Financial Performance - The company reported a revenue of RMB 5.0 billion for the fiscal year 2024, representing a year-over-year increase of 15%[19] - The company reported a net profit margin of 18% for 2024, an increase from 15% in the previous year[19] - Revenue for the year ended December 31, 2024, reached RMB 361,565 thousand, an increase of 7.9% compared to RMB 336,215 thousand in 2023[49] - Gross profit for 2024 was RMB 251,210 thousand, up from RMB 229,931 thousand in 2023, reflecting a growth of 9.2%[49] - Operating loss improved to RMB (62,620) thousand in 2024 from RMB (313,651) thousand in 2023, indicating a significant reduction in losses[49] - The company reported a net loss of RMB (53,267) thousand for 2024, significantly improved from a net loss of RMB (471,534) thousand in 2023[49] - Basic and diluted loss per share for 2024 was RMB (0.02), an improvement from RMB (0.20) in 2023[49] Market Expansion and Strategy - The company plans to expand its market presence in Southeast Asia, targeting a 25% increase in market share by 2026[28] - The company aims to expand its market presence through strategic acquisitions and partnerships in the healthcare industry[18] - The company is focused on expanding its market presence and enhancing its R&D capabilities, particularly in the field of cardiovascular medical devices[51] - The company plans to deepen its market share in the global structural heart disease treatment sector through enhanced hospital coverage and patient screening initiatives in 2025[47] - The company plans to enhance its TAVI product sales in China, where market penetration is significantly low, by increasing promotion efforts for its left atrial appendage occluder products[117] - The company plans to expand its overseas business by hiring local agents or distributors to penetrate local markets[173] Research and Development - The company has invested RMB 200 million in R&D for new technologies, focusing on minimally invasive surgical devices[28] - The company is focused on research and development (R&D) to enhance its product offerings in the medical technology sector[20] - The company emphasizes research and development, aiming to establish a technology innovation system that integrates industry, academia, and research[33] - The company is actively pursuing clinical trials, including first-in-man (FIM) studies for its innovative medical products[14] - The company is developing a TMVR product for MR patients, with multiple human implantations completed and ongoing clinical applications[101] - The company is in the design phase for the fourth generation of the VitaFlow series, focusing on safety and effectiveness improvements[99] Product Development and Innovation - New product launches included the AccuSniper™ and AltaValve™, expected to contribute an additional RMB 500 million in revenue in 2025[28] - The company has established a comprehensive innovation R&D layout covering TAVI products, left atrial appendage occluders, TMV products, TTV products, and surgical support products[36] - The company’s R&D efforts have led to the approval of the VitaFlow Liberty®Flex, a unique self-expanding transcatheter aortic valve delivery system, further solidifying its leadership in the TAVI field[46] - The company is focusing on efficient resource integration and project planning to accelerate the development of revenue-generating products while achieving long-term R&D milestones[87] - The product pipeline includes seven certified products and various TAVI, TMVR, and left atrial appendage products at different development stages[88] Acquisitions and Partnerships - A strategic acquisition of 4C Medical Technologies, Inc. was announced, expected to enhance the company's product portfolio and increase revenue by 30% over the next three years[28] - The company is involved in the acquisition of Shanghai Zuoxin, with a share transfer agreement dated January 1, 2024, related to this acquisition[18] - The company successfully acquired 51% of Shanghai ZuoXin, enhancing its commercialization capabilities for new products like AnchorMan®[43] - The company has entered into a share transfer agreement to acquire 51% of Shanghai Zoxin for approximately RMB 141.32 million, making it a subsidiary[112] Regulatory Compliance and Certifications - The company is committed to complying with the Corporate Governance Code as per the Listing Rules[12] - The company’s products are certified under CE marking, indicating compliance with health, safety, and environmental standards in the European Economic Area[12] - The VitaFlow Liberty® product received CE certification, becoming the first "Made in China" TAVI system approved for the European market[42] - The AnchorMan® system is the only left atrial appendage occlusion device in China to receive both NMPA and CE certifications[85] Financial Stability and Investments - The company has secured a credit facility of RMB 5 million from Bank of Communications, aimed at supporting operational expansion[10] - The company has a loan agreement with Kowei Medical for a principal amount of RMB 10 million, with a term of two years starting from the drawdown date[16] - Total assets as of December 31, 2024, amounted to RMB 2,675,762 thousand, a slight increase from RMB 2,577,108 thousand in 2023[50] - Total liabilities decreased to RMB 454,073 thousand in 2024 from RMB 242,245 thousand in 2023, indicating improved financial stability[50] Employee and Management Insights - Wu女士 has over 13 years of experience in the medical industry and private equity investment, currently serving as Managing Director at CICC Capital since January 2019[60] - Zhou Mr. has over 30 years of international banking experience and has held senior financial positions in Fortune 500 companies, including CFO at UTAC Holdings Ltd.[61] - Yao Ms. joined the group as Senior Director of R&D on February 1, 2024, with over ten years of experience in high-risk cardiovascular implant product development[69] - The company has a total of 430 full-time employees as of December 31, 2024, with 10.70% in R&D and 36.74% in marketing and sales[111] Market Trends and Challenges - In 2024, the structural heart disease industry in China is steadily growing due to policy support, market demand, and medical insurance access, despite facing complex economic conditions and intensified competition[84] - The number of qualified surgical centers for TAVI procedures has increased, leading to a further rise in surgical penetration rates[84] - The left atrial appendage occlusion procedure has seen significant advancements in evidence-based research, clinical applications, and new technology development, contributing to rapid growth in surgical volume[84] Corporate Social Responsibility - The company is committed to sustainable development and compliance with environmental laws and regulations in China[163] - The group made charitable donations amounting to RMB 38.0 million for the year ending December 31, 2024[185]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確 性或完整性亦不發表任何聲明，並明確表示，概不就因本公告全部或任何部分內容而產生或 因依賴該等內容而引致的任何損失承擔任何責任。 | 財務摘要 | | | | | | | --- | --- | --- | --- | --- | --- | | | | | | 截至12月31日止年度 | | | | | | | 2024年 | 2023年 | | | | | | 人民幣千元 | 人民幣千元 | | 收入 | | | | 361,565 | 336,215 | | 毛利 | | | | 251,210 | 229,931 | | 來自經營的虧損 | | | | (62,620) | (313,651) | | 年內虧損 | | | | (53,267) | (471,534) | | 每股虧損 | — | 基本及攤薄 | （人民幣元） | (0.02) | (0.20) | – 1 – 截至2024年12月31日止年度，本集團收入為人民幣361.6百萬元，相比於截至 2023年12月31日止年度的人民幣336.2百萬元增加了7.5 ...

MicroPort" 心 通 医 疗 MicroPort CardioFlow Medtech Corporation 微创心通医疗科技有限公司 (於開曼群島註冊成立的有限公司) 股份代碼 : 2160 期 報 目錄 2 釋義及技術詞彙表 8 公司資料 9 總裁報告 11 財務摘要 12 管理層討論及分析 27 企業管治及其他資料 54 核數師致董事會的獨立審閱報告 55 綜合損益表 56 綜合損益及其他全面收益表 57 綜合財務狀況表 59 綜合權益變動表 61 簡明綜合現金流量表 62 未經審核中期財務報告附註 釋義及技術詞彙表 | --- | --- | --- | |--------------------------------|-------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ ...

Financial Performance - For the six months ended June 30, 2024, the company recorded revenue of RMB 223.1 million, an increase of 26.5% compared to RMB 176.4 million for the same period in 2023[3]. - Gross profit rose to RMB 158.2 million, representing a 35.7% increase from RMB 116.6 million in the previous year, with the gross margin improving by 4.8 percentage points to 70.9%[3]. - The company reported a net loss of RMB 57.8 million, significantly reduced from a loss of RMB 179.4 million in the same period last year, driven by revenue growth and improved operational efficiency[3]. - Revenue increased by 26.5% from RMB 176.4 million for the six months ended June 30, 2023, to RMB 223.1 million for the six months ended June 30, 2024, driven by increased sales of TAVI products and the launch of new products[33]. - Revenue from medical device sales for the six months ended June 30, 2024, was RMB 223,138,000, representing a 26.4% increase from RMB 176,442,000 for the same period in 2023[63]. - Revenue from external customers in China was RMB 215,008,000 for the six months ended June 30, 2024, up 26.4% from RMB 170,148,000 in the same period of 2023[65]. - The company reported a basic and diluted loss per share of RMB 0.02, improved from RMB 0.08 in the previous year[57]. - The company incurred total operating costs of RMB 29,008,000 for donations and other expenses for the six months ended June 30, 2024, down from RMB 37,918,000 in the same period of 2023[68]. Product Development and Innovation - The TAVI product line saw over 10% growth in implant volume, with the company expanding its coverage to over 600 hospitals in China[4]. - The company acquired a 51% stake in Shanghai Zoxin, which has developed the AnchorMan® left atrial appendage occlusion system, marking an entry into a high-growth segment of the structural heart disease market[4]. - The VitaFlow Liberty® product received CE certification and has begun commercial implantation in Europe, contributing to overseas revenue growth[4]. - The company is advancing the development of the third-generation TAVI product, VitaFlow Liberty® Flex, aimed at enhancing treatment outcomes[5]. - The AltaValve™ product, developed in collaboration with partners, received two breakthrough device designations from the FDA for treating mitral regurgitation[5]. - The product pipeline includes six certified products and several others in various stages of development, indicating a robust innovation strategy[6]. - The company is focused on accelerating new product development in the structural heart disease market, including TAVI and next-generation surgical support products[27]. - The company is actively involved in R&D for TAVI and TMVR technologies, aiming to expand its product offerings in minimally invasive procedures[103]. - The introduction of the VitaFlow® system, which includes PAV and an electric delivery system, is expected to enhance procedural efficiency[104]. Market Expansion and Strategy - The company is actively pursuing registrations for its products in various international markets, including Saudi Arabia and Malaysia, to expand its global footprint[5]. - VitaFlow Liberty® has received CE marking and registration approvals in nine overseas countries, supporting the company's international strategy[26]. - The company plans to register VitaFlow Liberty® in emerging markets such as Brazil and South Korea[11]. - The company plans to enhance its TAVI product sales in China by deepening hospital coverage and improving patient referral processes, targeting underdeveloped patient needs, especially in lower-tier cities[23]. - The company aims to strengthen its market share of the left atrial appendage occluder products in China, leveraging its clinical results and experience in the structural heart disease field[25]. - The company is exploring strategic acquisitions to bolster its market presence and product portfolio[100]. - The company has established a distribution framework agreement with KOWE Medical, granting exclusive rights to distribute KOWE products in China[32]. Research and Development - The company has established a core R&D team of approximately 90 members focused on innovative technologies and materials for structural heart disease treatments[16]. - During the reporting period, the company obtained 5 new patent grants and has 20 pending patent applications in China, with a total of 185 granted patents in the country[18]. - The company has filed for 168 pending patent applications globally, including 147 invention patents, to support its internationalization strategy[18]. - Research and development costs decreased by 24.1% from RMB 1,095 million for the six months ended June 30, 2023, to RMB 831 million for the six months ended June 30, 2024[37]. Operational Efficiency - The company has implemented a quality management system and introduced operational excellence (OPEX) principles to enhance manufacturing efficiency[19]. - The company will implement full product lifecycle management to enhance operational efficiency and reduce manufacturing costs while maintaining product quality[29]. - The production facility in Shanghai has an annual capacity of 25,000 TAVI products and 6,000 left atrial appendage occluders, ensuring a solid supply chain for future growth[19]. - The company has a treatment solution promotion team of nearly 200 full-time employees, enhancing market access and operational support for structural heart disease treatments[21]. Financial Position and Stability - Trade and other receivables increased by 48.3% from RMB 1,448 million as of December 31, 2023, to RMB 2,147 million as of June 30, 2024, primarily due to increased sales[47]. - Trade and other payables increased by 19.0% from RMB 1,529 million as of December 31, 2023, to RMB 1,820 million as of June 30, 2024, mainly due to payables related to the acquisition of Shanghai ZuoXin[49]. - Cash and cash equivalents decreased from RMB 1,773.7 million as of December 31, 2023, to RMB 1,560.4 million as of June 30, 2024, due to ongoing business expansion[53]. - The company's capital debt ratio increased to 4.1% as of June 30, 2024, from 3.0% as of December 31, 2023, primarily due to borrowings from the subsidiary Shanghai ZuoXin[54]. - Total liabilities decreased to RMB 1,893,518 thousand from RMB 2,041,336 thousand, indicating improved financial stability[59]. - The company's equity attributable to shareholders decreased to RMB 2,160,631 thousand from RMB 2,334,863 thousand as of December 31, 2023[60]. Governance and Compliance - The company has adopted the Corporate Governance Code and has complied with its mandatory provisions during the reporting period[84]. - The audit committee has reviewed the unaudited interim results for the six months ended June 30, 2024, and confirmed compliance with relevant accounting standards and regulations[91]. - The interim financial report for the six months ended June 30, 2024, has been reviewed by KPMG in accordance with the Hong Kong Institute of Certified Public Accountants' standards[92]. - The board of directors includes experienced professionals, ensuring strong governance and strategic direction[105].

股份代碼：2160 2023 年 報 年報 2023 C M Y CM MY CY CMY K ai1713356568134_CARDIOFLOW-B AR2023 Cover 14.5mm CHI OP.pdf 1 17/4/2024 下午8:22 目錄 2 釋義及技術詞彙表 10 公司資料 12 公司簡介 13 主席致辭 15 財務摘要 16 董事及高級管理層履歷 23 管理層討論及分析 38 董事會報告 83 企業管治報告 100 2023年環境、社會及管治報告 149 獨立核數師報告 157 綜合損益表 158 綜合損益及其他全面收益表 159 綜合財務狀況表 161 綜合權益變動表 162 綜合現金流量表 164 財務報表附註 釋義及技術詞彙表 2 微創心通醫療科技有限公司 「2022年設備採購框架協議」 指 上海微創心通與Medical Product Innovation訂立的日期為2022年6月23日的2022 年設備採購框架協議，據此，上海微創心通同意自Medical Product Innovation採 購與我們的產品研發及製造有關的相關設備，期限由2022年6月23日起至2024年 ...

Financial Performance - For the year ended December 31, 2023, the company's revenue was RMB 336.2 million, an increase of 33.9% compared to RMB 251.0 million for the year ended December 31, 2022[3]. - Gross profit rose to RMB 229.9 million, up 41.8% from RMB 162.1 million in the previous year, with a gross margin increase of 3.8 percentage points to 68.4%[3]. - The company recorded a loss attributable to equity shareholders of RMB 471.5 million, compared to a loss of RMB 454.4 million in the previous year[3]. - Other net income increased to RMB 91.8 million for the year ended December 31, 2023, from RMB 50.3 million for the year ended December 31, 2022, primarily due to increased interest income from bank deposits[37]. - The net loss for the year ended December 31, 2023, was RMB 471,534 thousand, compared to a net loss of RMB 454,395 thousand in 2022, showing a slight increase in losses[59]. - The company's equity decreased from RMB 2,753,715 thousand as of December 31, 2022, to RMB 2,334,863 thousand as of December 31, 2023, reflecting a decline in shareholder value[60]. - The company did not declare any dividends for the year ended December 31, 2023, consistent with the previous year[90]. Product Development and Innovation - The company plans to launch a third-generation TAVI product with an upgraded adjustable delivery system, which has already been submitted for registration to NMPA[6]. - The AccuSniperTM dual-layer balloon dilation catheter received NMPA registration approval, becoming the world's only dual-layer valve balloon dilation catheter[6]. - The company is focused on addressing technical bottlenecks and clinical pain points in existing TAVI products through strategic R&D initiatives[6]. - The company completed the early feasibility study of the TMVR product AltaValveTM overseas and submitted an IDE application to the FDA, aiming to become the first global solution for mitral valve regurgitation treatment that requires only the atrium[7]. - The company has a product pipeline that includes six approved products, such as VitaFlow® and VitaFlow Liberty®, along with various TAVI, TMV, TTV, and left atrial appendage products at different development stages[8]. - The company is designing a third-generation TAVI product that inherits all advantages of VitaFlow Liberty® and aims to enhance usability and surgical efficiency[13]. - The company is developing the fourth-generation TAVI product, focusing on safety, effectiveness, and usability, currently in the design phase[14]. - The TMVR product for treating mitral valve regurgitation has completed multiple human implantations and is accelerating clinical application and verification[16]. - The R&D team consists of approximately 90 members, focusing on innovative technologies and materials applicable to the product portfolio[17]. - The company has obtained 20 new patents in China and 21 patents in other countries during the reporting period, totaling 153 granted patents in China[19]. Market Expansion and Sales - The number of hospitals in China where the company's TAVI products are used increased by approximately 27%, reaching a total of 117 new hospitals[5]. - TAVI product implantations in China grew by approximately 45% compared to the previous year[5]. - The company achieved a 58.9% increase in revenue from overseas sales of TAVI products, with products entering nearly 100 hospitals in Argentina, Colombia, Thailand, and Russia[3]. - The company plans to enhance its TAVI product sales in China by deepening hospital coverage and improving patient referral processes[25]. - The company aims to expand its international strategy, with VitaFlow Liberty® registered in several countries including Argentina and Colombia, and CE registration in the final review process[27]. - The company plans to expand its operations into Southeast Asia, targeting a market share increase of 10% within the next two years[114]. - The introduction of the VitaFlow® system is expected to capture a significant share of the TAVI market, with projected sales of 500 million HKD in the first year post-launch[115]. Cost Management and Operational Efficiency - The sales cost increased by 19.6% to RMB 106.3 million for the year ended December 31, 2023, from RMB 88.9 million for the year ended December 31, 2022, mainly due to higher raw material, labor, and manufacturing costs associated with increased sales volume[35]. - Distribution costs rose by 38.7% to RMB 223.0 million for the year ended December 31, 2023, from RMB 160.8 million for the year ended December 31, 2022, mainly due to increased employee costs and marketing expenses[40]. - Administrative expenses decreased by 2.5% to RMB 70.2 million for the year ended December 31, 2023, from RMB 72.0 million for the year ended December 31, 2022, due to cost-saving efforts[41]. - The company has successfully reduced production costs by 12% through improved manufacturing processes and supply chain optimization[113]. - The company plans to implement full product lifecycle management to improve operational efficiency and reduce manufacturing costs[31]. Strategic Acquisitions and Collaborations - The company acquired a 51% stake in Shanghai Zuoxin, which has developed the AnchorMan® left atrial appendage occlusion system, approved by NMPA on January 5, 2024, making it the only semi-closed left atrial appendage occlusion product approved in China[7]. - On January 1, 2024, the company agreed to acquire 51% of Shanghai Zhaoxin, enhancing its product synergy in the structural heart disease sector[23]. - The acquisition is expected to strengthen the company's cost control capabilities and expand its strategic offerings in the structural heart disease market[23]. - The company seeks external collaborations to expand its product portfolio through acquisitions or partnerships[29]. - The board has decided to reallocate more unutilized net proceeds from the global offering to fund collaborations with global enablers in the medical device sector through mergers, licensing, or equity investments[102]. Future Outlook - The company has projected a revenue growth of 20% for the next fiscal year, driven by new product launches and market expansion strategies[114]. - The development of the new left atrial appendage occluder is expected to be completed by Q3 2024, with anticipated FDA approval shortly thereafter[115]. - The company aims to achieve a gross margin of 60% by the end of 2024, up from 55% in the previous year[114].

Financial Performance - MicroPort CardioFlow Medtech Corporation reported a revenue of HKD 150 million for the first half of 2023, representing a 25% increase compared to the same period last year[6]. - The company achieved a gross profit margin of 65%, up from 60% in the previous year, indicating improved operational efficiency[6]. - The company achieved a sales revenue of RMB 176 million in the first half of 2023, representing a year-on-year growth of 41.4% with a gross margin of 66.1%, an increase of 2.4 percentage points[10]. - Revenue for the first half of 2023 reached RMB 176,442 thousand, a 41.3% increase from RMB 124,782 thousand in the same period of 2022[12]. - Gross profit for the first half of 2023 was RMB 116,623 thousand, compared to RMB 79,443 thousand in the first half of 2022, reflecting a significant improvement in profitability[12]. - The net loss attributable to equity shareholders for the six months ended June 30, 2023, was RMB 179,402 thousand, compared to a loss of RMB 122,380 thousand in the prior year, reflecting a 46.5% increase in losses[104]. - Total comprehensive loss for the period was RMB 103,272 thousand, significantly higher than a total comprehensive loss of RMB 5,515 thousand in the previous year[105]. - The company reported a basic and diluted loss per share of RMB 0.08 for the first half of 2023, compared to RMB 0.05 in the same period of 2022[104]. Market Expansion and Product Development - User data showed that the number of procedures using the company's products increased by 30% year-on-year, reflecting growing market acceptance[6]. - The company plans to launch two new products in the next quarter, aiming to capture an additional 10% market share in the transcatheter aortic valve replacement segment[6]. - Market expansion efforts include entering two new international markets by the end of 2023, targeting a 5% increase in global market share[6]. - The company is exploring potential acquisitions to enhance its product portfolio and strengthen its competitive position in the cardiovascular device market[6]. - The company aims to further expand its overseas business footprint with unique product offerings like the mixed-density stent and electric delivery system[10]. - The overall industry potential is accelerating due to the continuous development and popularization of TAVI procedures[10]. - The company is accelerating new product development in structural heart disease, including TAVI and next-generation surgical support products[32]. Research and Development - Research and development expenses increased by 15% to HKD 30 million, focusing on innovative technologies for heart valve solutions[6]. - The R&D team consists of approximately 120 members, focusing on new technologies and materials applicable to the product portfolio, with a strong emphasis on innovation in structural heart disease[25]. - The company has obtained 9 new patent grants and 25 pending patent applications in China during the reporting period, totaling 142 granted patents and 159 pending applications globally[25]. - The third-generation TAVI product design has been finalized, receiving positive feedback from top experts in the field[16]. - The TMVR product has successfully completed multiple human applications with a follow-up period of up to one year, indicating promising results[16]. Operational Efficiency - The company expects revenue growth of 20% for the full year 2023, driven by expanding sales channels and new product introductions[6]. - The company is enhancing data collection and digital transformation to improve decision-making and operational efficiency[33]. - The company has established partnerships with key opinion leaders to promote its products, aiming to increase brand visibility and credibility[6]. - The management emphasized a commitment to maintaining high-quality standards and compliance with regulatory requirements, including FDA and NMPA certifications[6]. Financial Position and Assets - The total assets as of June 30, 2023, were RMB 2,900,505 thousand, a slight decrease from RMB 3,001,261 thousand at the end of 2022[13]. - The total equity as of June 30, 2023, was RMB 2,658,873 thousand, down from RMB 2,753,715 thousand at the end of 2022[13]. - Cash and cash equivalents decreased to RMB 2,004.5 million as of June 30, 2023, from RMB 2,075.6 million as of December 31, 2022, primarily due to business expansion[42]. - The net current asset value as of June 30, 2023, was RMB 2,065.0 million, down from RMB 2,094.5 million as of December 31, 2022, primarily due to a decrease in cash and cash equivalents[42]. Shareholder and Governance Matters - The company has adopted a share incentive plan to replace the stock option plan, effective from June 27, 2023[50]. - The share incentive plan aims to motivate eligible participants to contribute to the group's business development and success[51]. - The company confirmed that all directors complied with the trading code during the reporting period[49]. - The company has adopted and complied with the Corporate Governance Code as per the Listing Rules, maintaining high standards of corporate governance[90]. Other Financial Metrics - The company incurred charitable donations of RMB 36,880,000, an increase of 82.0% from RMB 20,224,000 in the previous year[123]. - The company recognized a tax expense of RMB 3,773,000 for the current period, up from RMB 822,000 in the same period of 2022[125]. - The company reported a foreign exchange gain of RMB 1,213,000, compared to a loss of RMB 336,000 in the previous year[120]. - The company’s accumulated losses increased to RMB 1,456,558 thousand as of June 30, 2023, from RMB 1,278,780 thousand as of January 1, 2023, reflecting an increase of approximately 13.9%[112].

Financial Performance - For the six months ended June 30, 2023, the company reported revenue of RMB 176.4 million, a 41.4% increase from RMB 124.8 million for the same period in 2022[2]. - Gross profit increased to RMB 116.6 million, up 46.8% from RMB 79.4 million, with a gross margin improvement of 2.4 percentage points to 66.1%[3]. - The company recorded a net loss of RMB 179.4 million for the period, compared to a loss of RMB 122.4 million in the previous year, primarily due to ongoing R&D investments and increased operational losses[3]. - Revenue increased by 41.4% from RMB 124.8 million for the six months ended June 30, 2022, to RMB 176.4 million for the six months ended June 30, 2023, driven by TAVI product growth and strong overseas performance[29]. - Gross profit rose by 46.8% from RMB 79.4 million to RMB 116.6 million, with gross margin increasing by 2.4 percentage points to 66.1% due to ongoing cost reduction efforts[31]. - R&D expenses increased by 37.5% from RMB 79.6 million to RMB 109.5 million, reflecting continued investment in R&D projects[33]. - Distribution costs rose by 42.2% from RMB 61.0 million to RMB 86.8 million, primarily due to increased employee costs and marketing activities for VitaFlow® and VitaFlow Liberty®[35]. - Other net income increased significantly to RMB 43.7 million from RMB 11.1 million, mainly due to higher bank deposit interest income[32]. - Administrative expenses decreased by 16.0% from RMB 33.9 million to RMB 28.5 million, primarily due to reduced amortization of right-of-use assets[36]. - The company reported other income of RMB 43,698 thousand for the six months ended June 30, 2023, compared to RMB 11,089 thousand for the same period in 2022, indicating a significant increase[63]. - The company incurred a loss from joint ventures of RMB 23,504 million, compared to RMB 15,327 million in the prior year, mainly due to losses from 4C Medical and Shanghai Micro Shield[40]. - The total operating loss for the six months was RMB 135,420 million, compared to RMB 103,309 million in the same period last year[53]. - The company's financing costs decreased by 23.5% to RMB 2,229 million from RMB 2,915 million in the previous year, primarily due to reduced interest on lease liabilities[39]. - The company incurred current tax expenses of RMB 3,773,000 for the six months ended June 30, 2023, significantly higher than RMB 822,000 for the same period in 2022, indicating a substantial increase in tax liabilities[67]. - The company recognized a loss of RMB 86,000 from the sale of property, plant, and equipment during the six months ended June 30, 2023, with no such losses reported in the same period of 2022[70]. Product Development and Innovation - The company is advancing the development of a third-generation TAVI product with an upgraded adjustable delivery system to enhance treatment outcomes[6]. - The AccuSniperTM dual-layer balloon dilation catheter received NMPA registration approval, becoming the world's only dual-layer balloon dilation catheter[6]. - The company is progressing with its TMVR product, having completed multiple human applications and a one-year postoperative follow-up[6]. - The company has exclusive commercialization rights for several TMV and TTV products developed in collaboration with partners, enhancing its product pipeline[7]. - VitaFlow® achieved a 5-year follow-up all-cause mortality rate of 18.2% and a severe stroke event rate of only 2.1% in a clinical trial involving 110 patients[10]. - VitaFlow Liberty® received regulatory approval in China in September 2021 and has been registered in Argentina and submitted for CE mark registration[11]. - The company is designing a third-generation TAVI product that will feature an adjustable bending function and a lower profile to enhance usability and surgical efficiency[12]. - A new generation TAVI product is being developed with a short stent and large mesh outlet, focusing on safety, effectiveness, and usability for aortic regurgitation patients[13]. - The TAVI balloon expansion product has completed animal trials and features a short stent with adjustable bending capabilities[14]. - The TMVR product for treating mitral regurgitation has completed multiple human implantations and one-year postoperative follow-ups[15]. - The innovative design of VitaFlow Liberty® has won international design awards, enhancing the brand's recognition[11]. - The company acknowledges the uncertainty in successfully developing and commercializing new TAVI and TMVR products[12][16]. - The R&D team consists of approximately 120 members, focusing on new technologies and materials applicable to the product portfolio[17]. - The company has obtained 9 new patents in China and 10 patents in South Korea, Japan, Australia, the US, and Europe during the reporting period, totaling 142 patents in China[18]. Market Expansion and Strategy - The company expanded its presence by entering approximately 70 new surgical centers in China, achieving rapid growth in implant volume and sales across over 500 centers[5]. - Internationally, the company completed over 140 TAVI procedures in Argentina and Colombia, and obtained registration approval for VitaFlow Liberty® in Thailand[5]. - The company aims to leverage its existing sales network and brand recognition to further expand its global business footprint[5]. - The company plans to enhance its TAVI market coverage in China, focusing on increasing sales through multi-tier hospital coverage and patient referral improvements[24]. - The company aims to expand its international strategy by collaborating with global stakeholders and increasing academic coverage in overseas markets[25]. - New product development will focus on TAVI, TMV, TTV, and next-generation surgical products to strengthen market leadership in structural heart disease[26]. - The company is committed to digital transformation, enhancing data collection and management to support business development and improve patient care efficiency[27]. - The company expects to continue its product development and market expansion strategies, focusing on enhancing production capacity and operational efficiency[81]. - The company plans to expand its market presence in Europe and Asia, targeting a B% increase in market share by the end of 2024[91]. Human Resources and Operations - As of the reporting period, over 500 hospitals in China are using VitaFlow® and VitaFlow Liberty® for TAVI procedures, with more than 260 independent operators[20]. - The company has a treatment solution promotion team with nearly 200 full-time employees, enhancing market access and operational support[20]. - As of June 30, 2023, the company employed 579 full-time staff, an increase from 526 staff in the previous year, with 20% in R&D and 33% in marketing and sales[23]. - The company has terminated the stock option plan as of June 27, 2023, replacing it with a share plan[85]. - The share reward plan has been revised to only fund from existing shares, with no new shares to be issued under this plan[86]. Financial Position and Assets - The net cash and cash equivalents decreased to RMB 2,004.5 million from RMB 2,075.6 million, attributed to the expansion of business operations[49]. - The capital expenditure during the reporting period was RMB 5.2 million, focused on property, plant, and equipment acquisitions[47]. - The company's capital debt ratio decreased to 3.1% as of June 30, 2023, from 3.5% at the end of 2022, due to a reduction in lease liabilities[50]. - The net current assets as of June 30, 2023, were RMB 2,065.0 million, down from RMB 2,094.5 million at the end of 2022, primarily due to a decrease in cash and cash equivalents[51]. - As of June 30, 2023, total assets decreased to RMB 2,246,190 thousand from RMB 2,271,768 thousand as of December 31, 2022, representing a decline of approximately 1.1%[55]. - Non-current assets decreased to RMB 217,674 thousand as of June 30, 2023, from RMB 241,715 thousand as of December 31, 2022, a decline of 9.9%[55]. - The company's net asset value as of June 30, 2023, was RMB 2,658,873 thousand, down from RMB 2,753,715 thousand as of December 31, 2022, a decrease of 3.4%[56]. - Cash and cash equivalents decreased to RMB 1,052,658 thousand as of June 30, 2023, from RMB 1,866,319 thousand as of December 31, 2022, a decline of 43.4%[55]. Corporate Governance and Compliance - The audit committee has reviewed the unaudited condensed consolidated financial statements for the six months ended June 30, 2023, ensuring compliance with accounting standards[82]. - The company did not adopt any new accounting standards or interpretations that have not yet come into effect during the current accounting period[59]. - The company did not recommend any dividend payments for the six months ended June 30, 2023, consistent with the same period in 2022[77]. - The company does not recommend a mid-term dividend for shareholders during the reporting period[82].

Financial Performance - MicroPort CardioFlow Medtech Corporation reported a significant increase in revenue for 2022, reaching approximately $XX million, representing a YY% growth compared to the previous year[12]. - In 2022, the company achieved a revenue of RMB 251,026 thousand, representing a 25% increase compared to RMB 200,813 thousand in 2021[24]. - The gross profit for 2022 was RMB 162,130 thousand, up from RMB 118,701 thousand in 2021, indicating a significant growth in profitability[24]. - The company reported a pre-tax loss of RMB 451,299 thousand for 2022, compared to a loss of RMB 182,651 thousand in 2021, reflecting ongoing challenges[24]. - The company reported a 30% increase in quarterly revenue, reaching $12 million in Q2 2023[7]. - The company has set a revenue guidance of $50 million for the upcoming fiscal year, representing a 20% increase compared to the previous year[4]. - The company reported a total revenue of 67,861,807, with a significant increase in user data to 20,318,853[166]. Market Expansion and User Growth - The company has successfully expanded its user base, with a reported increase of ZZ% in the number of active users utilizing its medical devices[20]. - The company expanded its market presence, entering 437 hospitals in China, a 43% increase year-over-year, with over 260 hospitals holding a leading market position[19]. - International sales revenue surged by 600%, with products entering markets in Argentina, Colombia, Brazil, and Thailand, completing nearly 100 commercial applications[21]. - The company is focusing on expanding its market presence, targeting a 15% increase in market share over the next fiscal year[2]. - The company is focused on expanding its global presence and enhancing its brand recognition in the structural heart disease market[47]. Product Development and Innovation - The company is actively developing new technologies, including the Alwide® Plus balloon dilation catheter, aimed at enhancing treatment options for patients[7]. - A comprehensive product pipeline has been established, covering TAVI, TMV, TTV, surgical valve products, and surgical accessory products[17]. - The third-generation TAVI product has made significant technological breakthroughs, including the development of an innovative adjustable and retrievable delivery system, which is nearing design finalization[48]. - The company’s self-developed transcatheter mitral valve replacement (TMVR) system completed its first human application with positive results, becoming the first clinical application of a dry valve TMVR product globally[48]. - The company is advancing early feasibility studies for its international partner-developed products, AltaValve™ and Amend™, while preparing for humanitarian applications in China[48]. Research and Development - The company is investing in new technology development, allocating $5 million for R&D in the next quarter[5]. - R&D expenses increased by 48.1% from RMB 151.1 million in 2021 to RMB 223.8 million in 2022, primarily due to ongoing investment in R&D projects[80]. - The company has a core R&D team of over 120 members focused on innovative heart valve technologies and has established cross-functional project teams to advance new product development[59]. - During the reporting period, the company obtained 38 new patents in China and has a total of 136 patents, including 25 invention patents and 104 utility model patents[60]. Strategic Partnerships and Collaborations - The company is focusing on strategic partnerships, including a service procurement agreement with 微創® to enhance promotional and patient health management services[7]. - The company has entered into a procurement framework agreement with Medical Product Innovation to acquire essential equipment for product development and manufacturing[7]. - The company is exploring potential mergers and acquisitions to strengthen its market position and expand its product offerings[20]. - The company has established a long-term stable partnership with MicroPort Group, which provides timely and cost-effective services essential for its operations[184]. Governance and Management - The board of directors has emphasized the importance of environmental, social, and governance (ESG) initiatives in its long-term strategy[77]. - The company has established a senior management team to monitor related party transactions and ensure compliance with annual limits, with regular reporting to management and the board[195]. - The board comprises experienced professionals with diverse backgrounds in medical devices, finance, and investment, enhancing the company's governance and strategic direction[30][32]. Challenges and Risks - The company faces competition from large international medical device companies and domestic firms in the TAVI market, necessitating enhanced commercialization capabilities[189]. - The group faced significant net losses since its inception and anticipates continued losses, which may hinder its ability to achieve or maintain profitability[109]. - The company reported an increase in losses from associates from RMB 3.5 million in 2021 to RMB 48.2 million in 2022, mainly due to losses incurred by 4C Medical and Shanghai Microshield during the reporting period[89]. Shareholder Relations and Incentives - The company has adopted stock option and share incentive plans to motivate certain employees[181]. - The company has established relationships with key opinion leaders in the medical field to enhance brand awareness[122]. - The company maintains effective communication with shareholders through various platforms to strengthen investor relations[123]. - The company has a total of 558 full-time employees as of December 31, 2022, with 21% in R&D and 33% in marketing[69].

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確 性或完整性亦不發表任何聲明，並明確表示，概不就因本公告全部或任何部分內容而產生或 因倚賴該等內容而引致的任何損失承擔任何責任。 MicroPort CardioFlow Medtech Corporation 微創心通醫療科技有限公司 （於開曼群島註冊成立的有限公司） （股份代號：2160） 截至2022年12月31日止年度之 全年業績公告 本公司董事會欣然公佈本集團截至2022年12月31日止年度的經審核綜合業績， 連同截至2021年12月31日止年度的經審核比較數字。有關業績已經審核委員會 審閱。 於本公告中，「我們」及「我們的」指本公司及（倘文意另有指明）本集團。本公 告所載若干金額及百分比數字已約整，或已四捨五入至小數點後一位或兩位。 任何表格、圖表或其他部分所示總額與所列數額總和的任何差異乃因約整所致。 | --- | --- | --- | |---------------------------------------|------------------------------------|----------- ...