Orthocell Ltd (ASX:OCC, OTC:ORHHF) CEO and managing director Paul Anderson has presented to shareholders at the company’s AGM, pointing to consistent financial growth, some impressive milestones and plans for global expansion, including the launch of flagship product, Remplir™, into the highly lucrative US nerve repair market.
“There are not many opportunities to enter the Biotech sector in Australia with a company that has a strong balance sheet, no debt, growing revenues, unique patents, no ongoing cash diluting royalties and strong corporate governance,” chair John Van Der Wielen told shareholders in his introductory remarks.
“Strong corporate governance of companies is critical to sustainable success, and we are regularly reminded of this by both good and bad examples in corporate markets.”
Record revenue recorded
The regenerative medicine company achieved annual revenue of A$6.76 million for the 2024 financial year, which amounted to a 30.8% increase on the previous year.
Product sales revenue grew by 55.3% to A$3.01 million, driven by the clinical success of Remplir, along with Striate+™, a dental bone regeneration membrane.
Remplir continues to demonstrate superior clinical outcomes, achieving functional recovery in 85% of nerve repairs.
The product’s design reduces sutures, creates an optimal healing environment and improves surgical efficiency, making it a compelling alternative to existing solutions.
Consistent growth; strong cash reserves
Quarterly revenue has been growing consistently over the past two years, with the September quarter delivering a record A$2.03 million, supported by growing surgeon adoption and distributor performance.
The company’s financial position has been significantly strengthened by a successful A$17 million share placement, which was heavily oversubscribed.
As of October 31, 2024, Orthocell holds A$32.8 million in cash reserves and carries no debt, ensuring it is well-funded for its planned global expansion.
This capital will be used to support the launch of Remplir in the US, along with further regulatory and market development initiatives.
Remplir poised for US market entry
The upcoming launch of Remplir in the US represents a pivotal moment for Orthocell.
The company is on track to submit its 510(k) application to the US Food and Drug Administration (FDA) in the fourth quarter of this calendar year, with approval anticipated early in 2025.
The US nerve repair market, valued at US$1.6 billion annually, offers transformative potential for Orthocell’s revenue growth.
Orthocell is primed for the US market with a strong team of experienced executives to lead sales and medical affairs.
“The board’s approach is to govern Orthocell at the appropriate level for its size and to ensure our governance standards reflect our intention, which is to be a much larger and expansive company over the next few years,” said Van Der Wielen.
“In the last 12 months we have completed a full board renewal and attracted world-class directors; implemented appropriate governance policies; and carried out a detailed independent remuneration review of the executive team and key management personnel.”
Key global markets covered
The company continues to advance its global footprint elsewhere, with regulatory approvals for Remplir secured in Australia, New Zealand and Singapore.
Further applications are planned for Canada, Thailand, Europe and the UK in 2025.
The company’s own manufacturing facility in WA allows it to maintain high-quality production while capturing full profit margins, ensuring cost-effective scalability as it enters these new markets.
Striate+ is also seeing strong adoption in the US, Europe and Australia, with revenue from the product growing 14% year-on-year to A$3.41 million.
Orthocell’s partnership with BioHorizons, a subsidiary of Henry Schein (NASDAQ:HSIC), has accelerated market access and provided a platform for further international expansion.