Financial Performance - Revenue for 2022 was 113,657 thousand RMB, a decrease of 1.3% compared to 115,181 thousand RMB in 2021[1] - Operating loss for 2022 was 182,301 thousand RMB, an increase of 28.2% compared to 142,229 thousand RMB in 2021[1] - Gross profit decreased from RMB 70.2 million in 2021 to RMB 55.9 million in 2022, with overall gross margin dropping from 61.0% to 49.1%, while AI software solutions maintained a 64.0% gross margin[28] - R&D expenses increased by 95.4% from RMB 64.3 million in 2021 to RMB 125.6 million in 2022, driven by team expansion and investments in AI software solutions and hardware products[31] - Sales expenses rose by 37.8% from RMB 72.6 million in 2021 to RMB 100.0 million in 2022, primarily due to the expansion of the sales and marketing team[32] - The company recorded a loss of RMB 182.7 million in 2022, compared to a loss of RMB 142.5 million in 2021[35] - Pre-tax loss for the year ending December 31 was RMB 182,740 thousand, compared to RMB 142,527 thousand in the previous year[174] - Gross profit for 2022 was RMB 55.852 million, compared to RMB 70.241 million in 2021, RMB 29.087 million in 2020, and RMB 16.107 million in 2019[192] Assets and Liabilities - Non-current assets increased to 64,137 thousand RMB in 2022, up 32.1% from 48,566 thousand RMB in 2021[2] - Current assets decreased to 1,675,818 thousand RMB in 2022, down 9.2% from 1,845,611 thousand RMB in 2021[2] - Inventory increased from RMB 7.7 million in 2021 to RMB 29.6 million in 2022, mainly due to the procurement of raw materials for the production of self-developed fundus cameras[37] - Cash and cash equivalents decreased from RMB 1,784.6 million in 2021 to RMB 1,268.3 million in 2022, due to investments in financial assets, industrial funds, and operational expenses[39] - Accounts receivable increased from RMB 34.0 million in 2021 to RMB 63.9 million in 2022, with the average turnover days rising from 87 days to 169 days[62] - Contract liabilities increased from RMB 17.1 million in 2021 to RMB 18.2 million in 2022, driven by prepayments from new customer contracts in the second half of 2022[66] - Property, plant, and equipment decreased from RMB 45.0 million as of December 31, 2021, to RMB 33.1 million as of December 31, 2022, primarily due to increased depreciation of hardware equipment[88] - The company is in a net cash position as of December 31, 2022, making the debt-to-asset ratio not applicable[70] - The company has no bank loans or other borrowings as of December 31, 2022 (2021: none)[93] AI and Medical Device Development - The company's AI-based retinal imaging diagnostic product, Airdoc-AIFUNDUS (1.0), is the first AI retinal imaging recognition product to receive a Class III medical device certificate from the National Medical Products Administration[3] - Airdoc-AIFUNDUS (2.0) is expected to submit an application for Class III medical device certification for hypertensive retinopathy, retinal vein occlusion, and age-related macular degeneration in Q4 2022[9] - The company's AI diagnostic system (RAIDS) demonstrated a sensitivity of 89.8% in detecting 10 types of retinal diseases, with accuracy ranging from 95.3% to 99.9%[5] - The company's AI-FUNDUSCAMERA-P, a Class II medical device, was approved in March 2021[8] - Airdoc-AIFUNDUS (2.0) completed clinical trials in Q3 2022 and applied for new indications approval in Q4 2022, aiming to become China's first AI-assisted diagnostic SaMD with multiple approved indications[13] - RAIDS demonstrated 89.8% sensitivity in detecting 10 retinal diseases and accuracy ranging from 95.3% to 99.9% in distinguishing them, outperforming human retinal experts[18] - The AI-FUNDUSCAMERA-D, a fully automated desktop fundus camera, received Class II medical device registration from the Shanghai Medical Products Administration in July 2022[42] - The company has developed over 90 deep learning algorithms to cover a wide range of diseases, lesions, and health risks[43] - Airdoc-AIFUNDUS (2.0) expanded its indications to include hypertensive retinopathy, retinal vein occlusion, and age-related macular degeneration (AMD), with clinical trials completed in Q3 2022 and registration certificate updates applied for in Q4 2022[177] - AI-FUNDUSCAMERA-D, a fully automated desktop fundus camera, received Class II medical device registration from the Shanghai Medical Products Administration in July 2022, offering high-quality imaging at a lower cost compared to traditional high-end models[178] - The company developed AI-based retinal imaging solutions for early detection, diagnosis, and health risk assessment, covering a wide range of diseases and lesions[197] Health Risk Assessment Solutions - The company completed over 4.3 million tests in 2022 using its SaMD and health risk assessment solutions[8] - The company's health risk assessment solutions cover a wide range of conditions, including retinal abnormalities, cardiovascular abnormalities, and anemia[11] - The company's health risk assessment solutions cover 55 types of lesions and diseases, with plans to expand coverage to include conditions like hyperthyroidism, Graves' eye disease, and dementia[15] - The company's health risk assessment solutions can be sold in health and eye health management scenarios without requiring regulatory approval or registration[199] Customer and Market Expansion - Customer base grew from 244 in 2021 to 397 in 2022, with 2,371 service outlets using SaMD and health risk assessment solutions monthly, despite a 12% YoY decrease in total tests to 4.3 million[20] - The company's solutions served nearly 94 insurance companies, including top commercial insurers, and were used in over 780 pharmacies, with monthly service outlets increasing by over 200% YoY[23] - Revenue from Eagle Health reached RMB 41.8 million during the reporting period[23] - The company achieved solid progress in commercializing its three business pillars: Eagle Eye Medical, Eagle Eye Health, and Eagle Eye Eye Health, with AI-based SaMD, health risk assessment solutions, and hardware devices widely adopted across various health service scenarios[179] - The company established its own factory in Changsha, Hunan, enabling self-controlled production capabilities, and launched a myopia treatment product to diversify its product portfolio[179] Corporate Governance and Leadership - The Board continues to review and oversee operations to maintain high corporate governance standards[83] - The company's board consists of 4 executive directors, 2 non-executive directors, and 3 independent non-executive directors[119] - The company has entered into three-year service agreements with directors Chen Xin, Luo Ting, Wang Lin, and Zhu Tingyao, effective from their respective appointment dates[123] - The company provides professional development training for directors, with costs covered by the company and annual submission of signed training records required[116] - The company has arranged appropriate insurance coverage for directors and senior officers against potential legal liabilities arising from corporate activities, with annual review of coverage[127] - The company ensures compliance with listing rules by maintaining at least three independent non-executive directors, one of whom must have appropriate professional qualifications or accounting/financial management expertise[106] - The company has received annual written confirmations from independent non-executive directors regarding their independence in accordance with listing rules[121] - The company has established four board committees: Audit Committee, Remuneration and Appraisal Committee, Nomination Committee, and Strategy Committee[125] - The company provides updates on listing rules and regulatory developments to directors to ensure compliance with good corporate governance practices[129] - The company's board is responsible for leading and monitoring the company's affairs, providing strategic guidance, and overseeing operational and financial performance[113] - The company's directors are required to participate in continuous professional development to maintain and update their knowledge and skills[114] - Zhang Dalei, aged 40, was appointed as CEO on September 9, 2015, and currently serves as both Chairman and CEO, leveraging his extensive experience in the medical device industry[141] - Yang Wenting, aged 37, joined the company in June 2020 and was appointed as CFO on December 25, 2020, with a background in finance and investment management[133] - The company's board consists of four executive directors, two non-executive directors, and three independent non-executive directors, ensuring a balanced and independent governance structure[141] - The company has adopted the Corporate Governance Code as outlined in Appendix 14 of the Listing Rules to regulate its corporate governance practices[139] - All directors and supervisors confirmed compliance with the standard code regarding securities trading during the reporting period[142] - Newly appointed directors receive necessary onboarding training and information to ensure they understand the company's operations and their legal responsibilities[143] - Wu Gangping, aged 65, was appointed as an independent non-executive director on April 30, 2021, bringing over 30 years of professional experience in the accounting industry[147] - Dr. Wu Yangfeng, aged 60, was appointed as an independent non-executive director on December 25, 2020, with a background in clinical research and epidemiology[148] - The company emphasizes the importance of separating the roles of Chairman and CEO, although currently, both roles are held by Zhang Dalei due to his strategic importance to the company[141] - The company ensures that its senior management and directors are well-informed about legal and regulatory updates relevant to their roles[143] Research and Development - The company collaborated on a study published in Age and Ageing (IF:12.782), the first global research combining AI technology with fundus imaging to identify high-risk dementia populations[19] - The company has developed over 90 deep learning algorithms to cover a wide range of diseases, lesions, and health risks[43] Inventory and Sales Management - Inventory management is closely monitored to maintain optimal levels aligned with near-term usage expectations[89] - Sales cost increased by 28.6% from RMB 44.9 million in 2021 to RMB 57.8 million in 2022, mainly due to higher procurement costs for myopia treatment devices[53] - Sales cost for the year ending December 31 was RMB 57,805 thousand, a decrease from RMB 44,940 thousand in the previous year[174] Treasury and Financial Management - The company adopts a prudent treasury policy to ensure liquidity structure meets funding needs[71] - The company's H-shares were listed on the Main Board of the Hong Kong Stock Exchange on November 5, 2021, under Chapter 18A of the Listing Rules[175] Leadership and Expertise - Zhang Dalei, the founder, has over 13 years of experience in managing high-tech companies and specializes in AI technology R&D[97] - Dr. Chen Yuzhong, responsible for medical R&D and product registration, has over 21 years of experience in applying IT to clinical practice[74] - Chen Hailong, responsible for product structure design and R&D, has over 16 years of experience in the IT industry[101] - Wang Lin, appointed as an executive director in March 2023, has over 12 years of legal practice experience[102]
鹰瞳科技-B(02251) - 2022 - 年度财报