Financial Performance - Revenue increased by 11.3% from RMB 222.6 million in 2021 to RMB 247.7 million in 2022[1] - Gross profit rose by 11.2% from RMB 197.5 million in 2021 to RMB 219.7 million in 2022[1] - Profit attributable to owners decreased from RMB 58.7 million in 2021 to a loss of RMB 19.8 million in 2022[1] - Non-IFRS adjusted net profit increased by 1.5% from RMB 109.5 million in 2021 to RMB 111.1 million in 2022[1] - The net loss attributable to the company was RMB 19.8 million, a decrease of 133.6% year-on-year, indicating improved financial performance[8] - The adjusted net profit under non-IFRS was RMB 111.1 million, reflecting a 1.5% growth year-on-year[8] - The gross profit margin for 2022 was 88.7%, slightly down from 88.8% in 2021, while the net profit margin significantly decreased to -8.0% from 26.4%[48] - The company reported a net loss of RMB 198 million in 2022, down from a net profit of RMB 587 million in 2021[37] Research and Development - R&D expenses increased by 30.2% from RMB 41.4 million in 2021 to RMB 53.9 million in 2022[1] - The company is focused on providing safe, effective, and innovative medical solutions in the structural heart disease intervention market[3] - The company plans to enhance the innovation and development of biodegradable occluders and valve series products to capture significant market opportunities[17] - The company is currently evaluating the impact of new or revised accounting standards, with no significant impact expected on financial performance upon implementation[62] Product Development and Portfolio - The company has 18 commercialized occluder products and 10 products in registration review[3] - There are 27 products in various stages of development, including occluders and heart valves[3] - The product portfolio includes various occluders and surgical accessories, with several products in clinical trials and registration stages[4][5][6] - The company has 16 commercially available congenital heart disease occluder products, with the fourth-generation MemoSorb® fully biodegradable occluder system launched in 2022[9] - The fourth-generation MemoSorb® biodegradable atrial septal defect occluder is expected to submit a registration application in Q2 2023, aiming for approval and market launch in Q2 2024[9] - The company has 16 heart valve products under development, with the transcatheter aortic valve system completing clinical trial enrollment in September 2022[12] - The company is advancing into the mechanical circulatory support (MCS) device sector, with various products aimed at providing temporary or long-term support for patients[13] Market and Sales Performance - The congenital heart disease occluder products generated RMB 182.7 million in revenue, accounting for 73.8% of total revenue, with a year-over-year growth of 37.9%[19] - The revenue from occluder-related surgical accessory products was RMB 53.7 million, representing 21.7% of total revenue, with a growth of 29.2% compared to the previous year[19] - Sales revenue from congenital heart disease occluder products increased from RMB 132.5 million in 2021 to RMB 182.7 million in 2022, accounting for 73.8% of total revenue[20] - Sales revenue from atrial septal defect occluder products rose from RMB 99.8 million in 2021 to RMB 136.2 million in 2022, representing 55.0% of total revenue[21] - Sales revenue from related surgical accessory products increased from RMB 41.6 million in 2021 to RMB 53.7 million in 2022, making up 21.7% of total revenue[22] - Sales revenue from the oval foramen and left atrial appendage occluder products decreased from RMB 48.5 million in 2021 to RMB 11.1 million in 2022, accounting for 4.5% of total revenue[23] Cash Flow and Assets - The net cash flow from operating activities was RMB 65.5 million, down 37.8% compared to the previous year[8] - The total assets of the group reached RMB 1,809.6 million, an increase of 61.6% from the beginning of the year[8] - Cash and cash equivalents increased by 32.4% from RMB 713 million in 2021 to RMB 944 million in 2022, attributed to successful fundraising from the global offering[39] - As of December 31, 2022, the net current assets increased to RMB 1,265.9 million from RMB 62.5 million in 2021, primarily due to cash and cash equivalents increasing by RMB 601.6 million from global offering proceeds[42] Corporate Governance and Compliance - The company has adopted the Corporate Governance Code as its own governance guidelines and has complied with its provisions, except for specific deviations noted[82] - The audit committee consists of two independent non-executive directors and one non-executive director, who reviewed the consolidated financial statements for the year ended December 31, 2022[85] - The board believes that the current structure of the chairman and CEO roles, held by the same individual, benefits the company's business outlook[82] - The board will review its structure and composition periodically to maintain high standards of corporate governance[82] Future Outlook - The company plans to continue its focus on the development and sales of congenital heart disease intervention devices and related technologies[57] - Lepu ScienTech plans to launch three new medical devices in 2023, targeting a market share increase of 10% in the cardiovascular segment[93] - Lepu ScienTech aims to expand its market presence in Southeast Asia, with a target revenue contribution of 20% from this region by 2025[94] - The company is expected to fully utilize the net proceeds from the global offering by December 31, 2027, subject to business needs and market conditions[81]