Anteris Technologies (AVR) Q2 2025 TU earnings summary

Executive summary

• 130 patients implanted with DurAVR® THV since clinical development began, including 49 treated year-to-date and 21 in Q2 2025, with a world-first double DurAVR® implant in both mitral and aortic valve positions.

• IPO completed in December 2024, raising $80.0 million net proceeds; additional shares issued in January 2025.

• Submitted IDE for the PARADIGM Trial to the FDA, with enrollment expected to begin in Q3 2025; 79 clinical trial sites qualified across the U.S., Europe, and Canada.

• Hosted global investigator meetings and confirmed experienced co-chairs for the PARADIGM Trial.

• Appointed two new Non-Executive Directors to strengthen the Board.

Financial highlights

• Net sales for Q2 2025 were $0.6 million, down 2% year-over-year; six-month sales were $1.2 million, down 16%.

• Operating loss for Q2 2025 was $20.9 million, up 13% year-over-year; six-month operating loss was $42.7 million, up 18%.

• R&D expenses for Q2 2025 totaled $16.3 million, primarily for PARADIGM Trial preparations and clinical costs; six-month R&D expenses were $32.8 million, up 36%.

• Cash, cash equivalents, and restricted cash were $28.4 million as of June 30, 2025, down from $70.5 million at year-end 2024.

• Net operating cash outflows for the six months ended June 30, 2025 were $41.0 million, reflecting increased clinical, regulatory, and manufacturing activities.

Outlook and guidance

• Anticipates continued losses and negative cash flow until regulatory approvals and commercialization of DurAVR® THV.

• Additional capital will be required to fund operations and complete clinical trials.

• Expects to begin PARADIGM Trial enrollment in Q3 2025, with FDA and CE Mark approval processes running in parallel.

• Ongoing engagement with the FDA to progress the IDE for the PARADIGM Trial.

• Preparatory activities and manufacturing scale-up continue in anticipation of regulatory clearance and trial launch.