Anteris Technologies Global Corp(AVR) - 2025 Q1 - Quarterly Results

Anteris First Quarter 2025 Results Q1 2025 Highlights Anteris reported significant progress in its clinical and operational programs, highlighted by the submission of its IDE application, treating over 100 patients with DurAVR®, positive one-year clinical data, and a strong cash position - Submitted the Investigational Device Exemption (IDE) for the DurAVR® THV's global pivotal clinical trial (PARADIGM Trial) to the FDA[6] - Achieved a clinical milestone of over 100 patients successfully treated with the DurAVR® THV[6] - Reported positive one-year clinical data for DurAVR® THV, showing sustained favorable hemodynamic outcomes and a strong safety profile[6] - Ended the first quarter with a cash position of $49.0 million (A$78.0 million)[6] Business & Operations Update The company focused on advancing DurAVR® THV towards commercialization through PARADIGM pivotal trial preparations, including IDE submission, team scaling, manufacturing expansion, and significant clinical progress Preparations for the PARADIGM Trial Anteris submitted an IDE application for the PARADIGM Trial to the FDA, designing it as a head-to-head comparison against commercial TAVR devices, while expanding clinical teams and engaging trial centers for a Q3 2025 start - An IDE application for the PARADIGM Trial was submitted to the U.S. FDA, with trial commencement anticipated in Q3 2025, pending approval[7] - The PARADIGM Trial will be a randomized 1:1 study comparing the DurAVR® THV against commercially available devices like the SAPIEN or Evolut series THV[8] - A separate parallel registry is planned for valve-in-valve (ViV) TAVR patients to support market opportunity in this segment[9] - The company is expanding its global Clinical Specialist Team and working with its Contract Research Organisation to engage with planned trial centers in the U.S., Canada, and Europe[10] Clinical Milestones and Data Anteris achieved a major milestone by successfully treating over 100 patients with the DurAVR® THV system, with one-year clinical data demonstrating sustained favorable hemodynamics and a strong safety profile - The 100th patient was successfully treated with the DurAVR® THV System during the first quarter[11] - One-year data showed sustained favorable hemodynamics with an Effective Orifice Area (EOA) of 2.1 cm², Mean Pressure Gradient (MPG) of 8.6 mmHg, and Doppler Velocity Index (DVI) of 0.58[20] - The safety profile at one year was strong, with no valve or cardiovascular-related mortality and no reported prosthesis-patient mismatch (PPM) in small annuli patients[20] Manufacturing Capacity Expansion Anteris is significantly expanding its global manufacturing capacity to support the PARADIGM Trial and commercial demand, including scaling production into new facilities and diversifying ADAPT® tissue sourcing - Manufacturing capacity is being scaled to at least three times the 2024 levels to support the PARADIGM Trial and anticipated commercial demand[16] - To mitigate supply chain risks, the ADAPT® tissue for the DurAVR® THV will be sourced from both the U.S. and Australia[16] Q1 2025 Financial Results Anteris reported a 27% decrease in net sales to $0.6 million and a 36% increase in loss after income tax to $21.9 million, driven by higher R&D expenses, while SG&A expenses decreased Q1 2025 Financial Summary | Financial Metric | Q1 2025 ($ millions) | Q1 2024 ($ millions) | Change ($ millions) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Net Sales | 0.6 | 0.8 | -0.2 | -27% | | Loss after Income Tax | 21.9 | 16.2 | +5.8 | +36% | | R&D Expenses | 16.5 | 11.6 | +4.9 | +42% | | SG&A Expenses | 5.7 | 6.5 | -0.8 | -13% | - The increase in R&D expenses was primarily due to $3.5 million for upscaling manufacturing capabilities and $1.5 million for PARADIGM Trial preparatory activities[21] - The decrease in SG&A expenses was mainly due to a $1.2 million reduction in costs associated with the 2024 re-domicile and Nasdaq listing, partially offset by higher compliance costs[21] Corporate and Financing Activities Anteris raised an additional $0.47 million through a green shoe option exercise and gained increased visibility in the US equity market by being added to the FTSE Russell 2000® Index - In January 2025, underwriters partially exercised the green shoe option from the December 2024 IPO, raising an additional $0.47 million from the sale of 78,481 shares at $6.00 per share[22] - Anteris was added to the FTSE Russell 2000® Index, which measures the performance of the small-cap segment of the US equity market, effective March 24, 2025[23] About Anteris Anteris Technologies is a global structural heart company developing medical devices like the DurAVR® THV, a biomimetic valve made with patented ADAPT® tissue, to treat conditions such as aortic stenosis - Anteris is a global structural heart company focused on designing, developing, and commercializing medical devices to restore healthy heart function[26] - The lead product, DurAVR® THV, is the first biomimetic valve, shaped to mimic the performance of a healthy human aortic valve and is designed to treat aortic stenosis[27] - DurAVR® THV is made using ADAPT® tissue, a patented anti-calcification technology that is FDA-cleared and has been used in over 55,000 patients[27]