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Anteris Technologies Global Corp(AVR) - 2025 Q1 - Quarterly Results
2025-05-13 23:00
Exhibit 99.2 Anteris Announces Results for the First Quarter of 2025 MINNEAPOLIS, United States and BRISBANE, Australia 14 May 2025: Anteris Technologies Global Corp. (Anteris or the Company) (NASDAQ: AVR, ASX: AVR) a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function, today reported financial results for the quarter ended March 31, 2025, and provided a corporate update. First Quarter 2025 Highlights "Our foc ...
Anteris Technologies Global Corp(AVR) - 2025 Q1 - Quarterly Report
2025-05-13 21:22
Financial Performance - Net sales for the three months ended March 31, 2025, were $0.6 million, a decrease of $0.2 million (27%) compared to $0.8 million for the same period in the prior year, primarily due to lower demand for tissue products [106]. - Cost of products sold during the same period was $0.2 million, a decrease of $0.3 million (56%) compared to $0.5 million for the same period in the prior year, attributed to reduced net sales and changes in product mix [107]. - Loss before income taxes from continuing operations was $21.9 million for Q1 2025, an increase of $5.8 million (36%) compared to Q1 2024 [112]. - Net cash used in operating activities during Q1 2025 was $21.5 million, an increase of $6.0 million (38%) compared to $15.5 million in Q1 2024 [119]. - Cash and cash equivalents as of March 31, 2025, were $49.0 million, down from $70.5 million as of December 31, 2024 [115]. - The accumulated deficit as of March 31, 2025, was $298.3 million, up from $276.4 million as of December 31, 2024 [114]. Research and Development - R&D expenses increased to $16.5 million, an increase of $4.9 million (42%) compared to $11.6 million for the same period in the prior year, driven by upscaling manufacturing capabilities and preparatory activities for the Pivotal Trial [108]. - The company anticipates requiring substantial additional funds to achieve long-term goals and complete R&D of current products [116]. - The company expects to continue incurring substantial losses in the near future until regulatory approval is obtained for its products [116]. Operational Activities - The company has treated over 100 patients with the DurAVR® THV system across the United States, Canada, and Europe as of March 31, 2025 [85]. - The company is expanding global manufacturing capacity to support the PARADIGM Trial, aiming to increase capacity to at least three times the 2024 levels [96]. Capital and Financing - The initial public offering on December 12, 2024, raised net proceeds of $80.0 million after deducting underwriting discounts and expenses [86]. - Capital commitments relating to property leases were $1.3 million as of March 31, 2025 [115]. - The company had commitments to purchase $0.2 million of plant and equipment as of March 31, 2025 [124]. Other Income and Expenses - Selling, general and administrative expenses decreased to $5.7 million, a reduction of $0.8 million (13%) compared to $6.5 million for the same period in the prior year, mainly due to lower costs associated with the initial public offering [109]. - Other non-operating income decreased to $0.1 million, a decline of $0.3 million (78%) compared to $0.4 million for the same period in the prior year, primarily due to the recognition of additional government grants in the previous year [110]. - Net foreign exchange losses were $0.2 million, a change of $1.5 million (118%) compared to net foreign exchange gains of $1.2 million for the same period in the prior year, influenced by fluctuations in foreign exchange rates [111]. Cash Flow Activities - Net cash provided by investing activities during Q1 2025 was $1.1 million, a change of $1.8 million (255%) compared to cash outflows of $0.7 million in Q1 2024 [120]. - Net cash used in financing activities during Q1 2025 was $1.1 million, a change of $2.6 million (170%) compared to cash inflows of $1.6 million in Q1 2024 [121].
Anteris Technologies Global Corp(AVR) - 2024 Q4 - Annual Results
2025-03-12 22:03
Financial Performance - Net Sales for 2024 were $2.7 million, primarily from tissue product sales[11] - Net Loss after Income Tax for 2024 was $76.0 million, driven by increased operating expenses related to research and development[12] - Closing cash balance at December 31, 2024, was $70.5 million[11] - The company concluded 2024 with a strong cash position, having drawn down AUD $7.5 million from a secured convertible note facility[14] Fundraising and IPO - Anteris successfully raised $88.8 million through its U.S. IPO on Nasdaq, completing its re-domiciliation to the United States[5] Regulatory and Clinical Trials - The company plans to submit an Investigational Device Exemption (IDE) application to the FDA in Q1 2025 for the DurAVR® THV system's Pivotal Trial[4] - The Pivotal Trial is expected to include up to 80 sites and enroll 1,000 to 1,200 patients with severe aortic stenosis[10] - Anteris performed the first two cases of the DurAVR® THV's European Early Feasibility Study (EU-EFS) in January 2025[6] - The company has treated 86 patients with the DurAVR® THV to date, generating positive patient data to support the IDE submission[5] Manufacturing Expansion - Anteris expanded its manufacturing capabilities in Malaga, AU, and Minneapolis, US, to support the upcoming Pivotal Trial[9]
Anteris Technologies Global Corp(AVR) - 2024 Q4 - Annual Report
2025-03-12 21:02
Clinical Development and Trials - The DurAVR® THV system has been clinically developed with significant physician input, treating a total of 83 patients across the United States, Canada, and Europe as of January 2025[32]. - The FDA approved the early feasibility study for the DurAVR® THV system in November 2022, with 30-day post-procedure results showing a mean effective orifice area of 2.2 cm² and a mean pressure gradient of 7.5 mmHg[38]. - The anticipated design of the Pivotal Trial will be a prospective, randomized, controlled multicenter study to demonstrate non-inferiority of the DurAVR® THV compared to commercially available TAVR systems[36]. - The company has treated seven patients in ViV procedures using the DurAVR® THV system as of January 2025, indicating progress in clinical applications[39]. - Clinical trials have shown that the DurAVR® THV system resulted in an average effective orifice area (EOA) increase of 311% at 30 days and 294% at 12 months post-procedure in the first cohort[82]. - The mean pressure gradient (MPG) across the valve decreased by 87% at 30 days and 85% at 12 months from baseline in the first cohort[82]. - The six-minute walk test distance (6MWTD) improved by 21% at 30 days and 44% at 12 months post-procedure in the first cohort[82]. - The second cohort observed an average EOA increase of 164% at 30 days and 165% at 12 months post-procedure[83]. - The MPG across the valve in the second cohort decreased by 79% at 30 days and 80% at 12 months from baseline[83]. - The third cohort showed an average EOA increase of 170% at both 30 days and 12 months post-procedure[84]. - The MPG across the valve in the third cohort decreased by 87% at 30 days and 85% at 12 months from baseline[84]. - The fourth cohort demonstrated an average EOA increase of 165% at 30 days post-procedure[85]. - The fifth cohort reported an average EOA increase of 208% at 30 days post-procedure[86]. - The Early Feasibility Study (EFS) for the DurAVR® THV system commenced in August 2023, enrolling 15 patients across four heart valve centers in the U.S.[90]. - The EFS demonstrated a 100% precise placement and implant success for all 15 patients, with a 172% increase in average EOA from baseline at 30 days post-procedure[92]. - At 30 days post-procedure, there was an 82% reduction in mean pressure gradient (MPG) from baseline, and a 121% increase in DVI[92]. - No mortality, disabling stroke, life-threatening bleeding, or reinterventions were reported at 30 days post-procedure[92]. - The EU EFS is set to evaluate the safety and feasibility of the DurAVR® THV system, with plans to enroll up to 40 patients starting in January 2025[98]. - The DurAVR® THV was used for the first time in a Valve-in-Valve (ViV) procedure in Canada in July 2023, addressing patients with failing bioprosthetic aortic valves[96]. Market Opportunity and Financials - The total global market opportunity for TAVR related to severe aortic stenosis is expected to reach $9.9 billion by 2028, with North America and Europe accounting for 53% and 38% of the market share, respectively[46]. - The market opportunity for ViV procedures is projected to reach $2.5 billion by 2028, highlighting the growth potential in this segment[41]. - The annual volume of TAVR procedures in the United States has significantly increased, with an estimated 73,000 patients undergoing the procedure in 2019[41]. - The company reported total losses after income tax of $76.0 million for the year ended December 31, 2024, compared to $46.8 million for 2023, indicating a significant increase in losses year-over-year[209]. - Negative cash flows from operating activities were $61.2 million for 2024 and $34.6 million for 2023, reflecting ongoing financial challenges[209]. - As of December 31, 2024, the company had an accumulated deficit of $276.4 million, up from $200.1 million in 2023, highlighting the growing financial strain[209]. - The company completed its initial public offering on December 12, 2024, raising net proceeds of $80.1 million from the sale of 14,878,481 shares at a price of $6.00 per share[194]. Intellectual Property and Partnerships - The company has a strong intellectual property position with 51 issued patents and 53 pending patent applications, which supports its innovative technology[47]. - Anteris has a total of 51 active patents expiring between 2025 and 2042, and 53 pending patent applications as of December 31, 2024[102]. - The company entered into a development agreement with v2vmedtech in April 2023 to enhance its business operations and profitability through innovative heart valve repair technology[45]. - The company has a 30% interest in v2vmedtech, which focuses on implantable medical devices for mitigating heart valve regurgitation, with six pending patent applications[108]. - The company purchased 30% equity in v2vmedtech for $0.2 million and is providing development services for a heart valve repair device[121]. Regulatory Environment - The FDA regulates medical devices under the Federal Food, Drug, and Cosmetic Act, requiring extensive compliance for product design, testing, and marketing[149]. - New medical devices require either a 510(k) clearance, de novo classification, or pre-market approval (PMA), which can be resource-intensive and costly[150]. - Class III devices, such as the DurAVR® THV system, require PMA approval, which is generally more expensive and time-consuming than 510(k) processes[156]. - The FDA review of a PMA application typically takes between one and two years, but can be significantly longer depending on various factors[166]. - If the FDA's evaluation of a PMA is favorable, an approval letter is issued, allowing for commercial marketing of the device[168]. - Modifications to an approved device that affect safety or effectiveness require new PMAs or pre-market approval supplements[169]. - The IDE process is necessary for human clinical trials supporting medical device clearance, requiring FDA approval prior to commencing trials[162]. - The FDA may require post-approval studies or post-market surveillance for devices, ensuring long-term safety and effectiveness data[170]. - Manufacturers must comply with stringent cGMP regulations during the manufacturing process, including design, testing, and quality assurance procedures[172]. - The EUMDR, effective in 2021, imposes extensive regulatory requirements for medical devices in the EU, including clinical evidence and post-market surveillance[180]. - The IMDRF aims to harmonize medical device regulatory requirements across multiple countries, reducing the need for separate inspections[181]. - Non-compliance with FDA regulations can lead to sanctions, including fines, recalls, and operational restrictions[182]. Company Operations and Challenges - The company is committed to maintaining a strong corporate culture based on its AORTIC values (Accountability, Objectivity, Respect, Teamwork, Integrity, Courage) to enhance employee engagement and retention[201]. - The company has implemented training programs aimed at boosting company culture and increasing employee job satisfaction and productivity[203]. - The company is subject to evolving healthcare policies that may impact reimbursement rates and coverage for its products, potentially affecting market demand[190]. - The company faces regulatory compliance challenges due to numerous state, federal, and foreign laws governing health privacy and consumer protection, which could lead to significant penalties if not adhered to[191]. - The company is focused on developing and commercializing the DurAVR® THV system, with significant operating expenses expected to increase as the business grows[210]. - The company anticipates continued significant operating losses for the foreseeable future, raising doubts about its ability to achieve profitability[211]. - The company has historically devoted most of its financial resources to R&D, relying on equity financings and divestments to fund operations[217]. - The company faces substantial risks in completing clinical trials and obtaining regulatory approvals, which are critical for generating significant revenue[213]. - The company may encounter unforeseen expenses and complications typical of early-stage medical technology firms, impacting its financial condition[211]. - The ongoing geopolitical events, such as the war in Ukraine, may disrupt clinical studies and increase R&D expenses[228]. - The company must successfully manage growth and operational complexity to avoid negatively impacting its business and financial position[221]. - The company requires substantial additional financing to support R&D and commercialization efforts, with future capital requirements dependent on various factors[216]. - The lead product, DurAVR® THV system, is undergoing clinical trials necessary for FDA pre-market approval, with no assurance of successful completion[230]. - The company may face challenges in maintaining profitability and investor confidence if it cannot secure necessary funding or achieve commercial success[215].