Financial Performance - Revenue increased by 31.6% from RMB 247.7 million for the year ended December 31, 2022, to RMB 325.9 million for the year ended December 31, 2023[1]. - Gross profit rose by 31.5% from RMB 219.7 million for the year ended December 31, 2022, to RMB 288.8 million for the year ended December 31, 2023[1]. - Profit attributable to owners of the company was RMB 151.5 million for the year ended December 31, 2023, compared to a loss of RMB 19.8 million for the year ended December 31, 2022[1]. - Adjusted net profit increased by 55.4% from RMB 111.1 million for the year ended December 31, 2022, to RMB 172.6 million for the year ended December 31, 2023[1]. - The company recorded a net profit of RMB 151.5 million for the year ended December 31, 2023, compared to a net loss of RMB 19.8 million for the year ended December 31, 2022[40]. - Basic and diluted earnings per share for 2023 were RMB 0.44, compared to a loss per share of RMB 0.06 in 2022, indicating a strong recovery in profitability[52]. Research and Development - R&D expenses increased by 14.3% from RMB 53.9 million for the year ended December 31, 2022, to RMB 61.6 million for the year ended December 31, 2023[1]. - The company is exploring advanced fields including interventional devices for structural heart diseases and has 24 products in various stages of development[3]. - The company aims to accelerate the development of innovative products in congenital heart disease intervention devices to drive rapid business growth[19]. - The company plans to advance the development of the TMVr-F system and TMVR system for mitral valve regurgitation treatment, addressing a significant clinical need[20]. - The company continues to focus on the development and sales of medical devices for congenital heart disease, with ongoing investments in research and development[57]. Product Development and Market Expansion - The company has 22 products commercially available and 9 products under registration review or preparation as of the announcement date[3]. - The company has commercialized 10 congenital heart disease occluder products, with the third-generation MemoCarna® series becoming a key player in the market since its approval in 2020[9]. - The fourth-generation MemoSorb® fully biodegradable occluder system was approved for commercialization in 2022 and has quickly gained market traction[9]. - The company submitted a registration application for the fourth-generation MemoSorb® biodegradable septal occluder in June 2023, expecting approval and commercialization in Q2 2024[10]. - The company is advancing its transcatheter mitral valve clip system, with clinical trial enrollment expected to be submitted to the regulatory authority in the first half of 2024[13]. - The company is developing a series of products in the MCS and protective PCI markets, projected to reach a global market size of USD 3.4 billion by 2025[21]. - The company is focusing on international expansion and enhancing the market penetration of existing products[22]. Financial Health and Assets - The total assets of the group as of December 31, 2023, amounted to RMB 1,986.5 million, an increase of 9.8% from the beginning of the year[8]. - Cash and cash equivalents increased by 28.3% to RMB 1,212.0 million as of December 31, 2023, from RMB 944.5 million as of December 31, 2022, primarily due to an increase in cash generated from operating activities by RMB 98.7 million[42]. - The company’s total equity increased to RMB 1,926,674 thousand in 2023 from RMB 1,744,527 thousand in 2022, reflecting improved financial health[55]. - The current ratio increased to 24.1 times in 2023 from 20.9 times in 2022, driven by an increase in current assets and a decrease in current liabilities[51]. Expenses and Cost Management - Total sales cost rose by 32.5% from RMB 28.0 million in 2022 to RMB 37.1 million in 2023, with raw materials and consumables accounting for 39.4% of total sales cost in 2023[29]. - Distribution expenses grew by 29.6% from RMB 38.7 million in 2022 to RMB 50.1 million in 2023, primarily due to increased marketing and travel expenses as COVID-19 restrictions eased[33]. - General and administrative expenses decreased by 20.2% from RMB 53.7 million in 2022 to RMB 42.8 million in 2023, mainly due to a reduction in listing expenses[34]. Dividend and Shareholder Information - The board proposed a final dividend of RMB 0.57 per share (tax included) for the year ended December 31, 2023[1]. - The company proposed a final dividend of RMB 0.57 per share for the year ended December 31, 2023, totaling approximately RMB 197.6 million, compared to no dividend in 2022[73]. - The annual general meeting is scheduled for May 23, 2024, with relevant notices to be published on the company's and the stock exchange's websites[86]. Compliance and Governance - The company has adopted the Corporate Governance Code and has complied with its provisions during the reporting period, with some deviations noted[81]. - The audit committee, consisting of two independent non-executive directors and one non-executive director, has reviewed the consolidated financial statements for the year ending December 31, 2023[84]. - The company has confirmed compliance with the Standard Code for securities transactions by directors and supervisors during the reporting period[82].

智通财经APP讯，心泰医疗(02291)发布公告，集团预期截至2023年12月31日止年度将取得公司拥有人应 占纯利约人民币1.4亿元至约人民币1.6亿元，而截至2022年12月31日止年度则取得公司拥有人应占亏损 人民币1980万元。估计非国际财务报告准则利润约人民币1.6亿元至约人民币1.8亿元，而截至2022年12 月31日止年度则约为人民币1.11亿元。 公告称，股东应占纯利之预期增加主要是由于以下原因： (1) 集团之新一代镍钛合金封堵器产品于报告 期内的销量较截至2022年12月31 日止年度大幅增加。此增长乃受集团前瞻性研发策略思维、强大营销 能力、有效学术推广及广泛经销商网络所推动，从而令该等产品之市场销量进一步提高;及 (2) 鉴于集团 一直贯彻的研发创新策略，(i)于2022年2月取得中国国家药品监督管理局药品审评中心注册证书的 MemoSorb®全降解封堵器系统及 (ii)于2023年9月获得CDE注册证书的MemoSorb®生物可降解卵圆孔未 闭封堵器，上述两款产品作为集团之创新产品，于报告期内取得了较截至2022年12月31日止年度而言更 好的销售业绩。 公司相信，集团会维持和扩大其 ...

Financial Performance - The company reported a revenue increase of 25% year-over-year, reaching 500 million RMB in the first half of 2023[1]. - Revenue increased by 33.0% from RMB124.8 million for the six months ended June 30, 2022 to RMB165.9 million for the six months ended June 30, 2023[19]. - Profit attributable to owners of the Company increased by 213.7% from RMB24.3 million for the six months ended June 30, 2022 to RMB76.1 million for the six months ended June 30, 2023[19]. - The non-IFRS Adjusted Net Profit for the six months ended June 30, 2023 was RMB86.5 million[19]. - Profit for the Reporting Period increased by 213.7% from a net profit of RMB24.3 million for the six months ended June 30, 2022, to a net profit of RMB76.1 million for the same period in 2023[102]. - Gross profit increased by 34.8% from RMB109.5 million for the six months ended June 30, 2022 to RMB147.5 million for the six months ended June 30, 2023[19]. - The gross profit margin improved to 88.9% for the six months ended June 30, 2023, compared to 87.7% for the same period in 2022[111]. - Net profit margin significantly increased to 45.9% for the six months ended June 30, 2023, from 19.4% for the same period in 2022[111]. Market Expansion and Strategy - The company is expanding its market presence in Southeast Asia, targeting a 10% market share by the end of 2024[1]. - The company aims to expand its market presence through strategic partnerships and potential acquisitions[12]. - New product launches are expected to contribute an additional 100 million RMB in revenue by Q4 2023[1]. - The company plans to enhance its digital marketing efforts, aiming for a 25% increase in online sales by the end of 2023[1]. - The company is exploring potential acquisitions to enhance its product portfolio and market reach[1]. Research and Development - Investment in R&D increased by 30%, totaling 50 million RMB, focusing on innovative medical technologies[1]. - Research and development expenses increased by 36.5% from RMB19.6 million for the six months ended June 30, 2022 to RMB26.8 million for the six months ended June 30, 2023[19]. - The company is involved in the development of transcatheter aortic valve replacement (TAVR) technology[12]. - The company is actively engaged in the development of new products, including biodegradable interatrial shunt devices, which are currently in animal testing[52]. - The company has built out 16 heart valve product candidates and plans to submit a registration application for its TAVR system to the NMPA by the end of 2023[58]. Product Portfolio - The product portfolio includes various occluders, heart valves, and mechanical circulatory support devices, with several products already commercialized[45][46]. - As of the report date, the company had a total of 20 marketed occluders and accessory products, 8 products under registration review, and 27 product candidates in various stages of research and development[21]. - The company is preparing for CE registration materials for new products, indicating ongoing market expansion efforts[45][46]. - The company owns 8 commercially available occluder-related procedural accessories, with significant revenue growth expected from these products[60]. Financial Position and Cash Flow - As of June 30, 2023, total assets of the group were RMB1,890.1 million, an increase of 4.4% from the beginning of the reporting period[54]. - Total cash and cash equivalents increased by 12.9% from RMB944.5 million as of December 31, 2022, to RMB1,066.3 million as of June 30, 2023[103]. - Net cash flow generated from operating activities for the six months ended June 30, 2023, was RMB61.7 million, representing a period-on-period increase of 17.1%[54]. - The company reported a net cash inflow from investing activities of RMB 63,867,000 for the six months ended June 30, 2023, compared to a net cash outflow of RMB 102,765,000 in the same period of 2022[165]. Governance and Compliance - The company has complied with the Corporate Governance Code, except for the deviation where the roles of chairman and CEO are held by the same individual[134]. - The Board consists of two executive Directors, two non-executive Directors, and three independent non-executive Directors, ensuring a balance of power and authority[134]. - The Audit Committee has reviewed the unaudited interim financial information for the six months ended June 30, 2023, discussing accounting principles and internal controls with management[139]. - The interim financial information has been prepared in accordance with International Accounting Standard 34 "Interim Financial Reporting"[148]. Shareholder Information - As of June 30, 2023, the total number of issued shares was 346,749,997 shares[124]. - Dr. Pu holds a long position of 280,000,000 H Shares, representing 80.75% of the total issued share capital[124]. - Lepu Medical is a beneficial owner of 277,200,000 H Shares, accounting for 79.94% of the total issued share capital[124]. - The company does not recommend the payment of an interim dividend for the six months ended June 30, 2023[120].

Financial Performance - Revenue increased by 33.0% from RMB 124.8 million for the six months ended June 30, 2022, to RMB 165.9 million for the six months ended June 30, 2023[1]. - Gross profit rose by 34.8% from RMB 109.5 million for the six months ended June 30, 2022, to RMB 147.5 million for the six months ended June 30, 2023[1]. - Net profit attributable to owners increased by 213.7% from RMB 24.3 million for the six months ended June 30, 2022, to RMB 76.1 million for the six months ended June 30, 2023[1]. - The non-IFRS net profit for the six months ended June 30, 2023, was RMB 86.5 million[1]. - The profit attributable to the company's owners for the same period was RMB 76.1 million, reflecting a significant year-on-year increase of 213.7%[7]. - The operating profit for the six months ended June 30, 2023, was RMB 81,997 thousand, significantly higher than RMB 34,359 thousand for the same period in 2022[47]. - The adjusted net profit for the six months ended June 30, 2023, was RMB 86,545 thousand, after excluding share-based payment expenses[46]. - The net profit margin significantly increased to 45.9% for the six months ended June 30, 2023, from 19.4% in the same period of 2022[43]. Research and Development - R&D expenses grew by 36.5% from RMB 19.6 million for the six months ended June 30, 2022, to RMB 26.8 million for the six months ended June 30, 2023[1]. - The company is actively pursuing clinical trials and regulatory approvals for new products, including biodegradable occluders and various heart valve systems[3]. - The company has been engaged in the research and development of interventional treatment devices for congenital heart disease, focusing on occluders and heart valves[51]. - The company is accelerating the development of the TMVr-F system and TMVR system for treating mitral valve regurgitation diseases[14]. - The company has capitalized approximately RMB 28,339,000 and RMB 28,055,000 in R&D expenses for the six months ended June 30, 2023, and 2022, respectively[60]. Product Development and Market Expansion - The company has a total of 20 commercially available occluder products and 27 products in various stages of development[2]. - The company is advancing into the field of cardiac mechanical circulatory support devices, aiming to provide innovative medical solutions[2]. - The company has eight products under registration review and preparation, indicating ongoing expansion of its product portfolio[2]. - The company is developing a radiofrequency interatrial septal puncture system, which is positioned to quickly enter the market due to the lack of similar products domestically[15]. - The company plans to gradually introduce additional occluder-related surgical accessory products and heart valve-related surgical accessory products[20]. - The company plans to expand its sales network in China and enhance brand reputation among doctors and patients[16]. - The company will continue to track overseas market developments and clinical needs to advance the commercialization of innovative products in international markets[16]. Revenue Breakdown - Sales revenue from congenital heart disease occluder products increased by 38.0% to RMB 125.2 million, accounting for 75.4% of total revenue[19]. - Revenue from atrial septal defect occluder products rose by 34.1% to RMB 95.6 million, representing 57.6% of total revenue[19]. - Revenue from ventricular septal defect occluder products surged by 79.8% to RMB 18.5 million, making up 11.1% of total revenue[19]. - Sales revenue from occluder-related surgical accessory products increased by 24.7% to RMB 33.8 million, accounting for 20.4% of total revenue[20]. - Revenue from patent foramen ovale and left atrial appendage occluder products decreased by 0.03% to RMB 6.8 million, representing 4.1% of total revenue[21]. Cost and Expenses - Total sales cost rose by 20.0% to RMB 18.4 million, driven by increased material costs[23]. - Material and consumables costs increased by 50.8% to RMB 8.6 million, primarily due to higher sales volume of new products[24]. - Employee benefit expenses decreased by 5.1% to RMB 4.4 million, attributed to improved efficiency through automation[25]. - Public utility and office expenses surged by 135.2% to RMB 0.6 million, as previous rent reductions were no longer applicable[25]. - Distribution expenses rose by 34.4% from RMB 16.6 million to RMB 22.4 million, primarily due to increased marketing and travel expenses as COVID-19 restrictions eased[27]. - General and administrative expenses increased by 28.6% from RMB 16.4 million to RMB 21.1 million, driven by higher employee benefits and professional service fees[28]. Assets and Liabilities - The total assets of the group as of June 30, 2023, amounted to RMB 1,890.1 million, an increase of 4.4% from the beginning of the reporting period[7]. - The net current assets increased by 3.7% from RMB 1,265.9 million as of June 30, 2022, to RMB 1,312.8 million as of June 30, 2023, primarily due to increases in trade receivables and inventory[37]. - Total liabilities decreased to RMB 55,640 thousand from RMB 65,094 thousand, indicating a reduction of approximately 14.0%[50]. - Trade receivables increased to RMB 41,070 thousand from RMB 30,615 thousand, marking a significant rise of approximately 34.0%[48]. - Inventory levels rose to RMB 64,225 thousand, compared to RMB 57,398 thousand, representing an increase of about 11.9%[48]. Corporate Governance - The company has adopted the Corporate Governance Code as its own governance guidelines and has complied with its provisions during the reporting period, with some exceptions noted[84]. - The Audit Committee, consisting of two independent non-executive directors and one non-executive director, reviewed the unaudited interim financial information for the six months ended June 30, 2023[86]. - The company emphasizes the importance of a balanced power structure between the board and management to ensure effective decision-making[84]. - The company has a strong independent element in its board composition, which includes two executive directors, two non-executive directors, and three independent non-executive directors[84]. - The company is committed to ensuring that decisions made by the board are in the best interest of the company and its shareholders[84].

Company Overview and Listing Information - The company's stock code is 2291 and it is listed on the Main Board of the Stock Exchange[11] - Lepu ScienTech Medical Technology (Shanghai) Co., Ltd. was listed on the Main Board of the Stock Exchange on November 8, 2022[23] - The company is registered as a non-Hong Kong company under the Companies Ordinance (Chapter 622 of the Laws of Hong Kong)[28] - The company's legal address in the PRC is Room 201, Building 41, No. 258, Xinzhuan Road, Songjiang District, Shanghai[31] - The company's head office in the PRC is located at 1/F and 5/F, Building 41, No. 258, Xinzhuan Road, Songjiang District, Shanghai[31] - The principal place of business in Hong Kong is 31/F, Tower Two Times Square, 1 Matheson Street, Causeway Bay, Hong Kong[31] - The company's auditor is PricewaterhouseCoopers, Certified Public Accountants and Registered Public Interest Entity Auditor[31] Financial Performance and Statements - The company's 2022 Annual Report includes financial highlights, management discussion and analysis, and a corporate governance report[2][3] - The company's financial statements are prepared in accordance with International Financial Reporting Standards (IFRS)[18] - The company's financial statements include a consolidated statement of profit or loss, consolidated balance sheet, and consolidated statement of cash flows[3] - Revenue increased by 11.3% from RMB222.6 million in 2021 to RMB247.7 million in 2022[34] - Gross profit increased by 11.2% from RMB197.5 million in 2021 to RMB219.7 million in 2022[34] - Research and development expenses increased by 30.2% from RMB41.4 million in 2021 to RMB53.9 million in 2022[34] - Net other income and gains decreased from RMB22.6 million in 2021 to a net loss of RMB69.5 million in 2022[34] - Profit attributable to owners of the Company decreased from RMB58.7 million in 2021 to a loss of RMB19.8 million in 2022[34] - Non-IFRS Adjusted Net Profit increased by 1.5% from RMB109.5 million in 2021 to RMB111.1 million in 2022[34] - Net cash flow from operating activities decreased by 37.8% to RMB65.5 million in 2022[36] - Total assets increased by 61.6% to RMB1,809.6 million as of December 31, 2022[36] - Net assets increased by 352.9% to RMB1,744.5 million as of December 31, 2022[36] - Revenue for the year ended December 31, 2022, was RMB247.7 million, representing a year-on-year increase of 11.3%[59] - Loss attributable to owners of the company for the year ended December 31, 2022, was RMB19.8 million, a year-on-year decrease of 133.7%[59] - Non-IFRS Adjusted Net Profit for the year ended December 31, 2022, was RMB111.1 million, a year-on-year increase of 1.5%[59] - Net cash flow generated from operating activities for the year ended December 31, 2022, was RMB65.5 million, a year-on-year decrease of 37.8%[59] - Total assets as of December 31, 2022, were RMB1,809.6 million, an increase of 61.6% from the beginning of the year[59] - Net assets as of December 31, 2022, were RMB1,744.5 million, an increase of 352.9% from the beginning of the year[59] - The company reported a net loss of RMB19.8 million for 2022, compared to a net profit of RMB58.7 million in 2021[116] - Cash and cash equivalents increased by 32.4% from RMB713.5 million in 2021 to RMB944.5 million in 2022, primarily due to proceeds from the Global Offering and operational activities[117] - Net cash generated from operating activities decreased by RMB39.7 million to RMB65.5 million in 2022, attributed to extended payment collection periods and increased inventories and prepayments[119][120] - Net cash used in investing activities increased by RMB320.8 million to RMB406.0 million in 2022, mainly due to investments in wealth management products and long-term bank deposits[120] - Net cash generated from financing activities in 2022 was RMB577.8 million, a decrease of RMB94.4 million from RMB672.2 million in 2021[121] - Global Offering proceeds received in November 2022 amounted to RMB601.6 million, partially offset by share issuance costs of RMB21.9 million[121] - Net current assets increased to RMB1,265.9 million in 2022 from RMB62.5 million in 2021, driven by Global Offering proceeds and reclassification of redemption liabilities[124] - Redemption liabilities of approximately RMB775.0 million were derecognized upon completion of the Global Offering, with a difference of RMB103.5 million credited to other reserves[131] - Total capital expenditure for 2022 was approximately RMB83.4 million, compared to RMB91.8 million in 2021, primarily for property, plant, equipment, and R&D expenses[127] - Capital commitments as of December 31, 2022, were RMB1.3 million, primarily for property, plant, and equipment purchases[127] - Total staff costs for 2022 amounted to approximately RMB86.0 million, covering remuneration, bonuses, welfare, and social insurance fees[129] - The company had 236 full-time employees as of December 31, 2022, all based in China[129] - No outstanding borrowings or unutilized banking facilities as of December 31, 2022[123] - No material acquisitions, disposals, or significant investments during 2022[125] - Redemption liabilities decreased significantly from RMB 679,986 thousand in 2021 to RMB 0 in 2022 due to derecognition after the completion of the global offering[135][136] - The company's gross profit margin remained stable at 88.7% in 2022 compared to 88.8% in 2021[139] - Net profit margin dropped sharply from 26.4% in 2021 to -8.0% in 2022, primarily due to decreased net profit[139] - Current ratio increased dramatically from 1.1 in 2021 to 20.9 in 2022, driven by increased current assets and decreased current liabilities[139][141] - Non-IFRS adjusted net profit showed minimal growth, increasing from RMB 109,494 thousand in 2021 to RMB 111,089 thousand in 2022[143] - Listing expenses, net of tax, decreased from RMB 24,518 thousand in 2021 to RMB 15,329 thousand in 2022[143] - Net foreign exchange losses from retranslation of USD-denominated redemption liabilities were RMB 76,377 thousand in 2022, compared to gains of RMB 2,837 thousand in 2021[143] - Interest expense on redemption liabilities increased from RMB 11,316 thousand in 2021 to RMB 18,683 thousand in 2022[143] - Share-based payment expenses rose from RMB 17,800 thousand in 2021 to RMB 20,513 thousand in 2022[143] - The company had no borrowings as of December 31, 2021 and 2022, resulting in no gearing ratio being presented[139] Corporate Governance and Shareholders - The company's controlling shareholder is Lepu Medical, and the actual controller is Dr. Pu Zhongjie[11] - The company's corporate governance practices are in line with the Corporate Governance Code as set out in Appendix 14 to the Listing Rules[8] - The company's 2022 AGM is scheduled to be held on June 15, 2023[6] - The company's Pre-IPO investors include CDH Supermatrix D Limited and Huaihua Haozhi Enterprise Management Partnership[7][17] - The Pre-IPO Shareholders Agreement was signed on May 28, 2021, involving Lepu Medical, Dr. Pu, and other stakeholders[25] - The Prospectus for the Hong Kong public offering of shares was issued on October 27, 2022[25] - Net proceeds from the Global Offering amounted to approximately HK$567.3 million after deducting underwriting commissions and related expenses[183] - The company intends to fully utilize the net proceeds raised from the Global Offering by December 31, 2027, subject to changes in business needs and market conditions[184] - The company has not utilized any of the net proceeds raised from the Global Offering, except for a subscription of a wealth management product for treasury management purposes, which was fully redeemed by the date of the Annual Report[183] - The company raised a net amount of approximately HKD 567.3 million from its global offering, which was listed on the Hong Kong Stock Exchange on November 8, 2022[186] - The company plans to utilize the net proceeds from the global offering within the five fiscal years from 2023 to 2027, with full utilization expected by December 31, 2027, subject to changes due to evolving business needs and market conditions[186] Products and R&D - The company's products include the TAVR system, TMVCRS, and balloon dilatation catheter for aortic valve, which are developed, registered, and produced by the Retained Lepu Medical Group[10] - The company successfully launched the MemoSorb® fully biodegradable occluder system, the world's first commercially available product of its kind[35] - The company's third-generation CHD occluders, MemoCarna® oxide coating single-rivet occluder products, continued to increase in volume in 2022, becoming a backbone of the CHD occluder product segment[39][40] - The fourth-generation MemoSorb® fully biodegradable occluder system, approved in early 2022, has been successfully clinically applied in multiple hospital centers across regions including Beijing, Henan, Shaanxi, Anhui, Hubei, Sichuan, Guangdong, and Guangxi[39][40] - The MemoSorb® biodegradable ASD occluder product candidate completed its clinical trial stage, with registration application submission to the NMPA expected in Q2 2023 and approval anticipated in Q2 2024[39][40] - The MemoSorb® biodegradable PFO occluders entered the NMPA review stage in 2022 and are expected to be approved for marketing by the end of 2023[39][40] - The BioLefort® biodegradable LAA occluders have entered the clinical trial stage and completed the world's first clinical enrollment of FIM[39][40] - The company has a total of 18 marketed occluders and accessory products, 10 products under registration review and preparation, and 27 product candidates in various stages of R&D as of March 31, 2023[44] - The GuiBend® interventional delivery system II (Integrated) submitted the CE certification application in 2022, and the third-generation MemoCarna® oxide coating single-rivet occluder series products are preparing to submit CE certification applications[41][42] - The company is actively planning overseas clinical trials for biodegradable occluder series products to accelerate the commercialization process in overseas markets[41][42] - The company has established various technical platforms related to valve products, leveraging years of basic research, and is expected to become a leading enterprise in the valve products field[39][40] - The company aims to strengthen its technological leadership and market dominance in the structural heart diseases field through a series of innovative products launched and to be launched in the next three to five years[41][42] - MemoPart® ASD occluder (Double-rivet) and MemoPart® ASD occluder (Single-rivet) have been commercialized[47] - MemoCarna® Oxide coating ASD occluder with double-rivet is in preparation for CE registration materials[47] - MemoSorb® Biodegradable ASD occluder is in preparation for NMPA registration materials[47] - MemoPart® VSD Occluder (Double-rivet) and MemoPart® VSD Occluder (Single-rivet) have been commercialized[47] - MemoCarna® Oxide coating VSD occluder with single-rivet is in preparation for CE registration materials[47] - MemoSorb® full-degradable occluder systems are in preparation for initial overseas clinical trials[47] - MemoPart® PDA occluder (Double-rivet) and MemoPart® PDA occluder (Single-rivet) have been commercialized[49] - MemoCarna® Oxide coating PDA occluder is in preparation for CE registration materials[49] - MemoSorb® Biodegradable PFO occluder is undergoing supplementary materials submission for NMPA registration[49] - MemoLefort® LAA closure occluder systems have been commercialized[49] - The company has 16 commercially available CHD occluder products, with MemoCarna® III and MemoSorb® IV being key products[60] - The MemoSorb® biodegradable ASD occluder is expected to receive NMPA approval and be available for sale in the second quarter of 2024[60] - The MemoSorb® biodegradable PFO occluder is in the registration process and is expected to be approved by the NMPA within 2023[60] - The Bio-Lefort® biodegradable LAA occluder has entered the stage of multi-center clinical trial enrollment[60] - The company has six commercially available occluder-related procedural accessories, with the Snare II product expected to obtain a registration certificate and list for sale in the second half of 2023[62] - The company has built out 16 heart valve product candidates, with the TAVR system completing clinical trial enrollment in September 2022 and most patients completing six-month follow-ups with satisfactory results[62] - The ScienCrown® valve, with distinct structural advantages, is planned for a registration application to the NMPA by the end of 2023[62] - The transapical mitral valve clip system is in the final stage of clinical trial enrollment with satisfactory follow-up results[62] - The company has expanded into the mechanical circulatory support (MCS) devices field, with products in various stages of development, including the transcatheter left ventricular support system in preclinical type inspection preparation[63][64] - The company owns six types of valve-related procedural accessories, including a vascular closure device system with innovative design structure currently in preparation for inspection[65][66] - The company plans to continue developing new technologies and products targeting structural heart diseases, focusing on material innovation, structural design innovation, and production process optimization[69] - The company will leverage its market advantages in the CHD interventional devices field to increase the speed of iteration of innovative products and drive rapid business growth[70] - The company will promote the research and development of biodegradable occluder product candidates, including PFO and LAA occluders, to capitalize on growth potential in low penetration rate markets[70] - The company will focus on developing new technologies for structural heart disease, including material innovation, structural design innovation, and production process optimization, to enhance product innovation, functionality, and reliability[71] - The company is accelerating the R&D of the transfemoral mitral valve clip repair (TMVr-F) and the transcatheter mitral valve replacement system (TMVR) to achieve full coverage of mitral valve disease treatment[72] - The global market scale of MCS devices is expected to reach USD 3.4 billion in 2025, with a compound annual growth rate of 10.4% from 2021 to 2028[73] - The company is developing a surgically implantable sutureless heart valve and a transcatheter implantable aortic valve system for patients with simple aortic regurgitation, complementing the ScienCrown® transcatheter aortic valve replacement system[72] - The company has completed in-vitro durability tests for its artificial heart valve with polymer leaflets for more than 100 million times, showing promising results[72] - The market size of vascular closure devices in China is expected to increase from RMB 500 million in 2019 to RMB 4.5 billion in 2023, with a compound annual growth rate of 22.0%[75] - The company's radiofrequency atrial septal puncture system is in a leading position in China, with a potential treatment population of over 10 million[77] Subsidiaries and Investments - The company's subsidiary, Anhui Magete Medical Technology Co., Ltd., was established on November 22, 2016[6] - Lepu India, a wholly-owned subsidiary of Lepu Medical, was incorporated on April 30, 2016, in India[22] - Lepu Shanghai, a non-wholly owned subsidiary of Lepu Medical, was established on March 1, 2016, in China[23] - Ningbo Bingkun, a non-wholly owned subsidiary of Lepu Medical, was established on November 24, 2014, in China[23] - Ningbo Jiacheng, a shareholding platform for Lepu Medical Group employees, was established on February 22, 2021, in China[23] - Ningbo Jiadu, a shareholding platform for Lepu ScienTech employees, was established on February 22, 2021, in China[25] - Shanghai Shape Memory Alloy Co., Ltd. is a wholly-owned subsidiary established on May 5, 1994[26] - Sequoia Capital China Growth is a Pre-IPO investor incorporated under the laws of the Cayman Islands on April 12, 2021[26] Revenue Breakdown - Revenue increased from RMB222.6 million in 2021 to RMB247.7 million in 2022, representing an 11.3% growth[83][84] - CHD occluder products revenue grew from RMB132.5 million in 2021 to RMB182.7 million in 2022, accounting for 73.8% of total revenue[85][87] - ASD occluder products revenue increased from RMB99.8 million in 2021 to RMB136.2 million in 2022, representing 55.0% of total revenue[85][88] - VSD occluder products revenue rose from RMB19.8 million in 2021 to RMB28.5 million in 2022, accounting for 11.5% of total revenue[85][88] - PDA occluder products revenue increased from RMB12.9 million in 2021 to RMB

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]