MIRXES(02629) - 2025 - 中期业绩

Financial Highlights Interim Results Overview H1 2025 revenue grew 9.4% to $10.5 million, gross profit up 51.1% to 67.6% margin, and loss narrowed 36.2% to $28.4 million Key Financial Data Comparison for H1 2025 | Metric | 2025 H1 (million USD) | 2024 H1 (million USD) | Y-o-Y Change (%) | | :--- | :--- | :--- | :--- | | Revenue | 10.5 | 9.6 | 9.4% | | Early Detection & Precision Multi-omics Revenue | 10.5 | 7.0 | 50.0% | | Gross Profit | 7.1 | 4.7 | 51.1% | | Early Detection & Precision Multi-omics Gross Profit | 7.1 | 3.5 | 102.9% | | Loss Attributable to Equity Holders | (28.4) | (44.5) | -36.2% | Consolidated Financial Statements Consolidated Statement of Profit or Loss and Other Comprehensive Income For H1 2025, revenue reached $10.5 million, gross profit $7.1 million, operating loss narrowed, and loss attributable to equity holders decreased to $28.4 million Summary of Consolidated Statement of Profit or Loss and Other Comprehensive Income (for the six months ended June 30) | Metric | 2025 (USD) | 2024 (USD) | | :--- | :--- | :--- | | Revenue | 10,471,494 | 9,566,753 | | Cost of Sales | (3,368,970) | (4,901,164) | | Gross Profit | 7,102,524 | 4,665,589 | | Other Income and Other Gains / (Losses) | 8,766,264 | (3,279,511) | | Selling and Distribution Expenses | (6,287,446) | (7,044,074) | | Research and Development Expenses | (9,225,967) | (10,693,149) | | General and Administrative Expenses | (20,233,209) | (21,217,439) | | Results from Operating Activities | (19,956,308) | (37,568,584) | | Loss Before Tax | (28,254,881) | (44,387,160) | | Loss for the Period | (28,228,236) | (44,325,936) | | Loss Attributable to Equity Holders of the Company | (28,352,272) | (44,451,768) | | Basic and Diluted Loss Per Share | (0.185) | (0.370) | Consolidated Statement of Financial Position As of June 30, 2025, total assets increased to $163.2 million, net current assets turned positive to $96.6 million, and total equity shifted from deficit to $114.5 million due to convertible redeemable preferred shares conversion Summary of Consolidated Statement of Financial Position (as of June 30) | Metric | June 30, 2025 (USD) | December 31, 2024 (USD) | | :--- | :--- | :--- | | Total Assets | 163,211,156 | 71,354,352 | | Total Non-current Assets | 33,485,946 | 36,557,943 | | Total Current Assets | 129,725,210 | 34,796,409 | | Total Liabilities | 48,684,033 | 269,595,191 | | Total Current Liabilities | 33,137,108 | 48,108,811 | | Total Non-current Liabilities | 15,546,925 | 221,486,380 | | Net Current Assets / (Liabilities) | 96,588,102 | (13,312,402) | | Total Equity / (Deficiency) | 114,527,123 | (198,240,839) | Basis of Preparation This interim financial information is prepared under HKEX Listing Rules and IAS 34, using consistent accounting policies with the 2024 annual financial statements, including condensed consolidated financial statements and explanatory notes - Interim financial reports are prepared in accordance with the HKEX Listing Rules and International Accounting Standard 34, adopting the same accounting policies as the 2024 annual financial statements[10] - The report includes condensed consolidated financial statements and selected explanatory notes, aiming to explain significant changes in financial position and performance since December 31, 2024[11] Changes in Accounting Policies Revisions and new standards of IFRS effective in the current accounting period have not materially impacted the Group's current or prior period results and financial position - Multiple amendments and new standards issued by the IASB have not had a material impact on the Group's current or prior period results and financial position[12] Business Overview Company Profile Mirxes Holding Company Limited, incorporated in the Cayman Islands on November 17, 2020, and listed on the HKEX Main Board on May 23, 2025, specializes in developing and commercializing precise, non-invasive, affordable, blood-based miRNA test kit products for early cancer and other disease detection - The company was incorporated in the Cayman Islands on November 17, 2020, and listed on the Main Board of the Hong Kong Stock Exchange on May 23, 2025[8] - The Group primarily engages in the development and commercialization of precise, non-invasive, affordable, blood-based miRNA test kit products for early detection of cancer and other diseases[8] Product Pipeline The company boasts a diverse miRNA diagnostic pipeline for gastric, lung, colorectal, liver, breast, and multi-cancer detection, alongside pulmonary hypertension and heart failure, with core product GASTROClearTM commercialized in Singapore and granted FDA Breakthrough Device designation - As of June 30, 2025, the company has one core product (GASTROClearTM), two other commercialized products (LUNGClearTM and FortitudeTM), and six preclinical-stage candidate products[40] - GASTROClearTM is the world's first and only approved molecular diagnostic IVD product for gastric cancer screening, successfully commercialized in Singapore and granted FDA Breakthrough Device designation[43] - Various candidate products including LUNGClearTM, CRC-1, LV-1, BC-1, CADENCE, PHinder, and HF-1 are in different development stages, covering lung cancer, colorectal cancer, liver cancer, breast cancer, multi-cancer detection, pulmonary hypertension, and heart failure[44][45][46][47][48][49][50] Core Product: GASTROClearTM GASTROClearTM is the world's first and only approved molecular diagnostic IVD for gastric cancer screening, successfully commercialized in Singapore and granted FDA Breakthrough Device designation - GASTROClearTM is the world's first and only approved molecular diagnostic IVD product for gastric cancer screening, comprising 12 miRNA biomarkers[40][43] - It obtained Singapore HSA Class C IVD certification and successful commercialization in May 2019, CE-IVD certification in November 2017, and US FDA Breakthrough Device designation in May 2023[43] - The product serves as a supplementary test to the gold standard for gastric cancer screening, and its development experience was a valuable reference for drafting miRNA molecular diagnostic industry standards, including Singapore Standard 656[43] Other Candidate Products The company's pipeline includes LUNGClearTM commercialized as LDT in Southeast Asia and Japan, CRC-1 prototyping for IVD registration in Singapore and China, and early-stage development for LV-1, BC-1, CADENCE, PHinder, and HF-1 - LUNGClearTM (lung cancer screening) has been commercialized as an LDT service in Southeast Asia since December 2022 and in Japan since January 2023, aiming to enhance early lung cancer detection and reduce LDCT scan radiation[44] - CRC-1 (colorectal cancer screening) is expected to complete prototyping in H2 2025, with plans for IVD registration in Singapore and China, and clinical trials anticipated to start in 2026[45] - LV-1 (liver cancer screening), BC-1 (