Aroa Biosurgery Limited (ASX: ARX) is pleased to announce financial results for the September 2023 Quarter.
Highlights are listed below. To read the full announcement, click here.
• Strong cash receipts from customers for the quarter of NZ$14.8 million.
• In line with expectations, net cash outflows from operations reduced by NZ$1.6 million from the previous quarter to NZ$3.2 million. Net cash outflow from investing activities was NZ$1.2 million for the quarter, reflecting further investment into additional manufacturing plant & equipment capacity.
• Strong cash balance of NZ$34.0 million as at 30 September 2023, with net cash outflow from operations expected to move towards breakeven for the balance of FY24.
• FY24 product revenue guidance maintained at NZ$72-75 million (25-30% increase on FY23 on a constant currency basis), product gross margin guidance maintained at 85% and normalised EBITDA profit guidance maintained at NZ$1-2 million.
• H1 FY24 results to be released on 28th November 2023.
• AROA ended the quarter with ten field sales representatives at a current average run rate of at least US$750,000 per annum (up from eight and five respectively in the previous two quarters) and over half of the field sales team at an average run rate at least US$250,000 per annum.
• Myriad™ sales continued to grow, reflecting 67% of AROA’s direct sales mix in the quarter compared to 50% in Q2 FY23.
• In August, AROA submitted a US FDA 510(k) submission for Myriad Flow™, a new Myriad product that could be used in combination with AROA’s Enivo™ system.
• Peer-reviewed study published in industry leading journal during the quarter.
• 42 patients out of a target of 120 are now enrolled in the multi-center Symphony™ randomised control trial assessing the efficacy of Symphony in treating diabetic foot ulcers.
• Two additional participants were enrolled into the Enivo pilot clinical study taking the total treated to 3 of the planned 10 patients.
• Enrolments into MASTRR continue tracking well, with a total of 225 patients as at September 30, 2023 (increased by 41), with 9 study sites confirmed (increased by 5 sites).
• In September, following its annual audit by DEKRA, AROA was re-certified for compliance to ISO 13485 and for the Medical Device Single Audit Program.
• In July, CEO Brian Ward presented at the Macquarie Australia Conference. Brian Ward and James Agnew (CFO) also presented at the Wilsons Drug & Device Conference and the 2023 Morgans Conference, both in October.
• AROA was a finalist in the American Chamber of Commerce in New Zealand -DHL Express Success & Innovation Awards.
 Constant currency removes the impact of exchange rate movements. This approach is used to assess the AROA group’s (‘Group’) underlying comparative financial performance without any distortion from changes in foreign exchange rates, specifically the USD. The NZ$/US$ exchange rate of 0.65 has been used in the constant currency analysis. All references in this announcement to ‘constant currency’ or ‘CC’ are as set out in this footnote.
 Normalised EBITDA is non-conforming financial information, as defined by the NZ Financial Markets Authority, and has been provided to assist users of financial information to better understand and assess the Group’s comparative financial performance without any distortion from the one-off transactions. The impact of non-cash share-based payments expense and unrealised foreign currency gains or losses has also been removed from the Profit or Loss. This approach is used by Management and the Board to assess the Group’s comparative financial performance. All references to normalized EBITDA in this announcement are as set out in this footnote.
 This guidance is subject to there being no material decline in US medical procedure numbers or sustained disruption to AROA’s manufacturing or transportation activities and TELA Bio delivering on its CY23 revenue guidance of US$60-65 million. It also assumes an average NZ$/US$ exchange rate of 0.65 (compared to the average exchange rate of 0.62 in FY23).
 I.e. excluding sales to TELA Bio, Inc.