Artrya (AYA) Q2 2025 TU earnings summary

Executive summary

• Monthly cash burn reduced to AUD 1.2 million during the quarter, with a focus on maintaining momentum for FDA 510(k) application and future product submissions.

• 510(k) application with the FDA is progressing, with additional information requested and clearance for Salix Coronary Anatomy expected by end of March 2025.

• Successful AUD 5 million capital raise completed, with participation from a key U.S. partner and new institutional investors, strengthening the balance sheet.

• Integration with major U.S. health systems (Tanner, Northeast Georgia, Cone) nearly complete, positioning for rapid commercialization post-FDA clearance.

• Advanced negotiations with two of the top five Australian radiology providers, expected to close within weeks.

Financial highlights

• Quarterly revenue from Australian operations was approximately AUD 13,000–15,000 per site, with limited financial upside in the domestic market.

• Cash on hand at 31 December 2024 was AUD 7.6 million.

• Net cash inflow for the quarter was AUD 1.1 million, including AUD 4.7 million net from capital raising.

• Operating cash outflow for the quarter was AUD 3.6 million, reflecting ongoing clinical validation, regulatory work, and R&D.

• U.S. market opportunity is substantial, with individual health systems representing multi-million dollar annual revenue potential.

Outlook and guidance

• FDA clearance for the Salix Coronary Anatomy product expected by end of March 2025, with immediate U.S. commercial rollout upon approval.

• Submission for the Salix Coronary Plaque product targeted for late April, aiming for clearance by end of July/early August.

• SCF (blood flow) product development at 60%, targeting FDA submission and clearance by year-end.

• Ongoing negotiations with major radiology groups in Australia and further U.S. agreements expected in CY25.

• Focused on U.S. market expansion, with ongoing relationship-building with large health systems and strategic partners.