8-K: Anteris Technologies Reports Full Year 2024 Financial Results and Provides Corporate Update, Including Successful IPO and Pivotal Trial Preparations

Anteris Technologies reports its full year 2024 financial results, highlighting a successful IPO, progress on the DurAVR THV Pivotal Trial, and a strong cash position.

Summary

• Anteris Technologies Global Corp. reported its financial results for the year ended December 31, 2024.
• The company achieved a successful U.S. IPO, raising $88.8 million before costs and commissions.
• Preparations are underway to initiate the DurAVR Transcatheter Heart Valves (THV) randomized global pivotal study, with an Investigational Device Exemption (IDE) request planned for submission to the FDA in the first quarter of 2025.
• The company performed the first two cases of the DurAVR THVs European Early Feasibility Study (EU-EFS) in Denmark in January 2025.
• Design optimization of the balloon-expandable ComASUR delivery system was finalized, and manufacturing scale-up is underway to support the planned Pivotal Trial.
• The company concluded 2024 with a strong cash position of $70.5 million.
• Net sales for 2024 were $2.7 million, related to sales of tissue product.
• The net loss after income tax for 2024 was $76.0 million, driven by operating expenses related to research and development and increased selling, general, and administrative expenses.
• In December 2024, Anteris completed its US IPO, offering 14,800,000 shares of common stock at $6.00 per share, raising $79.6 million after costs and commissions.

Sentiment

Score: 6

Explanation: The sentiment is moderately positive due to the successful IPO and progress on the DurAVR THV Pivotal Trial, but tempered by the significant net loss and the auditor's concerns about the company's ability to continue as a going concern.

Positives

• Successful U.S. IPO, raising $88.8 million before costs and commissions.
• Strong cash position of $70.5 million at the end of 2024.
• Advancement of the DurAVR THV Pivotal Trial preparations, with IDE submission planned for Q1 2025.
• Positive patient data supporting IDE submission for DurAVR THV with 86 cases treated to date.
• Successful completion of the first two cases of the DurAVR THVs European Early Feasibility Study (EU-EFS) in January 2025.
• Finalized design optimization of the balloon-expandable ComASUR delivery system.
• Increased awareness of the DurAVR THV system in the global medical community through presentations at key congresses.
• Net tangible asset backing per share increased from $1.04 to $1.74 year over year.

Negatives

• Net loss after income tax for 2024 was $76.0 million.
• Revenues decreased slightly from $2.735 million to $2.703 million, a 1% decrease.
• The Independent Auditors opinion includes an Emphasis of Matter that the Company has suffered losses from operations that raise substantial doubt about its ability to continue as a going concern.

Risks

• The company's ability to obtain FDA approval to commence the Pivotal Trial for the DurAVR THV system is subject to regulatory review and may not be granted.
• The Pivotal Trial is expected to include up to 80 sites across the U.S. and other key markets with an estimated 1,000 to 1,200 patients having severe, calcific aortic stenosis, and subject to customary study exclusions.
• The company's future financial performance is dependent on the successful commercialization of the DurAVR THV system.
• The company faces competition from existing and emerging therapies for aortic stenosis.
• The company's forward-looking statements are subject to risks, uncertainties, and assumptions, including those described under Risk Factors in Anteris registration statement filed on December 10, 2024 with the SEC and ASX.

Future Outlook

The company plans to submit an IDE application to the FDA in the first quarter of 2025 to commence a Pivotal Trial for the DurAVR THV system.

Management Comments

• This has been a transformational year for Anteris as we made advancements across all aspects of our business, which positions us well to commence the Pivotal Trial of our DurAVR THV system in 2025, said Wayne Paterson, Vice Chairman and Chief Executive Officer of Anteris.

Industry Context

Anteris is operating in the structural heart market, specifically targeting aortic stenosis with its DurAVR THV system, competing with established players like Edwards Life Sciences (SAPIEN series) and Medtronic (Evolut series). The company aims to differentiate itself with its biomimetic valve design and ADAPT tissue technology.

Comparison to Industry Standards

• The Pivotal Trial is designed as a head-to-head comparison against the SAPIEN series (Edwards Life Sciences) and the Evolut series (Medtronic), which are established TAVR systems.
• The company's DurAVR THV aims to replicate normal aortic blood flow, potentially offering improved hemodynamic performance compared to existing TAVR devices.
• The use of ADAPT tissue, which has been clinically used for over 10 years in over 55,000 patients, provides a foundation of safety and efficacy for the DurAVR THV.

Related Party Transactions

• During the fourth quarter of 2024, the aggregate amount of payments for director fees, ATL Company secretarial fees and Chief Executive Officer remuneration was $374 thousand.

Stakeholder Impact

• Shareholders: The successful IPO provides capital for the company's operations and development programs.
• Patients: The DurAVR THV system has the potential to provide a new treatment option for aortic stenosis.
• Employees: The company's growth and development programs create opportunities for employees.
• Customers: The company's tissue product continues to generate revenue.

Next Steps

• Submission of an IDE application to the FDA in the first quarter of 2025 to commence the Pivotal Trial for the DurAVR THV system.
• Continuation of the DurAVR THVs European Early Feasibility Study (EU-EFS).
• Manufacturing scale-up to support the planned Pivotal Trial.

Key Dates

Keywords

DurAVR THV, aortic stenosis, transcatheter heart valve, TAVR, IPO, clinical trial, FDA, financial results, Anteris Technologies