报名：首届全球眼科大会 | 议程更新 报名：首届全球骨科大会 | 议程更新 报名：首届全球心血管大会 | 奖项申报 合作伙伴征集：2025全球手术机器人大会 心未来 2025年3月30日， 启明医疗 发布截至2024年12月31日止年度业绩公告。 # 财报数据 # 关于启明 医疗 启明医疗 是中国领先的心脏瓣膜微创介入治疗领域龙头企业，成立于2009年，总部位于杭州国家高新技术产 业开发区。公司专注于 结构性心脏病领域创新医疗器械的开发及商业化， 产品涵盖主动脉瓣、肺动脉瓣、二 尖瓣、三尖瓣等心脏瓣膜疾病，以及高血压肾动脉去交感神经消融术和手术配套产品等完整管线。 2024年公司实现营收 4.71亿 元，同比 下降4.2% 。 收入下降主要由于产品单价小幅下降及市场竞争加剧 所致。其中，主瓣产品VenusA系列实现收入3.80亿元，同比下降7.3%；肺瓣产品VenusP-Valve收入0.87 亿元，同比增长14.0%。经计算，公司H2实现收入2.20亿元，同比增长6.4%。 分地区来看， 2024年公司中国大陆实现收入3.88亿元， 同比下滑7.3%；海外地区实现收入0.83亿元，同 比增长13.5%，海外 ...

Core Viewpoint - The company reported a revenue of RMB 471 million for the fiscal year ending December 31, 2024, while focusing on the structural heart disease sector and enhancing its clinical development pipeline [1] Group 1: Financial Performance - The company achieved a revenue of RMB 471 million during the reporting period [1] Group 2: Product Development and Clinical Trials - The company has established a product pipeline consisting of ten innovative devices targeting heart valve diseases, with a focus on interventional treatments [2] - The product lineup includes four commercialized TAVR products and one TPVR product, along with two catheter-based surgical accessories [2] - Clinical trials are ongoing for new generation TAVR products and innovative devices that can be used for both TMVR and TTVR [2] Group 3: Clinical Milestones - The company has made significant progress in global clinical research projects, achieving multiple important milestones [1] - The first self-expanding TAVR product, Venus-PowerX, and the first balloon-expandable TAVR product, Venus-Vitae, have commenced clinical trials [1] - The Cardiovalve product has shown excellent safety and efficacy in key clinical studies in Europe, receiving positive feedback from overseas experts [1]

Financial Performance - Total revenue for the year ended December 31, 2024, was RMB 470,833,000, a decrease of 4.2% compared to RMB 491,373,000 in 2023[3] - Gross profit for the same period was RMB 367,746,000, down 5.5% from RMB 389,205,000 in 2023[3] - The company reported a net loss of RMB 717,373,000 for the year, a slight improvement of 1.6% compared to a loss of RMB 729,056,000 in 2023[3] - Non-IFRS commercial profit increased significantly by 112.6% to RMB 97,670,000, with a commercial profit margin of 20.7% compared to 9.3% in the previous year[3] - The company reported an adjusted non-IFRS EBITDA loss of RMB 253,671,000, an improvement of 45.6% compared to a loss of RMB 465,959,000 in 2023[3] - Other income decreased to RMB 33,999 thousand in 2024 from RMB 57,427 thousand in 2023, a decline of 40.7%[27] - The group reported a pre-tax loss attributable to equity holders of RMB 714,307,000 in 2024, compared to a loss of RMB 703,754,000 in 2023, indicating a slight increase in losses[41] - The company recognized a full impairment loss of RMB 73.6 million on its investment in Opus, reflecting significant uncertainty regarding its ongoing viability[101] - The impairment loss on intangible assets was fully recognized at RMB 62.0 million, compared to RMB 15.8 million in 2023, reducing the carrying amount to zero[103] - The net impairment loss on financial assets increased to RMB 21.4 million, up from a reversal of RMB 2.2 million in 2023, primarily due to provisions for other receivables[106] Research and Development - Research and development expenses decreased to RMB 341,185,000 from RMB 524,915,000, reflecting a reduction of 35%[6] - The company invested RMB 341.2 million and RMB 524.9 million in R&D for the years ending December 31, 2024, and December 31, 2023, respectively[74] - Research and development costs for the year ended December 31, 2024, were RMB 341.2 million, a reduction of 35.0% from RMB 524.9 million in the previous year[95] - The company is focused on optimizing its R&D pipeline to enhance efficiency and accelerate clinical progress in core areas[49] - The company has established three R&D centers in Hangzhou, Israel, and California to enhance global collaboration and innovation efficiency[72] Market Expansion and Product Development - The company plans to focus on market expansion and new product development to drive future growth[2] - The company has established a product pipeline consisting of ten innovative devices targeting heart valve diseases, including four commercialized TAVR products and several in clinical trials[52] - The company aims to continuously innovate and meet the growing demands of patients through the application of new technologies and materials[48] - The company is exploring potential mergers and acquisitions to enhance its product portfolio and market reach[160] - The company plans to expand its market presence in the United States and Europe, targeting a 25% increase in market share by 2025[160] Financial Position and Liquidity - The company’s cash and cash equivalents decreased to RMB 298,036,000 from RMB 774,396,000, indicating a significant reduction in liquidity[10] - Total non-current assets decreased to RMB 2,447,290,000 from RMB 2,805,647,000, a decline of 12.7%[10] - Total current liabilities decreased significantly to RMB 361,749 thousand from RMB 805,168 thousand in 2023, a reduction of 55.1%[24] - The company reported a total asset net value of RMB 440,731 thousand, down from RMB 802,899 thousand in 2023, a decrease of 45%[24] - The total borrowings of the group as of December 31, 2024, were RMB 283.0 million, down from RMB 705.9 million as of December 31, 2023[120] - The capital debt ratio as of December 31, 2024, was 16.7%, a decrease from 28.3% as of December 31, 2023[120] - The net current assets of the group as of December 31, 2024, were RMB 440.7 million, a decrease of 45.1% from RMB 802.9 million as of December 31, 2023[121] Corporate Governance and Compliance - The company is committed to maintaining compliance with corporate governance codes and has adhered to all mandatory provisions during the reporting period[137] - The audit committee has reviewed the financial information for the year ending December 31, 2024, and discussed internal controls and financial reporting matters with the independent auditor[145] - The company has not engaged in the purchase, sale, or redemption of any of its listed securities during the year ending December 31, 2024[139] Employee and Operational Changes - As of December 31, 2024, the company has a total of 691 employees, down from 865 employees as of December 31, 2023[132] - The company is implementing cost reduction and efficiency enhancement measures to significantly reduce losses in its valve membrane business[136] Future Outlook - The company plans to focus on its core heart valve business and has begun to divest from the healthcare industry park project due to changes in the real estate market[104] - The group anticipates increased cash flow from operations due to the growth of existing commercial product sales and the launch of new products[119] - The company aims to achieve a 30% reduction in production costs through new manufacturing technologies by 2024[160]

医疗器械的历史，是科技突破与医学进步交织的史诗。从公元前3400年战国时期的青铜"砭镰"，到18世纪的 手工骨锯、19世纪首台听诊器，再到20世纪人工心脏瓣膜等高精尖器械。这也是一场跨越世纪的产业角逐。 21世纪，全球医疗器械产业迈入高端化、全球化、资本化的新阶段。中国的医疗器械企业正在试图打破欧美 企业的长期垄断，但这也对自身组织能力、技术创新提出了更高要求。 在这场产业角逐中，启明医疗是如何选择产品赛道、制定国际化策略，并在企业治理层面优化自身，以适应全 球竞争的？ 思宇根据林总的访谈撰写本文给业内参考。毕竟，在医疗科技创新加速发展的今天，启明医疗的 探索不仅关乎自身的成长，也折射出整个中国医疗器械行业的未来趋势。 # 启明医疗的产品管线：创新、突破与聚焦 "从主动脉瓣到肺动脉瓣，再到二尖瓣、三尖瓣，我们的产品布局并非偶然，而是基于技术、专利和市场准入 的综合考量。"林浩昇在访谈中回忆道，"这些瓣膜治疗方案在技术上存在高度协同，适用于同一类手术体 系。当第一个产品成功落地并形成规模后，我们顺理成章地进行下一步的拓展。" 启明医疗的产品线布局，经历了 从单一主动脉瓣膜的突破到"四瓣一体"的协同，从国内市场主 ...

消息面上，近日，由启明医疗自主研发的自膨胀式经导管肺动脉瓣膜产品VenusP-Valve在澳大利亚 墨尔本权威医院The Royal Melbourne Hospital成功开展澳大利亚首例商业应用。公司表示，VenusP- Valve在这重要的市场实现了首例商业化植入，标志着这款全球首个且唯一在中国和欧洲获批上市的自 膨胀式肺动脉瓣膜产品已正式推开澳洲市场的大门。 启明医疗-B大涨超22% VenusP-Valve在澳大利亚成 功开展首例商业化植入 启明医疗-B(02500)大涨超22%，截至发稿，涨22.4%，报2.24港元，成交额3184.42万港元。 据悉，启明医疗的瓣膜业务仍展现出强劲韧性。在国内市场，公司在心脏瓣膜行业维持龙头地位， 产品不断取得创新突破：全球首款应用于经导管主动脉瓣置换术(TAVR)的全释放全回收干瓣系统Venus- PowerX已于2024年12月在华西医院完成注册临床研究的全球首例入组，该确证性临床试验的启动标志 着其向临床转化迈出关键一步，有望在今年完成全部患者的临床入组，成为公司的下一个增长点。 ...

Financial Performance - Revenue for the six months ended June 30, 2023, was RMB 230.72 million, a decrease of 9.7% compared to RMB 255.61 million in the same period last year[9]. - Gross profit for the same period was RMB 181.76 million, reflecting a 9.7% decline from RMB 201.25 million year-on-year[9]. - Loss before tax was RMB 213.58 million, a 42.3% improvement from a loss of RMB 370.34 million in the previous year[9]. - Net loss for the period was RMB 208.83 million, down 43.0% from RMB 366.22 million year-on-year[9]. - Non-IFRS commercial profit increased by 85% to RMB 34.13 million from RMB 18.43 million in the previous year[9]. - The company's losses attributable to the listed company decreased by 41% year-over-year for the first half of 2024[11]. - The non-IFRS EBITDA decreased by 48.7% year-over-year for the same period[11]. - The EBITDA for the six months ended June 30, 2024, was RMB (145.3) million, an improvement from RMB (283.1) million for the same period in 2023[43]. - The company reported a net loss of RMB 208,825,000 for the six months ended June 30, 2024, compared to a net loss of RMB 366,215,000 in the prior year, indicating a 42.9% improvement[104]. - The company reported a total comprehensive loss of RMB 195,123,000, compared to a loss of RMB 310,069,000 for the same period in 2023, indicating an improvement of approximately 37%[109]. Clinical and Product Development - The company has made significant progress in clinical trials, including the successful implantation of the VenusP-Valve in the U.S. as part of a pivotal study[10]. - The Cardiovalve product has shown excellent safety and efficacy in key clinical studies in Europe, receiving positive feedback from international experts[10]. - The company aims to continue focusing on structural heart disease, optimizing its R&D pipeline to enhance efficiency and clinical progress[10]. - The company has established a product pipeline consisting of ten innovative devices targeting heart valve diseases and hypertension[12]. - The VenusA series TAVR products have been commercialized in 13 countries and regions, with ongoing clinical trials for new generation TAVR products[13]. - VenusA-Valve, the first TAVR product approved in China, continues to demonstrate long-term safety and effectiveness in clinical follow-up studies[14]. - VenusP-Valve received CE MDR certification in April 2022 and NMPA approval in July 2022, marking it as the first self-expanding TPVR product approved in Europe and China respectively[15]. - The IDE (PROTEUS) pivotal clinical study for VenusP-Valve in the US is underway, with the first patient implanted in June 2024, aiming to enroll 60 participants[15]. - Venus-Vitae, the first balloon-expandable TAVR product, is entering the SMART-ALIGN global pivotal clinical trial phase, utilizing advanced anti-calcification technology for improved durability[16]. - Cardiovalve's clinical trial for mitral and tricuspid valve replacement is progressing, with nearly 100 patients enrolled in the TARGET CE pivotal trial across multiple countries[18]. Market Expansion and Revenue Generation - The number of TAVR implants reached approximately 2,300 units in the first half of the year, representing a 15% increase quarter-over-quarter[11]. - Overseas revenue from the Venus P-Valve product reached RMB 30.1 million, a year-over-year increase of 34%[11]. - The company expanded its commercial presence by entering 8 new countries, including Canada, Australia, India, Russia, and Singapore, bringing the total to 59 countries and regions[11]. - VenusA series products generated RMB 191.3 million in revenue, accounting for 82.9% of total revenue, while VenusP-Valve contributed RMB 38.3 million, representing 16.6%[28]. - Revenue from mainland China was RMB 200,620,000, down 13.9% from RMB 233,118,000 in the previous year[120]. - The revenue from other regions was RMB 30,100,000, an increase of 33.8% from RMB 22,492,000 in the previous year[120]. Financial Position and Assets - Total assets as of June 30, 2024, were RMB 3,402,412,000, down from RMB 3,608,546,000 as of December 31, 2023[106]. - Current assets decreased to RMB 1,095,145,000 from RMB 1,608,067,000, primarily due to a reduction in cash and cash equivalents[105]. - The company’s cash and cash equivalents were RMB 485,843,000, significantly lower than RMB 774,396,000 at the end of 2023[105]. - The total liabilities decreased to RMB 680,315,000 from RMB 689,200,000, reflecting a stable financial position[106]. - The company’s equity attributable to shareholders was RMB 2,725,525,000, down from RMB 2,920,648,000, indicating a decrease in shareholder value[106]. - The total interest-bearing bank borrowings decreased to RMB 395,571,000 as of June 30, 2024, down from RMB 705,907,000 at the end of 2023, representing a significant reduction of about 44%[134]. Governance and Compliance - The company has adopted and applied the principles and provisions of the corporate governance code, and has complied with the mandatory provisions during the reporting period[88]. - The board of directors currently consists of seven members, including three executive directors, two non-executive directors, and two independent non-executive directors, following the passing of an independent non-executive director[89]. - The company is in the process of identifying suitable candidates to fill the vacancy of independent non-executive director and related committee positions[89]. - The company is required to conduct a special audit and forensic investigation regarding unauthorized loans and other financial flows involving certain individuals and entities[94]. - The company has committed to timely disclosure of all significant information to shareholders and potential investors since the suspension of trading[98]. Employee and Shareholder Information - The total number of employees decreased to 778 as of June 30, 2024, from 1,006 as of June 30, 2023, with 652 based in China and 126 overseas[56]. - The total remuneration for key management personnel for the six months ended June 30, 2024, was RMB 4,273,000, a decrease from RMB 4,450,000 in the same period of 2023[142]. - The major shareholders include Horizon Binjiang LLC with 33,651,618 H shares, representing 7.63% of the total shares[66]. - The company has a significant ownership structure with various stakeholders, including Dinova Healthcare Delta Fund and Shenzhen Dinova, holding substantial shares[71][72]. Research and Development - The company has established three R&D centers located in Hangzhou, Tel Aviv, and Irvine, California, to enhance its global innovation capabilities[21]. - The company is focused on utilizing the proceeds from its fundraising efforts for strategic initiatives and operational enhancements[75][76][77]. - The company is actively pursuing market expansion and new product development strategies, although specific details were not disclosed in the provided content[175]. - The company is focused on enhancing its product offerings, particularly in the medical device sector, to align with regulatory standards such as CE MDR certification[175]. Legal and Regulatory Matters - The company has initiated arbitration proceedings against Xin Nuo Tong Investment Limited regarding unauthorized loans that remain unpaid[96]. - There were no significant litigation or arbitration matters during the reporting period[88]. - The company is subject to the EU Medical Device Regulation (MDR) 2017/745, which impacts its product compliance and market strategy[176].

Financial Performance - Revenue for the six months ended June 30, 2024, was RMB 230,720,000, a decrease of 9.7% compared to RMB 255,610,000 for the same period in 2023[2] - Gross profit for the same period was RMB 181,760,000, reflecting a 9.7% decline from RMB 201,249,000 year-over-year[2] - Loss before tax improved to RMB (213,581,000), a 42.3% reduction from RMB (370,339,000) in the prior year[2] - Net loss for the period was RMB (208,825,000), down 43.0% from RMB (366,215,000) in the previous year[2] - Non-IFRS commercial profit increased by 85% to RMB 34,131,000, compared to RMB 18,430,000 in the same period last year[2] - Non-IFRS EBITDA improved to RMB (145,286,000), a 48.7% reduction from RMB (283,098,000) year-over-year[2] - The basic and diluted loss per share attributable to ordinary shareholders was RMB (0.47), compared to RMB (0.80) in the same period last year, marking a 41.3% improvement[2] - The company's loss attributable to equity holders of the parent for the six months ended June 30, 2024, was RMB 206,487,000, compared to a loss of RMB 350,188,000 for the same period in 2023, representing a 41.0% improvement[22] Revenue Breakdown - Revenue from mainland China was RMB 200,620,000, down from RMB 233,118,000, reflecting a decline of 13.9%[13] - Revenue from other countries/regions increased to RMB 30,100,000, up 33.8% from RMB 22,492,000[13] - For the six months ended June 30, 2024, the company's revenue from medical equipment sales was RMB 230,720,000, a decrease of 9.7% compared to RMB 255,610,000 for the same period in 2023[13] - Revenue from VenusA series products accounted for 82.9% of total revenue, amounting to RMB 191.3 million, while VenusP-Valve contributed 16.6% with RMB 38.3 million for the six months ended June 30, 2024[52] Assets and Liabilities - Total assets as of June 30, 2024, were RMB 3,402,412,000, down from RMB 3,608,546,000 at the end of 2023[7] - Current liabilities decreased to RMB 494,350,000 from RMB 805,168,000 at the end of 2023[7] - Cash and cash equivalents were RMB 485,843,000, significantly lower than RMB 774,396,000 at the end of 2023[7] - The net current assets of the group as of June 30, 2024, were RMB 600.8 million, a decrease of 25.2% from RMB 802.9 million as of December 31, 2023[72] - The total borrowings of the group as of June 30, 2024, were RMB 395.6 million, down from RMB 705.9 million as of December 31, 2023, with a capital debt ratio of 18.3% compared to 28.3% previously[71] Operational Efficiency - The company is committed to improving operational efficiency and cost control, which is expected to enhance cash flow generation in the future[70] - The company aims to enhance operational efficiency and increase gross margin levels while controlling costs and optimizing resource allocation[84] - The company is focusing on cash flow management and may consider asset disposals and obtaining more bank credit to alleviate cash flow pressure[84] - The company has implemented new strategies to improve operational efficiency, aiming for a 10% reduction in production costs over the next year[92] Research and Development - The company invested RMB 180.8 million and RMB 294.7 million in R&D for the six months ending June 30, 2023, and 2024, respectively[43] - Research and development costs were RMB 180.8 million for the six months ended June 30, 2024, a reduction of 38.6% from RMB 294.7 million for the same period in 2023, primarily due to optimization of production line layout[57] - Research and development expenditures have increased by 15%, totaling RMB 300 million, to support innovation and new technology[92] - The company holds a total of 877 effective patents and patent applications, including 449 granted invention patents as of August 30, 2024[44] Market Expansion and Product Development - The company expanded its commercial presence by entering eight new countries, including Canada, Australia, and India, bringing the total to 59 countries and regions[30] - The company is actively pursuing market expansion strategies, targeting new regions in Europe and Asia to increase its market share[92] - New product development includes the launch of the Venus-PowerX Valve, which is currently in the research phase and expected to enhance the TAVR product line[93] - The company has completed a strategic acquisition of Cardiovalve Ltd., enhancing its product offerings in the aortic valve replacement market[92] Clinical Trials and Product Approvals - The company successfully completed the first patient implantation in the IDE pivotal clinical study for the VenusP-Valve product in the United States[29] - The IDE (PROTEUS) pivotal clinical study for VenusP-Valve in the U.S. is underway, with the first patient successfully implanted in June 2024, involving a total of 60 participants[36] - Venus-Vitae, the company's first balloon-expandable TAVR product, is set to enter the SMART-ALIGN global pivotal clinical trial phase, utilizing advanced anti-calcification technology[37] - The company has received CE MDR certification for its latest medical devices, ensuring compliance with European health and safety standards[91] Shareholder and Governance - The board of directors has proposed not to pay an interim dividend for the six months ending June 30, 2024, consistent with the previous year[85] - The company emphasizes the importance of protecting shareholder interests, particularly those of minority shareholders, amid ongoing challenges[84] - The audit committee has reviewed the interim financial results for the six months ending June 30, 2024, and found them to comply with relevant accounting standards[88] - The company is actively seeking suitable candidates to fill vacancies for independent non-executive directors to comply with listing rules[88]

Corporate Governance and Management Changes - The company appointed Lin Haosheng as the new General Manager effective November 20, 2023[4]. - The company has undergone significant changes in its board, with Hu Dingxu appointed as Chairman following the resignation of previous Chairman Zeng Min[4]. - The company has experienced changes in its board of directors, with several key resignations and appointments throughout 2023, including the resignation of the chairman and general manager[109][113]. - The board currently consists of seven directors, including three executive directors, two non-executive directors, and two independent non-executive directors, which does not meet the minimum requirements set by the listing rules[114]. - The company has established three board committees: the Audit Committee, the Remuneration and Assessment Committee, and the Nomination Committee[192]. - The company has a clear profit distribution plan and loss compensation strategy as part of its operational governance[184]. - The company has a structured approach to corporate governance, adhering to the corporate governance code and relevant regulations[194]. - The company is actively seeking suitable candidates to fill the vacancies of independent non-executive directors to comply with listing rules[114]. Financial Performance and Revenue Growth - Total revenue for the fiscal year ended December 31, 2023, reached RMB 491.37 million, an increase from RMB 406.46 million in 2022, representing a growth of approximately 20.9%[7]. - The company's total revenue for the year ended December 31, 2023, was RMB 491.4 million, an increase of 20.9% compared to RMB 406.5 million for the year ended December 31, 2022[32]. - Sales from the VenusA series products accounted for 83.4% of total revenue, while VenusP-Valve contributed 15.6% for the year ended December 31, 2023[33]. - The company's gross profit increased by 23.9% to RMB 389.2 million for the year ended December 31, 2023, compared to RMB 314.0 million for the previous year[35]. - The gross margin improved from 77.2% for the year ended December 31, 2022, to 79.2% for the year ended December 31, 2023, primarily due to economies of scale in production[35]. - Other income and gains for the year ended December 31, 2023, amounted to RMB 241.6 million, an increase of 63.2% compared to RMB 148.0 million for the year ended December 31, 2022, primarily due to fair value adjustments related to the acquisition agreement with Nuocheng[36]. Product Development and Market Expansion - The company is focusing on expanding its market presence and enhancing its product offerings[2]. - The company is committed to developing new technologies and products to strengthen its competitive position in the market[2]. - The company aims to deepen its international market expansion and enhance its commercialization pipeline through innovative product development[10]. - The company has established a product pipeline consisting of 12 innovative devices targeting heart valve diseases, hypertrophic cardiomyopathy, and hypertension[11]. - VenusP-Valve has entered over 50 countries and regions, including Germany, France, the UK, Italy, Spain, Australia, and Canada, with ongoing international expansion efforts[6]. - The company is actively pursuing strategic initiatives, including potential mergers and acquisitions, to drive growth[2]. - The company is focusing on expanding its product pipeline and enhancing its market position with innovative technologies and clinical trials[14][15][17][18]. Clinical Trials and Research - The company is advancing the Cardiovalve Target CE clinical trial for tricuspid valve replacement, with over 70 patients enrolled across more than 20 renowned centers in Europe and North America[6]. - The Venus-Vitae and Venus-PowerX products are in the critical clinical trial phase, with early feasibility studies completed in Argentina and Chile[12]. - The Liwen RF system for treating hypertrophic cardiomyopathy has completed patient enrollment for critical clinical studies[12]. - Cardiovalve's clinical trial for TMVR/TTVR products is progressing rapidly, with over 70 patients enrolled in the TARGET CE pivotal trial across more than 20 medical centers in the UK, Germany, Italy, and Canada[20]. - The Liwen RF radiofrequency ablation system achieved a treatment success rate of 86.1% (68/79) in a follow-up of 79 patients six months post-surgery, significantly improving key clinical endpoints[21]. Financial Challenges and Losses - The company reported a pre-tax loss of RMB 735.34 million for 2023, an improvement from a loss of RMB 1,156.34 million in 2022[7]. - The basic and diluted loss per share for 2023 was RMB 1.61, compared to RMB 2.42 in 2022, reflecting a reduction in losses[7]. - The company has faced cumulative losses since its establishment and anticipates potential future losses due to the high-risk nature of the medical device industry[71]. - Future growth is heavily dependent on the successful development and commercialization of its pipeline products, with significant risks associated with clinical trials and regulatory approvals[71]. Regulatory Compliance and Risk Management - The company is required to conduct a special audit and forensic investigation regarding loans provided to certain individuals and disclose the findings[62]. - Regulatory compliance is critical, as delays in obtaining necessary approvals could severely impact the commercialization of pipeline products[73]. - The company recognizes that risk management is crucial for business success, facing operational risks related to the medical device market and regulatory changes in China and globally[81]. - The audit committee oversees the overall risk management related to business operations, including reviewing and approving risk management policies and monitoring significant risks[82]. - The company has adopted a comprehensive risk management policy to identify, assess, and monitor key risks related to strategic objectives on a continuous basis[83]. Shareholder and Ownership Structure - As of December 31, 2023, the total issued share capital of the company is 441,011,443 shares, consisting of 441,010,235 H shares and 1,208 non-listed foreign shares[134]. - Major shareholder Mr. Zeng holds 33,651,618 H shares, representing 7.63% of the total issued share capital[136]. - The company has a diverse shareholder base, with multiple entities holding significant stakes, including Qiming Venture Partners III, L.P. with 40,018,283 H shares, or 9.07%[137]. - The total percentage of H shares held by major shareholders indicates a concentrated ownership structure, with the top three shareholders holding over 27% of the total shares[136][137]. Corporate Social Responsibility and Environmental Compliance - The company emphasizes sustainable and environmentally friendly practices, aiming to minimize its carbon footprint[103]. - The company has complied with all relevant environmental laws and regulations during the reporting period[103]. - The group reported charitable donations amounting to RMB 42.8 million during the reporting period, a decrease from RMB 70.3 million in the previous year[149]. Marketing and Sales Strategies - The company utilizes a strategic marketing model to promote its products through partnerships with hospitals and leveraging its opinion leader network for academic marketing in China[105]. - The company actively participates in significant cardiology conferences in China, showcasing product innovations and providing training on TAVR and TPVR procedures[106]. - The marketing efforts primarily target large tertiary hospitals, which have more resources for interventional cardiac valve procedures compared to smaller hospitals[106]. - The company relies on opinion leaders to introduce and recommend its products to physicians and hospitals, enhancing clinical benefits through academic incentives[106].

Financial Performance - Revenue for the year ended December 31, 2023, was RMB 491,373,000, representing a 20.9% increase compared to RMB 406,461,000 in 2022[2] - Gross profit for the year was RMB 389,205,000, up from RMB 313,998,000 in the previous year, reflecting a 24.0% increase[2] - Loss before tax decreased to RMB 752,462,000, a 34.9% improvement from RMB 1,156,344,000 in 2022[2] - Net loss for the year was RMB 746,178,000, down 33.5% from RMB 1,122,042,000 in the prior year[2] - Loss attributable to equity holders of the parent company was RMB 720,876,000, a reduction of 31.8% compared to RMB 1,057,699,000 in 2022[2] - Basic and diluted loss per share improved to RMB (1.65) from RMB (2.42) in the previous year, marking a 31.8% decrease in loss per share[2] - Total revenue for 2023 reached RMB 491,373,000, an increase of 20.9% compared to RMB 406,461,000 in 2022[17] - Revenue from mainland China was RMB 418,699,000, up 18.1% from RMB 354,567,000 in the previous year[15] - The company reported a significant increase in trade payables, which rose to RMB 33,855,000 from RMB 9,126,000, a growth of 270.5%[9] - The company’s total equity decreased to RMB 2,902,224,000 from RMB 3,631,311,000, reflecting a decline of 20.1%[9] Assets and Liabilities - Non-current assets totaled RMB 2,805,647,000, slightly down from RMB 2,813,865,000 in 2022[8] - Cash and cash equivalents decreased significantly to RMB 774,396,000 from RMB 1,879,431,000 in the previous year[8] - Trade receivables were RMB 290,607,000, down from RMB 303,388,000 in 2022[8] - Current liabilities increased significantly to RMB 805,168,000, compared to RMB 492,104,000 in 2022, marking a 63.7% rise[9] - The company's net asset value decreased to RMB 2,902,224,000 from RMB 3,631,311,000, a decline of 20.1% year-over-year[9] - The company’s total non-current liabilities decreased to RMB 689,200,000 from RMB 1,159,420,000, a reduction of 40.5%[9] - The expected revenue to be recognized within one year is RMB 28,842,000, compared to RMB 2,952,000 in the previous year, indicating a significant increase[19] Research and Development - Research and development costs for 2023 are RMB 524,915,000, slightly down from RMB 527,451,000 in 2022[22] - The company is increasing R&D investment in structural heart disease, focusing on innovative solutions to clinical pain points, and aims to maintain its leading position in the valve market[53] - The company has established a product pipeline consisting of 12 innovative devices targeting heart valve diseases, hypertrophic cardiomyopathy, and hypertension[39] - The company is advancing key clinical studies for its Cardiovalve product, with patient enrollment progressing smoothly[38] Product Development and Market Expansion - The first self-developed product, VenusP-Valve, has been approved for clinical research in the US, marking a significant milestone as the first Chinese artificial heart valve product to receive such approval[38] - The company has expanded its TAVR product sales to 10 countries and regions in Asia-Pacific and Latin America, enhancing its international market presence[37] - The VenusA series includes three commercialized TAVR products: VenusA-Valve, VenusA-Plus, and VenusA-Pro, with approvals in 10 countries including China, Asia-Pacific, and Latin America[40] - The company is advancing the VenusP-Valve in the US PROTEUS pivotal clinical trial, having received FDA approval for the IDE application in July 2023[46] - The company plans to continue expanding its international market through innovative product development and proactive commercialization strategies[37] Financial Management and Governance - The company has adopted corporate governance codes and has been providing monthly financial updates to the board since June 2023[103] - All directors and supervisors have confirmed compliance with the securities trading code of conduct for the year ending December 31, 2023[104] - The audit committee has reviewed the financial information for the year ending December 31, 2023, in accordance with the listing rules[106] - The board has proposed not to declare a final dividend for the year ending December 31, 2023[110] Employee and Operational Insights - The company has a total of 865 employees, with 735 located in China and 130 overseas, primarily in the United States and Israel[97] - The company has built a sales team of nearly 220 people, covering over 550 hospitals in China, enhancing its market presence[59] - The company participated in 52 third-party conferences and hosted 35 self-organized meetings in 2023, reaching over 3,900 experts and accumulating 850,000 views[59] Future Outlook - The company provided guidance for the next fiscal year, projecting a revenue growth of 20% and an EBITDA margin of 35%[118] - The company aims to expand in both Chinese and global markets through internal development, mergers, and acquisitions, supported by sufficient bank credit facilities[98] - The company is committed to addressing unmet medical needs and will continue to focus on international sales and clinical research in the structural heart disease treatment field in 2024[101]

Financial Performance - Revenue for the first half of 2023 reached RMB 255.61 million, representing a 21.7% increase compared to RMB 209.97 million in the same period of 2022[9]. - Gross profit for the same period was RMB 201.25 million, up 22.6% from RMB 164.18 million year-on-year[9]. - The company reported a pre-tax loss of RMB 370.34 million, a 50.3% increase from RMB 246.41 million in the previous year[9]. - The net loss for the first half of 2023 was RMB 366.22 million, reflecting a 52.8% increase compared to RMB 239.67 million in the same period of 2022[9]. - The loss attributable to equity holders of the parent company was RMB 350.19 million, a significant increase of 75.2% from RMB 199.93 million year-on-year[9]. - Revenue for the six months ended June 30, 2023, was RMB 255,610 thousand, representing a 21.7% increase from RMB 209,965 thousand in the same period of 2022[130]. - Gross profit for the same period was RMB 201,249 thousand, up from RMB 164,175 thousand, indicating a gross margin improvement[113]. - The net loss for the six months ended June 30, 2023, was RMB 366,215 thousand, compared to a net loss of RMB 239,668 thousand in the same period of 2022, representing a 52.7% increase in losses[113]. Research and Development - The company has invested RMB 294.7 million in R&D for the six months ended June 30, 2023, compared to RMB 220.3 million for the same period in 2022, reflecting a significant increase in R&D expenditure[25]. - Research and development costs increased to RMB 294,715 thousand, compared to RMB 220,316 thousand in the prior year, reflecting a 33.6% rise[113]. - The company is planning to enter two new international markets by the end of 2023, aiming to increase its global footprint[189]. - The company plans to continue its focus on research and development of biological heart valves, which is its primary business segment[124]. Product Development and Pipeline - The company has successfully established a product pipeline consisting of twelve innovative devices targeting heart valve diseases, hypertrophic cardiomyopathy, and hypertension[11]. - The Venus P-Valve product has been approved for commercialization in 30 countries, including Germany, and received FDA IDE approval for clinical research in the United States[10]. - The company is advancing its international clinical studies for innovative products such as Venus-Vitae and Venus-PowerX as planned[10]. - The Cardiovalve product is currently undergoing critical clinical research, with patient enrollment ongoing[10]. - The new generation TAVR product, Venus-Vitae, is set to enter the SMART-ALIGN global pivotal clinical trial phase, utilizing advanced anti-calcification technology[18]. - Venus-PowerX, the first self-expanding dry valve, is in early feasibility studies and will soon enter the IMPACT global pivotal clinical trial phase[19]. - The company aims to develop new materials, bionics, imaging fusion technology, and digital sensing to enhance its product offerings and meet patient needs[10]. Market Expansion and Sales - As of June 30, 2023, sales revenue for the VenusA series products reached RMB 229.8 million, a 16.9% increase from RMB 196.6 million for the same period in 2022[15]. - VenusP-Valve sales revenue for the six months ended June 30, 2023, was RMB 25.2 million, up from RMB 9.1 million for the same period in 2022, representing an increase of RMB 16.1 million[18]. - The company has expanded its sales coverage to 30 countries and regions, including Germany, France, and the UK[29]. - The company is actively pursuing market expansion and product development strategies across multiple jurisdictions[74]. Financial Position and Cash Flow - As of June 30, 2023, the total cash and cash equivalents were RMB 1,453.2 million, a decrease of 22.7% from RMB 1,879.4 million as of December 31, 2022, primarily due to increased R&D and operating expenses[47]. - The total interest-bearing bank borrowings amounted to RMB 778.7 million as of June 30, 2023, compared to RMB 796.0 million as of December 31, 2022, with all borrowings being at floating rates[48]. - The net current assets as of June 30, 2023, were RMB 1,473.0 million, a decrease of 25.5% from RMB 1,976.9 million as of December 31, 2022[49]. - The company experienced a net cash decrease of RMB 437,780,000, with cash and cash equivalents at the end of the period totaling RMB 1,453,165,000, down from RMB 2,121,267,000 a year earlier[123]. Corporate Governance and Compliance - The company has adopted and applied the principles of the corporate governance code, addressing previous compliance issues[106]. - The internal control review conducted by Zhonghui Anda highlighted key areas for operational improvement, which the company is actively addressing[189]. - The company has implemented enhanced internal control measures in response to identified concerns, including revised cash management and internal investigation procedures[104]. - The company has established internal control procedures for handling related party transactions, requiring approval from the general manager for exempt transactions under Listing Rule Chapter 14A[90]. Shareholder Information - The board has proposed not to declare an interim dividend for the six months ending June 30, 2023[60]. - As of June 30, 2023, the total issued share capital of the company is 441,011,443 shares, including 441,010,235 H-shares and 1,208 non-listed foreign shares[66]. - The stock option plan was approved at the extraordinary general meeting on July 12, 2023, allowing for the issuance of up to 44,101,023 H shares, representing approximately 10% of the total issued H shares[82]. Strategic Initiatives - The company plans to conduct international multi-center clinical trials for Venus-Vitae and Venus-PowerX in Europe and other regions to facilitate global market approval[19]. - The company aims to become a leader in the global structural heart disease intervention field, focusing on "international localization and local profitability" as part of its long-term strategy[56]. - The company has completed a strategic acquisition of a smaller competitor, which is projected to enhance its market share by 10%[189].