ARX’s Myriad product family led the company to strong growth in H1 FY24. Pic: Getty Images
Health & Biotech
Special Report: Aroa Biosurgery released strong H1 FY24 results with top-line growth led by sales of its Myriad product family which grew by 80% on H1 FY23 to NZ$10.2 million.
Soft tissue regeneration company Aroa Biosurgery (ASX:ARX) says Myriad accounted for 33% of H1 FY24 total product sales, up from 19% in H1 FY23 and 67% of its direct sales mix in Q2 FY24.
The Myriad family of products supports soft tissue reconstruction in a wide range of surgical specialties and procedures, including for complex wounds such as trauma.
ARX says continued growth reflects its targeted investment into its US commercial operations, including building momentum of its direct field sales team which continues to deliver results.
ARX ended the half year with 187 Myriad active accounts, up from 166 at the end of FY23 and key wins with the prestigious Cleveland Clinic, Case Western and Ohio State University.
“We are pleased to report that the team’s focused efforts also delivered deeper penetration within existing accounts,” ARX says.
Further financial highlights of H1 FY24 include:
ARX say the H1 FY24 results also reflect the field sales team’s accelerating productivity, with 10 field sales representatives at an average run rate of at least US$750k per annum and more than half (23) at an average run rate of at least US$250k.
ARX says full-year FY24 guidance has been updated to NZ$73-76 million total revenue with NZ$72-75 million product revenue, representing a 19-24% increase on FY23.
The company anticipates an 85% product gross margin and normalised EBITDA profit of NZ$1-2 million for FY24.
ARX forecasts H2 FY24 product revenue of ~NZ$41-$44 million, representing a ~30-40% increase on H1 FY24. H2 FY24 normalised EBITDA profit is expected to be ~NZ$4-5 million.
ARX reported several operational highlights for H1 FY24.
In August, ARX submitted a US FDA 510(k) application for Myriad Flow, a new Myriad product that could be commercialised in combination with the previously US FDA-cleared components of its Enivo™ system.
The company says five participants in its Enivo pilot clinical study have completed treatment and follow-up care, with no clinically relevant seroma reported. Seromas, an accumulation of clear fluid under the skin, are a common post-surgical complication which can disrupt healing, increase pain, oedema (swelling) and result in poor cosmetic outcomes. They can also lead to more severe complications.
ARX says seven peer-reviewed clinical studies were published in H1 FY24, including a retrospective case series published in leading plastic surgery journal, ePlasty. The case series indicated that complex traumatic wounds may heal faster, with less complications and require fewer applications, when treated with Myriad than current standard of care.
An article by interprofessional working group convened by ARX on surgical reconstruction of stage three and four pressure injuries was selected as a finalist for ‘Best Advance in Original Research’ at the 2023 Advances in Skin Wound Care awards. The awards are jointly sponsored by the American Professional Wound Care Association and highly regarded peer-reviewed Advances in Skin & Wound Care journal.
Enrolments into ARX’s Myriad Augmented Soft Tissue Regeneration Registry (MASTRR) saw 225 participants out of a target of 300 and nine out of 10 sites recruited in H1 FY24.
Furthermore, 42 participants out of a target of 120 were enrolled across eight study sites for ARX’s Symphony™ randomised clinical trial, which kicked off in June.
Symphony is a combination cellular and tissue product, combining multiple layers of AROA ECM™ with hyaluronic acid, which act synergistically to drive wound closure, particularly in patients whose healing is severely impaired or compromised due to disease.
During H1 FY24, experienced pharmaceutical executive Scott Sherriff started as Chief Operating Officer from July.
The company also continued investment into expanding its tissue manufacturing capacity, including taking delivery of an additional freeze dryer to at least double freeze-drying capacity.
Founder and CEO Brian Ward says he is pleased with the team’s efforts in what was expected to be a transitional year of relatively modest overall revenue growth.
“Myriad had to lead our growth and our people delivered,” Mr. Ward says.
He says the strong ARX performance validates the strategic importance of Myriad and building momentum of the company’s US commercial operations.
“We expect revenue to increase by ~30-40% in the second half, with continued strong Myriad performance bolstered by an anticipated re-alignment in demand from TELA Bio.
“That revenue uplift will significantly improve our bottom-line,” he says.
He says TELA Bio recently delivered its 11th consecutive quarter of at least 35% year-on-year growth, with their operations continuing to mature and a focus on lowering inventory levels and improving inventory management.
“These improvements will benefit AROA going forward by smoothing demand and bringing both parties’ sales into closer alignment,” he says.
“We are confident that AROA is well-placed to deliver compelling top-line growth and increasing profitability beyond FY24.
Mr. Ward says ARX has experienced robust portfolio growth, improved productivity, and a strong momentum in its US commercial operations.
“With an estimated H2 FY24 normalized EBITDA profit of around NZ$4-$5 million, net operations to approach breakeven in the second half and a healthy cash balance of NZ$34 million, we have the fundamentals for success in place,” he says.
This article was developed in collaboration with Aroa Biosurgery,a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
Health & Biotech
Health & Biotech
Health & Biotech
