AVR

Business Context and Reporting Period

Company: Anteris Technologies Global Corp. (AVR)
Reporting Period: Fiscal Year Ended December 31, 2025
Business Overview: Anteris is a clinical-stage structural heart company developing the DurAVR® THV System, a biomimetic transcatheter heart valve designed to treat aortic stenosis. The company utilizes proprietary ADAPT® anti-calcification tissue technology. As of December 2025, over 130 patients have been implanted with the DurAVR® THV. The company is currently conducting the PARADIGM Trial, a global pivotal study, having received FDA Investigational Device Exemption (IDE) approval in November 2025 for the first 200 patients.

Key Financial Metrics

Note: The filing does not provide specific gross margin percentages, but Cost of Products Sold was $569,000 in 2025 versus $1,437,000 in 2024.

Material Changes vs. Prior Period

• Revenue Decline: Net sales decreased 29% to $1.9 million, primarily due to the expiration of the LeMaitre Transition Services Agreement in January 2025, which ended sales of CardioCel® and VascuCel® products.
• Increased R&D Spend: Research and development expenses increased 34% to $69.1 million. This was driven by upscaling manufacturing and quality capabilities ($19.8 million increase) and preparatory activities for the PARADIGM Trial ($5.5 million increase).
• Cash Position: Cash and cash equivalents decreased significantly from $70.5 million to $12.6 million due to high operating burn and reduced financing inflows compared to the IPO year of 2024.
• Foreign Exchange: The company recorded a net foreign exchange loss of $0.7 million in 2025, compared to a gain of $1.4 million in 2024, due to the depreciation of the U.S. dollar against the Australian dollar.

Guidance, Outlook, and Risks

Outlook and Capitalization: Anteris expects to continue incurring substantial losses until commercialization. Subsequent to the reporting period (January 2026), the company completed a public offering and a private placement with Medtronic plc, generating approximately $320 million in gross proceeds. Management believes this liquidity is sufficient to fund operations for at least 12 months following December 31, 2025.

Key Risks and Contingencies:

• Internal Controls: The company identified material weaknesses in internal control over financial reporting (ICFR) related to a lack of documented procedures and deficiencies in segregation of duties. Remediation is ongoing but not yet fully validated.
• Regulatory Approval: Commercialization depends on successful completion of the PARADIGM Trial and subsequent FDA Premarket Approval (PMA) and CE Mark approval. There is no assurance these will be obtained.
• Profitability: The company has a history of operating losses and may not achieve profitability in the future. It requires substantial additional financing.
• Medtronic Relationship: Medtronic beneficially owns approximately 16.1% of the company following the January 2026 private placement. Conflicts of interest may arise as Medtronic is a direct competitor.

Investor Verification Checklist

• Internal Control Remediation: Verify the progress and timeline for remediation of the identified material weaknesses in ICFR.
• Cash Runway: Confirm the net proceeds from the January 2026 financings and the updated cash runway beyond the 12-month projection.
• PARADIGM Trial Status: Monitor enrollment rates and interim data from the PARADIGM Trial, which is critical for FDA PMA approval.
• Medtronic Agreements: Review the terms of the Investor Rights and Registration Rights Agreements with Medtronic, specifically regarding standstill provisions and board observer rights.
• Revenue Transition: Assess the timeline for transitioning from legacy tissue product sales (4C Medical Technologies agreement expiring June 2026) to commercial DurAVR® THV sales.