the company is assembling a dedicated team around the outpatient market and plans to launch NovoSorb SynPath in FY27. SynPath already has an HCPCS code, while PolyNovo says recent outpatient rules provide a clinical and reimbursement pathway for Medicare and federal accounts. The report also flags uncertainty around further reimbursement changes and private-payer coverage, making execution in this market as important as the product launch itself.

Manufacturing capacity and leadership reset

PolyNovo completed construction of an expanded Port Melbourne manufacturing facility during FY26, subject to regulatory approval, quality and safety assessments. The company ended the year with A$35.424 million in cash and A$3.632 million in borrowings, while capital expenditure reached A$13.797 million, largely reflecting investment in the manufacturing footprint.

The year also brought a new leadership structure, including CEO Bruce Peatey, Chief Scientific Officer Marthe D’Ombrain and General Counsel and Company Secretary Amy Demediuk, alongside board appointments. From FY27, PolyNovo intends to introduce a formal long-term incentive plan after operating FY26 without a broad-based executive LTI framework. The shift is designed to strengthen the connection between executive rewards, sustained performance and shareholder value, but it also gives investors a new framework against which to judge delivery.