Anteris Technologies (AVR) investor relations material

Executive summary

• Q3 net sales rose 21% YoY to $519K; operating loss widened to $29.8M as clinical enrollment and manufacturing scale-up increased spending.

• January equity raises generated ~$320M gross proceeds; cash, cash equivalents and restricted cash totaled $236.3M at September 30, with at least 12 months of operating cash coverage under the current plan.

• PARADIGM enrollment advanced across active sites in the U.S., Canada, Denmark, the Netherlands and France; Germany and Australia expansion approvals followed quarter-end.

• Northcross facility occupancy began September 1, adding capacity for DurAVR THVs and ComASUR delivery systems ahead of potential commercialization.

• PARADIGM is designed to enroll ~1,000 patients and assess non-inferiority against approved THVs on a one-year composite endpoint.

Financial highlights

• Q3 net loss was $26.8M vs. $22.2M YoY; 9M net loss was $78.5M vs. $65.2M, with 9M operating loss of $84.8M vs. $64.9M.

• Q3 net sales were $519K vs. $429K; 9M sales were $2.0M vs. $1.6M, reflecting increased tissue product sales to 4C.

• Q3 R&D expense rose 27% YoY to $21.3M; 9M R&D rose 25% to $62.2M. SG&A increased 55% to $8.9M in Q3 and 47% to $24.2M in 9M.

• Q3 net operating cash outflows were $22.9M, primarily for clinical, regulatory and manufacturing requirements; 9M operating cash use was $72.4M vs. $59.3M.

• Other non-operating income was $2.6M in Q3 and $6.7M in 9M, driven by investment income on higher cash balances and CMS PARADIGM Trial reimbursements.

Outlook and guidance

• Substantial losses are expected to continue; significant revenue is not expected until regulatory approval and commercial sales commence.

• Under the current operating plan, cash and cash equivalents are expected to meet operating requirements for at least 12 months from September 30, 2026.

• Future capital needs depend on PARADIGM scope, results and timing, FDA PMA costs and timing, and the cost of building marketing, sales and distribution capabilities.

• Northcross capacity expansion is intended to support scaling DurAVR THV and ComASUR production in preparation for commercialization.