Anteris Technologies Global Corp(AVR) - 2025 Q2 - Quarterly Report

PART I FINANCIAL STATEMENTS This section presents the unaudited condensed consolidated financial statements of Anteris Technologies Global Corp. for the first half of 2025 Financial Statements (Unaudited) This section presents Anteris Technologies' unaudited consolidated financial statements, highlighting increased losses, cash burn, and going concern doubt Condensed Consolidated Statements of Operations This section details the company's operating results, showing widening losses primarily due to increased R&D expenses Consolidated Statements of Operations Highlights (in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Net sales | $618 | $632 | $1,174 | $1,398 | | Research and development expense | $(16,340) | $(12,634) | $(32,796) | $(24,189) | | Operating loss | $(20,884) | $(18,471) | $(42,664) | $(36,256) | | Loss after income tax | $(21,062) | $(18,819) | $(42,993) | $(34,972) | | Basic and diluted loss per share | $(0.58) | $(0.98) | $(1.18) | $(1.90) | - The company's operating loss and net loss widened for both the three and six-month periods ended June 30, 2025, compared to the prior year, primarily due to a significant increase in Research and Development expenses[17] Condensed Consolidated Balance Sheets This section presents the company's financial position, showing a significant decrease in cash and total assets Consolidated Balance Sheet Highlights (in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents and restricted cash | $28,438 | $70,458 | | Total Current Assets | $32,212 | $74,651 | | TOTAL ASSETS | $39,878 | $80,699 | | TOTAL LIABILITIES | $15,846 | $18,017 | | TOTAL STOCKHOLDERS' EQUITY | $24,406 | $62,761 | - The company's cash position decreased significantly by approximately $42 million, from $70.5 million at the end of 2024 to $28.4 million as of June 30, 2025, reflecting high cash burn from operations[21] Condensed Consolidated Statements of Cash Flows This section outlines the company's cash movements, indicating increased cash usage from operating activities Consolidated Cash Flow Highlights (in thousands) | Metric | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :--- | :--- | :--- | | NET CASH USED IN OPERATING ACTIVITIES | $(41,024) | $(28,903) | | NET CASH PROVIDED BY (USED IN) INVESTING ACTIVITIES | $573 | $(1,363) | | NET CASH (USED IN) PROVIDED BY FINANCING ACTIVITIES | $(1,533) | $15,946 | | Net change during the period | $(42,020) | $(13,906) | - Net cash used in operating activities increased to $41.0 million for the first six months of 2025, up from $28.9 million in the same period of 2024, driven by the net loss adjusted for non-cash items[27] Notes to the Condensed Consolidated Financial Statements These notes detail the company's operations, going concern status, segment reporting, and key customer relationships - The company's principal activities consist of the continued research and development of its DurAVR® THV system, compiling data for FDA approval to commence the PARADIGM Trial, and co-developing a heart valve repair device with v2vmedtech, inc[35] - The financial statements have been prepared on a going concern basis, but the company's recurring losses ($43.0 million for H1 2025) and net cash outflows from operations ($41.0 million for H1 2025) raise substantial doubt about its ability to continue as a going concern for one year from the issuance date of the financials[49][54] - The company operates as a single reportable segment focused on the development and commercialization of the ADAPT® anti-calcification tissue, primarily for the DurAVR® THV system[89] - Two major customers, Customer A and Customer B, accounted for a significant portion of the company's revenue in the first six months of 2025 and 2024[97] Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses financial condition and results, highlighting R&D increases, recurring losses, and the need for additional capital - The company is a structural heart company focused on its lead product, the DurAVR® THV system, for treating aortic stenosis. As of June 2025, 130 patients have been treated with the device worldwide[100][101] - An Investigational Device Exemption (IDE) for the PARADIGM Trial was submitted to the FDA in Q1 2025. The company anticipates enrollment to begin in Q3 2025, subject to FDA approval[103] - In Q2 2025, the company focused on strengthening clinical infrastructure and manufacturing capabilities for the PARADIGM Trial, qualifying 79 trial sites across the U.S., Europe, and Canada[104] - The company's current cash on hand is not sufficient to fund its needs for the 12 months following June 30, 2025, and it will need to raise additional capital to fund operations[135] Results of Operations This section analyzes the company's financial performance, highlighting increased R&D expenses and widening operating losses Comparison of Operations (Six Months Ended June 30) | Line Item | 2025 (in thousands) | 2024 (in thousands) | % Change | | :--- | :--- | :--- | :--- | | Net sales | $1,174 | $1,398 | (16)% | | Research and development expense | $(32,796) | $(24,189) | 36% | | Selling, general and administrative expense | $(10,687) | $(12,679) | (16)% | | Operating loss | $(42,664) | $(36,256) | 18% | - R&D expenses for the six months ended June 30, 2025, increased by $8.6 million (36%) year-over-year, driven by the upscaling of manufacturing and quality capabilities ($9.1 million) and preparatory activities for the PARADIGM Trial ($2.5 million)[128] - Selling, general and administrative expenses decreased by $2.0 million (16%) for the first six months of 2025 compared to the prior year, primarily due to lower share-based payment expenses and reduced marketing spend[130] Liquidity and Capital Resources This section assesses the company's cash position and capital needs, emphasizing the necessity for additional funding - As of June 30, 2025, the company had cash, cash equivalents, and restricted cash of $28.4 million and an accumulated deficit of $319.1 million[134][135] - Management states that current cash is insufficient to fund operations for the next 12 months and that additional funds will be required to achieve long-term goals, including the completion of R&D and commercialization of products[135][136] Summary of Cash Flows (Six Months Ended June 30, in thousands) | Activity | 2025 | 2024 | | :--- | :--- | :--- | | Operating activities | $(41,024) | $(28,903) | | Investing activities | $573 | $(1,363) | | Financing activities | $(1,533) | $15,946 | Quantitative and Qualitative Disclosures About Market Risk As a smaller reporting company, Anteris is not required to provide market risk disclosures - The company is a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risk[157] Controls and Procedures Management concluded disclosure controls were ineffective due to material weaknesses in internal control over financial reporting - Management, including the CEO and CFO, concluded that as of June 30, 2025, the company's disclosure controls and procedures were not effective due to material weaknesses in internal control over financial reporting[158] - The identified material weaknesses relate to (i) a lack of appropriately designed, implemented, and documented procedures and controls, and (ii) deficiencies in the segregation of duties[161] - Remediation efforts are in process, including documenting processes and controls and reviewing segregation of duties. However, these controls have not operated for a sufficient period to confirm their effectiveness, and the material weaknesses are not yet considered remediated[162][163] PART II OTHER INFORMATION This section provides additional information on legal proceedings, risk factors, equity sales, and other corporate disclosures Legal Proceedings The company reports no material legal proceedings are currently active or threatened against it - The company is not party to any material legal proceedings[166] Risk Factors There have been no material changes to the risk factors previously disclosed in the company's Annual Report - There have been no material changes to the risk factors discussed in the company's Annual Report[167] Unregistered Sales of Equity Securities and Use of Proceeds This section details the allocation of $80.0 million net IPO proceeds for DurAVR® THV development and working capital - The company received net proceeds of $80.0 million from its initial public offering, which became effective on December 12, 2024[169] - As of June 30, 2025, the use of IPO proceeds included: - $37.6 million for DurAVR® THV development and the PARADIGM Trial - $14.1 million for net working capital, v2v expenditures, and other general corporate purposes, including debt repayment[174] Defaults Upon Senior Securities This item is not applicable to the company - Not applicable[171] Mine Safety Disclosures This item is not applicable to the company - Not applicable[172] Other Information No directors or officers adopted or terminated Rule 10b5-1 trading plans during Q2 2025 - No directors or officers adopted or terminated any Rule 10b5-1 trading plans during the three months ended June 30, 2025[173] Exhibits This section provides an index of all exhibits filed with the Form 10-Q, including CEO and CFO certifications - An index of exhibits filed with the Form 10-Q is provided, including certifications pursuant to the Sarbanes-Oxley Act of 2002[175][177]